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FORCE advocates for families facing hereditary breast and ovarian cancer in areas such as access to care, research funding, insurance, and privacy.

Advocacy > Issues > FORCE Fights for Medicare Coverage of Genetic Testing


Newsflash

11/1/2019 - FORCE, along with hundreds of medical and patient advocacy orgs, expressed support for a long-term reauthorization of PCORI.

10/28/2019 - We authored comments on the FDA's draft industry guidance on developing drugs for the treatment of male breast cancer.

9/27/2019 - FORCE and two dozen groups urged CMS to reconsider the 14-day Rule, which has created delays in patients receiving test results.

9/24/2019 - Signed onto a letter urging the President to waive out-of-pocket costs for seniors on Medicare who have precancerous polyps removed during a screening colonoscopy.

9/3/2019 - We joined over 50 orgs representing patients, advocates, caregivers, researchers, and physicians to support the appointment of Norman Sharpless as FDA Commissioner.

FORCE Fights for Medicare Coverage of Genetic Testing

Genetic Testing & Counseling

Overview

December 2019 - FORCE is fighting a proposed Medicare policy that essentially eliminates access to genetic testing for hereditary breast and ovarian cancer mutations. The proposal would permit Medicare Area Contractors (MACs) to develop genetic test coverage policies for Medicare beneficiaries with a cancer diagnosis other than breast or ovarian cancer and clinical indications or risk factors for inherited cancer. On November 26, numerous organizations joined us in submitting comments urging substantive changes to the policy.

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 January 2019, 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 groups explaining why this interpretation of the NCD is faulty. A press statement further elucidated the issue.

In February 2019, FORCE organized a group of 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.

The following month, 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." This was followed by public remarks from CMS leadership, indicating that they intended to revisit the policy in light of the community's concerns.

CMS ultimately opened the policy for reconsideration and in May 2019, over two dozen organizations joined FORCE in submitting comments outlining concerns and urging changes. Unfortunately, the resulting proposal falls significantly short of providing reasonable and necessary care.

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...

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