Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
On Thursday, HHS responded to President Biden’s executive order by announcing a Special Enrollment Period for Marketplace coverage starting Feb. 15. Read more about this action and other news below.
I. Regulations, Notices & Guidance
- On January 29, 2021, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) delayed implementation of a final rule entitled, Fraud and Abuse: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees. In accordance with the memorandum of January 20, 2021, from the Assistant to the President and Chief of Staff, entitled “Regulatory Freeze Pending Review,” and given the pendency of litigation, Pharmaceutical Care Management Association v. U.S. Department of Health and Hum an Services, et al., Civil Action No. 21-95 (JDB) (D.D.C.), challenging the final rule, this action temporarily delays for 60 days from the date of the memorandum the effective date of certain amendments as promulgated by the final rule titled “Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees.” This document announces that the effective date for the certain provisions of the final rule is delayed until March 22, 2021, the first business day after 60 days from the date of the memorandum. This document also corrects a technical error in the amendatory instructions.
- On January 29, 2021, the Centers for Medicare & Medicaid Services (CMS) delayed implementation of a final rule entitled, Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations. In accordance with the memorandum of January 20, 2021, from the Assistant to the President and Chief of Staff, entitled "Regulatory Freeze Pending Review," this action temporarily delays for 60 days the effective date of part of the final rule entitled, “Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations; Final Rule.” The effective date of the rule delayed to March 30, 2021. CMS is also providing an additional 30-day public comment period.
- On January 29, 2021, CMS delayed implementation of a final rule entitled, Secure Electronic Prior Authorization For Medicare Part D Program; Delay in Effective Date. In accordance with the memorandum of January 20, 2021 from the Assistant to the President and the Chief of Staff, entitled “Regulatory Review,” this action temporarily delays for 60 days the effective date of the December 31, 2020 final rule entitled, “Medicare Program; Secure Electronic Prior Authorization For Medicare Part D.” The effective date of the rule is delayed to March 30, 2021.
- February 2, 2021: FDA announced a public meeting entitled, Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials. The meeting is intended to gather industry, patient, clinician, researcher, institutional review board, ethicist, professional society and other stakeholder input on the scientific and ethical issues that surround the inclusion of pregnant women in clinical trials for drug development.
- February 2, 2021: The National Institutes of Health (NIH) announced a public meeting entitled, Meeting of the National Advisory Child Health and Human Development Council. The agenda will include opening remarks, administrative matters, Director’s Report, Division of Extramural Research Report, and other business of the Council.
- February 4, 2021: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee (NVAC). NVAC will hear presentations on vaccine safety, communication activities for COVID-19 vaccines, and immunization equity.
- February 10-11, 2021: HHS announced a public meeting entitled, Meeting of the Presidential Advisory Council on Combatting Antibiotic-Resistant Bacteria (PACCARB). The February 10-11 public meeting will be dedicated to presentations from two new working groups of the PACCARB, one on Inter-Professional Education and another on Antibiotics Access and Use, which were formed in response to a task letter from the Assistant Secretary for Health. The two-day virtual public meeting will also include an update on the impact of COVID-19 on antimicrobial resistance.
- February 11, 2021: NIH announced a public meeting entitled, Meeting of the National Cancer Institute President’s Cancer Panel. The purpose of the meeting is to discuss innovation to increase cancer screening.
- February 11-12, 2021: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. During the meeting, the Advisory Committee will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening. Agenda items include a presentation on potential processes for reviewing conditions on the RUSP; potential revisions to the condition nomination form; continuity of operations planning; innovations in long-term follow-up for conditions identified through newborn screening; and workgroup dates.
- February 17, 2021: HHS announced a public meeting entitled, Tenth Meeting of the National Clinical Care Commission. The tenth meeting will consist of updates from the Commission’s three subcommittees, and include another round of potential “action plans,” or recommendations, from each subcommittee.
- February 24-25, 2021: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on cholera vaccine, hepatitis B vaccine, influenza vaccines, zoster vaccine, orthopoxvirus vaccine, pneumococcal vaccine, rabies vaccine, and tickborne encephalitis vaccine. A recommendation vote on the rabies vaccine is scheduled.
II. Congressional Hearings
There were no health-related Congressional events this week.
III. Reports, Studies & Analyses
- On January 25, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, Key Issues for State Medicaid Programs When the COVID-19 Public Health Emergency Ends. The change in Presidential administration could have implications for state planning and decisions at the end of the Public Health Emergency (PHE), as the Biden Administration could revise the December 2020 guidance as well as the Trump Administration’s interim final rule (IFR) governing Maintenance of Eligibility provisions. Because the Trump Administration did not finalize the IFR following the end of the comment period in January, the Biden Administration will have the opportunity to review comments and could make modifications in response to comments before finalizing the rule. This brief highlights key issues from the new CMS guidance to states as issued in December 2020.
- On January 26, 2021, KFF published an issue brief entitled, Racial Diversity within COVID-19 Vaccine Clinical Trials: Key Questions and Answers. In this report, the authors review why racial diversity within COVID-19 vaccine clinical trials is important, discuss the barriers to participation in clinical trials among people of color, and examine the racial/ethnic composition of clinical trial participants for the Pfizer-BioNTech and Moderna vaccines.
- On January 28, 2021, the Government Accountability Office (GAO) published a report entitled, COVID-19: Critical Vaccine Distribution, Supply Chain, Program Integrity, and Other Challenges Require Federal Attention. The CARES Act includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This report examines the federal government’s continued efforts to respond to and recover from the COVID-19 pandemic. GAO is making 13 new recommendations for agencies that are detailed in this report.
- On January 28, 2021, RAND Corporation published a report entitled, International Prescription Drug Price Comparisons: Current Empirical Estimates and Comparisons with Previous Studies. The United States spends more on prescription drugs on a per capita basis than most other countries do. This report summarizes findings related to international prescription drug price comparisons presented in prior studies and presents new price comparisons that are based on 2018 data—both overall results and narrower analyses on specific categories of drugs, such as brand-name originator drugs, unbranded generic drugs, biologics, and nonbiologic drugs. The report also presents results from sensitivity analyses using different methodological steps and assumptions, such as prices and volume aggregated at different levels and volume weights calculated in different ways.
- On January 29, 2021, the Bipartisan Policy Center (BPC) published a report entitled, COVID-19: Urgent Federal Actions to Accelerate America’s Response. BPC looks forward to working with the 117th Congress and the new administration to effectively implement the new law, achieve consensus on additional legislative action, and institute further actions necessary to save lives and reduce the transmission of the virus. In this report, BPC’s health care leaders outline short-term recommendations for immediate execution to address the challenges of the current pandemic. They recommend focusing on six key issues: (1) testing and contact tracing; (2) vaccine transparency, equitable distribution, and uptake; (3) surge capacity; (4) supply chain management; (5) racial disparities; and (6) state, local, and provider funding.
IV. Other Health Policy News
- On January 28, 2021, HHS issued a fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to add additional categories of qualified persons authorized to prescribe, dispense, and administer COVID-19 vaccines authorized by the FDA. The amendment: (1) authorizes any healthcare provider who is licensed or certified in a state to prescribe, dispense, and/or administer COVID-19 vaccines in any other state or U.S. territory; (2) authorizes any physician, registered nurse, or practical nurse whose license or certification expired within the past five years to prescribe, dispense and/or administer COVID-19 vaccines in any state or U.S. territory so long as the license or certification was active and in good standing prior to the date it went inactive; and (3) requires any healthcare professional described above to complete CDC COVID-19 Vaccine Training and, for healthcare providers who are not currently practicing or whose license or certification is expired, requires an on-site observation period by a currently practicing healthcare professional. More information about this amendment can be found here.
- On January 28, 2021, President Joe Biden signed an executive order intended to strengthen Medicaid and the Affordable Care Act (ACA) and a memorandum on protecting women’s health. The executive order, entitled Strengthening Medicaid and the Affordable Care Act, directs the HHS Secretary to consider establishing a Special Enrollment Period (SEP) for uninsured and underinsured Americans to seek coverage through the Federally Facilitated Marketplace. The executive order also directs the heads of agencies with authorities related to Medicaid and the ACA to review several aspects of the programs. Additionally, the executive order revokes two of former president Trump’s executive orders—Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal and Promoting Healthcare Choice and Competition Across the United States—and directs agencies to consider suspending, revising, or rescinding any agency actions related to those Trump-era orders. The memorandum on Protecting Women’s Health at Home and Abroad states the new administration’s support for women’s reproductive health.
- On January 28, 2021, in response to President Biden’s executive order on strengthening Medicaid and the ACA, HHS announced an SEP for individuals and families for Marketplace coverage in response to the COVID-19 PHE. The SEP will begin on February 15, 2021 and extend through May 15, 2021. More information about the SEP can be found here.
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