The Board held a public hearing on these rules on June 4, 2010, and again on August 7, 2010. The Board, at its meeting of August 7, 2010, voted to make the following changes to the rules in response to comments received at the public hearings, and in response to written comments submitted by the staff of the Joint Administrative Procedures Committee (JAPC). The changes are as follows:
For Rule 64B8-9.0131:
1. The preamble to the rule shall now read: “THIS RULE IS APPLICABLE TO PHYSICIANS PRACTICING IN PRIVATELY OWNED PAIN MANAGEMENT CLINICS THAT ARE REQUIRED TO BE REGISTERED PURSUANT TO SECTION 458.3265, F.S., WHO PRIMARILY ENGAGE IN THE TREATMENT OF PAIN BY PRESCRIBING OR DISPENSING CONTROLLED SUBSTANCE MEDICATIONS.”
2. In subsection (1) of the rule the following language shall be inserted following the word “Definitions.” “The following definitions apply to this rule only.”
3. In paragraph (1)(d), the word “currently” shall be deleted.
4. In subparagraph (2)(c)3., “i.e.” shall be changed to “e.g.”
5. The last sentence of paragraph (2)(e) shall be changed to read as follows: “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.”
6. Subparagraph (2)(f)1., shall be changed to read as follows: “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;”
7. In subparagraph (2)(f)3., the phrase “CLIA-certified test” shall be changed to “CLIA-approved test”
8. Subparagraph (2)(h)1., shall be reworded to read as follows: “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 from 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 to 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.”
9. In sub-subparagraph (2)(i)1.i., the words “Medical Director or” shall be deleted.
10. In sub-subparagraph (2)(j)3.d., the word “clinics” shall be changed to “clinic’s.”
11. In paragraph (2)(l), all references to “Medical Director or Designated Physician” shall be changed to “Designated Physician.”
12. Paragraph (2)(m) shall be reworded to read:
(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 458.351, F.S.
2. The Designated Physician shall also report to the Board of 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 Medicine in writing, within 10 calendar days of beginning or ending his or her practice at a pain-management clinic.”
13. Paragraph (2)(n) shall be reworded to read as follows:
(n) Training Requirements. Effective July 1, 2012, physicians who have not met the qualifications set forth in 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 a pain medicine residency that is accredited by ACGME. Prior to July 1, 2012, physicians prescribing or dispensing controlled substance medications in pain-management clinics registered pursuant to Section 458.309(4), F.S., must meet one of the following qualifications:
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;
2. Board certification in pain medicine by the American Board of Pain Medicine (ABPM);
3. Successful completion of a pain medicine fellowship that is accredited by the Accreditation Council for Graduate Medical Education (ACGME) or a pain medicine residency that is accredited by the ACGME;
4. Successful completion of a residency program in physical medicine and rehabilitation, anesthesiology, neurology, neurosurgery, or psychiatry approved by the ACGME;
5. Current staff privileges at a Florida-licensed hospital to practice pain medicine or perform pain medicine procedures;
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 CME courses in pain management that address all the following subject areas:
a. The goals of treating both short term and ongoing pain treatment;
b. Controlled substance prescribing rules, including controlled substances agreements;
c. Drug screening or testing, including usefulness and limitations;
d. The use of controlled substances in treating short-term and ongoing pain syndromes, including usefulness and limitations;
e. Evidenced-based non-controlled pharmacological pain treatments;
f. Evidenced-based non-pharmacological pain treatments;
g. A complete pain medicine history and a physical examination;
h. Appropriate progress note keeping;
i. Comorbidities with pain disorders, including psychiatric and addictive disorders;
j. Drug abuse and diversion, and prevention of same;
k. Risk management; and
l. Medical ethics.
In addition to the CME set forth in paragraph 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 subparagraph 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. Upon completion of the 40 hours of CME set forth above, physicians qualifying under 6. above, must also document the completion of 15 hours of live lecture format, Category I CME in pain management for every year the physician is practicing pain management.
14. Paragraph (2)(o) shall be deleted.
15. The Rulemaking Authority and Law Implemented shall include Ch. 2010-211, Laws of Florida.
For Rule 64B8-9.0132:
1. All references in the rule to “Medical Director or Designated Physician” shall be changed to “Designated Physician.”
2. Paragraph (1)(c) shall be changed to read as follows: “(c) The Designated Physician must notify the Board within 10 calendar days, in writing, of any changes to the registration information, including the termination of his or her employment with the pain management clinic.”
3. Paragraph (2)(d) shall be changed to read as follows: “(d) The inspector(s) shall determine compliance with the requirements of Rule 64B8-9.0131, F.A.C. This shall include review of a random selection of patient records for patients who are treated for pain, selected by the inspector(s) for each physician practicing in the clinic or who has practiced in the clinic during the past six months.”
4. In the third sentence of paragraph (2)(e), the phrase “corrective action” shall be changed to “corrective action plan.”
5. Section 458.309(5), F.S. and Chapter 2010-211, Laws of Florida, shall be added to the Rulemaking Authority and the Law Implemented citations.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Larry McPherson, Executive Director, Board of Medicine, 4052 Bald Cypress Way, Bin #C03, Tallahassee, Florida 32399-3253