Tuesday, November 30, 2021

Very Brief Blog: Telepharmacy regulations proposed; relationship to "tele-laboratory"

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 We hear a great deal in the laboratory field about telemedicine and its impact on channels and processes for laboratory testing.    Just fo...

Very Brief Blog: Authors at FIRST DATABANK review FDA PGx Resources

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 See a new article in MedCityNews, by Christine Cheng, highlighting FDA and other resources for the uses and effectiveness of pharmacogeneti...

Very Brief Blog: CMS Publishes Transmittals for PFS CY2022 Final Rule

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 CMS published its physician fee schedule and hospital outpatient annual rules back around November 1, effective CY2022.   CMS has published...

Very Brief Blog: Q1 Diagnostics Hosts Boston Conference, December 6-7, 2021 (Plus notes on PMC and TriCon)

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We've had two years of mostly canceled conferences, or live conferences converted to Zoom-only events.    Here's an annual live meet...
Wednesday, November 24, 2021

First Look: CMS Payments for COVID Tests in CY2020

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On November 23, 2021, CMS released payment files for CY2020 for Part B services, by CPT code.  See my blog here . I've pulled out the CO...
Tuesday, November 23, 2021

CMS Publishes National Data File for Part B CY2020

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Every fall CMS publishes Part B utilization data, by CPT code, for the prior year, on this page: https://www.cms.gov/Research-Statistics-Dat...

CMS Publishes Final Decisions on New Lab Codes for CY2022

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Each summer, CMS has public meetings on how to price new lab codes.  CMS publishes proposed prices in September and final prices in November...
Friday, November 19, 2021

Rarity: Federal Register Mishandles CMS Physician Fee Schedule Final Rule

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Here's extreme Medicare nerdism, but it's one I've never seen before.   CMS released a "typescript" or "inspectio...

AMA Posts Webpage for February Meeting; Early Rapid Comment on Lab Codes is Open

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Three times a year, AMA opens a new webpage for the upcoming CPT meeting.  AMA has just opened the webpage for  For any meeting, check this ...

Stanford Biodesign Hosts Deep-Dive AMA CPT Webinar; And Another on FDA & Innovation

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Not brand new, but new to me, on September 27, 2021, Stanford Biodesign hosted a webinar with several AMA CPT executives on the present and...
Wednesday, November 17, 2021

Very Brief Blog: "Bridging the Gap" - Regulatory Affairs, Reimbursement, Product Life Cycle - Focus on Digital Pathology

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There have been a number of interesting lab industry policy articles originating from, or associated with, MGH in the last few months.  See ...
Tuesday, November 16, 2021

HHS Legally Withdraws Policy Keeping FDA Away from LDTs; and FDA EUA Updates

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In August 2020, the Trump administration issued a policy restricting FDA from reviewing LDTs.   (The August policy was based in part in a le...

21st Century Cures Version 2.0 Legislative Draft Released; Includes Reboot of "MCIT" Section 404

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After a year of discussion, and the circulation of draft versions, they've released a legislative draft of 21st Century Cures version 2....
Friday, November 12, 2021

MCIT Final Rule Includes Odd Treatment of "Diagnostic Tests"

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Today CMS issued a rule permanently canceling the MCIT program for breakthrough devices.  I wrote an adjacent blog about this - here . There...

Medicare Officially Cancels "MCIT" Rule

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 On November 12, 2021, CMS officially and finally announced it was *canceling* the "MCIT" rule, which had been finalized in the cl...