With Final Rule, PAMA Set to Spark Changes in Lab Market and IVD Strategy

With Final Rule, PAMA Set to Spark Changes in Lab Market and IVD Strategy

This blog post reviews regulatory developments in the United States relevant to the clinical lab services and U.S. in vitro diagnostics (IVD) markets. For more information regarding recent market developments or trends in either market, Kalorama Information offers the market research reports United States Market for In Vitro Diagnostic Tests and Clinical Laboratory Services Market.

In late June of this year, the Centers for Medicare and Medicaid Services (CMS) announced the final rule of the 2...


Recapping the ’Doc Fix’ Act’s Impacts on Medicare Lab Reimbursement

Recapping the ’Doc Fix’ Act’s Impacts on Medicare Lab Reimbursement

The clinical lab and IVD industries continue to assess the “Doc Fix” Bill or Protecting Access to Medicare Act of 2014 (H.R. 4032) following its passage in April 2014. The law, to be implemented by 2017, has seen no shortage of reactions from stakeholders. Under its provisions, the Act will allow CMS to systematically collect test payment rate and volume data from “applicable” private labs, including at least reference or commercial labs and likely hospital labs (or those with outreach businesse...