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.
This week, HHS announced $2 billion in additional Provider Relief Fund payments and issued the 2022 Mental Health Parity and Addition Equity Act Report to Congress. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On January 25, 2022, the Food and Drug Administration (FDA) issued guidance entitled, Patient Engagement in the Design and Conduct of Medical Device Clinical Studies; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders. The Patient Engagement Advisory Committee (PEAC) recommended that FDA and industry develop a framework to clarify how patient advisors can engage in the clinical investigation process. This guidance focuses on the applications, perceived barriers, and common challenges of patient engagement in the design and conduct of medical device clinical studies.
- On January 25, 2022, FDA issued guidance entitled, Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation; Guidance for Industry and Food and Drug Administration Staff, and Other Stakeholders. FDA encourages the collection, analysis, and integration of patient perspectives in the development, evaluation, and surveillance of medical devices, including digital health technologies. Patient-reported outcome (PRO) instruments facilitate the systematic collection of patient perspectives as valid scientific evidence to support the regulatory and healthcare decision-making process. This guidance describes principles that should be considered when using PRO instruments in the evaluation of medical devices and provides recommendations about the importance of ensuring the measures are fit-for-purpose.
- On January 25, 2022, the Occupational Safety and Health Administration (OSHA) issued a notice of withdrawal of its interim final rule entitled, COVID–19 Vaccination and Testing; Emergency Temporary Standard. OSHA is withdrawing the November 5, 2021, emergency temporary standard (ETS) which was issued to protect unvaccinated employees of large employers (100 or more employees) from the risk of contracting COVID–19 by strongly encouraging vaccination.
- On January 26, 2022, FDA issued guidance entitled, Good Abbreviated New Drug Applications Submission Practices; Guidance for Industry. This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs). This guidance highlights common, recurring deficiencies that may lead to a delay in the approval of an ANDA. It also makes recommendations to applicants on how to avoid these deficiencies with the goal of minimizing the number of review cycles necessary for approval.
- On January 26, 2022, FDA issued guidance entitled, Revising Abbreviated New Drug Application Labeling Following Revision of the Reference Listed Drug Labeling; Draft Guidance for Industry. This guidance provides recommendations for updating labeling for abbreviated new drug applications (ANDAs) following revisions to the labeling of a reference listed drug (RLD), including information on how to identify RLD labeling updates and how to submit labeling updates to both unapproved and approved ANDAs to conform to RLD labeling updates.
- On January 26, 2022, FDA issued guidance entitled, Information Requests and Discipline Review Letters Under Generic Drug User Fee Amendments; Guidance for Industry. This guidance explains how FDA will issue and use an information request (IR) and/or a discipline review letter (DRL) during the assessment of an original abbreviated new drug application (ANDA) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
- On January 26, 2022, the Department of the Treasury issued a final rule entitled, Coronavirus State and Local Fiscal Recovery Funds. This rule implements the Coronavirus State Fiscal Recovery Fund and the Coronavirus Local Fiscal Recovery Fund established under the American Rescue Plan Act.
- On January 28, 2022, FDA issued guidance entitled, Principles of Premarket Pathways for Combination Products; Guidance for Industry and Food and Drug Administration Staff. This guidance presents FDA’s current thinking on principles for premarket review of combination products. This guidance includes general, high-level information regarding what combination products are, coordination within FDA and interaction between FDA and sponsors regarding combination product regulation, and how combination products are reviewed by FDA before they are marketed. The guidance also includes recommendations on how to determine which type of premarket submissions may be appropriate for combination products.
- On January 28, 2022, the Department of Health and Human Services (HHS) Office of the Secretary issued its Semiannual Regulatory Agenda. This Agenda presents the regulatory activities that the Department expects to undertake in the foreseeable future to advance this mission. The purpose of the Agenda is to encourage more effective public participation in the regulatory process. The regulatory actions forecasted in this Agenda reflect the priorities of HHS Secretary Xavier Becerra and the Biden-Harris Administration.
Event Notices
- February 10, 2022: The National Institutes of Health (NIH) announced a public meeting of the National Cancer Institute Advisory Board. The meeting agenda includes the NCAB Subcommittee Meeting – Ad Hoc Subcommittee on Global Cancer Research, the Director’s and Program reports and presentations; and business of the Board.
- February 23-24, 2022: The Centers for Disease Control and Prevention (CDC) announced a public meeting of the Advisory Committee on Immunization Practices (ACIP). The committee is charged with advising the Director of the CDC on the use of immunizing agents.
- March 3, 2022: FDA announced a public meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues.
- March 7, 2022: The Office of the Assistant Secretary for Preparedness and Response (ASPR) announced a public meeting of the National Biodefense Science Board (NBSB). The NBSB provides expert advice and guidance on scientific, technical, and other matters of special interest to HHS regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate.
- March 8, 2022: NIH announced a public meeting of the Diabetes Mellitus Interagency Coordinating Committee (DMICC). The topic for this meeting will be “Opportunities for Research Supported by the Special Statutory Funding Program for Type 1 Diabetes Research.”
- March 16, 2022: NIH announced a public meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee. The agenda includes a strategic discussion of NCI’s Clinical and Translational Research Programs.
- April 12, 2022: FDA announced a public meeting entitled “Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.” The purpose of the virtual public meeting and the request for comments is to fulfill FDA’s commitment to seek stakeholder input related to data standards and the electronic submission system’s past performance, future targets, emerging industry needs, and technology initiatives. FDA will use the information from the public meeting as well as from comments submitted to the docket to provide input into data standards and electronic submissions initiatives.
- Various Dates: The Health Resources and Services Administration (HRSA) announced several public meetings of the Advisory Committee on Childhood Vaccines (ACCV). The ACCV provides advice and recommendations to the Secretary of HHS on policy, program development, and other issues related to the implementation of the National Vaccine Injury Compensation Program and other matters.
No Congressional hearings were held this week.
III. Reports, Studies & Analyses
- On January 27, 2022, the Government Accountability Office (GAO) published a report entitled, COVID-19: Significant Improvements Are Needed for Overseeing Relief Funds and Leading Responses to Public Health Emergencies. This report provides updates on topics like pandemic emergency rental assistance and tax relief for businesses. GAO made 5 recommendations, including ways the Treasury Department can more quickly recover rental assistance overpayments. GAO is also adding HHS’s leadership of public health emergencies to its High Risk List.
- On January 27, 2022, the Kaiser Family Foundation (KFF) published an issue brief entitled, What to Watch in Medicaid Section 1115 Waivers One Year into the Biden Administration. This issue brief summarizes waiver priorities and actions under the Biden Administration as well as pending waiver themes and other issues to watch.
- On January 27, 2022, KFF published an issue brief entitled, Simulating the Impact of the Drug Price Negotiation Proposal in the Build Back Better Act. This brief illustrates the potential scope of the drug price negotiation proposal in the Build Back Better Act (BBBA). Overall, the brief’s analysis suggests that the negotiation proposal in the Build Back Better Act could help to lower drug prices for some of the top-spending drugs covered under Medicare Part B and Part D, but some of the drugs with the highest total Medicare spending currently would be exempt from the negotiation process.
- On January 27, 2022, KFF published an issue brief entitled, Funding for Health Care Providers During the Pandemic: An Update. This brief describes the main sources of federal funds for health care providers and how those funds have been allocated. It also describes federal spending for COVID-19 testing, including at-home testing, using the most recent data available (as of September 2021).
IV. Other Health Policy News
- On January 21, 2022, HHS announced that it is awarding $6.6 million through the Title X family planning program to address increased need for family planning services where restrictive laws and policies have impacted reproductive health access. This competitive grant opportunity addressing dire family planning needs was announced as part of a series of recent actions HHS took to protect patients and health care providers in response to the Texas Law SB 8. More information on this funding can be found here.
- On January 25, 2022, the Departments of Labor, HHS, and the Treasury issued their 2022 Report to Congress on the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008. The report includes information that suggests health plans and health insurance issuers are failing to deliver parity for mental health and substance-use disorder benefits to those they cover. The report also highlights the departments' recent emphasis on greater MHPAEA enforcement in addition to guidance to correct those failures and makes recommendations to strengthen MHPAEA's consumer protections and enhance the departments' enforce abilities. More information on this report can be found here.
- On January 25, 2022, HHS announced it is making more than $2 billion in Provider Relief Fund (PRF) Phase 4 General Distribution payments to more than 7,600 providers across the country this week. These payments come on the heels of the nearly $9 billion in funding that was already released by HHS in December 2021. With this announcement, a total of nearly $11 billion in PRF Phase 4 payments has now been distributed to more than 74,000 providers in all 50 states, Washington D.C., and five territories. This is in addition to HRSA’s distribution of American Rescue Plan (ARP) Rural payments totaling nearly $7.5 billion in funding to more than 43,000 providers in December 2021. More information on this funding can be found here.
- On January 25, 2022, HHS Secretary Xavier Becerra announced the release of $100 million from the Bipartisan Infrastructure Law to help families pay their outstanding heating and cooling bills. This funding comes on top of investment in the Low-Income Home Energy Assistance Program (LIHEAP) through the American Rescue Plan and the Continuing Resolution most recently passed by Congress. The $100 million is the first installment of the five-year, $500 million investment in the program provided from President Biden’s Bipartisan Infrastructure Law. More information on this funding can be found here.
- On January 26, 2022, the Centers for Medicare & Medicaid Services (CMS) released data showing that Accountable Care Organizations (ACOs) are serving a growing patient population, according to CMS’ annual summary of the Medicare Shared Savings Program, which is Medicare’s national ACO program. CMS projects that over 11 million people with Medicare will be served by Shared Savings Program ACOs in 2022. More information on this data can be found here.
- On January 26, 2022, CMS announced that it will begin posting staff turnover rates and weekend staff levels for nursing homes on the Medicare.gov Care Compare website today. Staffing in nursing homes has a substantial impact on the quality of care and outcomes residents experience. Having access to this information helps consumers understand more about each nursing home facility’s staffing environment and choose a facility that provides the highest quality of care that best meets the healthcare needs of their loved one. More information on this announcement can be found here.
- On January 27, 2022, the Biden-Harris Administration announced that 14.5 million people have signed up for 2022 health care coverage through the Marketplaces during the Marketplace Open Enrollment Period (OEP) from November 1, 2021 through January 15, 2022 – including 5.8 million people who have newly gained coverage under the Administration. The American Rescue Plan lowered health care costs for most Marketplace consumers and increased enrollment to these records levels: HealthCare.gov consumers saw their average monthly premium fall by 23%, compared to the 2021 enrollment period that ended before the American Rescue Plan passed. More information on this announcement can be found here.
- On January 27, 2022, CMS committed $49.4 million to fund organizations that can connect more eligible children, parents, and pregnant individuals to health care coverage through Medicaid and the Children’s Health Insurance Program (CHIP). Awardees—including state/local governments, tribal organizations, federal health safety net organizations, non-profits, schools, and others—will receive up to $1.5 million each for a three-year period to reduce the number of uninsured children by advancing Medicaid/CHIP enrollment and retention. More information on this funding can be found here.
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