May 16, 2013
Indiana Governor Mike Pence signed Indiana Senate Bill 246 into law last week, which requires registration and possible inspection of practices, including pain management clinics, that prescribe controlled substances. Indiana’s law demonstrates the increasing trend of states passing legislation to regulate pain management clinics. The true extent of the legislation remains to be seen, however, because the Indiana Medical Licensing Board must adopt emergency rules and final rules. Below are four key points regarding the new law.
- Emergency Rules. Emergency rules must be adopted before Nov. 1, 2013, that (i) establish standards and protocols for the prescribing of controlled substances consistent with the standard medical practices in pain management treatment; and (ii) provide guidance regarding when the Indiana Attorney General can inspect a physician’s controlled-substances prescribing practices. Final rules must be adopted by Nov. 1, 2014.
- Registration of Pain Clinics. Beginning on Jan. 1, 2014, clinics that prescribe, dispense or administer controlled substances must register with the Indiana Medical Licensing Board and adopt reasonable procedures to ensure that employed or contracted individuals who are prescribing controlled substances are dispensing the controlled substances in compliance with Indiana laws, rules and regulations. A separate registration will be required for each principal place of business where the registrant employs or contracts with individuals to dispense controlled substances. If an owner fails to comply with the various registration requirements, the owner could face (i) an injunction; (ii) the appointment of a receiver; and (iii) monetary penalties up to $5,000 and the reasonable costs of the Attorney General’s investigation and prosecution.
- Attorney General Inspection. The new legislation will allow the Indiana Attorney General to request, investigate and prosecute physicians who are overprescribing controlled substances. The Medical Licensing Board will adopt emergency and final rules regarding the extent to which the Attorney General can request records without a court order and will provide safeguards and protections for physicians against unreasonable and oppressive examination authorizations.
- Drug Disposal. The legislation creates a commission to study pharmacy programs designed to take back and dispose of old and expired prescription drugs. The commission is charged with recommending solutions that would allow consumers to dispose of old and expired prescription drugs at local pharmacies without difficulty.
If you have questions regarding Indiana’s legislation or any state legislation regulating pain clinics’ operations, please contact one of the authors.