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, bipartisan members of the House and Senate introduced new PBM reform legislation, while ASTP/ONC released its Trusted Exchange Framework and Common Agreement (TEFCA) final rule.
I. Regulations, Notices & Guidance
- On December 9, 2024, the Agency for Healthcare Research and Quality (AHRQ) released a notice entitled, Supplemental Evidence and Data Request on Recurrent Nephrolithiasis in Adults and Children: Comparative Effectiveness of Preventive Medical Strategies. AHRQ is seeking scientific information submissions from the public to inform its review on Recurrent Nephrolithiasis in Adults and Children: Comparative Effectiveness of Preventive Medical Strategies, which is currently being conducted by AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
- On December 10, 2024, the Department of Health and Human Services (HHS) released a notice entitled, 12th Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act (PREP) for Medical Countermeasures Against COVID–19. This amendment was issued pursuant to section 319F–3 of the Public Health Service Act to extend the duration of the PREP Act Declaration to December 31, 2029, and to republish the Declaration in full.
- On December 10, 2024, HHS released a notice entitled, Request for Public Comments on the Scientific Report of the 2025 Dietary Guidelines Advisory Committee. HHS, along with the U.S. Department of Agriculture (USDA) invite the public to provide written comments and virtual oral comments on the Scientific Report of the 2025 Dietary Guidelines Advisory Committee.
- On December 11, 2024, HHS’ Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) released a final rule entitled, Health Data, Technology, and Interoperability: Trusted Exchange Framework and Common Agreement (TEFCA). This final rule has finalized certain proposals from a proposed rule published in August 2024 and in doing so advances interoperability and supports the access, exchange, and use of electronic health information (EHI). Specifically, this final rule amends the information blocking regulations by including definitions related to the TEFCA Manner Exception. It also implements provisions related to the TEFCA, which will support the reliability, privacy, security, and trust within TEFCA. Lastly, this final rule includes corrections and updates to current regulatory provisions of the ONC Health IT Certification Program.
- On December 11, 2024, HHS released a notice entitled, Statement of Organization, Functions, and Delegations of Authority. This document revises and restates the Statement of Organization, Functions, and Delegations of Authority for the HHS Office of the General Counsel (OGC).
- On December 11, 2024, AHRQ released a request for information (RFI) entitled, Request for Information Regarding Diagnostic Excellence Measurement. AHRQ invites public comment in response to this RFI on the development of measures of diagnostic excellence that may be calculated using administrative data or electronic health record (EHR) data. The purpose of diagnostic excellence measurement is to identify potential opportunities to improve the diagnostic process at a health system or geographic level. AHRQ welcomes comments on the importance and usability of existing measures and those that may be under development.
- On December 11, 2024, the Food and Drug Administration (FDA) released a notice entitled, Advisory Committee; Science Board to the Food and Drug Administration; Renewal. FDA is announcing the renewal of the Science Board to the Food and Drug Administration by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Science Board to the Food and Drug Administration for an additional two years beyond the charter expiration date. The new charter will be in effect until the June 26, 2026, expiration date.
- On December 12, 2024, HHS released a final rule entitled, Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and Modification of the Medicaid Pharmacy Subrogation Standard. This final rule adopts updated versions of the retail pharmacy standards for electronic transactions adopted under the Administrative Simplification subtitle of HIPAA. These updated versions are modifications to the currently adopted standards for the following retail pharmacy transactions: health care claims or equivalent encounter information; eligibility for a health plan; referral certification and authorization; and coordination of benefits. This final rule also adopts a modification to the standard for the Medicaid pharmacy subrogation transaction.
- On December 13, 2024, AHRQ released a notice entitled, Solicitation for Nominations for Members of the U.S. Preventive Services Task Force. AHRQ invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF). Nominations must be received electronically by March 15th of a given year to be considered for appointment to begin in January of the following year and can be submitted electronically via: https://uspstfnominations.ahrq.gov/register.
- On December 13, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a notice entitled, Fiscal Year (FY) 2024 Notice of Reissued Funding Opportunity. This notice is to inform the public that SAMHSA plans to withdraw the previously announced notice of funding opportunity (NOFO) for the Women’s Behavioral Health Technical Assistance Center SM-24-012 and reissue the NOFO as the National Women’s Behavioral Health Technical Assistance Center SM-25-014. The revised NOFO includes updates to the required activities and application evaluation criteria. The cancellation of NOFO SM-24-012 does not represent an assessment of the technical merits of any applications submitted. SAMHSA will notify organizations that submitted an application.
Event Notices
January 7, 2025: HHS announced a meeting of the Advisory Committee on Minority Health. This is a virtual meeting open to the public.
January 7, 2025: The Small Business Administration (SBA) announced a meeting of the National Women’s Business Council. This is an in-person meeting open to the public.
January 13, 2025: The National Institutes of Health (NIH) announced a meeting of the National Advisory Child Health and Human Development Council. This is a virtual meeting open to the public.
January 16, 2025: HHS announced a meeting of the Advisory Committee on Minority Health. This is a virtual meeting open to the public.
January 23, 2025: NIH announced a meeting of the National Deafness and Other Communication Disorders Advisory Council. This is a virtual meeting with one session open to the public.
January 27, 2025: NIH announced a meeting of the National Advisory Allergy and Infectious Diseases Council. This is a virtual meeting with some sessions open to the public.
January 28, 2025: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This is an in-person meeting open the public.
January 28, 2025: NIH announced a meeting of the National Advisory Council for Nursing Research. This is an in-person meeting open to the public.
February 5, 2025: FDA announced a joint public meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. This is a hybrid 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.
April 30, 2025: NIH announced a meeting of the National Library of Medicine Board of Scientific Counselors. This is a hybrid meeting with some sessions open to the public.
May 14, 2025: NIH announced a meeting of the National Advisory Council on Aging. This is an in-person meeting with one session open to the public.
II. Reports, Studies, & Analyses
- On December 10, 2024, the RAND Corporation released a report entitled, Prices Paid to Hospitals by Private Health Plans. The report analyzed medical claims data from a large population of privately insured individuals from 2020–2022 and provided comparisons of hospital prices across the United States. The study identified hospitals and hospital systems by name, a distinction not typically permitted under data use agreements. The report found that in 2022, employers and private insurers paid, on average, two hundred and fifty-four percent of what Medicare would have paid for the same inpatient and outpatient hospital services. Relative prices varied significantly across states, with Arkansas having the lowest prices at below one hundred and seventy percent of Medicare rates, while states such as California, Florida, and Wisconsin exceeded three hundred percent. Outpatient services performed in ambulatory surgery centers (ASCs) averaged one hundred and seventy-one percent of Medicare rates, while administered drug prices in hospitals averaged two hundred and eighty-one percent of the average sales price, compared to Medicare’s one hundred and six percent. The study noted that hospital market power, rather than the share of patients covered by Medicare or Medicaid, explained most of the variation in prices.
- On December 12, 2024, the Congressional Budget Office (CBO) released a report entitled, Options for Reducing the Deficit: 2025 to 2034. The report discussed the potential savings of seventy-six different policies that would affect mandatory spending, discretionary spending, or revenues. Of note, CBO assessed the budgetary effects of the following: caps on federal spending for Medicaid, limits on state taxes on health care providers, reducing federal Medicaid matching rates, increasing the premiums paid for Medicare Part B, reducing Medicare Advantage (MA) benchmarks, consolidating and reducing Medicare payments for graduate medical education (GME) at teaching hospitals, modifying payments to MA plans for health risk, reducing payments for hospital outpatient departments (HOPDs), reducing payments for drugs delivered by 340B hospitals, reducing tax subsidies for employment-based health benefits, imposing a new payroll tax, increasing the corporate income tax rate by one percentage point, and taxing all foreign income of U.S. corporations at the full statutory corporate rate.
III. Other Health Policy News
- On December 12, 2024, the Medicare Payment Advisory Commission (MedPAC) held a session during its December 2024 public meeting entitled, Assessing Payment Adequacy and Updating Payments: Physician and Other Health Professional Services. MedPAC staff reviewed background on physician and other health professional payments under Medicare and assessed beneficiary access to care under current payment structures. At the end of the presentation, staff outlined the Chair’s draft recommendation to be included in MedPAC’s 2025 Report to Congress. The draft recommendation included two key proposals: 1) update the 2025 Medicare base payment rate by the projected increase in the Medicare Economic Index (MEI) minus 1 percentage point, and 2) enact the Commission’s March 2023 recommendation to establish safety net payment for low-income Medicare beneficiaries, which would provide higher payment updates to primary care physicians and specialists serving this group. Commissioners largely supported the recommendations, with many emphasizing the importance of the safety net add-on in addressing access gaps. However, some expressed concerns about the adequacy of the proposed payment updates, and there were also calls for further exploration of non-physician provider roles in the Medicare system and better monitoring and measurement of access issues. Commissioners are expected to vote on the recommendations in 2025. Slides from the presentation are available here.
- On December 12, 2024, MedPAC held a session during its December 2024 public meeting entitled, Assessing Payment Adequacy and Updating Payments: Hospital Inpatient and Outpatient Services; and Mandated Report on Rural Emergency Hospitals. The Commission reviewed whether Medicare’s fee-for-service (FFS) payment policies were adequate to maintain beneficiaries’ access to care, the quality of care, access to capital, and FFS Medicare payment and costs. In light of this review, the Chair’s draft recommendation suggests that the Congress should, for FY 2026, update the 2025 Medicare base payment rates for general acute care hospitals by the amount specified in current law plus one percent, distribute existing disproportionate share hospital (DSH) and uncompensated care payments through the Medicare Safety-Net Index (MSNI), and add $4 billion to the MSNI pool. Most Commissioners were generally supportive of the recommendation, but some expressed concern, such as the blended nature of the draft recommendation, which uniformly covers both the Inpatient Prospective Payment System (IPPS) and Hospital Outpatient Prospective Payment System (OPPS), and that the methodology used to determine the recommendation is not dynamic enough to account for year-by-year variations. Slides from the presentation are available here.
- On December 12, 2024, MedPAC held a session during its December 2024 public meeting entitled, Assessing Payment Adequacy and Updating Payments: Inpatient Rehabilitation Facility Services. During the meeting, MedPAC staffers presented on the use of inpatient rehabilitation facilities (IRFs) and total spending for these services under FFS Medicare in FY 2023. MedPAC staff noted that beneficiary access to care and care quality remained either relatively stable or slightly increased, while IRF access to capital and profit margins grew. In particular, the commissioners were interested in why a significant difference in profitability existed between freestanding IRFs and hospital-based IRFs. Several commissioners also expressed concern at consolidation within the freestanding IRF market, with a single company owning fourty-four percent of freestanding IRFs. The Chair recommended that, for FY 2025, the Medicare base payment rate for IRFs be reduced by seven percent, which the Commissioners unanimously supported. Slides from the presentation are available here.
- On December 11, 2024 Senators Elizabeth Warren (D-MA) and Josh Hawley (R-MO), along with Representatives Diana Harshbarger (R-TN-1) and Jake Auchincloss (D-MA-4) announced the introduction of bipartisan legislation, the Patients Before Monopolies (PBM) Act, to prohibit PBMs and health insurers from owning pharmacies. The legislation proposes to:
- Prohibit a parent company of a PBM or a health insurer from owning a pharmacy business;
- Require that a parent company in violation of the PBM Act divest its pharmacy business within three years;
- Enable the Federal Trade Commission (FTC), HHS, Antitrust Division of the Department of Justice, and state attorneys general to issue orders requiring violators of the PBM Act to divest its pharmacy business and disgorge any revenue received during the period of such violation;
- Direct the FTC to distribute any disgorged revenue to harmed communities, including consumers overcharged at vertically integrated pharmacies; and,
- Mandate reporting of all divestitures to the FTC and allow the FTC to review all divestitures and subsequent acquisitions to protect competition, financial viability, and the public interest.
- The full text of the bill can be found here, and a one page summary can be found here. A press release with more information is available here.
- On December 11, 2024, ASTP/ONC released the final version of a portion of its proposed HTI-2 rule addressing health data, technology, and interoperability. Specifically, the final rule released includes the portions of the proposed rule that address proposals involving TEFCA and excludes provisions regarding protecting care access and voluntary certification of public health organizations and payers. The TEFCA final rule clarifies an exception to information blocking called the “Manner Exception”, stating that a provider’s requirement to exchange EHI exclusively through TEFCA does not constitute information blocking so long as both the provider and requestor are a part of TEFCA and the requestor is able to access, exchange, and use the EHI via TEFCA. The final rule also made several clerical updates to the existing regulations. ASTP/ONC has indicated that it will release its 2024 Fall Unified Agenda in the near future, which will provide more insight on its approach. The full released final rule can be found here. Of note, an additional final rule entitled Health Data, Technology, and Interoperability: Protecting Care Access cleared the Office of Management and Budget (OMB) on December 12, 2024, and may finalize additional portions of the HTI-2 proposed rule.
- On December 10, 2024, the Centers for Medicare & Medicaid Services (CMS) released a new health care delivery framework entitled, Optimizing Care Delivery: A Framework for Improving the Health Care Experience. The report outlines CMS’s five-year strategy to address administrative burdens and other frictions in the health care system with the goal of improving the care experience for patients, clinicians, and other stakeholders. According to the report, these burdens limit timely access to quality care, contribute to workforce challenges, and exacerbate health disparities.
- The Framework introduces a set of seven strategic priorities to guide CMS’s efforts in enhancing the delivery of care and the overall health care experience.
- Priority 1: Integrate the voice of the patient and caregiver into opportunities to increase equity in care access and delivery.
- Priority 2: Improve patient safety and reduce administrative burden in care transitions.
- Priority 3: Address well-being and experience for healthcare workers across the healthcare enterprise.
- Priority 4: Improve care approval processes to increase access to care and reduce care delays.
- Priority 5: Reduce redundant or outdated data collection, documentation, and reporting requirements.
- Priority 6: Leverage technology to accelerate innovation and the adoption of best practices.
- Priority 7: Convene and support public-private partnerships to advance the healthcare experience and burden reduction efforts.
- The Framework was informed by extensive stakeholder input, including public roundtables, CMS’ 2023 Conference on Optimizing Healthcare Delivery, and engagements focused on clinician well-being and other critical topics. Additionally, the initiative aligns with the goals of Executive Order 14058, which calls for reducing administrative burdens across federal agencies, and with CMS’s six strategic pillars: Advance Equity, Expand Access, Engage Partners, Drive Innovation, Protect Programs, and Foster Excellence. The framework also contributes to the National Quality Strategy, particularly in promoting safe and resilient health care systems. The framework is available here.
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