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

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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

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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

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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

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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-by-

case 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

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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

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In essence, CMS has changed its regulatory approach from

“trust but verify” to “meet the burden of proof”

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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 2015

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© 2014 OnePoint Patient Care. Not to be reproduced, distributed, or transferred in any form except with prior written consent of OPPC

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

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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

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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

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Hospice Operations

Part D

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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.

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Step 1: Gather Part D Information

• CMS- HETS My Ability Website

• Patient’s Part D Card

• Pharmacy Provider

• Record where available to everyone

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Reality

• Communications with Part D providers were

challenging – No incoming calls?

– No fax?

– No department for that?

• There was no consistent process, phone or fax-

this is improving with some Sponsors.

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Step 2

Determine Related Conditions

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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.

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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”.

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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”.

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Step 3

Determine Related Medications

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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

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Step 4

Determine which related meds

match the Hospice Plan of

Care

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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.

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Step 5

Have a conversation with the

patient/family regarding

medications (and therapies)

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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

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Step 6

Send Part D Communication

on Non-Related Drugs- and

Discharges

• Hospice is Done!

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Proactive removal of A3 block / Pre-communication

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• This form is available to NHPCO members on their website

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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

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Belief: Patient can obtain Medications as before

• Provide patient/facility with evidence of Part D

communication

• Patients will not be affected (or minimally

affected)

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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

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© 2014 OnePoint Patient Care. Not to be reproduced, distributed, or transferred in any form except with prior written consent of OPPC

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

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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

• Relationship to terminal prognosis or symptom management likely

– LOW

• 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

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Results of analysis

• 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%

84% 16%

% All Rx

Covered Non-covered

45%

43%

12%

Classification of Non-Covered Rx

Low Medium High

$21

$57

$91

$0

$10

$20

$30

$40

$50

$60

$70

$80

$90

$100

Average Cost / 15-day Rx

Low

Medium

High

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FY2015 Wage Index – CMS Report of Hospice

behavior and trends

• Released May 2, 2014. 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 124-144)

– 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

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