New Regulations in the Administration of Buprenorphine, Part One
Kentucky seems to be losing physicians who treat opioid addicted patients with buprenorphine therapy as tough new standards for prescribing the medication have been enacted by the Kentucky Board of Medical Licensure (“KBML”). At the same time, Kentucky’s Cabinet for Health and Family Services has created new types of providers that can offer behavioral health and substance disorder services, and, the Department of Medicaid Services (“DMS”) has eliminated the ability of physicians to provide medication assisted therapy to Medicaid patients in a cash only practice. Physicians facing increased regulations must be vigilant about compliance with these new regulatory hurdles, but may also find opportunity in providing the same services through a provider other than a private practice.
The Kentucky Board of Medical Licensure (“KBML”) recently enacted new regulations directed to physicians that prescribe buprenorphine or buprenorphine combined with naloxone, better known as the synthetic opiate Subutex and Suboxone. The KBML previously issued guidance in this area as an opinion, but its opinions were policy documents without the full effect of the law. The latest regulations, however, establish very detailed standards and specifications that physicians must abide by when providing opioid addiction treatment using these medications. Newly-enacted regulations that expand the type of providers that may treat patients with substance abuse disorders, point to a growing recognition that the first line of defense against a raging heroin epidemic is a robust system of care to rehabilitate addiction patients. While buprenorphine will remain within the spectrum of acceptable addiction treatments, the KBML and Kentucky’s Medicaid system is clearly sending a message to providers that it demands greater physician accountability and expects better patient outcomes.
The KBML’s new regulations in 201 KAR 9:270 set forth detailed professional standards for prescribing or dispensing the drugs for medically-supervised withdrawal or the treatment of opioid dependency. Except for the transdermal delivery of buprenorphine-mono-product for the treatment of pain, buprenorphine-mono-product or buprenorphine-combined-with-naloxone shall only be prescribed or dispensed for medically-supervised withdrawal or as a maintenance treatment for a patient diagnosed with opioid dependence. The regulation provides that buprenorphine-mono-product shall not be prescribed or dispensedto a pregnant patient, to a patient with demonstrated hypersensitivity to naloxone, or as an injectable treatment in a physician’s office or other healthcare facility.
With a narrow exception for treating a patient to address an extraordinary and acute medical need not to exceed 30 days, the medications may not be prescribed or dispensed to a patient who is also being prescribed benzodiazepines, other sedative hypnotics, stimulants or other opioids without consulting a physician who is certified by an addiction medicine board.
Like the administrative regulations resulting from House Bill 1, which regulate the prescribing of controlled substances for the treatment of pain, 201 KAR 9:270 sets forth detailed requirements for initiating treatment with Suboxone therapy. Prior to beginning treatment, physicians must document extensive information about the patient and his or her medical history, perform certain tests, obtain KASPER reports, perform a physical exam, diagnose a patient to be in opioid withdrawal, educate the patient about treatment, and obtain extensive consent to treatment. After the initial administration of the drug, the physician must then develop and implement a treatment plan of objective behavioral modification and a series of follow-up examinations at graduated intervals. Thereafter, the physician must regularly evaluate the patient’s progress and make determinations on continuation of the treatment every three months, documenting the medical necessity for continued treatment every twelve months. A physician must obtain at least eight drug screens from the patient during that time, and two must be random and include a pill count. At any twelve-month interval, if the daily therapeutic dose exceeds the equivalent of sixteen milligrams of buprenorphine per day and the physician is not board certified in addiction medicine, the physician must refer the patient to another physician who is certified by an addiction medicine board.
Physicians who prescribe buprenorphine medications should be very familiar with the requirements as pharmacists are now carefully scrutinizing prescriptions that are presented to be filled to assure that the prescription meets the requirements set forth the KBML’s regulations. The Kentucky Board of Pharmacy expects pharmacists to know the requirements for a legal prescription and may advise pharmacists to exercise his or her professional judgment in determining whether a prescription meets the requirements to be filled. For example, if a pharmacist determines that a buprenorphine prescription is written for a diagnosis of pain rather than opioid addition, the pharmacist will refuse to fill the prescription. Interestingly, a nurse practitioner may prescribe buprenorphine for acute pain for a 30 day period, but a physician may not pursuant to the KBML’s regulation. Likewise, a pharmacist may refuse to fill a prescription that is written for an amount of medication that exceeds the dosages set forth in the KBML’s regulation.
Please return on Thursday for part two of this article, detailing other new changes in Kentucky law concerning medication-assisted therapies.