Wednesday, May 27, 2015

NEJM Publishes Six Papers on Genomic Testing (May 27, 2015)

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On May 25, 2015, the New England Journal of Medicine published six policy papers on genomic sequencing applications, policy, and challenges....
Tuesday, May 26, 2015

FDA Continues Down-Classifying Genomic Tests

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Would FDA Overrun LDTs? In 2014, the FDA announced an extensive plan by which it would regulate laboratory-developed tests.   Concerns were...

CMS Releases Draft Gapfill Pricing for 2015 Molecular CPT Codes

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Addendum, September 2015:  May 2015 draft gapfill prices discussed in this blog entry.   Final September 2015 prices discussed here . -...

Growing Awareness that Pathology Policy is Crucial for Precision Oncology

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Over the past several days I noticed a flurry of interesting, potentially connectable policy articles in precision medicine for oncology.   ...
Friday, May 22, 2015

CCLA Federal Lawsuit Against LCDs: Dismissed for Lack of Standing.

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Over the past year, this blog has carried several entries about the California Clinical Lab Association effort to overturn Medicare LCDs as ...

MolDX Finalizes Coverage for Lung Cancer Comprehensive Genomic Profiling (CGP)

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In January 2015, the Medicare MolDX program published a draft coverage determination for comprehensive genomic profiling (CGP) in lung cance...
Thursday, May 21, 2015

CMS issues draft coverage for Genomic Health Oncotype DX Prostate Test

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On May 21, 2015, the Medicare contractor Palmetto GBA released draft coverage for the Oncotype DX Prostate prognostic gene panel test, as pa...
Wednesday, May 20, 2015

Medicare's 0.0023% Budget for Telemedicine - What Does New Legislation Do?

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According to an article in the May 14, 2015 "Inside CMS" trade journal, Medicare spending for telemedicine is currently at $14M - ...

Stem Cell Transplant: CMS Opens NCD Revision; LA Times Criticizes Wild Hype

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An  interesting collision of events in the past month.  Medicare has a longstanding policy for limited coverage of stem cell (bone marrow) t...
Tuesday, May 19, 2015

Medicare Announces MEDCAC on Peripheral Arterial Disease

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On April 27, 2015, Medicare announced the second MEDCAC of 2015: a public workshop on therapies for peripheral vascular disease.  Federal Re...
Thursday, May 14, 2015

Medicare publishes draft coverage for Nanostring Prosigna test

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On May 14, 2015, the Palmetto MolDX contractor published a draft local coverage decision favorable to the Nanostring Prosigna test.  Prosign...

Cancer Letter: MED-C in 10,000 Words

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Cancer Letter, a trade journal edited by Paul Goldberg, has published a cover article on MED-C, a proposed genomic registry to collate genom...

Congress Creates the Ten-Year Medicare Contractor

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A little-commented passage in MACRA - aka the SGR reform passed in April, 2015 - changes Medicare Administrative Contractor durations from a...
Wednesday, May 13, 2015

Congress Puts FDA "Structured Risk Benefit" Aims into Clearer English

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One of the most popular posts on this blog is a 2014 post on FDA and structured risk-benefit.  That post also asks whether there are any les...
Friday, April 24, 2015

PMC 2015 White Paper: How ACOs Impact Personalized Medicine

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In April 2015, the Personalized Medicine Coalition released a new 40-page white paper entitled, "Paying for Personalized Medicine: How ...