December 2, 2021

Volume XI, Number 336

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CMS Releases Instructions on PAMA Data Reporting

The Centers for Medicare & Medicaid Services (CMS) has now launched the new data reporting process for laboratories under the Protecting Access to Medicare Act (PAMA). Under CMS’s final PAMA rule, applicable laboratories must report private payor rates and other applicable information for certain clinical laboratory tests from a specified six-month data collection period. Additional technical information can be found on the CMS website, and in a slide presentation, available here.

The first PAMA collection period was January 1 to June 30, 2016, and the reporting period begins January 1, 2017 and ends March 31, 2017. Data for Advanced Diagnostic Laboratory Tests will be reported on a rolling basis, at the end of the third quarter of the test’s initial period. To report data, reporting entities must first register through the Enterprise Identity Management System (EIDM), which is independent from the specific CMS or the Clinical Laboratory Fee Schedule (CLFS) data collection systems. Due to the sensitive and confidential nature of the data reported under PAMA, CMS is requiring this step to ensure remote identity proofing, a mechanism that ensures that data submitters are properly identified. All reporting entities must receive an EIDM username and password in order to access CMS-specific data collection systems. For reporting entities that have already completed this process, CMS expects that a notification of access would have been received by November 14.

Once a reporting entity has been granted access, it must register with the Fee-for-Service Data Collection System (FFSDCS). Each entity must select:

(1) a “CLFS submitter” who submits all applicable information, validates the data, and makes any requested corrections; and

(2) a “CLFS certifier” who registers the data and certifies the accuracy and completeness of the data.

The CLFS certifier cannot make changes to the data. If the certifier identifies areas that need editing, the data must be sent back to the data submitter for those corrections. It is important that all changes are reviewed carefully before certification; once the data has been certified, it cannot be accessed by the laboratory.

© 2021 Covington & Burling LLPNational Law Review, Volume VI, Number 333
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About this Author

Shruti Barker, Covington Burling, Healthcare attorney
Associate

Shruti Barker is an associate in the firm’s Washington, DC office, where she practices in the areas of health care, federal-state programs, and employee benefits. Ms. Barker advises state agencies, providers, food manufacturers, and other clients on issues related to government-sponsored health care programs. Ms. Barker has experience with an array of healthcare statutes and regulations, including Medicare, Medicaid, Women, Infants, and Children (“WIC”), and the Supplemental Nutrition Assistance Program.

202-662-5031
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