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:
- 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 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:
- technological limitations that are not reasonably within the control of the practitioner; or
- 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:
- such designee is located in the state of New York when accessing the prescription monitoring program registry;
- 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;
- 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;
- 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
- 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:
- Become 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.