Navigating CMS Guidance on Part D Callene Bentoncoury, RN, BSN, MA Administrator, Casa de la Luz Hospice Julia Choate, RN, BSN Director of Quality &

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1 Navigating CMS Guidance on Part D Callene Bentoncoury, RN, BSN, MA Administrator, Casa de la Luz Hospice Julia Choate, RN, BSN Director of Quality & Compliance, Casa de la Luz Hospice Greg Dyke, Rph President of Clinical Consulting, OnePoint Patient Care Joseph Solien, PharmD, CGP Clinical Pharmacist, OnePoint Patient Care 1

2 Outline Related sponsor efforts Background: How did we get here? Medications: Responsibility of payment Hospice Operations Gathering Part D information Determining related medical conditions, medications Communicating with patients and families Communicating with Part D sponsors Quantifying financial impact on a hospice FY2015 Wage Index CMS report of hospice behavior and trends Our goal today is to build and confirm a common understanding of the current regulatory environment and share experiences and strategies to manage through these issues OnePoint Patient Care. Not to be reproduced, distributed, or transferred in any form except with prior written consent of OPPC

3 Hospice and Part D Sponsor Efforts NHPCO Relatedness Work Group May 5, 2014 national webinar Part D and Hospice Ongoing efforts Meetings with CMS Part D Plans Members of Congress Updates to NHPCO website NCPDP (National Council for Prescription Drug Programs) Work Group 9 Government Programs Hospice Task Group consisting of members from More than 20 drug Plans NHPCO Hospices Hospice pharmacies Hospice PBM s Work product Hospice Status and Plan of Care for Medicare Part D A3 Reject Override Instructions for Use document OnePoint Patient Care. Not to be reproduced, distributed, or transferred in any form except with prior written consent of OPPC

4 Since June 2013, CMS has been signaling its intent to reinterpret the hospice regulations June 2013 CMS sent out a directive to Part D sponsors to recoup all monies paid by Part D to pharmacies for analgesics dispensed for Medicare hospice beneficiaries Some Part D sponsors begin to send notices to hospices to verify hospice coverage Some Plan D sponsors begin to send demand letters for repayment October 2013 CMS sends additional letter to Part D sponsors providing clarity on the directive above Clarified guidance stated that for the purposes of recovery of monies for analgesics that a case-bycase analysis was not required and therefore ALL analgesic medications were considered related Recoupment for analgesics retroactive to January 1, 2011 Stated that payment resolution was to be handled directly with the hospices not pharmacies Recovery of monies for any other classes of medication should await further guidance from CMS November 2013 CMS sends first communication to hospice providers regarding the issue 2014 OnePoint Patient Care. Not to be reproduced, distributed, or transferred in any form except with prior written consent of OPPC 4

5 CMS (cont d)- December 6, 2013 CMS sends letter to all Part D plan sponsors and Medicare hospice providers: CMS view that hospice needs to provide virtually all the care needed by terminally ill individuals and that the number of drugs paid for by Part D should be minimal (in other words patients should only very rarely be taking drugs not covered under the Medicare Part A Hospice Benefit) Part D sponsor requirement regarding the placement of beneficiary level prior authorization requirements on all drugs to be billed to Medicare Hospices are expected to provide (and pay for) non-formulary meds when necessary to manage related symptoms CMS introduced the concept of an Independent Review Contractor to settle disagreements However, the Prior Authorization process is still very much unknown CMS discussed patient requests for specific drugs not on formulary: Hospice does not have to provide that drug if the IDT determines a formulary drug is sufficient If a patient insists on a medication that the hospice does not reasonably believe necessary, and that an alternate medication could meet the patients needs, the patient can still get their preferred med. However, hospice does not have to pay for it and the medication cannot be billed to Part D. In other words, the patient will have to pay cash for it! Hospice should be advised to document any such occurrences in their clinical record In essence, CMS has changed its regulatory approach from trust but verify to meet the burden of proof 2014 OnePoint Patient Care. Not to be reproduced, distributed, or transferred in any form except with prior written consent of OPPC 5

6 CMS (cont d)- March 10, 2014 released Final 2014 Guidance Effective date of clarification is May 1, 2014 Stated that there are many outstanding process questions and that rulemaking is required to resolve most of the issues Reviewed determination of payment responsibility for drugs 3 general categories: Hospice pay, Part D pay, patient pay Reiterated that hospice had the ability to shape drug use to the clinical standards of the hospice Continued with the point-of-view that Part D coverage will be unusual and exceptional Plan sponsors should place beneficiary level PA s (rejects) on ALL drugs adjudicated Hospice or prescriber must provide information to the Plan sponsor to justify lack of relatedness No standardization of contact type (hospice representative, MD, etc.), form and required information to be submitted, or response time from Plan Sponsor specified Time frame for Plan Sponsor response starts when they receive the explanation of unrelatedness from hospice or prescriber Reviewed determination of payment responsibility Prospective, Concurrent, Retrospective May 9, 2014 released memo to All Part D Plan Sponsors extending 2014 Guidance for coverage year OnePoint Patient Care. Not to be reproduced, distributed, or transferred in any form except with prior written consent of OPPC 6

7 Hospice medication payment responsibility: Medications reasonable and necessary for palliation and management of terminal illness and related conditions All medications needed to manage all the patient s health conditions related to the terminal prognosis, to minimize symptoms, and maximize comfort and quality of life Previous OIG Report highlighted the following as medications that are unlikely to be unrelated to terminal diagnosis / prognosis: analgesics, antiemetics, laxatives, and anxiolytics (high risk to hospice to not cover) CMS: Beneficiaries should only very rarely be taking medications not covered under the hospice per diem 2014 OnePoint Patient Care. Not to be reproduced, distributed, or transferred in any form except with prior written consent of OPPC 7

8 Importance of discontinuing non-essential meds Need to discontinue non-essential therapies Best practice for patient Minimize adverse effects, drug interactions, duplicate therapies, etc. They are not consistent with hospice philosophy / goals of care Avoids hospice payment; avoids patient payment Example non-essential / inappropriate therapies Futile therapies: psychotherapeutics (ex: Aricept, Namenda), chemotherapeutic agents, riluzole, HIV medications if terminal AIDS diagnosis Preventative therapies: cholesterol-lowering, bone protective/bisphosphonates,, antiplatelets, anticoagulants, vitamin/mineral supplements, herbals, some antibiotics Inappropriate therapies: metered dose inhalers for patients who can no longer effectively use them Duplicate therapy: Multiple medications within same therapeutic class Multiple medications with same indication from different classes may no longer be medically necessary with changing goals of care (ex: HTN, DM) Curative treatment attempts 2014 OnePoint Patient Care. Not to be reproduced, distributed, or transferred in any form except with prior written consent of OPPC 8

9 Discontinue or Change Medications Hospice may advise the patient to discontinue a medication Hospice can suggest a therapeutic alternative medication from their preferred drug list to replace a medication not on their list if they believe the original medication is not medically necessary If the patient disagrees and wishes to continue the medication, they must pay for the medication out of pocket Patient cannot bill Part D Hospices must fully inform the patient of their financial liability (not specific amount) Consider a standard process / form to document this type of recommendation and retain acknowledgement 2014 OnePoint Patient Care. Not to be reproduced, distributed, or transferred in any form except with prior written consent of OPPC 9

10 Hospice Operations Part D 10

11 Plan and Communicate Collaborate with Pharmacy Provider Establish a Process/Protocol Create Part D Communication form Letters/Communications to Community Patients/Representatives Provider Letters and Phone Calls Communicate with Hospice Staff Staff Meetings, IDT, Feedback, One-on-One Case Studies. 11

12 Step 1: Gather Part D Information CMS- HETS My Ability Website Patient s Part D Card Pharmacy Provider Record where available to everyone 12

13 Reality Communications with Part D providers were challenging No incoming calls? No fax? No department for that? There was no consistent process, phone or faxthis is improving with some Sponsors. 13

14 Step 2 Determine Related Conditions 14

15 Reality Related by Whose Definition? Hospice staff and 30 years of understanding Part D Insurers- clerks, pharmacists, doctors, administrators Patients and Families CMS System? Prognosis? Pathophysiology? Environment? Moving target. 15

16 CMS Defines Terminal Illness: Abnormal and advancing physical, emotional, social and/or intellectual processes which diminish and/or impair the individual's condition such that there is an unfavorable prognosis and no reasonable expectation of a cure; not limited to any one diagnosis or multiple diagnoses, but rather it can be the collective state of diseases and/or injuries affecting multiple facets of the whole person, are causing progressive impairment of body systems, and there is a prognosis of a life expectancy of six months or less. 16

17 CMS Defines Related Conditions: Those conditions that result directly from terminal illness; and/or result from the treatment or medication management of terminal illness; and/or which interact or potentially interact with terminal illness; and/or which are contributory to the symptom burden of the terminally ill individual; and/or are conditions which are contributory to the prognosis that the individual has a life expectancy of 6 months or less. 17

18 Step 3 Determine Related Medications 18

19 Reality See Related Conditions Requires comprehensive medication review Requires accurate, complete, information available in the record in one place Requires team discussion of meds not previously discussed 19

20 Step 4 Determine which related meds match the Hospice Plan of Care 20

21 Reality Patients are taking meds that have questionable value or that may be harmful. Patients and families may be attached to these drugs. Prescribers may be attached to these drugs. Hospice staff are attached to pleasing people. 21

22 Step 5 Have a conversation with the patient/family regarding medications (and therapies) 22

23 Reality There is an emotional side to everything Hospice staff doesn t want to (afraid or concerned) Hospice staff doesn t know how People see medications as hope Small risk (fear) can trump large benefit Staff needs tools and practice 23

24 Step 6 Send Part D Communication on Non-Related Drugs- and Discharges Hospice is Done! 24

25 Proactive removal of A3 block / Pre-communication This form is available to NHPCO members on their website 2014 OnePoint Patient Care. Not to be reproduced, distributed, or transferred in any form except with prior written consent of OPPC 25

26 Reality One Part D communication is one Part D communication. They don t always follow CMS guidance. They tend to treat like prior auth They respond in different ways- phone, fax, mail There is a lot of rework 26

27 Belief: Patient can obtain Medications as before Provide patient/facility with evidence of Part D communication Patients will not be affected (or minimally affected) 27

28 Reality Patients are turned away at pharmacy Delays in getting medications as Part D is processing Part D Communication sent (Election and DC)- Slow turn around Pharmacies are asking hospice to pay or provide Part D approval directly to them. VERY labor intensive 28

29 How much will these changes cost my hospice??? CMS is requiring hospices to pay for more medications Drug costs for hospices will increase How could the quantitative amount of the increase be estimated? Method: Start with complete list of all currently non-covered medications Analyze which medications will now be covered Approximate cost of those medications now covered 2014 OnePoint Patient Care. Not to be reproduced, distributed, or transferred in any form except with prior written consent of OPPC 29

30 Method details from individual hospice analysis List of non-covered medications divided into tiers HIGH Directly related to terminal diagnosis One of four drug classes identified by OIG report (analgesics/anxiolytics/bowel care/antiemetics) MEDIUM LOW Relationship to terminal prognosis or symptom management likely Medications that hospice should recommend discontinuation Ex: statins and other cholesterol lowering, bone protective agents Medications reasonable to continue, but less likely related to terminal prognosis Ex: glaucoma eye drops, thyroid medications Cost approximated by drug price lookup for typical regimen, 15 day-supply Number of times each Rx filled approximated by prior dispensing history 2014 OnePoint Patient Care. Not to be reproduced, distributed, or transferred in any form except with prior written consent of OPPC 30

31 Results of analysis % All Rx 84% 16% Covered Non-covered Classification of Non-Covered Rx 12% 45% 43% Low Medium High $100 $90 $80 $70 $60 $50 $40 $30 $20 $10 $0 $91 $57 $21 Average Cost / 15-day Rx Low Medium High Assumed hospice will now pay for: 100% all HIGH, 90% of MEDIUM, 0% of LOW Estimated number of fills per unique Rx as 4.6 Estimated total additional medication costs by: (No. HIGH Rx) x (Cost/HIGH Rx) x (No. Fills per Rx) plus (No. MEDIUM Rx) x (Cost/MEDIUM Rx) x (No. Fills per Rx) x 90% Estimated yearly increase in medication cost: 26% 2014 OnePoint Patient Care. Not to be reproduced, distributed, or transferred in any form except with prior written consent of OPPC 31

32 FY2015 Wage Index CMS Report of Hospice behavior and trends Released May 2, Items of note: maintains interpretation that when terminally ill, many health problems are brought on by underlying condition(s), as bodily systems are interdependent (pg 18) States the unique physical condition of each terminally ill individual makes it necessary for these decisions to be made on a case-by-case basis (pg22) solicits comments on definition of terminal illness and related conditions (various pgs 51-67) comments and definitions to strengthen and clarify concepts of holistic and comprehensive hospice care (pg 21) Care plan co-ordination with patient and family discusses coordination of benefit processes and appeals for Part D payment for drugs (pgs ) discusses timeframe for NOE and notice of termination/revocation of hospice benefit (pgs 77-86) provides information on determining hospice eligibility provides further clarification on reporting of hospice diagnosis on claims Major underlying, and frequently stated theme - concerns of program integrity Trends in Medicare Hospice Utilization (pg 30) Hospice Payment reform 2014 OnePoint Patient Care. Not to be reproduced, distributed, or transferred in any form except with prior written consent of OPPC 32