Given that electronic prescribing will be mandatory for all physicians as of March 27, 2016, coupled with the incredible magnitude of this issue (termed an epidemic by Gov. Cuomo and Attorney General Schneiderman) every physician throughout New York should take immediate note of their prescribing protocols and begin whatever process is necessary to comply with the law and maintain that compliance without fail or exception.

The Internet System for Tracking Over-Prescribing Act, (I-STOP), establishes an on-line, real-time, controlled substance reporting system that requires prescribers (including physicians) to consult the prescription monitoring registry prior to prescribing or dispensing Schedule II, III or IV Controlled Substances. In addition, pharmacists, who did not previously have access to the registry, as a result of I-STOP will have access to the registry in order to review the controlled substance history of an individual for whom one or more prescriptions for controlled substances are presented to the pharmacist. (Click here to view the report of Attorney General Eric Schneiderman)

Unknown to most physicians, the New York Department of Health (NYDOH) already maintains an on-line database accessible to the 49,000 DEA-licensed practitioners throughout New York known as the Prescription Monitoring Program (PMP). In fact, only 3,600 prescribers have ever accessed the PMP to obtain patient information. Moving forward, NY DOH will update the current PMP in an attempt to increase participation, however, compliance with I-STOP is not being delayed pending that update to the PMP.

However, what is being overlooked by most practicing physicians who seek to comply with I-STOP is that they must first have an active Health Commerce Account with The State of New York, Department of Health’s Health Commerce System.

To download the EPCS Registration form click here

Call at 315-362-9888 and one of our sales person will walk you through an easy, fast, and inexpensive solution to I-STOP compliance

New York's e-prescribing mandate: Are prescribers and pharmacies ready? (Excerpts from New York Chapter American College of Physicians)

In less than seven months, 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.

Practitioners in New York State (excluding veterinarians) will be required to issue all prescriptions, including prescriptions for controlled substances, in electronic format by March 27, 2016, in accordance with legislation enacted in 2012. An electronic prescription is:

- Created, recorded, transmitted or stored by electronic means;
- Issued and validated with the prescriber’s electronic signature;
- Electronically encrypted to prevent unauthorized access, alteration or use of the prescription; and,
- Transmitted electronically directly from the prescriber to a pharmacy or pharmacist.

Prescriptions generated on an electronic system that are printed out or transmitted via facsimile or e-mail are not considered electronic, and are not compliant with the e-prescribing mandate.

The NYS Education Department hosted a roundtable meeting on Tuesday, September 9, 2014, to discuss the e-prescribing mandate. Representatives from pharmacy, medical and institutional providers heard presentations from the NYS Department of Health Bureau of Narcotic Enforcement (BNE) regarding the electronic prescribing mandate and also heard from Surescripts regarding the state of readiness of NYS pharmacies and prescribers to comply with the mandate.

Stakeholders participating in the roundtable shared information that practitioner readiness is highly dependent in many cases on the readiness of their EHR vendors, many of which do not yet have e-prescribing software applications that have been certified and audited in accordance with U.S. Drug Enforcement Agency (DEA) regulations. It was reported during the meeting that there are over 140 active EHR vendors in NYS, many of whom do not yet have a compliant application to offer their customers to comply with the NYS mandate. When asked if there was a chance that the mandate would be delayed, BNE representatives indicated that they did not expect a delay but indicated that they are committed to working with all parties to address difficulties in complying.

According to Surescripts, approximately 70% of practitioners in NYS have sent e-prescriptions to pharmacies for non-controlled substances in the past month. Although the March 2013 regulations implementing the 2012 legislation allow electronic prescribing of controlled substances, less than 1% of prescribers in NYS are currently enabled to prescribe controlled substances electronically.

Mandatory Electronic Prescribing (Excerpts from Office of the Professions – NYSED)

Effective March 27, 2016, a new law will require nurse practitioners, midwives, dentists, podiatrists, physicians, physician assistants and optometrists in New York State ("prescribers") to issue prescriptions electronically directly to a pharmacy, with limited exceptions. The law will not require a prescriber to issue a prescription electronically when:

- Electronic prescribing is not available due to temporary technological or electronic failure;
- The prescriber has a waiver granted by the New York State Commissioner of Health;
- The prescriber reasonably determines that it would be impractical for the patient to obtain substances prescribed by electronic prescription in a timely manner; or,
- The prescription will be dispensed at a pharmacy located outside New York State.

The new law requires electronic prescribing for all types of medications (controlled substances and non-controlled substances) and for syringes and other medical devices dispensed at a pharmacy in New York.

Information about this law (Public Health Law §281) is available on the New York State Department of Health website.

Electronic Prescriptions

An electronic prescription is a prescription that is:

- Created, recorded, transmitted or stored by electronic means;
- Issued and validated with the prescriber’s electronic signature;
- Electronically encrypted to prevent unauthorized access, alteration or use of the prescription; and,
- Transmitted electronically directly from the prescriber to a pharmacy or pharmacist.


Electronic prescription computer technology must comply with federal and New York regulations. These regulations require prescribers and pharmacists to have a secure (encrypted and encoded) system for electronic transmission of the prescription from computer to computer in order to protect the confidentiality and security of patient information. Electronic prescribing computer applications must also be “certified” (i.e. audited by an organization or certified by the federal Drug Enforcement Agency to ensure it meets technical standards acceptable to federal government).

EMAILed prescriptions are NOT considered electronic prescriptions since EMAIL is not considered a secure method of electronically transmitting a prescription. A faxed prescription is NOT considered an electronic prescription.

Prescribers must personally generate and transmit electronic prescriptions to pharmacies or pharmacists and are not legally allowed to delegate this responsibility to other individuals. Electronic prescriptions must include the same information that written prescriptions do except that:

- All electronic prescriptions must include an NPI number;
- Electronic prescriptions must be electronically signed; and,
- The prescriber must specify whether a prescription must be dispensed as written, if a brand-name product is therapeutically required.

Government Requirements for Electronic Prescribing

Prescribers must obtain a number of government approvals and identification numbers and register their “certified electronic prescribing computer application” in order to issue electronic prescriptions to pharmacies. Here’s a brief summary of these requirements.
-A National Provider Identifier (NPI) issued by the US Center for Medicaid and Medicare Services (CMS).
All electronic prescriptions issued in New York State must include a NPI. Federal law requires health care providers (including hospitals and prescribers) to use NPIs on electronic health care transactions (i.e., processing claims, status inquiries, eligibility inquiries). CMS issues NPIs to institutional health care providers (i.e., hospitals) and to licensed prescribers. If a prescriber works in a hospital, the prescriber may use the hospital’s NPI when issuing prescriptions. In most other cases, the prescriber must include his or her personal NPI on the prescription. For more information about applying for a NPI, visit: www.cms.hhs.gov/nationalProvIdentstand Applications can be submitted online or by regular mail.

- A Federal Drug Enforcement Administration Registration (DEA) Number issued by the US Department of Justice- Drug Enforcement Administration. In New York, a DEA number must be on every prescription for a controlled substance issued by a prescriber. The DEA issues DEA numbers to institutional health care providers (i.e., hospitals) and to licensed prescribers. In most cases, a prescriber must obtain a DEA number in order to prescribe or dispense controlled substances. In some cases, prescribers who are employed at a hospital may, when acting in the usual course of employment, may dispense or prescribe controlled substances under the DEA number of the hospital. For more information about applying for a DEA number visit, www.DEAdiversion.USDOJ.gov or call 1-877-883-5789, 1-800-882-9539 or 212-337-1593. Prescibers who do not prescribe controlled substances do not need a DEA number.

- A Health Commerce System Account (HCSA) from the New York State Department of Health. All prescribers must have a HCSA in order access an online Prescription Monitoring Registry when prescribing controlled substances. New York Law requires prescribers, when prescribing controlled substances, to consult the registry, which contains information about prescriptions for controlled substances obtained their patients. Instructions for establishing a Health Commerce System Account are available at the New York State Department of Health’s web site: www.health.ny.gov/professionals/narcotic/ Prescribers who do not prescribe controlled substances do not need an HCSA account.

- Registration with the New York State Department of Health’s Bureau of Narcotic Enforcement. Each prescriber must register with the New York State Health Department’s Bureau of Narcotic Enforcement in order to prescribe controlled substances. The registration must be renewed every 2 years. Instructions on registering are available at the New York State Department of Health’s Bureau of Narcotic Enforcement web site: www.health.ny.gov/professionals/narcotic/ Prescribers who do not prescribe controlled substances do not need to register as a prescriber of controlled substances with the New York State Department of Health’s Bureau of Narcotic Enforcement.

- Registration of "Certified" Electronic Prescribing Computer Applications. Prescribers must ensure that they issue electronic prescriptions using electronic prescribing computer applications that meet federal regulatory criteria for protecting the confidentiality and security of patient information. Information relating to federal criteria for electronic prescribing computer applications is available at: www.deadiversion.usdoj.gov/ecomm/e_rx/thirdparty.htm Prescribers should verify with the computer company that licenses that their electronic prescribing computer application that the application is "certified" (i.e. audited by an organization or certified by the federal Drug Enforcement Agency to ensure that the application meets technical standards acceptable to federal government). Prescribers must then complete a "Practitioner EPCS Registration Form" and file it with the New York State Department of Health’s Bureau of Narcotics Enforcement. On the form, the prescriber must identify the “certified” electronic prescribing computer application that he or she uses. For information about registration send an email to narcotic@health.state.ny.us Include "Electronic Prescribing" in the subject. Addition information about electronic prescribing is at: www.health.ny.gov/professionals/narcotic/electronic_prescribing/

- A Medicaid Provider Number. Prescribers must obtain a Medicaid Provider Number in order to prescribe for Medicaid beneficiaries. To access application forms for Medicaid reimbursement, go to www.emedny.org and click on the provider enrollment tab at the top of the page. If a prescriber will not be participating as a provider in New York’s Medicaid Program, the prescriber does not need to obtain a Medicaid Provider Number.

More Information on Mandatory Electronic Prescribing Effective March 27, 2016 (Excerpts from New York Chapter American College of Physicians)

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.

Exceptions to EPCS mandate; waiver process

The e-prescribing regulations include several exceptions to the mandate including when -

- electronic prescribing is not available due to temporary technological or electronic failure;
- the prescriber has a waiver granted by the New York State Commissioner of Health;
- the prescriber reasonably determines that it would be impractical for the patient to obtain substances prescribed by electronic prescription in a timely manner; or
- the prescription will be dispensed at a pharmacy located outside New York State.

The e-prescribing regulations indicate that the Department of Health may grant waivers of the e-prescribing mandate for renewable periods of up to one year. Waivers may be granted based upon a practitioner’s showing that his or her ability to issue electronic prescriptions is unduly burdened by:
- economic hardship;
- technological limitations that are not reasonably within the control of the practitioner; or
- other exceptional circumstance demonstrated by the practitioner.

Although the Department has not provided guidance or examples of exceptional circumstances under which a waiver may be granted, Department representatives during the September 9 roundtable meeting indicated that waiver requests will be evaluated on a case-by-case basis. Department representatives also indicated that because waivers are only effective for one year periods, the Department does not anticipate acting on waiver requests until the first quarter of 2016.

Implications for retired practitioners

Many practitioners in New York State who have retired from practice choose to maintain their licensure in order to issue occasional prescriptions for friends or family members. Although not explicitly prohibited by statute or regulation, the practice is frowned upon by disciplinary bodies, and practitioners may be charged with professional misconduct for failing to maintain patient records that accurately reflect the evaluation and treatment of the family members or friends for whom they issue prescriptions. With the implementation of the e-prescribing mandate, retired practitioners will also need to utilize e-prescribing software to issue prescriptions. It is unlikely that a retired practitioner will be granted a waiver.

Effect of the Internet System for Tracking Over-Prescribing (I-STOP) Act on Physicians (Excerpts from New York Chapter American College of 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.

Experiencing a Delay in Processing Your Health Commerce Account - NYSDOH Statement
• 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

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)?
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 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)

1. 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

2. 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) 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?

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
• Hospice
• 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)

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:
1. Go to the HCS at: https://commerce.health.state.ny.us
2. 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).
3. Select "Applications" at the top of the page. Click on the letter "P".
4. Scroll down to "Prescription Monitoring Program Registry"
5. 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]
6. Click to open the program
7. Enter patient information and your DEA registration number
8. Review the Frequently Asked Questions within the application for further information

How to Assign a Designee (Access screenshots)

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:
1. 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
2. You may need to Register your Medical Practice if not done already - Paperless HCS Medical Practice Account Quick Reference Guide
3. 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

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:
http://www.health.ny.gov/professionals/narcotic/prescription_drug_abuse_awareness/
• 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