FORCE advocates for families facing hereditary breast and ovarian cancer in areas such as access to care, research funding, insurance, and privacy.
May 2019 - FORCE is fighting a new Medicare policy that significantly reduces access to genetic testing for BRCA, Lynch syndrome, and other hereditary cancer mutations. Medicare beneficiaries who don’t have "recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer" no longer qualify for genetic testing. In other words, people who have earlier stage cancers (stage I or II), those who have no evidence of disease or who are “cured” are not eligible for genetic test coverage. Medicare recently agreed to reconsider the policy in response to our concerns. Over two dozen other organizations joined FORCE in submitting extensive comments urging changes to the policy.
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 2018 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 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 Medicare Area Contractors (MACs); these tests have historically been covered by local coverage determinations (LCDs). National policies take precedence over local policies.
In late January, we coordinated a stakeholder letter to Seema Verma, Administrator of CMS, 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.
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 NCD for Next Generation Sequencing (NGS) to hereditary cancer genetic testing in addition to tumor (somatic) testing. See our blog on the meeting.
In early March, Medicare published an updated “transmittal” to the MACs giving the first outward indication that they were 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 intended to revisit the policy in light of the community's concerns.
Restriction of hereditary cancer genetic test coverage to only those Medicare beneficiaries with advanced cancer is short-sighted, and a step backward. FORCE supports germline 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 aimed at changing the Medicare statutes to allow for genetic 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...