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Appropriate use criteria

Background

On June 30th, 2018 HVPAA was approved as a CMS Qualified Provider Led Entity (PLE).  

Founded by a radiologist, HVPAA includes radiologists from 30 academic radiology departments, many of whom have experience with existing clinical decision support (CDS) tools to guide ordering of advanced imaging tests. HVPAA has members from >30 medical specialties/subspecialties and compiles multispecialty teams to design evidence based-appropriate use criteria for both diagnosis and treatment across a range of common clinical indications, beginning with the eight CMS clinical priority areas as defined in section 414.94(e)(5)

  • 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 pai
Policy and Procedures 

The HVPAA adheres to the evidence-based processes required when developing or modifying AUC. Detailed in this application are the HVPAA policies and procedures required by CMS for approval as a PLE:

  • Requirement 1: Utilizing an evidentiary review process when developing or modifying AUC.
  • Requirement 2: A multidisciplinary team with autonomous governance, decision-making and accountability for developing or modifying AUC. The multidisciplinary team is comprised of members including at least one practicing physician with expertise in the clinical topic related to the AUC being developed or modified.
  • Requirement 3: Identifying, resolving and publicly reporting conflicts of interest. 
  • Requirement 4: Dissemination and updating of AUC.
Requirement 1: Utilizing an evidentiary review process when developing or modifying AUC that includes:

HVPAA has partnered with the Harvard Medical School (HMS) Library of Evidence (LOE), which performed the necessary literature reviews and evidence grading as required by CMS for the 8 Priority Clinical Areas and more. Ideally, all QPLE and CDSMs should define appropriate imaging in a standardized evidence-based fashion, to reduce unwarranted variability in practice. The Harvard Library of Evidence has made this possible by creating a master database that can be used by other QPLEs.

HVPAA formulates our own AUC by reviewing the HMS LOE literature review and evidence grade assigned for each logic point and making an assessment as to whether the review and grading are acceptable when developing or modifying AUC, as required under the Final AUC Rule.

Additionally, HVPAA performs literature searches and creates evidence tables. In collaboration with an informationist, Katie Lobner, MLIS, Welch Medical Library, Johns Hopkins Medicine, we follow defined procedures and policies for evidence collection and review:

  1. Systematic literature review of the clinical topic and relevant imaging studies. The HVPAA performs systematic review based on comprehensive searches developed by an informationist in cooperation with subject specialists. The informationist assists in translating the clinical question into a functional search strategy, identifying the relevant databases (including, but not limited to MEDLINE/PubMed and Embase), running the search in each database, performing an initial deduplication of the results, and exporting the references for the team to screen. The informationist also updates the searches, as needed. Clinical guidelines and consensus statements by professional medical societies are included in the evidence assessment.
  2. The informationist provides all relevant documentation from the search process including databases searched, date(s) of search, number of references, and number of duplicate references.
  3. Results from the search strategy are reviewed in duplicate. Titles are excluded from the review when two independent reviewers determine to exclude the title. Included titles are reviewed at the abstract and full article levels with the same methodology applied. Data from included articles are abstracted in duplicate. The evidence is graded using widely recognized formal methodology for grading evidence and scores provided in an evidence table.
Requirement 2: A multidisciplinary team with autonomous governance, decision-making and accountability for developing or modifying AUC. At a minimum the team must be comprised of seven members including at least one practicing physician with expertise in the clinical topic related to the appropriate use criterion being developed or modified.

HVPAA’s multidisciplinary teams that develop AUC include 7 or more practicing physician members, and at least 1 practicing physician with expertise in the clinical topic related to the appropriate use criteria being developed or modified.

Requirement 3: Identifying, resolving and publically reporting conflicts of interest

HVPAA utilizes a transparent process for publicly identifying potential conflicts of interest and for resolving conflicts of interest of members on the multidisciplinary team, the PLE, and any other party participating in AUC development or modification. Resolution may include recusal or exclusion of individuals, as appropriate.

HVPAA requires all practicing physicians participating in the development of appropriate use criteria document the following information using the ICJME form. This information is publicly available in timely fashion upon request, for a period of not less than 5 years after the most recent published update of the relevant AUC:

  1. Direct or indirect financial relationships that exist between individuals, or their spouse or minor children, who have substantively participated in the development or modification of AUC and companies or organizations including the PLE and any other party participating in AUC development or modification that may financially benefit from the AUC. These financial relationships may include compensation arrangements such as salary, grant, speaking or consulting fees, contracts, or collaboration agreements.
  2. Ownership or investment interests between individuals, or their spouse or minor children, who have substantively participated in the development or modification of AUC and companies or organizations including the PLE or any other party participating in AUC development or modification that may financially benefit from the AUC.
Requirement 4: Dissemination and updating of AUC

HVPAA procedure and policy for website distribution and updating of AUC:

  1. Each individual criterion will be published on the HVPAA website page entitled Appropriate Use Criteria (https://hvpaa.org/auc/), including identifying title, all members of the multidisciplinary AUC development team who contributed to authorship of the AUC, and key references used to establish the evidence, along with an evidence table.
  2. Each AUC or subset relevant to a priority clinical area are listed as such on the website. In order to be identified as being relevant to a priority clinical area, the AUC or subset reasonably addresses the entire clinical scope of the corresponding priority clinical area.
  3. HVPAA identifies key points in an individual AUC 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, Grade Work Group Standards Workshop.
  4. HVPAA utilizes a transparent process for the timely and continual updating of each AUC. Each AUC will be reviewed annually, and updated as appropriate.
  5. The process for developing and modifying the AUC is posted on our website (https://hvpaa.org/auc/).
  6. The HVPAA will disclose parties external to the PLE if and when such parties have involvement in the AUC development process.