Prescription Drug Coverage Determinations and Exceptions, Appeals & Grievances

Coverage Determination, Appeals & Grievance Definitions:

Appeal: Any of the procedures that deal with the review of adverse coverage determinations made by the Part D plan sponsor on the benefits under a Part D plan the enrollee believes he or she is entitled to receive, including a delay in providing or approving the drug coverage (when a delay would adversely affect the health of the enrollee), or on any amounts the enrollee must pay for the drug coverage, as defined in §423.566(b). These procedures include redeterminations by the Part D plan sponsor, reconsiderations by the independent review entity (IRE), Administrative Law Judge (ALJ) hearings, reviews by the Medicare Appeals Council (MAC), and judicial reviews.

Complaint: A complaint may involve a grievance, coverage determination, or both. A complaint also may involve a low-income subsidy (LIS) or late enrollment penalty (LEP) determination. Every complaint must be handled under the appropriate process.

Coverage Determination: Any decision made by or on behalf of a Part D plan sponsor regarding payment or benefits to which an enrollee believes he or she is entitled.

Effectuation: Compliance with a complete or partial reversal of a Part D plan sponsor’s original adverse coverage determination. Compliance may entail payment of a claim, or authorization for or provision of a benefit.

Enrollee: A Part D eligible individual who has elected a Part D plan offered by a Part D plan sponsor.

Grievance: Any complaint or dispute, other than one that involves a coverage determination or an LIS or LEP determination, expressing dissatisfaction with any aspect of the operations, activities, or behavior of a Part D plan sponsor, regardless of whether remedial action is requested. A grievance may also include a complaint that a Part D plan sponsor refused to expedite a coverage determination or redetermination. Grievances may include complaints regarding the timeliness, appropriateness, access to, and/or setting of a provided item.

Independent Review Entity (IRE) : An independent entity contracted by CMS to review Part D plan sponsor denials of coverage determinations.

Inquiry: Any oral or written request to a Part D plan sponsor or one of its contractors that does not involve a request for a coverage determination/exception request.

Other Prescriber: A health care professional other than a physician who is authorized under State law or other applicable law to write prescriptions.

Quality Improvement Organization (QIO) : Organizations comprised of practicing doctors and other health care experts under contract to the Federal government to monitor and improve the care given to Medicare enrollees. They review complaints raised by enrollees about the quality of care provided by physicians, inpatient hospitals, hospital outpatient departments, hospital emergency rooms, skilled nursing facilities, home health agencies, Medicare managed care plans, Medicare Part D prescription drug plans, and ambulatory surgical centers. The QIOs also review continued stay denials in acute inpatient hospital facilities as well as coverage terminations in skilled nursing facilities (SNFs), home health agencies (HHAs) and comprehensive outpatient rehabilitation facilities (CORFs).

Quality of Care Issue: A quality of care issue may be filed through the Part D plan sponsor's grievance process and/or a QIO. A QIO must determine whether the quality of services (including both inpatient and outpatient services) provided by a Part D plan sponsor meets professionally recognized standards of health care, including whether appropriate health care services have not been provided or have been provided in inappropriate settings.

Responsibilities of the Part D Plan Sponsor

Each Medicare Part D plan sponsor and each Medicare Part D plan that it offers must establish and maintain procedures for:

1. Standard and expedited coverage determinations;
   
   
2. Standard and expedited appeals; and
   
   
3. Standard and expedited grievances.

Part D plan sponsors also must provide written information to enrollees about the grievance and appeal procedures that are available to them through the Part D plan sponsor, at the following times:

1. Grievance procedure - at initial enrollment, upon involuntary disenrollment initiated by the Part D plan sponsor, upon denial of an enrollee's request for expedited review, upon an enrollee's request, and annually thereafter;
   
   
2. Appeal procedure, including the right to expedited review - at initial enrollment, upon notification of an adverse coverage determination or denial, and annually thereafter. If a plan changes its formulary or the cost-sharing status of a drug that has been prescribed for an enrollee, the plan must provide written information about the grievance and appeal procedures to enrollees who are affected by the change
   
   
3. Quality of care complaint process available under the Quality Improvement Organization (QIO) process at initial enrollment, and annually thereafter.

Each plan sponsor must conduct meaningful and thorough coverage determinations and redeterminations by:

1. Attempting to contact prescribing physicians or other prescribers to obtain supporting statements and additional medical documentation necessary to evaluate a request, as appropriate;
   
   
2. Attempting to obtain representation documentation from a non-enrollee appellant who presents as a representative;
   
   
3. Ascertaining state law and validating the representative status of a non-enrollee appellant who presents as a representative on behalf of an incompetent or incapacitated enrollee; and
   
   
4. Issuing determinations in a timely manner and in accordance with exceptions policies and criteria.

Plan sponsors must promote timely, efficient, and meaningful reconsideration appeals at the IRE level by:

1. Promptly identifying all requests for case files from the IRE, including requests that are made by fax
   
   
2. Pursuant to an expedited case file request, delivering (by overnight delivery or fax) the complete case file to the IRE no later than 24 hours after receiving the request from the IRE;
   
   
3. Pursuant to a standard case file request, delivering (by overnight delivery or fax) the complete case file to the IRE as promptly as possible, but no later than 48 hours after receiving the request from the IRE; and
   
   
4. Complying with other applicable procedures for appeals processing set forth in the IRE Reconsideration Process Manual.

As with all contractual responsibilities in the Part D program, the plan may delegate any of its grievance, coverage determination, and/or appeals responsibilities to another entity or individual that provides or arranges Part D benefits. In cases of delegation, the Part D plan sponsor remains responsible and must therefore ensure that requirements are met completely by its delegated entity and/or individual.

Rights of Medicare Part D Enrollees

Relative to grievances, coverage determinations, and appeals, the rights of Part D enrollees include, but are not limited to, the following:

Grievances

1. The right to have grievances heard and resolved in accordance with the guidelines that are described in this chapter of the manual;
   
   
2. The right to request quality of care grievance data from Part D plan sponsors; and
   
   
3. The right to make a quality of care complaint under the QIO process.

Coverage Determinations

1. The right to a timely coverage determination;
   
   
2. The right to request an expedited coverage determination as described in this chapter;
   
   
3. The right to receive information from a network pharmacist regarding the enrollee’s ability to obtain a detailed written notice from the Part D plan sponsor regarding the enrollee’s Part D benefits;
   
   
4. The right to a detailed written notice of a Part D plan sponsor’s decision to deny a benefit in whole or in part, which includes the enrollee’s appeal rights; and
   
   
5. The right to receive notice when a coverage determination is forwarded to the IRE.

Representative Filing on Behalf of the Enrollee

An enrollee may have a representative who is either appointed by the enrollee or authorized under State or other applicable law to act on behalf of the enrollee in filing a grievance, requesting a coverage determination, or in dealing with any of the levels of the appeals process. An enrollee may appoint any individual (such as a relative, friend, advocate, attorney, physician or other prescriber, or an employee of a pharmacy, charity, state pharmaceutical assistance program, or other secondary payor) to act as his or her representative. Alternatively, an enrollee’s representative (surrogate) may be appointed by a court or authorized under State or other applicable law to act on the enrollee’s behalf. A surrogate could include, but is not limited to, a court appointed guardian, an individual who has Durable Power of Attorney or a health care proxy, or a person designated under a health care consent statute.

Note: With the exception of incapacitated or legally incompetent enrollees where appropriate legal papers, or other legal authority, support this representation, or where a state’s authorized representative rules require otherwise, both the enrollee making the appointment and the representative accepting the appointment must sign, date, and complete an appointment of representative form or similar written statement.

If an enrollee wishes to appoint a representative to act on his or her behalf, the enrollee must submit a written representative statement to the Part D plan sponsor. An enrollee may use Form CMS-1696 (Appointment Of Representative) or an equivalent written notice to make the appointment. A notice is an "equivalent written notice" if it:

1. Includes the name, address, and telephone number of enrollee;
   
   
2. Includes the enrollee’s HICN;
   
   
3. Includes the name, address, and telephone number of the individual being appointed;
   
   
4. Contains a statement that the enrollee is authorizing the representative to act on his or her behalf for the claim(s) at issue, and a statement authorizing disclosure of individually identifying information to the representative;
   
   
5. Is signed and dated by the enrollee making the appointment; and
   
   
6. Is signed and dated by the individual being appointed as representative, and is accompanied by a statement that the individual accepts the appointment
   
   
7. See Sesction 29, §270.1.3, of the Medicare Claims Processing Manual for more information about whether a notice is an "equivalent written notice."

A surrogate asserting that he or she is acting in accordance with a state’s authorized representative requirements must include a statement verifying his or her status under State law in the same manner that an appointed representative must submit a valid Form CMS-1696 or other equivalent notice. The Part D plan sponsor is responsible for determining whether a person or entity who asserts surrogate status is an appropriate surrogate under state law. If a surrogate submits the statement described above and the plan sponsor determines that the surrogate is acting in accordance with a state’s authorized representative requirements, the plan sponsor or other appeal entity cannot also require the authorized representative to submit an additional Form CMS-1696 or other equivalent notice. The plan sponsor must submit an attestation to the IRE certifying the validity of the representation under state law if the IRE requests an enrollee’s case file.