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.

New Regulations

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 dispensed except to 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.

Therapy Requirements

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.  Guidelines are as follows:

• 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.
• 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 certified, the physician must refer the patient to another physician who is board certified on an addiction medicine board.

Changes for Pharmacists

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.

 

 

Behavioral Health Providers

In addition to regulations regarding buprenorphine, the General Assembly passed a new law to bolster the ability of behavioral health providers to provide substance abuse disorder services and receive Medicaid reimbursement for them.. Senate Bill 192, recently signed into law by Governor Beshear, includes myriad provisions for fighting the state’s heroin scourge.

One section in particular provides for Medicaid credentialing of behavioral health providers that provide substance abuse disorder services. SB192 also includes a clause that requires DMS to provide expanded Medicaid coverage to include “a broad array of treatment options for those with heroin addiction and other substance use disorders.”

To meet the requirements of the ACA that state Medicaid programs cover behavioral health and substance disorder problems, the Cabinet for Health and Family Services has enacted new regulations that create new types of providers of these services and licenses  as well as expanding Medicaid  participation for these new provider types.

The most comprehensive of the new providers is the Behavioral Health Services Organization (BHSO), which is authorized to provide a comprehensive array of mental health and substance abuse disorder services.  Under a BHSO license, this provider may offer the gamut of services including residential and outpatient services as well as physician services for medically assisted treatment of addiction, which may include both buprenorphine treatments and the extended release injectable Vivitrol.

While providers scramble to form BHSOs and related entities, DMS is struggling to address reimbursement issues. The new law also specifically exempts residential substance use disorder treatment programs from certificate of need requirements thereby eliminating an expensive regulatory hurdle for implementation and encouraging new facilities.

When DMS promulgates the necessary regulations to expand Medicaid coverage, behavioral health physicians that treat substance abuse disorders may finally see the recognition of the growing need for these types of new and innovative therapies to combat drug addiction.

Hurdles Remain

Many hurdles for physicians that provide medication assisted treatments remain, however. For example, the current Medicaid fee schedule payment for substance abuse services still only pays $21.53 for physician visit.

Compare this to the enhanced rate for administering a flu vaccine – currently $15.30 – for a more complete understanding of the inadequate reimbursement rate for buprenorphine therapy in particular, a therapy that requires special DEA registration, the development of protocols, extensive examination and documentation of a patient’s history of addiction, and administrative burdens. Federal law limits the number of patients a single physician can treat with Buprenorphine as well, starting at 30 in the first year and maximum of 100 thereafter.

Physicians were once able to set up a separate, non-Medicaid practice to treat patients directly in a cash-only transaction; recent changes to Medicaid’s regulations have abolished this practice. Any Medicaid participating physician who sees a Medicaid recipient for a Medicaid-covered service must charge Medicaid for the service, regardless of whether the services are performed for another company or at another location that is not enrolled in Medicaid.

Physicians working to meet the standards and specifications in the regulations, with all attendant infrastructure necessary to implement the specific timelines and standards of administration of this medication-assisted therapy, may not be able to survive in a private practice dedicated solely to prescribing buprenorphine at such low reimbursement rates.

–Lisa English Hinkle is with McBrayer, McGinnis, Leslie & Kirkland.