Independent Diagnostic Testing Facility

Credentialing, Enrollment and Revalidation

Table of Contents

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Requirements

An IDTF must separately enroll each of its practice locations. This means that an enrolling IDTF can only have one practice location on the initial enrollment application (PECOS or CMS-855B). If an IDTF is adding a practice location to its existing enrollment, it must submit a new application for that location, pay an application fee, and have that location undergo a separate site visit.

Facilities considered IDTFs must meet all IDTF requirements, submit separate enrollment by entity listed as an IDTF, and enrollment records will show specialty as IDTF.

Examples are:

  • ASC
  • Cardiac Catheterization Facility
  • Radiology Facility
  • Radiopharmaceutical Facility
  • Trans-telephonic and Electronic Monitoring Facility
  • Ultrasonography Facility
  • Hospital Facility

An entity can be enrolled as an IDTF if it is considered independent. 

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Facilities that are not qualified:

  • CLIA
  • Slide preparation facility
  • Diagnostic mammography service
  • Slide preparation facility and radiation therapy centers
  • Therapeutic procedures
  • Portable X-ray service

A mobile IDTF that provides X-ray services is not classified as a portable X-ray supplier; therefore, keep in mind that transportation (HCPCS code R0070) and setup (HCPCS code Q0092) cannot be billed by an IDTF.

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Qualifications

IDTF shall ensure all state requirements are met. State requirements can vary by state; therefore, you may need to contact the appropriate state agency for specific details, meet all performance standards informed on the CMS-855B application as well as CMS standards per 42 CFR, Section 410.33(g).

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Application Forms You Will Need

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Required Application Fee

Institutional providers or suppliers must submit an application fee or *hardship exception for:

  • Initial enrollment
  • Revalidations
  • Additional practice location site is considered an initial enrollment

Note: Mobile facility location change of “base of operation” has no application fee.

*Clarification for hardship exception can be found at CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 10, Section 10.6.14.1(j). If applicable, hardship request must be submitted with application.

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Documentation

Mandatory for all IDTF types:

  • Comprehensive liability insurance policy
  • State licenses or certification for IDTF nonphysician personnel
  • Documentation verifying IDTF supervisory physician(s) proficiency

Mandatory for all provider/supplier types:

CMS-588 EFT

  • Voided check or bank confirmation letter submitted with the CMS-588.
  • Written confirmation from the IRS confirming your tax identification number with the legal business name
    • Examples of IRS documents are the IRS-CP575 or IRS-147C that displays the legal business name and TIN/EIN

Mandatory for all provider/supplier types, if applicable:

  • Business license
  • Final adverse legal action documentation
  • Application fee or hardship exception request
  • Attestation for government entities and tribal organizations
  • IRS confirmation of disregarded entity
  • Lending relationship ‒ statement in writing from the bank detailing agreement to waive its rights of offset for Medicare receivables

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State Survey, Tie-in Notice

  • Not applicable

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Site Visit

  • Are conducted

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Reassignment of Group Members

  • Not applicable

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Practice Location

  • IDTF Mobile Facility ‒ An application for each “Base of Operations,” as well as vehicle information and the geographic area serviced by these facilities are required
  • IDTF Fixed Site ‒ Physical location of fixed site

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Reporting Changes

You must report changes to information in your Medicare enrollment records within 30 days for:

  • Change in ownership
  • Change in practice location for IDTF or “base of operation” location for a mobile IDTF
  • Change in supervising physician(s)
  • Final adverse actions
  • License suspension, felony conviction, debarment

All other changes to your existing Medicare enrollment records must be submitted within 90 days.

  • Business structure
  • Legal business name
  • Change in TIN (will be initial enrollment)
  • Practice status
  • Banking data, correspondence, medical record correspondence or special payment address

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Supervision Definitions

  • Personal Supervision means a physician must be in attendance in the room during the performance of the procedure.
  • Direct Supervision means the physician must be present in the office suite and immediately available to provide assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed.
  • General Supervision means the procedure is provided under the physician’s overall direction and control, but the physician’s presence is not required during the performance of the procedure. General supervision also includes the responsibility that the nonphysician personnel who perform the tests are qualified and properly trained and that the equipment is operated properly, maintained, calibrated and that necessary supplies are available.

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Related Content

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CMS-855B for an Independent Diagnostic Testing Facility

Follow the instructions on the CMS-855B application.

Section General Guidelines
Section 1: Basic Information 1A – Select reason for submitting application and follow instructions as indicated.

1B – Check all that apply and complete the required sections
  • Change of information application, complete all required sections that are applicable for updating changes
Section 2: Identifying Information 2A1 – Complete all fields that apply:
  • The legal business name must match the NPPES Registry and the IRS document exactly, including any suffix, i.e. PC, PA, LLC, etc.
  • Specify the NPI and EIN/TIN
2A2 – Specify any state licenses and/or certifications that apply for the organization

2A3 – Enter the organization’s correspondence address and telephone number
  • Must be where the entity in 2A1 can be reached directly
  • May not report a billing agency or a medical management company address/phone number
2A4 – Enter the organization’s medical record correspondence address
  • May not report a billing agency or a medical management company address/phone number
2B – Specify the type of supplier
  • Independent Diagnostic Testing Facility
Section 3: Final Adverse Legal Actions Section must be answered and only a “yes” or “no” response is acceptable
  • If there are no final adverse legal actions, convictions, exclusions, revocations, or suspensions, be sure to check the box labeled ‘No’
  • If there are any actions whether under the current or a former name or business identity, check the box labeled “Yes” and list details and attach final adverse legal action documentation and/or resolutions
Section 4: Practice Location Information 4A – Complete this section for practice location where the IDTF will render services

4B – Enter special payment address (pay to address)

4C1 – Enter medical records storage location(s)

4C2 – Answer “yes” or “no” to electronic storage

4E, 4F, 4G – Complete these sections if a mobile or portable IDTF
Section 5: Ownership Interest and/or Managing Control Information (Organizations) Copy appropriate page as many times as necessary.

5A–5B – Complete these sections for each organization that has ownership interest or managing control
  • Each section 5A, complete a corresponding section 5B
Note: Submit an organizational structure diagram/flowchart identifying all the entities listed in Section 5 and their relationships with the provider and each other.
Section 6: Ownership Interest and/or Managing Control Information (Individuals) Copy appropriate page in each section as many times as necessary.

6A–6B – Complete these sections for every individual with ownership interest or managing control (i.e. manager, owner, board of trustees or other governing body, and authorized or delegated official)
  • Authorized official – at least one authorized official must be reported.
    • To report an authorized official, must select “Authorized Official” and an additional relationship:
      • Five percent or greater Direct/Indirect Owner
      • Partner
      • Director/Officer
    • If applicable, AO may also be Managing Employee
  • Managing Employee– at least one Managing Employee must be reported
  • Delegated official – is optional
    • To report a delegated official, must select “Delegated Official” and an additional relationship box
    • Cannot be a Contracted Managing Employee
  • Each section 6A, complete a corresponding section 6B
Section 8: Billing Agency/Agent Information

Complete with billing agency information or select the box indicating that this does not apply
Section 12: Supporting Documentation Submit all applicable supporting documents
  • Comprehensive liability insurance policy verification
  • CMS-588 (EFT) and a voided check or bank confirmation letter
  • State license or certifications for entity, personnel performing tests, interpreting and/or supervising physicians
  • IRS document
  • CMS-460
  • Organizational structure diagram/flowchart
  • Copy of all mobile vehicle registrations
Section 13: Contact Person Information Copy appropriate page as many times as necessary
  • Complete with the contact person’s information
Section 15: Certification Statement 15B – All newly added authorized official(s) need to print, sign and date.

15D – All newly added delegated officials need to print, sign, and date and be cosigned and dated by an authorized official with authorized official signature and date in section 15B too.

Note: Revalidation application, only one authorized or established delegated official signature and date is needed.

 
Attachment 2: Independent Diagnostic Testing Facilities Read guidelines and instructions.
A. Standards Qualifications Identify date (mm/dd/yyyy) IDTF met all current CMS qualification standards per 42 CFR, Section 410.33(g).

See IDTF Performance Standards for more information.
B. CPT-4 and HCPCS Codes Copy appropriate page as many times as necessary.
  • When applicable indicate change, add, or remove with effective date for reporting codes and equipment
  • Identify all CPT-4 and HCPC codes and associated equipment with model number information
See IDTF Claim Guidelines and IDTF Code Level Supervision for more information
C. Interpreting Physician information Either:
  • indicate section does not apply or
  • identify every interpreting physician information (copy appropriate page as many times as necessary) and when applicable indicate change, add or remove with effective date
  • All interpreting physicians must be currently enrolled with Medicare
See IDTF Interpreting Physicians and Personnel (Technicians) Who Perform Tests for more information
D. Personnel Technicians) Who Perform Tests Copy appropriate page as many times as necessary
  • Identify all personnel(technicians) performing tests and when applicable indicate change, add or remove with effective date
  • Attach state license or certification information per individual
See IDTF Interpreting Physicians and Personnel (Technicians) Who Perform Tests for more information
E. Supervising Physicians Read definition of types of supervision

IDTFs must report at least one supervisory physician, and at least one supervising physician must perform the supervision requirements stated in 42 C.F.R. 410.32(b)(3).

IDTF must have all three functions acknowledged
  • Assumes responsibility for the overall direction and control of the quality of testing performed.
  • Assumes responsibility for assuring that the nonphysician personnel who actually perform the diagnostic procedures are properly trained and meet required qualifications.
  • Assumes responsibility for the proper maintenance and calibration of the equipment and supplies necessary to perform the diagnostic procedures.
Supervising physician type must:
  • Currently be enrolled in Medicare
  • Identify type and function performing
  • Identify all other supervision at any other IDTF
  • Attest to responsibilities by signing and dating

Note: Under 42 CFR Section 410.33(b)(1), each supervising physician must be limited to providing general supervision at no more than three IDTF sites. This applies to both fixed sites and mobile units where three concurrent operations are capable of performing tests.

See IDTF Supervising Physicians for more information

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Who to Contact

Topic Questions Contact Information
NPI Changing an NPPES password

Establishing a new user ID and password for NPPES

Questions related to the NPI application		 NPI Enumerator:
Phone: 800-465-3203
TTY: 800-692-2326
Email: customerservice@npienumerator.com
PECOS (EUS) Errors encountered while accessing or entering information in PECOS

Forgotten PECOS user ID and password		 EUS Help Desk:
Phone: 866-484-8049
TTY: 866-523-4759
Email: EUSSupport@cgi.com
Medicare Enrollment Completing CMS-855 Forms
Updating enrollment records in PECOS
In-depth enrollment questions		 National Government Services
J6: IL, MN, WI at: 877-908-8476

JK: CT, MA, ME, NH, NY, RI, VT at:
888-379-3807

 

Note: Provider enrollment representatives will only be able to assist those listed as the contact person on the application, the provider themselves, and/or the authorized/delegated official for the practice.

Revised 10/23/2024