Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


Congress Departs for August Recess

Lawmakers completed their final workdays before the congressional August recess last week. While the Senate passed its $886 billion annual defense policy bill with overwhelming bipartisan support, Foreign Relations Chair Bob Menendez (D-N.J.) was unsuccessful in his attempt to attach a five-year reauthorization of the President’s Emergency Plan for AIDS Relief (PEPFAR) to the National Defense Authorization Act. Republicans are pushing to restore a Trump-era abortion restriction blocking funding for any groups that provide or promote abortion as a part of PEPFAR reauthorization.

For the first time since 2018, the Senate Appropriations Committee has completed work on all 12 annual spending bills, advancing the Labor-Health and Human Services-Education package out of committee on Thursday. All 12 of the Senate appropriations measures received bipartisan support. The Labor-HHS bill includes $224.4 billion in funding, a roughly $14.5 billion increase. The U.S. Department of Health and Human Services Department (HHS) would receive $117 billion. A full summary of the bill is available here. Bill text, as amended, is available here. The bill report, as amended, is available here. Adopted amendments are available here. Congressionally Directed Spending projects included in the bill are available here.

On the House side, Republicans pivoted away from plans to vote on the chamber’s fiscal year (FY) 2024 Agriculture-Rural Development-Food and Drug Administration appropriations bill on the floor last week. The bill faced pushback from conservatives demanding further spending cuts. Several moderate members also expressed reservations about a policy contained in the bill to restrict access to the abortion medication mifepristone.

The Senate is scheduled to reconvene on September 5, and the House is scheduled to return on September 12. Lawmakers will have a lengthy list of expiring programs and must-pass legislation to complete before September 30, including FY 2024 government funding, the Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization, animal drug user fee reauthorization, PEPFAR reauthorization, and funding for public health programs (community health centers, National Health Service Corps, Children’s Hospitals GME, etc.).

Congress Passes Bill to Overhaul Nationís Organ Transplant System

Congress passed the Securing the U.S. Organ Procurement and Transplantation Network Act (H.R. 2544) to increase competition in the nation’s organ transplant network last week. The bill would allow the Health Resources and Services Administration to open competitive bidding on multiple contracts for public and private entities to manage the Organ Procurement and Transplantation Network (OPTN). The legislation would also require a Government Accountability Office report on the financing of OPTN. The United Network for Organ Sharing (UNOS) has managed the OPTN contract since 1986. The current OPTN contract with UNOS is set to expire and be up for renewal on September 30. The legislation passed the House of Representatives by voice vote and was adopted by the Senate through unanimous consent. The bill will now be sent to President Joe Biden to be signed into law.

Senate Finance Advances PBM Package

The Senate Finance Committee voted 26-1 to advance a series of proposals to reform the pharmacy benefit manager (PBM) industry last week. Sen. Ron Johnson (R-Wis.) was the only member to vote against the bill. The Modernizing and Ensuring PBM Accountability (MEPA) Act would delink PBMs’ compensation from manufacturer list prices, requiring that payments to PBMs be based on a bona fide service fee that is not tied to the list price of a drug. It would ban the practice of spread pricing in state Medicaid programs, and require Medicare Advantage and Part D plans to use standardized pharmacy performance measures for the purposes of incentive payments, price concessions, or fees charged to a pharmacy. The bill also directs the U.S. Department of Health and Human Services Office of the Inspector General to review the state of PBM compensation and to study Part D drug mark-ups. The Congressional Budget Office (CBO) estimates that the measure would produce approximately $666 million in savings through 2028. The measures will likely be made a part of a larger package of drug pricing reforms expected to be considered by the Senate before the end of the year. In a statement released following Wednesday’s markup, Chairman Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) committed “to continue working on additional proposals that will constitute a more comprehensive suite of reforms, and requested feedback from the CBO on proposals that would help to cut out-of-pocket costs, increase pharmacy access and (ensure) that seniors benefit from lower-cost biosimilars.”

House Ways and Means Approves Health Care Transparency Bills Along Party Lines

The House Ways and Means Committee advanced legislation to increase transparency in the nation’s health care system last week. The Health Care Price Transparency Act (H.R. 4822) would require pharmacy benefit managers and group health plans to submit an annual report to Part D plan sponsors containing a series of information on prescription drug pricing and spending effective three years after enactment of the legislation. It would also limit beneficiary cost sharing in Part D to no more than the average net price of a drug staring in 2027. The bill also included provisions to address prior authorization policies in Medicare Advantage based on the bipartisan Improving Seniors’ Timely Access to Care Act which passed the House in the 117th Congress. The Providers and Payers COMPETE Act (H.R. 3284) would require an annual report from the U.S. Department of Health and Human Services on the effect of Medicare regulations on provider and payer consolidation, and the impact of such consolidation on the health care delivery system. The bills were approved by party line votes. Democrats argued that the bills will not meaningfully lower prescription drug costs, and expressed opposition to the exemption of Medicare Advantage plans from increased transparency requirements and the absence of reporting requirements to shed light on private equity involvement in the health care system. The two bills are expected to be incorporated into a larger health care package that includes other price transparency legislation advanced by the Education and the Workforce and Energy and Commerce committees earlier this year.

Sanders Postpones Primary Care, Workforce Markup

Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sanders (I-Vt.) postponed consideration of his primary care and health workforce package originally scheduled for markup last Thursday. In Sanders’ statement announcing the change of plans, the Chairman indicated that he is working with Sen. Roger Marshall, MD (R-Kan.) to prepare a “major piece of bipartisan primary care legislation” for consideration by the first week of September. The original package proposed by Sanders faced opposition from Republican members of the committee, who argued that the funding authorized by the measure – totaling $100 billion – was too high. The bill included between $10.2 billion and $13.42 billion per year for community health centers. It would have also prohibited hospitals from charging facility fees for services provided by off-site physicians. The reauthorization package advanced out of the House Energy and Commerce Committee provides only a slight increase for community health centers – from $4 billion to $4.2 billion annually for the next two years.

Lawmakers Urge Medicare Physician Payment Reform

Agroup of 101 lawmakers led by Reps. Larry Bucshon (R-Ind.) and Ami Bera (D-Calif.) have sent a letter to House of Representatives leadership on the need to prioritize Medicare physician payment reform. The lawmakers argue that the Medicare physician payment system’s failure to maintain levels of reimbursement and to adequately incentivize high- quality care has led to poorer health outcomes and shortages of health care providers. The lawmakers urge Congress to enact reforms to the Medicare Access and CHIP Reauthorization Act and to establish a stable payment mechanism that appropriately pays for health outcomes in order to “keep our patients safe, access to care available, and the health care workforce strong.”

E&C Republicans Release Drug Shortages Discussion Draft

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) released a discussion draft last week containing proposals to address the nation’s ongoing drug shortages. The bill would provide manufacturers of generic, sterile injectable drugs for serious diseases more market flexibility to invest in manufacturing and speed production when potential shortages arise. The draft would increase group purchasing organization disclosure requirements, require the Food and Drug Administration to exercise its existing reporting requirement authorities, and establish a pilot program to conduct preapproval inspections of new domestic sterile manufacturing facilities. It would also require analysis of the impact of federal policies like the 340B drug pricing program, the Medicaid generic drug inflationary rebate, and Medicare reimbursement policy on drug shortages. Feedback on the discussion draft should be submitted to [email protected] by August 25, 2023. Ranking Member Frank Pallone, Jr. (D-N.J.) criticized the bill, expressing concerns that its proposals are “handouts to pharmaceutical corporations that would increase costs for patients and potentially lead to more shortages.”

Bipartisan, Bicameral RFI on CBD Regulation

Bipartisan leadership of the Senate Health, Education, Labor, and Pensions Committee and the House Energy and Commerce Committee are requesting information from stakeholders about the Food and Drug Administration’s (FDA) regulation of cannabidiol (CBD). The effort seeks to address questions about the best way to provide a legal pathway to market for CBD products, and follows an announcement by the FDA earlier this year on the need for legislation to inform CBD product regulation. The information gathered will support the lawmakers’ assessment of the potential for a regulatory pathway for hemp-derived CBD products that prioritizes consumer safety and provides certainty to the U.S. market. Comments in response to the request for information (RFI) are due to the committees ([email protected] and [email protected]) by August 18.

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