1 Presented by Dana Crosby-Collier Assistant County Attorney, Orange County June 22, 2011
2 Local Pain Management Clinic Regulation
3 Orange County s playbook in enacting a Pain Management Clinic Moratorium and establishing a staff work group.
4 County ordinance was enacted in response to an urgent local situation and uncertainty of regulation at the state level
5 Introduction Summary of the Orange County Ordinance and staff work group State Law Overview/State Leadership Issues 2011 Update
6 Timeline: September 30, 2010 Former Orange County Mayor Richard Crotty announced plans for an ordinance regulating pain management clinics November 9, 2010 BCC work session on issues relating to regulation of pain management clinics and prescription drug/use and abuse December 7, 2010 Public Hearing on Ordinance
7 County Ordinance adopted December 7, 2010: Moratorium on issuance of business tax receipts for new pain management clinics (PMC). PMC defined per 2010 state law Any privately owned clinic, facility or office which advertises in any medium for any type of pain management services, or employs a physician who is primarily engaged in the treatment of pain by prescribing or dispensing controlled substance AND PMC is registered under requirements of state law.
8 Exemptions to moratorium mirror exemptions to registration under 2010 state law: -Licensed as a facility under Chapter 395, FS; -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 or dispense controlled substances for the treatment of pain; or -Facility is owned by a corporate entity exempt from federal taxation under 26 U.S.C. 501(c) (3) or (4).
9 Ordinance also Provides no PMC can demand cash only as a means of payment; Restricts operating hours of existing PMCs to 7 a.m. to 9 p.m. of the same day; and Establishes a staff work group to report back findings and recommendations to BCC by July 12, Ordinance effective December 15, Moratorium expires at the latest December 14, 2011
10 Work Group Members - Orange County Sheriff, - Metropolitan Bureau of Investigation, - County Planning, Zoning, 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
11 In spite of the ever growing numbers of PMCs in our state and associated deaths both in and out of our state, implementation of a statewide program has been fraught with issues.
12 In 2009 the Florida Legislature passed SB 462 ( , Laws of Florida): -Established a Prescription Drug Monitoring Program (PDMP) in Florida law; -PDMP is a central repository for controlled substance prescription medication information law required Florida s PDMP to be established by Dec. 1, 2010
13 Early issues with implementation of PDMP included delays to the project -DOH bid selection was challenged -DOAH ruled on the bid challenge March 8, 2011 Bottom line: PDMP was not implemented by Dec. 1, 2010 **Should be implemented by October 2011**
14 Governor Scott As part of his 2011 budget, Gov. Scott proposed repealing the state's PDMP saying the database is government overreach **May 2011 update Legislature passed a bill which left PDMP intact.** February 9, 2011 headline: Scott irresponsibly wrong on abolishing drug database OPINION, THE PALM BEACH POST Is that What?! or I Don t Care?
15 In 2010 the Florida Legislature passed SB 2272 ( , Laws of Florida): Defines PMC; Requires DOH to register, regulate and inspect PMCs; PMCs must designate a physician responsible for registration and operations of a PMC; Law contains stringent penalties for violations.
16 Additionally: Only a licensed physician may dispense medication at a PMC; Eff. July 2012, a physician cannot practice in a PMC without having completed a pain management fellowship or 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 a 72 hr supply of medication Act took effect October 2010; registration of PMCs commenced
17 Legislature Rules to implement regs for medical doctors practicing in PMCs stalled in November Why? HB 1565, which passed on veto override, required Legislature to approve rules with a specific fiscal impact. November 23, 2010 headline: As drug deaths mount, new law stalls tighter state regulation By Lee Logan, Times/Herald Tallahassee Bureau
18 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 as a criteria for defining PMC (1 st amendment challenge) -72 hour dispensing limit (should no longer be issue due to 2011 legislation) Case 4:10cv414 (filed )
19 MVP Attorney General Pam Bondi February 2, AG Bondi s top priority is to aggressively tackle pill mills as a public safety crisis. AG proposed legislation, aggressive enforcement, increased criminal prosecution, and prevention strategies. March 28, 2011 Gov. Scott and AG Bondi announce pill mill strike force to attack prescription drug abuse from a law enforcement angle. May 6, 2011 Gov. Scott and AG Bondi stand side by side to applaud passage of the 2011 PMC bill in House.
20 In 2011 bills filed on 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 was approved by Governor Scott June 3, 2011
21 HB 7095 (codified at ch , 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;
22 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 on pharmacy owners/controlling interest (down from once 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.
23 HB 7095 Identified Loopholes -- 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. Source: Law to Rein in Pill Mills has Loopholes, Orlando Sentinel (May 10, 2011).
24 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 an ordinance that offers a great model definition for PMC.
25 County workgroup is considering a two-pronged approach: Zoning and Substantive regulations Zoning regulation could limit location of PMCs, hours of operation, separation distances, loitering, and waiting room space (HB 7095 contains a requirement for a 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.
26 Orange County PMC workgroup will be merged with a more comprehensive Prescription Drug Abuse Task Force in the near future. Recommendations will most likely be brought to the BCC in the Fall.
27 Additional Local Regulation of the Secondary Metals Industry
28 Orange County enacted additional local regulation due to an increase of secondary metals theft in our community.
29 Introduction State Law Overview Summary of the Orange County and City of Orlando Ordinances State Leadership Issues
30 Timeline: August 30, 2010 City of Orlando adopted ordinance placing additional regulations on secondary metals dealers in the City August 31, 2010 County Commissioner Scott Boyd brought report to BCC September 22, 2010 County met with City, industry, law enforcement, and others to discuss options October 5, 2010 BCC discussed item; staff seeking Board direction November 4, 2010 County met with City, industry, law enforcement, and others to discuss draft ordinance December 7, 2010 Public Hearing on Ordinance
31 Part II, Chapter 538, Florida Statutes -- Significant changes to state law in Secondary metals recyclers must maintain a record of seller information on a FDLE form: - Identification information - Statement of ownership - Description of seller - Seller s thumbprint - Description of seller s vehicle - Photo or video of metal being sold - Photo of seller receiving money for sale Allows for law enforcement inspection of property and records
32 Part II, Chapter 538, Florida Statutes (cont d) - Provides no cash transaction over $ Requires all dealers register with the state State Law Prohibits: - Purchase of regulated metals between 9 pm and 6 am - Purchase anywhere but fixed location - Purchase of property not transported in a motor vehicle Florida Statutes did not prohibit County from imposing more stringent reporting requirements.
33 County Ordinance adopted December 7, 2010: Electronic reporting of all transaction details (except consideration amount) using the FINDER system Requires dealers have access to a fax machine to receive law enforcement alerts Creates a definition for restricted regulated metals and requires: Seller shows additional proof of ownership; Dealer processes as a cashless transaction (check is mailed or EFT); and Seller may receive a check at time transaction if exempt (civic, nonprofit, business to business, part of judicial process).
34 17 restricted regulated metal items including: Manhole cover Electric light pole or utility structure Guard rail Street sign or traffic signal Funeral marker or vase Historical marker Railroad equipment Metal item observably marked with name, initials, or logo of a governmental entity, utility company, or cemetery Copper or aluminum coils from heating or air conditioning unit not window units or auto a/c Stainless steel beer kegs Any part of a catalytic converter (except shell) unless sold with a vehicle Brass or bronze FDC valves and Shopping carts County s Ordinance took effect January 3, 2011
35 By comparison, City of Orlando: Adopted an ordinance Aug. 30, 2010 Ordinance took effect Jan. 3, 2011 Established a purely cashless system Listed 20 restricted items same as County s list plus copper tubing, copper or aluminum guttering, and aluminum siding.
36 Since Orange and Orlando adopted ordinances, numerous cities and counties are adopting ordinances similar to the both ordinances. Industry took language similar to the County s -- but with express preemption via grandfather clause -- to the Legislature in 2011.
37 In 2011 bills were filed on secondary metals HB 753 (by Ford) SB 1528 (by Altman) Both bills died in committee but they will probably be back next year.
38 The Orange County ordinances are included in your back up. If you need any additional information or wish to be added to my list for either item, please contact me at Dana Crosby-Collier Orange County Attorney s Office