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Independent diagnostic testing facility (IDTF) quick reference

Overview

IDTFs are required to report the exact CPT/HCPCS codes and procedures they intend to perform when enrolling with the CMS-855B form. If an IDTF that is already enrolled wants to perform additional CPT or HCPCS code tests that were not originally specified on its CMS-855B and that are for procedure types and supervision levels similar to its previously allowed codes, the contractor shall have the IDTF amend its CMS-855B to add the additional codes and equipment listing. A new site visit is not required. However, if the enrolled IDTF will be performing CPT or HCPCS codes for different types of procedures, or with different supervision levels, a new site visit is required. Claims submitted with procedure codes not reported on the CMS-855B form and reviewed by the contractor will be denied.

Each IDTF will have a specific and unique list of CPT/HCPCS codes for which it can be paid by the contractor, and it is the responsibility of the IDTF to obtain specific contractor approval to bill each CPT/HCPCS code that it intends to bill. 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.

JW and JZ Modifiers

When billing for Part B drugs and biologicals (except those provided under a competitive acquisition program [CAP]), the use of the JW modifier to identify unused drugs or biologicals from single use vials or single use packages that are appropriately discarded is required. The discarded amount shall be billed on a separate claim line using the JW modifier. Providers are required to document the discarded drug or biological in the patient’s medical record.

Any amount wasted must be clearly documented in the medical record and should include the date and time, amount of medication wasted, and the reason for the wastage. The use of the JZ modifier (attesting that there were no discarded amounts) is required on claims to report there are no discarded amounts of unused drugs or biologicals from single use vials or single use packages. Claims for drugs separately payable under Medicare Part B from single-dose containers are required to report either the JW or JZ modifier, to identify any discarded amounts or to attest that there are no discarded amounts, respectively.

The JW and JZ modifier policy does not apply for drugs that are not separately payable, such as packaged Outpatient Prospective Payment System (OPPS) or Ambulatory Surgical Center (ASC) drugs, or drugs administered in the Federally Qualified Health Center (FQHC) or Rural Health Center (RHC) setting. The JW and JZ modifiers do not apply to drugs assigned status indicator N (Items and Services Packaged into Ambulatory Payment Classification [APC] Rates) under the OPPS. Similarly, the JW and JZ modifiers do not apply to drugs assigned payment indicator “N1” (ASC). Please refer to the IOM 100-04, Chapter 17, Section 40 for complete information on the JW/JZ modifiers. 

Facilities 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
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
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 performs 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
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
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
Radiology Group
  • Many diagnostic tests are radiological procedures that require professional services of a radiologist. Generally, a radiologist's practice is 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
Radiation Therapy Center
  • Not IDTFs
  • Center provides therapeutic services
Services Requirements
Clinical Laboratory Improvement Act (CLIA) Test
  • Cannot be performed or billed 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
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
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 an IDTF 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
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 an 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

 

References