CMS Releases Part D and Hospice Medication Access Fix

Today, the Centers for Medicare and Medicaid Services (CMS) released interim guidance intended to address the highly problematic May 1 Guidance on Part D and hospice drug coverage.   See attached documents for the new, interim guidance.  Below is an overview of the challenging Spring guidance and a preliminary summary of the new, interim guidance which replaces the May 1 instructions to Hospice providers and Part D Prescription Drug Plans (PDPs). 

Problematic Spring Guidance

On March 10, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a memorandum to Part D Plan Sponsors and Medicare Hospice Providers entitled, "Part D Payment for Drugs for Beneficiaries Enrolled in Hospice – Final 2014 Guidance" (http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Downloads/Part-D-Payment-Hospice-Final-2014-Guidance.pdf).   The guidance, based on a 2012 Office of the Inspector General report (http://oig.hhs.gov/oas/reports/region6/61000059.pdf), identifies that Medicare is likely paying for Medicare-financed medications twice both through the Part D Prescription Drug Plans’ (PDP) capitation payments and through the hospice per diem.  The guidnace became effective on May 1, 2014.  

In brief, the guidance caused significant confusion among PDPs, hospice providers, pharmacies, consultant pharmacists, and skilled nursing center providers (SNF).  The results of this confusion were:

  • PDP prior authorization denials for medications and, because of such denials, beneficiaries who have elected hospice have been largely unable to access needed medications;
  • SNF providers have been left with the costs of medications denied by PDPs but still provided by the SNF; and
  • Allegations that  in some instances PDPs have denied drug prior authorizations and SNFs have denied delivery of medications because of unreimbursable costs. 

Preliminary Overview of New Replacement Guidance

Below is a short overview of the new guidance.  A more comprehensive explanation will be shared next week:

  1. Revised hospice Part D guidance was posted on HPMS this morning, and has or will released through the Medicare Learning Network (MLN).  The communication is addressed to plans and hospices, only
  2. The prior authorization (PA) requirements will be limited to the four categories in the DHHS Office of the Inspector General (OIG) report.   Based on OIG discussions with CMS and hospice representatives, OIG concluded that hospice beneficiaries generally experience common symptoms during the end of life regardless of their terminal diagnoses. These symptoms include pain, nausea, constipation, and anxiety. Four common categories of prescription drugs are typically used to treat these symptoms: analgesics,2 anti-nauseants, laxatives, and antianxiety drugs. Only drugs that address these symptoms and/or fall into these categories will require a PA. 
  3. For drugs in the four categories, hospices will only need to provide to the plans a statement that the drug is unrelated; they will not need to provide a clinical justification (although they will need to keep documentation for audit).  
  4. The memo strongly encourages hospices to complete the drug assessment form with the hospice patient’s list of drugs and provide it to the Part D plan immediately (CMS cannot require this but “encourages” all providers to use it). Part D plans may rely on the form, which should also include the effective date of hospice election.  The goals is to expedite the form, which presumably will arrive before the plan is notified by CMS of a beneficiary’s hospice enrollment.  In that instance the plan may rely on the form from hospice.
  5. The memo also clarifies what pharmacists can provide at the point of sale (POS), and it provides pharmacists with a greater role in assisting in moving the requests through the PA system.
  6. There is no distinction in how scripts from unaffiliated providers are processed; however, CMS anticipates and expects that they will provide confirmation that they have coordinated with the hospice.
  7. CMS is strongly encouraging hospices to complete first fills of all drugs on the hospice list and hopes this will help as well.
  8. Plans will have flexibility on providing additional messaging about the PA beyond the POS content.
  9. The policy takes effect immediately but parties will have until October 1 to have it in place.
  10. The policy is not being released as a draft nor  is it otherwise subject to comment, but CMS will be updating the FAQs by next week and will use the FAQ process for any clarification  needed.
  11. If there are any claims outstanding from application of the May 1 policy,  the new guidance can be applied to resolve them.
  12. Part D claims for hospice enrollees that are for drugs outside of the 4 classes are treated as they would be any other Part D enrollee (e.g. subject to PA if they would otherwise be subject to PA).  
  13. While CMS is interested in thinking about and working with stakeholders on a very clear long-term solution, this policy is in place for the foreseeable future.   
  14. CMS also tells us that enterprise-wide, they are committed to educating all stakeholders on this policy.
  15. CMS intends to update all pending FAQs by the end of next week, so it’s possible that additional issues, such as plan safe-harbors, may be addressed there.