Part D and Hospice

1. Part D and Hospice Judi Lund Person, MPH Jason Kimbrel, PharmD, BCPS Greg Dyke, RPh Joan Harrold, MD, MPH, FAAHPM, FACP Nancy Bridgman, Omnicare

2. Objectives • Update on Part D • Changes at your hospice • Admissions • Collect Part D information from beneficiary • Written materials • Giving staff the words • Medication management • Documentation of reason for unrelated • Discontinuation of meds • Review standardized form and draft instructions • FY2015 Hospice Wage Index proposed rule – Part D section • Questions

3. How did we get here? • OIG report issued in 2012 • Findings of $33 M in claims (FY2009) paid by Part D after beneficiary elects hospice – four classes of drugs • Additional analysis by CMS Center for Program Integrity • Ongoing and intense discussions about the “intersection between Part D and hospice” with CMS Part D and CMS Part A since summer 2013 • Final guidance issued by CMS on March 10 2014 • Proposed regulations for hospice and Part D issued on May 2 2014 for FY2015

4. Components of Final Guidance • Considered to be “subregulatory guidance” without CMS enforcement • Part D and hospice confusion • “Be ready by” date of May 1, 2014 – some Part D plans implemented earlier • Repeated reference to 2014 guidance • FY2015 Hospice Wage Index proposed rule posted on May 2 references changes to Part D/Hospice intersection

5. CMS Statements • We expect drugs covered under Part D for hospice beneficiaries will be unusual and exceptional circumstances. • 1983 Hospice final rule (48 FR 56010) was that the hospice benefit provides virtually all care for the terminally ill individual • It is a comprehensive, holistic approach to treatment that recognizes that the impending death of an individual necessitates a change from curative to palliative care. • NOTE: NHPCO continues to work with CMS on definitions and interpretations.

6. Key Issues • Hospice physician’s responsibility. • Must document “why” the drug is unrelated – form calls it “Rationale for Treatment” • Can the Part D plan override the hospice’s decisions? • How will the hospice initiate communication with the Part D plan? • How can hospices begin using the standardized form?

7. Admission process changes

8. Admission Process • Talk to patients and families about the changes in Part D coverage • Evaluate pre-admission med regimen • Review patient admission packet for changes • Provide letter to patients and families describing change • Provide letter patients and families can take to pharmacy with hospice contact information • Collect information on Part D from patient/family • Collect information on preferred pharmacy

9. Finding a Patient’s Part D Plan • Three ways • Ask for the patient’s Part D card during admission • Collect patient’s insurance number, Part D plan name, any other numbers on the card and any contact phone number • PREFERRED METHOD • Contact the pre-hospice medication dispenser (preferred pharmacy) for Part D coverage information • Request that the pharmacy submit an E1 query to the CMS Transaction Facilitator, which identifies: • Name and contact information of Part D plan sponsor • Takes time, depends on pharmacy workflow • Accuracy rate = 70%

10. Referral Sources • Letter explaining Part D changes • Ongoing communication about coordination with hospice • Close communication between Hospice and SNF PRIOR TO ordering medications • Expected in regulations for both hospice and SNF • Review payment responsibility • May protect SNF from difficulties with LTC pharmacy

11. Medication management

12. Four Buckets of “Relatedness” UNRELATED, BUT NO LONGER HELPFUL RELATED and HELPFUL RELATED, BUT NO LONGER HELPFUL – CONSIDER DISCONTINUE UNRELATED and HELPFUL— PART D PROCESSES 26

13. Responsibility for Drugs

14. When will my hospice interact with a Part D plan? • Role of hospice PBM • Role of contracted community pharmacy • Prescriptions written by unaffiliated prescriber • If not coordinated with the hospice, will be rejected at pharmacy • Understanding Part D “processing”

15. Medication Management • Treatment decisions should not be driven by costs, as opposed to clinical appropriateness. • CMS states: “Hospices should use thoughtful clinical judgment, with a patient-centered focus, when developing the hospice plan of care, including the recommendations for medication management.”

16. Reports from Beneficiaries • Anecdotal reports from Medicare hospice beneficiaries • They are not receiving medications related to their terminal illness and related conditions from their hospice • One reason stated – “those medications are not on the hospice’s formulary”

17. Formulary • Many hospices establish a formulary • Hospice can offer an alternative to drug not on formulary • If patient declines, patient pays • Formulary drug is not working? • Hospice must provide off-formulary drug as alternative

18. Medication Review with Patients and Families • Begin the discussion • Give staff the words for the conversation • Consider timing and prognosis of patient

19. ABN for Medications • No ABN Required: • For medications that are not reasonable and necessary and the hospice will not provide to the beneficiary • Documentation in the medical record is strongly suggested • ABN Required: • If the hospice provides and pays for a medication even though it is not reasonable and necessary, an ABN must be issued in order to charge the beneficiary

20. Beneficiary Appeal Rights • If the beneficiary feels that the Medicare hospice should cover the cost of the drug, the beneficiary may submit a claim for the medication directly to Medicare on Form CMS-1490S. • Appeal: Use if claim is denied under the appeals process set forth in part 405, subpart I.

21. Standardized form and instructions

22. Standardized Form and Instructions • Developed by National Council of Prescription Drug Plans (NCPDP) Hospice Task Group • Cooperative effort between Part D plans, NHPCO and hospice providers • “Hospice Status and Plan of Care for Medicare Part D A3 Reject Override”

23. Components of Form • Hospice information • Patient information • Diagnoses • Admit/discharge date • Prescriber information • Includes unaffiliated notation • Hospice PBM information • Signed by • Hospice or • Prescriber Unrelated medications • Name and strength • Dosing schedule • Quantity per month • Rational for treatment Medications under hospice plan of care • Determination of responsible party • Hospice • Patient

24. Patient Information • Diagnoses • Primary • Secondary • Unrelated • Admit/discharge date

25. Medications Unrelated • Medication name and strength • Dosing schedule • Quantity per month • Rationale for treatment • Why drug is unrelated? • 1-2 sentences • Must provide clinical basis

26. Instructions for Form • In draft form • Feedback from hospice providers and Part D plans once the form is in use

27. Unanswered Questions • Should beneficiary give up their Part D plan when they enroll in hospice? • Can beneficiary re-enroll in Part D plan if discharged or revoke hospice benefit? • List of Part D plan phone/fax numbers for hospice contacts? • Can hospice interact with Part D plan as prescriber? • Add questions to this list…

28. Fy2015 hospice wage index proposed rule – part d included

29. FY2015 Hospice Wage Index Proposed Rule • Proposed change in filing NOE • No more than 3 days after the date of election • Propose a Notice of Termination or Revocation (NOTR) • No more than 3 days after live discharge or revocation • Considering requiring Part D sponsors to accept NOE and NOTR information as use for coverage until official CMS notification is received

30. New Proposed Definitions • Terminal illness • Related conditions • CMS asks for comments on definitions • Definitions, when final, will guide Part D coverage for hospice patient medications

31. Independent Review Process • CMS considering • Separate and distinct from the enrollee appeals process • Independent Review Entity (IRE) decision would be binding on both the Part D sponsor and the hospice

32. Resources • NHPCO web page on Part D and Hospice • http://www.nhpco.org/regulatory-compliance-hospices/part-d-and-hospice • Compliance Guide • Sample Letters • Latest information