CMS Review Criteria
We have updated our process. For further background, refer to the discussion in our CY 2024 Final Rule (88 FR 78864 through 78872). This page now reflects our revised criteria, which we explain below.
Step 1. Determine whether the service is separately payable under the PFS.
Prior to submission, check the current year Addenda. Refer to this link for an example of the CY 2024 Addenda. Verify the payment status indicator is A, C, T, or R, for each candidate service. If the candidate service does not have one of these indicators, then CMS rejects the request. For further detail, refer to the CY 2024 PFS Final Rule (88 FR 78861 through 78863), which explains why CMS only considers requests that are separately payable under the Medicare Part B Physician Fee Schedule.
Step 2. Determine whether the service is subject to the provisions of section 1834(m) of the Act.
1834(m) of the Act, codified in our regulations at 42 CFR 410.78, may not apply to some other Communications-Based Technology Services (CTBS). If the candidate service is more like various other CTBS, then the least restrictive means of furnishing the service should apply.
For further detail, refer to the CY 2024 Final Rule (88 FR 78863). A service is subject to the provisions of section 1834(m) of the Act when at least some elements of the service, when delivered via telehealth, are a substitute for an in-person, face-to-face encounter, and, all of face-to-face elements of the service are furnished using an interactive telecommunications system as defined in 410.78(a)(3).
Step 3. Review the elements of the service as described by the HCPCS code and determine whether each of them is capable of being furnished using an interactive telecommunications system as defined in 410.78(a)(3).
A fair and consistent review process requires CMS to evaluate requests for candidate services(s) without changing the definition of the service itself.
Before gathering evidence, parse out elements of the candidate service(s). The effort should help avoid gathering information that is not necessary or useful for CMS to conduct a complete review.
To parse out each element of the candidate service, identify each clause in the long description. Separate elements that explain facts that do not vary from case to case with provision of the individual service(s). Then, identify elements of the description that may vary from case to case, based on individual circumstances. Examples of explanations of “static” elements include the care setting (e.g., office/outpatient), descriptions of an encounter between the clinician and patient (e.g., a visit), and conditional language that describes concrete constraints that must be met to consider the service complete (e.g., documentation requirements or time range requirements). Examples of “dynamic” elements that may vary from case to case would include language in the code descriptor that discusses the clinical action (e.g., complete patient history and/or physical exam).
Step 3 verifies that the complete substitution of static elements, with the use of A/V communications alone, as applicable, does not make it unlikely or impossible to complete any clinical actions within the description of the candidate service(s). Step 1 and Step 2 above verify that CMS has adopted the code(s) and assigned payment under the PFS, meaning the relative value and strength of evidence associated with the full in-person service are not at issue. As a result, a submission does not need to focus on the clinical value or importance of the clinical actions in a general way. We administer reviews of the understanding the clinical benefit and value of the in-person service are settled issues. In some circumstances, it may be necessary to gather evidence to show that the full service may be furnished via telehealth at all, to move past Step 3 analysis, or to establish that the virtual-only service does not typically generate a need in-person care that would have been avoided by furnishing the candidate service(s) in-person.
For further detail, refer to the CY 2024 Final Rule (88 FR 78863). The purpose of Step 3 is to verify that if CMS were to add the individual candidate service(s) to our definition of Medicare Telehealth, then doing so does not change clinical standards described in the candidate service(s), nor change the definition of the candidate service(s).
Step 4. Consider whether the service elements of the requested service map to the service elements of a service on the list that has a permanent status described in final rulemaking.
Most candidate service(s) do not have descriptions with the exact same elements. For analysis to end on Step 4, the candidate service(s) must map one to one with another service that has permanent status. Step 4 is likely most relevant when there are new successor codes that result from retirement or consolidation of legacy code(s). Examples include the recent changes to inpatient/observation E+M services and nursing home care E+Ms in CY 2023. We remind submitters that Step 4 is intended for this purpose. Submissions should not focus on Step 4 to avoid addressing head on questions of clinical benefit that should be addressed in Step 5.
For further detail, refer to the CY 2024 Final Rule (88 FR 78863)
Step 5. Consider whether there is evidence of clinical benefit analogous to the clinical benefit of the in-person service when the patient, who is located at a telehealth originating site, receives a service furnished by a physician or practitioner located at a distant site using an interactive telecommunications system.
The strength of a submission increases when a request includes verifiable, peer-reviewed evidence that compares clinical benefit using sufficient sample sizes, distinguishing between in-person only and virtual-only care described by the candidate service(s). Results should be generalizable to the Medicare population. A complete submission should include references that discuss analysis of utilization data where methodology examines the specific code(s).
Requestors should submit evidence indicating that the use of a telecommunications system in delivering the candidate telehealth service produces clinical benefit to the patient. The evidence submitted should include both a description of relevant clinical studies that demonstrate the service furnished by telehealth to a Medicare beneficiary improves the diagnosis or treatment of an illness or injury or improves the functioning of a malformed body part, including dates and findings and a list and copies of published peer reviewed articles relevant to the service when furnished via telehealth. Our evidentiary standard of clinical benefit will not include minor or incidental benefits. Some examples of clinical benefit include the following:
For further detail, refer to the CY 2024 Final Rule (88 FR 78864).