Pharmaceutical Product ID: An Industry in Crisis?
Levin, Aaron, Drug Topics
CHAINS and BUSINESS
What does "one" mean to a pharmacist trying to get reimbursed for a particular prescription? Sounds like a simple question, but in the realm of pharmaceutical products, the road to an answer is strewn with potholes, land mines, and washed-out bridges.
In real terms, knowing how to measure and identify what R.Ph.s dispense can make a big difference in reimbursements and/or rebates, so sorting out numbering systems is not the snore-inducing chore it might seem. "This is the most misunderstood area of the drug industry," said Linda Schock of Schock Heywood Consultancy at a recent conference in Baltimore sponsored by the National Council for Prescription Drug Programs (NCPDP). "Each player sees product identification differently, which has led to an identity crisis in our industry."
Schock offered a hypothetical example of a drug the manufacturer sells as one box, containing several packets. A distributor takes the packets out and sells them to RPh.s, who reconstitute the drug and dispense subdivided quantities of the liquid to patients. If the amount reported to the Centers for Medicare and Medicaid Services, or CMS (formerly the Health Care Financing Administration), is required to be the "smallest unit by which the drug is normally measured," exactly what is that number?
Merely identifying and counting the quantity of a drug dispensed to the satisfaction of providers, payers, and regulators is a complex, messy, and contradictory task. For instance, NCPDP's reporting standard says the basic unit is one tablet or capsule, while CMS permits counting by bottles. The result could make a hundred-- fold difference in the rebate claim.
Should oral contraceptives be reported as packages or as individual tablets? Some packages contain 21 tablets; others have 28. Then there's the issue of using metric quantities, which requires a confusing rounding-- up procedure before multiplying unit quantities and seems designed to create billing discrepancies. Take the conventional rendering of 1 fl. oz. into the metric system as 30 ml. If the manufacturer reports that amount exactly as 29.57 ml, a 0.43 ml discrepancy arises-small but not insignificant when multiplied over millions of Rxs.
This system should be phased out by next year, when the much simpler metric decimal quantities will come into use, said Tom Bizarro, R.Ph., product manager with First DataBank Inc. in Indianapolis. However, he noted, standards are now voluntary, so just to confuse things more, some pharmacy benefit managers may ask for either metric quantities or metric decimal quantities-- or even both-in order to compare and see if the resulting claims are equal.
Another complaint aired at the session addressed the use of nonstandard packaging by manufacturers. Odd package sizes are the result of a number of factors and don't simply crop up at the distribution stage, explained Beth Rader, manager of coverage and reimbursement for Genentech in South San Francisco.
"Formulations and doses reflect their development in the course of clinical trials, efficiencies in manufacturing or utilization, reduction of waste in shipping, or maximization of patient compliance and acceptance," said Rader. Adjusting contents to standardize packaging might require restarting the Food & Drug Administration approval process.
One goal of NCPDP, said Schock, is to make manufacturers responsible for knowing how their products are sold and dispensed. …