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:
This week, HHS announced it is providing $150 million to community-based health care providers to aid their response to COVID-19. Read more about this funding and other news below.
I. Regulations, Notices & Guidance
- On April 21, 2021, the Department of Health and Human Services (HHS) issued a final rule entitled, National Vaccine Injury Compensation Program: Rescission of Revisions to the Vaccine Injury Table. This action rescinds in its entirety the rule entitled “National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table,” published in the Federal Register on January 21, 2021.
- On April 23, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare Program; Durable Medical Equipment Fee Schedule Adjustments to Resume the Transitional 50/50 Blended Rates to Provide Relief in Rural Areas and Non-Contiguous Areas; Extension of Timeline for Final Rule Publication. This document announces the continuation of effectiveness of a Medicare interim final rule and the extension of the timeline for publication of the final rule regarding the 50/50 blended rates for rural areas and non-contiguous areas for durable medical equipment (DME). Section 1871(a)(3)(B) of the Social Security Act (the Act) specifies that a Medicare final rule must be published no later than 3 years after the publication date of the proposed or interim final rule, except under exceptional circumstances. In accordance with sections 1871(a)(3)(B) and 1871(a)(3)(C) of the Act, CMS is providing a notification of continuation for a Medicare interim final rule, announcing the different timeline on which CMS intends to publish the final rule, and explaining why CMS was unable to publish the final rule on the regular, required 3-year timeline.
- April 30, 2021: HHS announced a public meeting entitled, Meeting of the COVID-19 Health Equity Task Force. The purpose of this meeting is to consider interim recommendations specific to mental and behavioral health across the life course.
- May 5, 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 dengue vaccine and rabies vaccines. No recommendation votes are scheduled.
- May 5, 2021: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting entitled, Meeting of the Advisory Committee for Women’s Services (ACWS). The meeting will include discussions on assessing SAMHSA’s current strategies, including the mental health and substance use needs of the women and girl’s population. Additionally, the ACWS will be addressing priorities regarding the impact of COVID-19 on the behavioral health needs of women and children and directions around behavioral health services and access for women and children.
- May 11-12, 2021: The Food and Drug Administration (FDA) announced a public meeting entitled, Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. The general function of the subcommittee is to provide advice and recommendations to FDA on regulatory issues.
- May 13-14, 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 (ACHDNC). During the meeting, ACHDNC will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening.
- May 18-19, 2021: FDA announced a public meeting entitled, Potential Medication Error Risks with Investigational Drug Container Labels. The purpose of the public meeting is to solicit input from stakeholders (e.g., sponsors, clinical sites, entities that supply or otherwise label investigational drugs) on the risk of medication errors potentially related to the content and format of information on investigational drug container labels, the prevalence and nature of such errors, and to gather information on practices that minimize the potential for medication errors.
- June 9, 2021: FDA announced a public workshop entitled, Model Informed Drug Development Approaches for Immunogenicity Assessments. The purpose of this public workshop is to discuss the best practices and future directions of quantitative methods for predicting immunogenicity of biological products.
- June 16-17, 2021: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee (NVAC). During this meeting, NVAC will hear presentations on vaccine safety, communication activities for COVID-19 vaccines, and immunization equity.
- June 23, 2021: FDA announced a public workshop entitled, Fiscal Year 2021 Generic Drug Science and Research Initiatives Workshop. The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives.
II. Congressional Hearings
- On April 22, 2021, the Senate Committee on Health, Education, Labor, and Pensions held a hearing entitled, Protecting U.S. Biomedical Research: Efforts to Prevent Undue Foreign Influence. Witnesses present included: Dr. Michael Lauer, Deputy Director for Extramural Research, National Institutes for Health (NIH); Lisa Aguirre, Acting Director, Office of National Security, HHS; Gary Cantrell, Deputy Inspector General for Investigations, Office of Inspector General (OIG), HHS; and Candice Wright, Acting Director, Science, Technology Assessment, and Analytics, U.S. Government Accountability Office (GAO).
III. Reports, Studies & Analyses
- On April 19, 2021, RAND Corporation published a report entitled, Barriers to Price and Quality Transparency in Health Care Markets. Consumers of health care in the United States often lack information on the actual prices of the care they receive and can also lack access to information about the quality of their care. RAND researchers gathered information on how health care prices are set, price variation in health care markets, barriers to price and quality transparency for consumers, and the extent to which price and quality information is used in marketing efforts.
- On April 19, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, Relatively Few Drugs Account for a Large Share of Medicare Prescription Drug Spending. Drug pricing proposals raise the question of whether limiting the number of drugs subject to government price negotiation or international reference pricing might leave substantial savings on the table, even if this approach is more administratively feasible than subjecting all drugs to negotiation or reference pricing. This analysis provides context for this question by measuring the share of total Medicare Part D and Part B drug spending accounted for by top-selling drugs covered under each part. For this analyses, the authors ranked drugs by total spending in 2019, based on data from the Centers for Medicare & Medicaid Services’ Medicare Part D and Part B drug spending dashboards. For Part D, the authors calculated estimates of net total spending, taking into account average rebates reported by the Congressional Budget Office.
- On April 21, 2021, RAND Corporation published a research brief entitled, Reducing Hospital Spending: Three Policy Options. Hospital care accounts for one-third of total U.S. health care expenditures, which in 2018 totaled $1.2 trillion. Private insurers pay 40 percent of these costs. To address concerns about high and growing health care spending, policymakers have proposed reforms to reduce hospital prices. This research brief analyzes three policy options that have been proposed as ways to reduce hospital prices paid by private health plans: regulating prices, improving price transparency, and decreasing concentration in hospital markets to enhance price competition.
- On April 22, 2021, KFF published an issue brief entitled, Filling the Coverage Gap: Policy Options and Considerations. President Biden proposed during his campaign that a public option insurance plan would be broadly available and automatically enroll people in the coverage gap, but such a plan would be difficult to pass in a closely divided Congress. This issue brief examines some of the other options policymakers may consider to extend coverage to people in the gap, including increased fiscal incentives for states, a narrower public option, and making people with incomes below the poverty level eligible for enhanced Affordable Care Act (ACA) premium subsidies.
IV. Other Health Policy News
- On April 19, 2021, HHS announced the availability of nearly $150 million to community-based health care providers to aid their response to COVID-19. These funds will support approximately 100 Health Center Program look-alikes to respond to and mitigate the spread of COVID-19, strengthen vaccination efforts, and enhance health care services and infrastructure in communities across the country. More information about the announcement can be found here.
- On April 21, 2021, HHS announced that to continue its efforts to increase access to enrollment assistance for consumers, CMS will make $80 million available in grants to Navigators in Federal Marketplaces for the 2022 plan year. The funding, which will be used for outreach and education efforts, is the largest allocation CMS has made available for Navigator grants to date and represents an eight-fold increase in funding from the previous year. More information about the funding can be found here.
- On April 22, 2021, the Senate Committee on Finance held a business meeting to consider the nomination of Andrea Palm to serve as Deputy Secretary for HHS and Chiquita Brooks-LaSure to serve as CMS. The Committee advanced the nomination of Andrea Palm by a 20-8 vote; however, Ms. Brooks-LaSure’s nomination was split 14-14 along party lines. The nominations can now move to a Senate vote, but that process is likely to be slowed by the party split.