1. 1 Public Health Law Program Office for State, Tribal, Local and Territorial Support Centers for Disease Control and Prevention Pain Management Clinic Laws Akshara Menon, JD, MPH

2. 2 Disclaimer The 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.

3. 3 Today’s Presentation  Introduction  Scope of research  State laws  Definitions  State oversight  Ownership and operation requirements  Violations, penalties, and disciplinary rules  Summary and considerations

4. 4 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.

5. 5 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

6. 6 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

7. 7 Definitions of Pain Management Clinics Definition Provisions include:FLKYLAMSOHTNTXWV 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

8. 8  Kentucky Pain 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.” K Y. R EV. S TAT. A NN. § 218A.175 Definitions of Pain Management Clinics

9. 9 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.” M ISS. A DMIN. C ODE 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.” T ENN. C ODE A NN. § 63-1-304

10. 10 Summary of Ownership Requirements LawsFLKYLAMSOHTNTXWV Owner 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

11. 11 Ownership and Operation Requirements  Kentucky Only 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. K Y. R EV. S TAT. A NN. § 218A.175

12. 12  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.” L A. R EV. S TAT. A NN. § 40:2198.12 Ownership and Operation Requirements

13. 13  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.” F LA. S TAT. A NN. § 458.3265(e)(3) Ownership and Operation Requirements

14. 14  Florida—Violations and Range of Penalties A 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. F LA. A DMIN. C ODE A NN. r. 64B-7.002 Violations, Penalties, and Disciplinary Rules

15. 15  Ohio  Pain Management Clinic The 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. O HIO R EV. C ODE A NN. § 4729.552  Physician The 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... O HIO R EV. C ODE A NN. § 4731.054 Violations, Penalties, and Disciplinary Rules

16. 16  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. T ENN. C ODE A NN. § 63-1-306 Violations, Penalties, and Disciplinary Rules

17. 17 Summary of State Oversight and Disciplinary Provisions LawsFLKYLAMSOHTNTXWV 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

18. 18 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.

19. 19 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

20. 20 Thank you! Akshara Menon, JD, MPH 404-498-0419 amenon@cdc.gov