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.
Proficiency testing providers told CMS last year that an update to the rule, which has not been changed since 1992, is long overdue.
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.
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.
CMS says fee hike would bring in $62.1 million, an amount necessary to maintain critical regulatory functions of the CLIA program into fiscal year 2022.
Smaller labs that serve large Medicare populations, such as skilled nursing facility labs, have cut services and expressed concerns about their survival.
The firm has struggled in the past to convince payors of its test's clinical utility but remains dedicated to convincing the field that Epi proColon can help patients by closing CRC screening gaps.
New drugs, tests, and policies suggest steady and continued future growth in the space, though public awareness of personalized medicine continues to lag.