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Public Health Law ProgramOffice for State, Tribal, Local and

Territorial SupportCenters for Disease Control and

Prevention

Pain Management Clinic Laws

Akshara Menon, JD, MPH

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DisclaimerThe contents of this presentation do not represent

official CDC determinations or policies.

The findings and conclusions in this report are those of the authors and do not necessarily represent the official

position of the CDC.

The contents are for educational purposes only and are not intended as a substitute for

professional legal advice.

Always seek the advice of an attorney or other qualified professional with any questions

you may have regarding a legal matter.

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Today’s Presentation

Introduction Scope of research State laws

Definitions State oversight Ownership and operation

requirements Violations, penalties, and

disciplinary rulesSummary and considerations

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Introduction Pain management clinics are often called “pill

mills” when they become sources of large quantities of illegitimate prescriptions.

Pill mills are a contributing factor in the prescription drug epidemic.

States have enacted laws to prevent these facilities from prescribing and/or dispensing controlled substances indiscriminately or inappropriately.

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Scope of Research 50-state assessment Laws included?

Definitions State oversight requirements Ownership and operation requirements Disciplinary rules relating to express

failure to comply with operating standards

Laws excluded? General guidelines on treatment of

chronic pain Pain management councils General authority of state medical boards

Research conducted Laws current as of September 28, 2012

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States with Pain Management Clinic Laws

August 31, 2010—3 states Florida, Louisiana, and Texas

September 28, 2012—8 states Florida, Kentucky, Louisiana, Mississippi,

Ohio, Tennessee, Texas, and West Virginia

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Definitions of Pain Management Clinics

Definition Provisions include: FL KY

LA

MS

OH

TN

TX WV

Privately Owned Facilities Publicly Owned Facilities Pain management activity “primary” practice of facility

Pain treatment provided to majority(or more than 50%) of facility patients

“Controlled substances” or “narcotic medications”

“Opioids” Specific drugs (eg., carisoprodol, tramadol)

Advertising

Law states “a facility” WV has separate law on advertising

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KentuckyPain Management Facility

“[A] facility where the majority of patients of the practitioners at the facility are provided treatment for pain that includes the use of controlled substances and:

1. The facility’s primary practice component is the treatment of pain; or

2. The facility advertises in any medium for any type of pain management services.”

KY. REV. STAT. ANN. § 218A.175

Definitions of Pain Management Clinics

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State Oversight of Pain Management Clinics

Mississippi“A pain management clinic may not operate in the state of Mississippi without obtaining a certificate from the Mississippi State Board of Medical Licensure.”

MISS. ADMIN. CODE 30-17-2640:1.15

Tennessee“Each board shall have the authority to inspect a pain management clinic which utilizes the services of a practitioner licensed by that board.”

TENN. CODE ANN. § 63-1-304

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Summary of Ownership Requirements Laws FL KY LA M

SOH T

NTX W

VOwner Must be Physician *

*

Owner may be owned by Other Training Requirements for Physician Owner: Pain medicine certification/fellowship

*

Physician Owner: Must have unrestricted license and/or no drug-related felony

Physician Owner On-Site Requirements

* Law applies to all physicians who prescribe/dispense controlled substances in pain clinics ** Physician ownership requirement not enforced against any facility existing and operating on April 24, 2012, unless there is an administrative sanction or criminal conviction relating to controlled substances imposed on the facility or any person employed by the facility

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Ownership and Operation Requirements

KentuckyOnly a physician having a full and active license to practice medicine . . . shall have an ownership or investment interest in a pain management facility.

At least one of the owners or an owner’s designee who is a physician employed by and under the supervision of the owner shall be physically present practicing medicine in the facility for at least fifty percent of the time that patients are present in the facility.

KY. REV. STAT. ANN. § 218A.175

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Louisiana“All Pain Management Clinics to be owned and operated by physician certified in the subspecialty of pain management by a member board of the American Boards of Medical Specialties.”

LA. REV. STAT. ANN. § 40:2198.12

Ownership and Operation Requirements

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Florida“The department shall deny registration to any pain-management clinic owned by or with any contractual or employment relationship with a physician . . . [w]ho has been convicted of or pleaded guilty or nolo contendere to . . . an offense that constitutes a felony for receipt of illicit and diverted drugs.”

FLA. STAT. ANN. § 458.3265(e)(3)

Ownership and Operation Requirements

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Florida—Violations and Range of PenaltiesA clinic whose owner/designated physician has Failed to comply with any requirement of the Florida Drug

and Cosmetic Act; the Federal Food, Drug, and Cosmetic Act; the Drug Abuse Prevention and Control Act . . .

• First offense—fine of up to $5,000/violation and 6 months probation to 1 year suspension or revocation.

• Subsequent offense—fine of up to $5,000/ violation and a minimum of 1 year suspension to revocation.

Registered clinic through misrepresentation, fraud, or by making a false or fraudulent representation

• Fine of $10,000 per count or offense & up to 1 year suspension or revocation.

FLA. ADMIN. CODE ANN. r. 64B-7.002

Violations, Penalties, and Disciplinary Rules

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Ohio Pain Management ClinicThe board may impose a fine of not more than five thousand dollars for failure to obtain and maintain license and be in compliance with requirements . . . A separate fine may be imposed for each day the violation continues.

OHIO REV. CODE ANN. § 4729.552 PhysicianThe board may impose a fine of not more than twenty thousand dollars on a physician who fails to comply with rules adopted . . . The fine may be in addition to or in lieu of any other action that may be taken . . .

OHIO REV. CODE ANN. § 4731.054

Violations, Penalties, and Disciplinary Rules

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Tennessee If Department of Health finds that a clinic no longer

meets any requirement, it may impose lawful disciplinary action against the pain management clinic . . .

Any board which assesses any discipline or penalty against a provider that it licenses for a violation of rules shall inform the Department, which may consider such discipline or penalty as a basis for disciplinary action against the pain management clinic.

TENN. CODE ANN. § 63-1-306

Violations, Penalties, and Disciplinary Rules

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Summary of State Oversight and Disciplinary Provisions

Laws FL KY LA MS

OH TN

TX

WV

State Registration (Certificate, License)

*

State Inspection Authority ** Violations, Penalties and Disciplinary Rules

* Law provides some exceptions to state registration

** Board of Pharmacy has general inspection authority as licensing body, but there are no legal provisions specifically for Board of Pharmacy to inspect pain management clinics

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Different Type of Licensing

Ohio Pain Management Clinics shall hold Category III

Terminal Distributor of Dangerous Drugs License with a Pain Management Clinic Classification.

ALL pain management clinics must have this license Law does not distinguish between pain management

clinics that distribute drugs on premises versus those that do not.

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Pain Management Clinic Laws

Summary Regulation of pain

management clinics relatively new and evolving area of law

Laws typically require state oversight and ownership and operational requirements

Laws typically provide for penalties against pain management clinics and physicians not in compliance

Considerations Scope of coverage issues Potential new trends

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Thank you!

Akshara Menon, JD, MPH404-498-0419

amenon@cdc.gov