FORCE advocates for families facing hereditary breast and ovarian cancer in areas such as access to care, research funding, insurance, and privacy.
March 2019 - A recently implemented Medicare policy will significantly curtail genetic testing for BRCA, Lynch syndrome, and other mutations for cancer survivors who previously had access to these tests. Germline (hereditary) cancer genetic testing for beneficiaries who don’t have "recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer" will no longer be covered. In other words, people who have earlier stage cancer (stage I or II), those who have no evidence of disease or who are “cured” no longer qualify for coverage genetic testing.
On February 19, FORCE organized a group of approximately 20 stakeholders representing patient and health care professional organizations, and met with the leadership of Medicare’s Coverage and Analysis Group (CAG) to discuss application of the National Coverage Determination (NCD) for Next Generation Sequencing (NGS) to hereditary (germline) cancer genetic testing in addition to tumor (somatic) testing. See our blog on the meeting.
On March 7, Medicare published an updated “transmittal” to the Medicare Area Contractors giving the first outward indication that they are seriously contemplating changes to the NCD and/or its interpretation. The document extended the implementation date of the policy for 30 days and went on to state "CMS is sensitive to the concerns of its stakeholders regarding the interpretation of this policy and will work with the MACs to adjust their respective claims processing systems accordingly." The was followed by public remarks from CMS leadership on March 26, indicating that they will revisit the policy in light of the community's concerns.
To provide the background, in late 2017 The Centers for Medicare & Medicaid Services (CMS) issued a “Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer.” We submitted comments in January and the National Coverage Determination (NCD) was finalized in March 2018. All indications were that the policy only applied to genomic tumor (somatic) testing, which is very different from hereditary (germline) testing. However, on November 30, 2018, CMS released a guidance which clarifies the rule, ultimately eliminating coverage of germline tests except in advanced cancer settings where the patient is seeking further treatment. Medicare is comprised of about a dozen local regions managed by the MACs); these tests have historically been covered by local coverage determinations (LCDs). The guidance indicates that the new NCD takes precedence over these local policies.
Restriction of hereditary cancer genetic test coverage to only those Medicare beneficiaries with advanced cancer is short-sighted, and a step backward. We are actively exploring options to get a policy revision or clarification stating that hereditary/germline genetic testing is not included in the NCD.
On January 31, we coordinated a stakeholder letter to Seema Verma, Administrator Centers for Medicare & Medicaid Services, signed by over 60 patient advocacy groups, health professional organizations, labs and other industry explaining why this interpretation of the NCD is faulty. A press statement on the issue was released on February 1.
FORCE supports BRCA counseling and testing for all Medicare beneficiaries who have a known mutation in their family or meet established guidelines for hereditary cancer risk assessment. Beneficiaries without a personal history of cancer have never qualified for coverage of genetic testing under Medicare because the program is very specific about the preventive services it provides. We would like to change this.
FORCE is working to introduce federal legislation that will change the Medicare statutes to allow for BRCA counseling, testing, and related evidence-based preventive and risk-reducing services for anyone who meets national guidelines—survivors and previvors.
Check back frequently for updates on our efforts around this important coverage issue...