View guidance regarding types of entities that may or may not be sufficiently independent from a physician office or hospital to require enrollment as an IDTF. Generally, an entity should not be considered independent from a physician office or hospital if it has the below characteristics.
- It is a physician practice that is owned, directly or indirectly, by one or more physicians or by a hospital
- It primarily bills for physician services (e.g., evaluation and management (E/M)) 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
- Diagnostic tests are performed and interpreted at same location where practice physicians also treat patients for his/her medical conditions
Access the below IDTF related information from this page.
Facilities
| Facility | Requirements |
| Ambulatory Surgical Center (ASC) | - Cannot bill for separate diagnostic tests it performs during ASC scheduled hours of operation (see 42 CFR 416.2)
- If an entity, which owns an ASC, performs diagnostic tests in same physical facility as ASC but during a time period when ASC is not in operation, those diagnostic tests can be billed by an enrolled IDTF; therefore, in that instance, an additional separate enrollment by entity as an IDTF is required
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| Cardiac Catheterization Facility | - Can be set up either as a physician-directed clinic or an IDTF; however, an IDTF may not bill for interpretation of cardiac catheterization procedures. Cardiac catheterization procedures must be split billed (e.g., Technical component (TC)/Professional component (26) modifier) as they are not ‘diagnostic tests'
- Physician must bill for professional component (26) of cardiac catheterization services rendered
- Facility must bill technical component (TC) of procedure code for facility fee reimbursement
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| Hospital | - To be exempt from IDTF standards and enrollment as an IDTF, because applicant is part of a hospital, applicant should be provider-based in accordance with Section 404 of Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000, Publication L, Number 106–554
- Diagnostic tests billed by hospital to its own patients, which are performed under arrangement, do not require IDTF billings and therefore do not require IDTF enrollment; however, if entity providing under-arrangement diagnostic tests perform diagnostic tests that will be billed under its own billing number (not the hospital's), entity is subject to IDTF rules. Therefore, 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 hospital, if entity is located on hospital campus, or if it cannot qualify as provider-based
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| Mobile Unit | - Required to list their geographic service areas
- Supervisory physician performing direct or personal supervision for IDTF on a patient should be aware of prohibition concerning physician self-referral for testing
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| Slide Preparation Facility | - Not IDTFs
- Facility provides slide preparation and other types of services payable through technical component of surgical pathology service
- Facility does not provide professional component of surgical pathology services or other laboratory tests.
- Services provided are recognized by carriers for payment as codes in surgical pathology CPTs 88300 - 88399 with a technical component value under Medicare Physician Fee Schedule (MPFS) and are usually ordered and reviewed by a dermatologist
- Generally only have one or two people performing this service
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| Radiology Group | - Many diagnostic tests are radiological procedures that require professional services of a radiologist. Generally, a radiologist's practice is very different from those of other physicians because he/she usually does 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
- Below features indicate a radiology practice is not independent from a physician office or hospital
- Practice is owned by radiologists, a hospital or both
- Owner radiologists and any employed or contracted radiologists regularly perform physician services (e.g., test interpretations) at location where diagnostic tests are performed
- Billing patterns of enrolled entity indicate entity is not primarily a testing facility and that it is organized to provide professional services of radiologists (e.g., enrolled entity should not bill for a significant number of purchased interpretations, it should rarely bill only for technical component of a diagnostic test, and it should bill for a substantial percentage of all of interpretations of diagnostic tests performed by practice)
- Substantial majority of radiological interpretations are performed at practice location where diagnostic tests are performed
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| Radiation Therapy Center | - Not IDTFs
- Center provides therapeutic services
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Services
| Service | Requirements |
| Clinical Laboratory Improvement Act (CLIA) Test | - Cannot be performed or bill for by an IDTF; however, an entity with one Tax Identification Number (TIN) may own both an IDTF and an independent CLIA laboratory. Should be separately enrolled and should bill separately
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| Diagnostic Mammography Service | - If an IDTF performs diagnostic mammography, it must have a Food and Drug Administration (FDA) certification to perform mammography; however, an entity that only performs diagnostic mammography should not be enrolled as an IDTF
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| Portable X-ray Service | - A mobile IDTF that provides X-ray services is not classified as a portable X-ray supplier; therefore, it cannot bill for transportation (HCPCS R0070) and setup (HCPCS 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 portable X-ray supplier billing rules
- Portable X-ray suppliers are certified by state
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| Transtelephonic and Electronic Monitoring Service (e.g., 24-hour ambulatory EKG monitoring, pacemaker monitoring and cardiac event detection) | - May perform some services without actually seeing patient. Most, but not all, of these billing CPTs are 93041, 93224, 93225, 93226, 93268, 93270, 93271, 93280, 93283, 93288, 93289, 93293, 93294, 93295, 95950, 95951, 95953 and 95956
- These entities are considered IDTFs and must meet all IDTF requirements
- These entities must have a person available 24 hours a day to answer telephone inquiries. Use of an answering service in lieu of actual person is not acceptable
- Person performing attended monitoring should be listed in Form CMS 855 B, Attachment 2, Section 3. Person's qualifications are at carrier's discretion
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CPT Codes
- CPT code is a 5-digit code that is added to IDTF enrollment
- CPT Code is added for each machine that an IDTF will be working with that uses that code
- If IDTF plans on billing globally
- Bill only CPT itself
- Global billing means IDTF intends to bill for both technical component (modifier TC) and professional component or interpretation (modifier 26). Both components are combined in global code
- If IDTF plans on billing for technical component only
- Bill CPT code and append modifier TC, if CPT code requires it
- Some codes are inherently TC only and do not require it (e.g. injections, drug codes)
- If, on occasion, IDTF plans on billing globally or TC only
- Global: Bill global CPT code, no modifier
- TC only: Bill CPT code, append modifier TC
- This is not common scenario. IDTFs most often enroll as either global or TC
- If IDTF plans on billing for professional component/interpretation or technical component separately.
- Bill one claim, two lines. Include global CPT code, append modifier 26 and same global CPT code, append modifier TC
- This is not common scenario. IDTFs most often enroll as either global or TC
Resources
- CMS Internet Only Manual (IOM), Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80.6 - Requirements for Ordering and Following Orders for Diagnostic Tests
- CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 35 - CMS Guidance for IDTFs
- CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 10, Section 10.2.2.4 - IDTF enrollment requirements
