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, CMS announced additional funding to support the 2021 Special Enrollment Period (SEP) for Marketplace health coverage. Read more about the announcement and other news below.

I. Regulations, Notices & Guidance

• On March 4, 2021, the Food and Drug Agency (FDA) issued guidance entitled, COVID-19 Container Closure System and Component Changes. FDA is issuing this guidance to collate recommendations for appropriate reporting category and the content of post-approval change submissions across numerous FDA guidance documents. This guidance conveys recommendations to holders of approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) regarding the reporting and implementation of some common changes to container closure system (CCS) components consisting of glass vials and stoppers for approved sterile drug products, including biological products, administered parenterally. This guidance also discusses pathways available to application holders to obtain Agency feedback. Additionally, this guidance discusses risk-based tools available to facilitate the implementation of changes to CCSs consisting of glass vials and stoppers. This guidance does not apply to CCS types other than glass vials and stoppers.

Event Notices  

• March 18, 2021: The Agency for Healthcare Research and Quality (AHRQ) announced a public meeting entitled, Meeting of the National Advisory Council for Healthcare Research and Quality. The meeting will begin with an update on AHRQ’s recent accomplishments in Health Systems Research, Practice Improvement, Data and Analytics, and achieving organizational excellence. The agenda will also include a discussion of communication and value of health systems research, an update on PCOR Trust Funds, and a discussion of how AHRQ may advance health equity.
• March 24-25, 2021: FDA announced a public meeting entitled, Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss biologics license application (BLA) 761130, tanezumab subcutaneous injection, submitted by Pfizer Inc., for the proposed indication of relief of signs and symptoms of moderate to severe osteoarthritis in adult patients for whom use of other analgesics is ineffective or not appropriate.
• March 26, 2021: The Department of Health and Human Services (HHS) announced a public meeting entitled, Meeting of the COVID-19 Health Equity Task Force. The purpose of this meeting is to discuss equitable vaccine access and acceptance.
• March 31, 2021: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting entitled, Meeting of the Center for Substance Abuse Treatment. The agenda will include consideration of minutes from the SAMHSA CSAT NAC meeting of September 22, 2020; an update on CSAT activities; a discussion with SAMHSA leadership; a discussion about the use of technology in prevention and treatment of substance use disorders; and a discussion on rural and frontier communities.
• April 6, 2021: FDA announced a public meeting entitled, Meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the TransMedics Organ Care System (OCS) Heart, by TransMedics, Inc.
• April 15, 2021: FDA announced a public meeting entitled, Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee. The committee will discuss biologics license application (BLA) 125734 for donislecel (purified allogeneic deceased donor pancreas derived islets of Langerhans). The applicant, CellTrans, Inc., has requested an indication for the “treatment of brittle Type 1 diabetes mellitus (T1D).”

II. Congressional Hearings

U.S. House of Representatives

• On March 2, 2021, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, The Future of Telehealth: How COVID-19 is Changing the Delivery of Virtual Care. Witnesses present included: Dr. Megan Mahoney, Chief of Staff, Stanford Health Care; Dr. Ateev Mehrotra, Associate Professor of Health Care Policy, Harvard Medical School; Elizabeth Mitchell, President and CEO, Purchaser Business Group on Health; Dr. Jack Resneck, Board of Trustees, American Medical Association (AMA); and Frederic Riccardi, President, Medicare Rights Center.

III. Reports, Studies & Analyses

• On March 1, 2021, Kaiser Family Foundation (KFF) published an issue brief entitled, Limiting Private Insurance Reimbursement to Medicare Rates Would Reduce Health Spending by About $350 Billion in 2021. In this analysis, the authors use data from MarketScan and FAIR Health to estimate the total annual reduction in health care spending by employers and privately insured individuals that would result from having private insurers reimburse hospitals and other health care providers at Medicare rates. A variety of policy levers could be used to move the health system in this direction, including Medicare for all, a public option, or regulatory controls over private prices. The estimate illustrates the extreme of what could be accomplished in terms of reductions in spending; smaller reductions would be achieved if private sector health care prices were reduced to some multiple of current Medicare rates or if lower rates were phased in gradually. The authors discuss but do not model the potential effects of price reductions on the supply of services, utilization of health care services, or quality of health care. The authors also do not estimate the effects on tax obligations for individuals or employers, nor quantify the impact of this change on the federal budget or the Medicare program.
• On March 1, 2021, the Government Accountability Office (GAO) published a report entitled, Medicare Part B: Payments and Use for Selected New, High-Cost Drugs. The Consolidated Appropriations Act, 2018 included a provision for GAO to review the effect of Medicare's policy for packaging high-cost drugs after their pass-through payments have expired. This report describes (1) the payments associated with selected high-cost drugs when eligible for pass-through payments versus when packaged, and (2) hospitals' use of those drugs when eligible for pass-through payments versus when packaged.
• On March 3, 2021, GAO published Congressional testimony entitled, Drug Safety: FDA's Future Inspection Plans Need to Address Issues Presented by COVID-19 Backlog. GAO has had long-standing concerns about FDA's ability to oversee the increasingly global pharmaceutical supply chain, an issue highlighted in GAO's High Risk Series since 2009. This testimony is largely based on GAO's Drug Manufacturing Inspections enclosure in its January 2021 CARES Act report, as well as GAO's December 2019 and June 2020 testimonies. Specifically, it discusses (1) the number of FDA's foreign inspections, (2) FDA's response to the COVID-19 pandemic pause in inspections, and (3) persistent foreign inspection challenges. For that work, GAO examined FDA data from fiscal years 2012 through 2020, interviewed FDA investigators, and reviewed documents related to drug oversight during the COVID-19 pandemic, among other things.

IV. Other Health Policy News

• On March 1, 2021, the Centers for Medicare & Medicaid Services (CMS) announced that it is making approximately $2.3 million in additional funding available to current Navigator grantees in Federally-facilitated Marketplace (FFM) states to support the outreach, education and enrollment efforts around the 2021 Special Enrollment Period (SEP) that runs through May 15, 2021. The 30 organizations eligible to receive these funds work across 28 FFM states to help consumers access financial assistance through HealthCare.gov, complete their applications, and enroll in coverage through the Marketplace, Medicaid, or the Children’s Health Insurance Program (CHIP). More information about this announcement can be found here.
• On March 2, 2021, HHS announced additional Biden-Harris Administration appointments, building on an experienced team committed to President Biden’s mission to end the COVID-19 pandemic, expand affordable health care, and advance equity. More information about the new appointees and their roles can be found here.
• On March 2, 2021, the Biden Administration announced a historic manufacturing collaboration between two of the largest U.S. health care and pharmaceutical companies, Merck and Johnson & Johnson (J&J), to expand production of J&J’s COVID-19 vaccine. The collaboration will increase manufacture of vaccine drug substance, as well as its fill-finish capacity – two of the biggest bottlenecks facing J&J in the production of its vaccine. More information about this announcement can be found here.

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