Health Care Watch: August 26, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from August 18 – August 24. 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 August 19, a bipartisan group of Representatives sent a letter to Food & Drug Administration (FDA) Commissioner Dr. Robert Califf raising concerns regarding oversight of U.S. biopharmaceutical companies that have conducted trials in China over the past decade. The letter specifically flags concerns about trials conducted at hospitals affiliated with China’s military and in the Xinjiang region.
On August 21, Ways & Means Committee member Bill Pascrell (D-NJ) passed away at age 87.
The House returns from its August recess on September 9.
Senate
The Senate returns from its August recess on September 9.
REGULATORY UPDATE
On August 16, the Medicare Administrative Contractors (MACs) announced that they have considered all the feedback received from interested parties regarding the MolDx: Molecular Testing for Solid Organ Allograft Rejection proposed local coverage determination (LCD). The MACs stated that, in response to public comments and upon further review of the evidence, they are not finalizing the proposed LCD issued on August 10, 2023. The MACs intend to issue a new proposed LCD in the coming months.
On August 19, the Department of Health & Human Services (HHS) launched a national campaign to inform the public about common respiratory viruses and available vaccines. The campaign, Risk Less. Do More. aims to increase awareness of vaccines that reduce serious illness from influenza (flu), COVID-19, and respiratory syncytial virus (RSV) in high-risk populations and to limit the spread of these viruses.
On August 19, HHS’ Biomedical Advanced Research and Development Authority (BARDA) and Walgreensannounced a strategic partnership to increase innovation in decentralized clinical trials as part of the Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program. The program is designed to strengthen U.S. decentralized clinical research capabilities to support development of FDA-regulated products, enhance clinical innovation to execute more efficient and relevant clinical research, and evaluate other medical countermeasures in real world environments that may be used in a public health emergency.
On August 19, the Association for Molecular Pathology filed a lawsuit against FDA regarding the Agency’s final rule for laboratory-developed tests (LDTs). The group argues that FDA overstepped its regulatory authority, adding that modernizing the Centers for Medicare & Medicaid Services’ (CMS’) Clinical Laboratory Improvement Amendments regulations is a more effective way to oversee lab tests.
On August 19, FDA approved Lazcluze (lazertinib) in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
On August 20, the Health Resources and Services Administration (HRSA) announced more than $1.4 billion in Ryan White HIV/AIDS Program funding for the AIDS Drug Assistance Program and related awards. The awards aim to ensure that individuals with HIV who have low incomes receive lifesaving medication, quality HIV health care and essential support services.
On August 20, FDA released final guidance entitled Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA. The guidance contains recommendations on how generic drug applicants or prospective applicants can request and hold product-specific guidance meetings.
On August 20, FDA announced that it will convene its Vaccines and Related Biological Products Advisory Committee on September 20, 2024, to discuss pertussis vaccine development and hear an update on the agency’s Laboratory of Mucosal Pathogens and Cellular Immunology research program.
On August 21, HHS’ Office for Civil Rights (OCR) released a statement regarding the 28th anniversary of the signing of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Director of OCR, Melanie Fontes Rainer, stated that OCR continues to prioritize health information privacy by updating and rigorously enforcing the HIPAA Rules that safeguard national security in the health care system.
On August 22, FDA approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death.
On August 23, Johnson & Johnson (J&J) announced that it would be modify the way it makes 340B pricing available for two of its popular drugs: the Xarelto blood thinner and the Stelara plaque psoriasis treatment. Starting Oct. 15, J&J will require all disproportionate share hospitals (DSH) participating in the 340B Drug Pricing Program to purchase these drugs at full price and submit data to J&J. Upon verification of the drug’s 340B status, DSHs would receive a rebate for the discounted 340B price. IN response, the Health Resources and Services Administration (HRSA) issued a statement maintaining that the new approach is “inconsistent with the 340B statute” and “requires secretarial approval” adding that the “HHS Secretary has not approved J&J’s rebate model.” HRSA indicated that the Agency has communicated this information to J&J and will take “appropriate actions as warranted.”
WHITE HOUSE
On August 19 through 23, the Democratic National Convention (DNC) took place to officially nominate Kamala Harris and Tim Walz as the 2024 Democratic Party’s Presidential and Vice-Presidential nominees.
On August 21, the Democratic Party released its 2024 Party Platform. The Platform includes a variety of health care-related priories including: expanding protections against surprise billing, accelerating Medicare drug pricing negotiations, limiting Medicare cost-sharing for some generic drugs, mandating more transparency from pharmacy benefit managers (PBMs), and excluding medical debt from credit reporting.
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
Administrative Simplification: Modifications to NCPDP Retail Pharmacy Standards (CMS-0056); Final Rule; 6/27/24
HHS Notice of Benefit and Payment Parameters for 2026 (CMS-9888); Proposed Rule; 7/17/24
Amendments to Rules Governing Organ Procurement Organizations (CMS-3409); Proposed Rule; 8/8/24
Appeal Rights for Certain Changes in Patient Status (CMS-4204); Final Rule; 8/22/24
FDA
Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability; Notice; 7/9/24
Conducting Clinical Trials With Decentralized Elements; Guidance for Industry, Investigators, and Other Stakeholders; Availability (2023-814); Notice; 7/25/24
Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry; Availability; Notice; 7/25/24
OASH
Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act; 8/6/24; Proposed Rule
Public Health Service Policies on Research Misconduct; Final Rule; 8/7/24
OS
HHS Adoption of Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards; Interim Final Rule; 8/22/24
REPORTS
Office of Inspector General (OIG)
On August 19, OIG released a report examining Illinois Medicaid Management Information Systems (MMISs) and Eligibility and Enrollment (E&E) systems. OIG found that the Illinois MMIS and E&E system had adequate security controls in place to prevent simulated cyberattacks, resulting in a successful compromise; however, some of those security controls could be improved to better prevent certain cyberattacks and reduce Illinois’ risk of compromise. Specifically, Illinois did not correctly implement four security controls required by the National Institute of Standards and Technology (NIST) Special Publication 800-53, Revision 4. OIG made a series of recommendations for Illinois to improve its security controls over its MMIS and E&E system, including that it enhances its security control assessment testing procedures and takes corrective actions when deficiencies in controls are identified.
On August 20, OIG released a report examining for-profit nursing homes compliance with federal requirements regarding the infection preventionist (IP) position. OIG found that 76 of the 100 for-profit nursing homes in the sample complied with Federal requirements pertaining to IPs. However, 17 potentially did not comply with the requirement that the IP complete specialized infection prevention and control training prior to assuming the role and 7 potentially did not comply with the requirement to designate an IP. Based on the sample results, OIG estimated that 2,568 for-profit nursing homes nationwide may not have complied with Federal requirements pertaining to IPs during the audit period. OIG recommends that CMS: 1) instruct the State survey agencies to follow up with the 24 nursing homes that may not have complied with Federal requirements to verify that they have taken corrective actions; and 2) share the results of this audit with the State survey agencies and encourage them to focus their oversight on verifying that nursing homes designate an IP and that the IPs complete specialized training prior to filling that position.
HEARINGS
House
Ways & Means Committee
September TBD
Markup of health care legislation
Senate
HELP Committee
September 12; TBD
Testimony from Ralph De La Torre, CEO, Steward Health Care System
September 24; 10:00 AM; SD-562
ADDITIONAL POLICY NEWS
On August 20, New Jersey Governor Phil Murphy announced that the state will be using pandemic relief funds to forgive $100 million in medical debt. Gov. Murphy stated that by leveraging over $550,000 in American Rescue Plan funds and partnering with Undue Medical Debt, the administration is delivering relief to 17,905 New Jersey residents who had owed $61.6 million to Prime Healthcare hospitals and an additional 31,748 residents owing more than $38.4 million to other providers through the secondary debt market, primarily collections agencies.
On August 21, Judge Ada E. Brown, a federal district court judge in Dallas, blocked a Federal Trade Commission (FTC) rule banning noncompete agreements from taking effect. Judge Brown stated that FTC’s noncompete ban exceeded the agency’s authority and is “the product of an unconstitutional exercise of power.”
On August 22, the Medicare Payment Advisory Commission (MedPAC) released comment letters on CMS’ end-stage renal disease (ESRD) and home health prospective payment system (PPS) CY 2025 final rules.