The ASC must have a governing body that assumes full legal responsibility for determining, implementing, and monitoring policies governing the ASC's total operation. The governing body has oversight and accountability for the quality assessment and performance improvement program, ensures that facility policies and programs are administered so as to provide quality health care in a safe environment, and develops and maintains a disaster preparedness plan.
(a) Standard: Contract services. When services are provided through a contract with an outside resource, the ASC must assure that these services are provided in a safe and effective manner.
(b) Standard: Hospitalization. (1) The ASC must have an effective procedure for the immediate transfer, to a hospital, of patients requiring emergency medical care beyond the capabilities of the ASC.
(2) This hospital must be a local, Medicare-participating hospital or a local, nonparticipating hospital that meets the requirements for payment for emergency services under § 482.2 of this chapter.
(3) The ASC must periodically provide the local hospital with written notice of its operations and patient population served.
[73 FR 68811, Nov. 18, 2008, as amended at 81 FR 64022, Sept. 16, 2016; 84 FR 51814, Sep. 30, 2019]
Notes of Decisions
EMW Women's Surgical Ctr. v. Eric Friedlander, 978 F.3d 418 (6th Cir. 2020).
“30, 2019) (modifying 42 C.F.R. § 416.41 (b)). CMS explained that “removing this requirement [was] necessary and appropriate” because of the burdens it imposed and because transfer agreements are not a “necessary or effective method” to promote communication between ASCs and…”
Planned Parenthood Se., Inc. v. Strange, 33 F. Supp. 3d 1330 (M.D. Ala. 2014).
“42 C.F.R. § 416.41 (b)(3). . These are the same procedures which the staff-privileges requirement at issue in this case would require every doctor providing an abortion to have staff privileges to perform, not just the covering physician.”
Planned Parenthood of Wisconsin, Inc. v. Van Hollen, 94 F. Supp. 3d 949 (W.D. Wis. 2015).
“) See also 42 C.F.R. § 416.41 (b)(3) (providing that to be certified for coverage by Medicare or Medicaid, an ambulatory surgery center must either have a written transfer agreement with a hospital or ensure that their physicians have admitting privileges).”
McDaniel v. United States of Am. (D.N.M. 2022).
“As is true for the rules promulgated by CDPHE, scattered references to factors that may bear on patient safety — like requiring facilities to maintain a “safe environment,” 42 C.F.R. § 416.41 (2019), and to operate on patients “in a safe manner,” 42 C.”
v. Surgery Ctr., 2020 COA 145 (Colo. Ct. App. 2020).
“As is true for the rules promulgated by CDPHE, scattered references to factors that may bear on patient safety — like requiring facilities to maintain a “safe environment,” 42 C.F.R. § 416.41 (2019), and to operate on patients “in a safe manner,” 42 C.”
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