Health Care Watch: June 3, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from May 26 – June 1. 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 May 28, Reps. Larry Bucshon (R-IN), Buddy Carter (R-GA), and Diana Harshbarger (R-TN) introducedthe 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act). The legislation would establish oversight and transparency of the 340B program. The legislation would also introduce new requirements that would ensure that qualifying low-income and uninsured patients benefit directly from 340B through reduced out-of-pocket costs; codify a patient definition in statute; add new requirements for manufacturers, which currently do not have a statutory requirement to ship or facilitate delivery of 340B drugs to contract pharmacies; and establish eligibility requirements for hospitals, with specific requirements varying by hospital type.
The House returns to session on June 3.
Senate
On May 28, a bipartisan group of Senators Representatives, led by Rep. Kevin Mullin (D-CA) and Sen. Elizabeth Warren (D-MA), sent a letter to Food & Drug Administration (FDA) Commissioner Robert Califf, asking that the agency work with hearing aid companies to make certain they disclose whether their devices contain software that compels consumers to return it to the manufacturer or network-affiliated clinics or doctors for repairs, replacements, or adjustments.
On May 30, Finance Committee Chairman Ron Wyden (D-OR) sent a letter to Federal Trade Commission (FTC) Chair Lina Khan and U.S. Securities and Exchange Commission (SEC) Chair Gary Gensler urging the agencies to hold UnitedHealth Group (UHG) accountable for negligent cybersecurity practices, which caused harm to consumers, investors, the health care system, and U.S. national security.
The Senate returns to session on June 3.
REGULATORY UPDATE
On May 24, FDA announced that they granted Pfizer a priority review voucher for its oral COVID-19 treatment Paxlovid. The designation is meant to incentivize the development of medical countermeasures during public health emergencies (PHEs).
On May 28, FDA released draft guidance entitled Platform Technology Designation Program for Drug Development Guidance for Industry. The guidance outlines eligibility criteria for receiving a platform technology designation and provides recommendations for what sponsors should include in their applications to the agency. It also details potential benefits of participating in the program, including the ability to leverage data from a prior product that used the designated platform technology and receiving timely advice from the FDA during the drug development process. FDA will issue a determination within 90 days of receiving a platform technology designation request and expects 10 applications per year. FDA’s Federal Register notice can be found here.
On May 28, FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the following treatment indications, which are also currently approved for Soliris: the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis; and the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
On May 28, FDA announced a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 5 to discuss and recommend the composition of the coronavirus vaccine to be released in the fall.
On May 28, the National Institutes of Health (NIH) appointed an official, Dr. Lyric Jorgenson, to identify political meddling within the agency and will soon establish a scientific integrity council to review those cases.
On May 29, the Centers for Medicare & Medicaid Services (CMS) announced that it will host a Measures Management System’s Information Session, entitled Get a Clue About CBE Measure Reviews: PRMR, MSR, & E&M on June 26. The learning session will provide information about the goals and evaluation criteria for different types of measure review and provides an opportunity for measure developers to learn how and why they could participate in different reviews and a chance for interested parties to learn more about the value each review brings to the health care system. Registration can be found here.
On May 30, the Department of Health & Human Services (HHS), through its Administration for Community Living, released Aging in the United States: A Strategic Framework for a National Plan on Aging. The report lays the groundwork for a coordinated effort – across the private and public sectors and in partnership with older adults, family caregivers, the aging services network, and other stakeholders – to create a national set of recommendations for advancing healthy aging and age-friendly communities. The national plan on aging will advance best practices for service delivery, support development and strengthening of partnerships within and across sectors and identify solutions for removing barriers to health and independence for older adults.
On May 30, HHS Secretary Xavier Becerra approved FDA’s proposed reorganization. Through the reorganization, FDA will create a unified Human Foods Program (HFP), adopt a new model for its field operations and other significant modernization efforts. Additionally, the Office of Regulatory Affairs will become the Office of Inspections and Investigations. The reorganization implementation is currently targeted for October 1, 2024. The federal register announcement can be found here.
On May 30, CMS announced a Request for Applications (RFA) for participation in the Accountable Care Organizations (ACO) Primary Care (PC) Flex Model. The ACO PC Flex Model is a new, voluntary payment model that will focus on advanced primary care delivery in the Medicare Shared Savings Program (Shared Savings Program). The model will launch on January 1, 2025, and run for five years. An application Overview Webinar will be held on June 6. Registration can be found here.
On May 30, CMS released a CMS Diabetes Strategy Impact Report updating the diabetes work happening at CMS. This resource summarizes the advances made in improving diabetes care in Medicare in calendar year (CY) 2023, including prevention, screening, and diagnosis, as well as access to treatment, services, and support.
On May 31, HHS released a new tool to help communities prepare for extreme heat and prevent heat-related illness. The Heat and Health Index (HHI) is the first nationwide tool to provide heat-health outcome information at the ZIP code level. The HHI will help state and local officials identify communities, at the zip code level, most likely to experience negative health outcomes from heat, ensure that outreach and medical aid reach the people who need it most, and help decision-makers prioritize community resilience investments.
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 May 29, OIG released a report examining NIH-funded clinical trials and enrollment of underrepresented groups. OIG found that two-thirds of the clinical trials in the sample had inclusive enrollment plans, but one-third did not plan to include all racial and ethnic groups. Additionally, OIG found that slightly more than half of clinical trials in the sample were missing required information that would explain the planned target population, and most completed clinical trials in the sample missed planned enrollment targets for underrepresented groups. OIG recommends that NIH: 1) hold researchers accountable for clearly describing the rationale for planned study population, as required by NIH policy; 2) develop additional ways of supporting researchers in meeting inclusion enrollment targets; and 3) promptly take steps to align NIH’s demographic data collection and reporting with the revised OMB requirements and obtain more precise clinical trial inclusion enrollment data.
On May 28, OIG released a report examining Medicare waste, fraud, and abuse, related to off-the-shelf (OTS) orthotic braces which may result in improper payments and impact the health of enrollees. OIG found that: 1) providers ordered braces for enrollees for whom there was no history of a treating relationship; 2) new suppliers were located in geographic areas with known Medicare fraud; 3) Medicare paid more than private payers for OTS braces; and 4) suppliers used prohibited solicitation to contact enrollees. OIG recommends that CMS strengthen its oversight of Medicare billing for OTS braces by: 1) taking steps to prevent payments for claims for replacement OTS braces billed without required modifiers; 2) identifying providers who ordered OTS braces for enrollees with whom they had no treating relationships, and use that information to determine whether to provide additional education to or take administrative or legal action against the ordering providers or associated suppliers; 3) analyzing supplier billing patterns to determine whether to conduct additional prepayment or postpayment reviews of suppliers.
Government Accountability Office (GAO)
On May 30 GAO released a report examining Medicaid Managed Care plans’ prior authorization decisions for children. GAO found that selected states’ oversight of managed care plans’ prior authorizations, including for EPSDT services, generally fell into the following categories: 1) review of plans’ processes, this could include reviewing plans’ policies related to time frames for notifying beneficiaries of prior authorization decisions and reviewing some of the medical necessity criteria plans used to make authorization decisions for certain services; 2) data collection, all five selected states collected data from plans on either prior authorization approvals and denials or appeals of decisions and three states used these data to identify trends, such as the services being denied; and 3) review of a subset of denied authorizations, two of the five selected states reviewed the appropriateness of a small subset of denials for which a state fair hearing was requested. GAO recommends that CMS: 1) communicate expectations for how states are to monitor the appropriateness of plans’ prior authorization decisions and confirm that states meet these expectations; and 2) clarify whether managed care plans can require prior authorization for EPSDT services when the state does not have such requirements.
UPCOMING HEARINGS
House
Oversight and Accountability Committee
June 3; 10:00 AM; 2154 Rayburn
A Hearing with Dr. Anthony Fauci
Witnesses: Dr. Anthony Fauci, Former Director, National Institute of Allergy and Infectious Disease
Early June; TBD
Hearing on Pharmacy Benefit Manager (PBM) Practices
Energy and Commerce Committee
Subcommittee on Oversight and Investigations
June 4; 10:30 AM; 2322 Rayburn
Oversight of 340B Drug Pricing Program
Witnesses: Anthony DiGiordio, DO, Neurosurgeon, University of California San Francisco Health; Sue Veer, President and CEO, Carolina Health Center; Matthew Perry, President and CEO, Genesis Healthcare System.
A hearing memo can be found here.
Ways & Means Committee
Markup of health care innovation policies
TBD
Senate
Health, Education, Labor & Pensions Committee
June 4; 10:00 AM; SD-106
The Assault on Women’s Freedoms: How Abortion Bans Have Created a Health Care Nightmare Across America
OTHER POLICY NEWS
On May 29, MedPAC released a comment letter on CMS’ request for information (RFI) entitled: Medicare Program; Request for Information on Medicare Advantage (MA) Data. MedPAC stated that it strongly supports CMS’ efforts, as improved data would help beneficiaries and policymakers to better evaluate how MA affects access to care, quality of care, service use, and program spending. The Commission focused its comments on beneficiary access to care, MA marketing and plan offerings, quality and outcomes, market dynamics, special populations, and improvements to current data collection.
On May 29, the American Clinical Laboratory Association filed a lawsuit against FDA regarding the recently released laboratory developed test (LDT) proposed rule, claiming that the rule exceeds the agency’s authority. The lawsuit urges a Texas federal court to rule that FDA cannot legally regulate LDTs under the Federal Food, Drug and Cosmetic Act and requests an order vacating the policy.
On May 30, Battelle, a CMS certified consensus-based entity (CBE), announced that it is accepting nominations through June 7 for Partnership for Quality Measurement (PQM) committees supporting the Endorsement & Maintenance (E&M) and Pre-Rulemaking Measure Review (PRMR) processes. Nominations can be found here.