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 released the PFS, OPPS, ESRD, and Home Health final rules and Senators Bill Cassidy (R-LA) and Maggie Hassan (D-NH) released a new policy framework for site neutral payment reform.
I. Regulations, Notices & Guidance
- On October 30, 2024, the National Institutes of Health (NIH) released a notice entitled, Government Owned Inventions Available for Licensing/Collaboration: Using Artificial Intelligence To Diagnose Uveitis. The National Eye Institute seeks (NEI), an institute of NIH is giving notice of the licensing and collaboration opportunity for the inventions listed in the notice, which are owned by an agency of the U.S. government and are available for licensing/collaboration in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
- On October 30, 2024, the Food and Drug Administration (FDA) released final guidance entitled, M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms; International Council for Harmonisation; Guidance for Industry; Availability. The final guidance and supplemental questions and answers document were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance describes the scientific and technical aspects of study design and data analysis to support bioequivalence (BE) assessment of orally administered immediate release solid oral dosage forms of pharmaceutical drugs, such as tablets, capsules, and granules/ powders for oral suspension. The supplemental questions and answers document provides clarity to concepts covered in the guidance and rationales behind to facilitate implementation. The guidance is intended to provide globally harmonized scientific recommendations for conducting BE studies during both the development and post-approval phases of immediate release solid oral dosage forms. The guidance replaces the draft guidance M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms issued on February 1, 2023.
- On October 30, 2024, FDA released draft guidances entitled, Product-Specific Guidances; Revised Draft Guidances for Industry; Availability. The draft guidances provide product-specific recommendations on, among other things, the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled Bioequivalence Recommendations for Specific Products that explained the process that would be used to make product-specific guidances available to the public on FDA’s website. The draft guidances identified in this notice were developed using the process described in that guidance.
- On October 30, 2024, the Health Resources and Services Administration (HRSA) released 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, as 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 National Vaccine Injury Compensation Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
- On October 30, 2024, NIH released a notice entitled, National Institute of Neurological Disorders and Stroke, Interagency Pain Research Coordinating Committee (IPRCC) Call for Committee Membership Nominations. HHS has created the IPRCC and is seeking nominations for this committee. Nominations are due by 5:00 p.m. ET on December 17, 2024.
- On November 1, 2024, the Centers for Medicare & Medicaid Services (CMS) released a final rule entitled, Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments. In this annual final rule, CMS is addressing changes to the physician fee schedule (PFS), Medicare Part B Payment and Coverage Policies, the Medicare Shared Savings Program (MSSP), the Medicare Prescription Drug Inflation Rebate Program, and Medicare overpayments. Finalized average payment rates under the PFS will be reduced by 2.93 percent for calendar year (CY) 2025, compared to the average payment rates for CY 2024.With regard to the MSSP, CMS will allow eligible Accountable Care Organizations (ACOs) with a history of success in the program to receive an advance on their earned shared savings. CMS is also finalizing the addition of six new Merit-based Incentive Payment System (MIPS) Value Pathways that address: ophthalmology, dermatology, gastroenterology, pulmonology, urology, and surgical care. CMS will create new coding and payment for FDA-cleared digital mental health treatment devices, safety planning interventions that can help prevent suicides and overdoses, and services to better integrate behavioral health with primary care. CMS is also finalizing payments for certain dental services associated with dialysis services for the treatment of end-stage renal diseases (ESRDs). However, with some exceptions and absent Congressional action, beginning January 1, 2025, the statutory limitations that were in place for Medicare telehealth services prior to the COVID-19 public health emergency (PHE) will retake effect for most telehealth services. These include geographic and location restrictions on where services are provided and limitations on the scope of practitioners who can provide Medicare telehealth services.
- On November 1, 2024, CMS released a final rule entitled, Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, including the Hospital Inpatient Quality Reporting Program, etc. In this annual final rule, CMS is finalizing an update to Outpatient Prospective Payment System (OPPS) payment rates of 2.9 percent for hospitals that meet applicable quality reporting requirements. This update is based on the projected hospital market basket percentage increase of 3.4 percent reduced by a 0.5 percentage point productivity adjustment. Additionally, using the hospital market basket update, CMS is finalizing an update factor to the Ambulatory Surgical Center (ASC) payment rates for CY 2025 of 2.9 percent. The update applies to ASCs meeting relevant quality reporting requirements. This update is based on the projected hospital market basket percentage increase of 3.4 percent reduced by a 0.5 percentage point productivity adjustment. The final rule also updates Medicare payment rates for intensive outpatient program (IOP) services furnished in hospital outpatient departments and Community Mental Health Centers (CMHCs). CMS is maintaining the calculation of both hospital outpatient department and CMHC IOP payment rates for three services per day and four or more services per day based on cost per day using OPPS data that includes Partial Hospitalization Program (PHP) and non-PHP days. CMS is also finalizing the policy to include drugs and devices that qualify as non-opioid treatments for pain relief, and these products will be paid separately in both the hospital outpatient department (HOPD) and ASC settings starting in CY 2025. The qualifying drugs have FDA-approved indications to reduce post-operative pain or produce postsurgical analgesia, and the qualifying medical devices have demonstrated through evidence that they reduce opioid usage when used in the post-operative setting.
- On November 1, 2024, CMS released a final rule entitled, Calendar Year 2025 Home Health Prospective Payment System Rate Update; Quality Reporting Program Requirements; Value-Based Purchasing Expanded Model Requirements; etc. This annual final rule updates Medicare payment policies and rates for Home Health Agencies (HHAs). This rule also updates the intravenous immune globulin (IVIG) items and services’ payment rate for CY 2025 for Durable Medical Equipment (DME) suppliers. CMS estimates that Medicare payments to HHAs in CY 2025 will increase in the aggregate by 0.5 percent, or $85 million, compared to CY 2024. In addition, CMS is finalizing a crosswalk for mapping responses on the current Outcome and Assessment Information Set-E (OASIS-E) to the prior OASIS-D responses for use in the methodology to analyze the difference between assumed and actual behavior changes on estimated aggregate expenditures; recalibrated Patient-Driven Groupings Model (PDGM) case-mix weights; and updated low-utilization payment adjustment (LUPA) thresholds, functional impairment levels, and comorbidity adjustment subgroups. CMS is also finalizing and adopting the following: the most recent Office of Management and Budget (OMB) Core-Based Statistical Area (CBSA) delineations for the home health wage index; an occupational therapy (OT) LUPA add-on factor and updated physical therapy (PT), speech-language pathology (SLP), and skilled nursing (SN) LUPA add-on factors; and an updated CY 2025 fixed-dollar loss ratio (FDL) for outlier payments. Additionally, this rule finalizes the rate update for the CY 2025 intravenous immune globulin (IVIG) items and services’ payment under the IVIG benefit. Furthermore, CMS is finalizing updates to the HHA Conditions of Participation (CoPs) intended to reduce avoidable care delays by helping ensure that referring entities and prospective patients can select the most appropriate HHA based on their care needs.
- On November 1, 2024, CMS released a final rule entitled, End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, etc. This annual final rule updates payment rates and policies under the ESRD Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2025. This rule also finalizes an update to the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for CY 2025 and extends Medicare payment to dialysis in the home setting for beneficiaries with AKI. In addition, the final rule modifies how CMS will calculate the Transitional Drug Add-on Payment Adjustment (TDAPA) for oral-only phosphate binders beginning January 1, 2025. Furthermore, the rule updates requirements for the ESRD Quality Incentive Program (QIP), ESRD Facility Conditions for Coverage, and ESRD Treatment Choices Model. For CY 2025, CMS is increasing the ESRD PPS base rate to $273.82, which CMS expects will increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 2.7 percent. The CY 2025 ESRD PPS final rule also includes changes to the methodology for calculating the ESRD facility wage index, changes to the Low-Volume Payment Adjustment (LVPA) methodology, and several changes to the ESRD outlier policy.
Event Notices
November 6, 2024: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Clinical Laboratory Improvement Advisory Committee. This is a virtual meeting open to the public.
November 7, 2024: CDC announced a meeting of the Mine Safety and Health Research Advisory Committee. This is a hybrid meeting open to the public.
November 12, 2024: The National Institutes of Health (NIH) announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee. This is a hybrid meeting open to the public.
November 14, 2024: CDC announced a meeting of the Healthcare Infection Control Practices Advisory Committee. This is a virtual meeting that is open to the public.
November 14, 2024: HRSA announced a meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. This is a virtual meeting open to the public.
November 15, 2024: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry. This is a virtual meeting open to the public.
November 15, 2024: The Agency for Healthcare Research and Quality (AHRQ) announced a meeting to discuss implementation of the Executive Order to establish the Artificial Intelligence (AI) in Healthcare Safety Program. This is a virtual meeting open to the public.
November 20, 2024: AHRQ announced a meeting of the National Advisory Council for Healthcare Research and Quality. This is an in-person meeting open to the public.
November 20, 2024: CDC announced a meeting of the Board of Scientific Counselors, Office of Readiness and Response. This is a virtual meeting open to the public.
November 20, 2024: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Over-The-Counter (OTC) Monograph Drug User Fee Program (OMUFA) for fiscal years (FYs) 2026 through 2030. This meeting is open to the public.
November 21, 2024: FDA announced a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. This meeting is open to the public.
November 22, 2024: NIH announced a meeting of the Muscular Dystrophy Coordinating Committee (MDCC). This is a hybrid meeting open to the public.
December 2-3, 2024: NIH announced a meeting of the National Advisory Board on Medical Rehabilitation Research. This is a hybrid meeting open to the public.
December 3, 2024: CDC announced a meeting of the Advisory Council for the Elimination of Tuberculosis. This is a virtual meeting open to the public.
December 3, 2024: SAMHSA announced a meeting of the Center for Substance Abuse Prevention’s Drug Testing Advisory Board. This is a virtual meeting open to the public.
December 4, 2024: FDA announced a meeting of the Pharmacy Compounding Advisory Committee. This is a hybrid meeting open for public comment.
December 5, 2024: NIH announced a meeting of the Sleep Disorders Research Advisory Board. This is a virtual meeting open to the public.
December 9, 2024: NIH announced a briefing on the National Academies of Science, Engineering, and Medicine’s (NASEM) Assessment of NIH Research on Women’s Health. This is a hybrid meeting open to the public.
December 11, 2024: CDC announced a meeting of the Lead Exposure and Prevention Advisory Committee. This is a virtual meeting open to the public.
December 12, 2024: NIH announced a meeting of the Advisory Committee to the Director, National Institutes of Health. This is a hybrid meeting open to the public.
December 12, 2024: FDA announced a hearing of the Vaccines and Related Biological Products Advisory Committee. This is a virtual meeting open to the public.
January 13, 2025: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a virtual meeting open to the public.
April 3, 2025: NIH announced a meeting of the Board of Scientific Counselors for the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting open to the public.
II. Reports, Studies, & Analyses
- On October 30, 2024, the U.S. Government Accountability Office (GAO) released a report entitled, Medicaid: Menstrual Product Coverage. GAO found that 25 states had at least one Medicaid managed care plan that covered a quantity or dollar amount of menstrual products specifically, or covered a range of over-the-counter or personal care items, including menstrual products. This coverage was not offered by all the plans in each of these states. CMS officials reported that state Medicaid programs have other options to provide coverage of menstrual products, including seeking federal approval to cover the costs of menstrual products as part of a demonstration project, though no state has done so.
- On October 31, 2024, the Congressional Budget Office (CBO) released a cost estimate of H.R. 5012, the SHINE for Autumn Act of 2023. H.R. 5012 would authorize several activities of HHS related to research on stillbirths. Specifically, the bill would authorize $6 million annually over the 2024-2028 period for HHS to make grants to states to conduct surveillance and collect data on the incidence of and risk factors for stillbirths. The bill would direct HHS to issue guidelines for that data collection. The bill also would authorize $3 million annually over the same period to establish a fellowship program that would provide training in perinatal autopsy pathology; fund research on data collection from fetal autopsies; and address challenges in education, research, and data collection concerning stillbirths. Finally, H.R. 5012 would require HHS to report to Congress on the fellowship program’s progress and effectiveness. CBO found that H.R. 5012 alone did not affect direct spending or revenues, but, subject to appropriations, could cost up to $35 million between 2025 and 2029.
III. Other Health Policy News
- On October 29, 2024, CMS reported that MSSP had achieved its highest-ever net savings in 2023, generating $2.1 billion in savings while providing high-quality, coordinated care to Medicare enrollees. ACOs in the program received $3.1 billion in shared savings payments and excelled on numerous quality measures, including diabetes and blood pressure management, cancer screenings, and cardiovascular care. Primary care led ACOs demonstrated notably high savings, highlighting primary care’s critical role in MSSP’s success. In a press release, CMS noted that the agency is aiming for 100 percent of Traditional Medicare beneficiaries to be in accountable care by 2030 and is exploring program enhancements to support further primary care investment. A press release with more information is available here.
- On October 29, 2024, Representative Greg Murphy (R-NC-03) along a bipartisan group of House members, introduced the Medicare Patient Access and Practice Stabilization Act, which would increase Medicare payment for physicians and other practitioners. The legislation would provide a 4.73 percent payment update starting in 2025. This update would eliminate the impending 2.8 percent payment cut and instead would provide an approximate 1.9 percent update, which represents half of the 2025 Medicare Economic Index (MEI). In a related press release, Congressman Murphy emphasized that physicians are at a breaking point and access to health care for Medicare patients is at risk. The press release is available here. The bill is available here.
- On October 29, 2024, Senator Bill Cassidy (R-LA), Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and Senator Maggie Hassan (D-NH) released a draft of a site-neutral payment reform framework. Key policy changes proposed in the draft include expanding the number of off-campus locations subject to the site neutral policy enacted as part of the Bipartisan Budget Act of 2015 by eliminating the exception for grandfathered HOPD off-campus locations that were billing Medicare as of the date the law was enacted. The framework also includes a proposal to establish site neutral payments for certain common outpatient services based on a review of data on HOPDs, ambulatory surgical centers, and physician offices to determine where an outpatient service is most commonly performed. Additionally, the draft proposes reinvesting savings from the site-neutrality reimbursement proposal in rural hospitals, “high needs” hospitals, hospitals with core lines of services, and hospitals engaging in value-based reimbursement models. The proposal is still in the drafting stage and has yet to be introduced as a bill in the Senate. Legislative text likely will be introduced in early 2025. The full draft of the proposal is available here.
View our Health Care Legislative & Public Policy team.
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