The proposed rule amendments are intended to re-title the rule to “Training Requirements for Physicians Practicing in Pain Management Clinics” and to delete all the provisions in the rule except for the training requirements.

DEPARTMENT OF HEALTH
Board of Osteopathic Medicine

RULE NO.: RULE TITLE:
64B15-14.0051: Standards of Practice for Physicians Practicing in Pain Management Clinics
PURPOSE AND EFFECT: The proposed rule amendments are intended to re-title the rule to “Training Requirements for Physicians Practicing in Pain Management Clinics” and to delete all the provisions in the rule except for the training requirements.
SUMMARY: The rule is being amended to delete all language except for the training requirements.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:
The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the agency.
The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
RULEMAKING AUTHORITY: 459.0137(4) FS.
LAW IMPLEMENTED: 459.0137 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Anthony Jusevitch, Executive Director, Board of Osteopathic Medicine/MQA, 4052 Bald Cypress Way, Bin #C06, Tallahassee, Florida 32399-3256

THE FULL TEXT OF THE PROPOSED RULE IS:

64B15-14.0051 Training Requirements Standards of Practice for Physicians Practicing in Pain Management Clinics.

THIS RULE IS APPLICABLE TO PHYSICIANS PRACTICING IN PRIVATELY OWNED PAIN MANAGEMENT CLINICS THAT ARE REQUIRED TO BE REGISTERED PURSUANT TO SECTION 459.0137, F.S., WHO PRIMARILY ENGAGE IN THE TREATMENT OF PAIN BY PRESCRIBING OR DISPENSING CONTROLLED SUBSTANCE MEDICATIONS.

(1) Definitions. The following definitions apply to this rule only.

(a) Controlled Substance. A “controlled substance” is any substance named or described in Schedules I-V of Section 893.03, F.S.

(b) Adverse Incidents. An “adverse incident” is any incident set forth in Sections 459.026(4)(a)-(e), F.S.

(c) “Board–certified pain management physician” means a physician who possesses Board certification by a specialty board recognized by the American Board of Medical Specialties (ABMS) and holds a sub-specialty certification in pain medicine; or Board certification in pain medicine by the American Board of Pain Medicine (ABPM); or a Certificate of Added Qualification in Pain Management by the American Osteopathic Association (AOA).

(d) “Addiction medicine specialist” means a board certified psychiatrist with a subspecialty certification in addiction medicine or who is eligible for such subspecialty certification in addiction medicine or an addiction medicine physician certified or eligible for certification by the American Society of Addiction Medicine (ASAM), or who holds a Certificate of Added Qualification in Addiction Medicine from the AOA.

(e) “Mental health addiction facility” means a facility licensed pursuant to Chapter 394 or 397, F.S.

(2) Standards of Practice in Pain Management Clinics.

(a) Evaluation of Patient and Medical Diagnosis. A complete medical history and a physical examination must be conducted prior to commencement of any treatment and documented in the medical record. The exact components of the physical examination shall be left to the judgment of the clinician who is expected to perform a physical examination proportionate to the diagnosis that justifies a treatment. The medical record must, at a minimum, document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, a review of prior medical records, previous diagnostic studies, and history of alcohol and substance abuse. The medical record shall also document the presence of one or more recognized medical indications for the use of a controlled substance.

(b) Treatment Plan. The written individualized treatment plan shall state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and shall indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician shall adjust drug therapy to the individual medical needs of each patient. Other treatment modalities, including a rehabilitation program, shall be considered depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment. The interdisciplinary nature of the treatment plan shall be documented.

(c) Informed Consent and Agreement for Treatment. The physician shall discuss the risks and benefits of the use of controlled substances including the risks of abuse/addiction, as well as physical dependence and its consequences, with the patient, persons designated by the patient, or with the patient’s surrogate or guardian if the patient is incompetent. The physician shall employ the use of a written controlled substance agreement between physician and patient outlining patient responsibilities, including, but not limited to:

1. To assure the medical necessity and safety of any controlled substances that the physician may consider prescribing as part of the patient’s treatment plan, drug testing shall be conducted and the results reviewed prior to the initial issuance or dispensing of a controlled substance prescription, and thereafter, on a random basis at least twice a year and when requested by the treating physician;

2. Number and frequency of all prescription refills;

3. Patient compliance and reasons for which drug therapy may be discontinued ( e.g, violation of agreement); and

4. Agreement that controlled substances for the treatment of chronic nonmalignant pain shall be prescribed by a single treating physician unless otherwise authorized by the treating physician and documented in the medical record.

(d) Periodic Review. The patient shall be seen by the physician at regular intervals, not to exceed three months, to assess the efficacy of treatment, assure that controlled substance therapy remains indicated, evaluate the patient’s progress toward treatment objectives, consider adverse drug effects and review the etiology of the pain. Continuation or modification of therapy shall depend on the physician’s evaluation of the patient’s progress. If treatment goals are not being achieved, despite medication adjustments, the physician shall reevaluate the appropriateness of continued treatment. The physician shall monitor patient compliance in medication usage, related treatment plans, controlled substance agreements, and indications of substance abuse or diversion at a minimum of three-month intervals.

(e) Consultation. The physician shall refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention shall be given to those pain patients who are at risk for misusing their medications and those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder requires extra care, monitoring, and documentation, and requires consultation with or referral to an addictionologist or psychiatrist.

(f) Patient Drug Testing. To assure the medical necessity and safety of any controlled substances that the physician may consider prescribing as part of the patient’s treatment plan, patient drug testing shall be performed in accordance with one of the collection methods set forth below and shall be conducted and the results reviewed prior to the initial issuance or dispensing of a controlled substance prescription, and thereafter, on a random basis at least twice a year and when requested by the treating physician. Nothing in this rule shall preclude a pain management clinic from employing additional measures to assure the integrity of the urine specimens provided by patients.

1. Referral to an outside laboratory. A physician shall send the patient to a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory or a collection site owned or operated by a CLIA-certified laboratory;

2. Specimen collected in the pain management clinic and sent to an outside laboratory for testing. A physician shall collect in the office the patient specimen to be used for drug testing in a device that measures pH, specific gravity, and temperature and then the specimen shall be sent to a CLIA-certified laboratory. The physician shall follow the collection procedures required by the agreement the pain-management clinic has entered into with the CLIA-certified laboratory it uses.

3. Specimen collected and tested in office. A physician shall collect and test in the office the specimen to be used for drug testing using CLIA-waived point-of-care test or CLIA-approved test that uses a device that measures the pH, specific gravity, and temperature. Results of the drug test shall be read according to the manufacturer’s instructions.

(g) Patient Medical Records. The physician is required to keep accurate and complete records to include, but not be limited to:

1. The complete medical history and a physical examination, including history of drug abuse or dependence;

2. Diagnostic, therapeutic, and laboratory 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 testing results;

11. A photocopy of the patient’s government issued photo identification; and

12. If a written 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 record shall contain the physician’s full name presented in a legible manner. In addition, each clinic must maintain a log on the premises which shall contain the full name, presented in a legible manner, along with a corresponding sample signature and initials of every physician, anesthesiologist assistant, and physician assistant working in the clinic.

14. Medical records must remain current, they must be maintained in an accessible manner and readily available for review and must be in full compliance with Rule 64B15-15.004, F.A.C., and Section 459.015(1)(o), F.S.

(h) Denial or Termination of Controlled Substance Therapy.

1. If a patient’s initial drug testing reflects the adulteration of the specimen or the presence of illegal or controlled substances (other than medications with approved prescriptions), or when the testing result is questioned by either the patient or the physician, the specimen will be sent to a CLIA-certified laboratory for gas or liquid chromatography/mass spectrometry (GC/MS 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/MS/MS testing is positive, the physician shall refer the patient for further consultation with a board-certified pain management physician, an addiction medicine specialist, or to a mental health addiction facility as it pertains to drug abuse or addiction. After consultation is obtained, the physician shall document in the medical record the results of the consultation. The treating physician shall not prescribe or dispense any controlled substances until there is written concurrence of medical necessity of continued controlled substance therapy provided by a board-certified pain management physician, an addiction medicine specialist, or from a mental health addiction facility. If the treating physician is a board-certified pain management physician, or an addiction specialist, the physician does not need to refer the patient for further consultation. If the physician suspects diversion, then the patient shall be discharged and all results of testing and actions taken by the physician shall be documented in the patient’s medical record.

2. For patients currently in treatment by the physician or any other physician in the same pain management clinic, patients with signs or symptoms of substance abuse, shall be immediately referred to a board-certified pain management physician, an addiction medicine specialist, or a mental health addiction facility as it pertains to drug abuse or addiction unless the physician is board-certified or board-eligible in pain management. Throughout the period of time prior to receiving the consultant’s report, a prescribing physician shall clearly and completely document medical justification for continued treatment with controlled substances and those steps taken to assure medically appropriate use of controlled substances by the patient. Upon receipt of the consultant’s written report, the prescribing physician will incorporate the consultant’s recommendations for continuing, modifying, or discontinuing controlled substance therapy. The resulting changes in treatment shall be specifically documented in the patient’s medical record.

3. For patients currently in treatment by the physician or any other physician in the same pain management clinic, evidence or behavioral indications of diversion shall be followed by discontinuation of controlled substance therapy and the patient shall be discharged and all results of testing and actions taken by the physician shall be documented in the patient’s medical record.

(i) Facility and Physical Operations.

1. A pain management clinic shall be located and operated at a publicly accessible fixed location and shall contain the following:

a. A sign that can be viewed by the public that contains the clinic name, hours of operations, and a street address;

b. A publicly listed telephone number and a dedicated phone number to send and receive faxes with a fax machine that shall be operational twenty-four hours per day;

c. Emergency lighting and communications;

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;

i. A printed sign located in a conspicuous place in the waiting room viewable by the public disclosing the name and contact information of the clinic Designated Physician, and the names of all physicians practicing in the clinic;

j. Storage and handling of prescription drugs. Clinics that store and dispense prescription drug shall comply with Sections 499.0121, 893.07, F.S., and Rule 64F-12.012, F.A.C.

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

(j) Infection Control.

1. The clinic shall maintain equipment and supplies to support infection prevention and control activities.

2. The clinic shall identify infection risks based on the following:

a. Geographic location, community, and population served;

b. The care, treatment and services it provides; and

c. An analysis of its infection surveillance and control data.

3. The clinic shall maintain written infection prevention policies and procedures that address the following:

a. Prioritized risks;

b. Limiting unprotected exposure to pathogen;

c. Limiting the transmission of infections associated with procedures performed in the clinic; and

d. Limiting the transmission of infections associated with the clinic’s use of medical equipment, devices, and supplies.

(k) Health and Safety.

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 the protection of medical records and any controlled substances.

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

(l) Quality Assurance. Each pain management clinic shall have an ongoing quality assurance program that objectively and systematically monitors and evaluates the quality and appropriateness of patient care, evaluates methods to improve patient care, identifies and corrects deficiencies within the facility, alerts the Designated Physician to identify and resolve recurring problems, and provides for opportunities to improve the facility’s performance and to enhance and improve the quality of care provided to the public. The Designated Physician shall establish a quality assurance program that includes the following components:

1. The identification, investigation, and analysis of the frequency and causes of adverse incidents to patients,

2. The identification of trends or patterns of incidents,

3. The development of measures to correct, reduce, minimize, or eliminate the risk of adverse incidents to patients, and

4. The documentation of these functions and periodic review no less than quarterly of such information by the designated physician.

5. The Quality Assurance program must be reviewed once every three years by a Florida-licensed risk manager and documentation of said review must be provided to the Department together with any corrective action plan within 30 days of the review and maintained for inspection purposes.

(m) Data Collection and Reporting.

1. Reporting of adverse incidents. The Designated Physician for each pain-management clinic shall report all adverse incidents to the Department of Health as set forth in Section 459.026, F.S.

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 chronic, non-malignant pain;

b. The number of patients discharged due to drug abuse;

c. The number of patients discharged due to drug diversion; and

d. 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 even though he may temporarily reside elsewhere.

3. All physicians practicing in pain-management clinics shall advise the Board of Osteopathic Medicine in writing, within 10 calendar days of beginning or ending his or her practice at a pain-management clinic.

(n) Training Requirements. Effective July 1, 2012, physicians who have not met the qualifications set forth in subsections (1) through (6) subparagraphs 1. through 6., below, shall have successfully completed a pain medicine fellowship that is accredited by the Accreditation Council for Graduate Medical Education (ACGME) or the American Osteopathic Association (AOA) or a pain medicine residency that is accredited by ACGME or the AOA. Prior to July 1, 2012, physicians prescribing or dispensing controlled substance medications in pain management clinics registered pursuant to Section 459.0137(1), F.S., must meet one of the following qualifications:

(1)1. Board certification by a specialty board recognized by the American Board of Medical Specialties (ABMS) and holds a sub-specialty certification in pain medicine; or a Certificate of Added Qualification in Pain Management by the American Osteopathic Association;

(2)2. Board certification in pain medicine by the American Board of Pain Medicine (ABPM);

(3)3. Successful completion of a pain medicine fellowship that is accredited by the Accreditation Council for Graduate Medical Education (ACGME) or the American Osteopathic Association (AOA) or a pain medicine residency that is accredited by the ACGME or the AOA;

(4)(a)4.a. Successful completion of a residency program in physical medicine and rehabilitation, anesthesiology, neurology, neurosurgery, or psychiatry approved by the ACGME or the AOA;

(b)b. Successful completion of a residency program in family practice, internal medicine, or orthopedics approved by the AOA; or

(c)c. Current Certificate of Added Qualification approved by the AOA in hospice, palliative medicine or geriatric medicine.

(5)5. Current staff privileges at a Florida-licensed hospital to practice pain medicine or perform pain medicine procedures;

(6)6. Three (3) years of documented full-time practice, which is defined as an average of 20 hours per week each year, in pain-management and within six months of the effective date of this rule, attendance and successful completion of 40 hours of in-person, live-participatory AMA Category I or AOA Category IA CME courses in pain management that address all the following subject areas:

(a)a. The goals of treating both short term and ongoing pain treatment;

(b)b. Controlled substance prescribing rules, including controlled substances agreements;

(c)c. Drug screening or testing, including usefulness and limitations;

(d)d. The use of controlled substances in treating short-term and ongoing pain syndromes, including usefulness and limitations;

(e)e. Evidenced-based non-controlled pharmacological pain treatments;

(f)f. Evidenced-based non-pharmacological pain treatments;

(g)g. A complete pain medicine history and a physical examination;

(h)h. Appropriate progress note keeping;

(i)i. Comorbidities with pain disorders, including psychiatric and addictive disorders;

(j)j. Drug abuse and diversion, and prevention of same;

(k)k. Risk management; and

(l)l. Medical ethics.

In addition to the CME set forth in subsection (6) subparagraph 6. above, physicians must be able to document hospital privileges at a Florida-licensed hospital; practice under the direct supervision of a physician who is qualified in subsections (1) through (4) subparagraphs 1. through 4. above; or have the practice reviewed by a Florida-licensed risk manager and document compliance with all recommendations of the risk management review.

(7)7. Upon completion of the 40 hours of CME set forth above, physicians qualifying under (6) subparagraph 6. above, must also document the completion of 15 hours of in-person, live participatory AMA Category I or AOA Category 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 11-8-10, Amended 3-16-11,________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Osteopathic Medicine
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Osteopathic Medicine
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 19, 2011
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: January 6, 2012