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

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

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

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

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.

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?

Admission process changes

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

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%

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

Medication management

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

Responsibility for Drugs Hospice Part D Plan Sponsor Patient All medications related to the terminal illness and related conditions Unrelated to terminal illness and related conditions – submitted to Part D plan for processing No longer helpful and wish to continue – related and unrelated

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”

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.”

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”

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

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

ABN for Medications No ABN Required: 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

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.

Standardized form and instructions

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”

Components of Form Unrelated medications 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

Patient Information Diagnoses Admit/discharge date Primary Secondary Unrelated Admit/discharge date

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

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

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…

Fy2015 hospice wage index proposed rule – part d included

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

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

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

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