Protecting Access to Medicare Act

Statute and Regulation Highlights

• Protecting Access to Medicare Act of 2014 (PAMA)
  • PAMA Section 218(b), “Promoting Evidence-Based Care”
  • Requires ordering professionals to consult Appropriate Use Criteria (AUC) through a Clinical Decision Support (CDS) mechanism when ordering specified advanced imaging services
  • Consequence for non-compliance: no reimbursement for the technical or professional component of imaging

• CMS Rules for specifying applicable AUCs:
  • Proposed rule published July 15, 2015
  • Final rule released October 30, 2015, published November 16, 2015

• CMS Rules for CDS mechanisms:
  • Proposed rule published July 8, 2016 as part of 2017 PFS Rulemaking
  • Final rule expected November 2016

Statute and Regulation Detailed Analysis

The Statute changes the content of claims

"With respect to an applicable imaging service furnished in an applicable setting and paid for under an applicable payment system..., payment for such service may only be made if the claim for the service includes the following:

• (i) Information about which qualified clinical decision support mechanism was consulted by the ordering professional for the service.
• (ii) Information regarding
  • (I) whether the service ordered would adhere to the applicable appropriate use criteria specified under paragraph (2);
  • (II) whether the service ordered would not adhere to such criteria; or
  • (II) whether such criteria was not applicable to the service ordered.
• (iii) The national provider identifier of the ordering professional (if different from the furnishing professional)."

Appropriate Use Criteria (AUC), as defined by the final rule

• "criteria only developed or endorsed by national professional medical specialty societies or other provider-led entities to assist ordering professionals and furnishing professionals in making the most appropriate treatment decision for a specific clinical condition for an individual. To the extent feasible, such criteria must be evidence-based."
• "An AUC set is a collection of individual appropriate use criteria. An individual criterion is information presented in a manner that links:
  • a specific clinical condition or presentation;
  • one or more services; and,
  • an assessment of the appropriateness of the service(s)."

(Qualified) Provider Led Entities (QPLEs and PLEs), as defined by the final rule

• "Provider-led entity (PLE) means a national professional medical specialty society or other organization that is comprised primarily of providers or practitioners who, either within the organization or outside of the organization, predominantly provide direct patient care."
• "(c) Qualified provider-led entity. To be qualified by CMS, a PLE must adhere to the evidence-based processes described when developing or modifying AUC. A qualified PLE may develop AUC, modify AUC developed by another qualified PLE, or endorse AUC developed by other qualified PLEs."

Required evidence-based processes for QPLE Designation

A QPLE must perform all of the following when developing or modifying AUC:

• (1)* Utilize an evidentiary review process that includes
  • Systematic literature review of the clinical topic and relevant imaging studies;
  • Assessment of the evidence using a formal, published and widely recognized methodology for grading evidence
• (2) Utilize at least one multidisciplinary team with autonomous governance, decision-making and accountability for developing or modifying AUC:
  • At least 7 members including at least one physician with expertise in the clinical topic of the AUC, one physician with imaging expertise relevant to the AUC, one PCP, one expert in statistics, one expert in clinical trial design
• (3) Utilize a publicly transparent COI process
• (4)** Publish each criterion on the PLE website, identifying title, authors (all members of team), and key references for evidence
• (5)** Identify on the PLE website each AUC relevant to a priority clinical area
• (6)** Identify key points in an individual criterion as evidence-based or consensus-based, and grade such key points in terms of strength of evidence using a formal, published and widely recognized methodology
• (7)* Utilize a transparent process for updating all AUC
• (8)** Post the process for developing or modifying AUC on the PLE website
• (9) Disclose parties external to the PLE when such parties have involvement in the AUC development process

     * = Requirements met by Library.
     ** = Published by Library for QPLEs to display on their own websites.

Process to become a QPLE

• Submit application to CMS that documents adherence to each of the 9 requirements
• Meet the definition of PLE
• Apply by January 1 of any year (CMS 6 month review)
• Current List of QPLEs

See QPLEs and the Library

Local Adaptation of AUC

• On the substance of local best practices, CMS added:
  • "We believe that allowing for variations in AUC based on local circumstances is important to ensure that AUC consultation can be incorporated into clinical practice throughout the country. We agree that local variations should still meet the program requirements to ensure that the evidence to support modification is evaluated and graded and only performed by qualified PLEs.”

Timeline

• CMS clarified the schedule for proposing and finalizing the rules for CDS mechanisms, and stated that ordering professionals will not be required to consult applicable AUC on January 1, 2017.
  • CMS noted that the rule has massive impact across almost every medical specialty and “could have a particular impact on primary care physicians”
• "If we were to follow a similar process for CDS as we have for specifying AUC, the initial list of CDS mechanisms would be available in the summer of 2017.”
• "We anticipate including further discussion and adopting policies regarding claims-based reporting requirements in the CY 2017 and CY 2018 rulemaking cycles. Therefore, we do not intend to require that ordering professionals meet this requirement by January 1, 2017.”

Priority Clinical Areas

CMS has developed and are proposing eight priority clinical areas, reflecting both the significance and the high prevalence of some of the most disruptive diseases in the Medicare population. The Library of Evidence covers ALL of these priority clinical areas.

• Coronary artery disease (suspected or diagnosed)
• Suspected pulmonary embolism
• Headache (traumatic and non-traumatic)
• Hip pain
• Low back pain
• Shoulder pain (to include suspected rotator cuff injury)
• Cancer of the lung (primary or metastatic, suspected or diagnosed)
• Cervical or neck pain