NYS health commissioner uses discretion to issue blanket waiver to e-prescribing mandate in "exceptional circumstances"



March 18, 2016

Health Care Alert

Author(s): Michele A. Masucci, Laurie T. Cohen, Rebecca Simone

On March 16, 2016, the commissioner of the New York Department of Health issued a memorandum to practitioners and pharmacists granting a blanket waiver to the requirement to e-prescribe in certain “exceptional circumstances” as more specifically described below. As previously reported, the NY state mandate to electronically prescribe both controlled and non-controlled substances goes into effect on March 27, 2016. A thorough discussion of what the new requirements will entail can be found here. In accordance with the commissioner’s memorandum, health care professionals who fall within one of the “exceptional circumstances” categories can continue to use current methods of issuing prescriptions by utilizing the Official New York State Prescription Form or issuing oral prescriptions. The commissioner’s memorandum, however, cautions health care professionals to limit the use of oral prescriptions for controlled substances to emergency situations and other limited purposes, in accordance with Education Law § 6810 and Public Health Law §§ 3334 and 3337.

The blanket waiver applies to the following “exceptional circumstances”:

  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 issuance of the blanket waiver in the circumstances set forth above does not preclude a provider from seeking a general waiver from the requirement to e-prescribe. More information about seeking a general waiver can be found here.

The foregoing has been prepared for the general information of clients and friends of the firm. It is not meant to provide legal advice with respect to any specific matter and should not be acted upon without professional counsel. If you have any questions or require any further information regarding these or other related matters, please contact your regular Nixon Peabody LLP representative. This material may be considered advertising under certain rules of professional conduct.

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