E-Prescribing/I-STOP

New York Law Limiting Initial Opioid Prescribing Went Into Effect Friday, July 22

In an effort to curb prescription opioid abuse, New York passed legislation that limits prescriptions of Schedule II, III, or IV opioids to seven days upon initial consultation or treatment of acute pain. This new law went into effect on Friday, July 22, 2016. Here are additional details:

  • Acute pain is defined in NYS Public Health law as pain, whether resulting from disease, accidental or intentional trauma, or other cause, that the practitioner reasonably expects to last only a short period of time.
     
  • This rule SHALL NOT include chronic pain, pain being treated as part of cancer care, hospice or other end-of-life- care or pain being treated as part of palliative care practices. 
     
  • Upon subsequent consultations for the same pain, the practitioner may issue, in accordance with existing rules and regulations, any appropriate renewal, refill, or new prescription for an opioid.
     
  • Application of co-pays for the initial prescription of an opioid are also limited by the measure.  A prescriber can apply the co-pay one of two ways:
     
    1. A proportionate amount between the co-payment for a thirty day supply and the amount of drugs the patient was prescribed; or
       
    2. The equivalent to the copay for the full thirty-day supply provided that no additional co-pays may be charged for any additional prescriptions for the remainder of the thirty-day supply
  • Pharmacists are NOT required to verify with the prescriber whether an opioid prescription written for greater than a 7-day supply is in accordance with the statutory requirements. Pharmacists may continue to dispense opioids as prescribed, consistent with current laws, regulations, and Medicaid policies.

Additional information on opioids and this law may be obtained by contacting the NYS Department of Health’s Bureau of Narcotic Enforcement at 1-866-811-7957 or by clicking here.


10.6.16:NYACP Members Act and Governor Signs E-Prescribing Amendment

On Friday, September 30, Governor Cuomo signed as Chapter 350 of the Laws of 2016 legislation (A.9335/S.6778) changing e-prescribing exception regulations. Instead of sending an e-mail to the Department of Health containing an onerous amount of information about the issuance of the paper prescription every time an exception is invoked, as the regulations originally required, a prescriber can now make a notation in the patient's medical record indicating that they have issued a paper prescription and noting one of the three statutory exceptions as the reason why an e-prescription was not possible. This bill reduces an unnecessary administrative burden that was placed on physicians while preserving those measures within I-STOP that have been successful in reducing diversion and misuse of controlled substances.

Following a significant amount of effort by leaders and staff on this legislative priority, the bill was signed in part because of the large number of Chapter members that sent letters to Governor Cuomo through NYACP's Legislative Action Center, urging him to sign the bill.


10.6.16: Official Notice from the Bureau of Narcotic Enforcement Regarding Documentation of E-Prescribing Exceptions

Use of an exception to the e-prescribing mandate no longer requires a notification to the New York State Department of Health (as reported above). 

However, the prescribing practitioner must notate in the patient’s health record when they issue a non-electronic prescription for one of the approved exceptions below:

  • Temporary technological failure;
  • Temporary electrical failure;
  • To be dispensed by a pharmacy located outside the state, outside the country, or on federal property, including and not limited to the following examples; Veterans Administration, West Point, Fort Drum, and Indian Reservations;
  • The practitioner reasonably determines that it would be impractical for the patient to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the patient's medical condition.

BNE will be modifying its web page in the near future to reflect this information.


8.4.16: Bureau of Narcotic Enforcement (BNE) Releases Waiver Process for Practitioners
Prescribing 25 Prescriptions or Less

The Bureau of Narcotic Enforcement (BNE) has released the forms and an FAQ for practitioners who want to certify that they will not issue more than twenty-five prescriptions during a twelve-month period. Practitioners submitting a certification will not be required to issue prescriptions electronically. Prescriptions in both oral and written form for both controlled and non-controlled substances must be included in determining whether the practitioner will reach the limit of twenty-five prescriptions.

The practitioner can either submit a certification online through the Electronic Prescribing Waiver (EPW) application on the NYS Health Commerce System (login required) or by submitting a paper certification form to BNE at this address:

NYS Bureau of Narcotic Enforcement
OPP Registration Unit Riverview Center
150 Broadway Albany, NY 12204
FAX: (518) 402-1058


New York State E-Prescribing Waiver Exceptions

NYACP has received numerous questions regarding what physicians who have not been issued a waiver need to do if their electronic prescribing system is unavailable.

There are a few exceptions upon which a practitioner may rely if they are 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 is to be dispensed outside of New York State – PHL 281(3)(e).

In such cases, a physician may issue an Official New York State prescription form, oral prescription or a fax of an Official New York State prescription.

However, if a physician relies upon one of these exceptions, a note of such fact must be included in the patient’s record and notice must be sent to 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 information:

  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.

In those cases involving temporary technological or electrical failure, the  notice must be sent to DOH as soon as practicable, but in no instance more than 72 hours following the end of the technological or electrical failure that prevented the issuance of an electronic prescription. 

In the case of a prescription to be dispensed outside New York or the physician 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, such notice must be sent to DOH within 48 hours of the date the prescription was issued.

NYACP continues to monitor the implementation of the electronic prescribing mandate and encourages members to contact the Chapter office at (518) 427-0366 if they are experiencing problems.


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.

  • Any practitioner prescribing a controlled or non-controlled substance, containing two (2) or more products, which is compounded by a pharmacist;
  • 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;
  • Any practitioner prescribing a controlled or non-controlled substance that contains long or complicated directions;
  • 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;
  • 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;
  • Any practitioner prescribing an opioid antagonist that would allow a non-patient specific prescription;
  • Any practitioner prescribing a controlled or non-controlled substance under a research protocol;
  • 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;
  • 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;
  • A pharmacist dispensing prescriptions issued under a research protocol, or under approved protocols for expedited partner therapy, or for collaborative drug management;
  • A pharmacist dispensing non-patient specific prescriptions, including opioid antagonists, or prescriptions issued in response to a public health emergency issued; and
  • 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

Last Updated 11.3.16
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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