"WHY?" County ordinance enacted in was response to an - PDF document

O] 611612011 GOING HOME (RULE)! A DOUBLE-HEADER FEATURING RECENTL Y ENACTED ORDINANCES IN ORANGE COUNTY Presented by Dana Crosby-Collier Assistant County Attorney, Orange County June 22, 2011 GAM E 1 Local Pain Management Clh•ic Regulation "WHO'S ON FIRST?" Orange County's playbook in enacting a Pain Management Clinic Moratorium and establishing a staff work group.

02 6/16/2011 "WHY?" County ordinance enacted in was response to an urgent local situation and of regulation the uncertainty at state level... Starting Line Up Game 1 Introduction Summary of the Orange County Ordinance and staff work group State Law Overview/State Leadership Issues 2011 Update Introduction Timeline: September 30, 2010 Former Orange County Mayor Richard Crotty announced plans for ordinance regulating pain management clLrfics BCC work session on issues relating November 9, 2010 to regulation of pain management clinics and prescription drug/use and abuse Public Hearing on Ordinance December 7, 2010 2

03 6/16/2011 Summary of Ordinance adopted December 7, 2010: Country Ordinance issuance of business tax receipts for Moratorium pain management clinics (PMC). PMC defined per 2010 state law Any privately owned clinic, facility office which advertises in any medium for any type of pain management services, employs physician who is primarily engaged in the treatment of pain by prescribing dispensing controlled substance AND PMC is registered m•der requirements of state law. Summary of Ordinance Exemptions to moratorium mirror exemptions to registration under 2010 state law: facility under Chapter 395, FS; -Licensed -Majority of physicians in the office primarily provide surgical services; -Facility is owned by a publicly held corporation; -Facility affiliated with an accredited medical school at which training is provided for medical students, residents, or fellows; -Facility does not prescribe dispense controlled substances for the treatment of pain; -Facility is owned by a corporate entity exempt from federal taxation under 26 U.S.C. 501(c) (3) or (4). Summary of Ordinance Ordinance also demand cash only as a of Provides no PMC payment; Restricts operating hours of existing PMCs to 7 a.m. to 9 p.m. of the same day; and staff work group to report back findings and Establishes recommendations to BCC by July 12, 2011. Ordinance effective December 15, 2010 Moratorium expires at the latest December 14, 2011

O4 6/16/2011 Summary of Ordinance Work Group Members Orange County Sheriff, Metropolitan Bureau of Investigation, County Plamfng, ZonLng, and Code Enforcement, City of Orlando representatives, Ocoee, Apopka and Winter Park police departments, Florida Department of Law Enforcement, U.S. Attorney's office, Drug Enforcement Administration/HIDTA STATE LAW/STATE LEADERSHIP ISSUES In spite of the ever growing numbers of PMCs in our state and associated deaths both in and of implementation of state, out our a been fraught statewide program has with issues. State law/PDMP In 2009 the Florida Legislature passed SB 462 (2009-198, Laws of Florida): -Established a Prescription Drug Monitoring Program (PDMP) in Florida law; -PDMP is central repository for controlled substance prescription medication information 2009 law required Florida's PDMP to be established by Dec. 1, 2010 4

05 6/16/2011 State law/PDMP Early issues •dth implementation of PDMP included delays to the project- challenged -DOH bid selection -DOAH ruled the bid challenge March 8, 2011 not implemented by Dec. 1, 2010 Bottom line: PDMP **Should be implemented by October 2011"* State Leadership Issues/PDMP As part of his 2011 budget, Gov. Scott Governor Scott proposed repealing the state's PDMP saying the database is government "overreach" **May 2011 update Legislature passed bill which left PDMP intact.** "1 Don't Care?" is that"What?!" State law/PMC In 2010 the Florida Legislature passed SB 2272 (2010-211, Laws of Florida): Defines PMC; Requires DOH to register, regulate and inspect PMCs; PMCs must designate a physician responsible for registration and operations of PMC; Law contains stringent penalties for violations.

O6 6/16/2011 State law/PMC Additionally: licensed physician may dispense medication at eOnly PMC; physician cannot practice in eEff. July 2012, PMC without having completed pain management fellowship pain management residency; Physician must physically examine the patient at the time medication is dispensed; and Physician must document the reasons for giving more than 72 hr supply of medication. 2010 Act took effect October 2010; registration of PMCs commenced State Leadership Issues/PMC Legislat•re- Rules to implement regs for medical doctors practicing in PMCs stalled in November 2010. veto override, required Why? HB 1565, which passed Legislature to approve rules with a specific fiscal impact. Court Challenge/PMC U.S. District Court, Florida Northern (Tallahassee) -Ps originally pled many challenges to 2010 Act (vague and overly broad definition of PMC; equal protection; due process; free speech; anti-trust...) Most issues mooted by 2011 legislation; two issues remain: -Advertising a criteria for defining PMC (1 amendment challenge) -72 hour dispensing limit (should longer be issue due to 2Oll legislation) Case 4:10cv414 (fded 9-23-10) 6

07 6/16/2011 2011 Update Mve Attorney General Pare Bondi AG Bondi's "top priority" is to February 2, 2011 public safety crisis. aggressively tackle pill mills AG proposed legislation, aggressive enforcement, increased criminal prosecution, and prevention strategies. Gov. Scott and AG Bondi announce pill March 28, 2011 mill strike force to attack prescription drug abuse from law • enforcement angle. Gov. Scott and AG Bondi stand side by side to May 6, 2011 applaud passage of the 2011 PMC bill in House. 2011 Update State Law In 2011 bills fried PMCs SB 810 (by Fasano) SB 818 (by Fasano) HB 1147 (by Garcia) HB 7095 (Schenck) SB 1386 (Bogdanoff) HB 7095 passed the Legislature in 2011 and approved by Governor Scott June 3, 2011 2011 Update State Law HB 7095 (codified at ch. 2011-141, Laws of Florida)- Did not repeal regulations and standards of care from the 2010 legislation and did amend definition of PMC. Did not repeal PDMP but did change PDMP to require data be entered in 7 days (down from 15). Requires PDMP manager and staff to undergo criminal background checks/fingerprints; Contains a physician dispensing ban; Requires practitioners who prescribe controlled substances to register with DOH and comply with specific standards of care;

08 6/16/2011 2011 Update State Law HB 7095 (cont'd) Requires pharmacies that dispense Schedule II and III narcotics to go through rigorous permitting by July 2012; Requires additional reports of distributions of controlled substances; Requires DOH conduct annual Level 2 screening pharmacy owners/controlling interest (down from every 2 years); Tracks the wholesale distribution of controlled substances; Creates a mandatory buy-back program for physicians to return controlled substances to distributors; Imposes stronger administrative and criminal penalties for doctors who overprescribe narcotics. 2011 Update State Law Identified "Loopholes" HB 7095 Doctors and pharmacists are not required to check PDMP prior to giving the patient the drugs. (This has always been an issue with the PDMP.) Board-certified pain specialists, anesthesiologists, neurologists and surgeons need not register with the State. (State officials reply that the exempted doctors have not been the main offenders.) No drug testing required of patients though doctors must write a detailed treatment plan and monitor patients for abuse. S•z•nel (May 10, 2011). l•pholes, Update: County Workgroup Orange County workgroup has been meeting since January and has been considering recommendations for the Board. Threshold issue How do you define the PMC? The state amended the definition in 2011 but definition still may not catch all PMCs. Of note: Prior to HB 7095 Sarasota County drafted ordinance that offers great model dentition for PMC. 8

09 6/16/2011 Update: County Workgroup two-pronged approach: County workgroup is considering Zoning and Substantive regulations Zoning regulation could limit location of PMCs, hours of operation, separation distances, loitering, and waiting requirement for space (HB 7095 contains waiting room) Substantive regulation could extend to requiring local PMC providers check the PDMP before prescribing controlled substances, engage in daily reporting of operational records, and keep detailed staff records. Update: County Workgroup Orange County PMC workgroup will be merged comprehensive Prescription Drug with Abuse Task Force in the near future. Recommendalions will most likely be brought to the BCC in the Fall. GAME 2 Additional Local Regulation of the Secondary Metals Industry 9

]0 6/16/2011 "BECAUSE" Orange County enacted additional local regulation due to an increase of secondary metals theft in our coininunity. Starting Line Up Game 2 Introduction State Law Overview Summary of the Orange County and City of Orlando Ordinances State Leadership Issues Introduction Timeline: August 30, 2010 City of Orlando adopted ordInance placIng additional regulations on secondary metals dealers In the City County Commissioner Scott Boyd August 31, 2010 brought report to BCC September 22, 2010 County met with City, industry, law enforcement, and others to discuss options BCC discussed item; staff seeking Board October 5, 2010 direction November 4, 2010 -County met with City, Industry, law enforcement, and others to discuss draft ordInance December 7, 2010 Public Hearing Ordinance 10