A new coverage determination will prevent Medicare patients with certain cancers from accessing genetic testing, a move that advocates and testing companies say will severely limit early interventions and preventive care.
Medicare Administrative Contractors (MACs) for the Centers for Medicare & Medicaid Services finalized a decision on Jan. 9 not to cover nine genetic tests for cancer. The Local Coverage Determination was slated to take effect Feb. 23 but has been pushed to April 24 without explanation by Novitas Solutions, which manages two regions for CMS.
“We are disappointed by a finalized LCD that misunderstands the science of biomarker discovery and diagnostic test development in the context of the standard of care in urology,” said Pacific Edge chief executive Peter Meintjes. “We do not understand its framing of Cxbladder as a screening test of asymptomatic patients and the failure to acknowledge the views of the American Urological Association and the practicing clinicians that derive value from the test.”
Pacific Edge, based in New Zealand, is a global cancer diagnostics company that developed a suite of non-invasive genomic urine tests called Cxbladder to test for bladder cancer. The company’s website notes that bladder cancer has the highest rate of recurrence of all cancers, leading to what it calls the “highest lifetime cost” per patient for cancer. Bladder cancer is the sixth most common cancer among men and the ninth most common cancer overall.
MACs are private health insurance companies that regionally manage claims for Medicare patients. There are seven MACs nationwide, according to CMS.
In September 2023, 45 companies sent a letter to the contractor medical directors for Novitas Solutions Medical Affairs and First Coast Service Options Inc. — the two MACs issuing the coverage decision for “Genetic Testing in Oncology” — calling on the companies not to proceed with the coverage denials in early drafts of the rule.
“We fear that if the LCDs are finalized as drafted, Medicare beneficiaries with cancer will lose access to clinically appropriate genetic testing — and their treatment teams will lose access to critically important tools for diagnosing and managing the Medicare beneficiaries’ conditions,” the letter stated. “Timely access to diagnostics that inform treatment decisions is critical for all patients, especially those with cancer, and we worry that the presumptive non-coverage approach will harm the Medicare beneficiaries to whom we represent or provide care.”
Wey-Wey Kwok, a Center for Medicare Advocacy senior attorney, said coverage denials can be appealed. “Additionally, there is a process for requesting the MAC to reconsider and change the LCD provisions, based on new evidence that could materially affect the LCD’s content or basis.”
The September 2023 letter, though, noted that requests to reconsider a denial “could take a significant amount of time and prevent meaningful access to a test when a beneficiary is in the midst of a cancer diagnosis.” The letter also said there was no way to determine what kind of priority Novitas or First Coast would assign to such requests.
Bladder cancer is not the only cancer affected by the rule. Patients diagnosed with pancreatic, skin and thyroid cancers could lose access to genetic testing.
There is a precedence for overturning an LCD.
In 2023, the MACs decided to end coverage for blood tests to monitor transplant recipients for organ rejection, leading patients to rely on invasive biopsies. After significant pushback from advocates and members of Congress, CMS reversed the proposal. At the time, CMS defended the decision, saying the MACs had become “aware of improper billing and overutilization.”
There are similar efforts to bring attention to the LCD on genetic testing for cancer.
“Every day, thousands of Americans are diagnosed with cancer, the majority of which are seniors,” said Saul Anuzis, the president of the American Association of Senior Citizens. “The decision to end Medicare coverage of cancer tests will prevent doctors from being able to intervene earlier and match their patients with the treatment plans they need. It is disappointing to see middlemen repeatedly interfere in our healthcare and limit access to the innovative testing we deserve.”
