Legislative Requirements for the Imaging AUC Program

PAMA stipulated that, as of January 2017, providers ordering imaging  services (including primary care and specialty care providers) generally  will be required to consult AUC through a qualified CDSM. The results of  the AUC consultation generally must be documented on the claim  submitted by providers furnishing imaging services (typically radiologists)  in order to be paid by Medicare. Roll out imaging AUC program by January 1, 2017. Imaging services ordered by an outlier provider will be subject to prior  authorization from CMS. CMS’s Initial Implementation Plan Focuses on the Process for Specifying Applicable AUC and Establishing Priority Clinical Areas for Future Prior Authorization

In its July 2015 notice of proposed rulemaking, CMS outlined its initial  plan and timeframes for implementing the imaging AUC program. Specifying Applicable AUC

To respond to the PAMA requirement of specifying applicable AUC, CMS  is proposing to qualify provider-led entities such that all AUC developed,  endorsed, or modified by these entities may be eligible for use in the  imaging program. The agency does not intend to evaluate and select  AUC itself because of the volume of those potentially available, according  to CMS officials. CMS has proposed that individual AUC must link a specific clinical  condition, one or more imaging services, and an assessment of the  appropriateness of the service(s). To respond to PAMA’s requirement for  AUC development, the agency proposed that, to become qualified,  provider-led entities must demonstrate that their process for developing,  endorsing, or modifying AUC includes certain elements such as a rigorous evidentiary review process whereby key decision points  within each criteria are graded according to the strength of evidence  using a formal, published, and widely recognized methodology; a multidisciplinary team with autonomous governance to lead the AUC a publicly transparent process for identifying and disclosing potential public postings of their AUC and their AUC development process on  the entity’s website; and a transparent process for the timely and continual updating of each  AUC. Prior Authorization Policy

To respond to PAMA’s requirement that prior authorization be applied to  ordering providers with low adherence to appropriate ordering, CMS  plans to establish priority clinical areas and limit its identification of outlier  ordering providers to these areas. According to agency officials, given the variety of clinical scenarios for  which imaging services may be ordered, the aim of establishing priority  clinical areas is to narrow the potential scope of prior authorization. They  also stated that low back pain, nontrauma headache, and acute chest  pain are examples of potential priority clinical areas. To do so, CMS must determine which CDSMs are suitable  for use in the program. The agency’s July 2015 notice of proposed  rulemaking did not contain specifics on this implementation component. Provider-Led Entities Have Developed AUC Related to a Number of Services Deemed of Questionable or Low Value

Medical specialty societies and health care researchers have undertaken  efforts to identify services that are of questionable or low value under  certain circumstances and therefore have the potential to be used  inappropriately. Based on our examination of the AHRQ National  Guideline Clearinghouse, we found that provider-led entities—as defined  in CMS’s notice of proposed rulemaking—have developed AUC  associated with a number of these services. These questionable- and  low-value services with associated AUC are potential candidate services  if the AUC program were to expand beyond imaging services. In addition, researchers at Harvard Medical School compiled a list of 26  low-value Medicare-covered services, of which we reviewed 19  nonimaging services. The 19 nonimaging services  fell into 5 categories: cardiovascular testing and procedures, cancer  screening, diagnostic and preventive testing, preoperative testing, and  other surgery. Our  analysis of AHRQ’s National Guideline Clearinghouse indicated that  provider-led entities have developed AUC for more than half of the 36  questionable- or low-value services included in our review. For the remaining 13 services, we did not find any associated  Among the 17 radiation therapy and clinical pathology questionable-value  services identified by the respective medical specialty societies, 12  services had an associated AUC developed by a provider-led entity. Agency Comments and Our Evaluation

The Department of Health and Human Services reviewed a draft of this  report and provided technical comments, which we incorporated where  appropriate.
Why GAO Did This Study

PAMA required the establishment of a Medicare AUC program for advanced diagnostic imaging services. The Act also included a provision for GAO to report on the extent to which AUC could be used for other Medicare services, such as radiation therapy and clinical diagnostic laboratory services.
In this report, GAO describes (1) CMS's plans for implementing the imaging AUC program and (2) examples of questionable- or low-value nonimaging services where provider-led entities have developed AUC, among other objectives. GAO reviewed CMS's July 2015 Federal Register notice of proposed rulemaking outlining its initial plans for implementing components of the imaging AUC program and also interviewed CMS and AHRQ officials. To identify services for potential AUC program expansion, GAO focused on 36 nonimaging services deemed to be of questionable or low value as identified by the American Society for Radiation Oncology, the American Society for Clinical Pathology, and a 2014 study by researchers at Harvard Medical School. GAO also examined AHRQ's National Guideline Clearinghouse to determine whether AUC developed by provider-led entities were associated with those 36 services. GAO did not evaluate the extent to which the associated AUC are suitable for program implementation. Also, the resulting set of services is illustrative and not a comprehensive list of candidates for potential AUC program expansion.
HHS provided technical comments on a draft of this report, which were incorporated where appropriate.

What GAO Found

The Centers for Medicare & Medicaid Services (CMS)—an agency within the Department of Health and Human Services (HHS)—has proposed initial plans and timeframes for implementing the Medicare appropriate use criteria (AUC) program for advanced diagnostic imaging services, such as computed tomography, magnetic resonance imaging, and positron emission tomography. AUC are a type of clinical practice guideline intended to provide guidance on whether it is appropriate to perform a specific service for a given patient. Under the Protecting Access to Medicare Act of 2014 (PAMA), a health care provider ordering advanced diagnostic imaging services generally must consult AUC as a condition of Medicare payment for providers who furnish imaging services. Consulting AUC involves entering patient clinical data into an electronic decision tool to obtain information on the appropriateness of the service. The agency's July 2015 notice of proposed rulemaking focused largely on the process for specifying applicable AUC to be used in the program and a policy for identifying providers who must obtain authorization from CMS before ordering imaging services due to their low adherence to appropriate ordering.
CMS has proposed to qualify provider-led entities—such as national professional medical specialty societies—such that all AUC developed, endorsed, or modified by these entities would be eligible for use in the imaging program. To become a qualified source of AUC, provider-led entities must adhere to CMS standards for AUC development. The agency does not plan to evaluate and select imaging AUC itself because of the volume of those potentially available, according to CMS officials.
CMS plans to establish priority clinical areas, and providers with low adherence to appropriate ordering—as determined by the AUC—in those areas will be subject to prior authorization. The agency intends to establish a number of priority clinical areas—potentially including low back pain, nontrauma headache, or acute chest pain—through rulemaking beginning in 2016. CMS officials stated that, given the variety of clinical scenarios for which imaging services may be ordered, the aim of establishing priority clinical areas is to narrow the potential scope of prior authorization.
Medicare services with associated AUC developed by provider-led entities represent potential candidates for AUC program expansion. Medical specialty societies and health care researchers—including the American Society for Radiation Oncology, the American Society for Clinical Pathology, and researchers at Harvard Medical School—have compiled lists of services considered to be of questionable or low value in certain clinical circumstances. GAO reviewed 36 of these services and found that provider-led entities have developed associated AUC for more than half of them, according to a database of clinical practice guidelines maintained by Agency for Health Research Quality (AHRQ). Specifically, GAO found associated AUC across several service categories, including radiation therapy, clinical pathology, cardiovascular testing and procedures, cancer screenings, diagnostic and preventive testing, and preoperative testing.