| Pursuant to federal law (H.R. 2206 / Public Law 110-28, U.S. Troop Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability Appropriations Act, 2007), effective April 1, 2008, prescribing practitioners are required to use tamper-resistant prescription paper when writing a prescription for any drug for Medicaid recipients. |
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| The Texas Health and Human Services Commission (HHSC) requested an exemption to this regulation for its Medicaid providers. However, the federal Centers for Medicare and Medicaid Services (CMS) determined that it does not have the statutory authority to grant an exemption to federal law.
This regulation applies to all written prescriptions submitted for payment through the Vendor Drug Program (VDP) for all Texas Medicaid beneficiaries. The regulation does not apply to prescription orders transmitted to a pharmacy via telephone, fax, or electronically. According to CMS, the purpose of tamper-resistant prescription pads is to reduce instances of unauthorized, improperly altered, and counterfeit prescriptions.
In order for a written prescription to be considered tamper resistant by CMS, the prescription paper must meet the following three characteristics:
- Prevent unauthorized copying of completed or blank prescription forms.
- Prevent erasure or modification of information written on the prescription form.
- Prevent the use of counterfeit prescription forms.
The tamper-resistant requirement is only mandatory for prescriptions written for Medicaid clients. It is not a requirement for the Children’s Health Insurance Program (CHIP), Children with Special Health Care Needs (CSHCN) Services Program, or Kidney Health Care (KHC) program. If a client with both Medicaid and CSHCN eligibility presents a written, non tamper-resistant prescription to a pharmacy provider, the pharmacy may not bill CSHCN to circumvent the tamper-resistant pad regulation. HHSC encourages prescribers to adopt the use of tamper-resistant paper for all their patients. It will reduce their over-all risk and will avoid the confusion of determining which pad to use for which patient. |
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Schedule II Controlled Substances
CMS has determined that the prescription forms for Schedule II controlled substances, issued by the Texas Department of Public Safety (DPS) under the Texas Prescription Program, meet the baseline standards set forth above. Providers should continue using these pads for all prescriptions for Schedule II controlled substances. These pads should not be used to write prescriptions for non-Schedule II drugs.
Effective April 1, 2008, federal law requires Medicaid agencies to limit reimbursement for written (and non-electronic) prescriptions to only those executed on tamper-resistant pads. Prescribing practitioners should take necessary steps to ensure that tamper-resistant paper is used for all written or printed prescriptions provided to Medicaid clients, or that compliant, non-written alternatives are used for transmitting prescriptions, such as by telephone, fax, or electronic submittal. Pharmacies are required to ensure that all written Medicaid prescriptions submitted for payment to the Vendor Drug Program are written on a compliant tamper-resistant pad.
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Exceptions
Prescription orders transmitted to a pharmacy electronically, by telephone, or by fax are exempt from this requirement. Prescribing practitioners are encouraged to submit prescriptions through one of these approved processes whenever possible to ensure continuity of care and access to necessary medications for Medicaid recipients. The tamper-resistant requirement also does not apply to refills of a written prescription that was dispensed at a pharmacy before April 1, 2008. Please see the Questions and Answers (Appendix A)
for additional exemptions and exceptions. |
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Access to Care
The tamper-resistant prescription pad requirement is intended to reduce forged and altered prescriptions and deter drug abuse. It is not intended to restrict recipient access to medically necessary pharmaceuticals. If a Medicaid recipient presents with a non-compliant prescription, the pharmacist can obtain telephone verification from the prescriber and dispense the prescription in full (as written). The pharmacist must note the verification on the original written prescription. The pharmacist may also fill the prescription and obtain a compliant prescription by facsimile, electronic prescription, or re-written on tamper-resistant paper within 72 hours after the date the prescription was filled.
Any time a patient presents a written prescription and the pharmacist is unsure whether the prescription is compliant, the prescribing practitioner should be contacted for verification. See the NCPDP Guide of Summary Featues
Appendix B for a list of tamper-resistant features that are commonly available. To assist pharmacists in determining if a prescription is in compliance with the tamper-resistant requirements, prescribers are encouraged to purchase prescription paper that lists the security features. |
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Obtaining Prescription Pads
Prescribers may select their supplier of CMS-compliant prescription
pads. Information on available vendors may be obtained online by using a
keyword search of "secure prescription pads."
There are many compliant features available from security
prescription vendors. The National Council for Prescription Drug
Programs (NCPDP) has developed a guide to many of the available
features. Prescribers should refer to the NCPDP Guide of Summary Featues
(Appendix
B) before ordering tamper-resistant prescription pads or paper.
Pharmacists have voiced concerns about how to identify a
tamper-resistant prescription. HHSC encourages pharmacists to call the
prescriber every time they have a question. HHSC strongly encourages
all prescribers to order tamper-resistant prescription pads that clearly
list the security features. This will reduce the number of calls and
cause the least workflow disruption for both pharmacists and
prescribers.
The Texas Medical Association sent a message to physicians on
February 1, 2008. The notice is available on their website (www.texmed.org)
under the link "Tamper-Resistant
Rx Pads Required April 1." The notice also includes a consolidated
list of vendors of compliant pads.
In addition, some states such as California, Florida, Indiana,
Kentucky, Maine, West Virginia, and Wyoming currently have
tamper-resistant programs in place whereby they certify specific
printers for tamper-resistant prescription pads. These printers meet the
baseline requirements set by CMS. Links to printers approved by other
states are provided below:
- California:
- Florida:
- Maine:
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TRPP Compliance Referral Form
If you are a Vendor Drug contracted pharmacy and you believe the
Health and Human Services Commission's educational assistance may
benefit a prescriber’s compliance with the new federal law, please
download the Texas Medicaid
TRPP Compliance Referral Form. |
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| CMS Update - August 2008
The Centers for Medicare and Medicaid Services (CMS) previously stated that prescriptions printed from electronic medical records (EMRs) or ePrescribing applications would need special copy-resistant paper to be in compliance with the tamper-resistant prescription pad regulation. CMS has recently clarified this regulation and has stated that special copy-resistant paper is not a requirement for EMRs or ePrescribing generated prescriptions. These prescriptions may be printed on plain paper and will be fully compliant with all three categories of the tamper-resistant regulations, provided they contain at least one feature from each of the three categories.
The National Council for Prescription Drug Programs (NCPDP) has developed guidance and examples of best practices and examples
of
tamper-resistant prescriptions (handwritten and EMR generated). |
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| Additional Resources |
- U.S. Troop Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability Appropriations Act of 2007 (H.R. 2206), section 7002(b).
- Centers for Medicare & Medicaid Services (CMS) Letter to State Medicaid Director (SMDL #07-012, 8/17/2007).
- Centers for Medicare & Medicaid Services (CMS) Frequently Asked Questions Document published 9/13/2007.
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