Top 3 Key Regulatory Changes for 2021

There are several noteworthy regulatory changes that require action by Medicare Advantage and Part D Plans in 2021.

1. Provider-Facing Electronic Real-Time Benefit Tool (RTBT)

CMS issued a final rule in May 2019 (CMS-4180-F) that requires Part D Plans, by January 1, 2021, to implement a provider-facing electronic RTBT that is capable of integrating with at least one e-Prescribing (eRx) or electronic health record (EHR) system.  The provider will enter benefit information into the RTBT about the drug they intend to prescribe, as well as information about the associated enrollee and their preferred pharmacy.  The RTBT will then return a real-time, enrollee-specific response, displaying to the provider any utilization management requirements that have yet to be satisfied before the drug will be approved (e.g., step therapy or prior authorization), the enrollee’s cost-sharing for the drug at their preferred pharmacy, and formulary alternatives available that have different cost-sharing from the drug being considered (e.g., a lower cost share).  CMS implemented this requirement to help provide Part D providers information in real-time about when lower-cost drugs are available, with the goal of enhancing medication adherence.  While Part D Plans must implement this provider facing RTBT by January 1, 2021, CMS strongly encourages Plans to do so before the deadline.

RTBT Readiness To-Do List

• If your PBM hasn’t already engaged your Plan in discussions about the provider facing RTBT, you should schedule a discussion with them right away to:
  • Understand what data their RTBT solution will display and with which eRx or EH system it will integrate
  • Validate their solution’s compliance with CMS requirements
  • Understand when their RTBT solution will be production-ready
  • Clarify the Plan’s role in implementation
• Engage your Provider Network team to build training for your providers who will have access to the RTBT. Training should help providers understand the benefits of the RTBT and why they should use it.
• Incorporate the RTBT into your 2021 Readiness testing plan and ensure it is thoroughly tested prior to implementation.
• Educate your Provider Services team on this change, since providers with access to the RTBT may call asking questions about it.
• Setup post-go-live monitoring of the RTBT, as well as Provider Services calls and provider complaints, so you can detect any issues with the RTBT.

2. Part D EOB Changes

In the same May 2019 final rule (CMS-4180-F), CMS issued a requirement that Part D Plans include certain additional information on enrollees’ Part D Explanations of Benefit (EOBs).  Effective January 1, 2021, Part D Plans must include, for each prescription drug claim on an EOB: (1) the cumulative percentage increase, if any, in the negotiated price for each drug since the first claim of the current benefit year; and (2) lower cost alternatives to the drug, if available, that are included on the Plan’s approved formulary (the Plan may include therapeutic alternatives with the some cost-sharing if the negotiated price is lower).  CMS encourages, but is not requiring, Part D Plans to consider relevant enrollee-specific information when providing therapeutic alternatives, such as completed step therapy or exception requests and diagnosis. While Part D Plans must implement these Part D EOB changes by January 1, 2021, CMS strongly encourages Plans to do so before the deadline.

Part D EOB Changes To-Do List

• Be sure you are using the 2021 Part D EOB model.
• If your PBM hasn’t already engaged your Plan in discussions about the Part D EOB changes, you should schedule a discussion with them right away to:
  • Understand what their revised Part B EOB will look like
  • Validate their solution’s compliance with CMS requirements
  • Understand when Part D EOB changes will be production-ready
  • Clarify the Plan’s role in implementation of these changes
• Incorporate the Part EOB changes into your 2021 Readiness testing plan and ensure they are thoroughly tested and working as expected prior to implementation.
• Educate your Customer Service team about this team, since enrollees may call asking questions about what the new information on their Part D EOB means.
• Setup post-go-live monitoring of the Part D EOB changes to ensure EOBs are being correctly generated with the additional information
• Monitor Customer Service calls and enrollee grievances for issues about the Part D EOBs

3. Patient Access and Provider Directory Application Program Interfaces (APIs)

In May 2020, CMS issued a final rule (CMS-9115-F) requiring Medicare Advantage, Medicaid (both fee-for-service (FFS) and managed care plans (MCP)), Children’s Health Insurance Plans (CHIP) (both FFS and MCPs), and Qualified Health Plan issuers on the federally facilitated exchanges to make available a Patient Access API by January 1, 2021.  CMS subsequently announced that it would not enforce this rule until July 1, 2021, buying Plans a bit more implementation time.  The concept behind the Patient Access API is that an enrollee would be able to use a mobile device, such as a smartphone or tablet, to connect to a third-party application (app) of their choosing, use that app to download their claims data from their insurer, and display their claims data on their mobile device.  To enable this, Plans must establish a connection to any app that seeks to connect to their Patient Access API, unless the app poses an unacceptable risk of security to the Plan or to the protected health information in transit.

After authenticating the enrollee, Plans must make available the following data to the app: adjudicated medical and pharmacy claims (including enrollee cost-sharing and provider remittances) with dates of service on or after January 1, 2016, Encounter data, formularies or preferred drug lists, and clinical data received and maintained by the Plan as part of its normal operation.  Plans must ensure this data is available no later than one business day after the claim is adjudicated or the Encounter data is received by the Plan.  Additionally, Plans must make resources available to enrollees to explain strategies to consider when selecting an app and safeguarding the privacy and security of their data, as well as how to submit complaints related to use of the Patient Access API to the Office of Civil Rights or the Federal Trade Commission (which regulates apps).  The technical specifications that set forth the technical and content standards for the Patient Access API were published by the Office of the National Coordinator for Health Information Technology (ONC) and Department of Health and Human Services (HHS) in a separate May 2020 “21^st Century Cures Act” final rule (RIN 0955-AA01).

As part of this same CMS final rule, CMS finalized requirements for Medicare Advantage, Medicaid (FFS and MCP) and CHIP (FFS and MCP) Plans to also make available a Provider Directory API by January 1, 2021.  CMS is also exercising its enforcement discretion with this API requirement and will not enforce it until July 1, 2021.  The Provider Directory API must be made available to the public on the Plan’s website and will allow individuals to connect to the API and display a Plan’s provider and pharmacy directory data on their mobile device.  Like with the Patient Access API, when implementing the Provider Directory API, Plans must follow the technical specifications set forth in the “21^st Century Cures Act” final rule.  Plans need to ensure they incorporate the Provider Directory API into their data management strategy, because CMS requires Plans to update the directory information made available through this API within 30 days of receiving new or updated provider or pharmacy information.

Patient Access and Provider Directory APIs To-Do List

• Review the 21^stCentury Cures Act final rule to understand the technical specifications for these APIs.
• If your Plan hasn’t yet done so, either seek out a third-party vendor or your internal Information Technology (IT) team to discuss these requirements.
• Build a test plan to ensure the APIs are working appropriately and in conformance with the requirements.
• Engage your marketing team to determine how you will market these APIs to enrollees, so enrollees understand the functionality available.
• Prior to go-live, informat your Customer Service team about these changes, because enrollees may call asking questions about the APIs.
• Work with your IT team to setup ongoing monitoring for these APIs to ensure they continue to work as expected.
• Ensure your data management processes are designed to update the data made available via the Patient Access API within one business day after the claim is adjudicated or the Encounter data is received by the Plan.
• Ensure your data management processes are designed to update provider and pharmacy information made available via the Provider Directory API within 30 days of receiving new or updated information.