Health Care Watch: February 19, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from February 12 – February 17. 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 February 12, Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Health Subcommittee Chairman Brett Guthrie (R-KY), and Oversight & Investigations Subcommittee Chairman Morgan Griffith (R-VA) sent a letter to Government Accountability Office (GAO) Comptroller General Gene Dodaro requesting that GAO study the oversight by the Department of Health & Human Services (HHS) and U.S. Department of Agriculture (USDA) of sales of used and excess laboratory equipment and protective clothing that could be used to facilitate bioterrorism or warfare.
On February 15, Reps. Lori Trahan (D-MA) and David Valadao (R-CA) introduced the Reinforcing Essential Health Systems for Communities Act, legislation that would establish an “essential health system” designation in federal law, creating opportunity for more federal funding and support to flow to safety net hospitals. Under the proposed definition, it is predicted that more than 1,000 hospitals nationwide could be designated as “essential health systems” and made eligible for additional federal support.
The House is in recess until February 28.
Senate
On February 13, the Senate passed the national security supplemental and the FEND Off Fentanyl Act in a 70-29 vote. The $95.34 billion national security supplemental package includes $1.2 billion for the FEND off Fentanyl Act which aims to target, sanction, and block the flow of fentanyl and the financial assets of transnational criminal organizations, and address the ongoing opioid epidemic.
On February 15, Sen. Elizabeth Warren (D-MA) and Rep. Pramila Jayapal (D-WA) sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf asking that FDA issue updated guidance regarding how drugmakers list patents in the Orange Book.
The Senate is in recess until February 23.
REGULATORY UPDATE
On February 12, HHS, through the Office of the National Coordinator for Health Information Technology (ONC), announced that two additional organizations—CommonWell Health Alliance and Kno2—have been designated as Qualified Health Information Networks™ (QHINs™) capable of nationwide health data exchange governed by the Trusted Exchange Framework and Common AgreementSM(TEFCASM).
On February 12, HHS Secretary Xavier Becerra and the U.S. Interagency Council on Homelessness (USICH) met to discuss how the federal government can provide more support for innovative state and local efforts to meet the needs of people experiencing both homelessness and mental health or substance use disorders. Participants agreed that action must be taken to increase access to housing, voluntary treatment, and other wraparound support services.
On February 12, a federal court in Texas dismissed a lawsuit, backed by PhRMA, challenging the ongoing Medicare drug price negotiations. Senior U.S. District Judge David Alan Ezra stated that the court lacks jurisdiction over claims because the claims in the case “arise under” the Medicare Act and the claims do not fall under the exception carved out for when claims may completely avoid judicial or administrative review. In response, PhRMA stated, “we are disappointed with the court’s decision, which does not address the merits of our lawsuit, and we are weighing our next legal steps.”
On February 12, the Centers for Medicare & Medicaid Services (CMS) announced policy changes to research data and access requests. CMS stated that it will begin steering researchers to its Virtual Research Data Center (VRDC). The VRCD provides researchers with access to decades on federal health data but requires purchase of a license and prevents institutions from building their own data sets.
On February 13, the National Institutes of Health (NIH) announced that it is investing an additional $515 million over the next four years into the Researching COVID to Enhance Recovery (RECOVER) Initiative, a nationwide research program aimed at fully understanding, diagnosing, and treating Long COVID.
On February 14, HHS released the 2023 update to its Equity Action Plan, in coordination with the Biden-Harris Administration’s whole-of-government equity agenda. HHS’ Equity Action Plan outlines five priority areas to advance equity: 1) prevent neglect and improve care to help children thrive in their families and communities; 2) promote accessible and welcoming health care for all; 3) improve maternal health outcomes for rural, racial, and ethnic minority communities; 4) prioritize the behavioral health of underserved populations; and 5) increase clinical research and trial diversity to support innovation.
On February 14, HHS’ Office on Women’s Health (OWH) and CMS announced the winners of the second and final phase of the $1.8 million HHS Racial Equity in Postpartum Care Challenge. The national competition was developed to improve equity in postpartum care for Black or African American and American Indian/Alaska Native (AI/AN) women enrolled in Medicaid or the Children’s Health Insurance Program (CHIP). A full list of phasetwo winners can be found here.
On February 14, the Federal Trade Commission (FTC) and HHS jointly issued a Request for Information (RFI) to understand how the practices of two types of pharmaceutical drug middlemen groups—group purchasing organizations (GPOs) and drug wholesalers—may be contributing to generic drug shortages. The RFI seeks public comment regarding market concentration among large health care GPOs and drug wholesalers, as well as information detailing their contracting practices. Comments are due by April 14, 2024.
On February 14, HHS Secretary Xavier Becerra and leaders from across HHS met with state leaders and representatives from the National Governors Association (NGA) to announce the launch of HHS Secretary's Postpartum Maternal Health Collaborative. The six states that have agreed to participate in the Postpartum Maternal Health Collaborative are Iowa, Massachusetts, Maryland, Michigan, Minnesota, and New Mexico. The new collaborative seeks to bring together state experts, local providers, community partners, and federal experts to develop a better understanding of the challenges being experienced among the postpartum population and support new solutions that will improve postpartum mortality.
On February 14, HHS Secretary Xavier Becerra met with leaders from national Black civil rights, faith-based, and health organizations to discuss efforts to improve health and human services outcomes in the Black community and further advance health equity. During the roundtable, Secretary Becerra highlighted work being done to improve access to health care, lower health care costs, increase behavioral health investments, address environmental health hazards, strengthen supports for children and families, and further connect organizations to available HHS resources.
On February 14, CMS announced that it will host the Quality Counts, Safety Matters: Prioritizing Patient Safety Through Quality Measurement webinar. The webinar will discuss how quality measures and policies are being implemented to improve the patient experience. The webinar will be held on two dates – March 6 from 12:00 to 1:00 PM ET and March 21 from 2:00 to 3:00 PM ET.
On February 15, CMS released the second part of draft guidance for the Medicare Prescription Payment Plan that outlines requirements for Medicare Part D plan sponsors, including outreach and education requirements, pharmacy processes, and operational considerations, for the program’s first year, 2025. While the draft part one guidance largely focused on Part D plan sponsor operational requirements, the draft part two guidance centers on education and outreach for the program and contains: outreach and education requirements for Part D plan sponsors; requirements for Part D plan sponsor communications with prospective and current program participants; information about how CMS will perform outreach and education activities; and additional operational requirements for Part D plan sponsors. Additionally, the draft part two guidance includes requests for public comment on key elements of the Medicare Prescription Payment Plan. A fact sheet detailing the guidance can be found here. Comments are due by March 16, 2024.
On February 16, CMS issued a notice seeking public comments on the information required to be collected for a new Prior Authorization Demonstration for Certain Ambulatory Surgical Center (ASC) Services. CMS indicated that it seeks to develop and implement the demonstration project but does not provide a specific timeline or which ASC services would be subject to prior authorization. The demonstration will be developed under HHS’ Section 402 waiver authority, and not the authority granted to the Center for Medicare & Medicaid Innovation. Comments from the public are due by April 16, 2024.
On February 16, FDA granted accelerated approval to Iovance Biotherapeutics’ lifileucel, the first tumor-infiltrating lymphocyte (TIL) therapy for treatment of solid tumors. The treatment, known by the brand name Amtagvi, is indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor). According to Iovance, the wholesale acquisition cost of the therapy will be $515,000.
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
Alternative Payment Model Updates; Increasing Organ Transplant Access (IOTA) Model (CMS-5535); Proposed Rule; 11/9/23
Streamlining the Medicaid, CHIP, and BHP Application, Eligibility Determination, Enrollment, and Renewal Processes (CMS-2421); Final Rule’ 12/19/23
Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality (CMS-2439); Final Rule; 12/20/23
Ensuring Access to Medicaid Services (CMS-2442); Final Rule; 1/26/24
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2025 Rates (CMS-1808); Proposed Rule; 1/31/24
HHS Notice of Benefit and Payment Parameters for 2025 (CMS-9895); Final Rule; 2/15/24
FDA
Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act; Proposed Rule; 8/29/23
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 February 13, OIG released a reportexamining Medicare payments for evaluation and management (E/M) services provided via telehealth during the first 9 months of the COVID-19 public health emergency (PHE). OIG found that physicians and other practitioners that provided E/M services via telehealth generally complied with Medicare requirements. For 105 of the 110 sampled E/M services provided via telehealth, providers complied with Medicare requirements. However, for the remaining five sampled E/M services, providers did not comply with Medicare requirements. Medicare paid $446 for the five sampled E/M services for which providers did not document or insufficiently documented the services. OIG made no recommendations because providers generally met Medicare requirements when billing for E/M services provided via telehealth and unallowable payments OIG identified resulted primarily from clerical errors or the inability to access records.
On February 16, OIG released a reportexamining the reported impact of discarded-drug refunds on biosimilar biological products. OIG consulted with CMS, FDA, selected biosimilar drug manufacturers, and a relevant trade association to determine what effects, if any, the Infrastructure Investment and Jobs Act has had or may have on the licensure, market entry, market retention, or marketing of biosimilars, and how it may affect availability of biosimilars under Medicare Part B. OIG concluded that currently there is no known or expected impact on the licensure, market entry, market retention, or marketing of biosimilars as a result of legislation requiring refunds from manufacturers of certain single-dose container or single-use package drugs payable under Part B.