STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF HEALTH, BOARD OF ) MEDICINE, )
)
Petitioner, )
)
vs. ) Case No. 10-9430PL
) RICARDO JOSE SABATES, M. D., )
)
Respondent. )
)
RECOMMENDED ORDER
Patricia M. Hart, Administrative Law Judge of the Division of Administrative Hearings, conducted the final hearing by videoconference in Tallahassee, Florida, on December 21-22, 2010. The other videoconference site was in West Palm Beach, Florida. On June 14, 2011, due to the imminent retirement of Judge Hart, the case was transferred to Administrative Law Judge Robert E. Meale, who prepared the Recommended Order, pursuant to section 120.57(1)(a), Florida Statutes.
APPEARANCES
For Petitioner: Shirley L. Bates
Grace Kim
Assistant General Counsel Prosecution Services Unit
4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265
For Respondent: Sean Ellsworth
Ellsworth Law Firm, P.A.
1501 Collins Avenue, Suite 208 Miami Beach, Florida 33139
STATEMENT OF THE ISSUES
The issues are whether Respondent is guilty of: 1) failing to practice medicine within the applicable standard of care, as required by section 458.331(1)(t), Florida Statutes, by inappropriately and excessively prescribing one or more controlled substances and 2) failing to keep medical records that justify the course of treatment for prescribing one or more controlled substances, as required by section 458.331(1)(m), Florida Statutes, by failing to document patient histories, examination results, test results, results of drugs prescribed, dispensed or administered, or reports of consultations or hospitalizations, or failing to justify the amount and dosage of pills prescribed.
PRELIMINARY STATEMENT
By Administrative Complaint dated October 29, 2009, Petitioner alleged that Respondent prescribed one or more of the following drugs to each of ten patients: oxycodone, roxicodone, Percocet®, Norco®, methadone, and Oxycontin®. For each patient, the Administrative Complaint alleges three counts: a violation of section 458.331(1)(q), Florida Statutes, for prescribing, dispensing, administering, mixing, or otherwise preparing a
legend drug other than in the course of a professional practice by the excessive prescription of one or more controlled substances per patient; a violation of section 458.331(1)(m), Florida Statutes, for failing to keep medical records that justify the course of treatment of the patient by failing to justify the prescription of one or more controlled substances per patient; and a violation of section 458.331(1)(t), Florida Statutes, for failing to practice medicine with the level of care, skill, and treatment recognized in general law related to health care licensure. The section 458.331(1)(m) violation is referred to as the medical-records violation, and the section 458.331(1)(t) violation is referred to as the standard-of-care violation.
With this Administrative Complaint, Petitioner commenced DOAH Case No. 10-2124PL. By Order entered June 2, 2010, the administrative law judge then assigned to the case relinquished jurisdiction so the parties could present a settlement agreement to the Board of Medicine. On September 28, 2010, Petitioner filed a Motion to Re-Open Case because the parties had been unable to settle the case. The Clerk of the Division of Administrative Hearings opened a new file and assigned it DOAH Case No. 10-9430PL.
On October 15, 2010, Respondent filed a Motion to Dismiss the ten counts of the Administrative Complaint alleging
standard-of-care violations. Respondent argued that these counts relied on the same behavior as the ten counts alleging violations of section 458.331(1)(q). By Order entered
October 29, 2010, the administrative law judge then assigned to the case denied the motion, reasoning that, although punishment on both sets of counts would be unfair, Petitioner could plead them in the alternative.
On October 28, 2010, Petitioner filed an Amended Administrative Complaint. This was without leave of the administrative law judge then assigned to the case, but Respondent did not object, and leave is granted at this time. The Amended Administrative Complaint is identical to the Administrative Complaint, except that it drops the ten counts alleging violations of section 458.331(1)(q).
In the Joint Pre-Hearing Stipulation filed December 10, 2011, Petitioner stated the issues as follows: under section 458.331(1)(t), whether Respondent practiced below the applicable standard of care by inappropriately and excessively prescribing one or more controlled substances without justification; and, under section 458.331(1)(m), whether Respondent failed to keep legible medical records justifying the course of treatment for prescribing one or more controlled substances by failing to include one or more of the following in a patient's medical records: patient histories, examination results, test results,
records of drugs prescribed, dispensed or administered, reports of consultations or hospitalizations, and justification of the amount and dosage of pills prescribed.
In the Joint Pre-Hearing Stipulation, Respondent countered that he practiced within the applicable standard of care and his prescribing was not excessive, but was appropriate given the conditions with which the patients presented. Respondent also stated that his medical records were appropriate and justified the course of treatment of each patient.
The Joint Pre-Hearing Stipulation also identifies Respondent's prescriptions by drug, dosage, date, and name of patient. The Findings of Fact incorporate these stipulated facts, except for a correction for D. D. on June 30, 2008. On that date, Respondent prescribed 250 30-mg roxicodone pills and
290 30-mg (not 15-mg, as stipulated) roxicodone pills. Both parties agreed at the hearing to this amendment of the Joint Pre-Hearing Stipulation.
At the hearing, the parties offered Joint Exhibits 1-12.
Petitioner called one witness, Marc R. Gerber, M.D., and offered into evidence Petitioner Exhibits 1-7. Respondent called two witnesses, himself and patient W. C., and offered into evidence Respondent Exhibit 1, which is the deposition testimony of Forest S. Tennant, Jr., M.D. All exhibits were admitted except Petitioner Exhibits 6 and 7, which were proffered.
The two proffered exhibits are records of the discipline that the Board of Medicine has twice imposed on Respondent.
Respondent testified about these matters, so the Administrative Law Judge has considered this prior discipline in recommending a penalty.
The court reporter filed the transcript on January 12, 2011.
The parties filed proposed recommended orders on January 27, 2011.
FINDINGS OF FACT
Introduction
At all material times, Respondent has been a physician licensed to practice medicine in Florida. His license number is ME 33389. His practice is located in Delray. Respondent is not Board certified in any specialty. He appears to have practiced for many years.
In 1987, Respondent was disciplined for a failure to keep medical records. The Board of Medicine reprimanded Respondent, imposed $2000 of costs and one year's probation, required 30 hours' coursework in risk management and recordkeeping, and restricted Respondent's license by requiring the submission of quarterly reports covering prescribing activities, among other things.
In 2007, Respondent was disciplined for a violation of the requirements imposed on a dispensing practitioner. The
Board of Medicine imposed a fine and probation. The Board also required a drug course, a law and rules course, ten hours' coursework in the responsibilities of dispensing practitioners and 25 hours' community service.
This case involves Respondent's use of chronic opioid therapy for chronic and breakthrough pain not associated with cancer or other terminal disease. As detailed in the Conclusions of Law, the issues require consideration of whether Respondent's medical records are adequate to justify these prescriptions and whether these prescriptions are inappropriate, excessive, or otherwise unjustified, so as to violate the applicable standard of care.
In attempting to prove these two sets of violations, Petitioner has limited its allegations to Respondent's prescriptions of five Schedule II controlled substances and one Schedule III controlled substance. The five Schedule II controlled substances are oxycodone, roxicodone, Oxycontin®, Oxyfast®, and Percocet®. The lone Schedule III controlled substance is Norco®. A Schedule II controlled substance has a high potential for abuse and has a currently accepted, but severely restricted, medical use in treatment in the United States. Abuse of a Schedule II controlled substance may lead to severe psychological or physical dependence. A Schedule III controlled substance has a lower potential for abuse and a
currently accepted medical use in treatment in the United States. Abuse of a Schedule III controlled substance may lead to moderate or low physical dependence or high psychological dependence.
People have used opium for pain relief for thousands of years. The pharmacological production of opioid drugs started after the identification of the morphine alkaloid in 1806. By the end of the 19th century, in the United States, legal controls were imposed on opioids. By the 1940s, opioids could be legally used only if prescribed by physicians, pursuant to strict regulatory controls. By the end of the 20th century, tension had emerged between physicians reluctant to prescribe opioids due to professional-liability considerations and advocates of pain control. Particularly contentious issues are whether and how to prescribe opioid therapy for chronic pain not associated with terminal disease.
Oxycodone and hydrocodone are short-acting opioids with an onset of 30-90 minutes and duration of 4-6 hours. Roxicodone is oxycodone hydrochloride. In controlled-release form, such as Oxycontin®, oxycodone hydrochloride is a long-acting opioid with an onset of 1-12 hours and duration of 8-72 hours. With a quicker onset than oxycodone in pill form, Oxyfast® is a liquid containing 20 mg of oxycodone hydrochloride in a one-ml bottle.
Percocet® is oxycodone and acetaminophen: a dosage of "10/325" is 10 mg of oxycodone and 325 mg of acetaminophen. Norco® is hydrocodone and acetaminophen: a dosage of "10/325" is
10 mg of hydrocodone and 325 mg of acetaminophen.
Methadone is an inexpensive synthetic opioid with long- acting effect. The half-life of methadone typically ranges from 15-60 hours, but may extend to 120 hours. The long, variable half-life of Methadone discourages its wider use in pain control because of difficulties in maintaining not more than therapeutic levels.
During the time in question, Oxycontin® was relatively expensive among the opioids listed in the preceding paragraph. At that time, one 30-mg roxicodone pill cost an uninsured patient about $0.70-$1.00, one 40-mg Oxycontin® pill cost an uninsured patient about $8.00, and one 80-mg Oxycontin® pill cost an uninsured patient about $14.00. The record does not reliably establish street values for these drugs, but all of them were traded and consumed at high rates illegally on the street.
Short-acting opioids are more appropriate for breakthrough pain, which is a temporary spike in pain above chronic-pain levels due, for example, to physical exertion. A short-acting opioid is well-matched to the relatively short duration of breakthrough pain. This record does not permit resolution of the dispute over whether long-acting opioids are
more effective than short-acting opioids for the relief of chronic pain.
Generally, prescribed opioids pose distinct risks of consumption and diversion by the patient. For the opiate-naïve patient, doses of opioids that may be easily tolerated by the opiate-tolerant patient may cause potentially life-threatening side effects, including respiratory depression. For the opioid- tolerant patient who is consuming opioids not prescribed by the practitioner--from other, undisclosed practitioners or from street purchases--additional doses of prescribed opioids may cause the same life-threatening side effects as those faced by the opiate-naïve patient, although, with controlled dosing among opioid-tolerant patients, opioids typically may be increased until pain control is attained.
Pain medicine practitioners may manage these risks, in part, by administering periodic urinalyses to their patients. The urinalyses administered to the ten patients in this case were threshold tests that would detect the presence of various substances above a certain level. Such tests would uncover opioid-naïve patients and patients consuming other controlled substances, but not the level of any controlled substance detected by the test.
Sometimes, opioid rotation may achieve the desired analgesic effect at relatively low doses. Otherwise, chronic
pain may require increasing doses of the same opioid to obtain the same relief originally obtained by lower doses, although some patients may find effective relief for extended periods at a dosing level that is not increased. Less frequently, higher opioid doses may produce hyperalgesia.
Optimally, effective pain management is multifaceted, including such disciplines or techniques as psychotherapy, cognitive behavioral therapy, biofeedback, relaxation techniques, physical therapy, and reliance on nonopioid analgesics. But limits on insurance coverage or lack of insurance and the relatively high costs of most of these alternative disciplines or techniques may legitimately require the practitioner to rely more on the relatively inexpensive opioids. Even Petitioner's expert witness admitted, "Sometimes I have self-pay patients who are on opiates only because they can't afford anything else." (Pet. Ex. 4, p. 7.) Petitioner's expert acknowledged that roxicodone "is something you tend to give people who have no insurance." (Tr., p. 85.)
Cost considerations may also require that the practitioner break down what would be a single prescription of, say, 100 pills into two prescriptions of 50 pills each, so the patient can effectively pay for his prescription in two installments. Again, Petitioner's expert witness admitted that
there was nothing wrong with this practice. (Pet. Ex. 4. p. 41.)
None of the ten patients addressed in this case had insurance during the relevant period. (One patient potentially had COBRA coverage that would have expired long before the period in question.) Although at least a couple of patients were employed in professions in which at least moderate earnings might be expected, the record does not reliably describe the financial resources of any of the ten patients.
The record contains no evidence of injury to the patients discussed below in terms of the care, including prescribed opioids, that they received from Respondent. Excessive consumption of prescribed or diverted opioids is dangerous and can be fatal. But, as Respondent's expert witness testified, the fatal combination seen "excessively" in the eight deaths per day in Florida from prescription drug abuse is opioids; benzodiazepines, such as Xanax®; and muscle relaxants, such as Soma®. Although Respondent prescribed medications in all three categories, Petitioner has not alleged any violations arising from Respondent's prescriptions of any drug besides the opioids discussed above, so Respondent's prescriptions of benzodiazepines and muscle relaxants to these ten patients are generally omitted from the Findings of Fact.
As Petitioner's expert testified, there is no quantitative criterion for the standard of care in prescribing opioids. (Tr., pp. 29 and 108.) The standard-of-care determination is dependent on the facts. Two facts of importance are the achievement of pain relief and the restoration or maintenance of function in the patient. The record contains ample evidence of the extent of pain relief, although nearly all of it is in the form of reports from patients, whose credibility is difficult to assess. The record contains relatively little evidence of functionality for most patients.
As discussed in the Conclusions of Law, contrary to the testimony of Petitioner's expert, a standard-of-care violation is not established, per se, by a medical-records violation.
The record is problematic in several other respects.
Most notably: 1) Petitioner's expert witness stated in his initial report to Petitioner that Respondent's medical records were adequate and justified the course of treatment (Tr., pp. 111-22); but 2) Respondent's expert witness stated that Respondent's medical records were inadequate, at least based on present practices. (Depo. Tr., Forest S. Tennant, Jr., pp. 51- 52.) Also, in what probably came as a surprise to Petitioner, its expert witness three times opined that, under certain
conditions, a physician may lawfully deviate from the applicable standard of care in the prescription of opioids. (Tr., pp. 65, 90, and 95-96.)
The testimony of each expert witness was uneven. Most of the flaws of Petitioner's expert are listed above, but he repeatedly tended to agree with the attorney asking him questions. Neither expert displayed an over-familiarity with the details of the medical records; sometimes, Respondent seemed somewhat unfamiliar with them too.
Petitioner's expert is Board certified in the subspecialty of pain medicine and practices in Orlando; Respondent's expert is not Board certified in any specialty or subspecialty and has never practiced in Florida. But Respondent's expert thoughtfully explained how a higher blood pressure and pulse rate might be associated with under- medication, and a lower blood pressure and pulse rate might be associated with over-medication. Respondent's expert also recognized the difference between a medical-records violation and a standard-of-care violation.
During the time in question, Respondent saw 15 patients daily, not 60 or more patients daily, as are seen by some high-volume opioid-prescribing physicians. The ten patients in this case are all residents of Florida, not residents of other states drawn to the opioid-prescribing
practices of a compliant Florida physician. (One of the ten patients appears to have been a resident of Mississippi, but had a Florida driver license--tending dispel an inference that he was in Florida briefly for the purpose of obtaining opioids.) Almost always, Respondent obtained patient records from the physician who had been treating the patient immediately before he or she began seeing Respondent. And, at a time when the practice was not required by statute or rule, Respondent used urine screens to determine whether his patients were consuming the opioids that he was prescribing them.
For none of the ten patients has adherence to the dosing practice of a preceding physician, per se, constituted compliance with the applicable standard of care. Except for a relatively brief period after acquiring the patient, Respondent could only satisfy the applicable standard of care by appropriate treatment, regardless of the dosing practice of the preceding physician.
In large part, the purpose of administering urinalyses was to detect aberrant behavior by the patient. In this context, aberrant behavior means patient diversion of opioids or consumption of other opioids or other controlled substances without disclosure to Respondent or, in the case of illegal consumption of such substances, even with disclosure to Respondent.
W. C.
From February 12, 2007, through July 16, 2009, Respondent prescribed to W. C. 150 30-mg roxicodone pills and
120 15-mg roxicodone pills each month.
Respondent first saw W. C. on June 20, 2001, when Respondent served as the medical director of the Pain Management Center in Miami. At the time of this initial visit, according to Respondent's medical records, Respondent complained of rheumatorial arthritis of the left knee, on which he had had surgery, two years earlier, to repair a tear of the medial collateral ligament. W. C. also complained of lower back pain and tendonitis in the left elbow and shoulder. The patient's situation was exacerbated by his job, which involved moving refrigerators. The initial note states that the patient's general practitioner, Dr. Martin Coleman, had prescribed him
5-mg pills of Roxicet®, and the patient had taken some Xanax® from his wife to relieve spasms and stress.
The next office visit took place on July 16, 2001, at which time Respondent brought a "note," not medical records, from Dr. Coleman. According to Respondent's medical records, Dr. Coleman's note stated that the degenerative arthritis was of the right knee, not the left knee, which had been treated with Percocet®, which is similar to Roxicet®. Evidently relying on the patient's statement that he had tried his wife's Xanax®, the
July 16 record states: "His anxiety is helped tremendously with Xanax®."
At this time, Respondent saw W. C. for seven or eight months. These medical records are missing, but they are not at issue in this case.
At some point, W. C. transferred to the Delray office of the Pain Management Center while this office was staffed by Drs. Morency, Rabinsky, and Weed. In November 2005, W. C. suffered a wedge fracture of the T12 vertebra, which caused him severe back pain, as a result of an automobile accident.
On February 14, 2007, Respondent saw W. C. in the Delray office of the Pain Management Center, to which Respondent had since transferred. Among the records that Respondent reviewed was a neurological consultation dated September 7, 2006, in which the neurologist, Dr. Perry Hoeltzell, described cervical, left arm, left lower back, and left leg complaints since the November 2005 accident.
Respondent also examined an MRI of the spine taken on September 7, 2006, that showed a T12/L1 collapse of the disc with chronic anterior wedging of the T12 vertebra. The appearance was of a flexion trauma. These conditions supported the finding or complaint of cervical radiculopathy of C3 through C6 and lumbar radiculopathy of L4-5/L5-6.
W. C. informed Respondent that he liked the flexibility of his current prescription of 150 pills of 30-mg roxicodone and 120 pills of 15-mg roxicodone monthly, so he could decide which dose to take when. However, W. C. did not appear to be an uncritical consumer of every controlled substance that he could get. The July 16, 2009, medical note reports that W. C. declined a renewal of Cymbalta®, saying that it did not work and, "I didn't think I needed it."
At the time of the February 14, 2007, office visit and through the final office visit of July 16, 2009, W. C. was able to work and suffered no side effects. Each month, Respondent saw W. C. in the office and typically spent 15-30 minutes talking with him.
The medical records over this period are inadequate and do not justify the opioid prescriptions that Respondent gave
W. C. during this time. For two and one-half years, Respondent prescribed the same two prescriptions of roxicodone with medical records consisting of monthly reports of blood pressure, pulse, general appearance, patient history, and complaints, such as level of pain, the extent of pain relief, side effects, sleep, and mood. As tended to be his practice with all ten patients, Respondent never filled in the bottom of the medical-record form, which prompted insertion of the "plan." Respondent never
recorded any diagnosis or general assessment of W. C., or recorded how he was managing the patient.
For over two and one-half years, Respondent failed to document these important elements of medical records. This was too long for Respondent to claim that he was merely maintaining the prescription regime of the preceding physician until Respondent had the opportunity to assess the patient, discuss with the patient treatment alternatives, and develop a pain- management plan. In this timeframe, Respondent should have documented these tasks multiple times. The absence of this critical patient assessment and treatment information from the medical records means that the records fail to justify the course of treatment.
Petitioner's expert witness opined that Respondent violated the applicable standard of care due to the excessive prescription of medications. But when asked why the prescribed medications were excessive, the expert responded, "the medical records," which, he explained, failed to provide an understanding of how the patient was managed, failed to provide a diagnosis, assessment, or treatment plan, and omitted any description of level of functioning, clinical exams, or physical exams. (Tr., p. 23.) Petitioner's expert witness described Respondent's medical records as "poor." (Tr., p. 27.)
If there were any doubt that the basis of the expert's standard-of-care opinion was the inadequate medical records, he dispelled it in the following exchange:
Q: Dr. Gerber, this prescribing of roxicodone 30 mg of 150 pills in conjunction with roxicodone 15 mg of 120 pills, what is your opinion about the appropriateness and whether or not the prescribing of those
two--that combination is within the standard of care and why?
A: Well, without medical records justifying it, if falls below the standard of care.
There's no explanation of why these two potent opioids are being prescribed together. . . .
(Tr., pp. 24-25.)
Obviously, where the patients, other than W. C., do not testify, the ability of Petitioner's expert to opine as to the standard of care is limited to what he has learned of their care from the medical records and the testimony of Respondent, which supplies very little in addition to what is contained in the medical records. After an extensive discussion of the inadequacies of the medical records, in response to a standard- of-care question, the expert admitted that the lack of medical records left him "not able to formulate an opinion as to how this patient was managed." (Tr., p. 23.) Immediately after this statement, Petitioner's expert twice testified that the standard-of-care violation was due to the problems with the medical records. (Tr., pp. 23-24.) The frustration of
Petitioner's expert witness, although understandable, does not justify elevating a medical-records violation to a standard-of- care violation--again, as explained in the Conclusions of Law.
The sole attempt of Petitioner's expert to predicate a standard-of-care violation on something besides the inadequate medical records was unsuccessful. Although he elsewhere disclaimed reliance merely on the quantity of prescribed opioids as the sole basis of a standard-of-care violation, Petitioner's expert complained about Respondent's prescription of "these two potent opioids . . . together." (Tr., p. 25.) Of course, there is only one potent opioid at issue in the W. C. counts-- roxicodone. (Xanax®, which Respondent also prescribed to W. C., is not an opioid and, as noted above, is not alleged as a basis of any liability in this case.)
If the two opioids were the two dosages of roxicodone, the expert's complaint appears to be a back-door attempt to object to the quantity of prescribed opioids--in isolation from other relevant factors. Significantly, Petitioner's expert testified that, with acceptable documentation, "one [of the roxicodone prescriptions] by [itself] might be acceptable" (Tr.,
p. 25)--implying that his underlying problem is with the quantity of this opioid that Respondent has prescribed. But, as Petitioner's expert witness conceded, "patients can have a lot of pain and require high doses of opioids even with minimal
diagnostic studies." (Tr., p. 26.) Petitioner's expert eventually admitted that a monthly prescription of 120 pills of a hypothetical 45-mg roxicodone, which is slightly less than Respondent's prescription of 120 pills of 15-mg roxicodone and
150 pills of 30-mg roxicodone, might have met the standard of care, if "there was good documentation of physical functioning [and] the notes and records clearly documented an assessment and plan." (Tr., p. 31).
For W. C., clinical reports amply documented injuries that could have accounted for the pain that W. C. consistently reported during the period in question. The record establishes sustained function during the course of treatment--and even beyond. Alone among the patients, W. C. testified to his extensive orthopedic problems in his back and to the role of Respondent and his medication regime in preserving W. C.'s functionality.
Respondent's treatment of W. C. left one question unanswered. In general, Petitioner's expert rightly asked why Respondent did not offer or explore nonopioid treatments. (Tr.,
p. 27.) The absence of any consideration of nonopioid treatments is a deficiency in the medical records, but also relevant in determining whether Respondent met the standard of care. Respondent's usual explanation--the prohibitive costs of such alternative treatments--may not apply to W. C., who was
continuously employed throughout his treatment, possibly even as the owner of the company for which he worked. Respondent testified: "He was a laborer, he had his own moving company." (Tr., p. 209.) But, standing alone, this question does not establish a standard-of-care violation.
There is less, if any, value in the suggestion of Petitioner's expert that a standard-of-care violation may be based on Respondent's failure to prescribe methadone. As noted above, this record fails to establish that the standard of care requires the use of long-acting opioids for chronic pain, and this repeated suggestion by Petitioner's expert fails to account for the difficulties, noted above, in the use of this persistent opioid, which even Petitioner's expert admitted must be used "carefully." (Tr., p. 32.)
Petitioner proved a medical-records violation, but not a standard-of-care violation.
D. M.
From January 8, 2007, through July 18, 2007, Respondent prescribed to D. M. a monthly regime of roxicodone and Oxycontin®. The sole exception to the monthly office visits with Respondent is an office visit dated February 5, 2007, which, judging from the handwriting on the note, involved another physician at the Pain Management Center.
Respondent's prescriptions for January 8 and March 5 were for 100 30-mg roxicodone pills and 180 40-mg Oxycontin® pills. On April 2, Respondent increased the monthly prescription to 180 30-mg roxicodone pills while maintaining the number and dose of Oxycontin® pills. On April 30, Respondent increased the number of roxicodone pills to 200 monthly, but decreased the dosage to 15 mg, while maintaining the number and dose of Oxycontin® pills.
On May 24, Respondent issued a prescription for 200 15-mg roxicodone pills, 100 30-mg roxicodone pills, and 180 40-mg Oxycontin® pills. On June 21, Respondent prescribed 200
15-mg roxicodone pills and 180 40-mg Oxycontin® pills. On July 18, Respondent prescribed 100 30-mg roxicodone pills and 180 40-mg Oxycontin® pills.
D. M. is unique among the ten patients in two regards.
She has the shortest treatment period at six months, and she is the only patient to have received Oxycontin® monthly for the duration of her treatment under Respondent.
Another unusual aspect of D. M.'s case is Respondent's clear confusion about his treatment of her. Respondent testified that he first saw her on May 24, 2007. This testimony is contrary to the stipulation, and it is not borne out by the medical records. The medical notes for January 8 (Joint Ex. 2,
p. 159), March 5 (Joint Ex. 2, p. 157), April 2 (Joint Ex. 2, p.
156), and April 30 (Joint Ex. 2, p. 155) all appear to be in the handwriting of the physician who filled out the medical note for May 24 (Joint Ex. 2, p. 346).
D. M. bore a diagnosis of fibromyalgia, which is a diagnosis of a condition whose existence divides the medical community. However, associated with the diagnosis is widespread pain involving the muscles and soft tissues and sleep disturbances, both of which D. M. reported. Although the disease is not like a fracture or herniated disc in its ability to be confirmed by some form of imaging technology, the present record provides an inadequate basis to disregard the existence of this condition or dismiss the potential severity of the pain associated with this condition.
In 1995, D. M.'s physician, Thomas Fitzpatrick, M.D., referred D. M. to John H. Gridley, Jr., M.D., who specialized in internal medicine and rheumatology. After an examination of this 35-year-old patient, Dr. Gridley diagnosed D. M. with what is now referred to as fibromyalgia. She has borne this diagnosis ever since.
D. M. had been a patient of the Kendall office of the Pain Management Center since 2003. Her condition had deteriorated since 1995; she had spent two years in bed. During this time, she had received the opioids that Respondent later maintained.
When D. M. first saw Respondent nearly 12 years later, she had gained 70 pounds, and her systolic blood pressure had increased 34 mm to 144/72. D. M. advised Respondent that the only medication that relieved her pain was Oxycontin®, so, after discussing diet and exercise, Respondent continued her existing prescription of Oxycontin® with roxicodone for breakthrough pain.
On D. M.'s next visit, on March 5, no vital signs were taken. On her next visit, on April 2, her blood pressure had dropped to 102/78, although her pulse was 78. Her pain, which was reported as "6" on her first visit, was down to "5" on this visit.
In addition to his confusion over when he started treating D. M., Respondent seemed confused by his own treatment plan for this patient. Alluding to his much-used explanation of financial constraints precluding the prescription of Oxycontin®, Respondent testified that, due to "financial reasons," "we converted one Oxycontin® to Roxy 30s, giving her exactly the same dosage. The patient was having financial problems. I remember that." (Tr., p. 227.) However, the record reveals no reduction in the relatively expensive Oxycontin® prescription, only an increase in the roxicodone prescription on April 30 and again on May 24.
Later, Respondent testified that his office mistakenly increased the roxicodone prescription on April 30 from "100 to
180 milligrams." (Tr., p. 228.) However, this increase amounted to only 20 30-mg pills for the month or about 20 mg daily. The increase on May 24 was much larger--from 6000 mg/month of roxicodone to 9000 mg/month of roxicodone. This was also a mistake, but a much bigger one.
D. M. never informed Respondent of the prescription error, which Respondent "didn't like." (Tr., p. 228.) Respondent reduced the June 21 prescription, probably to allow
D. M. to use some of the extra roxicodone that she had on hand. (Tr., p. 228.) However, Respondent never attempted to explain how these two dosing mistakes happened or, if they were not mistakes, what justified these dramatic increases in opioids being prescribed to the patient. Respondent probably did not attempt a justification of these increased dosages because no justification existed: D. M. reported a small increase in pain from April 30 to May 24, but only from a "5" to a "6."
Consistent with his refusal to predicate a standard- of-care violation strictly on the quantity of opioids prescribed, Petitioner's expert witness admitted, "counting pills is not the best way of managing a patient." (Tr., p. 43.) But his standard-of-care analysis regarding Respondent's care for D. M. includes the quantity of pills in the context of patient complaints, the underlying diagnosis, and the existence
of alternative means of treating the patient's pain, such as a fentanyl patch. (Tr., pp. 40 and 45.)
The standard-of-care violation for D. M. relies on this broader record of Respondent's care for this patient, not on the following testimony of Petitioner's expert: "So, the whole case boils down to, you shouldn't be putting patients with fibromyalgia on this much medication." (Tr., p. 44.)
Neither in May 2007 nor three and one-half years later at the hearing did Respondent have any idea why he dramatically increased D. M.'s roxicodone prescription on May 24. To the extent that Respondent claimed a "mere" mistake, his explanation would have carried more weight, if he had not also offered his well-worn financial argument that the patient could not afford the additional cost of the long-acting opioid, Oxycontin®. This argument did not apply to D. M., who was already paying for Oxycontin® each month. This makeshift defense, the unjustified increase of opioids, the mistaken recollection of the substitution of roxicodone for Oxycontin®, and the failure to recall when Respondent's treatment of this patient started combine to make Respondent's brief treatment of D. M. appear random and chaotic. On these facts, Respondent's prescription of opioids was inappropriate, excessive, and otherwise unjustified.
Petitioner proved a medical-records violation and a standard-of-care violation.
R. H.
From January 29, 2007, through July 7, 2009, Respondent prescribed to R. H. a monthly regime of 30-mg roxicodone and 10/235 Norco®. For January 29 and March 2, the dosages were 60 roxicodone pills and 240 Norco® pills. On March 27, Respondent raised the roxicodone prescription to 90 pills. This prescription continued through visits on April 24, May 22, June 20, and July 18.
On August 2, which was only two weeks after the preceding office visit, Respondent doubled the number of roxicodone pills to 180. On September 28, Respondent increased the roxicodone by one-third, from 180 to 240 pills.
On November 30, Respondent increased the roxicodone prescription to 300 roxicodone pills and, for the first time, changed the Norco® prescription, raising it from 240 pills to 300 pills. Respondent maintained these prescriptions through 14 "monthly" visits in 2008--actually, 13, as the last is on December 23, 2008--and visits on January 21 and February 17,
2009.
On March 17, Respondent decreased the Norco® to 280
pills. On the final visit, on July 7, 2009, Respondent decreased the roxicodone to 270 pills and Norco® to 240 pills.
Respondent first saw R. H. in 2001 due to failed-back syndrome following a car accident three or four years earlier and a micro-discectomy of L5/S1, which had resulted in additional complications. R. H. had been wheelchair-bound for eight months and was learning to walk again; she was in intractable pain. A psychiatrist later diagnosed her with severe anxiety disorder and post-traumatic stress disorder.
R. H. visited the Pain Management Center after a referral by her physician, who was no longer comfortable prescribing her Vicodin ES®. R. H. disclosed in her 2001 initial office visit that she had recently had another automobile accident, for which she had been charged for driving under the influence. R. H. reported that epidural injections had failed to control her pain, and she had gained 50 pounds in the past couple of years.
An unsettling consultation note is in R. H.'s medical records. On January 31, 2001, Anjan K. Ghosh, M.D., of the Anesthesia Pain Care Consultants, Inc., saw R. H. in consultation. Dr. Ghosh concluded the R. H. suffered from lumbar post-laminectomy pain syndrome "with conflicting physical signs on examination," mechanical lumbar axial pain, severe anxiety disorder, and gastroesophagael reflux disease. In a detailed plan of treatment, Dr. Ghosh proposed a caudal catheter neuroplasty and nerve root decompression to treat R. H.'s recurrent lumbar radiculitis. Based evidently in part on an
adverse surgical experience, R. H. refused this treatment, saying, "the reason I was sent to see you [was] for only pain medication." After Dr. Ghosh explained that he would continue her Vicodin ES® only for two weeks, R. H. asked again if she could consider the surgical intervention later, but, for now, obtain prescriptions for an opioid regimen, which Dr. Ghosh declined to do.
R. H. was an unusual patient because, even though she was in her mid-thirties when she first saw Respondent, she often brought her mother, who, according to Respondent, "doled" out her prescribed opioids. (Tr., p. 242.) In contradictory statements, Respondent testified: "She did well. She was able to function. She lost jobs constantly." (Tr., p. 243.) Respondent's testimony about this patient is surprisingly brief based on the lengthy two and one-half years that he saw her, as covered by this case; the dramatic increase in roxicodone from 1800 mg monthly to 9000 mg monthly, with a smaller increase in Norco®; and the instability of the patient, as reflected by her dogged pursuit of opioids, her DUI arrest five or six years earlier, and the role of her mother as the gatekeeper to her prescribed opioids.
Petitioner's expert witness noted that the March 27, 2007, medical note, in which Respondent raised the roxicodone from 60 pills to 90 pills monthly, contained no explanation for
the increase. Likewise, Petitioner's expert found no justification in the medical records for the doubling of the roxicodone from 90 pills to 180 pills monthly in August 2007, the increase from 180 pills to 240 pills monthly two months later, or the increase of the Norco® from 240 pills to 300 pills monthly one month later. Petitioner's expert noted these increases in opioids were not accompanied by physical exams, physical findings, or any consideration of alternative therapies, such as nonsteroidal anti-inflammatory drugs.
Respondent's medical records reveal a "4" for reported pain on March 1, 2007, but no vitals, and no pain report or vitals on March 27, 2007, when Respondent hiked the roxicodone by 50% and prescribed Neurontin®, which Respondent testified at the hearing he did not "even know what it is." (Tr., p. 240- 41.) The medical note for April 24, 2007, consists of a few scribbled lines without any vitals or pain report. On May 22 and June 20, 2007, the medical records contain vitals, but no pain report. Finally, on July 18, the medical note contains a pain report, but it is still a "4." Two weeks later, when Respondent doubled the roxicodone from 90 to 180 pills monthly, the medical note reflects that the pain is still only a "4."
During this period of time, R. H. had had a molar surgically removed on April 7, 2007, and had been passing out weekly since that event. In mid-September 2007, R. H. was
admitted to a local hospital one week after an automobile accident. In the followup to the automobile accident, a CT scan of the brain revealed vascular abnormality, which required a followup hospital admission that did not reveal anything especially serious.
However, the accident had resulted in some upper extremity pain and some back pain. At the time of the hospital admission in connection with this accident, R. H. admitted only to the use of Soma® and Valium®, as well as occasional marijuana, but not the extensive opioids that Respondent was prescribing. All of this information is in Respondent's medical records.
R. H. reported a pain level of "8" on the September 28 medical note, despite the large increase in roxicodone prescribed two months earlier. If there was a discussion of the recent automobile accident, it does not emerge from the nearly illegible notes, and Respondent did not testify to any analysis of the effect of this recent accident. At this time, Respondent increased the roxicodone by 50%--from 180 pills to 240 pills monthly.
On November 1, 2007, the medical note reveals that
R. H. reported pain at a level of "5." On a patient questionnaire, R. H. reported that pain had not interfered at all in the past month with her mood, walking, sleeping, concentrating, appetite, work, or relationships, and she denied
any side effects. Despite this information, one month later, on November 30, with the pain reported at only a "4," Respondent increased the roxicodone by 60 pills monthly.
While Respondent maintained this prescription through 2008, R. H. reported pain at only a "4." On February 17, 2009, in a medical review, Respondent noted that R. H.'s urine had tested positive for THC. This note records R. H.'s difficulty in keeping a job. This note describes a treatment plan to continue the present pain medications, possibly taper benzodiazepines, and continue to refer R. H. to psychotherapy.
There is little connection between the medical records--most notably, the self-reported pain levels--and the amount of opioids that Respondent prescribed. Given the obvious difficulties that this patient was experiencing and the large increases in opioids that Respondent prescribed her, the treatment plan described in the preceding paragraph was insufficient.
These facts do not depict merely a failure of the medical records to justify the course of treatment. Even without regard to the single indication of marijuana use, R. H. was a substance abuser who lied to health-care providers about what she was taking and required her mother to control her access to the opioids that Respondent prescribed. Respondent's treatment "plan" was to give R. H. exactly what she wanted,
including one drug with which Respondent was completely unfamiliar. This patient needed help, and Respondent, for two and one-half years, failed to practice in accordance with the applicable standard of care by continuing to supply her with an increasing supply of opioids--essentially, failing to treat her. Under these circumstances, Respondent's opioid prescriptions were inappropriate, excessive, and otherwise unjustified.
Petitioner proved a medical-records violation and a standard-of-care violation.
K. L.
From March 15, 2007, through July 16, 2009, Respondent prescribed to K. L. a monthly regime of mostly 30-mg roxicodone with occasional 10/325 Percocet®, 80-mg Oxycontin®, and 15-mg roxicodone. On March 15, 2007, Respondent prescribed 420 30-mg roxicodone pills (all roxicodone prescriptions for K. L. are for
30 mg unless otherwise stated) and 120 Percocet® pills. This prescription continued through office visits on April 11, May 9, and June 6, at which time Respondent dropped the Percocet® prescription.
From July 2, 2007, through November 14, 2007, which covers five and one-half months, Respondent prescribed "monthly"--on six occasions--420 pills of roxicodone. On December 12, 2007, Respondent reduced the prescription to 400 pills of roxicodone, but added 60 Percocet® pills. This
prescription continued through office visits on January 8, 2008, and February 7.
On March 5, 2008, Respondent dropped the Percocet® from the prescription, but raised the roxicodone to 420 pills. This prescription continued until January 5, 2009--so as to cover 11 months with 12 "monthly" prescriptions.
On January 30, 2009, Respondent reduced the roxicodone from 420 pills to 360 pills. On February 26, 2009, Respondent effectively increased the prescription by reducing the 30-mg roxicodone from 360 pills to 280 pills, but adding 200 pills of 15-mg roxicodone.
On March 5 and 6, 2009, Respondent prescribed 90 roxicodone pills, 30 Percocet® pills, and 26 Oxycontin® pills (in two prescriptions). Four days later, on March 10, Respondent prescribed 120 roxicodone pills. Fifteen days later, on March 26, Respondent prescribed 390 roxicodone pills.
On April 22, Respondent prescribed 360 roxicodone pills. On May 20, he prescribed 330 roxicodone pills. And on June 17 and July 16, 2009, Respondent prescribed 300 roxicodone pills each office visit.
At the initial visit, K. L. informed Respondent that he had been seeing another pain physician, Frederick Swartz, M.D., but was required to visit every three weeks and found the office hours inconvenient. One may safely infer that the
frequency of visits was part of Dr. Swartz's attempt to restrict
K. L.'s aberrant behavior.
Dr. Swartz had prescribed, every three weeks, 84 Percocet®, 284 roxicodone, and 84 Xanax®. On a monthly basis, the 84 pills translate to about 121 pills, and the 284 pills translate to about 410 pills. Respondent's initial prescription thus maintained the levels of Percocet® and roxicodone that the preceding physician had prescribed.
During the initial interview, K. L. advised Respondent that he had suffered orthopedic injuries from being struck in the face with a baseball bat many years earlier, as well as two automobile accidents more recently. Having previously worked as a personal trainer, according to the notes, K. L. "works now in the New York State Business." The meaning of this statement remains known only to its author, but does not necessarily mean that K. L. was an out-of-state patient.
K. L. informed Respondent that he obtained adequate pain relief from the 14 roxicodone that he took daily. K. L. stated that he had tried Oxycontin® for a couple of days, but did not like it due to cognitive impairment. His only surgical history involved the repair of the eye socket following the baseball bat injury. K. L. rated his pain as a "6."
Respondent testified that, after four months, he eliminated the Percocet® because there was no need for K. L. to
be taking two short-acting opioids simultaneously, and Respondent was concerned about potential acetaminophen toxicity. These were prudent concerns.
A major issue in this patient's treatment developed when, on March 15, 2007, he took a urinalysis, and it tested positive for opiates, in addition to the oxycodone and benzodiazepine that Respondent had been taking, as prescribed. The test results distinguish between the oxycodone present in the roxicodone and Percocet® that had been prescribed for K. L., and other, nonprescribed opiates, such as heroin and codeine.
K. L. failed subsequent urinalyses administered by Respondent. On May 9, 2007, his urine tested positive for oxycodone and other opiates, but not benzodiazepines. On February 7, 2008, January 30, 2009, and February 26, 2009,
K. L.'s urine tested positive for oxycodone, morphine (another opiate that evidently is disclosed separately from opiates), and benzodiazepines.
Respondent's contradictory testimony confirms his mishandling of the patient. Initially, Respondent testified that he had concluded, when K. L.'s urinalyses first disclosed opiates, that K. L. suffered from some sort of rare condition in which the liver failed to metabolize the oxycodone and caused the urinalyses to detect the oxycodone as other opiates. This explanation is discredited because Respondent failed to order
additional lab work on liver function at the time and failed generally to proceed to rule out or otherwise deal with any liver problems. Respondent later admitted, in cross- examination, that he was not concerned about K. L.'s liver in 2007 (Tr., p. 339.), but only became concerned about it in 2009. (Tr., p. 340.)
The actual explanation for the failed urinalyses was
K. L.'s consumption of other opiates that he was not disclosing to Respondent. And Respondent was aware of this aberrant behavior. Undermining his testimony about a later suspicion of liver dysfunction, Respondent, reading from a medical note dated January 30, 2009, testified: "I even put [K. L.] on probation because I thought he was lying to me." Obviously, he would not have put a patient on probation for impaired liver function.
Even if Respondent were telling the truth that he did not realize, until January 30, 2009, that K. L. had been lying to him about other opiate use--which he was not--two facts nonetheless undermine Respondent's attempted explanations. First, from March 15, 2007, through January 30, 2009, Respondent prescribed to K. L. over 10,000 roxicodone pills. After Respondent claimed to have concluded that K. L. was lying about other opiate use, Respondent prescribed, from February 26, 2009, through July 16, 2009, over 2000 more roxicodone pills plus 200 15-mg roxicodone pills.
As was the case with R. H., these facts do not depict merely a failure of the medical records to justify the course of treatment. K. L. is also a substance abuser, engaging in the especially dangerous behavior of combining his prescribed opioids with unprescribed opioids. For almost two years, Respondent joined K. L. in an elaborate rationalization process designed to avoid confronting the patient's urgent problem.
K. L. needed help, and Respondent, for two years, failed to practice in accordance with the applicable standard of care by continuing to supply him with an increasing supply of opioids-- essentially, failing to treat him. Under these circumstances, Respondent's opioid prescriptions were inappropriate, excessive, and otherwise unjustified.
Petitioner proved a medical-records violation and a standard-of-care violation.
J. K.
From May 22, 2007, through July 27, 2009, Respondent prescribed to J. K. a monthly regime of 30-mg roxicodone plus Oxyfast® occasionally. (All roxicodone prescriptions for J. K. are for 30 mg.)
On May 22, 2007, Respondent provided J. K. with two prescriptions of 120 roxicodone pills each. On June 19, Respondent wrote J. K. two roxicodone prescriptions--one for 150 pills and one for 170 pills. On July 16, Respondent wrote J. K.
a prescription for 150 roxicodone pills, a prescription for 120 roxicodone pills, and one bottle of Oxyfast®. On August 13, Respondent wrote J. K. a prescription for 300 roxicodone pills, five roxicodone pills, and two bottles of Oxyfast®. On September 10, Respondent wrote J. K. a prescriptions for 295 roxicodone pills, five roxicodone pills, and one bottle of Oxyfast®.
On October 8, Respondent reduced the numbers of roxicodone pills by giving J. K. prescriptions for 190 roxicodone pills, 140 roxicodone pills, ten roxicodone pills, and one bottle of Oxyfast®. On November 2, Respondent maintained these prescriptions, dropping only the prescription for ten roxicodone pills. But, three days later, Respondent gave J. K. a prescription for ten roxicodone pills.
On December 3, 2007, Respondent greatly increased the prescription, raising it to 410 roxicodone pills and two bottles of Oxyfast®. On January 4, 2008, Respondent reduced the prescription to 330 roxicodone pills in one prescription and ten roxicodone pills in the other, as well as two bottles of Oxyfast®.
Again, on February 1, 2008, Respondent increased the prescription, raising it to 380 roxicodone pills, but dropping the Oxyfast®. Respondent repeated this prescription on February
28 and raised it to 410 roxicodone pills on March 28.
Respondent lowered it to 380 roxicodone pills on May 22. Then,
on May 22, June 19, July 17, and August 13, Respondent prescribed 450 roxicodone pills each month.
Respondent did not see J. K. for the next five months. On January 19, 2009, Respondent gave J. K. separate prescriptions of 200 and 250 roxicodone pills. On February 13, Respondent issued J. K. a single prescription for 450 roxicodone pills.
On March 12, Respondent issued five roxicodone prescriptions for 200 pills, 100 pills, 100 pills, 50 pills, and
70 pills--for a total of 520 pills. Six days later, on March 18, Respondent gave J. K. another roxicodone prescription--this time for 30 pills. On April 7, Respondent gave J. K. two roxicodone prescriptions--one for 100 pills and one for 250 pills. Six days later, on April 13, Respondent gave J. K. two more roxicodone prescriptions--one for 200 pills and one for 50 pills.
On May 5, Respondent gave J. K. a roxicodone prescription for 250 pills. On June 1, Respondent gave J. K. roxicodone prescriptions for 250 and 200 pills each. And on June 29 and July 27, Respondent gave J. K. roxicodone prescriptions for 450 pills each.
J. K. had been a semi-professional hockey player who retired prematurely due to back pain. He exacerbated his back
problems when he was involved in an automobile accident on April 19, 2004.
On July 16, 2007, J. K. reported a pain level of "7," but this increased to a "9" on August 13, 2007. At this time, Respondent increased the roxicodone prescription. However, the medical records do not reveal escalating pain reports during the first half of 2008 when Respondent twice ramped up the roxicodone levels.
The complaints of Petitioner's expert witness are that Respondent prescribed short-acting opioids for chronic pain, and Respondent prescribed excessive opioids for the injury at issue, which Petitioner's expert first identified as the older hockey injury, not the newer injury from the car wreck. These complaints appear ungrounded. As noted above, this record fails to reveal the superiority of long-acting opioids over short-acting opioids for the treatment of chronic pain, and Petitioner's expert acknowledged that a practitioner must sometimes prescribe roxicodone, rather than a long-acting opioid, such as Oxycontin®, due to cost considerations. Obviously, in suggesting that J. K.'s pain was disproportionate to his injury, Petitioner's expert would have enjoyed greater credibility if he had not first based his testimony on the much- older hockey injury to the face, rather than the newer injuries to the back from the automobile accident.
In her cross-examination of Respondent, Petitioner's counsel tried to suggest that Respondent violated the standard of care by resuming the roxicodone prescription, after a five- month hiatus in visits between August 2008 and January 2009. However, Respondent first confirmed that J. K. was positive for oxycodone and, thus, not opioid-naïve. Respondent also explained that J. K. had seen a doctor in New Jersey while he was there visiting his mother.
Essentially, for J. K., the standard-of-care opinion of Petitioner's expert witness is based entirely on inadequate medical records. The expert noted correctly that Respondent's medical records, which span two years, lack assessments, diagnoses, and treatment plans. At times, the medical records fail to support changes in medications. But Petitioner has failed to prove that Respondent's treatment of J. K. itself violates the standard of care because there is some correspondence between pain reports and prescription quantities.
Petitioner proved a medical-records violation, but not a standard-of-care violation.
K. G.
From June 19, 2007, through July 27, 2009, Respondent prescribed to K. G. a monthly regime of 30-mg roxicodone pills. (All roxicodone prescriptions to K. G. are for 30-mg doses, unless otherwise indicated.)
For the first four months, Respondent prescribed 300 roxicodone pills monthly. For the next four months, Respondent prescribed 280 pills monthly.
For the next year, Respondent did not see K. G. When
K. G. returned on December 19, 2008, Respondent prescribed 280 roxicodone pills, which he maintained for the next two months' prescriptions. On April 6, 2009, Respondent maintained the prescription at 160 30-mg roxicodone pills plus 240 15-mg roxicodone pills, which is the equivalent of 280 30-mg pills. On April 30, 2009, Respondent provided two prescriptions of 160 and 120 roxicodone pills, and, on May 26, June 24, and July 27, 2009, Respondent prescribed 280 roxicodone pills each month.
K. G. presented to Respondent with complaints of lower back pain, probably resulting from two automobile accidents. An MRI of the lumbar spine showed a herniated disc at L5/S1, causing impingement of the right and left S1 nerve root, and a herniated disc at L4/L5. Dr. Deluca, who was no longer practicing, had been prescribing K. G. 120 80-mg Oxycontin® pills and 420 30-mg Oxycontin® pills, presumably monthly. K. G. had been switched to Suboxone®, which is used to withdraw a patient from opioids, but K. G. admitted to buying and using Oxycontin® on the street.
The initial note contains a treatment plan. Claiming a pain level of "9," K. G. asked to resume Oxycontin®, but
Respondent declined, based in part of K. G.'s history of high intake of opiates. Respondent instead suggested interventional pain management. A urinalysis administered on the initial visit was negative as to "everything." Respondent then prescribed ten roxicodone pills daily, perhaps revealing a belief that K. G. was not, in fact, opioid-naïve at the time.
On K. G.'s next visit, on July 17, 2007, he tested positive for THC. In a medical note dated October 22, 2007, Respondent noted that K. G. had not seen the orthopedist, to whom he had referred him. Respondent found K. G. difficult to manage because he traveled a lot, working as a market maker for stocks. K. G. took Suboxone®, but only to avoid withdrawal symptoms from interruptions in his roxicodone regime while he was in other countries, where he presumably could not take his roxicodone. On January 4, 2008, Respondent placed K. G. on probation due to unspecified aberrations in behavior.
K. G. promptly discontinued seeing Respondent for over ten months between January 4 and November 21, 2008. On his return, K. G. again tested positive for THC. Respondent testified that he counseled him not to continue to use marijuana, but his records do not document this fact. Respondent continued treating K. G. for another eight months without administering another urinalysis.
Again, the medical records reveal no assessment, diagnosis, or treatment plan.
Petitioner's expert witness pursued some false trails in trying to establish a standard-of-care violation. He complained about a split prescription on April 30, 2009, but there were only three such prescriptions over two years, and this record fails to reveal a sinister purpose in splitting prescriptions. About the worst thing that Petitioner's expert has to say about the practice is that he is "not sure of the purpose for that." (Tr., p. 70.)
Petitioner's expert witness raised the issue of short-acting versus long-acting opioids, but this has already been addressed. Petitioner's expert objected to Respondent's prescription of Xanax® and Soma®, but, as already noted, Petitioner did not plead these matters.
Petitioner's expert witness mentioned the polysubstance use of benzodiazepines and oxycodone--both prescribed--with marijuana. Petitioner's expert opined that patients who persist in using marijuana "need to be tapered off their [opioids] and referred for [substance abuse] counseling." (Tr., pp. 72 and 145.) Respondent's expert opined that practitioners are divided in what to do with patients whose aberrant behavior involves exclusively marijuana use. The
standard of care as applied to marijuana use is discussed in the Conclusions of Law.
Petitioner's expert finds firmer footing when he ties in the other aberrant behavior of K. G., including obtaining Oxycontin® on the street and K. G.'s on-again, off-again misuse of Suboxone® as a opiate-substitute, not as an agent to assist in opiate detoxification. When K. G. ignored Respondent's referral to an orthopedist, K. G. blatantly ignored Respondent's lone attempt to initiate a reexamination of the patient's underlying condition. There were one or more unspecified aberrant behaviors, and, when Respondent finally placed the patient on probation, K. G. quit seeing Respondent for ten months: on his return, he promptly tested positive for marijuana again.
These facts are the grounds of the standard-of-care violation. As was the case with R. H. and K. L., so it is with
K. G. By continuing to prescribe opioids and not treating the underlying condition, or tapering him off and then dismissing
K. G. as a patient, if he refused to stop his aberrant behavior, Respondent essentially deprived K. G. of the treatment that he required.
Petitioner proved a medical-records violation and standard-of-care violation.
D. D.
From June 30, 2008, through June 3, 2009, Respondent prescribed to D. D. a monthly regime of 290 30-mg roxicodone pills. And, in this case, a one-year span produced only 12 prescriptions.
At his initial visit on June 30 or July 1, 2008,
D. D., a diabetic in his 50s, presented with pain in both knees.
His left knee had been replaced two years earlier and was doing well, but he was awaiting replacement of his right knee. D. D. had an abscess at L5/S1. He was on SSI disability. Although taking 30-mg and 15-mg roxicodone, D. D. wanted to get off the 30-mg pills because he had no insurance. Obese at 192 pounds,
D. D. reported his pain to be an "8."
The treatment plan involved converting D. D.'s 15-mg roxicodone pills for 30-mg roxicodone pills, despite his interest in dropping the 30-mg pills, but Respondent maintained the same dosage as had been prescribed by the preceding physician. Otherwise, the treatment plan consisted of discussing the rules of the Pain Management Center.
Petitioner's expert witness complimented Respondent on his initial medical record: he called it a "well presented medical record, a good history there. I think this is an appropriate medical record." (Tr., p. 85.) And it is.
Petitioner's expert also testified that the patient required opiate management. Laboring under a misunderstanding as to the amount of roxicodone that Respondent had prescribed on the first visit, Petitioner's expert was alarmed by what he thought had been a doubling on the second visit; in fact, the quantity had remained unchanged. In this case, given the short time of treatment and the extensive medical difficulties of the patient, whom Respondent described aptly as "one of the saddest patients I have" (Tr., p. 230), Petitioner's expert lacked support in the record for his opinion that Respondent was required to address eliminating pain medications from D. D.'s life. D. D. was a low-functioning person when he presented to Respondent, and the standard of care did not require, within one year, that Respondent either get D. D. off opioids or substantially improve his function. However, toward the end of the treatment period, D. D. enjoyed greater functionality, as he was able to help raise his grandson.
Petitioner failed to prove a medical-records violation or a standard-of-care violation.
J. M.
From October 1, 2007, through July 3, 2009, Respondent prescribed J. M. a monthly regime of 30-mg roxicodone pills and Oxyfast bottles. (All roxicodone prescriptions to
J. M. are for 30-mg doses, unless otherwise indicated.)
On October 1, 2007, Respondent prescribed 240 roxicodone pills and one bottle of Oxyfast.® On October 23, Respondent maintained the roxicodone, but doubled the Oxyfast® to two bottles. Respondent maintained this prescription level the next month. On December 21, Respondent essentially maintained the same prescription level by prescribing 105 30-mg roxicodone pills and 273 15-mg roxicodone pills, as well as two bottles of Oxyfast.® On January 18, 2008, Respondent again maintained the same prescription level by prescribing 70 30-gm roxicodone pills and 340 15-mg roxicodone pills, plus two bottles of Oxyfast.®
But four days later, Respondent prescribed another 70 roxicodone pills.
On February 18, Respondent prescribed 240 roxicodone pills in two prescriptions--one for 70 pills and one for 170 pills--but no Oxyfast.® On March 25, Respondent prescribed 240 roxicodone pills--in separate prescriptions of 110 and 130 pills--and two bottles of Oxyfast®. Respondent repeated this prescription, but with a single roxicodone prescription each
month, for the next nine months. The only exceptions were split prescriptions of 140 pills each on June 17 and the discontinuation of visits between June 17 and September 8.
On February 24, 2009, Respondent reduced the prescription to 60 pills of 15-mg roxicodone. On March 23, he raised it to 300 pills of roxicodone--split into prescriptions
of 120 pills and 180 pills--and two bottles of Oxyfast.® On April 17, Respondent prescribed two bottles of Oxyfast®, and, on April 23, Respondent prescribed 70 roxicodone pills.
On May 15 and June 10, 2009, Respondent prescribed
300 roxicodone pills--divided into two prescriptions of equal amounts--and two bottles of Oxyfast®. On July 3, 2009, Respondent prescribed 300 roxicodone pills--divided into prescriptions of 80 and 220 pills--and two bottles of Oxyfast®.
In the initial visit in 2002, J. M. presented as a 32-year-old male with lower back pain. He reported that he had injured his back a few months earlier picking up an object.
Unable to lift, J. M. had had to quit working as a gardener. He had been taking four or five Percocet 10/325's daily. The treatment plan, which was prepared by Respondent, was to help
J. M. quit smoking tobacco and convert him from Percocet, with the potential acetaminophen toxicity, to roxicodone. J. M. told Respondent that his girlfriend had let him try some of her Xanax®, which had helped him with spasms and sleeping, so Respondent prescribed that too. They also discussed that J. M. should exercise his COBRA rights on his insurance because he was going to get some evaluations, as well as epidural injections.
An MRI of the lumbar spine performed on February 6, 2008, revealed multilevel central disc herniations at L2/L3, L3/L4, L4/L5, and L5/S1 with annular tears in the herniations at
L3/L4, L4/L5, and L5/S1. The MRI disclosed mild spinal stenosis at L4/L5. None of the ten patients involved in this case displayed the same extent of objective bases for the pain of which he or she complained.
In August 2007, while being seen by Dr. Morency at the Pain Management Center, J. M. expressed a desire to be seen by a different physician, but the medical record fails to reveal why. On October 1, 2007, when first treating J. M., Respondent continued the level of opioids that Dr. Morency had been prescribing. Respondent prescribed Oxyfast® with roxicodone because the former, as a liquid, has a faster onset than the pill, which can take 45 minutes to take effect.
Respondent testified that he doubled the Oxyfast® on October 23 because the pain was worse. But, according to the medical records, J. M. reported pain of "5" on October 1, 2007, and, three weeks later, reported pain of only "3."
On July 3, 2009, a urinalysis revealed THC. Respondent discussed with J. M. his aberrant behavior and placed him on probation, warning him not to test positive for marijuana again. However, J. M. had tested positive for marijuana on April 17, 2006, August 7, 2007, and October 23, 2007--each time he had been tested. Respondent did not test J. M. again for nearly two years.
Petitioner's expert faulted Respondent for his handling, or lack of handling, of J. M.'s apparently ongoing marijuana use during treatment. This is addressed in the Conclusions of Law.
Petitioner's expert witness faulted Respondent for using short-acting opioids rather than long-acting opioids, but this has been dealt with already.
Except for the doubling of the Oxyfast® early in the period of treatment, the medical records fail to establish a correspondence between pain reports and prescription levels of roxicodone on three occasions: the two months during which Respondent supplemented the roxicodone prescription with 70 pills and the 25% increase in roxicodone in early 2009. The medical records lack assessments, diagnoses, and treatment plans. In particular, the medical records are deficient because they do not justify the three increases in prescribed opioids.
But there is insufficient evidence of a standard-of- care violation as to J. M. There is insufficient evidence of aberrant behavior that would require Respondent to taper off
J. M. from pain medications--despite well-documented sources of pain--while he obtained counseling to help him stop using marijuana. And the three instances in which increased prescriptions were not justified in the medical records prove a medical-records violation, not a standard-of-care violation, as
discussed in the Conclusions of Law. No other evidence in the record establishes a lack of justification for the prescribed opioids.
Petitioner proved a medical-records violation, but not a standard-of-care violation.
M. L.
From April 26, 2007, through March 3, 2009, Respondent prescribed to M. L. a monthly regime of 30-mg roxicodone pills, except for a single prescription of oxycodone and two prescriptions of Percocet® 10/325. (All roxicodone prescriptions to M. L. are for 30-mg doses.)
On April 26, 2007, Respondent prescribed 440 mg of roxicodone pills in two prescriptions--one for 200 pills and one for 240 pills. Respondent repeated this prescription monthly for seven months--eight times--when, on December 6, 2007, he raised it to 540 mg in two prescriptions--one for 290 pills and one for 250 pills.
Starting January 8, 2008, Respondent returned to his initial pattern of prescribing 440 pills of roxicodone in two prescriptions. This continued through 2008--again, counting January 8, this amounted to 13 prescriptions, not 12, over the year.
Respondent continued this prescription pattern on January 6 and February 2--the latter incorporating 40 15-mg
roxicodone pills to achieve the same total prescription in dosage. On March 3, 2009, Respondent prescribed 150 roxicodone pills, 210 5-mg oxycodone pills, and 210 Percocet® 10/325 pills.
In 1999, David Buchalter, M.D., referred M. L. to the Pain Management Center with a report stating that an MRI suggested that the patient had a small herniated disc at C3/C4, a mild disc bulge at C4/C5, and degenerative disc space narrowing at C5/C6.
By the time that Respondent saw M. L., he had been complaining of neck and lower back pain for many years. M. L. could not afford Oxycontin®, but a urinalysis confirmed that he was taking his prescribed short-acting opioids. M. L. had been seen by the Pain Management Center for several years, and he had never exhibited aberrant behavior.
Nothing stands out in the record concerning the care received by M. L., although, again, two years of medical records contain no assessment, diagnosis, or treatment plan.
Petitioner proved a medical-records violation, but not a standard-of-care violation.
M. P.
From February 12, 2007, through July 7, 2009, Respondent prescribed to M. P. a monthly regime of Oxycontin and methadone initially and, later, mostly roxicodone. (All
roxicodone prescriptions for M. P. are for 30 mg, unless otherwise indicated.)
M. P. had been seen by the Pain Management Center since at least 2002. He was operating a forklift in 1999 when boxes fell on him, injuring his neck. An MRI revealed a ruptured disk at C3/C4, a disc bulge at C4/C5, and degenerative disc disease at C5/C6. At the time of the office visit, M. P. was still employed driving a forklift, but was taking 120 mg of Oxycontin® daily.
Despite a medical record dated January 5, 2006, stating that M. P. could not afford Oxycontin®, he was still on this relatively expensive, long-acting opioid at the start of the period in question. During his years of treatment at the Pain Management Center, M. P. had never displayed any aberrant behavior, as periodic urinalyses revealed that M. P. was taking his prescribed opioids and nothing else.
The medical records during the period in question contain no patient assessments or treatment plans, nor do they explain the switching of medications.
Of particular interest, as to the standard of care, is the relatively long period that Respondent prescribed two long-acting opioids, methadone and Oxycontin®. As Petitioner's expert testified, such overlapping is appropriate during a dosage-transition phase, as the practitioner transitions the
patient from one such opioid to another. But here, Respondent prescribed methadone and Oxycontin for five months. At the end of this period, Respondent discontinued the Oxycontin®, but there is no constant tapering off of Oxycontin® during this period.
From February to July 2007, the monthly prescriptions for Oxycontin® are for 14,400 mg, 14,400 mg, 14,400 mg, 14,400 mg, 0 mg, and 4800 mg.
As noted above, methadone is difficult to use for analgesic purposes. Doubtlessly, this difficulty is increased by adding another long-acting opioid, even if its half life is much shorter than the half-life of methadone. But this is really all that Petitioner presents for a standard-of-care violation. Although it is a close question, Petitioner's evidence fails to convince that five months' dual prescribing of two long-acting opioids was inappropriate, excessive, or unjustified.
Petitioner's expert questioned the amount of roxicodone prescribed, in conjunction with methadone, for back pain. This criticism was less well-founded, as Respondent eventually discontinued the methadone also. Additionally, M. P. tended to report high pain levels during the period in question.
Again, during the two and one-half years of relevant treatment, the medical records fail to include an assessment,
diagnosis, or treatment plan, including any guide to the transitioning of the patient off of two long-acting opioids.
Petitioner proved a medical-records violation, but not a standard-of-care violation.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the subject matter. §§ 120.569, 120.57(1), and 456.073(5), Fla. Stat. (2008).
Section 458.331(1), Florida Statutes, provides in relevant part:
The following acts constitute grounds for denial of a license or disciplinary action, as specified in s. 456.072(2):
* * *
(m) Failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed physician or the physician extender and supervising physician by name and professional title who is or are responsible for rendering, ordering, supervising, or billing for each diagnostic or treatment procedure and that justify 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.
* * *
Notwithstanding s. 456.072(2) but as specified in s. 456.50(2):
Committing medical malpractice as defined in s. 456.50. The board shall give great weight to the provisions of s. 766.102 when enforcing this paragraph. Medical malpractice shall not be construed to require more than one instance, event, or act.
* * *
Nothing in this paragraph shall be construed to require that a physician be incompetent to practice medicine in order to be disciplined pursuant to this paragraph. A recommended order by an administrative law judge or a final order of the board finding a violation under this paragraph shall specify whether the licensee was found to have committed "gross medical malpractice," "repeated medical malpractice," or "medical malpractice," or any combination thereof, and any publication by the board must so specify.
This is a case of medical malpractice, not gross medical malpractice or repeated medical malpractice. Section 456.50(1)(g) defines "medical malpractice" 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. . . .
Section 456.50(1)(e) provides: "Level of care, skill, and treatment recognized in general law related to health care licensure" means the standard of care specified in
s. 766.102." Section 766.102(1) provides:
. . . 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.
As in effect in 2008, Florida Administrative Code Rule 64B-9.003 provides:
Medical records are maintained for the following purposes:
To serve as a basis for planning patient care and for continuity in the evaluation of the patient’s condition and treatment.
To furnish documentary evidence of the course of the patient’s medical evaluation, treatment, and change in condition.
To document communication between the practitioner responsible for the patient and any other health care professional who contributes to the patient’s care.
To assist in protecting the legal interest of the patient, the hospital, and the practitioner responsible for the patient.
A licensed physician shall maintain patient medical records in English, in a legible manner and with sufficient detail to clearly demonstrate why the course of treatment was undertaken.
The medical record shall contain sufficient information to identify the patient, support the diagnosis, justify the treatment and document the course and results of treatment accurately, by including, at a minimum, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; reports of consultations and hospitalizations; and copies of records or reports or other documentation obtained from other health care practitioners at the request of the physician and relied upon by the physician in determining the appropriate treatment of the patient.
* * *
As in effect in 2008, Florida Administrative Code Rule 64B8-9.013 provides:
Pain management principles.
The Board of Medicine recognizes that principles of quality medical practice dictate that the people of the State of Florida have access to appropriate and effective pain relief. The appropriate application of up-to-date knowledge and treatment modalities can serve to improve the quality of life for those patients who suffer from pain as well as reduce the morbidity and costs associated with untreated or inappropriately treated pain. The Board encourages physicians to view effective pain management as a part of quality medical practice for all patients with pain, acute or chronic, and it is especially important for patients who experience pain as a result of terminal illness. All physicians should become knowledgeable about effective methods of pain treatment as well as statutory requirements for prescribing controlled substances.
Inadequate pain control may result from physicians’ lack of knowledge about pain management or an inadequate understanding of addiction. Fears of investigation or sanction by federal, state, and local regulatory agencies may also result in inappropriate or inadequate treatment of chronic pain patients. Physicians should not fear disciplinary action from the Board or other state regulatory or enforcement agencies for prescribing, dispensing, or administering controlled substances including opioid analgesics, for a legitimate medical purpose and that is supported by appropriate documentation establishing a valid medical need and treatment plan. Accordingly, these
standards have been developed to clarify the Board’s position on pain control, specifically as related to the use of controlled substances, to alleviate physician uncertainty and to encourage better pain management.
The Board recognizes that controlled substances, including opioid analgesics, may be essential in the treatment of acute pain due to trauma or surgery and chronic pain, whether due to cancer or non-cancer origins. The medical management of pain including intractable pain should be based on current knowledge and research and includes the use of both pharmacologic and non-pharmacologic modalities. Pain should be assessed and treated promptly, and the quantity and frequency of doses should be adjusted according to the intensity and duration of the pain. Physicians should recognize that tolerance and physical dependence are normal consequences of sustained use of opioid analgesics and are not synonymous with addiction.
The Board of Medicine is obligated under the laws of the State of Florida to protect the public health and safety. The Board recognizes that inappropriate prescribing of controlled substances, including opioid analgesics, may lead to drug diversion and abuse by individuals who seek them for other than legitimate medical use. Physicians should be diligent in preventing the diversion of drugs for illegitimate purposes.
The Board will consider prescribing, ordering, administering, or dispensing controlled substances for pain to be for a legitimate medical purpose if based on accepted scientific knowledge of the treatment of pain or if based on sound clinical grounds. All such prescribing must be based on clear documentation of unrelieved pain and in compliance with applicable state or federal law.
Each case of prescribing for pain will be evaluated on an individual basis.
The Board will not take disciplinary action against a physician for failing to adhere strictly to the provisions of these standards, if good cause is shown for such deviation. The physician’s conduct will be evaluated to a great extent by the treatment outcome, taking into account whether the drug used is medically and/or pharmacologically recognized to be appropriate for the diagnosis, the patient’s individual needs including any improvement in functioning, and recognizing that some types of pain cannot be completely relieved.
The Board will judge the validity of prescribing based on the physician’s treatment of the patient and on available documentation, rather than on the quantity and chronicity of prescribing. The goal is to control the patient’s pain for its duration while effectively addressing other aspects of the patient’s functioning, including physical, psychological, social, and work-related factors. The following standards are not intended to define complete or best practice, but rather to communicate what the Board considers to be within the boundaries of professional practice.
Definitions.
Acute Pain. For the purpose of this rule, “acute pain” is defined as the normal, predicted physiological response to an adverse chemical, thermal, or mechanical stimulus and is associated with surgery, trauma, and acute illness. It is generally time-limited and is responsive to opioid therapy, among other therapies.
Addiction. For the purpose of this rule, “addiction” is defined as a neurobehavioral syndrome with genetic and environmental influences that results in psychological dependence on the use of substances for their psychic effects and is characterized by compulsive use despite harm. Addiction may also be referred to by terms such as “drug dependence” and “psychological dependence.” Physical
dependence and tolerance are normal physiological consequences of extended opioid therapy for pain and should not be considered addiction.
Analgesic Tolerance. For the purpose of this rule, “analgesic tolerance” is defined as the need to increase the dose of opioid to achieve the same level of analgesia. Analgesic tolerance may or may not be evident during opioid treatment and does not equate with addiction.
Chronic Pain. For the purpose of this rule, “chronic pain” is defined as a pain state which is persistent.
Pain. For the purpose of this rule, “pain” is defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.
Physical Dependence. For the purpose of this rule, “physical dependence” on a controlled substance is defined as a physiologic state of neuro-adaptation which is characterized by the emergence of a withdrawal syndrome if drug use is stopped or decreased abruptly, or if an antagonist is administered. Physical dependence is an expected result of opioid use. Physical dependence, by itself, does not equate with addiction.
Pseudoaddiction. For the purpose of this rule, “pseudoaddiction” is defined as a pattern of drug-seeking behavior of pain patients who are receiving inadequate pain management that can be mistaken for addiction.
Substance Abuse. For the purpose of this rule, “substance abuse” is defined as the use of any substances for non- therapeutic purposes or use of medication for purposes other than those for which it is prescribed.
Tolerance. For the purpose of this rule, “tolerance” is defined as a physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce the same effect, or a
reduced effect is observed with a constant dose.
Standards. The Board has adopted the following standards for the use of controlled substances for pain control:
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 physical and 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.
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 individual 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.
Informed Consent and Agreement for Treatment. The physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient, or with the patient’s surrogate or guardian if the patient is incompetent. The patient should receive prescriptions from one physician and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the physician should employ the use of a written agreement between physician and patient outlining patient
responsibilities, including, but not limited to:
Urine/serum medication levels screening when requested;
Number and frequency of all prescription refills; and
Reasons for which drug therapy may be discontinued (i.e., violation of agreement).
Periodic Review. At reasonable intervals based on the individual circumstances of the patient, the physician should review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy should depend on the physician’s evaluation of the patient’s progress. If treatment goals are not being achieved, despite medication adjustments, the physician should reevaluate the appropriateness of continued treatment. The physician should monitor patient compliance in medication usage and related treatment plans.
Consultation. The physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention should 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 may require consultation with or referral to an expert in the management of such patients.
Medical Records. The physician is required to keep accurate and complete records to include, but not be limited to:
The medical history and physical examination, including history of drug abuse or dependence, as appropriate;
Diagnostic, therapeutic, and laboratory results;
Evaluations and consultations;
Treatment objectives;
Discussion of risks and benefits;
Treatments;
Medications (including date, type, dosage, and quantity prescribed);
Instructions and agreements; and
Periodic reviews. Records must remain current and be maintained in an accessible manner and readily available for review. Records must remain current and be maintained in an accessible manner and readily available for review.
Compliance with Controlled Substances Laws and Regulations. To prescribe, dispense, or administer controlled substances, the physician must be licensed in the state and comply with applicable federal and state regulations. Physicians are referred to the Physicians Manual: An Informational Outline of the Controlled Substances Act of 1970, published by the U.S. Drug Enforcement Agency, for specific rules governing controlled substances as well as applicable state regulations.
Petitioner must prove the material allegations by clear and convincing evidence. Dep't of Banking & Fin. v. Osborne Stern & Co., Inc., 670 So. 2d 932 (Fla. 1996) and Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987).
As stated in the Findings of Fact, Petitioner has proved medical-records violations for all ten patients, except
D. D., and Petitioner has proved standard-of-care violations for
M., R. H., K. L., and K. G., but not the other six patients.
The law governing medical records requires no elaboration. Section 458.331(1)(m) requires medical records
that "justify the course of treatment." Rule 64B-9.003 restates this requirement and explains the reasons for its existence.
For the use of controlled substances for pain control, Rule 64B8-9.013(1)(e) requires that pain prescriptions "must be based on clear documentation of unrelieved pain." Rule 64B8- 9.013(3)(f) requires, specifically, that the medical records contain diagnostic and therapeutic results, evaluations, treatment objectives, and discussions of risks and benefits, among other things. For the most part, Respondent's records contained none of these required elements and generally failed to justify the course of treatment, except as to D. D.
A medical-records violation, even if egregious, is not a standard-of-care violation. Barr v. Dep't of Health, 954 So. 2d 668 (Fla. 1st DCA 2007). In Barr, the court ruled that a dentist, who had satisfied the standard of care, could not be found guilty of failing to meet the standard of care on the basis of a medical-records violation.
As Petitioner's expert witness complained, incomplete or absent medical records may frustrate Petitioner in trying to establish a standard-of-care violation, as medical records are a source of evidence on which Petitioner may rely in proving a standard-of-care violation. In this case, the medical records provide much of the proof of random treatment patterns for D. H. and the failure to treat underlying conditions revealed by the
aberrant behavior of R. H., K. L., and K. G. But the standard- of-care violations involving these four patients are not merely a restatement of the medical-records violations.
The ultimate responsibility for determining whether a practitioner has violated the statutes and rules, as well as for identifying a reasonable standard of care, is a conclusion of law to be determined by the Board of Medicine. § 456.073(5), Fla. Stat. The effect of section 456.073(5) is to assign to the Board of Medicine, rather than the Administrative Law Judge, the responsibility of ultimate factfinding as to the identification of the standard of care and whether a practitioner has violated it.
This statutory allocation of the responsibility for identifying a standard of care probably did not effect much of a change in existing case law. In S. Fla. Cargo Carriers Ass'n v. Dep't of Bus. & Prof'l Reg., 738 So. 2d 391, 394 (Fla. 3d DCA 1999), the court distinguished between evidentiary findings and ultimate factual findings, which usually resolve the legal issues. Citing McDonald v. Dep't of Banking & Fin., 346 So. 2d 569, 579 (Fla. 1st DCA 1977), the Cargo Carriers court reasoned that greater agency deference attaches to ultimate findings calling for agency expertise. As the McDonald court noted: "The displaced findings of [the] hearing officer . . . lessen in probative force as the 'facts' blur into opinions and opinions
into policies, and the Department's power to substitute findings based on record evidence correspondingly increases." Id. at
593.
However, this allocation of responsibility between
the Administrative Law Judge and the Board of Medicine for identifying the standard of care may not relieve the Board of Medicine of the necessity of basing its conclusions on the existing record in a given case. For example, in tort law, the plaintiff must prove the "foundation facts," on which the finder of fact may rely in determining whether a physician met the standard of care. See, e.g., Posner v. Walker, 930 So. 2d 659, 665 (Fla. 3d DCA 2006) (citing Harris v. Josephs of Greater Miami, Inc., 122 So. 2d 561, 562 (Fla. 1960)). Even though the statute designates the identification of the standard of care as a conclusion of law, section 456.073(5) probably does not authorize the Board of Medicine, without any support from the record or notice to the practitioner, to identify a standard of care and conclude that a practitioner has violated it.
A clearer, more thoughtful and more cogent performance by Petitioner's expert witness would have provided more visible record support for the standard of care, and a violation thereof, that have been determined in this Recommended Order. However, the standard of care and its violation, as described in this Recommended Order, are sufficiently supported
by the record to meet the requirements set forth in the preceding paragraph for identifying a standard of care and determining its violation.
As derived from sections 456.50 and 766.102, cited above, the standard of care is necessarily flexible to accommodate the myriad factual scenarios confronted by a practitioner and ongoing developments in medical science and technology. But, by definition, it is a minimal practice standard, below which a practitioner may not lawfully practice, contrary to some careless testimony of Petitioner's expert witness, as noted above. The first two sentences of rule 64B8- 9.013(1)(f), which allow some deviation from the standards of rule 64B-9.013, do not justify a failure to meet the applicable standard of care. Especially when read in conjunction with the remainder of rule 64B8-9.013(1)(f), these two sentences underscore the flexibility that must be inherent in identifying a standard of care for practitioners prescribing opioids for pain relief--a standard that must account for, among other things, the treatment outcome and functional level of the patient.
In their present form, the care standards of rule 64B8-9.013(3)(a)-(d) generally lack the enforceable quality of the records standards of rule 64B8-9.013(3)(f) due to the former's use of "should" and the latter's use of "shall." The
Board of Medicine has proposed a rule amendment to address this matter. Fla. Admin. Wkly, Vol. 30, No. 33, pp. 3895-96 (Aug.
20, 2010).
But the limitations of rule 64B8-9.013(3)(a)-(d) in serving as an enforceable statement of the standard of care do not prevent the identification of the standard of care in this case. As Petitioner's expert witness and rule 64B8-9.013(1)(g) assure, no standard-of-care violation may be predicated merely on the basis of the number of opioids prescribed to a patient. As in all cases, the standard of care for the appropriate, justified prescription of opioids requires consideration of all relevant factors, including the number of opioids prescribed to the patient, the pain levels of the patient during the course of the treatment, the availability of other pain treatments, the availability of treatment for the conditions or injuries causing the pain, the extent to which the subject physician is reasonably assured that the patient is not engaged in aberrant behavior by diverting the prescribed opioids or consuming opioids from other sources unknown to the subject physician, the restoration or maintenance of the patient's function, and the outcome of treatment.
For D. M., the standard of care precludes the prescription of the quantity of opioids that Respondent prescribed as part of the delivery of random treatment in place
of effective treatment. For R. H., K. L., and K. G., the standard of care precludes the prescription of the quantity of opioids that Respondent prescribed while Respondent ignored substance-abuse issues that directly jeopardized each patient's health and posed unreasonably high risks of patient diversion.
As Respondent knew, R. H. lied to another health care provider and concealed opioid prescriptions, and she required her mother to prevent her from overusing or diverting her prescribed opioids. On these facts, the standard of care was violated when Respondent prescribed R. H. vast increases in opioids without any increases in reported pain and when he failed to ensure that R. H. either eliminate her obvious problem with opioids or taper her off in preparation for dismissal as a patient.
Respondent continued to prescribe K. L. thousands of roxicodone pills while his urinalyses kept revealing other opioids. The standard of care was violated when Respondent kept prescribing K. L. large quantities of opioids, knowing that he had other opioids in his system, but not knowing the level of other opioids in K. L.'s system. Alternatively, Respondent could have required K. L. to eliminate his obvious problem with opioids or taper him off in preparation for dismissal as a patient.
Respondent continued to prescribe K. G. with opioids despite Respondent's knowledge that K. G. illegally purchased and consumed Oxycontin® on the street, misused Suboxone® as a substitute for roxicodone, refused to follow up on a referral to an orthopedist who might have been able to treat the condition causing the pain from which K. G. suffered, and quit seeing Respondent when he put K. G. on probation. When Respondent immediately resumed treating K. G. on his return, the patient, not the physician, seemed to be in charge of the opioid treatment being prescribed by Respondent.
Respondent's expert witness alluded to an evolving standard of care in pain medicine. Of course, the standard of care evolves, as dictated by advances in medical science and technology, as well as other relevant circumstances. But recent legal restrictions on the prescribing of opioids for pain do not preclude an earlier standard of care imposing meaningful restrictions on the prescribing of opioids for the safety of the patient under treatment and the public. The dangers of opioids have been widely recognized for over 100 years, and meaningful restrictions have been imposed on their use for at least the past 60 years. These facts were available, during the relevant treatment periods, to inform the extent to which the standard of care required urinalyses, depending on the circumstances of the patient, and required Respondent to take meaningful action,
depending on the outcomes of urinalyses and the circumstances of the patient.
For R. H., K. L., and K. G., the standard of care required the administration of multiple urinalyses, while these patients were treated by Respondent, to determine if Respondent could safely prescribe opioids to them without fear of diversion or excessive consumption due to the consumption of other opioids unknown to Respondent. And the standard of care required that Respondent act on what he learned in terms of the consumption of other opioids by ensuring that the patients discontinued the use of other opioids or by tapering them off their prescribed opioids, referring them to counseling, and dismissing them as patients until they were willing and able to proceed as compliant patients.
On the other hand, the standard of care less clearly required or requires the same treatment of a patient whose only aberrant behavior is the use of marijuana. In one respect, this behavior raises a safety issue because a patient willing to disregard society's drug laws as to one drug may be willing to disregard these laws as to other drugs. In another respect, though, this behavior is very different from aberrant behavior involving other opioids. The present record reveals mortal dangers to the patient from the combination of opioids with
other opioids and opioids with benzodiazepines and muscle relaxants, but not opioids with marijuana.
J. M. squarely raises this issue. He has the most extensively imaged source of pain, consistently consumed marijuana, and was not otherwise guilty of aberrant behavior, except for sampling his girlfriend's Xanax®. Where there is no demonstrated risk of opioid overdose from the illegal substance that the patient is consuming and there is considerable evidence of the sources of his pain, the standard of care should not require a physician to dismiss the patient if he does not stop his consumption of marijuana.
Section 456.072(2) provides:
When the board, or the department when there is no board, finds any person guilty of the grounds set forth in subsection (1) or of any grounds set forth in the applicable practice act, including conduct constituting a substantial violation of subsection (1) or a violation of the applicable practice act which occurred prior to obtaining a license, it may enter an order imposing one or more of the following penalties:
Refusal to certify, or to certify with restrictions, an application for a license.
Suspension or permanent revocation of a license.
Restriction of practice or license, including, but not limited to, restricting the licensee from practicing in certain settings, restricting the licensee to work only under designated conditions or in certain settings, restricting the licensee from performing or providing designated
clinical and administrative services, restricting the licensee from practicing more than a designated number of hours, or any other restriction found to be necessary for the protection of the public health, safety, and welfare.
Imposition of an administrative fine not to exceed $10,000 for each count or separate offense. If the violation is for fraud or making a false or fraudulent representation, the board, or the department if there is no board, must impose a fine of
$10,000 per count or offense.
Issuance of a reprimand or letter of concern.
Placement of the licensee on probation for a period of time and subject to such conditions as the board, or the department when there is no board, may specify. Those conditions may include, but are not limited to, requiring the licensee to undergo treatment, attend continuing education courses, submit to be reexamined, work under the supervision of another licensee, or satisfy any terms which are reasonably tailored to the violations found.
Corrective action.
Imposition of an administrative fine in accordance with s. 381.0261 for violations regarding patient rights.
Refund of fees billed and collected from the patient or a third party on behalf of the patient.
Requirement that the practitioner undergo remedial education.
In determining what action is appropriate, the board, or department when there is no board, must first consider what sanctions are necessary to protect the public or to compensate the patient. Only after those sanctions have been imposed may the disciplining authority consider and include in the order requirements designed to rehabilitate the practitioner. All costs associated with compliance with orders
issued under this subsection are the obligation of the practitioner.
Florida Administrative Code Rule 64B8-8.001(2)(m) provides that, for a first offense for failure to keep medical records, the penalty range is reprimand to two years' suspension following by probation, 50-100 hours' community service, and an administrative fine of $1000-$10,000. For a second offense, the rule provides that the penalty range is probation to suspension, 100-200 hours' community service, and an administrative fine of
$5000-$10,000.
Rule 64B8-8.001(2)(t) provides that, for a first offense for a violation of the standard of care, the penalty range is from one year's probation, 50-100 hours' community service, to revocation and an administrative fine of $1000-
$10,000. For a second offense, the rule provides that the penalty range is two years' probation, 100-200 hours' community service, to revocation and an administrative fine of $5000-
$10,000.
Rule 64B8-8.001(1) authorizes higher penalties for multiple counts of the violated provisions. Rule 64B8-8.001(3) recognizes among aggravating and mitigating conditions the exposure of the patient or public to injury, the number of counts, the number of times that the licensee has committed the
same offense, and the licensee's disciplinary history and length of practice.
The two disciplinary events in the relatively long practice history of Respondent almost balance out to neutral, so this is a minor aggravating factor. There is affirmative evidence of some good that Respondent did for W. C. and D. D.
As to the other patients, there is no evidence of loss of function or injury as a result of Respondent's failures.
The nine medical-records violations warrant administrative fines of $67,500, costs, six months' suspension,
50 hours' community service, some coursework in keeping medical records, and one year's probation after completion of the suspension. This is the second time that Respondent has been guilty of a medical-records violation. A sizeable fine and short suspension improve the odds that he will absorb the lessons of the coursework this time.
The penalty for the four standard-of-care violations is more difficult to assess. In different ways, Respondent essentially failed to treat each of these four patients. But the violation as to D. M. is less serious than the violations as to R. H., K. L., and K. G. An elevated risk of opioid diversion or excessive opioid consumption exists as to each of these three patients. How much of an elevated risk is impossible to determine. But, for each of these three patients, Respondent
displayed a distinct lack of diligence in addressing clear evidence of dangerous aberrant behavior. By doing so, he failed to treat adequately and safely these three patients, and he failed to take adequate precautions against the diversion of dangerous drugs. These are the three most serious aggravating factors.
The four standard-of-care violations warrant administrative fines of $40,000, costs, three and one-half years' suspension to be served consecutively with the six months' suspension for the medical-records violations, 150 hours' community service, five years' probation to be served consecutively with the probation for the medical-records violations, such restrictions on his license thereafter as the Board of Medicine deems prudent and for as long as the Board of Medicine deems prudent, and such educational courses in the prescription of controlled substances, including the handling of patients with aberrant behavior, as the Board of Medicine may require.
It is
RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of nine counts of medical-records violations and four counts of standard-of-care violations and imposing $107,500 in administrative fines, four years'
suspension from the practice of medicine, 200 hours' community service, six years' probation after completion of the suspension, restrictions upon Respondent's license after it is reinstated, coursework, and costs.
DONE AND ENTERED this 23rd day of June, 2011, in Tallahassee, Leon County, Florida.
S
ROBERT E. MEALE
Administrative Law Judge
Division of Administrative Hearings The DeSoto Building
1230 Apalachee Parkway
Tallahassee, Florida 32399-3060
(850) 488-9675 SUNCOM 278-9675
Fax Filing (850) 921-6847 www.doah.state.fl.us
Filed with the Clerk of the Division of Administrative Hearings this 23rd day of June, 2011.
COPIES FURNISHED:
Shirley L. Bates, Esquire Grace Kim, Esquire Department of Health
4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399-1701
Sean Michael Ellsworth, Esquire Ellsworth Law Firm, P.A.
1501 Collins Avenue, Suite 208 Miami Beach, Florida 33139
Renee Alsobrook, Acting General Counsel Department of Health
4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Larry McPherson, Jr., Executive Director Board of Medicine
Department of Health 4052 Bald Cypress Way
Tallahassee, Florida 32399
NOTICE OF RIGHT TO SUBMIT EXCEPTIONS
All parties have the right to submit written exceptions within
15 days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the Final Order in this case.
| Issue Date | Document | Summary |
|---|---|---|
| Aug. 25, 2011 | Agency Final Order | |
| Jun. 23, 2011 | Recommended Order | Discipline for 9 counts of medical-records violations and 4 counts of standard-of-care violations by physician prescribing opioids for treatment of pain. |
BOARD OF MEDICAL EXAMINERS vs. TARIQUE HUSSAM ABDULLAH, 10-009430PL (2010)
DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs DONALD A. TOBKIN, M.D., 10-009430PL (2010)
DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs JEROME F. WATERS, M.D., 10-009430PL (2010)
DEPARTMENT OF HEALTH, BOARD OF CHIROPRACTIC vs LESLIE PACHTER, D.C., 10-009430PL (2010)
