Form CMS-10538 Hospice Information for Medicare Part D Plans

Medicare Part D Hospice Care

Hospice Information for Medicare Part D Plans

Table of Contents

Introduction 2

Background 2

Purpose 2

1) To document that a drug is unrelated to a beneficiary’s terminal prognosis 3

2) To communicate a beneficiary’s change in hospice status. 3

3) To communicate medications listed on the plan of care 4

Users of the form and recommendations for use: 4

Hospice Provider 4

Prescriber 5

Medicare Part D Plan Sponsor/PBM 6

Pharmacy Provider 7

Signature Requirements: 7

Limited Customization of the Format 8

Introduction

In response to CMS’ request for comment on guidance issued December 6, 2013 many industry commenters recommended that CMS implement a standard Prior Authorization (PA) form to facilitate coordination between Part D sponsors, hospices and prescribers. In March, 2014 CMS guidance included a list of data elements that would be expected to be used in a Part D hospice PA form or documented by the sponsor when received verbally. Subsequently, the industry worked through the National Council of Prescription Drug Plans (NCPDP) Work Group 9 Hospice Task Group to develop a draft form to be used for documenting Part D coverage of drugs for beneficiaries enrolled in hospice. The form included the data elements CMS had included in our March guidance and is already in use by some Part D sponsors.

A slightly modified version of the form was included with the revised guidance issued on July 18, 2014 and we encourage all Part D sponsors and hospices to implement this version as a standard form. We believe that use of a uniform process and form will improve communication between hospice providers and Part D plans thereby enhancing the efficiency of the PA process, and will be to the overall benefit of Medicare beneficiaries.

Background

The Social Security Act in section 1861(dd) and Federal regulations in 42 CFR §418.106 and §418.202(f) require hospice programs to provide individuals under hospice care with drugs and biologicals related to the palliation and management of the terminal illness as defined in the hospice plan of care. Medicare payment is made to the hospice for each day an eligible beneficiary is under the hospice’s care, regardless of the amount of services provided on any given day. Because hospice care is a Medicare Part A benefit, drugs provided by the hospice and covered under the Medicare payment to the hospice program are not covered under Part D.

For prescription drugs to be covered under Part D when the enrollee has elected hospice, the drug must be for treatment of a condition that is unrelated to the terminal prognosis of the individual. The DHHS Office of the Inspector General (OIG) released a report in June 2012 identifying situations where Medicare may be paying twice for prescription drugs for hospice beneficiaries, who in turn could also be paying unnecessary co-payments for prescription drugs¹. As described in this report, “Hospice beneficiaries generally experience common symptoms during the end of life, regardless of their terminal diagnosis. These symptoms include pain, nausea, constipation, and anxiety.”

Purpose

The form will facilitate coordination between Part D sponsors, hospices, and pharmacists. Two primary uses are to document that a drug is unrelated to a beneficiary’s terminal prognosis and to convey a beneficiary’s change in hospice status. It may also be used for hospice providers to communicate and update the medications list from the beneficiary’s plan of care. These uses are discussed below:

1) To document that a drug is unrelated to a beneficiary’s terminal prognosis

CMS July 18, 2014 guidance² strongly encouraged Part D sponsors to place beneficiary-level PA requirements on the four categories of prescription drugs identified by the DHHS Office of Inspector General (OIG) discussed above: analgesics, antinauseants (antiemetics), laxatives, and antianxiety drugs (anxiolytics) for plan enrollees who have elected hospice. Hospice providers and Part D sponsors identified the need for a standardized form that would facilitate communication between all involved parties.

The form is to be used prospectively (i.e., prior to the submission of claim to Part D), to prevent a drug claim from rejecting at point-of-sale when a drug in any of the four classes is prescribed for a condition that is unrelated to a beneficiary’s terminal prognosis and the beneficiary is prepared to procure the drug. In this case, the hospice provider completes and submits this form to the plan sponsor to ensure that the beneficiary can access the drug at the point of sale.

Alternatively, if this documentation is not provided prospectively, the plan will be unable to determine whether the drug is related or unrelated to a beneficiary’s terminal prognosis and, therefore, whether the drug is covered under Part D. Thus, the pharmacy will receive an A3 reject, meaning that the claim has been rejected as “This Product May Be Covered Under Hospice – Medicare A” in combination with reject 75- Prior Authorization Required. In this case, the pharmacy will notify the beneficiary of the reject and may also notify the prescriber or the hospice. Once notified of the reject, the hospice provider or prescriber can complete and submit the form to the plan sponsor. The plan sponsor should accept it and use it to satisfy the CMS requirements and allow for normal processing of the claim. If a coverage determination is requested by the beneficiary prior to the sponsor’s receipt of the documentation, the plan sponsor must contact either the prescriber or the hospice provider to complete and submit the form. The plan sponsor should accept it and use it to satisfy the CMS requirements for removal of the A3 edit.

2) To communicate a beneficiary’s change in hospice status.

There is an inherent reporting lag between when beneficiaries elect the Medicare hospice benefit or are discharged/terminated from hospice and when a Part D sponsor is notified of the election or discharge/termination. This means that a Part D sponsor may pay claims that should be rejected for a beneficiary-level hospice prior authorization because the hospice election is unknown or reject claims at the point-of-sale because it believes the beneficiary is still in hospice. CMS has directed sponsors to use documentation presented by the hospice provider, beneficiary, or prescriber, similar to the manner in which best available evidence (BAE) is used to document low-income subsidy eligibility. Part D Plan sponsors should use the information to update the beneficiary’s hospice information until the official notice is received from CMS on the daily transaction reply report (TRR). If the TRR continues to reflect a different hospice status than the one communicated by the hospice, the Part D sponsor and the hospice should attempt to reconcile the difference so that the correct status is known for each beneficiary. The form may be used to convey the following:

a) Beneficiary’s hospice election/admission date;

b) Beneficiary’s revocation/discharge date;

c) Confirmation of the hospice election/admission or revocation/discharge date

3) To communicate medications listed on the plan of care

Medicare hospice providers are required to conduct and document a patient-specific comprehensive assessment in writing. The assessment must also include a drug profile with all of the patient’s prescription and over-the-counter (OTC) drugs, herbal remedies, and other alternative treatments that could affect drug therapy. Medication information obtained through the assessments, including whether the medications are related or unrelated to the terminal prognosis, should be provided to the Part D sponsor prospectively, before a hospice beneficiary presents a prescription for fill.

The form provides a uniform way for a hospice provider to provide initial and updated drug profiles to the Part D sponsor. It is important for the Part D sponsor to be aware of all drugs which the beneficiary will be taking as well as the source of payment for each drug. As a reminder the beneficiary must assume the financial liability for a drug that is beyond what is considered reasonable and necessary. If the patient or his/her representative does not agree with the hospice plan of care and refuses to accept medications prescribed to meet the assessed needs, then the hospice is required to document this in the clinical record.

Users of the form and recommendations for use:

The following lists the anticipated users of the form and recommendations for use.

Hospice Provider

To prospectively provide “unrelated” drug information to the Part D plan:

The hospice provider can use the form to identify drugs on the beneficiary’s treatment plan that fall into any of the four previously specified categories of prescription drugs and are unrelated to the terminal prognosis. Initiating communication prior to a claim’s submission will provide early notice to the Part D plan sponsor/PBM and reduce the number of claims rejected at the point of sale.

To provide information to override an A3 reject:

The hospice provider will:

• “Identify the beneficiary’s Medicare Part D plan information from the beneficiary’s Medicare Part D card or by contacting the pharmacy provider.

• Call the beneficiary’s Medicare Part D plan to obtain the appropriate fax number or other contact information to which the completed form should be directed.

• Complete and sign Section I.

• At the hospice’s option, complete Section II. Section II is not required to override the A3 reject. However, it is recommended that the hospice provider complete this section and provide copies to the beneficiary and the Medicare Part D plan to facilitate prospective/retrospective drug review processes.

• Transmit the completed form to the beneficiary’s Medicare Part D plan.

In some instances a hospice is made aware of a hospice A3 reject for one of their beneficiaries and the drug was prescribed by a community physician unaffiliated with the hospice. In those cases, the hospice should coordinate with the community physician who should complete and sign the form.

To report only a change in hospice status:

The hospice provider will:

• Check the “Enrollment” or “Termination”: box

• Complete the “To:” and “From:” information segment as well as the first 6 fields in the “Patient Information” segment.

• Complete the Hospice Admit or Discharge Date as applicable.

• Check the box in Section 1 B to indicate which document will be attached to the form (NOE or NOTR).

• Transmit the form and attachments to the beneficiary’s Part D plan.

To report plan of care information:

The hospice provider’s completion of Section II, which provides the plan of care information, is optional as it is not required to either override the A3 reject or communicate a change in the beneficiary’s hospice status. However, it is recommended that copies be provided to the beneficiary and to the Part D plan sponsor. Informing the plan sponsor of the additional medications prescribed and designating the responsible financial party will assist the sponsor in better managing the beneficiary’s coverage and providing appropriate access to medication.

Prescriber

To provide information to override an A3 reject:

Prescribers will:

• Identify the beneficiary’s Medicare Part D plan and obtain the appropriate fax number or other contact information to which the completed form should be directed.

• Complete Section 1 reporting each drug that is unrelated to the terminal prognosis.

• Transmit the completed form to the beneficiary’s Medicare Part D plan.

Prescribers unaffiliated with the hospice provider should also:

Contact the hospice provider to confirm that the medication is unrelated to the terminal prognosis, and check the box on Page 1 under the prescriber’s signature.

A signature indicates that the prescriber is aware that a medication is unrelated to the hospice prognosis. Part D sponsor may need to process more than one form for a beneficiary who is has multiple prescribers.

Medicare Part D Plan Sponsor/PBM

To prospectively satisfy PA requirements for a member enrolled in hospice:

When a Part D sponsor/PBM receives prospective notification of drug information from the hospice provider indicating that a beneficiary who has elected hospice is using Part D drugs in the four categories that are unrelated to the terminal illness, the sponsor/PBM will accept the form and use it to satisfy the PA requirement. These prospective communications are not requests for coverage determinations and need not comply with coverage determination timeframes and notice requirements. This is the case regardless of how the form is transmitted to the plan sponsor/PBM. For example, even if the notification is sent through the coverage determination fax line, it would not be considered a coverage determination because it was communicated prior to the sponsor/PBM’s receipt of a claim and a hospice provider cannot request a coverage determination.

To override A3 reject:

When the necessary information has been provided, the sponsor/PBM will override the A3 reject for the medications listed as being unrelated to the terminal prognosis. In order for the request to be considered complete all fields in Section I must be completed EXCEPT for the following:

Part A Plan sponsor Website Link

Hospice Pharmacy Benefit Manager (PBM) Information if not applicable

Upon receipt of the completed form, the Part D sponsor will override the A3 reject for the drugs listed. In addition the Part D sponsors will concurrently obtain and review the information necessary to promptly determine whether any applicable drug-specific UM requirement has been satisfied (or, alternatively, whether an exception to that UM requirement has been requested).

To process a change in hospice status:

When the necessary information has been provided, the plan sponsor/PBM will use the information submitted on and with the form as Best Available Evidence (BAE) to update the beneficiary’s hospice enrollment status. In order for the request to be considered complete the following fields in Section I must be completed:

Part A

Part B, Patient Name, DOB, Patient HICN# Prescriber, Name, Prescriber NPI

An indication whether an NOE or NOTR is attached

The appropriate form must be attached

The plan sponsor/PBM will ensure that the beneficiary’s hospice information is reflected in the sponsor’s systems until a Transaction Reply Report (TRR) is received from CMS with the updated election/termination information.

Use of plan of care information:

The plan sponsor/PBM may receive a form with the Section II completed. Although completion of Section II, which provides the plan of care information, is optional (i.e., it is not required to either override the A3 reject or communicate a change in the beneficiary’s hospice status), it is encouraged. When received by the sponsor/PBM, the information regarding the additional medications prescribed and the responsible financial party will assist the sponsor in their utilization review and coordination of care activities.

Pharmacy Provider

Assist the beneficiary in accessing unrelated drugs

When a Medicare Part D claim rejects with an A3 reject code, the pharmacy may contact the beneficiary’s hospice provider to provide the contact information for the Part D plan included in the supplemental messaging received with the A3 reject.

If the hospice provider is unknown and other sources have been exhausted to identify the beneficiary’s hospice, the pharmacy may contact the prescriber to alert him or her of the hospice election and determine whether this prescription is under the plan of care.

For “unrelated” medications, the pharmacy should request the hospice provider or prescriber to complete the Section I information for the Part D plan sponsor/PBM to override the A3 reject, and transmit to the beneficiary’s Medicare Part D plan.

When a pharmacy receives a copy of a completed form from the beneficiary, the pharmacy may transmit a copy to the Part D sponsor/PBM. This may be done prospectively prior to the submission of a drug claim or in response to the pharmacy’s receipt of an A3 reject.

Signature Requirements:

1. Section 1 of the form must be signed and dated by either the hospice representative or the prescriber when the form is utilized in the following ways:

1. to prospectively inform the Part D plan sponsor/PBM of drugs in the 4 categories that will likely be dispensed because they are both included in the plan of care and are unrelated to the terminal prognosis.

2. to document a change in hospice status and the appropriate signed (NOE or NOTR) is attached

The sponsor’s/PBM’s pharmacy help desk staff may sign the form in these two instances as well when staff complete the form based on a telephone contact with the hospice provider or prescriber. As part of the signature process, help desk staff should sign their name and include the name and contact information for the person who phoned in the information as well as the date the call was received.

2. All requests for a Hospice A3 Reject Override must be signed by the prescriber, the beneficiary or the hospice representative.

3. If Section II is completed, a hospice representative and the beneficiary/representative must sign.

Limited Customization of the Format

The form has been developed to provide a template for use by Part D sponsors. If the form is used, sponsors may customize it by including a plan logo and to facilitate electronic submission of the required information. For example plans may include bar coding on the form for clerical purposes. No other modifications are permitted.

HOSPICE INFORMATION FOR MEDICARE PART D PLANS

SECTION I -HOSPICE INFORMATION TO OVERRIDE AN “HOSPICE A3 REJECT” OR TO UPDATE HOSPICE STATUS

A. Purpose of the form (please check all appropriate boxes) :

Admission Proactive Rx Communication A3 Reject Override Termination

To: Medicare Part D Plan

From: Hospice Provider

Plan Name

Hospice Name

PBM Name

Address

Phone #

( ) -

Phone #

( ) -

Fax #

( ) -

Fax #

( ) -

Secure E-Mail

NPI

Contact Name

Contact Name

Plan Sponsor Website Link:

B. Patient Information

Prescriber Information

Patient Name

Prescriber Name

Patient DOB

Prescriber NPI

Patient ID # (HICN)

Practice Name

Hospice Admit Date

Practice Address

Hospice Discharge Date

Contact Name

Principal Diagnosis Code

Practice Phone Number

( ) -

Other Diagnosis Code (s)

Practice Fax #

( ) -

Unrelated Diagnosis Code (s)

Hospice Affiliated

• YES NO

For change in hospice status update documentation is required. Please check to indicate which document is attached.

Notice of Election Notice of Termination /Revocation

C. Hospice Pharmacy Benefit Manager (PBM) Information
PBM Name		BIN		Cardholder ID
PBM Phone #	( ) -	PCN		Group ID

D. Prior Authorization Process: Enter a separate line for each Analgesic, Antinauseant (antiemetic), Laxative, and Antianxiety drug (anxiolytic) Medication that is Unrelated to Terminal Prognosis . Drugs outside of these four classes do not require prior authorization.

Medication Name and Strength

Dosing Schedule

Quantity/

Month

Rationale to Support the Medication is Unrelated to Terminal Prognosis (Optional)

E. Signature of Hospice Representative or Prescriber (Required).

Representative Date / /

Title _______________________________________________

Prescriber* Date / / _

No

Yes

*If the prescriber of the medication is unaffiliated with the Hospice provider, has the prescriber confirmed with the Hospice provider that the medication is unrelated to the terminal prognosis?

SECTION II – PLAN OF CARE (Optional)

Hospice Name

Hospice NPI

Patient Name

Patient ID# (HICN)

Patient DOB

/ /

Additional Medications Under Hospice Plan of Care and Designation of Financial Responsibility
Medication Name and Strength	Hospice	Patient	Medication Name and Strength	Hospice	Patient

Signature of Hospice Representative

Representative Date / /

Signature of Beneficiary or Beneficiary Authorized Representative

Beneficiary/Representative Date / /

PRA Disclosure Statement

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-New. The time required to complete this information collection is estimated to average 5 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.

1 Office of the Inspector General, Department of Health and Human Services. Medicare Could Be Paying Twice for Prescription Drugs for Beneficiaries in Hospice. June, 2012. A-06-10-00059.

2 Part D Payment for Drugs for Beneficiaries Enrolled in Hospice-Final 2014 Guidance available at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Downloads/Part-D-Payment-Hospice-Final-2014-Guidance.pdf