On July 18, 2014 the Centers for Medicare & Medicaid Services (CMS) released a memorandum, Part D Payment for Drugs for Beneficiaries Enrolled in Medicare Hospice, which updates the guidance previously released in March. Under the new guidance, in lieu of placing a beneficiary-level prior authorization (PA) on all drugs for beneficiaries who have elected hospice, CMS strongly encourages Part D sponsors to place beneficiary-level PA requirements on only four categories of prescription drugs: analgesics, antinauseants (antiemetics), laxatives, and antianxiety drugs (anxiolytics).
Drugs prescribed for hospice patients under these four categories and paid for under Part D were the subject of a 2012 Office of the Inspector General (OIG) report in which concerns were raised that Medicare may be paying twice for drugs for hospice patients -- once under the bundled hospice per diem that includes drugs that are prescribed for the terminal diagnosis and related conditions and again under Part D.
In the memo, CMS conveys that it expects that medications in these four drug classes will rarely be unrelated to the patient’s principal terminal diagnosis and related conditions so hospice will be paying for these medications most of the time. While CMS indicates that the change is effective immediately and strongly encourages plans to implement the guidance as soon as possible, plans MUST implement the guidance by until Oct. 1, 2014.
Requirements under the previous guidance - across-the-board PA for drugs processed by Part D for hospice patients - resulted in significant problems for patients and their families in accessing needed medications, as well as for hospice providers and Part D plans. On June 25 CMS officials met with a wide array of stakeholders, including representatives of the National Association for Home Care & Hospice, who documented these problems. The issue also generated widespread media attention and engagement of members from both houses of Congress.
In the July 18 memo, CMS points out that hospice providers should note that there are drugs that are statutorily excluded from the Part D benefit, including drugs for the symptomatic relief of cough and cold, most prescription vitamins, and nonprescription (i.e., OTC) drugs. In order to lessen beneficiary confusion, hospices should avoid referring beneficiaries to their Part D plan/pharmacy for coverage for these medications.
While the Part D-hospice coordination PA requirement is lifted for drugs that do not fall under the 4 categories of drugs identified in the memo, drugs prescribed for beneficiaries who have elected the hospice benefit that are unrelated to the terminal illness and related conditions continue to be subject to standard Part D formulary management practices, including quantity limitations, step therapy, and prior authorization that have been approved by CMS.
This new guidance replaces previous guidance and is in effect until something more permanent is identified. This means the guidance is just that – guidance. Part D plans are still able to develop their own policies, procedures, and forms for the PA for hospice beneficiary medications.
This is a continuing concern for NAHC and we strongly encourage providers to share information with us about problems that arise under which patients are unable to receive Part D-covered medications in a timely manner. Please send information to email@example.com Katie@nahc.org, and put “Part D/Hospice Coordination” in the subject line.
A summary of the key changes in the guidance is below.
There are some changes that should expedite the patient receiving his/her medications. The Part D plans are encouraged to accept information directly from the hospices. Specifically, the Part D plan should not wait for the beneficiary, beneficiary’s representative, or the prescriber to formally request a determination. If a claim has been rejected by a sponsor due to the beneficiary-level hospice PA, the pharmacy or beneficiary may contact the hospice provider for a statement that the drug is unrelated to the terminal illness and related conditions. The hospice provider should contact the Part D sponsor to provide an oral or written statement or provide a written statement to the pharmacy or the beneficiary to transmit to the Part D sponsor. The sponsor should accept this information to override the point of sale (POS) reject without requiring that the beneficiary, or others on their behalf, request a coverage determination. When the beneficiary, the beneficiary’s appointed representative or the prescriber requests a coverage determination, the sponsor should contact either the prescriber or the hospice provider and accept and use the statement that the drug is unrelated to the terminal illness and/or related conditions provided by either the prescriber or hospice.
Likewise, hospice providers are encouraged to report a beneficiary’s Medicare hospice election to the Part D sponsor and identify any drugs in the four categories determined to be coverable under Part D because the drugs are unrelated to the terminal illness and/or related conditions prior to the submission of a claim.
The documentation that a medication is unrelated no longer must include a detailed statement of the clinical reasons why the medication is unrelated. Instead a simple statement which could be “U” or “unrelated” is to be accepted by the Part D plan in order to provide the medication to the patient. However, the hospice should still have clearly documented the reason(s) the medication is unrelated in the patient’s medical record. Consistent with the guidance set forth above, Part D sponsors should accept the prescriber’s or hospice provider’s statement and retain the documentation.
CMS is strongly encouraging hospice providers to supply a compassionate “first fill” for any medication needed by a beneficiary who is experiencing difficulty in accessing the drug at POS. If the drug provided is unrelated to the terminal illness and related conditions, the hospice provider should contact the Part D sponsor to negotiate recovery of the hospice’s payment to the pharmacy at a later date.
CMS is also encouraging use of a standardized formwhich should be accepted by all Part D plans. This form replaces the list of data elements previously identified by CMS for a PA. The first page of the form captures the information necessary for the prior authorization of drugs in the four categories; the second page captures information on drugs related to the terminal illness and/or related conditions and specifies whether each of these drugs is the responsibility of the hospice or beneficiary. The form provides space for a rationale to support the drug is unrelated; however, no clinical justification for that determination is necessary. While hospice providers are not required to complete the second page of the form, should they choose to complete it, the information will assist sponsors in care coordination activities. Although CMS encourages Part D sponsors and hospice providers to use this two-page form, sponsors should not require its use. As long as the necessary statement that the drug is unrelated is provided, the sponsors should accept it in any format.
CMS does not expect Part D sponsors to retrospectively review paid claims for drugs outside of the four categories specifically for the purpose of determining whether the drugs were unrelated to the hospice beneficiary’s terminal illness and related conditions. However, all Part D retrospective review requirements continue to apply to these claims. It is unclear how CMS or the Part D plans may choose to review/pursue this in the future.
NAHC is updating its “Part D Toolkit” and those revisions should be available to member hospices in the very near future. NAHC is also developing a list of questions related to the revised process for submission to CMS to gain greater clarity on certain aspects of the revised process. For more on NAHC's reaction to CMS' easing of PA requirements, please see NAHC Report, July 18, 2014.