By Adrienne Dresevic, Esq., and Carey Kalmowitz, Esq., of The Health Law Partners, P.C.
On July 7, 2016, CMS released the 2017 Medicare Physician Fee Schedule Proposed Rule (MPFS), which addresses Medicare payment and quality provisions, among others, for physicians. The MPFS was published in the Federal Register on July 15. Comments are due to CMS by September 6, 2016. CMS estimates an overall impact of the MPFS proposed changes to radiology to be a 1% decrease. Interventional radiology would see an aggregate decrease of 7%, and radiation oncology and nuclear medicine should see a 0% change if the proposals are finalized. On July 8, AHRA shared an ACR Summary of the MPFS. This article will provide a brief summary of proposals in the MPFS related to the appropriate use criteria (AUC) requirements for advanced imaging services.
Appropriate Use Criteria Requirements for Advanced Diagnostic Imaging Services
By way of brief background, Section 218 (b) of PAMA amended the Social Security Act to add a new section [1834(q)] in order to establish a program to promote the use of AUC for advanced diagnostic imaging services. In the 2016 MPFS Final Rule, CMS addressed the initial component of the new Medicare AUC program, establishing evidence-based process and transparency requirements for the development of AUC. In the 2017 Proposed MPFS, CMS proposes:
- Requirements and process for specification of qualified clinical decision support mechanisms (CDSMs) under the Medicare AUC program
- The initial list of priority clinical areas
- Exceptions to the requirement that ordering professionals consult specified applicable AUC when ordering applicable imaging services
CDSM Qualifications and Process
CMS uses the 2017 MPFS rulemaking process as the vehicle to establish requirements for CDSMs, and the process to specify qualified CDSMs, in a transparent manner that allows for stakeholder involvement. The final CDSM requirements and the process for the CDSMs to become qualified would be published in the 2017 MPFS Final Rule with comment period on or about November 1, 2016.
CMS proposes to amend regulations at Section 414.94, “Appropriate Use Criteria for Certain Imaging Services,” including a proposal to define CDSM as follows: “an interactive, electronic tool for use by clinicians that communicates AUC information to the user and assists them in making the most appropriate treatment decision for a patient’s specific clinical condition.”
CMS states that a CDSM would incorporate specific applicable AUC sets from which an ordering professional could select, and that the CDSM may be a module within or available through certified EHR technology or private sector mechanisms independent from certified EHR technology. Further, with respect to CDSM qualifications and process, CMS proposes to add a new section [414.94(g) (1)] setting forth requirements for qualifications of CDSMs and a process to specify qualified CDSMs. In summary, the proposed qualification requirements direct CDSMs to make available certain supporting information, appropriate feedback, certification or documentation, and electronic reporting related to applicable AUC to the consulting professionals. The proposals also require that CDSMs update AUC content each year, comply with privacy and security standards, maintain electronic storage of information related to the consults for a minimum of 6 years, and comply with any new requirements or modifications.
The proposals also specify the following process for CDSM qualification:
- The CDSM developer must submit an application to CMS for review that documents adherence to each of the CDSM requirements outlined above;
- applications must be received by CMS annually by January 1;
- all qualified CDSMs specified by CMS each year will be included on the list of specified qualified CDSMs posted to the CMS website by June 30 of that year;
- qualified CDSMs are specified by CMS as such for a period of 5 years; and
- qualified CDSMs are required to re-apply during the fifth year after they are specified by CMS in order to maintain their qualified status.
CMS proposes that the first applications for CDSMs be accepted from the date of publication of the 2017 MPFS Final Rule until January 1, 2017, with the announcement of the qualified CDSMs to be made by June 30, 2017.
Initial List of Priority Clinical Areas
In addition to the CDSM proposals above, CMS proposes to establish a new section [414.94 (e) (5)] to set forth the initial list of priority clinical areas. This concept allows CMS to implement both a focused and comprehensive approach to the AUC program. They compiled the list using Medicare claims data, using a process which required subjective clinical judgment on whether a particular ICD-9 code should be included in a clinical group. The initial list is comprised of the top eight clinical groupings (by volume of procedures) and accounts for roughly 40% of part B advanced diagnostic imaging services paid for by Medicare in 2014.
The proposed priority clinical areas include: chest pain (includes angina, suspected myocardial infarction, and suspected pulmonary embolism), abdominal pain, headache (traumatic and non-traumatic), low back pain, suspected stroke, altered mental status, cancer of the lung (primary or metastatic suspected or diagnosed), and cervical or neck pain.
Exceptions for Ordering Professionals
Note that although CMS is working to implement the AUC program, ordering professionals will not be expected to consult qualified CDSMs by January 1, 2017. CMS anticipates that practitioners may begin reporting as early as January 1, 2018. The reporting delay is necessary to allow time for order practitioners who are not already aligned with a qualified CDSM to research and evaluate options so they may make informed decisions. Although there will be further rulemaking next year, CMS announced the January 1, 2018 date so that physicians and stakeholders can begin to prepare themselves to begin reporting on that date.
Under the AUC program, there are certain exceptions to the AUC consultation and reporting requirements including for emergencies, for inpatients, and for certain hardships. CMS proposes to provide exceptions for:
- emergency services when provided to individuals with emergency medical conditions;
- an inpatient for whom payment is made under Medicare Part A; and
- ordering professionals who are granted a significant hardship exception to the Medicare EHR Incentive Program payment adjustment for that year.
Summary of the Appropriate Use Criteria Proposals
In summary, in the 2017 MPFS Proposed Rule, CMS proposes qualifications requirements and process requirements for CDSMs, identifies the initial list of priority clinical areas, and sets forth certain exceptions to the consulting and reporting requirements under the AUC program. CMS invites the public to submit comments on the proposal. In particular, CMS is seeking comment on the proposed priority clinical areas and the requirements that must be met by CDSMs to become qualified.
It is important to note that is only a proposed rule and that the final rule will not be released until early November of this year. CMS also clearly establishes in the 2017 MPFS Proposed Rule that reporting and consulting by ordering professionals is expected to begin as early as January 1, 2018, not by January 1, 2017.
Adrienne Dresevic, Esq, is a founding shareholder of The Health Law Partners, PC, a nationally recognized healthcare law firm with offices in Michigan and New York. Practicing in all areas of healthcare law, she devotes a substantial portion of her practice to providing clients with counsel and analysis regarding compliance, Stark Law, Anti-Kickback Statute, and compliance related issues. Ms. Dresevic serves on the American Bar Association Health Law Section’s Council, which serves as the voice of the national health law bar within the ABA. Ms. Dresevic also serves as the ABA Health Law Section’s Co-Chair of the Physicians Legal Issues Conference Committee, Vice Chair of the Programs Committee (Executive Leadership), and Vice Chair of the Sponsorship Committee. She is licensed to practice law in Michigan and New York, and can be contacted at firstname.lastname@example.org.
Carey F. Kalmowitz, Esq. graduated from NYU Law School. Practicing healthcare law, he concentrates on corporate and financial aspects, eg, structuring physician group practice transactions; diagnostic imaging and ancillary services, IDTFs, provider acquisitions, CON, compliance, and Stark and fraud/abuse.
The authors are members of The Health Law Partners, PC and may be reached at (248) 996-8510 or (212) 734-0128, or at www.thehlp.com.