Mandatory Posting of IDTF Standards

IDTF Standards
Consistent with 42 CFR § 410.33(g), each IDTF must certify on its CMS-855B
enrollment application that it meets the following standards and all other requirements:

1. Operates its business in compliance with all applicable Federal and State
licensure and regulatory requirements for the health and safety of patients.
• The purpose of this standard is to ensure that suppliers are licensed in the
business and specialties being provided to Medicare beneficiaries. Licenses are required by State and/or Federal agencies to make certain that guidelines and regulations are being followed to ensure businesses are furnishing quality services to Medicare beneficiaries.
• The responsibility for determining what licenses are required to operate a
supplier’s business is the sole responsibility of the supplier. The contractor is not responsible for notifying any supplier of what licenses are required or that any changes have occurred in the licensure requirements. No exceptions to applicable State licensing requirements are permitted.
• The contractor shall not grant billing privileges to any business not
appropriately licensed as required by the appropriate State or Federal agency. If a supplier is found providing services for which it is not properly licensed, billing privileges may be revoked and appropriate recoupment actions taken.

2. Provides complete and accurate information on its enrollment application. Any change in enrollment information must be reported to the designated fee-for-service contractor on the Medicare enrollment application within 30 calendar days of the change.

3. Maintains a physical facility on an appropriate site. For the purposes of this
standard, a post office box or commercial mail box is not considered a physical facility. The physical facility, including mobile units, must contain space for equipment appropriate to the services designated on the enrollment application, facilities for hand washing, adequate patient privacy acommodations, and the storage of both business records and current medical records within the office setting of the IDTF, or IDTF home office, not within the actual mobile unit.
• The requirements in 42 CFR § 410.33(g)(3) take precedence over the
guidelines in sections 4.4(A) and 4.4.2 of this manual pertaining to the supplier’s
practice location requirements.
• The physical location must have an address, including the suite identifier,
which is recognized by the United States Postal Service (USPS).

4. Has all applicable diagnostic testing equipment available at the physical site
excluding portable diagnostic testing equipment. The IDTF must—
(i) Maintain a catalog of portable diagnostic equipment, including diagnostic
testing equipment serial numbers at the physical site;
(ii) Make portable diagnostic testing equipment available for inspection within
2 business days of a CMS inspection request; and
(iii) Maintain a current inventory of the diagnostic testing equipment, including
serial and registration numbers, and provide this information to the designated fee-forservice contractor upon request, and notify the contractor of any changes in equipment within 90 days.

5. Maintain a primary business phone under the name of the designated business. The IDTF must have its--
(i) Primary business phone located at the designated site of the business or
within the home office of the mobile IDTF units.
(ii) Telephone or toll free telephone numbers available in a local directory and
through directory assistance.
• The requirements in 42 CFR § 410.33(g)(5) take precedence over the
guidelines in sections 4.4(A) and 4.4.2 of this manual pertaining to the supplier’s telephone requirements.
• IDTFs may not use “call forwarding” or an answering service as their
primary method of receiving calls from beneficiaries during posted operating hours.

6. Have 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 policy must be carried by a nonrelative-owned company.

7. Agree not to directly solicit patients, which include, but is not limited to, a
prohibition on telephone, computer, or in-person contacts. The IDTF must accept only those patients referred for diagnostic testing by an attending physician, who is furnishing a consultation or treating a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary’s specific medical problem. Nonphysician practitioners may order tests as set forth in §410.32(a)(3).
• By the signature of the authorized official in section 15 of the CMS-855B,
the IDTF agrees to comply with 42 CFR § 410.33(g)(7).
• The supplier is prohibited from directly contacting any individual
beneficiary for the purposes of soliciting business for the IDTF. This includes contacting
the individual beneficiary by telephone or via door-to-door sales.
• There is no prohibition on television, radio or internet advertisements,
mass mailings, or similar efforts to attract potential clients to an IDTF.
• If the contractor determines that an IDTF is violating this standard, the
contractor should notify its DPSE contractor liaison immediately.

8. Answer beneficiaries’ questions and respond to their complaints.

9. Openly post these standards for review by patients and the public.

10. Disclose to the government any person having ownership, financial, or
control interest or any other legal interest in the supplier at the time of enrollment or within 30 days of a change.

11. Have its testing equipment calibrated and maintained per equipment
instructions and in compliance with applicable manufacturers suggested maintenance and calibration standards.

12. Have technical staff on duty with the appropriate credentials to perform
tests. The IDTF must be able to produce the applicable Federal or State
licenses or certifications of the individuals performing these services.

13. Have proper medical record storage and be able to retrieve medical records
upon request from CMS or its fee-for-service contractor within 2 business days.

14. 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. The IDTF must---
(i) Be accessible during regular business hours to CMS and
beneficiaries; and
(ii) Maintain a visible sign posting its normal business hours.
The IDTF must meet all of the standards in 42 CFR § 410.33 – as well as all other Federal and State statutory and regulatory requirements – in order to be enrolled in, and to maintain its enrollment in, the Medicare program. Failure to meet any of the standards in 42 CFR § 410.33 or any other applicable requirements will result in the denial of the supplier’s CMS-855 application or, if the supplier is already enrolled in Medicare, the revocation of its Medicare billing privileges.