As of April 1, 2008, written prescriptions for Medicaid recipients, with certain exceptions, must be written on prescription pads containing at least one tamper resistant feature. CMS has explained that "tamper resistant features" include features which:

Prevent unauthorized copying of a completed or blank prescription form;
Prevent the erasure or modification of information written on the prescription by the prescriber; or
Prevent the use of counterfeit prescription forms.

As of October 1, written prescriptions will need to contain one or more features designed to meet each of the three tamper resistance goals described by CMS. The precise means by which these features should be implemented, however, (for instance, watermarks or ink which shows "VOID" when the prescription has been copied) has been left to the discretion of the individual state Medicaid programs. Providers should consult their state authorities to determine which specific methods have been approved for the April 1 and October 1 deadlines.

Implementation History and Details
As part of the U.S. Troop Readiness, Veterans’ Care, Katrina Recovery, and Iraq Accountability Appropriations Act of 2007 (Public Law 110-28) Congress added a new paragraph to section 1903(i) of the Social Security Act (42 U.S.C. 1396b(i)) providing that "payment shall not be made" with respect to "amounts expended for medical assistance for covered outpatient drugs (as defined in section 1927(k)(2)) for which the prescription was executed in written (and non-electronic) form unless the prescription was executed on a tamper resistant pad."

Pub. L. No. 110-28 §7002. Originally, the law was to take effect October 1, 2007, but the TMA, Abstinence Education and QI Programs Extension Act of 2007, signed in September of 2007, extended that deadline until April 1, 2008. Pub. L. No. 110-90.

Importantly, the referenced definition of "covered outpatient drugs" specifically excludes any drug, biological product, or insulin provided as part of, or as incident to and in the same setting as, inpatient hospital services, hospice services, dental services (except in those circumstances where a state has authorized direct reimbursement for the drug to the dispensing dentist), physician services, outpatient hospital services, nursing facility services, services provided by an intermediate care facility for the mentally retarded, laboratory and x-ray services, and renal dialysis. 42 U.S.C. 1396r-8(k)(3).

CMS has also explained that the requirement will not apply to e-prescriptions, prescriptions transmitted to the pharmacy by facsimile, prescriptions communicated to the pharmacy (or confirmed by the pharmacy) by telephone, or where a managed care entity pays for the prescription. MLN Matters Number SE0736 (revised October 2, 2007). CMS’s focus in regard to these prescriptions appears to be on the patient’s contact with the prescription rather than the inclusion of electronic features – an electronic prescription which is printed out and handed to a patient for delivery to a pharmacy, for instance, must be printed on tamper resistant paper, whereas a written prescription on plain paper will be considered acceptable where the pharmacist contacts the prescriber and documents his or her verbal confirmation of the prescription. Further, prescriptions issued in institutional settings will be considered acceptable so long as "the patient never has the opportunity to handle [the] written order. "Frequently Asked Questions concerning the Tamper-Resistant Prescription Pad Law (Section 7002(b) of the U.S. Troop Readiness, Veterans' Care Katrina Recoverey and Iraq Accountability Appropriations Act of 2007," available at: www.cms.hhs.gov/DeficitReductionAct/30_GovtInfo.asp. It is important to note that a physician need not personally transmit prescription information to the pharmacy — CMS has explained that a nurse or administrative staff person who is authorized to act on the prescriber’s behalf may phone the pharmacy or send the prescription via facsimile or other electronic means.

Ober|Kaler’s Comments: Providers wishing for additional information regarding acceptable tamper resistant features, or with more specific questions regarding the applicability of the new requirements, should contact their state Medicaid authorities (keeping, as always, careful records of the instructions they receive). CMS has tasked each individual state with identifying acceptable tamper resistant features and has noted that seven states already require tamper resistant features which meet or exceed the new federal requirements.