State Operations Manual (Pub. 100-07), Ch. 6 § 6102.4

Change of Testing Performed by a Laboratory

Last amended: 2025Year: 2025Length: 134 wordsOfficial source
6102.4 – Change of Testing Performed by a Laboratory (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) If a laboratory, other than a laboratory with a Certificate of Waiver (CoW) or PPM, begins to perform additional tests, a SA survey or resurvey may be required. (For laboratories with a Certificate of Waiver that want to expand services to include nonwaived testing, see section 6014 and section 6018). The regulations permit laboratories with a certificate to add services for 6 months prior to notification to CMS, although laboratories will not be eligible for Medicare or Medicaid payments until they have made the notification and their certificate has been revised. If a regularly scheduled survey occurs during the 6-month period a laboratory has added services but has not notified CMS, the SA surveys the added services.
State Operations Manual (Pub. 100-07), Ch. 6 § 6102.4: Change of Testing Performed by a Laboratory | Justis AI