Monday, January 17, 2022

Catching Up With MolDx: December Meeting on Rheumatoid Arthritis Therapy Selection

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On December 7, 2021, MOLDX held a multi-jurisdictional advisory meeting on the topic, "Predictive Testing to Guide Targeted Therapy Sel...
Sunday, January 16, 2022

The Government *Can* Require Vaccinations: Supreme Court History

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We often hear conservative politicians emphasizes to audiences that the government can't make you get a vaccine .   That's misleadin...
Saturday, January 15, 2022

AMA Publishes January Applicants for New PLA Codes

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 The AMA takes applications for new PLA codes quarterly and handles them within several weeks.  For the January 2022 quarter, the submitted ...
Thursday, January 13, 2022

Hearings on the Hill: House, New Med Tech (Dec 8), Senate, Covid Omicron (Jan 11). Bonus: Amy Abernethy Futurism.

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Two interesting Congressional hearings in the past weeks. HOUSE: FUTURE OF BIOMEDICINE On December 8, 2021, House Energy & Commerce held...

Revisiting the Stormy and Controversial Legal Path to "Coverage with Evidence Development"

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On January 11, 2022, CMS released a proposed decision on the class of present and future anti-amyloid Alzheimer drugs, allowing them to be c...
Wednesday, January 12, 2022

CMS NCD Proposal for ADUHELM; Will CMS Cover Larger Registry Trials if "Supported" by NIH?

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On January 11, 2022, CMS released the proposed version of its much-debated NCD on amyloid-directed monoclonal drugs in Alzheimer's disea...
Friday, January 7, 2022

Very Brief Blog: Yes, CMS Does Plan to Revisit "MCIT" Breakthrough Technology Policy

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From August 2020 to December 2021, the Trump then Biden administrations put out successive comment rounds and rulemaking announcements about...
Thursday, January 6, 2022

Very Brief Blog: CMMI Grapples with "Direct Contracting" Messaging

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Very early in the Biden Administration, HHS appointed long time Washington policy expert Liz Fowler as head of the Center for Innovation (CM...

Very Brief Blog: Brookings Report on "Precision Medicine Through Agile Governance"

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New report from Brookings to kick off January 2022, " Advancing precision medicine through agile governance ."  Find it here: http...

Very Brief Blog: Flagging a Great Article by Matthew Holt: Simple Bills Aren't Simple

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Journalist and health policy expert Matthew Holt offers a detailed and well-researched blog on the theme,, "Simple Billing is Not So Si...

Precision Diagnostics for Drug Selection: Context Counts

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In one of my favorite articles of 2021, Adashek et al. pointed out that even with modern expansive genomic testing, most cancer patients do...
Tuesday, January 4, 2022

New Study Documents Medicare Advantage Denial Rates, Causes of Denials

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In the January 2022 issue of Health Affairs, Schwartz et al. study the rate of denials in Medicare Advantage, using Aetna data (most authors...

DEX Z-Codes Contracted to More Medicare Advantage Plans; Announcements on Website

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Diagnostics providers working in the MolDx regions have to track three MolDx-related websites.   Palmetto GBA, the actual MAC, holds the LCD...
Monday, January 3, 2022

Very Brief Blog: Some Notes on Devices, Value Based Purchasing; with a Critical Note

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In December, I had the chance to give a talk for a major device manufacturer on trends in value based purchasing and managed care.   I noted...

Lost in the Holidays: FDA Slow-pedaled COVID Variant Tests Before "Now"

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Possibly lost over the holidays were several important articles on the FDA's handling of COVID variant assays and Omicron, and how we go...