CMS issues guidance on tamper-resistant prescription pads

On Aug. 17, the Centers for Medicare & Medicaid Services (CMS) issued guidance for state Medicaid directors on the new requirement that written, nonelectronic prescriptions for Medicaid outpatient drugs must be issued on tamper-resistant prescription pads. Under the U.S. Troop Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability Appropriations Act of 2007, this requirement takes effect October 1, 2007.

The provision applies to all written, nonelectronic prescriptions provided in settings other than certain specified institutional and clinical settings. According to the recently issued guidance, it will not apply to prescriptions transmitted to pharmacies electronically, orally or via facsimile, nor will it apply to emergency fills of prescriptions when an oral, faxed, electronic or compliant written prescription is sent within 72 hours of the date on which the prescription was filled. The requirement also does not apply to Medicaid managed care enties.

Since the announcement of this provision, many questions have been raised regarding the definition of "tamper-resistant." As part of the guidance, CMS clarified that tamper-resistant prescription pads must meet one of the following characteristics for October 1, 2007:

• Contain one or more industry-recognized features designed to prevent unauthorized copying of a completed or black prescription form;
• Use one or more industry-recognized features designed to prevent the erasure or modification of information written on the prescription by the prescriber; or
• Include one or more industry-recognized features designed to prevent the use of counterfeit prescription forms.
  
  

By Oct. 1, 2008, prescription pads must meet all of the above characteristics to be considered tamper-resistant. Under the guidance, CMS has given flexibility to state Medicaid directors to determine exactly how each state will meet the new requirement. Note that states that currently have laws and regulations governing tamper-resistant prescription pads will be considered in compliance with the CMS guidance.

Top four most frequently asked questions on tamper-resistant prescription pads

Q: Which of the characteristics has your practice chosen to meet for Oct. 1, 2007?

A: The medical practice does not get to choose which of the three characteristics its prescription pads must meet for Oct. 1, 2007. It is up to the state Medicaid director to make that decision and to decide how the state will meet that characteristic.

Q: Doesn't this requirement only apply to outpatient prescription drugs dispensed in the office?

A: No, this requirement applies to all written, nonelectronic prescriptions for outpatient drugs, whether the drugs are dispensed in the office or by a pharmacy.

Q: Does this apply to Medicaid HMO plans?

A: No, the tamper-resistant requirement does not apply to Medicaid managed care products.

Q: My practice transmits prescriptions electronically. What do I need to do to comply with this requirement?

A: If you transmit prescriptions via e-prescribing, verbal communication or facsimile, this requirement does not apply to you. This requirement is designed to promote e-prescribing because it is already considered tamper-resistant.

Resources

View the CMS letter to state Medicaid directors at http://www.cms.hhs.gov/SMDL/downloads/SMD081707.pdf.

Read the CMS guidance to state health policymakers at http://www.cms.hhs.gov/SMDL/downloads/SMD081707.pdf.

Read the provider education article on tamper-resistant prescription pads at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0736.pdf.