By David A. Zarett, Esq. Email David
By letter dated February 13, 2019, the New York State Department of Health released written guidance to physicians who prescribe opioids for pain lasting longer than three (3) months. Effective April 1, 2018, legislation signed by Governor Cuomo, as part of the 2018-2019 New York State Fiscal Year Budget, has added a new section to the law pertaining to controlled substance prescriptions. The new section, Public Health Law § 3331(8), provides as follows:
No opioids shall be prescribed to a patient initiating or being maintained on opioid treatment for pain which has lasted more than three months or past the time of tissue healing, unless the medical record contains a written treatment plan that follows generally accepted national professional or governmental guidelines. The requirements of this paragraph shall not apply in the case of patients who are being treated for cancer that is not in remission, who are in hospital or other end-of-life care, or whose pain is being treated as part of palliative care practices.
To summarize, any prescribing of opioid medications lasting longer than three months must be accompanied by a treatment plan placed in the patient’s medical record. The only exceptions to this practice are the ones specifically stated in the new law, and include active cancer pain, end-of-life care, and palliative care. According to the NYS Department of Health, the treatment plan must follow generally accepted national professional or governmental guidelines. For example, the Centers for Disease Control and Prevention (CDC) have their own published guidelines. Additionally, a treatment plan must be accompanied by documentation of certain criteria in the medical record. Some of these criteria include goals for pain management and functioning, tapering and/or discontinuing treatment with opioids, and an evaluation or risk factors. Documentation and discussion of the specified criteria must be done, at minimum, on an annual basis.
As discussed in our previous article regarding prescribing of opioids, with the advent of the opioid crisis, physicians should aspire to implement every reasonable safeguard against allegations of improper prescribing practices. These measures include extensive documentation on every patient interaction and clinical decision related to opioid treatment, conducting toxicology screens on patients, attempting alternative treatments, and obtaining continuing education on drug abuse and treatment. Also, recall that it is now mandatory that physicians consult New York’s prescription monitoring database prior to every controlled substance prescription, without exception.
In the present climate, it is essential that clinicians who prescribe opioid medications maintain a comprehensive compliance plan and adhere to that plan rigidly. Those who prescribe opioid medications on a widespread and consistent basis are especially vulnerable to scrutiny by legal and regulatory authorities such as the Office of Professional Medical Conduct and the Drug Enforcement Administration. Thus, at such time that any type of regulatory authority decides to come knocking, it would be highly advantageous for a physician to be able to say that all practical measures against diversion and abuse of opioids had been taken.
Weiss Zarett Brofman Sonnenklar & Levy, P.C. is a Long Island law firm providing a wide array of legal services to the members of the health care industry, including corporate and transactional matters, civil and administrative litigation, healthcare regulatory issues, bankruptcy and creditors’ rights, and commercial real estate transactions.
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