Last updated: November 2026
An ambulatory surgery center (ASC) takes part in Medicare only if it meets the definition in 42 CFR 416.2 and has an agreement with CMS in effect. A new center therefore needs to meet its state's licensure requirements, file a Medicare enrollment application and be surveyed against the 14 Conditions for Coverage in 42 CFR Part 416, Subpart C. Integral Healthcare Solutions (IHS) is a consulting firm that builds the development sequence, policy set, governing body and quality documents and a mock survey.
This is compliance services and program development work, two of the three IHS practice lines alongside accreditation consulting. We read eCFR text current through October 30, 2026, opened November 2, 2026.
What does a new ambulatory surgery center need to take part in Medicare?
Section 416.2 defines an ASC as "any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization and in which the expected duration of services would not exceed 24 hours following an admission," and the entity must have an agreement with CMS and meet the conditions in Subparts B and C. Section 416.25 limits participation to facilities that meet that definition and have an agreement in effect.
In what order do the license, enrollment and survey happen?
The rules we read do not fix a calendar order for the license, the application filing and the survey, but 42 CFR 424.510(a)(1) says "Once the provider or supplier successfully completes the enrollment process, including, if applicable, a State survey and certification or accreditation process, CMS enrolls the provider or supplier into the Medicare program." Section 416.40 says "The ASC must comply with State licensure requirements," and the enrollment application must include documentation, among it "All applicable Federal and State licenses, certifications" (section (d)(2)(iii)(A)). The supplier "must be operational to furnish Medicare covered items or services before being granted Medicare billing privileges" (section (d)(6)). IHS reading, an inference: plan the license date ahead of the filing date.
How does the CMS agreement get made?
Unless CMS deems the ASC in compliance, the State survey agency must survey the facility and report its findings to CMS (42 CFR 416.26, paragraph (b)(1)). If CMS determines, after reviewing the survey agency recommendation and other evidence, that the facility meets the requirements of Part 416, it sends written notice and two copies of the agreement; if the ASC wishes to participate, its authorized representative signs both and the ASC files them with CMS; if CMS accepts, it returns one copy with a notice specifying the effective date (paragraphs (c) to (e)).
When does the agreement take effect?
Under 42 CFR 489.13, paragraph (b), the agreement is effective on the date the survey (including the Life Safety Code survey, if applicable) is completed, or on the effective date of the accreditation decision, as applicable, if on that date the supplier meets all applicable Federal requirements. It may not be earlier than the latest of the dates on which CMS determines that each applicable Federal requirement is met, and those requirements include the enrollment requirements in 42 CFR Part 424, Subpart P.
If not every standard is met on the survey date, paragraph (c)(2) applies, assuming no other Federal requirements remain. This summary covers the survey path only. The date is the earlier of the date the ASC meets all applicable conditions, and the date it is found to meet all conditions but has lower-level deficiencies and CMS or the State survey agency receives an acceptable plan of correction, or CMS receives an approvable waiver request. With both an approvable plan of correction and an approvable waiver request submitted, paragraph (c)(3) sets the later of the two resulting dates; receipt counts regardless of when CMS approves. If other Federal requirements remain, the date may not be earlier than the latest date CMS determines each is met.
What do the 14 Conditions for Coverage cover?
416.40 state licensure; 416.41 governing body; 416.42 surgical services; 416.43 quality assessment and performance improvement; 416.44 environment; 416.45 medical staff; 416.46 nursing; 416.47 medical records; 416.48 pharmacy; 416.49 laboratory and radiology; 416.50 patient rights; 416.51 infection control; 416.52 admission and discharge; 416.54 emergency preparedness.
Who needs it and what triggers it
Physicians or a developer need this work when they plan a new center.
How IHS helps
Thomas G. Goddard, JD, PhD, a former URAC Chief Operating Officer and General Counsel, leads the work. IHS drafts a gap assessment against each Subpart C condition; a work plan that sequences the license, enrollment filing, survey and agreement; the policy set, governing body charter and quality plan for your clinicians to approve; an enrollment checklist; and a mock survey.
What you supply. The building and equipment, the physician roster, the license application and enrollment filing, your authorized official's signature, and clinical approval by your medical director and nurse leader.
The real limit. IHS cannot credential physicians, equip an operating room or issue a license. IHS does not file with, or contact, CMS, a state agency or an accrediting body for you.
What to have ready
- The state license (42 CFR 424.510, section (d)(2)(iii)(A)). If it is not yet issued, bring the application status so the work plan can date the filing; that is an IHS planning step, not rule text.
- Legal business name, tax identification number and a Type 2 NPI; the CMS-855B says applicants using it require a Type 2 NPI (form, 12/2025). Add owners and managing control information and an organizational structure diagram, which the form's supporting documents list includes ("if applicable").
- Your authorized official, the CMS-588 form for electronic funds transfer payment (section (e)) and the application fee or a hardship exception request (42 CFR 424.514(a); IHS reads an ASC as an institutional provider, see the cost section). The supplier is legally responsible for the application's accuracy even if another party completed it (section (d)(10)).
- Governing body bylaws and charter (§ 416.41).
- Policies and plans: privileging (§ 416.42, § 416.45), history and physical (§ 416.52(a)(1)), infection control (§ 416.51(b)), quality (§ 416.43(e)(3)) and emergency preparedness (§ 416.54).
- A decision on the survey route; the CMS-855B asks whether the ASC is accredited, has applied or is pending, or is not accredited.
The free introductory call turns that list into a dated work plan.
How it compares
A State survey agency surveys unless CMS deems the ASC in compliance (42 CFR 416.26, paragraph (b)(1)). One of three conditions for deemed status is accreditation by a national accrediting body, or licensing by a State agency, that CMS determines provides reasonable assurance (paragraph (a)(1)); the FAQ below lists the other two. CMS surveys deemed ASCs on a sample basis for validation (paragraph (b)(2)). For accrediting bodies, see ACHC ambulatory surgery center accreditation and AAAHC and Joint Commission ASC accreditation.
What it costs
The federal Medicare enrollment application fee for an institutional provider is 750 dollars for initial enrollment, revalidation or a new practice location, for an application submitted on or after January 1, 2026, and on or before December 31, 2026 (Federal Register notice 2025-21877). 42 CFR 424.502 defines an institutional provider to include a supplier that submits a CMS-855B on paper or through PECOS, not including physician and nonphysician practitioner organizations; IHS reads an ASC as within it. The fee is nonrefundable except when submitted with an approved hardship exception request, an application rejected before screening begins, or an application denied because of a temporary moratorium (42 CFR 424.514(d)(2)(v)).
State license and accrediting body fees are not stated here; verify current fees with CMS, your state licensing agency and any accrediting body. IHS scopes each engagement after a free introductory call.
What this is not
- It is not legal advice. IHS is a consulting firm, not a law firm, and a mock survey promises no result.
- It is not a guarantee. A license, a survey result and an agreement are decisions of the state agency, CMS or an accrediting body.
- IHS drafts and your organization files. IHS does not submit applications or contact CMS, a state agency or an accrediting body for you.
- It does not cover certificate of need. The text of Part 416 contains no match for that phrase, and whether your state requires one is a question for your counsel.
Frequently asked questions
What counts as an ambulatory surgery center under Medicare?
Section 416.2 defines an ASC as any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization and in which the expected duration of services would not exceed 24 hours following an admission, with an agreement with CMS.
What is the order of the state license, Medicare enrollment and the survey?
CMS enrolls the supplier once it completes the enrollment process, including, if applicable, a State survey and certification or accreditation process (42 CFR 424.510(a)(1)). The application must include all applicable Federal and State licenses (424.510(d)(2)(iii)(A)), and the supplier must be operational before billing privileges are granted (424.510(d)(6)).
Can a new center bill Medicare before it has an agreement?
No. Section 416.25 limits participation as an ASC to facilities that have an agreement in effect. Section 424.520(a) points billing-privilege dates for suppliers requiring State survey, certification or accreditation to section 489.13; IHS reads an ASC as within that group, an inference. Under section 489.13(b) the agreement is effective on the survey completion date or the accreditation decision date, as applicable, if all applicable Federal requirements are met on that date, and never earlier than the latest date CMS determines each is met.
Does accreditation replace the state survey?
It can, under conditions. CMS may deem an ASC in compliance with any or all Subpart C conditions if the ASC is accredited by a national accrediting body, or licensed by a State agency, that CMS determines provides reasonable assurance; if, for deemed status through accreditation, it complies with State licensure requirements where State law requires licensure; and if it authorizes release of the survey findings to CMS (416.26(a)). Unless CMS deems the ASC in compliance, the State survey agency must survey it (416.26(b)(1)).
Which patients need a history and physical before surgery?
Section 416.52(a)(1) requires a policy that identifies the patients who need a medical history and physical examination before surgery and includes the timeframe. It must address, but is not limited to, age, diagnosis, the type and number of procedures on the same surgery date, known comorbidities and the planned anesthesia level.
How often must the emergency plan be reviewed and tested?
The plan must be reviewed and updated at least every 2 years (416.54(a)), and the ASC must conduct exercises to test it at least annually (416.54(d)(2)). That includes a community-based full-scale exercise every 2 years or, when one is not accessible, a facility-based functional exercise every 2 years; an actual emergency that requires activation of the plan exempts the ASC from its next required community-based or facility-based functional exercise following the onset of the emergency event.
Who signs the Medicare enrollment application for an ASC?
For an organization, an authorized official signs the certification statement (42 CFR 424.510(d)(3)(i)(C)). The signer must have authority to bind the supplier legally and financially and an ownership or control interest, or a similar position of status and authority (424.510(d)(3)).
What does IHS draft, and what do the physicians and owners supply?
IHS drafts the work plan, the Subpart C gap assessment, the policy set, the governing body charter, the quality plan and mock survey tracers. Your medical director and nurse leader approve the clinical content, and your authorized official signs and files the enrollment application.