An independent diagnostic testing facility (IDTF) is, in CMS's words, "a facility independent of both an attending or consulting physician's office and a hospital" (CMS MLN909060), and it must meet the performance standards in 42 CFR 410.33 to enroll and bill Medicare. This page is for owners and compliance leaders of fixed or mobile diagnostic businesses facing a new Medicare enrollment, a location or ownership change, or remediation of an operation already enrolled. Integral Healthcare Solutions (IHS) maps your tests, supervision and site records to the IDTF standards and drafts the procedures; your physicians set supervision and test scope, and your organization files its own enrollment.

Last reviewed: October 2026.

What is an independent diagnostic testing facility?

The governing text is 42 CFR 410.33, "Independent diagnostic testing facility," which we read in the current eCFR text (up to date as of September 30, 2026). CMS explains the rules in MLN Booklet MLN909060, "Independent Diagnostic Testing Facility," dated February 2026. The regulation says "An IDTF may be a fixed location, a mobile entity, or an individual nonphysician practitioner" (42 CFR 410.33(a)(1)).

The core of the regulation is a list of standards the facility attests to. Section 410.33(g) says "The IDTF must certify in its enrollment application that it meets the following standards and related requirements." Among them, the IDTF must "Openly post these standards for review by patients and the public" (410.33(g)(9)) and must "Permit CMS, including its agents, or its designated fee-for-service contractors, to conduct unannounced, on-site inspections to confirm the IDTF's compliance with these standards" (410.33(g)(14)).

Two further rules shape daily operations. Supervision is capped: "Each supervising physician must be limited to providing general supervision to no more than three IDTF sites" (410.33(b)(1)). Ordering is restricted: "All procedures performed by the IDTF must be specifically ordered in writing by the physician who is treating the beneficiary" (410.33(d)).

Who needs IDTF enrollment and what triggers the work

The buyer is a diagnostic testing business that operates apart from a physician's office and a hospital and wants to bill Medicare for its tests. The events that start the work come from the booklet and the regulation:

• A first enrollment. "An IDTF should be open and operational when it submits the Medicare Enrollment Application-Clinics/Group Practices and Other Suppliers (CMS-855B) to initially enroll in Medicare" (MLN909060). The booklet names the CMS-855B with Attachment 2.
• A new practice location. "If an IDTF is adding a practice location to its existing enrollment, it must submit a new complete application and undergo a separate site visit for that location" (MLN909060).
• A new mobile unit. "Each IDTF mobile unit must enroll separately" (MLN909060).
• A change in ownership, location or supervision. "An IDTF must report changes in ownership, location, general supervision, or final adverse actions to MACs within 30 calendar days. An IDTF must report all other changes to the enrollment application within 90 days" (MLN909060).
• Remediation, where an enrolled IDTF wants its records and procedures to hold up to an unannounced inspection under 410.33(g)(14).

How IHS helps

IHS works from the governing text outward: every finding and every drafted procedure ties back to a paragraph of 42 CFR 410.33 or a statement in the CMS booklet.

1. Gap assessment. IHS reads your operation against the 410.33 standards and MLN909060, using questionnaires on the tests you list, your supervising physicians, technicians, equipment and sites.
2. Document and evidence mapping. IHS builds a crosswalk from each enrolled test to its supervising physician and technician credentials, and ties each 410.33(g) standard to the record that shows it is met.
3. Drafting. IHS drafts the complaint, change-reporting, equipment and records procedures. Any clinical content is drafted for your physicians to review and approve.
4. Mock site review. IHS walks the site records the way an unannounced inspection would test them and lists what is missing.
5. Readiness support. IHS drafts enrollment text for your organization to file and keeps the change-reporting calendar in your procedures.

What you supply: the test list, physician and technician credentials, equipment records and site details.

The limit: test scope, supervision levels and equipment suitability are clinical and technical calls that stay with your physicians. IHS does not file enrollment and does not deal with your Medicare Administrative Contractor (MAC) or CMS. IHS drafts; your organization files and corresponds.

What to have ready

Each item ties to 42 CFR 410.33 (current eCFR text, up to date as of September 30, 2026) or CMS MLN909060 (February 2026).

• A short statement of how your business is independent of a physician's office and a hospital, matching the definition in MLN909060.
• Your entity type: fixed location, mobile entity or individual nonphysician practitioner (42 CFR 410.33(a)(1)).
• A list of every mobile unit, since "Each IDTF mobile unit must enroll separately" (MLN909060).
• A roster of supervising physicians showing how many IDTF sites each one covers, against the limit of three in 410.33(b)(1).
• A test list with the supervising physician and technician credentials for each test.
• Proof of a liability policy that meets 410.33(g)(6): "a comprehensive liability insurance policy of at least $300,000 per location that covers both the place of business and all customers and employees of the IDTF."
• The posted copy of the standards, which 410.33(g)(9) requires you to "Openly post."
• Your order-intake process, showing each procedure is "specifically ordered in writing by the physician who is treating the beneficiary" (410.33(d)).
• A site that is open and operational before you file the CMS-855B, and records kept ready for an unannounced site visit (MLN909060; 410.33(g)(14)).
• A change-reporting calendar with the 30-day and 90-day reporting windows from MLN909060.

The introductory call is the place to walk through this list against your own operation.

How IDTF enrollment compares with other arrangements

Several arrangements can deliver diagnostic tests to Medicare patients. The sources we reviewed draw these lines:

For the portable X-ray route, see portable X-ray supplier certification readiness. Which arrangement fits your business is your decision with your counsel and reimbursement advisers.

What IDTF enrollment costs

CMS's published fee is the Medicare enrollment application fee. For calendar year 2026, CMS announced "a $750.00 calendar year (CY) 2026 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location" (Federal Register 2025-21877). The notice defines institutional providers to include CMS-855B filers other than physician and non-physician practitioner organizations.

IHS's reading, October 2026: because an IDTF enrolls on the CMS-855B, the fee applies to an initial IDTF application and to a new practice location. MLN909060 itself does not state the fee. Under 42 CFR 424.514(a), an applicant submits the fee, a request for a hardship exception, or both, when it files. Verify current fees with CMS.

The $300,000-per-location liability insurance minimum in 410.33(g)(6) is a cost of operating, not a CMS fee. IHS scopes each engagement after a free introductory call.

What this is not

• IHS does not file your enrollment, correspond with your MAC or CMS, or attend to the site visit for you. Your organization files; IHS drafts.
• IHS does not decide test scope, supervision levels or whether equipment is suitable. Those are clinical and technical calls for your physicians.
• This page is not legal or billing advice, and IHS's work does not guarantee an enrollment decision.

Frequently asked questions

What is an independent diagnostic testing facility (IDTF) under Medicare?

CMS defines an IDTF as "a facility independent of both an attending or consulting physician's office and a hospital" (MLN909060). Under 42 CFR 410.33(a)(1), "An IDTF may be a fixed location, a mobile entity, or an individual nonphysician practitioner."

Do I need to enroll as an IDTF, or can my diagnostic tests be billed through a physician practice?

The IDTF definition requires independence from a physician's office, so a practice billing its own tests is a different arrangement. The billing rules for that arrangement are outside the sources on this page. Take the choice to your counsel and reimbursement advisers before you file.

What are the IDTF performance standards in 42 CFR 410.33(g)?

Section 410.33(g) lists standards the IDTF "must certify in its enrollment application" that it meets. They include a liability policy "of at least $300,000 per location," posting the standards openly "for review by patients and the public," and permitting CMS or its agents "to conduct unannounced, on-site inspections" (42 CFR 410.33(g)). Read the full list in the regulation before you attest.

How many IDTF sites can one supervising physician cover?

Three. The regulation says "Each supervising physician must be limited to providing general supervision to no more than three IDTF sites" (42 CFR 410.33(b)(1)). A roster showing how many IDTF sites each supervising physician covers is the simplest way to show you are within it.

Does each mobile unit need its own IDTF enrollment?

Yes. CMS says "Each IDTF mobile unit must enroll separately" (MLN909060). Plan one enrollment per unit, with its own records.

What happens during the IDTF site visit, and is it announced?

It is unannounced. For a new practice location, "The MAC gets the application and starts processing it; then CMS or its agent will conduct an unannounced site visit" (MLN909060). Section 410.33(g)(14) requires the IDTF to permit unannounced on-site inspections to confirm compliance with the standards.

How long do I have to report a change in ownership, location or supervising physician?

30 calendar days. CMS says an IDTF "must report changes in ownership, location, general supervision, or final adverse actions to MACs within 30 calendar days," and "all other changes to the enrollment application within 90 days" (MLN909060).

What liability insurance does an IDTF need?

Section 410.33(g)(6) requires "a comprehensive liability insurance policy of at least $300,000 per location that covers both the place of business and all customers and employees of the IDTF." The minimum is per location, so a multi-site IDTF needs coverage at each site.

How much is the Medicare enrollment application fee for an IDTF in 2026?

CMS set the CY 2026 application fee for institutional providers at $750.00 (Federal Register 2025-21877). IHS's reading, October 2026: the fee applies to an IDTF because it enrolls on the CMS-855B, which the notice covers for suppliers other than physician and non-physician practitioner organizations. Verify current fees with CMS.

IDTF versus portable X-ray supplier: which enrollment fits a mobile imaging business?

They are separate supplier types. CMS says a portable X-ray supplier "can be simultaneously enrolled as a mobile independent diagnostic testing facility (IDTF), though they cannot bill for the same service," and that a portable X-ray supplier "requires a state survey, while a mobile IDTF does not (although an IDTF requires a site visit)" (CMS Transmittal 11574). The choice of route is yours, with your counsel.