Pursuant to the Section 218(b) Protecting Access to Medicare Act, which amended Title XVIII of the Social Security Act, the Center for Medicare & Medicaid Services (“CMS”) was directed to establish a program for appropriate use criteria (“AUC”) for advanced diagnostic imaging services. CMS-1693-P at 437. CMS indicated that the development of AUC for advanced diagnostic imaging services would be an “evidence-based process and transparen[t],” and would be developed by a list of provider-led entities (“PLE”) Id. (citing 80 Fed. Reg. 70886, 71105); see https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/PLE.html for a list approved PLEs (last visited July 24, 2018).
An AUC is “specific clinical condition or presentation; one or more services; and an assessment of the appropriateness of the service(s).” CMS-1693-P at 439. AUCs are meant to assist practitioners in selecting the best diagnostic imaging services to improve patient health outcomes. By January 1, 2020, when a practitioner orders advanced diagnostic imaging services, he or she will be required to consult an applicable AUC through a qualified clinical decision support mechanism (“CDSM”) and to report that information to Medicare. A CDSM is an electronic portal, which can be integrated with an electronic health record (“EHR”) system, through which a practitioner can access the AUC during the patient workup. See https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM.html for a list of qualified CDSMs (last visited July 24, 2018).
The proposed rule is seeking to clarify who may be able to perform the required AUC consultation, clarify who is required to report the consultation, make changes to when a provider may qualify for a significant hardship exception for the consultation requirement, and to determine a mechanism for claims-based reporting.
The proposed rule is seeking to expand the list of facilities required to consult the AUC and report to CMS to include independent diagnostic testing facilities (“IDTFs”) in the definition of an “applicable setting,” which also includes physicians’ offices, hospital outpatient departments, and ambulatory surgical centers, such that the AUC consultation and reporting requirements apply to IDTFs. CMS-1693-P at 445. CMS is proposing to change the consultation and reporting requirement so that not only would it apply to physicians and other practitioners ordering advanced diagnostic imaging services, but it would apply “in an applicable setting and paid for under an applicable payment system.” CMS-1693-P at 449. Thus, an IDTF performing services and billing for the service would be required to consult the AUC and report that information to Medicare, the same as the ordering practitioner.
The proposed rule is seeking to expand the list of who may act as an “ordering professional” to include clinical staff members acting within their scope of practice and working under the direction of, and incident to, an ordering professional. Id.; see CMS Pub. 100-02, Medicare Benefits Policy Manual, ch. 15 § 60 for the “incident to” requirements.
CMS has determined that while there are some good reasons to develop a “unique consultation identifier” (“UCI”) to assist in reporting to CMS that the AUC consultation has been performed, CMS is going to continue to use coding structures already in place, such as G-codes and other modifiers, rather than attempting to develop separate UCIs to report the AUC consultation.
Finally, CMS is proposing the addition of the following criteria for the significant hardship exception found in 42 C.F.R. § 414.94(i)(3) to include: a practitioner with insufficient internet access due to the location of where the service is ordered; issues with an EHR or CDSM system, such as temporary technical problems, a system upgrade, a vendor ceasing operations, or when the practitioner’s CDSM system is disqualified by CMS; and extreme and uncontrollable circumstances, such as disasters, both naturally occurring and man-made, that have a significant negative impact on health care operations, area infrastructure, or communications systems.
Effects of Changes
Should the proposed changes go into effect, there would be an increased burden on practitioners once reporting becomes a requirement on January 1, 2020. Practitioners will need to review and amend their policies and procedures so that they ensure they are consulting AUC before ordering diagnostic imaging services and to ensure that they are appropriately billing those services to ensure they are reported correctly.
Once the rule is finalized, Chapman Law Group will review the new rules and can assist practitioners who might be affected in drafting a compliance plan to prepare for the new AUC consulting and reporting requirements.