Advocacy - Lab Advocate

PAMA Rule in Final Review at OMB

The Office of Management and Budget (OMB) is currently reviewing final regulation that would implement the clinical laboratory provisions of the Protecting Access to Medicare Act (PAMA). OMB reviews all federal regulations to ensure rules reflect Administration priorities and include an economic analysis to assess the impact of the directive.  Typically, OMB takes up to 90 days to conduct a review, which means a final rule should be published by the end of July.

PAMA, once implemented, will require the Centers for Medicare and Medicaid Services (CMS) to rebase laboratory payments under Medicare to reflect private sector rates.  The statute permits the agency to cut reimbursement, per test, up to 75 percent over a six-year period. For 2017-2019, CMS payment cuts are limited to 10 percent per year. For 2020-2022, the agency can reduce fees by up to 15 percent a year. After 2022, there are no limits on how much CMS could cut payments.

One of the key issues for clinical laboratories is which testing facilities will be required to submit payment data to CMS. Many in the laboratory community, including AACC, have urged the agency to ensure that payment information is gathered from a cross-section of testing facilities, including hospitals and physicians office laboratories (POLs). Data skewed towards large commercial laboratories will result in even larger reductions in payment rates since hospitals and POLs generally are not able to offer the volume discounts that larger laboratories provide.

Although scheduled to take effect on January 1, 2017, many in the laboratory community and Congress have recommended that the agency delay the payment changes until January 1, 2018 because laboratories still need to gather and submit data for CMS to assess and finalize the payment amounts.  It is unlikely these tasks can be completed by the January 1 deadline; therefore, a delay seems likely.