CMS Proposes New Pathway for Medicare Coverage of Innovative Devices, Standards for “Reasonable and Necessary” Determinations; Extends COVID-19 Measure in MIPS

November 10, 2020

The Association for Clinical Oncology (ASCO) submitted comments on two rules from the Centers for Medicare & Medicaid Services (CMS). The Medicare Coverage for Innovative Devices (MCIT) and Definition of Reasonable and Necessary proposed rule would establish a new Medicare coverage pathway for innovative new medical devices and create regulatory standards for making “reasonable and necessary” determinations for Medicare Part A and Part B items and services. The interim final rule (IFC), Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, extends the COVID-19 registry Merit-Based Incentive Payment System (MIPS) Improvement Activity (IA) through the end of 2021.

In its comments on the MCIT proposal, ASCO supported establishing a pathway for immediate national Medicare coverage of Food and Drug Administration (FDA)-market authorized, designated breakthrough devices that meet specified criteria—as well as the voluntary, opt-in nature of the program. ASCO agreed with CMS that coverage of a breakthrough device by the agency should not alter a manufacturer’s obligation to adhere to FDA’s requirements regarding post-market data collection (or other study).

The proposal would also codify regulations in the Program Integrity Manual (PIM) definition of “reasonable and necessary” with modifications, including an added reference to Medicare patients and a reference to commercial health insurer coverage policies. ASCO urged CMS to affirm that the proposed addition of commercial plan coverage as a criterion for Medicare coverage would function as an additional consideration for coverage, not as a substitute. Additionally, the absence or paucity of commercial coverage for a specific item or service should not serve as a basis for CMS to deny Medicare coverage of such an item or service. The Association stated that, if coverage is lacking in the commercial market, CMS should revert to consideration of the original criteria for “appropriate,” as they currently exist in the PIM.

ASCO emphasized that it does not support any use of commercial coverage policies that could narrow coverage under Medicare, or that would permit CMS or Medicare Administrative Contractors (MACs) to narrow coverage without their own independent review and analysis of the evidence. The Association does support CMS’ proposal to initially adopt the least restrictive coverage policy for an item or service among the commercial plan offerings CMS examines,  and ASCO supported transparency in the process that CMS finalizes for consideration of commercial plans when determining coverage for Medicare patients.

CMS’ third IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, addresses the COVID-19 pandemic. The agency extended reporting to a coronavirus registry as a MIPS IA through the end of 2021. CMS clarified that to receive credit for this IA, a MIPS eligible clinician or group must participate in a COVID-19 clinical trial or care for patients with COVID-19 and submit relevant data to a clinical data registry. ASCO’s comments thanked CMS for confirming that the American Society of Clinical Oncology’s Survey on COVID-19 in Oncology Registry is an acceptable registry for the attestation of this highly-weighted IA and for extending this option through the end of 2021. Given the impact the coronavirus is having on cancer care, the association asserts the importance of oncologists having the opportunity to submit meaningful IA data that reflect real-world events and that are of value to patients with cancer and clinicians.

Bookmark ASCO in Action for updates as these proposals are implemented.