Link To Medicare Part B Reference Manual, Chapter 3 - Provider Enrollment 

Independent Diagnostic Testing Facilities

The Centers for Medicare and Medicaid Services (CMS) issued standards for all Independent Diagnostic Testing Facilities (IDTF).  The requirements were effective for IDTFs as of January 1, 2007.   The standards were revised effective January 1, 2008.  Any newly enrolling IDTF or changes to existing IDTFs will be reviewed to ensure that the standards are met.

The standards in their entirety can be referenced in CFR 42. §410.33 (g).  The standards provide that the IDTF must:

1.  Operate its business in compliance with all applicable Federal and State licensure and regulatory requirements for the health and safety of patients.

2.  Provide complete and accurate information on its enrollment application.  Changes in ownership, changes of locations, changes in general supervision, and adverse legal actions must be reported to the Medicare fee-for-service contractor on the Medicare enrollment application within 30 calendar days of the change.  All other changes to the enrollment application must be reported within 90 days.

3.  Maintain a physical facility on an appropriate site. For the purposes of this standard, a post office box or commercial mail box, hotel or morel is not considered an appropriate site.  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 accommodations, 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.

             IDTF suppliers that provide services remotely and do not see beneficiaries at their practice location are exempt from providing hand washing and adequate patient privacy accommodations.

4.  Have all applicable diagnostic testing equipment available at the physical site excluding portable diagnostic testing equipment.  A catalog of portable diagnostic equipment, including diagnostic testing equipment serial numbers, must be maintained at the physical site. In addition, portable diagnostic testing equipment must be available for inspection within two business days of a CMS inspection request.  The IDTF must maintain a current inventory of the diagnostic testing equipment, including serial and registration numbers, provide this information to the designated fee-for-service 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 primary business phone must be located at the designated site of the business, or within the home office of the mobile IDTF units.  The telephone number or toll free numbers must be available in a local directory and through directory assistance.  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 non-relative owned company.  Failure to maintain required insurance at all times will result in revocation of the IDTF’s billing privileges retroactive to the date the insurance lapsed.  IDTF suppliers are responsible for providing the contact information for the issuing insurance agent and the underwriter.  In addition, the IDTF must (1) ensure that the insurance policy must remain in force at all times and provide coverage of at least $300,000 per incident and (2) notify the CMS designated contractor in writing of any policy changes or cancellations.

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).

8.  Answer, document, and maintain documentation of a beneficiary’s written clinical complaint at the physical site of the IDTF.  (For mobile IDTFs, this documentation would be stored at the home office.)  This includes but is not limited to the following:

• The name, address, telephone number, and health insurance claim number of the beneficiary
• The date the complaint was received, the name of the person receiving the complaint, and a summary of actions taken to resolve the complaint.
• If an investigation was not conducted, the name of the person making the decision and the reasons for the decision.

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 be accessible during regular business hours to CMS and beneficiaries and must maintain a visible sign posting the normal business hours of the IDTF.

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 enrollment in the Medicare program.  Failure to meet any of the standards or any other applicable requirements will result in the denial of the supplier’s CMS-855 application or the revocation of the Medicare billing number.

In addition to the IDTF Standards provided above, suppliers enrolling as IDTF must provide specific information on Attachment 2 of the CMS-855B.  Each practice location and mobile unit must be distinctly enrolled.  A separate CMS-855B must be submitted for each location and/or mobile unit.  The data on the CMS-855B must be correlated to the individual practice location or mobile unit.  Each location must meet the standards as a distinct Medicare supplier.   A site visit is required for each practice location and each mobile unit and a separate Medicare billing number is assigned to the practice location.

Sharing of Space and Equipment

Effective January 1, 2008, with the exception of hospital-based and mobile IDTFs, a fixed-based IDTF does not:

• Share a practice location with another Medicare-enrolled individual or organization
• Lease or sublease its operations or its practice location to another Medicare-enrolled individual or organization
• Share diagnostic testing equipment used in the initial diagnostic test with another Medicare enrolled individual or organization.

Diagnostic tests

IDTFs are required to report the exact CPT codes/procedures they intend to perform when enrolling with the CMS 855B Application for Health Care Suppliers.   The corresponding equipment for each service is required on the 855B Application.  Unless the IDTF has reported deletions or changes to the CPT codes that were initially reported, it is imperative that the IDTF continue to bill only those codes after enrollment has taken place. Any change of information related to the equipment or services billed must be reported to the carrier within 90 days. Claims submitted with CPT codes, not reported and reviewed by the Carrier will be denied.   In order for an IDTF to receive reimbursement, the diagnostic test reported must meet the specified criteria for physician supervision, nonphysician technician and equipment credentialing guidelines for the test performed.   Additional services related to, or generally considered required for, performing diagnostic tests are also payable to an IDTF if they are commonly separately reimbursed to a physician in a physician’s office setting. An IDTF can bill these practitioner’s services when they are performed by a qualified practitioner in accordance with coverage, payment and general billing rules, and in accordance with the reassignment of benefit and purchased test rules. However, an IDTF is not allowed to bill for surgical procedures that are clearly not related to, or required for a diagnostic test.

Technicians

All technicians must meet the standard of a state license or certification, or national credentialing body.  The certification for each technician must be included with the CMS-855B

Interpreting Physicians

When enrolling or updating information, the IDTF shall list all physicians whose diagnostic test interpretations it will bill (global billing). This includes physicians who are providing purchased interpretations to the IDTF as well as physicians who are reassigning their benefits to the IDTF. The contractor will review and document that all physicians listed are Medicare enrolled. The contractor will ensure that all interpreting physicians who are reassigning their benefits to the IDTF have the right to do so.

All interpreting physicians must complete and submit an Individual Reassignment of Benefit (CMS 855R) if:

• The interpreting physician is an employee of the IDTF.
• A contractor is working in a practice location that the IDTF owns or leases.

The IDTF must also report all independent contractor physicians (for which it will bill) who perform professional interpretations off the premises of the IDTF’s practice location. For these interpretations to be billable by the IDTF, they must meet the conditions shown in Publication 100-4, Medicare Claims Processing, Chapter 1, §30.2.9, “Payment to Physician or Other Supplier for Purchased Diagnostic Tests.”  A CMS-855R is not required for the interpreting physician in these situations.

Supervising Physicians

Medicare requires that diagnostic tests payable under the physician fee schedule, must be performed under the supervision of an individual meeting the definition of a “physician” in section 1861(r) of the Social Security Act in order to be considered reasonable and necessary and, therefore, covered under Medicare. The basis for the Medicare requirement that physicians supervise diagnostic testing has always been to try to ensure the safety and effectiveness of the diagnostic testing furnished to Medicare beneficiaries.

An IDTF’s supervising physician(s) must be enrolled in the Medicare program and must evidence proficiency in the performance and interpretation of each type of diagnostic procedure they are supervising. An IDTF must have one or more supervising physicians who are responsible for the direct and ongoing oversight of the quality of the testing performed, the proper operation and calibration of the equipment used to perform tests, and the qualification of nonphysician personnel who use the equipment. This level of supervision is the requirement for general supervision.   The supervising physician must be licensed to practice in the State(s) where the diagnostic tests he or she supervises will be performed. In the case of a procedure requiring the direct or personal supervision of a physician, the IDTF’s supervising physician must personally furnish this level of supervision whether the procedure is performed in the IDTF or, in the case of mobile services, at the remote location.

In the case of procedures requiring direct supervision, the supervising physician may

oversee concurrent procedures. The IDTF must maintain documentation to demonstrate sufficient physician attendance during all hours of operation to assure that the required physician supervision is furnished.

Under 42 CFR §410.33 (h) (1), each supervising physician must be limited to providing supervision to no more than three IDTF sites