Thursday, June 22, 2023

What's More Dull than NCCI Coding Edits? A Lawsuit about NCCI Coding Edits.

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When entities like CMS MACs lose contracts, it's common that there is at least one round of protests by the losing party (and sometimes,...

MolDx Finalizes "Molecular Prognostic and Predictive Classifiers" for Bladder Cancer (L38647)

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Back in July 2022, the MolDx MACs put out draft LCDs on prognostic and/or predictie classifieres for bladder cancer.    The final LCD isout,...

Hold Your Breath, But Not For Too Long: DME MAC Wins Its Own Jurisdiction, Again

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 DME MACs and A/B MACs undergo regular "re-competes" but they are usually won by the incumbent.  So to for Jurisdiction B DME, CMS...
Wednesday, June 21, 2023

Exact Sciences Investor Day - Meanwhile at AMA, Cologuard Code Revision "Rejected"

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Exact Sciences held its June investor day, covered in a number of news stories.  Here , here .  A new version of the Cologuard test had its ...
Tuesday, June 20, 2023

FDA Launches Pilot Program with Criteria for LDTs

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 With a press release, guidance document, and comment period, FDA launches a pilot program.   Drug developers will release performance crite...

Journal Club: CMS AI Playbook (2022, 38pp)

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Did you know there's a CMS "AI Playbook?"   There is, coming in at 38 pages, last updated 2022.  It's more about agency pr...

UCSF: Papers on Liquid Biopsy: (1) Payor Policy for LBX & MRD Today; (2) MCED and Payor Views and Forecasts

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Two papers currently from the UCSF TRANSPERS team. The first, Douglas et al., in JNCCN, looks at payor policies for liquid biopsy (both fo...
Sunday, June 18, 2023

Digitalization of Pathology Slide Codes: AMA Says OK, CMS Outpatient Rules say "Nix"

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HEADER:  The article discusses the new codes established by AMA for the digitalization of pathology slides.   The codes, though not priced o...
Saturday, June 17, 2023

Diagnostic Test Coverage: Would It Be Improved by GRADE's "EVIDENCE TO DECISION" Framework?

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HEADER.  This blog quickly surveys some approaches to molecular test evaluation.  Then, we describe the "GRADE Evidence To Decision...
Friday, June 16, 2023

CMS Says "TCET" Coverage Rule is Imminent Now

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CMS could release its long-awaiting "Transitional Coverage for Emerging Technology" rule any time.  It's been assigned number...

Nerd Note: Coverage vs Pricing: MolDx Non Covers Test, Then Prices It at $3159

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It's a cliche' that Medicare makes coverage decisions and pricing decisions in separate silos.  People ask, will it matter how much ...

Journal Club: New Waves of Genomic Drugs (Nature)

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Nature Reviews Drug Discovery has an interesting article on "waves of drug discovery" that will soon occur in genomic medicines (...
Thursday, June 15, 2023

Snapshot: How Complicated Are MediGap Plans

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I believe the basic structure of Medigap plans evolved some years ago, but boy, it's complicated.  A current MEDPAC report to Congress t...

Brief Blog: CMS Grants isoPSA Test Coverage under NCD for PSA Screening Benefit

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UPDATE AUGUST 2023:  COVERAGE CANCELED. https://www.discoveriesinhealthpolicy.com/2023/08/the-lord-given-taketh-away-cms-rescinds.html #### ...

NEJM Review on Squamous Cell Carcinoma: LCDs and Reviews and Guidelines

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HEADER.   A review in the NEJM surveys diagnosis and management of squamous cell carcinoma.  Despite recent non-coverage LCDs, gene expressi...