BOM Rules Regs

8/3/2019 BOM Rules Regs

1/13

BILL MC COLLUMATTORNEY GENERALSTATE OF FLORIDA

M E M O R A N D U M

;' ) I j (I '. '", '" ,

9:35

OFFICE OF THE ATTORNEY GENERALAdministrative Law Bureau

PL-Ol, The CapitolTallahassee, Florida 32399-10 50Telephone (850) 414-3300Fax (850) 922-6425

TO:FROM:

Anthony Director, Board of Osteopathic MedicineNancy A. Operations & Management Consultant I

RE: Rules 64BI5-14.0051 & 14.0052DATE: October 20, 20 I 0

The above- referenced rules were filed for final adoption with the Secretary of State on October19,2010. Attached is a copy for your records. Please be advised that the rules become effectiveon November 8, 2010.Please contact me if you have any questions regarding the rules.

attachmentcc: Office of the General Counsel, DOH


2/13

THE FULL TEXT OF THE PROPOSED RULE IS:64BlS-14.00S1 Standards of Practice for Practicing in Pain Manaement Clinics. THIQ

RULE IS APPLICABLE TO PHYSICIANS PRACTICING IN PRIVATELY O'iiNED PAINMANAGEMENT CLINICS THAT ARE RgQUIRED TO BE PURSUANT TO SECTION459.0137. F.S., WHO PRIMARILY ENGAGE IN Tf[E TREATMENT OF PAIN BY PRESCRIBING ORDISPENSING CONTROLLED SUBSTANCE MEDICATIONS.

0') Definitions. The following dcppitions apply to this rule only.(a) Controlled Substance. A "controlled substarJce" is any substance or descriD..r9. in Schedules

I-V of Section 893.03, Flor:ida Statutes,(b) Adverse Incidents. An "adverse incident" is an y incident set fortir i rLSection459.026(4)(a\-(el,

Florida Statutes.Cd "Board-certified pain management nhysician" means a phYsician who possesses Board

certification by a specialty board recognized bv the American Board of Medical Specialties (ABMS) andholds a sub-snccialty certification in uain medicine; or Board certification in pain medicine by theAmerican Board afPain Medicine (ABPM); or a Certificate of Added Qualification in Pain Managemgillby the American Osteopathic Association (AOA).

Cd) "Addiction medicine specialist" means a board certified psychiatrist with a subspe9ialtycertification in addiction medicine or who is eligible for such subspecialty certification in addictionmedicine or an addiction medicine physician certified or eligible for certification by the American Societyof Addiction Medicine (ASAM). or who holds a Certificate of Added QualifIcation in Addiction Medicinefrom the AOA.

(e) "Mental bealth addiction facility" means a facility licensed pursuant to Chapters 394 or 397,Florida Statutes.

(2) Standards o[Practice in Pain Management Clinics.(a) Evaluation of Patient and Medical Diagnosis. A complete medical history and a physical

examination must be conducj:ed prior to commencement of any treatment and documented in the medicalrecord. The exact components of the physical examination shall be left to the judgment of the clinicianis expected to perform a physical ex,amination proportionate to the diagnosis that justifies a treatment.

1


3/13

Ihe medical must. at ,3 minimum. document the nature and intensity of the pain, cJd.I[ent and past!Teatments for pain, UIlderlyinu or coexisting diseases or cO[lditions, the effect qfthe pain on phys!cgilllldpsychological fllnction, a revi_ew of prio r medical records, previous_ diagnostic studies. an


4/13

@ Periodic Review. The p_


5/13

laboratory, The physician shall fol1o:w the collection procdures required by the manage ment clinic has entereg into with the CLIA-c;ertified lab.Qratory it uses.

3. Specimen and tested in office. A physiciaI). shall and test in the office to Q_e used for drug using CLIA-w.?-ived point:o.f-"c;are test or CLlA-approved test that u:..a device that measures the pI-I. specific gravity, and temperature. Results of the dmg test shall be readaccording to the manufacturer's instructions

Medical Records. The physic ian is requiredJo keep accurate and complete records toinclude, but not be limited to:

1. The complete:; medica] history and a physical examination. history of drug abuse ordependence;

2. Diagnostic, therapeutic, and laborato ry results:3. Evaluations and consultations;4. Treatment objectives;5. Discussion of risks and benefits:6. Treatments;7. Medications (including date, type. dosage, and quantity prescribed);8. Instructions and agreements:9. Periodic reviews;10. Drug results;II . A photocopy of the patient's government issued photo identification: and12. If a \Vfitten prescription for a controlled substance is given to the patient. a duplicate of said

prescription must be maintained in the patient's medical record.13. Each pain management clinic physician's medical re:ford shall contain the physician 's full name

presented in a legible maruler. In addition, each clinic must maintain a log on the premises which shallcontain the full name, presented in a legible maIlller, along with a corresponding sample sienature andinitials of every nhysician, anesthesiologist assistant and physician assistant working in the clinic,

4


6/13

14. Mediqtl records must remain current. they ruust be maintained in an accessible Hl,g,!l1er andreadily available for review and must be in full compliance with Rule 64B15-15.004. F.A.C.. and Sef.tism459.015(1)(0). F.S.

iliLl?.enial or Termination of Controlled Substance Tlierapy.1. Ifa patient's initial drug testing reflects the adulteration of the specimen or the of illegal

or than medications wit4 approved prescriptions), or when the testin!! result isfllLestioned by either the patient or the physician. the sps;cimen \Yin be sent to a eLlA-certified for gas or liquid chromatoeraphy/mass spectrometry (GClMS or LC/MS or LC/MS/MS or gC/MS/MS)confirmation. If the result of the GC/MS or LC/MS or LC/MS/MS or GC/MSIMS testing is positive. thephysician shall the patient for further consultatio_il with a board-certified P"!in management physician,an addiction medicine sne.f,ialist. or to a mental health addiction facility as it pertains to drug abuse OJ:addiction. After consultation is obtained. the physician shall document in the medical record the results ofthe consultation.:._ The trea!jng physician shall not prescribe or dispense any controlled substances untilthere is written conCllTence of medical necessity of continued controlled substance therapy provided by aboard-certified pain managenlent physicia:rt an addiction medicine specialist, or from a mental healthaddiction facility. If the treating physician is a board-certified pain management physician, or an addictionspecialist the physician does not need to refer the p-tient for further consultation. If the physician suspectsdiversion, then the patient shall be discharged and all results of testing and actions taken by the phYsicianshall be documented in the patient's medical record.

2. For patients currently in treatment by the physician or any other physician in the same painmanagement clinic, patients wi th signs or symptoms of substance abuse, shall be immediately referred to aboard-certified pain management physician. an addiction medicine specialist. or a mental health addictionfacility as it pertains to drug abuse or addiction unless the physician is board-celiified or board-eligible inpain management. Throughout the period of time orior to receiving the consul tant's reDort. a prescribingphysician shall clearly and completely document medical justification for continued treatment withcontrolled substances and those steps taken to assure medically appropriate use of controlled substances bythe patient. Upon receipt o:(the consultant's \Vl'itten report. the prescribing physician will incorporate the

5


7/13

consultant's re,fommendations for continuing, modifying, or discontinuing controlled substance The resulting chang.es in treatment shall be specificaUy dOC1,gl1ented in the-Ratient's medical record.

3. For patlents currently in treatment by the physician or any other physician in the same pail}manageruy_nt or beha.Yl9ral indicatiQns of diverg,i9J1 shall be fQ.11owed bv. discontinuation ofcontrolled substance therapy_and the patient.shall be and all results oftesting and ,!ytions tak.enby the physician shall be Q.Qcumented in the patient's l}1edical record.,.

(i) Facili tv an4_Physical Operations.'. A pain management cl inic shall be located and operated at a publicly accessible fixed t9sation and

shall cOl,tain the fg))myjtlg:a. A sign tvat can viewed by the public that contains the clini.f: name. hours of operatjg.D5, and a

street address;L.6J1ublicly Listed telephone number and a dedicated phone number to send an4 receive faxes with a

fax machine that shall be twenty-four hours per day;c. Emergency lighting and connnuJlications;d. Reception and waiting area;e. Restroom:f. Administrative area including room for storage of medical records. supplies and equipment:g. Private patient examination room(s);h. Treatment room(s) if treatment is being provided to the patient;L A printed sign located in a conspicuous place in the waiting room viewable by tbe public disclosing

the name and contact information of the clinic Designated Physician, and the names of all physicianspracticing in the clinic:

1. Storage and handllng of prescription drugs. Clinics t4..at store and dispense prescription drug shallcomply with Section 499.012 L Florida Statntes. Section 893.07. Florida Statutes. and Rule 64F-12.012,Florida Administrative Code.

2. Nothing in this subsection shall excuse a physician from providing any treatment or perfonning anymedical duty without the proper equipment and materials as required by the standard of care.

(j) Infection Control.

6


8/13

L., The clilli,c shall maintain equipment and sll12plies to suppOli infection prevention apd controlactivities.

2..The clinic shall identify infection risks based on the following:a. Geographic location. community, an4. -population served;1;>. The care", treatment and services it ..e:.lldc. An analysis of infection syrveillance, and control data.3. The clinic shall maintain written in(ection prevention policies and ]J.:rocedures that addrcs_Lthe

foilowiuKa. Prioritize(;Lrisks;p. Limiting unprotected exposure to pathogen;c. Limiting the transmission of infections associatyd with pcrfOlIDedjn the clinic; andd. Limiting the transmission of infections associated with the clinic's use of medical

devicgs, and suppUes.(k) Health and 1. The clinic. including its grounds. buildings, furniture, appliances and equipment shall be

structurally sound, in good repair, clean, and free from health and safety hazards.2. The clinic shall have evacuation procedures in the event of an emergency which shall include

provisions for the evacuation of disabled patients and employees.3. The clinic shall have a written facility-specific disaster plan which sets forth actions that will be

taken in the event of clinic closure due to unforeseen disasters which shall include provisions for theprotection of medical records and any controlled substances.

4. Each clinic shall have at least one employee on the premises during patient care hours that iscertified in Basic Life Support and is trained in reacting to accidents and medical emergencies untilemergencv medical personnel alTive.

(1) Quality Assurance. Each pain management clinic shall have an ongoing: quality assurance programthat objectively and systematically monitors and evaluates the quality and appropriateness of patient evaluates methods to improve patient care, identifies and corrects deficiencies within the facility, alerts theDesignated Physician to identify and resolve recurring problems, and provides for opportunities to improve

7


9/13

the facilitv's performance and to enhance and improve the quality of care provided TheDesif'.:nated PJwsiciaE 11all establi_sh a quality assurance program that includes the following cOID"p'onents:

1. The identifIcation, iuvestif'.:ation, and analvsis of the frequency and cause.?. of adverse incidents topatients.

2. The identifi.cation of trends or o:f..!gcidenJs.;L.The development of measures to con-ect, reduce, minimize, or eliminate the risk of adverse incidents

1Q...atients. and4. The of these fUllctions and periodic review.no less than gUaJ.1erly of such information

by the designated physician.5. The Quality ASSUI?ilCe program must be reviewed bv a Florida-licensed Ijsk manager. and

documentatioJ;Lof said aIiliual review must be provided to the Department together with any correctiveaction plan within 30 days of the annual review and maintai.ned for inspection purposes.

(m) Data Collection and Reporting.1. Reporting of adverse incidents. The Designated Physician for each pain-management clinic shaH

report all adverse incidents to the Department ofHealth as set forth in Section 459.026, Florida Statutes.2. The Designated Physician shall also report to the Board of Osteopathic Medicine, in writing. on a

quarterly basis the following data:a. Number of new and repeat patients seen and treated at the clinic who are prescribed or dispensed

controlled substance medications for the treatment of cm:onic. non-malignant pain;b. The number of patients discharged due to drug abuse;c. The number ofpatients discharged due to drug diversion: andd. The number of patients treated at the pain clinic whose domicile is located somewhere other than in

Florida. A patient's domicile is the patient's fixed or permanent home to which he intends to return eventhough he may temporarilY reside elsewhere.

3. All PllYsiciaIls practicing in pain-managemc_nt clinics shaH advise the Board of OsteopathicMedicine in writing. within 10 calendar days ofbef'.:inning or ending his or her practicc at a pain-management clinic.

8


10/13

ill) Training Requirements. July L ?lIlo have not met the qualifications setforth in subparaQI


11/13

!=. Drug screenilfg or testing:c)nch.t4iIJ_g and linlitations;of controlled substances in tTeat)ng short-tenn and ol1!loing pain synqromes. inclu9!.M

usefulness and limit'!tions;phalJ}}sLCological pain treatments;f. Evidenced:.h.?-sed non-pharmacological LA complete pain medicine hist9ry and a physical examinatiill!;,mMress note keeping;i. Comorbidities wi th pain djsorciers..l. including and addictive disorders;j. Dmg abuse and diversion,_and prevglltion of same:K:._Risk management; and

L Medic,,) ethics.In additionJo the CME set forth in subparagJ.:.aph 6. above, physicians :gIllst be able to document hospitalprivilege_s_ at a Florida-licel!sed hospital; practice under the direct supe1\lision of a physician who isqualified in subparagraphs 1. through 4. above; or have the practice reviewed by a Florida-licensed riskmanaller and document compliance with all recommendations of the risk management review.

7. Upon completion ofthe 40 hours ofeME set forth above, physicians qualifying under 6. above.must also document the completion of 15 hours of in-person, live uarticipatory AMA Category lo r AOACategory IA CME in pain management for every year the physician is practicing pain management.Rulemaking Authority: 459.0137 (4), FS.Law Implemented: 459.0137, FS.History: New

64B15-14J)052 Requirement for Pain Management Clinic Rellistration: Inspection or Accreditation( 1) Registration.(a) Every designated phYsician of a pain management clinic, as defined in Section 459.013.1i .l1

Florida Statutes. shall register the clinic with the Department of Health. It is the Designated Physician'sresponsibility to ensure that the clinic is registered, regardless of whether other physicians are practicing inthe same office or whether the office is non-physician owned.

10


12/13

[hL In ordcr.to register a pain managemep.t clinic, Designated Physician m,\dst comply withDepartment Rule 64B-4.00S and 64B-4906, provide documentat.ion to supportcompliance!'lith R]lJe 64BIS-14.0l2, F.A.c'

Designated Physician must notify the Board within 10 calendar d.'dvs, in writing, 9(illlY,changes to the registration infoITIlation, including the termination ofhis or her employment with the...Qainmanagement clinic.

J:.QL Documentation ofregistratipn shall be posted in a conspicuous place in the roomviewabie by the public.

II I Inspection(a) the Physician has previously provided lNritten notification of current

accreditation by a nationally recognized accrediting agency approved by the Board the shall submitto an annual inspection by the Department. All nationally recognized accrediting qrganizations shall beheld to the saI)le Board-determined practice standards for Florida pain management clinic sites.

Cb) The Department shall conduct ullaI1l10unced annual inspections of pain clinics pursuant to this

(c) The Designated Physician shall cooperate with the inspector(s), make medical records availableto the inspector. and be responsive to all reasonable requests.

(d) The inspector(s) shall determine compliance with the requirements ofRule 64BIS-14.00SI,F A. C. This shall include review of a random selection of patient records for patients who are treated forpain, selected by the inspector(s) for each physician practicing in the clinic or who has practiced in theclinic during the past six months.

(e) If the clinic is detennined tojJe in noncompliance, the Designated Physician shall be notified andshall given a written statement at the time of inspection. Such vvritten notice shall specify the!is;:ficiencies. Unless the deficiencies constitute an immediate and immipent danger to the public, theDesignated Physician shall be given 30 days from the date of inspection to correct any documenteddeficiencies and notify the Department of corrective action plan. Upon written notification from thePhysician that all deficiencies have been corrected, the Department is authorized to Ie-inspectfor compliance. If the Designated Physic.ian fails to submit a corrective action plan within 30 days of the

11


13/13

inspection, the is authorized to re-inm-est the office to ensure that the defjciencies hve beencouected.

ULThe writ1;9D results of the insnection, deficjencv notice and any subsequent documentation shalLbefonyarded to the DepaJiment. Thi$ slE!.Jl inc!!'lde:L_Whether the defic!9ncies constituted f!}}jnmlediate and serious danger to the public:2. Whether the Designated PhysicimWTovided the Depar tment with doc_ul1}entation of conection of all

within 30 davs from the date of inspection: and3. The results of any I:.einspection.(g) The Department shall review the results oftlle inspection(;:;;) and detennine whether against

the clinic registration is merited.herein shall limit the authority orthe Department to investigate a complaint without prior

!:totice.0) If the clinic is accredited by a nationally recggnized accrediting agency approved by the Board.

Designated Physician shall submit written notification of the current accreditation survey of his or herofficers) in lieu of undergoing an inspection bv the Department.

l iL3he Designated Physician shall submit, within thirty (30) days of accreditation, a coPY of thecun-ent accreditation survey of the clinic and shaH immediately notify the Board of Osteopathic Medicineof any accreditation changes that occur. F or purposes of initial registration. the Desig:nated Physician shallsubmit a copy of the most recent accreditation survey of the clinic in 1ieu of undergoing an inspection bythe Department.

(Ic) If a provisional or conditional accreditation is received, the Designated Physician shall notify theBoard of Osteopathic Medicine in writing and shaH include a plan of conection.Rulemaking Authority: 459.0137(4) FS.Law Implemented: 459.0137 FS.Historv New.

12

BOM Rules Regs

Documents