Frequently Asked Questions

Q: How do I ensure that my prescriptions will meet the "baseline characteristics" for tamper-resistant pads required by CMS?

A: The security features included in our program meet or exceed all CMS standards.

Q: Will CMS publish a list of approved vendors that print prescription pads on compliant, tamper-resistant paper?

A: No. As long as the prescription pads meet the requirements of the guidance in the SMD Letter, providers are free to choose whatever vendor they wish.

Q: Does the requirement of the use of an ink pen satisfy the second characteristic set forth on page two of the SMD Letter (i.e., a feature that "prevents the erasure or modification" of information on a prescription)?

A: No, it does not. Ink can be erased and modified, and in part for those reasons, the use of an ink pen is not an industry recognized standard.

Q: Who will be responsible for ensuring that there is compliance with the requirements of section 7002(b)?

A: Primary responsibility for auditing Medicaid providers rests with the states. However, there are some circumstances in which CMS, the Office of the Inspector General of the U.S. Department of Health & Human Services, or some other Federal agency may have occasion to audit a pharmacy provider. When that occurs, the Federal agency will have authority to determine compliance with section 7002(b).

Q: Are there exceptions to the new tamper-resistant rules?

A: Yes. These requirements are exempted when the prescription is sent by the prescriber electronically, verbally or by fax; when a managed care entity pays for the prescription; or when drugs are provided in certain institutional and clinical facilities. The requirements also allow emergency fills as long as the prescriber provides a verbal, faxed, electronic or compliant written prescription within 72 hours.