CMS Should Expand NGS Coverage, ASCP Urges

ASCP urged the Centers for Medicare and Medicaid Services (CMS) to expand its coverage policies for Next Generation Sequencing (NGS) testing for breast and ovarian cancers. The proposal would provide national coverage for Food and Drug Administration (FDA)-approved or -cleared tests, provided the patient had clinical indications and risk factors for these cancers. CMS also proposed to allow Medicare Administrative Contractors (MACs) to provide coverage for NGS laboratory developed tests (LDTs) provided the patient has: (1) a cancer diagnosis other than breast or ovarian cancer; (2) clinical indications for germline testing; (3) risk factors for germline cancer other than inherited breast or ovarian cancer; and (4) has not previously been testing using NGS.

In a letter to the Agency, ASCP noted that for all practical purposes, the proposed coverage policy fails to cover germline breast and ovarian cancers, since the FDA has yet to clear or approve any such tests and the Agency would block local MACs from providing coverage for NGS LDTs for these cancers. ASCP urged CMS to change the policy to allow MACs to provide coverage for NGS LDTs for ovarian and breast cancer.

In addition, ASCP urged CMS to allow testing of individuals who are at high risk of developing breast and ovarian germline cancers. ASCP also opposed CMS’s proposal to limit NGS testing to one covered service per lifetime as this could preclude coverage for individuals who have previously had cancer or who develop subsequently develop cancer. For a copy of ASCP’s letter, click here.

Other articles in the January 2020 ePolicy News:

Congress Delivers Key Legislative Victory
ASCP Calls for Elimination of Stark Pathology Exemption
ASCP Supports Opioid Workforce Act

To read more articles from ePolicy News click here.

For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202) 408-1110.