1. Prescription Drug Monitoring Programs: Analysis of State Level Usage Requirements Matthew Penn, JD, Carla Chen, JD Director, Public Health Law Program Legal Fellow, Public Health Law Program Office for State, Tribal, Local and Territorial Support Centers for Disease Control and Prevention State Health Department Training and Technical Assistance Meeting: From Epidemiology to Policy: Prescription Drug Overdose April 22 and 23, 2013 Centers for Disease Control and Prevention Office for State, Tribal, Local and Territorial Support

2. Disclaimer The contents of this presentation do not represent official CDC determinations or policies. 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. 2

3. Introduction  CDC Collaboration: Public Health Law Program (PHLP) & National Center for Injury Prevention and Control  National Alliance for Model State Drug Laws (NAMSDL): Prescription Drug Monitoring Project  Status of State Prescription Monitoring Programs (PMPs)  Variety of legal issues  “States that Require Prescribers and/or Dispensers to Access PMP Information in Certain Circumstances” 3

4. 4 States with PMP Usage Laws

5. PMP Usage Laws: PHLP  10 states have laws requiring PMP usage  Prescriber and dispenser trends Certain drugs Certain circumstances  Exceptions  Enforcement  Unique Provisions  6 states have laws related to usage but do not require checks for prescribing and dispensing 5

6. PMP Usage Laws: Detecting Fraud, Abuse, or Diversion States with prescribing or dispensing laws Provision applies to prescribing Provision applies to dispensing Colorado Delaware Kentucky Louisiana Nevada New York Ohio Oklahoma Tennessee West Virginia 6

7. PMP Usage Laws: Detecting Fraud, Abuse, or Diversion  States that require prescribers or dispensers to check PMPs when they suspect fraud, abuse, or diversion  Delaware, Ohio, and Nevada: Reasonable belief of nonmedical use  Kentucky and Ohio: Long-term prescribing  Tennessee: Aware or reasonably certain of fraud 7

8. PMP Usage Laws: Certain Schedules or Drug Types States with prescribing or dispensing Laws Provision applies to prescribing Provision applies to dispensing Colorado Delaware Kentucky Louisiana Nevada New York Ohio Oklahoma Tennessee West Virginia 8

9. PMP Usage Laws: Certain Schedules or Drug Types  States that require prescribers or dispensers to check PMPs when dealing with certain schedules or types of drugs  New York: By schedule  Colorado, Oklahoma, and West Virginia: By drug type  Kentucky and Tennessee: By schedule and drug type 9

10. PMP Usage Laws: Explicit Frequency or Duration States with Prescribing or Dispensing Laws Provision Applies to Prescribing Provision Applies to Dispensing Colorado Delaware Kentucky Louisiana Nevada New York Ohio Oklahoma Tennessee West Virginia 10

11. PMP Usage Laws: Explicit Frequency or Duration  States that require prescribers or dispensers to check PMPs with an expressed frequency or duration  Kentucky: at least once every three months  Ohio: at least once annually for long-term prescribing  Tennessee and West Virginia: annually  Delaware, Nevada, and Ohio: data must span at least previous twelve months 11

12. PMP Usage Laws: Exceptions States with Usage Laws Exception for temporary access problems Waiver for longer term lack of access Direct administration of drugs Environment -focused exceptions Patient- focused exceptions Colorado Delaware Kentucky Louisiana Nevada New York Ohio Oklahoma Tennessee West Virginia 12

13. PMP Usage Laws: Exceptions  Temporary access problems  Kentucky: Unable to obtain PMP report in a timely manner  Ohio, Tennessee, and New York: PMP report or internet is not available  Waiver for longer term lack of access  Delaware and New York: Technological limitations  Tennessee: Undue hardship 13

14. PMP Usage Laws: Exceptions  Direct administration of drugs  Delaware, Tennessee, and New York: Generally or for emergency patient care  Environment-focused exceptions  Delaware, Kentucky, New York, Ohio, and Tennessee: Emergency departments, surgery, healthcare facilities  Patient-focused exceptions  New York: potential adverse impact to patient  Kentucky: younger than 18 years of age with ADD/ADHD 14

15. PMP Usage Laws: Enforcement  Explicit reference to enforcement  Kentucky: enforceable through licensing penalties  Colorado: enforceable through workers’ compensation statute  Delegation of enforcement  Delaware, New York, Tennessee, and West Virginia: Administrative bodies to promulgate rules and regulations regarding procedures, implementation, and penalties  No enforcement language within usage provision  Louisiana, Nevada, Ohio, and Oklahoma 15

16. PMP Usage Laws: Unique Provisions  Law does not apply if PMP is not operational  Delaware: dependent upon funding  Ohio: dependent upon state pharmacy board maintaining the PMP  Provisions dealing with liability  Delaware, New York, Tennessee, and West Virginia: Provisions range from providing immunity from civil liability to providing an absolute defense in civil or criminal actions  What to do when fraud is suspected  Kentucky: cease prescribing/dispensing; shall notify law enforcement  West Virginia: practitioner may notify law enforcement 16

17. Laws Related to Using PMPs States with laws related to using PMPs Usage required at other times Practice sites required to provide access Rulemaking authority delegated Colorado Kentucky Massachusetts Ohio Tennessee West Virginia 17

18. Laws Related to Using PMPs  States that require usage at times other than prescribing or dispensing  Colorado: for medical history and drug screens  Kentucky: for admission to a hospital, long term care facility, or surgical center  States that require practice site access to PMP  Tennessee: each person operating a practice site shall provide for electronic access  West Virginia: opioid treatment program shall allow access to PMP 18

19. Laws Related to Using PMPs  States with provisions delegating authority to make rules about PMP usage  Massachusetts: the department of public health  Ohio: state dental board, board of nursing, board of optometry, board of pharmacy, and medical board to develop regulations  Tennessee: medical directors at pain management clinics 19

20. PMP Registration Laws  “States that Require All Licensed Prescribers and/or Dispensers to Register with PMP Database” (http://www.namsdl.org/documents/StatesthatRequirePractitionersto RegisterorHaveAccesstoPMP09112012.pdf )http://www.namsdl.org/documents/StatesthatRequirePractitionersto RegisterorHaveAccesstoPMP09112012.pdf  8 states: Arizona, Kentucky, Maine, Massachusetts, New Hampshire, New Mexico, Tennessee, Utah 20

21.  Kentucky  Massachusetts  Tennessee  Colorado  Delaware  Louisiana  New York  Nevada  Ohio  Oklahoma  West Virginia 21

22. Questions?  Definition of terms  Application and implementation of provisions  Timeline on implementing regulations  Mechanism for registration in states without mandatory registration  Others? 22

23. For more information, please contact CDC’s Office for State, Tribal, Local and Territorial Support 4770 Buford Highway NE, Mailstop E-70, Atlanta, GA 30341 Telephone: 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 E-mail: OSTLTSfeedback@cdc.govWeb: http://www.cdc.gov/stltpublichealthOSTLTSfeedback@cdc.govhttp://www.cdc.gov/stltpublichealth The findings and conclusions in this presentation are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. Thank You Matthew Penn, JD mpenn@cdc.gov http://www.cdc.gov/phlp/ Centers for Disease Control and Prevention Office for State, Tribal, Local and Territorial Support