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Controlled Substance Monitoring Database Program

Legislative Update - 2015

Public Chapter 26

This legislation deletes the Intractable Pain Act.  This becomes effective on July 1, 2015.

Public Chapter 502

This act allows the Joint Government Operations Committee (the legislative committee that reviews all rules) to stay a rule up to 75 days instead of 60 days.  Present law authorizes the Joint Government Operations Committee to consider the following factors when reviewing rules: authority, clarity, consistency, justification, necessity and reference. This act adds arbitrariness and capriciousness as two new considerations.

Public Chapter 396

This creates the “Addiction Treatment Act of 2015.”  It prevents certain criminal drug charges from being filed against an individual who is experiencing a drug overdose or is in the company of an individual who is experiencing a drug overdose and seeks or is the subject of a request for medical assistance.  Any such person is immune to penalties for a violation of a permanent or temporary protective order or restraining order or sanctions for a violation of a condition of pretrial release, condition of probation, or condition of parole based on a drug violation.  This immunity does not provide protection against seizure of any evidence or contraband, limit the admissibility of any evidence in connection with the investigation or prosecution of a crime for an individual who doesn’t qualify for the aforementioned exemptions, or limit the authority of a law enforcement officer to detain or take into custody a person in the course of an investigation or to effectuate an arrest for any offense not immune by the aforementioned exemptions.  This immunity only applies to the person’s first such drug overdose.

This bill further mandates that only M.D.’s or D.O.’s are permitted to prescribe buprenorphine for opioid dependence and it may only be prescribed for uses recognized by the FDA unless the patient has a documented opiate addiction, receives treatment from a DEA registered addiction treatment practice, and is counted as one of the total allowable number of patients the provider is allowed to treat.  Only pregnant women, nursing mothers, or patients with a hypersensitivity to naloxone may be prescribed buprenorphine mono.  These provisions do not apply to perioperative surgery or ventilator sedation performed in a licensed facility, or to inpatients and outpatients of a hospital.

The BME and the BOE are required to promulgate rules establishing requirements for licensees to qualify as addiction specialists. 

This act takes effect on July 1, 2015.

Public Chapter 371

This act defines biological product and interchangeable biological product and allows their use under all circumstances unless:

An adverse reaction has previously taken place
The interchangeable has been previously deemed ineffective
Any other clinically based prescriber determined need or the interchangeable biologic is not available

When prescriber determines biological is medically necessary he/she must  

Place these instructions on the prescription showing intent in writing
If orally the prescriber must alert the pharmacist
An electronic communication between prescriber and pharmacist that only the biological product be communicated
When a biologic is issued a pharmacist must

Notify the patient of the substitution on the prescription label

Communication within 5 days to the prescriber by:

Add it to the interoperable electronic medical records system
Communication can be set forth in collaborative pharmacy agreement
That this communication only applies to the original communication and not the refill

Maintain a record of the biologic dispensed

This does not apply if the product if the product is

Is directly dispensed to the patient
Is dispensed in a nursing home or assisted living facility

The board of pharmacy shall maintain a link on its website to the current list of all biological products determined by the FDA to be interchangeable.

Public Chapter 475

Changes the requirements for who can become a certificate holder of a pain clinic. Certificate holders:

Must be a Tennessee licensed Medical Doctor, Doctor of Osteopathy, Advanced Practice Nurse or Physician’s Assistant and
Must have an unrestricted unencumbered license

Requires anyone with any ownership interest in a pain clinic to be eligible to meet the requirements of the certificate holder
Adds requirements to be a pain medicine specialist to the law

ABMS certification
ABPM diplomate
ABIPP exam 1 passage
An active pain management practice in a clinic accredited in outpatient interdisciplinary pain rehabilitation by the commission on accreditation of rehabilitation facilities

All medical directors of pain clinics must be pain medicine specialists by July 1, 2016
All Physicians Assistants and Advanced Practice Nurses must be supervised by any pain medicine specialist to practice in a certified pain clinic
Requires the pain clinic certificate holder to be an owner of the clinic for which he or she holds the certificate
Requires the pain clinic certificate to show that the pain clinic has a medical director that is a pain specialist

This directs the commissioner of the department of health to develop pain clinic standards that can be used by a pain clinic as guidelines for operation.  This act takes effect on July 1, 2015.

Public Chapter 476

Currently, the top 50 prescribers of controlled substances in the state are annually identified and sent a letter notifying them of their inclusion on this list and asked to respond with a justification for their prescribing patterns.  This legislation expands on this list and requires the top 10 prescribers from all of the combined counties having populations of fewer than 50,000 to also be on this annual list.

Separate from this provision, the bill also specifies that a provider of home medical equipment or services that provides its own company-branded insulin pumps and related supplies does not have to have a physical place of business in the state if the provider maintains an employee presence in the state, is accredited by the Joint Commission on Accreditation of Healthcare Organizations and maintains a 24-7 service telephone number.

This act took effect on April 22, 2015.