Medicare Part D - Enrollment Deadline

SOME BENEFICIARY CONCERNS ABOUT THE MEDICARE PART D APPEALS PROCESS

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Scope of Maximus Review: De Novo or Limited to PDP Application of Exceptions Policy

The Center for Medicare Advocacy is concerned about an apparent conflict between the regulations and the QIC Reconsideration Procedure Manual [QIC Manual] regarding the scope of QIC review. The regulations state that the IRE will review whether the drug is medically necessary. 42 C.F.R. ง 423.600. However, the QIC Manual limits the scope of CHDR Maximus review to whether the Prescription Drug Plan (PDP) applied its own exceptions process/criteria correctly. QIC Manual ง 4.2 EXCEPTIONS REQUESTS, p. 18. Since the PDP’s exceptions process/criteria could exclude a drug that is medically necessary, this definition of the issue for review will result in IRE affirmations of denials of drugs that are medically necessary.

Therapeutic Substitution: Whether Attending Physician Agreement is Required

The Center is concerned that the regulations imply that attending physician agreement with therapeutic substitution is not required, since there would be no appeals on this issue if therapeutic substitutions could be made only with physician approval. The Part D statute allows an exception to the formulary whenever the prescribing physician determines that a PDP preferred drug would not be as effective or have adverse effects. S.S.A. ง 1860D-4(g)(2). The regulations refer to FDA determinations of therapeutic equivalency, but as an adjunct to physician agreement rather than as a substitute for it. 42 C.F.R. งง 423.100, 423.578. If the use of therapeutic substitution is limited to situations where the physician has given approval, there would be no appeal of such substitutions because appeals require physician support.

Redetermination Process, ง 423.586: Whether Beneficiary Can Present Evidence in Person

There is serious concern that Maximus interprets this provision of the regulations as simply allowing the beneficiary to deliver evidence to the PDP site in person (e.g., no in person hearing available at the redetermination level). The Part D regulations quite rightly state that the PDP must allow a beneficiary and physician to present evidence and argument in person. 42 C.F.R. ง 423.586. However, the QIO Manual nullifies this straightforward requirement by the interpreting it to require only that the evidence and argument may be “hand delivered.” ง 4.3 REDETERMINATIONS, Manual, p. 20.

Exceptions Process, ง 423.578: Lack of Weight Given to Prescribing Physician’s Opinion

A serious concern is that the Part D appeal regulations expressly preclude deference to the attending physician’s opinion in making determinations about requests for exceptions. In contrast, the statute gives determinative effect to opinion of the attending physician in the following language: “a nonpreferred drug could be covered under the terms applicable for preferred drugs if the prescribing physician determines that the preferred drug for treatment of the same condition either would not be as effective for the individual or would have adverse effects for the individual or both. “ S.S.A. ง 1860D-4(g)(2). However, the regulations conflict with this clear-cut statutory directive by explicitly precluding deference to the physician’s support for an exception. 42 C.F.R. ง 423.578(f).

Reconsideration Process: Non-Participation of Beneficiary

The Center’s final concern is that the QIO Manual creates an appeal process dominated by the PDP. In this process, the PDP is relied upon to present both its and the beneficiary’s positions to CHDR Maximus. There is much emphasis in the manual on developing a close, ongoing relationship between the PDP and the IRE, and no process for obtaining input directly from the beneficiary or the beneficiary’s doctor. See, e.g., Manual ง 3.3.2 (PDP designates key contacts with QIC, p. 12); ง 4.2 (PDP submits file upon which QIC makes decision, pp. 13); ง 4.5 (PDP decides who can bring an appeal, p. 23); ง 5.3 - 5.3.2. (description of information PDP should submit to justify its denial decision, pp. 32 - 37 (emphasis added)); ง 6.3.2 (no oral communication allowed between QIC and parties, p. 42); ง 6.6 - 6.6.3 (PDP should submit additional information if QIC needs it, p.43.) This design of the IRE process is almost certain to produce bias in favor of the PDP. In this regard it will replicate the current CHDR Maximus process for reviewing MA decisions, which not surprisingly has resulted in a low rate of decisions for the beneficiary.