The following provides guidance regarding the types of entities that may or may not be sufficiently independent from a physician office or hospital to require enrollment as an independent diagnostic testing facility (IDTF). An entity generally should not be considered independent from a physician office or hospital if it has the following characteristics:
- It is a physician practice that is owned, directly or indirectly, by one or more physicians or by a hospital
- The entity primarily bills for physician services (e.g., evaluation and management (E/M) codes) and not for diagnostic tests
- It furnishes diagnostic tests primarily to patients whose medical conditions are being treated or managed on an ongoing basis by one or more physicians in the practice
- The diagnostic tests are performed and interpreted at the same location where the practice physicians also treat patients for their medical conditions
Many diagnostic tests are radiological procedures that require the professional services of a radiologist. A radiologist’s practice is generally very different from those of other physicians because radiologists usually do not bill E/M codes or treat a patient’s medical condition on an ongoing basis. Nevertheless, a radiologist or a group of radiologists should not necessarily be required to enroll as an IDTF. The following features would indicate that a radiology practice is not independent from a physician office or hospital:
- The practice is owned by radiologists, a hospital or both
- The owner radiologists and any employed or contracted radiologists regularly perform physician services (e.g., test interpretations) at the location where the diagnostic tests are performed
- The billing patterns of the enrolled entity indicate the entity is not primarily a testing facility and that it was organized to provide the professional services of radiologists (e.g., the enrolled entity should not bill for a significant number of purchased interpretations, it should rarely bill only for the technical component of a diagnostic test, and it should bill for a substantial percentage of all of the interpretations of the diagnostic tests performed by the practice)
- A substantial majority of the radiological interpretations are performed at the practice location where the diagnostic tests are performed
To be exempt from the IDTF standards and enrollment as an IDTF, because the applicant is a part of a hospital, the applicant should be provider-based in accordance with Section 404 of the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000, Publication L, Number 106–554. Diagnostic tests billed by the hospital to its own patients, which are performed under arrangement, do not require IDTF billings and therefore do not require IDTF enrollment. However, if the entity providing the under-arrangement diagnostic tests perform diagnostic tests that will be billed under its own billing number (not the hospital’s), the entity is subject to the IDTF rules. Therefore, the entity may or may not require enrollment as an IDTF for its own patients. An entity can be enrolled as an IDTF (it is considered independent) if it requires IDTF enrollment as stated above. This is the case even if there is joint ownership with the hospital, if the entity is located on the hospital campus, or if it cannot qualify as provider-based.
Mobile units are required to list their geographic service areas. A supervisory physician performing direct or personal supervision for the IDTF on a patient should be aware of the prohibition concerning physician self-referral for testing.
Portable X-ray Services
A mobile IDTF that provides X-ray services is not classified as a portable X-ray supplier. Therefore, it cannot bill for transportation (HCPCS code R0070) and setup (HCPCS code Q0092). If it desires to bill for these services, it must also enroll, qualify and bill as a portable X-ray supplier in accordance with the portable X-ray supplier billing rules.
Note: Portable X-ray suppliers are certified by the state.
Transtelephonic and Electronic Monitoring Services
Transtelephonic and electronic monitoring services (e.g., 24-hour ambulatory EKG monitoring, pacemaker monitoring and cardiac event detection) may perform some of their services without actually seeing the patient. Most but not all of these billing CPT codes are 93041, 93224, 93225, 93226, 93268, 93270, 93271, 93280, 93283, 93288, 93289, 93293, 93294, 93295, 95950, 95951, 95953 and 95956. These monitoring service entities are considered IDTFs and must meet all IDTF requirements. The entity actually must have a person available 24 hours a day to answer telephone inquiries. Use of an answering service in lieu of the actual person is not acceptable. The person performing the attended monitoring should be listed in Form CMS 855 B, Attachment 2, Section 3. The qualifications of the person are at the carrier’s discretion.
Slide Preparation Facilities
Slide preparation facilities are not IDTFs. Slide preparation facilities are entities that provide slide preparation and other types of services that are payable through the technical component of the surgical pathology service. These entities do not provide the professional component of surgical pathology services or other laboratory tests. The services they provide are recognized by carriers for payment as codes in the surgical pathology CPT code range 88300 through 88399 with a technical component value under the physician fee schedule. The services provided by these entities are usually ordered and reviewed by a dermatologist. Slide preparation facilities generally only have one or two people performing this service.
Radiation Therapy Centers
Radiation therapy centers provide therapeutic services and, therefore, are not IDTFs.
If an IDTF performs diagnostic mammography, it must have a Food and Drug Administration certification to perform the mammography. However, an entity that only performs diagnostic mammography should not be enrolled as an IDTF.
An IDTF may not perform or bill for Clinical Laboratory Improvement Act (CLIA) tests. However, an entity with one Tax Identification Number (TIN) may own both an IDTF and an independent CLIA laboratory. They should be separately enrolled and should bill separately.
A cardiac catheterization facility can be set up either as a physician-directed clinic or an IDTF. However, an IDTF may not bill for the interpretation of the cardiac catheterization procedures. Cardiac catheterization procedures must be split billed (e.g., TC HCPCS modifier/26 CPT modifier). They are not ‘diagnostic tests’; the physician must bill for the professional component. The cardiac catheterization procedure with the 26 CPT modifier must be billed by the physician providing the service. The cardiac catheterization facility would bill with the TC HCPCS modifier for the facility fee reimbursement and the physician (the cardiologist) would be reimbursed for his services by submitting the code with the 26 CPT modifier. This represents payment for the surgical aspect of the procedure.