42 C.F.R. § 423.566

Coverage determinations

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(a) Responsibilities of the Part D plan sponsor. Each Part D plan sponsor must have a procedure for making timely coverage determinations in accordance with the requirements of this subpart regarding the prescription drug benefits an enrollee is entitled to receive under the plan, including basic prescription drug coverage as specified in § 423.100 and supplemental benefits as specified in § 423.104(f)(1)(ii), and the amount, including cost sharing, if any, that the enrollee is required to pay for a drug. The Part D plan sponsor must have a standard procedure for making determinations, in accordance with § 423.568, and an expedited procedure for situations in which applying the standard procedure may seriously jeopardize the enrollee's life, health, or ability to regain maximum function, in accordance with § 423.570.

(b) Actions that are coverage determinations. The following actions by a Part D plan sponsor are coverage determinations:

(1) A decision not to provide or pay for a Part D drug (including a decision not to pay because the drug is not on the plan's formulary, because the drug is determined not to be medically necessary, because the drug is furnished by an out-of-network pharmacy, or because the Part D plan sponsor determines that the drug is otherwise excludable under section 1862(a) of the Act if applied to Medicare Part D) that the enrollee believes may be covered by the plan;

(2) Failure to provide a coverage determination in a timely manner, when a delay would adversely affect the health of the enrollee;

(3) A decision concerning an exceptions request under § 423.578(a);

(4) A decision concerning an exceptions request under § 423.578(b); or

(5) A decision on the amount of cost sharing for a drug.

(c) Who can request a coverage determination. Individuals who can request a standard or expedited coverage determination are—

(1) The enrollee;

(2) The enrollee's representative, on behalf of the enrollee; or

(3) The prescribing physician or other prescriber, on behalf of the enrollee.

(d) Who must review coverage determinations. If the Part D plan sponsor expects to issue a partially or fully adverse medical necessity (or any substantively equivalent term used to describe the concept of medical necessity) decision based on the initial review of the request, the coverage determination must be reviewed by a physician or other appropriate health care professional with sufficient medical and other expertise, including knowledge of Medicare coverage criteria, before the Part D plan sponsor issues the coverage determination decision. The physician or other health care professional must have a current and unrestricted license to practice within the scope of his or her profession in a State, Territory, Commonwealth of the United States (that is, Puerto Rico), or the District of Columbia.

[70 FR 4525, Jan. 28, 2005, as amended at 74 FR 1546, Jan. 12, 2009; 76 FR 21576, Apr. 15, 2011; 86 FR 6119, Jan. 19, 2021]

Notes of Decisions

Cited in 9 cases (4 in the last 5 years), 2008–2023 · leading case: Do Sung Uhm v. Humana, Inc.

Sort: Relevance Newest Treatment

Do Sung Uhm v. Humana, Inc. (2010) ca9 “” 42 C.F.R. § 423.566 (b)(1) (2005). Although the Uhms do not allege that Humana affirmatively denied any request for benefits, its failure to make benefits available to the Uhms on January 1, 2006, was tantamount to such a denial.”

Southwest Pharmacy Solutions, Inc. v. Centers for Medicare & Medicaid Services (2013) ca5 · cites it 2× “See 42 C.F.R. § 423.566 (c). Consequently, in order to obtain judicial review of a regulatory challenge to the PPR, a provider must seek to be appointed as the representative of an enrollee.”

Uhm v. Humana Inc. (2008) ca9 “42 C.F.R. § 423.566 (b). Although the Uhms argue that their claim is antecedent to the coverage determination process — -that is, their complaint is that they were never able to request drug benefits in the first instance, let alone dispute the plan’s potential denial of a…”

Alston v. United Healthcare Servs., Inc. (2018) mtd “See 42 C.F.R. § 423.566 . See 42 C.F.R. § 423.”

Ani Gharibian v. Valley Campus Pharmacy, Inc. (2023) ca9 “, 42 C.F.R. § 423.566 (b). Because the SAC fails to adequately plead materiality with respect to the two remaining allegations, the district court did not commit reversible error in dismissing the SAC in its entirety.”

Akebia Therapeutics, Inc. v. Azar (2021) mad “§§ 1395w-104(g), 1395w-22(g)(1)–(3); 42 C.F.R. § 423.566 (b)(1). Second, if the sponsor denies coverage, a beneficiary, an appointed representative, or a prescribing physician may request a redetermination by the sponsor.”

Medicaid and Medicare Advantage Products Association of Puerto Rico, Inc. v. Carrau-Martinez (2022) prd “2; 42 C.F.R. 423.566; see Comp. at ¶ 53. ERISA-covered health plans are sponsored by employers and employee organizations and provide health benefits to employees.”

Medicaid and Medicare Advantage Products Association of Puerto Rico, Inc. v. Carrau-Martinez (2023) prd “2; 42 C.F.R. 423.566; see Comp. at ¶ 53. ERISA-covered health plans are sponsored by employers and employee organizations and provide health benefits to employees.”

Uhm v. Humana Inc (2008) ca9 “42 C.F.R. § 423.566 (b). [11] Although the Uhms argue that their claim is anteced- ent to the coverage determination process—that is, their com- plaint is that they were never able to request drug benefits in the first instance, let alone dispute the plan’s potential denial of a…”

Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.