Payors' demands for clinical utility evidence can be met through greater use of databases and registries, Harold Varmus and Rebecca Eisenberg said.
The government payor made some adjustments in finalizing the 2018 clinical lab fee schedule, but the industry continues to feel CMS is ignoring its most salient concerns.
The agency is excluding certain advanced diagnostic lab tests and molecular pathology tests from a billing regulation that created administrative headaches for many labs.
Anthem said the automated system is an efficient way to ensure coverage for medically necessary genetic tests, but that's not what genetic counselors have described.
Smaller labs, hospital outreach labs, and labs servicing high numbers of elderly are thought to face the highest risks.
Piper Jaffray analyst William Quirk said the pricing, which was much higher than expected, will help push CareDx toward profitability.
The biggest losers following the release of the preliminary PAMA rates may be Quest and LabCorp, analysts said today.
The government payor proposed rates that would reduce payment by $670 million, though CMS previously estimated a $390 million cut in 2018.
The study is part of an effort to drive health plan coverage for Exosome's ExoDx Prostate IntelliScore prostate cancer test.
Since last year the AMA has issued 23 PLA codes for firms that want to better track use of their tests, but the effect of the codes on improving reimbursement remains to be seen.
BUPA Global and other private health insurers have approved reimbursement for OncoDNA's test, which is intended to provide a complete genetic profile of a patient's tumor.
The final LCD covers AlloSure in renal allograft recipients who have a probability of active renal allograft rejection.
The partners will collaborate on clinical studies aimed at driving health plan coverage for molecular diagnostic products.
The genomic test is designed to help doctors decide which patients are at low enough risk that they can be more conservatively managed.
Payors say online, automated systems will bring standardization and efficiency to prior authorizations, but doctors and labs are uncertain about the impact on patient care.
Once these coverage decisions are fully implemented, 90 percent of breast cancer patients will have coverage for EndoPredict, Myriad estimated.
The program, called Genetic Testing Solution, went into effect July 1 among Anthem Blue Cross' fully-insured and self-insured members.
Interpace Diagnostics said that the test will now be covered for Cigna's roughly 15 million members nationwide.
The company announced positive coverage decisions from Palmetto GBA, 14 BCBS plans, and Aetna.
Starting Oct. 1, the insurer will require clinicians and labs who order genetic and molecular tests for their patients to first get approval.
Researchers have sequenced the northern white rhinoceros to gauge whether it could be brought back from the edge of extinction, the New York Times reports.
Bavaria expands its forensic genetic analyses to include DNA phenotyping, raising discrimination concerns.
Tufts University researchers found a role for miRNA in transmitting stress between generations, the Economist reports.
In Science this week: gut microbiome influences liver cancer growth, spread; and more.