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, President Biden signed a “laddered” continuing resolution, averting a government shutdown, and the House Energy & Commerce Health Subcommittee advanced 21 healthcare bills to the full Committee. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On November 13, the Health Resources and Services Administration (HRSA) issued a notice entitled, National Vaccine Injury Compensation Program; List of Petitions Received. HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program required by the Public Health Service (PHS) Act, as amended. While the Secretary of the Department of Health and Human Services (HHS) is named as the respondent in all proceedings brought by the filing of petitions for compensation under the program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
- On November 13, (HRSA) issued a notice entitled, National Rural Health Information Clearinghouse Program. HRSA provided supplemental award funds to the National Rural Health Information Clearinghouse Program recipient to develop toolkits and other resources that address strategies to promote rural community health.
- On November 14, the Federal Drug Administration (FDA) issued a notice entitled, Advisory Committee; Nonprescription Drugs Advisory Committee; Renewal. The FDA is announcing the renewal of the Nonprescription Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Nonprescription Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the August 27, 2025, expiration date.
- On November 15, the Centers for Medicare & Medicaid Serves (CMS) issued a final rule entitled, Medicare and Medicaid Programs; Disclosures of Ownership and Additional Disclosable Parties Information for Skilled Nursing Facilities and Nursing Facilities; Medicare Providers’ and Suppliers’ Disclosure of Private Equity Companies and Real Estate Investment Trusts. This final rule will implement portions of section 6101 of the Patient Protection and Affordable Care Act (Affordable Care Act), which require the disclosure of certain ownership, managerial, and other information regarding Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities. It will also finalize definitions of private equity company and real estate investment trust for Medicare provider enrollment purposes.
- On November 16, CMS issued a proposed rule entitled, Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2025; Updating Section 1332 Waiver Public Notice Procedures; Medicaid; Consumer Operated and Oriented Plan (CO-OP) Program; and Basic Health Program. This proposed rule includes payment parameters and provisions related to the HHS-operated risk adjustment program, as well as 2025 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This proposed rule also includes proposed requirements related to the auto re-enrollment hierarchy; essential health benefits; failure to file and reconcile; non-standardized plan option limits and an exceptions process; standardized plan options; special enrollment periods (SEPs); direct enrollment (DE) entities; Insurance Affordability Program enrollment eligibility verification process; requirements for agents, brokers, web-brokers, and DE entities assisting Exchange consumers; network adequacy; public notice procedures for section 1332 waivers; prescription drug benefits; updates to the Consumer Operated and Oriented Plan (CO-OP) Program; State flexibility on the financial methodology used for Medicaid eligibility determinations for non-modified adjusted gross income (MAGI) populations; and State flexibility on the effective date of coverage in the Basic Health Program (BHP).
- On November 16, CMS issued a notice entitled, Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection. On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the “generic” clearance process. Generally, this is an expedited process by which agencies may obtain OMB’s approval of collection of information requests that are “usually voluntary, low-burden, and uncontroversial collections,” do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938–1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day.
- November 28, 29, 30, 2023: CMS announced a virtual public meeting entitled, New Revisions to the Healthcare Common Procedure Coding System (HCPCS) to discuss preliminary coding, Medicare benefit category, and payment determinations for new revisions to the HCPCS Level II code set for non-drug and nonbiological products.
- November 29, 2023: The National Institutes of Health (NIH) announced the National Cancer Institute will hold a meeting of their Frederick National Laboratory Advisory Committee. This is a virtual meeting open to the public.
- November 29, 2023: FDA announced a meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.
- November 30, 2023: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Board of Scientific Counselors, Deputy Director for Infectious Diseases. This is a virtual meeting open to the public.
- November 30, 2023: FDA announced a public workshop entitled, Advancing the Development of Pediatric Therapeutics on Drug Dosing in Pediatric Patients with Renal Impairment. The workshop will discuss the current landscape of drug dosing in pediatric patients with renal impairment, discuss the gaps in knowledge, and consider innovative approaches to improve the current paradigm for dosing in pediatric patients with renal impairment.
- December 4 and 5, 2023: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The meeting will be videocast and is open to the public.
- December 5, 2023: HRSA announced the Maternal and Child Health Bureau Office of Epidemiology and Research, Division of Research is hosting the next Engaging Research Innovations & Challenges (EnRICH) webinar entitled, The National Survey of Children’s Health: New Data, Opportunities, and Directions. This is a virtual meeting open to the public.
- December 5 and 6, 2023: HRSA announced a meeting of the Advisory Committee on Infant and Maternal Mortality (ACIMM). This is a hybrid meeting open to the public.
- December 6, 2023: The Substance Use and Mental Health Services Administration (SAMHSA) announced a meeting of the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). The meeting will include reports from the ISUDCC working groups and discussion of the ISUDCC’s recommendations to the Department of Health and Human Services (HHS) on how the federal government can further integrate and coordinate harm reduction approaches and strategies across the continuum of prevention, treatment, and recovery policies, programs, and practices. This is a virtual meeting open to the public.
- December 6, 2023: The Department of Veterans Affairs (VA) announced a meeting of the National Research Advisory Council. This meeting is open to the public and will include time reserved for public comment at the end of the meeting.
- December 7, 2023: NIH announced the National Heart, Lung, and Blood Institute will hold a meeting to update their Advisory Board and public stakeholders on research agendas across NIH for fiscal year (FY) 2024. This is a virtual public meeting that requires registration to attend.
- December 7, 2023: CDC announced Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health will hold a meeting open to the public.
- December 8, 2023: NIH announced the Muscular Dystrophy Coordinating Committee will hold a meeting, The meeting will bring together committee members, representing government agencies, patient advocacy groups, other voluntary health organizations, and patients and their families to update one another on progress relevant to the Action Plan for the Muscular Dystrophies and to coordinate activities and discuss gaps and opportunities leading to better understanding of the muscular dystrophies, advances in treatments, and improvements in patients' and their families' lives.
- December 12 and 13, 2023: CDC announced a meeting of the Advisory Council for the Elimination of Tuberculosis (ACET) will hold a meeting open to the public.
- December 13 and 14, 2023: HHS announced it will hold a virtual public town hall meeting to discuss FY 2025 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS).
- December 14, 2023: FDA announced a meeting on Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement. This is a public meeting that will be held virtually.
- December 14 and 15, 2023: NIH announced a meeting of the Advisory Committee to the Director, National Institutes of Health. This is a hybrid meeting open to the public.
- January 11, 2024: HHS announced a Meeting of the Advisory Committee on Blood and Tissue Safety and Availability. The meeting will be open to the public via webcast.
- January 24, 2024: NIH announced the Interagency Autism Coordinating Committee will hold a meeting to discuss committee business, updates, and issues related to autism research and services activities. This is a hybrid meeting open to the public.
- January 29, 2024: NIH announced the National Heart, Lung, and Blood Institute Sickle Cell Disease Advisory Committee will hold a virtual meeting open to the public.
- February 2, 2023: FDA announced the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee will hold a meeting that is open to the public.
- February 6, 2024: FDA announced the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee hill hold a meeting that is open to the public.
II. Hearings & Markups
- On November 14, 2023, the Senate Committee on Finance Health Subcommittee Hearing held a hearing entitled, Ensuring Medicare Beneficiary Access: A Path to Telehealth Permanency. Witnesses present included Nicki Perisho, BSN, RN, Principal Investigator & Program Director, Northwest Regional Telehealth Resource Center; Dr. Eric Wallace, MD, FASN. Professor Of Medicine, UAB EMedicine, Medical Director, Co-Director Of Home Dialysis, Director Of Rare Genetic Kidney Disease Clinic, Division Of Nephrology, Department Of Medicine, University of Alabama at Birmingham; Dr. Chad Ellimoottil, MD, MS, Associate Professor, Medical Director Of Virtual Care, University of Michigan; and Dr. Ateev Mehrotra, MD, MPH, Professor Of Health Care Policy, Department Of Health Care Policy, Harvard Medical School.
U.S. House of Representatives
- On November 15, 2023, the House Committee on Energy and Commerce Health Subcommittee held a markup entitled, Health Subcommittee Markup Of 21 Legislative Proposals. All 21 bills were adopted and ordered reported favorably to the Full Committee on Energy & Commerce.
III. Reports, Studies, & Analyses
- On November 14, 2023, the Kaiser Family Foundation (KFF) released a report entitled, Medicaid Enrollment and Spending Growth Amid the Unwinding of the Continuous Enrollment Provision: FY 2023 & 2024. The report surveyed state Medicaid directors and found that states expect the national Medicaid enrollment to drop by 8.6 percent in fiscal year (FY) 2024 as Medicaid unwinding continuous. These decreases come after Medicaid achieved record high enrollment numbers during the pandemic. The report found that, even with the enrollment decrease, the state share of Medicaid spending is projected to increase by 17.2 percent in FY 2024 because pandemic-related, enhanced federal Medicaid funds will be completely phased out by December 31, 2023.
- On November 15, 2023, the Government Accountability Office (GAO) released a report entitled, COVID-19 Relief Funds: State Experiences Could Inform Future Federal Relief Funding. The report analyzed the burdens states experienced when planning and using COVID-19 relief funds, including staff capacity challenges, delays in funds and federal guidance, and challenges with communication and technical assistance. GAO highlighted different strategies that states could use in the future when planning for and using federal assistance fundings, including leveraging the structure and processes of pre-existing programs, leveraging staff expertise from previous federal funding initiatives, or establishing new staff units and processes for federal relief funds.
- On November 16, 2023, the Office of the Inspector General (OIG) released a report entitled, 2023 Top Management & Performance Challenges Facing HHS. This year’s report highlighted management and performance challenges HHS has faced across five categories: 1) Safeguarding Public Health; 2) Ensuring the Financial Integrity of HHS Programs; 3) Improving Outcomes in Medicare and Medicaid; 4) Protecting HHS Beneficiaries; and, 5) Securing Data and Technology. Within each category, OIG recognized elements of each challenge and highlighted key areas for improvement. Additionally, the report provided examples of HHS and OIG action to address the identified challenges and provided recommendations for future areas of action.
IV. Other Health Policy News
- On Tuesday, November 14, the House of Representatives passed a short-term spending bill to maintain federal funding into early next year and one day later the Senate voted in favor as well. The Continuing Resolution, H.R. 6363, takes a “laddered” approach by extending funding for four spending bills through January 19 and funds the remainder of the government through February 2nd. Multiple health care programs, such as continued authorization of the National Health Services Corps and Community Health Center Fund, are slated to continue until January 19, 2024. Additionally, scheduled Medicaid Disproportionate Share Hospital (DSH) cuts and the termination of the Medicare Work Geographic Index Floor were delayed until January 19, 2024. The bill is a clean short-term spending bill, meaning it will extend existing funding with no additional funding cuts nor controversial policy riders. The lack of additional spending cuts surprised some members of the House Republican conference but increased the bill’s chances of gaining Democratic support in both the House and Senate. The Continuing Resolution passed the House by a vote of 336 to 95 and the Senate by a vote of 87-11. President Biden signed the bill on November 16, 2023. Without this bill, government funding would have run out at midnight November 17, 2023.
- On November 15, 2023, CMS issued the HHS Notice of Benefit and Payment Parameters for 2025 proposed rule, which includes proposed standards for issuers and Marketplaces, as well as requirements for agents, brokers, web-brokers, direct enrollment entities, and assisters that support Marketplace consumers. The proposed rule also includes several proposals impacting the Medicaid program and Children’s Health Insurance Program (CHIP). The changes in the proposed rule are intended to advance health equity by addressing health disparities that underlie the U.S. health system. They also are intended to expand access to quality, affordable health coverage by increasing access to care, simplifying and improving the plan selection process, enhancing standards and guaranteed consumer protections, reinterpreting the authority to access certain data through Medicaid, CHIP, and Marketplace services, and strengthening markets. Specifically, the proposed rule includes, among other proposals, payment parameters and provisions related to the HHS-operated risk adjustment program, as well as 2025 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs).
- On November 15, 2023, House GOP leadership delayed a final vote for the 2024 spending bill that would fund the Departments of Health and Human Services, Labor, and Education. Representative Michael Burgess (R-TX) hinted that members of the Republican caucus were not supportive of the bill, despite the bill being full of Republican policy priorities. Democrats oppose the bill, and its controversial provisions, which includes prohibiting funding for Planned Parenthood and blocking the implementation of CMS’s COVID-19 vaccine mandate for health care providers. Most of the day before, the House voted on a slew of amendments to the bill, many of them related to health. Of note, the following health related amendments to the bill passed:
- An amendment that would prohibit funds to enforce a measure in the Ambulatory Surgical Center Quality Reporting Program (ASCQR) which requires ASCs to report their COVID-19 Vaccination Coverage Among Health Care Personnel data,
- An amendment that prohibits funds to finalize, implement or enforce policies related to the proposed limitation for state directed payments as stated in the May 3, 2023, proposed rule titled “Medicaid Program; Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality,”
- An amendment that would prohibit funds from being used to finalize, implement, or enforce the proposed rule entitled: “Medicare and Medicaid Programs: Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting,” and
- An amendment that prevents funds from being used to finalize, implement, or enforce the proposed rule published by the Department of Health and Human Services entitled “Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program.”
It is unclear when the House will vote on the bill. The White House threatened to veto the bill.
- On November 15, 2023, the Center for Medicare & Medicaid Innovation (CMMI) released a Request for Applications (RFA) to participate in the Guiding an Improved Dementia Experience (GUIDE) Model. Originally announced on July 31, 2023, the model is designed to improve quality of life for patients living with dementia, lessen the burden on their unpaid caregivers (i.e., family members), and enable individuals with dementia to continue living in their homes and communities. The GUIDE model is a response to poor health outcomes for many dementia patients, including high rates of hospitalization, emergency department visits, post-acute care utilization, as well as elevated rates of depression and behavioral health conditions. CMMI also highlighted that many unpaid caregivers report high levels of stress and depression, which negatively affects their health and increases their risk for serious illness, hospitalization, and mortality.
- On November 16, 2023, Senators Elizabeth Warren (D-MA), Bernie Sanders (I-VT), and Richard Blumenthal (D-CT) released a report entitled, Residents at Risk: Quality of Care Problems in Understaffed Nursing Homes and the Need for a New Federal Nursing Home Staffing Standard. The report was released in support of the CMS proposed rule that would create minimum staffing standards for nursing homes. The report uses a data analysis conducted by the Congressional Research Service that compares the quality of care at nursing homes that meet the proposed staffing requirements and those that do not. The analysis and report reveal that nursing homes that do not currently meet the purposed staffing requirement are more likely to:
- Have lower average quality ratings from the CMS Five-Star Quality Rating System;
- Be designated as “special focus facilities” due to problems with the quality of care;
- Have serious care deficiencies, as found by state regulators during annual inspections; and
- Have residents that suffer from abuse.
- On November 15, 2023, CMS announced the second round of Medicare-funded full-time equivalent (FTE) medical residency positions or “slots” to qualifying hospitals. Authorized by the Consolidated Appropriations Act, 2021, the distribution of new Medicare-funded FTE medical residency positions are intended to enhance the health care workforce and fund additional positions in hospitals serving underserved communities. CMS established policies to distribute 1,000 new Medicare-funded FTE residency positions to qualifying hospitals in the fiscal year (FY) 2022 Inpatient Prospective Payment System (IPPS) final rule. Specifically, a phased-in approach was implemented with 200 new slots being distributed annually over five years. In allocating these new residency slots, CMS prioritized hospitals with training programs in geographic areas with the greatest need for additional providers, as determined by being located in Health Professional Shortage Areas (HPSAs) and other criteria. The second round of 200 residency positions will go into effect July 1, 2024. Additional information is available here. The list of the Round 2 awards is available here.
- On November 16, 2023, CMS announced the release of the first of two Notice of Funding Opportunity (NOFO) application periods for the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model. The intent of this model is to better equip participating states to promote health equity, increase access to primary care services, set health care expenditures on a more sustainable trajectory, and lower health care costs for patients. Through this new voluntary model, CMS will partner with states to redesign statewide and regionwide health care delivery in an effort to improve the total population health of a participating state or region by improving the quality and efficacy of care delivery, reducing health disparities, and improving health outcomes. Strengthening primary care is a key objective of this program.
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