New York's e-prescribing mandate: Are prescribers and pharmacies ready?



September 11, 2014

Health Care Alert

Author(s): Laurie T. Cohen

Practitioners in New York State (excluding veterinarians) will be required to issue all prescriptions, including prescriptions for controlled substances, in electronic format by March 27, 2015, in accordance with legislation enacted in 2012. An electronic prescription is:

  • Created, recorded, transmitted or stored by electronic means;
  • Issued and validated with the prescriber’s electronic signature;
  • Electronically encrypted to prevent unauthorized access, alteration or use of the prescription; and,
  • Transmitted electronically directly from the prescriber to a pharmacy or pharmacist.

Prescriptions generated on an electronic system that are printed out or transmitted via facsimile or e-mail are not considered electronic, and are not compliant with the e-prescribing mandate.

The NYS Education Department hosted a roundtable meeting on Tuesday, September 9, 2014, to discuss the e-prescribing mandate. Representatives from pharmacy, medical and institutional providers heard presentations from the NYS Department of Health Bureau of Narcotic Enforcement (BNE) regarding the electronic prescribing mandate and also heard from Surescripts regarding the state of readiness of NYS pharmacies and prescribers to comply with the mandate. 

Stakeholders participating in the roundtable shared information that practitioner readiness is highly dependent in many cases on the readiness of their EHR vendors, many of which do not yet have e-prescribing software applications that have been certified and audited in accordance with U.S. Drug Enforcement Agency (DEA) regulations. It was reported during the meeting that there are over 140 active EHR vendors in NYS, many of whom do not yet have a compliant application to offer their customers to comply with the NYS mandate. When asked if there was a chance that the mandate would be delayed, BNE representatives indicated that they did not expect a delay but indicated that they are committed to working with all parties to address difficulties in complying.

According to Surescripts, approximately 70% of practitioners in NYS have sent e-prescriptions to pharmacies for non-controlled substances in the past month. Although the March 2013 regulations implementing the 2012 legislation allow electronic prescribing of controlled substances, less than 1% of prescribers in NYS are currently enabled to prescribe controlled substances electronically.

E-prescribing controlled substances

In order to electronically prescribe controlled substances, a practitioner must satisfy four basic requirements. First, the practitioner must use e-prescribing software that has been certified and audited in accordance with DEA regulations. The practitioner must also complete an identity proofing process and obtain two factor authentications in accordance with the DEA regulations.   Lastly, NYS will require that a practitioner register the controlled substance e-prescribing software with BNE. If the practitioner works at multiple locations and different e-prescribing software is used at such sites, the practitioner will need to register each software program used to prescribe controlled substances. BNE representatives reported that in the next month there will be an online process for pharmacies and prescribers to register their software programs. Until the electronic registration process is available, practitioners and pharmacies must enroll using the paper form(s) that are available to print from the BNE webpage.

Exceptions to the mandate; waiver process

With less than seven months to go before the mandate goes into effect, there is serious concern about the ability of prescribing practitioners to comply with the e-prescribing requirement by the 2015 deadline. The e-prescribing regulations include several exceptions to the mandate including when:

  • electronic prescribing is not available due to temporary technological or electronic failure;
  • the prescriber has a waiver granted by the New York State Commissioner of Health;
  • the prescriber reasonably determines that it would be impractical for the patient to obtain substances prescribed by electronic prescription in a timely manner; or
  • the prescription will be dispensed at a pharmacy located outside New York State.

The e-prescribing regulations indicate that the Department of Health may grant waivers of the e-prescribing mandate for renewable periods of up to one year. Waivers may be granted based upon a practitioner’s showing that his or her ability to issue electronic prescriptions is unduly burdened by:

  • economic hardship;
  • technological limitations that are not reasonably within the control of the practitioner; or
  • other exceptional circumstance demonstrated by the practitioner.

Although the Department has not provided guidance or examples of exceptional circumstances under which a waiver may be granted, Department representatives during the September 9 roundtable meeting indicated that waiver requests will be evaluated on a case-by-case basis. Department representatives also indicated that because waivers are only effective for one year periods, the Department does not anticipate acting on waiver requests until the first quarter of 2015.

Implications for retired practitioners

Many practitioners in New York State who have retired from practice choose to maintain their licensure in order to issue occasional prescriptions for friends or family members. Although not explicitly prohibited by statute or regulation, the practice is frowned upon by disciplinary bodies, and practitioners may be charged with professional misconduct for failing to maintain patient records that accurately reflect the evaluation and treatment of the family members or friends for whom they issue prescriptions. With the implementation of the e-prescribing mandate, retired practitioners will also need to utilize e-prescribing software to issue prescriptions. It is unlikely that a retired practitioner will be granted a waiver.

For more information about the e-prescribing mandate, visit the NYS Department of Education website.

The foregoing has been prepared for the general information of clients and friends of the firm. It is not meant to provide legal advice with respect to any specific matter and should not be acted upon without professional counsel. If you have any questions or require any further information regarding these or other related matters, please contact your regular Nixon Peabody LLP representative. This material may be considered advertising under certain rules of professional conduct.

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