February 26, 2013

On August 27, 2012 Governor Cuomo signed the Internet System for Tracking Over-Prescribing (I-STOP) Act into law to address a pressing concern: that “controlled substances, are increasingly subject to criminal diversion and abuse, which can result in addiction, adverse drug events, accidental death due to overdose, violent or self-injurious behavior, family conflicts, and increased costs to businesses and the health care system.”  In response, the legislature determined that such diversion and abuse would be mitigated by: establishing a prescription monitoring program registry containing data about controlled substances dispensed to individuals, reported on a real time basis; requiring health care practitioners and permitting pharmacists to access such registry before prescribing or dispensing additional such substances; and requiring that prescriptions be transmitted electronically from practitioners to pharmacists.   

Government’s Creation of Controlled Substance Registry
Effective August 27, 2013, pursuant to the Internet System for Tracking Over-Prescribing (I-STOP) Act, the Commissioner of Health shall be required to have established and to maintain an electronic system for collecting, monitoring and reporting information concerning the prescribing and dispensing of controlled substances.  This electronic system shall be known as the prescription monitoring program registry.  The registry shall include information reported by pharmacies on a real-time basis, included but not limited to:

      (i) the patient's name;
      (ii) the patient's residential address;
      (iii) the patient's date of birth;
      (iv) the patient's gender;
      (v) the date on which the prescription was issued;
      (vi) the date on which the controlled substance was dispensed;
      (vii) the metric quantity of the controlled substance dispensed;
      (viii) the number of days supply of the controlled substance dispensed;
      (ix) the name of the prescriber;
      (x) the prescriber's identification number, as assigned by the drug enforcement administration;
      (xi) the name or identifier of the drug that was dispensed; and
      (xii) the payment method.

A record of the patient’s controlled substances prescribed shall be available for no less than six months and no more than five years (the pharmacy retention requirement).  Pursuant to Section 3343-a of the Public Health Law, NYS government is required for maintaining the security of the registry and for implementing the registry, which is required to be secure, easily accessible, interoperable and compatible with the electronic transmission of prescriptions for controlled substances.  Protocols for the registry shall include the ability for the government to monitor and record access to the registry, which shall identify the authorized individual accessing and each controlled substance history accessed.

Practitioner’s Duty to Consult
The more relevant requirement of I-STOP, aggravating practitioners NY-Statewide is the duty, as of August 27, 2013, to consult the prescription monitoring program registry prior to prescribing.  As of that date, every practitioner (except the list below) shall be required to consult the registry prior to prescribing or dispensing any schedule II, III or IV controlled substance.  NYS Public Health law does provide that practitioners may delegate the “consulting” responsibility to an authorized and competent designee employed by the practice. At all times the registered practitioner shall be remain responsible for ensuring that access to the registry is proper, and shall remain responsible for any breach.  Also, the ultimate decision as to whether or not to prescribe or dispense a controlled substance shall at all times remain with the practitioner.   If any designee of the practice is terminated or leaves the practice’s employ for any reason, the practitioner shall have the responsibility of notifying the Department of Health and adequately protecting registry access. 
Now, we are six months from passage, and six months from implementation.  Where are we?  What does this mean for our practices?  What will you have to do?  Let’s talk about what we know – we know a controlled substance registry is to be created and maintained by the government, and we know practitioners are going to be required to check it.   We also know the government has already gotten to work.  Check out the DOH website for more information - http://www.health.ny.gov/professionals/narcotic/practitioners/online_notification_program/.  We also know who is required to consult the registry and who you may delegate to in your practice.  What information are we missing? Well, we do not know exactly what enforcement will look like here, specifically how severe of liability a pracititioner will be facing for prescribing when potentially ill-advised.  For some specialties this issue may be a greater threat than others.   Like many new initiatives, we will have to see how this plays out.  Prior to implementing registry usage in your practice, BE SURE TO IMPLEMENT PROPER POLICIES AND PROCEDURES so that information is kept confidential and protected under HIPAA, access is restricted and you are aware of who has access under your ID at all times!     
Contact our practice for assistance with proper policies and procedures.  Also, do not forget your September 2013 HIPAA deadline for new policies!
The requirement to consult the registry shall not apply to:
      (i) veterinarians;
      (ii) a practitioner dispensing pursuant to subdivision three of section thirty-three hundred fifty-one of this article;
      (iii) a practitioner administering a controlled substance;
      (iv) a practitioner prescribing or ordering a controlled substance for use on the premises of an institutional dispenser pursuant to section thirty-three hundred forty-two of this title;
      (v) a practitioner prescribing a controlled substance in the emergency department of a general hospital, provided that the quantity of controlled substance prescribed does not exceed a five day supply if the controlled substance were used in accordance with the directions for use;
      (vi) a practitioner prescribing a controlled substance to a patient under the care of a hospice, as defined by section four thousand two of this chapter;
      (vii) a practitioner when:
         (A) it is not reasonably possible for the practitioner to access the registry in a timely manner;
         (B) no other practitioner or designee authorized to access the registry, pursuant to paragraph (b) of this subdivision, is reasonably available; and
         (C) the quantity of controlled substance prescribed does not exceed a five day supply if the controlled substance were used in accordance with the directions for use;
      (viii) a practitioner acting in compliance with regulations that may be promulgated by the commissioner as to circumstances under which consultation of the registry would result in a patient's inability to obtain a prescription in a timely manner, thereby adversely impacting the medical condition of such patient;
      (ix) a situation where the registry is not operational as determined by the department or where it cannot be accessed by the practitioner due to a temporary technological or electrical failure, as set forth in regulation; or
      (x) a practitioner who has been granted a waiver due to technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner, pursuant to a process established in regulation, and in the discretion of the commissioner.

Reference: NY CLS Pub Health § 3343-a