C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—MEDICARE PROGRAM › PART 422—MEDICARE ADVANTAGE PROGRAM › Subpart M—Grievances, Organization Determinations and Appeals

42 C.F.R. § 422.566

Organization determinations

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(a) Responsibilities of the MA organization. Each MA organization must have a procedure for making timely organization determinations (in accordance with the requirements of this subpart) regarding the benefits an enrollee is entitled to receive under an MA plan, including basic benefits as described under § 422.100(c)(1) and mandatory and optional supplemental benefits as described under § 422.102, and the amount, if any, that the enrollee is required to pay for a health service. The MA organization must have a standard procedure for making determinations, in accordance with § 422.568, and an expedited procedure for situations in which applying the standard procedure could seriously jeopardize the enrollee's life, health, or ability to regain maximum function, in accordance with §§ 422.570 and 422.572. For an applicable integrated plan, beginning January 1, 2021, the MA organization must comply with §§ 422.629 through 422.634 in lieu of §§ 422.566(c) and (d), 422.568, 422.570 and 422.572 with regard to the procedures for making determinations, including integrated organization determinations and integrated reconsiderations, on a standard and expedited basis.

(b) Actions that are organization determinations. An organization determination is any determination made by an MA organization with respect to any of the following:

(1) Payment for temporarily out of the area renal dialysis services, emergency services, post-stabilization care, or urgently needed services.

(2) Payment for any other health services furnished by a provider other than the MA organization that the enrollee believes—

(i) Are covered under Medicare; or

(ii) If not covered under Medicare, should have been furnished, arranged for, or reimbursed by the MA organization.

(3) The MA organization's refusal, pre- or post-service or in connection with a decision made concurrently with an enrollee's receipt of services, to provide or pay for services, in whole or in part, including the type or level of services, that the enrollee believes should be furnished or arranged for by the MA organization.

(4) Reduction, or premature discontinuation, of a previously authorized ongoing course of treatment.

(5) Failure of the MA organization to approve, furnish, arrange for, or provide payment for health care services in a timely manner, or to provide the enrollee with timely notice of an adverse determination, such that a delay would adversely affect the health of the enrollee.

(c) Who can request an organization determination. (1) Those individuals or entities who can request an organization determination are—

(i) The enrollee (including his or her representative);

(ii) Any provider that furnishes, or intends to furnish, services to the enrollee; or

(iii) The legal representative of a deceased enrollee's estate.

(2) Those who can request an expedited determination are—

(i) The enrollee (including his or her representative); or

(ii) A physician (regardless of whether the physician is affiliated with the MA organization).

(d) Who must review organization determinations. If the MA organization 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 organization determination must be reviewed by a physician or other appropriate health care professional with expertise in the field of medicine or health care that is appropriate for the services at issue, including knowledge of Medicare coverage criteria, before the MA organization issues the organization determination decision. The physician or health care professional reviewing the request need not, in all cases, be of the same specialty or subspecialty as the treating physician or other health care provider. 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.

[63 FR 35067, June 26, 1998, as amended at 65 FR 40329, June 29, 2000; 68 FR 50858, Aug. 22, 2003; 70 FR 4739, Jan. 28, 2005; 75 FR 19812, Apr. 15, 2010; 75 FR 32859, June 10, 2010; 76 FR 21569, Apr. 15, 2011; 84 FR 15834, April 16, 2019; 88 FR 22334, Apr. 12, 2023; 90 FR 15910, Apr. 15, 2025]
Notes of Decisions
Cited in 35 cases (9 in the last 5 years), 2001–2025 · leading case: Giesse v. Secretary of the Department of Health & Human Services
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Giesse v. Secretary of the Department of Health & Human Services (2008) ca6 · cites it 6× “42 C.F.R. § 422.566 (b). If an enrollee disagrees with the “agency determination” of the M+C provider, the enrollee can request the provider to reconsider its decision.”
Global Rescue Jets, LLC v. Kaiser Foundation Health Plan (2022) ca9 · cites it 3× “42 C.F.R. § 422.566 (a). Importantly for our purposes, organization determinations encompass determinations regarding not only basic benefits (i.”
Humana Medical Plan, Inc. v. Reale (2015) fladistctapp · cites it 8× “” 16 Relatedly, the Reales and the dissent both argue that Humana never actually issued an organization determination because the letter Humana sent to the Reales 19 for a grievance is more limited than that of an organization determination, the Reales claim this somehow exempts…”
Rencare, Ltd. v. Humana Health Plan of Texas, Inc., Doing Business as Humana Health Plan of San Antonio Humana Hmo of Te (2005) ca5 · cites it 2× “” 42 C.F.R. § 422.566 . More specifically, an organization determination may be the M + C organization’s “refusal to provide or pay for services, in whole or in part, .”
Christus Health Gulf Coast v. Aetna, Inc. (2007) tex · cites it 3× “” 42 C.F.R. § 422.566 (a) (emphasis added).”
Caris MPI v. UnitedHealthcare (2024) ca5 · cites it 3× “” 42 C.F.R. § 422.566 . Organization determinations include an MAO’s “refusal to provide or pay for services, in whole or in part, .”
Prime Healthcare Huntington Beach, LLC v. Scan Health Plan (2016) cacd · cites it 3× “2 See 42 C.F.R. §§ 422.566 (c)(1)(ii) (stating that providers may request MAO determinations), 422.”
Christus Health Gulf Coast v. Aetna, Inc. (2005) texapp · cites it 4× “§ 1395w-22(g)(l)(A); 42 C.F.R. § 422.566 (a), (b) (2003). 4 Disputes over organization determinations are governed by a different and more elaborate administrative procedure.”
Ohio State Chiropractic Ass'n v. Humana Health Plan Inc. (2016) ca6 “§ 1395w-22(g)(l)(A); see 42 C.F.R. § 422.566 . Bosnian failed to exhaust administrative remedies, Humana contends, because non-contract providers must seek administrative review before contesting organization determinations in federal court.”
Main & Associates, Inc. v. Blue Cross & Blue Shield (2012) ala · cites it 6× “42 C.F.R. § 422.566 (c)(1)(ii). “Organization determinations” are defined to include, among other things, “any determination made by [a Medicare Advantage] organization with respect to .”
Tenet HealthSystem GB, Inc. v. Care Improvement Plus South Central Insurance Company (2017) ca11 “(5) Failure of the MA organization to approve, furnish, arrange for, or provide payment for health care services in a timely manner, or to provide the enrollee with timely notice of an adverse determination, such that a delay would adversely affect the health of the enrollee, 42…”
United Behavioral Health v. Maricopa Integrated Health System (2016) ariz · cites it 2× “42 C.F.R. § 422.566 (providing that an MA Organization’s refusal to provide medical services to an enrollee is an “organization determination” governed by the Act); Lone Star OB/GYN Assocs.”
Show all 35 citing cases →
— 42 C.F.R. § 422.566(b)(3) — 1 case
Humana Medical Plan, Inc. v. Reale (2015) fladistctapp “” 16 Relatedly, the Reales and the dissent both argue that Humana never actually issued an organization determination because the letter Humana sent to the Reales 19 for a grievance is more limited than that of an organization determination, the Reales claim this somehow exempts…”
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