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Prescription for confusion

Congress needs to give physicians more time to comply with an anti-prescription fraud law -- as well as limit the law's scope

Editorial. Oct. 1, 2007.

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When Congress passed a law requiring physicians to use tamper-resistant pads for certain Medicaid prescriptions, the intent was to prevent people from using fraudulent means to get the medication they should not receive.

But in its haste to accomplish that noble goal, Congress is creating an unintended consequence -- preventing people from using legitimate means to get the medication they should receive.

After the Centers for Medicare & Medicaid Services took about three months to issue guidance regarding the law signed on May 25, physicians, states and pharmacists were left with an unrealistic 1½ months to meet the Oct. 1 deadline for complying with the law. By the National Assn. of Chain Drug Stores' count, that law would have affected 330 million Medicaid prescriptions written in 2006. This figure takes into account a number of exemptions in the law including faxed, electronic and Medicaid managed care prescriptions.

To prevent the risk that these patients will not get their prescriptions while physicians struggle to hurry up and follow the law, Congress needs to pass legislation quickly that would delay the earlier law's implementation and limit its scope to schedule II narcotics -- the real target of efforts to prevent prescription fraud.

In the 13 states that have adopted similar measures affecting Medicaid patients, great pains often were taken to ensure that physicians and pharmacists had the necessary time to adapt. In New York, for example, the state worked 18 months with physicians before its anti-prescription fraud legislation became effective in April 2006. It even provided, for free, tamper-proof prescription pads to physicians.

Congress, on the other hand, gave states, physicians and pharmacists only 4½ months to comply, with most of that time waiting for CMS to issue its interpretation, as it generally does. It ruled that by Oct. 1, states would be required to implement only one of the three antifraud features for written prescriptions -- prevention of unauthorized copying, prevention of erasure and modification, and prevention of counterfeiting. But all three must be in place by Oct. 1, 2008.

With only about six weeks to prepare (not that the four full months would have been enough, either), physicians could find out their Medicaid patients can't get their prescriptions, because of confusion over whether the prescription is compliant with the law.

Physicians have to find out first from their individual state which one of the antifraud features it is requiring now. As AMA Executive Vice President and CEO Michael D. Maves, MD, MBA, wrote in a Sept. 10 letter to Senate Majority Leader Harry Reid (D, Nev.), there is no consensus on what exactly qualifies as a tamper-resistant pad.

This assumes, of course, that states were ready themselves by Oct. 1 -- something that was not possible, according to a Sept. 6 letter to four Congressional leaders written by the American Public Human Services Assn. and one of its affiliates, the National Assn. of State Medicaid Directors (and also signed by the AMA). This follows an Aug. 16 letter, signed by the AMA and 75 other medical organizations, to the Dept. of Health and Human Services asking for a six- to 12-month delay.

According to the Sept. 6 letter, states said six weeks wasn't enough time to notify physicians, pharmacists and recipients of the new requirements, and then have the recipients come back for newly written prescriptions. The letter also notes that states didn't have enough time to finish proscribed procurement processes for the supplies necessary to fulfill the law.

Legislation introduced in the House and Senate is seeking to rectify these problems. The Senate bill would limit the current implementation of the earlier law to schedule II narcotics only, while moving the deadline for other drugs back to April 1, 2009. The House bill includes no delay but does limit the current law to schedule II narcotics. There are efforts under way to attempt to attach these measures to a funding bill -- the same way the original law got through Congress.

The best course of action for Congress would be to pass legislation that was limited to schedule II narcotics and give physicians, states and pharmacists more time to implement it. That way, progress can be made in limiting prescription fraud without having the unintended consequence of limiting prescriptions.

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