{"abstract":"This final rule updates the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies the CLIA fee regulations. This final rule implements a process for sustainable funding for the CLIA program through a biennial two-part increase of CLIA fees. We are finalizing the incorporation of limited/specific laboratory fees, including fees for follow-up surveys, substantiated complaint surveys, and revised certificates. We are also finalizing the distribution of the administrative overhead costs of test complexity determination for waived tests and test systems with a nominal increase in Certificate of Waiver (CoW) fees. In addition, we are finalizing the clarification of the methodology used to determine program compliance fees. This final rule ensures the continuing quality and safety of laboratory testing for the public. This final rule also amends histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate technological changes. In addition, this final rule amends the provisions governing alternative sanctions (including civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and onsite State monitoring) to allow for the imposition of such sanctions on CoW laboratories.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2023/12/28/2023-28170.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"493","title":42}],"citation":"88 FR 89976","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"These regulations are effective January 27, 2024, except for instruction 3, amending Sec. 493.2; instructions 14 through 19, amending Sec. Sec. 493.945, 493.1273, 493.1274, 493.1278, 493.1359, and 493.1405; instruction 20 removing Sec. 493.1406; instructions 21 through 30, amending Sec. Sec. 493.1407, 493.1411, 493.1417, 493.1423, 493.1443, 493.1445, 493.1449, 493.1451, 493.1455, and 493.1461; instruction 31 removing Sec. 493.1462; and instructions 32 through 36, amending Sec. Sec. 493.1463, 493.1469, 493.1483, 493.1483, 493.1489, and 493.1491, which are effective December 28, 2024.","disposition_notes":null,"docket_ids":["CMS-3326-F"],"dockets":[{"supporting_documents":[],"agency_name":"CMS","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2023-12-28T15:56:31.878-05:00","comment_url":"https://www.regulations.gov/commenton/CMS-2022-0119-20565","allow_late_comments":null,"id":"CMS-2022-0119-20565","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"CMS-2022-0119","title":"Clinical Laboratory Improvement Amendments Fees: Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326-P)"}],"document_number":"2023-28170","effective_on":"2024-01-27","end_page":90044,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/12/28/2023-28170.xml","html_url":"https://www.federalregister.gov/documents/2023/12/28/2023-28170/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and","images":{"ER28DE23.009":{"large":"https://img.federalregister.gov/ER28DE23.009/ER28DE23.009_large.png","medium":"https://img.federalregister.gov/ER28DE23.009/ER28DE23.009_medium.png","original_size":"https://img.federalregister.gov/ER28DE23.009/ER28DE23.009_original_size.png"},"ER28DE23.000":{"large":"https://img.federalregister.gov/ER28DE23.000/ER28DE23.000_large.png","medium":"https://img.federalregister.gov/ER28DE23.000/ER28DE23.000_medium.png","original_size":"https://img.federalregister.gov/ER28DE23.000/ER28DE23.000_original_size.png"},"ER28DE23.011":{"large":"https://img.federalregister.gov/ER28DE23.011/ER28DE23.011_large.png","medium":"https://img.federalregister.gov/ER28DE23.011/ER28DE23.011_medium.png","original_size":"https://img.federalregister.gov/ER28DE23.011/ER28DE23.011_original_size.png"},"ER28DE23.022":{"large":"https://img.federalregister.gov/ER28DE23.022/ER28DE23.022_large.png","medium":"https://img.federalregister.gov/ER28DE23.022/ER28DE23.022_medium.png","original_size":"https://img.federalregister.gov/ER28DE23.022/ER28DE23.022_original_size.png"},"ER28DE23.010":{"large":"https://img.federalregister.gov/ER28DE23.010/ER28DE23.010_large.png","medium":"https://img.federalregister.gov/ER28DE23.010/ER28DE23.010_medium.png","original_size":"https://img.federalregister.gov/ER28DE23.010/ER28DE23.010_original_size.png"},"ER28DE23.021":{"large":"https://img.federalregister.gov/ER28DE23.021/ER28DE23.021_large.png","medium":"https://img.federalregister.gov/ER28DE23.021/ER28DE23.021_medium.png","original_size":"https://img.federalregister.gov/ER28DE23.021/ER28DE23.021_original_size.png"},"ER28DE23.020":{"large":"https://img.federalregister.gov/ER28DE23.020/ER28DE23.020_large.png","medium":"https://img.federalregister.gov/ER28DE23.020/ER28DE23.020_medium.png","original_size":"https://img.federalregister.gov/ER28DE23.020/ER28DE23.020_original_size.png"},"ER28DE23.008":{"large":"https://img.federalregister.gov/ER28DE23.008/ER28DE23.008_large.png","medium":"https://img.federalregister.gov/ER28DE23.008/ER28DE23.008_medium.png","original_size":"https://img.federalregister.gov/ER28DE23.008/ER28DE23.008_original_size.png"},"ER28DE23.019":{"large":"https://img.federalregister.gov/ER28DE23.019/ER28DE23.019_large.png","medium":"https://img.federalregister.gov/ER28DE23.019/ER28DE23.019_medium.png","original_size":"https://img.federalregister.gov/ER28DE23.019/ER28DE23.019_original_size.png"},"ER28DE23.007":{"large":"https://img.federalregister.gov/ER28DE23.007/ER28DE23.007_large.png","medium":"https://img.federalregister.gov/ER28DE23.007/ER28DE23.007_medium.png","original_size":"https://img.federalregister.gov/ER28DE23.007/ER28DE23.007_original_size.png"},"ER28DE23.018":{"large":"https://img.federalregister.gov/ER28DE23.018/ER28DE23.018_large.png","medium":"https://img.federalregister.gov/ER28DE23.018/ER28DE23.018_medium.png","original_size":"https://img.federalregister.gov/ER28DE23.018/ER28DE23.018_original_size.png"},"ER28DE23.006":{"large":"https://img.federalregister.gov/ER28DE23.006/ER28DE23.006_large.png","medium":"https://img.federalregister.gov/ER28DE23.006/ER28DE23.006_medium.png","original_size":"https://img.federalregister.gov/ER28DE23.006/ER28DE23.006_original_size.png"},"ER28DE23.017":{"large":"https://img.federalregister.gov/ER28DE23.017/ER28DE23.017_large.png","medium":"https://img.federalregister.gov/ER28DE23.017/ER28DE23.017_medium.png","original_size":"https://img.federalregister.gov/ER28DE23.017/ER28DE23.017_original_size.png"},"ER28DE23.005":{"large":"https://img.federalregister.gov/ER28DE23.005/ER28DE23.005_large.png","medium":"https://img.federalregister.gov/ER28DE23.005/ER28DE23.005_medium.png","original_size":"https://img.federalregister.gov/ER28DE23.005/ER28DE23.005_original_size.png"},"ER28DE23.016":{"large":"https://img.federalregister.gov/ER28DE23.016/ER28DE23.016_large.png","medium":"https://img.federalregister.gov/ER28DE23.016/ER28DE23.016_medium.png","original_size":"https://img.federalregister.gov/ER28DE23.016/ER28DE23.016_original_size.png"},"ER28DE23.004":{"large":"https://img.federalregister.gov/ER28DE23.004/ER28DE23.004_large.png","medium":"https://img.federalregister.gov/ER28DE23.004/ER28DE23.004_medium.png","original_size":"https://img.federalregister.gov/ER28DE23.004/ER28DE23.004_original_size.png"},"ER28DE23.015":{"large":"https://img.federalregister.gov/ER28DE23.015/ER28DE23.015_large.png","medium":"https://img.federalregister.gov/ER28DE23.015/ER28DE23.015_medium.png","original_size":"https://img.federalregister.gov/ER28DE23.015/ER28DE23.015_original_si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