It is a notable and rare success for the clinical laboratory profession to convince the House and Senate to pass a law that is favorable to the interests of patients and the clinical laboratories that serve them.
Yet that is what happened when Congress passed the Laboratory Access for Beneficiaries (LAB) Act in December and President Trump signed it into law before the end of the year. (See pages 3-6.) This is evidence that a major- ity of representatives and senators are aware that access to local, high-quality medical laboratory testing must be maintained if Medicare beneficiaries and other patients are to be properly served by the U.S. healthcare system.
Now is when the oft-repeated adage of “the devil is in the details” will come into play. First, will the Medicare Payment Advisory Commission (MedPAC) deliver recommendations to the federal Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) that truly address the flaws and biases in how CMS officials have interpreted the language of the Protecting Access to Medicare Act of 2014 (PAMA)? Will MedPac recommend proper fixes to the methods CMS has used to limit both the number and types of clinical labs required to report private payer lab test price data, as well as the formulas being used to analyze the data and set prices for the Clinical Laboratory Fee Schedule (CLFS)?
The second question plays off the first. Assume MedPAC recommends appropriate changes in how CMS conducts the private payer market study and uses that data to set Medicare CLFS prices, will CMS actually follow those recommendations? It can be credibly argued that actions taken by CMS officials since PAMA was enacted into law clearly conflict with both the intent of Congress and the language of the statute.
Even more to this point, that both houses of Congress felt the need to pass the LAB Act—which was written specifically to correct the flaws, bias, and problems created in how CMS officials are implementing the PAMA statute—is the most powerful fact supporting this assertion.
On one hand, pathologists and lab managers can see passage of the Lab Act as a positive step forward to fix a problem that threatens to undermine the clinical and financial stability of the nation’s clinical laboratories. On the other hand, it remains to be seen whether officials at CMS will faithfully implement the recommendations that MedPAC will produce.