Friday, February 1, 2019

Very Brief News Flash: ACLA and 60 Groups Oppose CMS Interpretation That Blocks Germline Testing for Cancer Management

Lead news on February 1, 2019, at the ACLA website:

Over 60 groups sign letter to CMS administrator Seema Verma, asking to halt an "interpretation" of the 2018 CMS NCD that would now act to block germline testing in cancer patients (with stage 1,2 cancers).  This is likely over half of BRCA testing, as breast cancers are usually detected before stage 3 and 4.  However, I think for multiple reasons the NCD is itself clearly ambiguous or, taken as a whole, self-contradictory, and that will eventually surface.  The very fact that it took nine months for this issue to arise suggests the position is hardly clear.

See the ACLA press release here.
See the Collective Sign-On Letter online at AMP, here.

For additional background:

  • March 2018
    • I discussed application to germline testing as a possible, but likely ill-conceived, interpretation of NCD - here.
  • January 2, 2019
    • I noted that MolDx LCDs on germline testing were now, after nine months, being revised to refer readers to the NCD for limits of coverage - here.
  • January 22, 2019
    • Genomeweb publishes an article about growing unrest in the oncology community, here.  I discussed further in blog here.
  • January 31, 2019
    • Washington Analysis Group publishes investor article with headline, "Myriad Genetics (MYGN) & Invitae (NVTA): Medicare Germline BRCA Coverage Halted?" 
  • February 1, 2019
    • Noridian amends its BRCA LCD for its jurisdictions (e.g. mountain states, west coast) - here.  (See also discussion of NCD effective date, here.)

ACLA press release clipped below the break.

The crux of the matter is that, while the NCD could be squinted-at and considered ambiguous (for many reasons, read as a whole, and interpreted to avoid absurdity, I don't think it is ambiguous) November CMS issued a transmittal on the NCD that contains the wholly new sentence, "A diagnostic laboratory test using NGS is non-covered when cancer patients do not have the above-noted indications for cancer under either national or local coverage criteria." And CMS gave this new sentence an effective date retroactive to March 2018, which raises problematic issues under the statutory voluntary repayment law (here).



Reimbursement and Coverage

More than 60 Leading Health Care Organizations Call on CMS to Maintain Coverage for Medically Necessary Cancer Testing

Overly broad interpretation of national coverage determination for next generation sequencing restricts Medicare beneficiary access to vital testing and adversely impacts cancer care
 WASHINGTON, DC – February 1, 2019 – Leading health care companies and organizations representing patients, providers, academic medical centers, laboratories, and diagnostic manufacturers urged the Centers for Medicare and Medicaid Services (CMS) to revise its interpretation of the National Coverage Determination (NCD) for Next Generation Sequencing (NGS). In a letter to CMS Administrator Seema Verma, 63 organizations expressed serious concerns that the overly broad interpretation will restrict patient access to medically necessary and relevant clinical tests and adversely impact cancer care and outcomes.
CMS’ latest guidance directly undermines beneficiaries’ coverage as finalized in last year’s NCD. NGS-based testing is now the standard of care for cancer patients, and the current interpretation implies NGS-based testing will become non-covered for many Medicare beneficiaries. This has a direct result on beneficiaries’ access and coverage to essential testing that can make a fundamental difference in their treatment.
In particular, those with early-stage cancer who may have a genetic predisposition based on family history or other acceptable criteria will not be eligible for testing using NGS-based methods. Restricting patients with early-stage cancers from accessing hereditary testing may lead to poorer outcomes as they are not receiving optimal therapy based on their genetic status.
“It is essential that CMS unequivocally maintain coverage for medically necessary NGS-based tests. Imposing broad restrictions on standard of care testing will have serious consequences for Medicare beneficiaries and negatively impact their care,” said Julie Khani, President of the American Clinical Laboratory Association.
“CMS’ interpretation of the NGS NCD contradicts and reverses previously established policies. The NCD supersedes existing local coverage determinations that provide crucial coverage of NGS-based genetic testing for mutations associated with inherited cancer syndromes—like BRCA mutations and Lynch syndrome—in patients without advanced cancer,” said Sue Friedman, Executive Director of FORCE: Facing Our Risk of Cancer Empowered. “This action will harm patients! We are extremely disappointed that there was never an opportunity for patient advocacy groups to formally comment or discuss the implementation of this policy and frustrated that these medically necessary tests are now not eligible for Medicare coverage.”
“AMP is committed to working with key stakeholders to preserve broad patient access to the thousands of clinically- and analytically-validated NGS-based testing for cancer and other conditions that benefit patients each and every day,” said Mary Steele Williams, Executive Director of Association for Molecular Pathology. “Rather than creating additional barriers, we urge CMS to consider the collective comments from this diverse community of health care organizations and reinstate coverage for these medically necessary hereditary cancer tests. Without precision diagnostics, there is no precision medicine.”
To view the full letter and list of undersigned organizations, please visit

The American Clinical Laboratory Association (ACLA) is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 277,000 people directly and generates over 115,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $100 billion to the nation’s economy. For more information, visit Media contact: Clare Krusing,
About FORCE 
No one should have to face hereditary breast, ovarian and related cancers alone. Facing Our Risk of Cancer Empowered (FORCE) is the voice of the hereditary cancer community, providing support, education and awareness to help those facing hereditary breast, ovarian and related cancers know their healthcare options and make informed decisions. The organization is the de facto leader in guiding critical research and policy issues that impact the hereditary cancer community. For more information about FORCE and hereditary cancers, please visit Media contact: Lisa Schlager,

The Association for Molecular Pathology (AMP) was founded in 1995 to provide structure and leadership to the emerging field of molecular diagnostics. AMP’s 2,500+ members practice in the various disciplines of molecular diagnostics, including bioinformatics, infectious diseases, inherited conditions, and oncology. They include individuals from academic and community medical centers, government, and industry; including pathologist and doctoral scientist laboratory directors; basic and translational scientists; technologists; and trainees. Through the efforts of its Board of Directors, Committees, Working Groups, and members, AMP is the primary resource for expertise, education, and collaboration in one of the fastest growing fields in healthcare. AMP members influence policy and regulation on the national and international levels, ultimately serving to advance innovation in the field and protect patient access to high quality, appropriate testing. For more information, visit Follow AMP on Twitter: @AMPath. Media contact: Andrew Noble,