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...
Wednesday, October 28, 2015

Sudden Change Can Happen: Legislation on Medicare's Outpatient Location Payments

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Often change at Medicare - whether within the agency or from the Hill - appears to come very slowly.  This week was an example of an unexpe...
Tuesday, October 27, 2015

AMA and Coalition Support Enhanced CLIA

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On October 27, 2015, the American College of Medical Genetics issued a press release that it had joined AMA and a broader coalition in suppo...

FDA and Theranos: FDA Promised Tougher Enforcement when LDTs are DTC

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As is well known in the laboratory and FDA policy communities, the FDA has generally let laboratory developed tests (LDTs) operate under ...

FDA's Updated October 2015 Documents on 23andMe: Class II Without 510(k)

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In February 2015, the FDA announced not only that it would allow 23andMe's DTC carrier screening tests to begin moving forward, but that...
Tuesday, October 20, 2015

Version 2 of the Diagnostic Test Working Group Proposal is Circulating

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According to the subscription trade journal Inside Health Policy, the Diagnostic Test Working Group (DTWG) is circulating a revised version ...

Medicare Posts Video of October 19, 2015 Diagnostics Advisory Board

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CMS has posted the morning an afternoon sessions of the October 19, 2015 CLFS advisory panel online.  Links at: Morning (3h30min):   here ....
Wednesday, October 14, 2015

My Talk at PMC/BIO Solution Summit for Personalized Medicine (October 14, 2015)

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On October 14, 2015, I had the privilege of being invited to give the morning keynote address at the 2nd Annual Personalized Medicine Soluti...
Wednesday, October 7, 2015

CMS Updates 2015 Gapfill Spreadsheet: Oncotype DX Now $3416 not $2900

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On September 25, CMS released a spreadsheet of final CY2015 gapfill prices from its MACs, which listed Oncotype DX Breast at a price (beginn...
Saturday, October 3, 2015

Keeping Track of CMS Comment Periods for Labs and for MACRA

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CMS currently has four comment periods open, one on 2015 gapfill, one on 2016 proposed gapfill/crosswalks, one on PAMA rulemaking, and one o...

More CMS MAC Contractors Publish Next-Gen Sequencing LCDs for Lung Cancer

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On Thursday, September 30, two Medicare MAC contractors issued proposed LCDs for the field on next generation sequencing in oncology.  See a...
Friday, October 2, 2015

Medicare to Hold Extra Clin Lab Advisory Panel: October 19, 2015

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Medicare will hold a second meeting of its new Clinical Laboratory advisory panel on October 19, 2015.  Register to attend in person before ...
Monday, September 28, 2015

Genomeweb posts detailed article on competing LDT regulation proposals

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For those with access to the trade journal Genomweb, on September 28, 2015, that site published a detailed discussion of competing proposals...