Health Care Watch: September 16, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from September 8– September 14. 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 September 9, the House passed the BIOSECURE Act in a 306-81 bipartisan vote. The BIOSECURE Act would ban federal money from being used to procure or use products or services offered by “companies of concern,” including five Chinese or Chinese-owned companies named in the legislative text.
On September 11, Republican leadership pulled their six-month stopgap funding bill hours before a scheduled floor vote. Speaker Mike Johnson stated that they will delay the vote until next week as they work to secure the votes necessary for passage.
On September 11, the Energy & Commerce Oversight and Investigations Subcommittee held a hearing entitled A Year Removed: Oversight of Securing the U.S. Organ Procurement and Transplantation Network (OPTN) Act Implementation. Committee members largely supported the legislation but expressed concerns about its effectiveness thus far in helping patients and combating corruption. Witnesses and Members discussed continued mismanagement and conflicts of interest within the organ transplant system as well as stories and allegations of Medicare and Medicaid fraud.
On September 11, the Education and Workforce Committee advanced three health care bills during a full committee markup. The Committee advanced an amended version of the Transparent Telehealth Bills Act in a 34-0 vote, which would prevent hospitals from charging facility fees for care given virtually. Additionally, the committee advanced the Healthy Competition for Better Care Act, which includes several provisions aimed at promoting competition and transparency including allowing employers to contract with individual hospitals, and a House Resolution that would overturn the Biden administration’s recent attempt to rescind a Trump-era rule that expanded access to association health plans.
On September 11, the House Judiciary Subcommittee on the Administrative State, Regulatory Reform, and Antitrust held a hearing entitled The Role of Pharmacy Benefit Managers (PBMs). Members and witnesses discussed the role of PBMs in the healthcare industry, including their ability to control access to and pricing of pharmaceutical products. Witnesses included a variety of academic experts from various universities and think tanks from across the country.
On September 16, the House will consider:
H.R. 3800, Chronic Disease Flexible Coverage Act;
H.R. 8111, Medicaid Program Improvement Act;
H.R. 8112, To amend title XIX of the Social Security Act to further require certain additional provider screening under the Medicaid program;
H.R. 8089, Medicare and Medicaid Fraud Prevention Act of 2024;
H.R. 6160, To amend the Public Health Service Act to reauthorize a lifespan respite care program; and
H.R. 7858, Telehealth Enhancement for Mental Health (TELEMH) Act of 2025
Senate
On September 11, Health, Education, Labor & Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) sent a letter to Health Resources and Services Administration (HRSA) Administrator Carole Johnson expressing concerns regarding HRSA’s delays in implementing the Securing the U.S. Organ Procurement and Transplantation Network (OPTN) Act. Specifically, the letter asks that HRSA respond to questions regarding their timeline for implementation of important provisions included in the OPTN Act, as well as steps HRSA plans to take to improve the OPTN’s IT infrastructure and modernize the OPTN.
On September 11, HELP Committee Primary Health and Retirement Security Subcommittee Chairman Edward Markey (D-MA), released a report entitled The Steward Health Care Report: How Corporate Greed Hurt Patients, Health Workers, and Communities. The report highlights patient and worker experiences, hospital quality data, and information on hospital closures in Massachusetts and around the country, to document the impacts of Steward Health Care’s mismanagement. The report came in advance of the September 12 HELP Committee hearing on Steward’s bankruptcy for which Steward CEO Dr. Ralph de la Torre was subpoenaed to testify. Subsequently, on September 12, HELP Committee Chairman Bernie Sanders (I-VT) announced that the Committee plans to hold the Steward CEO in contempt of Congress after he failed to appear before the committee after being subpoenaed. The HELP Committee will vote on September 19 on whether to hold Dr. Ralph de la Torre in contempt.
REGULATORY UPDATE
On September 9, the Departments of Labor, Health & Human Services (HHS) and the Treasury issued final rules to clarify and strengthen protections to expand access to mental health and substance use disorder care. The rules build on the Departments’ commitment to achieving the full promise of the Mental Health Parity and Addiction Equity Act of 2008. Specifically, the final rules will: require health plans to make changes when they are providing inadequate access to mental health and substance use care; make it clear that health plans cannot use more restrictive prior authorization, or other medical management techniques, or narrower networks to make it harder for people to access mental health and substance use disorder benefits; and close existing loopholes that did not require non-federal governmental health plans to comply with its requirements. Most final rule provisions apply generally to group health plans and health insurance issuers that offer group health insurance coverage starting on the first day of the first plan year beginning on or after January 1, 2025. A fact sheet detailing the final rules can be found here.
On September 9, the Agency for Healthcare Research and Quality (AHRQ) announced a Notice of Funding Opportunity (NOFO) to establish state-based Healthcare Extension Cooperatives. The NOFO aims to accelerate the implementation and dissemination of patient-centered outcomes research (PCOR) into health care delivery through improvements in health care policy, payment, and practice, and to reduce health care disparities, especially among people who receive Medicaid, are uninsured, and/or are medically underserved. AHRQ will award up to 15 grants to establish and support state-based Healthcare Extension Cooperatives over five years.
On September 10, the Substance Abuse and Mental Health Services Administration (SAMHSA), awarded $68 million in grants for suicide prevention and mental health care programs. Awards announced include: $15.3 million for Cooperative Agreements for the Garrett Lee Smith (GLS) State/Tribal Youth Suicide Prevention and Early Intervention Program; $2.2 million for GLS Campus Suicide Prevention; $7.5 million for a new National Center for Mental Health: Dissemination, Implementation, and Sustainment (MHDIS); and $42.9 million for Grants for Expansion and Sustainability of the Comprehensive Community Mental Health Services for Children with Serious Emotional Disturbances (SED).
On September 11, the Food & Drug Administration (FDA) issued warning letters to two Chinese nonclinical testing laboratories, citing both for laboratory oversight failures and animal care violations that raise concerns about the quality and integrity of data generated by the labs. Warning letters were issued to Mid-Link Testing Company Ltd. in Tianjin, China, and Sanitation & Environmental Technology Institute of Soochow University Ltd. in Suzhou, China.
On September 11, CMS announced that it will host a webinar to provide an overview of the Cell and Gene Therapy (CGT) Access Model Notice of Funding Opportunity (NOFO). During the session, the CGT Access Model team and the Office of Acquisition and Grants Management will discuss the NOFO, Cooperative Agreement funding, and application submission, as well as federal award requirements and resources for participating states. The webinar will take place on September 24, 2024, from 2:00 to 3:00 PM ET. Registration can be found here.
On September 12, HHS launched the KidneyX Sustainability Prize, a $7.25 million challenge that aims to drive meaningful change in the sustainability of kidney care. This challenge, the latest initiative from the Kidney Innovation Accelerator (KidneyX), aims to seize opportunities for sustainability by identifying and supporting innovations to reduce water or power usage during dialysis care. HHS will hold a virtual listening session on the challenge on September 25, 2024. Registration and additional information regarding the challenge can be found here.
On September 12, the Centers for Medicare & Medicaid Services (CMS) approved New Hampshire’s Medicaid State Plan Amendment for community-based mobile crisis intervention teams to provide services for people experiencing a mental health or substance use disorder crisis. This approval marks 20 states and the District of Columbia that have expanded access to community-based mental health and substance use services under a new Medicaid option.
On September 12, FDA authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones. Once installed and customized to the user’s hearing needs, the Hearing Aid Feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.
On September 12, HHS’ Office of Research Integrity (ORI), finalized the 2024 Public Health Service (PHS) Policies on Research Misconduct. The rule updates the 2005 regulation and clarifies requirements for addressing research misconduct in PHS-funded research. Specifically, the final rule streamlines institutional responsibilities in the general conduct of misconduct proceedings, provides a clear appeal process and administrative remedies for respondents, and adds commonly used definitions to clearly highlight how these concepts are applied by ORI when conducting oversight.
On September 12, HHS, through the Office of the Assistant Secretary for Health (OASH) and HRSA, announced a Notice of Proposed Rulemaking (NPRM) to amend the regulations implementing the National Organ Transplant Act of 1984. The proposed rule, if finalized, would remove clinical research and institutional review board (IRB) requirements for transplantation of kidney and livers from donors with human immunodeficiency virus (HIV) to recipients with HIV. Comments are due on October 15.
On September 12, HHS’ Administration for Strategic Preparedness and Response (ASPR) announced a $14 million award to the API Innovation Center (APIIC) to boost domestic production of key starting materials and active pharmaceutical ingredients (APIs) used in essential medications, many of which are currently listed on FDA’s drug shortage list. HHS indicated that the agreement with APIIC is funded by ASPR’s Center for Industrial Base Management and Supply Chain (IBMSC) under the Defense Production Act (DPA).
WHITE HOUSE
On September 10, Vice President Kamala Harris and former President Donald Trump participated in a presidential debate. Both candidates discussed various health care topics including abortion, the Affordable Care Act (ACA), and handling of the COVID-19 pandemic. A full transcript of the debate can be found here.
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
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
Mitigating the Impact of Significant, Anomalous, and Highly Suspect Billing Activity on Medicare Shared Savings Program Financial Calculations in Calendar Year 2023 (CMS-1799); Final Rule; 8/23/24
FDA
Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability; Notice; 7/9/24
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Notice; 8/26/24
OASH
Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act; 8/6/24; Proposed Rule
HEARINGS
House
Ways & Means Committee
Health Subcommittee
September 18; 2:00 PM; 1100 Longworth
Investing in a Healthier America: Chronic Disease Prevention and Treatment
September TBD
Markup of health care legislation
Energy & Commerce
September TBD
Markup of telehealth legislation
Senate
Finance Committee
September 17; 10:00 AM; 215 Dirksen
Lower Health Care Costs for Americans: Understanding the Benefits of the Inflation Reduction Act
Witnesses: Judy Aiken, Retired Registered Nurse; Jeanne Lambrew, Director of Health Care Reform and Senior Fellow, The Century Foundation; Rena Conti, Dean’s Research Scholar and Associate Professor, Markets, Public Policy And Law, Questrom School Of Business, Boston University; Kirsten Axelsen, Nonresident Fellow, The American Enterprise Institute, Senior Policy Advisor at DLA Piper; Theo Merkel, Senior Research Fellow, The Paragon Health Institute, Senior Fellow at the Manhattan Institute.
HELP Committee
September 24; 10:00 AM; SD-562