Coalition to Strengthen the Future of Molecular Diagnostics

A diverse group of stakeholders across healthcare industries and patient advocacy organizations has formed a Coalition to Strengthen the Future of Molecular Diagnostics (CSFMD). Clinical labs, cancer patient-advocacy organizations, and pharmaceutical companies that manufacture medicines to treat cancer and other conditions are part of the coalition.

The purpose of the coalition is to advance and support sustainable Medicare pricing for novel precision diagnostic testing. The below cost reimbursement for molecular diagnostics observed today results directly from the recent plummet in Medicare pricing for molecular diagnostic testing.

The objective of the coalition is to inform policy makers and the Centers for Medicare and Medicaid Services (CMS, Baltimore County, MD, USA) about the value of genetic testing and the impact timely and accurate diagnosis has on treatment decisions and patient outcomes. The coalition supports CMS’ decision for more transparency and a new more efficient pricing methodology, but is concerned about the process by which newly proposed interim pricing was determined and accepted.

Molecular diagnostic testing can determine, by identifying specific genetic mutations, which therapy an individual’s cancer or disease is more likely to respond to and start the patient on the appropriate treatment immediately. These tests are eliminating trial and error treatments that waste valuable healthcare dollars and cost cancer patients precious time, as well as dramatically increase life longevity and quality of care for many patients.

Prior to 2013, molecular diagnostic tests were reimbursed through a method known as “code stacking,” where each step or process used to perform a test was billed and reimbursed. CMS announced it would restructure the current reimbursement process, and assigned individual CPT codes to more than 100 existing tests. During these ongoing deliberations aimed at determining a permanent pricing structure for 2014, interim pricing, derived by the Medicare Administrative Contractors (MACs) from a seldom used pricing method known as gap-fill, for diagnostic testing was posted by CMS and effectively cut payment rates for many critical tests, by an average of about 20 % (and as high as 80% in some cases) from 2012 levels.

In an opinion editorial published on May 23, in a congressional newspaper the Hill author Randall Oyer, MD, Medical Director of the oncology program at Lancaster Hospital in Lancaster, PA, cautioned, “If labs conducting molecular diagnostic testing have to close or offer inferior testing due to Medicare reimbursement rates well below the cost of testing itself, pharmaceutical companies will have little incentive to continue research, development and bring to clinical trials cancer therapies with no ‘companion diagnostic.’ Such a potentially dangerous domino effect could compromise innovation, tie the hands of the physician, and turn a dream come true for the cancer patient into a nightmare.”

Related Links:
Centers for Medicare and Medicaid Services