CMS Regulations: The Mandate for Secure Prescription Solutions

Most recently The Centers for Medicaid and Medicare Services (CMS) created a new set of regulations to combat the estimated $5 billion in annual prescription fraud throughout the United States, requiring tighter security for prescriptions written to Medicaid beneficiaries. The new CMS Regulations call for secure prescriptions which are unable to be copied, altered and counterfeit.

On October 1, 2008, the second phase of the tamper-resistant prescription law went into effect. The regulations require that all handwritten and/or computer generated printed prescriptions for Medicaid patients are fully compliant with federal and/or state guidelines for prescription tamper-resistance. While the first phase of the regulations, which has been in place since October 2007, required prescribers to use only one feature from only one of the three categories of tamper-resistance, the second phase mandates that prescriptions are to have at least one industry-recognized feature from each of the three categories of tamper resistance. No one feature may be counted twice.

A letter went out to the State Medicaid Directors in August of 2007 stating that the following were the three characteristics that each prescription must contain:

1. One or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form
2. One or more industry-recognized features designed to prevent the erasure or modification of information written/printed on the prescription by the prescriber
3. One or more industry-recognized features designed to prevent the use of counterfeit prescription forms

While the law specifies the term "prescription pad," CMS stated that these requirements are also applicable to prescriptions printed electronically. The regulation requires that each prescription must be secure - not that the paper must be secure.

On June 26, 2008, the National Council for Prescription Drug Programs (NCPDP) held an industry forum where all segments of the industry impacted by the new regulations were represented. Attendees were invited to take part in a review of the implementation of phase two regulations and a discussion of the next steps necessary to ensure a smooth transition. The following is a summary of the features that have been identified as best practices for implementation of the three categories. Prescriptions for Medicaid patients that are telephoned, faxed or e-prescribed are exempt from these requirements.

Operating under tight deadlines, healthcare providers have scrambled to comply with the new regulations, employing a variety of approaches that range in technological sophistication, cost, and convenience.  While many healthcare facilities are focused on moving toward e-prescribing they are looking for ways to print the exception items to a secure document while complying with CMS regulations.   TROY SecureRx solutions provide they capability. 

The TROY SecureRx prescription printing solutions provides the capacity to print security features from all three of the categories:  Copy Resistant, Erasure/Modification Resistant, and Counterfeit Resistant.  All of this while virtually eliminating burden on staff and reducing printing cost.   TROY SecureRx, a prescription printer, is equipped with security software and hardware that can easily integrate with an existing electronic medical records (EMR) system to produce prescriptions.

Rockingham Memorial Hospital (RMH) currently utilizes the TROY SecureRx Solution in their Emergency Department, which has helped to reduce supply cost and eliminate service calls.  Many area pharmacies have complimented the new format and easy-to-evaluate security features, according to RMH Pharmacy Coordinator of Informatics and Technology.   RMH will be expanding their use of SecureRx to other areas of the hospital.  Full Case Study is Available:  Rockingham Memorial Hospital Uses TROY SecureRx to Achieve Cost Effective CMS Compliance.

What is CMS?

The Centers for Medicaid and Medicare Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS).   The responsibilities of CMS extend beyond Medicaid and Medicare programs, this government agency has responsibilities for CHIP (Children's Health Insurance), HIPPA (Health Insurance Portability and Accountability Act), CLIA (Clinical Laboratory Improvement Amendments), as well as several other programs.