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. 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: At the time of report publication DOD indicated it did not concur with this recommendation. However after publication, the department indicated it concurred with the recommendation. As of September 2020, DOD is continuing to take actions to address this recommendation. When actions have been completed, GAO will update the status of the recommendation.

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: DOD concurred with this recommendation. As of July 2018, the department indicated that it was addressing the recommendation by requiring the military services to submit a report in March 2018 and March 2019 on how they are monitoring adherence to policies related to screening certain servicemembers for PTSD and TBI prior to separation for misconduct. In August 2020, the department indicated it completed a cycle of compliance reporting by the military services in April 2020. DOD stated it would conduct a final compliance reporting cycle in March 2021. GAO maintains that monitoring of compliance on a routine basis (i.e., ongoing) is necessary and will keep the recommendation open until the department indicates that routine monitoring will occur.

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: DOD concurred with this recommendation. As of September 2020, the department is continuing to take actions to address this recommendation. When actions have been completed, GAO will update the status of the recommendation.

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: DOD concurred with this recommendation. As of July 2018, the department indicated that it was addressing the recommendation by requiring the military services to submit a report in March 2018 and March 2019 on how they are monitoring adherence to policies related to counseling about VA benefits and services during the process of separating certain servicemembers for misconduct. In August 2020, the department indicated it completed a cycle of compliance reporting by the military services in April 2020. DOD stated it would conduct a final compliance reporting cycle in March 2021. GAO maintains that monitoring of compliance on a routine basis (i.e., ongoing) is necessary and will keep the recommendation open until the department indicates that routine monitoring will occur.

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: The Army concurred with this recommendation. As of August 2020, an Army Medical Command official stated that the Warrior Transition Unit manpower model is under review by the U.S. Army Manpower Analysis Agency and that the scheduled date for the release of the review is unknown.

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 December 2017, the U.S. Department of Health and Human Services (HHS) indicated that it had further reviewed our recommendation and determined that updating the agency's study on the effect of VA-provided Medicare-covered services on per capita county Medicare fee-for-service (FFS) spending rates using the Department of Veterans Affairs' (VA) utilization and diagnosis data was not feasible. Challenges cited by HHS included (1) pricing each VA encounter using Medicare payment rules; (2) determining which Medicare provider would have treated each beneficiary; and (3) the resources required to have an ongoing data feed with VA and to protect VA utilization and diagnosis data. While we acknowledge that there may be challenges associated with incorporating VA utilization and diagnosis data into HHS's analysis, we believe that HHS needs to do additional work before it can determine whether such an approach is feasible. For example, while HHS noted resource concerns related to sharing and storing sensitive VA data, the agency already receives and stores some VA data. It remains unclear whether HHS has assessed what additional resources would be needed to store VA utilization and diagnosis data and whether such data would need to be shared via an ongoing data feed-another challenge mentioned by HHS. As of June 2020, HHS has not provided us with any additional information about actions it has taken to address this recommendation. We continue to believe that HHS should assess the feasibility of implementing a methodology for estimating the effect of VA-provided Medicare-covered services on per capita county Medicare FFS spending rates that incorporates VA data.

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: In December 2017, the U.S. Department of Health and Human Services (HHS) indicated that there are a number of limitations that would impede the Centers for Medicare & Medicaid Services' (CMS) ability to conduct an analysis of veteran versus nonveteran payments to MA plans. HHS indicated that in order to conduct a thorough assessment, CMS would need utilization and diagnosis data from the Department of Veterans Affairs (VA), which would take several years to collect and analyze. In addition, HHS indicated that if CMS determined an adjustment was needed, the agency would have to overcome other data, operational, and financial challenges related to making the adjustment. As a result, HHS indicated that implementing such an adjustment would be infeasible. However, CMS currently adjusts the benchmark to account for VA spending on Medicare-covered services without VA utilization and diagnosis data. While we agree that VA utilization and diagnosis data may improve the accuracy of an adjustment to MA payments to ensure that payments to MA plans are equitable for veterans and nonveterans, it is unclear why CMS could not make an adjustment without VA utilization and diagnosis data. As of June 2020, HHS has not provided us with any additional information about actions it has taken to address this recommendation. In order for us to close this recommendation, CMS would need to assess whether an additional adjustment to MA payments is needed.

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: CMS is working to improve the accuracy of its calculation of coding intensity, as GAO recommended in April 2016. In October 2017, CMS officials told GAO that the agency is reevaluating the design of the risk adjustment data validation audits to ensure their rigor in the context of all the payment error data acquired since the original design of the audits. As part of this work, CMS officials told GAO that the agency will examine whether coding intensity is the best criterion to use to select contracts for audit. As a result, in October 2018, CMS told GAO that rather than coding intensity, it plans to implement a new methodology using payment error as the key sampling driver beginning with audits for payment year 2014. Additionally, CMS was taking steps to modernize its audit system to improve reliability. For example, it initiated a project to explore how to directly receive electronic medical record documentation. As of January 2020, the agency is continuing to reevaluate the design of these audits. Unless CMS takes this and other actions to improve the risk adjustment data validation contract-level audit process, it will fail to recover improper payments of hundreds of millions of dollars annually.

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: CMS is working to modify the selection of MA contracts for audit, as GAO recommended in April 2016. In October 2017, CMS officials told GAO that the initial RADV audit design was based on a limited set of payment error data available at the time. As part of efforts to improve the audits, CMS officials told GAO that the agency will examine whether coding intensity is the best criterion to select contracts for audit. In October 2018, CMS told GAO that it plans to implement a new methodology using payment error as the key sampling driver-rather than coding intensity-beginning with audits for payment year 2014. As of January 2020, the agency is using the revised methodology on the 2014 and 2015 payment year audits. They expect to conclude this process in late fiscal year 2020 and 2021, respectively. Unless CMS completes actions to improve the RADV contract-level audit process, it will fail to recover improper payments of hundreds of millions of dollars annually.

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: HHS concurred with this recommendation in its fiscal year 2021 budget justification. HHS reaffirmed its commitment to identifying and correcting improper payments in the MA program. It has begun taking steps to improve the timeliness of the contract-level RADV audit process, such as aligning the time frames in CMS's contract-level RADV audits with those of the national RADV audits. Once completed, CMS needs to provide evidence that the actions taken by the agency have enhanced the timeliness of CMS's contract-level RADV process.

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: CMS is working to improve the timeliness of the agency's contract-level risk adjustment data validation appeals process, as GAO recommended in April 2016. In October 2017, CMS officials told GAO that the agency is actively considering options for expediting the appeals process. For example, CMS is considering the appropriate number of days for rendering reconsideration decisions while allowing for a complete and thorough adjudication. In December 2019, CMS officials told GAO they expect to issue a final rule in January 2021 that will establish uniform timelines to expedite the appeals process. Specifically, they plan to require that a findings determination be made within 60-90 days of an arbiter's receipt of each party's arguments at each stage of an appeal. Unless CMS takes such actions to improve the risk adjustment data validation contract-level audit process, it will fail to recover improper payments of hundreds of millions of dollars annually.

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: CMS has attempted to incorporate a recovery audit contractor in the Medicare Advantage program, as GAO recommended in April 2016. After failing to receive any proposals when CMS first issued a request for proposals (RFP) in 2014, CMS issued a request for information to industry in December 2015, which included a draft Statement of Work to solicit feedback, gauge interest, and conduct market research regarding CMS entering into a contract with a recovery audit contractor to identify underpayments and overpayments associated with diagnosis data submitted to CMS by Medicare Advantage Organizations. CMS reported that it subsequently issued another RFP in 2016 and did not receive any proposals for a second time. In December 2019, CMS officials told GAO that the functions of the Part C recovery Audit programs are being performed through other program integrity mechanisms. CMS subsequently reported in its fiscal year 2021 budget justification that CMS believes the proposed scope of the Part C RAC has been subsumed by RADV and CMS will demonstrate that the RADV program satisfies this recommendation. Until CMS completes efforts to improve the risk adjustment data validation contract-level audit process and demonstrates that it has satisfied the requirement to incorporate a recovery audit contractor in the MA program, CMS will fail to recover improper payments of hundreds of millions of dollars annually.

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: DOD concurred with this recommendation and stated that any policy that it may issue related to the monitoring of prescribing practices would be directed toward all of the military services. In May 2018 DOD stated that it planned to (1) conduct a comprehensive review of existing prescribing practices for the treatment of PTSD; (2) develop policy guidance for addressing prescribing practices for the management of PTSD that deviate from the clinical practice guideline; and (3) implement an automated dashboard that will flag medications that the PTSD guideline discourages from use. In its February 26, 2020 response, DOD stated that July 30, 2020 is the estimated completion date for these planned actions. To close this recommendation, DOD needs to implement its planned actions and provide documentation showing that the Department is monitoring medications discouraged from use under the PTSD guideline and addressing identified deviations.

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
Priority recommendation

Comments: The Department of Transportation (DOT) has not developed a national aviation-preparedness plan to respond to communicable disease threats from abroad. In June 2020, we urged Congress to take legislative action to require the Secretary of Transportation to work with relevant agencies and stakeholders to develop a national aviation-preparedness plan to limit the spread of communicable disease threats, and minimize travel and trade impacts (see GAO-20-625). GAO's periodic updates on the CARES Act of 2020 provide information about actions taken by Congress to address this matter. DOT partially concurs with our recommendation and agrees that an aviation preparedness plan is needed, but continues to suggest that the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS) have responsibility for communicable disease response and preparedness planning, respectively, and that these departments should lead any efforts to address planning for communicable disease outbreaks, including for transportation. In the absence of a national aviation-preparedness plan, DOT officials point to ongoing efforts to engage with interagency partners at DHS and HHS, as well as industry stakeholders, to better collaborate on communicable disease response and preparedness as they relate to civil aviation. For example, in July 2020, DOT, HHS, and DHS issued guidance to airports and airlines for implementing measures to mitigate public health risks associated with COVID-19. While this guidance is a positive step, DOT has not yet taken action to develop an aviation preparedness plan for future communicable disease threats that incorporate such things as protocols for responding to the threat and coordination among stakeholders.

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: As of March 2020, no legislative action had been identified that changes how PCHs are paid for inpatient services, as GAO suggested in February 2015. The 21st Century Cures Act-Pub. L. No. 114-255, ?16002, 130 Stat. 1033, 1325 (2016), 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. Until Medicare pays these cancer hospitals in a way that encourages greater efficiency, Medicare remains at risk for overspending.

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 January 2020, HHS had not changed its position. 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 January 2020, HHS had not changed its position. We will update the status of this recommendation when we receive additional information.

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. Although CMS has taken initial steps relevant to self-referral, the steps do not require a provider to indicate whether anatomic pathology services billed to Medicare are self-referred or not. Specifically, CMS has noted that Section 6409(a) of the Patient Protection and Affordable Care Act required the Secretary of the Department of Health and Human Services, in cooperation with the Inspector General of the Department of Health and Human Services, to establish a Medicare self-referral disclosure protocol that sets forth a process to enable providers of services and suppliers to self-disclose actual or potential violations of the physician self-referral statute. However, the protocol is voluntary and specific to actual or potential violations regarding self-referral, which is not relevant to our recommendation. As of January 2020, CMS has not provided any additional information about actions it has taken to address our recommendation. We continue to believe that inserting a flag on Part B claims to indicate whether an anatomic pathology service is self-referred would improve CMS's ability to monitor self-referred services, which in turn may help them take action to avoid unnecessary increases in these services.

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) did not concur with this recommendation and does not believe it would address overutilization that occurs as a result of self-referral. In November 2017, CMS officials noted that the agency does not have the ability to identify self-referred anatomic pathology services during medical reviews. As of January 2020, CMS has not provided any additional information about actions it has taken to address the recommendation. 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.

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. As of January 2020, CMS has not provided any additional information about actions it has taken to limit the financial incentives associated with referring a higher number of specimens. We continue to believe that CMS should develop a payment approach that addresses this incentive.

Recommendation: To help ensure that ADI suppliers provide consistent, safe, and high-quality imaging to Medicare beneficiaries, the Administrator of CMS should determine the content of and publish minimum national standards for the accreditation of ADI suppliers, which could include specific qualifications for supplier personnel and requiring accrediting organization review of clinical images.

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

Comments: In June 2019, HHS officials informed us that they plan to implement this recommendation in March 2020. We will update the status of this recommendation when we receive additional information.

Recommendation: To help ensure that ADI suppliers provide consistent, safe, and high-quality imaging to Medicare beneficiaries, the Administrator of CMS should develop an oversight framework for evaluating accrediting organization performance, which could include collecting and analyzing information on accreditation results and conducting validation audits.

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

Comments: In June 2019, HHS officials informed us that they plan to implement this recommendation in March 2020. We will update the status of this recommendation when we receive additional information.

Recommendation: To help ensure that ADI suppliers provide consistent, safe, and high-quality imaging to Medicare beneficiaries, the Administrator of CMS should develop more specific requirements for accrediting organization mid-cycle audit procedures and clarify guidance on immediate-jeopardy deficiencies to ensure consistent identification and timely correction of serious care problems for the duration of accreditation.

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

Comments: In June 2019, HHS officials informed us that they plan to implement this recommendation in March 2020. We will update the status of this recommendation when we receive additional information.

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. CMS believes that a new checkbox on the claim form identifying self-referral would be complex to administer and providers may not characterize referrals accurately. 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 January 2020, CMS continues to indicate it will not take additional 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 inherent in providing multiple advanced imaging services by the same physician. Further, CMS does not think a payment reduction for self-referred services would be effective. For example, the agency believes 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, our report shows that self-referring providers generally referred more MRI and CT services, regardless of differences in specialties, and CMS did not indicate how this recommendation would implicate the prohibition on paying a differential by specialty. 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. As of January 2020, the agency has no plans to take further action regarding 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 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 did not concur with this recommendation, according to its fiscal year 2021 budget justification. To fully implement this recommendation, CMS should determine and implement an approach to ensure the appropriateness of advanced imaging services referred by self-referring providers.

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 August 2019, CMS stated that the agency's long-term plan is to use the Transformed Medicaid Statistical Information System (T-MSIS) to analyze information on children's receipt of Early and Periodic Screening, Diagnostic and Treatment (EPSDT) services. As of June 2020, CMS had developed a new CMS-416 reporting form that gives states the option of having CMS calculate the measures for the report using T-MSIS. CMS stated that it intends to implement this option for states for fiscal year 2020 CMS-416 reports, which are due in April 2021. As of August 2020, the new CMS-416 form was undergoing Paperwork Reduction Act review. CMS is also exploring using T-MSIS to generate the Core Set of Children's Health Care Quality Measures for Medicaid and CHIP, some of which are included in the CHIP annual report. As of June 2020, CMS had begun a pilot test to generate five of the Core Set measures using 2018 T-MSIS data. GAO considers this recommendation open and will continue to monitor CMS's progress towards its long-term goal of using T-MSIS to monitor children's receipt of EPSDT services.

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: CMS, as required by the Protecting Access to Medicare Act of 2014 (PAMA), delayed until 2024 when the bundled payment for dialysis care is expanded to cover oral-only ESRD drugs. Because PAMA requires CMS to use the most recent year of data available to implement this payment change, CMS has been unable to implement our recommendation. We will update the status of this recommendation upon receipt of additional information from CMS.