Source: https://www.imprivata.com/i-stop-faq
Timestamp: 2019-04-20 20:58:13+00:00

Document:
Q1: What is Electronic Prescribing of Controlled Substances or EPCS?
A1: Amendments to Title 10 NYCRR Part 80 Rules and Regulations on Controlled Substances have been adopted and became effective as final regulations on March 27, 2013. The amendments authorize a practitioner to issue an electronic prescription for controlled substances in Schedules II through V and allow a pharmacist to accept, annotate, dispense and electronically archive such prescriptions. A definition of an electronic prescription can be found in Section 3302 Article 33 Public Health Law. Click on the following link for Section 3302; Section 3302 Article 33 Public Health Law.
Q2: Is Electronic Prescribing mandatory for New York State practitioners?
A2: As of March 27, 2016 it will be mandatory for practitioners, excluding veterinarians, to issue electronic prescriptions for controlled and non-controlled substances. Electronic prescribing of controlled substances will require additional security features and registration of the certified software application with the Bureau of Narcotic Enforcement.
Q3: Why will electronic prescribing of controlled and non-controlled substances be mandatory effective March 27, 2016?
A3: New York Education Law Article 137 §6810 requires that all prescriptions be transmitted electronically three years from the Department of Health’s promulgating regulations allowing for the electronic prescribing of controlled substances. These regulations became effective on March 27, 2013. Utilizing modern prescription technology has the potential to minimize medication errors for patients in New York State. Electronic prescribing also allows for the integration of prescription records directly into the patient’s electronic medical record. Electronic prescribing has the potential to reduce prescription theft and forgery.
Q4: Will the use of Official New York State Prescription forms be prohibited as of March 27, 2016?
Q5: Should I return all of my unused Official New York State Prescription forms to BNE?
A5: Not necessarily. Under limited circumstances, the use of an Official NYS Prescription form will still be allowed, including events of a power outage or technological failure. However, it is unlikely that practitioners and institutions will need to continue to keep a similar inventory as in the past. Please consider the amount of prescription paper you will need to keep on hand, safeguard any stored Official New York State Prescription forms and return unneeded or unwanted forms to the Bureau of Narcotic Enforcement at 150 Broadway, Albany, NY 12204. The Bureau of Narcotic Enforcement will continue to supply Official New York State Prescription forms to practitioners and institutions.
Q6: I currently electronically prescribe non -controlled substances. Are there any additional steps I need to complete in order to electronically prescribe controlled substances?
First, the software you currently use must meet all the federal security requirements for EPCS, which can be found on the Drug Enforcement Agency’s (DEA) web page. http://www.deadiversion.usdoj.gov/ecomm/e_rx/ Note that federal security requirements include a third party audit or DEA certification of the software.
Second, you must complete the identity proofing process as defined in the federal requirements.
Third, you must obtain a two-factor authentication as defined in the federal requirements.
Fourth, practitioners must update/renew their Official Prescription Program (OPP) registration and register the DEA certified EPCS software with the Bureau of Narcotic Enforcement (BNE).
Q7: Can I electronically prescribe controlled substances before it becomes mandated on March 27, 2016?
The EPCS software application meets all of the federal security requirements for EPCS, which can be found on the DEA’s web page. http://www.deadiversion.usdoj.gov/ecomm/e_rx/ Note that federal security requirements include a third party audit or DEA certification of the software.
The practitioner has registered their DEA certified EPCS software application with the Bureau of Narcotic Enforcement (BNE). Please refer to the Registration instructions included below in the section titled “Practitioner and Pharmacy EPCS Registration Form”.
Q9: Can a prescriber fax a prescription to a pharmacy after March 27, 2016?
If issued in NY, must be on an Official New York State Prescription form.
In most instances, faxed prescriptions for controlled substances must comply with requirements for oral prescriptions for controlled substances, including issuance of the follow-up prescription. A facsimile is not an electronic prescription and must bear a manual signature.
Q10: Will it be permissible for a NY practitioner to fax a prescription for a 30 day supply of a controlled substance for a patient in a Hospice Program or a RHCF to a NY pharmacy once e-prescribing becomes mandatory?
A10: No, unless the prescription is issued pursuant to one of the exceptions in the regulation, 10NYCRR Sec. 80.64. Faxed prescriptions are not considered electronic prescriptions.
Q11: Is an electronic facsimile of a prescription considered an electronic prescription?
A11: No. A definition of an electronic prescription can be found in Section 3302 Article 33 Public Health Law and specifically states that a prescription generated on an electronic system that is printed out or transmitted via facsimile is not considered an electronic prescription. Click on the following link for Section 3302: Section 3302 Article 33 Public Health Law.
Q12: Is it permissible for an intermediary to convert an electronic prescription for a controlled substance to an electronic fax in the event of a transmission failure?
A12: At no time may an intermediary convert an electronic prescription for a controlled substance to facsimile for transmission to the pharmacy if the electronic transmission fails.
Q13: Is it permissible for an intermediary to convert a non-controlled substance electronic Prescription to an electronic fax in the event of a transmission failure of the electronic prescription?
A13: At no time may an intermediary convert an electronic prescription to a facsimile prescription for transmission to the pharmacy if the electronic transmission fails. Education Law, Section 6802 specifically excludes facsimiles from the definition of an electronic prescription. In order to be an acceptable prescription a facsimile must be issued on the Official New York State Prescription and contain a manual signature. In the event of a transmission failure, an intermediary may send a facsimile notification to the pharmacy. This notification will be for informational purposes only and is not considered a valid prescription.
Q14: I work for the Department of Veterans Affairs on federal property. Do I need to register my certified EPCS software application with BNE?
A14: No, practitioners who practice on federal property do not fall under the jurisdiction of New York State. However, a practitioner working on federal property who also practices off of federal property within New York State, the EPCS software application that is used off of federal property must be registered with BNE.
Q15: Can a practitioner who prescribes controlled substances electronically from multiple practice sites change the practice site address on the prescribing software or choose from multiple practices site addresses within the software to transmit the correct practice site address to the pharmacy?
A15: Practitioners should speak to their software vendor regarding the functionality around practice site addresses.
Q16: Will practitioners be required to issue electronic prescriptions for compounds containing a controlled substance ingredient as of March 27, 2016?
A16: BNE is aware that there may be system limitations due to the NCPDP script standard. Please monitor BNE’s webpage for more information.
Q17a: : Will practitioners be required to electronically prescribe non-prescription items, including durable medical equipment?
A17a: No, an electronic prescription will not be required. Section 281 (1) of the Public Health Law specifically references the use of electronic prescriptions for prescription drugs only.
Q17b: If a third party payor requires a prescription for payment of non-prescription items, including durable medical equipment, can it be electronically prescribed?
A17b: Consult with your electronic prescribing software vendor to ascertain if the e-prescribing software is capable of transmitting these items correctly. If not, a written ONYSRx, manually signed, is permissible. A “failover” electronic fax is never permissible. The only acceptable facsimile is a manually signed ONYSRx.
Q18: Can an agent or employee of the prescriber create or prepare an electronic prescription?
A18: Yes. Education law 6802 and Sections 80.67 and 80.69 of Title 10 NYCRR Part 80 do not prohibit an agent of the practitioner from preparing an electronic prescription for his or her review and electronic signature.
Q19: Can an agent or employee of the prescriber electronically sign an electronic prescription?
A19: No. Practitioners are authorized to prescribe by virtue of his or her license to practice medicine or dentistry. Therefore, only the practitioner may review and sign the prescription.
Q20: Can an agent or employee of the prescriber transmit an electronic prescription to the pharmacy?
A20: The signing and transmission of an electronic prescription are two distinct actions. Only the practitioner may review and electronically sign the prescription. Once signed, an agent or employee of the practitioner may transmit the prescription on behalf of the practitioner. The act of transmission must be independent of the review and signature process.
Q21: Can a Physician Assistant electronically prescribe controlled and non-controlled substances?
A21: Yes. All electronic prescriptions issued and signed by a Physician Assistant must contain the name of their supervising physician.
Q22: Is the supervising physician’s name required on an electronic prescription issued by a physician assistant?
A22: Yes, the supervising physician’s name is required on all prescriptions (controlled and non-controlled substances) issued by a physician assistant, including electronic prescriptions, handwritten official prescriptions, and official prescriptions generated on an EMR system.
Q23: Can a physician assistant register for EPCS if their supervising physician does not?
A23: Yes. The supervising physician is not required to register for EPCS if they have no intention of electronically prescribing controlled substances.
Note: Both the supervising physician and physician assistant must maintain active registrations for the Official Prescription Program.
Q24: Can an unlicensed resident, intern or foreign physician electronically prescribe controlled and noncontrolled substances?
A24: Yes. Please refer to 10 NYCRR 80.75 for further information.
Q25: Is a resident, intern or foreign physician’s supervising physician/attending’s name or signature required to be on an electronic prescription?
A25: BNE does not require the supervising physician/attending’s name or signature to be on an electronic prescription, however third party payors or government programs may have additional requirements.
Q26: Are residents, interns and foreign physicians required to provide their DEA suffix when prescribing electronically?
A26: Yes. 10NYCRR Part 80 §80.75(e) provides the authority for residents, interns and foreign physicians to use the DEA registration number of the institution by whom they are employed and they must include the suffix assigned by the institution to prescribe and dispense controlled substances (may be up to 21 characters).
Q27: Is an attending physician that oversees residents, foreign physicians, and interns required to register for EPCS?
A27: The attending physician is not required to register for EPCS if they have no intention of electronically prescribing controlled substances.
Q28: Are unlicensed medical residents required to register their EPCS software with BNE?
A28: No. The facility must maintain a current list of unlicensed residents with prescriptive privileges within the facility who have been authorized to access the facility’s EPCS software. This information must be available to BNE upon request.
Q29: Does a practitioner still have to consult the Prescription Monitoring Program (PMP) Registry when e-prescribing?
A29: Yes. The practitioner must consult the PMP Registry prior to prescribing a controlled substance in Schedules II-IV regardless of how the prescription is issued.
Q30: I am not licensed or practicing in New York, but have a patient who uses a pharmacy in New York. Do I have to register my certified EPCS software application with BNE to send electronic prescriptions for controlled substances to pharmacies in the state of New York?
A30: Practitioners who are not practicing in New York State are not required to register their certified EPCS software application with BNE. They must follow their state’s law and regulations.
Q31: Can I send an electronic prescription for a controlled substance to an out-of-state pharmacy?
A31: You may or may not be able to depending upon the laws of that state. The pharmacy must dispense the prescription following the laws of the state in which the prescription is being dispensed.
Q32: I don’t have a DEA number, therefore, I don’t prescribe controlled substances. Do I have to register the software application used to electronically prescribe non-controlled substances with BNE?
A32: There is no current requirement to register E-prescribing software applications that only transmit non-controlled substance prescriptions. However, all prescriptions must be issued electronically unless an exception applies.
Q33: I am a veterinarian and would like to electronically prescribe controlled substances. What should I do?
A33: Practitioners issuing electronic prescriptions for controlled substances must use a software application that meets all DEA (federal) security requirements, which includes a third party audit or DEA certification indicating that all federal requirements are met. The New York State Department of Health requires practitioners licensed in New York State issuing electronic prescriptions for controlled substances to register their certified EPCS software application with BNE.
Q34: Regulations (Title 10 NYCRR Part 80 §80.67(5) and §80.69(5))state that the quantity of the dosage units must be indicated in both numerical and written word form on an Official New York State prescription (ONYSRx). Does this pertain to electronic prescriptions as well?
A34: No. While a quantity is required on all prescriptions, both the “numerical and written word form” are required to be on the ONYSRx form only. The intention of including both formats on the ONYSRx is to prevent alteration of the quantity on a written prescription.
a. Practitioner Name: Enter your first and last name in this field. If you are a Physician Assistant, please attach a list of your Supervising Physician(s) with their corresponding NYS license number and DEA registration number.
c. DEA Number for NYS: Enter each New York State DEA number that will be utilized to electronically prescribe controlled substances.
d. Practitioner Email Address: Enter the practitioner’s email address.
e. Practitioner Telephone Number: Phone number of the practitioner.
f. Name of Certified E-prescribing Software Application: Name of the application you are using to electronically prescribe controlled substances. If you are not sure what the name of your software application is, contact your software application vendor.
g. Software Version Certified: Version number of the EPCS application. If you are not sure what version you are currently using, contact your software application vendor.
h. Name of Software Application Provider (Company Name): Name of the company (or corporation if you are not using a vendor) providing the certified EPCS software application.
i. Practitioner Signature: Signature of the practitioner.
j. Date: Date that the form was signed by the practitioner.
k. Print Name: The practitioner’s name should be printed in this field.
Q35: Regulations (Title 10 NYCRR Part 80 §80.67 and §80.69 ) allow a practitioner to issue a prescription for greater than a 30 day supply of a controlled substance for certain conditions by specifying either the name of the condition, or the condition code, in accordance with codes designated in these sections, on the prescription. If no field for specifying the condition exists within the electronic prescribing application format, where should this be placed on an electronic prescription?
A35: A practitioner may use the notes field on the electronic prescription to indicate an approved condition or its corresponding code. A practitioner may also name the condition as part of the directions to the patient (sig. field).
Q36: Is the phrase “Authorization for Emergency Dispensing” required on the follow-up prescription for an emergency oral prescription for a schedule II controlled substance?
A36: Both 21 CFR Part 1300 §1306.11(d)(4) and New York Public Health Law Article 33 §3334(3) require the phrase “Authorization for Emergency Dispensing” on follow-up prescriptions for emergency oral prescriptions for Schedule II controlled substances.
Q37: Does an electronic prescription for a controlled substance require a written follow-up prescription be sent to the pharmacy?
A37: No. The electronic prescription is the prescription and does NOT require a hard copy follow up prescription.
Q38: Is it mandatory for pharmacies to receive electronic prescriptions for controlled substances?
A38: No. However, it will be mandatory for practitioners, with some exceptions, to issue electronic prescriptions for both controlled and non-controlled substances effective March 27, 2016.
Q39: What are the practitioner and pharmacist responsibilities in the event of a transmission failure of an electronic prescription for a controlled substance?
A39: The responsibilities of the practitioner and the pharmacist with regard to failed transmission of an electronic controlled substance prescription may be found in detail in 10 NYCRR Part 80 Sections 80.67,80.69, 80.73 and 80.74.
Q40: What should I do if I am notified that the security of my certified EPCS software application is noncompliant with federal requirements?
A40: If your EPCS software application no longer meets federal security requirements, your software shall NOT be used to process electronic prescriptions for controlled substances until your software is in compliance with DEA requirements and you re-register the software application with BNE.
Q41: What should I do if my credentials used to sign electronic prescriptions have been lost, stolen or compromised?
A41: In addition to any federal requirements, practitioners must immediately notify BNE that his or her credentials have been lost, stolen or compromised. Please send an email to [email protected] with the subject of credentials lost, stolen or compromised or call BNE’s toll free number (866-811-7957, Option 1).
Q42: What should I do if I suspect or am notified of a security breach with my certified EPCS software application?
A42: If there has been a security breach, you may not process electronic prescriptions for controlled substances. You must notify the DEA and BNE. After security has been restored, you must re-register the certified software application with BNE.
Q43: What is the difference between the third party audit or certification required by the DEA and the registration that BNE requires?
A43: Practitioners and pharmacies processing electronic prescriptions for controlled substances must use a software application that meets all DEA (federal) security requirements, which includes a third party audit or DEA certification indicating that all federal requirements are met. The New York State Department of Health does not certify software applications. However, practitioners and pharmacies licensed in New York State processing electronic prescriptions for controlled substances are required to register their certified EPCS software application with BNE.
Q44: Why do I need to register my certified EPCS software application with the Bureau of Narcotic Enforcement (BNE)? My software vendor already notified BNE.
A44: Each individual practitioner and pharmacy, not the software vendor, is required by regulation to register their certified EPCS software application with BNE.
Q45: My pharmacy is NOT physically located in New York, however, it is registered with the New York State Board of Pharmacy. Are we required to register our certified pharmacy software application with BNE to process electronic prescriptions for controlled substances received from practitioners in the state of New York?
A45: Yes, non-resident pharmacies registered with the New York State Board of Pharmacy must register their certified pharmacy software application with BNE to receive electronic prescriptions for controlled substances.
Q46: My pharmacy is NOT located in New York. We are NOT registered with the New York State Board of Pharmacy. Do we have to register our certified pharmacy software application with BNE to process electronic prescriptions for controlled substances received from practitioners in the state of New York?
A46: No, pharmacies located outside of New York State that are NOT registered with the New York State Board of Pharmacy are not required to register their certified software applications with BNE.
Q47: If a pharmacy does not dispense controlled substances, does their computer system have to be certified to meet the DEA security standards?
A47: No. Computer systems only need to be certified that they meet the DEA security standards if they will be used to dispense controlled substances.
Q48: Can pharmacies receive electronic prescriptions for controlled substances from practitioners before it becomes mandated on March 27, 2016?
The pharmacy software application meets all of the federal security requirements included in the DEA’s Interim Final Rule.
The pharmacy can submit controlled substance prescription data to BNE using ASAP version 4.2.
The certified pharmacy software application is registered with BNE.
Q49: Can I accept an out-of-state electronic prescription for a controlled substance?
A49: A pharmacist may dispense a controlled substance medication pursuant to an out-of-state electronic prescription as defined in Section 80.78 Title 10 Part 80 Rules and Regulations on controlled substances. Electronic prescriptions may be created, signed and transmitted from another state, provided the practitioner complies with all requirements, state and federal, for issuing controlled substance prescriptions electronically. It is prudent on the part of the pharmacist to verify the authenticity of any controlled substance prescription presented to them.
Q50: Is the prescription valid for dispensing if the practitioner has not registered their certified EPCS application with BNE?
A50: Yes. The prescription is valid for dispensing if the practitioner has not registered their certified EPCS software application with BNE and the prescription meets all other federal and State requirements. Pharmacists are not expected to verify that a practitioner has registered their application with BNE.
Q51: Can a pharmacy accept an electronic prescription as a follow-up to an oral prescription?
A51: Yes. A pharmacy may accept an electronic prescription as a follow-up to an oral prescription. It is incumbent on the pharmacist to know the limitations of their software application and if it can accurately accept and archive an electronic follow-up prescription. If the software application cannot do this, a paper prescription is necessary and permissible. This should be communicated to the practitioner at the time the prescription is called in, and the need for the follow-up is discussed.
Q52: Certain elements may be changed or added to a controlled substance prescription by a pharmacist with practitioner authorization. If a prescription is sent electronically that requires information to be added or changed, how should the information be added to the electronic prescription?
A52: Information added/changed on an electronic prescription must be annotated and maintained electronically. Pharmacists should consult their software vendor or corporate headquarters for guidance to ensure annotation meets all federal requirements. The process of annotating a prescription may vary based on the software used.
Q53: How does a pharmacist annotate an electronic prescription?
A53: Pharmacists should consult their software vendor or corporate headquarters for guidance to ensure annotation meets all federal requirements. The process of annotating a prescription may vary based on the software used.
Q54: Do I need to re-register if my pharmacy software application changes?
A54: If you switch to a new software application, you must re-register with BNE.
Q55: In order to fill an electronic prescription for a controlled substance, do I need to verify that the practitioner has registered with BNE?
A55: No. BNE does not publish a list of practitioners or pharmacies who have registered their certified EPCS software applications with BNE. It is the responsibility of the practitioner to register their certified EPCS software application with BNE. BNE will follow-up with practitioners who have not registered.
Q56: Now that I have registered my pharmacy software with BNE and have received registration confirmation from BNE, can I receive electronic prescriptions for controlled substances?
The State Issued Rx Serial Number field (AIR02) must be populated with the letter E eight times (EEEEEEEE).
The Electronic Prescription Reference Number field (DSP20) must be populated.
The Electronic Prescription Order Number field (DSP21) must be populated.
Q57: Does BNE provide EPCS software?
A57: No. BNE does not provide software for practitioners or pharmacies to use.
Q58: Where do I find the software that will allow a practitioner to electronically prescribe controlled substances?
A58: BNE does not endorse a specific EPCS software for practitioners to use. You may research different options on the internet, speak to your professional colleagues or professional associations that you are associated with to determine what options are available. You may also wish to contact your current Electronic Health Record (EHR) software application provider, if you are currently using EHR.
Q59: How do I know if my software has been certified to process electronic prescriptions for controlled substances?
A59: Please contact your software vendor, they should be able to provide you with this information.
Q60: Are additional fields required by BNE on the submission of controlled substance data from electronic prescriptions?
Q61: Are any specific specialties or fields excluded from the requirement to electronically prescribe prescriptions?
Q62: What exceptions are there from the requirement to electronically prescribe?
A62: The following is a list of exceptions from the requirement to electronically prescribe and may be accessed from the following link: Article 2A - Section 281.
Prescriptions issued by a practitioner under circumstances where the practitioner reasonably determines that it would be impractical for the patient to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the patient's medical condition. In addition to these circumstances, the quantity of controlled substances cannot exceed a five day supply if the controlled substance were used in accordance with the directions for use.
Q63: Can practitioners apply for a waiver from the requirement to electronically prescribe?
A63: The Prescription Drug Reform act- Chapter 447 of the laws of 2012 and Title 10 Part 80 of the Official Compilation of Codes, Rules and Regulations of the State of New York (§80.64(c)(3)) allows the Commissioner of Health to grant a practitioner a waiver, not to exceed a time period of one year, from the requirement to electronically prescribe. Waivers may be granted based upon a showing of economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner.
Q64: I already have a waiver from the requirement to consult the Prescription Monitoring Program Registry. Am I exempt from electronic prescribing since I have this waiver?
A64: No. A separate waiver is required. The Prescription Drug Reform act- Chapter 447 of the laws of 2012 and Title 10 Part 80 of the Official Compilation of Codes, Rules and Regulations of the State of New York (§80.64(c)(3)) allows the Commissioner of Health to grant a practitioner a waiver, not to exceed a time period of one year, from the requirement to electronically prescribe. Waivers may be granted based upon a showing of economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner.
Q65: Where can I obtain information regarding the DEA’s federal requirements for EPCS?
A65: You may visit the DEA’s web page for additional information regarding federal security requirements: http://www.deadiversion.usdoj.gov/ecomm/e_rx/.
Q66: Where can I obtain information regarding New York State’s requirements for EPCS?
Q67: Where can I obtain information regarding Electronic Data Transmission requirements for EPCS?
The questions and answers below have been copied directly from the New York State Department of Health, Bureau of Narcotic Enforcement (BNE) website, ‘Frequently Asked Questions For Electronic Prescribing Of Controlled Substances: EPCS, Revised: August 2014’. These FAQs are intended to summarize and provide general information for practitioners and pharmacists regarding the Amendments to Title 10 NYCRR Part 80 Rules and Regulations on Controlled Substances, which became effective as final regulations on March 27, 2013. These regulations interact with the Drug Enforcement Administration (DEA) Interim Final Rule with Request for Comment “Electronic Prescriptions for Controlled Substances” (75 FR 16236, March 31, 2010) [Docket No. DEA-218, RIN 1117-AA61]. The information in this FAQ document is not intended to convey specific information about every aspect of the New York State Department Of Health’s BNE legislation, or of the DEA’s EPCS Interim Final Rule, nor is it a substitute for the regulations themselves. The information in this section is subject to change, and we advise we advise practitioners and pharmacists who plan to introduce EPCS to their work flows to retain legal counsel and to directly consult the official wording of the BNE’s regulations, and the DEA’s Interim Final Rule, in order to ensure full legal compliance.

References: §6810
 §80
 §80
 §80
 §80
 §80
 §1306
 §3334