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CMS Issues Additional Guidance on Tamper Resistant Prescriptions
February 7, 2008

The Centers for Medicare and Medicaid Services (CMS) have provided additional guidance on the tamper-resistant prescription requirement regarding the addition of features to a prescription and on computer generated prescriptions.

Provider Additions to Otherwise Non-Tamper-Resistant Paper

Several States have had specific questions about whether a provider can add a feature to a prescription to make it compliant with the tamper-resistant prescription requirement. States have proposed various features, including particular kinds of ink to write the prescription (gel or indelible); writing out the drug quantities rather than just the number (i.e. “thirty” vs. “30”); and embossed logos. The statute states that all written prescriptions must be “executed on a tamper-resistant pad.” As a result, features added to the prescription after they are printed do not meet the requirement of the statute. Features that would make the prescription tamper-resistant include certain types of paper as well as certain items that can be pre-printed on the paper.

Computer Generated Prescriptions

CMS is also clarifying that during the period between April 1, 2008 and October 1, 2008, computer generated prescriptions printed by a provider on plain paper, including Electronic Medical Record (EMR) computer generated prescriptions, may meet CMS guidance by containing one or more industry-recognized features designed either to prevent the erasure or modification of information contained on the prescription, or to prevent the use of counterfeit prescription forms.

However, based on its understanding of current prescription security technology, CMS does not believe that computer generated prescriptions printed by a prescriber on plain paper will be able to meet the first baseline requirement that prescriptions contain one or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form. In other words, prescriptions printed on plain paper will not be able to meet all three baseline characteristics outlined by CMS. Therefore, beginning October 1, computer generated prescriptions must be printed on paper that meets that requirement.

More Tamper-Resistant Prescription Pads Information

February 8, 2008