Summary
Congress is out on spring recess and returns next week to resume work on various health care and public health policy priorities.
The Senate Health, Education, Labor and Pensions (HELP) Committee plans to mark-up drug pricing legislation on April 19 focused on pharmacy benefit managers and generic drugs, though the markup has not yet been officially scheduled. The package is likely to feature provisions that increase transparency of PBM practices and support the development of biosimilar and generic drugs. The bill may include provisions from the following:
- The Pharmacy Benefit Manager Transparency Act ( 127), which prohibits spread pricing and clawbacks; increases transparency; and allows for reporting exemption if rebates are passed through and certain information is disclosed
- The Drug Price Transparency in Medicaid Act (R. 1613), which prohibits spread pricing in Medicaid
- The Stop STALLING Act ( 148), which prohibits sham FDA citizen petitions.
- The Preserve Access to Affordable Generics and Biosimilars Act ( 142), which prohibits pay for delay agreements between brand and generic or biosimilar manufacturers.
- The Increasing Transparency in Generic Drug Applications Act (775), which streamlines the approval process for generic drugs by requiring the FDA to disclose differences between the generic and brand drug during the approval process.
- The Affordable Prescriptions for Patients Act of 2023 ( 150), which prohibits product hopping, where manufacturers switch the patient population to a follow-on product, when the reference product’s patent is set to expire.
Additionally, the Senate HELP Committee is working on bipartisan bills to address the health care workforce shortage and reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA). The House Energy and Commerce Subcommittee on Health is also preparing for PAHPA reauthorization.
Regulatory Update
We are waiting for several rules on Medicare payments for acute care hospitals and long-term care hospitals, reproductive health care privacy, and health IT and interoperability. They have all cleared review at the Office of Management and Budget (OMB).
- Medicare Payments – The proposed rule for inpatient and long-term care hospital prospective payment systems (PPS) is the last of the fiscal year 2024 Medicare payment updates. Our summaries of PPS proposed rules are available here: inpatient psychiatric facilities; inpatient rehabilitation facilities; skilled nursing facilities; and hospices.
- Reproductive Health Care Privacy – The Department of Health and Human Services is expected to issue proposed modifications to the HIPAA Privacy Rule to support reproductive health care privacy. Following the Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, HHS issued guidance on how the HIPAA Privacy Rule applies to information relating to reproductive health care. The guidance explains that disclosures for purposes not related to health care, such as disclosures to law enforcement officials, are permitted only in narrow circumstances tailored to protect the individual’s privacy and support their access to health care, including abortion care. The forthcoming proposed rule will likely seek to strengthen privacy protections, particularly within the context of states with bans or severe restrictions on abortions.
- Health IT and Interoperability – The Office of National Coordinator for Health Information Technology (ONC) will release a proposed rule implementing certain provisions of the 21st Century Cures Act, including:
- Electronic Health Record Reporting Program condition and maintenance of certification requirements under the ONC Health IT Certification Program;
- Process for health information networks that voluntarily adopt the Trusted Exchange Framework and Common Agreement (TEFCA) to attest to such adoption of the framework and agreement;
- Enhancements to support information sharing under the information blocking regulations.
The rule will also proposals for new standards and certification criteria under the Certification Program related to the United States Core Data for Interoperability, real-time benefit tools, electronic prior authorization, and potentially other revisions to the Certification Program.
MedPAC
Later this week, the Medicare Payment Advisory Commission (MedPAC) will convene to discuss a range of issues relating to prescription drug prices, payment systems, telehealth, and behavioral health. MedPAC will vote on recommendations for the June 2023 Report to Congress on:
- Addressing the high prices of drugs covered under Medicare Part B,
- Reforming Medicare’s prospective payment system’s use of wage indexes,
- Aligning fee-for-service payment rates across ambulatory settings, and
- Establishing a unified post-acute care prospective payment system.
MACPAC
The Medicaid and CHIP Payment and Access Commission (MACPAC) will also convene to continue discussions regarding:
- Integrating care for dually eligible beneficiaries,
- Access to Medicaid coverage and care for adults leaving incarceration,
- Unwinding of continuous enrollment requirements,
- Home and community-based services, and
- Managed care.
MACPAC will also vote on recommendations for automatic adjustments to disproportionate share hospital allotments, which will be included in the June 2023 Report to Congress. Lastly, MACPAC will discuss the proposed rule on Medicaid disproportionate share hospital third-party payer policy.