CMS to reconsider NGS NCD Common Questions and Helpful Hints - - PowerPoint PPT Presentation

CMS to reconsider NGS NCD

Common Questions and Helpful Hints

Policies within CMS Organizational Structure

CMS CCSQ CAG DPCI DPER EDD DBO QSOG CM HAPG DAS

NCD Consideration and Reconsideration

Formal Complete Request

Tracking Sheet Notification

30 day public comment Proposed Decision 30 day public comment Final Decision

Instructions to Implement

In the absence of a Formal Complete Request

š“To provide a complete picture of the cancer patient, a clinician may order both tests of somatic (cancer) and germline (inherited) mutations. It is important that tests detect these mutations accurately and produce valid results that are useful in guiding therapies to improve

• utcomes for patients with cancer. Therefore, CMS is

internally opening this decision. ”

Public Comment Periods

Solicitation of Public Comments

š Interested in comments that include scientific evidence. š Requested comments that address the breadth of the proposed decision. š Provided questions in an effort to prompt substantive input from stakeholders.

Scope of Proposed Decision

š Patients:

š recurrent, metastatic, or advanced cancer; š not been previously tested using the same NGS test; š decided to seek further cancer treatment.

š NGS Tests:

š FDA-approved š FDA-cleared

š CMS proposes non-coverage of NGS as a diagnostic laboratory test when patients do not have the above-noted indications for cancer or when the test does not meet the above-noted criteria.

Public Comment Periods

Scope of Public Comments

š After reviewing the public comments, the final NCD nationally covers any FDA approved or cleared in vitro companion diagnostic laboratory tests using NGS only for certain patients (at this time there are 4 specific FDA approved companion diagnostic tests using NGS). All other diagnostic lab tests are at contractor discretion

• nly if the patient criteria are met. Contractor

discretion means that Medicare Administrative Contractors will act on behalf of CMS to make reasonable and necessary determinations under section 1862(a)(1)(A) of the Act, so long as specific limitations are satisfied.

Scope of Final Decision

š Patients:

š recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; not been previously tested for the same cancer using the same NGS test; decided to seek further cancer treatment.

š NGS Tests:

š FDA-cleared or approved companion diagnostics.

š Medicare Administrative Contractor discretion of

• ther NGS tests.

š Non-coverage of NGS as a diagnostic laboratory test when patients do not have the above-noted indications for cancer or when the test does not meet the above-noted criteria.

Public Comment Periods

Scope of Tracking Sheet Public Comments Expectations of Proposed Decision

š It is important that tests detect these mutations accurately and produce valid results that are useful in guiding therapies to improve outcomes for patients with cancer. š Specifically, we are only reconsidering the evidence available for tests of germline mutations to identify those with hereditary cancer who may benefit from targeted treatments based on results of the test; all other tests are beyond the scope of this reconsideration. š 82 public comments submitted. š Discussed:

š Patient coverage criteria š Diagnostic test characteristics š Local coverage of MACs š Non-coverage š Implementation and cost

Are the following Comments outside the scope of the NGS NCD Tracking Sheet?

š First, we ask that CMS make clear that "advanced stage..." cancer is the same as "grade" of cancer and that there is no difference for purposes of coverage between stage and grade. š Evidence is building that establishes the value of multiple NGS tests throughout the duration of a patient’s treatment. š Tests for early stage cancer detection, repeated tests for disease monitoring, or new biomarkers, are non-covered and would require a re-opening of the NCD to obtain coverage.

Kim Long Kimberly.Long@cms.hhs.gov 410-786-5702

NCD Consideration and Reconsideration

Tracking Sheet Notification Public Comments Proposed Decision Feedback on Implementation Instructions Final Decision

CMS final CAR-T NCD

Common Questions and Helpful Hints

Final NCD on CAR-T

š The Centers for Medicare & Medicaid Services (CMS) covers autologous treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) and used for a medically accepted indication as defined at Social Security Act section 1861(t)(2) i.e., is used for either an FDA-approved indication (according to the FDA-approved label for that product), or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia. š The use of non-FDA-approved autologous T-cells expressing at least one CAR is non-

• covered. Autologous treatment for cancer with T-cells expressing at least one CAR is non-

covered when the requirements in Section A are not met. š This policy continues coverage for routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310.1.

CMS Reasoning for Final Decision

š CAR T-cell therapies continue to evolve as research and clinical trials are ongoing. š We CMS is finalizing an NCD that provides for uniform national coverage. š We also recognize that there is important ongoing research by scientists and manufacturers and note that the routine costs of clinical trials where CAR T-cell therapy is an investigational agent would be covered per our existing Clinical Trial Policy [NCD 310.1].

Coverage and Analysis Group

DPCI

š Janet Brock š Wanda Belle š Patti Brocato š Linda Gousis

DBO

š Michelle Atkinson š Leah Cromwell š Maria Ellis š John Manlove

DPER

š Lori Ashby š Jim Rollins š Sarah Fulton š Kim Long š David Dolan š Beth Koller š Joseph Hutter š Susan Miller

EDD

š Andrew Ward š Rosemarie Hakim š Xiufen Sui š Philip Connor š Carl Li

Areas for Proactive Engagement

š Role of on-going Clinical Trials in Clinical Evidence Review š Implementation Instructions for Medicare Administrative Contractors š Appendix A: General Methodological Principles of Study Design

š Assessing Individual Studies š Generalizability of Clinical Evidence to the Medicare Population š Assessing the Relative Magnitude of Risks and Benefits