PA Electronic Prescription Requirement for Controlled Substances Takes Effect

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:

  1. Provides the capability to create an electronic prescription and send it to a pharmacy; and
  2. 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:

  1. Technological or electrical failure;
  2. Circumstances where an electronic prescription would result in an untimely delay causing an adverse impact on the patient’s medical condition;
  3. Pharmacy is not set up to process electronic prescriptions; and
  4. 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.

Authorities’ Use of Big Data May Harm—or Help—Your Chances of Investigation

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Attorney Efrem M. Grail shares strategies to help protect your practice in Practical Pain Management this month

As pain practitioners well know, two recent developments – one federal, one state – have combined to increase the risk of providers being investigated for prescribing opioids for their patients. The federal government has formed special task forces to focus on this matter while state governments are increasingly requiring controlled substance prescription reporting by physicians and authorized DEA registrants. Many of the prosecutions arising from these investigations will have merit; some will not. With so much emphasis now placed on diversion, misuse, and abuse, some very well-meaning doctors, who may be less than careful with their documentation or prescribing habits, are bound to be swept up in this ongoing battle against opioids. To avoid becoming a subject of an investigation, now is the time to understand the increased risk and protect your practice.

This is an excerpt from the September 2018 issue of Practical Pain Management. Read the full article here.

Stay out of Opioid-Related Prescription Trouble

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Practitioners must take significant precautions to prevent diversion of prescription narcotics and other controlled substances they prescribe and dispense in light of the increased federal law enforcement initiatives.

In an effort to stem the nationwide opioid abuse epidemic, last summer the Justice Department set up task forces in eleven different geographic regions headed up by specially-funded, full-time Assistant U.S. Attorneys dedicated to “investigating and prosecuting health care fraud related to prescription opioids, including pill mill schemes and pharmacies that unlawfully divert or dispense prescription opioids for illegitimate purposes.”

These task forces, headquartered in Florida, Michigan, Alabama, Tennessee, Nevada, Kentucky, Maryland, Pennsylvania, Ohio, California, North Carolina, and West Virginia are supported by federal agents from, primarily from the Drug Enforcement Agency (DEA) and the Office of the Inspector General for the Department of Health & Human Services.

In announcing the new program’s roll-out, Attorney General Jeff Sessions referenced a new “data analytics program” to identify physicians “writing opioid prescriptions at a rate that far exceeds their peers…”  In conjunction with stepped-up requirements for prescribers through next-day narcotic reporting through state-run websites, these federally-funded and supported enforcement task force have already come after physicians and other

DEA registrants who do not adequately prevent diversion of scheduled narcotics through their medical practices.Here are six more tips on how to keep from becoming caught up in the government’s newly-energized enforcement initiative.  They should strike every medical practitioner as self-evident — none of this is rocket science.  But every one of them is based on some enforcement action where a medical professional faced the prospect of state board discipline, loss of DEA registration, or worse.

1. Be aware of “frequent flyer” pharmaceutical consumers, especially those of scheduled substances and narcotics.

If a patient presents with the need for an amount of drugs that, under the circumstances, is “consistent with a readily-diagnosable condition,” consider if she should be referred to a pain management clinic or other specialist.  Otherwise, protect yourself by documenting in the patient’s file why the treatment would be recognized as proper by “a responsible segment of the medical profession,” as regulations most states and the federal government require.

2. When it comes to dangerous drugs, especially narcotics, practice medicine defensively.

While a physician should not automatically distrust a patient, experience teaches that they don’t always tell the truth. Not everyone you see in your medical practice always acts in good faith.  The life you save could be theirs, but the career you save is your own.

3. If a request for narcotics, from anyone — including from another physician — sounds suspect, it probably is.
When you get a request for a narcotics prescription — even if from a trusted colleague, friend, or family member — and it sounds suspicions, it probably is.  Fellow practitioners, medical professionals, and loved ones are not immune from addiction and misuse.  A large minority of enforcement proceedings against practitioners involve diversion to colleagues, friends and family whom the doctors know and trust.

4. Avoid the “Holy Trinity” at all costs.

Everyone has a pet peeve and all diversion enforcement agents share the same one: practitioners who prescribe Oxycodone or Hydrocodone, along with Soma and Xanax (or other drugs from their classes) together.  If you have justifiable medical reasons to prescribe a drug from each of these three categories of controlled substances simultaneously, be certain to document your reasons each and every time you write the prescriptions.  Be certain you have entered the drug orders into the state Prescription Drug Monitoring Program as required.  If scripts aren’t medically necessary, don’t write them, regardless of patient pressure.

5. Be attuned to “Red Flag” prescribing situations.

There are other “hot buttons” for the prescription police to watch out for: doctors who write scripts for the same or similar opioids in the same quantities for large numbers of patients, often on the same day or in the same week, patients who routinely travel long distances just to see you, especially when other, closer clinics closer to them could be consulted, patients arriving in the waiting room as a group, but who act as if they don’t know each other, and prescriptions written for the same quantities of controlled substances for family members or other patients who all share the same last name(s) on the same day of treatment.

6.  Addiction Treatment Requires Special Considerations

Even though Buprenorphine may well be at least one of the “wonder drugs” that helps end the opioid crisis, law enforcement is still coming down hard on practitioners who prescribe it in ways that support usage outside of legitimate medical treatment.  If you practice office-based (i.e., non-methadone) addiction therapy, be certain to confirm that a patient seeking Suboxone or Subutex in fact has an addiction, instead of a resale business, and determine if the patient is seeking other necessary treatment (such as therapy) to manage their addiction, before you prescribe.

The first six tips and part one of this series is here.