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The test is designed to determine which early-stage, estrogen receptor-positive breast cancer patients are likely to benefit from extended endocrine therapy.
The LCD will enable coverage of Envisia in patients for whom imaging does not lead to a definitive diagnosis of idiopathic pulmonary fibrosis.
The agency said its aim is to analyze the way CMS has chosen to implement PAMA and to estimate the potential financial impact to Medicare as a result of those choices.
The diversity of the organizations that have signed the letter to CMS demonstrates widespread concern over this policy.
The non-coverage decision came despite appeals by the company following a draft non-coverage determination issued last year.
After a GAO report found that CMS may be overpaying for lab tests, the legislator is asking the government payor to explain how it will ensure appropriate use of taxpayer funds.
CMS's move to restrict coverage could limit test access for early-stage cancer patients and negatively impact lab revenues.
Data from the GUIDED study will be central to commercial payor discussions, a Medicare LCD reconsideration request, and eventually expansion into the primary care market.
In a letter to CMS, AMP made a case for crosswalking existing CPT codes for BRCA1/2 testing to codes that more accurately reflect the work required to analyze these genes.
Smaller labs that serve large Medicare populations, such as skilled nursing facility labs, have cut services and expressed concerns about their survival.
New drugs, tests, and policies suggest steady and continued future growth in the space, though public awareness of personalized medicine continues to lag.
The group recommends Myriad Genetics' EndoPredict, NanoString's Prosigna, and Genomic Health's Oncotype DX tests for guiding chemotherapy decisions if certain conditions are met.
A study of the detection of potential adverse drug events or interactions found that using PGx information led to better prediction of serious issues, despite no significant change overall.
HHS Secretary Azar's implementation of PAMA resulted in market-based Medicare prices that don't accurately represent the market, ACLA argues.
ACLA was critical of the report, saying it "fails to reflect market reality" and calling on Congress to intervene to prevent further cuts.
BioReference Laboratories — which is already an in-network lab with Horizon BCBS — said that the preferred lab status includes its GeneDx subsidiary.
The health insurer renewed its longstanding clinical lab services relationship with LabCorp and added Quest as an in-network provider of such services.
The unique, test-specific PLA codes make it easier for insurers to identify tests and apply positive or negative coverage policies, billing experts say.
Newly announced changes will enable more hospital outreach laboratories to submit lab pricing data, but lab groups say more changes are needed.
The decision, issued by Medicare Administrative Contractor Palmetto GBA, is effective Dec. 10 and provides coverage of the test for about 25,000 Medicare patients.