Medicare: Considerations for Expansion of the Appropriate Use Criteria Program
Released: 2015-09-30T00:00:00


Highlights: section_title: Why GAO Did This Study
paragraphs: 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.

section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: Many researchers—including those at the Institute of Medicine, Medicare  Payment Advisory Commission, and Dartmouth Institute for Health Policy  and Clinical Practice—have reported considerable variation in how health  care services are used and that patients are likely receiving some  unnecessary services. In response, a number of national professional  medical societies have identified tests and procedures that offer minimal  benefit or that could even harm under certain circumstances and have  made recommendations to improve the quality of health care. However,  because a particular service may be appropriate for some patients but not  for others, difficulties arise in customizing population-based  recommendations to individual patients. Provider efforts to develop and  apply appropriate use criteria (AUC)—a more patient-focused approach  to reducing inappropriate care—may help enhance the quality of care and  lead to health care savings.

Over the past decade, questions have been raised about the potential  overuse of advanced diagnostic imaging services—including magnetic  resonance imaging, computed tomography and positron emission  tomography—among other services and supplies covered by Medicare. In  a 2008 report, we found that Medicare spending on advanced diagnostic  imaging services more than doubled from 2000 through 2006, growing far   We  faster than other imaging services, such as ultrasound and x-rays. recommended that Centers for Medicare & Medicaid Services (CMS)— the agency within the Department of Health and Human Services (HHS)  that administers the Medicare program— examine the feasibility of adding  more front-end approaches, including prior authorization, to manage the  spending growth. However, according to CMS, the general consensus  among health care providers and researchers is that the use of AUC to  guide clinical practice is preferable to across-the-board utilization  management controls that do not differentiate interventions that add value  from those that cause harm or add no value. To test the impact AUC may  have on advanced imaging service use, CMS conducted a 2-year  Medicare imaging demonstration from 2011 through 2013, as required by  law. The Protecting Access to Medicare Act of 2014 (PAMA) directed  HHS to establish an AUC program for advanced imaging services  furnished to Medicare fee-for-service beneficiaries. The law stipulated  that providers who order imaging services must consult with AUC as a  condition of payment for providers who furnish imaging services.  Consulting with AUC involves entering patient data into an electronic  decision tool to obtain information on the appropriateness of the service.  The law further required that AUC must be developed or endorsed by  national medical professional societies or other provider-led entities.  Under the program, providers with a history of low adherence to  appropriate ordering will be subject to prior authorization from CMS.

In addition to requiring the Medicare imaging AUC program, PAMA  included a provision for us to report on the extent to which AUC could be  used for other Part B services, such as radiation therapy and clinical  diagnostic laboratory services. For purposes of this report, we will refer to  advanced diagnostic imaging services as imaging services. In this report,  we describe  1.  CMS’s plan for implementing the imaging AUC program,  2.  examples of questionable- or low-value nonimaging services where  provider-led entities have developed AUC to assist providers in  making the most appropriate treatment decisions, and  3.  considerations that would facilitate AUC program implementation and  potential expansion to other services.

To describe CMS’s plan for implementing the imaging AUC program, we  reviewed the agency’s July 2015 Federal Register notice of proposed  rulemaking.the program to clarify the agency’s proposed definitions and phased  rollout of the program.

We also interviewed CMS officials responsible for managing  To describe examples of questionable- or low-value nonimaging services  where provider-led entities have developed AUC, we took a two-step  approach. First, we selected eight radiation therapy and nine clinical  diagnostic laboratory services that the American Society for Radiation  Oncology and the American Society for Clinical Pathology, respectively,  considered of questionable value when provided in certain clinical  situations. We also selected 19 Medicare services considered to be of  low value included in a 2014 study prepared by researchers at Harvard  Medical School (hereafter referred to as the Harvard study). We  reviewed the methodologies used to identify questionable- and low-value  services and considered them to be sufficiently reliable for the purposes  of our report.

Second, we determined whether any of these 36 questionable- and low-  value services had associated AUC developed by provider-led entities.   To do this, a physician on our study team examined the National  Guideline Clearinghouse—a database of clinical practice guidelines  maintained by HHS’s Agency for Healthcare Research and Quality  (AHRQ).interview with knowledgeable agency officials, we determined that the  data in the National Guideline Clearinghouse were sufficiently reliable for  the purposes of this report. We considered an AUC to be associated with  a service if it closely corresponded to the questionable- or low-value  application of the service as described by the medical specialty societies   Based on our review of related documentation and an  or Harvard researchers. We also considered an AUC to be associated  with a service if the AUC addressed a clinically specific use of a service  that was broadly described. The resulting set of services found to have  associated AUC is for illustrative purposes and does not represent a  comprehensive list of potential candidates for AUC program expansion. In  addition, the associated AUC we found had varying levels of  comprehensiveness in terms of the range of clinical scenarios to which  the AUC may be applied. We did not evaluate the extent to which the  associated AUC are in a format suitable for program implementation.

To describe considerations that would facilitate AUC program  implementation and potential expansion to other services, we reviewed  the 2014 evaluation of CMS’s 2-year Medicare imaging demonstration  performed by RAND.medical professional publications related to the use of AUC by providers.  In addition, we interviewed officials from CMS and AHRQ regarding  participant experience with the Medicare imaging demonstration and the  format and scope of AUC, respectively.

To supplement this information, we reviewed  We conducted this performance audit from May 2015 to September 2015  in accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
subsections: section_title: Background
subsections: section_title: AUC Development and Use
paragraphs: RAND and the University of California at Los Angeles (UCLA) School of  Medicine developed a process for determining the appropriateness of a  specific health care service for a particular patient, known as the  RAND/UCLA appropriateness method. An appropriate service was  defined as one in which the expected health benefit exceeds the  expected negative consequences by a sufficiently wide margin that the  procedure is worth doing, exclusive of cost. In selecting services for AUC  development, the RAND/UCLA authors outlined the following factors for  consideration. A service should be frequently used, be associated with a substantial amount of morbidity and/or mortality, exhibit wide variations among geographic areas in rates of use, or be controversial.

Numerous groups—including provider-led entities, such as medical  specialty societies, and government or non-profit entities, such as the  Centers for Disease Control and Prevention or the American Cancer  Society—have developed AUC to assist providers in making the most  suitable treatment decision for a particular patient.

section_title: Testing AUC for Imaging Services under Medicare Part B
paragraphs: From October 2011 through September 2013, CMS conducted the  Medicare imaging demonstration to estimate the impact applying AUC  would have on provider ordering practices and utilization. AUC were  programmed into clinical decision support mechanisms (CDSM)— electronic tools in which providers enter patient characteristics, such as  symptoms, diagnoses, prior test results, and demographic information.  From the CDSM, providers received a rating on the degree of  appropriateness of their imaging order (appropriate, equivocal or  uncertain, or inappropriate). If the order could not be linked to any criteria  in the CDSM, no rating would be assigned. Instead, the CDSM would  notify the provider that the order was not covered by the guidelines.

The RAND evaluation of the demonstration found an increase in the  percentage of orders that were rated as appropriate over the course of  the demonstration. However, the authors noted that, due to the large  proportion of orders that could not be linked to any criteria, the results do  not necessarily indicate an improvement in the rate of appropriate  ordering. For this reason, among others, the evaluation of the  demonstration recommended against expanding the use of AUC for  imaging services to a broader population of Medicare beneficiaries.

section_title: Legislative Requirements for the Imaging AUC Program
paragraphs: 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. (See fig. 1.)

To fully implement the imaging AUC program, CMS must complete  several components over the next 5 years, as outlined in PAMA:

Specify applicable AUC by November 15, 2015. Through  rulemaking, and in consultation with stakeholders, CMS must specify  one or more AUC. The AUC may only be developed or endorsed by  national professional medical specialty societies or other provider-led  entities, not by CMS. The agency must take into account whether the  AUC have stakeholder consensus, are scientifically valid and  evidence-based, and are derived from studies that are published and  reviewable by stakeholders. CMS must annually review AUC to  determine the need for any updates or revisions.

Publish a list of qualified CDSMs by April 1, 2016. With  stakeholder input, CMS must specify one or more qualified CDSMs  that may be used by ordering providers for AUC consultation.  Mechanisms may include modules in certified electronic health record  technology, other private sector CDSMs, or mechanisms established  by CMS. The CDSMs must be able to execute certain functions, such  as generating and providing a certification or documentation that the  CDSM was used by the ordering provider. The list must be updated  periodically and include one or more CDSMs per imaging service that  are available free of charge.

Roll out imaging AUC program by January 1, 2017. Ordering  providers generally must provide to the furnishing provider certification  that they have consulted with specified AUC using a qualified CDSM.  Furnishing providers generally will only be paid if their Medicare  claims for imaging services indicate which CDSM was used, whether  the order would or would not adhere to any applicable AUC, and the  ordering provider identification number.

Begin the process for identifying outlier ordering providers on  January 1, 2017. For services furnished beginning in 2017, CMS  must annually determine up to 5 percent of all ordering providers who  are outliers based on their low adherence to appropriate ordering. In  making these determinations, CMS must use 2 years of data starting  from January 1, 2017 and consult with stakeholders in order to  develop methods to identify outlier ordering providers. CMS must also  establish a process for determining when a provider’s outlier  designation should be removed.

Implement prior authorization beginning January, 1, 2020.  Imaging services ordered by an outlier provider will be subject to prior  authorization from CMS. In applying prior authorization, the agency  may only use specified AUC.

section_title: CMS’s Initial Implementation Plan Focuses on the Process for Specifying Applicable AUC and Establishing Priority Clinical Areas for Future Prior Authorization
paragraphs: In its July 2015 notice of proposed rulemaking, CMS outlined its initial  plan and timeframes for implementing the imaging AUC program. While  CMS’s initial plan touches on each implementation component of the  program, it focused largely on the process for specifying applicable AUC  and establishing priority clinical areas for future prior authorization policy.  Given the need to consider stakeholder comments and that progress on  early components affects the timing of subsequent components, CMS’s  initial plans to implement certain components of the program extend  beyond the dates outlined in PAMA.
subsections: section_title: Specifying Applicable AUC
paragraphs: 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. Once an entity is qualified by CMS, all applicable AUC  developed, endorsed, or modified by that entity would become specified  applicable AUC under the program. In addition, CMS is proposing  recertification every 6 years. The agency’s proposed definition for a  provider-led entity is a national professional medical specialty society or  an organization that is comprised primarily of providers and is actively  engaged in the practice and delivery of health care, such as hospitals and  health systems.

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.

Under PAMA, CMS is required to specify applicable AUC by November  15, 2015. However, CMS does not anticipate posting its initial set of  qualified entities on its website until the summer of 2016. As a result, the  agency does not expect to specify applicable AUC until at least   7 months after the PAMA-specified timeframe.

section_title: Prior Authorization Policy
paragraphs: 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. In developing the priority clinical areas,  CMS may consider incidence and prevalence of diseases, volume and  variability of utilization, strength of evidence for imaging services, and  applicability to a variety of care settings and to the Medicare population.  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. CMS expects to  identify the first set of priority clinical areas in the rulemaking cycle that  begins in 2016 in consultation with stakeholders and to further develop its  policy to identify outlier ordering providers. Additional priority clinical  areas may be added during each rulemaking cycle.

In addition, the agency is proposing a process by which it will be made  aware of potentially nonevidence-based AUC associated within the  established priority clinical areas. CMS is planning to have a standing  request for public comments in all future AUC-related rulemaking notices  so the public has ongoing opportunities to assist the agency in identifying  AUC that may not be sufficiently evidence-based. CMS may consult the  Medicare Evidence Development and Coverage Advisory Committee in  reviewing any potentially nonevidence-based AUC. If, through this  process, AUC are determined to be insufficiently evidence-based, and the  provider-led entity that produced the criteria does not make a good faith  attempt to correct the issue, this information could be considered when  the provider-led entity applies for requalification.

According to CMS officials, the proposed process does not include review  of potentially nonevidence-based AUC outside of the established priority  clinical areas. To respond to PAMA’s requirement that specified  applicable AUC be reviewed each year, they stated that, in addition to  accepting public comments regularly on potentially nonevidence-based  AUC associated with the established priority clinical areas, they will also  review the requirements and process for AUC development as a part of  CMS’s annual rulemaking.

section_title: Status of Identifying Qualified CDSMs
paragraphs: Under PAMA, CMS is required to publish a list of qualified CDSMs by  April 1, 2016. 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.  The agency plans to provide clarifications, develop definitions, and  establish the process by which it will specify qualified CDSMs through the  rulemaking process in 2016. The agency stated that it does not plan to  publish a list of qualified CDSMs until after November 1, 2016, at least   7 months after the PAMA-specified timeframe.

section_title: Provider-Led Entities Have Developed AUC Related to a Number of Services Deemed of Questionable or Low Value
paragraphs: 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.
subsections: section_title: Many Services Have Been Identified As Having Questionable Or Low Value
paragraphs: Since 2012, as a part of the Choosing Wisely® initiative, national medical  specialty societies have identified health care services of questionable  value. Among the hundreds of services included in the Choosing Wisely®  initiative, we reviewed 17 radiation therapy and clinical pathology services  of questionable value under certain circumstances. The following are  among those we reviewed:

The American Society for Radiation Oncology surveyed its members  to collect a list of potential services, convened a work group to select  key services from the initial list, conducted literature reviews, and  received input from its board of directors to inform its final selection.  For example, the group recommended against routine follow-up  mammography more often than annually for women who have had  radiotherapy following breast conserving surgery. In addition, it  recommended that providers not routinely prescribe proton beam  therapy over other forms of definitive radiation therapy for prostate  cancer.

The American Society for Clinical Pathology convened a review panel  of pathology and laboratory medicine experts to evaluate the literature  and identify services that are frequently performed; that are of no  benefit or harmful; that are costly and do not provide higher quality  care; and where eliminating the service or alternatives are within the  control of the provider. Among the services identified, the group  recommended against prescribing testosterone therapy without  laboratory evidence of testosterone deficiency. The group also  recommended avoiding routine preoperative testing for low-risk  elective surgeries without a clinical indication.

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 researchers deemed a service to be of low  value if, on average, it provided little to no clinical benefit, either in  general or in specific clinical scenarios. They developed their set of low- value services from the Choosing Wisely® initiative, the U.S. Preventive  Services Task Force ratings of services with a ‘D” grade, the National  Institute for Health and Care Excellence “do not do” recommendations,  the Canadian Agency for Drugs and Technologies in Health technology  assessments, and peer-reviewed literature. The 19 nonimaging services  fell into 5 categories: cardiovascular testing and procedures, cancer  screening, diagnostic and preventive testing, preoperative testing, and  other surgery. In addition, the Harvard study estimated the proportion of  Medicare beneficiaries receiving the low-value services and total  spending devoted to these services.

section_title: Provider-Led Entities Have Developed AUC For Some, But Not All, Questionable- And Low- Value Services
paragraphs: We found that provider-led entities have developed AUC for some, but  not all, of the questionable- or low-value services we reviewed. 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. Specifically,  23 services had at least 1 associated AUC developed by a provider-led  entity.AUC in the National Guideline Clearinghouse.

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. (See  table 1.) For example, the American College of Radiology has developed  an AUC for appropriate radiation therapy following hysterectomy for  endometrial cancer patients. In other cases, we found multiple associated  AUC for a single questionable service. For instance, the American  College of Obstetricians and Gynecologists and the American Society for  Colposcopy and Cervical Pathology have each developed criteria for the  appropriate use of human papilloma virus testing for low-risk abnormal  pap smears.

In addition, we found associated AUC developed by provider-led entities  for 11 of the 19 low-value services identified in the Harvard study. (See  table 2.) For example, the American College of Physicians has developed  AUC regarding the appropriate use of stress testing for those with stable  coronary disease. In addition, the American College of Radiology has  developed criteria outlining the appropriate conditions under which inferior  vena cava filters may be used to prevent pulmonary embolism.

As indicated in the RAND/UCLA report, the selection of services for an  AUC program generally takes into account the service’s frequency of use  and resources consumed, among other factors. The Harvard researchers  used claims and enrollment data—such as procedural codes, beneficiary  diagnoses, and age—to determine the extent to which the low-value  services were used and the associated expenditures. The researchers  reported their results as a range using two approaches. The more narrow  approach was based on higher specificity and was less likely to  misclassify appropriate use as inappropriate. The broader approach  focused on higher sensitivity, capturing more inappropriate use but also  some potentially appropriate use. For example, in 2009, estimated  inappropriate spending for colorectal cancer screening ranged from $7  million for beneficiaries 85 years and older to $573 million for those 75  years and older and affected 0.9 to 7.7 percent of beneficiaries of each  group, respectively. The wide range in inappropriate service use, as  measured by the two approaches, indicates how difficult it may be to  select services for program expansion that have the most potential for  improving health care quality and reducing wasteful spending.

section_title: Clinical Decision Tool Capabilities and Provider Confidence Are Among Key Considerations for an Effective AUC Program
paragraphs: We identified several issues that are key to the effective implementation  of the imaging AUC program or any future expansion of the program,  including the utility of the CDSM and provider confidence in the applicable  criteria. Such issues surfaced during the Medicare imaging demonstration  and, according to the RAND evaluation of the demonstration, may have  limited its success. Because they are not specific to imaging services,  they likely would apply to services considered for program expansion as  well.

Effectively mapping clinical indications to applicable AUC.  Programming an adequate variety of patient characteristics into  CDSMs would allow the mapping of clinical indications to available  AUC to be sufficiently robust. During the demonstration, almost two- thirds of orders placed by providers could not be linked to any criteria  in CDSMs; therefore, providers did not receive an appropriateness  rating (appropriate, uncertain or equivocal, or inappropriate) for these  orders. Providers reported issues with locating a diagnosis or clinical  scenario relevant to their patient or that the clinical information they  did successfully enter about their patients into the CDSM did not  result in any matches to AUC. The evaluators of the demonstration  cited technical issues with mapping clinical indications to the  distinguishing features of each AUC programmed into the CDSMs.

Enhancing clinical decision making. Only well-developed CDSMs  can adequately assist providers with meaningful clinical decisions.  Many providers in the demonstration found the CDSM feedback  presented to them—that is, the appropriateness rating or the links to  the AUC, if applicable—was not specific enough to assist with  decisions for specific patients or situations. Providers said that they  expected detailed, actionable feedback about their orders to guide  them in their decision making. In addition, providers reported that the  CDSMs would have been more helpful if they had provided feedback  before the order was placed, rather than after; specifically, some said  they would have preferred entering the clinical indication or other  patient information first in order to receive guidance on what to order.

Designing CDSMs for ease of use. Whether CDSMs are integrated  with electronic health record systems or web-based or stand-alone  software applications, providers prefer those that can be used quickly  and efficiently. In the demonstration, providers using web-based or  stand-alone software applications experienced frustration with the lack  of integration between the CDSM and their electronic health record  system. For example, providers had to click out of their electronic  health record system and go through an entirely new platform to order  imaging services. Additionally, providers wanting to change orders  would have to start from the beginning and go through the entire  process again. This process caused workflow inefficiencies for busy  providers.

Ensuring provider confidence in appropriateness ratings and  their underlying evidence. To secure provider buy-in, it is important  that ratings not be based on outdated evidence or conflict with local  guidelines or other best practice guidelines. Providers who  participated in the demonstration were not always comfortable with  the appropriateness ratings that were assigned to their orders and  wanted more transparency than was available about how the ratings  were assigned, especially when evidence was known to be limited.  Providers wanted more information regarding the quality of evidence  used to generate AUC and more detail about the level of agreement  associated with appropriateness ratings.

Allowing sufficient preparation time for implementation. Due to  the complex and wide scope of changes associated with  implementing AUC, allowing adequate preparation time for  stakeholders is critical. Providers who participated in the  demonstration noted that all phases of the demonstration were too  short to address the large number of challenges related to  successfully engaging providers and staff, aligning existing and new  workflow patterns, and introducing providers and staff to the CDSM  software and guidelines. Providers reported inadequate time for set  up, planning, pilot testing, implementation, internal evaluation, and  change. Efforts to move forward rapidly during the demonstration  were confounded by CDSM software challenges beyond the control of  participants and their practices, as well as escalating frustrations and  disengagement by providers.

section_title: Agency Comments and Our Evaluation
paragraphs: The Department of Health and Human Services reviewed a draft of this  report and provided technical comments, which we incorporated where  appropriate.

We are sending copies of this report to appropriate congressional  committees and the Administrator of CMS. In addition, the report is  available at no charge on the GAO website at http://www.gao.gov.

If you or your staff have any questions about this report, please contact  me at (202) 512-7114 or cosgrovej@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. GAO staff who made key contributions to this  report are listed in appendix I.

section_title: Appendix I: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact

section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Rosamond Katz, Assistant  Director; Kye Briesath; Stella Chiang; Maria A. Maguire; Vikki L. Porter;  and Jennifer M. Whitworth made key contributions to this report.

section_title: Related GAO Products
paragraphs: Medicare: Higher Use of Costly Prostate Cancer Treatment by Providers  Who Self-Refer Warrants Scrutiny. GAO-13-525. Washington, D.C.:   July 19, 2013.

Medicare: Action Needed to Address Higher Use of Anatomic Pathology  Services by Providers Who Self-Refer. GAO-13-445. Washington, D.C.:  June 24, 2013.

Medicare: Higher Use of Advanced Imaging Services by Providers Who  Self-Refer Costing Medicare Millions. GAO-12-966. Washington, D.C.:  September 28, 2012.

Medicare: Use of Preventive Services Could Be Better Aligned with  Clinical Recommendations. GAO-12-81. Washington, D.C.: January 18,  2012.

Medicare Part B Imaging Services: Rapid Spending and Shift to Physician  Offices Indicate Need for CMS to Consider Additional Management  Practices. GAO-08-452. Washington, D.C.: June 13, 2008.


Question-summary annotations: questions: question: How is the implementation of appropriate use criteria being handled?
answer: 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.
child_questions: question: What are AUC?
answer: 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.

question: How are AUC used by health care providers?
answer: 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.

question: How can health-care providers interface with AUC?
answer: Consulting AUC involves entering patient clinical data into an electronic decision tool to obtain information on the appropriateness of the service.

question: How is CMS examining the AUC imaging process?
answer: 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.

questions: question: How might the AUC expansion be dispersed amongst any relevant groups?
answer: 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.
child_questions: question: How can organizations become CMS-endorsed?
answer: To become a qualified source of AUC, provider-led entities must adhere to CMS standards for AUC development.

question: Why is the CMS not involving itself directly in the development of AUC?
answer: The agency does not plan to evaluate and select imaging AUC itself because of the volume of those potentially available, according to CMS officials.

questions: question: How will the implementation of AUC be controlled to ensure the proper areas are managed first?
answer: 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.
child_questions: question: How will these priority areas be established?
answer: 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.

question: How will the process of establishing priority clinical areas help streamline the imaging process?
answer: 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.

questions: question: How will the AUC program be expanded?
answer: Medicare services with associated AUC developed by provider-led entities represent potential candidates for AUC program expansion.
child_questions: question: How is the quality of these associated AUCs determined?
answer: 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.

question: How prevalent is the independent development of associated AUC?
answer: 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).
child_questions: question: To what extent are the AUC distributed across multiple service catagories?
answer: 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.

questions: question: To what extent have the previous AUC attempts been evaluated in formulating a new imaging AUC program?
answer: 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.
child_questions: question: How did GAO begin its investigation?
answer: 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.

question: How did GAO determine which AUC areas needed the most review?
answer: 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.
child_questions: question: How did GAO examine related provider-led AUCs?
answer: GAO also examined AHRQ's National Guideline Clearinghouse to determine whether AUC developed by provider-led entities were associated with those 36 services.

question: To what extent did GAO examine these provider-led AUCs?
answer: GAO did not evaluate the extent to which the associated AUC are suitable for program implementation.

question: How can this report be improved upon?
answer: Also, the resulting set of services is illustrative and not a comprehensive list of candidates for potential AUC program expansion.