||The problem of U.S. pharmaceutical drug shortages is one that has steadily grown in
severity over the course of the past decade, particularly in the years since 2006.
Some types of drugs have proven to be more susceptible to shortage than others, particularly
sterile injectable drugs. Many oncology drugs are sterile injectables, and an increasing
number of sterile injectable oncology drugs have been subject to shortage in recent
years. Shortages can led to delayed treatments, errors stemming from the use of alternative
drugs, increased costs, and negative patient outcomes including death. While shortages
occur for a number of different reasons, some have blamed changes contained within
the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 that
changed the way that Medicare reimbursement rates for drugs were calculated. Contrary
to assertions that MMA is capping the growth rates of reimbursements for drugs and
thus causing shortages to occur, the new MMA rate formula does not appear to be limiting
the rate at which reimbursements can grow. This report does recommend, however, that
the current reimbursement formula be adjusted so that rates are based on data gathered
monthly rather than quarterly, reducing the length of the delay between price signals
from the drug market and the adjustment of reimbursement rates.