Under a collaboration with GeneDx, Boston Children's has rapidly sequenced the exomes of 20 NICU babies and have arrived at a likely diagnosis in around 85 percent.
As payors increase controls over reimbursements for genetic lab testing, labs are increasingly using genetic counselors as middlemen in lab test reimbursements, genetic counselors say.
The lawsuits were filed after the HHS OIG subpoenaed the firm as part of an investigation into how it billed Medicare and Medicaid for the myRisk test.
A private payor survey by ClearView Healthcare Partners found that medical directors viewed CMS's decision with caution; half had no plans to align commercial plan coverage.
The policy states that lab tests without FDA's blessing may pursue local coverage via Medicare contractors, but national coverage requires premarket approval or clearance.
The final determination also adds coverage for FDA-approved tests in stage III patients, and for repeat testing if patients receive a new primary diagnosis.
The lab industry's appeal to CMS follows Missouri's Medicaid agency's reduction of lab reimbursements from 100 percent to 80 percent of Medicare rates.
These lobbying efforts aim to shore up willingness among legislators to step in and halt implementation of the NCD if certain provisions remain in the final version.
Interpace said that its two thyroid tests are now covered for over 280 million patients nationwide including Medicare, Medicare Advantage, and national and regional health plans.
A perspective that hasn't gotten as much attention is that the CMS draft coverage decision could be bad for patients by increasing off-label drug use based on the results of NGS panels.
The OIG recommends that CMS direct Medicare contractors to recover the improper payments from providers and strengthen system edits to prevent further improper payments.
An assessment concluded that Oncotype Dx has not demonstrated a significant enough impact on outcomes or cost effectiveness compared to current practice.
