What’s Ahead for Rulemaking: Medicare Edition

With Congress in recess this week, we look ahead to what is underway on the administrative front with respect to Medicare – including changes to electronic prior authorization, Medicare payment updates, Medicare Advantage (MA) and Part D Advance Notice, and modifications to Medicare enrollment. A lookahead for key Medicaid-focused changes is available here.

• March 23 – Electronic Prior Authorization RFI Comment Deadline: As a reminder, the Office of the National Coordinator of Health Information Technology (ONC) issued a request for information (RFI) last month seeking stakeholder input on whether to adopt additional standards, implementation specifications, and certification criteria regarding electronic prior authorization as part of its ONC Health IT Certification Program (WHG summary). ONC seeks feedback across a range of areas related to potential electronic prior authorization requirements, including how new certification criteria should be structured; new implementation specifications for electronic prior authorization; and what the impact of any new requirements would have on patients, providers, developers, and payers. The comment period for the RFI is underway and will end in a month on March 23, 2022.In addition to this RFI, the Administration has several other items related to electronic prior authorization and interoperability on its rulemaking agenda for later this year. These include –
  • February – Proposed Rule for Certain Health Plans: A forthcoming proposed rule to place new requirements on certain health plans to improve the electronic exchanges of health data, streamline processes related to prior authorization, and reduce burden. The plan types that would be affected by this proposed rule include Medicare Advantage (MA) organizations, Medicaid and CHIP managed care and state agencies, and Qualified Health Plan (QHP) issuers. The target date for the proposed rule is February 2022.
  • March – Final Rule Authorizing OIG to Investigate Information Blocking: A final rule from the HHS Office of Inspector General (OIG) that would authorize the OIG to investigate claims of information blocking and provide HHS the authority to impose civil monetary penalties for information blocking. The target date for the final rule is March 2022.
  • July – Proposed Rule for the ONC Certification Program: A proposed rule to propose new standards and certification criteria under the ONC Certification Program related to real-time benefit tools and prior authorization, and implement certain provisions of the 21^st Century Cures Act related to health information exchange and information blocking. The target date for the proposed rule is July 2022.
• April – Fiscal Year (FY) 2023 Medicare Payment Update Proposed Rules: Joining the list of CY 2023 proposed Medicare payment updates under review by the Office of Management and Budget (OMB) is the FY 2023 Inpatient Psychiatric Facilities Prospective Payment System Rate. As a reminder, the proposed payment updates already at OMB include updates to the Hospice Wage Index and the Inpatient Prospective Payment System. Promulgation of these proposed rules are expected in April.
• April 4 – Contract Year (CY) 2023 MA and Part D Advance Notice: As an additional reminder, CMS recently issued its CY 2023 Advance Notice for MA and Part D plans (WHG summary). Notably, the Advance Notice would result in a nearly 8 percent rate increase for plans. It also included a series of requests for feedback on health equity-focused considerations for MA and Part D plans. Potential changes include updates to the Star Ratings measures that would encourage plans to monitor enrollees’ social risk factors and improve the ability for measures to be stratified by such factors. Comments on the Advance Notice are due by Marcy 4, 2022. CMS expects to publish the final 2023 Rate Announcement by April 4, 2022.
• Updates to Medicare Enrollment & Coverage of Immunosuppressive Drugs: Last week, a proposed rule to implement certain provisions of the Consolidated Appropriations Act, 2021 (CAA, L. 116-260) arrived at OMB for review. Specifically, the proposed rule would implement section 120 of the CAA, which allows Medicare coverage to take effect earlier for those enrolling in the General Enrollment Period or within the last three months of their initial enrollment period. It also authorizes the Department of Health and Human Services (HHS) to establish a SEP for exceptional circumstances. In addition, the proposed rule would implement section 402 of the CAA, which extends immunosuppressive drug coverage beyond the current 36-month limit for certain individuals. The Administration originally targeted a January 2022 timeframe for promulgation of the proposed rule, which suggests the proposed rule could be issued as early as the next few weeks.