LEGISLATION AND EVIDENCE FOR REIMBURSEMENT OF MEDICAL FOODS IN WORKER'S COMPENSATION SYSTEMS

Purpose:  Examine the legislation surrounding the use of medical foods (MF) for chronic diseases, the quality of the scientific evidence, and the extent and costs of MF use within California Workers Compensation System (CAWC).

Methods:  We conducted an internet-based search of each state’s Workers’ Compensation System (WC) website and WC laws to determine rules of coverage, current pricing methodologies, and a legal definition of MF within each state’s statutes and regulations. We determined the quality of the scientific evidence for each MF by systematically reviewing publications from PubMed, EMBASE, and Web of Science databases using Toolbox Scientific Evidence Critique . We reviewed the CAWC claims database of all physician and pharmacy-dispensed drugs/supplies, including MF from 2011 to 2013 to determine the effect of California’s October 2011 pricing regulations on prescribing practices using t-test.

Result s: Only three states had policies and regulations directly addressing MF reimbursement. Of these, only Florida and Washington explicitly state that they do not reimburse pharmacy or physician-dispensed MF. California also lacks laws addressing reimbursement for pharmacy-dispensed MF but has laws addressing reimbursement methodology for physician-dispensed MF. Literature review demonstrated most studies supporting MFs do not follow study designs that meet standard recognized scientific principles.  Furthermore, for some disease states there is no evidence that a nutritional component is required for treatment.

The database contains a total 4,153,588 pharmacy-dispensed claims and 16,944,271 physician-dispensed claims. MF claims billed were only 0.15% and 0.53% of all prescription claims totaling $3,012,962/year. 36% and 35% of physician and pharmacy-dispensed MFs billed were denied and an additional 60% of each had pricing adjustments leaving $2,877,932/year paid.  Physicians billed fewer MF after pricing regulations (p <.001).

Conclusions:  California still reimburses some MFs, but the prescription volume is decreasing since the enactment of physician-dispensed MF reimbursement policy specifying pricing restrictions. The scientific evidence required for the use of MF is lacking due to poor quality of supporting studies and lack of a disease need for a nutritional component as evidenced by FDA warning letters.  Based on this review, we recommend that CAWC consider denying coverage for all MFs except in special cases.  Other WC systems should consider initiating pricing regulations or regulations denying coverage for most MFs.