What’s New with Part D? Tools to Guide Your Relatedness Journey

Since our last Part D blog, CMS issued the Revised Guidance for Part D, on July 18th, 2014, effective as of that date. There are some detailed, comprehensive resources (listed below) that address this complex issue. The purpose of this blog is to synthesize and recap “what’s new” in the Revised Guidance for Part D and highlight tools for navigating these changes.

What hasn’t changed?  

In the words of CMS:

  • Hospices are still required to “provide virtually all the care” needed by their patients
  • “Beneficiaries should only very rarely be taking drugs that are not covered under the hospice per diem”
  • “Unless there is clear evidence that a condition is unrelated to the terminal illness, all service would be considered related”
  • The hospice physician must “document why a patient’s medical need(s) would be unrelated to the terminal prognosis” (boldness added)

The A-Z of the prior authorization process

  • Prior Authorization (PA) is now limited to 4 categories of medications:

    • Analgesics
    • Anti-emetics
    • Laxatives
    • Anti-anxiety
  • Any pharmacy claim for Part D payment for a medication in these categories will trigger a rejection and initiate the PA process
  • The hospice or non-hospice affiliated prescriber must then provide documentation (verbal or written) to the Part D sponsor to substantiate the unrelatedness of the rejected medication
  • All other unrelated medications outside of these 4 categories do not require prior authorization and will be reviewed by Part D sponsors and paid subject to the Part D regulations 

Using the standardized form

  • Fulfills the PA requirement if initiated prior to submission of a claim for Part D payment for medications in one of the 4 categories
  • Does not require any supporting documentation on the form other than the designation of “U” for unrelatedness 
  • Physician must still document rationale for unrelatedness for each medication in the patient's clinical record
  • Available in fillable format at nhpco.org/regulatory or non-fillable format at cms.gov

Classifying medications by relatedness and determining coverage responsibility

Hospice must do’s 

  • Document all medications in the initial and comprehensive assessment and any updates to the plan of care
  • The medication profile must include:
    • Prescription medications
    • Over the counter (OTC) medications
    • Herbal medications/supplements
    • Complementary medications/supplements
  • Educate staff and patients/families that drugs for the "symptomatic relief" of cough and cold, most prescription vitamins, and OTC drugs are not covered by Part D

Hospice formularies 

  • Hospices have the responsibility to determine if they will have a formulary and, if so, what medications will be included in the formulary
  • If a patient/family refuses a formulary medication that is determined to be able to meet the patient’s medical needs, the patient will be responsible for the cost of the non-formulary alternative if chosen
  • If the formulary does not contain a medication that is needed to meet the medical needs of a patient related to their prognosis, then the hospice must provide and pay for a non-formulary option

Advance beneficiary notice

  • An Advance Beneficiary Notice (ABN) must be issued by the hospice to the patient/representative if:
    • The hospice provides a medication that is not reasonable and necessary and therefore outside of the plan of care (not covered by Part A or Part D)
    • The ABN is issued so that the patient can be charged

Best practices 

  • Use the standardized form to preempt the Prior Authorization process when coverage by Part D is requested for an unrelated medication in one of the four designated categories
  • Use the standardized form to proactively report hospice election or termination (discharge or revocation) to Part D sponsor.  This can be done even if there are no unrelated medications in the four categories to be reported
  • Facilitate collaboration with Part D sponsors by filling out page two of the standardized form to communicate information about related medications in the drug profile
  • Encourage physician and pharmacist collaboration in the determination process of medication relatedness
  • Initiate discussion with patient/family and team on admission and throughout hospice course, about discontinuance of medications determined to be medically unnecessary
  • Provide short term provision of unrelated medications as a “compassionate first fill” to minimize point-of-sale access issues
  • Develop audit processes for timely and clear physician documentation of relatedness determinations
  • Establish processes along the continuum of care (admission to discharge), to facilitate team to patient/family communication regarding the patient’s medication profile in the plan of care and coverage responsibilities
  • Proactively educate physicians (hospice and non-hospice affiliated) and the interdisciplinary group (IDG) regarding processes for Part D relatedness determinations, documentation, and coverage
  • Educate external providers (e.g., nursing facilities) on the Part D determination process and routinely review facility clinical records to ensure proper identification of the appropriate payer source
  • Document all communication about coverage determinations that occurs across the continuum of care, involving all stakeholders (physicians, IDG team, patient/family, contracted facilities, pharmacies, Part D sponsors)


Posted by Suzanne Karefa-Johnson, MD, Senior Physician Consultant, Weatherbee Resources, Inc.

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