As regulatory scrutiny intensifies around the dispensing of controlled substances, pharmacies, pharmacists, and prescribers must stay vigilant to avoid compliance pitfalls. The Drug Enforcement Administration (DEA) and state agencies are following a trend of increasingly strict oversight into various aspects of controlled substances, including prescription transfers and reimbursement.
DEA Red Flags and Compliance Considerations
The DEA has outlined numerous red flags that pharmacies and prescribers must recognize to prevent the diversion of controlled substances. The Federal Controlled Substances Act requires prescribers to issue prescriptions for a controlled substance for a legitimate medical purpose in their usual course of practice. Pharmacies have a corresponding responsibility to ensure that these prescriptions are issued for a legitimate purpose, complying with both federal and state requirements. These red flags, as detailed in the DEA’s guidance include:
- Patients traveling long distances to fill prescriptions
- Prescriptions for highly abused medications in excessive quantities
- Multiple patients receiving the same prescriptions from the same provider
- Cash payments for controlled substances
- Patterns of early refills or doctor shopping
Failing to identify and act on these warning signs can result in DEA audits, fines, and legal action. Our legal team assists pharmacies in developing and implementing compliance programs, conducting internal audits, and developing policies aligned with DEA expectations.
Challenges in Electronic Prescription Transfers
State boards of pharmacies have nuanced requirements for permissible prescription transfer protocols. For example, some states may require confirmation of the transfer, whether through facsimile transmission of the original prescription or verbally confirming the contents of the prescription. Pharmacists must be aware not only of these state requirements, but also of applicable federal rules and updates thereto.
On June 16, 2024, the Centers for Medicare & Medicaid Services announced an update to the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard for the electronic transmission of prescription drugs. A notable difference between these versions is that current version 2017071 does not support the transfer of electronic controlled substance prescriptions while the updated 2023011 version does. As of January 1, 2028, the updated NCPDP SCRIPT standard will be required for electronic prescribing of prescription drugs for Medicare Part D eligible beneficiaries.
With states adopting NCPDP SCRIPT standards, conflicts can arise for pharmacies adhering to current NCPDP SCRIPT standards that may not enable compliance with state rules. For example, the Washington Pharmacy Quality Assurance Commission issued a position statement indicating that the Commission will not take action against, or find licensees deficient for, failing to timely transfer an electronic prescription for initial dispensing of a controlled substance (in accordance with state rules) if the failure results from the licensee’s use of NCPDP SCRIPT standard version 2017071. Upon request, however, pharmacies must demonstrate their timeline for adopting 2023011.
This example highlights the importance of adhering to both state and federal regulations, especially with regards to electronically transferring controlled substance prescriptions. Pharmacies must update their systems to keep pace with evolving requirements while ensuring regulatory compliance. Even where federal law does not require compliance before a specified date, state boards of pharmacy may require pharmacies to have a plan of action in place for adoption of updated standards. Further, states may impose heightened standards for prescription transfers of controlled substances beyond what is mandatory at a federal level.
States May Impose Additional Limitations for Controlled Substance Prescriptions
Following increasing scrutiny of excessive prescribing of controlled substances, states are recognizing the dangers of overdose, death, and other negative physiological effects associated with benzodiazepines. Idaho Medicaid imposes additional oversight on dispensing of benzodiazepines, including for high risk benzodiazepines such as alprazolam (Xanax). Recognizing the dangers of overreliance, Idaho Medicaid limits new fills of benzodiazepines to 14 days. In the near future, the state will also require prior authorization for all benzodiazepine prescriptions. Pharmacies and prescribers must remain apprised of heightened standards for certain controlled substances and implement appropriate procedures to ensure compliance.
Frier Levitt regularly assists pharmacies navigate state-specific Medicaid requirements, ensuring proper documentation and adherence to prior authorization protocols. While pharmacies can offer support to prescribers to streamline the prior authorization process, there are numerous regulatory considerations to navigate in the provision of these services.
How Our Law Firm Can Help
For pharmacies, pharmacists, and prescribers, understanding and adhering to an evolving web of federal, state and payor rules and requirements is essential to mitigating legal liability, maintaining licensure, and serving patients effectively. Frier Levitt offers regulatory guidance to assist clients with DEA and state-specific compliance, including implementing appropriate training and policies to adhere to DEA red flag policies as well as controlled substance prescription transfer protocols. Contact us to learn how we can assist you in navigating the increasing scrutiny on controlled substances and focus on delivering quality patient care.
