Friday, October 30, 2020

Policy Worth Watching: CMS Announces Diverse Modifications to DME Policies, including CGM

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Earlier this week, CMS released a wide-ranging set of policy modifications to DME policy, ranging from HCPCS code procedures to benefit cate...
Thursday, October 29, 2020

CMS Issues Two Rules: National Healthcare Price Transparency, and COVID Price Transparency

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CMS had two major announcements this week - one, a national rule on price transparency in healthcare payments, and second, a "fourth in...
Wednesday, October 28, 2020

Regarding Diagnostics, How Confused Were Authors of Medicare's Breakthrough Coverage Proposal?

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Nearly two months ago, CMS released a groundbreaking proposal to cover medical devices reviewed under the FDA Breakthrough Pathway for four ...

USPSTF Releases Draft New Report on Colorectal Screening: Comment to November 23

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On October 16, 2020, CMS released a proposed NCD which would allow FDA-approved colorectal cancer screening tests by liquid biopsy on a roll...
Tuesday, October 27, 2020

Very Brief Blog: Exact Sciences to Aquire THRIVE for $2B

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Exact Sciences, whose Cologuard test is the largest single molecular test paid by Medicare in 2019, has been on a roll since October 2014, w...
Monday, October 26, 2020

Very Brief Blog; JAMA Posts Article Series on Sequencing, WGS, Clinical Implementation

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JAMA posts a UCSF new article on the clinical value of sequencing, including whole genome sequencing, and the need for implementation (trans...
Friday, October 23, 2020

MolDx (And Noridian) Finalize Prostate Cancer Tissue Prognostics LCD

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Since May 2020, MOLDX watchers have often been perplexed by the new discrepancies between system-wide MolDx LCDs (in four MACs) and unique m...
Thursday, October 22, 2020

CMS Releases Final Gapfill Pricing for CY2021 Lab Codes

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 Each year, CMS considers all new lab codes in a summer pricing meeting, and CMS sets some quickly by "crosswalk" to an existing p...
Tuesday, October 20, 2020

AMA Releases 4Q2020 PLA Code Applications; Meeting November 5.

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AMA takes PLA code applications every quarter (e.g. circa July 1, circa October 1) and briefly posts them for public inspection a couple wee...
Saturday, October 17, 2020

My Video About the New CMS Colorectal Liquid Biopsy NCD

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Here's my video and deck about Medicare's October 16, 2020, announcement of an all-new approach to covering future liquid biopsy tes...
Friday, October 16, 2020

CMS Posts Administrator's Ruling That Creates $75 and $100 Tiers for COVID testing

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On Thursday, October 15, CMS announced it would drop the price of COVID high throughput testing from $100 to $75, at the same time, that it ...

CMS sets up coverage for FDA colon cancer screening LBx tests - but proposes Epi proColon falls short

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The Epigenomics Epi proColon test was the first liquid biopsy test to receive FDA approval, in April 2016 ( here ).  The test detects epigen...

CMS Oddity: CMS Issues Notice, No National Decision, Only LCD's, for ALLOMAP test.

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CareDx is one of the leading genomics companies, with a market cap today of $2.5B ( here ).  Their pioneering product, covered by CMS since...

Very, Very Nerdy Note: CMS Again Updates Proposed CLFS Prices for CY2021 (V4)

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  CMS holds public meetings each summer to price 100+ new lab codes for the coming calendar year.  CMS released proposed prices about Septem...
Thursday, October 15, 2020

CMS to Reprice COVID Testing: $75 for Slow High Throughput, $100 for Fast High Throughput

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UPDATE: CMS POSTS THE ACTUAL NEW "R2" RULING, EFFECTIVE DATE AS 1/1/2021:  https://www.cms.gov/files/document/cms-ruling-2020-1-r2...