Tuesday, September 22, 2020

CMS Releases Proposed Prices for Clin Lab Fee Schedule CY2021 - Public Comment Open

›
CMS has posted Preliminary Payment Determinations for the CY2021 Clinical Lab Fee Schedule on its website .  I've also placed a cloud co...
Monday, September 21, 2020

Very Brief Blog: Next PLA Deadline October

›
  PLA codes continue to grow - numbers up to have been assigned, and another couple dozen codes will be released at the end of September.   ...

Tiny Handheld from Silicon Valley Startup gets EUA for COVID PCR

›
A Silicon Valley startup that I had the chance to give some early advice to, a Stanford spinout, has won EUA for a tiny COVID PCR advice. Se...
Sunday, September 20, 2020

Palmetto Rebrands DEX (TM) Diagnostics Exchange as "PALMETTO" Entity; Palmetto Letter re Pricing File

›
 I spend a lot of time on the MolDx and the DEX (TM) Diagnostics Exchange websites, and around Sunday, August 16, I noted that MolDx had pos...
Friday, September 18, 2020

After Five Months, MOLDX Authorizes Use of PGDx ELIO IVD Cancer Assay

›
Personal Genome Diagnostics (PGDx) got FDA clearance for its multi-hundred gene elio test in late April, 2020 - here .   Styled as clearance...

Digital Health Applications: Debates Similar to the "LDT" Debate in Labs; Nature Digital Medicine Journal

›
Part of my work is in digital health, and that community of companies has debates about FDA regulation of digital health, similar to the dia...
Thursday, September 17, 2020

Seema Verma Makes Somewhat Vague Remarks on COVID test reimbursement

›
 As first reported in a subscription article at Inside Health Policy, and as summarized open access by McKnights...  Seema Verma made some r...

Medicare Releases Claims Processing Instructions for New 2020 NCD for Germline NGS in Cancer

›
Early in 2020, CMS released a major update to its NCD for uses of NGS testing in cancer patients.  The update focused on new rules and cover...
Wednesday, September 16, 2020

Very Nerdy Note: CMS Releases State Part B Carrier Data File

›
 Each summer and fall, CMS releases three forms of Part B data. (1)  Carrier (State) Data File CMS releases a data file for each MAC subzone...

MolDx Reprices Myriad Genesight Test at Lower Price of $1568

›
This summer, MolDx retired special coverage of the Myriad Genesight test (a psychiatric drug gene panel with algorithm), and announced the t...
Friday, September 11, 2020

MEDPAC discusses PAMA, Growth in Molecular Pathology Spending

›
Just a few weeks ago, the OIG issued its annual report on PAMA and lab test spending at CMS - see report here , see blog here .  While the m...