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    Subject Term: "Medical equipment"

    8 publications with a total of 11 open recommendations including 1 priority recommendation
    Director: Kathleen M. King
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: The Administrator of CMS should evaluate the possible costs and savings of using disposable devices that could potentially substitute for DME, including options for benefit categories and payment methodologies that could be used to cover these substitutes, and, if appropriate, seek legislative authority to cover these devices.

    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: King, Kathleen M
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To ensure MACs' provider education efforts are focused on areas vulnerable to improper billing and to strengthen CMS's oversight of those efforts, CMS should require sufficient detail in MAC reporting to allow CMS to determine the extent to which MACs' provider education department efforts focus on areas identified as vulnerable to improper billing.

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

    Comments: HHS concurred with this recommendation and said it would take steps to implement it. In April 2017, CMS released a revised Provider Customer Service Program Activity Report (PAR) template to Medicare Administrative Contractors (MAC). This revised template collects additional information from MACs on their provider outreach and education activities that are specifically geared towards reducing their improper payment rate. All PAR Reports submitted after July 2017 will include information on these topics. Additionally, CMS is implementing increased reporting by MACs in the Provider Customer Service Program Contractor Information Database to track whether education was provided related to the prioritization of efforts to reduce the error rate. CMS expects these additional reporting requirements to be released to the MACs in fall 2017. GAO will continue to monitor CMS efforts.
    Recommendation: To ensure MACs' provider education efforts are focused on areas vulnerable to improper billing and to strengthen CMS's oversight of those efforts, CMS should explicitly require that Medicare Part A and B claims, DME, and home health and hospice MACs work together to educate referring providers on documentation requirements for DME and home health services.

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

    Comments: HHS concurred with this recommendation and said it would take steps to implement it. CMS is developing instructions for the Medicare Administrative Contractors (MAC) that will require MACs to collaborate on a regular basis to provide education to referring providers on documentation and other requirements relative to durable medical equipment and home health services. CMS expects these new instructions to be released to MACs in fall 2017. Additionally, CMS is implementing increased reporting by MACs in the Provider Customer Service Program Contractor Information Database to track the instances of collaboration with other MACs. CMS expects these additional reporting requirements to be released to the MACs in fall 2017. Finally, CMS revised the Provider Customer Service Program Activity Report (PAR) to collect additional information from MACs on education topics where MACs collaborated with each other and with external partners. This new template was released to MACs in April 2017, and all PARs submitted after July 2017 will include information on these topics. GAO will continue to monitor CMS efforts.
    Recommendation: To ensure MACs' provider education efforts are focused on areas vulnerable to improper billing and to strengthen CMS's oversight of those efforts, for any future probe and educate reviews, CMS should establish performance metrics that will help the agency determine the reviews' effectiveness in reducing improper billing.

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

    Comments: HHS concurred with this recommendation and said it would take steps to implement it. Through the Targeted Probe and Educate Pilot, currently under way in Jurisdiction F and set to expand in the near future to additional jurisdictions, CMS has been working to develop more thorough metrics to monitor the outcome and impact of the probe and educate reviews. Detailed metrics in the expanded pilot include service and provider specific error rates, claims metrics, financial impact, education metrics, provider/suppler behavior metrics, as well as volume and outcome of appeals both pre- and post-probe and educate implementation. GAO will continue to monitor CMS efforts.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To ensure that FDA can effectively coordinate and integrate its medical product centers' programs and emerging issues, the Secretary of Health and Human Services should direct the Commissioner of FDA to engage in a strategic planning process to identify challenges that cut across the medical product centers and document how it will achieve measurable goals and objectives in these areas.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: On 9/8/16, FDA provided an update on its actions to address this recommendation. FDA concurred with the recommendation and reiterated that it had started a process to identify key crosscutting themes for the medical products centers, which it would then use to develop an overarching strategic planning framework to guide the work of these centers. The agency indicated that it would provide additional updates in fiscal year 2018.
    Director: Mackin, Michele
    Phone: (202) 512-4841

    1 open recommendations
    including 1 priority recommendation
    Recommendation: To help mitigate confusion about the use of reverse auctions in federal acquisitions, the Director of the Office of Management and Budget should take steps to amend the FAR to address agencies' use of reverse auctions.

    Agency: Executive Office of the President: Office of Management and Budget
    Status: Open
    Priority recommendation

    Comments: In providing comments on this report, OMB generally concurred with this recommendation but, as of July 2017, had not yet publicly released a draft of any related proposed FAR rule(s). In July 2017, OMB staff stated that a FAR team had drafted proposed regulatory changes to address the use of reverse auctions in response to GAO's recommendation. OMB staff said that the draft changes were undergoing review and they expected they would be published for public comment before the end of the calendar year.
    Director: King, Kathleen M
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To improve the effectiveness of the unpublished MUEs and better ensure Medicare program integrity, the CMS Administrator should consider periodically reviewing claims to identify the providers exceeding the unpublished MUE limits and determine whether their billing was proper.

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

    Comments: In its comments on a draft of this report, HHS concurred with this recommendation and indicated that CMS would conduct further analysis to determine the most appropriate way to respond. In July 2015, HHS told us that CMS has established a process to identify providers exceeding the unpublished MUE limits and determine whether their billing was proper. In August 2016, CMS informed us that the agency is developing a process to review provider level data to determine potential improper billing that exceeds unpublished MUE limits. However, as of September 2016, CMS has not yet implemented this process. We requested that CMS provide documentation of the process once it has been implemented. With this documentary support, we hope to close the recommendation.
    Director: Cosgrove, James C
    Phone: (202)512-7029

    2 open recommendations
    Recommendation: Congress may wish to consider reducing home oxygen payment rates to better align them with home oxygen suppliers' costs.

    Agency: Congress
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To establish rates that more accurately reflect the distinct costs of providing each type of home oxygen equipment, the Administrator of CMS should restructure Medicare's home oxygen payment methodology. This should include removing the payment for portable oxygen refills from that for stationary equipment and paying for refills only for the equipment types that require them.

    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: Crosse, Marcia G
    Phone: (202)512-3407

    1 open recommendations
    Recommendation: The Secretary of Health and Human Services should direct the FDA Commissioner to expeditiously take steps to issue regulations for each class III device type currently allowed to enter the market through the 510(k) process. These steps should include issuing regulations to (1) reclassify each device type into class I or class II, or requiring it to remain in class III, and (2) for those device types remaining in class III, require approval for marketing through the PMA process.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA has taken steps to respond to this recommendation; however we are leaving the recommendation open because the agency has not yet taken final steps to reclassify or require premarket approval (PMA) for two class III device types allowed to enter the market through the less stringent 510(k) process. In 2009, FDA began a 5-step process to reclassify or to require PMAs for 26 class III device types. This process was modified by the Food and Drug Administration Safety and Innovation Act (FDASIA)--instead of issuing regulations as the final step, FDA issues an administrative order to reclassify or require PMAs for the device types. In 2014, the agency reported it had set a goal to have all remaining devices finalized by the second quarter of 2015; however, as of August 2017, FDA had not finished the process of reclassifying or requiring PMAs for 2 of 26 devices types. The agency reported completing the process for 24 device types, and provided new planned milestones to complete the process for the remaining device types by the middle of 2018. We will leave this recommendation open until FDA makes progress in reclassifying or requiring PMAs for the remaining device types.
    Director: Aronovitz, Leslie G
    Phone: (312)220-7767

    1 open recommendations
    Recommendation: The Administrator of CMS should require the PSCs to develop thresholds for unexplained increases in billing--and use them to develop automated prepayment controls as one component of their manual medical review strategies.

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

    Comments: Despite progress in identifying potentially improper groups of claims by provider, CMS has not developed thresholds for unexplained increases in billing by providers and used them to develop automated prepayment controls, as GAO recommended in January 2007. CMS took action in July 2011 to improve Medicare payment accuracy by introducing predictive analytics to help identify patterns of potentially improper claims and has some other prepayment controls in place. Specifically, the Small Business Jobs Act of 2010 requires CMS to use predictive modeling and other analytic techniques?known as predictive analytic technologies?to identify improper claims and prevent improper payments under the Medicare fee-for-service program. CMS is streaming every Medicare fee-for-service claim through a predictive modeling technology system, known as the Fraud Prevention System (FPS), prior to payment. The FPS uses a series of algorithms to identify potentially fraudulent claims. As each claim streams through the FPS, the system builds profiles of providers, networks, and billing patterns. Using these profiles, CMS estimates a claim's likelihood of being fraudulent and prioritizes providers with the most suspicious groups of claims for further investigation. CMS also has other prepayment controls in place, for example, to identify duplicate billing. As of December 2015, CMS did have algorithms in FPS to flag providers with unexpected increases in billings for investigation. CMS also instituted prepayment controls that can deny a claim before payment, however these controls are related to Medicare coverage requirements and do not address the issue of large increases in provider billing. Prepayment controls can suspend claims processing or deny claims before claims are paid, which would provide a greater assurance that Medicare funds are not going to potentially fraudulent providers. As of August 2016, HHS officials reported that they have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.