Friday, July 29, 2016

RockHealth's Report on Digital Biomarkers in Healthcare

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RockHealth is a San Francisco based organization that funds and supports innovative ventures in digital health.  (For their portfolio of 60 ...
Thursday, July 28, 2016

FDA Panel Supports Landmark CGM Indication for Insulin Management; Medicare Needs to Change

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For years, Medicare has held a bizarre position that continuous glucose meters (CGM) are not covered because they are "precautionary...

FDA Issues Two Guidances on Real World Evidence; NEJM Article

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Better use of pragmatic and real world evidence is critical for health care delivery.   While the gold standard for effectiveness is held to...
Tuesday, July 26, 2016

Aetna's Mike Kolodziej MD: Flatiron's National Medical Director

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Update:  MK moved to the ADVI Consultancy in October 2017 . For info on the 2018 acquisition of Flatiron by Roche, here . ___ Press rel...

Germline Genetic Testing: Evidence and Accuracy

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Two articles in the June 2016 issue of the American Journal of Human Genetics address evidence and accuracy for germline sequencing. The f...

Transcript for Medicare's July 18 2016 CLFS Public Meeting

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In the cloud, find a 77 page transcript of Medicare's July 18, 2016 all-day public workshop on pricing new CPT codes for 2017... here . ...
Monday, July 25, 2016

Commercialization of Molecular Diagnostics: NextGenDX Conference in DC, August 24-25

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The multi-track Next Generation Diagnostics Conference is holdings its eighth annual event in Washington, August 23-26, 2016.   The conferen...
Thursday, July 21, 2016

Real World Evidence, Bipartisan Policy, and the FDA

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In June 2016, the Regulatory Focus newsletter at RAPS published an article, "New Report Calls on FDA to Clarify Use of Real World Evide...

A Very Brief History of Pricing By Indication

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After running into several white papers on Pricing By Indication (PBI), and recalling a 2014 article in JAMA by Peter Bach on the topic, I p...
Wednesday, July 20, 2016

CMS July 2018 CLFS Crosswalk/Gapfill Meeting: Powerpoint Files

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On July 18, 2016, CMS held the annual summer "crosswalk/gapfill" meeting for new AMC CPT codes to be used in CY2017.   CMS post...
Tuesday, July 19, 2016

PAMA Lab Panel Member Makes Gross Error; Nobody Corrects Him

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On July 18, 2016, CMS held its annual meeting on policy for the Clinical Laboratory Fee Schedule, paired with an annual meeting of the Clini...
Friday, July 15, 2016

CMS Proposes Pre-Diabetic Preventive Benefit - Raises Concern about Dhealth Delivery of DPP

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Last March, CMS announced successful program metrics for a pilot diabetes prevention program (DPP) targeted to patients meeting prediabeti...
Thursday, July 14, 2016

CMS Posts Agenda for Annual Lab Policy Meeting (Monday, July 18).

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CMS posts the agenda for the annual laboratory policy meeting.  PDF is online at CMS, here .  I have also clipped the text of the PDF below ...
Friday, July 8, 2016

CMS Releases CY2017 Proposed Physician Fee Schedule Rule: Start Hearing about PAMA 220

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On Friday, July 8, CMS released the Proposed Physician Fee Schedule Rule for CY2017. The CMS website for the rule, and its extensive attac...
Thursday, July 7, 2016

CMS Releases CY2017 Proposed Outpatient Rulemaking: Implementing New Law for Hospital Place of Service

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Each summer, around July 1, CMS releases hundreds of pages of proposed policy updates, separately for hospital outpatient services and for p...