October 24, 2019
Last Thursday, October 24, 2019, a Pennsylvania law went into effect concerning a provider’s duty to prescribe controlled substances electronically (i.e., e-prescribe). This e-prescribe requirement is mandated by Act 96 of 2018, signed into law in October 2018 as part of the state’s effort to combat the opioid epidemic. The intended purpose of this law is to minimize medication errors and reduce forgery, diversion and theft in Pennsylvania.
Pursuant to this law, all healthcare practitioners are required to issue electronic prescriptions for Schedule II-V controlled substances unless they meet one of the following eleven (11) statutory exceptions:
Prescriptions by a veterinarian;
E-prescribing is not available due to a temporary technological or electrical failure;
The dispensing pharmacy is located out of state;
The prescribing practitioner either does not have internet access or does not have an electronic health record system (“EHR”);
Prescriptions for patients treated in an emergency department or other health care facility where the practitioner reasonably believes that e-prescribing a controlled substance would be impractical for the patient or cause an untimely delay resulting in an adverse impact on the patient’s medical condition;
Prescriptions for a patient enrolled in a hospice program or residing in a nursing home or residential health care facility;
For compounded prescriptions and prescriptions containing certain elements required by the FDA or another government agency that are not able to be accomplished via e-prescribing;
Prescriptions pursuant to an established and valid collaborative practice agreement between a practitioner and pharmacist, a standing order or a drug research protocol;
Prescriptions issues in an emergency situation pursuant to federal or state law and regulations of the PA Department of Health;
The dispensing pharmacy is not set up to process electronic prescriptions; or
Prescriptions for controlled substances that are not required to be reported to the Prescription Drug Monitoring Program (“PDMP”) system administered by the PA Department of Health.
The PA Department of Health has published helpful guidance in the form of frequently asked questions (“FAQ”) (available here) to assist practitioners in determining whether they are required to comply with the e-prescribing mandate, and the specific elements necessary to meet the statutory exceptions. If a practitioner is subject to the e-prescribe mandate but is unable to comply, he/she may apply for a temporary exemption from the mandate based upon economic hardship, technical limitations or other exceptional circumstances. Practitioners are notified via electronic mail whether their exemption is approved. The PA Department of Health directs practitioners to allow the Department at least five (5) business days to respond, which time-frame may be extended based on the volume of requests received. If the practitioner is approved for the exemption, such exemption will expire one (1) year after the date of approval and the practitioner will be required to re-apply for the exemption on an annual basis, as needed.
For those practitioners that do not meet a statutory exception and are not approved for an exemption, failure to comply with the e-prescribe mandate comes with administrative penalties in the amounts of: (1) $100 per violation for the first through tenth violations, and (2) $250 per violation for the eleventh and any subsequent violations, up to a maximum cumulative fine per calendar year of $5000. On a positive note, the assessment of any such penalties will not be reported, and need not be self-reported, to the practitioner’s licensing board, nor will they be considered a disciplinary action.
If you are unsure whether you are subject to this new e-prescribing mandate, would like assistance applying for an exemption, or simply want to better understand your prescribing duties moving forward, please contact our firm.