Senators Whitehouse (D-RI) and Grassley (R-IA) have launched a bipartisan investigation into private-equity firms’ involvement in healthcare. The senators are demanding information from two hospital systems to assess how much profit they have generated and to what extent patients and clinicians have been harmed.

The House Oversight Subcommittee on Healthcare and Financial Services sent a letter to FDA Commissioner Robert Califf requesting a briefing on the decision to label phenylephrine, commonly used as a nasal decongestant, as ineffective. The request asks for the briefing to occur no later than December 11th 

The House Energy and Commerce Committee advanced a slate of healthcare legislation in a 2-day marathon markup session this week. The Committee advanced bipartisan healthcare priorities that have been a focus throughout this year, including transparency measures for pharmacy benefit managers, reining in prescription drug costs for Medicare Part D beneficiaries, and averting next year’s Medicare Physician Fee Schedule cuts. The Committee also advanced legislation that would diminish the scope of CMS’ national and local coverage determinations and would reform the Medicare Physician Fee Schedule reimbursement model.

Notable bills that advanced during the mark-up includeH.R. 6545, which includes a 2.5% mitigation to the 2024 Medicare Physician Fee Schedule Conversion Factor reduction (consistent with the Senate Finance Committee’s proposal), in addition to a 2.5% APM bonus.

• H.R. 6371, Provider Reimbursement Stability Act, which would increase the Physician Fee Schedule (PFS) budget neutrality threshold, provide for a lookback period to reconcile overestimates and underestimates of pricing adjustments for individual services, requires HHS update prices and rates for direct cost inputs for practice expense relative value units no less than every 5 years, and sets a limitation on year-to-year conversion fact (CF) variance.
• H.R. 2880, Protecting Patients Against PBM Abuses Act, which limits PBMs to receiving flat dollar amount service fees for their services when working with Medicare Part D plans.
• H.R. 5385, Medicare PBM Accountability Act, which increases transparency measures for PBMs working with Medicare Part D plans.
• H.R. 5389, National Coverage Determination Transparency Act, would require CMS to provide missing information to the requesting entity and provide technical assistance for entities that request NCDs.
• H.R. 5396, Coverage Determination Clarity Act of 2023, would require CMS to review all existing LCDs to determine if the LCD denies, limits, or conditions coverage beyond what is provided by an NCD that covers the same service. If the review finds that the LCD limits coverage compared to the NCD, the MAC would be required to revise the LCD to eliminate this conflict. CMS would also require MACs to prevent conflicts with NCDs for all new LCDs.

Despite these bills passing through the Committee, they still face an uncertain future. In particular, the House and the Senate will need to reconcile differences between PBM legislation proposed in both chambers. Cathy McMorris Rodgers (R-WA), Chair of the Committee, acknowledged that she is interested in exploring Senate-endorsed measures, including banning spread pricing in the future.

Issues where the House and Senate are aligned, including mitigating physician fee schedule cuts and implementing PBM transparency measures, have a greater chance of successfully being passed in Congress. It remains to be seen whether these measures will advance in a year-end package before the end of the year, or if these priorities will be on Congress’ to-do list once Congress returns from recess after the holidays.

Nearly 7.3 million Americans have enrolled in a health plan through the Affordable Care Act (ACA) state exchanges. 1.6 million of those enrollees are newly enrolled in a plan through the ACA marketplace.

The U.S. Department of Commerce released guidance detailing under which circumstances high-cost drugs that were manufactured with support from the federal government could have their patents seized. Price and supply would be considered in determining which drugs would be subject to “march-in action”

The Biden Administration is preparing a healthcare plan for a potential second term. The plan includes expanding drug pricing measures in the Inflation Reduction Act, making enhanced federal premium subsidies permanent, expanding access to Medicaid, and creating a private healthcare insurance option that would compete with private health plans.

Blue Cross Blue Shield of Massachusetts has joined Cigna and UnitedHealthcare in announcing plans to reduce the utilization of prior authorization. Blue Cross and Blue Shield of Massachusetts eliminated 14,000 prior authorizations for services related to home healthcare, including physical and occupational therapy and home visits from aides, nurses, and social workers.

CVS announced plans to shift to a new prescription drug pricing model. In the new model, PBMs and payers will reimburse CVS pharmacies based on the cost of the drug, a set markup, and a flat fee – instead of rebates.

CMS released the National Coverage Determination (NCD) Dashboard, which indicates 3 NCDs have been finalized in the past 12 months, 2 are open, and 7 are on the waitlist. CMS prioritizes NCD requests based on the magnitude of the potential impact on the Medicare program and beneficiaries, and CMS strives to keep the process open, transparent, and accessible.

On Monday, CMS finalized a rule that would require states to submit a corrective action plan if they are found to be out of compliance with federal reporting or eligibility requirements related to the Medicaid redetermination process. If states don’t comply, CMS can suspend disenrollments, levy fines against states, and reduce funding to a noncompliant state’s Medicaid program.

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