By Michael Gallagher, IntelliSuite Technologies
In recent discussions with our business partners, such as the Huron Valley Physicians Association in Ann Arbor, Michigan, I learned that many practices around the country are experiencing a great deal of frustration complying with recent legislation requiring prescriptions to be issued on tamper-resistant paper. I decided to do some research and consolidate my findings in this article to help the practices we work with navigate through this maze. During my research, I was fortunate to have had a conversation with Stephen Singer, the president of Micro Format, Inc. in Wheeling, Illinois. Stephen proved to be a wealth of knowledge. Below is the most up-to-date information and a list of resources to help you gain a better understanding of the background, detail, and challenges of this legislation.
Background
Effective April 1, 2008, Medicaid requires all written prescriptions for outpatient controlled and over the counter drugs to be on tamper-resistant pads. Originally, the federal law was due to go into effect in October of last year. On August 17th of last year, the Centers for Medicare & Medicaid Services (CMS) issued a guidance document clarifying what constitutes “tamper-resistant” as well as related exemptions. Congress extended the date from October of last year to April 1, 2008 to allow for extra time for the guidelines to be made widely known and understood.
In summary; as of April 1st, prescriptions must contain at least one of the following three tamper-resistant characteristics, and by October 1st of 2008 must contain all three of these tamper-resistant characteristics:
1. One or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form.
Industry Recognized Features
- Void Pantograph Background (Hidden Message Technology)
- Reverse Rx Symbol
- Micro Printing
- Artificial Watermark on back of script
2. One or more industry-recognized features designed to prevent the erasure or modification of information written on the prescription by the prescriber.
Industry Recognized Features
- Colored Shaded Pantograph background
- Toner Grip Security Coating
- "Check and Balance" printed features such as: “Quantity" check boxes, and space to indicate "Number of Medications" written on prescription form
3. One or more industry-recognized features designed to prevent the use of counterfeit prescription forms.
Industry Recognized Features
- Security Feature Warning Box and Warning Bands
- Security Back Printing
- Coin Activated Ink
- Batch Number identification
- Secure Rub Color Change Ink
- Consecutive Numbering
Exemptions
The following exemptions have been defined by the CMS in the letter issued to State Medicaid Directors on August 17, 2007 (SMDL #07-012).
The tamper-resistant requirement does not apply to the following:
1. Written prescription refills presented to a pharmacy before April 1, 2008.
2. Prescription orders transmitted to a pharmacy electronically, by telephone, or by fax.
3. Prescriptions for patients in nursing homes and other facilities, where the patient does not handle the prescription directl
Compliance
The enforcement, definition, and interpretation of this legislation has been left up to each individual state. If you or your practice do not meet the exemptions listed above, you must understand your state’s interpretation of this law.
Compliant prescriptions can be issued on a prescription pad, laser printer, or thermal printer provided the paper and ink meet the industry-recognized tamper-resistant requirements defined by the federal legislation, the CMS, and your state. In my research, I found that most states are reluctant to certify or endorse any specific tamper-resistant paper vendors. Be sure that your vendor meets your state’s individual requirements before using their product.
States which adopted security requirements that meet or exceed the security measures defined by this law prior to the Medicaid legislation are not required to make changes to their current program. This includes California, Florida, Indiana, Kentucky, Maine, New Jersey, New York, West Virginia, and Wyoming.
States which now require all prescriptions to be formatted specifically as mandated by each respective state are: Louisiana, Massachusetts, Mississippi, Pennsylvania, and Texas.
Printer Considerations
Laser Printers: The majority of tamper-resistant paper I found in the market was 24# paper which is the same thickness as the paper used for printable checks. Standard printer paper is 20# paper. As long as you find a supplier that does not exceed the 24# weight, you should not run into any printer feeding or calibration issues. Heavier weighted paper may require you to have your printer recalibrated.
Laser printers with a second tray will become very helpful for this initiative. You can populate your second tray with tamper-resistant paper which will prevent an employee from changing paper every time you need to print prescriptions. The settings in your prescription software can be changed to print from the second tray as a default so you should not have any extra steps in the process of printing.
Before purchasing a new printer for your environment you should contact your practice management system, electronic medical record, and/or e-prescribe vendor to identify which printers and/or technologies they have certified and tested for their platforms. Printers have several methods of connecting to a network and it is important to understand what your infrastructure requires in order for a printer to function properly within your environment.
Thermal Printers: Thermal printers do not meet the tamper-resistant requirements for all states. Be sure to identify whether or not your state’s guidelines can be met by a thermal printer before investing in this technology.
Helpful Advice
Tamper-resistant features can be separated into two categories, overt (active) and covert (passive). Overt features are used to identify an original document by sight and/or touch. Covert features become apparent when a document is photocopied or scanned. Additional action is required to activate this feature.
Some of the technologies used in tamper-resistant paper are not always 100% effective. For example, an anti-copy watermark may not work with every copy machine so it is possible that this feature may not be recognized by your patient’s pharmacy. To avoid unnecessary phone calls between your practice and the pharmacies filling the prescriptions, it is a best practice to list the security features used somewhere on your prescription. I would also suggest that you use a supplier that uses multiple features to meet each of the three characteristics defined by this legislation.
Internet Resources
Centers for Medicare & Medicaid Services
http://www.cms.hhs.gov/Pharmacy/RX/list.asp - Information, policies, educational resources, legislative updates, and guidance regarding Federal legislation.
Micro Format, Inc. Websites
http://www.highsecuritypaper.com/Securitytechnologies.html - List and descriptions of tamper-resistant security technologies.
http://www.rxpaper.com/ - Tamper-resistant pads, laser paper, and thermal paper. Information regarding security features, legislative updates, frequently asked questions, pharmacy script validation, and state level security requirements.