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    Subject Term: "Medical devices"

    3 publications with a total of 3 open recommendations
    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: As of November 2017, the Department of Health and Human Services (HHS) has not taken any steps to implement this recommendation. According to HHS, conducting such a study is premature because only Congress has the authority to create new benefit categories and payment systems, and additional information on potential substitutes is needed. However, while congressional action may be required for Medicare to cover some of the potential disposable DME substitutes we identified, GAO continues to believe that without conducting a study to identify the potential costs and benefits of covering such devices, CMS will lack the necessary clinical and cost information to determine if it would be beneficial to reassess clinical current statutory and regulatory coverage rules. In other instances, CMS has used the national and local coverage determination processes to establish clinically based policies related to DME. Moreover, CMS is uniquely positioned to consider the extent to which coverage of any clinically appropriate substitutes would benefit the federal government and beneficiaries.
    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: 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.