Starting on March 27, 2016, New York prescribers are required to issue all prescriptions electronically, subject to limited exceptions. By shifting to electronic prescriptions, New York hopes to minimize medication errors, integrate prescription records with electronic health records, and minimize prescription theft and forgery. The requirement was initially scheduled to take effect on March 27, 2015, but the state delayed the effective date due to prescriber readiness concerns. Although the requirement took effect yesterday, pharmacies, PBMs, hubs, and manufacturers are all still developing processes to comply with the new requirements and it is unclear as to how the market and the regulating body will respond.
Prescribers are not required to issue electronic prescriptions for scripts that will be dispensed by a non-resident pharmacy. Additional temporary exceptions to the electronic prescribing requirement exempt prescriptions for many specialty products. Both New York resident pharmacies and non-resident pharmacies dispensing controlled substances via electronic prescribing in the state must, however, register their certified electronic prescribing application with the New York Bureau of Narcotic Enforcement (BNE).
Specialty pharmacies should carefully consider the potential impact of the law on their relationships with pharmaceutical hub programs. Pre-existing New York law requires all prescriptions to be written on a state approved prescription form, which complicates the use of combined prescription and hub enrollment forms. Further, guidance associated with the new electronic prescription law indicates that prescriptions should be sent directly to the pharmacy or pharmacist, which would preclude direct hub referrals.
The burden of the electronic prescribing requirement rests on the prescriber; pharmacies are not required by law to receive prescriptions electronically. A prescriber who willfully violates New York’s electronic prescribing requirement may be found guilty of a misdemeanor punishable by imprisonment and/or an up to $10,000 fine.1 There is no corresponding penalty for a pharmacy or pharmacist.
Electronic Prescribing Required
Under New York law, an “electronic prescription” is a prescription that is:
- created, recorded, or stored by electronic means;
- issued and validated with the prescriber’s electronic signature; and
- electronically transmitted.2
Electronic prescriptions must be electronically encrypted to prevent access, alteration, or use by an unauthorized person. Fax and email are not permissible transmission mechanisms for electronic prescriptions under New York law. Guidance from the New York Board of Pharmacy suggests that the transmission must be made directly from the prescriber to a pharmacist or pharmacy, which could affect manufacturer hub programs that require prescribers send prescriptions to hubs rather than directly to the pharmacy.3
The equipment used for electronic transmission of prescriptions must be physically located in a place that ensures the security and confidentiality of the prescription transmission. Electronic prescribing systems may not limit a patient’s freedom of choice of pharmacy.4 Just as with any other prescription, pharmacies are responsible for assuring the validity of electronic prescriptions.
The electronic prescribing requirement applies to all prescriptions, including prescriptions for controlled substances. Electronic prescribing of controlled substances must be conducted in compliance with stringent state and federal security safeguards.5 The BNE has released a detailed response to frequently asked questions related to electronic prescribing for controlled substance requirements.
Registration of Electronic Prescription Application Required
Additionally, pharmacies (including non-resident pharmacies), facilities, and practitioners prescribing or dispensing controlled substances must register their certified electronic prescription software with the BNE in order to receive or transmit electronic prescriptions for controlled substances.6 A pharmacy dispensing controlled substances pursuant to electronic prescriptions must complete the Pharmacy Electronic Prescribing of Controlled Substances (EPCS) Registration form and submit the form via email to the BNE.
Practitioners and pharmacies processing electronic prescriptions for controlled substances must obtain a third party audit or Drug Enforcement Administration (DEA) certification indicating that the registrant’s electronic prescribing application meets all federal requirements. The BNE does not require that the registrant provide a copy of the audit or certification, but documentation of such should be made available to the BNE upon request. The registration must be renewed two years from the date of DEA certification or third party audit or whenever functionality related to controlled substance prescription requirements is altered, whichever occurs first. If a prescriber or pharmacy uses more than one software application for controlled substance prescribing, each application must be individually registered with the BNE.
Pharmacies are not expected or required to verify that prescribers have registered their prescribing applications with the BNE. If a pharmacy does not dispense controlled substances to New York patients, no application registration is required.
Exceptions to the Electronic Prescribing Requirement
All prescriptions issued by New York prescribers must be transmitted electronically and directly to the pharmacy, except for prescriptions issued:
- by veterinarians;
- during a temporary technological or electrical failure;
- by a practitioner who has received a waiver from the electronic prescribing requirement;
- when the prescriber reasonably determines that it would be impractical for the patient to obtain the prescribed product in a timely manner through electronic prescription and such delay would adversely impact the patient’s medical condition; or
- by a practitioner to be dispensed by a pharmacy located outside New York State.7
When a prescriber issues a non-electronic prescription to be dispensed by a pharmacy located outside of New York, that prescriber must file information related to the issuance with the New York Department of Health within 48 hours of issuance.8 Prescribers may seek to partner with pharmacies capable of receiving electronic prescriptions in order to avoid this potentially onerous reporting requirement.
On March 16, 2016, the New York State Department of Health, due to concerns about readiness and software capability, promulgated an additional set of temporary exceptions, which will extend until March 26, 2017.9 Practitioners issuing prescriptions in the below-listed exceptional circumstances are temporarily exempted from the electronic prescribing requirement and may either use the Official New York State Prescription Form or issue an oral prescription:
- when a prescription is issued for a compounded substance containing two or more products;
- when a prescription is issued for a substance that will be compounded for direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion;
- when a prescription will require long or complicated directions;
- when the FDA requires certain elements to be included on the prescription and those elements are not able to be included on an electronic prescription;
- when a prescription is issued for an opioid antagonist and the prescription is non-patient specific;
- when a prescription is issued for a substance under a research protocol; and
- when a prescription is issued for a substance and communicated to a pharmacist serving as a vendor of pharmaceutical services, by an agent who is a healthcare practitioner, for patients in nursing homes and residential healthcare facilities.10
Pharmacists dispensing prescriptions in the below-listed circumstances are temporarily exempted from the electronic prescribing requirement so long as the prescription is issued on the Official New York State Prescription Form or as a valid oral prescription:
- when dispensing prescriptions for compounded products, prescriptions containing long or complicated directions, and prescriptions containing certain elements required by the FDA or any other governmental agency that are not able to be accomplished with electronic prescribing;
- when dispensing prescriptions issued under a research protocol, or under approved protocols for expedited partner therapy, or for collaborative drug management;
- when dispensing non-patient specific prescriptions, including opioid antagonists, or prescriptions issued in response to a public health emergency issued; and
- when serving as a vendor of pharmaceutical services dispensing a substance communicated by an agent who is a healthcare practitioner for patients in nursing homes and residential healthcare facilities.11
Many prescriptions to be dispensed by specialty pharmacies will fall within one of the temporary exceptions listed above due to the detailed information required for a specialty pharmacy to dispense certain products.
Practitioners may be eligible for a temporary waiver of the electronic prescribing requirement in limited, exceptional circumstances.12
When a pharmacy receives a valid, non-electronic prescription it is not required to determine which of the above exceptions, if any, applies to the prescription. A pharmacy is not required to report prescribers who issue prescriptions non-electronically to the BNE.
Conclusion
Although pharmacies are not required by law to receive electronic prescriptions, the new default for New York prescribers is the electronic transmission of prescriptions. Other states may follow New York’s lead and institute their own electronic prescribing requirements as reducing prescription drug abuse continues to be a public health priority. Bass, Berry & Sims will continue to monitor the implementation and enforcement of New York’s electronic prescribing requirement. Should you have any questions, please contact one of the authors listed or any member of our Specialty Pharmacy team.
1 N.Y. Pub. Health Law § 12-b.
2 N.Y. Comp. Codes R. & Regs. tit. 8, § 63.6.
3 Note that New York State requires that all non-electronic prescriptions written by New York prescribers be issued on the Official New York State Prescription Forms provided by the Department of Health. N.Y. Pub. Health Law § 281.
4 N.Y. Comp. Codes R. & Regs. tit. 8, § 63.6.
5 See 21 C.F.R. § 1311.100, et seq. for DEA requirements.
6 N.Y. Comp. Codes R. & Regs. tit. 10, § 80.64.
7 N.Y. Pub. Health Law § 281.
8 N.Y. Comp. Codes R. & Regs. tit. 10, § 80.64.
9 Letter from Howard Zucker, Comm’r , N.Y. Dep’t of Health, to Practitioners and Pharmacists (Mar. 16, 2016).
10 Id.
11 Id.
12 N.Y. Comp. Codes R. & Regs. tit. 10, § 80.64.