Summary
The House and Senate are both back in session this week, with a full agenda to tackle over the 11 legislative days before the government runs out of funding on September 30. The Senate will be taking up the first appropriations “minibus” package this week which will include the Committee passed Agriculture, Military Construction-VA, and Transportation bills.
On the House side, the Department of Defense Appropriations bill may see floor action this week, followed by Homeland Security and State-Foreign Ops next week. Over 300 amendments have been filed on the DOD bill, including several “culture war” focused amendments.
A recently introduced bipartisan package may also be squeezed in this month. Leadership from the Energy and Commerce (E&C), Ways and Means (W&M), and Education and Workforce Committees introduced the Lower Costs, More Transparency Act (Impact Health summary). The bill largely includes previously marked up and advanced legislation from the three Committees and features provisions that will:
- Increase transparency of hospital prices, clinical diagnostic laboratory test prices, imaging prices, ambulatory surgical center prices, health coverage prices, and pharmacy benefit manager (PBM) practices;
- Provide parity in Medicare payments for hospital outpatient department services furnished off-campus;
- Prohibit spread pricing in Medicaid;
- Reauthorize for Community Health Centers, the Teaching Health Center GME program, National Health Service Corps; and the Special Diabetes Program;
- Delay Disproportionate Share Hospital (DSH) reductions under Medicaid; and
- Increase plan fiduciary access to health data and requiring hidden fee disclosures.
House Energy & Commerce: On Thursday, the House Energy and Commerce Committee Health Subcommittee will hold a hearing on Thursday on drug shortages. This will focus on Chair Cathy McMorris Rodgers’ proposal and four other bills from both sides of the aisle that address the drug shortages facing America. Committee Democrats had pushed to include a drug shortage provision in the Committee’s PAHPA Reauthorization bill (Impact Summary) that passed in July, but the majority argued it wasn’t the appropriate vehicle. Later in the month it is reported that the Oversight and Investigations subcommittee will hold an IRA focused hearing and the Health Subcommittee will hold a hearing on Medicare innovation.
Other Hearings: As noted below, Congress will convene four hearings – three in the Senate and one in the House – on artificial intelligence to inform legislation establishing guardrails for AI and oversight and enforcement mechanisms. The House Oversight Select Subcommittee on the Coronavirus Pandemic will convene a hearing to examine COVID-19 pandemic’s effect on the doctor-patient relationship.
Regulatory Update
The Office of Management and Budget (OMB) completed reviewing the first of two final rules intended to simplify the processes for eligible individuals to enroll and retain eligibility in Medicaid, CHIP and the Basic Health Program. The first final rule expected in September 2023 will remove barriers and facilitate enrollment of new applicants, particularly those dually eligible for Medicare and Medicaid. The second final rule expected in February 2024 will implement changes to align enrollment and renewal requirements for most individuals in Medicaid and promote maintenance of coverage.
OMB is also reviewing the following rules:
- CMS Enforcement of State Compliance with Medicaid Reporting and Renewal Requirements –The interim final rule would establish rules regarding CMS enforcement of states’ compliance with reporting requirements and renewal requirements during the period that begins on July 1, 2023 and ends on June 30, 2024. The interim final rule may codify existing guidance and provide more details on how CMS may enforce the requirements. The interim final rule was not included in the Spring 2023 Unified Agenda.
- Food and Drug Administration (FDA) Regulation of Laboratory-Developed Tests (LDTs) – Proposed rule would make explicit that LDTs are devices under the Federal Food, Drug, and Cosmetic Act and subject to FDA regulation.
- Annual Rulemaking for Commercial Insurers – Proposed rules for the CY 2025 Policy and Technical Changes to Medicare Advantage and Part D (expected in October 2023) and CY 2025 Notice of Benefit and Payment Parameters (expected in November 2023)
- Surprise Billing Regulations – A proposed rule to amend requirements for the independent dispute resolution (IDR) process, as well as a proposed rule to set fees for IDR. Due to legal challenges, the IDR process is temporarily suspended for all disputes.
- Over-the-Counter Contraception – A request for information regarding coverage of over-the-counter preventive products arrived at OMB for review last week. The RFI was not included in the Unified Agenda. It stems from President Biden’s Executive Order on Strengthening Access to Affordable, High-Quality Contraception and Family Planning Services, which requires HHS, Labor, and Treasury to pursue actions increasing access to affordable OTC contraception. The first and only FDA-approved OTC oral contraceptive will be available in early Q1 2024.