C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER G—STANDARDS AND CERTIFICATION › PART 482—CONDITIONS OF PARTICIPATION FOR HOSPITALS › Subpart B—Administration

42 C.F.R. § 482.11

Condition of participation: Compliance with Federal, State and local laws

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(a) The hospital must be in compliance with applicable Federal laws related to the health and safety of patients.

(b) The hospital must be—

(1) Licensed; or

(2) Approved as meeting standards for licensing established by the agency of the State or locality responsible for licensing hospitals.

(c) The hospital must assure that personnel are licensed or meet other applicable standards that are required by State or local laws.

Notes of Decisions
Cited in 13 cases (4 in the last 5 years), 1993–2024 · leading case: Fischer v. United States, 529 U.S. 667 (2000).
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Fischer v. United States, 529 U.S. 667 (2000). · cites it 2× “Hospitals, for instance, must satisfy licensing standards, 42 CFR § 482.11 (1999); possess a governing body to "ensure that there is an effective, hospital-wide quality assurance program to evaluate the provision of patient care," § 482.”
Waldmann v. Fulp, 259 F. Supp. 3d 579 (S.D. Tex. 2016). · cites it 2× “” 42 C.F.R. § 482.11 . The regulations also require that “[surgical privileges must be delineated' for all practitioners performing surgery in accordance with the competencies of each practitioner.”
Blue Valley Hosp., Inc. v. Azar, 919 F.3d 1278 (10th Cir. 2019). “See 42 C.F.R. § 482.11 . And if a facility is in violation of the Conditions of Participation, the Secretary may deny that facility further payments under the Medicare Act by terminating its provider agreement.”
Univ. of Texas Sw. Med. Ctr. at Dallas v. Gentilello, 317 S.W.3d 865 (Tex. App. 2010). “See 42 C.F.R. § 482.11 . The hospital’s governing body must ensure the medial staff is accountable to the governing body for the quality of care provided to patients.”
United States Ex Rel. Sanders v. East Alabama Healthcare Auth., 953 F. Supp. 1404 (M.D. Ala. 1996). “(quoting 42 C.F.R. § 482.11 (b)(2)). Therefore, according to the Plaintiffs, the submission of Medicare and Medicaid claims by an improperly licensed hospital constitutes the submission of false claims.”
Evelyn v. v. Kings Cnty. Hosp. Ctr., 819 F. Supp. 183 (E.D.N.Y 1993). “” 42 C.F.R. § 482.11 (b)(2). In short, the Secretary carries out the requirement of § 1395z by leaving the enforcement of state standards to the states.”
Trust Under the Will of James Wills v. Burwell, 306 F. Supp. 3d 684 (E.D. Pa. 2018). “See 42 C.F.R. §§ 482.11 through 482.58. Additionally, such an applicant must qualify as a "hospital" under section 1861 of the Medicare Act.”
Matter of John E. Andrus Mem., Inc. v. Comm'r of Health of the N.Y. State Dept. of Health, 2024 NY Slip Op 01220 (N.Y. App. Div. 2024). “1 [b];42 CFR 482.11, 488.301). There does not appear to be a dispute that DOH properly initiated the investigation after receiving the complaint from the daughter.”
Question Submitted by: Rep. Marcus McEntire, Oklahoma House of Representatives, Dist. 50, 2024 OK AG 14 (Okla. Att’y Gen. 2024). · cites it 2× “" 42 C.F.R. § 482.11 (c) (2020). Consequently, the Governor's request to opt-out of the physician-supervision requirement for CRNAs under 42 C.”
Matter of John E. Andrus Mem., Inc. v. Comm'r of Health of the N.Y. State Dept. of Health, 2024 NY Slip Op 01220 (N.Y. App. Div. 2024). “1 [b];42 CFR 482.11, 488.301). There does not appear to be a dispute that DOH properly initiated the investigation after receiving the complaint from the daughter.”
Steve F. Montoya, Jr., M.D., West Texas Renal Care & West Texas Nephrology v. San Angelo Cmty. Med. Ctr. & Kirk Brewer, M.D. (Tex. App. 2016). “42 USC 1395cc(a)(l)(l)(iii) ,42 CFR 482.11 and 42 CFR 482.22. 14.4 All nephrology patients that go on to dialysis are covered under Medicare- thus are paying patients for the doctor and hospital Physicians on staff are required to take all the referrals in their specialty.”
Mattie Cooper v. Thomas Jefferson Univ. Ho (3rd Cir. 2018). “4 42 C.F.R. § 482.11 . 2 license.”5 The policy established processes for verifying license renewal and suspending employees who did not renew in advance of the deadline.”
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— 42 C.F.R. § 482.11(c) — 1 case
Question Submitted by: Rep. Marcus McEntire, Oklahoma House of Representatives, Dist. 50, 2024 OK AG 14 (Okla. Att’y Gen. 2024). “" 42 C.F.R. § 482.11 (c) (2020). Consequently, the Governor's request to opt-out of the physician-supervision requirement for CRNAs under 42 C.”
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