Federal legislation fully effective October 1, 2008, required that 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.
As outlined by Centers for Medicare & Medicaid Services (CMS), to be considered tamper-resistant on April 1, 2009, a prescription pad must contain all three of the following 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; and (3) One or more industry-recognized features designed to prevent the use of counterfeit prescription forms.
Prescribers 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. Providers will need their prescriber’s state license number and a copy of their DEA Registration when they place their order.
The directory of approved companies can be found at www.ag.ca.gov/bne/security_printer_list.php.
The federal requirement does not apply to:
(A) E-prescriptions transmitted to the pharmacy;
(B) Prescriptions faxed to the pharmacy;
(C) Prescriptions communicated to the pharmacy by telephone by a prescriber;
(D) 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;
(E) 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;
(F) Drugs dispensed or administered directly to the recipient from or in the physician’s office or clinic;
(G) Emergency contraception dispensed by a pharmacist under protocol pursuant to section 4052.3 of the Business and Professions Code;
(H) Emergency fills, provided that the prescriber provides a verbal, faxed, electronic or compliant written prescription within 72 hours;
(I) 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;
(J) 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.
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.
Any questions or comments should be directed to: tgreen@greenassoc.com. Tracy Green is a principal at Green and Associates in Los Angeles, California. The firm has represented many Medi-Cal providers in compliance, administrative, qui tam, and criminal proceedings.
