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Compliance and Operational Considerations for Medicare Advantage Plans with Increasing Enrollment of End Stage Renal Disease (ESRD) Beneficiaries

By September 30, 2020Enrollment, ESRD, MA

For the first time, starting in 2021, the 21st Century Cures Act allows beneficiaries diagnosed with ESRD to enroll in MA plans. These beneficiaries have previously been required to stay on Medicare Fee-for-Service (FFS).  Plan beneficiaries who developed ESRD while on the Plan were not required to disenroll, so while Plans have experience managing the ESRD population, this change is expected to significantly increase the Plan’s ESRD membership. While there are many cost and clinical considerations in managing ESRD beneficiaries, there are also compliance and operational considerations that should be reviewed.

Sales and Enrollment

It is critical for Plans to train their eligibility and enrollment department and their sales force that beneficiaries with ESRD are now allowed to enroll in Medicare Advantage Plans. If the sales force or enrollment department are unaware of this change, this could result in enrollments being wrongfully denied and/or inappropriate sales practices.  Plans and their sales agents should be prepared for ESRD beneficiaries inquiring about enrollment now that they are able to enroll in MA Plans.

Continuity of Care, Quality and Beneficiary Satisfaction

ESRD beneficiaries have complex care needs.  Plans that have an increase in ESRD beneficiaries will need to ensure their plan is easy to navigate for an incoming ESRD beneficiary.  For example, beneficiaries with ESRD who are on dialysis and under the care of a nephrologist might join Plans that do not contract with their established care team. Plans will need to ensure appropriate review and application of continuity of care processes for new ESRD beneficiaries to ensure they are given the time necessary to transition to in network providers.

Plans will also need to integrate ESRD beneficiaries into their strategic planning for plan quality initiatives, taking into consideration that the primary care provider for most of these beneficiaries is their nephrologist .

ESRD B vs D Drug Coverage Determination Best Practices

A Medicare Part B versus Part D determination must be made when processing prescription drug claims for Medicare beneficiaries with ESRD  or a Medicare-covered transplant.  Certain drugs associated with the treatment of ESRD are covered under Medicare Part B in the following situations:

  • Drugs (i.e. access management, anemia management, bone and mineral metabolism, and cellular management) used for the ESRD beneficiaries receiving maintenance renal dialysis; and
  • Immunosuppressants for the treatment of a Medicare-covered kidney transplant.

Additionally, drugs (i.e. antiemetics, anti-infectives, anti-pruritic, anxiolytic, excess fluid management, fluid and electrolyte management including volume expanders, and pain management) in the “ESRD maybe” category are included under the ESRD Prospective Payment System (PPS) when furnished to a beneficiary for the treatment of ESRD.  If the drugs in these seven categories are not being used for the treatment of ESRD, then separate payment must be made under Part D.

Point-of-sale logic must be coded correctly to ensure payment under the appropriate benefit.  Best practices and key considerations include the following:

  • Does the Plan have the appropriate processes in place to communicate to their pharmacy benefit manager (PBM) whether a beneficiary has ESRD or has had a Medicare-covered transplant?
  • Does the Plan’s PBM have the necessary pre-processing drug lists in place to support accurate ESRD and transplant claims adjudication?
    • Drug lists (e.g. “ESRD always” drug list, “ESRD maybe” drug list, immunosuppressant B versus D drug list)
    • Maintenance of the drug lists
  • Does the Plan have ESRD prior authorization requirements on the seven categories of drugs considered to be “ESRD maybe”drugs? If so, the Plan should remove these PA requirements as CMS expects that these drugs are not being used for the treatment of ESRD.
  • Does the Plan have reporting in place to assist with identifying any claims that should have been covered under Part B instead of Part D?
  • Does the Plan have a recoupment process to recover payment from the ESRD facility for drugs that were inappropriately billed to Part D? The Dialysis Facility Compare tool located at can be used identify contact information for local dialysis facilities.
  • Does the Plan have a process in place to exclude prescription drug event records when the drug should have been covered under the ESRD PPS bundle?
  • Does the Plan have the ability to enter an ESRD or transplant override? For instance, if the Plan learns that a beneficiary is no longer receiving dialysis and the information has not been received via the transaction reply report yet, the Plan needs to be able to override the medications on the “ESRD always” list since the medications are no longer being used to treat ESRD.  Additionally, if the Plan learns that a member who has had a Medicare-covered transplant is using an immunosuppressant for a non-transplant indication, the Plan should be able to enter an override to allow the drug to process under Part D rules.

By reviewing existing ESRD and transplant processes ahead of the CY2021, Plan can ensure that beneficiaries with ESRD do not experience a delay in receiving needed prescription drugs.

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