The I-STOP Act and E-Prescribing Updated News!
Late last Friday, March 13, Governor Cuomo signed legislation S.2486(Hannon)/A.4274 (McDonald) into law to delay by one year the implementation of New York's e-prescribing requirements. While the mandate to electronically transmit all prescriptions, including controlled substances is delayed until March 27, 2016, we urge all members to continue to work with their vendors now to get their e-prescribing software up and running as soon as possible. Those who have already begun e-prescribing including controlled substances have reported great satisfaction and success. There are extensive resources for finding certified vendors and preparing your practice for implementing e-prescriptions available on the NYACP website.
The e-prescribing requirements were a part of the State's Internet System for Tracking Over Prescribing (I-STOP) laws, enacted in 2012. I-STOP requires all prescribers to
1) consult the Prescription Monitoring Program (PMP) prior to prescribing Schedule II, III and IV controlled substances and
2) electronically transmit all prescriptions.
To do so, each prescriber must have an individual Health Commerce System Account (HCS) to gain access to the PMP registry at https://commerce.health.state.ny.us
New York's e-prescribing mandate: Are prescribers and pharmacies ready?
This time next year, practitioners in New York State (except for veterinarians) will be required to issue all prescriptions in electronic format. The NYS Education Department recently hosted a roundtable to discuss the e-prescribing mandate and the state of readiness of NYS pharmacies and prescribers to comply with the mandate. Pharmacy, medical and institutional providers should familiarize themselves with the requirements of the mandate and work with their IT vendors to ensure that they will be able to comply by March 27, 2016.
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For more information on the content of this alert,
contact your Nixon Peabody attorney or:
Laurie T. Cohen, 518-427-2708, firstname.lastname@example.org
Brooke A. Lane, 516-832-7572, email@example.com
NYACP Announces New Member Benefit
The New York Chapter Amercian College of Physicians is pleased to announced a new member benefit to help physicians comply with the I-STOP E-Prescribing Mandate effective March 27, 2015.
NYACP and DrFirst are working together to offer members a discount on a standalone e-prescribing solution.
For more information about the I-STOP e-prescribing mandate, DrFirst's standalone e-prescribing products and discount pricing for NYACP members only, please click on the following links:
- Request Standalone e-Prescribing Product and SPECIAL DISCOUNT PRICING FOR NYACP MEMBERS ONLY
- The Controlled Substance Abuse Epidemic and I-STOP
- How To Comply with I-Stop and Helpful Steps
- DrFirst's Standalone E-Prescribing Solution
- Medication History, Medication Adherence and E-Prescribing
Frequently Asked Questions For
Electronic Prescribing of Controlled Substances
More Information on Mandatory Electronic Prescribing Effective March 27, 2016
By March 27, 2016, all prescriptions (including prescriptions for non-controlled substances) issued in New York State must be electronically transmitted, with certain limited exceptions.
For electronic prescribing of controlled substances (EPCS), the regulations require a practitioner to register their certified electronic prescribing computer application with the New York State Department of Health, Bureau of Narcotic Enforcement (BNE). To register your computer application with BNE, please complete the enclosed EPCS Registration form and email it to firstname.lastname@example.org with "Practitioner EPCS Registration" in the subject line.
The DEA requires two-factor authentication for signing controlled substance prescriptions. The factors must include two of the three following authentication modalities: Something you know (password, key, security question); Something you have (PKI smartcard, key fob token); or Something you are (biometric). For example, a key fob token and password would work as they combine two different modalities: something you have and something you know. The e-prescribing software vendors who are certified for EPCS will support at least one of these options for two-factor authentication.
Identity Proofing and Registration - Once you have ePrescribing software that’s been audited and certified, and have put in place supported two-factor authentication technologies, physicians must also go through an identity proofing process.
- Individual care providers using their own DEA numbers need to go through an identity proofing process to get their EPCS signing credentials. If they are using their own DEA number, they need to use a federally approved Credential Service Provider (CSP) or certificate authority (CA).
- Care providers in healthcare organizations like hospitals can use the institutional DEA number if it is combined with a unique “internal code” assigned to that prescriber. In this case, the practitioner gets EPCS signing credentials from the hospital credentialing office.
Care providers must then register their authentication credentials and request EPCS privileges. Any security breaches, including a lost or stolen token, must be reported within one business day. If an electronic prescription is unsuccessful, the replacement process must indicate that the original electronic attempt was sent unsuccessfully to the pharmacy.
New York State Regulations related to Electronic Prescribing of Controlled Substances may also be accessed electronically. Specific regulations pertaining to issuing electronic prescriptions for controlled substances may be accessed in 10 NYCRR 80.64
If you have met all federal security requirements and would like to register the application with the Bureau of Narcotic Enforcement, send an email to email@example.com. Include "Electronic Prescribing" in the subject.
- Letter to Pharmacies Regarding Electronic Prescribing Registration
- Letter to Practitioner Regarding Electronic Prescribing Registration
- Practitioner EPCS Registration (DOH-5121)
- Instructions for Practitioner EPCS registration form
Effect of the Internet System for Tracking Over-Prescribing (I-STOP) Act on Physicians
In response to concerns over the abuse and diversion of controlled substances, Governor Andrew Cuomo signed the I-STOP act into law in 2012. The law requires all prescribers to consult the Prescription Monitoring Program (PMP) prior to prescribing Schedule II, III and IV controlled substances. Each prescriber must have an individual Health Commerce System Account (HCS) to gain access to the PMP registry. The New York State Department of Health is in the process of enhancing the PMP which will provide detailed information to practitioners about a patient’s controlled substance prescription history. >Access Frequently Asked Questions
- What is the Health Commerce System?
- The Benefits of the Enhanced Prescription Monitoring Program
- Obtaining a Health Commerce System (HCS) Account for Licensed Medical Professionals - Paperless Process
- Obtaining a Health Commerce System (HCS) Account for Unlicensed Medical Professionals - Paperless Process
- How Does This Affect My Practice?
- How to Gain Access to the Prescription Monitoring Program
- How to Assign a Designee
- Talking with Patients About Substance Abuse, Diversion and ISTOP
- Additional resources
IF YOU ARE EXPERIENCING A DELAY IN PROCESSING YOUR HEALTH COMMERCE ACCOUNT | Top
The NYS Department of Health has issued the following statement:
“The updated Prescription Monitoring Program Registry is operational and has been available on-line since June 12, 2013. All users must access the PMP Registry through the Department of Health's secure Health Commerce System ("HCS"). With the upcoming effective date of the I-STOP law requiring the use of the PMP Registry, a large late surge of practitioners are now submitting requests for HCS accounts. Although the Department of Health is working diligently to process all requests, this significant influx has resulted in a delay in processing accounts.
During this transition period, practitioners who are making a good faith effort to apply but are unable to establish HCS accounts, should continue to provide treatment to their patients in the same manner as they currently do, including the prescribing of controlled substances without accessing PMP Registry. We expect this transition period to last through October.”
The statement can be accessed by visiting: http://www.health.ny.gov/professionals/narcotic/prescription_monitoring
What is the Health Commerce System (HCS)? | Top
The Prescription Monitoring Program (PMP) is an application within the Health Commerce System. The Health Commerce System is a secure online communications system operated by the NYS Department of Health. It supports the exchange of routine and emergency statewide health information by local health departments and health facilities, providers and practitioners. Through this system, practitioners now order official prescription pads, subscribe to public health alerts through the Health Alert Network, and access registries along with other health information exchange applications that focus on preparedness, planning, communications, response and recovery.
- To access the Health Commerce System, please visit: https://commerce.health.state.ny.us If you already have a HCS account, check to make sure your password is up to date.
Obtaining a Health Commerce System (HCS) Account for Licensed Medical Professionals - Now a Paperless Process | Top
The Health Commerce System (HCS) Medical Professions account request is now paperless and does not require signatures and notary. Apply for an HCS account by filling out an online form. Have your NYS DMV Driver License or NYS DMV Non-driver Photo ID ready. Medical Professionals that do not have a NYS DMV Driver License or NYS DMV Non-driver Photo ID can still apply for an HCS medical professions account using the existing process which requires signatures and a notary.
- Apply for an HCS Medical Professions account through the New York State Department of Health.
> Need help? Access this Quick Reference Sheet
Obtaining a Health Commerce System (HCS) Account for Unlicensed Medical Professionals - Now a Paperless Process | Top
To enroll using the paperless process, you must have a NYS DMV Driver License or NYS DMV Non-driver Photo ID. This is a two step process. It is recommended that you review the reference guide before applying. Professionals that do not have a NYS DMV Driver License or NYS DMV Non-driver Photo ID can still apply for an HCS user account using the existing process which requires signatures and a notary. Please see your HCS Coordinator to apply. If you do not know your HCS Coordinator, please call the Commerce Accounts Management Unit (CAMU) at 1-866-529-1890 option1 (M-F 8am-4:45pm)
- Register for an Health Commerce System account through the New York State Department of Health.
> Need help? Refer to Step A in this quick reference guide
- Enroll your account on the HCS. This step must be done with the HCS Coordinator.
> Need help? Refer to Step B in the quick reference guide
Need Further Assistance Activating Account or Logging In?
Please call the Commerce Account Management Unit (CAMU) help desk for assistance with logging in / activating your HCS account 1-866-529-1890. Please note: Telephone lines are extremely busy. NYACP DOES NOT have access to your HCS account information.
The Benefits of the Enhanced Prescription Monitoring Program (PMP) | Top
The Prescription Monitoring Program (PMP) registry will provide practitioners with confidential reports from data provided by pharmacies across the state. Accessed through the secure, online New York Health Commerce System, results will be available in real-time. The registry is a tool to help enhance understanding of a patient’s controlled substance utilization, guide management, and improve quality of care. For questions related to the Prescription Monitoring Program, the NYS Department of Health Bureau of Narcotic Enforcement has a toll-free number that you can call: 1-866-811-7957.
How Does This Affect My Practice? | Top
Beginning August 27th, 2013, practitioners are required to consult the Prescription Monitoring Program (PMP) registry in most cases prior to prescribing any controlled substance listed in Schedule II, III or IV. In order to consult the registry, practitioners must have an established Health Commerce Account.
Practitioners are permitted to designate another person employed by or under contract with their practice to access information from the Registry on behalf of the practitioner, however the duty to consult and review is with the prescriber. Instructions on how to designate another person are found below and you can register unlicensed professionals now for a health commerce account.
Exceptions to the "Duty to Consult" include:
- Practitioner administering a controlled substance
- For use within an institutional dispenser
- Emergency Department (if limited to a 5 day supply)
- Practitioner is unable to access in a timely manner (5 day supply)
- Consultation would adversely impact a patient’s medical condition
- Methadone programs
- Technological failure of PMP or practitioner’s hardware
- Practitioner has been granted a waiver by DOH based on technological limitations or exceptional circumstances not within practitioner’s control
How to Gain Access to the Prescription Monitoring Program (PMP) | Top
The online PMP program, formerly referred to as the Controlled Substance Information program (CSI), allows you to review your patients' recent controlled substance prescription history at any time, therefore, giving you more information to exercise your professional judgment in treating your patients. As of June 13, 2013, the first phase of the new PMP is active. After logging into your HCS account, the PMP can be accessed from the first page of the HCS by clicking onto the NYS PMP logo. Over the next two months additional features will be added, including designee access, bulk patient searches and DEA prescribing histories.
Currently, any New York State licensed prescriber who holds a valid DEA registration may access the PMP registry. Each prescriber must have an individual Health Commerce System Account (HCS) to gain access.
You can also access the PMP by following these directions:
- Go to the HCS at: https://commerce.health.state.ny.us
- Log onto the system with your user ID and password (If you can't remember your password, call the Commerce Account Management Unit at 1-866-529-1890, Option 1, for assistance).
- Select "Applications" at the top of the page. Click on the letter "P".
- Scroll down to "Prescription Monitoring Program Registry"
- Click the green plus sign under the Add/Remove column to add this application to your favorites so you don't have to scroll down each time in the HCS [optional]
- Click to open the program
- Enter patient information and your DEA registration number
- Review the Frequently Asked Questions within the application for further information
How to Assign a Designee (Access screenshots) | Top
Only licensed practitioners are able to add or review Designees. Possible designees include: Medical Residents, Limited Permit Physicians, Medical Assistants and Administrative Staff. Registration of your medical practice is required in order for you to establish HCS accounts for employees who will access the Prescription Monitoring Program (PMP) as your designee. Be sure to follow these steps to obtain an account, register your practice and set up users as designees:
- You must have/apply for an HCS Medical Professions account - https://apps.health.ny.gov/pub/top.html
Paperless HCS Medical Professions Account Quick Reference Guide
- You may need to Register your Medical Practice if not done already - Paperless HCS Medical Practice Account Quick Reference Guide
- Your deisgnee must Register for an HCS user account at https://apps.health.ny.gov/pub/usertop.html
In order to assign a designee, licensed practitioners will need to:
- Log into the Health Commerce System (HCS) and access the Prescription Monitoring Program (PMP).
- Click on the Designation tab. The Designation page can be accessed at any time from the “Designation” link in the horizontal menu at the top of the screen.
- Input the Designee's (HCS) ID
- Click "Search".
- The Designee's name will appear with a button that says designate. Click on the button and the person is designated.
- To remove a Designee, click the checkbox next to it and then click the “Remove” button. Multiple Designees may be removed at the same time.
How to Add an Unlicensed Resident or Medical Intern to the PMP Designee Role and a HCS User to the PMP Designee Reviewer Role at Medical Teaching Facilities
Two new roles have been created in the Health Commerce System for HCS Coordinators to easily monitor and designate any medical residents or medical interns working at a facility. Download this document for a description of the roles, instructions for assigning someone to each role, and instructions for obtaining a HCS account for a resident/intern.
Talking with Patients About Substance Abuse, Diversion and ISTOP | Top
As of right now, there is not a specific fact sheet for patients regarding the ISTOP Act.
Treatment program information is available from the NYS Office of Alcoholism and Substance Abuse Services at www.oasas.ny.gov or by calling 1-877-846-7369. You may also access the Substance Abuse and Mental Health Services Administration (SAMHSA) website at www.buprenorphine.samhsa.gov to locate a participating opioid addiction physician in your area.
NYSDOH patient education materials are available and include the following. You may call this number to request copies of any of these materials: 1-866-811-7957
- The Prescription Drug Awareness section on the NYSDOH Bureau of Narcotic Enforcement website. There are a number of brochures/posters that you can request copies of at no charge:
- A popular poster called Tell the Doctor : http://www.health.ny.gov/publications/1066.pdf
- A brochure that was developed for practitioners and pharmacists describing the NYS PMP: http://www.health.ny.gov/publications/1084.pdf
After reviewing the PMP for a patient, if the practitioner suspects diversion, there is link on the bottom of the Confidential Drug Utilization Report to report a prescription discrepancy, or you may send questions or comments about the report to the Bureau of Narcotic Enforcement. The practitioner may also contact the Bureau of Narcotic Enforcement office in your area to speak to a narcotic investigator:
- Albany/Central Office: (866) 811-7957 Opt. #2
- Western Area Regional Office (Buffalo Area): (716) 847-4532
- Rochester Office: (585) 423-8043
- Syracuse Office: (315) 477-8459
- New York City Metropolitan Area Regional Office: (212) 417-4103
ACP Center for Practice Support Resources
- ACP Internist, June 2013: Center for Practice Support (CSP) Tips - Reducing the risks of opioid management
- ACP Inernist, July/August 2013: Center for Practice Support Tips - Documenting opioid management is as important as doing it
Additional Resources | Top
New York State Department of Health
- NYSDOH ISTOP/Prescription Monitoring Program (PMP) Resource Page - Information for Practitioners
- Bureau of Narcotic Enforcement Contact Information
- NYS PMP Frequently Asked Questions - Updated in July 2013
- NYS PMP Brochure for Practitioners and Pharmacists
- How to Access the NYS PMP Registry
- How to Assign a Designee to the NYS PMP - Screenshots
- How to Add an Unlicensed Resident or Medical Intern to the PMP Designee Role
- How to Access the NYS PMP Registry as an Unlicensed Professional
- Spring 2013 Update - Bureau of Narcotic Enforcement Newsletter
- NYSDOH Medication Drop Box Program
Laurie Cohen, Esq., Partner at Nixon Peabody and Chapter's Legal Counsel
- Unlicensed Medical Residents and the NY Prescription Monitoring Program
- What’s the Impact of New York’s Prescription Monitoring Program on Hospitalists?
- NYS Department of Health Issues Proposed Regulations to Implement Enhanced Prescription Monitoring Program
Last Updated: 10.03.13