Congressional:
House Passes BIOSECURE Act
On Monday, the House passed legislation by a bipartisan 306-81 vote that would prohibit federal agencies from procuring or using products made by companies of concern from China. The BIOSECURE Act from Rep. Brad Wenstrup (R-OH) would also prohibit the government from contracting with companies that use any products or technologies from the companies of concern, including five Chinese or Chinese-owned companies named in the text. In March, the Senate Homeland Security and Governmental Affairs Committee passed its version of the bill in an 11-1 vote. Read the bill here.
House Education and Workforce Advances 3 Health Care Bills in Markup
On Wednesday, the House Education and Workforce Committee held a markup, advancing three health care bills. The committee passed a resolution to stop the Biden-Harris rule limiting access to association health plans (H.J. Res. 181) on party lines. The Healthy Competition for Better Care Act (H.R. 3120) was passed via voice vote and includes several provisions to promote competition and transparency, including allowing employers to contract with individual hospitals. Lastly, the Transparent Telehealth Bills Act of 2024 (H.R. 9457), which would require that fees for services offered via telehealth could not include facility fees, passed on a bipartisan 34-0 vote. Read the bills and amendments here.
House Education and Workforce Subcommittee Holds Hearing on ERISA
On Tuesday, the Health Education and Workforce Health, Employment, Labor, and Pensions Subcommittee held a hearing commemorating the 50th anniversary of the Employee Retirement Income Security Act (ERISA) and the role that employer-sponsored coverage plays in delivering high-quality, low-cost health care. During the hearing, there was bipartisan support for the ERISA preemption clause, which overrides state laws and allows for uniform health benefits standards. Republicans widely supported short-term limited duration and association health plans, which were restricted under the Biden-Harris Administration. Democrats focused on the health care system's inefficiencies and rising costs. The witness panel included Ms. Ilyse Schuman, Senior Vice President of Health and Paid Leave Policy at the American Benefits Council; Ms. Holly Wade, Executive Director of the National Federation of Independent Business Research Center; and Dr. Paul Fronstin of the Employee Benefit Research Institute. Read Mehlman’s hearing summary here.
House Judiciary Regulatory Reform Subcommittee Holds Hearing on the role of PBMs
On Wednesday, the House Judiciary Administrative State, Regulatory Reform, and Antitrust Subcommittee held a hearing examining the role of Pharmacy Benefit Managers (PBMs). During the hearing, members expressed bipartisan concern over the role and impact of PBMs on drug pricing, access to medications, and the survival of independent pharmacies, particularly in rural areas. Members expressed interest in finding legislative solutions for greater transparency in PBM operations, including how they define drugs, negotiate prices with manufacturers, and determine pharmacy reimbursements. Members also emphasized finding solutions at both the state and federal levels, including specific reforms like payment adjustments for rural pharmacies and creating high-quality, transparent pricing benchmarks to help market participants assess fairness in PBM transactions. Witnesses discussed the vertical integration of PBMs with insurance companies, pharmacies, and other healthcare entities, highlighting concerns about market power and potential anti-competitive practices. Read more on the hearing here.
House Energy & Commerce Subcommittee Holds Hearing Examining Organ Transplant System
On Wednesday, the House Energy and Commerce Oversight and Investigations Subcommittee held a hearing to examine which oversight might be needed in the Health Resources and Services Administration’s (HRSA) overhaul of the network that obtains and transplants organs. During the hearing, members expressed alarm over allegations of Medicare and Medicaid fraud, as well as improper organ harvesting, by the organ procurement organizations (OPOs). Members also debated who might sit on the board of directors overseeing the Organ Procurement and Transplantation Network. The witnesses testified that a multi-contract system would allow for more innovative technology that could keep organs to be transplanted viable longer. They asked Congress to open a pathway for whistleblowers to safely report concerns. Read witness testimonies here.
Senate HELP Ranking Member Cassidy Raises Concerns over Delayed Implementation of Bipartisan Law to Improve Organ Donation System
On Wednesday, Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, raised concerns over the Health Resources and Services Administration’s (HRSA) delays in implementing his Securing the U.S. Organ Procurement and Transplantation Network Act, legislation which streamlines the U.S. organ donation network to allow more Americans access to lifesaving organ transplants. Cassidy wrote, “HRSA’s lack of urgency implementing these important reforms is very concerning,” and “HRSA must ensure that the OPTN improves its efficiency so that more patients can receive the gift of a lifesaving organ.” Read the letter here.
Senate HELP Committee Holds Hearing on Steward Health Care Bankruptcy
On Thursday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on Steward Health Care’s bankruptcy and larger concerns about private equity in health care. Steward CEO Ralph de la Torre, who said he would not testify in the hearing, could face criminal contempt charges for failing to show up after being subpoenaed in July. During the hearing, Senate HELP Chair Bernie Sanders (I-VT) and ranking member Bill Cassidy (R-LA) announced the panel would vote to adopt resolutions for civil enforcement and criminal contempt in response to de la Torre’s absence. The civil charges would instruct the Senate’s legal counsel to pursue litigation, whereas criminal charges would go through the Justice Department. Both resolutions would require approval of the full Senate. Witnesses at the hearing included patients, medical professionals, and "community members affected by Dr. de la Torre's Steward Health Care." Read the witness testimonies here.
Senator Markey Unveils New Steward Health Care Report
On Tuesday, Senator Edward J. Markey (D-MA), in advance of the September 12 Senate HELP Committee hearing on Steward’s bankruptcy, unveiled “The Steward Health Care Report: How Corporate Greed Hurt Patients, Health Workers, and Communities.” The report spotlights 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. The report details data from the Centers for Medicare and Medicaid Services (CMS) and the Lown Institute, and reports from health workers, bankruptcy documents, and other public reporting. Read the report here.
Notable Bills Introduced:
Rep. Miller-Meeks Introduces IVF Tax Credit Legislation
On Monday, Rep. Mariannette Miller-Meeks, along with co-sponsors Reps. Lori Chavez-DeRemer (R-OR) and Mike Lawler (R-NY) introduced legislation that would promote access to in vitro fertilization (IVF) through a fully refundable tax credit of up to $30,000. The Internal Revenue Service (IRS) currently offers a limited medical expense deduction for IVF-related expenses, but the members argue it is insufficient. Read the press release here and the bill here.
Reps. Davis and Nunn Introduces Legislation to Enhance Healthcare for Rural Seniors
On Tuesday, Don Davis (D-NC) and Zach Nunn (R-IA) introduced the bipartisan Pharmacy and Medically Underserved Areas Enhancement Act, which would reimburse state-licensed pharmacists through Medicare for essential healthcare services like diabetes management and health screenings. Current law does not provide Medicare payments for pharmacists who render these services, disincentivizing them from providing health care to patients, particularly seniors, in rural and remote communities that rely on local health care facilities. Senators Grassley, Brown, Hyde-Smith, and Lujan introduced the senate companion in May 2023. Read the press release here and the bill here.
Select Subcommittee on the Coronavirus Pandemic Democrats Introduce Legislation to Strengthen Nursing Home Infection Prevention and Control
On Tuesday, Rep. Raul Ruiz (D-CA), Ranking Member of the Select Subcommittee on the Coronavirus Pandemic, led Select Subcommittee Democrats in introducing legislation to increase and ensure that sustainable funding will be available for Centers for Medicare and Medicaid Services (CMS) Survey and Certification activities. The Sustained Allocations For Evaluations and Reviews of Nursing Homes Act (SAFER Nursing Homes Act) would increase CMS Survey and Certification Activities funding in the upcoming fiscal year to $492 million (21% above Fiscal Year 2023 funding). In subsequent fiscal years, the SAFER Nursing Homes Act reforms the CMS Survey and Certification funding stream to classify it as a mandatory funding stream. Read the press release here and the bill here.
Bipartisan Senate Health Care Leaders Introduce Legislation to Protect Dialysis Patients
On Wednesday, Senators Bill Cassidy (R-LA), Corey Booker (D-NJ), and Martin Heinrich (D-NM) introduced the Restore Protections for Dialysis Patients Act. The new bipartisan legislation would ensure that patients can continue to access dialysis treatments through their private insurance during the statutory 30-month coordination period with Medicare. A companion bill (H.R. 6860) was introduced by Representatives Mike Kelly (R-PA), John Joyce, MD (R-PA), Neal Dunn (R-FL), Yvette Clark (D-NY), Danny Davis (D-IL), and Raul Ruiz, MD (D-CA) last December. Read the press release here.
Sens. Durbin, Braun Introduce Protecting Patients From Deceptive Drug Ads Online Act
On Thursday, Senate Majority Whip Dick Durbin (D-IL) and Sen. Mike Braun (R-IN) introduced the Protecting Patients from Deceptive Drug Ads Online Act, bipartisan legislation that would protect public health and close regulatory loopholes by having the Food and Drug Administration (FDA) address false and misleading prescription drug promotions by social media influencers and telehealth companies. The bill would address false and misleading prescription drug promotions by having the FDA issue warning letters, followed by fines for noncompliance, to influencers and telehealth companies that engage in communications that accrue a financial benefit to the speaker and contain false or inaccurate statements, omit labeling or other key facts regarding a medication, or fail to include traditional risk and side effect disclosures. The legislation includes commonsense exemptions to limit the scope of the legislation to flagrantly deceptive commercial speech. Read the press release here and the bill here.
Sens. King, Rounds Introduce Bipartisan Legislation to Create a National Falls Prevention Plan
On Thursday, Senators Angus King (I-ME) and Mike Rounds (R-SD) introduced bipartisan legislation to help prevent household accidents. The Stand Strong Falls Prevention Act would create an Advisory Committee on Falls Prevention within the Department of Health and Human Services (DHHS), which would develop a National Falls Prevention Plan to evaluate falls prevention efforts under the federal government and make recommendations for improving federal policies. Under the National Plan, the advisory committee would develop recommendations for how Medicare could develop a falls prevention pilot or demonstration program that would provide coverage of home modifications such as grab bars or staircase handrails as part of a falls prevention Medicare program. Currently, traditional Medicare does not cover or offer reimbursements for such modifications. Read the press release here and the bill here.
Reps. Raskin and Bacon Introduce New Bipartisan Legislation to Expand Evidence-Based Suicide Prevention Care
On Thursday, Reps. Jamie Raskin (D-MD) and Don Bacon (R-NE) introduced new bipartisan legislation, the Stabilization to Prevent (STOP) Suicide Act, to expand access to evidence-based stabilization care for individuals with serious thoughts of suicide. The legislation would create a new grant program at the Substance Abuse and Mental Health Services Administration (SAMHSA) to expand access to effective and timely outpatient and virtual stabilization care and treatment. Read the press release here and the bill here.
Reps. Salinas, Molinaro Introduce Bipartisan Bill to Grow America’s Mental and Behavioral Health Workforce
On Thursday, Reps. Andrea Salinas (D-OR) and Marc Molinaro (R-NY) introduced a bipartisan bill to grow America’s mental and behavioral health workforce. The Substance Use Disorder Treatment and Recovery (STAR) Plus Scholarship Act would create a new scholarship program for students pursuing a degree in the mental health, behavioral health, or substance use disorder treatment professions. Read the press release here and the bill here.
Executive Branch:
Biden-Harris Administration Announces Final Rules Strengthening Access to Mental Health, Substance Use Disorder Benefits
On Monday, the Biden-Harris Administration announced final rules, which build on the departments’ commitment to achieving the full promise of the Mental Health Parity and Addiction Equity Act of 2008. The act requires group health plans and health insurance issuers offering group and individual health insurance coverage that offer mental health or substance use disorder benefits to cover those benefits in parity with medical and surgical benefits without imposing greater restrictions on mental health or substance use disorder benefits as compared to medical and surgical benefits. The rules also require plans and issuers to collect and evaluate data related to the nonquantitative treatment limitations they place on mental health and substance use disorder care and make changes if the data shows they are providing insufficient access. Read the press release here and the final rule here.
Biden-Harris Administration Issues Proposed Rule to Expand Access to Life-Saving Organs for People with HIV
On Thursday, the Department of Health and Human Services (HHS), through the Office of the Assistant Secretary for Health (OASH) and the Health Resources and Services Administration (HRSA), announced a Notice of Proposed Rulemaking (NPRM) to amend the regulations implementing the National Organ Transplant Act of 1984. The proposed rule would streamline the process of transplanting a kidney or a liver from an HIV-positive donor to another HIV patient. If finalized, the rule would remove clinical research and institutional review board requirements that the agency said are burdensome and slow down the process. A 2013 law made it possible to transplant organs from donors with HIV to other donors with HIV under certain research protocols. The proposed rule is open for comments through October 15. Read the press release here and the proposed rule here.
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