Independent diagnostic testing facility (IDTF)

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Home ► Independent diagnostic testing facility (IDTF)

Last Modified: 4/12/2024 Location: FL, PR, USVI Business: Part A, Part B

Independent diagnostic testing facility (IDTF)

Qualification requirements: IDTF practice location

Independent diagnostic testing facilities (IDTF) must meet all of the following criteria:

• Meet the standards and requirements specified in the CMS IOM Pub. 100-08 Medicare Program Integrity Manual, Chapter 10, section 10.2.2.4 external pdf file

including but not limited to:

• Each practice location must maintain a physical facility on an appropriate site

Note: A post office box, commercial mail box, hotel, or motel is not considered an appropriate site

• Each practice location must operate in compliance with all applicable federal and state licensure, statutory, and regulatory requirements with regard to the health and safety of patients

• Each IDTF practice location must have one or more supervising physicians who are collectively responsible for the direct and ongoing oversight of the quality of the testing performed, proper operation and calibration of equipment used to perform tests, and the qualifications of non-physician IDTF personnel who use the equipment

• Each practice location must maintain documentation that the practice location’s supervising physicians, interpreting physicians, and technicians are licensed and/or certified in the state in which IDTF services are performed

• Each practice location must maintain a comprehensive liability insurance policy (carried by a non-relative-owned company) of at least $300,000 per location that covers the place of business as well as all customers and employees of the IDTF

Note: Per MLN Matters article MM12502 Incorporation of recent provider enrollment regulatory changes into Chapter 10 of CMS Publication (Pub.) 100-08 external pdf file

, this requirement does not apply to indirect IDTFs. For more information, review the MLN Matters article and the CMS IOM Pub. 100-08 Medicare Program Integrity Manual, Chapter 10 external pdf file

• Each practice location’s testing equipment must be calibrated and maintained per equipment instructions and in compliance with applicable manufacturers suggested maintenance and calibration standards.

• Meet the standards and requirements specified in the Code of Federal Regulations (CFR) -- 42 CFR, Section 410.33 -- Independent diagnostic testing facility external pdf file

Note: Each IDTF practice location, including mobile units, must submit a separate enrollment application and must meet the requirements listed above.

Qualification requirements: IDTF supervising physician

IDTF supervising physicians must meet all of the following criteria:

• Licensed to practice in the state(s) in which the diagnostic tests he or she supervises will be performed

• Enrolled in Medicare

• Meets the proficiency standards for any tests he or she is supervising

• Not currently excluded or barred

• Provides general supervision for no more than three IDTF sites

Qualification requirements: IDTF interpreting physician

IDTF interpreting physicians must meet all of the following criteria:

• Licensed to practice for the diagnostic tests he or she interprets

• Enrolled in Medicare

• Not currently excluded or barred

Qualification requirements: IDTF technician

IDTF technicians must meet all of the following criteria:

• Meets the licensure and/or certification standards of the state in which tests are performed at the time of the IDTF’s enrollment and/or at the time any tests were performed

• Qualified to perform the types of tests (codes) listed in the enrollment application

Documentation requirements and recommendations

• Each IDTF practice location must complete and submit a separate CMS-855B external pdf file

enrollment application (including attachment 2), which must list the codes for all diagnostic tests performed, all technicians who will be performing the tests, and all physicians who will be interpreting test results.

Note: To expedite the processing of your provider enrollment application, you may use the internet-based PECOS external link

, which will automatically select the appropriate form and allow you to complete the application process online.

• Copy of complete, current comprehensive liability policy of at least $300,000 (per location) that covers the place of business as well as all customers and employees of the IDTF

Note: Per MLN Matters article MM12502 Incorporation of recent provider enrollment regulatory changes into Chapter 10 of CMS Publication (Pub.) 100-08 external pdf file

, this requirement does not apply to indirect IDTFs. For more information, review the MLN Matters article and the CMS IOM Pub. 100-08 Medicare Program Integrity Manual, Chapter 10 external pdf file

• Signed and dated certification statement -- all signatures must be original and signed in ink (blue ink preferred). Stamped, faxed, or copied signatures will not be accepted.

Note: If you submitted your application through internet-based PECOS, you may sign the application electronically or you must submit your paper certification statement within 15 days of your electronic submission.

• Signed and dated Attestation Statement for Supervising Physicians external pdf file

-- all supervising physicians responsible for the provision of supervisory services for the IDTF practice location must complete this section. All signatures must be original and signed in ink (blue ink preferred). Stamped, faxed, or copied signatures will not be accepted.

• Completed Electronic Funds Transfer (EFT) Authorization Agreement (CMS-588) external pdf file

and associated documentation (e.g., copy of a voided check and/or a deposit slip). Please click here for more information.

Note: If a provider/supplier already receives payments electronically and is not making a change to his/her banking information, the CMS-588 is not required. In addition, physicians and non-physician practitioners who are reassigning their benefits to another entity are not required to submit the CMS-588.

Note: A provider/supplier located in Puerto Rico or U.S. Virgin Islands must include a copy of his or her Letter of Good Standing. The letters for Puerto Rico providers/suppliers will be considered valid if it was issued within 12 months of First Coast’s receipt of the enrollment application. The letters for U.S. Virgin Islands providers/suppliers will be considered valid if it was issued within six months of First Coast’s receipt of the enrollment application.

Additional documentation requirements (when applicable)

Medicare may require additional documentation, when applicable, to validate key information contained within the enrollment application (e.g., name change, tax identification number, proof of citizenship) or to address specific issues that could adversely affect a practitioner’s potential eligibility for enrollment (e.g., adverse legal actions, financial relationships).

• Marriage license

• Written confirmation from the IRS verifying provider’s TIN is associated with the provider’s legal business name (e.g., IRS CP 575)

• Final adverse action documentation: Please include copies of legal documents associated with any final adverse action(s) taken against the provider as well as copies of any the legal documents showing its resolution (e.g., notifications, reinstatement letters).

Note: Documents containing a summary of the adverse actions taken or their resolution will not be accepted.

• Completed Medicare Participating Physician or Supplier Agreement (CMS-460) external pdf file

• Statement in writing from the applicant’s bank (or other financial institution) -- if Medicare payments will be sent to an applicant’s bank with which the applicant has a lending relationship (i.e., any type of loan), then the applicant must provide a statement in writing from the bank -- which must be specified in the loan agreement -- that the lender has agreed to waive its right of offset for Medicare receivables.

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