Non-compliant practices can result in criminal charges, fines.

On January 1, 2021, the Support Act made mandatory the use of electronic subscribing for all controlled substances (EPCS) covered under Medicare Part D. However, compliance will not be enforced until January 1, 2022, to give health care organizations adequate time to adjust workflows to meet the new standards.

The goal of the Act is to clamp down on illegal prescribing of schedule II-IV drugs. To that end, three components will be required to confirm the prescriber identity:

  • Identity proofing – to confirm the identity of the prescriber
  • Digital signature – to authenticate the prescription
  • Two-factor identification – in addition to identity proofing, practices will need to adapt either biometrics or tokens to verify the prescriber

The DEA mandates that providers cannot delegate their signatory approval under any circumstance and are responsible for ensuring all prescription elements are valid, including drug name, strength, and quantity. The DEA also compels staff members to maintain custody of their hard token. “…The practitioner must retain sole possession of the hard token… and must not share the password or other knowledge factor with any other (staff member). The practitioner must not allow any other person to use the token or enter the knowledge factor or other identification means to sign prescriptions for controlled substances.”

According to the National Federal Defense Lawyer Group, prescription drug fraud is usually considered a 3rd or 4th-degree felony. Persons convicted of third-degree felonies can be punished for up to five years in prison, while 4th-degree felons can receive up to 18 months. A recent case in Williamsville, NY, illustrates the importance of safeguarding tokens to protect against e-prescribing fraud. A doctor was fined $60,000 when her employee used her token and password to write over 150 illegal prescriptions for controlled substances.

Although it is critical to be aware of federal regulations, compliance with state laws may be a more pressing concern for many organizations since they often place further restrictions on how prescriptions are transmitted to a pharmacy.

State laws may be more restrictive than federal

Many state laws regulate prescription preparation, validation, and transmission. For example, NY expressly prohibits employees of a provider from electronically signing a prescription, although the staff can prepare prescriptions for signature. A staff member can only transmit an electronic prescription if it is independent of the review and signature process; if a token is required for submission, the provider must submit the prescription.  NY also prohibits anyone but the practitioner from converting an electronic prescription for a controlled substance into an electronic fax. Find a guide to state laws concerning prescriptions here.

Standing orders and refills may not be exempt from regulations

According to a leading nursing education organization, “RNs cannot order medications or refills… An RN is allowed to transmit an order by an authorized healthcare provider, but… the order must be reviewed, approved, and signed (or some other form of attestation) before transmitted.”

Other crimes can be associated with prescription fraud

Non-compliant prescription practices can leave your organization vulnerable to crimes other than prescription fraud, including identity theft, forgery, health care fraud, and insurance fraud – all of which can bring hefty fines and prison sentences no matter where your office is located.

According to the CDC, opioid deaths have increased more than six times since 1999 and account for over 70% of all drug overdose deaths. Unfortunately, health care workers are in an ideal position to obtain drugs illegally. It may seem easier and quicker to delegate prescription writing and e-prescription authority to healthcare staff, but ultimately, you put your practice and reputation at risk. In the end, providers need to weigh the time-saving benefit of granting staff prescription writing authority against the penalties associated with facilitating prescription drug fraud. Many providers would agree that choosing to spend a few extra minutes attending to prescriptions is a better alternative to fines and imprisonment.

Changing health care rules and policies can be confusing – using the right partner for practice management software and billing makes it easy. Contact us today at (412) 424-2265 or visit to learn how we can help you optimize workflows, streamline claims, and maximize revenue.