Monday, October 3, 2022

AMA Releases Nine New Final PLA Codes (Effective Jan. 1, 2023)

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Each quarter, AMA releases a new batch of PLA codes.   These were submitted about 90 days before the release date, and, will be "effect...

Tufts Policy Center Releases White Paper on Medicare & Emerging Technologies

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 A major new white paper has been released by the Tufts CEVR - the Center for the Evaluation of Value and Risk in Health.   It's titled ...
Sunday, October 2, 2022

Very Brief Blog: Strange CMS PGX Pricing as Entertaining Video

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I have joked that I thought I could use September's Medicare pricing of 7 pharmacogenetic tests as a simple teaching lesson in how the c...
Friday, September 30, 2022

Very Brief Blog: Obama Speaks at Genomics Conference in San Diego

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 This week, President Obama was a keynote speaker at a genomics conference in San Diego.  He spoke highly supportively of genomics and pre...
Thursday, September 29, 2022

National LASKER Award Goes to Genomics: NIPT

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The LASKER Award is considered one of the most prestigious in medicine, and this year it goes to the development of NIPT testing .  The awa...

FDA Releases Final Guidance on Clinical Decision Support Software, Some Experts Express Shock

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 On September 27, 2022, FDA releases a number of guidances for the device and software industries, including an important guidance on when &...
Wednesday, September 28, 2022

The Quirky World of CMS Pharmacogenetics Pricing (Fall 2022 Price Proposals)

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On Friday evening, September 23, 2022, CMS released some 100 new codes and proposed prices for CY2022, and accepts public comment for 30 day...
Friday, September 23, 2022

CMS Releases Proposed Lab Test Prices for CY2023

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After a series of summer meetings, CMS has released its proposed prices for new lab test codes, to be effective 1/1/2023.   CMS accepts publ...

McKinsey Launches 5-Part Series: The Gathering Storm, US Healthcare

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On September 16, 2022, McKinsey launches the first article in a five-part series, "The Gathering Storm: Uncertain Future of US Healthca...
Wednesday, September 21, 2022

October 12: National Academies Workshop on "Potential of Genomics across Continuum of Precision Health Care"

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On October 12, 2022, National Academies of Science, Engineering, Medicine will host an all day workshop on the topic:  "Realizing the ...
Tuesday, September 20, 2022

Genomeweb Highlights $94M Genetics Fraud Case; See My Very Recent Blog & Video

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In an open access article, Genomeweb highlights a new guilty plea in a $94M genetic testing scheme case. A Ft. Lauderdale lab is highlighted...

AdvaMed Comments to CMS: New Thinking on TCET, on Software Reimbursement

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In the past few weeks, AdvaMed  has published several important examples of policy thought capital for CMS. AdvaMed and TCET First, on Augus...
Sunday, September 18, 2022

JAMA: Cost of Developing Complex Medical Devices $500M

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Sertkaya et al in JAMA Network Open - "Estimated Cost of Developing a Complex Medical Device in the US."  Find it here:  https://j...
Friday, September 16, 2022

New Video: Keeping Up with the Busy "TCET" Scorecard: Innovative Technologies

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 I've put together a 5-minute video that shows the viewer the full spectrum of 2020, 2021, 2022 activities around innovations in Medicar...

UCSF Article Debates Value of Coverage with Evidence Development

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We've seen a flurry of activity about CMS "Coverage with Evidence Development" (see below.)  Here's another entry:  A deta...