Beginning October 24, 2019, pursuant to Act 96 of 2018 (“Act”), every licensed health care practitioner in Pennsylvania will be required to electronically prescribe controlled substances by sending the prescription directly to a pharmacy via the Internet. The Act replaces the traditional method of prescribing controlled substances to a patient, i.e. paper prescription pads.
The primary goal of the Act is to combat the opioid epidemic by using electronic prescriptions to reduce medication errors and minimize the chances of prescription forgery, diversion, and theft. To comply with the Act, a practitioner must use an electric health record (“EHR”) system or similar software that:
- Provides the capability to create an electronic prescription and send it to a pharmacy; and
- Is DEA federal security-certified for electronic prescribing of controlled substances.
There are a number of exceptions to the Act, including, but not limited to:
- Controlled substance prescriptions for drugs dispensed by a physician in their office;
- Practitioners or health care facilities that do not have either Internet access or an EHR; and
- Practitioners treating patients in the emergency room or a health care facility when the practitioner reasonably determines that electronically prescribing a controlled substance would be impractical or cause an untimely delay resulting in an adverse impact on the patient’s medical condition.
A practitioner or health care facility that does not meet an exception to the Act can apply for a temporary exemption from the law’s requirements based on economic hardship, technical limitations or exceptional circumstances. The exemption expires one year after it is issued or the date on which final electronic prescription regulations are issued by the Pennsylvania Department of Health (“Department”) (whichever is earlier)[1]. The Department estimates it will take a minimum of ten business days to render a decision on an exemption application, though the time period could be longer depending on the number of requests.
Practitioners must document in the patient’s medical record when they are unable to electronically prescribe a controlled substance for the patient in any of the following scenarios:
- Technological or electrical failure;
- Circumstances where an electronic prescription would result in an untimely delay causing an adverse impact on the patient’s medical condition;
- Pharmacy is not set up to process electronic prescriptions; and
- Transmission of electronic prescription failed (in which case another can be submitted).
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. [2]
The Act’s obligations should not be viewed as cumbersome in this day and age of widespread Internet access. The Act will better protect practitioners from unscrupulous patients and employees attempting to divert controlled substances through fraudulent prescriptions. It also will help practitioners keep better records of their controlled substance prescriptions.
Practitioners should ensure their timely compliance with the Act. Law enforcement continues to aggressively enforce controlled substance prescription laws and is less inclined in the current opioid epidemic climate to allow any flexibility for violators of this type of law. Those not yet in or near compliance with the Act should expedite measures to do so, or promptly contact the Department about obtaining an exemption.
The Grail Law Firm has extensive experience representing medical professionals and health care facilities in federal and state criminal and regulatory actions involving controlled substance prescription issues. Feel free to contact us to discuss how the Act will affect your practice and related compliance issues.
[1] The Department is required to issue regulations by April 22, 2020.
[2] The Department has provided a quick reference document for more information on the Act – See Electronic Prescribing of Controlled Substances FAQs – https://www.health.pa.gov/topics/Documents/Programs/FINAL_EPCS_Public%20FAQ_9-5-2019.pdf.
