Thursday, February 13, 2025

Where Coverage Policy Comes From: Drugs & Medicare Advantage; USPSTF on Preventive Services

Coverage under Medicare and under the Affordable Care Act comes from multiple sources, and there's a storm blowing in terms of potential changes.  Just a couple highlighted here.

Braidwell Case - Update on Prevention

Kaiser Foundation provides a  detailed but readable analysis of the Braidwell case, which would up-end the Affordable Care Act's policies about preventive services coverage (predicated on USPSTF decisions).   See the Kaiser report here.    The cases has been ping-ponging up and down between  federal district court and federal appeals court but is likely to eventually reach the Supreme Court.   

CMS and AHRQ/USPSTF and Coverage

Meanwhile, Medicare coverage for new preventive benefits can be created, through an NCD, for services newly endorsed by USPSTF.   

However, there said to be efforts to "cancel" funding for AHRQ, the division that USPSTF sits inside of.   

(And note also:  Besides preventive services, CMS NCDs that use "coverage with evidence development" are predicated on a statutory interaction with AHRQ, which couldn't occur if AHRQ were disbanded.)

Should Medicare Advantage Govern Pt B Drug Policy? A 180 Degree Flip?

Current policy for Medicare Advantage plans is predicated on having M.A. coverage at least match fee for service coverage, such as LCDs.   

At least for drugs, a Manhattan Institute proposal would invert that 180 degrees.   The proposal would set fee for service coverage to match what at least half the M.A. plans cover.  Besides coverage, drug pricing would also mimick M.A. prices.

>> See a detailed white paper at Manhattan Institute here.

EU HTA

See a report from Evidera on how to face health technology assessment (HTA) in the E.U. - here.

Sidebar: WSJ

Meanwhile, WSJ runs a long article on insurance denials (here) and how to fight them (here).


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AI CORNER
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Here's an AI summary of the Manhattan Institute drug proposal.
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Market-Based Reform for Medicare Part B Drug Pricing

The Manhattan Institute proposes a market-driven approach to lower Medicare Part B drug prices for expensive, limited-competition drugs, arguing that current price controls (IRA) and Trump’s MFN pricing do not effectively address these costs.

Key Issues Identified:

  • Medicare Overpays for Part B drugs due to the ASP + 6% reimbursement model, which works well for competitive drugs but fails for high-cost, single-source drugs (e.g., oncology, ophthalmology, rheumatology).
  • IRA price controls only begin affecting Part B in 2028 and exclude biologics for 13 years, meaning most costly new drugs remain unaffected.
  • Most Favored Nation (MFN) pricing may not work since the U.S. gets novel drugs first, and manufacturers could withhold drugs in foreign markets to avoid price suppression.

Proposed Reform:

  • Medicare Advantage (MA) plans negotiate drug prices. If 50% of MA plans reach an agreement, the drug is covered at the highest negotiated price, which then becomes the reimbursement rate for both MA and traditional Medicare.
  • Manufacturers must accept the “clearing price” (highest MA-negotiated price minus 1%) to participate in Medicare.
  • If not enough MA plans reach a deal, the drug won’t be covered for the next year.

Expected Benefits:

  • Reduces Medicare’s role as a “price taker” by forcing negotiation rather than passively accepting high prices.
  • Avoids government price controls (IRA), allowing market participants to determine drug value.
  • Encourages competition while keeping provider reimbursement intact.

The report argues that market-based pricing is superior to government price controls since it accounts for patient demand, provider input, and insurer cost-balancing while adapting to changing market conditions.

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According to some sources like Washington Post, NSF and other grant-giving agencies are searching grants for keywords like "equity."   According to Chat GPT, in last fall's final CMS PFS rulemaking (November 2024), the word "equity" occurred 329 times, in the CMS OPPS final rule, "equity" occurred 306 times, and in the December proposed Medicare Advantage (Part C & D) rule, the word "equity" appeared 50 times.
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I checked these results against the final PFS and OPPS rules of December 2020 (the last work products of the first DJT administration.)   The OPPS rule for CY2021 appears to have "equity" only once (and by quoting a WH executive order) and the PFS rule, 11 times.  
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The easiest way to count is to upload to Chat GPT and ask it; or, to save as TXT file and upload to Word and search "equity" for matches. (The two methods matched to about 2%).