Hospice and Access to Medications Update: CMS Replacement Guidance

Quick Summary

When Medicare beneficiaries elect the hospice benefit, they waive Medicare coverage for all care and services related to the terminal illness that are not on the hospice plan of care and provided through the hospice provider.  This means that when a terminally ill beneficiary elects hospice, all of the medications needed to control the pain and symptoms related to the terminal illness should be paid for by the hospice provider from the hospice Medicare payment.  All medications that are not related to the terminal illness should continue to be paid for by the beneficiary’s Medicare Part D Plan Sponsor (insurance company that administers the beneficiary’s prescription drug benefit).

On July 18, 2014, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum to Part D Plan Sponsors and Medicare hospice providers replacing its March 10, 2014 Guidance. Pursuant to the replacement guidance, the only Part D medications requiring a “hospice prior authorization” are:  analgesics (medications used to treat pain); antiemetics (medications used to treat nausea); laxatives; and anxiolytics (medications used to treat anxiety which we find out here).   This means that when Medicare beneficiaries elect hospice they should not have difficulty accessing medically necessary medications that are not related to their terminal condition through their Part D plans.

Brief History

On March 10, 2014, CMS issued a memorandum entitled, “Part D Payment for Drugs for Beneficiaries Enrolled in Hospice – Final 2014 Guidance.”  The Guidance directed Part D Plan Sponsors to “place beneficiary-level prior authorization (PA) requirements on all drugs for beneficiaries who have elected hospice…”  This direction was based on the mistaken assumption that once a beneficiary elects hospice, all of her medications will be related to the terminal illness and thus the financial responsibility of the hospice provider.  After the original memorandum was issued, the Center for Medicare Advocacy and over 40 other advocate and provider organizations, including the American Medical Association, asked CMS to rescind the policy because it created significant barriers for beneficiary access to necessary Part D medications.

Replacement Guidance

In response to our efforts, CMS issued an immediately-effective replacement guidance on July 18th.  Cryptically, within the text of the replacement guidance, CMS indicates that Part D Plan Sponsors are “encouraged” to fully implement the policy by no later than October 1, 2014.  Pursuant to the replacement guidance, once a Medicare beneficiary elects the hospice benefit, Part D Plan Sponsors should continue to fill medications as they were filled prior to the election except for analgesics, antiemetics, laxatives, and anxiolytics.  For these four categories, the Part D Plan Sponsors should require prior authorization.  This is because these four categories are usually related to palliative treatment for the terminal illness and related conditions, and thus are usually, (but not always) covered as part of the Medicare hospice benefit.

Under the Medicare Conditions of Participation, when a beneficiary elects the hospice benefit and is admitted to a hospice agency, the hospice provider should complete a drug profile which includes all the patient’s prescription and over-the-counter medications.  Going forward, hospice providers should use this information to complete the standardized Hospice Information for Medicare Part D form and send it to the Medicare Part D Plan Sponsor.  The form will pre-emptively identify for the Plan Sponsor any medications which fall into the identified categories and are unrelated to palliation of the terminal illness or related conditions.  On the form, hospice providers need not justify why the medication is unrelated to the terminal illness.  They are expected, however, to document the clinical basis for this conclusion in the patient’s medical record and to provide this information to the Plan Sponsor should it be requested at a later date.

The Plan Sponsor should use the information provided by the hospice provider as evidence of a hospice election and to override the point of service reject requiring prior authorization for any medications identified by the hospice as within one of the four categories, but not related to palliative care for the terminal illness or related conditions.  As a failsafe, CMS asks hospice providers to pay for a “compassionate first fill” in the event a beneficiary is turned away from the pharmacy without her medically necessary medications.  If a beneficiary’s Medicare Part D Plan Sponsor refuses to pay for a medication because the beneficiary has elected hospice, the beneficiary should ask the hospice provider for immediate assistance with this matter, including the “compassionate first fill.”

If a hospice provider has not completed the Hospice Information for Medicare Part D form, and the Medicare beneficiary attempts to fill a prescription for a medication in one of the identified four categories, the pharmacist will get a computer generated statement indicating that hospice prior authorization is required.  At that point, the pharmacist or the beneficiary will need to contact the hospice provider or prescribing physician.  The hospice provider or prescribing physician will need to provide an oral or written statement to the pharmacy or the Part D Sponsor indicating that the medication is not related to the terminal illness.  Once this information is received, the Plan Sponsor should override the point of service rejection.

In the event that neither the hospice provider nor the prescribing physician will provide the necessary statement, the pharmacy will provide the standardized pharmacy notice which will instruct the beneficiary on how to contact the Part D Plan Sponsor for a coverage determination.  If the beneficiary requests a coverage determination, the Plan Sponsor should contact the prescriber and ask whether the medication is related to the terminal illness.  If the Plan Sponsor cannot contact the prescribing physician, it may contact the hospice provider to determine whether the medication is related to the terminal illness. Once the prescribing physician or the hospice provider renders the statement indicating that the medication is unrelated to the terminal illness, the Plan Sponsor will have 24 hours (for and expedited request) or 72 hours (for a standard request) to issue a coverage decision.

When Medicare beneficiaries are discharged from hospice or revoke the hospice benefit, the Medicare Part D Plan Sponsor immediately resumes responsibility for all coverable Part D medications.  At the time of the discharge, hospices are again encouraged to send the Hospice Information for Medicare Part D standardized form to the Part D Plan Sponsor with information indicating the date of discharge or revocation.  In the event that a hospice fails to comply with this request, the replacement guidance directs Part D Plan Sponsors to accept a copy of the hospice revocation, the Notice of Medicare Non-Coverage, or the hospice discharge summary as sufficient evidence to override the point of service prior authorization requirement.

Analysis

The replacement guidance is significantly better than the original.  Fewer medications will require prior authorization and as long as Part D Plan Sponsors, pharmacists, and hospice providers comply with its requirements, Medicare beneficiaries should not experience difficulty accessing their Part D medications.

Unfortunately, the replacement guidance, like the original relies upon the good will and prompt diligence of hospice providers, pharmacies, and Part D Plan Sponsors to ensure Medicare beneficiaries do not lose access to medications necessary to prevent pain, nausea, constipation, and anxiety.  It also gives no time frames, with the exception of a formal coverage request, to ensure that the sponsors, pharmacists, and providers act expeditiously.

Moreover, the replacement guidance, like the original, provides no real appeal process for hospice patients who believe the hospice provider is providing the wrong medication or not enough medication to control the symptoms related to the terminal illness.  This oversight will be discussed further in a forthcoming CMA Alert.

Conclusion

As of July 18, 2014, Medicare beneficiaries who elect the hospice benefit should encounter no coverage change for medications billed to their Medicare Part D Sponsor unless the medication is related to pain management, anti-nausea, laxatives, or anti-anxiety.  If the medication falls into one of these categories, it is probably related to the terminal illness and should be billed to the hospice provider.  If it is unrelated to the terminal illness, the hospice provider should proactively notify the Part D Plan Sponsor (ideally via the standardized Hospice Information for Medicare Part D). This notification permits the Sponsor to override the prior authorization requirement and so long as the medication meets all other Part D coverage requirements, pay the claim.

July 24, 2014 – Terry Berthelot