New Medicare Part B Requirements: What Payers Need to Know


Learn more about recent changes to Medicare Part B requirements, including questions to ask to ensure your organization has the correct processes in place.

Over the past two years, we’ve seen several indications that the Centers for Medicare & Medicaid Services (CMS) will continue to increase its focus on Part B drugs. First came the updated Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance. Then came the 2021 draft Part C audit protocols that logically called out Part B drugs. And let’s not forget the updated standardized Notice of Denial of Medicare Part D Prescription Drug Coverage (CMS-10146).

The updated Part D Integrated Denial Notice (IDN) model was introduced in an August 2020 HMPS Memo[PJ1]  and is currently available for use. CMS began to enforce use of the notice starting January 1, 2021. The revised version of the Part D IDN has been modified to include instructions for Part B step therapy, as applicable for MAPD plans. Specifically, if the plan determines that the requested drug is typically covered under Part B and processes the request as a Part C organization determination, the plan must send the IDN (CMS-10003) if coverage is denied under Part B (e.g., Part B drug step therapy requirements have not been met). For your reference, here’s the list of drugs covered by Medicare Part B.

The coordination required to identify such requests and send the appropriate notice can be challenging for payer organizations.

Assessing Your Organization’s Processes Related to Part B Drugs

Organizations need to look closely at their Part B drug benefits administration to ensure there is coordination in relation to Part B versus Part D drugs. Though the instructions for coordination between Part D and Part B are not new, now is a good time to review and make sure that you have processes in place that cover the following:

  • Denial notices include clearly written specific denial rationale.
  • The ability to add text covering Part B versus Part D scenarios in the Part D IDN (CMS-10146). The text added would be:

    “This request was denied under your Medicare Part D benefit; however, coverage/payment for the requested drug(s) has been approved under Medicare Part A/B {include an explanation of the conditions of approval in a readable and understandable format}. If you think Medicare Part D should cover this drug for you, you may appeal.”

As a reminder, when reviewing Part B versus Part D drugs, you’ll need to account for the following scenarios in the Part D IDN:

  • If you deny under Part D, there may need to be a reference to reviewing under Part B in the denial notice.
  • If you deny under Part D and have also made an adverse Part B determination, the notice needs to reference that it has been denied under both Part D and Part B.
  • If you deny under Part D and have a Part B determination to approve under Part B, the notice needs to reference that it has been denied under Part D and approved under Part B.

Collaborating with other departments, partners, and vendors

Again, coordination is key here. When determining Part B and Part D decisions, plans often interact with other departments within their organization and/or with outside vendors. It’s not unusual for outside companies to make the decisions since the management of Part B and/or Part D drugs may be delegated to separate entities. If the function is handled by a different company, the notice must still reference the plan; and coordination with the plan is required.

To review and assess your plan’s processes involving Part B drugs, ask the following questions:

  • Do our related policies and procedures include Part B versus Part D requirements?
  • Do I have documented workflows that reflect the needed coordination?
  • Practically speaking, do the handoffs happen?
  • Are our processes efficient in meeting CMS timeframes?

Remember, the receipt date is the receipt date. All determinations need to be completed within 72 hours for standard determinations and 24 hours for expedited determinations. No extensions may be taken. You may have some extra time for expedited cases, however, as the clock starts when the case reaches the correct department or delegate.

Need assistance with maintaining regulatory compliance? The experts on our Medicaid and Medicare consulting team are ready to help. 

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