AACC and more than 60 other medical societies, patient advocacy groups, and laboratories are calling on the Centers for Medicare and Medicaid Services (CMS) to change its interpretation of which next-generation sequencing (NGS) tests Medicare will cover and ensure that all medically necessary testing is accessible to patients.
Many in the field supported the initial coverage policy CMS adopted in March 2018 that clarified how Medicare would cover the cost of NGS testing for advanced cancer. However, laboratories discovered that even though the national coverage determination (NCD) was aimed at somatic-based NGS tests, CMS instructed Medicare Administrative Contractors to apply the terms of the NCD to both somatic and germline testing.
“The implication of this interpretation is both germline and somatic tumor NGS-based testing will become noncovered for Medicare beneficiaries with early-stage cancer,” the groups wrote in a letter to CMS administrator Seema Verma. “Our organizations believe that the inclusion of NGS-based testing for germline mutations represents significant policy overreach by CMS that will have unintended consequences on the care delivered to Medicare beneficiaries, particularly those who may have a genetic predisposition to cancer based on a family history or other relevant criteria.”
The groups contend that the new interpretation “contradicts and reverses” previous policies that have provided coverage for NGS-based testing for hereditary breast and ovarian cancer syndromes and Lynch syndrome in patients who do not have advanced cancer. In addition, CMS provided no notice and comment period on this policy change. “If the agency continues to proceed with this problematic interpretation that expands the NCD to germline testing for patients with cancer, patients with early- stage cancer will receive suboptimum care,” the groups wrote.
Federal Task Force Calls for Better Use of Urine Drug Testing
A draft report from a federal pain management task force underscores the need for clinical laboratorians’ expertise and guidance to help clinicians utilize urine drug testing (UDT) consistently and properly. The Pain Management Best Practices Inter-Agency Task Force was created by the Comprehensive Addiction and Recovery Act, which President Obama signed into law in 2016. This advisory committee’s mandate includes proposing updates to best practices and recommending ways to address gaps in care.
Among the many issues in pain management the task force’s first report deals with is the use of UDT. The report notes that UDT provides information about drug use that may not be reported by a patient and potentially informs treatment.
However, the report emphasizes that a systematic review by the Agency for Healthcare Research and Quality found a lack of evidence demonstrating the effectiveness of UDTs for risk mitigation during opioid prescribing for pain. The report also remarks that clinicians can misinterpret UDT results and harm patients through stigmatization or inappropriate termination from care.
In addition, the report finds that clinicians use UDT inconsistently in part because they don’t have the time to explain UDT testing or order confirmatory testing and don’t feel confident interpreting and acting on results.
To deal with the gaps in care related to UDT, the report calls for better compensation for time and payment for services to implement UDT and other screening measures. The document also calls on clinicians to consistently use appropriate UDT for risk assessment prior to starting opioid therapy and as a tool to re-evaluate risk.