Beginning on October 24, 2019, every licensed health care practitioner in Pennsylvania (excluding veterinarians) will be required to electronically prescribe controlled substances (regardless of the dosage) by sending the prescription directly to a pharmacy via the Internet. Faxes will not qualify as an electronic transmission under the Law.
The primary goals of Act 96 of 2018, passed by the Pennsylvania General Assembly on October 24, 2018 (the “Law”), are to fight the opioid epidemic by using electronic prescriptions to minimize medication errors, and reduce prescription forgery, diversion and theft. However, to be clear, this law requires practitioners to issue electronic prescriptions for all controlled substances, not just opioids.
There are a number of exceptions to the Law, including, but not limited to, the following:
- Prescriptions for drugs dispensed by a pharmacy outside of Pennsylvania;
- Prescriptions for drugs dispensed by the practitioner in-office;
- Where there are temporary technological or electrical failures, provided that the practitioner seeks to correct any issue that is reasonably within his or her control within 72 hours;
- By a practitioner or health care facility that does not have either internet access or an electronic health record system;
- By a practitioner treating a patient in an emergency department or a health care facility when the practitioner reasonably determines that electronically prescribing a controlled substance would be impractical for the patient to obtain the controlled substance by electronic prescription or would cause an untimely delay resulting in an adverse impact on the patient’s medical condition; and
- By a practitioner who has obtained a temporary exemption from the Law.
A practitioner or health care facility that does not meet an exception to the Law and is unable to timely comply with the electronic prescribing requirements may apply for a temporary exemption from the requirements based on economic hardship, technical limitations or exceptional circumstances. The exemption will expire one year after it is issued or the date on which final electronic prescription regulations are issued by the PA Department of Health (whichever is earlier). The application for temporary exemption may be completed electronically at this link: E-Prescribing Temporary Exemption Application
To comply with the Law, a practitioner must use an electronic health record (EHR) system or similar software that:
(1) provides the capability to create an electronic prescription and send it to a pharmacy; and
(2) is certified by the DEA as meeting the federal security requirements for electronic prescribing of controlled substances (for further information, see this link: DEA E-Prescribing Software Requirements).
Penalties for violating the Law are $100 per violation for the first 10 violations and $250 per violation thereafter, with a $5,000 per year cap.
Practitioners must document in the patient’s medical record when the practitioner is unable to electronically prescribe a controlled substance for the patient in any of the following scenarios:
(1) a technological or electrical failure;
(2) circumstances where an electronic prescription would cause an untimely delay resulting in an adverse impact on the patient’s medical condition;
(3) where the pharmacy that receives the prescription is not set up to process electronic prescriptions; or
(4) when transmission of the electronic prescription failed (in which case another can be submitted).
The PA Department of Health is required to issue regulations in connection with the Law by April 22, 2019. FAQs regarding the Law can be found online at the following link: E-Prescribing FAQs
Stay tuned to Fox Rothschild’s Physician Law Blog for further details. If you have any questions regarding how the Law will affect your practice, please feel free to contact us.