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, President Biden unveiled a $2.25 trillion infrastructure and tax proposal called the American Jobs Plan. Read more about the plan and other news below.

I. Regulations, Notices & Guidance

• On March 30, 2021, the Department of Health and Human Services (HHS) issued its Semiannual Regulatory Agenda. HHS is the Federal government's lead agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. HHS enhances the health and well-being of Americans by promoting effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. This Agenda presents the regulatory activities that the Department expects to undertake in the foreseeable future to advance this mission. HHS has an agency-wide effort to support the Agenda's purpose of encouraging more effective public participation in the regulatory process.

Event Notices 

• April 6, 2021: The Food and Drug Administration (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).”
• 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 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 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

There were no health-related Congressional hearings this week.

III. Reports, Studies & Analyses

• On March 30, 2021, the Bipartisan Policy Center (BPC) published a report entitled, Tackling America’s Mental Health and Addiction Crisis Through Primary Care Integration. BPC’s recommendations provide a clear pathway to integration within both existing and new value-based payment structures. They improve the ability of primary care clinicians to handle some behavioral health needs of their patients by providing enhanced payments, training, and technical assistance, and improving access to behavioral health providers for consultation and referral. In order to expand the current workforce and guarantee accessibility, the task force recommends extending federal health care program payments to additional types of providers and reinforcing network adequacy requirements in health plan networks. The recommendations would also address workforce shortages by permanently breaking down barriers to the use of telehealth services.

IV. Other Health Policy News

• On March 29, 2021, HHS announced that through a partnership between the CDC and the Administration for Community Living (ACL), it will provide nearly $100 million to help increase vaccinations among older adults and people with disabilities. This effort will help advance the key goals of protecting those most vulnerable and advancing equity within President Biden's National Strategy for the COVID-19 Response and Pandemic Preparedness. More information about these efforts can be found here.
• On March 31, 2021, President Biden unveiled a roughly $2.25 trillion infrastructure and tax proposal entitled, the American Jobs Plan. The package is intended to be an historic capital investment in America to improve competitiveness, create millions of jobs, rebuild infrastructure, and position the economy to face future crises and threats. The plan, which is high-level at this point, includes few specific health provisions. Most of the health-related spending is directed toward pandemic preparedness and prevention, with $30 billion to be directed to the Strategic National Stockpile, development of testing and therapies for emerging diseases, prototype vaccines, and improved technology for faster vaccine production. The plan also includes $400 billion in funding to expand access to long-term care services under Medicaid by expanding access to home- and community-based services (HCBS) and improving wages and benefits for home care workers. Speaker of the House Nancy Pelosi (D-CA) has said that she would like the House to pass the infrastructure package by July 4. Note that the final package will likely need to meet the rules under budget reconciliation, which allows the Senate to pass legislation with a simple majority.
• On April 1, 2021, HHS announced additional measures to encourage vaccinations and increase vaccine confidence as part of the next phase of its COVID-19 public education campaign. The Administration is launching the COVID-19 Community Corps—a nationwide, grassroots network of local voices people know and trust to encourage Americans to get vaccinated. More information about this network can be found here.
• On April 1, 2021, HHS Secretary Xavier Becerra announced that additional savings and lower health care costs are available for consumers on HealthCare.gov. The American Rescue Plan (ARP) has increased tax credits available to consumers, helping to reduce premiums and giving consumers access to affordable health care coverage. Premium tax credit calculations for the Marketplaces on HealthCare.gov are now adjusted so that most consumers qualify for more substantial advance payments of premium tax credits. More information about this announcement can found here.

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