Research & Presentations
Clinical Trials: Our Relationship With the Payor Goes Beyond Mere Reimbursements By Michael Wininger, PhD Introduction Clinicians are reimbursed for their services when they provide approved treatments for patients with covered indications, i.e., symptoms or diagnoses that are recognized by the payor as valid reasons for prescription. Payor policy is determined by panel review of the best available information regarding treatment efficacy. There are five main sources of information on which policy is written: clinical science, meta-analyses, professional guidelines, expert guidance, and stakeholder opinion. Stakeholder opinion is expected to be experiential in nature: a forum for the patient, the family member, the nonprofit, etc., to speak to the human element of medicine.
The four remaining forms of information are mostly or entirely empirical. And these branches of information all share a common root: the clinical trial.
A View From the Outside As a case study, consider the implantable cardioverter defibrillator (ICD), a biomedical device with a long history of coverage determination review by CMS. The ICD was first approved for implantation by the U.S. Food and Drug Administration (FDA) in 1985, and the first CMS coverage determination letter was published in 1986, with several reviews to the national coverage determination (NCD) over the subsequent 30 years.
Table 1 A Brief History of CMS Coverage Determinations for the Implantable Cardioverter Defibrillator 1985 FDA approval of first implantable defibrillator 1986 Coverage for life-threatening ventricular tachyarrhythmias 1991 Ventricular fibrillation not due to transient or reversible cause 1999 Demonstrated or risk of developing ventricular tachyarrhythmia 2003 Previous myocardial infarction, low ejection fraction, wide QRS interval 2004 Clarification of device investigational device exemption Category B 2005 Expansion of device-eligible patient categories 2018
14 O&P News | April 2018
Clarification of eligibilities, exceptions to waiting periods, ending registry requirement
