Alston & Bird Health Care Week in Review, April 29, 2022

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care 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 issued the CY 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs final rule. Read more about this rule and other news below.

I. Regulations, Notices & Guidance

• On April 25, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and other Revisions to Medicare Enrollment and Eligibility Rules. This proposed rule would implement certain provisions of the Consolidated Appropriations Act, 2021 (CAA). Additionally, CMS is proposing to delete references to specific Medicare forms from the text of existing regulations in order to provide greater administrative flexibility. Finally, this proposed rule would update the various federal regulations that affect a state’s payment of Medicare Part A and B premiums for beneficiaries enrolled in the Medicare Savings Programs and other Medicaid eligibility groups.
• On April 27, 2022, the Food and Drug Administration (FDA) issued a final guidance entitled, Providing Submissions in Electronic Format--Postmarketing Safety Reports; Guidance for Industry; Availability. This guidance provides general information pertaining to electronic submission of post-marketing safety reports (individual case safety reports (ICSRs), attachments to ICSRs (ICSR attachments), and other post-marketing safety reports) for certain human drugs, biological products, and combination products.
• On April 27, 2022, the National Institutes of Health (NIH) issued a notice entitled, Government-Owned Inventions; Availability for Licensing. The invention, Replication-Competent Adenovirus Type-4 HIV Env Vaccines, is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development.
• On April 27, 2022, FDA issued a notice entitled, Request for Nominations on the Pediatric Advisory Committee. FDA is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Pediatric Advisory Committee for the Office of the Commissioner notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the Pediatric Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative.
• On April 27, 2022, CMS issued a final rule entitled, Medicare Program; Accrediting Organizations - Changes of Ownership. This final rule adds new requirements and a specified process to address change of ownership (CHOW) for Accrediting Organizations (AOs) in regard to the transfer of the existing CMS approval for the AO’s accreditation programs to the new AO owner. These regulations are intended to provide CMS with the ability to receive notice when an AO is undergoing or negotiating a CHOW, as well as to review the prospective new AO owner’s capability to perform its tasks after a CHOW has occurred, in order to ensure the ongoing effectiveness of the transferred accreditation program(s) and to minimize risk to patient safety.
• On April 28, 2022, FDA issued draft guidance entitled, The Accredited Third-Party Certification Program: Questions and Answers; Draft Guidance for Industry; Availability. The draft guidance, when finalized, will answer frequently asked questions relating to the requirements of the Accredited Third-Party Certification Program, and is intended to assist accreditation bodies’, third-party certification bodies’, and eligible entities’ understanding of the regulation and program requirements.
• On April 28, 2022, FDA issued draft guidance entitled, Crohn’s Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability. This draft guidance addresses FDA’s current thinking about necessary attributes of clinical trials for developing drugs for the treatment of Crohn’s disease in adults, including recommendations for trial population, trial design, and efficacy and safety considerations.
• On April 28, 2022, FDA issued draft guidance entitled, Ulcerative Colitis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability. This draft guidance addresses FDA’s current thinking about necessary attributes of clinical trials for developing drugs for the treatment of ulcerative colitis in adults, including recommendations for trial population, trial design, and efficacy and safety considerations.
• On April 28, 2022, the Department of Health and Human Services (HHS) issued revised guidance entitled, Screening Framework Guidance for Providers and Users of Synthetic Oligonucleotides. The revised guidance sets forth recommended baseline standards for the gene and genome synthesis industry, as well as best practices for Institutions, Principal Users, End Users, and Third-Party Vendors of oligonucleotides, regarding screening orders and maintaining records consistent with current U.S. regulations. In addition, this revised guidance seeks to encourage best practices to address biosecurity concerns associated with the potential misuse of synthetic oligonucleotides to bypass existing regulatory controls and commit unlawful acts.
• On April 28, 2022, FDA issued a proposed rule entitled, Tobacco Product Standard for Characterizing Flavors in Cigars. FDA is proposing a tobacco product standard that would prohibit characterizing flavors (other than tobacco) in all cigars and their components and parts. This proposed product standard would reduce the appeal of cigars, particularly to youth and young adults, and thereby decrease the likelihood of experimentation, development of nicotine dependence, and progression to regular use. FDA is taking this action to reduce the tobacco-related death and disease associated with cigar use. The proposed standard also is expected to reduce tobacco-related health disparities and advance health equity.
• On April 28, 2022, FDA issued a proposed rule entitled, Tobacco Product Standard for Menthol in Cigarettes. FDA is proposing a tobacco product standard that would prohibit menthol as a characterizing flavor in cigarettes. This proposed product standard would reduce the appeal of cigarettes, particularly to youth and young adults, and thereby decrease the likelihood that nonusers who would otherwise experiment with menthol cigarettes would progress to regular smoking. In addition, the proposed tobacco product standard would improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood of cessation. FDA is taking this action to reduce the tobacco-related death and disease associated with menthol cigarette use. The proposed standard also is expected to reduce tobacco-related health disparities and advance health equity.
• On April 29, 2022, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Solicitation of Nominations for Appointment as Members of the Community Preventive Services Task Force (CPSTF). CDC is soliciting nominations for appointment of individuals qualified to serve as new members of the Community Preventive Services Task Force (CPSTF). New CPSTF members will serve a five-year term starting in either 2023 or 2024.
• On April 29, 2022, NIH issued a request for comment entitled, National Institute on Deafness and Other Communication Disorders Draft 2022-2027 Strategic Plan. The Strategic Plan serves as a guide to the National Institute on Deafness and Other Communication Disorders (NIDCD) in prioritizing its research investment and to address gaps in our research portfolio. The draft Plan presents a series of themes and goals that represent the most promising research needs within the NIDCD’s mission areas of hearing, balance, taste, smell, voice, speech, and language.
• On April 29, 2022, CMS issued a final rule entitled, Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs; Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency; Additional Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency. This final rule will revise the Medicare Advantage (MA) (Part C) program and Medicare Prescription Drug Benefit (Part D) program regulations to implement changes related to marketing and communications, past performance, Star Ratings, network adequacy, medical loss ratio reporting, special requirements during disasters or public emergencies, and pharmacy price concessions. This final rule will also revise regulations related to dual eligible special needs plans (D-SNPs), other special needs plans, and cost contract plans.

Event Notices

• May 17-18, 2022: CDC announced a public meeting of the Mine Safety and Health Research Advisory Committee (MSHRAC). The agenda will include discussions on the National Institute for Occupational Safety and Health (NIOSH) mining safety and health research organizational structure, capabilities, projects, and outcomes. The meeting will also include an update from the NIOSH Associate Director for Mining.
• May 26-27, 2022: NIH announced a public meeting of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). During the meeting, the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and ICCVAM members will give presentations on member agencies’ current activities related to the development and validation of alternative test methods and approaches.
• June 6-7, 2022: NIH announced a public meeting of the Fogarty International Center. The agenda will include an update and discussion of current and planned Fogarty International Center activities.
• June 7, 2022: NIH announced a public meeting of the Interagency Pain Research Coordinating Committee (IPRCC). The meeting will cover committee business items and IPRCC member updates. Items discussed will include updates on pain workforce enhancement, pain research, patient engagement, and diversity efforts.
• June 7-8, 2022: NIH announced a public meeting of the National Advisory Environmental Health Sciences Council. The agenda will include a discussion of program policies and issues, as well as a Council Discussion. The agenda will also include the Division of Extramural Research and Training (DERT) Director’s report.
• June 13 and 15, 2022: FDA announced a public meeting and listening sessions to discuss proposed regulations to establish tobacco product standards for menthol in cigarettes and characterizing flavors in cigars. During the public meeting and listening sessions, FDA will provide information on the proposed rules to the public and provide the public an opportunity to provide open public comment.

II. Congressional Hearings

U.S. House of Representatives

• On April 27, 2022, the House Committee on Energy & Commerce Subcommittee on Health held a hearing entitled, The Fiscal Year 2023 HHS Budget. Witnesses present included: The Honorable Xavier Becerra, Secretary, HHS.
• On April 27, 2022, the House Committee on Oversight and Reform held a hearing entitled, McKinsey & Company’s Conduct and Conflicts at the Heart of the Opioid Epidemic. Witnesses present included: The Honorable Maura Healey, Attorney General, Commonwealth of Massachusetts; Ms. Gillian Feiner, Senior Enforcement Counsel, Massachusetts Attorney General’s Office; Mr. Bob Sternfels, Global Managing Partner, McKinsey & Company; Professor Jessica Tillipman, Assistant Dean for Government Procurement Law Studies, George Washington University Law School; and Mr. Uttam Dhillon, Chair, Regulatory Defense, Compliance & White Collar Practice Group, Michael Best & Friedrich LLP.
• On April 28, 2022, the House Committee on Ways and Means held a hearing entitled, Proposed Fiscal Year 2023 Budget with Health and Human Services Secretary Becerra. Witnesses present included: The Honorable Xavier Becerra, Secretary, HHS.
• On April 29, 2022, the House Select Subcommittee on the Coronavirus Crisis held a hearing entitled, Ensuring Scientific Integrity At Our Nation’s Public Health Agencies. Witnesses present included: Ms. Anita Desikan, Senior Analyst, Center for Science and Democracy, Union of Concerned Scientists; The Honorable Gene Dodaro, Comptroller General of the United States, Government Accountability Office; Dr. Sonja Rasmussen, Former Editor-in-Chief, Morbidity and Mortality Weekly Report, Centers for Disease Control and Prevention; and Ms. Candice Wright, Director, Science, Technology Assessment, and Analytics, Government Accountability Office.

U.S. Senate

• On April 26, 2022, the Senate Committee on Health, Education, Labor, and Pensions held a hearing entitled, FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients, FDA Center Directors. Witnesses present included: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research, United States Food and Drug Administration; Peter Marks, M.D., Ph.D, Director, Center for Biologics Evaluation and Research, United States Food and Drug Administration; and Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health, United States Food and Drug Administration.
• On April 28, 2022, the Senate Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies held a hearing entitled, A Review of the President’s Fiscal Year 2023 Budget Request for the Food and Drug Administration. Witnesses present included: The Honorable Dr. Robert Califf, Commissioner, Food and Drug Administration.

III. Reports, Studies & Analyses

• On April 26, 2022, the RAND Corporation published a report entitled, A Risk Assessment of National Critical Functions During COVID-19: Challenges and Opportunities. This report presents insights into best practices in risk assessment; challenges in the implementation of the National Critical Function (NCF) risk assessment framework to characterize risk to critical infrastructure associated with the COVID-19 pandemic; recommendations for improving the framework; and suggestions for further characterization of NCFs' interdependence, vulnerability, and geographic variation that could improve risk assessment processes.
• On April 27, 2022, the HHS Office of Inspector General (OIG) issued a report entitled, Review of the Department of Health and Human Services’ Compliance with the Federal Information Security Modernization Act of 2014 for Fiscal Year 2021. OIG’s objective was to determine whether HHS’ overall information technology security program and practices were effective as they relate to Federal information security requirements.
• On April 27, 2022, the Government Accountability Office (GAO) issued a report entitled, Current and Future Federal Preparedness Requires Fixes to Improve Health Data and Address Improper Payments. 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—GAO’s 10th comprehensive report—examines the federal government’s continued efforts to respond to, and recover from, the COVID-19 pandemic.
• On April 27, 2022, the Congressional Budget Office (CBO) gave a presentation entitled, A Discussion of Recent Research on Health Care Prices: Prescription Drugs, Hospitals’ Services, and Physicians’ Services. The presentation gave an overview of how prices for prescription drugs are determined and the changes in the number of brand-name and generic prescription drugs dispensed through Medicare Part D or Medicaid, as well as the share prescriptions dispensed for generic drugs. The presentation also gave an overview of how traditional fee-for-service (FFS) Medicare determines prices for hospitals’ and physicians’ services, as well as the effects of higher prices paid by commercial insurers on health insurance premiums, benefits, out-of-pocket costs, and wages.
• On April 28, 2022, the Kaiser Family Foundation (KFF) published an issue brief entitled, Medicaid Administrative Data: Challenges with Race, Ethnicity, and Other Demographic Variables. In this issue brief, KFF uses the Medicaid Data Quality (DQ) Atlas and Transformed Medicaid Statistical Information System (T-MSIS) analytic files to examine the data quality of race/ethnicity and other demographic variables in calendar year (CY) 2019 T-MSIS data.
• On April 28, 2022, OIG issued a report entitled, Some Medicare Advantage Organization Denials of Prior Authorization Requests Raise Concerns About Beneficiary Access to Medically Necessary Care. OIG investigated this issue because a central concern about the capitated payment model used in Medicare Advantage is the potential incentive for Medicare Advantage Organizations (MAOs) to deny beneficiary access to services and deny payments to providers in an attempt to increase profits. OIG determined that MAOs sometimes delayed or denied Medicare Advantage beneficiaries’ access to services, even though the requests met Medicare coverage rules.

IV. Other Health Policy News

• On April 27, 2022, HHS announced it had developed new, free informational resources that inform Americans of their rights under law on coverage for mental health benefits. The new resources include an updated trifold pamphlet explaining mental health parity, detailing what it means to the consumer, and listing the protections the parity law provides. They also include an overview of parity geared toward parents, family members or caregivers with information and tools to help them obtain behavioral health services for children or family members in their care. Finally, there is a training tool which provides state regulators and behavioral health staff an overview of mental health and substance use disorder parity and how to implement and comply with the federal parity law regarding employee-sponsored health plans and group and individual health insurance. More information on these materials can be found here.
• On April 29, 2022, HHS announced that the total enrollment for Medicaid expansion, Marketplace coverage, and the Basic Health Program in participating states has reached an all-time high of more than 35 million people as of early 2022. The announcement comes following a report from the Office of the Secretary for Planning and Evaluation (ASPE) that also describes new estimates from the National Health Interview Survey, showing that the uninsured rate in the fourth quarter of 2021 was at nearly an all-time low of 8.8 percent for the full population (similar to the 8.9 percent rate in the third quarter of 2021), compared to 10.3 percent in the fourth quarter of 2020. More information on the announcement and report can be found here and here.

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