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All rights reserved, Phelps Dunbar LLP Health Law Update is published as a service to clients and friends of Phelps Dunbar LLP, and should not be construed as legal or professional advice or as opinion on specific fact.

Tamper-Resistant Prescription Pads

January 9, 2008

Section 7002(b) of the U.S. Troop Readiness, Veterans’ Health Care, Katrina Recovery and Iraq Accountability  Appropriations Act of 2007 requires the use of tamper-resistant prescription drug pads for all written, non-electronic prescriptions for Medicaid patients.  The purpose of the requirement is to reduce the incidence of unauthorized, improperly altered and counterfeit prescriptions and to encourage e-prescriptions.  Federal reimbursement may be denied to states that do not enforce this requirement.

Section 7002(b) was to become effective for prescriptions written on or after October 1, 2007.  Subsequent legislation, however, delayed the effective date until April 1, 2008.

As of April 1, 2008, a written prescription will be compliant if it is written on a prescription pad that has one of the following characteristics:

• One or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form, such as a high security watermark on the reverse side or thermochromic ink;

• One or more industry-recognized features designed to prevent the erasure or modification of information written on the prescription by the prescriber, such as tamper-resistant background ink showing erasures or attempts to change written information; or

• One or more industry-recognized features designed to prevent the use of counterfeit prescription forms, such as sequentially numbered blanks or duplicate/triplicate blanks. 

By October 1, 2008, Medicaid prescriptions must be written on prescription pads with all three of the characteristics described above. 

According to CMS, this requirement applies to all written, non-electronic prescriptions for outpatient drugs for Medicaid patients, including over-the-counter drugs that are reimbursed by Medicaid.  The requirement applies whether Medicaid is the primary or secondary payor.

The requirement, however, does not apply to prescriptions that are: 

• Communicated by the prescriber to the pharmacy electronically, by phone or by facsimile;

• Refills of written prescriptions presented to the pharmacy before the effective date;

• In certain institutional settings, such as nursing homes, written as an order into the medical record with the order then communicated by the staff directly to the pharmacy with no opportunity for the patient to handle the written order; or

• Provided and paid by a managed care entity.

CMS has not issued any regulations at this time, although Frequently Asked Questions on the topic are found at http://www.cms.hhs.gov/DeficitReductionAct/30_GovtInfo.asp.  For further guidance, Louisiana prescribers may go the Louisiana Medicaid website at www.lamedicaid.com.  Mississippi prescribers may access the Mississippi Medicaid website.

If you have questions, please contact one of the Phelps Dunbar health care attorneys listed below.

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