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New Medicaid Regulation for Tamper-Resistant Prescription Pads

Effective April 1, 2008, all Medicaid prescriptions must be written on pads that contain at least one industry-recognized feature to prevent copying, erasing, or counterfeiting. By October 1, 2008, all prescription pads must prevent all three forms of tampering.

As of April 1, 2008,  an amendment to 42 U.S.C. § 1396(b)(i) requires that all written, nonelectronic prescriptions must be issued on “tamper-resistant” prescription pads.

The amendment applies to Medicaid prescriptions for covered outpatient drugs. Under Section 7002(b) of the federal law 110-28, all Medicaid prescriptions must be written on “tamper-resistant” prescription pads in order to be eligible for pharmacy reimbursement.

The provision, enacted to reduce government spending on fraudulent prescriptions, is intended to make it more difficult for patients to obtain controlled drugs illegally. The Centers for Medicare and Medicaid Services (CMS) has outlined the characteristics of tamper-resistant prescription pads. Each State will define which features it will require to meet these characteristics in order to be considered tamper-resistant. To be considered tamper resistant on April 1, 2008, a prescription pad must have 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. [Note: an example might be a high-security watermark on the reverse side of the prescription or thermochromic ink with a latent void pattern printed on the front of the prescription; if it is copied, the word “void” will appear across the entire front of the prescription.]
  2. One or more industry-recognized features designed to prevent the erasure or modification of information written on the prescription by the provider (such as tamper-resistant background ink that shows erasures or attempts to change the written information).
  3. One or more industry-recognized features designed to prevent the use of counterfeit prescription forms (by using duplicate or triplicate forms or sequential numbered blanks).

A prescription pad will be required to have all three characteristics by October 1, 2008. CMS encourages the use of e-prescriptions and has made them an exception, along with prescriptions communicated by telephone by a prescriber and prescriptions faxed to the pharmacy. (Some prescriptions, however, are not allowed to be faxed because the Drug Enforcement Administration classifies them as controlled substances.)

Several states have laws and regulations concerning mandatory, tamper-resistant prescription pad programs. CMS deems that the tamper-resistant prescription pad characteristics required by these States’ laws and regulations meet or exceed the baseline standard.

The following states are included:
  • California
  • Florida
  • Idaho (has only one of the three characteristics)
  • Indiana
  • Kentucky
  • Maine
  • New Jersey
  • New York
  • Wyoming

CMS provided clarification to several state Medicaid programs about certain specific tamper-resistant prescription features. CMS will require computer generated prescriptions, including those from electronic medical records, be printed on paper that contains one or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form. In a letter from CMS to State Medicaid Directors, emergency fills are allowed as long as a prescriber provides a verbal, faxed, electronic, or compliant prescription within 72 hours after the date on which the prescription is filled. The AMA and others sought congressional legislation to delay implementation. On July 18, 2007, the Patient and Pharmacy Protection Act of 2007 was introduced in the U.S. House of Representatives. The bill, which would limit the prescription pad requirement only to Schedule II controlled substances, would help mitigate problems with the new prescription writing law. However, this legislation is not likely to delay the October 1 implementation of the existing legislation.

The requirement does not apply:
  • When the prescription is electronic, faxed, or verbal; (CMS encourages the use of e-prescribing)
  • When managed care entity pays for the prescription;
  • To refills of written prescriptions presented to the pharmacy before April 1, 2008;
  • In most situations when drugs are provided in nursing facilities, intermediated care facilities for the mentally retarded, institutions for mental disease, and certain other institutional and clinical facilities.
For additional information on this new requirement, click on the following links:

 

The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each health care provider in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.