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Campus. JordanstownThe postholder will contribute to the development and delivery of Diagnostic Radiography education and in particular Medical Ultrasound, through lecturing, practical sessions, placement and related professional and academic activity. S/he will also be required to develop a research profile in line with the strategy of the School’s Research Institute. (The post is available on a full-time, part-time or job share basis).The School of Health Sciences holds a Bronze Athena SWAN Award in recognition of our commitment to advancing Gender equality. You can read more about what this means at www.ecu.ac.uk/equality-charters/athena-swan and on our University website https://www.ulster.ac.uk/peopleandculture/employee-benefits/equality-diversity/athena-swan.

The University has a range of initiatives to support a family friendly working environment, including flexible working.We prefer to issue and receive applications via our on-line recruitment website by clicking Apply.Hard copy applications can be obtained by telephoning 028 7012 4072The University is an equal opportunities employer and welcomes applicants from all sections of the community, particularly from those with disabilities. Appointment will be made on merit.Closing Date. 4 November 2020Campus. JordanstownThe postholder will contribute to the development and delivery of Diagnostic Radiography and specialist diagnostic imaging education through lecturing, practical sessions, placement and related professional and academic activity. S/he will also be required to develop a research profile in line with the strategy of the School’s Research Institute.

(The post is fixed-term until August 2022 and available on a full-time, part-time or job share basis).The School of Health Sciences holds a Bronze Athena SWAN Award in recognition of our commitment to advancing Gender equality. You can read more about what this means at www.ecu.ac.uk/equality-charters/athena-swan and on our University website https://www.ulster.ac.uk/peopleandculture/employee-benefits/equality-diversity/athena-swan. The University has a range of initiatives to support a family friendly working environment, including flexible working.We prefer to issue and receive applications via our on-line recruitment website by clicking Apply.Hard copy applications can be obtained by telephoning 028 7012 4072The University is an equal opportunities employer and welcomes applicants from all sections of the community, particularly from those with disabilities. Appointment will be made on merit.Closing Date. 4 November 2020.

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Start Preamble Announcement how to get casodex without a doctor Type. Initial Key Dates. February 15, how to get casodex without a doctor 2021, first award cycle deadline date.

August 15, 2021, last award cycle deadline date. September 15, 2021, last award cycle deadline date for supplemental loan repayment program funds. September 30, 2021, entry how to get casodex without a doctor on duty deadline date.

I. Funding Opportunity Description The Indian Health Service (IHS) estimated budget for fiscal year (FY) 2021 includes $34,800,000 for the IHS Loan Repayment Program (LRP) for health professional educational loans (undergraduate and graduate) in return for full-time clinical service as defined in the IHS LRP policy at https://www.ihs.gov/​loanrepayment/​policiesandprocedures/​ in Indian health programs. This notice is being published early to coincide with the recruitment activity of the IHS which competes with other Government and private health management organizations to employ qualified how to get casodex without a doctor health professionals.

This program is authorized by the Indian Health Care Improvement Act (IHCIA) Section 108, codified at 25 U.S.C. 1616a. II.

Award Information The estimated amount available is approximately $24,283,777 to support approximately 539 competing awards averaging $45,040 per award for a two-year contract. The estimated amount available is approximately $14,203,650 to support approximately 575 competing awards averaging $24,702 per award for a one-year extension. One-year contract extensions will receive priority consideration in any award cycle.

Applicants selected for participation in the FY 2021 program cycle will be expected to begin their service period no later than September 30, 2021. III. Eligibility Information A.

Eligible Applicants Pursuant to 25 U.S.C. 1616a(b), to be eligible to participate in the LRP, an individual must. (1) (A) Be enrolled— (i) In a course of study or program in an accredited institution, as determined by the Secretary, within any State and be scheduled to complete such course of study in the same year such individual applies to participate in such program.

Or (ii) In an approved graduate training program in a health profession. Or (B) Have a degree in a health profession and a license to practice in a State. And (2) (A) Be eligible for, or hold an appointment as a commissioned officer in the Regular Corps of the Public Health Service (PHS).

Or (B) Be eligible for selection for service in the Regular Corps of the PHS. Or (C) Meet the professional standards for civil service employment in the IHS. Or (D) Be employed in an Indian health program without service obligation.

And (3) Submit to the Secretary an application for a contract to the LRP. The Secretary must approve the contract before the disbursement of loan repayments can be made to the participant. Participants will be required to fulfill their contract service agreements through full-time clinical practice at an Indian health program site determined by the Secretary.

Loan repayment sites are characterized by physical, cultural, and professional isolation, and have histories of frequent staff turnover. Indian health program sites are annually prioritized within the Agency by discipline, based on need or vacancy. The IHS LRP's ranking system gives high site scores to those sites that are most in need of specific health professions.

Awards are given to the applications that match the highest priorities until funds are no longer available. Any individual who owes an obligation for health professional service to the Federal Government, a State, or other entity, is not eligible for the LRP unless the obligation will be completely satisfied before they begin service under this program. 25 U.S.C.

1616a authorizes the IHS LRP and provides in pertinent part as follows. (a)(1) The Secretary, acting through the Service, shall establish a program to be known as the Indian Health Service Loan Repayment Program (hereinafter referred to as the Loan Repayment Program) in order to assure an adequate supply of trained health professionals necessary to maintain accreditation of, and provide health care services to Indians through, Indian health programs. For the purposes of this program, the term “Indian health program” is defined in 25 U.S.C.

1616a(a)(2)(A), as follows. (A) The term Indian health program means any health program or facility Start Printed Page 64484funded, in whole or in part, by the Service for the benefit of Indians and administered— (i) Directly by the Service. (ii) By any Indian Tribe or Tribal or Indian organization pursuant to a contract under— (I) The Indian Self-Determination Act, or (II) Section 23 of the Act of April 30, 1908, (25 U.S.C.

47), popularly known as the Buy Indian Act. Or (iii) By an urban Indian organization pursuant to Title V of the Indian Health Care Improvement Act. 25 U.S.C.

1616a, authorizes the IHS to determine specific health professions for which IHS LRP contracts will be awarded. Annually, the Director, Division of Health Professions Support, sends a letter to the Director, Office of Clinical and Preventive Services, IHS Area Directors, Tribal health officials, and Urban Indian health programs directors to request a list of positions for which there is a need or vacancy. The list of priority health professions that follows is based upon the needs of the IHS as well as upon the needs of American Indians and Alaska Natives.

(a) Medicine—Allopathic and Osteopathic doctorate degrees. (b) Nursing—Associate Degree in Nursing (ADN) (Clinical nurses only). (c) Nursing—Bachelor of Science (BSN) (Clinical nurses only).

(d) Nursing (NP, DNP)—Nurse Practitioner/Advanced Practice Nurse in Family Practice, Psychiatry, Geriatric, Women's Health, Pediatric Nursing. (e) Nursing—Certified Nurse Midwife (CNM). (f) Certified Registered Nurse Anesthetist (CRNA).

(g) Physician Assistant (Certified). (h) Dentistry—DDS or DMD degrees. (i) Dental Hygiene.

(j) Social Work—Independent Licensed Master's degree. (k) Counseling—Master's degree. (l) Clinical Psychology—Ph.D.

Or PsyD. (m) Counseling Psychology—Ph.D. (n) Optometry—OD.

(o) Pharmacy—PharmD. (p) Podiatry—DPM. (q) Physical/Occupational/Speech Language Therapy or Audiology—MS, Doctoral.

(r) Registered Dietician—BS. (s) Clinical Laboratory Science—BS. (t) Diagnostic Radiology Technology, Ultrasonography, and Respiratory Therapy.

Associate and B.S. (u) Environmental Health (Sanitarian). BS and Master's level.

(v) Engineering (Environmental). BS and MS (Engineers must provide environmental engineering services to be eligible.). (w) Chiropractor.

B. Cost Sharing or Matching Not applicable. C.

Other Requirements Interested individuals are reminded that the list of eligible health and allied health professions is effective for applicants for FY 2021. These priorities will remain in effect until superseded. IV.

Application and Submission Information A. Content and Form of Application Submission Each applicant will be responsible for submitting a complete application. Go to http://www.ihs.gov/​loanrepayment for more information on how to apply electronically.

The application will be considered complete if the following documents are included. Employment Verification—Documentation of your employment with an Indian health program as applicable. Commissioned Corps orders, Tribal employment documentation or offer letter, or Notification of Personnel Action (SF-50)—For current Federal employees.

License to Practice—A photocopy of your current, non-temporary, full and unrestricted license to practice (issued by any State, Washington, DC, or Puerto Rico). Loan Documentation—A copy of all current statements related to the loans submitted as part of the LRP application. Transcripts—Transcripts do not need to be official.

If applicable, if you are a member of a federally recognized Tribe or an Alaska Native (recognized by the Secretary of the Interior), provide a certification of Tribal enrollment by the Secretary of the Interior, acting through the Bureau of Indian Affairs (BIA) (Certification. Form BIA—4432 Category A—Members of federally Recognized Indian Tribes, Bands or Communities or Category D—Alaska Native). B.

Submission Dates and Address Applications for the FY 2021 LRP will be accepted and evaluated monthly beginning February 15, 2021, and will continue to be accepted each month thereafter until all funds are exhausted for FY 2021 awards. Subsequent monthly deadline dates are scheduled for the fifteenth of each month until August 15, 2021. Applications shall be considered as meeting the deadline if they are either.

(1) Received on or before the deadline date. Or (2) Received after the deadline date, but with a legible postmark dated on or before the deadline date. (Applicants should request a legibly dated U.S.

Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or U.S. Postal Service. Private metered postmarks are not acceptable as proof of timely mailing).

Applications submitted after the monthly closing date will be held for consideration in the next monthly funding cycle. Applicants who do not receive funding by September 30, 2020, will be notified in writing. Application documents should be sent to.

IHS Loan Repayment Program, 5600 Fishers Lane, Mail Stop. OHR (11E53A), Rockville, Maryland 20857. C.

Intergovernmental Review This program is not subject to review under Executive Order 12372. D. Funding Restrictions Not applicable.

E. Other Submission Requirements New applicants are responsible for using the online application. Applicants requesting a contract extension must do so in writing by February 15, 2021, to ensure the highest possibility of being funded a contract extension.

V. Application Review Information A. Criteria The IHS will utilize the Health Professional Shortage Area (HPSA) score developed by the Health Resources and Services Administration for each Indian health program for which there is a need or vacancy.

At each Indian health facility, the HPSA score for mental health will be utilized for all behavioral health professions, the HPSA score for dental health will be utilized for all dentistry and dental hygiene health professions, and the HPSA score for primary care will be used for all other approved health professions. In determining applications to be approved and contracts to accept, the IHS will give priority to applications made by American Indians and Alaska Natives and to individuals recruited through the efforts of Indian Tribes or Tribal or Indian organizations. B.

Review and Selection Process Loan repayment awards will be made only to those individuals serving at facilities with have a site score of 17 or above through March 1, 2021, if funding is available.Start Printed Page 64485 One or all of the following factors may be applicable to an applicant, and the applicant who has the most of these factors, all other criteria being equal, will be selected. (1) An applicant's length of current employment in the IHS, Tribal, or Urban program. (2) Availability for service earlier than other applicants (first come, first served).

(3) Date the individual's application was received. C. Anticipated Announcement and Award Dates Not applicable.

VI. Award Administration Information A. Award Notices Notice of awards will be mailed on the last working day of each month.

Once the applicant is approved for participation in the LRP, the applicant will receive confirmation of his/her loan repayment award and the duty site at which he/she will serve his/her loan repayment obligation. B. Administrative and National Policy Requirements Applicants may sign contractual agreements with the Secretary for two years.

The IHS may repay all, or a portion, of the applicant's health profession educational loans (undergraduate and graduate) for tuition expenses and reasonable educational and living expenses in amounts up to $20,000 per year for each year of contracted service. Payments will be made annually to the participant for the purpose of repaying his/her outstanding health profession educational loans. Payment of health profession education loans will be made to the participant within 120 days, from the date the contract becomes effective.

The effective date of the contract is calculated from the date it is signed by the Secretary or his/her delegate, or the IHS, Tribal, Urban, or Buy Indian health center entry-on-duty date, whichever is more recent. In addition to the loan payment, participants are provided tax assistance payments in an amount not less than 20 percent and not more than 39 percent of the participant's total amount of loan repayments made for the taxable year involved. The loan repayments and the tax assistance payments are taxable income and will be reported to the Internal Revenue Service (IRS).

The tax assistance payment will be paid to the IRS directly on the participant's behalf. LRP award recipients should be aware that the IRS may place them in a higher tax bracket than they would otherwise have been prior to their award. C.

Contract Extensions Any individual who enters this program and satisfactorily completes his or her obligated period of service may apply to extend his/her contract on a year-by-year basis, as determined by the IHS. Participants extending their contracts may receive up to the maximum amount of $20,000 per year plus an additional 20 percent for Federal withholding. VII.

Agency Contact Please address inquiries to Ms. Jacqueline K. Santiago, Chief, IHS Loan Repayment Program, 5600 Fishers Lane, Mail Stop.

OHR (11E53A), Rockville, Maryland 20857, Telephone. 301/443-3396 [between 8:00 a.m. And 5:00 p.m.

(Eastern Standard Time) Monday through Friday, except Federal holidays]. VIII. Other Information Indian Health Service area offices and service units that are financially able are authorized to provide additional funding to make awards to applicants in the LRP, but not to exceed the maximum allowable amount authorized by statute per year, plus tax assistance.

All additional funding must be made in accordance with the priority system outlined below. Health professions given priority for selection above the $20,000 threshold are those identified as meeting the criteria in 25 U.S.C. 1616a(g)(2)(A), which provides that the Secretary shall consider the extent to which each such determination.

(i) Affects the ability of the Secretary to maximize the number of contracts that can be provided under the LRP from the amounts appropriated for such contracts. (ii) Provides an incentive to serve in Indian health programs with the greatest shortages of health professionals. And (iii) Provides an incentive with respect to the health professional involved remaining in an Indian health program with such a health professional shortage, and continuing to provide primary health services, after the completion of the period of obligated service under the LRP.

Contracts may be awarded to those who are available for service no later than September 30, 2021, and must be in compliance with 25 U.S.C. 1616a. In order to ensure compliance with the statutes, area offices or service units providing additional funding under this section are responsible for notifying the LRP of such payments before funding is offered to the LRP participant.

Should an IHS area office contribute to the LRP, those funds will be used for only those sites located in that area. Those sites will retain their relative ranking from their Health Professions Shortage Areas (HPSA) scores. For example, the Albuquerque Area Office identifies supplemental monies for dentists.

Only the dental positions within the Albuquerque Area will be funded with the supplemental monies consistent with the HPSA scores within that area. Should an IHS service unit contribute to the LRP, those funds will be used for only those sites located in that service unit. Those sites will retain their relative ranking from their HPSA scores.

Start Signature Michael D. Weahkee, Assistant Surgeon General, RADM, U.S. Public Health Service, Director, Indian Health Service.

End Signature End Preamble [FR Doc. 2020-22649 Filed 10-9-20. 8:45 am]BILLING CODE 4165-16-PIn the upper Midwest, physicians see median compensation that's 10%-15% higher than the national average.Rural hospitals, as many healthcare organizations, are struggling financially through the pandemic.

But it's a different story when it comes to physician compensation, particularly in the upper Midwest, where physicians see median compensation that's 10%-15% higher than the national average.This discovery comes courtesy of a survey conducted by Faegre Drinker healthcare attorney Aaron Dobosenski, which revealed compensation and productivity metrics for 11 physician specialties and eight advanced provider types, as well as statistics on provider benefits and recruitment and retention in Midwest rural hospitals, with comparisons to national survey data throughout.With the assistance of the Minnesota Hospital Association and the Iowa Hospital Association, the Midwest Rural Hospital Provider Compensation Survey was sent to about 250 rural hospitals in the upper Midwest. Roughly half of the 44 rural hospital respondents are independent hospitals, and half are rural hospitals affiliated with systems. Thirty-nine of the respondents are certified critical access hospitals.There were significant disparities in compensation-related metrics in Midwest rural hospitals as compared to national physician compensation surveys.

The survey reports that, on average in 2019, median compensation was 10%–15% higher, work relative value unit (wRVU) productivity was 20%–25% lower, and median total compensation per wRVU was 40%–50% higher in Midwest rural hospitals than was reported in the most recent surveys.The likely reason for the discrepancies is that rural facilities tend to pay physicians more due to the difficulty in recruiting new talent to rural communities. The upper Midwest in this survey encompassed Minnesota, Wisconsin, North Dakota, South Dakota and Iowa.WHAT'S THE IMPACT?. Some of the results were surprising.

In emergency medicine, for example, the typical ER physician is paid about 5% more in a rural hospital than in a large health system. But that same physician typically produces about 50% less in professional services volume in terms of wRVU than those in urban settings. It's an important consideration for hospitals concerned about whether they're paying their physicians fair market value.Family medicine physicians account for roughly 30% of all physicians employed by the survey respondents, by far the most prevalent physician specialty.

Median compensation for these physicians is 5%-10% higher than reported in national surveys. But median wRVU production is about 10% lower, and median compensation per wRVU is 15-20% higher.While general surgeons represent fewer overall physicians than other specialties, more respondents reported employing at least one general surgeon than any other physician specialty except family medicine. Median compensation for respondents' general surgeons is 10%-15% higher than in national surveys.

Median wRVU production is 35%-40% lower, and median compensation per wRVU is about 70% higher than national survey medians for general surgery. Only about 25% of respondents reported employing hospitalists. For those that do, median compensation was 5%-10% higher than the national average.

Median wRVU production is about 20% lower, and median compensation per wRVU is about 40% higher.Like hospitalists, only about 25% of respondents reported employing internal medicine physicians, likely engaging them as hospitalists to some degree. But the numbers were similar. Median compensation is 10%-15% higher than the average, median wRVU production is 25%-30% lower and median compensation per wRVU is 55%-60% higher.The report found similar numbers among obstetrics and gynecology physicians, ophthalmologists, orthopedic surgeons and pediatricians.THE LARGER TRENDThe COVID-19 pandemic has significantly altered the job market for physicians, leading to the temporary reduction of both starting salaries and practice options for doctors, according to a July Merritt Hawkins report.While there was an increase in physician-search engagements over the 12-month period ending March 31, demand for physicians since March 31, as gauged by the number of new search engagements, has declined by over 30%.

At the same time, the number of physicians inquiring about job opportunities has increased, which has created an opportune market for those healthcare facilities seeking physicians.The Medical Group Management Association indicates that physician-practice revenue has declined by an average of 55%, since patients have been either unable or unwilling to seek medical treatment. As a result, fewer physician practices and hospitals are seeking physicians as they struggle with lower revenues and a focus on treating coronavirus patients. Twitter.

@JELagasseEmail the writer. Jeff.lagasse@himssmedia.com.

Start Preamble casodex online no prescription Announcement Type. Initial Key Dates. February 15, 2021, first award casodex online no prescription cycle deadline date. August 15, 2021, last award cycle deadline date. September 15, 2021, last award cycle deadline date for supplemental loan repayment program funds.

September 30, 2021, entry casodex online no prescription on duty deadline date. I. Funding Opportunity Description The Indian Health Service (IHS) estimated budget for fiscal year (FY) 2021 includes $34,800,000 for the IHS Loan Repayment Program (LRP) for health professional educational loans (undergraduate and graduate) in return for full-time clinical service as defined in the IHS LRP policy at https://www.ihs.gov/​loanrepayment/​policiesandprocedures/​ in Indian health programs. This notice is being published early to coincide with the recruitment activity of casodex online no prescription the IHS which competes with other Government and private health management organizations to employ qualified health professionals. This program is authorized by the Indian Health Care Improvement Act (IHCIA) Section 108, codified at 25 U.S.C.

1616a. II. Award Information The estimated amount available is approximately $24,283,777 to support approximately 539 competing awards averaging $45,040 per award for a two-year contract. The estimated amount available is approximately $14,203,650 to support approximately 575 competing awards averaging $24,702 per award for a one-year extension. One-year contract extensions will receive priority consideration in any award cycle.

Applicants selected for participation in the FY 2021 program cycle will be expected to begin their service period no later than September 30, 2021. III. Eligibility Information A. Eligible Applicants Pursuant to 25 U.S.C. 1616a(b), to be eligible to participate in the LRP, an individual must.

(1) (A) Be enrolled— (i) In a course of study or program in an accredited institution, as determined by the Secretary, within any State and be scheduled to complete such course of study in the same year such individual applies to participate in such program. Or (ii) In an approved graduate training program in a health profession. Or (B) Have a degree in a health profession and a license to practice in a State. And (2) (A) Be eligible for, or hold an appointment as a commissioned officer in the Regular Corps of the Public Health Service (PHS). Or (B) Be eligible for selection for service in the Regular Corps of the PHS.

Or (C) Meet the professional standards for civil service employment in the IHS. Or (D) Be employed in an Indian health program without service obligation. And (3) Submit to the Secretary an application for a contract to the LRP. The Secretary must approve the contract before the disbursement of loan repayments can be made to the participant. Participants will be required to fulfill their contract service agreements through full-time clinical practice at an Indian health program site determined by the Secretary.

Loan repayment sites are characterized by physical, cultural, and professional isolation, and have histories of frequent staff turnover. Indian health program sites are annually prioritized within the Agency by discipline, based on need or vacancy. The IHS LRP's ranking system gives high site scores to those sites that are most in need of specific health professions. Awards are given to the applications that match the highest priorities until funds are no longer available. Any individual who owes an obligation for health professional service to the Federal Government, a State, or other entity, is not eligible for the LRP unless the obligation will be completely satisfied before they begin service under this program.

25 U.S.C. 1616a authorizes the IHS LRP and provides in pertinent part as follows. (a)(1) The Secretary, acting through the Service, shall establish a program to be known as the Indian Health Service Loan Repayment Program (hereinafter referred to as the Loan Repayment Program) in order to assure an adequate supply of trained health professionals necessary to maintain accreditation of, and provide health care services to Indians through, Indian health programs. For the purposes of this program, the term “Indian health program” is defined in 25 U.S.C. 1616a(a)(2)(A), as follows.

(A) The term Indian health program means any health program or facility Start Printed Page 64484funded, in whole or in part, by the Service for the benefit of Indians and administered— (i) Directly by the Service. (ii) By any Indian Tribe or Tribal or Indian organization pursuant to a contract under— (I) The Indian Self-Determination Act, or (II) Section 23 of the Act of April 30, 1908, (25 U.S.C. 47), popularly known as the Buy Indian Act. Or (iii) By an urban Indian organization pursuant to Title V of the Indian Health Care Improvement Act. 25 U.S.C.

1616a, authorizes the IHS to determine specific health professions for which IHS LRP contracts will be awarded. Annually, the Director, Division of Health Professions Support, sends a letter to the Director, Office of Clinical and Preventive Services, IHS Area Directors, Tribal health officials, and Urban Indian health programs directors to request a list of positions for which there is a need or vacancy. The list of priority health professions that follows is based upon the needs of the IHS as well as upon the needs of American Indians and Alaska Natives. (a) Medicine—Allopathic and Osteopathic doctorate degrees. (b) Nursing—Associate Degree in Nursing (ADN) (Clinical nurses only).

(c) Nursing—Bachelor of Science (BSN) (Clinical nurses only). (d) Nursing (NP, DNP)—Nurse Practitioner/Advanced Practice Nurse in Family Practice, Psychiatry, Geriatric, Women's Health, Pediatric Nursing. (e) Nursing—Certified Nurse Midwife (CNM). (f) Certified Registered Nurse Anesthetist (CRNA). (g) Physician Assistant (Certified).

(h) Dentistry—DDS or DMD degrees. (i) Dental Hygiene. (j) Social Work—Independent Licensed Master's degree. (k) Counseling—Master's degree. (l) Clinical Psychology—Ph.D.

Or PsyD. (m) Counseling Psychology—Ph.D. (n) Optometry—OD. (o) Pharmacy—PharmD. (p) Podiatry—DPM.

(q) Physical/Occupational/Speech Language Therapy or Audiology—MS, Doctoral. (r) Registered Dietician—BS. (s) Clinical Laboratory Science—BS. (t) Diagnostic Radiology Technology, Ultrasonography, and Respiratory Therapy. Associate and B.S.

(u) Environmental Health (Sanitarian). BS and Master's level. (v) Engineering (Environmental). BS and MS (Engineers must provide environmental engineering services to be eligible.). (w) Chiropractor.

Licensed. (x) Acupuncturist. Licensed. B. Cost Sharing or Matching Not applicable.

C. Other Requirements Interested individuals are reminded that the list of eligible health and allied health professions is effective for applicants for FY 2021. These priorities will remain in effect until superseded. IV. Application and Submission Information A.

Content and Form of Application Submission Each applicant will be responsible for submitting a complete application. Go to http://www.ihs.gov/​loanrepayment for more information on how to apply electronically. The application will be considered complete if the following documents are included. Employment Verification—Documentation of your employment with an Indian health program as applicable. Commissioned Corps orders, Tribal employment documentation or offer letter, or Notification of Personnel Action (SF-50)—For current Federal employees.

License to Practice—A photocopy of your current, non-temporary, full and unrestricted license to practice (issued by any State, Washington, DC, or Puerto Rico). Loan Documentation—A copy of all current statements related to the loans submitted as part of the LRP application. Transcripts—Transcripts do not need to be official. If applicable, if you are a member of a federally recognized Tribe or an Alaska Native (recognized by the Secretary of the Interior), provide a certification of Tribal enrollment by the Secretary of the Interior, acting through the Bureau of Indian Affairs (BIA) (Certification. Form BIA—4432 Category A—Members of federally Recognized Indian Tribes, Bands or Communities or Category D—Alaska Native).

B. Submission Dates and Address Applications for the FY 2021 LRP will be accepted and evaluated monthly beginning February 15, 2021, and will continue to be accepted each month thereafter until all funds are exhausted for FY 2021 awards. Subsequent monthly deadline dates are scheduled for the fifteenth of each month until August 15, 2021. Applications shall be considered as meeting the deadline if they are either. (1) Received on or before the deadline date.

Or (2) Received after the deadline date, but with a legible postmark dated on or before the deadline date. (Applicants should request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or U.S. Postal Service. Private metered postmarks are not acceptable as proof of timely mailing).

Applications submitted after the monthly closing date will be held for consideration in the next monthly funding cycle. Applicants who do not receive funding by September 30, 2020, will be notified in writing. Application documents should be sent to. IHS Loan Repayment Program, 5600 Fishers Lane, Mail Stop. OHR (11E53A), Rockville, Maryland 20857.

C. Intergovernmental Review This program is not subject to review under Executive Order 12372. D. Funding Restrictions Not applicable. E.

Other Submission Requirements New applicants are responsible for using the online application. Applicants requesting a contract extension must do so in writing by February 15, 2021, to ensure the highest possibility of being funded a contract extension. V. Application Review Information A. Criteria The IHS will utilize the Health Professional Shortage Area (HPSA) score developed by the Health Resources and Services Administration for each Indian health program for which there is a need or vacancy.

At each Indian health facility, the HPSA score for mental health will be utilized for all behavioral health professions, the HPSA score for dental health will be utilized for all dentistry and dental hygiene health professions, and the HPSA score for primary care will be used for all other approved health professions. In determining applications to be approved and contracts to accept, the IHS will give priority to applications made by American Indians and Alaska Natives and to individuals recruited through the efforts of Indian Tribes or Tribal or Indian organizations. B. Review and Selection Process Loan repayment awards will be made only to those individuals serving at facilities with have a site score of 17 or above through March 1, 2021, if funding is available.Start Printed Page 64485 One or all of the following factors may be applicable to an applicant, and the applicant who has the most of these factors, all other criteria being equal, will be selected. (1) An applicant's length of current employment in the IHS, Tribal, or Urban program.

(2) Availability for service earlier than other applicants (first come, first served). (3) Date the individual's application was received. C. Anticipated Announcement and Award Dates Not applicable. VI.

Award Administration Information A. Award Notices Notice of awards will be mailed on the last working day of each month. Once the applicant is approved for participation in the LRP, the applicant will receive confirmation of his/her loan repayment award and the duty site at which he/she will serve his/her loan repayment obligation. B. Administrative and National Policy Requirements Applicants may sign contractual agreements with the Secretary for two years.

The IHS may repay all, or a portion, of the applicant's health profession educational loans (undergraduate and graduate) for tuition expenses and reasonable educational and living expenses in amounts up to $20,000 per year for each year of contracted service. Payments will be made annually to the participant for the purpose of repaying his/her outstanding health profession educational loans. Payment of health profession education loans will be made to the participant within 120 days, from the date the contract becomes effective. The effective date of the contract is calculated from the date it is signed by the Secretary or his/her delegate, or the IHS, Tribal, Urban, or Buy Indian health center entry-on-duty date, whichever is more recent. In addition to the loan payment, participants are provided tax assistance payments in an amount not less than 20 percent and not more than 39 percent of the participant's total amount of loan repayments made for the taxable year involved.

The loan repayments and the tax assistance payments are taxable income and will be reported to the Internal Revenue Service (IRS). The tax assistance payment will be paid to the IRS directly on the participant's behalf. LRP award recipients should be aware that the IRS may place them in a higher tax bracket than they would otherwise have been prior to their award. C. Contract Extensions Any individual who enters this program and satisfactorily completes his or her obligated period of service may apply to extend his/her contract on a year-by-year basis, as determined by the IHS.

Participants extending their contracts may receive up to the maximum amount of $20,000 per year plus an additional 20 percent for Federal withholding. VII. Agency Contact Please address inquiries to Ms. Jacqueline K. Santiago, Chief, IHS Loan Repayment Program, 5600 Fishers Lane, Mail Stop.

OHR (11E53A), Rockville, Maryland 20857, Telephone. 301/443-3396 [between 8:00 a.m. And 5:00 p.m. (Eastern Standard Time) Monday through Friday, except Federal holidays]. VIII.

Other Information Indian Health Service area offices and service units that are financially able are authorized to provide additional funding to make awards to applicants in the LRP, but not to exceed the maximum allowable amount authorized by statute per year, plus tax assistance. All additional funding must be made in accordance with the priority system outlined below. Health professions given priority for selection above the $20,000 threshold are those identified as meeting the criteria in 25 U.S.C. 1616a(g)(2)(A), which provides that the Secretary shall consider the extent to which each such determination. (i) Affects the ability of the Secretary to maximize the number of contracts that can be provided under the LRP from the amounts appropriated for such contracts.

(ii) Provides an incentive to serve in Indian health programs with the greatest shortages of health professionals. And (iii) Provides an incentive with respect to the health professional involved remaining in an Indian health program with such a health professional shortage, and continuing to provide primary health services, after the completion of the period of obligated service under the LRP. Contracts may be awarded to those who are available for service no later than September 30, 2021, and must be in compliance with 25 U.S.C. 1616a. In order to ensure compliance with the statutes, area offices or service units providing additional funding under this section are responsible for notifying the LRP of such payments before funding is offered to the LRP participant.

Should an IHS area office contribute to the LRP, those funds will be used for only those sites located in that area. Those sites will retain their relative ranking from their Health Professions Shortage Areas (HPSA) scores. For example, the Albuquerque Area Office identifies supplemental monies for dentists. Only the dental positions within the Albuquerque Area will be funded with the supplemental monies consistent with the HPSA scores within that area. Should an IHS service unit contribute to the LRP, those funds will be used for only those sites located in that service unit.

Those sites will retain their relative ranking from their HPSA scores. Start Signature Michael D. Weahkee, Assistant Surgeon General, RADM, U.S. Public Health Service, Director, Indian Health Service. End Signature End Preamble [FR Doc.

2020-22649 Filed 10-9-20. 8:45 am]BILLING CODE 4165-16-PIn the upper Midwest, physicians see median compensation that's 10%-15% higher than the national average.Rural hospitals, as many healthcare organizations, are struggling financially through the pandemic. But it's a different story when it comes to physician compensation, particularly in the upper Midwest, where physicians see median compensation that's 10%-15% higher than the national average.This discovery comes courtesy of a survey conducted by Faegre Drinker healthcare attorney Aaron Dobosenski, which revealed compensation and productivity metrics for 11 physician specialties and eight advanced provider types, as well as statistics on provider benefits and recruitment and retention in Midwest rural hospitals, with comparisons to national survey data throughout.With the assistance of the Minnesota Hospital Association and the Iowa Hospital Association, the Midwest Rural Hospital Provider Compensation Survey was sent to about 250 rural hospitals in the upper Midwest. Roughly half of the 44 rural hospital respondents are independent hospitals, and half are rural hospitals affiliated with systems. Thirty-nine of the respondents are certified critical access hospitals.There were significant disparities in compensation-related metrics in Midwest rural hospitals as compared to national physician compensation surveys.

The survey reports that, on average in 2019, median compensation was 10%–15% higher, work relative value unit (wRVU) productivity was 20%–25% lower, and median total compensation per wRVU was 40%–50% higher in Midwest rural hospitals than was reported in the most recent surveys.The likely reason for the discrepancies is that rural facilities tend to pay physicians more due to the difficulty in recruiting new talent to rural communities. The upper Midwest in this survey encompassed Minnesota, Wisconsin, North Dakota, South Dakota and Iowa.WHAT'S THE IMPACT?. Some of the results were surprising. In emergency medicine, for example, the typical ER physician is paid about 5% more in a rural hospital than in a large health system. But that same physician typically produces about 50% less in professional services volume in terms of wRVU than those in urban settings.

It's an important consideration for hospitals concerned about whether they're paying their physicians fair market value.Family medicine physicians account for roughly 30% of all physicians employed by the survey respondents, by far the most prevalent physician specialty. Median compensation for these physicians is 5%-10% higher than reported in national surveys. But median wRVU production is about 10% lower, and median compensation per wRVU is 15-20% higher.While general surgeons represent fewer overall physicians than other specialties, more respondents reported employing at least one general surgeon than any other physician specialty except family medicine. Median compensation for respondents' general surgeons is 10%-15% higher than in national surveys. Median wRVU production is 35%-40% lower, and median compensation per wRVU is about 70% higher than national survey medians for general surgery.

Only about 25% of respondents reported employing hospitalists. For those that do, median compensation was 5%-10% higher than the national average. Median wRVU production is about 20% lower, and median compensation per wRVU is about 40% higher.Like hospitalists, only about 25% of respondents reported employing internal medicine physicians, likely engaging them as hospitalists to some degree. But the numbers were similar. Median compensation is 10%-15% higher than the average, median wRVU production is 25%-30% lower and median compensation per wRVU is 55%-60% higher.The report found similar numbers among obstetrics and gynecology physicians, ophthalmologists, orthopedic surgeons and pediatricians.THE LARGER TRENDThe COVID-19 pandemic has significantly altered the job market for physicians, leading to the temporary reduction of both starting salaries and practice options for doctors, according to a July Merritt Hawkins report.While there was an increase in physician-search engagements over the 12-month period ending March 31, demand for physicians since March 31, as gauged by the number of new search engagements, has declined by over 30%.

At the same time, the number of physicians inquiring about job opportunities has increased, which has created an opportune market for those healthcare facilities seeking physicians.The Medical Group Management Association indicates that physician-practice revenue has declined by an average of 55%, since patients have been either unable or unwilling to seek medical treatment. As a result, fewer physician practices and hospitals are seeking physicians as they struggle with lower revenues and a focus on treating coronavirus patients. Twitter. @JELagasseEmail the writer. Jeff.lagasse@himssmedia.com.

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Minnesota marketplace highlights and updatesOpen casodex pills online enrollment for 2021 health plans. November 1, casodex pills online 2020 through December 22, 2020. Residents with qualifying events can still enroll or make changes to their 2020 coverage.Insurers implementing modest rate increases for 2021, after three straight years of average rate decreases. Quartz has joined the exchange for 2021, bringing total number of insurers to five.117,520 people enrolled for 2020, a new record for MNsure.Insurer participation in casodex pills online MNsure.

2014 to 2021.Reinsurance program received federal approval, began operation in 2018.With reinsurance, rates decreased for 2018 and again, even more significantly, for 2019. But reinsurance also reduced funding for MinnesotaCare.The elimination of CSR funding further reduced MinnesotaCare funding, but this has been partly restored by a court ruling.MN provided premium relief for non-subsidy-eligible enrollees for 2017 only.Governor vetoed a proposed 2019 switch to HealthCare.gov.MNsure’s small business exchange no longer has any participating casodex pills online insurers.Minnesota health exchange overviewMinnesota’s one of the states fighting the hardest to preserve the Affordable Care Act’s gains. See actions Minnesota has taken.Minnesota’s state-run exchange, MNsure, has five participating insurers for 2021, up from four in 2020. The exchange has more than 117,000 individual market enrollees as of 2020.As a result of the COVID-19 pandemic, MNsure joined most of the other state-run exchanges in offering a special enrollment period during which people who were uninsured could enroll in a health casodex pills online plan.

MNsure’s special enrollment period began March 23, and continued through April 21. Nearly 9,500 Minnesota residents enrolled in private plans through MNsure during this window, as well as another 13,700 who enrolled in MinnesotaCare or Medicaid (enrollment in those programs is open year-round for eligible residents).Allison O’Toole, who led MNsure as CEO for casodex pills online three years, announced her resignation in March 2018, and the exchange named Nate Clark, the MNsure COO, as acting CEO. A few months later, the MNsure board named Clark as the permanent CEO. O’Toole left MNsure to work as director of state affairs for United States casodex pills online of Care, a non-profit created by Andy Slavitt, who was the acting administrator of CMS under the Obama Administration.Throughout 2017, Minnesotans who bought their own health insurance (on or off-exchange) and weren’t eligible for ACA subsidies were provided with 25 percent premium rebates from the state as a result of S.F.1, signed into law by Governor Dayton in early 2017.

The subsidies helped to offset the large premium increases that applied in Minnesota in 2017, and helped to stabilize the individual health insurance market in 2017. But the premium rebate program expired at the end of 2017.Thanks in large part to the new reinsurance program that Minnesota created (details below), premiums decreased in Minnesota’s individual market in 2018, 2019, and again in casodex pills online 2020, although rates are increasing modestly for 2021. In May 2019, Minnesota leaders reached an agreement on a budget that included an extension of the reinsurance program through 2020 and 2021 (it has already been granted federal approval through the end of 2022, but the state has to continue to cover its share of the cost. Minnesota Governor Tim Walz had hoped to implement a premium subsidy program and a new tax credit in casodex pills online Minnesota starting in 2020.

But a compromise in the budget ended up with the state opting to continue the existing reinsurance program for two more years instead.).But the waiver that provides federal pass-through funding for reinsurance also resulted in a sharp and unexpected decrease in federal funding for MinnesotaCare, the Basic Health Program that provides coverage for people with income between 138 percent and 200 percent of the poverty level (between $16,642 and $24,120 for a single person).In addition, the elimination of federal funding for cost-sharing reductions (CSR) in October 2018 resulted in a funding cut for MinnesotaCare, since the program is funded in large part by federal funds that would otherwise have been used to pay for premium subsidies and cost-sharing reductions in the exchange for the population that is instead eligible for MinnesotaCare. After an ensuing legal battle, a judge ordered HHS to restore funding for MinnesotaCare, although a resolution of the situation is ongoing, and the casodex pills online amount that HHS agreed to pay was still less than MinnesotaCare would have received if CSR funding had continued.Open enrollment for 2021 health plans extended through December 22, 2020. Insurers implementing modest rate increases for 2021, after three years of overall rate decreasesMNsure enabled window shopping for 2021 health plans as of October 12, 2020. This gives residents a few weeks to browse the available plans before open enrollment starts on November 1, casodex pills online 2020.

And MNsure has announced that open enrollment will continue through December 22, 2020. That’s a casodex pills online week longer than the open enrollment period that will apply in states that use the federally-run exchange. The flexibility to extend open enrollment is often cited as one of the benefits of having a fully state-run exchange. (MNsure had a similar extension last December, for 2020 health plans).For 2021, Quartz is joining the casodex pills online Minnesota marketplace.

Quartz currently offers plans in Illinois and Wisconsin, and is expanding into Minnesota for 2021. And two casodex pills online of the existing insurers — HealthPartners and UCare — are expanding their coverage areas for 2021 (BluePlus and Medica offer coverage statewide, and will continue to do so in 2021).The following average rate changes have been approved for MNsure’s insurers:Blue Plus. 4.21 percent increase (down from casodex pills online an initially proposed 7.12 percent increase)Group Health/Health Partners (GHI). 0.67 percent increase (down from an initially proposed 4.15 percent increase)Medica.

2.42 percent increase (down from an initially proposed casodex pills online 7.06 percent increase)UCare. 1.6 percent increase (up from an initially proposed 1.39 percent decrease)Quartz. New for casodex pills online 2021, so no applicable rate changePreferredOne Insurance Company, which offers plans outside the exchange, is increasing premiums by 1.05 percent (down from an initially proposed average increase of 5.09 percent). Rate changes in previous years2015.

Average increase casodex pills online of 4.5 percent. MNsure critics characterized the official announcement as misleading as it failed to take into account low-cost 2014 plans from PreferredOne. Consumers who bought a PreferredOne plan through MNsure for 2014 casodex pills online could only renew their policies for 2015 by working directly with the insurer, since PreferredOne stopped offering plans in the exchange at the end of 2014. However, PreferredOne rates went up an average of 63 percent, and consumers didn’t qualify for subsidies if they shopped outside the exchange.

2016. Average increase of 41.4 percent for the individual market, and about 38.5 for plans sold in MNsure (ie, not counting PreferredOne). Rates increased significantly in 2016 across the entire individual market in Minnesota — including plans sold through MNsure, the state-run exchange.Approved rates for 2016 were announced on October 1, 2015, ranging from about 15 percent for Medica to 49 percent for Blue Cross Blue Shield of Minnesota. In general, the carriers cited higher-than-expected claims costs over the past year, along with the impending phase-out of the ACA’s reinsurance program as justification for their 2016 rate requests.

But Governor Mark Dayton called some of the higher proposed increases “outrageous,” and promised a rigorous review of the filed rate changes and justifications. Ultimately, regulators were able to limit the highest rate increases to 49 percent — as opposed to the 54 percent that had been requested by Blue Plus and BCBS of MN — but the final weighted average rate increase in the individual market in Minnesota still ended up being the highest in the nation. But Minnesota still had the lowest overall premiums in the upper midwest (although Minnesota had the highest average rate increase in the country for 2016, they had the lowest overall rates in the country in 2014 and 2015).Minnesota Commerce Commissioner Mike Rothman called the rate increases “unacceptably high,” and Gov. Dayton noted that he was “extremely unhappy” with the rate changes.

But Rothman noted that his office “objected to all of the rates across the board,” and “squeezed out everything we could that was not actuarial justified.” In other words, the final rates, although much higher than officials and policyholders would have liked, were justified based on medical claims costs — the population enrolled in individual health plans in Minnesota was sicker than expected, and drug costs had been particularly onerous.Only about 55 percent of people who had 2015 coverage through MNsure received premium subsidies. But due to the sharp premium increases, that had increased to about 63 percent for the people who had purchased or renewed coverage as of June 2016.2017. When the Minnesota Department of Commerce announced health insurance rates for 2017 for the individual and small group markets, the rate hikes were somewhat reasonable in the small group market (ranging from a decrease of 1 percent to an increase of 17.8 percent), but the individual market was “experiencing serious disruptions in 2017” and “on the verge of collapse.” The four carriers that offered plans through MNsure had the following average rate increases in 2017:Blue Plus = 55 percentHealthPartners/Group Health (GHI) = 50 percent (HealthPartners is only offering plans in 10 of the 67 counties where they offered plans in 2016. Their enrollment cap is 72,000 for 2017)Medica = 57.5 percent (enrollment cap is 50,000 for 2017)UCare = 66.8 percent (UCare capped enrollment at 30,000 for 2017, but only had 16,000 enrollees in 2016)The enrollment caps that HealthPartners, Medica, and UCare employed for 2017 were approved as part of the rate review process, and are designed to protect carriers from further financial losses as they absorb BCBSMN’s enrollees who are shopping for new coverage during open enrollment.In a news release relating to the rate announcement for 2017, the Minnesota Department of Commerce didn’t mince words.

They noted that the individual market in the state was on the brink of collapse, and that they did everything in their power to save the market. While they succeeded in keeping the state’s individual market viable for 2017, with only one carrier exiting (BCBSMN, although their HMO affiliate, Blue Plus, remained in the exchange), they reiterated very clearly that substantial reforms would be needed to keep the market stable in future years, and highlighted the fact that rates would be sharply higher and that carriers would limit enrollment in 2017.2018. Final rates for 2018 were approved in October 2017 (comprehensive information about the approved rates is here), based on the Minnesota Premium Security Plan (MSPS) being implemented but cost-sharing reductions (CSR) not being funded by the federal government (the cost of CSRs was added to on-exchange Silver plans). Average approved rate changes for MNsure insurers ranged from a 13.3 percent decrease for UCare to a 2.8 percent increase for Blue Plus.

Three of the four MNsure insurers decreased their average premiums for 2018.On September 21, MNsure had posted a notice indicating that if the reinsurance program were not approved, rates would be about 20 percent higher than they would otherwise be in 2018. Fortunately for Minnesota residents, the reinsurance program did receive federal approval, and average rates declined slightly for 2018.But some enrollees who don’t get ACA premium subsidies still experienced a rate increase, due to the termination of the one-year, state-funded 25 percent premium rebates at the end of 2017.PreferredOne, which exited MNsure at the end of 2014 and only offers coverage in the off-exchange market, proposed dramatically lower rates for 2018. A 38 percent average decrease if MSPS were to be approved, and a 23 percent average decrease if not. The 38 percent decrease was implemented, and no adjustments were necessary to account for CSR funding, since PreferredOne does not offer plans in the exchange, and CSRs are only available on silver exchange plans.2019.

Average premium decrease of 12.4 percent. Average premiums dropped for all five insurers in the individual market in 2019. This was the second year in a row of declining rates in Minnesota, but Blue Plus had a small rate increase for 2018, so 2019 was the first year that all five insurers decreased their average rates. Minnesota insurance regulators noted that rates in 2019 were about 20 percent lower than they would have been without the reinsurance program.But most of Minnesota’s insurers charged higher rates in 2019 than they would have if the individual mandate penalty hadn’t been eliminated, and if access to short-term plans and association health plans hadn’t been expanded by the Trump administration.

For example, UCare’s rate filing notes that while average rates were decreasing by about 10 percent, the rate decrease would have been nearly 15 percent if the individual mandate penalty had remained in place.At ACA Signups, Charles Gaba calculated a weighted average rate decrease of 12.4 percent for 2019 in Minnesota, but noted that the average decrease would have been nearly 19 percent without those changes at the federal level.2020. Average premium decrease of 1 percent. Four of the five insurers (including PreferredOne, which only offers coverage off-exchange) in Minnesota’s individual market decreased their average premiums for 2020. This was the third year in a row that average individual market premiums dropped in Minnesota’s individual market, due in large part to the reinsurance program that the state has established.The following average rate changes were implemented for 2020:Blue Plus.

1.5 percent decrease (Blue Plus had originally proposed a 4.8 percent increase)Group Health/Health Partners (GHI). 1.26 percent decrease (GHI had originally proposed a 2.1 percent increase)Medica. 1.01 percent decrease (Medica had originally proposed an average decrease of 1.4 percent)UCare. 0.18 percent increase (UCare originally proposed a 0.3 percent increase)PreferredOne, which only offers off-exchange coverage, reduced their rates by an average of 20 percent, on the heels of an 11 percent decrease in 2019.

MNsure enrollment exceeded 116k in 2018, dropped to 113k for 2019, but grew to more than 1117k in 2020From 2014 through 2018, enrollment in MNsure’s individual market plans increased every year, reaching 116,358 people by 2018. That was the highest open enrollment total in MNsure’s history, despite the shorter enrollment period, which ended in mid-January instead of the end of January (open enrollment for 2018 coverage ended on December 15, 2017 in states that use HealthCare.gov, but MNsure opted to extend their enrollment window that year, and have also extended subsequent enrollment windows).Enrollment dropped for the first time in 2019, when 113,552 people enrolled in individual market plans through MNsure. In most states that use HealthCare.gov, enrollment peaked in 2016 and has been dropping since then. But MNsure’s drop-off in 2019, which amounted to only a 2.4 percent reduction in enrollment, is the only time year-over-year enrollment has declined.

Notably, the ACA’s individual mandate penalty was eliminated as of 2019, and regulations that the Trump administration implemented in late 2018 now make it more feasible for healthy people to use short-term plans instead of ACA-compliant plans (Minnesota has its own rules for short-term plans, but they’re more relaxed than the Obama-era federal rules that applied in 2017 and most of 2018).And for 2020, enrollment grew again, reaching a record high of 117,520 enrollees.Here’s a look at the number of people who have signed up for individual market plans through MNsure during each year’s open enrollment period. These numbers all represent total enrollment at the end of open enrollment. Effectuated enrollment is always lower, and MNsure provides periodic effectuated enrollment data on their board meeting materials page. Insurer participation in MNsure.

2014-20212014. Five insurers offered individual policies through MNsure for 2014. Blue Cross Blue Shield of Minnesota, HealthPartners/Group Health, Medica, PreferredOne, and UCare. Kaiser Health News reported that Minnesota offered some of the lowest premiums for silver (mid-level) plans in the U.S.

Four of Minnesota’s nine regions made Kaiser’s list of the 10 least expensive places to buy health insurance.2015. But PreferredOne, which offered the lowest rates in the nation in 2014 and captured a large portion of 2014 enrollees, withdrew from MNsure for 2015. PreferredOne said remaining on the exchange was “not administratively and financially sustainable.” A Star Tribune business writer attributed PreferredOne’s departure as a market dynamics issue rather than a problem with MNsure.However, Blue Plus (an affiliate of Blue Cross Blue Shield of MN, offering HMO plans) joined the exchange for 2015, so there were still five insurers offering plans for 2015. Blue Cross Blue Shield of Minnesota, Blue Plus, Health Partners/Group Health, Medica, and UCare.

MNsure offered 84 plans statewide, up from 78 for 2014.2016. BCBSMN, Blue Plus, Health Partners/Group Health, Medica, and UCare offered individual market plans through MNsure for 2016.2017. In an effort to recruit more carriers to offer plans through MNsure for 2017 — particularly outside the Twin Cities metro area — state regulators sent out a request for proposals from health insurers on August 15, 2016. Regulators noted that insurers could propose waivers of regulations in order to make it feasible for them to offer coverage through MNsure, although any such waiver requests would have to be approved by regulators.Steven Parente, a health insurance expert at the University of Minnesota, called the state’s effort to recruit insurers to MNsure a “distress call” and noted that August 15 is awfully late in the year to be putting out a request for insurer participation, given that open enrollment begins November 1.

And ultimately, no new insurers opted to join MNsure for 2017.Blue Cross Blue Shield of MN dropped their individual market PPO plans at the end of 2016 due to significant financial losses. That left Blue Plus (which offered HMOs and covered roughly 13,000 people in 2016 in the individual market) as the only BCBSMN affiliate in the exchange. Roughly 103,000 people had to select new plans during open enrollment.Most of those BCBSMN enrollees had off-exchange coverage, though. There were only about 20,400 MNsure enrollees (a little more than one in five MNsure enrollees) with coverage under BCBSMN who needed to switch to another plan during open enrollment.

BCBSMN had individual PPO options available in all 87 counties in Minnesota through MNsure in 2016, while the Blue Plus coverage area — comprised of four separate HMO networks — was available in 77 of the state’s counties.Nationwide, carriers have been shifting away from PPOs and towards HMOs and EPOs. In Colorado, Anthem Blue Cross Blue Shield also dropped their PPOs at the end of 2016. In Indiana, there were no PPOs available in the individual market by 2017. Blue Cross Blue Shield of New Mexico dropped all of their individual market plans at the end of 2015 except one off-exchange HMO.

Blue Cross Blue Shield of Texas dropped their individual market PPO plans at the end of 2015.The broad network offered by PPOs tends to be attractive to enrollees who have health problems. They’re often willing to pay higher premiums in trade for access to broad network of hospitals and specialists. But PPOs are expensive for carriers, as enrollees don’t need primary care referrals to see specialists, and it’s more challenging for carriers to hold down costs when there are more providers in the network.All of the MNsure carriers except Blue Plus are also limiting their total enrollment for 2017. By November 11, 2016, less than two weeks into open enrollment for 2017 coverage, Medica had hit their 50,000 member enrollment cap for 2017 (including on and off-exchange enrollments, and also accounting for expected renewals of 2016 Medica plans), and their policies were no longer available in the individual market in Minnesota, on or off-exchange.

The only exception was five counties (Benton, Crow Wing, Mille Lacs, Morrison, and Stearns) where Medica agreed not to limit enrollment, as all of the other available carriers in those counties have imposed enrollment caps too. In those five counties, Medica plans continued to be available.At that point, Medica’s market share in MNsure for 2017 stood at 34.2 percent. By December 14, Medica’s market share had dropped to 27.7 percent, as enrollments had continued to climb for the remaining carriers.On January 31, Medica re-opened enrollment for 2017. This was because a smaller-than-expected number of 2016 Medica enrollees renewed their plans for 2017, meaning that the carrier still had some wiggle room under their 50,000 member cap.

At that point, they had room for about 7,000 more enrollees. Medica plans were thus available throughout the duration of the special enrollment period that was added on at the end of open enrollment, and continue to be available for people with qualifying events.2018. Plans continued to be available from Blue Plus, Health Partners/Group Health (GHI), Medica, UCare. In the months before a decision was reached regarding an extension of the open enrollment window for 2018 plans (the first year that the federal government imposed a shorter, month-and-a-half enrollment window), two of MNsure’s participating insurers had differing positions.

UCare believed the exchange should add an additional two-week special enrollment period, while Medica did not want the exchange to have the option to extend the newly-scheduled six-week enrollment window. Notably, Medica capped their enrollment very early during the 2017 open enrollment period, and while UCare also had an enrollment cap, it was set with a target of nearly doubling their 2016 enrollment. But Medica is the only MNsure insurer that didn’t set an enrollment cap for 2018.As was the case for 2017, enrollment caps were used in the individual market in Minnesota for 2018 by all insurers other than Medica (Medica did have an enrollment cap for 2017, which they hit very early in open enrollment. However, they resumed enrollments at the end of January 2017).

Details about the insurers’ enrollment caps are in the plan binders in SERFF. For 2018, MNsure insurers implemented the following enrollment caps:Blue Plus. 55,000 member cap (aiming for a target of 50,000 effectuated enrollees, but effectuated enrollment is always lower than the number of people who initially enroll)Health Partners/Group Health (GHI). 73,400 member cap (aiming for a target of 70,000 effectuated enrollees)Medica.

No enrollment capUCare. 35,000 member cap (aiming for a target of 30,000 effectuated enrollees)MNsure confirmed in May 2018 that none of their insurers had hit their enrollment caps for 2018.Outside the exchange, PreferredOne had an enrollment cap of 3,000 members, although their 2017 membership was only about 300 people.2019 and 2020. Blue Plus, Health Partners/Group Health, UCare, and Medica have continued to offer plans through MNsure, and all of them continued to participate in 2020 as well. Blue Plus expanded to once again offer statewide coverage in 2020, for the first time since 2016.2021.

Quartz joined the exchange for 2021, joining the four existing insurers. HealthPartners and UCare are both expanding their coverage areas for 2021.Minnesota Premium Security Plan. 1332 waiver proposal approved by CMS, but with a significant funding cut for MinnesotaCareIn May 2017, Minnesota Governor Mark Dayton submitted a 1332 waiver proposal to CMS. The 1332 waiver was based on H.F.5, which was enacted without Dayton’s signature in April 2017 (Dayton had proposed an alternative measure that would have allowed people in Minnesota to buy into MinnesotaCare.

That measure was not able to pass the state’s Republican-dominated legislature).[For more than two decades, MinnesotaCare was a state program subsidizing health insurance for low-income residents. As of January 1, 2015, it transitioned to a Basic Health Program under the ACA, becoming the first BHP in the nation.]H.F.5 created the Minnesota Premium Security Plan (MPSP), which is a state-based reinsurance program (similar to the one the ACA implemented on a temporary basis through 2016, and that Alaska created for 2017. Several other states have since implemented reinsurance programs). The reinsurance program, which took effect in Minnesota in 2018, covers a portion of the claims that insurers face, resulting in lower total claims costs for the insurers, and thus lower premiums (average individual market premiums in Minnesota decreased from 2017 to 2018 as a result of the reinsurance program).

The reinsurance kicks in once claims reach $50,000, and covers them at 80 percent up to $250,000 (this is similar to the coverage under the transitional reinsurance program that the ACA provided from 2014 through 2016).H.F.5 was contingent upon approval of the 1332 waiver, because it relies partially on federal funding, in addition to state funding. Under the federal approval that was granted in September 2017, the federal government is giving Minnesota the money that they save on premium tax credits, and that money is combined with state funds to implement the reinsurance program (lower premiums — as a result of the reinsurance program — result in the federal government having to pay a smaller total amount of premium tax credits, since the tax credits are smaller when premiums are smaller).It was expected that CMS would approve the state’s 1332 waiver proposal, and Governor Dayton requested that the approval process be swift so that the state could move forward with the implementation of the Minnesota Premium Security Plan in time for the 2018 plan year. Dayton indicated that his office had been told that approval would come in August 2017, but CMS didn’t approve the waiver until September 22. And the waiver approval letter noted that the federal savings for MinnesotaCare (the state’s Basic Health Program, or BHP) resulting from the reinsurance program would not be eligible to be passed along to the state — in other words, CMS would keep those savings instead.[Federal BHP funding is equal to 95 percent of the amount that the federal government would have otherwise spent on premium subsidies and cost-sharing reductions for the population that ends up being eligible for the BHP.

So lower premiums — as a result of reinsurance — for qualified health plans in the exchange means that the amount the federal government would have had to spend on premium subsidies for that population is lower. That translates into a smaller amount of funding for the state’s BHP, according to the approach that HHS took for Minnesota’s waiver approval.]And based on the scathing letter that Dayton sent CMS a few days earlier, it appeared at that point that Minnesota could actually lose money on the deal — losing more in federal funding for MinnesotaCare than they gain in reinsurance funding. Dayton noted in his letter that the 1332 waiver approval process had been “nightmarish,” and that Minnesota went to great lengths to follow instructions from CMS at every turn, throughout the process of drafting H.F.5 and the 1332 waiver proposal. He explains that CMS provided Minnesota with explicit guidance in terms of how to draft the reinsurance program while maintaining full federal funding for MinnesotaCare, and highlighted the fact that the state never deviated from the instructions that were provided.The StarTribune editorial board called out then-Secretary of HHS, Tom Price and the Trump Administration for their lack of clarity on the issue, for apparently misleading the state during the 1332 waiver drafting process, and for effectively punishing the state of Minnesota for taking an innovative approach to ensuring that as many people as possible have health insurance.Insurers filed rates based on reinsurance being available.

And by the time the waiver was approved, there was very little time to evaluate the potential impacts of the funding changes, as rates had to be finalized by October 2 in Minnesota. The finalized rates did incorporate the reinsurance program. The state has accepted the approved waiver, but Gov. Dayton sent a letter to HHS on October 3, asking them to reconsider the MinnesotaCare funding cuts, but the issue has remained unresolved.Elimination of CSR funding results in additional funding cut for MinnesotaCare, but a lawsuit has partially restored that fundingNationwide, 54 percent of exchange enrollees benefit from cost-sharing subsidies.

But in Minnesota, only 13 percent of exchange enrollees are receiving cost-sharing subsidies. This is because of MinnesotaCare, which covers all enrollees with income up to 200 percent of the poverty level. That’s the same group that would otherwise benefit the most from cost-sharing subsidies, so the fact that MinnesotaCare is available means that most of the people who would otherwise be enrolled in cost-sharing subsidy plans are instead enrolled in MinnesotaCare.At first glance, this would appear to have made the uncertainty surrounding cost-sharing subsidy funding in 2017 a little less of a pressing issue in Minnesota than it was in many other states, since private insurers weren’t facing the sort of losses that insurers in other states were facing without federal funding for CSR. But when the Trump Administration eliminated federal funding for CSR in October 2017, HHS took the position tha t since CSR funding had been eliminated, the CSR portion of the federal funding for the BHPs in New York and Minnesota would be reduced to $0.

This was not a cut-and-dried conclusion, however, as explained earlier in 2017 by Michael Kalina.In January 2018, the Attorneys General for New York and Minnesota filed a lawsuit against the US Department of Health and Human Services, seeking to restore funding for their Basic Health Programs. A judge ruled in favor of the states in May 2018, ensuring that MinnesotaCare would continue to receive at least some CSR-based funding. The amount awarded to the state for the first quarter of 2018 was just over half of what the state had initially expected in CSR-related funding, but a larger chuck of the funding was restored later in 2018. According to the Star Tribune, however, Minnesota still ended up losing $161 million in federal funding for MinnesotaCare due to the CSR funding cuts.In early 2019, the Trump administration proposed yet another funding cut (a third, after the cuts imposed by the reinsurance program and the elimination of CSR funding) as part of a new methodology for calculating BHP funding.

This one was much smaller than the other two cuts, but taken together the funding reductions are pushing MinnesotaCare towards a looming budget shortfall. SHOP exchange. Down to one carrier as of 2016, zero by 2018 (and still zero in 2019)In 2015, there were two carriers in MNsure’s SHOP exchange for small businesses. Blue Cross Blue Shield of Minnesota, and Medica.

But Medica announced in 2015 that they would exit the SHOP exchange in Minnesota, North Dakota, and Wisconsin at the end of the year. That left BCBS as the only small group carrier available through MNsure in 2016, but it didn’t change much from a practical standpoint, since 83 percent of MNsure’s small groups were enrolled in plans through BCBS in 2015. Indeed, Medica’s reason for exiting the small business exchange was based on low enrollment in the first two years.Blue Cross Blue Shield of Minnesota continued to be the only insurer offering SHOP coverage via MNsure in 2017, but announced in July 2017 that they would no longer offer SHOP coverage in 2018, and would instead transition their SHOP enrollees to small business coverage outside the exchange. At that point, there were only 3,287 people enrolled in SHOP coverage in Minnesota — far below the 155,000 people that were originally projected to have coverage through MNsure’s SHOP program by 2016 (this much lower-than-anticipated enrollment has been the case in nearly every state’s SHOP exchange.

This situation is not unique to Minnesota). State law provided 25% premium rebate in 2017. Amendment to allow plans without essential benefits was cut from final legislationThroughout 2016, then-Governor Dayton called for a state-funded premium rebate for people who buy their own insurance but aren’t eligible for the ACA’s premium subsidies (those are only available for people with income up to 400 percent of the poverty level, or $100,400 for a family of four in 2019).Governor Dayton also noted that the government needed to act quickly to stabilize the individual market in Minnesota, and by late November 2016, his patience with lawmakers was wearing thin. In a November 23 press conference, Dayton said that House Republicans needed to “stop dilly-dallying” and decide whether to move forward with Dayton’s rebate proposal.Dayton had also indicated that he was considering calling a special session of the legislature after election day to address the situation, and that was being negotiated for December 20.

But the talks fell through when Dayton and Republican House Speaker Kurt Daudt couldn’t agree on the three bills that would have been addressed in the special session. As a result, there was no special session.Instead, the issue was taken up by lawmakers as soon as the 2017 legislative session began. On January 5, Minnesota Senators Michelle Benson (R, 31st District) and Gary Dahms (R, 16th District) introduced S.F.1. The bill called for using $300 million in state funding to provide a 25 percent rebate to roughly 125,000 people in Minnesota.S.F.1 passed the Minnesota Senate by a 35-31 vote on January 12.

Only one DFL Senator (Melisa Franzen, from Edina) voted with Republicans in favor of the legislation. It was then sent to the House, where an amendment was added that stripped out the requirement that health plans provide various mandated benefits (see “Journal of the Day” section “Top of page 154” in this version of the bill. Under the terms of the amendment, as long as a carrier offered at least one plan with all the mandated benefits, they would have been allowed to offer others without mandated benefits).The amended bill was sent back to the Senate on January 23. Differences between the bills that the two chambers passed had to be reconciled before being sent to Governor Dayton for his signature.

By that point, the amendment to allow less-robust plans to be sold had garnered national attention, and public outrage helped to push lawmakers away from the provision. S.F.1 had also called for $150 million to be appropriated for fiscal year 2018 (through June 30, 2019) from the state general fund to a state-based reinsurance program to stabilize the individual market (Alaska did something similar in 2016, preventing a market collapse), but that provision was also removed in the final version (Minnesota did ultimately set up a reinsurance program, effective in 2018, which has served to stabilize the market and reduce premiums).A Conference Committee in the Senate recommended that the House “recede from its amendments” and the Conference Committee report passed the Senate on a 47-19 vote. The House passed the bill a few hours later, 108-19. It was sent to Governor Dayton, who immediately signed it into law.

DFLers did have to compromise on one issue during the process. S.F.1 allows for-profit HMOs to begin operating in Minnesota’s individual market, which had long been limited to non-profit HMOs.Consumers were told to expect the premium rebates to show up by April 2017, but they were retroactively effective to January 2017. So a person who had been paying full price for a plan since January 2017 saw a substantial premium reduction on the April or May invoice. Going forward, for the remainder of the year, a 25 percent rebate applied each month.Since S.F.1 was signed into law with only a few days remaining in open enrollment (it ended January 31 that year), Governor Dayton and exchange officials were worried that there wouldn’t be enough time for people to learn about the rebate and apply for coverage before January 31.

In December, Dayton had asked HHS to allow MNsure to extend its enrollment deadline to February 28 (instead of January 31) in order to allow lawmakers more time to work out the details of a state-based premium rebate while still allowing people to enroll after the legislative process is complete.HHS denied the request for a blanket extension, but MNsure used their own authority on January 28 to grant a one-week special enrollment period (February 1 to February 8) due to exceptional circumstances. Although the state-based 25 percent premium rebate was available on or off the exchange, the one-week extension was only valid through MNsure. Health insurers did not have to accept off-exchange enrollments without a qualifying event after January 31.The 25 percent premium rebate program in Minnesota was only authorized for one year, so the rebates did not continue into 2018. And although almost 100,000 people received premium relief through the program in 2017, it ended up costing less than the legislature had allocated, and about $100 million was returned to the state’s budget at the end of 2017.Protecting Medicaid enrollees from estate liensIn every state, Medicaid is jointly funded by the state and the federal government.

Longstanding federal regulations, which predate the ACA, require states to “seek recovery of payments from the individual’s estate for nursing facility services, home and community-based services, and related hospital and prescription drug services” for any Medicaid enrollee over the age of 55. This applies essentially to long-term care services, but states also have the option to go after the individual’s estate to recover costs for other care that was provided by Medicaid after age 55.Prior to 2014, this wasn’t typically an issue, as Medicaid eligibility was generally restricted by asset tests or requirements that applicants be disabled or pregnant (although Minnesota did have much more generous Medicaid eligibility guidelines than most states prior to 2014). But as of 2014, in states that expanded Medicaid under the ACA, the only eligibility guideline is income. Applicants with income that doesn’t exceed 138 percent of the poverty level are directed to Medicaid, regardless of any assets they might have.When applicants use the health insurance exchange — MNsure in Minnesota — they’re automatically funneled into Medical Assistance (Medicaid) if their income is under 138 percent of the poverty level.

But what these enrollees didn’t know was that the state also had a program in place to put liens on estates for Medicaid-provided services for people age 55 and older.The combination of these systems caught numerous residents off guard. They were enrolled in Medical Assistance through MNsure based on their income, but were not aware that liens were being placed on their homes so that the state could recoup the costs upon their deaths.State Senator Tony Lourey (DFL, District 11) addressed the issue with language included in HF2749, the Omnibus supplemental budget bill, which was signed into law by Governor Dayton on June 1, 2016. The legislation limits estate recovery to just what’s required under federal Medicaid rules (ie, essentially, long-term care costs for people age 55 or older), and makes the provision retroactive to January 1, 2014.Early tech strugglesMNsure opened for business in the fall of 2013, but technological issues persisted well into 2015, despite numerous improvements throughout 2014. Given MNsure’s difficult launch, the state conducted a series of audits and reviews.

The first audit reviewed how MNsure spent state and federal money. Auditors concluded that the exchange has generally adequate internal controls and found no fraud or abuse. The review was conducted by the state Office of the Legislative Auditor, and the report was published in October 2014.Another audit, also conducted by the Office of the Legislative Auditor and released in November 2014, found that the MNsure system in some cases incorrectly determined who qualified for public health benefits. The errors occurred during the first open enrollment period, before a series of system fixes were implemented.

The audit did not quantify the total financial impact of the errors. The state Human Services commissioner said a consultant working on technical fixes to MNsure concluded that the eligibility functionality was working correctly as of June 2014.A third audit, a performance evaluation report released in February 2015, said “MNsure’s failures outweighed its achievements.” Among other criticisms, auditors said MNsure staff withheld information from the board of directors and state officials, the enrollment website was seriously flawed and launched without adequate testing, and the first-year enrollment target was unrealistically low.In April 2014, MNsure hired Deloitte Consulting to audit MNsure’s technology and improve the website to make enrolling in coverage and updating life events easier and more streamlined. Deloitte has been involved in successful state-run marketplaces for Connecticut, Kentucky, Rhode Island and Washington.Software upgrades were installed in August 2014, and system testing continued right up until the start of open enrollment. To reduce wait times for consumers and insurance professionals, MNsure increased its call center and support staff and launched a dedicated service line for agents and brokers.More in-person assisters were available in Minnesota for the 2015 open enrollment period.

MNsure encourages residents to utilize the exchange’s assister directory to find local navigators and brokers who can help with the enrollment process.MNsure has improved dramatically in terms of its technology since the early days of ACA implementation, and enrollment increased every year from 2014 through 2019.Lawmakers approved switching to HealthCare.gov as of 2019, but governor vetoedOn May 9, 2017, lawmakers in Minnesota passed SF800, an omnibus health and human services bill. Among many other things, the legislation called for switching from MNsure to the federally-run marketplace (HealthCare.gov) starting in 2019 (see Section 5). But Governor Dayton vetoed it.Gov. Dayton has long been supportive of MNsure, and had previously clarified that he would veto the bill.

In noting his plans to veto the legislation, Dayton made no mention of the transition to HealthCare.gov that was included in the legislation, but focused instead on the sharp budget cuts in the bill. But his veto ensured that MNsure would remain in place, at least for the time being.The Senate’s original version of SF800 did not call for scrapping MNsure, but the bill went through considerable back-and-forth between the two chambers, and the version that passed was the 4th engrossment of the bill.In March 2015, Dayton had asked the legislature to create a Task Force on Health Care Financing that would study MNsure along with possible future alternatives. Dayton noted in his letter that he supported making MNsure “directly accountable to the governor and subject to the same legislative oversight as other state agencies” and his budget included half a million dollars devoted to the task force. The spending bill was approved by the legislature in May, and the 29-member task force was appointed in the summer.One of the possibilities that the task force considered was the possibility of switching to Healthcare.gov, but it’s clear that there was no cut-and-dried answer to the question of whether Minnesota is better served by having a state-run exchange, switching to a federally-run exchange, or teaming up with the federal government on either a supported state-based marketplace or partnership exchange.In a December 2015 meeting of the task force, the MN Department of Human Services presented a financial analysis of the alternatives available to MNsure.

They determined that switching entirely to Healthcare.gov would cost the state an additional $5.1 million in one-time costs from June 2016 to June 2017. And switching to a supported state-based marketplace would cost an additional $6.6 million during that same time frame. If the state had opted to switch to Healthcare.gov, the soonest it could have happened was 2018, since HHS requires a year’s notice from states wishing to transition to Healthcare.gov, and Minnesota wouldn’t have been in a position to make a decision until sometime in 2016.There were significant reservations about making that switch prior to the Supreme Court’s ruling on King v. Burwell.

The Court ruled in June 2015 that subsidies are legal in every state, including those that use Healthcare.gov. Prior to the decision, a switch to Healthcare.gov could have jeopardized subsidies for tens of thousands of Minnesota residents. But once it was clear that Healthcare.gov’s subsidies are safe, some stakeholders began calling for Minnesota to scrap its state-run exchange and use Healthcare.gov instead. Because the MNsure task force was included in the 2016 budget, no hasty decisions were made.In January 2016, the task force submitted their recommendations to the legislature.

They covered a broad range of issues, but did not recommend that MNsure transition to the federal enrollment platform. Lawmakers essentially left the exchange alone during the 2016 legislative session.The magnitude of the 2016 rate increases that were announced in October resulted in MNsure opponents renewing their calls to switch to Healthcare.gov. But it’s important to keep in mind that the 41 percent weighted average rate hike in Minnesota was market-wide, and did not just apply to MNsure enrollees. In fact, the off-exchange carrier (PreferredOne) had among the highest rate hikes in the state for 2016, at 39 percent, and the exchange’s weighted average rate increase (38.5 percent) was lower than the weighted average rate increase for the whole individual market (41 percent).Minnesota health insurance exchange linksMNsure855-3MNSURE (855-366-7873)State Exchange Profile.

MinnesotaThe Henry J. Kaiser Family Foundation overview of Minnesota’s progress toward creating a state health insurance exchange.Louise Norris is an individual health insurance broker who has been writing about health insurance and health reform since 2006. She has written dozens of opinions and educational pieces about the Affordable Care Act for healthinsurance.org. Her state health exchange updates are regularly cited by media who cover health reform and by other health insurance experts.Key takeaways Medicaid expansion in HawaiiHawaii adopted Medicaid expansion through the Affordable Care Act, extending eligibility for Medicaid to adults with income up to 133 percent of the poverty level (138 percent with the automatic 5 percent income disregard).

Medicaid expansion took effect in January 2014.According to the Kaiser Family Foundation, about 70,000 Hawaii residents were uninsured in 2015. With Medicaid expansion now covering low-income, nonelderly adults, 50 percent of Hawaii’s remaining uninsured population at that point was eligible for Medicaid – although they may not realize that they’re eligible. According to U.S. Census data, only 3.5 percent of Hawaii residents were uninsured as of 2016, down from 6.7 percent in 2013.

Although the state’s uninsured rate was reduced by nearly half from 2013 to 2016, it was already less than half of the national average uninsured rate even in 2013, before the bulk of the ACA’s provisions had taken effect. Hawaii’s Prepaid Health Care Act, which has been in place since the 1970s, had already resulted in nearly all of the state’s population having insurance coverage, even before the ACA took effect. However, with the coronavirus outbreak, job losses and the subsequent loss of employer-provided insurance have contributed to a jump in the uninsured rate across the U.S. As of May 2020, Hawaii’s uninsured rate was 10 percent.Medicaid expansion helped cement top-ranking health scores Federalpoverty levelcalculator 0.0% of Federal Poverty Level Hawaii has a long history of supporting initiatives to make health insurance broadly available to residents.

Hawaii was among the first six states that implemented a Medicaid program in January 1966, just six months after federal legislation authorizing the program was enacted. In 1974, Hawaii implemented its Prepaid Health Care Act, which mandated that most employers make health insurance available to employees who work at least 20 hours a week.In conjunction with the Affordable Care Act (ACA), Hawaii initially implemented a state-run health insurance marketplace and adopted Medicaid expansion. The marketplace transitioned to a federally-supported state-run marketplace for 2016, and transitioned again to a fully federally-run exchange for 2017, largely in an effort to take advantage of the economies of scale that the federally-run exchange could bring to a state with low overall enrollment in the individual market (because of Hawaii’s Prepaid Health Care Act, nearly all non-elderly Hawaii residents get coverage from an employer, and relatively few need coverage under individual market plans). Nothing changed about Medicaid with the switch to Healthcare.gov though.

The expanded Medicaid eligibility guidelines are still in effect in Hawaii.Through its efforts, Hawaii consistently has low uninsured rates and high overall health scores. As of 2015, Hawaii was ranked the healthiest state in the nation according to the Gallup Healthways Physical Wellbeing Index, and the state consistently scores near the top in other ranking systems (number 2 the America’s Health Rankings 2017 survey, and number 3 in the Commonwealth Fund’s 2017 Scorecard on State Health System Performance).Who is eligible for Medicaid in Hawaii?. Hawaii’s Medicaid eligibility levels for children are much higher than the national average and about average for pregnant women and parents.Children ages 0-18 qualify with family income levels up to 308 of the federal poverty level (FPL)Pregnant women qualify with family income up to 191 percent of FPLParents and other adults qualify with family income up to 138 percent of FPLHawaii also uses Medicaid funds to help cover premium costs for Hawaii residents who aren’t U.S. Citizens but who are citizens of nations that have entered into the Compact of Free Association (COFA) with the U.S.How do I enroll in Medicaid in Hawaii?.

Hawaii’s Medicaid program is called MED-QUEST (MQD). QUEST stands for Quality care, Universal access, Efficient utilization, Stabilizing costs, and Transforming the way health care is provided to recipients.You can apply for MED-QUEST. Hawaii Medicaid enrollment numbersMore than 351,000 people were enrolled in Hawaii’s Medicaid and CHIP programs as of June 2020. This figure is a 22% increase over 2013 (pre-ACA) enrollment, when about 288,000 people were enrolled.

Accordingly to the Kaiser Family Foundation, 107,300 of those enrolled in Hawaii Medicaid are part of the ACA-authorized expansion as of June 2019.Hawaii Medicaid historyHawaii implemented its Medicaid program in January 1966.In the early 1990s, Hawaii implemented the State Health Insurance Program (SHIP) to cover people who weren’t eligible for Medicaid. Then, in 1994, CMS approved Hawaii’s section 1115 Medicaid waiver (one of the first in the nation) to wrap SHIP in with Medicaid in an effort to achieve universal insurance coverage (in combination with the state’s Prepaid Health Care Act). The result of the waiver was the creation of Hawaii’s MED-QUEST program, which initially covered low-income women and children, but has since expanded (as of 2009) to cover nearly all of Hawaii’s Medicaid beneficiaries. The MED-QUEST waiver is subject to renewal every five years.Medicaid in Hawaii is separated into two different methods of providing services.

The fee-for-service (FFS) program and the managed care program, called MED-QUEST or MQD. Under the FFS program, doctors and other healthcare providers bill Medicaid directly to be reimbursed for services provided to Medicaid beneficiaries. Under MED-QUEST, the state contracts with managed care plans who in turn provide healthcare services to Medicaid beneficiaries.As of 2011, more than 98 percent of the people enrolled in Hawaii’s Medicaid program were covered through managed care. By March 2015, Kaiser Family Foundation reported that 335,007 Medicaid enrollees in Hawaii were covered under managed care programs.

That’s higher than the August 2015 total Medicaid/CHIP enrollment count, but KFF notes that the managed care number includes people who are covered under Hawaii’s fully-state-funded Medicaid program, in addition to the majority of enrollees who are in regular Medicaid that’s funded partially by the state and partially by the federal government.In August 2017, Hawaii submitted a waiver amendment to CMS in order to gain federal approval to use Medicaid funding to provide housing services to qualified Medicaid enrollees who are homeless and also have behavioral health and/or substance abuse problems. That waiver request was still pending as of February 2018.Louise Norris is an individual health insurance broker who has been writing about health insurance and health reform since 2006. She has written dozens of opinions and educational pieces about the Affordable Care Act for healthinsurance.org. Her state health exchange updates are regularly cited by media who cover health reform and by other health insurance experts..

Minnesota marketplace highlights and updatesOpen enrollment for 2021 health plans casodex online no prescription. November 1, casodex online no prescription 2020 through December 22, 2020. Residents with qualifying events can still enroll or make changes to their 2020 coverage.Insurers implementing modest rate increases for 2021, after three straight years of average rate decreases. Quartz has joined the exchange for 2021, bringing total number of insurers to five.117,520 people enrolled for 2020, casodex online no prescription a new record for MNsure.Insurer participation in MNsure.

2014 to 2021.Reinsurance program received federal approval, began operation in 2018.With reinsurance, rates decreased for 2018 and again, even more significantly, for 2019. But reinsurance also reduced funding for MinnesotaCare.The elimination of CSR funding further reduced MinnesotaCare funding, but this has been partly restored by a court ruling.MN provided premium relief for non-subsidy-eligible enrollees for 2017 only.Governor vetoed a proposed casodex online no prescription 2019 switch to HealthCare.gov.MNsure’s small business exchange no longer has any participating insurers.Minnesota health exchange overviewMinnesota’s one of the states fighting the hardest to preserve the Affordable Care Act’s gains. See actions Minnesota has taken.Minnesota’s state-run exchange, MNsure, has five participating insurers for 2021, up from four in 2020. The exchange has more than 117,000 individual market enrollees as of 2020.As casodex online no prescription a result of the COVID-19 pandemic, MNsure joined most of the other state-run exchanges in offering a special enrollment period during which people who were uninsured could enroll in a health plan.

MNsure’s special enrollment period began March 23, and continued through April 21. Nearly 9,500 Minnesota residents enrolled in private plans through MNsure during this window, as well as another 13,700 who enrolled in MinnesotaCare or casodex online no prescription Medicaid (enrollment in those programs is open year-round for eligible residents).Allison O’Toole, who led MNsure as CEO for three years, announced her resignation in March 2018, and the exchange named Nate Clark, the MNsure COO, as acting CEO. A few months later, the MNsure board named Clark as the permanent CEO. O’Toole left MNsure to work as director of state affairs for United States of Care, a non-profit created by Andy Slavitt, who was the acting administrator of CMS under the Obama Administration.Throughout 2017, Minnesotans who bought their own health insurance (on or off-exchange) casodex online no prescription and weren’t eligible for ACA subsidies were provided with 25 percent premium rebates from the state as a result of S.F.1, signed into law by Governor Dayton in early 2017.

The subsidies helped to offset the large premium increases that applied in Minnesota in 2017, and helped to stabilize the individual health insurance market in 2017. But the premium rebate program expired at the end of 2017.Thanks in large part to the new reinsurance program that Minnesota casodex online no prescription created (details below), premiums decreased in Minnesota’s individual market in 2018, 2019, and again in 2020, although rates are increasing modestly for 2021. In May 2019, Minnesota leaders reached an agreement on a budget that included an extension of the reinsurance program through 2020 and 2021 (it has already been granted federal approval through the end of 2022, but the state has to continue to cover its share of the cost. Minnesota Governor Tim Walz had hoped to casodex online no prescription implement a premium subsidy program and a new tax credit in Minnesota starting in 2020.

But a compromise in the budget ended up with the state opting to continue the existing reinsurance program for two more years instead.).But the waiver that provides federal pass-through funding for reinsurance also resulted in a sharp and unexpected decrease in federal funding for MinnesotaCare, the Basic Health Program that provides coverage for people with income between 138 percent and 200 percent of the poverty level (between $16,642 and $24,120 for a single person).In addition, the elimination of federal funding for cost-sharing reductions (CSR) in October 2018 resulted in a funding cut for MinnesotaCare, since the program is funded in large part by federal funds that would otherwise have been used to pay for premium subsidies and cost-sharing reductions in the exchange for the population that is instead eligible for MinnesotaCare. After an ensuing legal battle, a judge ordered HHS to restore funding for MinnesotaCare, although a resolution of the situation is ongoing, and the amount that HHS agreed to pay was still less than MinnesotaCare would have received if CSR funding had continued.Open enrollment for 2021 health casodex online no prescription plans extended through December 22, 2020. Insurers implementing modest rate increases for 2021, after three years of overall rate decreasesMNsure enabled window shopping for 2021 health plans as of October 12, 2020. This gives residents a few weeks to browse the available plans before open enrollment starts on November 1, 2020 casodex online no prescription.

And MNsure has announced that open enrollment will continue through December 22, 2020. That’s a week longer than the open enrollment period that will casodex online no prescription apply in states that use the federally-run exchange. The flexibility to extend open enrollment is often cited as one of the benefits of having a fully state-run exchange. (MNsure had a similar extension last December, for 2020 health plans).For casodex online no prescription 2021, Quartz is joining the Minnesota marketplace.

Quartz currently offers plans in Illinois and Wisconsin, and is expanding into Minnesota for 2021. And two of the existing insurers — HealthPartners and UCare — are expanding their coverage areas for 2021 (BluePlus and Medica offer coverage statewide, and will continue to do so in 2021).The following average rate changes have been casodex online no prescription approved for MNsure’s insurers:Blue Plus. 4.21 percent casodex online no prescription increase (down from an initially proposed 7.12 percent increase)Group Health/Health Partners (GHI). 0.67 percent increase (down from an initially proposed 4.15 percent increase)Medica.

2.42 percent increase (down from casodex online no prescription an initially proposed 7.06 percent increase)UCare. 1.6 percent increase (up from an initially proposed 1.39 percent decrease)Quartz. New for 2021, so no applicable rate changePreferredOne Insurance Company, which offers plans outside the exchange, is casodex online no prescription increasing premiums by 1.05 percent (down from an initially proposed average increase of 5.09 percent). Rate changes in previous years2015.

Average increase of 4.5 casodex online no prescription percent. MNsure critics characterized the official announcement as misleading as it failed to take into account low-cost 2014 plans from PreferredOne. Consumers who bought a PreferredOne plan through MNsure for 2014 could only renew their policies for 2015 by working directly with the insurer, since PreferredOne stopped offering plans in the exchange casodex online no prescription at the end of 2014. However, PreferredOne rates went up an average of 63 percent, and consumers didn’t qualify for subsidies if they shopped outside the exchange.

2016. Average increase of 41.4 percent for the individual market, and about 38.5 for plans sold in MNsure (ie, not counting PreferredOne). Rates increased significantly in 2016 across the entire individual market in Minnesota — including plans sold through MNsure, the state-run exchange.Approved rates for 2016 were announced on October 1, 2015, ranging from about 15 percent for Medica to 49 percent for Blue Cross Blue Shield of Minnesota. In general, the carriers cited higher-than-expected claims costs over the past year, along with the impending phase-out of the ACA’s reinsurance program as justification for their 2016 rate requests.

But Governor Mark Dayton called some of the higher proposed increases “outrageous,” and promised a rigorous review of the filed rate changes and justifications. Ultimately, regulators were able to limit the highest rate increases to 49 percent — as opposed to the 54 percent that had been requested by Blue Plus and BCBS of MN — but the final weighted average rate increase in the individual market in Minnesota still ended up being the highest in the nation. But Minnesota still had the lowest overall premiums in the upper midwest (although Minnesota had the highest average rate increase in the country for 2016, they had the lowest overall rates in the country in 2014 and 2015).Minnesota Commerce Commissioner Mike Rothman called the rate increases “unacceptably high,” and Gov. Dayton noted that he was “extremely unhappy” with the rate changes.

But Rothman noted that his office “objected to all of the rates across the board,” and “squeezed out everything we could that was not actuarial justified.” In other words, the final rates, although much higher than officials and policyholders would have liked, were justified based on medical claims costs — the population enrolled in individual health plans in Minnesota was sicker than expected, and drug costs had been particularly onerous.Only about 55 percent of people who had 2015 coverage through MNsure received premium subsidies. But due to the sharp premium increases, that had increased to about 63 percent for the people who had purchased or renewed coverage as of June 2016.2017. When the Minnesota Department of Commerce announced health insurance rates for 2017 for the individual and small group markets, the rate hikes were somewhat reasonable in the small group market (ranging from a decrease of 1 percent to an increase of 17.8 percent), but the individual market was “experiencing serious disruptions in 2017” and “on the verge of collapse.” The four carriers that offered plans through MNsure had the following average rate increases in 2017:Blue Plus = 55 percentHealthPartners/Group Health (GHI) = 50 percent (HealthPartners is only offering plans in 10 of the 67 counties where they offered plans in 2016. Their enrollment cap is 72,000 for 2017)Medica = 57.5 percent (enrollment cap is 50,000 for 2017)UCare = 66.8 percent (UCare capped enrollment at 30,000 for 2017, but only had 16,000 enrollees in 2016)The enrollment caps that HealthPartners, Medica, and UCare employed for 2017 were approved as part of the rate review process, and are designed to protect carriers from further financial losses as they absorb BCBSMN’s enrollees who are shopping for new coverage during open enrollment.In a news release relating to the rate announcement for 2017, the Minnesota Department of Commerce didn’t mince words.

They noted that the individual market in the state was on the brink of collapse, and that they did everything in their power to save the market. While they succeeded in keeping the state’s individual market viable for 2017, with only one carrier exiting (BCBSMN, although their HMO affiliate, Blue Plus, remained in the exchange), they reiterated very clearly that substantial reforms would be needed to keep the market stable in future years, and highlighted the fact that rates would be sharply higher and that carriers would limit enrollment in 2017.2018. Final rates for 2018 were approved in October 2017 (comprehensive information about the approved rates is here), based on the Minnesota Premium Security Plan (MSPS) being implemented but cost-sharing reductions (CSR) not being funded by the federal government (the cost of CSRs was added to on-exchange Silver plans). Average approved rate changes for MNsure insurers ranged from a 13.3 percent decrease for UCare to a 2.8 percent increase for Blue Plus.

Three of the four MNsure insurers decreased their average premiums for 2018.On September 21, MNsure had posted a notice indicating that if the reinsurance program were not approved, rates would be about 20 percent higher than they would otherwise be in 2018. Fortunately for Minnesota residents, the reinsurance program did receive federal approval, and average rates declined slightly for 2018.But some enrollees who don’t get ACA premium subsidies still experienced a rate increase, due to the termination of the one-year, state-funded 25 percent premium rebates at the end of 2017.PreferredOne, which exited MNsure at the end of 2014 and only offers coverage in the off-exchange market, proposed dramatically lower rates for 2018. A 38 percent average decrease if MSPS were to be approved, and a 23 percent average decrease if not. The 38 percent decrease was implemented, and no adjustments were necessary to account for CSR funding, since PreferredOne does not offer plans in the exchange, and CSRs are only available on silver exchange plans.2019.

Average premium decrease of 12.4 percent. Average premiums dropped for all five insurers in the individual market in 2019. This was the second year in a row of declining rates in Minnesota, but Blue Plus had a small rate increase for 2018, so 2019 was the first year that all five insurers decreased their average rates. Minnesota insurance regulators noted that rates in 2019 were about 20 percent lower than they would have been without the reinsurance program.But most of Minnesota’s insurers charged higher rates in 2019 than they would have if the individual mandate penalty hadn’t been eliminated, and if access to short-term plans and association health plans hadn’t been expanded by the Trump administration.

For example, UCare’s rate filing notes that while average rates were decreasing by about 10 percent, the rate decrease would have been nearly 15 percent if the individual mandate penalty had remained in place.At ACA Signups, Charles Gaba calculated a weighted average rate decrease of 12.4 percent for 2019 in Minnesota, but noted that the average decrease would have been nearly 19 percent without those changes at the federal level.2020. Average premium decrease of 1 percent. Four of the five insurers (including PreferredOne, which only offers coverage off-exchange) in Minnesota’s individual market decreased their average premiums for 2020. This was the third year in a row that average individual market premiums dropped in Minnesota’s individual market, due in large part to the reinsurance program that the state has established.The following average rate changes were implemented for 2020:Blue Plus.

1.5 percent decrease (Blue Plus had originally proposed a 4.8 percent increase)Group Health/Health Partners (GHI). 1.26 percent decrease (GHI had originally proposed a 2.1 percent increase)Medica. 1.01 percent decrease (Medica had originally proposed an average decrease of 1.4 percent)UCare. 0.18 percent increase (UCare originally proposed a 0.3 percent increase)PreferredOne, which only offers off-exchange coverage, reduced their rates by an average of 20 percent, on the heels of an 11 percent decrease in 2019.

MNsure enrollment exceeded 116k in 2018, dropped to 113k for 2019, but grew to more than 1117k in 2020From 2014 through 2018, enrollment in MNsure’s individual market plans increased every year, reaching 116,358 people by 2018. That was the highest open enrollment total in MNsure’s history, despite the shorter enrollment period, which ended in mid-January instead of the end of January (open enrollment for 2018 coverage ended on December 15, 2017 in states that use HealthCare.gov, but MNsure opted to extend their enrollment window that year, and have also extended subsequent enrollment windows).Enrollment dropped for the first time in 2019, when 113,552 people enrolled in individual market plans through MNsure. In most states that use HealthCare.gov, enrollment peaked in 2016 and has been dropping since then. But MNsure’s drop-off in 2019, which amounted to only a 2.4 percent reduction in enrollment, is the only time year-over-year enrollment has declined.

Notably, the ACA’s individual mandate penalty was eliminated as of 2019, and regulations that the Trump administration implemented in late 2018 now make it more feasible for healthy people to use short-term plans instead of ACA-compliant plans (Minnesota has its own rules for short-term plans, but they’re more relaxed than the Obama-era federal rules that applied in 2017 and most of 2018).And for 2020, enrollment grew again, reaching a record high of 117,520 enrollees.Here’s a look at the number of people who have signed up for individual market plans through MNsure during each year’s open enrollment period. These numbers all represent total enrollment at the end of open enrollment. Effectuated enrollment is always lower, and MNsure provides periodic effectuated enrollment data on their board meeting materials page. Insurer participation in MNsure.

2014-20212014. Five insurers offered individual policies through MNsure for 2014. Blue Cross Blue Shield of Minnesota, HealthPartners/Group Health, Medica, PreferredOne, and UCare. Kaiser Health News reported that Minnesota offered some of the lowest premiums for silver (mid-level) plans in the U.S.

Four of Minnesota’s nine regions made Kaiser’s list of the 10 least expensive places to buy health insurance.2015. But PreferredOne, which offered the lowest rates in the nation in 2014 and captured a large portion of 2014 enrollees, withdrew from MNsure for 2015. PreferredOne said remaining on the exchange was “not administratively and financially sustainable.” A Star Tribune business writer attributed PreferredOne’s departure as a market dynamics issue rather than a problem with MNsure.However, Blue Plus (an affiliate of Blue Cross Blue Shield of MN, offering HMO plans) joined the exchange for 2015, so there were still five insurers offering plans for 2015. Blue Cross Blue Shield of Minnesota, Blue Plus, Health Partners/Group Health, Medica, and UCare.

MNsure offered 84 plans statewide, up from 78 for 2014.2016. BCBSMN, Blue Plus, Health Partners/Group Health, Medica, and UCare offered individual market plans through MNsure for 2016.2017. In an effort to recruit more carriers to offer plans through MNsure for 2017 — particularly outside the Twin Cities metro area — state regulators sent out a request for proposals from health insurers on August 15, 2016. Regulators noted that insurers could propose waivers of regulations in order to make it feasible for them to offer coverage through MNsure, although any such waiver requests would have to be approved by regulators.Steven Parente, a health insurance expert at the University of Minnesota, called the state’s effort to recruit insurers to MNsure a “distress call” and noted that August 15 is awfully late in the year to be putting out a request for insurer participation, given that open enrollment begins November 1.

And ultimately, no new insurers opted to join MNsure for 2017.Blue Cross Blue Shield of MN dropped their individual market PPO plans at the end of 2016 due to significant financial losses. That left Blue Plus (which offered HMOs and covered roughly 13,000 people in 2016 in the individual market) as the only BCBSMN affiliate in the exchange. Roughly 103,000 people had to select new plans during open enrollment.Most of those BCBSMN enrollees had off-exchange coverage, though. There were only about 20,400 MNsure enrollees (a little more than one in five MNsure enrollees) with coverage under BCBSMN who needed to switch to another plan during open enrollment.

BCBSMN had individual PPO options available in all 87 counties in Minnesota through MNsure in 2016, while the Blue Plus coverage area — comprised of four separate HMO networks — was available in 77 of the state’s counties.Nationwide, carriers have been shifting away from PPOs and towards HMOs and EPOs. In Colorado, Anthem Blue Cross Blue Shield also dropped their PPOs at the end of 2016. In Indiana, there were no PPOs available in the individual market by 2017. Blue Cross Blue Shield of New Mexico dropped all of their individual market plans at the end of 2015 except one off-exchange HMO.

Blue Cross Blue Shield of Texas dropped their individual market PPO plans at the end of 2015.The broad network offered by PPOs tends to be attractive to enrollees who have health problems. They’re often willing to pay higher premiums in trade for access to broad network of hospitals and specialists. But PPOs are expensive for carriers, as enrollees don’t need primary care referrals to see specialists, and it’s more challenging for carriers to hold down costs when there are more providers in the network.All of the MNsure carriers except Blue Plus are also limiting their total enrollment for 2017. By November 11, 2016, less than two weeks into open enrollment for 2017 coverage, Medica had hit their 50,000 member enrollment cap for 2017 (including on and off-exchange enrollments, and also accounting for expected renewals of 2016 Medica plans), and their policies were no longer available in the individual market in Minnesota, on or off-exchange.

The only exception was five counties (Benton, Crow Wing, Mille Lacs, Morrison, and Stearns) where Medica agreed not to limit enrollment, as all of the other available carriers in those counties have imposed enrollment caps too. In those five counties, Medica plans continued to be available.At that point, Medica’s market share in MNsure for 2017 stood at 34.2 percent. By December 14, Medica’s market share had dropped to 27.7 percent, as enrollments had continued to climb for the remaining carriers.On January 31, Medica re-opened enrollment for 2017. This was because a smaller-than-expected number of 2016 Medica enrollees renewed their plans for 2017, meaning that the carrier still had some wiggle room under their 50,000 member cap.

At that point, they had room for about 7,000 more enrollees. Medica plans were thus available throughout the duration of the special enrollment period that was added on at the end of open enrollment, and continue to be available for people with qualifying events.2018. Plans continued to be available from Blue Plus, Health Partners/Group Health (GHI), Medica, UCare. In the months before a decision was reached regarding an extension of the open enrollment window for 2018 plans (the first year that the federal government imposed a shorter, month-and-a-half enrollment window), two of MNsure’s participating insurers had differing positions.

UCare believed the exchange should add an additional two-week special enrollment period, while Medica did not want the exchange to have the option to extend the newly-scheduled six-week enrollment window. Notably, Medica capped their enrollment very early during the 2017 open enrollment period, and while UCare also had an enrollment cap, it was set with a target of nearly doubling their 2016 enrollment. But Medica is the only MNsure insurer that didn’t set an enrollment cap for 2018.As was the case for 2017, enrollment caps were used in the individual market in Minnesota for 2018 by all insurers other than Medica (Medica did have an enrollment cap for 2017, which they hit very early in open enrollment. However, they resumed enrollments at the end of January 2017).

Details about the insurers’ enrollment caps are in the plan binders in SERFF. For 2018, MNsure insurers implemented the following enrollment caps:Blue Plus. 55,000 member cap (aiming for a target of 50,000 effectuated enrollees, but effectuated enrollment is always lower than the number of people who initially enroll)Health Partners/Group Health (GHI). 73,400 member cap (aiming for a target of 70,000 effectuated enrollees)Medica.

No enrollment capUCare. 35,000 member cap (aiming for a target of 30,000 effectuated enrollees)MNsure confirmed in May 2018 that none of their insurers had hit their enrollment caps for 2018.Outside the exchange, PreferredOne had an enrollment cap of 3,000 members, although their 2017 membership was only about 300 people.2019 and 2020. Blue Plus, Health Partners/Group Health, UCare, and Medica have continued to offer plans through MNsure, and all of them continued to participate in 2020 as well. Blue Plus expanded to once again offer statewide coverage in 2020, for the first time since 2016.2021.

Quartz joined the exchange for 2021, joining the four existing insurers. HealthPartners and UCare are both expanding their coverage areas for 2021.Minnesota Premium Security Plan. 1332 waiver proposal approved by CMS, but with a significant funding cut for MinnesotaCareIn May 2017, Minnesota Governor Mark Dayton submitted a 1332 waiver proposal to CMS. The 1332 waiver was based on H.F.5, which was enacted without Dayton’s signature in April 2017 (Dayton had proposed an alternative measure that would have allowed people in Minnesota to buy into MinnesotaCare.

That measure was not able to pass the state’s Republican-dominated legislature).[For more than two decades, MinnesotaCare was a state program subsidizing health insurance for low-income residents. As of January 1, 2015, it transitioned to a Basic Health Program under the ACA, becoming the first BHP in the nation.]H.F.5 created the Minnesota Premium Security Plan (MPSP), which is a state-based reinsurance program (similar to the one the ACA implemented on a temporary basis through 2016, and that Alaska created for 2017. Several other states have since implemented reinsurance programs). The reinsurance program, which took effect in Minnesota in 2018, covers a portion of the claims that insurers face, resulting in lower total claims costs for the insurers, and thus lower premiums (average individual market premiums in Minnesota decreased from 2017 to 2018 as a result of the reinsurance program).

The reinsurance kicks in once claims reach $50,000, and covers them at 80 percent up to $250,000 (this is similar to the coverage under the transitional reinsurance program that the ACA provided from 2014 through 2016).H.F.5 was contingent upon approval of the 1332 waiver, because it relies partially on federal funding, in addition to state funding. Under the federal approval that was granted in September 2017, the federal government is giving Minnesota the money that they save on premium tax credits, and that money is combined with state funds to implement the reinsurance program (lower premiums — as a result of the reinsurance program — result in the federal government having to pay a smaller total amount of premium tax credits, since the tax credits are smaller when premiums are smaller).It was expected that CMS would approve the state’s 1332 waiver proposal, and Governor Dayton requested that the approval process be swift so that the state could move forward with the implementation of the Minnesota Premium Security Plan in time for the 2018 plan year. Dayton indicated that his office had been told that approval would come in August 2017, but CMS didn’t approve the waiver until September 22. And the waiver approval letter noted that the federal savings for MinnesotaCare (the state’s Basic Health Program, or BHP) resulting from the reinsurance program would not be eligible to be passed along to the state — in other words, CMS would keep those savings instead.[Federal BHP funding is equal to 95 percent of the amount that the federal government would have otherwise spent on premium subsidies and cost-sharing reductions for the population that ends up being eligible for the BHP.

So lower premiums — as a result of reinsurance — for qualified health plans in the exchange means that the amount the federal government would have had to spend on premium subsidies for that population is lower. That translates into a smaller amount of funding for the state’s BHP, according to the approach that HHS took for Minnesota’s waiver approval.]And based on the scathing letter that Dayton sent CMS a few days earlier, it appeared at that point that Minnesota could actually lose money on the deal — losing more in federal funding for MinnesotaCare than they gain in reinsurance funding. Dayton noted in his letter that the 1332 waiver approval process had been “nightmarish,” and that Minnesota went to great lengths to follow instructions from CMS at every turn, throughout the process of drafting H.F.5 and the 1332 waiver proposal. He explains that CMS provided Minnesota with explicit guidance in terms of how to draft the reinsurance program while maintaining full federal funding for MinnesotaCare, and highlighted the fact that the state never deviated from the instructions that were provided.The StarTribune editorial board called out then-Secretary of HHS, Tom Price and the Trump Administration for their lack of clarity on the issue, for apparently misleading the state during the 1332 waiver drafting process, and for effectively punishing the state of Minnesota for taking an innovative approach to ensuring that as many people as possible have health insurance.Insurers filed rates based on reinsurance being available.

And by the time the waiver was approved, there was very little time to evaluate the potential impacts of the funding changes, as rates had to be finalized by October 2 in Minnesota. The finalized rates did incorporate the reinsurance program. The state has accepted the approved waiver, but Gov. Dayton sent a letter to HHS on October 3, asking them to reconsider the MinnesotaCare funding cuts, but the issue has remained unresolved.Elimination of CSR funding results in additional funding cut for MinnesotaCare, but a lawsuit has partially restored that fundingNationwide, 54 percent of exchange enrollees benefit from cost-sharing subsidies.

But in Minnesota, only 13 percent of exchange enrollees are receiving cost-sharing subsidies. This is because of MinnesotaCare, which covers all enrollees with income up to 200 percent of the poverty level. That’s the same group that would otherwise benefit the most from cost-sharing subsidies, so the fact that MinnesotaCare is available means that most of the people who would otherwise be enrolled in cost-sharing subsidy plans are instead enrolled in MinnesotaCare.At first glance, this would appear to have made the uncertainty surrounding cost-sharing subsidy funding in 2017 a little less of a pressing issue in Minnesota than it was in many other states, since private insurers weren’t facing the sort of losses that insurers in other states were facing without federal funding for CSR. But when the Trump Administration eliminated federal funding for CSR in October 2017, HHS took the position tha t since CSR funding had been eliminated, the CSR portion of the federal funding for the BHPs in New York and Minnesota would be reduced to $0.

This was not a cut-and-dried conclusion, however, as explained earlier in 2017 by Michael Kalina.In January 2018, the Attorneys General for New York and Minnesota filed a lawsuit against the US Department of Health and Human Services, seeking to restore funding for their Basic Health Programs. A judge ruled in favor of the states in May 2018, ensuring that MinnesotaCare would continue to receive at least some CSR-based funding. The amount awarded to the state for the first quarter of 2018 was just over half of what the state had initially expected in CSR-related funding, but a larger chuck of the funding was restored later in 2018. According to the Star Tribune, however, Minnesota still ended up losing $161 million in federal funding for MinnesotaCare due to the CSR funding cuts.In early 2019, the Trump administration proposed yet another funding cut (a third, after the cuts imposed by the reinsurance program and the elimination of CSR funding) as part of a new methodology for calculating BHP funding.

This one was much smaller than the other two cuts, but taken together the funding reductions are pushing MinnesotaCare towards a looming budget shortfall. SHOP exchange. Down to one carrier as of 2016, zero by 2018 (and still zero in 2019)In 2015, there were two carriers in MNsure’s SHOP exchange for small businesses. Blue Cross Blue Shield of Minnesota, and Medica.

But Medica announced in 2015 that they would exit the SHOP exchange in Minnesota, North Dakota, and Wisconsin at the end of the year. That left BCBS as the only small group carrier available through MNsure in 2016, but it didn’t change much from a practical standpoint, since 83 percent of MNsure’s small groups were enrolled in plans through BCBS in 2015. Indeed, Medica’s reason for exiting the small business exchange was based on low enrollment in the first two years.Blue Cross Blue Shield of Minnesota continued to be the only insurer offering SHOP coverage via MNsure in 2017, but announced in July 2017 that they would no longer offer SHOP coverage in 2018, and would instead transition their SHOP enrollees to small business coverage outside the exchange. At that point, there were only 3,287 people enrolled in SHOP coverage in Minnesota — far below the 155,000 people that were originally projected to have coverage through MNsure’s SHOP program by 2016 (this much lower-than-anticipated enrollment has been the case in nearly every state’s SHOP exchange.

This situation is not unique to Minnesota). State law provided 25% premium rebate in 2017. Amendment to allow plans without essential benefits was cut from final legislationThroughout 2016, then-Governor Dayton called for a state-funded premium rebate for people who buy their own insurance but aren’t eligible for the ACA’s premium subsidies (those are only available for people with income up to 400 percent of the poverty level, or $100,400 for a family of four in 2019).Governor Dayton also noted that the government needed to act quickly to stabilize the individual market in Minnesota, and by late November 2016, his patience with lawmakers was wearing thin. In a November 23 press conference, Dayton said that House Republicans needed to “stop dilly-dallying” and decide whether to move forward with Dayton’s rebate proposal.Dayton had also indicated that he was considering calling a special session of the legislature after election day to address the situation, and that was being negotiated for December 20.

But the talks fell through when Dayton and Republican House Speaker Kurt Daudt couldn’t agree on the three bills that would have been addressed in the special session. As a result, there was no special session.Instead, the issue was taken up by lawmakers as soon as the 2017 legislative session began. On January 5, Minnesota Senators Michelle Benson (R, 31st District) and Gary Dahms (R, 16th District) introduced S.F.1. The bill called for using $300 million in state funding to provide a 25 percent rebate to roughly 125,000 people in Minnesota.S.F.1 passed the Minnesota Senate by a 35-31 vote on January 12.

Only one DFL Senator (Melisa Franzen, from Edina) voted with Republicans in favor of the legislation. It was then sent to the House, where an amendment was added that stripped out the requirement that health plans provide various mandated benefits (see “Journal of the Day” section “Top of page 154” in this version of the bill. Under the terms of the amendment, as long as a carrier offered at least one plan with all the mandated benefits, they would have been allowed to offer others without mandated benefits).The amended bill was sent back to the Senate on January 23. Differences between the bills that the two chambers passed had to be reconciled before being sent to Governor Dayton for his signature.

By that point, the amendment to allow less-robust plans to be sold had garnered national attention, and public outrage helped to push lawmakers away from the provision. S.F.1 had also called for $150 million to be appropriated for fiscal year 2018 (through June 30, 2019) from the state general fund to a state-based reinsurance program to stabilize the individual market (Alaska did something similar in 2016, preventing a market collapse), but that provision was also removed in the final version (Minnesota did ultimately set up a reinsurance program, effective in 2018, which has served to stabilize the market and reduce premiums).A Conference Committee in the Senate recommended that the House “recede from its amendments” and the Conference Committee report passed the Senate on a 47-19 vote. The House passed the bill a few hours later, 108-19. It was sent to Governor Dayton, who immediately signed it into law.

DFLers did have to compromise on one issue during the process. S.F.1 allows for-profit HMOs to begin operating in Minnesota’s individual market, which had long been limited to non-profit HMOs.Consumers were told to expect the premium rebates to show up by April 2017, but they were retroactively effective to January 2017. So a person who had been paying full price for a plan since January 2017 saw a substantial premium reduction on the April or May invoice. Going forward, for the remainder of the year, a 25 percent rebate applied each month.Since S.F.1 was signed into law with only a few days remaining in open enrollment (it ended January 31 that year), Governor Dayton and exchange officials were worried that there wouldn’t be enough time for people to learn about the rebate and apply for coverage before January 31.

In December, Dayton had asked HHS to allow MNsure to extend its enrollment deadline to February 28 (instead of January 31) in order to allow lawmakers more time to work out the details of a state-based premium rebate while still allowing people to enroll after the legislative process is complete.HHS denied the request for a blanket extension, but MNsure used their own authority on January 28 to grant a one-week special enrollment period (February 1 to February 8) due to exceptional circumstances. Although the state-based 25 percent premium rebate was available on or off the exchange, the one-week extension was only valid through MNsure. Health insurers did not have to accept off-exchange enrollments without a qualifying event after January 31.The 25 percent premium rebate program in Minnesota was only authorized for one year, so the rebates did not continue into 2018. And although almost 100,000 people received premium relief through the program in 2017, it ended up costing less than the legislature had allocated, and about $100 million was returned to the state’s budget at the end of 2017.Protecting Medicaid enrollees from estate liensIn every state, Medicaid is jointly funded by the state and the federal government.

Longstanding federal regulations, which predate the ACA, require states to “seek recovery of payments from the individual’s estate for nursing facility services, home and community-based services, and related hospital and prescription drug services” for any Medicaid enrollee over the age of 55. This applies essentially to long-term care services, but states also have the option to go after the individual’s estate to recover costs for other care that was provided by Medicaid after age 55.Prior to 2014, this wasn’t typically an issue, as Medicaid eligibility was generally restricted by asset tests or requirements that applicants be disabled or pregnant (although Minnesota did have much more generous Medicaid eligibility guidelines than most states prior to 2014). But as of 2014, in states that expanded Medicaid under the ACA, the only eligibility guideline is income. Applicants with income that doesn’t exceed 138 percent of the poverty level are directed to Medicaid, regardless of any assets they might have.When applicants use the health insurance exchange — MNsure in Minnesota — they’re automatically funneled into Medical Assistance (Medicaid) if their income is under 138 percent of the poverty level.

But what these enrollees didn’t know was that the state also had a program in place to put liens on estates for Medicaid-provided services for people age 55 and older.The combination of these systems caught numerous residents off guard. They were enrolled in Medical Assistance through MNsure based on their income, but were not aware that liens were being placed on their homes so that the state could recoup the costs upon their deaths.State Senator Tony Lourey (DFL, District 11) addressed the issue with language included in HF2749, the Omnibus supplemental budget bill, which was signed into law by Governor Dayton on June 1, 2016. The legislation limits estate recovery to just what’s required under federal Medicaid rules (ie, essentially, long-term care costs for people age 55 or older), and makes the provision retroactive to January 1, 2014.Early tech strugglesMNsure opened for business in the fall of 2013, but technological issues persisted well into 2015, despite numerous improvements throughout 2014. Given MNsure’s difficult launch, the state conducted a series of audits and reviews.

The first audit reviewed how MNsure spent state and federal money. Auditors concluded that the exchange has generally adequate internal controls and found no fraud or abuse. The review was conducted by the state Office of the Legislative Auditor, and the report was published in October 2014.Another audit, also conducted by the Office of the Legislative Auditor and released in November 2014, found that the MNsure system in some cases incorrectly determined who qualified for public health benefits. The errors occurred during the first open enrollment period, before a series of system fixes were implemented.

The audit did not quantify the total financial impact of the errors. The state Human Services commissioner said a consultant working on technical fixes to MNsure concluded that the eligibility functionality was working correctly as of June 2014.A third audit, a performance evaluation report released in February 2015, said “MNsure’s failures outweighed its achievements.” Among other criticisms, auditors said MNsure staff withheld information from the board of directors and state officials, the enrollment website was seriously flawed and launched without adequate testing, and the first-year enrollment target was unrealistically low.In April 2014, MNsure hired Deloitte Consulting to audit MNsure’s technology and improve the website to make enrolling in coverage and updating life events easier and more streamlined. Deloitte has been involved in successful state-run marketplaces for Connecticut, Kentucky, Rhode Island and Washington.Software upgrades were installed in August 2014, and system testing continued right up until the start of open enrollment. To reduce wait times for consumers and insurance professionals, MNsure increased its call center and support staff and launched a dedicated service line for agents and brokers.More in-person assisters were available in Minnesota for the 2015 open enrollment period.

MNsure encourages residents to utilize the exchange’s assister directory to find local navigators and brokers who can help with the enrollment process.MNsure has improved dramatically in terms of its technology since the early days of ACA implementation, and enrollment increased every year from 2014 through 2019.Lawmakers approved switching to HealthCare.gov as of 2019, but governor vetoedOn May 9, 2017, lawmakers in Minnesota passed SF800, an omnibus health and human services bill. Among many other things, the legislation called for switching from MNsure to the federally-run marketplace (HealthCare.gov) starting in 2019 (see Section 5). But Governor Dayton vetoed it.Gov. Dayton has long been supportive of MNsure, and had previously clarified that he would veto the bill.

In noting his plans to veto the legislation, Dayton made no mention of the transition to HealthCare.gov that was included in the legislation, but focused instead on the sharp budget cuts in the bill. But his veto ensured that MNsure would remain in place, at least for the time being.The Senate’s original version of SF800 did not call for scrapping MNsure, but the bill went through considerable back-and-forth between the two chambers, and the version that passed was the 4th engrossment of the bill.In March 2015, Dayton had asked the legislature to create a Task Force on Health Care Financing that would study MNsure along with possible future alternatives. Dayton noted in his letter that he supported making MNsure “directly accountable to the governor and subject to the same legislative oversight as other state agencies” and his budget included half a million dollars devoted to the task force. The spending bill was approved by the legislature in May, and the 29-member task force was appointed in the summer.One of the possibilities that the task force considered was the possibility of switching to Healthcare.gov, but it’s clear that there was no cut-and-dried answer to the question of whether Minnesota is better served by having a state-run exchange, switching to a federally-run exchange, or teaming up with the federal government on either a supported state-based marketplace or partnership exchange.In a December 2015 meeting of the task force, the MN Department of Human Services presented a financial analysis of the alternatives available to MNsure.

They determined that switching entirely to Healthcare.gov would cost the state an additional $5.1 million in one-time costs from June 2016 to June 2017. And switching to a supported state-based marketplace would cost an additional $6.6 million during that same time frame. If the state had opted to switch to Healthcare.gov, the soonest it could have happened was 2018, since HHS requires a year’s notice from states wishing to transition to Healthcare.gov, and Minnesota wouldn’t have been in a position to make a decision until sometime in 2016.There were significant reservations about making that switch prior to the Supreme Court’s ruling on King v. Burwell.

The Court ruled in June 2015 that subsidies are legal in every state, including those that use Healthcare.gov. Prior to the decision, a switch to Healthcare.gov could have jeopardized subsidies for tens of thousands of Minnesota residents. But once it was clear that Healthcare.gov’s subsidies are safe, some stakeholders began calling for Minnesota to scrap its state-run exchange and use Healthcare.gov instead. Because the MNsure task force was included in the 2016 budget, no hasty decisions were made.In January 2016, the task force submitted their recommendations to the legislature.

They covered a broad range of issues, but did not recommend that MNsure transition to the federal enrollment platform. Lawmakers essentially left the exchange alone during the 2016 legislative session.The magnitude of the 2016 rate increases that were announced in October resulted in MNsure opponents renewing their calls to switch to Healthcare.gov. But it’s important to keep in mind that the 41 percent weighted average rate hike in Minnesota was market-wide, and did not just apply to MNsure enrollees. In fact, the off-exchange carrier (PreferredOne) had among the highest rate hikes in the state for 2016, at 39 percent, and the exchange’s weighted average rate increase (38.5 percent) was lower than the weighted average rate increase for the whole individual market (41 percent).Minnesota health insurance exchange linksMNsure855-3MNSURE (855-366-7873)State Exchange Profile.

MinnesotaThe Henry J. Kaiser Family Foundation overview of Minnesota’s progress toward creating a state health insurance exchange.Louise Norris is an individual health insurance broker who has been writing about health insurance and health reform since 2006. She has written dozens of opinions and educational pieces about the Affordable Care Act for healthinsurance.org. Her state health exchange updates are regularly cited by media who cover health reform and by other health insurance experts.Key takeaways Medicaid expansion in HawaiiHawaii adopted Medicaid expansion through the Affordable Care Act, extending eligibility for Medicaid to adults with income up to 133 percent of the poverty level (138 percent with the automatic 5 percent income disregard).

Medicaid expansion took effect in January 2014.According to the Kaiser Family Foundation, about 70,000 Hawaii residents were uninsured in 2015. With Medicaid expansion now covering low-income, nonelderly adults, 50 percent of Hawaii’s remaining uninsured population at that point was eligible for Medicaid – although they may not realize that they’re eligible. According to U.S. Census data, only 3.5 percent of Hawaii residents were uninsured as of 2016, down from 6.7 percent in 2013.

Although the state’s uninsured rate was reduced by nearly half from 2013 to 2016, it was already less than half of the national average uninsured rate even in 2013, before the bulk of the ACA’s provisions had taken effect. Hawaii’s Prepaid Health Care Act, which has been in place since the 1970s, had already resulted in nearly all of the state’s population having insurance coverage, even before the ACA took effect. However, with the coronavirus outbreak, job losses and the subsequent loss of employer-provided insurance have contributed to a jump in the uninsured rate across the U.S. As of May 2020, Hawaii’s uninsured rate was 10 percent.Medicaid expansion helped cement top-ranking health scores Federalpoverty levelcalculator 0.0% of Federal Poverty Level Hawaii has a long history of supporting initiatives to make health insurance broadly available to residents.

Hawaii was among the first six states that implemented a Medicaid program in January 1966, just six months after federal legislation authorizing the program was enacted. In 1974, Hawaii implemented its Prepaid Health Care Act, which mandated that most employers make health insurance available to employees who work at least 20 hours a week.In conjunction with the Affordable Care Act (ACA), Hawaii initially implemented a state-run health insurance marketplace and adopted Medicaid expansion. The marketplace transitioned to a federally-supported state-run marketplace for 2016, and transitioned again to a fully federally-run exchange for 2017, largely in an effort to take advantage of the economies of scale that the federally-run exchange could bring to a state with low overall enrollment in the individual market (because of Hawaii’s Prepaid Health Care Act, nearly all non-elderly Hawaii residents get coverage from an employer, and relatively few need coverage under individual market plans). Nothing changed about Medicaid with the switch to Healthcare.gov though.

The expanded Medicaid eligibility guidelines are still in effect in Hawaii.Through its efforts, Hawaii consistently has low uninsured rates and high overall health scores. As of 2015, Hawaii was ranked the healthiest state in the nation according to the Gallup Healthways Physical Wellbeing Index, and the state consistently scores near the top in other ranking systems (number 2 the America’s Health Rankings 2017 survey, and number 3 in the Commonwealth Fund’s 2017 Scorecard on State Health System Performance).Who is eligible for Medicaid in Hawaii?. Hawaii’s Medicaid eligibility levels for children are much higher than the national average and about average for pregnant women and parents.Children ages 0-18 qualify with family income levels up to 308 of the federal poverty level (FPL)Pregnant women qualify with family income up to 191 percent of FPLParents and other adults qualify with family income up to 138 percent of FPLHawaii also uses Medicaid funds to help cover premium costs for Hawaii residents who aren’t U.S. Citizens but who are citizens of nations that have entered into the Compact of Free Association (COFA) with the U.S.How do I enroll in Medicaid in Hawaii?.

Hawaii’s Medicaid program is called MED-QUEST (MQD). QUEST stands for Quality care, Universal access, Efficient utilization, Stabilizing costs, and Transforming the way health care is provided to recipients.You can apply for MED-QUEST. Hawaii Medicaid enrollment numbersMore than 351,000 people were enrolled in Hawaii’s Medicaid and CHIP programs as of June 2020. This figure is a 22% increase over 2013 (pre-ACA) enrollment, when about 288,000 people were enrolled.

Accordingly to the Kaiser Family Foundation, 107,300 of those enrolled in Hawaii Medicaid are part of the ACA-authorized expansion as of June 2019.Hawaii Medicaid historyHawaii implemented its Medicaid program in January 1966.In the early 1990s, Hawaii implemented the State Health Insurance Program (SHIP) to cover people who weren’t eligible for Medicaid. Then, in 1994, CMS approved Hawaii’s section 1115 Medicaid waiver (one of the first in the nation) to wrap SHIP in with Medicaid in an effort to achieve universal insurance coverage (in combination with the state’s Prepaid Health Care Act). The result of the waiver was the creation of Hawaii’s MED-QUEST program, which initially covered low-income women and children, but has since expanded (as of 2009) to cover nearly all of Hawaii’s Medicaid beneficiaries. The MED-QUEST waiver is subject to renewal every five years.Medicaid in Hawaii is separated into two different methods of providing services.

The fee-for-service (FFS) program and the managed care program, called MED-QUEST or MQD. Under the FFS program, doctors and other healthcare providers bill Medicaid directly to be reimbursed for services provided to Medicaid beneficiaries. Under MED-QUEST, the state contracts with managed care plans who in turn provide healthcare services to Medicaid beneficiaries.As of 2011, more than 98 percent of the people enrolled in Hawaii’s Medicaid program were covered through managed care. By March 2015, Kaiser Family Foundation reported that 335,007 Medicaid enrollees in Hawaii were covered under managed care programs.

That’s higher than the August 2015 total Medicaid/CHIP enrollment count, but KFF notes that the managed care number includes people who are covered under Hawaii’s fully-state-funded Medicaid program, in addition to the majority of enrollees who are in regular Medicaid that’s funded partially by the state and partially by the federal government.In August 2017, Hawaii submitted a waiver amendment to CMS in order to gain federal approval to use Medicaid funding to provide housing services to qualified Medicaid enrollees who are homeless and also have behavioral health and/or substance abuse problems. That waiver request was still pending as of February 2018.Louise Norris is an individual health insurance broker who has been writing about health insurance and health reform since 2006. She has written dozens of opinions and educational pieces about the Affordable Care Act for healthinsurance.org. Her state health exchange updates are regularly cited by media who cover health reform and by other health insurance experts..

Casodex bicalutamide

€œIf countries casodex bicalutamide are serious about opening, they must be serious about suppressing transmission and saving lives”, said WHO chief Tedros Adhanom Ghebreyesus, briefing reporters from Geneva. “Opening up without having control, is a recipe for disaster.”We are 8 months into the #COVID19 casodex bicalutamide pandemic &. We understand that people are tired &.

Yearn to get on with their lives, but no country can just pretend the pandemic is casodex bicalutamide over. This virus spreads easily, &. We all must casodex bicalutamide remain serious about suppressing its transmission &.

Saving lives. Pic.twitter.com/1d2jR5FfvE— Tedros Adhanom Ghebreyesus (@DrTedros) August 31, 2020 While this may seem an impossible balance, it can be done if countries are casodex bicalutamide in control of transmission, he said. The more control they have, the more they can open.

The reality is that coronavirus casodex bicalutamide spreads easily, he said. It can be fatal for people of all ages and most people remain susceptible.Prevention, prevention, preventionTo control transmission, he said it is essential to prevent events that lead to outbreaks. COVID-19 spreads efficiently among clusters of people, with explosive outbreaks linked to gatherings at places casodex bicalutamide such as sports stadiums, nightclubs and places of worship.

At the same time, there are ways to hold gatherings safely, Tedros said. Decisions about how and when must be made with a risk-based approach, tailored to casodex bicalutamide local conditions. Tedros said countries experiencing significant community transmission may need to postpone such events.

Those casodex bicalutamide seeing sporadic cases or small clusters, on the other hand, can find creative ways to hold events while minimizing risk.He advocated a focus on reducing deaths by protecting the elderly, people with underlying conditions and essential workers. Countries that do this well may be able to cope with low levels of transmission as they open.Individuals must play their part by staying at least one metre away from others, cleaning their hands regularly, practicing respiratory etiquette by wearing a mask and avoiding close-contact settings.For governments, widespread stay-at-home orders can be avoided if they take temporary, geographically targeted interventions. It is important to find, isolate, test and care for COVID-19 cases – and both casodex bicalutamide trace and quarantine contacts.

WHO guidance for safe reopeningThe UN health agency chief said WHO has a range of evidence-based guidance that can be applied in different transmission scenarios, most recently for hotels, cargo ships and fishing vessels.Meanwhile, the agency is working with its partners through the ACT Accelerator and COVAX Global Vaccines Facility to ensure that a vaccine, once developed, is available equitably to all communities. He thanked the European Commission, which announced today it would join the COVAX Facility, for its €400 million contribution.Health systems under pressureTo be sure, all countries are under casodex bicalutamide extreme pressure, he declared. A WHO survey on the impact of COVID-19 on health systems in 105 countries found that 90 per cent of those surveyed have experienced disruption to their health services, with low- and middle-income countries reporting the greatest difficulties.

Most nations reported that routine and elective services have been suspended, while critical care – such as cancer screenings and treatment, and HIV therapies – have seen high-risk interruptions in low-income countries.While many casodex bicalutamide countries are now implementing WHO-recommended strategies to mitigate service disruptions, only 14 per cent have reported the removal of user fees, which WHO recommends, offsetting potential financial difficulties for patients.He said WHO is also developing the COVID-19 Health Services Learning Hub, a web-based platform that will allow countries to share their experiences.Aftermath of Beirut explosionTedros also touched on WHO’s response to the 4 August blast in Beirut, which injured 6,500 people, left more than 300,000 homeless and severely damaged health infrastructure.He said the agency is ensuring access to basic health and mental health care for the injured. It is also expanding COVID-19 testing and treatments, buying medicines and protecting health workers.To sustain these efforts, Tedros said WHO had launched a $76 million appeal. The WHO Foundation on Monday launched a casodex bicalutamide campaign into which any individual or organization can contribute.“This virus thrives when we are divided,” he said.

“When we are united, we can defeat it.”“Despite a new wave which began on 25 July which Viet Nam is now also in the process of bringing under effective control, it is globally recognized that Viet Nam demonstrated one of the world’s most successful responses to the COVID-19 pandemic between January and April 16. After that date, no cases of local transmission were casodex bicalutamide recorded for 99 consecutive days.There were less than 400 cases of infection across the country during that period, most of them imported, and zero deaths, a remarkable accomplishment considering the country’s population of 96 million people and the fact that it shares a 1,450 km land border with China.Long-term planning pays offKamal Malhotra is the UN Resident Coordinator in Viet Nam. , by UN Viet Nam/Nguyen Duc HieuViet Nam’s success has drawn international attention because of its early, proactive, response, led by the government, and involving the whole political system, and all aspects of the society.

With the support of theWorld Health Organization (WHO) and other partners, Viet Nam had already put a long-term plan in place, to enable it to cope with public health emergencies, building on its experience dealing with previous disease outbreaks, such as SARS, which it also handled remarkably well.Viet Nam’s successful management of the COVID-19 outbreak so far can, therefore, be at least partly put down to the its investment during casodex bicalutamide “peacetime”. The country has now demonstrated that preparedness to deal with infectious disease is a key ingredient for protecting people and securing public health in times of pandemics such as COVID-19.As early as January 2020, Viet Nam conducted its first risk assessment, immediately after the identification of a cluster of cases of “severe pneumonia with unknown etiology” in Wuhan, China. From the time that the first two COVID-19 cases were confirmed in Viet casodex bicalutamide Nam in the second half of January 2020, the government started to put precautionary measures into effect by strengthening entry-screening measures and extending the Tết (Lunar New Year) holiday for schools.

© UNICEFTeachers and students were able to return to school in Lao Cai, Viet Nam, in May.By 13 February 2020, the number of cases had climbed to 16 with limited local transmission detected in a village near the capital city, Hanoi. As this had the potential to cause a further spread of the virus in Viet Nam, the country implemented a targeted three-week village-wide quarantine, affecting 11,000 people casodex bicalutamide. There were then no further local cases for three weeks.But Viet Nam had simultaneously developed its broader quarantine and isolation policy to control COVID-19.

As the next wave began in early March, through an imported case from the UK, the government knew that it was crucial to contain virus transmission as fast as possible, in order also to safeguard its economy.Viet Nam therefore closed its borders and suspended international flights from mainland China in February, extending this to UK, Europe, the US and then the rest of the world progressively in March, whilst requiring all travelers entering the country, including its nationals, to undergo 14-day mandatory quarantine on arrival.This helped the authorities keep track of imported cases of COVID-19 and prevent casodex bicalutamide further local transmission which could have then led to wider community transmission. Both the military and local governments were mobilized to provide testing, meals and amenity services to all quarantine facilities which remained free during this period.No lockdown requiredWhile there was never a nationwide lockdown, some restrictive physical distancing measures were implemented throughout the country. On 1 April 2020, the Prime Minister issued a nationwide two week physical distancing directive, which was extended by a week casodex bicalutamide in major cities and hotspots.

People were advised to stay at home, non-essential businesses were requested to close, and public transportation was limited.Such measures were so successful that, by early May, following two weeks without a locally confirmed case, schools and businesses resumed their operations and people could return to regular routines. Green One casodex bicalutamide UN House, the home of most UN agencies in Viet Nam, remained open throughout this period, with the Resident Coordinator, WHO Representative and approximately 200 UN staff and consultants physically in the office throughout this period, to provide vital support to the Government and people of Viet Nam.Notably, the Vietnamese public had been exceptionally compliant with government directives and advice, partly as a result of trust built up thanks to real time, transparent communication from the Ministry of Health, supported by the WHO and other UN agencies. Innovative methods were used to keep the public informed and safe.

For instance, regular text updates were sent by the Ministry of Health, on preventive measures and casodex bicalutamide COVID-19’s symptoms. A COVID-19 song was released, with lyrics raising public awareness of the disease, which later went viral on social media with a dance challenge on Tik Tok initiated by Quang Dang, a local celebrity.. UN Viet Nam/Nguyen Duc HieuYoung people in Viet Nam take part in International Youth Day 2020 festivities casodex bicalutamide in June.

Protecting the vulnerableStill, challenges remain to ensure that the people across the country, especially the hardest hit people, from small and medium-sized enterprises (SMEs) and poor and vulnerable groups, are well served by an adequately resourced and effectively implemented social protection package. The UN casodex bicalutamide in Viet Nam is keen to help the government support clean technology-based SMEs, with the cooperation of international financial institutions, which will need to do things differently from the past and embrace a new, more inclusive and sustainable, perspective on growth.Challenges remainAs I write, Viet Nam stands at a critical point with respect to COVID-19. On 25 July, 99 days after being COVID-free in terms of local transmission, a new case was confirmed in Da Nang, a well-known tourist destination.

Hundreds of thousands of people flocked to the city and surrounding region over the summer.The government is once again demonstrating its serious commitment to containing local virus transmission. While there have been a few hundred new local transmission cases and 24 deaths, all centered in a major hospital in Danang (sadly, all the deaths were of people with multiple pre-conditions) aggressive contact tracing, proactive case management, extensive quarantining measures and comprehensive public communication activities are taking place.I am confident that the country will be successful in its efforts to once again successfully contain the virus, once more over the next few weeks.”.

€œIf countries are serious about casodex online no prescription opening, they must be serious about suppressing transmission and saving lives”, said WHO chief Tedros Adhanom Ghebreyesus, briefing reporters from Geneva. “Opening up without having control, is a recipe for disaster.”We are casodex online no prescription 8 months into the #COVID19 pandemic &. We understand that people are tired &. Yearn to get on with their lives, but no country casodex online no prescription can just pretend the pandemic is over. This virus spreads easily, &.

We all must remain serious casodex online no prescription about suppressing its transmission &. Saving lives. Pic.twitter.com/1d2jR5FfvE— Tedros Adhanom Ghebreyesus (@DrTedros) August 31, 2020 While casodex online no prescription this may seem an impossible balance, it can be done if countries are in control of transmission, he said. The more control they have, the more they can open. The reality is that coronavirus spreads easily, casodex online no prescription he said.

It can be fatal for people of all ages and most people remain susceptible.Prevention, prevention, preventionTo control transmission, he said it is essential to prevent events that lead to outbreaks. COVID-19 spreads efficiently among clusters of people, with explosive outbreaks linked to gatherings casodex online no prescription at places such as sports stadiums, nightclubs and places of worship. At the same time, there are ways to hold gatherings safely, Tedros said. Decisions about how and casodex online no prescription when must be made with a risk-based approach, tailored to local conditions. Tedros said countries experiencing significant community transmission may need to postpone such events.

Those seeing sporadic cases or small clusters, on the other hand, can find creative ways to hold events while minimizing risk.He advocated a focus on reducing deaths by protecting the elderly, people with underlying conditions and essential casodex online no prescription workers. Countries that do this well may be able to cope with low levels of transmission as they open.Individuals must play their part by staying at least one metre away from others, cleaning their hands regularly, practicing respiratory etiquette by wearing a mask and avoiding close-contact settings.For governments, widespread stay-at-home orders can be avoided if they take temporary, geographically targeted interventions. It is important to find, isolate, test and care for casodex online no prescription COVID-19 cases – and both trace and quarantine contacts. WHO guidance for safe reopeningThe UN health agency chief said WHO has a range of evidence-based guidance that can be applied in different transmission scenarios, most recently for hotels, cargo ships and fishing vessels.Meanwhile, the agency is working with its partners through the ACT Accelerator and COVAX Global Vaccines Facility to ensure that a vaccine, once developed, is available equitably to all communities. He thanked the European Commission, casodex online no prescription which announced today it would join the COVAX Facility, for its €400 million contribution.Health systems under pressureTo be sure, all countries are under extreme pressure, he declared.

A WHO survey on the impact of COVID-19 on health systems in 105 countries found that 90 per cent of those surveyed have experienced disruption to their health services, with low- and middle-income countries reporting the greatest difficulties. Most nations reported that routine and elective services have been suspended, while critical care – such as cancer screenings and treatment, and HIV therapies – have seen high-risk interruptions in low-income countries.While many countries are now implementing WHO-recommended strategies to mitigate service disruptions, only 14 per cent have reported the removal of user fees, which WHO recommends, offsetting potential financial difficulties for patients.He said WHO is also developing the COVID-19 Health Services Learning Hub, a web-based platform that will allow countries to share their experiences.Aftermath of Beirut explosionTedros also touched on WHO’s response to the casodex online no prescription 4 August blast in Beirut, which injured 6,500 people, left more than 300,000 homeless and severely damaged health infrastructure.He said the agency is ensuring access to basic health and mental health care for the injured. It is also expanding COVID-19 testing and treatments, buying medicines and protecting health workers.To sustain these efforts, Tedros said WHO had launched a $76 million appeal. The WHO Foundation on Monday launched a campaign into which any individual or casodex online no prescription organization can contribute.“This virus thrives when we are divided,” he said. “When we are united, we can defeat it.”“Despite a new wave which began on 25 July which Viet Nam is now also in the process of bringing under effective control, it is globally recognized that Viet Nam demonstrated one of the world’s most successful responses to the COVID-19 pandemic between January and April 16.

After that casodex online no prescription date, no cases of local transmission were recorded for 99 consecutive days.There were less than 400 cases of infection across the country during that period, most of them imported, and zero deaths, a remarkable accomplishment considering the country’s population of 96 million people and the fact that it shares a 1,450 km land border with China.Long-term planning pays offKamal Malhotra is the UN Resident Coordinator in Viet Nam. , by UN Viet Nam/Nguyen Duc HieuViet Nam’s success has drawn international attention because of its early, proactive, response, led by the government, and involving the whole political system, and all aspects of the society. With the support of theWorld Health Organization (WHO) and other partners, Viet Nam had already put a long-term plan in place, to enable it to cope with public health emergencies, building on its experience dealing with previous disease outbreaks, such as SARS, which it also handled remarkably well.Viet Nam’s successful management of the COVID-19 outbreak so far can, therefore, be casodex online no prescription at least partly put down to the its investment during “peacetime”. The country has now demonstrated that preparedness to deal with infectious disease is a key ingredient for protecting people and securing public health in times of pandemics such as COVID-19.As early as January 2020, Viet Nam conducted its first risk assessment, immediately after the identification of a cluster of cases of “severe pneumonia with unknown etiology” in Wuhan, China. From the time that the first two COVID-19 cases were confirmed in Viet Nam in the second half casodex online no prescription of January 2020, the government started to put precautionary measures into effect by strengthening entry-screening measures and extending the Tết (Lunar New Year) holiday for schools.

© UNICEFTeachers and students were able to return to school in Lao Cai, Viet Nam, in May.By 13 February 2020, the number of cases had climbed to 16 with limited local transmission detected in a village near the capital city, Hanoi. As this casodex online no prescription had the potential to cause a further spread of the virus in Viet Nam, the country implemented a targeted three-week village-wide quarantine, affecting 11,000 people. There were then no further local cases for three weeks.But Viet Nam had simultaneously developed its broader quarantine and isolation policy to control COVID-19. As the next wave began in early March, through casodex online no prescription an imported case from the UK, the government knew that it was crucial to contain virus transmission as fast as possible, in order also to safeguard its economy.Viet Nam therefore closed its borders and suspended international flights from mainland China in February, extending this to UK, Europe, the US and then the rest of the world progressively in March, whilst requiring all travelers entering the country, including its nationals, to undergo 14-day mandatory quarantine on arrival.This helped the authorities keep track of imported cases of COVID-19 and prevent further local transmission which could have then led to wider community transmission. Both the military and local governments were mobilized to provide testing, meals and amenity services to all quarantine facilities which remained free during this period.No lockdown requiredWhile there was never a nationwide lockdown, some restrictive physical distancing measures were implemented throughout the country.

On 1 April 2020, the casodex online no prescription Prime Minister issued a nationwide two week physical distancing directive, which was extended by a week in major cities and hotspots. People were advised to stay at home, non-essential businesses were requested to close, and public transportation was limited.Such measures were so successful that, by early May, following two weeks without a locally confirmed case, schools and businesses resumed their operations and people could return to regular routines. Green One UN House, the home of most UN agencies in Viet Nam, remained open throughout this period, with the Resident Coordinator, WHO Representative and approximately 200 UN casodex online no prescription staff and consultants physically in the office throughout this period, to provide vital support to the Government and people of Viet Nam.Notably, the Vietnamese public had been exceptionally compliant with government directives and advice, partly as a result of trust built up thanks to real time, transparent communication from the Ministry of Health, supported by the WHO and other UN agencies. Innovative methods were used to keep the public informed and safe. For instance, regular text updates were casodex online no prescription sent by the Ministry of Health, on preventive measures and COVID-19’s symptoms.

A COVID-19 song was released, with lyrics raising public awareness of the disease, which later went viral on social media with a dance challenge on Tik Tok initiated by Quang Dang, a local celebrity.. UN Viet Nam/Nguyen Duc HieuYoung people in Viet Nam take part in International Youth Day 2020 festivities casodex online no prescription in June. Protecting the vulnerableStill, challenges remain to ensure that the people across the country, especially the hardest hit people, from small and medium-sized enterprises (SMEs) and poor and vulnerable groups, are well served by an adequately resourced and effectively implemented social protection package. The UN in Viet Nam is keen to help the government support clean technology-based SMEs, with the cooperation of international casodex online no prescription financial institutions, which will need to do things differently from the past and embrace a new, more inclusive and sustainable, perspective on growth.Challenges remainAs I write, Viet Nam stands at a critical point with respect to COVID-19. On 25 July, 99 days after being COVID-free in terms of local transmission, a new case was confirmed in Da Nang, a well-known tourist destination.

Hundreds of thousands of people flocked to the city and surrounding region over the summer.The government is once again demonstrating its serious commitment to casodex online no prescription containing local virus transmission. While there have been a few hundred new local transmission cases and 24 deaths, all centered in a major hospital in Danang (sadly, all the deaths were of people with multiple pre-conditions) aggressive contact tracing, proactive case management, extensive quarantining measures and comprehensive public communication activities are taking place.I am confident that the country will be successful in its efforts to once again successfully contain the virus, once more over the next few weeks.”.

How to get casodex over the counter

Patients Figure 1 how to get casodex over the counter. Figure 1. Enrollment and Randomization how to get casodex over the counter.

Of the 1107 patients who were assessed for eligibility, 1063 underwent randomization. 541 were how to get casodex over the counter assigned to the remdesivir group and 522 to the placebo group (Figure 1). Of those assigned to receive remdesivir, 531 patients (98.2%) received the treatment as assigned.

Forty-nine patients had remdesivir treatment discontinued before day 10 because of an adverse event or a serious adverse event other than death (36 patients) or because the patient withdrew consent (13). Of those assigned to receive placebo, 518 how to get casodex over the counter patients (99.2%) received placebo as assigned. Fifty-three patients discontinued placebo before day 10 because of an adverse event or a serious adverse event other than death (36 patients), because the patient withdrew consent (15), or because the patient was found to be ineligible for trial enrollment (2).

As of April 28, 2020, a total of 391 patients in the remdesivir group and 340 in the placebo group had completed the trial through day 29, recovered, or died how to get casodex over the counter. Eight patients who received remdesivir and 9 who received placebo terminated their participation in the trial before day 29. There were 132 patients in the remdesivir group and 169 how to get casodex over the counter in the placebo group who had not recovered and had not completed the day 29 follow-up visit.

The analysis population included 1059 patients for whom we have at least some postbaseline data available (538 in the remdesivir group and 521 in the placebo group). Four of the 1063 patients were not included in the primary analysis because no postbaseline data were available at the time of the database freeze. Table 1 how to get casodex over the counter.

Table 1. Demographic and Clinical Characteristics at Baseline how to get casodex over the counter. The mean age of patients was 58.9 years, and 64.3% were male (Table 1).

On the basis of the evolving how to get casodex over the counter epidemiology of Covid-19 during the trial, 79.8% of patients were enrolled at sites in North America, 15.3% in Europe, and 4.9% in Asia (Table S1). Overall, 53.2% of the patients were white, 20.6% were black, 12.6% were Asian, and 13.6% were designated as other or not reported. 249 (23.4%) were Hispanic or Latino.

Most patients had either one (27.0%) or how to get casodex over the counter two or more (52.1%) of the prespecified coexisting conditions at enrollment, most commonly hypertension (49.6%), obesity (37.0%), and type 2 diabetes mellitus (29.7%). The median number of days between symptom onset and randomization was 9 (interquartile range, 6 to 12). Nine hundred forty-three (88.7%) how to get casodex over the counter patients had severe disease at enrollment as defined in the Supplementary Appendix.

272 (25.6%) patients met category 7 criteria on the ordinal scale, 197 (18.5%) category 6, 421 (39.6%) category 5, and 127 (11.9%) category 4. There were 46 (4.3%) patients who had missing ordinal scale data how to get casodex over the counter at enrollment. No substantial imbalances in baseline characteristics were observed between the remdesivir group and the placebo group.

Primary Outcome Figure 2. Figure 2 how to get casodex over the counter. Kaplan–Meier Estimates of Cumulative Recoveries.

Cumulative recovery estimates are shown in the overall population (Panel A), in patients with a baseline score of 4 on how to get casodex over the counter the ordinal scale (not receiving oxygen. Panel B), in those with a baseline score of 5 (receiving oxygen. Panel C), in those with a baseline score of 6 (receiving high-flow oxygen or noninvasive mechanical ventilation how to get casodex over the counter.

Panel D), and in those with a baseline score of 7 (receiving mechanical ventilation or ECMO. Panel E). Table 2 how to get casodex over the counter.

Table 2. Outcomes Overall how to get casodex over the counter and According to Score on the Ordinal Scale in the Intention-to-Treat Population. Figure 3.

Figure 3 how to get casodex over the counter. Time to Recovery According to Subgroup. The widths of the confidence intervals have not been adjusted for multiplicity and therefore cannot be used to infer treatment effects.

Race and ethnic group were reported how to get casodex over the counter by the patients. Patients in the remdesivir group had a shorter time to recovery than patients in the placebo group (median, 11 days, as compared with 15 days. Rate ratio how to get casodex over the counter for recovery, 1.32.

95% confidence interval [CI], 1.12 to 1.55. P<0.001. 1059 patients (Figure 2 and Table 2).

Among patients with a baseline ordinal score of 5 (421 patients), the rate ratio for recovery was 1.47 (95% CI, 1.17 to 1.84). Among patients with a baseline score of 4 (127 patients) and those with a baseline score of 6 (197 patients), the rate ratio estimates for recovery were 1.38 (95% CI, 0.94 to 2.03) and 1.20 (95% CI, 0.79 to 1.81), respectively. For those receiving mechanical ventilation or ECMO at enrollment (baseline ordinal scores of 7.

272 patients), the rate ratio for recovery was 0.95 (95% CI, 0.64 to 1.42). A test of interaction of treatment with baseline score on the ordinal scale was not significant. An analysis adjusting for baseline ordinal score as a stratification variable was conducted to evaluate the overall effect (of the percentage of patients in each ordinal score category at baseline) on the primary outcome.

This adjusted analysis produced a similar treatment-effect estimate (rate ratio for recovery, 1.31. 95% CI, 1.12 to 1.54. 1017 patients).

Table S2 in the Supplementary Appendix shows results according to the baseline severity stratum of mild-to-moderate as compared with severe. Patients who underwent randomization during the first 10 days after the onset of symptoms had a rate ratio for recovery of 1.28 (95% CI, 1.05 to 1.57. 664 patients), whereas patients who underwent randomization more than 10 days after the onset of symptoms had a rate ratio for recovery of 1.38 (95% CI, 1.05 to 1.81.

380 patients) (Figure 3). Key Secondary Outcome The odds of improvement in the ordinal scale score were higher in the remdesivir group, as determined by a proportional odds model at the day 15 visit, than in the placebo group (odds ratio for improvement, 1.50. 95% CI, 1.18 to 1.91.

P=0.001. 844 patients) (Table 2 and Fig. S5).

Mortality was numerically lower in the remdesivir group than in the placebo group, but the difference was not significant (hazard ratio for death, 0.70. 95% CI, 0.47 to 1.04. 1059 patients).

The Kaplan–Meier estimates of mortality by 14 days were 7.1% and 11.9% in the remdesivir and placebo groups, respectively (Table 2). The Kaplan–Meier estimates of mortality by 28 days are not reported in this preliminary analysis, given the large number of patients that had yet to complete day 29 visits. An analysis with adjustment for baseline ordinal score as a stratification variable showed a hazard ratio for death of 0.74 (95% CI, 0.50 to 1.10).

Safety Outcomes Serious adverse events occurred in 114 patients (21.1%) in the remdesivir group and 141 patients (27.0%) in the placebo group (Table S3). 4 events (2 in each group) were judged by site investigators to be related to remdesivir or placebo. There were 28 serious respiratory failure adverse events in the remdesivir group (5.2% of patients) and 42 in the placebo group (8.0% of patients).

Acute respiratory failure, hypotension, viral pneumonia, and acute kidney injury were slightly more common among patients in the placebo group. No deaths were considered to be related to treatment assignment, as judged by the site investigators. Grade 3 or 4 adverse events occurred in 156 patients (28.8%) in the remdesivir group and in 172 in the placebo group (33.0%) (Table S4).

The most common adverse events in the remdesivir group were anemia or decreased hemoglobin (43 events [7.9%], as compared with 47 [9.0%] in the placebo group). Acute kidney injury, decreased estimated glomerular filtration rate or creatinine clearance, or increased blood creatinine (40 events [7.4%], as compared with 38 [7.3%]). Pyrexia (27 events [5.0%], as compared with 17 [3.3%]).

Hyperglycemia or increased blood glucose level (22 events [4.1%], as compared with 17 [3.3%]). And increased aminotransferase levels including alanine aminotransferase, aspartate aminotransferase, or both (22 events [4.1%], as compared with 31 [5.9%]). Otherwise, the incidence of adverse events was not found to be significantly different between the remdesivir group and the placebo group.Trial Design and Oversight The RECOVERY trial was designed to evaluate the effects of potential treatments in patients hospitalized with Covid-19 at 176 National Health Service organizations in the United Kingdom and was supported by the National Institute for Health Research Clinical Research Network.

(Details regarding this trial are provided in the Supplementary Appendix, available with the full text of this article at NEJM.org.) The trial is being coordinated by the Nuffield Department of Population Health at the University of Oxford, the trial sponsor. Although the randomization of patients to receive dexamethasone, hydroxychloroquine, or lopinavir–ritonavir has now been stopped, the trial continues randomization to groups receiving azithromycin, tocilizumab, or convalescent plasma. Hospitalized patients were eligible for the trial if they had clinically suspected or laboratory-confirmed SARS-CoV-2 infection and no medical history that might, in the opinion of the attending clinician, put patients at substantial risk if they were to participate in the trial.

Initially, recruitment was limited to patients who were at least 18 years of age, but the age limit was removed starting on May 9, 2020. Pregnant or breast-feeding women were eligible. Written informed consent was obtained from all the patients or from a legal representative if they were unable to provide consent.

The trial was conducted in accordance with the principles of the Good Clinical Practice guidelines of the International Conference on Harmonisation and was approved by the U.K. Medicines and Healthcare Products Regulatory Agency and the Cambridge East Research Ethics Committee. The protocol with its statistical analysis plan is available at NEJM.org and on the trial website at www.recoverytrial.net.

The initial version of the manuscript was drafted by the first and last authors, developed by the writing committee, and approved by all members of the trial steering committee. The funders had no role in the analysis of the data, in the preparation or approval of the manuscript, or in the decision to submit the manuscript for publication. The first and last members of the writing committee vouch for the completeness and accuracy of the data and for the fidelity of the trial to the protocol and statistical analysis plan.

Randomization We collected baseline data using a Web-based case-report form that included demographic data, the level of respiratory support, major coexisting illnesses, suitability of the trial treatment for a particular patient, and treatment availability at the trial site. Randomization was performed with the use of a Web-based system with concealment of the trial-group assignment. Eligible and consenting patients were assigned in a 2:1 ratio to receive either the usual standard of care alone or the usual standard of care plus oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days (or until hospital discharge if sooner) or to receive one of the other suitable and available treatments that were being evaluated in the trial.

For some patients, dexamethasone was unavailable at the hospital at the time of enrollment or was considered by the managing physician to be either definitely indicated or definitely contraindicated. These patients were excluded from entry in the randomized comparison between dexamethasone and usual care and hence were not included in this report. The randomly assigned treatment was prescribed by the treating clinician.

Patients and local members of the trial staff were aware of the assigned treatments. Procedures A single online follow-up form was to be completed when the patients were discharged or had died or at 28 days after randomization, whichever occurred first. Information was recorded regarding the patients’ adherence to the assigned treatment, receipt of other trial treatments, duration of admission, receipt of respiratory support (with duration and type), receipt of renal support, and vital status (including the cause of death).

In addition, we obtained routine health care and registry data, including information on vital status (with date and cause of death), discharge from the hospital, and respiratory and renal support therapy. Outcome Measures The primary outcome was all-cause mortality within 28 days after randomization. Further analyses were specified at 6 months.

Secondary outcomes were the time until discharge from the hospital and, among patients not receiving invasive mechanical ventilation at the time of randomization, subsequent receipt of invasive mechanical ventilation (including extracorporeal membrane oxygenation) or death. Other prespecified clinical outcomes included cause-specific mortality, receipt of renal hemodialysis or hemofiltration, major cardiac arrhythmia (recorded in a subgroup), and receipt and duration of ventilation. Statistical Analysis As stated in the protocol, appropriate sample sizes could not be estimated when the trial was being planned at the start of the Covid-19 pandemic.

As the trial progressed, the trial steering committee, whose members were unaware of the results of the trial comparisons, determined that if 28-day mortality was 20%, then the enrollment of at least 2000 patients in the dexamethasone group and 4000 in the usual care group would provide a power of at least 90% at a two-sided P value of 0.01 to detect a clinically relevant proportional reduction of 20% (an absolute difference of 4 percentage points) between the two groups. Consequently, on June 8, 2020, the steering committee closed recruitment to the dexamethasone group, since enrollment had exceeded 2000 patients. For the primary outcome of 28-day mortality, the hazard ratio from Cox regression was used to estimate the mortality rate ratio.

Among the few patients (0.1%) who had not been followed for 28 days by the time of the data cutoff on July 6, 2020, data were censored either on that date or on day 29 if the patient had already been discharged. That is, in the absence of any information to the contrary, these patients were assumed to have survived for 28 days. Kaplan–Meier survival curves were constructed to show cumulative mortality over the 28-day period.

Cox regression was used to analyze the secondary outcome of hospital discharge within 28 days, with censoring of data on day 29 for patients who had died during hospitalization. For the prespecified composite secondary outcome of invasive mechanical ventilation or death within 28 days (among patients who were not receiving invasive mechanical ventilation at randomization), the precise date of invasive mechanical ventilation was not available, so a log-binomial regression model was used to estimate the risk ratio. Table 1.

Table 1. Characteristics of the Patients at Baseline, According to Treatment Assignment and Level of Respiratory Support. Through the play of chance in the unstratified randomization, the mean age was 1.1 years older among patients in the dexamethasone group than among those in the usual care group (Table 1).

To account for this imbalance in an important prognostic factor, estimates of rate ratios were adjusted for the baseline age in three categories (<70 years, 70 to 79 years, and ≥80 years). This adjustment was not specified in the first version of the statistical analysis plan but was added once the imbalance in age became apparent. Results without age adjustment (corresponding to the first version of the analysis plan) are provided in the Supplementary Appendix.

Prespecified analyses of the primary outcome were performed in five subgroups, as defined by characteristics at randomization. Age, sex, level of respiratory support, days since symptom onset, and predicted 28-day mortality risk. (One further prespecified subgroup analysis regarding race will be conducted once the data collection has been completed.) In prespecified subgroups, we estimated rate ratios (or risk ratios in some analyses) and their confidence intervals using regression models that included an interaction term between the treatment assignment and the subgroup of interest.

Chi-square tests for linear trend across the subgroup-specific log estimates were then performed in accordance with the prespecified plan. All P values are two-sided and are shown without adjustment for multiple testing. All analyses were performed according to the intention-to-treat principle.

The full database is held by the trial team, which collected the data from trial sites and performed the analyses at the Nuffield Department of Population Health, University of Oxford.Trial Population Table 1. Table 1. Characteristics of the Participants in the mRNA-1273 Trial at Enrollment.

The 45 enrolled participants received their first vaccination between March 16 and April 14, 2020 (Fig. S1). Three participants did not receive the second vaccination, including one in the 25-μg group who had urticaria on both legs, with onset 5 days after the first vaccination, and two (one in the 25-μg group and one in the 250-μg group) who missed the second vaccination window owing to isolation for suspected Covid-19 while the test results, ultimately negative, were pending.

All continued to attend scheduled trial visits. The demographic characteristics of participants at enrollment are provided in Table 1. Vaccine Safety No serious adverse events were noted, and no prespecified trial halting rules were met.

As noted above, one participant in the 25-μg group was withdrawn because of an unsolicited adverse event, transient urticaria, judged to be related to the first vaccination. Figure 1. Figure 1.

Systemic and Local Adverse Events. The severity of solicited adverse events was graded as mild, moderate, or severe (see Table S1).After the first vaccination, solicited systemic adverse events were reported by 5 participants (33%) in the 25-μg group, 10 (67%) in the 100-μg group, and 8 (53%) in the 250-μg group. All were mild or moderate in severity (Figure 1 and Table S2).

Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-μg group, all 15 in the 100-μg group, and all 14 in the 250-μg group, with 3 of those participants (21%) reporting one or more severe events. None of the participants had fever after the first vaccination. After the second vaccination, no participants in the 25-μg group, 6 (40%) in the 100-μg group, and 8 (57%) in the 250-μg group reported fever.

One of the events (maximum temperature, 39.6°C) in the 250-μg group was graded severe. (Additional details regarding adverse events for that participant are provided in the Supplementary Appendix.) Local adverse events, when present, were nearly all mild or moderate, and pain at the injection site was common. Across both vaccinations, solicited systemic and local adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site.

Evaluation of safety clinical laboratory values of grade 2 or higher and unsolicited adverse events revealed no patterns of concern (Supplementary Appendix and Table S3). SARS-CoV-2 Binding Antibody Responses Table 2. Table 2.

Geometric Mean Humoral Immunogenicity Assay Responses to mRNA-1273 in Participants and in Convalescent Serum Specimens. Figure 2. Figure 2.

SARS-CoV-2 Antibody and Neutralization Responses. Shown are geometric mean reciprocal end-point enzyme-linked immunosorbent assay (ELISA) IgG titers to S-2P (Panel A) and receptor-binding domain (Panel B), PsVNA ID50 responses (Panel C), and live virus PRNT80 responses (Panel D). In Panel A and Panel B, boxes and horizontal bars denote interquartile range (IQR) and median area under the curve (AUC), respectively.

Whisker endpoints are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. The convalescent serum panel includes specimens from 41 participants. Red dots indicate the 3 specimens that were also tested in the PRNT assay.

The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent serum panel. In Panel C, boxes and horizontal bars denote IQR and median ID50, respectively. Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR.

In the convalescent serum panel, red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent panel. In Panel D, boxes and horizontal bars denote IQR and median PRNT80, respectively.

Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. The three convalescent serum specimens were also tested in ELISA and PsVNA assays. Because of the time-intensive nature of the PRNT assay, for this preliminary report, PRNT results were available only for the 25-μg and 100-μg dose groups.Binding antibody IgG geometric mean titers (GMTs) to S-2P increased rapidly after the first vaccination, with seroconversion in all participants by day 15 (Table 2 and Figure 2A).

Dose-dependent responses to the first and second vaccinations were evident. Receptor-binding domain–specific antibody responses were similar in pattern and magnitude (Figure 2B). For both assays, the median magnitude of antibody responses after the first vaccination in the 100-μg and 250-μg dose groups was similar to the median magnitude in convalescent serum specimens, and in all dose groups the median magnitude after the second vaccination was in the upper quartile of values in the convalescent serum specimens.

The S-2P ELISA GMTs at day 57 (299,751 [95% confidence interval {CI}, 206,071 to 436,020] in the 25-μg group, 782,719 [95% CI, 619,310 to 989,244] in the 100-μg group, and 1,192,154 [95% CI, 924,878 to 1,536,669] in the 250-μg group) exceeded that in the convalescent serum specimens (142,140 [95% CI, 81,543 to 247,768]). SARS-CoV-2 Neutralization Responses No participant had detectable PsVNA responses before vaccination. After the first vaccination, PsVNA responses were detected in less than half the participants, and a dose effect was seen (50% inhibitory dilution [ID50].

Figure 2C, Fig. S8, and Table 2. 80% inhibitory dilution [ID80].

Fig. S2 and Table S6). However, after the second vaccination, PsVNA responses were identified in serum samples from all participants.

The lowest responses were in the 25-μg dose group, with a geometric mean ID50 of 112.3 (95% CI, 71.2 to 177.1) at day 43. The higher responses in the 100-μg and 250-μg groups were similar in magnitude (geometric mean ID50, 343.8 [95% CI, 261.2 to 452.7] and 332.2 [95% CI, 266.3 to 414.5], respectively, at day 43). These responses were similar to values in the upper half of the distribution of values for convalescent serum specimens.

Before vaccination, no participant had detectable 80% live-virus neutralization at the highest serum concentration tested (1:8 dilution) in the PRNT assay. At day 43, wild-type virus–neutralizing activity capable of reducing SARS-CoV-2 infectivity by 80% or more (PRNT80) was detected in all participants, with geometric mean PRNT80 responses of 339.7 (95% CI, 184.0 to 627.1) in the 25-μg group and 654.3 (95% CI, 460.1 to 930.5) in the 100-μg group (Figure 2D). Neutralizing PRNT80 average responses were generally at or above the values of the three convalescent serum specimens tested in this assay.

Good agreement was noted within and between the values from binding assays for S-2P and receptor-binding domain and neutralizing activity measured by PsVNA and PRNT (Figs. S3 through S7), which provides orthogonal support for each assay in characterizing the humoral response induced by mRNA-1273. SARS-CoV-2 T-Cell Responses The 25-μg and 100-μg doses elicited CD4 T-cell responses (Figs.

S9 and S10) that on stimulation by S-specific peptide pools were strongly biased toward expression of Th1 cytokines (tumor necrosis factor α >. Interleukin 2 >. Interferon γ), with minimal type 2 helper T-cell (Th2) cytokine expression (interleukin 4 and interleukin 13).

CD8 T-cell responses to S-2P were detected at low levels after the second vaccination in the 100-μg dose group (Fig. S11).Trial Design and Oversight We conducted this three-group trial at 55 hospitals in Brazil. The trial was designed by the executive committee (see the Supplementary Appendix, available with the full text of this article at NEJM.org) and approved by the Brazilian National Commission for Research Ethics, the Brazilian Health Regulatory Agency (ANVISA), and ethics committees at the participating sites.

The trial was funded by the hospitals and research institutes participating in Coalition Covid-19 Brazil (see the Supplementary Appendix). EMS Pharma provided additional funding and logistic support for the trial and also donated and supplied the trial drugs. EMS Pharma had no role in the conduct of the trial, the analysis, or the decision to submit the manuscript for publication.

The trial was overseen by an independent international data and safety monitoring committee. The executive committee vouches for the completeness and accuracy of the data and for the fidelity of the trial to the protocol (available at NEJM.org). Participants The trial included consecutive patients who were 18 years of age or older and who had been hospitalized with suspected or confirmed Covid-19 with 14 or fewer days since symptom onset.

Among the reasons for exclusion from the trial were the use of supplemental oxygen at a rate of more than 4 liters per minute as administered by a nasal cannula or at a level of at least 40% as administered by a Venturi mask. The use of supplemental oxygen administered by a high-flow nasal cannula or invasive or noninvasive ventilation. Previous use of chloroquine, hydroxychloroquine, azithromycin, or any other macrolide for more than 24 hours before enrollment (and since the onset of symptoms).

And a history of severe ventricular tachycardia or electrocardiographic findings with a corrected QT interval (QTc) of at least 480 msec. Complete information on the inclusion and exclusion criteria is provided in the Supplementary Appendix. All the patients provided written or electronic informed consent before randomization.

Randomization, Interventions, and Follow-up Patients were randomly assigned in a 1:1:1 ratio to receive standard care (control group), standard care plus hydroxychloroquine at a dose of 400 mg twice daily for 7 days (hydroxychloroquine-alone group), or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once a day for 7 days. Randomization was performed in blocks of six and was stratified according to the use or nonuse of supplemental oxygen at the time of randomization. Randomization was performed centrally by means of an electronic case-report form system (RedCap) as described in the Supplementary Appendix.12 The current standard care for Covid-19 was at the discretion of the treating physicians.

The use of glucocorticoids, other immunomodulators, antibiotic agents, and antiviral agents was allowed (see the Supplementary Appendix). The administration of hydroxychloroquine or chloroquine was not allowed in the control group, and the use of macrolides was not allowed in the control group or the hydroxychloroquine-alone group. Guidance was provided to the investigators about how to adjust or interrupt treatment according to side effects and laboratory abnormalities.

Data were collected daily, from randomization until day 15, in the electronic case-report form. For patients who were discharged before day 15, a structured telephone call to the patient or the patient’s family was conducted on or after day 15 by an interviewer who was unaware of the assigned trial group in order to assess vital status and return to routine activities. Outcomes The primary outcome was clinical status at 15 days, evaluated with the use of a seven-level ordinal scale.

Scores on the scale were defined as follows. A score of 1 indicated not hospitalized with no limitations on activities. 2, not hospitalized but with limitations on activities.

3, hospitalized and not receiving supplemental oxygen. 4, hospitalized and receiving supplemental oxygen. 5, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation.

6, hospitalized and receiving mechanical ventilation. And 7, death. Secondary outcomes included clinical status at 7 days, evaluated with the use of a six-level ordinal scale (see below and see the Supplementary Appendix).

An indication for intubation within 15 days. The receipt of supplemental oxygen administered by a high-flow nasal cannula or noninvasive ventilation between randomization and 15 days. Duration of hospital stay.

In-hospital death. Thromboembolic complications. Acute kidney injury.

And the number of days alive and free from respiratory support up to 15 days. A day alive and free from respiratory support was defined as any day in which the patient did not receive supplemental oxygen or invasive or noninvasive mechanical ventilation, from randomization to day 15. Patients who died during the 15-day window were assigned a value of 0 days alive and free from respiratory support in this assessment.

Safety outcomes are listed in the Supplementary Appendix. All the trial outcomes were assessed by the site investigators, who were aware of the trial-group assignments (except as noted above for patients who had been discharged before day 15 and who were assessed for the primary outcome by means of a blinded telephone interview). No formal adjudication of trial outcomes was performed.

Sample-Size Calculation and Protocol Changes We had originally planned for the trial to include 630 patients, using the intention-to-treat analysis population, with a six-level ordinal outcome as the primary outcome, as described in the Supplementary Appendix. However, before the first interim analysis was conducted, we changed the primary-outcome assessment to the seven-level ordinal scale and the main analysis population from the intention-to-treat population to a modified intention-to-treat population that included only patients with a diagnosis of Covid-19 that had been confirmed by reverse-transcriptase–polymerase-chain-reaction (RT-PCR) testing (using the test available at each site). The change to the use of the seven-level ordinal scale was adopted because on April 10, 2020 (before the first enrolled patient had reached 15 days of follow-up), we established the capability to obtain 15-day information on limitations on activities with the use of blinded telephone interviews.

We therefore added another level to the six-level ordinal outcome, dividing the first level (not hospitalized) into two levels (level 1, not hospitalized and with no limitations on activities. And level 2, not hospitalized but with limitations on activities). The change to the modified intention-to-treat population was adopted because, under the hypothesis that treatment would have beneficial effects on the primary outcome only for patients who had a confirmed diagnosis, the inclusion of unconfirmed cases would decrease the estimated effect size and power.

As a related change, we added external adjudication of unconfirmed cases, which were classified as probable, possible, or probably not Covid-19 (see the Supplementary Appendix). The sample size was revised with the use of the overall distribution of the seven-level ordinal outcome at day 15 observed among the first 120 patients, with the levels 1 through 7 having the following proportions of patients. 60%, 19%, 7%, 1%, 1%, 5%, and 7%, respectively.

With 630 patients who had undergone randomization and 510 patients included in the modified intention-to-treat analysis, we calculated that the trial would have 80% power to detect an odds ratio of 0.5 between groups (two-by-two comparisons), at a significance level of 5% and with Bonferroni adjustment for multiple comparisons (α=5%, divided by 3 for each comparison).13 Statistical Analysis The primary outcome was analyzed by mixed ordinal logistic regression with random intercept according to site, assuming proportional odds. We report all two-by-two comparisons. Binary outcomes were assessed with the use of a mixed logistic-regression model, except for in-hospital mortality, which was assessed with a Cox proportional-hazards model.

Continuous outcomes were evaluated by means of generalized linear regression or mixed models for repeated variables, as appropriate. All models were adjusted for age and the use of supplemental oxygen at admission. We also performed sensitivity analyses that included all the patients who had undergone randomization (intention-to-treat population) and sensitivity analyses for the primary outcome for the following groups.

Patients with definitive, probable, or possible Covid-19. And patients with definitive or probable Covid-19. Two additional populations were considered.

An efficacy population included patients with a confirmed diagnosis who received at least one dose of the assigned trial drug. The safety population included patients according to the medications received, regardless of the assigned trial group or the result of Covid-19 testing. We planned three interim analyses, to be conducted when 120 patients, 315 patients, and 504 patients had completed 15 days of follow-up.

However, only the first interim analysis was conducted. Owing to faster-than-expected enrollment, primary-outcome data for the second and third interim analyses were available only after trial recruitment was finished. After discussion with the data and safety monitoring committee, the second and third interim analyses were cancelled.

The data and safety monitoring committee used Haybittle–Peto14 stopping boundaries, with a P-value threshold of less than 0.001 to interrupt the trial for safety and a P-value threshold of less than 0.0001 to interrupt the trial for efficacy. We did not adjust the final values of the hypothesis test for sequential analyses. Analyses were performed with the use of R software (R Core Team).15 P values for the primary outcome were adjusted with the use of Bonferroni correction.

No P values are reported for secondary outcomes. The widths of the confidence intervals for the secondary outcomes have not been adjusted for multiple comparisons, so the intervals should not be used to infer definitive treatment effects. P values for the safety analyses were not adjusted given the importance of identifying potential signals of harm.

Additional details about the statistical analyses are provided in the Supplementary Appendix.Interactive GraphicThere is broad consensus that widespread SARS-CoV-2 testing is essential to safely reopening the United States. A big concern has been test availability, but test accuracy may prove a larger long-term problem.While debate has focused on the accuracy of antibody tests, which identify prior infection, diagnostic testing, which identifies current infection, has received less attention. But inaccurate diagnostic tests undermine efforts at containment of the pandemic.Diagnostic tests (typically involving a nasopharyngeal swab) can be inaccurate in two ways.

A false positive result erroneously labels a person infected, with consequences including unnecessary quarantine and contact tracing. False negative results are more consequential, because infected persons — who might be asymptomatic — may not be isolated and can infect others.Given the need to know how well diagnostic tests rule out infection, it’s important to review assessment of test accuracy by the Food and Drug Administration (FDA) and clinical researchers, as well as interpretation of test results in a pandemic.The FDA has granted Emergency Use Authorizations (EUAs) to commercial test manufacturers and issued guidance on test validation.1 The agency requires measurement of analytic and clinical test performance. Analytic sensitivity indicates the likelihood that the test will be positive for material containing any virus strains and the minimum concentration the test can detect.

Analytic specificity indicates the likelihood that the test will be negative for material containing pathogens other than the target virus.Clinical evaluations, assessing performance of a test on patient specimens, vary among manufacturers. The FDA prefers the use of “natural clinical specimens” but has permitted the use of “contrived specimens” produced by adding viral RNA or inactivated virus to leftover clinical material. Ordinarily, test-performance studies entail having patients undergo an index test and a “reference standard” test determining their true state.

Clinical sensitivity is the proportion of positive index tests in patients who in fact have the disease in question. Sensitivity, and its measurement, may vary with the clinical setting. For a sick person, the reference-standard test is likely to be a clinical diagnosis, ideally established by an independent adjudication panel whose members are unaware of the index-test results.

For SARS-CoV-2, it is unclear whether the sensitivity of any FDA-authorized commercial test has been assessed in this way. Under the EUAs, the FDA does allow companies to demonstrate clinical test performance by establishing the new test’s agreement with an authorized reverse-transcriptase–polymerase-chain-reaction (RT-PCR) test in known positive material from symptomatic people or contrived specimens. Use of either known positive or contrived samples may lead to overestimates of test sensitivity, since swabs may miss infected material in practice.1Designing a reference standard for measuring the sensitivity of SARS-CoV-2 tests in asymptomatic people is an unsolved problem that needs urgent attention to increase confidence in test results for contact-tracing or screening purposes.

Simply following people for the subsequent development of symptoms may be inadequate, since they may remain asymptomatic yet be infectious. Assessment of clinical sensitivity in asymptomatic people had not been reported for any commercial test as of June 1, 2020.Two studies from Wuhan, China, arouse concern about false negative RT-PCR tests in patients with apparent Covid-19 illness. In a preprint, Yang et al.

Described 213 patients hospitalized with Covid-19, of whom 37 were critically ill.2 They collected 205 throat swabs, 490 nasal swabs, and 142 sputum samples (median, 3 per patient) and used an RT-PCR test approved by the Chinese regulator. In days 1 through 7 after onset of illness, 11% of sputum, 27% of nasal, and 40% of throat samples were deemed falsely negative. Zhao et al.

Studied 173 hospitalized patients with acute respiratory symptoms and a chest CT “typical” of Covid-19, or SARS-CoV-2 detected in at least one respiratory specimen. Antibody seroconversion was observed in 93%.3 RT-PCR testing of respiratory samples taken on days 1 through 7 of hospitalization were SARS-CoV-2–positive in at least one sample from 67% of patients. Neither study reported using an independent panel, unaware of index-test results, to establish a final diagnosis of Covid-19 illness, which may have biased the researchers toward overestimating sensitivity.In a preprint systematic review of five studies (not including the Yang and Zhao studies), involving 957 patients (“under suspicion of Covid-19” or with “confirmed cases”), false negatives ranged from 2 to 29%.4 However, the certainty of the evidence was considered very low because of the heterogeneity of sensitivity estimates among the studies, lack of blinding to index-test results in establishing diagnoses, and failure to report key RT-PCR characteristics.4 Taken as a whole, the evidence, while limited, raises concern about frequent false negative RT-PCR results.If SARS-CoV-2 diagnostic tests were perfect, a positive test would mean that someone carries the virus and a negative test that they do not.

With imperfect tests, a negative result means only that a person is less likely to be infected. To calculate how likely, one can use Bayes’ theorem, which incorporates information about both the person and the accuracy of the test (recently reviewed5). For a negative test, there are two key inputs.

Pretest probability — an estimate, before testing, of the person’s chance of being infected — and test sensitivity. Pretest probability might depend on local Covid-19 prevalence, SARS-CoV-2 exposure history, and symptoms. Ideally, clinical sensitivity and specificity of each test would be measured in various clinically relevant real-life situations (e.g., varied specimen sources, timing, and illness severity).Assume that an RT-PCR test was perfectly specific (always negative in people not infected with SARS-CoV-2) and that the pretest probability for someone who, say, was feeling sick after close contact with someone with Covid-19 was 20%.

If the test sensitivity were 95% (95% of infected people test positive), the post-test probability of infection with a negative test would be 1%, which might be low enough to consider someone uninfected and may provide them assurance in visiting high-risk relatives. The post-test probability would remain below 5% even if the pretest probability were as high as 50%, a more reasonable estimate for someone with recent exposure and early symptoms in a “hot spot” area.But sensitivity for many available tests appears to be substantially lower. The studies cited above suggest that 70% is probably a reasonable estimate.

At this sensitivity level, with a pretest probability of 50%, the post-test probability with a negative test would be 23% — far too high to safely assume someone is uninfected.Chance of SARS-CoV-2 Infection, Given a Negative Test Result, According to Pretest Probability. The blue line represents a test with sensitivity of 70% and specificity of 95%. The green line represents a test with sensitivity of 90% and specificity of 95%.

The shading is the threshold for considering a person not to be infected (asserted to be 5%). Arrow A indicates that with the lower-sensitivity test, this threshold cannot be reached if the pretest probability exceeds about 15%. Arrow B indicates that for the higher-sensitivity test, the threshold can be reached up to a pretest probability of about 33%.

An of this graph is available at NEJM.org.The graph shows how the post-test probability of infection varies with the pretest probability for tests with low (70%) and high (95%) sensitivity. The horizontal line indicates a probability threshold below which it would be reasonable to act as if the person were uninfected (e.g., allowing the person to visit an elderly grandmother). Where this threshold should be set — here, 5% — is a value judgment and will vary with context (e.g., lower for people visiting a high-risk relative).

The threshold highlights why very sensitive diagnostic tests are needed. With a negative result on the low-sensitivity test, the threshold is exceeded when the pretest probability exceeds 15%, but with a high-sensitivity test, one can have a pretest probability of up to 33% and still, assuming the 5% threshold, be considered safe to be in contact with others.The graph also highlights why efforts to reduce pretest probability (e.g., by social distancing, possibly wearing masks) matter. If the pretest probability gets too high (above 50%, for example), testing loses its value because negative results cannot lower the probability of infection enough to reach the threshold.We draw several conclusions.

First, diagnostic testing will help in safely opening the country, but only if the tests are highly sensitive and validated under realistic conditions against a clinically meaningful reference standard. Second, the FDA should ensure that manufacturers provide details of tests’ clinical sensitivity and specificity at the time of market authorization. Tests without such information will have less relevance to patient care.Third, measuring test sensitivity in asymptomatic people is an urgent priority.

It will also be important to develop methods (e.g., prediction rules) for estimating the pretest probability of infection (for asymptomatic and symptomatic people) to allow calculation of post-test probabilities after positive or negative results. Fourth, negative results even on a highly sensitive test cannot rule out infection if the pretest probability is high, so clinicians should not trust unexpected negative results (i.e., assume a negative result is a “false negative” in a person with typical symptoms and known exposure). It’s possible that performing several simultaneous or repeated tests could overcome an individual test’s limited sensitivity.

However, such strategies need validation.Finally, thresholds for ruling out infection need to be developed for a variety of clinical situations. Since defining these thresholds is a value judgement, public input will be crucial..

Patients Figure casodex online no prescription 1 Learn More Here. Figure 1. Enrollment and casodex online no prescription Randomization. Of the 1107 patients who were assessed for eligibility, 1063 underwent randomization.

541 were assigned to the remdesivir group and casodex online no prescription 522 to the placebo group (Figure 1). Of those assigned to receive remdesivir, 531 patients (98.2%) received the treatment as assigned. Forty-nine patients had remdesivir treatment discontinued before day 10 because of an adverse event or a serious adverse event other than death (36 patients) or because the patient withdrew consent (13). Of those assigned to casodex online no prescription receive placebo, 518 patients (99.2%) received placebo as assigned.

Fifty-three patients discontinued placebo before day 10 because of an adverse event or a serious adverse event other than death (36 patients), because the patient withdrew consent (15), or because the patient was found to be ineligible for trial enrollment (2). As of April 28, 2020, a total casodex online no prescription of 391 patients in the remdesivir group and 340 in the placebo group had completed the trial through day 29, recovered, or died. Eight patients who received remdesivir and 9 who received placebo terminated their participation in the trial before day 29. There were 132 patients in the remdesivir group and 169 in the placebo group who casodex online no prescription had not recovered and had not completed the day 29 follow-up visit.

The analysis population included 1059 patients for whom we have at least some postbaseline data available (538 in the remdesivir group and 521 in the placebo group). Four of the 1063 patients were not included in the primary analysis because no postbaseline data were available at the time of the database freeze. Table 1 casodex online no prescription. Table 1.

Demographic and Clinical casodex online no prescription Characteristics at Baseline. The mean age of patients was 58.9 years, and 64.3% were male (Table 1). On the basis of casodex online no prescription the evolving epidemiology of Covid-19 during the trial, 79.8% of patients were enrolled at sites in North America, 15.3% in Europe, and 4.9% in Asia (Table S1). Overall, 53.2% of the patients were white, 20.6% were black, 12.6% were Asian, and 13.6% were designated as other or not reported.

249 (23.4%) were Hispanic or Latino. Most patients had either one (27.0%) or two or more (52.1%) of the prespecified coexisting conditions at enrollment, most commonly hypertension (49.6%), obesity (37.0%), and type 2 diabetes mellitus casodex online no prescription (29.7%). The median number of days between symptom onset and randomization was 9 (interquartile range, 6 to 12). Nine hundred forty-three (88.7%) patients had severe disease at enrollment as casodex online no prescription defined in the Supplementary Appendix.

272 (25.6%) patients met category 7 criteria on the ordinal scale, 197 (18.5%) category 6, 421 (39.6%) category 5, and 127 (11.9%) category 4. There were 46 (4.3%) patients who had missing casodex online no prescription ordinal scale data at enrollment. No substantial imbalances in baseline characteristics were observed between the remdesivir group and the placebo group. Primary Outcome Figure 2.

Figure 2 casodex online no prescription. Kaplan–Meier Estimates of Cumulative Recoveries. Cumulative recovery estimates are casodex online no prescription shown in the overall population (Panel A), in patients with a baseline score of 4 on the ordinal scale (not receiving oxygen. Panel B), in those with a baseline score of 5 (receiving oxygen.

Panel C), in those with a baseline score of 6 (receiving high-flow oxygen casodex online no prescription or noninvasive mechanical ventilation. Panel D), and in those with a baseline score of 7 (receiving mechanical ventilation or ECMO. Panel E). Table 2 casodex online no prescription.

Table 2. Outcomes Overall and According to Score casodex online no prescription on the Ordinal Scale in the Intention-to-Treat Population. Figure 3. Figure 3 casodex online no prescription.

Time to Recovery According to Subgroup. The widths of the confidence intervals have not been adjusted for multiplicity and therefore cannot be used to infer treatment effects. Race and ethnic group were reported by casodex online no prescription the patients. Patients in the remdesivir group had a shorter time to recovery than patients in the placebo group (median, 11 days, as compared with 15 days.

Rate ratio for casodex online no prescription recovery, 1.32. 95% confidence interval [CI], 1.12 to 1.55. P<0.001. 1059 patients (Figure 2 and Table 2).

Among patients with a baseline ordinal score of 5 (421 patients), the rate ratio for recovery was 1.47 (95% CI, 1.17 to 1.84). Among patients with a baseline score of 4 (127 patients) and those with a baseline score of 6 (197 patients), the rate ratio estimates for recovery were 1.38 (95% CI, 0.94 to 2.03) and 1.20 (95% CI, 0.79 to 1.81), respectively. For those receiving mechanical ventilation or ECMO at enrollment (baseline ordinal scores of 7. 272 patients), the rate ratio for recovery was 0.95 (95% CI, 0.64 to 1.42).

A test of interaction of treatment with baseline score on the ordinal scale was not significant. An analysis adjusting for baseline ordinal score as a stratification variable was conducted to evaluate the overall effect (of the percentage of patients in each ordinal score category at baseline) on the primary outcome. This adjusted analysis produced a similar treatment-effect estimate (rate ratio for recovery, 1.31. 95% CI, 1.12 to 1.54.

1017 patients). Table S2 in the Supplementary Appendix shows results according to the baseline severity stratum of mild-to-moderate as compared with severe. Patients who underwent randomization during the first 10 days after the onset of symptoms had a rate ratio for recovery of 1.28 (95% CI, 1.05 to 1.57. 664 patients), whereas patients who underwent randomization more than 10 days after the onset of symptoms had a rate ratio for recovery of 1.38 (95% CI, 1.05 to 1.81.

380 patients) (Figure 3). Key Secondary Outcome The odds of improvement in the ordinal scale score were higher in the remdesivir group, as determined by a proportional odds model at the day 15 visit, than in the placebo group (odds ratio for improvement, 1.50. 95% CI, 1.18 to 1.91. P=0.001.

844 patients) (Table 2 and Fig. S5). Mortality was numerically lower in the remdesivir group than in the placebo group, but the difference was not significant (hazard ratio for death, 0.70. 95% CI, 0.47 to 1.04.

1059 patients). The Kaplan–Meier estimates of mortality by 14 days were 7.1% and 11.9% in the remdesivir and placebo groups, respectively (Table 2). The Kaplan–Meier estimates of mortality by 28 days are not reported in this preliminary analysis, given the large number of patients that had yet to complete day 29 visits. An analysis with adjustment for baseline ordinal score as a stratification variable showed a hazard ratio for death of 0.74 (95% CI, 0.50 to 1.10).

Safety Outcomes Serious adverse events occurred in 114 patients (21.1%) in the remdesivir group and 141 patients (27.0%) in the placebo group (Table S3). 4 events (2 in each group) were judged by site investigators to be related to remdesivir or placebo. There were 28 serious respiratory failure adverse events in the remdesivir group (5.2% of patients) and 42 in the placebo group (8.0% of patients). Acute respiratory failure, hypotension, viral pneumonia, and acute kidney injury were slightly more common among patients in the placebo group.

No deaths were considered to be related to treatment assignment, as judged by the site investigators. Grade 3 or 4 adverse events occurred in 156 patients (28.8%) in the remdesivir group and in 172 in the placebo group (33.0%) (Table S4). The most common adverse events in the remdesivir group were anemia or decreased hemoglobin (43 events [7.9%], as compared with 47 [9.0%] in the placebo group). Acute kidney injury, decreased estimated glomerular filtration rate or creatinine clearance, or increased blood creatinine (40 events [7.4%], as compared with 38 [7.3%]).

Pyrexia (27 events [5.0%], as compared with 17 [3.3%]). Hyperglycemia or increased blood glucose level (22 events [4.1%], as compared with 17 [3.3%]). And increased aminotransferase levels including alanine aminotransferase, aspartate aminotransferase, or both (22 events [4.1%], as compared with 31 [5.9%]). Otherwise, the incidence of adverse events was not found to be significantly different between the remdesivir group and the placebo group.Trial Design and Oversight The RECOVERY trial was designed to evaluate the effects of potential treatments in patients hospitalized with Covid-19 at 176 National Health Service organizations in the United Kingdom and was supported by the National Institute for Health Research Clinical Research Network.

(Details regarding this trial are provided in the Supplementary Appendix, available with the full text of this article at NEJM.org.) The trial is being coordinated by the Nuffield Department of Population Health at the University of Oxford, the trial sponsor. Although the randomization of patients to receive dexamethasone, hydroxychloroquine, or lopinavir–ritonavir has now been stopped, the trial continues randomization to groups receiving azithromycin, tocilizumab, or convalescent plasma. Hospitalized patients were eligible for the trial if they had clinically suspected or laboratory-confirmed SARS-CoV-2 infection and no medical history that might, in the opinion of the attending clinician, put patients at substantial risk if they were to participate in the trial. Initially, recruitment was limited to patients who were at least 18 years of age, but the age limit was removed starting on May 9, 2020.

Pregnant or breast-feeding women were eligible. Written informed consent was obtained from all the patients or from a legal representative if they were unable to provide consent. The trial was conducted in accordance with the principles of the Good Clinical Practice guidelines of the International Conference on Harmonisation and was approved by the U.K. Medicines and Healthcare Products Regulatory Agency and the Cambridge East Research Ethics Committee.

The protocol with its statistical analysis plan is available at NEJM.org and on the trial website at www.recoverytrial.net. The initial version of the manuscript was drafted by the first and last authors, developed by the writing committee, and approved by all members of the trial steering committee. The funders had no role in the analysis of the data, in the preparation or approval of the manuscript, or in the decision to submit the manuscript for publication. The first and last members of the writing committee vouch for the completeness and accuracy of the data and for the fidelity of the trial to the protocol and statistical analysis plan.

Randomization We collected baseline data using a Web-based case-report form that included demographic data, the level of respiratory support, major coexisting illnesses, suitability of the trial treatment for a particular patient, and treatment availability at the trial site. Randomization was performed with the use of a Web-based system with concealment of the trial-group assignment. Eligible and consenting patients were assigned in a 2:1 ratio to receive either the usual standard of care alone or the usual standard of care plus oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days (or until hospital discharge if sooner) or to receive one of the other suitable and available treatments that were being evaluated in the trial. For some patients, dexamethasone was unavailable at the hospital at the time of enrollment or was considered by the managing physician to be either definitely indicated or definitely contraindicated.

These patients were excluded from entry in the randomized comparison between dexamethasone and usual care and hence were not included in this report. The randomly assigned treatment was prescribed by the treating clinician. Patients and local members of the trial staff were aware of the assigned treatments. Procedures A single online follow-up form was to be completed when the patients were discharged or had died or at 28 days after randomization, whichever occurred first.

Information was recorded regarding the patients’ adherence to the assigned treatment, receipt of other trial treatments, duration of admission, receipt of respiratory support (with duration and type), receipt of renal support, and vital status (including the cause of death). In addition, we obtained routine health care and registry data, including information on vital status (with date and cause of death), discharge from the hospital, and respiratory and renal support therapy. Outcome Measures The primary outcome was all-cause mortality within 28 days after randomization. Further analyses were specified at 6 months.

Secondary outcomes were the time until discharge from the hospital and, among patients not receiving invasive mechanical ventilation at the time of randomization, subsequent receipt of invasive mechanical ventilation (including extracorporeal membrane oxygenation) or death. Other prespecified clinical outcomes included cause-specific mortality, receipt of renal hemodialysis or hemofiltration, major cardiac arrhythmia (recorded in a subgroup), and receipt and duration of ventilation. Statistical Analysis As stated in the protocol, appropriate sample sizes could not be estimated when the trial was being planned at the start of the Covid-19 pandemic. As the trial progressed, the trial steering committee, whose members were unaware of the results of the trial comparisons, determined that if 28-day mortality was 20%, then the enrollment of at least 2000 patients in the dexamethasone group and 4000 in the usual care group would provide a power of at least 90% at a two-sided P value of 0.01 to detect a clinically relevant proportional reduction of 20% (an absolute difference of 4 percentage points) between the two groups.

Consequently, on June 8, 2020, the steering committee closed recruitment to the dexamethasone group, since enrollment had exceeded 2000 patients. For the primary outcome of 28-day mortality, the hazard ratio from Cox regression was used to estimate the mortality rate ratio. Among the few patients (0.1%) who had not been followed for 28 days by the time of the data cutoff on July 6, 2020, data were censored either on that date or on day 29 if the patient had already been discharged. That is, in the absence of any information to the contrary, these patients were assumed to have survived for 28 days.

Kaplan–Meier survival curves were constructed to show cumulative mortality over the 28-day period. Cox regression was used to analyze the secondary outcome of hospital discharge within 28 days, with censoring of data on day 29 for patients who had died during hospitalization. For the prespecified composite secondary outcome of invasive mechanical ventilation or death within 28 days (among patients who were not receiving invasive mechanical ventilation at randomization), the precise date of invasive mechanical ventilation was not available, so a log-binomial regression model was used to estimate the risk ratio. Table 1.

Table 1. Characteristics of the Patients at Baseline, According to Treatment Assignment and Level of Respiratory Support. Through the play of chance in the unstratified randomization, the mean age was 1.1 years older among patients in the dexamethasone group than among those in the usual care group (Table 1). To account for this imbalance in an important prognostic factor, estimates of rate ratios were adjusted for the baseline age in three categories (<70 years, 70 to 79 years, and ≥80 years).

This adjustment was not specified in the first version of the statistical analysis plan but was added once the imbalance in age became apparent. Results without age adjustment (corresponding to the first version of the analysis plan) are provided in the Supplementary Appendix. Prespecified analyses of the primary outcome were performed in five subgroups, as defined by characteristics at randomization. Age, sex, level of respiratory support, days since symptom onset, and predicted 28-day mortality risk.

(One further prespecified subgroup analysis regarding race will be conducted once the data collection has been completed.) In prespecified subgroups, we estimated rate ratios (or risk ratios in some analyses) and their confidence intervals using regression models that included an interaction term between the treatment assignment and the subgroup of interest. Chi-square tests for linear trend across the subgroup-specific log estimates were then performed in accordance with the prespecified plan. All P values are two-sided and are shown without adjustment for multiple testing. All analyses were performed according to the intention-to-treat principle.

The full database is held by the trial team, which collected the data from trial sites and performed the analyses at the Nuffield Department of Population Health, University of Oxford.Trial Population Table 1. Table 1. Characteristics of the Participants in the mRNA-1273 Trial at Enrollment. The 45 enrolled participants received their first vaccination between March 16 and April 14, 2020 (Fig.

S1). Three participants did not receive the second vaccination, including one in the 25-μg group who had urticaria on both legs, with onset 5 days after the first vaccination, and two (one in the 25-μg group and one in the 250-μg group) who missed the second vaccination window owing to isolation for suspected Covid-19 while the test results, ultimately negative, were pending. All continued to attend scheduled trial visits. The demographic characteristics of participants at enrollment are provided in Table 1.

Vaccine Safety No serious adverse events were noted, and no prespecified trial halting rules were met. As noted above, one participant in the 25-μg group was withdrawn because of an unsolicited adverse event, transient urticaria, judged to be related to the first vaccination. Figure 1. Figure 1.

Systemic and Local Adverse Events. The severity of solicited adverse events was graded as mild, moderate, or severe (see Table S1).After the first vaccination, solicited systemic adverse events were reported by 5 participants (33%) in the 25-μg group, 10 (67%) in the 100-μg group, and 8 (53%) in the 250-μg group. All were mild or moderate in severity (Figure 1 and Table S2). Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-μg group, all 15 in the 100-μg group, and all 14 in the 250-μg group, with 3 of those participants (21%) reporting one or more severe events.

None of the participants had fever after the first vaccination. After the second vaccination, no participants in the 25-μg group, 6 (40%) in the 100-μg group, and 8 (57%) in the 250-μg group reported fever. One of the events (maximum temperature, 39.6°C) in the 250-μg group was graded severe. (Additional details regarding adverse events for that participant are provided in the Supplementary Appendix.) Local adverse events, when present, were nearly all mild or moderate, and pain at the injection site was common.

Across both vaccinations, solicited systemic and local adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Evaluation of safety clinical laboratory values of grade 2 or higher and unsolicited adverse events revealed no patterns of concern (Supplementary Appendix and Table S3). SARS-CoV-2 Binding Antibody Responses Table 2. Table 2.

Geometric Mean Humoral Immunogenicity Assay Responses to mRNA-1273 in Participants and in Convalescent Serum Specimens. Figure 2. Figure 2. SARS-CoV-2 Antibody and Neutralization Responses.

Shown are geometric mean reciprocal end-point enzyme-linked immunosorbent assay (ELISA) IgG titers to S-2P (Panel A) and receptor-binding domain (Panel B), PsVNA ID50 responses (Panel C), and live virus PRNT80 responses (Panel D). In Panel A and Panel B, boxes and horizontal bars denote interquartile range (IQR) and median area under the curve (AUC), respectively. Whisker endpoints are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. The convalescent serum panel includes specimens from 41 participants.

Red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent serum panel. In Panel C, boxes and horizontal bars denote IQR and median ID50, respectively. Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR.

In the convalescent serum panel, red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent panel. In Panel D, boxes and horizontal bars denote IQR and median PRNT80, respectively. Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR.

The three convalescent serum specimens were also tested in ELISA and PsVNA assays. Because of the time-intensive nature of the PRNT assay, for this preliminary report, PRNT results were available only for the 25-μg and 100-μg dose groups.Binding antibody IgG geometric mean titers (GMTs) to S-2P increased rapidly after the first vaccination, with seroconversion in all participants by day 15 (Table 2 and Figure 2A). Dose-dependent responses to the first and second vaccinations were evident. Receptor-binding domain–specific antibody responses were similar in pattern and magnitude (Figure 2B).

For both assays, the median magnitude of antibody responses after the first vaccination in the 100-μg and 250-μg dose groups was similar to the median magnitude in convalescent serum specimens, and in all dose groups the median magnitude after the second vaccination was in the upper quartile of values in the convalescent serum specimens. The S-2P ELISA GMTs at day 57 (299,751 [95% confidence interval {CI}, 206,071 to 436,020] in the 25-μg group, 782,719 [95% CI, 619,310 to 989,244] in the 100-μg group, and 1,192,154 [95% CI, 924,878 to 1,536,669] in the 250-μg group) exceeded that in the convalescent serum specimens (142,140 [95% CI, 81,543 to 247,768]). SARS-CoV-2 Neutralization Responses No participant had detectable PsVNA responses before vaccination. After the first vaccination, PsVNA responses were detected in less than half the participants, and a dose effect was seen (50% inhibitory dilution [ID50].

Figure 2C, Fig. S8, and Table 2. 80% inhibitory dilution [ID80]. Fig.

S2 and Table S6). However, after the second vaccination, PsVNA responses were identified in serum samples from all participants. The lowest responses were in the 25-μg dose group, with a geometric mean ID50 of 112.3 (95% CI, 71.2 to 177.1) at day 43. The higher responses in the 100-μg and 250-μg groups were similar in magnitude (geometric mean ID50, 343.8 [95% CI, 261.2 to 452.7] and 332.2 [95% CI, 266.3 to 414.5], respectively, at day 43).

These responses were similar to values in the upper half of the distribution of values for convalescent serum specimens. Before vaccination, no participant had detectable 80% live-virus neutralization at the highest serum concentration tested (1:8 dilution) in the PRNT assay. At day 43, wild-type virus–neutralizing activity capable of reducing SARS-CoV-2 infectivity by 80% or more (PRNT80) was detected in all participants, with geometric mean PRNT80 responses of 339.7 (95% CI, 184.0 to 627.1) in the 25-μg group and 654.3 (95% CI, 460.1 to 930.5) in the 100-μg group (Figure 2D). Neutralizing PRNT80 average responses were generally at or above the values of the three convalescent serum specimens tested in this assay.

Good agreement was noted within and between the values from binding assays for S-2P and receptor-binding domain and neutralizing activity measured by PsVNA and PRNT (Figs. S3 through S7), which provides orthogonal support for each assay in characterizing the humoral response induced by mRNA-1273. SARS-CoV-2 T-Cell Responses The 25-μg and 100-μg doses elicited CD4 T-cell responses (Figs. S9 and S10) that on stimulation by S-specific peptide pools were strongly biased toward expression of Th1 cytokines (tumor necrosis factor α >.

Interleukin 2 >. Interferon γ), with minimal type 2 helper T-cell (Th2) cytokine expression (interleukin 4 and interleukin 13). CD8 T-cell responses to S-2P were detected at low levels after the second vaccination in the 100-μg dose group (Fig. S11).Trial Design and Oversight We conducted this three-group trial at 55 hospitals in Brazil.

The trial was designed by the executive committee (see the Supplementary Appendix, available with the full text of this article at NEJM.org) and approved by the Brazilian National Commission for Research Ethics, the Brazilian Health Regulatory Agency (ANVISA), and ethics committees at the participating sites. The trial was funded by the hospitals and research institutes participating in Coalition Covid-19 Brazil (see the Supplementary Appendix). EMS Pharma provided additional funding and logistic support for the trial and also donated and supplied the trial drugs. EMS Pharma had no role in the conduct of the trial, the analysis, or the decision to submit the manuscript for publication.

The trial was overseen by an independent international data and safety monitoring committee. The executive committee vouches for the completeness and accuracy of the data and for the fidelity of the trial to the protocol (available at NEJM.org). Participants The trial included consecutive patients who were 18 years of age or older and who had been hospitalized with suspected or confirmed Covid-19 with 14 or fewer days since symptom onset. Among the reasons for exclusion from the trial were the use of supplemental oxygen at a rate of more than 4 liters per minute as administered by a nasal cannula or at a level of at least 40% as administered by a Venturi mask.

The use of supplemental oxygen administered by a high-flow nasal cannula or invasive or noninvasive ventilation. Previous use of chloroquine, hydroxychloroquine, azithromycin, or any other macrolide for more than 24 hours before enrollment (and since the onset of symptoms). And a history of severe ventricular tachycardia or electrocardiographic findings with a corrected QT interval (QTc) of at least 480 msec. Complete information on the inclusion and exclusion criteria is provided in the Supplementary Appendix.

All the patients provided written or electronic informed consent before randomization. Randomization, Interventions, and Follow-up Patients were randomly assigned in a 1:1:1 ratio to receive standard care (control group), standard care plus hydroxychloroquine at a dose of 400 mg twice daily for 7 days (hydroxychloroquine-alone group), or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once a day for 7 days. Randomization was performed in blocks of six and was stratified according to the use or nonuse of supplemental oxygen at the time of randomization. Randomization was performed centrally by means of an electronic case-report form system (RedCap) as described in the Supplementary Appendix.12 The current standard care for Covid-19 was at the discretion of the treating physicians.

The use of glucocorticoids, other immunomodulators, antibiotic agents, and antiviral agents was allowed (see the Supplementary Appendix). The administration of hydroxychloroquine or chloroquine was not allowed in the control group, and the use of macrolides was not allowed in the control group or the hydroxychloroquine-alone group. Guidance was provided to the investigators about how to adjust or interrupt treatment according to side effects and laboratory abnormalities. Data were collected daily, from randomization until day 15, in the electronic case-report form.

For patients who were discharged before day 15, a structured telephone call to the patient or the patient’s family was conducted on or after day 15 by an interviewer who was unaware of the assigned trial group in order to assess vital status and return to routine activities. Outcomes The primary outcome was clinical status at 15 days, evaluated with the use of a seven-level ordinal scale. Scores on the scale were defined as follows. A score of 1 indicated not hospitalized with no limitations on activities.

2, not hospitalized but with limitations on activities. 3, hospitalized and not receiving supplemental oxygen. 4, hospitalized and receiving supplemental oxygen. 5, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation.

6, hospitalized and receiving mechanical ventilation. And 7, death. Secondary outcomes included clinical status at 7 days, evaluated with the use of a six-level ordinal scale (see below and see the Supplementary Appendix). An indication for intubation within 15 days.

The receipt of supplemental oxygen administered by a high-flow nasal cannula or noninvasive ventilation between randomization and 15 days. Duration of hospital stay. In-hospital death. Thromboembolic complications.

Acute kidney injury. And the number of days alive and free from respiratory support up to 15 days. A day alive and free from respiratory support was defined as any day in which the patient did not receive supplemental oxygen or invasive or noninvasive mechanical ventilation, from randomization to day 15. Patients who died during the 15-day window were assigned a value of 0 days alive and free from respiratory support in this assessment.

Safety outcomes are listed in the Supplementary Appendix. All the trial outcomes were assessed by the site investigators, who were aware of the trial-group assignments (except as noted above for patients who had been discharged before day 15 and who were assessed for the primary outcome by means of a blinded telephone interview). No formal adjudication of trial outcomes was performed. Sample-Size Calculation and Protocol Changes We had originally planned for the trial to include 630 patients, using the intention-to-treat analysis population, with a six-level ordinal outcome as the primary outcome, as described in the Supplementary Appendix.

However, before the first interim analysis was conducted, we changed the primary-outcome assessment to the seven-level ordinal scale and the main analysis population from the intention-to-treat population to a modified intention-to-treat population that included only patients with a diagnosis of Covid-19 that had been confirmed by reverse-transcriptase–polymerase-chain-reaction (RT-PCR) testing (using the test available at each site). The change to the use of the seven-level ordinal scale was adopted because on April 10, 2020 (before the first enrolled patient had reached 15 days of follow-up), we established the capability to obtain 15-day information on limitations on activities with the use of blinded telephone interviews. We therefore added another level to the six-level ordinal outcome, dividing the first level (not hospitalized) into two levels (level 1, not hospitalized and with no limitations on activities. And level 2, not hospitalized but with limitations on activities).

The change to the modified intention-to-treat population was adopted because, under the hypothesis that treatment would have beneficial effects on the primary outcome only for patients who had a confirmed diagnosis, the inclusion of unconfirmed cases would decrease the estimated effect size and power. As a related change, we added external adjudication of unconfirmed cases, which were classified as probable, possible, or probably not Covid-19 (see the Supplementary Appendix). The sample size was revised with the use of the overall distribution of the seven-level ordinal outcome at day 15 observed among the first 120 patients, with the levels 1 through 7 having the following proportions of patients. 60%, 19%, 7%, 1%, 1%, 5%, and 7%, respectively.

With 630 patients who had undergone randomization and 510 patients included in the modified intention-to-treat analysis, we calculated that the trial would have 80% power to detect an odds ratio of 0.5 between groups (two-by-two comparisons), at a significance level of 5% and with Bonferroni adjustment for multiple comparisons (α=5%, divided by 3 for each comparison).13 Statistical Analysis The primary outcome was analyzed by mixed ordinal logistic regression with random intercept according to site, assuming proportional odds. We report all two-by-two comparisons. Binary outcomes were assessed with the use of a mixed logistic-regression model, except for in-hospital mortality, which was assessed with a Cox proportional-hazards model. Continuous outcomes were evaluated by means of generalized linear regression or mixed models for repeated variables, as appropriate.

All models were adjusted for age and the use of supplemental oxygen at admission. We also performed sensitivity analyses that included all the patients who had undergone randomization (intention-to-treat population) and sensitivity analyses for the primary outcome for the following groups. Patients with definitive, probable, or possible Covid-19. And patients with definitive or probable Covid-19.

Two additional populations were considered. An efficacy population included patients with a confirmed diagnosis who received at least one dose of the assigned trial drug. The safety population included patients according to the medications received, regardless of the assigned trial group or the result of Covid-19 testing. We planned three interim analyses, to be conducted when 120 patients, 315 patients, and 504 patients had completed 15 days of follow-up.

However, only the first interim analysis was conducted. Owing to faster-than-expected enrollment, primary-outcome data for the second and third interim analyses were available only after trial recruitment was finished. After discussion with the data and safety monitoring committee, the second and third interim analyses were cancelled. The data and safety monitoring committee used Haybittle–Peto14 stopping boundaries, with a P-value threshold of less than 0.001 to interrupt the trial for safety and a P-value threshold of less than 0.0001 to interrupt the trial for efficacy.

We did not adjust the final values of the hypothesis test for sequential analyses. Analyses were performed with the use of R software (R Core Team).15 P values for the primary outcome were adjusted with the use of Bonferroni correction. No P values are reported for secondary outcomes. The widths of the confidence intervals for the secondary outcomes have not been adjusted for multiple comparisons, so the intervals should not be used to infer definitive treatment effects.

P values for the safety analyses were not adjusted given the importance of identifying potential signals of harm. Additional details about the statistical analyses are provided in the Supplementary Appendix.Interactive GraphicThere is broad consensus that widespread SARS-CoV-2 testing is essential to safely reopening the United States. A big concern has been test availability, but test accuracy may prove a larger long-term problem.While debate has focused on the accuracy of antibody tests, which identify prior infection, diagnostic testing, which identifies current infection, has received less attention. But inaccurate diagnostic tests undermine efforts at containment of the pandemic.Diagnostic tests (typically involving a nasopharyngeal swab) can be inaccurate in two ways.

A false positive result erroneously labels a person infected, with consequences including unnecessary quarantine and contact tracing. False negative results are more consequential, because infected persons — who might be asymptomatic — may not be isolated and can infect others.Given the need to know how well diagnostic tests rule out infection, it’s important to review assessment of test accuracy by the Food and Drug Administration (FDA) and clinical researchers, as well as interpretation of test results in a pandemic.The FDA has granted Emergency Use Authorizations (EUAs) to commercial test manufacturers and issued guidance on test validation.1 The agency requires measurement of analytic and clinical test performance. Analytic sensitivity indicates the likelihood that the test will be positive for material containing any virus strains and the minimum concentration the test can detect. Analytic specificity indicates the likelihood that the test will be negative for material containing pathogens other than the target virus.Clinical evaluations, assessing performance of a test on patient specimens, vary among manufacturers.

The FDA prefers the use of “natural clinical specimens” but has permitted the use of “contrived specimens” produced by adding viral RNA or inactivated virus to leftover clinical material. Ordinarily, test-performance studies entail having patients undergo an index test and a “reference standard” test determining their true state. Clinical sensitivity is the proportion of positive index tests in patients who in fact have the disease in question. Sensitivity, and its measurement, may vary with the clinical setting.

For a sick person, the reference-standard test is likely to be a clinical diagnosis, ideally established by an independent adjudication panel whose members are unaware of the index-test results. For SARS-CoV-2, it is unclear whether the sensitivity of any FDA-authorized commercial test has been assessed in this way. Under the EUAs, the FDA does allow companies to demonstrate clinical test performance by establishing the new test’s agreement with an authorized reverse-transcriptase–polymerase-chain-reaction (RT-PCR) test in known positive material from symptomatic people or contrived specimens. Use of either known positive or contrived samples may lead to overestimates of test sensitivity, since swabs may miss infected material in practice.1Designing a reference standard for measuring the sensitivity of SARS-CoV-2 tests in asymptomatic people is an unsolved problem that needs urgent attention to increase confidence in test results for contact-tracing or screening purposes.

Simply following people for the subsequent development of symptoms may be inadequate, since they may remain asymptomatic yet be infectious. Assessment of clinical sensitivity in asymptomatic people had not been reported for any commercial test as of June 1, 2020.Two studies from Wuhan, China, arouse concern about false negative RT-PCR tests in patients with apparent Covid-19 illness. In a preprint, Yang et al. Described 213 patients hospitalized with Covid-19, of whom 37 were critically ill.2 They collected 205 throat swabs, 490 nasal swabs, and 142 sputum samples (median, 3 per patient) and used an RT-PCR test approved by the Chinese regulator.

In days 1 through 7 after onset of illness, 11% of sputum, 27% of nasal, and 40% of throat samples were deemed falsely negative. Zhao et al. Studied 173 hospitalized patients with acute respiratory symptoms and a chest CT “typical” of Covid-19, or SARS-CoV-2 detected in at least one respiratory specimen. Antibody seroconversion was observed in 93%.3 RT-PCR testing of respiratory samples taken on days 1 through 7 of hospitalization were SARS-CoV-2–positive in at least one sample from 67% of patients.

Neither study reported using an independent panel, unaware of index-test results, to establish a final diagnosis of Covid-19 illness, which may have biased the researchers toward overestimating sensitivity.In a preprint systematic review of five studies (not including the Yang and Zhao studies), involving 957 patients (“under suspicion of Covid-19” or with “confirmed cases”), false negatives ranged from 2 to 29%.4 However, the certainty of the evidence was considered very low because of the heterogeneity of sensitivity estimates among the studies, lack of blinding to index-test results in establishing diagnoses, and failure to report key RT-PCR characteristics.4 Taken as a whole, the evidence, while limited, raises concern about frequent false negative RT-PCR results.If SARS-CoV-2 diagnostic tests were perfect, a positive test would mean that someone carries the virus and a negative test that they do not. With imperfect tests, a negative result means only that a person is less likely to be infected. To calculate how likely, one can use Bayes’ theorem, which incorporates information about both the person and the accuracy of the test (recently reviewed5). For a negative test, there are two key inputs.

Pretest probability — an estimate, before testing, of the person’s chance of being infected — and test sensitivity. Pretest probability might depend on local Covid-19 prevalence, SARS-CoV-2 exposure history, and symptoms. Ideally, clinical sensitivity and specificity of each test would be measured in various clinically relevant real-life situations (e.g., varied specimen sources, timing, and illness severity).Assume that an RT-PCR test was perfectly specific (always negative in people not infected with SARS-CoV-2) and that the pretest probability for someone who, say, was feeling sick after close contact with someone with Covid-19 was 20%. If the test sensitivity were 95% (95% of infected people test positive), the post-test probability of infection with a negative test would be 1%, which might be low enough to consider someone uninfected and may provide them assurance in visiting high-risk relatives.

The post-test probability would remain below 5% even if the pretest probability were as high as 50%, a more reasonable estimate for someone with recent exposure and early symptoms in a “hot spot” area.But sensitivity for many available tests appears to be substantially lower. The studies cited above suggest that 70% is probably a reasonable estimate. At this sensitivity level, with a pretest probability of 50%, the post-test probability with a negative test would be 23% — far too high to safely assume someone is uninfected.Chance of SARS-CoV-2 Infection, Given a Negative Test Result, According to Pretest Probability. The blue line represents a test with sensitivity of 70% and specificity of 95%.

The green line represents a test with sensitivity of 90% and specificity of 95%. The shading is the threshold for considering a person not to be infected (asserted to be 5%). Arrow A indicates that with the lower-sensitivity test, this threshold cannot be reached if the pretest probability exceeds about 15%. Arrow B indicates that for the higher-sensitivity test, the threshold can be reached up to a pretest probability of about 33%.

An of this graph is available at NEJM.org.The graph shows how the post-test probability of infection varies with the pretest probability for tests with low (70%) and high (95%) sensitivity. The horizontal line indicates a probability threshold below which it would be reasonable to act as if the person were uninfected (e.g., allowing the person to visit an elderly grandmother). Where this threshold should be set — here, 5% — is a value judgment and will vary with context (e.g., lower for people visiting a high-risk relative). The threshold highlights why very sensitive diagnostic tests are needed.

With a negative result on the low-sensitivity test, the threshold is exceeded when the pretest probability exceeds 15%, but with a high-sensitivity test, one can have a pretest probability of up to 33% and still, assuming the 5% threshold, be considered safe to be in contact with others.The graph also highlights why efforts to reduce pretest probability (e.g., by social distancing, possibly wearing masks) matter. If the pretest probability gets too high (above 50%, for example), testing loses its value because negative results cannot lower the probability of infection enough to reach the threshold.We draw several conclusions. First, diagnostic testing will help in safely opening the country, but only if the tests are highly sensitive and validated under realistic conditions against a clinically meaningful reference standard. Second, the FDA should ensure that manufacturers provide details of tests’ clinical sensitivity and specificity at the time of market authorization.

Tests without such information will have less relevance to patient care.Third, measuring test sensitivity in asymptomatic people is an urgent priority. It will also be important to develop methods (e.g., prediction rules) for estimating the pretest probability of infection (for asymptomatic and symptomatic people) to allow calculation of post-test probabilities after positive or negative results. Fourth, negative results even on a highly sensitive test cannot rule out infection if the pretest probability is high, so clinicians should not trust unexpected negative results (i.e., assume a negative result is a “false negative” in a person with typical symptoms and known exposure). It’s possible that performing several simultaneous or repeated tests could overcome an individual test’s limited sensitivity.

However, such strategies need validation.Finally, thresholds for ruling out infection need to be developed for a variety of clinical situations. Since defining these thresholds is a value judgement, public input will be crucial..

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Under Medicaid managed care. Plan formularies will be comparable to but not the same as the Medicaid formulary. Managed care plans are required can you buy casodex to have drug formularies that are “comparable” to the Medicaid fee for service formulary. Plan formularies do not have to include all drugs covered listed on the fee for service formulary, but they must include generic or therapeutic equivalents of all Medicaid covered drugs.

The Pharmacy Benefit will vary by plan. Each plan will have its own formulary and drug coverage policies like prior can you buy casodex authorization and step therapy. Pharmacy networks can also differ from plan to plan. Prescriber Prevails applies in certain drug classes.

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The Department of Health plans to build capacity for interactive searches allowing for comparison of coverage across plans in the near future. Standardized Prior Autorization (PA) Form -- The Department of Health worked with managed care plans, provider organizations and other state agencies to develop a standard prior authorization form for the pharmacy benefit in Medicaid managed care. The form will can you buy casodex be posted on the Pharmacy Information Website in July of 2013. Mail Order Drugs -- Medicaid managed care members can obtain mail order/specialty drugs at any retail network pharmacy, as long as that retail network pharmacy agrees to a price that is comparable to the mail order/specialty pharmacy price.

CAN CONSUMERS SWITCH PLANS IN ORDER TO GAIN ACCESS TO DRUGS?. Changing can you buy casodex plans is often an effective strategy for consumers eligible for both Medicaid and Medicare (dual eligibles) who receive their pharmacy service through Medicare Part D, because dual eligibles are allowed to switch plans at any time. Medicaid consumers will have this option only in the limited circumstances during the first year of enrollment in managed care. Medicaid managed care enrollees can only leave and join another plan within the first 90 days of joining a health plan.

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STEPS CONSUMERS CAN TAKE WHEN A MANAGED CARE PLAM DENIES ACCESS TO A NECESSARY DRUG As a first step, consumers should try to work with their providers to satisfy plan requirements for prior authorization or step therapy or any other utilization control requirements. If the plan still denies access, consumers can pursue review processes specific to managed care while at the same time pursuing a fair hearing. All plans are required to maintain an internal and external review process for complaints and appeals can you buy casodex of service denials. Some plans may develop special procedures for drug denials.

Information on these procedures should be provided in member handbooks. Beginning April 1, 2018, Medicaid managed care enrollees whose plan denies prior approval of a prescription drug, or discontinues a drug that had been approved, will receive an Initial Adverse Determination notice from the plan - See Model Denial IAD Notice and IAD Notice to Reduce, Suspend or can you buy casodex Stop Services The enrollee must first request an internal Plan Appeal and wait for the Plan's decision. An adverse decision is called a 'FInal Adverse Determination" or FAD. See model Denial FAD Notice and FAD Notice to Reduce, Suspend or Stop Services.

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The full Medicaid formulary can be can you buy casodex searched on the eMedNY website. Even in fee for service Medicaid, prescribers must obtain prior authorization before prescribing non-preferred drugs unless otherwise indicated. Prior authorization is required for original prescriptions, not refills. A prior authorization is effective for the original dispensing and up to five can you buy casodex refills of that prescription within the next six months.

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TPS is a temporary immigration status granted to eligible individuals of a certain country designated can you buy casodex by the Department of Homeland Security because serious temporary conditions in that country, such as armed conflict or environmental disaster, prevents people from that country to return safely. On January 21, 2010 the United States determined that individuals from Haiti warranted TPS because of the devastating earthquake that occurred there on January 12. TPS gives undocumented Haitian residents, who were living in the U.S. On January 12, 2010, protection from forcible deportation can you buy casodex and allows them to work legally.

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Related Resources on TPS and Public Health Insurance o The New York Immigration Coalition (NYIC) has compiled a list of can you buy casodex agencies, law firms, and law schools responding to the tragedy in Haiti and the designation of Haiti for Temporary Protected Status. A copy of the list is posted at the NYIC’s website at http://www.thenyic.org. o USCIS TPS website with links to status in all countries, including HAITI. O For information on eligibility for public health insurance programs call The Legal Aid Society’s Benefits Hotline 1-888-663-6880 Tuesdays, Wednesdays and Thursdays.

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The Medicaid pharmacy benefit includes all FDA approved prescription drugs, as well as some over-the-counter drugs and medical supplies. Under Medicaid managed care. Plan formularies will be comparable to but not the same as the casodex online no prescription Medicaid formulary. Managed care plans are required to have drug formularies that are “comparable” to the Medicaid fee for service formulary.

Plan formularies do not have to include all drugs covered listed on the fee for service formulary, but they must include generic or therapeutic equivalents of all Medicaid covered drugs. The Pharmacy casodex online no prescription Benefit will vary by plan. Each plan will have its own formulary and drug coverage policies like prior authorization and step therapy. Pharmacy networks can also differ from plan to plan.

Prescriber Prevails casodex online no prescription applies in certain drug classes. Prescriber prevails applys to medically necessary precription drugs in the following classes. atypical antipsychotics, anti-depressants, anti-retrovirals, anti-rejection, seizure, epilepsy, endocrine, hemotologic and immunologic therapeutics. Prescribers will need to demonstrate reasonable profession judgment and supply plans witht requested information casodex online no prescription and/or clinical documentation.

Pharmacy Benefit Information Website -- http://mmcdruginformation.nysdoh.suny.edu/-- This website provides very helpful information on a plan by plan basis regarding pharmacy networks and drug formularies. The Department of Health plans to build capacity for interactive searches allowing for comparison of coverage across plans in the near future. Standardized Prior Autorization (PA) Form -- The Department of Health worked with managed care plans, provider organizations and other state agencies to develop a standard prior authorization form for the pharmacy benefit in Medicaid casodex online no prescription managed care. The form will be posted on the Pharmacy Information Website in July of 2013.

Mail Order Drugs -- Medicaid managed care members can obtain mail order/specialty drugs at any retail network pharmacy, as long as that retail network pharmacy agrees to a price that is comparable to the mail order/specialty pharmacy price. CAN CONSUMERS casodex online no prescription SWITCH PLANS IN ORDER TO GAIN ACCESS TO DRUGS?. Changing plans is often an effective strategy for consumers eligible for both Medicaid and Medicare (dual eligibles) who receive their pharmacy service through Medicare Part D, because dual eligibles are allowed to switch plans at any time. Medicaid consumers will have this option only in the limited circumstances during the first year of enrollment in managed care.

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After the first 12 months of enrollment, Medicaid managed care enrollees can switch plans at any time. STEPS CONSUMERS CAN TAKE WHEN A MANAGED CARE PLAM DENIES ACCESS TO A NECESSARY DRUG As a first step, consumers should try to work with their providers to satisfy plan requirements for prior authorization or step therapy or any other utilization control requirements. If the plan still denies access, casodex online no prescription consumers can pursue review processes specific to managed care while at the same time pursuing a fair hearing. All plans are required to maintain an internal and external review process for complaints and appeals of service denials.

Some plans may develop special procedures for drug denials. Information on these procedures should be provided casodex online no prescription in member handbooks. Beginning April 1, 2018, Medicaid managed care enrollees whose plan denies prior approval of a prescription drug, or discontinues a drug that had been approved, will receive an Initial Adverse Determination notice from the plan - See Model Denial IAD Notice and IAD Notice to Reduce, Suspend or Stop Services The enrollee must first request an internal Plan Appeal and wait for the Plan's decision. An adverse decision is called a 'FInal Adverse Determination" or FAD.

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Enrollees who are in the first 90 days of enrollment, or past the first 12 months of enrollment also have the option of switching plans to improve access to their medications. Consumers who experience problems with access to prescription drugs should always file a complaint with the State Department of Health’s Managed Care Hotline, number casodex online no prescription listed below. ACCESSING MEDICAID'S PHARMACY BENEFIT IN FEE FOR SERVICE MEDICAID For those Medicaid recipients who are not yet in a Medicaid Managed Care program, and who do not have Medicare Part D, the Medicaid Pharmacy program covers most of their prescription drugs and select non-prescription drugs and medical supplies for Family Health Plus enrollees. Certain drugs/drug categories require the prescribers to obtain prior authorization.

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Click here to search for a specific drug from the most frequently prescribed drug list and this site can also provide you with the locations of pharmacies that provide this drug as well as their costs. Click here to view New York State Medicaid’s Pharmacy Provider casodex online no prescription Manual. WHO YOU CAN CALL FOR HELP Community Health Advocates Hotline. 1-888-614-5400 NY State Department of Health's Managed Care Hotline.

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1-800-771-7755Haitian individuals and immigrants from some other countries who have applied for Temporary Protected Status (TPS) may be eligible for public health insurance in New York State. 2019 updates - The Trump administration has taken steps to end TPS status. Two courts have temporarily enjoined the termination casodex online no prescription of TPS, one in New York State in April 2019 and one in California in October 2018. The California case was argued in an appeals court on August 14, 2019, which the LA Times reported looked likely to uphold the federal action ending TPS.

See US Immigration Website on TPS - General TPS website with links to status in all countries, including HAITI. See also Pew Research March 2019 article casodex online no prescription. Courts Block Changes in Public charge rule- See updates on the Public Charge rule here, blocked by federal court injunctions in October 2019. Read more about this change in public charge rules here.

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On January 12, 2010, protection from forcible deportation and allows them to work legally. It is important to note that the U.S. Grants TPS to individuals from other countries, as well, including individuals from El Salvador, Honduras, Nicaragua, casodex online no prescription Somalia and Sudan. TPS and Public Health Insurance TPS applicants residing in New York are eligible for Medicaid and Family Health Plus as long as they also meet the income requirements for these programs.

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All Medicaid offices and enrollers are required to offer free translation and interpretation services to anyone who cannot communicate effectively in English. A bilingual worker or an interpreter, whether in-person casodex online no prescription or over the telephone, must be provided in all interactions with the office. Important documents, such as Medicaid applications, should be translated either orally or in writing. Interpreter services must be offered free of charge, and applicants requiring interpreter services must not be made to wait unreasonably longer than English speaking applicants.

An applicant must never be asked to bring casodex online no prescription their own interpreter. Related Resources on TPS and Public Health Insurance o The New York Immigration Coalition (NYIC) has compiled a list of agencies, law firms, and law schools responding to the tragedy in Haiti and the designation of Haiti for Temporary Protected Status. A copy of the list is posted at the NYIC’s website at http://www.thenyic.org. o casodex online no prescription USCIS TPS website with links to status in all countries, including HAITI.

O For information on eligibility for public health insurance programs call The Legal Aid Society’s Benefits Hotline 1-888-663-6880 Tuesdays, Wednesdays and Thursdays. 9:30 am - 12:30 pm FOR IMMIGRATION HELP. CONTACT THE New York State New Americans Hotline for a referral to an organization to advise you. 212-419-3737 Monday-Friday, from 9:00 a.m.

To 8:00 p.m.Saturday-Sunday, from 9:00 a.m. To 5:00 p.m. Or call toll-free in New York State at 1-800-566-7636 Please see these fact sheets and web sites of national organizations for more information about the new PUBLIC CHARGE rules. Printable Fact Sheets for Distribution This article was co-authored by the New York Immigration Coalition, Empire Justice Center and the Health Law Unit of the Legal Aid Society.

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Limited resources mean that physicians must treat some patients and not others, while still treating them with equal respect. Examiners must pass some students and not others, while still can you buy casodex over the counter usa giving their work equal consideration. Employers may only be able to hire one applicant, while still being required to treat all applicants fairly, and so on. The 800 m is meant to be one of these practices.

A level and equidistance running track from which one victor is can you buy casodex over the counter usa intended to emerge. The case of Caster Semenya raises challenging questions about what makes level-playing-fields level, questions that extend beyond any given playing field.In the Feature Article for this issue Loland provides us with new and engaging reasons to support of the Court of Arbitration for Sport (CAS) decision in the Casta Semenya case. The impact of can you buy casodex over the counter usa the CAS decision requires Casta Semenya to supress her naturally occurring testosterone if she is to compete in an international athletics events. The Semenya case is described by Loland as creating a ‘dilemma of rights’.i The dilemma lies in the choice between ‘the right of Semenya to compete in sport according to her legal sex and gender identity’ and ‘the right of other athletes within the average female testosterone range to compete under fair conditions’ (see footnote i).No one denies the importance of Semenya’s right.

As Carpenter explains, ‘even where inconvenient, sex assigned at birth should always be respected unless an individual seeks otherwise’.2 Loland’s conclusions, Carpenter argues, ‘support a convenience-based approach to classification of sex where choices about the status of people with intersex variations are made by others according to their interests at that time’ (see footnote ii). Carpenter then further explains how the CAS decision is representative of ‘systemic forms of can you buy casodex over the counter usa discrimination and human rights violations’ and provides no assistance in ‘how we make the world more hospitable and more accepting of difference’ (see footnote ii).What is therefore at issue is the existence of the second right. Let me explain how Loland constructs it. The background principle is the principle of fair equality of opportunity, which requires that ‘individuals with similar endowments and talents and similar ambitions should be given similar opportunities and roughly equivalent prospects for competitive success’(see footnote i).

This principle can you buy casodex over the counter usa reflects, according to Loland, a deeper deontological right of respect and fair treatment. As we can appreciate, when it comes to the principle of fair equality of opportunity, a lot turns on what counts as ‘similar’ (or sufficiently different) endowments and talents and what counts as ‘similar’ (or sufficiently different) opportunities and prospects for success.For Loland, ‘dynamic inequalities’ concern differences in capabilities (such as strength, speed, and endurance, and in technical and tactical skills) that can be ‘cultivated by hard work and effort’ (see footnote i). These are capabilities that are ‘relevant’ can you buy casodex over the counter usa and therefore permit a range differences between otherwise ‘similar’ athletes. €˜Stable inequalities’ are characterises (such as in age, sex, body size, and disability/ability) are ‘not-relevant’ and therefore require classification to ensure that ‘similar’ athletes are given ‘roughly equivalent prospects for success’.

It follows for Loland that athletes with ‘46 XY DSD conditions (and not for individuals with normal female XX chromosones), with testosterone levels above five nanomoles per litre blood (nmol/L), and who experience a ‘material androgenizing effect’’ benefit from a stable inequality (see footnote i). Hence, the ‘other athletes within the average female testosterone can you buy casodex over the counter usa range’ therefore have a right not to compete under conditions of stable inequality. The solution, according to Knox and Anderson, lies in more nuance classifications. Commenting in (qualified) support of Loland, they suggest that ‘classification according to sex alone is no longer adequate’.3 Instead, ‘all athletes would be categorised, making classification the norm’ (see footnote iii).However, as we have just seen, Loland’s distinction between stable and dynamic inequalities depends on their ‘relevance’, and ‘relevance’ is a term that does not travel alone.

Something is relevant (or irrelevant) only in relation to the value, purpose, or aim, of can you buy casodex over the counter usa some practice. One interpretation (which I take Loland to be saying) is that strength, speed, and endurance (and so on) are ‘relevant’ to ‘performance outcomes’. This can be misleading can you buy casodex over the counter usa. Both dynamic and stable inequalities are relevant to (ie, can have an impact on) an athletic performance.

Is a question of whether we ought to permit them to have an impact. The temptation is then to say that can you buy casodex over the counter usa dynamic inequalities are relevant (and stable inequalities are irrelevant) where the aim is ‘respect and fair treatment’. But here the snake begins to eat its tail (the principle of fair treatment requires sufficiently similar prospects for success >similar prospects for success require only dynamic inequalities>dynamic inequalities are capabilities that are permitted by the principle of fair treatment).In order to determine questions of relevance, we need to identify the value, purpose, or aim, of the social practice in question. If the aim of an athletic event is to have a victor emerge from a completely level playing field, then, as Chambers notes, socioeconomic inequalities are a larger affront to fair treatment than athletes with 46 XY DSD conditions.4 If the aim is to have a victor emerge from completely level hormonal playing field then ‘a man with low testosterone levels is unfairly disadvantaged against a man whose natural levels are higher, and so men’s competitions are unfair’ (see footnote iv).

Or, at least very high testosterone males should be on hormone suppressants in order to give the ‘average’ competitor a ‘roughly equivalent prospect can you buy casodex over the counter usa for competitive success’.The problem is that we are not interested in the average competitor. We are interested in the exceptional among us. Unless, it can you buy casodex over the counter usa is for light relief. In every Olympiad there is the observation that, in every Olympic event, one average person should be included in the competition for the spectators’ reference.

The humour lies in the absurd scenarios that would follow, whether it be the 100 m sprint, high jump, or synchronised swimming. Great chasms of natural ability would be laid bare, the results of a lifetime of training and dedication would can you buy casodex over the counter usa be even clearer to see, and the last place result would be entirely predictable. But note how these are different attributes. While we may admire Olympians, it is unclear whether it is because of their God-given ability, their grit and determination, or their role in the unpredictable theatre of sport.

If sport is a worthwhile social practice, we need to start can you buy casodex over the counter usa spelling out its worth. Without doing so, we are unable to identify what capabilities are ‘relevant’ or ‘irrelevant’ to its aims, purpose or value. And until we can explain why one naturally occurring capability is ‘irrelevant’ to the aims, purposes, or values, of sport, while the remainder of them are relevant, I can only identify one right in play in the Semenya case..

Sport is predicated on the idea of casodex online no prescription victors emerging from a level playing field. All ethically informed evaluate practices are like this. They require an equality of respect, consideration, and opportunity, while casodex online no prescription trying to achieve substantively unequal outcomes. For instance.

Limited resources mean that physicians must treat some patients and not others, while still treating them with equal respect. Examiners must pass some students and not others, while casodex online no prescription still giving their work equal consideration. Employers may only be able to hire one applicant, while still being required to treat all applicants fairly, and so on. The 800 m is meant to be one of these practices.

A level and equidistance running casodex online no prescription track from which one victor is intended to emerge. The case of Caster Semenya raises challenging questions about what makes level-playing-fields level, questions that extend beyond any given playing field.In the Feature Article for this issue Loland provides us with new and engaging reasons to support of the Court of Arbitration for Sport (CAS) decision in the Casta Semenya case. The impact of the CAS decision requires Casta Semenya to supress her naturally casodex online no prescription occurring testosterone if she is to compete in an international athletics events. The Semenya case is described by Loland as creating a ‘dilemma of rights’.i The dilemma lies in the choice between ‘the right of Semenya to compete in sport according to her legal sex and gender identity’ and ‘the right of other athletes within the average female testosterone range to compete under fair conditions’ (see footnote i).No one denies the importance of Semenya’s right.

As Carpenter explains, ‘even where inconvenient, sex assigned at birth should always be respected unless an individual seeks otherwise’.2 Loland’s conclusions, Carpenter argues, ‘support a convenience-based approach to classification of sex where choices about the status of people with intersex variations are made by others according to their interests at that time’ (see footnote ii). Carpenter then further explains how the CAS decision is representative of ‘systemic forms of discrimination and human rights violations’ and provides no assistance in ‘how we make the world more hospitable and more accepting of difference’ (see casodex online no prescription footnote ii).What is therefore at issue is the existence of the second right. Let me explain how Loland constructs it. The background principle is the principle of fair equality of opportunity, which requires that ‘individuals with similar endowments and talents and similar ambitions should be given similar opportunities and roughly equivalent prospects for competitive success’(see footnote i).

This principle casodex online no prescription reflects, according to Loland, a deeper deontological right of respect and fair treatment. As we can appreciate, when it comes to the principle of fair equality of opportunity, a lot turns on what counts as ‘similar’ (or sufficiently different) endowments and talents and what counts as ‘similar’ (or sufficiently different) opportunities and prospects for success.For Loland, ‘dynamic inequalities’ concern differences in capabilities (such as strength, speed, and endurance, and in technical and tactical skills) that can be ‘cultivated by hard work and effort’ (see footnote i). These are capabilities that are ‘relevant’ and therefore permit a casodex online no prescription range differences between otherwise ‘similar’ athletes. €˜Stable inequalities’ are characterises (such as in age, sex, body size, and disability/ability) are ‘not-relevant’ and therefore require classification to ensure that ‘similar’ athletes are given ‘roughly equivalent prospects for success’.

It follows for Loland that athletes with ‘46 XY DSD conditions (and not for individuals with normal female XX chromosones), with testosterone levels above five nanomoles per litre blood (nmol/L), and who experience a ‘material androgenizing effect’’ benefit from a stable inequality (see footnote i). Hence, the ‘other athletes within the average female testosterone range’ therefore have a right not to compete under conditions of casodex online no prescription stable inequality. The solution, according to Knox and Anderson, lies in more nuance classifications. Commenting in (qualified) support of Loland, they suggest that ‘classification according to sex alone is no longer adequate’.3 Instead, ‘all athletes would be categorised, making classification the norm’ (see footnote iii).However, as we have just seen, Loland’s distinction between stable and dynamic inequalities depends on their ‘relevance’, and ‘relevance’ is a term that does not travel alone.

Something is relevant (or irrelevant) only in relation to the value, purpose, or aim, casodex online no prescription of some practice. One interpretation (which I take Loland to be saying) is that strength, speed, and endurance (and so on) are ‘relevant’ to ‘performance outcomes’. This can be misleading casodex online no prescription. Both dynamic and stable inequalities are relevant to (ie, can have an impact on) an athletic performance.

Is a question of whether we ought to permit them to have an impact. The temptation is then to say that dynamic inequalities are relevant (and stable inequalities are irrelevant) where the casodex online no prescription aim is ‘respect and fair treatment’. But here the snake begins to eat its tail (the principle of fair treatment requires sufficiently similar prospects for success >similar prospects for success require only dynamic inequalities>dynamic inequalities are capabilities that are permitted by the principle of fair treatment).In order to determine questions of relevance, we need to identify the value, purpose, or aim, of the social practice in question. If the aim of an athletic event is to have a victor emerge from a completely level playing field, then, as Chambers notes, socioeconomic inequalities are a larger affront to fair treatment than athletes with 46 XY DSD conditions.4 If the aim is to have a victor emerge from completely level hormonal playing field then ‘a man with low testosterone levels is unfairly disadvantaged against a man whose natural levels are higher, and so men’s competitions are unfair’ (see footnote iv).

Or, at least very high testosterone males should be on hormone suppressants in order to give the ‘average’ competitor a ‘roughly equivalent prospect for competitive success’.The problem is that we are not interested in the casodex online no prescription average competitor. We are interested in the exceptional among us. Unless, it is casodex online no prescription for light relief. In every Olympiad there is the observation that, in every Olympic event, one average person should be included in the competition for the spectators’ reference.

The humour lies in the absurd scenarios that would follow, whether it be the 100 m sprint, high jump, or synchronised swimming. Great chasms of natural ability would casodex online no prescription be laid bare, the results of a lifetime of training and dedication would be even clearer to see, and the last place result would be entirely predictable. But note how these are different attributes. While we may admire Olympians, it is unclear whether it is because of their God-given ability, their grit and determination, or their role in the unpredictable theatre of sport.

If sport casodex online no prescription is a worthwhile social practice, we need to start spelling out its worth. Without doing so, we are unable to identify what capabilities are ‘relevant’ or ‘irrelevant’ to its aims, purpose or value. And until we can explain why one naturally occurring capability is ‘irrelevant’ to the aims, purposes, or values, of sport, while the remainder of them are relevant, I can only identify one right in play in the Semenya case..

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