Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.
History/Background and/or General Information
An Independent Diagnostic Testing Facility (IDTF) is an entity independent of a hospital or physician’s office in which diagnostic tests are performed. It was created by regulation (42CFR§410.33) as published in the Federal Register, Vol. 62, number 211, October 31, 1997.
This local coverage determination (LCD) addresses the structure, approved services, credentialing requirements and coding and billing for an IDTF. Diagnostic testing performed in an IDTF must follow the supervision and credentialing guidelines set forth in this LCD. All enrolling IDTFs must meet the supervising physician qualification/proficiency requirements and technician qualification requirements at the time of their enrollment.
IDTF regulations in this LCD do not apply to approved portable x-ray suppliers or to procedures (e.g., pathology and laboratory) furnished in a physician’s office, group practices, multi-specialty clinics or groups.
Required Characteristics of an IDTF:
Please refer to the CFR, Title 42, Volume 2, Chapter IV, Part 410.33 Independent diagnostic testing facility, CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 35, Section 50 Therapeutic Procedures, and CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 10 Medicare Enrollment.
Covered Indications
Diagnostic tests performed by an IDTF will be covered when the procedures are medically necessary and the criteria in this LCD are met. The procedures in this document are also subject to applicable National and Local Coverage Determinations (LCDs).
Please refer to CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 10 Medicare Enrollment regarding the Form CMS-855B enrollment application.
Please refer to CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 35, Section 50 Therapeutic Procedures.
Additional Services/Supplies
Additional services/items (e.g., radiopharmaceutical agents, special contrast agents, medications, etc.) related to, or generally considered required for, performing a diagnostic test 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 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.
These additional services/items which are necessary for the performance of specific diagnostic tests may be billed by an IDTF if approval is granted by the contractor for the IDTF to bill for the specific test(s) that require such items/services. The additional items or services may not be listed on the IDTF CPT/HCPCS code table. For example, some procedures require an injection of a joint for arthrography and would be allowed if the procedure is integral to the diagnostic test the IDTF is permitted to perform. However, an IDTF is not allowed to bill for surgical procedures that are clearly not related to, or required for a diagnostic test.
Ordering of Tests
Please refer to the CFR, Title 42, Volume 2, Chapter IV, Part 410.33(d) Ordering of tests and CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 35, Section 20 Ordering of Test.
Although all procedures performed by the IDTF must be specifically ordered in writing by the practitioner treating the beneficiary as noted in the CFR, Title 42, Volume 2, Chapter IV, Part 410.33(d), the mere fact that the test(s) were properly ordered does not reflect or imply coverage for these services. Medical necessity must be apparent and statutory exclusions, national and local coverage determinations (LCDs) apply.
As noted in the CFR, Title 42, Volume 2, Chapter IV, Part 410.33(d), the results of any diagnostic test performed by the IDTF must actually be used in the management of the beneficiary’s specific medical problem. If a beneficiary’s medical care will not be significantly altered by the results of a test performed by an IDTF, even if properly ordered, it will not be paid. Similarly, any test performed by an IDTF must be in an appropriate place of service.
Multi-State Entities
Please refer to the CFR, Title 42, Volume 2, Chapter IV, Part 410.33(e) Multi-State entities.
Physician Supervision
Please refer to the CFR, Title 42, Volume 2, Chapter IV, Part 410.33(a)(2) Exceptions, Part 410.33(b) Supervising physician, CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, and CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 10, Section 10.2.2, I. Independent Diagnostic Testing Facilities (IDTFs), Parts 13 and 14.
It is required that the supervising physician meet the qualification requirements as listed in the Credentialing Matrix found in Local Coverage Article: Billing and Coding: Independent Diagnostic Testing Facility (IDTF) (A57807).
*Note: The minimal level of physician supervision, which applies to ALL diagnostic tests, with the exceptions cited in the CFR, Title 42, Volume 2, Chapter IV, Part 410.33(a)(2), is “general supervision”.
Tests Personally Performed by a Physician
Physician supervision of any type is not required for diagnostic tests personally performed by a physician when they are authorized by the State to perform such tests and the testing is within the scope of their practice. In this case, technician requirements would not apply since the qualified physician is performing the test.
Nonphysician Personnel
Please refer to the CFR, Title 42, Volume 2, Chapter IV, Part 410.33(a) General rule, Part 410.33(c) Nonphysician personnel, CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, and CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 10, Section 10.2.2, I. Independent Diagnostic Testing Facilities (IDTFs), Parts 10-12.
It is expected that nonphysician personnel must maintain an active status in order for the diagnostic tests to be covered.
When a Medicare payable diagnostic test is not subject to State license or certification of the technician performing the test, and no generally accepted national credentialing body exists. In that instance, the technician should be listed and the IDTF should submit as an attachment any education/credentialing and/or experience that the person has.
The contractor does not establish a credentialing service but the contractor is authorized to determine which organizations it recognizes. For example, the use of the word “national” in the organization’s name does not, in itself, meet Medicare standards for national credentialing.
The supervising physician and nonphysician personnel credentialing requirements are listed in the Credentialing Matrix found in Local Coverage Article: Billing and Coding: Independent Diagnostic Testing Facility (IDTF) (A57807).
Note: For all credentialed technologists, licensed personnel and personnel in which no credentialing or licensing board is available, it is a requirement that the individual demonstrate proficiency in the service one is performing. This must be documented and verified by the supervising physician.
Requirements for Cardiac Catheterization Procedures Performed in an IDTF:
Effective for services performed on or after January 12, 2006, CMS repealed section 20.25, titled Cardiac Catheterization in Other than a Hospital Setting, of publication 100-03 (Medicare National Coverage Determinations (NCD) Manual). Therefore, determinations of coverage for cardiac catheterization when performed outside the hospital setting is at the discretion of the local Medicare contractor through their local coverage determinations (LCDs).
The original language from section 20.25 of publication 100-03 required that Medicare contractors, in consultation with the Peer Review Organizations (PROs), renamed Quality Improvement Organizations (QIOs), review freestanding Cardiac Catheterization facilities to determine that procedures can be performed safely. This function of the QIOs is no longer in their scope of work as their focus has shifted to include other functions. It is now at the contractor’s discretion through LCDs to make decisions regarding the coverage of Cardiac Catheterization in freestanding facilities.
A diagnostic cardiac catheterization performed in an IDTF will be considered as medically reasonable and necessary when the following criteria are met:
- Performed by a *qualified physician as defined below; AND
- Performed with the assistance of a cardiology technologist credentialed as follows:
- Credentialed by The American Registry of Radiologic Technologists (ARRT) as a Cardiac-Interventional Radiographer (ARRT: CI); OR
- Credentialed by Cardiovascular Credentialing International (CCI) as a Cardiovascular Invasive Specialist (CCI: RCIS); AND
- Performed with the assistance of a Registered Nurse (RN) with Advanced Cardiac Life Support (ACLS) certification; OR
- Performed in an IDTF accredited by an **approved accreditation organization as a cardiac catheterization lab.
*Training Requirements for Physicians Performing Cardiac Catheterizations in an IDTF:
The American College of Cardiology (ACC) and the American Heart Association (AHA) have issued joint guidelines on training in cardiac catheterization and interventional cardiology. Providers who perform diagnostic catheterization services in an IDTF setting must have a minimum of Level 2 training as outlined by the ACC/AHA Task Force 3.
** Accepted Accreditation Organizations for Cardiac Catheterization Labs:
- Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
- Accreditation Association for Ambulatory Health Care (AAAHC).
This procedure must always be performed under personal physician supervision, which means the physician must be present in the room while the entire cardiac catheterization is being performed.
The IDTF must have a formal relationship with a tertiary hospital for the emergency transfer of patients, have equipment for intubation and ventilatory support, and have quality assurance and quality improvement programs in place. In addition, the physicians must be able to perform endotracheal intubations and insert an intra-aortic balloon pump.
Limitations:
Left heart catheterization by transseptal puncture through intact septum or by transapical puncture is not considered safe when performed in an independent diagnostic testing facility setting and therefore, is not covered.
Patients having a cardiac catheterization performed in an IDTF must be in stable condition and at the lowest risk for complications. Higher risk patients include those with recent myocardial infarction (MI) with post-infarction ischemia, class IV cardiac disease, refractory unstable angina, and New York Heart Association (NYHA) Class III or IV heart failure, among others.
As a reminder, reimbursement may be made to IDTFs only for procedure codes for which they are approved, based on equipment and personnel requirements, IDTFs are required to submit a list of all procedure codes performed by the facility to Medicare Provider Enrollment. The codes and equipment should be listed on Attachment 2, Section 1 of Enrollment Application Form CMS-855B.
As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.
Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.
