C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—MEDICARE PROGRAM › PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT › Subpart U—Reopening, ALJ Hearings and ALJ and Attorney Adjudicator Decisions, Council Review, and Judicial Review

42 C.F.R. § 423.2062

Applicability of policies not binding on the ALJ and Council

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(a) ALJs or attorney adjudicators and the Council are not bound by CMS program guidance, such as program memoranda and manual instructions, but will give substantial deference to these policies if they are applicable to a particular case.

(b) If an ALJ or attorney adjudicator or Council declines to follow a policy in a particular case, the ALJ or attorney adjudicator or Council decision must explain the reasons why the policy was not followed. An ALJ or attorney adjudicator or Council decision to disregard a policy applies only to the specific coverage determination or at-risk determination being considered and does not have precedential effect.

[74 FR 65363, Dec. 9, 2009, as amended at 82 FR 5137, Jan. 17, 2017; 83 FR 16754, Apr. 16, 2018]
Notes of Decisions
Cited in 1 case (1 in the last 5 years), 2021–2021 · leading case: Akebia Therapeutics, Inc. v. Azar (D. Mass. 2021).
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Akebia Therapeutics, Inc. v. Azar (D. Mass. 2021). “42 C.F.R. § 423.2062 . Thus, in an administrative review of a Part D participant’s claim that Auryxia should be covered, the ALJ and/or MAC would either adhere to the CMS decision by denying coverage or disregard the CMS decision (but only for that particular participant).”
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