On December 10, 2021, the Centers for Medicare and Medicaid Services (CMS) issued Change Request 12502 to incorporate various new regulatory changes into the Medicare Program Integrity Manual for a variety of Medicare supplier categories, including independent diagnostic testing facilities (IDTFs).
In the CY 2022 Medicare Physician Fee Schedule (MPFS) final rule, CMS modernized its rules to recognize the performance of tests that use certain emerging technologies and that are not conducted in person with the patient ("indirect, non-person tests"). In such circumstances, diagnostic services are performed via computer modeling and analytics, or other forms of testing not involving direct patient interaction. The services are often conducted by a technologist 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.
Currently, 42, C.F.R. § 410.33 contains various standards that IDTFs must meet to maintain their Medicare enrollment status. Section 410.33(c) requires that all non-physician personnel (NPP), such as technologists, that the IDTF uses to perform diagnostic tests must demonstrate the basic qualifications to perform these tests as evidenced by state licensure or state certification. In the absence of a state licensing board, the technologist or other NPP must be certified by an appropriate national credentialing body.
But for IDTF regulations beginning in 2022, the rules for tests that do not require direct patient interaction revise the qualifications of the NPP performing these indirect tests. These technologists should meet whatever state requirements exist for such services. However, for those states without licensure for this non-physician category, the new rule does not include any reference to national credentialing bodies for those performing indirect, non-in-person tests. The new CMS transmittal incorporates this change into the Program Integrity Manual.
Additionally, CMS has exempted that IDTFs performing indirect, non-in-person tests from the following IDTF program integrity requirements found in § 410.33(g).
- § 410.33(g)(6)) – The IDTF must have a comprehensive liability insurance policy of at least $300,000 per location that covers both the place of business and all customers and employees of the IDTF.
- § 410.33(g)(8)) – The IDTF must answer, document, and maintain documentation of a beneficiary's written clinical complaint at the physical site of the IDTF.
- § 410.33(g)(9)) – The IDTF must openly post the standards outlined in § 410.33(g) for review by patients and the public.
CMS has informed Medicare administrative contractors that if an IDTF performs both direct and indirect tests it must meet the exempted standards in § 410.33(g)(6), (g)(8), and (g)(9). An IDTF must exclusively perform tests involving no beneficiary interaction, treatment, or testing in order to be exempt from these standards.
Additionally, it should be noted that Change Request 12502 incorporates various other new regulatory changes into the Medicare Program Integrity Manual, including those for federally qualified health centers, home health agencies, and physician assistants.