Wednesday, November 18, 2015

CMS Quality Measures and PSA Testing

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On an obscure webpage, CMS issued a request for public comment for a physician performance metric that would financially penalize physicians...

House Hearings on FDA LDT Regulation: Key Quotes, Video, Detailed Notes

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The House has posted a two hour, twenty minute video on the November 17, 2015 hearing, "Examining the Regulation of Diagnostic Tests an...
Tuesday, November 17, 2015

CMS Locks Down Final Crosswalks for New CY2016 Codes; Others in Gapfill; Drug Testing Finalized

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On November 17, 2015, CMS released final decisions on how it will handle new laboratory codes for January, 2016.  As has been discussed in s...

CMS Finalizes CY2015 Gapfill Prices

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CMS has released final decisions on the CY2015 gapfill process, that is, for codes that were new in January 2015.   There was a stir in Sept...
Monday, November 16, 2015

FDA Tells World (And Hill) It Needs to Regulate LDTs

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On November 16, 2015, the FDA released a detailed white paper on why LDTs need to be more stringently regulated. The FDA Blog introduces t...

30 Slide Deck on PAMA - the New Lab Test Pricing Law

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In October, BIO invited me to provide a webinar on PAMA, the law that will eventually create a new pricing system for laboratory tests in 20...

Yes, Virginia, MolDX is really coming to J15 (OH/KY)

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In mid August, Noridian announced that MolDX would expand to Jurisdiction F - the northwestern and mountain states (my blog here ). At tha...
Friday, November 13, 2015

My Interview on Mendelspod

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I've enjoyed the genomics podcast Mendelspod for a couple years.  It was a special treat to be interviewed by Theral Timpson for a podca...
Wednesday, November 11, 2015

PAMA CLFS COMMENTS: DUE NOV 24; EARLY RETURNS

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[UPDATE: SEE THE UPDATED DECEMBER 16 BLOG  WRITTEN AFTER THE CLOSE OF THE COMMENT PERIOD: HERE .] November 12, 2015: Medicare issued...
Tuesday, November 10, 2015

New Flurry of Letters to LDT Labs: FDA Found You!

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November opens with the FDA sending letters to at least three LDT labs, DNA4Life, DNA CardioCheck, and Interleukin Genetics, in Alabama, Ill...
Sunday, November 8, 2015

Much Interest in CMS Reform of Physician Incentive Metrics ("MIPS" regulations)

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Last spring, Congress repealed the longstanding SGR policy for the CMS Part B physician fee schedule.  The legislation also set in motion wh...
Thursday, November 5, 2015

Medicare Releases CY2014 Utilization of Part B Genomic Tests

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Data on CMS payments for CY2014 genetic CPT codes have been released.  Total payments were about $650M in Part B; about 10% flowed through ...
Saturday, October 31, 2015

House to Hold Hearing on DTWG in November 2015; Posts Legislative Draft

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According to the trade journal Gray Sheet (subscription; here ), on November 17, 2015, the House will hold a hearing on a legislative reform...

Medicare OPPS Rule: Complex Handling of Protein and DNA/RNA MAAA Tests

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On October 30, CMS issued its final rule for the hospital outpatient, or "OPPS," fee schedule for CY2016.  (Full listing here ). ...

Medicare Publishes OPPS, PFS Final Rules (October 30, 2015)

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On October 30, 2015, Medicare published "final rules with comment" for both the OPPS and PFS payment systems.   OPPS, PFS, Medicai...