CMS Continues to Ignore Deadline to Post Molecular Pathology Pricing

As most labs are aware, CMS was supposed to post the molecular pathology fee schedules along with details on how the pricing was determined by May 1st. To call it disappointing that this deadline has not been met would be an understatement. Laboratories were hoping that the mandatory release of these prices would trigger the obligatory release of much needed payments as it would signal that any payment delays due to lack of pricing would no longer be an issue. The vast majority of molecular pathology procedures billed to Medicare Contractors related to the tier 1 and tier 2 fee schedules have not been paid this year. MACs have used a variety of excuses from software glitches to pricing and/or gap-filling information being unavailable to explain why these ongoing procedures are not being paid. While many in the healthcare industry have felt an increase in pricing pressure, CMS’ handling of molecular pathology codes demonstrates something different altogether. The behavior and decision making of CMS throughout this process feels much more antagonistic and shows blatant disregard for the laboratories who perform molecular diagnostic testing, including those at the forefront of innovation and the patients depending on them. Not to mention the disregard for timely payment and transparency rules.

 

Molecular diagnostics has seen a dramatic uptick in recent years. Tests analyzing molecular biomarkers are performed on a large variety of patients, but the area where they have seen the greatest growth is in helping to determine optimal, patient specific therapeutic regimes. In order to comfortably make a decision, physicians generally need results that are definitive. Most of them are not molecular pathologists and need clear and definitive guidance on how such biomarkers relate to which drugs a patient might be prescribed. In performing the more expensive and elaborate tests, labs provide an objective tool for physicians to diagnose and treat patients quickly, correctly, and efficiently. Essentially, better molecular diagnostic tests with a higher degree of specificity and sensitivity are finally making good on the long awaited promise of personalized medicine that was expected in the aftermath of the human genome project, but was slow to come. Often these definitive tests may be perceived as more expensive. However, the high costs of developing, validating and bringing these tests to market, as well as the tremendous clinical value they bring, can make them a “bargain.” They aid in reducing the greater than 50% of therapies that are known to be inappropriate for a given patient, and ultimately save health care dollars and lives. In pricing these tests as low as they have, CMS (via their MACs) has effectively told labs that they do not believe better and more useful tests are medically necessary. More importantly, their unresponsiveness to the fact that hundreds of millions of dollars of molecular diagnostic claims are simply not getting paid due to “administrative” issues is outrageous. 

 

It is imperative for the prices to be posted so comments and questions can be submitted. It is equally critical that labs coordinate efforts to bring this situation to the attention of their legislators. For some labs it may be too late, as we have indications from certain independent labs that they have already moved tests from their menu or reduced their staffing, and the survival of some is in question. Unfortunately, we are not expecting any pleasant surprises.