Model Pain Clinic Regulations

Description

Model pain clinic regulations are designed to prevent facilities from prescribing controlled substances indiscriminately or inappropriately.

Objective(s)

To reduce the over-prescription and/or inappropriate prescription of controlled substances

Typical Elements

The National Alliance for Model State Drug Laws (NAMSDL) and the National Safety Council (NSC) jointly developed model pain clinic regulations for states (NAMSDL & NSC, 2014).

  • Note: State definitions of “pain clinics” vary; however, they are generally defined as facilities that focus on treating and managing pain through the prescription and dispensation of controlled substances. While some pain clinics can become illicit “pill mills,” legitimate pain clinics are valid medical facilities (U.S. Department of Health and Human Services, 2013).

The model regulations recommend that states develop certification requirements, which allow pain clinics to demonstrate adherence to state regulations. NAMSDL and NSC recommend that the certification process include the following (NAMSDL & NSC, 2014):

  • A description and definition of key terms (such as “pain clinic”)
  • A description of the required certification processes and procedures for clinics, for example:
    • Posting the certificate in a clearly visible location
    • Submitting a new certification application when there are changes in clinic ownership
    • Making certifications valid for only one or two years, at which point they must be renewed
    • Making certifications valid for only a single physical location, and requiring each location to obtain a separate certification
    • Reporting modifications to a clinic’s name, address, and ownership to the relevant regulatory agency within a specified time frame
  • The criteria for denying or revoking certification, for example:
    • Lack of adherence to certification requirements
    • Lack of qualified staff
    • Lack of proper care
    • Felony conviction of a clinic’s owner or core staff member
    • Drug Enforcement Administration revocation of the clinic’s license number
    • Provision of false or misleading statements or materials to state authorities
    • Misdemeanors or felonies involving controlled substances
    • Failure to file required reports
    • Failure to maintain proper patient and prescription records
  • An explanation of which facilities are exempt from pain clinic regulations, for example (NAMSDL & NSC, 2014, pp. 14­–15):
    • Ambulatory surgical centers
    • Clinics that do not prescribe controlled substances for pain treatment
    • Surgical clinics that prescribe narcotics for post-operative pain
    • Hospices
    • Federally operated hospitals
    • Hospitals and associated outpatient facilities 
    • Medical or dental schools and associated outpatient clinics
    • Nursing homes  
    • Nursing schools and associated outpatient clinics
    • Osteopathic schools and associated outpatient clinics
    • Long-term care facilities
    • State-operated facilities
  • The penalties for operating, owning, or managing a non-exempt pain clinic without certification, which can include civil or criminal fines and prosecution
  • What is required of clinic owners (for example, holding certain licenses and/or board certifications, not having criminal convictions)

The model regulations recommend that states require pain clinics to do the following (NAMSDL & NSC, 2014):

  • Designate one person (such as a clinical director) who is responsible for day-to-day clinic operations and compliance
  • Ensure that certain individuals (including owners, medical directors, and clinic managers) are onsite for at least a certain percentage of the operating hours
  • Follow state restrictions regarding the prescription and dispensation of controlled substances (for example, requiring a physical exam prior to prescribing)
  • Interact with the state’s Prescription Drug Monitoring Program
  • Ensure that clinic professionals meet all state medical board requirements
  • Meet physical environment standards, for example (Office of National Drug Control Policy, 2011):
    • Sanitary facilities
    • Clearly posted signs and notifications
    • Adequate reception and waiting areas
    • Private examination rooms
    • Appropriate file storage
    • Locked storage for controlled substances
    • Restrooms for staff and patients
    • Counterfeit-resistant prescription pads
  • Follow state inspection requirements, such as procedures for allowing state inspectors to review patient records
  • Maintain and securely store records and/or collect certain data, for example (NAMSDL & NSC, 2014):
    • Patient identifiers
    • Medical history
    • Prescription monitoring reports
    • The chief complaint and diagnosis
    • Lab orders and results
    • Pathology and radiology reports
    • Substances prescribed or dispensed
    • A patient-signed agreement regarding treatment

Populations

Pain clinic directors, providers, patients

Outcomes

In Florida, when combined with other state initiatives and enforcement actions, model pain clinic regulations were associated with reductions in the following (Johnson, Paulozzi, Porucznik, Mack, & Herter, 2014):

  • Number of drug prescriptions
  • Number of prescribers dispensing a high volume of oxycodone prescriptions
  • Overdose deaths
  • Drug diversion rates

Guidelines

Menu of Pain Management Clinic Regulation.

State Statutes and Regulations Relative to Chronic Pain and Pain Management. Emphasis on Pain Management Clinics: Brief Summary of Federal Provisions. 

Acknowledged by

National Conference of Insurance Legislators.Best Practices to Address Opioid Abuse, Misuse and Diversion. 

Office of National Drug Control Policy. Epidemic: Responding to America’s Prescription Drug Abuse Crisis.

References

Johnson, H., Paulozzi, L., Porucznik, C., Mack, K., & Herter, B. (2014). Decline in drug overdose deaths after state policy changes—Florida, 2010–2012. Morbidity and Mortality Weekly Report, 63(26), 569–574. Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6326a3.htm

National Alliance for Model State Drug Laws & National Safety Council. (2014). Prescription drug abuse, addiction and diversion: Overview of state legislative and policy initiatives. Part 2: State regulation of pain clinics and legislative trends relative to regulating pain clinics.

Office of National Drug Control Policy. (2011). Epidemic: Responding to America’s prescription drug abuse crisis. Retrieved from https://www.ncjrs.gov/pdffiles1/ondcp/rx_abuse_plan.pdf 

U.S. Department of Health and Human Services. (2013). Addressing prescription drug abuse in the United States: Current activities and future opportunities. Behavioral Health Coordinating Committee, Prescription Drug Abuse Subcommittee. Retrieved from https://www.cdc.gov/drugoverdose/pdf/HHS_Prescription_Drug_Abuse_Report_09.2013.pdf