This past Sunday, March 27, 2016, New York State began monitoring and enforcing physician compliance with a New York State law requiring all physicians to prescribe controlled and non-controlled substances electronically. The new law went into effect a year later than anticipated, an initiative New York State took in order to allow physicians adequate time to prepare.
New York’s new e-prescribing requirements rely heavily on the Drug Enforcement Agency’s (DEA) Final Rule regarding E-Prescribing of Controlled Drug Substances, released in 2010. In order for a prescriber, or a pharmacy, to properly register an e-prescribing application, the DEA (and New York, by virtue of its reliance on DEA guidance) requires the provider’s application to have the following capabilities:
- (i) prescriber-only electronic signature of e-prescriptions (this function is not delegable to a prescriber’s agent)
- (ii) two-factor prescriber authentication
- (iii) be accessible to third party audit or DEA certification
- (iv) identity proofing
- (v) controlled substance prescriptions per prescriber monthly log retention
- (vi) ability to retain a list of auditable events
In addition to the DEA’s requirements, New York implemented its own registration process for e-prescribing applications. All e-prescribing applications conforming to DEA standards must be registered with the New York Department of Health (DOH), Bureau of Narcotic Enforcement, for each location at which controlled or non-controlled substances are prescribed and for each pharmacy receiving e-prescriptions.
Although the intent of the full integration and implementation of New York’s new law is to eliminate the use of written prescriptions, the DOH has described circumstances in which written prescriptions would be permitted. This is true for prescriptions that contain detailed instructions for use, and may also hold true for compound prescriptions in those cases where e-prescribing applications cannot accommodate compound formulations. While written prescriptions are permitted in limited circumstances, for any prescription issued by a prescriber in writing, outside of the registered e-prescribing application, the prescriber must submit an explanation to the DOH, detailing the reason for the issuance of a written prescription.
Both the DEA and New York state saddle prescribers with the responsibility for ensuring that all legal requirements of the e-prescribing application they use are satisfied, and assign pharmacies with a corresponding responsibility to ensure the validity of e-prescriptions. Prescribers that have not yet taken action to ensure compliance, or are not fully compliant may be subject to penalties that include both fines and disciplinary action. Frier Levitt has substantial experience assisting both prescribers and pharmacies understand and implement their e-prescribing responsibilities and obligations, as well as obtaining waivers and extensions from the DOH. Contact us today to speak to an attorney.
