A-04-

STATE OF FLORIDA - DEPARTMENT OF Hl:ALTH

DEPARTMENT OF HEALTH,

PETITIONER,

V.

· ANGEL _M. GARCIA, M.D.,

RESPONDENT.

CASE NO.: 2007-28234

,,

ADMINISTRATIVE COMPLAINT

COMES· NOW, Petitioner, Department of Health, by and through its undersigned counsel, and files this Administrative Complaint before the Board of Medicine against Respondent, Angel M. Garcia, M.D., and in support thereof alleges:

1. Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes.

   
   

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   Filed December 27, 2012 9:42 AM Division of Administrative Hearings

2. At all times material to this Complaint, Respondent was a licensed physician within the State of Florida, having been issued license number ME 42709.

3. Respondent's address of record is 5944 Coral Ridge Drive, #229, Coral Springs, Florida 33076.

4. At all times material hereto Respondent was employed by Rehab, Physicians of Miami. Rehab Physicians of Miami operates an internet website, www.progressivemedicalconsultants.com, (Progressive), which provides prescriptions for legend drugs to Patients requesting them.

5. At all times material hereto Respondent was a physician providing telemedicine services on behalf of Progressive.

6. Patients seeking prescriptions for legend drugs through Progressive are required to complete an online medical questionnaire.

7. The completed online medical questionnaires are reviewed by Respondent. Based on the information provided in the questionnaire Respondent decides whether the Patient seeking the legend drug will receive a prescription.

8. For those qualified Patients, prescriptions are called in by Respondent or someone on Respondent's behalf to the pharmacy of the Patient's choice.

9. On or about May 31, 2007, October 5, 2007, and November 15, 2007, Patient K.H. sought a prescription for Lortab 10/500 through Progressive, (Lortab 10/500 is a schedule III narcotic legend drug controlled pursuant to Chapter 893, Florida Statute, containing Hydrocodone and Acetaminophen).

10. Under Section 893.03(3), Florida Statutes (2007), compounds or mixtures containing limited quantities of Hydro odone (hereinafter ­ "hydrocodone'') are schedule III controlled substances, meaning that they have a currently accepted medical use in treatment in the United States and their abuse may lead to moderate or low physical dependence and high psychological dependence.

11. Hydrocodone is an analgesic used to treat pain and is a legend drug, meaning it is not legally available to the public without a prescription.

12. On or about May 31, 2007, October 5, 2007, and November 15, 2007, Patient K.H. completed a medical questionnaire through Progressive in conjunction with her request for Lortab.

13. On or about May 31, 2007, October 5, 2007, and November 15, 2007, Patient K.H.'s request though Progressive for a prescription for Lortab was approved by Respondent.

14. · o n or about May 31, 2007, October 5, 2007, and November 15,

    
    

    2007, · Respondent or someone on Respondent's behalf called in a prescription for 9d pills of Lortab 10/500 on behalf of Patient K.H.

15. On or near the dates listed in paragraph fourteen, above,

    
    

    Respondent prescribed Lortab 10/500 to K.H, in the quantities described therein, without conducting or documenting one or more of the following: complete medical histories or physical examinations, the nature and intensity of the patient's pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, history of substance abuse, the presence of one or more recognized medical indications for the use of a controlled substance and without documenting written treatment plans that state objectives that will be used to determine treatment success or indicate if any further diagnostic evaluations or other treatments are planned.

16. On or near the dates listed in paragraph fourteen, above,

    Respondent prescribed Lortab 10/500 hydrocodone to K.H., by means of one or more of the following: Internet, telephone or facsimile ("telemedicine prescribing''). Respondent did so without performing or documenting one or more of the following: a patient evaluation, including a patient history and a physical examination to establish the diagnosis for which any legend drug is prescribed; discussion with the patient regarding treatment options and the risks and benefits of treatment; maintaining contemporaneous medical records meeting the requirements of Rule 64B8- 9.003, Florida Administrative Code.

    Count One

    
    

17. Petitioner reincorporates and realleges paragraphs one through sixteen as if fully set forth herein.

18. Section 458.331(1)(nn), Florida Statutes (2007), provides that violating any provision of chapters 456 or 458, Florida Statutes (2007), or any rules adopted pursuant thereto, is grounds for discipline by the Board of Medicine.

19. Rule 6488-9.013(3), Florida Administrative Code (2007), provides as follows:

    The Board has adopted the following standards for the use of controlled substances for pain control:

    
    

    1. Evaluation of the Patient. A complete medical history and physical examination must be conducted and documented in the medical record. The medical record should 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 physica·land psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.

       
       

    2. Treatment Plan. The written treatment plan should state objectives that . will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and -should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the Patient medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.

    
    

20. On or near the dates listed in paragraph fourteen, above, Respondent violated Rule 64B8-9.013(3), Florida Administrative Code (2007), by prescribing Lortab 10/500 hydrocodone to K.H. above, in the quantities described therein, without conducting or documenting complete medical histories or physical examinations on K.H. and without documenting one or more of the following: the nature and intensity of the patients' pain, current and past treatments for pain, underlying· or coexisting diseases or conditions, the effect of the pain on physical and

    psychological function or history of substance abuse, the presence of one or more recognized medical indications for the use of a controlled substance and without documenting written treatment plans that state

    ·objectives that will be used to determine treatment success or indicate if

    
    

    any further diagnostic evaluations or other treatments are planned.

    
    

21. · Based on the foregoing, Respondent has violated Section 458.331(1)(nn), Florida Statutes (2007), by violating Rule 64B8-9.013(3), Florida Administrative Code (2007).

    Count Two

    
    

22. Petitioner reincorporates and realleges paragraphs one through sixteen as if fully set forth herein.

23. Chapter 64B8-9.013(3)·, Florida Administrative Code (2007), as more particularly set forth in paragraph 19 herein of is adopted and realleged.

24. Section 458.331(1)(t), Florida Statutes (2007), provides that committing medical malpractice constitutes grounds for disciplinary action by the Board of Medicine. Medical Malpractice is defined in Section 456.50, Florida Statutes (2007), as the failure to practice medicine in accordance with the level of care, skill, and treatment recognized in general law related

    to health care licensure. For purposes of S ction 458.331(1)(t), Florida Statutes (2007), the Board shall give great weight to the provisions of Section 766.102, Florida Statutes (2007), which provide that the prevailing professional standard of care for a given health care provider shall be that level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers.

25. On or near one or more of the dates listed in paragraph fourteen, above, Respondent failed to practice with the level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers by violating Rule 64B8-9.013(3), Florida Administrative Code (2007), in one or more of the following ways: by prescribing Lortab 10/500 to K.H. in paragraph fourteen, above, in the quantities described therein, · without conducting or documenting complete medical histories or physical examinations on K.H. and without documenting one or more of the following: the nature and intensity of the patient's pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and

    psychological function or history of substance abuse, the presence of one or more recognized medical indications for the use of a controlled substance and without documenting written treatment plans that state objectives that will be used to determine treatment success or indicate if any further diagnostic evaluations or other treatments are planned.

26. Respondent failed to practice medicine with that leve·l of care,

    
    

    skill and treatment which is recognized by a reasonably prudent similar physidan as being acceptable under similar conditions and circumstances by failing to establish a reasonable doctor-patient relationship with Patient

    K.H. prior to prescribing Lortab 10/500 on the dates alleged herein.

    
    

27. Based on the foregoing, Respondent has violated Section 458.331(1)(t), Florida Statutes (2007).

    Count Three

    
    

28. Petitioner reincorporates and realleges paragraphs one through sixteen as if fully set forth herein.

29. Section 458.331(1)(m), Florida Statutes (2007), provides that failing to keep legible medical records justifying the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or

    administered; and reports of consultations and hospitalizations is grounds for discipline by the Board of Medicine.

30. On or near the dates listed in paragraph fourteen, above,

    
    

    Respondent failed to keep legible medical records justifying the .course of treatment of Patient K.H. by failing to document one or more of the following: a complete medical history or a physical examination of Patient K.H., the nature and intensity of the patient's pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, history of substance abuse, the presence of one or more recognized medical indications for the use of a controlled substance or written treatment plans. that state objectives that will be used to determine treatment success or indicate if any further diagnostic evaluations or other treatments are planned.

31. Based on the foregoing, Respondent has violated Section 458.331(1)(m), Florida Statutes (2007).

    Count Four

    
    

32. Petitioner reincorporates and realleges paragraphs one through sixteen as if fully set forth herein.

33. Section 458.331(1)(nn), Florida Statutes (2007), provides that violating any provision of chapters 456 or 458, Florida Statutes, or any rules adopted pursuant thereto, is grounds for discipline by the Board of Medicine.

34. Rule 6488-9.014(2)(5), Florida Administrative Code (2007), titled "Standards for Telemedicine Prescribing Practices" provides as follows:

    
    

    1. Physicians and physician assistants shall not provide

       treatment recommendations, including issuin.g a prescription,

       via electronic or other means, unless the following elements have been met: ·

       1. A documented patient evaluation, including history and physical examination to establish the diagnosis for which any legend drug is prescribed.

       2. Discussion between the physician or the physician assistant and the patient regarding treatment options and the risks and benefits of treatment.

       3. Maintenance of contemporaneous medical records meeting the requirements of Rule 64B8-9.003, Florida Administrative Code.

    
    

    (5) For purposes of this rule, the term "telemedicine" shall include, but is not limited to, prescribing legend drugs to patients through the following modes of communication:

    1. Internet;

    2. Telephone; and

    3. Facsimile.

    
    

35. On or near the dates listed in paragraph fourteen, above,

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    Respondent violated Rule 64B8-9.014(2) and (5), Florida Administrative Code, by prescribing Lortab 10/500 K.H. in the quantities described therein, by means of one or more of the following: Internet, telephone or facsimile ("telemedicine prescribing'') without performing or documenting one or more of the following: patient evaluations, including history and physical examination to establish the diagnosis for which any legend drug is prescribed; discussion with the patient regarding treatment options and the risks and benefits of treatment; and without maintaining contemporaneous medical records m eting the requirements of Rule 64B8-9.003, Florida Administrative Code.

36. Based on the foregoing,- Respondent has violated Section 458.331(1)(nn), Florida Statutes (2007), by violating Rule 64B8- 9.014(2)(5), Florida Administrative Code (2007).

    Count Five

    
    

37. Petitioner reincorporates and realleges paragraphs one through sixteen as if fully set forth herein.

38. Section 458.331(1)(q), Florida Statutes (2007), provides as follows: prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in

    the course of the physician's· professionalpractice is grounds for discipline by the Board of Medicine. For purposes of this paragraph, it shall be legally presumed that prescribing, dispensing, administering, mixing, or otherwise preparing legend drugs, including all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the physician's professional practice, without regard to his intent.

39. On or near one or more of the dates listed in paragraph fourteen, above, Respondent prescribed a legend drug, including controlled substances, to Patient K.H . listed in paragraph fourteen, above, in the quantities listed therein inappropriately or in excessive or inappropriate quantities and outside the course of his professional practice by doing so in one or more of the following ways:

    1. without conducting or documenting complete medical histories or physical examinations on patient K.H., without documenting one or more of the following: the nature and intensity of the patient's pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function or history of

       substance abuse, the presence of one or more recognized medical indications for the use of a controlled substance and without documenting written treatment plans that state objectives that will be used to determine treatment success or indicate if any further diagnostic evaluations or other treatments are planned.

    2. by failing to keep legible medical records justifying the

       ,

       course of treatment of Patient K.H by failing to document one

       
       

       or more of the following: complete medical history or physical examination on Patients K.H, the nature and intensity of the patient's pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, history of substance abuse, the presence of one or more recognized medical indications for the use of a controlled substance or written treatment plans that state objectives that will be used to determine treatment success or indicate if any further diagnostic evaluations or other treatments are planned.

    3. by prescribing Lortab 10/500 to Patient K.H., in the listed

    quantities, by means of one or more of the following: Internet, telephone or facsimile ("telemedicine prescribing'') without performing or documenting one or more of the following: patient evaluation, including history and physical examination to establish the diagnosis for which any legend drug is prescribed; discussion with the patient regarding treatment options and the risks and benefits of treatment; maintaining contemporaneous medical records meeting the requirements of Rule 64B8-9.003, Florida Administrative Code (2007).

40. Based on the foregoing, Respondent has violated Section 458.331(1)(q), Florida Statutes (2007).

    Count Six

    
    

41. Petitioner reincorporates and realleges paragraphs one through fourteen as if fully set forth herein.

    
    

42. Section 456.072(1)(ff), Florida Statutes (2007), provides that the following is grounds for discipline by the Board of Medicine:

    
    

    Engaging in a pattern of practice when prescribing medicinal drugs or controlled substances which demonstrates a lack of reasonable skill or safety to patients, a violation of any

    provision of this chapter, a violation of the applicable practice act, or a violation of any rules adopted pursuant to this chapter

    or the applicable practice act of the prescribing practitioner. Notwithstanding s. 456.073(13), the department may initiate an . investigation and establish such a pattern from billing records, data, or any other information obtained by the department.

43. Between the dates listed in paragraph fourteen,· above, Respondent engaged in a pattern of practice when prescribing medicinal drugs or controlled substances to the Patient K.H., herein that demonstrated one or more of the following: a lack of reasonable skill or safety to patients, a violation of any provision of chapters 456 or 458, Florida Statues (2007), or any rules adopted pursuant thereto, by issuing the prescriptions listed in paragraph fourteen above:

    
    

    1. without conducting or documenting complete medical history or physical examination on Patients K.H., and without documenting one or more of the following: the nature and intensity of the patient's pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function or history of substance abuse, the presence of one or more recognized medical indications for the use of a controlled substance and

       without documenting written treatment plans that state objectives that will be used to determine treatment success or indicate if any further diagnostic evaluations or other treatments are planned.

    2. without keeping legible medical records that justify the course of treatment of Patient K.H., by failing to document one or more of the following: complete medical history or physical examinations on Patient K.H, the nature and intensity of the patient's pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect_of the pain on physical and psychological function, history of substance abuse, the presence of one or more recognized medical indications for the use of a controlled substance or written treatment plans that state objectives that will be used to determine treatment success or indicate if any further diagnostic evaluations or oth.er

       treatments are planned.

       
       

    3. by prescribing Lortab 10/500 to Patient K.H.,, in the listed quantities, by means of one or more of the following: Internet, telephone or facsimile ("telemedicine prescribing'') without

    performing or documenting one or more of the following: patient evaluations, including history and physical examination to establish the diagnosis for which any legend drug is prescribed; discussion with the patient regarding treatment options and the risks and benefits of treatment; and without maintaini_ng contemporaneous medical records meeting the requirements of Rule 6488-9.003, Florida Administrative Code (2007).

    
    

44. Based on the foregoing, Respondent has violated Section 456.072(1)(ff), Florida Statutes (2007).

· WHEREFORE, the Petitioner respectfuliy requests that the Board of Medicine enter an order imposing one or more of the following penalties: permanent revocation or suspension of Respondent's license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of the Respondent on probation, corrective action, refund of fees billed or collected, remedial education and/or any other relief that the Board deems appropriate.

SIGNED thisday f                      , 2008.

FILED

DEPARTMENT OF HEALTH

-.DEfUTY CLERK

CLERK: KQJ(_Q -(5?5

DATE._ .,..;_ - -

, obert A. ilne

Assistant General Counsel Florida Bar # 622338

DOH Prosecution Services Unit 4052 Bald Cypress Way-Bin C-65 Tallahassee, Florida 32399-3265

(850) 245-4640 Office

(850) 245-4681 Facsimile

PCP: June 27, 2008

PCP Members: El-Bahri, Thomas & Long

NOTICE OF RIGHTS

Respondent has the right to request a hearing . to be conducted in accordance with Section 120.569 and 120.57, Florida Statutes, to be represented by counsel or other qualified representative, to present evidence and argument, to call and cross-examine witnesses and to have subpoena and subpoena duces tecum issued on his or h r behalf if a hearing is requested.

NOTICE REGARDING ASSESSMENT OF COSTS

Respondent is placed on notice that Petitioner has incurred costs related to the investigation and prosecution of this matter. Pursuant to Section 456.072( 4), Florida Statutes, the Board shall assess costs related to the investigation and prosecution of a disciplinary matter, which may include attorney hours and costs, on the Respondent in addition to any other discipline imposed.

Docket for Case No: 12-004146PL