1 Electronic Prescribing In New York State Joshua S. Vinciguerra, Director Bureau of Narcotic Enforcement October 28, 2015
2 October 28, Overview Review the problem & e-prescribing mandate Describe the practitioner EPCS registration process Describe the exceptions to the e-prescribing mandate & waiver application process Discuss implications for prescription drug crimes & investigative techniques
3 October 28, The Connection
4 States with more opioid pain reliever sales tend to have more drug overdose deaths Death rate, 2013, National Vital Statistics System. Opioid pain reliever sales rate, 2013, DEA s Automation of Reports and Consolidated Orders System
5 October 28, Official Prescription Program NY issues forge-proof official prescription forms to all registered practitioners within the State Contain a number of security features Trackable From issued ~1.4 B prescription forms At a cost of $78.7 M 5
6 October 28, Prescription Drug Reform Act 2012 Part A: Part B: I-STOP Electronic Prescribing Part C: Schedule Changes Controlled Substance Part D: Part E: 3309 Work Group Safe Disposal Program
7 October 28, Definition of Electronic Prescribing A prescription issued with an electronic signature and transmitted by electronic means in accordance with regulations of the commissioner of health and the commissioner of education and consistent with federal requirements. A prescription generated on an electronic system that is printed out and manually signed or transmitted via facsimile is NOT considered an electronic prescription. Electronic prescribing is a paperless process. Public Health Law 3302
8 October 28, Why Electronic Prescribing? Next step in medical technology Curtail forged and counterfeit prescriptions Reduce medication errors associated with bad handwriting Improved workflow
9 October 28, Reducing Fraud & Forgery Easier to track and review records. Originate from one place with unique identifiers. Should reduce the volume of paper scripts in circulation that may be lost/stolen/forged.
10 October 28, Benefits of Electronic Prescribing Secure method of prescribing outside the practice site Patients no longer have to come to the office to pick up their prescription Reduction in office staff responsibilities Eliminates the two-step procedure for follow-up prescriptions
11 October 28, Electronic Prescribing Non-controlled Substances Controlled Substances
12 October 28, Electronic Prescribing DEA Interim Final Rule (IFR) Background Effective June 1, 2010, allows for electronic prescribing of controlled substances. The federal security requirements are included in the IFR regarding electronic prescriptions for controlled substances. The rule may be accessed via the U.S Department of Justice, DEA Office of Diversion Control website.
13 October 28, EPCS DEA Rule Background 21 CFR Part 1300 Definitions and 21 CFR Part 1311 Requirements for Electronic Orders & Prescriptions Provides practitioners with the option of signing and transmitting prescriptions for controlled substances electronically Permits pharmacies to receive, dispense and archive electronic prescriptions Maintains a closed system for controlled substance prescribing and dispensing through rigorous security requirements and audit trails CII-V can be prescribed electronically
14 October 28, Electronic Prescribing DEA Interim Final Rule (IFR) Background Use a certified application (software) that records, stores and transmits controlled substance information required under Parts 1306 and 1311 of 21 CFR. Note: BNE does not certify software applications.
15 October 28, Electronic Prescribing DEA Interim Final Rule (IFR) Background Identity-proofing - the process by which a credential service provider or certification authority validates sufficient information to uniquely identify a person Obtain and use a two factor authentication credential Something you have (token) Something you know (password, PIN) Something you are (biometric) Ensures prescription integrity and non-repudiation
16 October 28, EPCS Pharmacy Application Requirements Must meet DEA s requirements May only process controlled substance prescriptions using a certified pharmacy application Application must be able to set access controls Application must be able to import, store and display prescription requirements and verify the practitioner s digital signature Application must allow for pharmacist annotations and be maintained electronically
17 October 28, EPCS Pharmacy Application Requirements Be capable of retrieving controlled substance prescriptions by practitioner name, patient name, drug name and date dispensed. Allow downloading of prescription data into a database or spreadsheet that is readable and sortable. Maintain an audit trail of a number of actions (e.g., receipt annotation, alteration, changes in logical access). Conduct internal audits and protect records. Retain archived records electronically.
18 October 28, EPCS Transmission Copies of EPCS transmitted prescription must state Copy only not valid for dispensing. EPCS application must not allow for electronic transmission if original was printed prior to electronic transmission At no time may an intermediary convert the electronic prescription to another form (e.g., facsimile) for transmission
19 October 28, EPCS Transmission EPCS application must transmit the electronic prescription as soon as possible after signature by the practitioner Electronic prescription may be printed only if practitioner has been notified of transmission failure Printed version must contain information relating to original electronic transmission failure
20 October 28, Electronic Prescribing NYS Regulations Effective March 27, 2013, NYS Regulations allow for electronic prescribing of controlled substances (EPCS). Electronic prescribing of controlled and non-controlled substances becomes mandatory for all practitioners as of March 27, Additional information pertaining to electronic prescribing of noncontrolled substances is available on the NYSED Office of the Professions Website
21 October 28, NYS Regulations Electronic Prescribing Electronic prescriptions must be preserved for a period of five years Such records that are maintained electronically shall be made available to the DOH upon request, in a hardcopy format that is readily understandable, at the premises where the licensed activities are conducted.
22 October 28, NYS Regulations Electronic Prescribing Requires all practitioners and pharmacists engaging in electronic prescribing and dispensing of controlled substances to utilize computer applications that meet federal security requirements and to register such computer applications with the NYS DOH/BNE
23 October 28, Registration of Controlled Substance Software All practitioners should complete the registration of their EPCS software with BNE after the application has been installed by their vendor and the practitioner has completed all the necessary steps to begin transmitting controlled substance prescriptions.
24 October 28, Registration of Controlled Substance Software Re-registration is required, whichever occurs first: At least every two years, or Whenever functionality related to controlled substance prescription requirements is altered with the computer application.
25 October 28, EPCS NYS Regulations Registering Certified Application with BNE Current Process forms are available online Or online registration process Once Registration Form is Received About one week to process Registrant will receive an advising that application has been registered with NYS
26 October 28, Registration of Controlled Substance Software Physicians register online through the HCS using an application called ROPES = Registration for Official Prescriptions and E-prescribing Systems Facility Single Practitioners Nearly 30,000 practitioners have registered their certified EPCS software Official Prescription Program registration can be renewed at the same time Registration itself does not activate the software, this is a software vendor function.
27 October 28, ROPES EPCS Registration Screen
28 October 28, Information Required to Register Name of software company (ie. Microsoft) Name of the software application (ie. Windows) Version of the software (ie. 10)
29 October 28, Prescriber Responsibilities Safeguard credentials An electronic prescription may ONLY be reviewed and signed by the prescribing practitioner. Practitioners must retain sole possession of hard tokens, if used, and must not share passwords, other knowledge factors, or biometric information with any other person.
30 October 28, Prescriber Responsibilities Practitioners must notify the Bureau immediately upon discovery that the hard token has been lost, stolen, or compromised or the authentication protocol has been otherwise compromised. Failure to comply with this provision may result in prescribers being held responsible for any controlled substance prescriptions written using their two-factor authentication credential.
31 October 28, What Are We Telling Prescribers? Contact your software vendor to determine if the e-prescribing software meets all the federal security requirements for controlled substances If you have implemented EPCS software where you practice and registered it with BNE, start using it now If an institution: understand the federal rules associated with credentialing and logical access For practitioners, pharmacies and institutions ensure that your EPCS certified software is registered with BNE Check BNE s website often for more information BNE Newsletter and EPCS FAQ document
32 October 28, EPCS Take Aways Permissive now--mandated for ALL prescriptions March 27, 2016 Practitioners and pharmacists are required to use a certified software application for issuing and dispensing electronic prescriptions for controlled substances Certified software application must be registered with BNE If the prescription starts electronically, it remains electronic. Fax does NOT equate to electronic Proper safeguarding of credentials *** Token = Signature***
33 October 28, Electronic Prescribing Exceptions Technological or electrical failure; Use of EP would impact the patient s medical condition (up to 5 day supply for controlled substances); Prescriptions issued by a practitioner to be dispensed outside of New York State; Veterinarians; Practitioners who have received a waiver from the Department of Health. 33
34 October 28, Electronic Prescribing Waivers Practitioners may apply for a waiver from the requirement to electronically prescribe controlled substances. BNE is developing an online application for requesting a waiver. Waivers will be granted upon a proper showing of economic hardship, technological limitations outside of the practitioner s control or other exceptional circumstances. By statute, waivers are good for one year, after which a practitioner may apply for a renewal. 34
35 October 28, The Waiver Process Waiver timeline; What must be submitted to complete a waiver request; How we intend to review waivers under our interpretation of the statutory criteria; What situations may constitute exceptional circumstances.
36 October 28, Implications: Prescription Drug Crimes Pill Mills Identity Theft/Forgery Computer Trespass Diversions New Methods
37 October 28, Implications: Investigative Techniques Search Warrants Computer Forensic Analysis Subpoena Practice/ISP s, Software Providers Witness Interviews
38 October 28, Implications: Investigative Techniques Search Warrants - Search and Seize - What Does Token Control? - Describe with Particularity - Instrumentality of Crime
39 October 28, Implications: Investigative Techniques Computer Forensic Analysis - Are there two sets of records? - Access Logs
40 October 28, Implications: Investigative Techniques Subpoena Practice/ISP s, Software Providers Witness Interviews
41 October 28, Resources Federal Rule Electronic Prescriptions for Controlled Substances 10 NYCRR Part 80 Rules Click on the link to New York State Regulations related to Electronic Prescribing of Controlled Substances State Education Department Office of the Professions
42 October 28, Bureau of Narcotic Enforcement Joshua S. Vinciguerra, Director (518) Toll Free (866) Website: Riverview Center 150 Broadway, 6 th Floor Albany, New York 12204