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    Subject Term: "Disease detection or diagnosis"

    16 publications with a total of 45 open recommendations including 4 priority recommendations
    Director: Debra A. Draper
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To help ensure that the WTC Health Program quality assurance (QA) program addresses required QA elements, including the three elements mandated in the Zadroga Act, the Director of NIOSH should develop and implement procedures for conducting systematic reviews of each clinic's QA plan (recommendation 1).

    Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention: National Institute for Occupational Safety and Health
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To help ensure that the WTC Health Program QA program addresses required QA elements, including the three elements mandated in the Zadroga Act, the Director of NIOSH should develop and disseminate guidance that clearly specifies how the clinics should address mandated elements in their QA plans (recommendation 2).

    Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention: National Institute for Occupational Safety and Health
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To help ensure that the WTC Health Program QA program addresses required QA elements, including the three elements mandated in the Zadroga Act, the Director of NIOSH should develop uniform performance measures that clinics are required to use to consistently evaluate mandated elements through their audits every quarter (recommendation 3).

    Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention: National Institute for Occupational Safety and Health
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Melissa Emrey-Arras
    Phone: (617) 788-0534

    3 open recommendations
    Recommendation: To help ensure VHA medical examiners are prepared to conduct the Gulf War general medical exam, the Secretary of Veterans Affairs should direct the Under Secretary for Health to require medical examiners to complete training, such as the 90-minute Gulf War Illness web-based course, before conducting these exams.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA agreed this recommendation and stated it has plans to address it. Specifically, VA said it plans to make its 90-minute web-based training course mandatory for its medical examiners who conduct Gulf War Illness exams.
    Recommendation: To provide more complete information to veterans whose Gulf War Illness claims are denied, the Secretary of Veterans Affairs should direct the Under Secretary for Benefits to update guidance to require that decision letters indicate whether Gulf War Illness medical issues were evaluated under both a presumptive and direct service connection method.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA agreed this recommendation and stated it has plans in place to address it. Specifically, VA noted it would improve how it communicates decisions to veterans and is in the process of updating its guidance to the regional offices to clarify the language required for its Gulf War Illness decision letters.
    Recommendation: To increase the likelihood of making progress toward developing a single case definition of Gulf War Illness, the Secretary of Veterans Affairs should direct the Under Secretary for Health to prepare and document a plan to develop a single case definition of Gulf War Illness. This plan should include near- and long-term specific actions, such as analyzing and leveraging information in existing datasets and identifying any areas for future research to help VA achieve this goal.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA agreed this recommendation and stated it has plans to address it. Specifically, VA noted it would convene a group of subject matter experts to work on a plan - as described in our report - to establish a single case definition of Gulf War Illness.
    Director: Persons, Timothy M
    Phone: (202) 512-6412

    4 open recommendations
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of the Food and Drug Administration to consolidate information from individual diagnostic test labels and make this information available in a form that enables users to more readily compare information across tests.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us that the Food and Drug Administration is working to consolidate and make available on its website information for Zika virus diagnostic tests that have emergency use authorization.
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of the Food and Drug Administration to require manufacturers to list the identity of comparator assays on their diagnostic test labels.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us that the Food and Drug Administration plans to recommend to sponsors of Zika virus diagnostic tests that they provide a description of the comparator assay.
    Recommendation: The Secretary of Health and Human Services should direct the Director of Centers for Disease Control and Prevention to establish a transparent process to provide CDC diagnostic tests, upon request, to manufacturers that are in the final stages of diagnostic test authorization.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us that the Centers for Disease Control and Prevention (CDC) Technology Transfer Office is working to establish a transparent process that ensures CDC diagnostic tests can be provided to manufacturers.
    Recommendation: The Secretary of Health and Human Services should direct the Director of Centers for Disease Control and Prevention to include information on CDC-developed tests distributed to or shared with public health laboratories on CDC's website, including laboratory developed tests.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us the Centers for Disease Control and Prevention (CDC) provides information on CDC-developed diagnostic tests on the Food and Drug Administration?s (FDA) website. CDC stated that their website will feature a direct link to FDA information on CDC-developed tests. CDC will continue to explore additional outlets for publication of information on CDC-developed diagnostic tests.
    Director: Randall B. Williamson
    Phone: (202) 512-7114

    5 open recommendations
    Recommendation: To increase its assurance that PTSD and TBI are appropriately considered prior to separating certain servicemembers from the military for misconduct, the Secretary of Defense should direct the Air Force and Navy to address inconsistencies with DOD policy in their policies related to screening certain servicemembers, including servicemembers separating in lieu of trial by court-martial, for PTSD and TBI and reviewing the results prior to separation for misconduct.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase its assurance that PTSD and TBI are appropriately considered prior to separating certain servicemembers from the military for misconduct, the Secretary of Defense should direct the Air Force and Navy to address inconsistencies with DOD policy in their policies related to training servicemembers, including officers, on how to identify mild TBI symptoms in the deployed setting.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase its assurance that PTSD and TBI are appropriately considered prior to separating certain servicemembers from the military for misconduct, the Secretary of Defense should ensure that the military services routinely monitor adherence to policies related to screening certain servicemembers for PTSD and TBI prior to separation for misconduct.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase its assurance that PTSD and TBI are appropriately considered prior to separating certain servicemembers from the military for misconduct, the Secretary of Defense should ensure that the military services routinely monitor adherence to policies related to training servicemembers, including officers, on how to identify mild TBI symptoms in the deployed setting.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase its assurance that PTSD and TBI are appropriately considered prior to separating certain servicemembers from the military for misconduct, the Secretary of Defense should ensure that the military services routinely monitor adherence to policies related to counseling about VA benefits and services during the process of separating certain servicemembers for misconduct.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Brenda S. Farrell
    Phone: (202) 512-3604

    7 open recommendations
    Recommendation: To increase oversight of the Army's Warrior Transition Unit program, the Secretary of the Army should direct the Army Surgeon General to assess the Triad of Care model's effectiveness in light of the changes in WTU diagnoses and take the appropriate action.

    Agency: Department of Defense: Department of the Army
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase oversight of the Army's Warrior Transition Unit program, the Secretary of the Army should direct the Army Surgeon General to exercise oversight responsibility to track full adherence to selection processes for squad leaders and platoon sergeants, including the requirement to conduct interviews for these positions.

    Agency: Department of Defense: Department of the Army
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase oversight of the Army's Warrior Transition Unit program, the Secretary of the Army should direct the Army Surgeon General to develop a mechanism to conduct post-training assessments on squad leaders and platoon sergeants' application of training to the work environment and incorporate the results into the training program.

    Agency: Department of Defense: Department of the Army
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase oversight of the Army's Warrior Transition Unit program, the Secretary of the Army should direct the Army Surgeon General to develop plans to adjust staff levels, if needed, to accommodate a potential future surge in demand.

    Agency: Department of Defense: Department of the Army
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase oversight of the Army's Warrior Transition Unit program, the Secretary of the Army should direct the Army Surgeon General to establish a process that assigns oversight responsibility for tracking instances in which Commanders make exceptions to WTU entrance criteria so that the Army Surgeon General is aware of the extent Commanders' decisions are consistent with program goals.

    Agency: Department of Defense: Department of the Army
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase oversight of the Army's Warrior Transition Unit program, the Secretary of the Army should direct the Army Surgeon General to develop and implement an approach and associated procedures for providing senior leadership, such as the Warrior Transition Command, with complaints information concerning the WTU program and WTU soldiers.

    Agency: Department of Defense: Department of the Army
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To help ensure the best use of resources for managing the medical care of soldiers recovering from serious medical conditions, the Secretary of the Army should direct the Chief of the Army Reserve, in conjunction with the Army Surgeon General, to develop an analysis that compares the costs and benefits of maintaining the current system of Community Care Units with the costs and benefits of expanding the Reserve Component Managed Care program.

    Agency: Department of Defense: Department of the Army
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: James Cosgrove
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: The Secretary of Health and Human Services should direct the Administrator of CMS to assess the feasibility of updating the agency's study on the effect of VA-provided Medicare-covered services on per capita county Medicare FFS spending rates by obtaining VA utilization and diagnosis data for veterans enrolled in Medicare FFS under its existing data use agreement or by other means as necessary.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In July 2016, the U.S. Department of Health and Human Services (HHS) reiterated its disagreement with our recommendation. HHS stated that the Centers for Medicare & Medicaid Services (CMS) uses Medicare fee-or-service(FFS) spending rates when setting the benchmark, which excludes services provided by Department of Veterans Affairs (VA) facilities. In addition, HHS stated that incorporating VA utilization and diagnosis data into CMS's analysis may not materially improve the analysis and the resulting adjustment. HHS indicated that it will continue to review the need for incorporating additional data or for methodology changes in the future. As we note in the report, only VA's utilization and diagnosis data can account for services provided by and diagnoses made by VA. Depending on the number and mix of services provided by and the diagnoses made by VA, risk-adjusted Medicare FFS spending for veterans may either be higher or lower than it would be if CMS accounted for VA-provided services and diagnoses. Therefore, relying exclusively on Medicare FFS spending to estimate the effect of VA spending on Medicare FFS-enrolled veterans could result in an inaccurate estimate of how VA spending on services for Medicare FFS-enrolled veterans affects per capita county Medicare FFS spending. While there may be challenges associated with incorporating VA utilization and diagnosis data into CMS's analysis, we maintain that CMS should work to do so given the implications that not incorporating the data may have on the accuracy of payment to MA plans.
    Recommendation: If CMS makes an adjustment to the benchmark to account for VA spending on Medicare-covered services, the Secretary of Health and Human Services should direct the Administrator of CMS to assess whether an additional adjustment to MA payments is needed to ensure that payments to MA plans are equitable for veterans and nonveterans.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: The Department of Health and Human Services (HHS)has proposed adjusting the benchmark for 2017 to account for the Department of Veterans Affairs (VA) spending on Medicare-covered services. As of July 2016, HHS had not yet completed its assessment of whether an additional adjustment to MA payments is needed to ensure that payment to Medicare Advantage (MA) plans are equitable for veterans and nonveterans. In order to close this recommendation, CMS will need to complete its assessment.
    Director: James Cosgrove
    Phone: (202) 512-7114

    5 open recommendations
    including 1 priority recommendation
    Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments and to improve the accuracy of CMS's calculation of coding intensity, the Administrator should modify that calculation by taking actions such as the following: (1) including only the three most recent pair-years of risk score data for all contracts; (2) standardizing the changes in disease risk scores to account for the expected increase in risk scores for all MA contracts; (3) developing a method of accounting for diagnostic errors not coded by providers, such as requiring that diagnoses added by MA organizations be flagged as supplemental diagnoses in the agency's Encounter Data System to separately calculate coding intensity scores related only to diagnoses that were added through MA organizations' supplemental record review (that is, were not coded by providers); and (4) including MA beneficiaries enrolled in contracts that were renewed from a different contract under the same MA organization during the pair-year period.

    Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments. The Administrator should modify CMS's selection of contracts for contract-level RADV audits to focus on those contracts most likely to have high rates of improper payments by taking actions such as the following: (1) selecting more contracts with the highest coding intensity scores; (2) excluding contracts with low coding intensity scores; (3) selecting contracts with high rates of unsupported diagnoses in prior contract-level RADV audits; (4) if a contract with a high rate of unsupported diagnoses is no longer in operation, selecting a contract under the same MA organization that includes the service area of the prior contract; and (5) selecting some contracts with high enrollment that also have either high rates of unsupported diagnoses in prior contract-level RADV audits or high coding intensity scores.

    Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments. The Administrator should enhance the timeliness of CMS's contract-level RADV process by taking actions such as the following: (1) closely aligning the time frames in CMS's contract-level RADV audits with those of the national RADV audits the agency uses to estimate the MA improper payment rate; (2) reducing the time between notifying MA organizations of contract audit selection and notifying them about the beneficiaries and diagnoses that will be audited; (3) improving the reliability and performance of the agency's process for transferring medical records from MA organizations, including assessing the feasibility of updating Electronic Submission of Medical Documentation for use in transferring medical records in contract-level RADV audits; and (4) requiring that CMS contract-level RADV auditors complete their medical record reviews within a specific number of days comparable to other medical record review time frames in the Medicare program.

    Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
    Status: Open
    Priority recommendation

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments. The Administrator should improve the timeliness of CMS's contract-level RADV appeal process by requiring that reconsideration decisions be rendered within a specified number of days comparable to other medical record review and first-level appeal time frames in the Medicare program.

    Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments. The Administrator should ensure that CMS develops specific plans and a timetable for incorporating a RAC in the MA program as mandated by the Patient Protection and Affordable Care Act.

    Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Debra Draper
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: The Secretary of Defense should direct the Secretary of the Army to implement processes to review and monitor the Army military treatment facility prescribing practices for medications discouraged under the PTSD guideline and address identified deviations.

    Agency: Department of Defense
    Status: Open

    Comments: We requested an update on the status of this recommendation. As of June 21, 2016, we are waiting for a response from DOD.
    Director: Gerald Dillingham, Ph.D
    Phone: (202) 512-2834

    1 open recommendations
    Recommendation: To help improve the U.S. aviation sector's preparedness for future communicable disease threats from abroad, the Secretary of Transportation should work with relevant stakeholders, such as the Department of Health and Human Services, to develop a national aviation-preparedness plan for communicable disease outbreaks. Such a plan could establish a mechanism for coordination between the aviation and public health sectors and provides clear and transparent planning assumptions for a variety of types and levels of communicable disease threats.

    Agency: Department of Transportation
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: James Cosgrove
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To help the Department of Health and Human Services better control spending and encourage efficient delivery of care, Congress should consider requiring Medicare to pay PCHs as it pays PPS teaching hospitals, or provide the Secretary with the authority to otherwise modify how Medicare pays PCHs. To generate cost savings from any reduction in outpatient payments to PCHs, Congress should also provide that all forgone outpatient payment adjustment amounts be returned to the Supplementary Medical Insurance Trust Fund.

    Agency: Congress
    Status: Open

    Comments: The 21st Century Cures Act enacted in December 2016 slightly reduces the additional payments to PCHs for outpatient services furnished on or after January 1, 2018, and returns savings to the Supplementary Medical Insurance Trust Fund. However, the law does not substantively change how PCHs are paid for outpatient services, which differs from how Medicare pays PPS teaching hospitals. In addition, as of March 1, 2017, no legislative action had been identified that changes how PCHs are paid for inpatient services, as GAO suggested in February 2015. Until Medicare pays these cancer hospitals in a way that encourages greater efficiency, Medicare remains at risk for overspending.
    Director: Crosse, Marcia G
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: In order to reduce the administrative costs associated with a fragmented MAI grant structure that diminishes the effective use of HHS's limited HIV/AIDS funding, and to enhance services to minority populations, HHS should consolidate disparate MAI funding streams into core HIV/AIDS funding during its budget request and allocation process.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS stated that it does not support the consolidation of Minority AIDS Initiative (MAI)funds into core funding. As of September, 2016, we are still awaiting an update from HHS on the status of any efforts to implement this recommendation. We will update the status of this recommendation when we receive additional information.
    Recommendation: In order to reduce the administrative costs associated with a fragmented MAI grant structure that diminishes the effective use of HHS's limited HIV/AIDS funding, and to enhance services to minority populations, HHS should seek legislation to amend the Ryan White Comprehensive AIDS Resources Emergency Act of 1990 or other provisions of law, as necessary, to achieve a consolidated approach.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS stated that it does not support the consolidation of Minority AIDS Initiative (MAI) funds into core funding. As of September, 2016, we are still awaiting an update from HHS on the status of any efforts to implement this recommendation. We will update the status of this recommendation when we receive additional information.
    Director: Cosgrove, James C
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: In order to improve CMS's ability to identify self-referred anatomic pathology services and help CMS avoid unnecessary increases in these services, the Administrator of CMS should insert a self-referral flag on Medicare Part B claim forms and require providers to indicate whether the anatomic pathology services for which the provider bills Medicare are self-referred or not.

    Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
    Status: Open

    Comments: In June 2013, we recommended that the Administrator of the Centers for Medicare & Medicaid Services (CMS) insert a self-referral flag on Medicare Part B claim forms and require providers to indicate whether the anatomic pathology services for which the provider bills Medicare are self-referred or not. The Department of Health and Human Services (HHS) did not concur with this recommendation, noting that CMS does not believe that this recommendation will address overutilization that occurs as a result of self-referral. We continue to believe that such a flag on Part B claims would likely be the easiest and most cost-effective way for CMS to identify self-referred anatomic pathology services and monitor the behavior of those providers who self-refer these services. As of June 2017, CMS has not provided any additional information about actions to address this recommendation.
    Recommendation: In order to improve CMS's ability to identify self-referred anatomic pathology services and help CMS avoid unnecessary increases in these services, the Administrator of CMS should determine and implement an approach to ensure the appropriateness of biopsy procedures performed by self-referring providers.

    Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
    Status: Open

    Comments: In June 2013, we recommended that the Administrator of the Centers for Medicare & Medicaid Services (CMS) implement an approach to ensure the appropriateness of biopsy procedures performed by self-referring providers. The Department of Health and Human Services (HHS) does not concur with this recommendation and does not believe it would address overutilization that occurs as a result of self-referral. HHS noted that it would be difficult to make recommendations regarding whether anatomic pathology services are appropriate without reviewing a large number of claims. We continue to believe that it is important for CMS to monitor the self-referral of anatomic pathology services on an ongoing basis and determine if those services are inappropriate or unnecessary. We also continue to believe this can be achieved without reviewing a large number of claims. CMS could, for example, consider performing targeted audits of providers that perform a higher average number of biopsy procedures compared to providers of the same specialty treating similar numbers of Medicare beneficiaries. As of June 2017, CMS has not provided any additional information about actions to address this recommendation.
    Recommendation: In order to improve CMS's ability to identify self-referred anatomic pathology services and help CMS avoid unnecessary increases in these services, the Administrator of CMS should develop and implement a payment approach for anatomic pathology services that would limit the financial incentives associated with referring a higher number of specimens--or anatomic pathology services--per biopsy procedure.

    Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
    Status: Open

    Comments: In June 2013, we recommended that the Administrator of the Centers for Medicare & Medicaid Services (CMS) develop and implement a payment approach for anatomic pathology services under the Physician Fee Schedule that would limit the financial incentives associated with referring a higher number of specimens--anatomic pathology services--per biopsy procedure. Although health care providers have discretion in determining the number of tissue samples from biopsy procedures that become specimens (anatomic pathology services), CMS's current payment system under the Physician Fee Schedule provides a financial incentive for providers to refer more specimens per biopsy procedure. Specifically, CMS pays for each specimen that a provider submits to be analyzed. HHS indicated that it concurred with our recommendation and that it had addressed this recommendation by reducing payment for the most commonly furnished anatomic pathology service (Current Procedural Terminology [CPT] code 88305) by approximately 30 percent in calendar year 2013. However, CMS's payment reduction did not change the financial incentive providers have to refer more specimens per biopsy procedure because they will still be paid separately for each specimen submitted. We continue to believe that CMS should develop a payment approach that addresses this incentive. As of June 2017, CMS had not provided any additional information about actions it has taken to address this recommendation.
    Director: Cosgrove, James C
    Phone: (202)512-7029

    3 open recommendations
    including 3 priority recommendations
    Recommendation: In order to improve CMS's ability to identify self-referred advanced imaging services and help CMS address the increases in these services, the Administrator of CMS should insert a self-referral flag on its Medicare Part B claims form and require providers to indicate whether the advanced imaging services for which a provider bills Medicare are self-referred or not.

    Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
    Status: Open
    Priority recommendation

    Comments: HHS did not concur with this recommendation, noting that CMS did not think this recommendation would be effective in addressing overutilization resulting from self-referral and that it would be complex to administer. We continue to believe that such a flag on Part B claims would likely be the easiest and most cost-effective way for CMS to identify self-referred advanced imaging services and monitor the behavior of those providers who self-refer these services even though the agency has no plans to take further action. As of October 2016, CMS has not provided any additional information about actions to address this recommendation.
    Recommendation: In order to improve CMS's ability to identify self-referred advanced imaging services and help CMS address the increases in these services, the Administrator of CMS should determine and implement a payment reduction for self-referred advanced imaging services to recognize efficiencies when the same provider refers and performs a service.

    Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
    Status: Open
    Priority recommendation

    Comments: HHS did not concur with this recommendation, noting that CMS did not believe that a payment reduction would address overutilization that occurs as a result of self-referral and that the agency's multiple procedure payment reduction policy for advanced imaging already captures efficiencies inhering in providing multiple advanced imaging services by the same physician. Further, CMS officials stated that providers in self-referring arrangements could avoid this reduction by having one provider refer an advanced imaging service while having another perform the service. Finally, CMS questioned whether implementing our recommendation would violate the Medicare statute prohibiting paying a differential by physician specialty for the same service. Our recommendation, however, refers to specific self-referral arrangements in which the same provider refers and performs an imaging service, and therefore would not be addressed by CMS's multiple procedure payment reduction policy. As noted in our report, this payment reduction would affect about 10 percent of advanced imaging services referred by self-referring providers. In addition, while CMS raised questions about whether implementing our recommendation would violate Medicare's prohibition on paying a differential by physician specialty for the same service, the agency did not indicate how it would do so as of October 2016. We continue to believe that CMS should determine and implement a payment reduction to recognize efficiencies for advanced imaging services referred and performed by the same provider even though, as of October 2016, the agency has no plans to take further action.
    Recommendation: In order to improve CMS's ability to identify self-referred advanced imaging services and help CMS address the increases in these services, the Administrator of CMS should determine and implement an approach to ensure the appropriateness of advanced imaging services referred by self-referring providers.

    Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
    Status: Open
    Priority recommendation

    Comments: HHS noted that it would consider this recommendation. The Secretary of HHS has the authority to establish a program to promote the use of appropriate use criteria - criteria that are evidenced-based (to the extent feasible) and that assist professionals to make the most appropriate treatment decisions for a specified clinical condition - for advanced imaging services under the Protecting Access to Medicare Act of 2014. CMS has begun developing its appropriate use criteria program (e.g., in November 2015, CMS established criteria to identify Qualified Provider Led Entities that are responsible for developing appropriate use criteria and has since selected Qualified Provider Led Entities), but full implementation of the program will not occur until at least January 1, 2018. If it - and the subsequent prior authorization program that incorporates appropriate use criteria - are implemented broadly enough (i.e., they ensure the appropriateness of advanced imaging services by all physicians, including those who self-refer), we could close the recommendation.
    Director: Iritani, Katherine M
    Phone: (206)287-4820

    2 open recommendations
    Recommendation: In light of the need for accurate and complete information on children's access to health services under Medicaid and CHIP, the requirement that states report information to CMS on certain aspects of their Medicaid and CHIP programs, and problems with accuracy and completeness in this state reporting, the Administrator of CMS should establish a plan, with goals and time frames, to review the accuracy and completeness of information reported on the CMS 416 and CHIP annual reports and ensure that identified problems are corrected.

    Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
    Status: Open

    Comments: In September 2016, CMS said that it was taking new steps to review data on children's access and quality of care by reviewing required reports that evaluate states' Medicaid managed care plans; however, these reports do not represent a consistent set of measures used by all states that CMS can use for oversight purposes. Accurate, complete, and reliable data for both Medicaid and CHIP are necessary for CMS's oversight of children's access to services. GAO considers this recommendation open.
    Recommendation: In light of the need for accurate and complete information on children's access to health services under Medicaid and CHIP, the requirement that states report information to CMS on certain aspects of their Medicaid and CHIP programs, and problems with accuracy and completeness in this state reporting, the Administrator of CMS should work with states to identify additional improvements that could be made to the CMS 416 and CHIP annual reports, including options for reporting on the receipt of services separately for children in managed care and fee-for-service delivery models, while minimizing reporting burden, and for capturing information on the CMS 416 relating to children's receipt of treatment services for which they are referred.

    Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
    Status: Open

    Comments: In September 2016, CMS said that it had changed the instructions for completing the CMS 416 to provide more detailed guidance for states on capturing required information on the total number of children who were referred for treatment services. However, CMS is not planning to require states to submit information on whether children received the treatment services for which they were referred. We maintain that having ability to monitor receipt of treatment services, receipt of services in managed care separate from fee-for-service, and having data from all states is important to CMS oversight. GAO considers this recommendation open.
    Director: Cosgrove, James C
    Phone: (202)512-7029

    2 open recommendations
    Recommendation: To help ensure that Medicare beneficiaries have access to high-quality dialysis care, the Administrator of CMS should assess the extent to which the bundled payment for dialysis care will be sufficient to cover an efficient dialysis organization's costs to provide such care when the bundled payment expands to cover oral-only ESRD drugs. The Administrator should conduct this assessment before implementing this expanded bundled payment.

    Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: In order to ensure effective monitoring of treatment of mineral and bone disorder, the Administrator of CMS should continue collecting data for quality measures related to this condition from sources such as the Elab Project until CROWNWeb is fully implemented and concerns about its data reliability have been adequately addressed.

    Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Currie, Christopher
    Phone: (404)679-3000

    1 open recommendations
    Recommendation: In order to help build and maintain a national biosurveillance capability---an inherently interagency enterprise---the Homeland Security Council should direct the National Security Staff to, in coordination with relevant federal agencies, charge this focal point with the responsibility for developing, in conjunction with relevant federal agencies, a national biosurveillance strategy that: 1) defines the scope and purpose of a national capability; 2) provides goals, objectives and activities, priorities, milestones, and performance measures; 3) assesses the costs and benefits associated with supporting and building the capability and identifies the resource and investment needs, including investment priorities; 4) clarifies roles and responsibilities of leading, partnering, and supporting a national capability; and 5) articulates how the strategy is integrated with and supports other related strategies' goals, objectives, and activities.

    Agency: Executive Office of the President: Homeland Security Council
    Status: Open

    Comments: In July 2012, the White House released the National Strategy for Biosurveillance to describe the U.S. government's approach to strengthening biosurveillance. A strategic implementation plan was to be completed within 120 days of the strategy issuance. As we testified in September 2012, the strategy did not fully meet the intent of our recommendation; however, when the implementation plan is complete, it may meet our recommendation. Specifically, the strategy did not provide the mechanism GAO recommended to identify resource and investment needs, including investment priorities. As of September 2015, GAO has not received a copy of the implementation plan for review and has not been able to confirm that it has been finalized and is considered operational by the White House and the key interagency partners.