Commonwealth of Massachusetts Executive Office of Health and Human Services Office of Medicaid 600 Washington Street Boston, MA 02111 www.mass.gov/masshealth MassHealth All Provider Bulletin 174 April 2008 TO: All Providers Participating in MassHealth FROM: Tom Dehner, Medicaid Director RE: Massachusetts Implementation of Tamper-Resistant Prescription Requirements Background This bulletin updates information in All Provider Bulletins 167 and 168 (issued September and October 2007, respectively) as it relates to tamper-resistant prescription requirements that are being phased in this year. Immediate Effective April 1, 2008, the Centers for Medicare & Medicaid Services (CMS) require Requirements that all Medicaid prescription blanks incorporate at least one of the characteristics below. To be considered tamper-resistant after October 1, 2008, prescription blanks must include all three of the following characteristics: • one or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form; • one or more industry-recognized features designed to prevent erasure or modification of information written on the prescription by the prescriber; and • one or more industry-recognized features designed to prevent the use of counterfeit prescription forms. MassHealth met with representatives from pharmacy and medical organizations to develop the characteristics of a tamper-resistant blank that would meet the federal requirements and be easily used by all providers. Based on discussions with that group, MassHealth suggests including the following features. CMS Characteristics MassHealth Suggested Features prevent unauthorized copying of a completed or blank prescription form use of a latent, repetitive, printed word “VOID” that will appear across the front of the prescription if it is scanned or photocopied. This feature must be patterned in such a way as not to obscure prescribing information prevent erasure or modification of information written on the prescription by the prescriber erasure protection, such that the prescription has a background that resists alteration and erasure (e.g., special security paper) prevent the use of counterfeit prescription forms a heat-sensitive feature that will either change color or disappear and then reappear when rubbed (e.g., sensing imprint or thermochromic ink) (continued on next page) Immediate In addition, MassHealth recommends including a warning band that describes the Requirements security features on the prescription to make it easier for pharmacists to notice that (cont.) your prescription is tamper resistant. Prescriptions must also continue to meet all other requirements of federal and state laws and regulations. Updated In All Provider Bulletin 167 (September 2007), MassHealth listed sequentially Information numbered, duplicate, or triplicate blanks as a feature to prevent the use of counterfeit prescription forms. According to CMS, sequentially numbered prescriptions or duplicate blanks, in and of themselves, do not meet the standard for tamper-resistance. That solution works only if the number ties back into a central registry that is reported to, or maintained by, the state (such as in New York state). Massachusetts does not maintain such a registry, and we have taken steps to alert hospital-based prescribers to the CMS directive. Computer-Generated MassHealth has received requests for additional guidance on computer-generated Prescriptions prescriptions using sequentially numbered blanks and barcodes to meet the tamper- resistant requirements. After a recent discussion with CMS, MassHealth has approved the following features to satisfy the April 1, 2008, deadline for a single- characteristic tamper-resistant prescription requirement. Feature Description quantity border and fill (for computer- generated prescriptions on paper only) Quantities are surrounded by special characters, such as an asterisk, to prevent alteration, e.g. QTY **50**. Values may also be expressed as text, e.g., (FIFTY). refill border and fill (for computer- generated prescriptions on paper only) Refill quantities are surrounded by special characters, such as an asterisk, to prevent alteration, e.g. QTY **5**. Values may also be expressed as text, e.g., (FIVE). quantity check-off boxes In addition to the written quantity on the prescription, quantities are indicated in ranges. It is recommended that ranges be in increments of 25, with the highest range being “151 and over.” The box corresponding to the quantity prescribed MUST be checked for the prescription to be valid. CMS recently provided updated information that may be of value to health facilities or others using tamper-resistant paper. The update is accessible at http://www.cms.hhs.gov/DeficitReductionAct/Downloads/TamperUpdate.pdf. Purchasing Tamper- MassHealth does not plan to endorse specific suppliers of tamper-resistant blanks. Resistant Blanks The Massachusetts Medical Society, however, has listed some Web sites to help providers find vendors for tamper-resistant blanks at www.massmed.org/rx. (continued on next page) Exceptions to the Exceptions to the tamper-resistant requirements include prescriptions that are: Tamper Resistant Requirements Emergency Fills Emergency fills are allowed as long as a prescriber provides the pharmacy with a compliant prescription in writing or by telephone, fax, or e-prescription, within 72 hours. For a Schedule II medication, a written prescription must comply with state and federal law. If a prescription is written on a non-tamper-resistant prescription blank, the pharmacist may contact the prescriber and verify the prescription, recording the authentication in writing on the back of the prescription, in order to meet the tamper- resistant requirements. Additional The Centers for Medicare & Medicaid Services (CMS) has a list of frequently Resources asked questions about the tamper-resistant prescription requirements. All information in this document remains relevant, except for the effective date, which is now April 1, 2008. This list is accessible at http://www.cms.hhs.gov/DeficitReductionAct/Downloads/MIPTRPFAQs9122007.pdf Questions If you have any questions about the information in this bulletin, please contact MassHealth Customer Service at 1-800-841-2900, e-mail your inquiry to providersupport@mahealth.net, or fax your inquiry to 617-988-8974. • submitted electronically, verbally, or via fax; • reimbursed through a MassHealth managed care organization (MCO); • for drugs reimbursed as part of a bundled rate; or • refilled when the original prescription was filled before April 1, 2008.