Biden CMS Leaders Write: "Med Adv Plans Need Prior Auth Guardrails"

Two experts with leadership roles in the Biden CMS have penned a new article at Health Affairs, on a series of issues with Prior Authorization in Medicare Advantage.

A number of proposals were floated in November 2024 annual Med Adv rulemaking.   The outcome of that rulemaking will be up to new Trump officials, when it is finalized in March or April.   

(Though not related to Prior Auth, the same November proposed rule contained various paragraphs and protections about transgender and even intergender issues, which will likely be nixed in the final rule.  "Equity" was mentioned about 50 times in the proposed rule.)

Find the Health Affairs article by Turco and Seshamani here:

https://www.healthaffairs.org/content/forefront/prioritize-prior-authorization-reforms-medicare-advantage

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Separately, AMA releases new data on the burden of prior auth:

https://www.healthcaredive.com/news/prior-authorization-stands-in-way-medically-necessary-care-american-medical-association/740876/

CAP Officially Urges HHS to Drop FDA Regulation, Use Other Channels

The College of American Pathologists (CAP) has officially asked HHS to drop its support of the FDA LDT regulation, and thus pursue the "deregulation" that the new government is all about.

See their February 24, 2025, press release here:

https://newsroom.cap.org/latest-news/cap-urges-hhs-to-heed-executive-order-and-revoke-fda-ldt-regulation/s/51fe11f5-0ccd-4b4b-aad4-c9be890a4ab7

The press release cites the President's own executive order to de-regulate.  The article links to a February 14 letter to RFK Jr and a January 21 letter to the DJT team.   

They also link to the "Freedom for Laboratory Innovation and Testing Act (FLITA) which would stop FDA funding from being used to implement the rule.   This is consistent with current efforts to avoid government debt by de-funding numerous types of programs.

Labcorp Offers Liquid Biopsy Tumor Gene Panel Test

See a February 25, 2025, press release from LabCorp.   Labcorp announce the clinical availability of a ctDNA based tumor gene profiling test, called Labcorp Plasma Complete (R).  Here's their description, "Labcorp Plasma Complete detects genomic alterations in ctDNA across 521 genes. This includes single nucleotide variants (SNVs) and insertions/deletions (InDels), amplifications in 12 genes, translocations associated with 12 genes, and microsatellite instability (MSI) high status."

Find the full press release here:

https://www.labcorp.com/labcorp-announces-clinical-availability-liquid-biopsy-test-guide-personalized-treatment-plans

The announcement is paired with a March 2025 publication in J Molec Dx (AMP), by Verner et al.   It's titled, "Analytical Validation of the Labcorp Plasma Complete Test, a Cell-Free DNA Comprehensive Genomic Profiling Tool for Precision Oncology."  Open Access; find it here:

https://www.jmdjournal.org/article/S1525-1578%2825%2900008-X/fulltext

Is it covered by MolDx?

Not sure.   I couldn't find it on the MolDx DEX Registry, but Labcorp has >700 tests at dozens of lab locations and I may have missed something.  Something called Labcorp Plasma Focus was listed, with the remark, "not covered."   But that's not Plasma Complete, which my limited search effort did not find.

Trump Administration: Will Defend USPSTF Preventive Benefits under ACA

The Affordable Care Act, USPSTF, and the Braidwood Case: A Legal Shift?

The Affordable Care Act (ACA) mandates that most commercial health insurance plans cover preventive services recommended by the U.S. Preventive Services Task Force (USPSTF) without cost-sharing. While the connection to Medicare is less direct, Medicare can choose to create National Coverage Determinations (NCDs) that align with USPSTF-endorsed services on a case-by-case basis.

A major legal challenge, Braidwood v. Becerra—now likely renamed Braidwood v. Kennedy—questions USPSTF's authority to set these benefit requirements. The plaintiffs have seen some legal victories, raising the possibility that USPSTF’s role in shaping mandatory preventive coverage could be canceled.

Notably, a newly filed brief reveals an unexpected legal stance: the Trump Administration will support USPSTF’s authority. 

That means Trump’s legal team will argue to overturn lower court rulings that challenged USPSTF’s power. However, winning this argument at the Supreme Court (SCOTUS) this spring is key. Merely defending USPSTF's authority isn’t enough—the administration must prevail at SCOTUS to maintain the current structure of preventive care coverage under the ACA, and "Braidwell" have been winning so far.

Here's an upload of the 62-page brief:

https://www.scribd.com/document/830575445/20250218171629934-24-316tsUnitedStates-1

Here's my Google Drive open access copy:

https://drive.google.com/file/d/1Vfor_nPLNKkfqE6nq3M2gXtXOdvgqeuR/view?usp=sharing

See the website of the Center for Value-Based Insurance Design:

https://vbidcenter.org/initiatives/braidwood-becerra/

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AI CORNER

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Here is an AI review of the DOJ brief, why it thinks lower courts have been getting this case wrong.

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From the DOJ's brief in the 62-page Braidwood v. Kennedy case, here are the key reasons why the DOJ is hopeful of winning at SCOTUS and upholding the USPSTF’s authority:

1. Strong Precedent on Inferior vs. Principal Officers

• The DOJ argues that USPSTF members are “inferior officers” rather than principal officers, meaning their appointment process is constitutional.
• SCOTUS has previously ruled in Edmond v. United States (1997) and Arthrex (2021) that officers are “inferior” when they are supervised by a higher-ranking official, which applies here since the HHS Secretary can remove Task Force members at will and influence their work.

2. The HHS Secretary Has Final Authority Over USPSTF Recommendations

• The DOJ highlights that the HHS Secretary can override or delay the implementation of Task Force recommendations, meaning they are not truly independent decision-makers with final authority.
• In past SCOTUS cases, if a superior officer retains oversight power, the Appointments Clause challenge usually fails.

3. Court's Misinterpretation of the “Independence” Clause

• The Fifth Circuit interpreted the statutory language requiring the USPSTF to be “independent” as completely insulating them from HHS oversight, but the DOJ argues this is a misreading.
• The phrase “to the extent practicable” in the law means there is room for executive oversight, which the government argues is sufficient to meet constitutional requirements.

4. Severability as a Safety Net

• Even if SCOTUS agrees that USPSTF’s structure is flawed, the DOJ argues that the problem can be fixed by severing a single provision (42 U.S.C. § 299b-4(a)(6)), just as SCOTUS did in Arthrex.
• This approach would allow Task Force recommendations to continue with explicit review power by HHS, rather than dismantling the entire system.

5. The Implications of Overturning USPSTF Authority

• The DOJ warns that a broad ruling against USPSTF could throw many other federal health advisory bodies into legal uncertainty, such as the Advisory Committee on Immunization Practices (ACIP) and others that influence public health decisions.
• SCOTUS may hesitate to issue a destabilizing decision with widespread consequences beyond preventive care.

Conclusion: DOJ’s Confidence at SCOTUS

• While Braidwood has won in lower courts, the DOJ sees SCOTUS as more likely to apply precedent that favors the government—especially since the at-will removal authority and HHS oversight are clear on paper.
• The Fifth Circuit’s failure to sever the problematic statute gives SCOTUS a clean path to fix the issue rather than striking down USPSTF’s role entirely.

These factors make the DOJ optimistic that SCOTUS will side with them and uphold the USPSTF’s authority—or at least provide a limited ruling that avoids dismantling the ACA’s preventive care mandate.

"Make America Health Again" Commission - Recommend Thomas Sullivan's Review

 The "Make America Health Again" federal commission is officially launched.    I'll link to the original  document, and I can recommend the excellent Linked In "review & implications" from Thomas Sullivan.

The White House Executive Order, dated February 13, is here:
https://www.whitehouse.gov/presidential-actions/2025/02/establishing-the-presidents-make-america-healthy-again-commission/

Policy Expert Thomas Sullivan has the best overview I know of, and he isn't share about extrapolating some take-home lessons   Find his essay on MAHA here:

https://www.policymed.com/2025/02/president-trump-establishes-make-america-healthy-again-commission-implications-for-life-science-journal-publications-and-continuing-healthcare-education.html  

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AI Corner

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I'd recommend Sullivan's essay above.  But, here is an AI review of the same executive order.

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The Make America Healthy Again (MAHA) Commission is established by Executive Order (Feb 13, 2025) to address the growing health crisis in the U.S., particularly chronic diseases, mental health issues, obesity, and childhood health concerns.

Key Points:

• Purpose: The U.S. lags behind developed nations in life expectancy and has rising rates of chronic illnesses, mental health conditions, and childhood diseases (e.g., obesity, diabetes, ADHD, autism, fatty liver disease).
• Policy Focus: Shift national health efforts toward prevention, transparency in research, improved nutrition, reduced reliance on medication, and environmental impacts.
• MAHA Commission Composition: Led by the HHS Secretary with officials from Agriculture, Education, VA, EPA, FDA, NIH, CDC, and other agencies.
• Initial Priority: Childhood Chronic Disease—Investigating root causes (e.g., diet, toxins, medication overuse, environmental factors) and proposing solutions.
• Deliverables:
  • Within 100 days: Report on childhood chronic disease trends, medication risks, transparency issues, and best practices.
  • Within 180 days: A national strategy to reform federal health policies, improve children’s health, and implement effective solutions.

Big Picture

The MAHA Commission seeks to overhaul U.S. healthcare priorities—moving from disease management to prevention and root-cause solutions. The focus is on children’s health first, with plans to expand to broader public health issues.

?? Open access journals?

Yes, the MAHA Executive Order emphasizes transparency and open-source data in federally funded health research but does not explicitly mention open access journals.

Relevant sections:

• Sec. 2(a): Mandates that all federally funded health research should be transparent and open-source, avoiding conflicts of interest.
• Sec. 5(a)(vii): Requires transparency of all current data and unpublished analyses on childhood chronic diseases.
• Sec. 5(a)(ix): Calls for restoring the integrity of science, including eliminating undue industry influence and increasing methodological rigor.

While open access publishing is not directly stated, the order strongly pushes for public access to government-funded research and data transparency.

ACLA vs FDA on LDT: Hearing in Texas Court February 19

In the ongoing federal court case, ACLA & AMP vs FDA on lab-developed tests, today reached an oral hearing before a Texas-based judge.

The audio is not available, but I assume that at some point today's transcript will be appear in the docket at PACER (a court archive).  The judge in the Texas Eastern District is Sean Jordan.

Meanwhile, at Endpoints News (free w/ email), Nicole DeFeudis summarizes the afternoon:

https://endpts.com/government-is-set-to-address-its-lab-developed-test-rule-in-court/

And Shannon Bennett summarizes at Linked In:

https://www.linkedin.com/feed/update/urn:li:activity:7298346983667208192/

And see Christine Bump's summary at Linked In:

https://www.linkedin.com/pulse/aclas-amps-suits-over-ldt-final-rule-summary-judgement-bump-h3nyc/

Positions Were Predictable

The positions were predictable, but at least before the last week or two, it wasn't certain what position the incoming Trump administration would take.  There's been at least one case (regarding transgender law) where the Trump federal attorneys quickly took a position 180 degrees opposite that of earlier  Biden federal attorneys.   

And, back to the LDT case, CAP has officially asked the DJT administration to evolve the position of the FDA and its attorneys and develop a new schema via lawmaking.   (CAP page here.)

• For FDA and HHS, DOJ attorney Gabriel Schonfeld restated his position that, "The final rule is both within the FDA statutory authority, and not arbitrary or capricious."  (Quoting from Endpoints).
• For ACLA/AMP,  Michael Schumsky, Hyman Phelps McNamara, for the plaintiffs, argued that the FDA's position is "as unreasonable as calling a surgical procedure 'a device.'  "  (Quoting from Endpoints).

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What will happen?

Back on December 25, I fed the final legal arguments into Chat GPT and it predicted the FDA would lose, a blog that was picked up by an article in Dark Report.   

And I've always felt (as a policy-watcher but non-attorney) that the ACLA-AMP arguments seemed fairly sound.  For example, doesn't it seem odd that CLIA would have rules and guidance allowing LDTs (or LDT variations of IVDs), yet at the same time, the same test results were illegal (not FDA)?

I could add a few more comments:

• Today's DOJ Not Tomorrow's DOJ.  While the DOJ defended the 2024 position of the FDA today, if it gets a "stinging take-down" in the judge's opinion, in March or April, it may reconsider whether to fight on.  Toss-up, but an extra shot on goal for ACLA.
• Lobbying continues.  As mentioned, various organizations like CAP are urging the WH, HHS, FDA, to take a different approach, a process that will continue.  Favors ACLA.
• Judge may lean toward agreeing with DJT position, because it is the DJT position.  
• I've seen that a lot of conservative judges are all-too-happy to accuse federal agencies of going too far in their regulations.   Favors ACLA.
• But - let's balance that - by the possibility a federal judge may see a cleaner promotion pathway (such as to federal appeals court) by reasonably supporting positions of the newly Republican DOJ wherever he can, rather than building a record of disagreeing with them if he doesn't feel he has to.  Favors FDA.

Shannon Bennett notes in his Linked In article, the FDA offered that if plaintiffs prevail, there are intermediate possible stops other than simply vacating the rule.  That could lead to a complicated time-course.

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AI CORNER

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Summary of the FDA LDT Oral Hearing (ACLA/AMP v. FDA) – February 20, 2025

The oral arguments in the ACLA/AMP lawsuit against the FDA’s LDT Final Rule took place in Plano, Texas, presided over by Judge Sean D. Jordan. The hearing lasted over three hours, with both sides presenting arguments on whether laboratory-developed tests (LDTs) should be regulated as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).

Key Issues and Judge’s Focus Areas

1. Defining LDTs: Are They Devices?

• ACLA & AMP’s Argument: LDTs are a professional service, not a physical product, and therefore do not meet the FDCA’s definition of a "device". They emphasized that LDTs are developed and performed within a single laboratory and are not manufactured for sale in interstate commerce.
• FDA’s Argument: LDTs are a subset of in vitro diagnostic (IVD) test systems, which are already regulated as medical devices. The agency argued that LDTs are "test systems" that include physical components (e.g., reagents, instruments) and could be packaged and sold as kits—but laboratories choose to offer them as a service instead of selling them.

📌 Judge’s Reaction: He asked both sides to clarify whether LDTs are a "physical thing" introduced into interstate commerce and pressed FDA on whether its definition of "device" includes all LDTs.

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2. Statutory Interpretation of FDCA & CLIA

• ACLA & AMP: Congress has never explicitly given FDA authority over LDTs, and the legislative history (FDCA 1938, Medical Device Amendments 1976, CLIA 1988) suggests LDTs were always meant to be regulated under CLIA, not FDA.
• FDA: The FDCA’s definition of "device" includes terms like "contrivance" and "article," which cover LDTs. FDA claims its authority has existed since 1938, even if it exercised enforcement discretion until now.

📌 Judge’s Reaction: He pushed both sides on whether Congress’s intent was to exclude LDTs from FDA oversight and asked for clarification on how the CLIA framework differs from FDA’s regulatory authority.

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3. Impact on Public Health and Costs

• ACLA & AMP: Enforcing FDA regulations on LDTs will cost billions of dollars, significantly reduce access to rare disease testing, and force labs to shut down tests. The plaintiffs cited $115 billion in initial costs and $14.5 billion annually.
• FDA: The Final Rule balances patient safety and innovation, ensuring that all tests meet proper regulatory standards.

📌 Judge’s Reaction: He acknowledged concerns about economic impact and patient access, but he also noted that FDA claims authority over LDTs regardless of financial burdens.

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4. Dueling Surgical Analogies

• ACLA & AMP: Compared LDTs to surgeons using different tools during a procedure—just because they combine devices, they don’t become a device manufacturer.
• FDA: Countered with the example of a defective heart stent—even if a surgeon implants it, the stent remains a regulated medical device.

📌 Judge’s Reaction: He pushed both sides on these examples and seemed to find merit in both analogies, though it’s unclear which argument he favored.

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5. Remedy If Plaintiffs Win

• ACLA & AMP: If the court rules against FDA, the entire rule should be vacated.
• FDA: The court does not have to fully vacate the rule—it could apply only to specific tests or manufacturers.

📌 Judge’s Reaction: He asked both sides about potential partial vs. full vacatur, indicating he is weighing a more limited ruling.

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Final Takeaways

• Judge Jordan demonstrated strong knowledge of the case and asked pointed questions on statutory interpretation, public health impact, and analogies.
• The ruling could come soon, as the judge acknowledged the May 6, 2025, Phase 1 deadline under the FDA’s phaseout policy.
• The case will likely hinge on how SCOTUS interprets “device” under the FDCA and whether Congress clearly delegated regulatory authority over LDTs to FDA.

This hearing highlights the ongoing legal battle over LDTs, with huge implications for laboratories, diagnostics, and regulatory precedent.

State Laws: Prior Authorization as well as Biomarkers

Many in the precision medicine community track the progress of state biomarker access laws which regulate insurance - here, here.

States are also passing laws in the policy area of "prior authorization."  The state laws are individualized, so they defy a simplistic summary.   Remember that state laws generally govern "insurance" health plans but not "administrative services only, employer self-funded" health plans.

But you can catch up here:

AMA Chart (a 32--page table)

https://www.ama-assn.org/system/files/prior-authorization-state-law-chart.pdf

AIMED Alliance Chart

https://aimedalliance.org/prior-authorization-enacted-laws/

AMA: Review of 10 State Approaches

https://www.ama-assn.org/practice-management/prior-authorization/10-states-have-tackled-prior-authorization-so-far-2024

Kaiser update; Focus on Montana, 2/2025

https://kffhealthnews.org/news/article/montana-legislation-bills-prior-authorization-denials-delays-2025/

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Medicare regularly updates Prior Auth rules for Medicare Advantage; look for the next final rule around April 2025.

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Although not a Prior Auth Reg, California law proposal SB363 would regulate communications about denials and appeals.  However, it would only cover about 1/3 of California health plans, those falling under state law. LA Times.

Writing, "California could become one of only a handful of states that require insurers to disclose denial rates and reasoning, data the industry often considers proprietary information. The measure also seeks to force insurers to be more judicious with denials, by fining them up to $1 million per case if more than half of appeals filed with regulators are overturned in a year."

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AI Corner

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AI Summarizes the 32-page AMA Table

Analysis of the 2024 AMA Prior Authorization State Law Chart

Key Takeaways for Policy Experts

The AMA’s 32-page chart provides an exhaustive summary of state-specific prior authorization (PA) laws and proposals, offering insights into how different states regulate PA processes, including response times, transparency, gold carding, appeals, and exemptions. Below is a structured breakdown to help policy professionals digest the overwhelming detail:

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1. Common Themes and Variations Across States

Response Times and PA Length

• Most states mandate 48 to 72 hours for urgent requests and 2-5 business days for non-urgent ones.
• Some states (e.g., Illinois, New Jersey, and Minnesota) require extended validity for prior authorizations, ensuring continuity of care when patients switch insurance plans.
• Arkansas and Louisiana prevent insurers from retroactively denying payments on previously approved services unless fraud or misrepresentation is involved.

Retrospective Denials and Appeals

• Many states (e.g., Alaska, Arizona, Illinois) prohibit or severely limit retroactive PA denials.
• Mandatory peer-to-peer reviews with specialists of the same field are becoming more common (e.g., Georgia, New York, Louisiana).

Gold Carding and Exemptions

• Several states (Texas, Arkansas, Michigan) now have “gold carding” laws, exempting high-performing providers from frequent PA requirements.
• Some states (e.g., New Hampshire, Kentucky, New Jersey) exempt specific emergency services, cancer treatments, and mental health care from PA requirements altogether.

Transparency & Data Reporting

• Several states now mandate insurers to report PA statistics, including denial rates, approval timelines, and appeal outcomes (e.g., California, Louisiana, New Jersey).
• Some states (e.g., Colorado, Indiana, Minnesota, and New Jersey) require that insurers post all PA requirements online, ensuring physicians have easy access.

Peer Review and Medical Necessity Criteria

• Many states (e.g., New York, California, Illinois) now require medical necessity determinations to be based on peer-reviewed clinical guidelines.
• Specialist matching rules are becoming more stringent—appeals reviewers must be in the same or related specialty as the requesting physician.

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2. States Leading PA Reform

Certain states stand out for progressive PA reform aimed at reducing administrative burdens on providers:

Arkansas

• PA cannot be rescinded within 90 days unless fraud is involved.
• Gold carding: Providers with a 90% approval rate for certain procedures are exempt from PA.
• Insurers must publicly report approval/denial rates categorized by specialty, procedure, and medical justification.

Illinois

• PA lasts for 6-12 months for chronic conditions and long-term treatments.
• Extended reporting mandates require insurers to provide detailed statistics on PA denials and appeals.
• Retroactive denials restricted unless fraud or misrepresentation is found.

New Jersey

• PA must be reviewed by board-certified specialists in the same or similar field.
• Mandatory disclosure of PA policies on insurer websites.
• 60-day transition period for patients switching plans.

Louisiana

• Gold carding pilot programs allow low-denial-rate providers to bypass PA requirements.
• PA reviews must be conducted by licensed physicians with experience treating the condition in question.
• Public-facing reporting requirements for PA approvals, denials, and response times.

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3. Implications for Health Policy and Strategy

For Payers (Insurance Plans)

• Expect continued legislative pressure to reduce PA-related administrative burdens and increase transparency in approvals and denials.
• States are moving toward standardized forms, real-time electronic PA systems, and automatic renewals for chronic conditions to streamline the process.

For Providers (Physicians, Hospitals)

• More gold carding opportunities will reward providers with high approval rates by exempting them from PA.
• Faster appeal processes (e.g., mandatory 24-48 hour peer-to-peer reviews) will reduce treatment delays.
• Greater transparency in insurer decisions will help providers challenge denials more effectively.

For Policymakers & Advocates

• States with more aggressive PA reforms (e.g., New Jersey, Illinois, Louisiana, Arkansas) provide a blueprint for reducing PA-related delays.
• Data collection mandates in states like California and Louisiana allow for better policy evaluation and accountability of insurers.
• The growing trend of banning retroactive denials signals a stronger commitment to patient protection.

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4. Key Takeaways for Health Policy Experts

• State-Level PA Regulations Vary Widely: Some states are aggressively reforming PA laws, while others maintain minimal oversight.
• Gold Carding is Expanding: Several states reward low-denial providers with PA exemptions, reducing administrative burdens.
• Transparency & Data Reporting are Increasing: More states require insurers to disclose PA approval rates, denials, and appeals, allowing policymakers to track and address inequities.
• Retroactive Denials are Being Limited: Many states prohibit or restrict PA denials after treatment has been provided, ensuring greater payment predictability.
• Electronic PA Systems are Becoming Standard: Multiple states now mandate real-time electronic PA systems to reduce administrative delays.
• 
  

How does the AI review of the 32 page AMA Table, compare with the AMA"s own summary (link 3 in the original listing)

Comparison of AMA's Summary vs. My "AI" De Novo Analysis

Key Differences in Scope, Depth, and Focus

1. Focus of the AMA Summary

The AMA’s own summary, written in a journalistic and advocacy-oriented tone, highlights recent legislative wins in 10 states in 2024. It emphasizes:

• Legislative momentum, describing how states have responded to prior authorization (PA) burdens.
• Specific state examples (e.g., Minnesota, Vermont, Wyoming), showing how new laws improve patient care continuity, transparency, and response times.
• Key advocacy points, such as gold carding, chronic condition exemptions, and data reporting mandates.
• Federal-level support, promoting the Improving Seniors’ Timely Access to Care Act to reform PA in Medicare Advantage.

2. Scope and Structure of My Summary

In contrast, my ("AI") analysis provides a systematic and comprehensive breakdown of all 32 pages of the AMA’s state law chart, including:

• State-by-state common themes (e.g., response time requirements, transparency mandates, and PA validity periods).
• Comparative trends across multiple states, including those not mentioned in the AMA’s article (e.g., Arkansas, Illinois, Louisiana, and New Jersey).
• Policy implications for payers, providers, and policymakers.
• Identification of states leading PA reform, with specific details on how their laws address administrative burdens and care delays.
• Explicit breakdown of data reporting mandates, such as the level of PA denials and appeals insurers must disclose.

3. Key Similarities

Both summaries:

• Identify major themes in prior authorization reform, such as faster response times, gold carding, data transparency, and chronic disease exemptions.
• Showcase state progress, though the AMA focuses on recent 2024 laws, while my summary includes a broader historical and regulatory perspective.
• Recognize insurer accountability trends, such as preventing retroactive denials and requiring more rigorous reporting on PA decisions.

4. Unique Insights in My Summary

• Deeper comparisons across multiple states, including how gold carding programs vary (e.g., Texas vs. Arkansas).
• Explicit discussion on how state regulations impact payers, providers, and policymakers, rather than just advocacy for reform.
• More granular analysis of the data reporting requirements, showing how transparency mandates differ by state.

Final Thought

The AMA article provides an engaging, advocacy-driven summary of the most recent state legislative wins. My summary, in contrast, offers a structured, analytical deep dive, making it more useful for policy experts, payers, and compliance professionals who need a comparative, high-level regulatory analysis.

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Is it true that HILL efforts on PA in recent years focused on M.A. plans rather than health insurance as a whole?

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Yes, that aligns with what we’ve seen in federal legislative efforts—prior authorization reform at the federal level has primarily targeted Medicare Advantage (MA), rather than the entire U.S. insurance market.

Key Federal Efforts Focused on Medicare Advantage

1. Improving Seniors’ Timely Access to Care Act (2024)

   • This bipartisan, bicameral bill aims to streamline prior authorization in Medicare Advantage by:
     • Mandating real-time electronic prior authorization systems.
     • Requiring CMS to standardize PA reporting, including approval/denial rates and appeal outcomes.
     • Gold carding provisions—exempting providers with high PA approval rates from excessive prior auth requirements.
   • The bill passed the House in 2022 but stalled in the Senate. A renewed push in 2024 suggests it may gain traction.

2. CMS Rule on Medicare Advantage Prior Authorization (April 2023)

   • CMS issued a final rule requiring Medicare Advantage plans to:
     • Align PA requirements with Medicare fee-for-service coverage rules.
     • Honor prior authorizations for a full course of treatment rather than requiring frequent renewals.
     • Provide electronic prior authorization decisions within 72 hours for urgent requests and 7 days for standard ones.
   • These rules went into effect in January 2024.

3. 21st Century Cures Act (2016) and Interoperability Rules

   • This law indirectly impacts PA by requiring insurers to share prior authorization data electronically through HL7 FHIR-based APIs (a standardized data-sharing method).
   • Medicare Advantage, Medicaid, and ACA Exchange plans must comply with these electronic PA mandates by 2026.

Why the Focus on Medicare Advantage?

• CMS Oversight Authority: The federal government has direct regulatory control over Medicare Advantage (MA) plans but not over private employer-sponsored or state-regulated ACA plans.
• High Utilization of PA in MA: Studies show that Medicare Advantage plans use prior authorization more aggressively than traditional Medicare.
• Congressional Buy-In: Legislators see MA reform as a politically feasible step, whereas mandating changes for the entire commercial insurance market would require navigating ERISA preemption issues (which protect self-funded employer plans from state-level regulation).

Federal Inaction on Commercial Insurance

Unlike state-level laws that impact private insurers, Medicaid MCOs, and fully insured plans, federal efforts have largely ignored employer-sponsored and ACA marketplace plans. This is why we’re seeing states take the lead in gold carding programs, response time mandates, and PA transparency reforms for commercial insurers.

## Compare Hill and State efforts ###

Comparative Analysis: State-Level Prior Authorization Reforms vs. Federal Efforts in Medicare Advantage

State laws and federal policies on prior authorization (PA) share common goals—reducing administrative burdens, preventing care delays, and improving transparency—but they take different approaches due to regulatory constraints and payer structures. This analysis highlights key differences, areas of overlap, and gaps in PA reform at the state vs. federal level.

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1. Overview of Regulatory Differences

Aspect	State-Level Reforms	Federal Efforts (Medicare Advantage)
Who is impacted?	- State-regulated plans (individual, small-group, Medicaid MCOs) - Some fully insured employer plans (but not self-funded ERISA plans)	- Medicare Advantage (MA) plans only (does not apply to employer plans, ACA marketplace plans, or Medicaid MCOs)
Regulatory Authority	- State insurance commissioners & legislatures	- CMS (Medicare & Medicaid Services) & Congress
Prior Auth Scope	- All types of insurance PA (procedures, drugs, imaging, therapies, etc.)	- Medicare Advantage PA (focus on medically necessary services)
Payer Accountability	- Insurers must report PA denial rates & approval data to state agencies	- Medicare Advantage plans must submit PA data to CMS but no commercial insurer reporting requirement exists at the federal level
Gold Carding (Exemptions)	- Implemented in multiple states (e.g., Texas, Louisiana, Michigan) to exempt high-performing providers from frequent PA requirements	- 2024 federal proposal would implement a gold-carding pilot in Medicare Advantage, but not yet law
Retroactive Denial Limits	- Some states ban or limit insurers from retroactively denying PAs after approval (e.g., Illinois, Arkansas, Louisiana)	- Medicare Advantage rules do not prohibit retroactive denials, though CMS is monitoring the practice
Data Transparency	- More states are mandating insurers to disclose PA approval & denial rates (e.g., California, New Jersey, Louisiana)	- CMS rule requires Medicare Advantage plans to report PA decisions electronically starting in 2026
Appeals & Peer Review	- Many states require PA denials to be reviewed by a specialist in the same field as the requesting physician (e.g., New York, Illinois)	- MA plans must provide PA denials in writing & allow appeals, but do not require same-specialty reviewers
Urgent & Routine Response Times	- Mandated PA turnaround times in several states (e.g., 24-48 hours for urgent requests, 5 days for standard requests)	- New CMS rule requires MA plans to process PA within 72 hours (urgent) or 7 days (standard)

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2. Major Themes in State vs. Federal PA Reforms

A. Gold Carding (Provider Exemptions)

• State-Level: Several states (e.g., Texas, Arkansas, Louisiana, Wyoming) have gold carding laws that exempt physicians with a high PA approval rate from repeated PA requests.
• Federal-Level: The Improving Seniors’ Timely Access to Care Act (pending) proposes a gold carding system for Medicare Advantage, but it has not yet passed.
• Gap: No national requirement for commercial insurers to implement gold carding.

B. Chronic Condition & Continuity of Care Protections

• State-Level: Some states prohibit insurers from requiring repeat PA for chronic conditions (e.g., Minnesota, Vermont, New Jersey).
• Federal-Level: CMS now mandates Medicare Advantage PA approvals to last for the full course of treatment but does not extend to all chronic conditions.
• Gap: State reforms generally go further in ensuring continuity of care than Medicare Advantage policies.

C. PA Transparency & Reporting Mandates

• State-Level: Laws in California, Louisiana, and New Jersey require insurers to report PA data (e.g., denial rates, appeals, and processing times).
• Federal-Level: CMS mandates PA data reporting for Medicare Advantage plans starting in 2026.
• Gap: Commercial insurers outside Medicare Advantage face no federal-level PA reporting requirements.

D. Appeals & Peer-Review Process

• State-Level: Many states now require same-specialty reviewers (e.g., Illinois, New York), ensuring a cardiologist reviews a cardiologist's PA appeal.
• Federal-Level: CMS requires MA plans to provide written denials and allow appeals, but no same-specialty review requirement exists.
• Gap: Stronger state protections for provider-level appeals than in Medicare Advantage.

E. Retroactive PA Denials

• State-Level: Some states ban or limit insurers from revoking PAs after services are rendered (e.g., Illinois, Arkansas, Louisiana).
• Federal-Level: Medicare Advantage does not prohibit retroactive PA denials.
• Gap: No federal guardrails on retroactive denials in MA or commercial plans.

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3. Policy Implications: Future Trends

A. Will Federal PA Reforms Expand Beyond Medicare Advantage?

• Federal reform efforts focus solely on Medicare Advantage due to CMS’s authority.
• Extending PA reform to ACA marketplace, employer-sponsored, and Medicaid plans would require Congressional legislation, which is unlikely without bipartisan support.
• States will likely remain the primary battleground for commercial insurance PA reform.

B. Will State PA Reforms Influence Medicare Policy?

• Gold carding, transparency mandates, and same-specialty appeals in state laws may serve as prototypes for future Medicare Advantage regulations.
• CMS is monitoring state efforts, and future MA rule changes could reflect successful state-based approaches.

C. The Role of Litigation

• Employer-sponsored plans (self-funded under ERISA) are exempt from state PA laws, but states may challenge this preemption.
• Legal challenges could shape how much power states have over prior authorization in commercial insurance markets.

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4. Final Takeaways

Key Insight	State Reforms	Federal (Medicare Advantage) Reforms
Gold Carding Exemptions	Multiple states have implemented gold carding	Proposed for MA, but not yet law
PA Data Reporting	Some states require insurers to disclose PA stats	CMS requires PA reporting in MA by 2026
Retroactive PA Denials	Banned or restricted in some states	Still allowed in MA
Chronic Condition Exemptions	Stronger protections in some states	MA now requires PA validity for full course of treatment
Same-Specialty Appeals	Required in some states	Not required in MA
Urgent PA Response Times	24-48 hours in several states	72-hour requirement in MA

Bottom Line:

• States are leading the way on PA reform, with gold carding, transparency mandates, and appeals protections.
• Federal reform is limited to Medicare Advantage—and even those reforms aren’t as aggressive as state laws.
• CMS regulations for Medicare Advantage could be a model for federal PA reform in employer-sponsored and commercial plans in the future.
• Self-funded employer plans remain largely untouched by PA reform, due to ERISA preemption.

Would you like further insights into potential legal challenges to ERISA preemption of state PA laws or how insurers are responding to these state mandates?

Changes at HHS; RFK Jr Sworn In; CMS Deadlines; CMS Regulations re"Equity"

#1 - HHS Secretary;  #2 CMS Deadlines;  #3 CMS Regs & "Equity" Rules

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#1

RFK Jr - Secretary of HHS

On Wednesday, February 12, RFK Jr was approved by the Senate as Secretary of HHS (vote, 52-48), and on Thursday he was sworn-in in the Oval Office in a 15-minute ceremoney.

See a full transcript in Google Doc, here.  AI news summary at bottom (below).

See also the February 13 White House declaration regarding the national "Make America Healthy Again" committee to begin immediately and be chaired by the Secretary, etc.   Here.

See the laudatory letter from American College of Physicians (ACP; Internal Medicine), to the new Administration, here.

See Secretary Kenney's first speech to HHS staff, 20 minutes, February 18, YouTube.  Press.  AI autosummary.

#2

CMS Proposals on Upcoming Deadlines

Transmittals

CMS normally sends a constant stream of Transmittals to contractors and providers - these appear to have stopped a month ago, on January 17 (2025 Transmittals).

Medicare Advantage Final Rule

Several documents are timely this spring, either in pending final form, or pending proposed form.   CMS issued its proposed Medicare Advantage / Part D rule in November, with comment through January.   That final rule would be expected in April 2025. 

Inpatient Proposed Rule

CMS issues its annual inpatient proposed rulemaking in April (e.g. on April 10, 2023), with finalization in August, effective for the fiscal year October 1.  

#3

Use of the Word "Equity" in CMS Rulemaking

With "equity" decisions so much in the news, you might wonder if this affects the writing of Medicare regulations. To a degree, it does, at least at the level of emphasis.   See the November 2024 final regulations for Physician Fee Schedule, for Hospital Outpatient schedule, and for the proposed Medicare Advantage rule.    Word counts for "equity" were 329, 306, and 50, respectively.     

You can compare the last CMS rules under the first DJT administration.  In the November 2020 PFS final rule, word count of "equity" was 11, in the 2020 OPPS final rule, 1.

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AI Corner

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I asked Chat GPT 4o for a summary of the swearing-in Google doc.  Quotes may be paraphrases.

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Robert F. Kennedy Jr. Sworn In as Secretary of Health and Human Services

February 13, 2025 — Washington, D.C.

Robert F. Kennedy Jr. was officially sworn in as the Secretary of Health and Human Services (HHS) in an Oval Office ceremony on Tuesday. The event, attended by President Donald Trump, Supreme Court Justice Neil Gorsuch, and members of Kennedy’s family, marks a significant moment in the administration’s approach to healthcare policy.

President Trump, in his remarks before the swearing-in, praised Kennedy’s commitment to public service and his willingness to cross party lines in pursuit of shared national goals. Trump highlighted Kennedy’s background as an advocate for environmental and health issues, as well as his ability to build a broad coalition of supporters during his 2024 presidential campaign. The president framed Kennedy’s appointment as part of a broader initiative to address what he called a "chronic disease crisis" in America.

“There’s no better person to lead our campaign of historic reforms and restore faith in American healthcare,” Trump stated. He cited concerns over increasing rates of chronic illnesses, including cancer and autism, and announced the creation of a new presidential commission, chaired by Kennedy, to investigate these issues and recommend policy solutions. “We’re going to figure it out, and Bobby is going to lead the way,” he said.

Justice Gorsuch administered the oath of office, after which Kennedy addressed those in attendance. He thanked President Trump for the opportunity and expressed gratitude for the support of his family. Kennedy reflected on his family’s legacy in public service, recalling a childhood visit to the Oval Office to meet with his uncle, President John F. Kennedy, and discussions about physical fitness and environmental conservation.

Kennedy reiterated his longstanding focus on public health, emphasizing his desire to investigate and combat the rise of chronic diseases among Americans. He acknowledged skepticism about his views on vaccines but argued that his position has been misrepresented. “When people actually hear what I think about vaccines, which is common sense—that vaccines should be tested, they should be safe, and everybody should have informed consent—people support it,” Kennedy said.

The new HHS secretary also laid out his early priorities, emphasizing “radical transparency” and reforms at key public health agencies, including the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC). He pledged to root out conflicts of interest and restore what he described as “gold standard science” in federal health policy.

Kennedy’s appointment has been met with mixed reactions. Supporters see his leadership as a needed shake-up in federal health policy, while critics remain concerned about his history of controversial statements.

“I’m going to do everything I can to work with you, whether you’re a Democrat or Republican, to restore children’s health in this country,” Kennedy said.

The event concluded with Trump reaffirming his confidence in Kennedy’s leadership. “He’s going to be running it. He’s going to do a great job,” the president said. When asked about Kennedy’s first steps as secretary, Trump indicated that uncovering “secrets” within the health system and addressing systemic health challenges would be top priorities.  [DJT also discussed an executive order for a MAHA commission, chaired by RFK Jr, to understand drivers of ill-health in the U.S.]

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One of the DJT executive orders bans agencies from using "gender" in the context of sex; in the proposed M.A. rule, which CMS will soon review and finalize, besides 50 uses of "equity," "gender" occurs 5 times, including in regulation 422.112 (a)(8)(i)(E).  (In the 2024 Medicare finalized PFS rule,"gender" appeared 11 times, in the OPPS rule, 9 times.)

RFK Jr Confirmed as Secretary of HHS: AI Predicted 65% Chance Using Hearing Transcripts

On February 13, 2025, RFK Jr was confirmed by the Senate as Secretary of Health.   

Chat GPT predicted a 65% chance of his confirmation, on January 30, based on "reading" the two-day confirmation hearings transcript.  The Chat GPT analysis was quite detailed:

https://www.discoveriesinhealthpolicy.com/2025/01/ai-corner-chat-gpt-assesses-rfk-jr.html

See coverage at Politico.

HHS has 80,000 employees, including CMS, NIH, FDA, CDC.   The vote was 52-48, the only exception to the 53 Republican senators being Mitch McConnell.

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%).