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DEPARTMENT OF HEALTH AND HUMAN SERVICES
DEPARTMENTAL APPEALS BOARD
DECISION OF MEDICARE APPEALS COUNCIL
Docket Number: M-12-
In the case of
J.S.
(Appellant)
(Enrollee/Beneficiary)
Claim for
Prescription Drug Benefits (Part D)
Medica Health Care Plans (Part D Plan)
(HIC Number)
(ALJ Appeal Number)
The Administrative Law Judge (ALJ) issued a decision dated April 30, 2012, concerning the enrollee’s request for Medicare Part D coverage of Percocet® 5/325 mg. (Percocet) (generic name: oxycodone/acetaminophen). The ALJ denied coverage on the grounds that Percocet was not a medication covered by the enrollee’s Part D plan and the enrollee’s physician had not documented that Percocet was a medically reasonable and necessary exception to the Part D plan’s formulary needed to treat the enrollee’s condition.
The regulations at 42 C.F.R. § 423.2100 et seq. provide that an enrollee who is dissatisfied with an ALJ hearing decision concerning Medicare Part D prescription drug benefits may request that the Council review the ALJ’s decision. The Council reviews the ALJ’s decision de novo. 42 C.F.R. §§ 423.2100(b), 423.2108(a). The Council will limit its review of the ALJ’s action to the exceptions raised by the enrollee in the request for review, unless the enrollee is unrepresented. 42 C.F.R. § 423.2112(c).
The enrollee’s request for review has been entered into the record as Exhibit (Exh.) MAC-1. Having considered the record
and the contentions, the Council concludes that there is no basis for changing the ALJ’s decision and, accordingly, adopts the ALJ’s decision.
DISCUSSION
The enrollee’s pertinent medical history includes chronic back pain related to a herniated lumbar disc. Prior to the dates at issue here, the enrollee states that he received coverage for this drug, and the record reflects that the enrollee had been taking the drug since at least April 2011. Exh. 4, at 20.^1
(^1) While it is not clear from the record, it appears that the prescription drug plan may have covered the drug in 2011 but dropped it from the formulary beginning January 1, 2012.
The enrollee’s Part D prescription drug plan (PDP) denied the enrollee’s request for coverage of Percocet on February 14, 2012, finding that the enrollee’s physician did not provide the necessary supporting documentation. Exh. 6, at 23. The PDP upheld the denial on the grounds that “medical necessity was not met / alternatives available on formulary.” Exh. 8, at 31.
The enrollee sought reconsideration by an Independent Review Entity (IRE). The IRE denied coverage, following physician review. Exh. 9, at 38-39. The IRE noted that a PDP must grant an exception for a drug that is not on its formulary whenever it determines that the drug is medically necessary, consistent with the prescriber’s statement, and that the drug would be covered but for the fact that it is not on the formulary. However, in order to grant such an exception, the statement must show that all of the covered drugs on any tier of the plan’s formulary for treatment of the enrollee’s condition would not be as effective as the non-formulary drug or would have adverse effects for the enrollee. See 42 C.F.R. 423.578(b). The IRE noted that the beneficiary was intolerant to the generic form of the drug and that the brand name drug had been effective and well tolerated in the past. However, the IRE denied coverage on the grounds that the enrollee did not meet the exceptions criteria because the prescribing physician did not state why the alternative formulary drugs were likely to be unsafe or ineffective. Exh. 9, at 39.
On further appeal and in the decision which followed, the ALJ set out the applicable Part D legal authorities, including the regulations pertaining to the formulary exceptions process. Dec. at 3-9. The ALJ noted that the appellant testified that the generic equivalent drug (oxycodone/acetominophen) made him sluggish and lethargic and that he did not want to take
formulary exception. Thus, it is not necessary for the enrollee to provide the Council with the MRI, as offered.
The Council therefore adopts the ALJ decision.
MEDICARE APPEALS COUNCIL
/s/ Gilde Morrisson Administrative Appeals Judge
Date: June 05, 2012
