E-Prescribing/I-STOP

E-Prescribing

Health Commerce System

Overview & News

Prescription Monitoring Program


E-Prescribing Mandate Effective Immediately!

While ALL PRESCRIPTIONS, including prescriptions for controlled substances, must be submitted in electronic format, your Chapter continues efforts on your behalf to seek clarifications and solutions to several unresolved issues as identified by our members. We seek to minimize the burden on our members, their practices and their patients – so as you encounter any problems, at the bottom of this article we ask you to keep us informed so we can continue to work toward resolution of these challenges. 

There has been constant discussion with the Department of Health (DOH) and the Bureau of Narcotic Enforcement (BNE) since the delay of the e-prescribing mandate one year ago, but now it is urgent to keep the lines of communication open.

On March 16, 2016, the Commissioner of the New York State Department of Health issued a memorandum to practitioners and pharmacists granting a “blanket one year waiver” of the requirement to e-prescribe in certain “exceptional circumstances”. Prescriptions written under this blanket waiver do not need to be reported to the DOH as they are treated as a waiver for one year.  

You can view the Commissioner’s Letter here.


These circumstances had been identified as barriers to patient care, and is precisely why the Chapter needs to continue to monitor issues you face as you implement the e-prescribing law in your practice.

  1. Any practitioner prescribing a controlled or non-controlled substance, containing two (2) or more products, which is compounded by a pharmacist;
  2. Any practitioner prescribing a controlled or non-controlled substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion;
  3. Any practitioner prescribing a controlled or non-controlled substance that contains long or complicated directions;
  4. Any practitioner prescribing a controlled or non-controlled substance that requires a prescription to contain certain elements required by the federal Food and Drug Administration (FDA) that are not able to be accomplished with electronic prescribing;
  5. Any practitioner prescribing a controlled or non-controlled substance under approved protocols under expedited partner therapy, collaborative drug management or in response to a public health emergency that would allow a non-patient specific prescription;
  6. Any practitioner prescribing an opioid antagonist that would allow a non-patient specific prescription;
  7. Any practitioner prescribing a controlled or non-controlled substance under a research protocol;
  8. A practitioner prescribing a controlled or non-controlled substance either through an Official New York State Prescription form or an oral prescription communicated to a pharmacist serving as a vendor of pharmaceutical services, by an agent who is a health care practitioner, for patients in nursing homes and residential health care facilities as defined in section twenty-eight hundred one of the public health law;
  9. A pharmacist dispensing controlled and non-controlled substance compounded prescriptions, prescriptions containing long or complicated directions and prescriptions containing certain elements required by the FDA or any other governmental agency that are not able to be accomplished with electronic prescribing;
  10. A pharmacist dispensing prescriptions issued under a research protocol, or under approved protocols for expedited partner therapy, or for collaborative drug management;
  11. A pharmacist dispensing non-patient specific prescriptions, including opioid antagonists, or prescriptions issued in response to a public health emergency issued; and
  12. A pharmacist serving as a vendor of pharmaceutical services dispensing a controlled or non-controlled substance through an Official New York State Prescription form or an oral prescription communicated by an agent who is a health care practitioner, for patients in nursing homes and residential health care facilities as defined in section twenty-eight hundred one of the public health law.

The blanket waivers do not impact any general waiver that a practitioner has obtained directly from the Department (see reference below on how to obtain a waiver).

What does need to be reported to DOH:

Of special importance, there are only a few exceptions upon which a practitioner may rely if he or she is unable to issue a prescription electronically. These are:

•       Temporary technological or electrical failure - PHL 281(3)(b).
•       Issued by a practitioner under circumstances where, notwithstanding the practitioner’s present ability to make an electronic prescription, a 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, provided that if such prescription is for a controlled substance, the quantity of controlled substances does not exceed a five day supply if the controlled substance were used in accordance with the directions for use - PHL 281(3)(d).
•       A prescription issued by a prescriber to be dispensed outside of New York State – PHL 281(3)(e).

If you rely upon one of these exceptions, you must make a note of such fact in the patient’s record and you must also notify the NYS Department of Health (DOH) by email. The e-mail notification to the Department should be sent to erx@health.ny.gov and must include the following:

  1. That it is a notification to the Department pursuant to Public Health Law Section 281(4) or (5);
  2. Practitioner’s name;
  3. Practitioner’s license number;
  4. Practitioner’s telephone number;
  5. Practitioner’s preferred work e-mail address;
  6. Practitioner’s work address;
  7. Patient initials only (the Department does not want patient confidential information to be sent); and
  8. The reason(s) for the exception(s), including the citation(s) to PHL Section(s) 281(3)(b), (d), and (e) as referenced in the bullets above.

I-STOP REMINDER:  

There were two important sections of the I-STOP (Internet System for Tracking Over Prescribing) law – one was mandating use of the Prescription Monitoring Program (PMP) and the second was e-prescribing.

As we remain in the midst of a serious opioid epidemic, the new CDC opioid guidelines recommend the use of PMP's as a central way to track opioid prescriptions. Utilizing the PMP allows you to obtain your patient’s history of access to controlled substances from yourself and other prescribers and helps to inform your decision to prescribe a controlled substance to your patients at the time of care.

These are the original I-STOP exemptions (those who do not need to consult the PMP prior to writing a controlled substance script):

  • Veterinarians
  • Certain prescriptions for methadone
  • Controlled substances administered in the prescriber’s office
  • Prescriptions and orders for controlled substances for use within a hospital or clinic
  • Prescriptions written in an emergency department for no more than a 5-day supply
  • Prescriptions written for hospice patients
  • Not reasonably possible to access the registry in a timely manner
  • Registry not operational, or waiver granted due to technological limitations

Patient Education: ACP Develops Safe Opioid Use Resources

In response to public health concerns over the adverse impact of opioid misuse, two new patient education resources have been developed by ACP. 

The “Patient FACT” sheet on Safe Opioid Use answers the following questions

  1. What Are Opioids?
  2. Will Opioids Help My Pain?
  3. What Are the Side Effects of Opioids?
  4. What Are the Risks of Opioids?
  5. Using Your Opioid Medicine Safely and
  6. Questions for My Doctor. 

The “Patient FACT” sheet on Chronic Pain provides responses to:

  1. What is Chronic Pain?
  2. What Are the Symptoms of Chronic Pain?
  3. How is Chronic Pain Diagnosed?
  4. How is Chronic Pain Treated?
  5. How Can I Manage My Chronic Pain and
  6. Questions For My Doctor.

Please feel free print out these documents for distribution to your patients.  


CDC Issues Recommendations for Prescribing Opioids for Chronic Pain

The Centers for Disease Control and Prevention (CDC) issued 12 recommendations about opioid prescribing for primary care clinicians treating adult patients with chronic pain outside of active cancer treatment, palliative care, and end-of-life care.

The recommendations are intended to improve communication about the benefits and risks, improve safety and effectiveness of pain treatment, and reduce risks associated with long-term opioid therapy. They were published March 15 by the Journal of the American Medical Association.

The recommendations focused on 3 areas:

Starting or continuing opioids for chronic pain

  • Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioids only if expected benefits for both pain and function outweigh risks to the patient.
  • Before starting opioids, clinicians should establish realistic goals for pain and function, and should consider how therapy will be stopped if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.
  • Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy.

Opioid selection, dosage, duration, follow-up, and discontinuation

  • When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release or long-acting opioids.
  • Clinicians should prescribe the lowest effective dosage to start. Clinicians should carefully reassess evidence of individual benefits and risks when increasing dosage to 50 morphine milligram equivalents (MME) or more per day, and should avoid or carefully justify a decision to increase dosage to 90 MME or more per day.
  • When opioids are used for acute pain, clinicians should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than 7 days will rarely be needed.
  • Clinicians should evaluate benefits and harms within 1 to 4 weeks of starting opioid therapy or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids.

Assessing risk and addressing harms of opioid use

  • Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone for opioid overdose risk factors such as history of overdose, history of substance use, higher opioid dosages (≥50 MME/d), or concurrent benzodiazepine use.
  • Clinicians should review the patient's history of controlled substance prescriptions using state prescription drug monitoring program data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. This should be done when starting opioids and thereafter every 3 months for every prescription.
  • Clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.
  • Clinicians should avoid prescribing opioids at the same time as benzodiazepines whenever possible.
  • Clinicians should offer or arrange treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

Electronic Prescribing Waiver Application Now Available Through the Health Commerce System


The Bureau of Narcotic Enforcement has announced the availability of the Electronic Prescribing Waiver (EPW) application on the Health Commerce System (HCS). This application allows a Practitioner, Medical Group Practice or Institution to submit a request for a waiver from the requirement to electronically prescribe, but requires detailed information and documentation for each request.

Instructions for using the online application based on the type of requester: 

A paper version for each requester type is available upon request. More on this process and the E-Prescribing deadline will follow in upcoming YCIA editions.



Frequently Asked Questions For Electronic Prescribing of Controlled Substances


Click here to review the Laws and Regulations for Electronic Prescribing of Controlled Substances (EPCS) as well as an FAQ
Revised: January 2016

Standalone E-Prescribing Vendor List

Additional Resources


Pain Management Courses (worth CME!)

  • SAFE Opioid Prescribing
  • Pri-Med Courses
  • Pri-Med Opioid Screening Now Available

    With approximately 100 million adults in the U.S. suffering from chronic pain, the nonmedical use of prescription opioids has become a public health issue, and prompted the U.S. Food and Drug Administration to establish the Risk Evaluation and Mitigation Strategy (REMS) mandate.  A total of 26 Continuing Medical Education (CME) and Continuing Education providers, including ACP, have created educational initiatives to help prescribers ensures that the benefits of a drug outweigh the risks for patients receiving extended release and long acting opioids.

    ACP developed online training modules, with Pri-Med, to educate clinicians about best practices when prescribing opioids to patients and to help prescribers manage risk for abuse and inappropriate use. The REMS training modules provide comprehensive educational information for primary care clinicians, and can be completed for CME credit.  Access the online modules for additional information. 

    A brief video from Steven Weinberger, MD, FACP, executive vice president and CEO of ACP, highlights the initiative’s goal of reducing misuse, abuse and overdose deaths associated with prescription opioids. 

    Note: an ACP Username/password is required to login)

New York State Department of Health

 

Overview


What is the I-STOP Act?


I-STOP


The I-STOP (Or the Internet System for Tracking Over-Prescribing) Act was passed by the New York State legislature to help combat the rising rates of prescription drug abuse in New York. The law requires that:

  • Expansion and mandatory consultation of the Prescription Monitoring Program (PMP prior to issuing any prescription for a controlled substance in New York State
  • E-prescribing of all substances, including controlled substances, by March 27, 2016
      (note – recently extended from the original e-rx requirement date of March 27, 2015)
  • Changes by the State to controlled substance schedules
  • Establishment by the State of a Prescription Pain Medication Awareness Program
  • Creation of a safe disposal program (operated through some local police departments)

The Prescription Monitoring Program


How to Gain Access to the Prescription Monitoring Program (PMP)


The online PMP program, formerly referred to as the Controlled Substance Information program (CSI), gives you access 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.  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.

Currently, any New York State licensed prescriber who holds a valid DEA registration must access the PMP registry prior to issuing a legend of controlled substance prescription. 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. Click on the PNP Icon
  4. Log in
  5. Click to open the program                                                                  
  6. Enter patient information and your DEA registration number
  7. Review the Frequently Asked Questions within the application for further 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?


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

Talking with Patients About Substance Abuse, Diversion and I-STOP


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 atwww.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

 There is a Prescription Drug Awareness section on the NYSDOH Bureau of Narcotic Enforcement website, with 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/

In addition, there are a few materials physicians can use in their practice:

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:


The Health Commerce System


What is the Health Commerce System (HCS)? 


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


Are You Having Trouble Logging Into the Health Commerce System for Use in I-STOP, E-Prescribing or Ordering Prescription Forms?


On November 18, 2015, the Health Commerce System (HCS), New York State DOH's primary resource for communications with licensed physicians, implemented several important updates to their interface. As a result, older internet browsers and operating systems may not work properly. You can test the compatibility of your browser at https://www.ssllabs.com/ssltest/viewMyClient.html 

Due to application and data security requirements, HCS support for unsecured Internet browsers and operating systems will be discontinued. Specifically, this change will target older versions of Internet Explorer (versions 6, 7, 8 and 9) and the Windows XP operating system.  Windows XP reached its end-of-life on April 8, 2014 and has not received security updates for over 19 months and is therefore considered unsecure. Microsoft has announced that "beginning January 12, 2016, only the most current version of Internet Explorer available for a supported operating system will receive technical support and security updates" (https://support.microsoft.com/en-us/gp/microsoft-internet-explorer). Older versions of Internet Explorer will rapidly become unsecure and the transmission or exchange of data through these browsers and Windows XP is at risk.

To upgrade your operating system please visit http://www.microsoft.com to determine if your computer is compatible with the latest Windows operating system and if you qualify for a free upgrade or will have to purchase a license. Please note that Windows 10 users will still need to install Microsoft Internet Explorer 11 or Google Chrome as most of HCS applications do not yet support the Microsoft Edge browser.

On the Windows platform, the HCS currently supports Microsoft Internet Explorer and Google Chrome, and offers partial support for Mozilla Firefox. Download the latest version of these browsers from the following links:

If you require any further assistance, please contact the NYACP Office at 518-427-0366 and ask for Ben Max.


Obtaining a Health Commerce System Account
 

 Obtaining a HCS Account for LICENSED Medical Professionals

 Obtaining a HCS Account for UNLICENSED Medical Professionals

  • Paperless Process
  • Does not require signature and a notary
  • Have NYS DMV Driver License or
    NYS DMV Non-driver Photo ID ready*.
  • You can apply here
  • Need help? Quick Reference sheet
  • If you do not know your HCS Coordinator, please call
    Commerce Accounts Management Unit (CAMU)
    at 1-866-529-1890 option1 (M-F 8am-4:45pm)
  • Paperless Process
  • Two step process that requires NYS DMV Driver License or
    NYS DMV Non-driver Photo ID*
  • It is recommended to review the reference guide before applying
  • Please see your HCS Coordinator to apply
  • If you do not know your HCS Coordinator, please call
    Commerce Accounts Management Unit (CAMU)
    at 1-866-529-1890 option1 (M-F 8am-4:45pm)


*If no valid Photo ID is available, licensed medical professionals can still apply by using the existing process, which requires a signature and a notary

For Unlicensed Professionals:

  1. Register for a Health Commerce System account through the New York State Department of Health
  2. Enroll your account on the HCS. This step must be done with the HCS Coordinator

Refer to this quick reference guide for assistance
Users can refer to Step A
Coordinators can refer to Step B


ROPES: Registration for Official Prescriptions and E-Prescribing Systems


The online registration process for registering certified Electronic Prescribing of Controlled Substance (EPCS) software application(s) with the Department of Health, Bureau of Narcotic Enforcement (BNE) is known as ROPES: Registration for Official Prescriptions and E-Prescribing Systems.

ROPES allows the practitioners to renew their registration for the Official Prescription Program (OPP) and register their certified electronic prescribing software application(s) for controlled substances. Practitioners that do no issue prescriptions for controlled substances do not have to obtain certified EPCS software and, therefore, do not have to register their E-prescribing software for non-controlled substances with BNE.

The practitioner’s certified EPCS software application(s) must be registered with BNE after the practitioner has completed ALL three of the following:

  1. Implementation of the certified EPCS software application(s) into production;
  2. Identity proofing; and
  3. Receipt of the two-factor authentication credentials

Should you have any questions regarding numbers 2 and 3 above, please consult your e-prescribing software vendor or review the DEA Interim Final Rule section 1311.100 at http://www.deadiversion.usdoj.gov. Once all three of these steps are completed, the practitioner should complete the EPCS registration using ROPES.

How to access ROPES and register for OPP and EPCS:

  1. Login to the Health Commerce System at https://commerce.health.ny.us
  2. Select “My Content” at the top of the page
  3. Scroll down and select “All Applications”
  4. Scroll over and select “R”
  5. Scroll down and select ROPES
  6. Follow screen prompts to renew your OPP registration – confirm address information is correct
  7. Click button “Register EPCS System”
  8. Enter certified EPCS software information or select software from the dropdown menu
  9. Click “Yes” if you agree with the EPCS Attestation

Additional information regarding EPCS may be found at the following link: http://www.health.ny.gov/professionals/narcotic/electronic_prescribing/

Should you have any questions about ROPES, please contact BNE by email at narcotic@health.ny.gov or by phone at 866-811-7957, Option 1.

In addition, the New York State Department of Health has an FAQ that covers a variety of questions pertaining to EPCS and ROPES that can be accessed here.


IF YOU ARE EXPERIENCING A DELAY IN PROCESSING YOUR HEALTH COMMERCE ACCOUNT


The New York State 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


Resources

 

Laurie Cohen, Esq., Partner at Nixon Peabody and Chapter's Legal Counsel

 

Last Updated: 2.3.2016

New York Chapter of the American College of Physicians
744 Broadway, Albany NY 12207
Tel: 518-427-0366
Fax: 518-427-1991
Email: info@nyacp.org