Tamper-Resistant Prescription Pads Requirement

New federal legislation requires that effective April 1, 2008, in order for Medi-Cal outpatient drugs to be reimbursable by the federal government, all written, non-electronic prescriptions must be executed on tamper-resistant pads. The tamper resistant prescription pad requirement applies to all outpatient drugs, including over-the-counter drugs. It also applies whether Medi-Cal is the primary or secondary payer of the prescription being filled. This new law impacts all physicians, dentists, optometrists, nurse practitioners and other providers who prescribe outpatient drugs.

Section 7002(b) of the U.S. Troop Readiness, Veterans’ Care, Katrina Recover, and Iraq Accountability Appropriations Act of 2007 signed into law on May 25, 2007 required implementation of the tamper-resistant pad requirement effective October 1, 2007. However, on September 29, 2007, President Bush signed the “Transitional Medical Assistance, Abstinence Education, and QI Programs Extension Act of 2007,” delaying the implementation date for all paper Medicaid prescriptions to be written on tamper-resistant paper until April 1, 2008.

The Centers for Medicare & Medicaid Services (CMS) has issued guidance to the States on implementing the new federal requirement. This guidance allows for compliance with the tamper-resistant prescription pad requirement to occur in two phases. For the first phase, a prescription will have to contain at least one of the three characteristics outlined below by April 1, 2008, in order to be considered “tamper-resistant”. All three characteristics are required by October 1, 2008.

All guidance CMS has issued on this requirement can be found on the CMS Web site.

As outlined by CMS, to be considered tamper-resistant on April 1, 2008, a prescription pad must contain at least one of the following three characteristics:

1. One or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form;
2. One or more industry-recognized features designed to prevent the erasure or modification of information written on the prescription by the prescriber; or,
3. One or more industry-recognized features designed to prevent the use of counterfeit prescription forms.

By October 1, 2008, to be considered tamper-resistant, a prescription pad must contain all of the foregoing three characteristics.

The federal requirement does not apply to:

• E-prescriptions transmitted to the pharmacy;
• Prescriptions faxed to the pharmacy;
• Prescriptions communicated to the pharmacy by telephone by a prescriber;
• Transfer of a prescription between two pharmacies, provided that the receiving pharmacy is able to confirm by facsimile or phone call the authenticity of the tamper-resistant prescription with the original pharmacy;
• Written orders prepared in an institutional setting (which include Intermediate Care Facilities and Nursing Facilities), provided that the recipient never has the opportunity to handle the written order and the order is given by licensed staff directly to the dispensing pharmacy;
• Drugs dispensed or administered directly to the recipient from or in the physician’s office or clinic;
• Emergency contraception dispensed by a pharmacist under protocol pursuant to section 4052.3 of the Business and Professions Code.
• Written prescriptions dispensed to Medi-Cal recipients who become retroactively eligible after April 1, 2008, provided the prescription was filled on or after April 1, 2008, and before the recipient became retroactively eligible for Medi-Cal.
• Emergency fills, provided that the prescriber provides a verbal, faxed, electronic or compliant written prescription within 72 hours;
• Refills of written prescriptions presented at a pharmacy before April 1, 2008;
• Written prescriptions paid for by Medicare, a Medicare Part D plan or Medicare Advantage Plan, unless Medi-Cal fee-for-service is a secondary payer. Excluded drugs paid for by Medi-Cal must be executed on a tamper-resistant pad, or;
• Prescriptions paid for by Medi-Cal managed care entities as defined by 1932(a)(1)(B), provided that the drug is not carved out. Written prescriptions for drugs carved out of managed care must be executed on a tamper-resistant pad.

As noted above, pursuant to Section 1903(i), prescriptions paid for by managed care entities as defined by Section 1932(a)(1)(B) of the Social Security Act are exempt from this requirement. With the exception of Health Plan of San Mateo (HPSM), written prescriptions for COHS plans (CalOptima, Santa Barbara Health Initiative, Partnership Health Plans and Central Coast Alliance for Health) must comply with the tamper-resistant prescription pad requirements pursuant to the definition of managed care entities in Section 1932(a)(1)(B).

A prescriber may not know when fee-for-service is the secondary payer to private insurance or if a prescribed drug is carved out of managed care; therefore, Department of Health Care Services (DHCS) recommends that prescribers use tamper resistant prescription pads for all Medi-Cal recipients.

Prescription drugs provided to Family PACT Program enrollees and to Medi-Cal recipients through the California Children’s Services (CCS) and Genetically Handicapped Persons Programs (GHPP) meet the federal definition of a covered outpatient drug. Therefore, prescriptions written for recipients in these programs must also comply with the tamper-resistant prescription pad requirement.

Per CMS guidance, pharmacies that are presented with a Medi-Cal prescription on a non-tamper-resistant prescription pad may satisfy the federal requirement by calling the provider’s office and verbally confirming the prescription with the physician or prescriber. The pharmacy shall document on the original non-compliant prescription form that such communication and confirmation has taken place.

The California-required tamper-resistant prescription pads for controlled drugs fully meet the October 1, 2008 federal compliance requirements under the new Medi-Cal requirement. Therefore, prescribers are encouraged to use the current pads in order to fulfill the new federal law, and may order tamper-resistant prescription pads from security prescription printer companies that have been pre-approved to produce the forms by the California Department of Justice and Board of Pharmacy. The directory of approved companies can be found at www.ag.ca.gov/bne/security_printer_list.php. This directory provides an alphabetical listing of companies and is updated as new security prescription printers are approved. Providers will need their prescriber’s state license number and a copy of their DEA Registration when they place their order. Other security prescription printer companies are available and may be used as needed.

Reminder:

To comply with California statute, regardless of how a provider chooses to procure tamper-resistant prescription pads for all other written Medi-Cal prescriptions, providers must continue to procure tamper-resistant prescription pads for controlled drugs from the list of approved security prescription printer companies.