ACLA Outlines Key Changes Required to Protect Beneficiaries’ Access to Cancer Testing

December 03, 2019 Categories: Comments and Letters, Featured News, ACLA Press Releases

WASHINGTON, D.C. – Recent proposals from the Centers for Medicare & Medicaid Services (CMS) would have widespread, detrimental consequences on cancer care for millions of Medicare beneficiaries, specifically for patients with a genetic predisposition for breast and ovarian cancer. In new comments submitted to the agency, the American Clinical Laboratory Association (ACLA) called on CMS to remove barriers to coverage of germline tests using NGS technology – now the standard of care for cancer patients – and to ensure those with early-stage cancers can access the tests that will directly benefit their health.

Earlier this year, ACLA and more than 60 other leading health care organizations called on CMS to reverse initial guidance that would have imposed significant restrictions on NGS-based testing. In response, CMS has opened a reconsideration of the NCD and opened a comment period on a proposed decision memo requesting additional stakeholder feedback on how best to address a number of Medicare policy provisions moving forward.

“Restricting access to vital, ground-breaking clinical testing for cancer care will undermine the tremendous progress that we have made to improve the health and lives of millions of Americans,” Julie Khani, ACLA President, said. “It’s imperative CMS ensures that providers, seniors and their families have the clinical tools, including NGS-based testing, that are necessary to intervene early and prevent the progression of cancer in the future.”

As part of its formal response to the proposed decision memo, ACLA reiterated its support for national Medicare coverage of germline tests using NGS technology. Key highlights from the letter are included below:

  • “We are concerned that CMS’s proposed coverage decision would be detrimental to Medicare beneficiaries’ access to precision diagnostics to guide cancer treatments.”
  • “CMS should nationally cover a hereditary breast and ovarian cancer test using NGS technology, whether the test is a laboratory-developed test (LDT) or has been cleared or approved by the Food and Drug Administration (FDA).”
  • “Medicare Administrative Contractors (MACs) should retain discretion to cover a germline test using NGS technology or another technology platform when the test is performed in a CLIA-certified laboratory, the test is ordered by a treating physician, and the patient is seeking treatment and weighing medical management options based on germline mutation status.”
  • “CMS should remove overly-broad language in the NCD on coverage for a test using NGS in a beneficiary who was ‘previously tested using NGS.’ Proposed language describing national coverage for hereditary breast and ovarian tests using NGS technology and MAC discretion to cover other germline tests states that the patient must not have ‘been previously tested using NGS.’ Yet it is not uncommon for germline-tested patients already to have undergone somatic NGS testing, and different germline tests may cover different sets of genes. The NCD’s language would have the effect of limiting Medicare coverage for medically necessary laboratory testing in a number of circumstances.”

CMS is expected to finalize the national coverage determination by the end of January 2020.

To read the ACLA’s full comments, click here.

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