Health Care Watch: June 17, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from June 9 – June 16. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
On June 11, the Energy & Commerce Committee released a report entitled Interim Staff Report into Risky MPXV Experiment at the National Institute of Allergy and Infectious Diseases. The report details the Committee’s investigation, which was launched following a 2022 Science magazine interview in which Dr. Bernard Moss of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) revealed that he was planning to insert segments of a lethal strain of MPXV into a more transmissible strain of the virus.
On June 12, the Energy & Commerce Committee held a markup of 13 pieces of health care legislation. The Committee voted unanimously to advance all 13 pieces of legislation which range in topic from preventing Medicaid fraud to increasing health care access for children.
On June 13, the Energy & Commerce Health Subcommittee held a hearing entitled Checking-In on CMMI: Assessing the Transition to Value-Based Care. Elizabeth Fowler, Deputy Administrator and Director of the Center for Medicare and Medicaid Innovation (CMMI), testified before the committee on CMMI’s progress towards expanding value-based care. The hearing discussed CMMI’s successful models as well as the recent Congressional Budget Office (CBO) report which found that CMMI increased government spending by $5.4 billion over its first decade rather than creating savings.
On June 13, the Budget Committee held a hearing entitled Medicare and Social Security: Examining Solvency and Impacts to the Federal Budget. The hearing discussed program solvency and included expert testimony from the chief actuaries from CMS and the Social Security Administration.
The House is in recess until June 25.
Senate
On June 12, a bipartisan, bicameral group of legislators reintroduced the Improving Seniors’ Timely Access to Care Act. The legislation aims to streamline the prior authorization (PA) process under Medicare Advantage (MA). Specifically, the legislation would: establish an electronic prior authorization process for MA plans including a standardization for transactions and clinical attachments; increase transparency around MA prior authorization requirements and its use; clarify the Centers for Medicare and Medicaid Services’ (CMS) authority to establish timeframes for e-PA requests; expand beneficiary protections to improve enrollee experiences and outcomes; and require the Department of Health and Human Services (HHS) and other agencies to report to Congress on program integrity efforts and other ways to further improve the e-PA process. The bill differs from the version that passed the House unanimously last Congress and was marked up by the Ways & Means Committee last summer by eliminating the requirement for HHS to establish a process for “real-time decisions” for items and services that are routinely approved.
On June 14, Health, Education, Labor & Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) dropped his call to subpoena the Head of North America Operations and President of Novo Nordisk Inc. to provide testimony about the company’s pricing of its drugs Ozempic and Wegovy – after the company’s global CEO Lars Jorgensen confirmed he will appear before the Committee in early September.
REGULATORY UPDATE
On June 10, the Food & Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) unanimously recommended that FDA approve Lilly’s Alzheimer's drug, donanemab, stating that the drug’s benefits to patients outweigh its potential risks.
On June 10, the Supreme Court agreed to review a case challenging how HHS calculates Disproportionate Share Hospital (DSH) payments. The lawsuit was filed by more than 200 hospitals across 32 states. The organizations argue that HHS incorrectly adopts the view that a patient is entitled to Supplemental Security Income (SSI) benefits only if the patient actually received cash SSI payments during a hospital stay, an interpretation inconsistent with an earlier Supreme Court decision from 2022 in Becerra v. Empire Health Foundation. Previously, a D.C. Circuit court ruled in favor of HHS.
On June 10, FDA announced a new “meeting program” – the Emerging Drug Safety Technology Meeting (EDSTM) program – to understand how emerging artificial intelligence (AI) tools can be used to conduct pharmacovigilance (i.e., the monitoring, detection, assessment and prevention of drug adverse events). The EDSTM will facilitate discussions between federal regulators and academia, contract research organizations, vendors and software developers to discuss the use of AI.
On June 12, the CMS’ Office of the Actuary (OACT) released projections of National Health Expenditures (NHE) and health insurance enrollment for the years 2023-2032. OACT projects that, over 2023-2032, average annual growth in NHE (5.6%) will outpace average annual growth in gross domestic product (GDP) (4.3%), resulting in an increase in the health spending share of GDP from 17.3% in 2022 to 19.7% in 2032. NHE projects that average annual Medicare expenditure growth will be 7.4% for 2023-2032, Medicaid spending is projected to be 5.2%, private insurance spending is projected to be 5.6%, and out-of-pocket spending is projected to average 4.7%. All NHE projections can be found here.
On June 12, the HHS’ National Syphilis and Congenital Syphilis Syndemic Federal Task Force issued new considerations for health care providers who test patients for syphilis. The new HHS document,Considerations for the Implementation of Point of Care Tests for Syphilis, outlines four main differences between syphilis point of care tests and laboratory-based serologic syphilis tests and highlights the best settings to consider use of point-of-care tests. It also examines parameters for point of care testing program implementation and management, provides answers to common questions, and lists links to related resources.
On June 13, the Supreme Court ruled unanimously in the case of FDA v. Alliance for Hippocratic Medicine that the Alliance for Hippocratic Medicine does not have legal standing to challenge FDA’s decisions in 2016 and 2021 to relax various regulatory requirements around the drug mifepristone.
On June 13, HHS, through the Health Resources and Services Administration (HRSA), awarded more than $11 million to 15 organizations to establish new residency programs in rural communities. Building on HRSA’sEnhancing Maternal Health Initiative, one program will create the first obstetrics and gynecology Rural Track Program in the country, and six others will develop new family medicine residency programs with enhanced obstetrical training in rural communities.
On June 13, the Biomedical Advanced Research and Development Authority (BARDA) announced up to $500 million in Project NextGen funding to plan and execute multiple Phase 2b clinical trials evaluating novel vaccines administered as a nasal spray or as a pill to protect against symptomatic COVID-19. The project awards were made through BARDA’s Rapid Response Partnership Vehicle (RRPV) to support the following companies in planning for and preparing the vaccine candidates for Phase 2b clinical trials: up to $453 million to Vaxart who is developing an oral pill vaccine candidate, adenovirus serotype 5 (Ad-5); and approximately $34 million to Castlevax who is developing an intranasal vaccine candidate, CVAX-01; and approximately $40 million to Cyanvac who is developing an intranasal vaccine candidate, CVXGA.
On June 13, CMS released a final rule that would revise the Medicare Prescription Drug Benefit (Part D) and Office of the National Coordinator for Health Information Technology (ONC) regulations to implement changes related to required standards for electronic prescribing and adoption of health information technology (IT) standards for HHS use. The final rule will require Part D sponsors, prescribers, and dispensers of covered Part D drugs for Part D eligible individuals to comply with standards CMS has either adopted directly or is requiring by cross-referencing standards ONC adopts for electronically transmitting prescriptions and prescription-related information.
On June 13, CMS announced that it will host a listening session on July 31 to discuss the 2023 Health Equity Confidential Feedback Reports which were released to Post-Acute Care (PAC) providers in the Home Health (HH), Inpatient Rehabilitation Facility (IRF), Long-Term Care Hospital (LTCH), and Skilled Nursing Facility (SNF) settings. Registration for the event can be found here.
On June 14, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced notices of funding opportunities aimed at improving behavioral health for racial and ethnic minorities, and other underserved populations, providing training and technical assistance to programs serving these populations, and integrating primary and behavioral health care. The funding totals $31.4 million and supports continued efforts to address the mental health and overdose crises.
WHITE HOUSE
On June 10, the Biden Administration released a fact sheet detailing ways that the Administration has and will continue to strengthen cybersecurity and bolster protections for Americans’ access to health care. The fact sheet states that, as part of the initiative to improve security and resilience of the rural hospital system, private sector partners have committed to extending nonprofit programs to provide grants and up to a 75% discount on security products optimized for smaller organizations and providing endpoint security advice to rural hospitals and non-profit organizations at no cost.
On June 11, the Biden Administration announced actions from the Consumer Financial Protection Bureau’s (CFPB) that would remove medical debt from credit reports of more than 15 million Americans. Under the CFPB proposed rule, the Administration estimates no one will have medical debt listed on their credit reports, down from 46 million in 2020. Vice President Harris also called on states, local governments, and health care providers to take comprehensive action to reduce the burden of medical debt by: leveraging public dollars to purchase and eliminate medical debt; preventing accumulation of medical debt and protect patients from aggressive debt collectors by expanding access to charity care; and protecting patients and consumers by limiting coercive debt collections practices by health care providers and third-party debt collectors.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Healthcare System Resiliency and Modernization (CMS-3426); Proposed Rule; 10/12/23
Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434); Final Rule; 3/22/24
CY 2025 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1805); Proposed Rule; 4/18/24
CY 2025 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1807); Proposed Rule; 4/18/24
CY 2025 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1809); Proposed Rule; 4/24/24
CY 2025 Home Health Prospective Payment System Rate Update and Home Infusion Therapy and Home IVIG Services Payment Update (CMS-1803); Proposed Rule; 4/26/24
Mitigating the Impact of Anomalous Increases in Billing on Medicare Shared Savings Program Financial Calculations (CMS-1799); Proposed Rule; 5/28/24
FDA
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies; Guidance for Industry; Notice; 4/10/24
Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Notice; 5/21/24
ONC
Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability; Proposed Rule; 1/18/24
REPORTS
Office of Inspector General (OIG)
On June 13, OIG released a report examining program safeguards to prevent and detect improper Medicare payments for short inpatient stays. OIG identified three weaknesses in the established program safeguards for preventing and detecting improper payments for short inpatient stays and recovering overpayments. Specifically, CMS did not have: 1) adequate information to identify short inpatient stays at risk for noncompliance with the two-midnight rule; 2) prepayment edits for claims at risk for noncompliance with the two‑midnight rule; and 3) adequate policies and procedures to review claims at risk for noncompliance with the two‑midnight rule and to recover overpayments. OIG recommends that CMS work with its contractors to: 1) add information to inpatient claims indicating any stay that did not span two or more midnights because of an unforeseen circumstance; 2) develop a list of inpatient procedure codes associated with the outpatient procedure codes on the inpatient-only procedures list; 3) implement prepayment edits for claims for short inpatient stays at risk for noncompliance with the two-midnight rule; and 4) update policies and procedures for postpayment reviews to focus on claims for short inpatient stays identified as at risk for noncompliance with the two-midnight rule and to focus on overpayment recoveries.
UPCOMING HEARINGS
House
Oversight and Accountability Committee
Early June; TBD
Hearing on Pharmacy Benefit Manager (PBM) Practices
Ways and Means Committee
TBD
Markup of Health Care Innovation Policies
Senate
HELP Committee
Early September
Hearing on Novo Nordisk’s drug pricing strategies
ADDITIONAL POLICY NEWS
On June 13, the Medicare Payment Advisory Commission (MedPAC) released its June 2024 Report to the Congress: Medicare and the Health Care Delivery System. The report includes six chapters on the following topics: 1) approaches for updating clinical payments and incentivizing participation in alternative payment models; 2) provider networks and prior authorization; 3) assessing data sources for measuring health care utilization by Medicare Advantage enrollees (encounter data and other sources); 4) paying for software technologies in Medicare; 5) considering ways to lower Medicare payments for select conditions in inpatient rehabilitation facilities; and 6) Medicare’s Acute Hospital Care at Home. The report’s executive summary can be found here.