For more information about this blog post, please contact Khaled J. Klele, Ryan M. Magee, Ryan L. O’Neill, Connor Breza, William R. Meiselas or Labinot Alexander Berlajolli.

HHS Proposes New Rule for Medicare Advantage Drug Coverage and Advertisements 

The U.S. Department of Health and Human Services ("HHS"), through the Centers for Medicare & Medicaid Services ("CMS"), recently published a proposed rule (87 FR 79452) seeking to improve the prior authorization process, coverage guidelines, and plan marketing requirements for Medicare Advantage and Medicare Part D.

Regarding Medicare Advantage plans, the proposed rule seeks to ensure Medicare Advantage enrollees receive the same access to medically necessary care they would receive in traditional Medicare. For example, the rule proposes regulatory  changes which would clarify and refine the way in which Medicare Advantage plans develop and implement coverage criteria and utilization management policies. Additionally, the rule also proposes streamlining prior authorization requirements by requiring that a granted prior authorization approval remain valid for a beneficiary’s full course of treatment, requiring Medicare Advantage plans to annually review utilization management policies, and requiring coverage determinations be reviewed by professionals with relevant expertise. Notably, these changes would complement CMS’ recently announced Advancing Interoperability and Improving Prior Authorization Processes Proposed Rule (CMS-0057-P).

Additionally, the proposed rule seeks to protect the public from confusing and potentially misleading Medicare and Medicare Advantage marketing. In order to do so, CMS is (1) prohibiting ads that do not mention a specific plan name, use words and imagery that may be confusing, or use language or logos in a way that is misleading; (2) codifying guidance protecting people from misleading marketing or high-pressure enrollment techniques; and (3) strengthening the role of plans in monitoring agent and broker activity.

Moreover, the proposed rule contains significant changes affecting beneficiary access to certain medical services and incentivizing provider adherence to CMS’s health equity and coverage initiatives. For behavioral health services, CMS proposes revised minimum wait time standards for behavioral health and primary care services, heightened patient notice requirements for providers who are dropped from their networks, and requirements that most types of Medicare Advantage plans include behavioral health services in care coordination programs. Regarding CMS health equity and coverage initiatives, CMS proposes establishing a health equity index in the Star Ratings program, which would reward excellent care for underserved populations by Medicare Advantage and Medicare Part D plans, as well as requiring plans to provide culturally competent and equitable care to an expanded list of populations.

CMS has issued a fact sheet summarizing the proposed rule’s wide range of potential rule and policy changes. The public comment window for this proposed rule closes on February 13, 2023.

Axing the Faxing? CMS Proposes Simplification of Healthcare Attachment Transactions 

CMS recently proposed a rule (87 FR 78438) seeking to reduce administrative costs by adopting standards to simplify transactions involving “health attachments,” such as medical charts, x-rays and provider notes. Every health plan has requirements with which a health care provider must comply for the plan to authorize and pay the provider for health care services, frequently requiring the provider to utilize manual processes (mail, fax, internet web portals, etc.) to provide such health attachments in support of their claims. CMS estimates that providers’ efforts to comply with each plan’s varying health attachment methods and standards results in nearly $454 million of waste per year.

The rule modifications would simplify and streamline the healthcare claims and prior authorization processes, create standards for electronic signatures used with healthcare attachments transactions, and update the standard for the referral certification and authorization transaction.

CMS has issued a fact sheet summarizing this proposed rule. The public comment window for this proposed rule closes on March 21, 2023.

Federal Program Will Reimburse Pharmacists as Providers for COVID-19 Services

The U.S. Office of Personnel Management ("OPM") announced that it will begin listing and reimbursing pharmacists as clinical care providers on certain U.S. government employees' insurance bills.  On December 8, 2022 the OPM, which is the federal agency that handles employer-sponsored health insurance for civilian federal workers, issued a letter to all federal employee health benefit ("FEHB") carriers stating that it will require pharmacists to be reimbursed as clinical care providers for patient assessment and prescribing the COVID-19 therapy Paxlovid.

The OPM’s coverage letter specifically builds on the July 2022 decision by the FDA to allow state-licensed pharmacists to prescribe Paxlovid. Notably, the OPM coverage letter strongly suggests that FEHB carriers should have been reimbursing pharmacists as clinical providers since the FDA’s July 2022 clearance for state-licensed pharmacists to prescribe Paxlovid. Pharmacists seeking clarification on reimbursement for Paxlovid from FEHB carriers may contact the OPM via email at OPMPharmacy@opm.gov.