December 7, 2021

Volume XI, Number 341

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December 06, 2021

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CMS Publishes Final Rule to Implement Protecting Access to Medicare Act’s Changes to Laboratory Test Reimbursement

Last week, the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register its long-awaited final rule implementing the significant payment and related changes for clinical diagnostic laboratory tests under the Medicare Clinical Laboratory Fee Schedule.  The changes were directed by the Protecting Access to Medicare Act of 2014 (“PAMA”), which establishes a new formula and process to set Medicare payment amounts at the weighted median of private payor rates.  Our client alert discussing the final rule’s key takeaways and the ways it differs from CMS’s proposed rule can be accessed here.

In its final rule, CMS delayed the PAMA-directed effective date by one year, until January 1, 2018.  The additional time was intended to help alleviate, among other things, administrative and other burdens on industry.  Payment updates will be calculated using private payor data from affected laboratories for a six-month collection period, beginning January 1 through June 30, 2016.  Data for the first update must be reported to CMS between January 1 and March 31, 2017 and CMS will release the new Medicare rates by November 2017.  The data collection and reporting time lines will be repeated every three years for most tests and every year for certain advanced tests.  Details on registration and reporting procedures, as well as other operational requirements, are forthcoming.  To ensure compliance, affected companies should begin preparations to understand and incorporate the complex regulatory criteria into their operations.

© 2021 Covington & Burling LLPNational Law Review, Volume VI, Number 183
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About this Author

Esther Scherb, Covington, food and drug attorney
Of Counsel

Esther Scherb’s practice focuses on healthcare and regulatory matters, with an emphasis on Medicare, Medicaid and other government programs administered by the U.S. Department of Health and Human Services (HHS).  She counsels clients on reimbursement and compliance issues faced by the healthcare and life sciences industries.

Dr. Scherb assists providers, medical device, pharmaceutical and biotechnology manufacturers, private equity firms, investment bankers and other industry groups in various matters, including development and implementation of comprehensive...

202.662.5054
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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