Medicaid "Tamper Proof" Prescription Requirement Effective April 1, 2008
March 12, 2008
Dear Colleague,
With the new Medicaid tamper-resistant prescription pad requirement set to go into effect at the end of the month, we wanted to take this opportunity to thank you again for supporting efforts to provide additional time to educate prescribers, pharmacists and patients about the new requirement. Like you, we also want to ensure that all Medicaid patients will be able to receive their needed medications on April 1, 2008, and are including valuable information for your staff to help answer constituent questions and facilitate implementation.
Review of Centers for Medicare & Medicaid Services (CMS) Regulation
As of April 1, 2008 a prescription pad must contain a security feature with at least one of the following three characteristic categories:
- One or more industry recognized features designed to prevent unauthorized copying.
- One or more industry recognized features designed to prevent the modification of information.
- One or more industry recognized features designed to prevent the use of counterfeit prescriptions.
By October 1, 2008, a prescription must contain all three security features. This includes computer-generated prescriptions that are printed using paper inserted into a printer. Please note that electronic prescriptions, faxed prescriptions and prescriptions sent over the telephone are exempt from this requirement.
There is NO national standard. CMS has deferred to the states to define the features that they will accept for a prescription to be considered tamper-resistant. With such potential variation, the National Association of State Medicaid Directors has compiled all state and federal guidance on its website at http://www.nasmd.org/issues/TRPP.asp. If your state requirements are not listed, it is recommended that you contact your State Medicaid Director to encourage additional clarification for prescribers, pharmacists and beneficiaries.
With the moratorium set to expire, American Pharmacists Association (APhA), National Association of Chain Drug Stores (NACDS) and National Community Pharmacists Association (NCPA) developed educational materials for prescribers, pharmacists and beneficiaries that are available on the National Council for Prescription Drug Programs (NCPDP) website at: http://www.ncpdp.org/pdf/Tamper_resistant_01-16-08.zip. You should feel free to use these documents to answer questions from your constituents regarding implementation. This link also includes recommendations to State Medicaid Directors for tamper-resistant prescription pad features as well as other materials.
Thank you again to all Members who assisted in delaying these requirements to provide stakeholders with much needed time to help minimize the potential impact on patient access. For additional information please see a list of frequently asked questions below.
Sincerely,
Charles A Wilson Marion Berry Mike Ross
Member of Congress Member of Congress Member of Congress
Frequently Asked Questions on Tamper Resistant Pad Rule
When does the tamper-resistant prescription pad requirement start?
On April 1, 2008, all hand-written (which includes computer-generated) Medicaid prescriptions will need to have at least one approved tamper-resistant feature to prevent: copying, erasure, or counterfeiting. Starting October 1, 2008, all hand-written Medicaid prescriptions must have at least one feature from all three of the previously mentioned categories.
How can I determine if a prescription is written on a compliant tamper-resistant prescription pad for my State?
It is recommended that you contact your state Medicaid agency to determine the appropriate requirements for your state. The National Association of State Medicaid Directors also has state-specific materials available on its Web site at http://www.nasmd.org/issues/TRPP.asp. Additionally, APhA, NACDS and NCPA developed education materials that are available on the NCPDP website at http://www.ncpdp.org/pdf/Tamper_resistant_01-16-08.zip.
Does this requirement pertain to prescriptions received by fax, telephone or electronically?
No. Since fax, telephone, and electronic prescriptions are sent directly to the pharmacy, they are excluded from the new Federal requirements. The direct communication from the physician/prescriber to the pharmacist is considered tamper-resistant.
Does the tamper-resistant requirement apply to over-the-counter (OTC) products?
Yes. OTC products that require a prescription for reimbursement under Medicaid must be written on a tamper resistant prescription paper.
Does this requirement pertain to prescriptions that are written using a computer and printed on standard paper?
Yes. Any prescription that is transferred to paper (whether by writing or by printing) must be on a tamper-resistant prescription paper.
Sometimes my patients become Medicaid-eligible retroactively. If not originally written on tamper-resistant prescription pads, will their original prescriptions need to be corrected?
No. If presented to the pharmacy before April 1, 2008, an original written prescription does not need to be written on a tamper-resistant prescription paper. However, refills and all subsequent prescriptions will need to be written on tamper-resistant prescription pads.
What do I do if I receive a hand-written Medicaid prescription from another state?
Pharmacists must first determine which state Medicaid program is going to pay for the prescription and then make sure that the prescription meets that state’s tamper-resistant prescription pad requirements.
If pharmacists, prescribers and Medicaid beneficiaries have additional questions, who can they call?