Header: CMS is trying to modernize some of its payment and benefit pathways, including the creation of "Indirect IDTFs" that don't see patients and perform only software services. Thanks to Susan Xu for pointing this out.
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Decades ago, CMS created an entity called IDTF - Independent Diagnostic Testing Facility - that allows enrollment to perform diagnostic tests (like MRI scans) without being a medical entity like a medical (radiology) group practice. Longstanding regs are at 42 CFR 410.33.
Over the past five or six years, companies with business models like HeartFlow have challenged this model, because they don't see patients on-site, like CMS expected. Over the years I've put together different parts of the HeartFlow story from adminstrativev law judge (ALJ) records, from annual CMS rulemaking, public comment letters, and even from FOIA (freedom of information) records. Suffice it to say that HeartFlow "didn't take no for an answer" despite an arcade-like series of roadblocks to overcome.
The "Indirect IDTF" 42 CFR 410.33(g) and PIM Ch 10.2.
One of the biggest testaments to the change was the explicit creation of the "Indirect IDTF" effective 1/1/2022. To read about this, see three sources:
- Federal regulation 410.33. Here.
- CMS seems to have not revised the reg here, but put program manual "exemptions" in writing, which "exempt" an "indirect IDTF" from clauses 410.33(c)(2) and (g) (6,8,9).
- Medlearn Matters explanatory bulletin "Independent Diagnostic Testing Facility," 13pp. Here.
- Program Manual PIM, Ch 10, 10.2.2.4. Here.
- Some health care entities have developed or utilize diagnostic tests that do not require such interaction (hereafter occasionally referenced as “indirect IDTFs”). That is, certain IDTFs perform diagnostic services via computer modeling and analytics, or other forms of testing not involving direct beneficiary interaction.
- The service is often conducted by a technician who undertakes a computer analysis offsite or at another location at which the patient is not present. The physician then reviews the image to determine the appropriate course of action. In short, these entities generally, though not exclusively, have two overriding characteristics.
- First, the tests they perform do not involvedirect patient interaction, meaning that the test is conducted away from the patient’s physical presence and is non-invasive.
- Second, the test involves off-site computer modeling and analytics.
If no state licensure requirements for such personnel exist, the contractor need not undertake additional verification activities under § 410.33(c)(2) concerning the technician in question; the contractor shall not establish its own additional certification, credentialing, or similar technician requirements (e.g., federal accreditation) above and beyond the requirements.
