Concerns About NGS Coverage Resonate with CMS

On October 29, CMS released a proposed coverage policy for the next generation sequencing (NGS) of breast and ovarian cancers. Several of its coverage provisions follow ASCP’s advocacy recommendations to the Agency on NGS coverage policy.

The proposed coverage memo would extend Medicare coverage for NGS testing of patients with clinical indications and risk factors for germline breast or ovarian cancers. Earlier this year, ASCP raised concern about CMS’s policy of only covering NGS services in cases of advanced cancers, which it defined as Stage III and IV. ASCP advocated that Medicare should cover Stage I and II cancers as well. In addition, ASCP has urged CMS to revise its policies to allow coverage of laboratory developed NGS testing services developed in compliance with the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

CMS has adopted both of these ASCP recommendations into this proposed coverage policy. In it, CMS would require that NGS tests for breast or ovarian cancer must be cleared or approved by the Food and Drug Administration (FDA). That said, CMS also included provisions that would allow Medicare Administrative Contractors (MACs) to provide coverage for diagnostic NGS testing 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. As a result, MACs would be able to extend Medicare coverage for laboratory developed NGS for germline cancers, with the exception of breast or ovarian cancers.

ASCP will be submitting formal comments in response to the proposed coverage policy prior to its 30 comment deadline. Those interested in submitting comments to CMS on its coverage policy may do so here.

Other articles in the November 2019 ePolicy News:

• ASCP and the BOC Advocate for Better CLIA Personnel Standards
• ASCP Scores Major Victory with CMS on Laboratory Date of Service Policy
• Medicare Physician Fee Schedule Rule Mixed, But Trouble Lies Ahead
• ASCP Pushes CMS to Improve PFS QPP Rule for Pathologists
• ASCP Continues Patient Advocacy Efforts on Surprise Billing Legislation
• CMS Fails to Close Pathology Loophole in Self-Referral Rules

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.