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New script pad rule is looming
WASHINGTON — A controversial regulation that will require the use of tamper-resistant prescription pads for Medicaid becomes effective April 1. The rule, to be implemented by the Centers for Medicare and Medicaid Services (CMS), had been delayed for six months in response to criticism by retail pharmacies and other organizations that the original October 1, 2007, deadline did not leave sufficient time for pharmacies, prescribers and beneficiaries to prepare for the changes.
Manufacturers of pads also maintained they were receiving so many orders that they were encountering difficulty keeping pace with demand.
The prescription pad change is intended to help reduce both the number of fraudulent prescriptions as well as the millions of dollars that are paid out for them.
The Congressional Budget Office has estimated that tamper-resistant pads will save taxpayers about $335 million over the next 10 years by cutting down on fake prescriptions. For example, in the past abusers have used such techniques as adding a zero to a prescription order, often then receiving 100 tablets or capsules of a medication rather than the prescribed 10.
CMS has advised that the use of indelible ink will not meet the legal requirements.
Earlier this year the National Association of Chain Drug Stores was among 90 state and national pharmacy and medical organizations to send a letter to state Medicaid directors requesting that additional guidance be provided to pharmacies regarding compliance with the federal statute. A second letter was dispatched earlier this month to 16 Medicaid programs that NACDS has identified as having not sent out provider notices since late last year. Also in March, NACDS and the Coalition for Community Pharmacy faxed letters to physicians notifying them of the approaching April 1 implementation date.
NACDS has also reached out to CMS and Congress requesting they encourage states to be more aggressive in notifying prescribers about the upcoming implementation.
Although CMS has outlined three baseline characteristics of tamper-proof pads, each state defines which features it will require to meet those characteristics in order to be considered tamper-resistant.
The baseline characteristics must prevent unauthorized copying of a completed or blank prescription form, must prevent the erasure or modification of information written on the prescription by the provider, and must prevent the use of counterfeit prescription forms.
According to the letter NACDS and the other groups sent state Medicaid directors, CMS’ original guidance allowed states to phase in the requirement over a year’s time. In the second and final phase (not later than October 1, 2008) a prescription pad would have been required to meet all three characteristics.
But in late September, after President Bush signed a law delaying the effective date to April 1 of this year (from October 1, 2007), CMS advised affected stakeholders that, despite the six-month initial implementation delay, all pads would still be required to have all three of the required characteristics by October 1, 2008.
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