On Wednesday, September 15, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule that would, among other things, repeal the pending new definition for items and services that are considered “reasonable and necessary” under Medicare Parts A and B scheduled to go into effect on December 15, 2021. Proposing to repeal the “Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’” (“MCIT/R&N”) final rule that was published on January 14, 2021, CMS explains that if implemented this final rule would modify the longstanding “reasonable and necessary” definition by allowing CMS to consider private payer coverage services. CMS explains in the proposed rule that “[e]xpanding the reasonable and necessary definition [as planned by the MCIT/R&N final rule] to systemically consider commercial insurer coverage presents implementation and appeals process challenges.” The proposed rule would also repeal the MCIT pathway that would permit faster Medicare coverage of medical devices designated as breakthrough by the Food and Drug Administration (“FDA”). Furthermore, national Medicare coverage under MCIT would start on the date of FDA market authorization and continue for 4 years or on a date chosen by the manufacturer within 2 years thereafter. CMS will accept public comments to the proposed rule until October 15, 2021.

On Friday, September 10, 2021, the Departments of Health and Human Services (“HHS”), Treasury, and Labor, with the Office of Personnel Management, issued a proposed rule that would implement certain provisions of Title I (“No Surprises Act”) and Title II (“Transparency”) of Division BB of the Consolidated Appropriations Act, 2021 (“CAA”). The proposed rule would implement provisions in the No Surprises Act mandating that health plans and health insurance issuers in the group and individual markets and Federal Employees Health Benefits carriers be more transparent regarding air ambulance services and submit certain data on these costs to HHS, the Departments of Treasury and Labor and the Office of Personnel Management. Further, the proposed rule would create processes by which HHS could initiate investigations and determine whether a provider, facility and/or air ambulance service provider violated the Public Health Service Act and impose civil monetary penalties for certain violations. For more information on other provisions in the proposed rule, a fact sheet is available here. Public comments in response to the proposed rule will be accepted until October 18, 2021.