Your Controlled Substance Prescriptions: NYS Department of Health Issues Proposed Regulations to Implement Enhanced Prescription Monitoring Program

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

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

With the stated goals of reducing “doctor shopping” and the “over prescribing” of controlled substances, New York enacted legislation in 2012 that will require real time reporting of controlled substances dispensed by pharmacists and practitioners and also require most practitioners to consult a prescription monitoring program (PMP) registry prior to writing a prescription for a controlled substance listed on Schedule II, III or IV.   To implement the new law which is effective August 27, 2013, the NYS Department of Health (DOH) has issued proposed regulations which address the duty to consult the PMP registry as well as the reporting requirements.

Duty to Consult PMP Registry

Specifically, the proposed regulations provide that a practitioner must consult the PMP registry no more than 24 hours prior to prescribing or dispensing any controlled substance listed on schedule II, III, or IV for the purpose of reviewing a patient’s controlled substance history.   Further, the proposed regulation states that a practitioner must document such consultation in the patient’s medical record.

Even if the practitioner is not required to consult the PMP registry because an exception to the consultation requirement applies (See list of exceptions below), the practitioner must document in the patient’s medical record the applicable exception.  In addition, if the practitioner has not consulted the PMP registry based upon the exception it is not reasonably possible for the practitioner to access the registry in a timely manner and no other practitioner or designee authorized to access the registry is reasonably available and the quantity of controlled substance prescribed does not exceed a five-day supply, the practitioner must further document in the patient’s medical record “the conditions, occurrences, or circumstances that caused such consultation to be unreasonable”  including “the barrier(s) to accessing the registry, and the efforts made by the practitioner to contact other designees”.

Furthermore, if the practitioner has not consulted the PMP registry based upon that  exception that such consultation would, as determined by the practitioner, result in a patient’s inability to obtain a prescription in a timely manner, thereby adversely impacting the medical condition of such patient, provided that the quantity of the controlled substance does not exceed a five-day supply , the practitioner must document in the patient’s medical record “a description of the circumstances supporting the practitioner’s conclusion that consultation of the registry would adversely impact the patient’s ability to obtain a prescription in a timely manner and the relationship between that delay and the patient’s medical condition.”

Exceptions to the Duty to Consult PMP Registry     

The specific exceptions to the duty to consult the prescription monitoring program registry include:

  • (i) veterinarians;
  • (ii) a practitioner dispensing for interim treatment for an addict on a waiting list for admission to an authorized maintenance program;
  • (iii) a practitioner administering a controlled substance whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject;
  • (iv) a practitioner prescribing or ordering a controlled substance for a patient of hospital, clinic, nursing home or similar facility approved and certified by the department for use on the premises of, or during an emergency transfer from facility;
  • (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,
  • (vii) a practitioner when:
    1. it is not reasonably possible for the practitioner to access the registry in a timely manner; and
    2. no other practitioner or designee authorized to access the registry is reasonably available; and
    3. 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 circumstances under which consultation of the registry would, as determined by the practitioner, result in a patient’s inability to obtain a prescription in a timely manner, thereby adversely impacting the medical condition of such patient, provided that the quantity of the controlled substance does not exceed a five-day supply if the controlled substance were used in accordance with the directions for use;
  • (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. In the instance of a temporary technological or electrical failure, a practitioner shall, without undue delay, seek to correct any cause for the failure that is reasonably within his or her control; or
  • (x) a practitioner to whom the commissioner has granted a waiver from the requirement to consult the registry. A waiver may be issued by the commissioner based upon a showing by a practitioner that his or her ability to consult the registry in accordance with this section is unduly burdened by:
    1. technological limitations that are not reasonably within the control of the practitioner; or
    2. other exceptional circumstance demonstrated by the practitioner.


Practitioner’s Ability to Designate another Person to Consult Registry

Consistent with the statute, the proposed regulations permit a practitioner to authorize one or more designees to consult the prescription monitoring program registry on his or her behalf.  The practitioner must make the final decision as to whether or not to prescribe or dispense a controlled substance after considering the patient’s controlled substance history information obtained from the registry and may not delegate such decision-making to the designee.

Specifically, the proposed regulation states that “A practitioner may only appoint a designee if:

  1. such designee is located in the state of New York when accessing the prescription monitoring program registry;
  2. the designee is employed by the same professional practice or is under contract with such practice. For purposes of this subparagraph, professional practice shall include, but not be limited to, an institutional dispenser where the designating practitioner is employed, under contract, or otherwise has privileges or authorization to practice;
  3. the practitioner takes reasonable steps to ensure or has actual knowledge that such designee is sufficiently competent in the use of the registry and that such designee is aware of and conforms to all relevant federal and state privacy statutes;
  4. the practitioner remains responsible for ensuring that access to the registry by the designee is limited to authorized purposes and occurs in a manner that protects the confidentiality of the information obtained from the registry, and the practitioner remains responsible for any breach of confidentiality; and
  5. the practitioner selects and maintains all active designees authorized to access the prescription monitoring program registry in a format acceptable to the department.

The Practitioner will also be expected to notify the DOH immediately if the designee’s authority is revoked due to termination of the designee’s employment or otherwise.

Pharmacists are also permitted under the proposed regulations to consult the PMP registry in order to review the controlled substance history of an individual prior to dispensing controlled substances and may    designate another pharmacist or a pharmacy intern to consult the PMP registry on the pharmacist’s behalf.

 Reports Regarding Dispensing of Controlled Substances

The proposed regulations also provide that reports currently required to be made to the DOH Bureau of Narcotic Enforcement by pharmacists and dispensing practitioners would need to be filed electronically within 24 hours of the delivery of such controlled substances.  In addition, pharmacies delivering prescriptions by mail or licensed express delivery services would be required to file the prescription information not later than 72 hours after the substance was shipped from the pharmacy.

Additional Exceptions to Patient Confidentiality

The proposed regulations will also permit increased disclosure of patient information regarding controlled prescribing and dispensing including to the Medicaid fraud control unit to investigate fraud, waste or abuse of the Medicaid program; to a local health department for the purpose of conducting public health research or education with certain additional conditions; to a medical examiner or coroner;  to an individual for the purpose of providing such individual with his or her own controlled substance history; and to appropriate law enforcement agencies where the department has reason to believe that a crime related to the diversion of controlled substances has been committed.

The comment period on the proposed regulations expires on August 5, 2013.

In anticipation of the law’s August 27, 2013 effective date, physicians and other practitioners should:

  • NYS Prescription Monitoring ProgramBecome familiar with using the PMP registry which can now be accessed by logging into their Health Commerce Systems account at  https://commerce.health.state.ny.us
  • A licensed prescriber can also establish an account  following the instructions at https://hcsteamwork1.health.state.ny.us/pub/top.html
  • Update login / passwords for existing accounts (you have an account if you are using State provided single script forms.
  • To the extent that the registry will need to be consulted no sooner than 24 hours prior to writing a prescription, practitioners should begin to plan possible changes to office procedures and work flow, including whether to use designees and which staff are best suited to serve as designees to consult the PMP registry.

Practitioners can find additional information about the PMP and future updates at http://www.health.ny.gov/professionals/narcotic/practitioners/

Laurie Cohen, Esq., Partner at Nixon Peabody and the Chapter’s attorney provides members with support and direction by answering questions relevant to general practice.

She has a broad range of health care experience providing services to physician groups. She also has extensive knowledge in the areas of professional licensure, group practice formation, employment and managed care contracting, provider joint ventures, self-referral, anti-kickback, and fee splitting.

10 Responses to “Your Controlled Substance Prescriptions: NYS Department of Health Issues Proposed Regulations to Implement Enhanced Prescription Monitoring Program”


  1. 1 Ed Stehlik June 27, 2013 at 9:43 am

    The proposal to require documentation in the medical record is unnecessary and burdensome. Clearly if a record was being critically examined for accuracy the statement in the chart would not be adequate to confirm that the duty to consult had been performed. Since the process is “invisible” except to the metatdata in the database, the database would still need to be queried to confirm that the duty had been performed properly. Thus this documentation step is unnecessary and cruelly burdensome, and adds more to the long list of unnecessary administrative tasks that slow down workflow and interfere with patient care.

    This proposal is also a contradiction to the information supplied by state officials in previous NYACP meetings when they said this unnecessary duplicative documentation would not be required as part of I-STOP.

    There is also insufficient clarity as to who would document the database query when a physician designee performs the query on the physician’s behalf and of what type of documentation or language is expected in such a situation. Designee searches will presumably (and hopefully) be the norm and not the exception as office efficiency would strongly favor using designees for the most laborious and time-consuming features of this law. So it is especially important that those expectations be made clearer than this description so far provides.

    • 2 NYACP June 28, 2013 at 2:49 pm

      Thank you for your comment. NYACP will be submitting comments to the NYSDOH on the proposed ISTOP Act regulations and will consider your comments in its submission.

  2. 3 Paul Chrzanowski,MD June 28, 2013 at 8:35 am

    Doctors and patients will suffer . Just another example of New York being a bad place to do business ( run by a negligence lawyer , overregulated by legislators,and over taxed with a reputation for being corrupt and dysfunctional).

    • 4 NYACP June 28, 2013 at 4:38 pm

      We recognize that the legislative and regulatory process is complex and at times highly volatile and frustrating in New York and as such advocated strongly regarding our members concerns over this legislation as it was presented and amended. We will file a response to the proposed regulations and will continue to host educational events on the importance challenges of pain management.

      We advocate for responsible legislative action on public policy relating to health care for the benefit of the public, patients, the medical profession and our members. We encourage you to participate and share your concerns when the Chapter calls its member to action through the newsletter “Your Chapter in Action” and our Grassroots Action Center.

  3. 5 A. Mundia, MD (oncologist) June 29, 2013 at 9:51 am

    It would be extremely burdensome for Cancer patients and doctors to obtain and prescribe pain medications, and will enhance pain and suffering of cancer patients tangled in this bureaucratic hassle. Under current NYS prescriptions all information is available to the state on the patients and prescriber and it is for the enforcement agencies to take necessary steps to investigate the abusers.

  4. 6 Perry Pong, MD July 6, 2013 at 9:25 pm

    It is a huge burden for the honest practitioners; there are better ways to investigate criminal physicians, pharmacies and patients as all prescriptions are numbered and entered by pharmacies. Any college freshman could write an algorithm that would catch rogue pharmacies and patients. Besides oncologists, psychiatrists will be tremendously burdened and many of these medications for their patients are chronic medication.

  5. 7 Shawn July 16, 2013 at 12:49 pm

    How can a non-physician/non-licensed employee (resident) become a designee for the licensed practitioner?

  6. 10 Irwin Abraham MD FACP July 24, 2013 at 7:51 pm

    A good number of my patients with chronic pain are on opiods, most typically oxycodone. Almost all of them were started and continued on opiods by some other physician years before. A number of them were seeing some doctor who now is in jail or lost a license for prescribing excessive amounts to allocmers. Now I gained a little more knowledge abut who might be getting a prescription from some other doctor at the same time as from me. I have been in medicine for over 40 years and am well aware how difficult it is to get a complete answer form a patient even when they may be desperate to tell me everything possible about themselves.

    Now I can find out this information on the day of the appointment. Usually my secretary does this simple task and adds a paper copy to the chart. If not, it only takes a minute or 2. It is more accurate than asking the patient who else they saw recently and exactly what medications they were prescribed.

    Several months ago, I went to a lecture about the new I-Stop law given by the NY STATE department of health’s narcotic enforcement Bureau. He detailed the problem of thousands of persons in this state getting opiod prescriptions and deaths in the thousands from overdoses of prescription medications. I was already aware that in 2010, over 1 million prescriptions for opidos were prescribed in Staten Island where the population is 375,000. Do the math and you can guess that many more written than medically needed.

    We physicians have to concern ourselves first and foremost with the health and safety of persons in and outside of our practices, for public health as well as the individual health of our patients.


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