# Larry C. Daniels, M.D.; Decision and Order

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A2021-24206

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** November 5, 2021
- **Citation:** 86 FR 61630

## Text

DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 19-33]
Larry C. Daniels, M.D.; Decision and Order

On June 21, 2019, a former Assistant Administrator of Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to Larry C. Daniels M.D., (hereinafter, Respondent or Dr. Daniels) of Shreveport, Louisiana. Administrative Law Judge Exhibit (ALJ-- 1, (OSC) at 1. The OSC proposed to deny his pending application No. W18024499C for a DEA Certificate of Registration (hereinafter, COR or registration) pursuant to 21 U.S.C. 823(f) and 824(a)(1) for the reason that Respondent's “registration would be inconsistent with the public interest,” and because he “materially falsified [his] application for registration.”
Id.

In response to the OSC, Respondent requested a hearing before an Administrative Law Judge. ALJ-2. The hearing in this matter was held in Shreveport, Louisiana on November 13-15, 2019. On January 24, 2020, Administrative Law Judge Charles Wm. Dorman (hereinafter, the ALJ) issued Recommended Rulings, Findings of Fact, Conclusions of Law and Decision (hereinafter, Recommended Decision or RD), and on February 11, 2020, the Respondent filed exceptions (hereinafter, Resp Exceptions) to the Recommended Decision. The Government filed exceptions (hereinafter, Govt Exceptions) to the Recommended Decision on February 13, 2020. I address the Government's Exceptions, which were limited to the material falsification allegations, in the RD at Section Analysis.III. I address the Respondent's Exceptions, which were focused on the ALJ's finding that Dr. Daniels had not accepted responsibility and his recommended sanction, in the Sanction Section, and I issue the final order in this case following the RD. The ALJ transmitted the record to me on February 19, 2020. Having reviewed the entire record, I adopt the ALJ's rulings, findings of fact, as modified, conclusions of law and recommended sanction with minor modifications, where noted herein.
*A

*A
I have made minor modifications to the RD. I have substituted initials or titles for the names of witnesses and patients to protect their privacy and I have made minor, nonsubstantive, grammatical changes and nonsubstantive, conforming edits. Where I have made substantive changes, omitted language for brevity or relevance, or where I have added to or modified the ALJ's opinion, I have noted the edits with an asterisk, and I have included specific descriptions of the modifications in brackets following the asterisk or in footnotes marked with a letter and an asterisk. Within those brackets and footnotes, the use of the personal pronoun “I” refers to myself—the Administrator.

Joshua H. Packman, Esq. and David M. Locher, Esq. for the Government

Sam L. Jenkins, Jr., Esq. for the Respondent

Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision

*B
The issue

before the Administrator is whether the record as a whole establishes b a preponderance of the evidence thatg the DEA should den the application for a Certificate of Registration of Larr C. Daniels, M.D., Application Number W18024499C, pursuant to 21 UJ.SC. §§ 823(f) and 824(a)(1) and (a)(4), because he materiall falsified his application and because granting him a registration would be inconsistent with the public interest. ALJ-7.

*B
I have submitted the RD's discussion of the procedural histor to avoid repetition with m introduction.

In issuing this Recommended Decision, I have considered the entire Administrative Record, including all of the testimony, admitted exhibits, and the oral and written arguments of counsel.

The Allegations

Material Falsification

1. On March 12, 2018, the Louisiana State Board of Medical Examiners (“the Board”) issued a Consent Order that “imposed a continuing restriction on [Dr. Daniels'] ability to practice medicine and to prescribe controlled substances for pain management or addiction treatment.” ALJ-1, at 3-4, para. 8(c). Dr. Daniels' application for a DEA certificate of registration, dated March 16, 2018, failed to disclose the restriction imposed by the Board's Consent Order on his Louisiana state controlled substance license.
Id.
at 3-4, paras. 8-9. Dr. Daniels' failure to disclose the restriction imposed by the Board's Consent Order on his state controlled substance license constitutes a material falsification of his application for DEA registration, in violation of 21 U.S.C. 824(a)(1).
Id.

Addiction Treatment

2. Between May 2016 and September 2017, Dr. Daniels prescribed controlled substances to patients AK, CA, MN, JD, SB, and CM. ALJ-1, at 4, paras. 10-12. Dr. Daniels' prescriptions for controlled substances to these patients exhibited the following deficiencies:

a. Dr. Daniels failed to conduct a physical examination of any of these patients;

b. Dr. Daniels failed to request these patients' medical records concerning prior substance abuse or past treatment of substance abuse;

c. Dr. Daniels failed to obtain a report from the Louisiana Prescription Monitoring Program for any of these patients;

d. Dr. Daniels failed to address in these patients' medical records the results of abnormal urine drug screens, to include results that were positive for illicit substances and negative for substances that Dr. Daniels prescribed;

e. Dr. Daniels failed to document in these patients' medical records his rationale for his medical treatment of these patients, to include his reason for initiating buprenorphine treatment at high dosages. ALJ-1, at 5, para. 12(a)-(e).

3. In addition, Dr. Daniels issued to patients AK, CA, MN, SB, and CM, prescriptions for both buprenorphine (Subutex) and clonazepam. ALJ-1, at 5, para. 13. Prescribing these controlled substances to a patient at the same time can pose potential risks for that patient.
Id.
Dr. Daniels failed to document in the patients' medical records any rationale that justified prescribing buprenorphine and clonazepam at the same time.
Id.
Dr. Daniels also failed to document in the patients' medical records that he discussed with them the risks of taking these controlled substances at the same time.
Id.
Specifically, Dr. Daniels issued the following prescriptions in violation of state and federal law:

a. Between January 2017 and August 2017, Dr. Daniels prescribed AK buprenorphine (Subutex) on nine occasions and clonazepam (Klonopin) on at least eight of those occasions. ALJ-1, at 5, para. 14(a).

b. Between June 2016 and September 2017, Dr. Daniels prescribed CA buprenorphine (Subutex) and clonazepam (Klonopin) on at least 19 occasions, an amphetamine-dextroamphetamine mixture (Adderall) on 18 of those occasions.
Id.
at 6, para. 14(b). Dr. Daniels failed to document in CA's medical record any rationale for prescribing Adderall to CA.
Id.
at 6, para. 14(b)(i).

c. Between May 2017 and August 2017, Dr. Daniels prescribed MN buprenorphine (Subutex) and clonazepam (Klonopin) on at least five occasions.
Id.
at 6, para. 14(c).

d. Between August 2016 and August 2017, Dr. Daniels prescribed JD buprenorphine (Subutex) on at least 15 occasions.
Id.
at 6, para. 14(d).

e. Between January 2017 and July 2017, Dr. Daniels prescribed SB

buprenorphine (Subutex) and clonazepam (Klonopin) on at least seven occasions.
Id.
at 6, para. 14(e).

f. Between May 2016 and September 2017, Dr. Daniels prescribed CM buprenorphine (Subutex) on at least 18 occasions and clonazepam (Klonopin) on 10 of those occasions.
Id.
at 6, para. 14(f).

4. For the reasons listed in Allegations 2 and 3, the prescriptions that Dr. Daniels issued to AK, CA, MN, JD, SB, and CM, were beneath the standard of care for the practice of medicine in Louisiana, outside the usual course of professional practice, and not for a legitimate medical purpose, in violation of 21 U.S.C. 841(a), 842(a); 21 CFR 1306.04(a); La. Admin. Code tit. 46, Pt. LIII, § 2745(B)(1); La. Admin. Code tit. 46, Pt. XLV, §§ 6919, 6921; and La. Admin. Code tit. 48, Pt. I, §§ 5637, 5647, 5723, 5725, 5731. ALJ-1, at 4-6, paras. 10-15.

Pain Management

5. Dr. Daniels issued controlled substance prescriptions for pain management to JW that exhibited the following deficiencies:

a. Dr. Daniels' records for follow-up visits with JW lack any indicia of a meaningful doctor-patient relationship, because the physical examination records for JW are incomplete, cursory, non-diagnostic, non-contributory, and/or lack notations of vital signs. ALJ-1, at 6, para. 16(a).

b. Dr. Daniels duplicated the therapeutic effect of the opioids he prescribed to JW by prescribing JW oxycodone-acetaminophen (Percocet), oxycodone extended release (OxyContin), and hydrocodone-acetaminophen (Lortab), after initially prescribing him methadone.
Id.
at 6, para. 16(b). Therapeutic duplication increases the risk of unintentional overdose.
Id.

c. Between March 2014 and January 2017, Dr. Daniels prescribed JW OxyContin and methadone at the same time.
Id.
at 7, para. 16(c). In July 2014, Dr. Daniels prescribed JW Percocet and Lortab at the same time.
Id.
Dr. Daniels failed to document in JW's medical records any justification for these prescriptions.
Id.
at 7, para. 16(d).

d. In addition, Dr. Daniels failed to document in JW's medical records any justification for increasing JW's monthly methadone prescription in January 2016 from 150 units of methadone 10 mg to 180 units.
Id.
at 7, para. 16(d).

e. Between August 2013 and April 2017, Dr. Daniels issued to JW at least 56 prescriptions for Percocet; 7 prescriptions for OxyContin (5 at the same time as Percocet); and 1 prescription for Lortab. ALJ-1, at 7, para. 17.

f. Between January 2016 and March 2017, Dr. Daniels issued to JW at least 15 prescriptions for methadone at the increased dosage of 180 units, 5 at the same time as prescriptions for Percocet.
Id.
at 7, para. 17.

6. For the reasons listed in Allegation 5, the prescriptions that Dr. Daniels issued to JW were beneath the standard of care for the practice of medicine in Louisiana, outside the usual course of professional practice, and not for a legitimate medical purpose, in violation of 21 U.S.C. 841(a), 842(a); 21 CFR 1306.04(a); La. Admin. Code tit. 46, Pt. LIII, § 2745(B)(1); and La. Admin. Code tit. 46, Pt. XLV, §§ 6919, 6921. ALJ-1, at 6-7, paras. 16-17.

Undercover Officer (“TC”)

7. On September 13, 2017, Dr. Daniels prescribed 60 units of Suboxone (buprenorphine/naloxone) 8/2 mg to TC. ALJ-1, at 7, para. 18. Among other issues, this prescription exhibited the following deficiencies:

a. Dr. Daniels failed to conduct a physical examination of TC;

b. Dr. Daniels failed to request any medical records of TC's prior substance abuse or past treatment for substance abuse;

c. Dr. Daniels failed to obtain a *[Prescription Monitoring Program (hereinafter,] PMP) report for TC.
Id.
at 7, para. 19.

8. Furthermore, Dr. Daniels initiated Suboxone treatment for TC at 16/4 mg per day despite TC's negative urine drug screen; TC's report to Dr. Daniels that he had not taken any opioids for two-to-three weeks; and Dr. Daniels' recognition that TC's presentment of addiction was not severe. ALJ-1, at 8, para. 19.

9. Dr. Daniels' medical records for TC fail to provide adequate information about Dr. Daniels' evaluation and treatment plan for TC, and are so cursory that they lack credibility. ALJ-1, at 8, para. 19.

10. For the reasons listed in Allegations 7-9, the prescription that Dr. Daniels issued to TC was beneath the standard of care for the practice of medicine in Louisiana and outside the usual course of professional practice, in violation of 21 U.S.C. 841(a) and 842(a); 21 CFR 1306.04(a); and La. Admin. Code tit. 46, Pt. LIII, § 2745(B)(1). ALJ-1, at 8, para. 19.

Witnesses

I. The Government's Witnesses

The Government presented its case through the testimony of three witnesses. The Government first presented the testimony of a Diversion Investigator (“the DI”). Tr. 25-72. The DI also testified as a rebuttal witness. Tr. 588-99.

This witness has been a Diversion Investigator for 11 years. Tr. 26. She briefly testified concerning her work history with the DEA and her training. Tr. 26-28. The DI became familiar with Dr. Daniels after the Shreveport Resident Office of the DEA received information that Dr. Daniels was prescribing excessive amounts of controlled substances. Tr. 28.

The DI reviewed the Consent Order (“the Order”) issued to Dr. Daniels by the Louisiana State Board of Medical Examiners (“the Board”), highlighting restrictions placed on Dr. Daniels' ability to practice medicine by that Order. Tr. 33-34. The DI then reviewed Dr. Daniels' application for a DEA Certificate of Registration, noting that he had provided affirmative answers to two of the liability questions on the application. Tr. 38-39. The DI testified that had Dr. Daniels provided information that was more consistent with the content of the Order, that that information would have been relevant in assisting the DEA when making a decision about what action to take on Dr. Daniels' application. Tr. 39-41. *[The DI stated that the Order was “ambiguous” and that “it's a requirement for the registrant to notify DEA that he has specific restrictions as in reference to controlled substances.” Tr. 65;
see also
Tr. 72.] *[The DI testified that] the application itself, however, does not inform an applicant to provide the *[incident result] information that the DI asserted was missing from Dr. Daniels' application, which *[DEA alleged] constituted a material misrepresentation. [Tr. 70]. The information Dr. Daniels provided on his application, however, placed the DEA on notice that it should not summarily approve Dr. Daniels' application, but rather DEA should investigate it. Tr. 71.

Testifying as a rebuttal witness, the DI identified Government Exhibit 29 as a subpoena issued to the Louisiana Board of Pharmacy's Prescription Monitoring Program. Tr. 590. She also identified Government Exhibit 30 as the response to Government Exhibit 29. Tr. 593. In response to the subpoena, the Board of Pharmacy produced a 20-page history of Dr. Daniels' logins to the Louisiana PMP from June 2, 2016, through September 9, 2019. Tr. 593, 599. The history showed that Dr. Daniels had queried the PMP with respect to only two of the named patients in the OSC, patients TC and CA. Tr. 597. Both inquiries were made on September 13, 2017. Tr. 598.

During the Government's case-in-chief, and as a rebuttal witness, the DI presented her testimony in a professional, clear, and concise manner, and her demeanor was appropriate. Accordingly, I fully credit her testimony.

The Government's second witness was Task Force Officer (“TC”), a detective with the DeSoto Parish Sheriff's Office. Tr. 73-104. TC provided a brief overview of his law enforcement training. Tr. 74-76. He became aware of Dr. Daniels during undercover operations, in which he went to the doctor's office. Tr. 76. TC went to Dr. Daniels' office twice in September 2017, and made audio and video recordings during each visit. Tr. 76-77, 80; GE-24, 27. TC testified that Government Exhibit 24 is a complete and accurate recording of his visit with Dr. Daniels on September 13, 2017. Tr. 85.

TC detailed what happened during his visit to the clinic on September 12, 2017. Tr. 77-80. During that visit, TC provided a urine sample, his vitals were taken, and he talked with a counselor.
Id.
The details of what he told the counselor are documented in the counselor's notes. Tr. 87; GE-23, at 2-6. TC's urine screen was negative. Tr. 89; GE-23, at 9.

TC also detailed what happened when he returned to the clinic on September 13, 2017. Tr. 80-85. During that visit, he informed Dr. Daniels of his prior use of Lortab, Percocet, Adderall, and Suboxone, which he obtained “off the street.” Tr. 82-84. He also told Dr. Daniels that he drank alcohol. Tr. 82. Dr. Daniels did not caution TC about combining medications with each other or with alcohol and he did not physically examine TC. Tr. 82-84; GE-25. TC left the appointment with a prescription for Suboxone that Dr. Daniels issued to him. Tr. 85; GE-23, at 1.

TC presented his testimony in a professional, clear, and concise manner. In addition, his testimony was consistent with other evidence of record. Accordingly, I credit his testimony.

The third witness called by the Government was its expert, Dr. Gene Kennedy, M.D. He testified during the Government's case-in-chief, Tr. 106-416, and as a rebuttal witness. Tr. 600-04.

Dr. Kennedy currently maintains his own pain practice, Island Pain Care, on St. Simon's Island, Georgia. Tr. 107. He detailed his education, training, and professional experience. Tr. 107-111. Dr. Kennedy graduated from LSU with a degree in biology. Tr. 107. He obtained his medical degree from New York Medical College, and he then did a residency in family medicine in Wheeling, West Virginia, and then practiced family medicine in Ohio for many years.
Id.
In 2000, Dr. Kennedy relocated to Georgia. Tr. 109. Dr. Kennedy has been involved in pain management since his residency because a lot of family practice deals with pain management.
Id.
Dr. Kennedy opened his pain management clinic in 2004-05. Dr. Kennedy also treats patients who have substance abuse disorders, and he prescribes Suboxone to them. Tr. 109-10. Dr. Kennedy has a DEA Certificate of Registration, which includes an “X” number. Tr. 111. Dr. Kennedy identified Government Exhibit 26 as his resume. Tr. 111-12. Dr. Kennedy lectures on the differences between legitimate and illegitimate prescribing of controlled substances. Tr. 114-15. He has also testified as an expert witness at administrative hearings, and in both civil and criminal cases. Tr. 115. Dr. Kennedy testified that the standard of care that a doctor needs to meet is, for the most part, standard across the country, recognizing that individual states may have individual requirements. Tr. 119-34. *[ He further testified that “there are individual variations with states, and understanding that nobody's medical records are perfect then you analyze the chart and apply the regulations as best you reasonably can when doing a review.” Tr. 120.]

There being no objection
*C

raised by Dr. Daniels, I accepted Dr. Kennedy as an expert in the areas of addiction treatment, pain management, and the standard of care for prescribing controlled substances for addiction treatment, and for pain management in the State of Louisiana. Tr. 134, 140.

*C
Despite not raising objections at the hearing, Dr. Daniels suggests in his posthearing brief that Dr. Kennedy's testimony should be considered in light of the fact that he “has never practiced medicine in the State of Louisiana.” Respondent's Posthearing, at 4. In this case, I find that Dr. Kennedy primarily relied on Louisiana law and regulations to formulate his opinion regarding the standard of care and usual course of professional practice and the laws provide extremely strong support for his testimony.
See infra
Analysis.V.

Dr. Kennedy testified that the standard of care for prescribing controlled substances for the treatment of chemical dependency requires: An adequate physical examination; obtaining a medical history and past medical records; obtaining PMP reports; conducting drug screening; and maintaining complete and accurate medical records. Tr. 141-51. Dr. Kennedy recognized that no doctor can document everything that occurs during a patient encounter, but the doctor should document the important, pertinent information such that it will give a picture of what happened during the encounter to an objective reviewer of those records. Tr. 151-52. Dr. Kennedy also acknowledged that a reviewer of medical records must keep an open mind, and, at times, afford the treating doctor the benefit of the doubt. Tr. 153, 294, 296-98, 336.

In preparation for his testimony, Dr. Kennedy reviewed the medical records and the PMP reports of the patients identified in the Order to Show Cause. Tr. 159. In rendering his opinions concerning the prescriptions he reviewed, Dr. Kennedy noted that “rarely is [his opinion] based on a single thing,” rather it is developed after reviewing medical records and “[i]t reaches a point where . . . it's simply not possible to say that what I'm looking at is credible medical care.” Tr. 195. Dr. Kennedy further noted that accidents do happen in medical records, “but when you have a repetitive pattern of medical records missing critical information, it's not excusable.” Tr. 295. With respect to treatment plans, Dr. Kennedy testified that he does not criticize a treatment plan “as long as I can determine that there is a rationale behind it.” Tr. 298.

Dr. Kennedy proceeded to review the patient files contained in this case, and rendered his opinion that most of the prescriptions identified in the Order to Show Cause, written by Dr. Daniels, were issued outside the usual or acceptable course of professional medical practice and were not issued for legitimate medical purposes. Tr. 191-92, 206, 220, 231, 238, 244, 255, 261, 266, 278-83, 372-73. As a rebuttal witness, Dr. Kennedy slightly modified his testimony concerning Dr. Daniels' treatment of patient TC. Tr. 601-04. While Dr. Kennedy's opinion had not changed as to whether the prescription that Dr. Daniels issued to TC was outside the standard of care, and outside the usual course of professional practice, Tr. 602-03, he testified that Dr. Daniels may have believed he had a legitimate medical purpose to issue the prescription. Tr. 602. Concerning the question of “whether or not it was issued for a legitimate medical purpose,” Dr. Kennedy testified that he “would have to go over everything again to make a final decision . . . .” Tr. 602.
*D

*D
Ultimately, I find that the distinction that Dr. Kennedy makes here with regard to whether the prescription had a legitimate medical purpose is not entirely relevant considering Louisiana law and the CSA regulations. As explained below, Louisiana law mirrors the DEA regulations in providing that “[a]n order purporting to be a prescription issued

not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of the Controlled Substances Act.” La. Admin. Code tit. 46, Pt. LIII, § 2745(B)(1);
see also
21 CFR 1306.04(a) (same). Therefore, the fact that Dr. Kennedy had concluded that this prescription was issued outside the usual course of professional treatment and beneath the standard of care, Tr. 602-03, demonstrates that there was a violation of law for the purpose of consideration under Factor Four of the public interest factors.
See infra
Analysis.V (Patient TC);
infra
n.27;
see also Ester Mark, M.D.,
16,760, 16,778 (citing
Wesley Pope, M.D.,
82 FR 14,944, 14,967 n.38 (2017) (explaining “there is no material difference between” the dual criteria of Section 1306.04(a).”) Prescribing a controlled substance outside the course of professional practice is enough to violate DEA's prescription requirement.
Id.

Dr. Kennedy presented his testimony in a professional, candid, and straightforward manner. He also presented his testimony in an objective manner, and as a witness who had no stake in the outcome of the case. In addition, the testimony of Dr. Kennedy was sufficiently detailed, plausible, and internally consistent. Furthermore, Dr. Kennedy's testimony went unrebutted.
1

Therefore, I merit it as fully credible in this Recommended Decision.

1
“When an administrative tribunal elects to disregard the uncontradicted opinion of an expert, it runs the risk of improperly declaring itself as an interpreter of medical knowledge.”
Zvi H. Perper, M.D.,
77 FR 64131, 64140 (2012) (citing
Ross
v.
Gardner,
365 F.2d 554 (6th Cir. 1966)).

II. Respondent's Witnesses

Respondent presented his case through the testimony of two witnesses. The Respondent's first witness was LW (“LW”). Tr. 418-69. LW was the owner of the Medical Clinic (“the Clinic”) where Dr. Daniels worked. Tr. 419. The Clinic closed on October 3, 2017.
Id.
While in operation, the Clinic provided services for patients who had low, to mid-level incomes, and who were being treated for some kind of opioid addiction. Tr. 421-22. Between January 2016 and April 24, 2017, LW was at the Clinic one evening a week.
Id.
On April 24, 2017, LW started working at the Clinic full time and oversaw its day-to-day operations. Tr. 420. LW is a medical assistant. Tr. 445.

LW provided testimony about how the Clinic operated after April 24, 2017. Tr. 430-31. After that date, Dr. Daniels worked at the Clinic just one evening a week and saw about 25 patients a week. Tr. 424-25. He was the only doctor who worked at the Clinic. Tr. 427. In addition to Dr. Daniels and LW, the Clinic employed five other individuals. Tr. 425-26. LW testified about the duties of those employees. Tr. 428-29, 431-34, 436-41. Each of the employees played a part in assembling the patients' medical records. Tr. 427, 438. LW testified that each new patient submitted to a urine drug screen and that the Clinic checked the patient's PMP. Tr. 442-43, 446. Information about the results of the drug screening and the PMP were provided to Dr. Daniels. Tr. 443. Although LW testified that after she started working at the Clinic full-time, Clinic employees always checked the PMP, she did not know if that information was placed into a patient's medical record. Tr. 448.

In general, I found LW to be a sincere and credible witness who testified about how she thought the Clinic was running after she took over the day-to-day operations. It was also obvious that she has a sincere interest in providing health services to an underserved community. For someone who was overseeing the day-to-day operations of the Clinic, however, her testimony was less than clear about when and how PMPs were run, and how the results of the PMP search and of the urine drug screens were provided to Dr. Daniels. Although she testified that the PMP report was run for each patient, Tr. 442, it was not clear when the clinic ran PMP's on patients. She testified it was run when the patient came in, and it was run after they saw the social worker, “it was run constantly.” Tr. 457-59. Further, LW was not clear on what information from the PMP was shared with Dr. Daniels. Tr. 460-465. In that her testimony about running PMP reports on every patient is directly contradicted by Government Exhibit 30,
2

I give little weight to this testimony. Further, while LW testified that urine drug screens were taken for each patient, Tr. 443, she also testified that the Clinic discovered that the results of those tests were not always in the patients' charts. Tr. 427, 439. I find that LW's testimony about having patients submit to urine drug screening is generally consistent with other evidence of record, namely the large number of drug screening reports that are in the patients' medical records. Thus, with the exception of LW's testimony about PMPs, I give credit to LW's testimony.

2
Government Exhibit 30, however, gives some support to Dr. Daniels' position that he was checking the PMP, *[at least with respect to two of the patients].

Next, Dr. Larry Daniels, M.D., testified on his own behalf. Tr. 475-586. Dr. Daniels worked at the Shreveport Job Corps Center, the Diabetes Management Center, and the Clinic. Tr. 475. Dr. Daniels has practiced medicine in Louisiana since 1983. Tr. 476. He practiced for one year in Houston, Texas, from 1999 to 2000. Tr. 476-77. Dr. Daniels received compensation for his services at the Clinic from the Clinic itself, and not from patients. Tr. 480. Throughout his career, Dr. Daniels has worked for multiple clinics that provide medical services to low-income patients, and he has treated patients who had chemical dependencies. Tr. 482-84. Dr. Daniels worked at the Clinic on Wednesday evenings. Tr. 488. He would normally see about 10-20 patients on those evenings.
Id.

The Clinic was located in Minden, Louisiana, which is a rural area. Tr. 480. Dr. Daniels worked at the David Raines Community Health Center (“Community Health Center”) at the same time that he worked at the Clinic.
Id.
Before working at the Clinic, Dr. Daniels had experience in private practice and at the Community Health Center in treating chemical dependency. Tr. 482.

Dr. Daniels acknowledged that there is information missing from the patients' charts. Tr. 487. Dr. Daniels testified that the patient charts in this case do not include sticky notes and other notes that would have been on the inside of the manila folder that held the charts. Tr. 488. Dr. Daniels testified that a doctor learns the patient's medical history by talking to the patient about his or her past medical conditions and any current problems, to include the patient's chief complaint. Tr. 491. He stated that a doctor also acquires the patient's medical history by discussing the patient's family and social history.
Id.

Dr. Daniels acknowledged that he did not always document the justification for the prescriptions he wrote. Tr. 523. When Dr. Daniels saw a patient at the Clinic, some of the patient's medical history was available on forms that the patient completed before the visit. Tr. 492. He explained that because he has worked in several mental health-counseling clinics, he has gained familiarity and experience in treating certain conditions.
Id.
Dr. Daniels also noted that the Clinic saw an increase in patients when it received its waiver to treat 100 patients. Tr. 489. Previously it only held a waiver for 30 patients.
Id.

Dr. Daniels agreed with Dr. Kennedy's testimony about physical examinations. Tr. 492. Dr. Daniels testified that in situations where there is limited staff and when other patients are waiting, a doctor sometimes needs to make a “judgment call” about examining the patient, and not inconveniencing the waiting patients. Tr. 493. In those situations, in Dr. Daniels' view, the doctor performs “enough of an exam” in order to “move forward” with the patient, allowing the doctor time to see other patients. Tr. 493. Dr. Daniels also testified that a doctor can perform an examination by observing the patient,

and noting the patient's demeanor, activity, mood, and physical appearance. Tr. 493-94. Sometimes, Dr. Daniels decided to do a more thorough physical examination. Tr. 512.

Dr. Daniels testified that in general he would ask each patient: About his or her medication; whether the medication was working; who initially prescribed it; and how long the patient had been taking it. Tr. 517. Similarly, Dr. Daniels testified that the purpose of checking a patient's PMP report was to see which medications, if any, the patient has received before, when the patient received those medications, and the doctors who prescribed them. Tr. 495. Although there is no requirement to print out a copy of a patient's PMP report, Dr. Daniels testified that it would be ideal to obtain a printout. Tr. 496.

Dr. Daniels testified that when searching for a patient on the PMP, he was mostly concerned with looking at the past 30 days. Tr. 496-97. It is normal to delegate the duty to check the PMP to someone other than the doctor. Tr. 497. Normally, a staff member of the Clinic would run a PMP report and provide the results to Dr. Daniels. Tr. 514, 522. The Clinic did not document the results of the PMP report. Tr. 522.

With respect to urine drug screens, Dr. Daniels testified that in most cases he addressed abnormalities with the patient but did not document that fact in the patient's chart. Tr. 498, 502. He acknowledged it would be best practice to document efforts to address an abnormal urine drug screen. Tr. 501. He also acknowledged that “a couple of patients” tested negative for their prescribed medications. Tr. 502. It is unclear, however, whether he was referring to the patients in this case. Testing negative for a prescribed controlled substance raises the concern of diversion.
Id.
When this occurred, he would refer it to the clinical social worker. Tr. 503. These actions, in his opinion, should have been better documented.
Id.

Dr. Daniels testified that the current standard is not to discharge a noncompliant patient. Tr. 499-500. It was unclear from his testimony when this standard began. For example, Dr. Daniels made an analogy to a diabetic patient whose sugars are elevated after not complying with his or her prescribed diet.
Id.
Dr. Daniels said that a doctor would not discharge this patient simply because the patient failed to comply with his or her diet. Tr. 500. According to Dr. Daniels, the same is true for doctors treating patients for chemical dependency.
Id.
He explained that it is better for a patient in the long-term to be kept on medication than to discharge the patient.
Id.
Discharging a patient could lead to a relapse or to the patient taking dangerous street drugs.
Id.
In Dr. Daniels' opinion, none of the patients in this case should have been discharged because of a urine drug screen. Tr. 501-02.

Some of the patients who presented with opioid addiction also had other issues, such as anxiety and depression, and Dr. Daniels had to formulate a treatment plan for those issues as well. Tr. 506. Most of the patients also needed counseling. Tr. 501, 504, 506. If Dr. Daniels was not going to be at the Clinic, he would sometimes write a prescription for the patient and have the staff check the patient's vitals and take a urine drug screen. Tr. 508-10. If the patient was taking Suboxone, Dr. Daniels would discuss the Suboxone treatment regimen plan with the patient. Tr. 516. He would also ask the patient if he or she signed the treatment contract, and whether the patient understood it. Tr. 516. He would only address specific provisions of the treatment contract if he believed there might be a particular issue with the patient's ability to comply with the contract. Tr. 516.

When asked about the physical examination he conducted of patient AK, at AK's first visit on January 18, 2017, Dr. Daniels said he checked-off neat and clean on the record, and noted AK had a depressed affect. Tr. 512; GE-6, at 25. Patient AK also took a urine drug screen at this first visit. Tr. 514; GE-6, at 29. AK's initial urine drug screen was positive for methamphetamine, but not when he returned to the next visit. Tr. 515; GE-6, at 29. It was also positive for marijuana.
Id.
Dr. Daniels testified that he was not concerned when a patient tested positive for THC because “it's so ubiquitous in this population that I see,” and he did not believe it would be unsafe for AK to take marijuana. Tr. 515. Dr. Daniels' treatment plan for AK at the first visit was to conduct monthly and random urine drug screens, provide AK counseling, prescribe Subutex 8 mg TID and Klonopin 2 mg, and have AK return to the Clinic in one month. Tr. 515, 518.

Dr. Daniels could not remember what was found on AK's PMP report, if anything, because AK's PMP results are not documented. Tr. 514. Dr. Daniels testified that he was able to conclude that AK had an opioid addiction based on AK's medical history, the physical examination that Dr. Daniels described, and AK's urine drug screen. Tr. 515. AK also had an anxiety disorder and pain. Tr. 517-18. Dr. Daniels did not see pain recorded in AK's chart. Tr. 517. Dr. Daniels did not see AK's counseling records in his chart. Tr. 515-16. Dr. Daniels testified that the Food and Drug Administration has advised that patients should not be denied Subutex simply because the patient is also taking a benzodiazepine. Tr. 518. In Dr. Daniels' opinion, he believed it was justified to prescribe Subutex and Klonopin to AK because AK had pain and had taken opioids and Klonopin before. Tr. 518. Dr. Daniels acknowledged, however, that AK's chart does not document that AK had taken opioids before *[for a pain condition].
Id.
Dr. Daniels believed prescribing a higher dose of Subutex to AK was warranted because in addition to opioid addiction AK also had pain, and Subutex can be used to relieve pain. Tr. 517-18. In Dr. Daniels' opinion, the prescriptions in Stipulation 17 were written to treat AK's substance abuse disorder, anxiety, and chronic pain. Tr. 520.

On June 22, 2016, patient CA presented with an opioid addiction, and history of abdominal pain, hand fracture, arthritis, anxiety, ADHD, and TMJ. Tr. 521. CA had received Subutex from another doctor for opioid addiction, as well as Adderall for ADHD and Klonopin for anxiety. Tr. 521-22. When asked about the physical examination he conducted of CA, Dr. Daniels testified that he looked at CA's person, place, and orientation; noted that CA's affect was “blunted and flat”; and observed that he was “depressed and anxious.” Tr. 521. Dr. Daniels testified that CA's history, his answers, and his demeanor were consistent with ADHD. Tr. 523. Based on CA's history and Dr. Daniels' examination of CA, he was able to diagnose CA with an opioid addiction, anxiety disorder, and ADHD. Tr. 522. Dr. Daniels testified that CA had received treatment from another provider before CA had seen him. Tr. 528.

Dr. Daniels' treatment plan for CA included monthly urine drug screens, counseling, Subutex at his current dosage, Klonopin 1 mg TID, and Adderall 30 mg. Tr. 523. In Dr. Daniels' opinion, the prescriptions in Stipulation 22 were written to treat CA's diagnosed conditions of opioid addiction, anxiety, chronic abdominal pain, ADHD, and TMJ. Tr. 524; GE-10, at 53.

Patient MN's chief complaint was an addiction to Subutex. Tr. 526. After talking with her, he learned that she had been addicted to other medications as well.
Id.
MN had already been prescribed Subutex for opioid dependence by other doctors before seeing Dr. Daniels. Tr. 528-29. MN also had anxiety. Tr. 529. Dr. Daniels' chart for MN included a note that Suboxone

gave her migraines. Tr. 527; GE-14, at 29. Dr. Daniels described it as “a very limited note,” but explained that “sometimes with interruptions in the clinic, you get limited information to put in the chart.” Tr. 527.

When asked whether he physically encountered MN, Dr. Daniels said that he did not “see a document of physical encounter.” Tr. 527. Dr. Daniels testified, however, that he did see MN, and he did conduct a physical examination. Tr. 527-28. MN's chart includes some medical history collected by the Clinic's staff and the counselor. Tr. 528. When asked whether he was able to diagnose MN, he stated that he diagnosed her with an opioid addiction based on her history. Tr. 528-29. Dr. Daniels' treatment plan for MN included Subutex 8 mg TID and Klonopin. Tr. 529. In Dr. Daniels' opinion, the prescriptions in Stipulation 24 were written to treat MN's opioid dependency and anxiety. Tr. 529-30.

Patient JD presented with a history of back pain and opioid abuse. Tr. 531. JD had been prescribed Lortab for his back pain by another physician, but he later began taking Percocet and methadone, which he bought on the street.
Id.
A previous physician had also prescribed Subutex to JD for an opioid addiction, and his urine drug screen was “consistent with having [taken] Subutex.” Tr. 532.

Dr. Daniels' treatment plan for JD included Subutex 8 mg TID, monthly drug screens, and counseling.
Id.
He additionally testified that JD remained in the Clinic past this initial visit and that the Subutex prescription was meant to address JD's back pain as well as his addiction. Tr. 533.

Patient SB's chief complaint was panic attacks and a history of recreational drug abuse. Tr. 534. SB had been treated by another physician with Suboxone, but after experiencing side effects was treated with Subutex instead.
Id.
In addition to taking vitals, height, and weight, Dr. Daniels ordered a urine drug screen for SB.
Id.
SB tested positive for methamphetamine, marijuana, and Subutex.
Id.
While he did not make a note of it in SB's file, Dr. Daniels testified that in this situation, his general recommendation would have been for more frequent counseling. Tr. 535-36. However, he prescribed SB with Subutex for addiction, and with Klonopin for panic attacks. Tr. 535.

Patient CM came to the Clinic with a history of abusing oxycodone and roxycodone. Tr. 537. CM had previously been prescribed Subutex by another physician.
Id.
Dr. Daniels took CM's vitals, recorded height and weight, and made some other notes about CM's appearance and habits.
Id.
CM did a urine drug screen, which came back positive for marijuana and Suboxone. Tr. 538. Dr. Daniels also noted that CM “appeared to have an anxiety disorder.” Tr. 540.

Dr. Daniels' treatment plan for CM included Subutex for “chemical dependencies,” and Klonopin for anxiety.
Id.
When pressed about the Klonopin prescription, Dr. Daniels testified that Klonopin is what is usually prescribed for anxiety. Tr. 542. He also recommended counseling. Tr. 540. According to Dr. Daniels, CM remained a patient with the clinic for some time and was making progress. Tr. 539-40.

In detailing his treatment of patient JW, Dr. Daniels noted that JW was a professional colleague of his who owned the Clinic before Ms. LW took it over. Tr. 543. JW is a professional counselor who has known Dr. Daniels since 2003.
Id.
Dr. Daniels testified that JW began developing chronic pain in 2013, and a local physician was treating him with methadone. Tr. 544. JW had been referred to a pain specialist in Shreveport who was unable to see him because of an insurance issue.
Id.
Dr. Daniels agreed to see JW temporarily because he was in terrible pain and “almost unable to ambulate.”
Id.
Though he says it was not his intent to treat JW long term, he treated him until 2017.
Id.

Dr. Daniels determined that JW had hypertension, lumbar disc disease, chronic back pain, a history of carpal tunnel syndrome, and multiple surgeries in the past. Tr. 547. The initial plan was to follow up on medical records.
Id.

Dr. Daniels prescribed OxyContin to JW because he had just had knee surgery, and he was complaining of severe knee pain. Tr. 548. He chose OxyContin because JW had developed a tolerance to other pain medications. Tr. 549. He claims that he wrote the prescription for every 4-6 hours by mistake and that the usual dose is every 12 hours.
Id.
He also believes that JW was taking it “correctly,” meaning every 12 hours. Tr. 550. Dr. Daniels also prescribed Percocet to JW so that he could “rotate [the pain medications] around” for “different options on pain relief,” because JW described being able to take certain medications on some days, but not on others.
Id.
Dr. Daniels saw JW as a patient at least once per week, but sometimes two or three times per week, in addition to encountering him professionally on a regular basis. Tr. 550-51. On cross-examination, Dr. Daniels agreed that five of the prescriptions he wrote to JW for OxyContin were written with the wrong dosing instructions. Tr. 577-79.

When Dr. Daniels first saw the undercover agent (“TC”) as a patient, TC initially told him that he was taking 4-5 pain pills per day that he had bought off of the street, presuming them to be Lortab. Tr. 552. Dr. Daniels believed that TC would benefit from counseling.
Id.
From further conversation, Dr. Daniels got the impression that TC was actually taking more pills than he was letting on and that he was not completely sure that the pills were, in fact, Lortab. Tr. 553. TC also “indicated that he was taking Suboxone off the street” and “taking maybe Adderall.” Tr. 554. This led Dr. Daniels to prescribe Suboxone.
Id.

TC took a urine drug screen which tested negative. Tr. 556. However, based on his understanding of “the local people that [he] had been treating for so many years” and TC's history, Dr. Daniels felt that the dose of Suboxone he prescribed was appropriate because he believed it to be one that would prevent a relapse. Tr. 557. Dr. Daniels testified that the reason why some of his discussions with TC did not get documented in the medical record was “because it was cumbersome.” Tr. 506.

As to his licensing history, Dr. Daniels testified that he had never been denied a COR. Tr. 560. Regarding his state authority, Dr. Daniels entered into a consent order with the state medical board, and he testified that there had been concerns that he was not properly monitoring patients or supervising staff.
Id.
*[He stated that the state medical board “felt like that [he], as an individual practitioner, trusted people too much, that I gave too much confidence in the people when I would ask them to do things or expect them to bring things to me.” Tr. 561.] Citing personal stress, Dr. Daniels testified that he “had not be[en] able to really take full advantage of the opportunity to see these patients” leading to potential risks given the areas he was practicing in. Tr. 561. At the state medical board's recommendation, Dr. Daniels attended continuing medical education seminars on controlled substance prescribing, ethics, and boundaries. Tr. 562. After completing these recommendations, the medical board restored his license, but he was not allowed to practice in the areas of managing: Addiction; chronic pain; or obesity. Tr. 563.

Dr. Daniels re-applied for a COR once his state license was reinstated. Tr. 564. In filling out the form, he claims he did not realize that he “would have to be more complete” and that he “wasn't aware that the high risk practice areas

was where they were restricting [him].” Tr. 565. His understanding was that the state medical board had fully reinstated his controlled substance prescribing authority.
Id.
Dr. Daniels claims that he did not intend to be evasive or misleading.
Id.
He additionally testified that he has been struggling professionally without a COR because he currently works at a diabetes management clinic where Lyrica, a Schedule V controlled substance, is an important part of treatment. Tr. 568-69.

* [Dr. Daniels testified that he felt “like he had made every attempt to make sure that these patients were getting proper evaluations, and that the medicines that [he] was prescribing were safe and effective, and that [he] admit[s] some of the records fall short. [He] failed. But [he] feel[s] that still the overall diagnoses were correct, and the treatment plans were good.” Tr. 570.]

Despite being the witness with the most at stake in these proceedings, and thus the witness with the strongest motive to fabricate, Dr. Daniels presented generally as candid and sincere. However, there were notable inconsistencies between his descriptions of his prescribing history to various patients and objective data such as the PMP report for the relevant period. * [Additionally, I note that regarding the undercover TC, Dr. Daniels stated, “[a]nd he did tell me about alcohol and he was drinking. And we talked about some of the things that needed to be understood about the contract that he signed that he would not drink alcohol when taking these medicines.” Tr. 555. However, the transcript of their recorded conversation does not reflect any mention of the contract that TC signed or not drinking alcohol when taking the medicines, despite TC bringing up his alcohol use twice in the conversation.
See
GE-25, at 3;
see also
Tr. Tr. 82-84. I find this statement to weigh against Dr. Daniels' credibility and to be an attempt to minimize the egregiousness of his actions.] Thus, I generally credit Dr. Daniels' testimony, but where his testimony conflicts with that of other witnesses or record evidence, I consider it with close scrutiny.

The Facts

I. Stipulations

The Parties agree to 49 stipulations (“Stip.”), which the Parties have accepted as facts in these proceedings. Tr. 10.

Background

1. Dr. Daniels is a physician licensed to practice medicine by the Louisiana State Board of Medical Examiners in the State of Louisiana.

2. Dr. Daniels was previously registered with the DEA to handle controlled substances in Schedules II through V under DEA COR No. AD2802937 at 1514 Doctors Drive, Bossier City, Louisiana 71111.

3. Dr. Daniels surrendered DEA COR No. AD2802937 for cause on September 29, 2017.

4. Government Exhibit No. 1 is a true and correct copy of Dr. Daniels' signed surrender of his DEA COR No. AD2802937, dated September 29, 2017.

5. On September 20, 2017, the Louisiana State Board of Medical Examiners (“LSBME”) issued a notice partially suspending Dr. Daniels' medical license and prohibiting him from “prescribing, dispensing or administering controlled substances to any patient, effective September 21, 2017.”

6. Government Exhibit No. 2 is a true and correct copy of the notice issued by the LSBME on September 20, 2017.

7. Dr. Daniels filed a new application for a DEA COR on or about March 16, 2018.

8. Government Exhibit No. 3 is a true and correct copy of Dr. Daniels' March 16, 2018 application for a DEA COR.

9. Government Exhibit No. 4 is a true and correct copy of the Certification of Registration History showing Dr. Daniels' answers to the liability questions in his March 16, 2018 application for a DEA COR.

Consent Order

10. On March 12, 2018, the LSBME issued a Consent Order for Reprimand to Dr. Daniels that, among other things, did the following:

a. The Consent Order recalled the suspension of Dr. Daniels' authority to prescribe, dispense, or administer controlled substances issued on September 20, 2017.

b. The Consent Order accepted Dr. Daniels' representations to the LSBME that he would permanently refrain from prescribing controlled substances for chronic pain or obesity and refrain from associating himself with a drug treatment clinic.

c. The Consent Order imposed continuing restrictions on Dr. Daniels' authority to prescribe, dispense, or administer controlled substances, namely that it required Dr. Daniels to meet with the LSBME or a designee in advance and to abide by any suggestions or conditions the LSBME might recommend if Dr. Daniels ever wished to resume the acts he promised to discontinue.

11. Government Exhibit No. 5 is a true and correct copy of the Consent Order for Reprimand issued by the LSBME on March 12, 2018.

12. Dr. Daniels referenced the Consent Order, a public document, in his application for the COR.

Patient AK

13. Government Exhibit No. 6 is a true and correct copy of Dr. Daniels' patient file for Patient AK.

14. Government Exhibit No. 7 is a true and correct copy of a DEA subpoena issued to the CVS Pharmacy located at 2735 Beene Boulevard, Bossier City, Louisiana, regarding Dr. Daniels' prescriptions to Patient AK.

15. Government Exhibit No. 8 is a true and correct copy of various prescriptions that Dr. Daniels issued to Patient AK and that DEA obtained from the CVS Pharmacy located at 2735 Beene Boulevard, Bossier City, Louisiana.

16. Government Exhibit No. 9 is a true and correct copy of a DEA subpoena issued to Super One Pharmacy located at 745 Shreveport Barksdale Highway, Shreveport, Louisiana, regarding Dr. Daniels' prescriptions to Patient AK, and the response that DEA received from Brookshire Grocery Company, Pharmacy Operations, 1600 WSW Loop 323, Tyler, Texas, containing copies of prescriptions Respondent issued to Patient AK

17. As listed below, Dr. Daniels issued prescriptions for controlled substances, including Subutex (buprenorphine) and Klonopin (clonazepam), to Patient AK on at least the following occasions:

Date issued
Prescription

1/16/2017
15 units of Subutex 8 mg.

1/18/2017
90 units of Subutex 8 mg; 30 units of Klonopin 2 mg.

2/23/2017
90 units of Subutex 8 mg; 30 units of Klonopin 2 mg.

3/22/2017
90 units of Subutex 8 mg; 30 units of Klonopin 2 mg.

4/18/2017
90 units of Subutex 8 mg; 30 units of Klonopin 2 mg.

5/18/2017
90 units of Subutex 8 mg; 30 units of Klonopin 2 mg.

7/28/2017
90 units of Subutex 8 mg; 30 units of Klonopin 2 mg.

8/25/2017
90 units of Subutex 8 mg; 30 units of Klonopin 2 mg.

Patient CA

18. Government Exhibit No. 10 is a true and correct copy of Dr. Daniels' patient file for Patient CA.

19. Government Exhibit No. 11 is a true and correct copy of a DEA subpoena issued to Benzer Pharmacy located at 2951 E. Texas Street, Bossier City, Louisiana, regarding Dr. Daniels' prescriptions to Patient CA.

20. Government Exhibit No. 12 is a true and correct copy of various prescriptions that Dr. Daniels issued to Patient CA and that DEA obtained from Benzer Pharmacy located at 2951 E. Texas Street, Bossier City, Louisiana.

21. Government Exhibit No. 13 is a true and correct copy of a response to a DEA Subpoena from Walgreen's Pharmacy located at 9209 Mansfield Road, Shreveport, Louisiana, containing a prescription that Dr. Daniels issued to Patient CA.

22. As listed below, Dr. Daniels issued prescriptions for controlled substances, including Subutex, Klonopin, and Adderall (amphetamine-dextroamphetamine mixture), to Patient CA on at least the following occasions:

Date issued
Prescription

6/9/2016
90 units of Subutex 8 mg; 30 units of Klonopin 1 mg.

6/22/2016
90 units of Klonopin 1 mg; 30 units of Adderall 30 mg.

7/6/2016
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg; 30 units of Adderall 30 mg.

8/31/2016
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg; 30 units of Adderall 30 mg.

9/28/2016
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg; 30 units of Adderall 30 mg.

10/26/2016
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg; 30 units of Adderall 30 mg.

11/16/2016
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg; 30 units of Adderall 30 mg.

12/14/2016
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg; 30 units of Adderall 30 mg.

1/11/2017
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg; 30 units of Adderall 30 mg.

2/8/2017
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg; 30 units of Adderall 30 mg.

3/8/2017
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg; 30 units of Adderall 30 mg.

4/5/2017
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg; 30 units of Adderall 30 mg.

5/3/2017
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg; 30 units of Adderall 30 mg.

5/31/2017
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg; 30 units of Adderall 30 mg.

6/29/2017
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg; 30 units of Adderall 30 mg.

7/26/2017
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg; 30 units of Adderall 30 mg.

8/23/2017
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg; 30 units of Adderall 30 mg.

9/13/2017
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg; 30 units of Adderall 30 mg.

Patient MN

23. Government Exhibit No. 14 is a true and correct copy of Dr. Daniels' patient file for Patient MN.

24. As listed below, Dr. Daniels issued prescriptions for controlled substances, including Subutex and Klonopin, to Patient MN on at least the following occasions:

Date issued
Prescription

5/3/2017
90 units of Subutex 8 mg; 60 units of Klonopin 2 mg.

5/31/2017
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg.

6/28/2017
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg.

7/28/2017
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg.

8/29/2017
90 units of Subutex 8 mg; 90 units of Klonopin 2 mg.

Patient JD

25. Government Exhibit No. 15 is a true and correct copy of Dr. Daniels' patient file for Patient JD.

26. Government Exhibit No. 16 is a true and correct copy of a response to a DEA Subpoena from Brookshire's Pharmacy located at 1125 Highway 80, Haughton, Louisiana, containing prescriptions that Dr. Daniels issued to Patient JD.

27. As listed below, Dr. Daniels issued prescriptions for controlled substances, including Subutex, to Patient JD on at least the following occasions:

Date issued
Prescription

8/3/2016
90 units of Subutex 8 mg.

8/31/2016
90 units of Subutex 8 mg.

9/28/2016
90 units of Subutex 8 mg.

10/26/2016
90 units of Subutex 8 mg.

11/16/2016
90 units of Subutex 8 mg.

12/14/2016
90 units of Subutex 8 mg.

1/18/2017
90 units of Subutex 8 mg.

2/8/2017
90 units of Subutex 8 mg.

3/8/2017
90 units of Subutex 8 mg.

4/5/2017
90 units of Subutex 8 mg.

5/3/2017
90 units of Subutex 8 mg.

6/7/2017
90 units of Subutex 8 mg.

7/5/2017
90 units of Subutex 8 mg.

8/2/2017
90 units of Subutex 8 mg.

8/30/2017
90 units of Subutex 8 mg.

Patient SB

28. Government Exhibit No. 17 is a true and correct copy of Dr. Daniels' patient file for Patient SB.

29. As listed below, Dr. Daniels issued prescriptions for controlled substances, including Subutex and Klonopin, to Patient SB on at least the following occasions:

Date issued
Prescription

1/18/2017
60 units of Subutex 8 mg; 60 units of Klonopin 1 mg.

2/15/2017
60 units of Subutex 8 mg; 60 units of Klonopin 1 mg.

3/15/2017
60 units of Subutex 8 mg; 60 units of Klonopin 1 mg.

4/12/2017
60 units of Subutex 8 mg; 60 units of Klonopin 1 mg.

5/10/2017
60 units of Subutex 8 mg; 60 units of Klonopin 1 mg.

6/24/2017
60 units of Subutex 8 mg; 60 units of Klonopin 1 mg.

7/19/2017
60 units of Subutex 8 mg; 60 units of Klonopin 1 mg.

Patient CM

30. Government Exhibit No. 18 is a true and correct copy of Dr. Daniels' patient file for Patient CM.

31. As listed below, Dr. Daniels issued prescriptions for controlled substances, including Subutex and Klonopin, to Patient CM on at least the following occasions:

Date issued
Prescription

5/4/2016
90 units of Subutex 8 mg.

6/1/2016
90 units of Subutex 8 mg.

6/29/2016
90 units of Subutex 8 mg.

7/27/2016
90 units of Subutex 8 mg.

8/24/2016
90 units of Subutex 8 mg.

9/21/2016
90 units of Subutex 8 mg.

10/19/2016
90 units of Subutex 8 mg.

11/16/2016
90 units of Subutex 8 mg.

12/14/2016
90 units of Subutex 8 mg; 60 units of Klonopin 2 mg.

1/11/2017
90 units of Subutex 8 mg; 60 units of Klonopin 2 mg.

2/22/2017
90 units of Subutex 8 mg; 60 units of Klonopin 2 mg.

3/20/2017
90 units of Subutex 8 mg; 60 units of Klonopin 2 mg.

4/19/2017
90 units of Subutex 8 mg; 60 units of Klonopin 2 mg.

5/17/2017
90 units of Subutex 8 mg; 60 units of Klonopin 2 mg.

6/14/2017
90 units of Subutex 8 mg; 60 units of Klonopin 2 mg.

7/12/2017
90 units of Subutex 8 mg; 60 units of Klonopin 2 mg.

8/9/2017
90 units of Subutex 8 mg; 60 units of Klonopin 2 mg.

9/5/2017
90 units of Subutex 8 mg; 60 units of Klonopin 2 mg.

Patient JW

32. Government Exhibit No. 19 is a true and correct copy of Dr. Daniels' patient file for Patient JW.

33. Government Exhibit No. 20 is a true and correct copy of a DEA subpoena issued to the CVS Pharmacy located at 1118 Homer Road, Minden, Louisiana, regarding Dr. Daniels' prescriptions to Patients CA, JD, CM, and JW.

34. Government Exhibit No. 21 is a true and correct copy of various prescriptions that Dr. Daniels issued to Patients CA, JD, CM, and JW, and that DEA obtained from the CVS Pharmacy located at 1118 Homer Road, Minden, Louisiana.

35. As listed below, Dr. Daniels issued prescriptions for controlled substances, including methadone, Percocet (oxycodone-acetaminophen), OxyContin (oxycodone extended release), and Lortab (hydrocodone-acetaminophen), to Patient JW on at least the following occasions:

Date issued
Prescription

7/5/2013
90 units of methadone 10 mg.

7/22/2013
150 units of methadone 10 mg.

8/9/2013
30 units of Percocet 10/325 mg.

8/16/2013
150 units of methadone 10 mg.

8/23/2013
60 units of Percocet 10/325 mg.

9/6/2013
60 units of Percocet 10/325 mg.

9/13/2013
150 units of methadone 10 mg.

10/11/2013
150 units of methadone 10 mg.

10/18/2013
60 units of Percocet 10/650 mg.

11/8/2013
150 units of methadone 10 mg; 60 units of Percocet 10/325 mg.

12/6/2013
150 units of methadone 10 mg; 60 units of Percocet 10/325 mg.

12/20/2013
60 units of Percocet 10/325 mg.

1/3/2014
150 units of methadone 10 mg; 90 units of Percocet 10/325 mg.

1/17/2014
90 units of Percocet 10/325 mg.

1/31/2014
150 units of methadone 10 mg; 90 units of Percocet 10/325 mg.

2/14/2014
90 units of Percocet 10/325 mg.

2/28/2014
90 units of Percocet 10/325 mg.

3/14/2014
30 units of OxyContin 10 mg.

3/19/2014
90 units of Percocet 10/325 mg.

3/21/2014
150 units of methadone 10 mg.

3/28/2014
20 units of OxyContin 10 mg; 90 units of Percocet 10/325 mg.

4/11/2014
20 units of OxyContin 10 mg; 90 units of Percocet 10/325 mg.

4/17/2014
150 units of methadone 10 mg.

4/25/2014
20 units of OxyContin 10 mg; 120 units of Percocet 10/325 mg.

5/9/2014
20 units of OxyContin 10 mg; 120 units of Percocet 10/325 mg.

5/16/2014
20 units of OxyContin 10 mg; 120 units of Percocet 10/325 mg.

5/23/2014
150 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

6/6/2014
120 units of Percocet 10/325 mg.

6/20/2014
150 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

7/10/2014
60 units of Lortab 10/325 mg.

7/16/2014
150 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

8/8/2014
120 units of Percocet 10/325 mg.

8/22/2014
150 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

9/5/2014
120 units of Percocet 10/325 mg.

9/19/2014
150 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

10/17/2014
150 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

11/14/2014
150 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

12/5/2014
120 units of Percocet 10/325 mg.

12/12/2014
150 units of methadone 10 mg.

12/23/2014
120 units of Percocet 10/325 mg.

1/5/2015
120 units of Percocet 10/325 mg.

1/12/2015
150 units of methadone 10 mg.

1/23/2015
120 units of Percocet 10/325 mg.

2/6/2015
120 units of Percocet 10/325 mg.

2/20/2015
120 units of Percocet 10/325 mg.

3/6/2015
150 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

3/20/2015
120 units of Percocet 10/325 mg.

4/2/2015
150 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

4/17/2015
120 units of Percocet 10/325 mg.

5/1/2015
150 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

5/15/2015
120 units of Percocet 10/325 mg.

6/1/2015
150 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

6/15/2015
120 units of Percocet 10/325 mg.

7/1/2015
150 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

7/30/2015
150 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

8/14/2015
120 units of Percocet 10/325 mg.

8/31/2015
150 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

9/14/2015
120 units of Percocet 10/325 mg.

9/26/2015
150 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

10/14/2015
180 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

11/24/2015
180 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

12/9/2015
120 units of Percocet 10/325 mg.

12/19/2015
120 units of Percocet 10/325 mg.

12/30/2015
180 units of methadone 10 mg.

1/12/2016
120 units of Percocet 10/325 mg.

1/27/2016
180 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

2/24/2016
180 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

3/16/2016
120 units of Percocet 10/325 mg.

3/23/2016
180 units of methadone 10 mg.

4/6/2016
120 units of Percocet 10/325 mg.

4/27/2016
180 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

5/18/2016
120 units of Percocet 10/325 mg.

5/25/2016
180 units of methadone 10 mg.

6/8/2016
120 units of Percocet 10/325 mg.

6/22/2016
180 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

7/20/2016
180 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

8/10/2016
120 units of Percocet 10/325 mg.

8/24/2016
180 units of methadone 10 mg.

8/31/2016
120 units of Percocet 10/325 mg.

9/21/2016
180 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

10/5/2016
120 units of Percocet 10/325 mg.

10/26/2016
180 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

11/9/2016
120 units of Percocet 10/325 mg.

12/14/2016
120 units of Percocet 10/325 mg.

12/21/2016
180 units of methadone 10 mg.

1/4/2017
120 units of Percocet 10/325 mg.

1/6/2017
30 units of OxyContin 10 mg.

1/18/2017
180 units of methadone 10 mg.

1/30/2017
120 units of Percocet 10/325 mg.

2/13/2017
120 units of Percocet 10/325 mg.

2/21/2017
180 units of methadone 10 mg.

3/1/2017
120 units of Percocet 10/325 mg.

3/22/2017
180 units of methadone 10 mg; 120 units of Percocet 10/325 mg.

4/5/2017
120 units of Percocet 10/325 mg.

Patient TC

36. Government Exhibit No. 23 is a true and correct copy of Dr. Daniels' patient file for Patient TC.

37. On September 13, 2017, Dr. Daniels issued a prescription to Patient TC for 60 units of Suboxone (buprenorphine/naloxone) 8/2 mg.

38. Government Exhibit No. 24 is a true and correct video recording of Dr. Daniels' interaction with Patient TC on September 13, 2017.

39. Government Exhibit No. 25 is a true and correct transcript of Dr. Daniels' interaction with Patient TC on September 13, 2017.

40. Government Exhibit No. 27 is a true and correct video recording of Patient TC's visits to Dr. Daniels' office on September 12 and 13, 2017.

Controlled Substances

41. DEA lists Subutex (buprenorphine) as a Schedule III controlled substance under 21 CFR 1308.13(e)(2)(i).

42. DEA lists Klonopin (clonazepam) as a Schedule IV controlled substance under 21 CFR 1308.14(c)(11).

43. DEA lists Adderall (amphetamine-dextroamphetamine mixture) as a Schedule II controlled substance under 21 CFR 1308.12(d)(1).

44. DEA lists methadone as a Schedule II controlled substance under 21 CFR 1308.12(c)(15).

45. DEA lists Percocet (oxycodone-acetaminophen) as a Schedule II controlled substance under 21 CFR 1308.12(b)(1)(xiii).

46. DEA lists OxyContin (oxycodone extended release) as a Schedule II controlled substance under 21 CFR 1308.12(b)(1)(xiii).

47. DEA lists Lortab (hydrocodone-acetaminophen) as a Schedule II controlled substance under 21 CFR 1308.12(b)(1)(vi).

48. DEA lists Suboxone (buprenorphine/naloxone) as a Schedule III controlled substance under 21 CFR 1308.13(e)(2)(i).

49. Respondent's Exhibit No. 2 is a true and correct copy of a March 9, 2018 letter from Dr. Daniels' counsel to Cecilia Mouton, M.D., the Director of Investigations for the Louisiana State Board of Medical Examiners, and which is countersigned by Cecilia Mouton, M.D., on behalf of the Louisiana State Board of Medical Examiners.

II. Findings of Fact

The Application

1. Dr. Daniels has never been denied a COR. Tr. 560.

2. Dr. Daniels entered into a consent order with the State Medical Board (“the Board”), following concerns that he was not properly monitoring patients or supervising staff. Tr. 560.

3. At the Board's recommendation, Dr. Daniels attended continuing medical education seminars on controlled substance prescribing, ethics, and boundaries. Tr. 562. After completing those seminars, the Board restored Dr. Daniels' medical license, but he was not allowed to practice in the areas of managing: Addiction; chronic pain; or obesity. Tr. 563.

4. Dr. Daniels re-applied for a COR once his license was reinstated. Tr. 564. In filling out the application, he did not realize that he “would have to be more complete” and that he was not “aware that the high risk practice areas was where they were restricting [him].” Tr. 565. His understanding was that the Board and the State Pharmacy Board had fully reinstated his controlled substance prescribing authority.
Id.

5. The application for a COR does not inform an applicant to provide the detailed information that the DEA asserted was missing from Dr. Daniels' application. Tr. 70.

6. The information Dr. Daniels provided on his application placed the DEA on notice that it should not summarily approve Dr. Daniels' application, but rather that DEA should investigate it. Tr. 70-71.

7. Dr. Daniels did not intend to be evasive or misleading when he submitted his application for a Certificate of Registration. Tr. 565.

8. Dr. Daniels is struggling professionally without a COR because he currently works at a diabetes management clinic where Lyrica, a Schedule V controlled substance, is an important part of treatment. Tr. 568-69.

The Clinic

9. The Clinic was located in Minden, Louisiana, which is a rural area. Tr. 480.

10. LW had full control of the Clinic from April 2017 to September 2017. Tr. 479.

11. The Clinic provided services for low, to mid-level, income individuals, but it focused its service on those with low incomes. Tr. 421. The Clinic provided services to a wide array of patients including those suffering from drug addiction and those with mental health problems. Tr. 421-22. Most of the patients had some type of opioid addiction. Tr. 424. The Clinic stayed open late on Wednesdays to make it convenient for patients to seek treatment. Tr. 422-23.

12. Dr. Daniels would see patients at the Clinic one day a week, arriving around 5:00 p.m., and staying until 9:00 to 10:00 p.m. Tr. 424-25. Dr. Daniels was scheduled to see 25 patients a week, but sometimes he saw more. Tr. 425.

13. Dr. Daniels was the only physician who worked at the Clinic. Tr. 425. Most of the patients he saw had some kind of opioid addiction. Tr, 427.

14. The Clinic also employed a licensed practical nurse, a registered nurse, a licensed clinical social worker, a receptionist, and a phlebotomist. Tr. 425-26.

15. The Clinic struggled with establishing a reliable system for

ensuring the patients' charts were complete and accurate. Tr. 486-87.

16. The entire staff of the Clinic worked on medical records, but the Clinic brought in an RN to work on the records because the Clinic had seen a lot of deficiencies in the records. Tr. 427. These changes were made after LW began working full-time in the Clinic. Tr. 428. As of April 2017, the Clinic was attempting to organize and re-structure. Tr. 435.

17. Various employees at the Clinic inserted documents into the patients' charts as well as taking the patient's vital signs. Tr. 437-38. The office staff as a whole was responsible for making sure the documents got into the patient's medical record. Tr. 438.

18. The registered nurse was hired to audit the medical records, and she was also in the office with Dr. Daniels when he saw patients. Tr. 436.

19. When a patient came into the Clinic, the licensed clinical social worker would conduct a clinical/behavioral assessment to determine whether the patient met the criteria to be treated at the Clinic. Tr. 429, 443.

20. Most of the Clinic's patients had previously been seen at other clinics. Tr. 429.

21. All new patients were required to submit urine samples for drug screening. Tr. 432, 443. The results of the screening were passed on to the licensed clinical social worker.
Id.

22. The phlebotomist did the urine drug screens and bloodwork. Tr. 441.

23. If a patient met the Clinic's requirements, the patient was scheduled to see Dr. Daniels. Tr. 432.

24. Dr. Daniels wanted to see the patients' vitals, as well as their drug screens. Tr. 438.

25. The work that the Clinic employees performed was at Dr. Daniels' request. Tr. 441. Information gathered in the assessments was provided to Dr. Daniels. Tr. 441-42.

26. Generally, PMPs were tracked for each patient and if anything was out of line Dr. Daniels was informed. Tr. 442, 446. Of the patients named in the Order to Show Cause, however, Dr. Daniels' PMP account was used to check the prescriptions filled by only two patients, CA and TC. Tr. 597-99; GE-30. The PMP was checked for both of these patients on September 13, 2017, which was the last day CA received a prescription from Dr. Daniels, and the only time he issued a prescription to TC. Tr. 598; GE-30, at 2; Stip. 22, 37.

27. The Clinic's default setting used for reviewing PMPs was one year, but Dr. Daniels was more concerned about what a patient had received within the last 30 days. Tr. 496-97.

28. Normally a staff member of the Clinic would run a PMP report and provide the results to Dr. Daniels. Tr. 448, 497, 514, 522. The results of the PMP report would not be documented. Tr. 522.

29. Ideally, a doctor gets a print-out of a patient's PMP report, but there is no requirement to print it out. Tr. 496.

30. The Clinic did not check a patient's PMP when the patient came in to pick up a prescription. Tr. 451.

Dr. Daniels' Clinic Practices

31. Dr. Daniels used Suboxone and Subutex to treat opioid addiction. Tr. 506.

32. Dr. Daniels did not put together the patient charts at the Clinic. Tr. 485-86.

33. Dr. Daniels acknowledged that there is information missing from the patients' charts. Tr. 487. Dr. Daniels testified that the patient charts in this case do not include sticky notes and other notes that would have been on the inside of the manila folder that held the charts. Tr. 488.

34. When Dr. Daniels saw a patient at the Clinic, some of the patient's medical history was available on forms that the patient completed before the visit. Tr. 492.

35. In general, Dr. Daniels would ask each patient: About his or medication; whether the medication was working; who initially prescribed it; and how long the patient had been taking it. Tr. 517.

36. Dr. Daniels testified that a doctor can perform an examination by observing the patient, and noting the patient's demeanor, activity, mood, and physical appearance. Tr. 493-94. Sometimes Dr. Daniels decided to do a more thorough physical examination. Tr. 512.

37. Dr. Daniels testified that in situations where there is limited staff and other patients are waiting, a doctor sometimes needs to make a “judgment call” about examining the patient, and not inconveniencing waiting patients. Tr. 493. In that situation, in Dr. Daniels' view, the doctor performs “enough of an exam” in order to “move forward” with the patient, allowing the doctor time to see other patients. Tr. 493.

38. With respect to urine drug screens, Dr. Daniels testified that he was provided the results of the screens. Tr. 510. He testified that in most cases he addressed abnormalities with the patient, but did not document that fact in the patient's chart. Tr. 498, 502, 510. He acknowledged it would be best practice to document efforts to address an abnormal urine drug screen. Tr. 501.

39. Dr. Daniels testified that the current standard is to not discharge a patient who is noncompliant with the treatment plan. Tr. 499-500.

40. In Dr. Daniels' view, it is better to keep a long-term patient on medication than to discharge the patient. Tr. 500. Discharging a patient could lead to a relapse, or to the patient taking dangerous street-drugs.
Id.

41. If the new patient was already taking Suboxone, Dr. Daniels would discuss the Suboxone treatment regimen plan with the patient. Tr. 516. He would also ask the patient if he or she signed the treatment contract, and whether the patient understood it.
Id.
He would only address specific provisions of the treatment contract if he believed there might be a particular issue with the patient's ability to comply with the contract.
Id.

42. Dr. Daniels reviewed the PMP to: See what medications a patient has been on; determine previous providers; and, determine when the patient received medications. Tr. 495.

43. When one of Dr. Daniels' substance-abuse patients tested positive for marijuana he did not address the issue with the patient because it was “so ubiquitous in the population” that Dr. Daniels treated. Tr. 515.

44. While working at the Clinic, Dr. Daniels was under quite a bit of personal stress and he “had not be[en] able to really take full advantage of the opportunity to see these patients,” which lead to potential risks given the areas in which he was practicing. Tr. 561.

General Facts Derived From Expert Testimony

45. Klonopin (clonazepam) is a benzodiazepine. Tr. 177.

46. To prescribe controlled substances in Louisiana for the treatment of chemical dependency, the standard of care requires the treating physician to: conduct an adequate physical examination; obtain past medical records; obtain PMP reports; conduct drug screening; and maintain medical records. Tr. 141-42, 492.

47. The standard of care requires that a patient's medical record be “complete and accurate.” Tr. 151.

48. A doctor need not document everything that occurred during a patient encounter, but the doctor should document the important, pertinent information that will give an objective viewer a picture of what happened during the encounter. Tr. 151-52.

49. Changes in medical treatment, and the reasons for those changes, must be documented. Tr. 150. The treatment plan is updated over time.
Id.

50. When there is a consistent absence of pertinent information in a patient's medical records such as: PMP reports; a credible physical examination; past medical records; resolution of abnormal drug screens, the records reach a point where it is not possible to say that the treatment has been within the scope of acceptable medical practice or that the prescriptions are legitimate. Tr. 154;
see also
Tr. 384.

51. Because the application of medicine needs to be individualized, a sufficiently adequate physical examination would not necessarily be the same for every patient. Tr. 144-45, 492.

52. In conducting a physical examination for a patient who has chemical dependency the doctor should: Look for track marks; note how the patient's pupils look and whether the patient's mucous membranes are dry; look for goosebumps; look for signs of withdrawal such as whether the patient is sweaty and/or shaky, and/or whether the patient is obtunded. Tr. 143, 289, 492. Much of this information can be obtained through a discussion with the patient. Tr. 290, 492. If the chemical dependency originated following treatment of an injury to a part of the body, the physical examination should also include an examination of that body part. Tr. 388-89, 492.

53. As part of a physical examination for a patient who has a chemical dependency, a doctor should ask the patient questions such as: What are you using?; How long have you been using?; Why did you start using?; Are you around people who are using?; and, How do the drugs affect your life? Tr. 144, 492.

54. It is possible to treat a patient even without obtaining prior medical records; however, contained within the patient's medical records should be a documented good-faith effort to obtain the prior records, and an explanation of why treatment has begun without those prior records. Tr. 292.

55. Obtaining past medical records is important because such records contain an abundance of information that a treating doctor needs to know. Tr. 145. Obtaining past medical records is mandatory. Tr. 146. Even if the patient presents with medical documentation, the physician is not relieved of the obligation to attempt to obtain past medical records. Tr. 291.

56. A physician also needs to take a medical history and/or look for past medical records upon the patient's initial visit. Tr. 146. It is also important to update the patient's medical history. Tr. 147.

57. The failure to take a medical history, and/or to obtain past medical records, makes it difficult to argue that the doctor knows what he or she is doing at any particular instance of the patient's care. Tr. 147.

58. In Louisiana, the treatment plan must talk about what is being done for a patient, and why. Tr. 148, 503. The treatment plan allows another physician to pick up the patient's record and understand the treatment. Tr. 148-49. The treatment plan assists with continuity of care. Tr. 149.

59. For a patient with a chemical dependency, the treatment plan is dependent on what has been done in the past, and where the medical treatment is intended to take the patient. Tr. 149. *[For opioid addiction, Dr. Kennedy testified that in a treatment plan, he “would expect there to be goals as far as where it is that we're heading with this. In other words, is this somebody that we expect that we're going to wean and discharge from this medication eventually? What are the likelihood of doing dosage adjustments if it works or if it doesn't work? What are we going to do if the patient has problems with some social issue . . . . All of the other kind of things that would go into any treatment record, where you're hoping that the patient is going to have an improved life.” Tr. 301]

60. Informed consent is not obtained by having a signature on a form. Tr. 306. Informed consent is obtained by a conversation between the physician and the patient in which the doctor explains the dangers, the side effects of treatment, and that the treatment might not work.
Id.

61. A prescription itself is not sufficient documentation of medical treatment. Tr. 234.

62. In Louisiana, a doctor who is treating a patient for addiction or chemical dependency is required to document the results of an abnormal urine drug screen, and the actions the physician took in response to it. Tr. 173, 225-26. If the test is abnormal, the results must be documented, as well as documenting the type of action that was taken in response to the abnormal test. Tr. 310-11, 318, 336, 378. Ignoring an abnormal urine drug screen, or saying nothing about it, is outside the course of acceptable medical practice in Louisiana. Tr. 378. *[Regarding the standard of care for chemical dependency, Dr. Kennedy stated, “If we're talking about treating patients with chemical dependency, with the way that the regulations, the way the systems are designed, there's a reason we have to check PDMP reports and there's a reason that we have to get drug screens and there's a reason that we have to get past medical records and all of these other things, and it's not because we're counting on the patients being compliant, it's because of the likelihood of patients being noncompliant.” Tr. 299.]

63. For a doctor to treat a diagnosis there must be supporting information. Tr. 323. A diagnosis alone is not sufficient to support a prescription for controlled substances. Tr. 371.

64. A clinical licensed social worker cannot make a diagnosis. Tr. 408. Thus, the diagnosis made by the social worker contained in Government Exhibit 14, pages 31-39, is not a valid diagnosis.
See also
Tr. 380 (no evidence that Dr. Daniels reviewed the diagnosis).

65. Prior to 2018, doctors in Louisiana were not required to check a patient's PMP before writing a prescription for a controlled substance, but it was considered the standard of care. Tr. 393.

66. The use of multiple pre-signed medical forms and/or identical copied handwritten treatment notes do not support a finding of legitimate medical care and are not credible in medical records. Tr. 190, 196;
cf.
GE-6 at 12, GE-14, at 14, and GE-18, at 26; and GE-6, at 26, and GE-10, at 57.

67. Signed forms do not provide sufficient advice concerning the dangers of combining alcohol with buprenorphine when the patient had a history of abusing drugs, and an abnormal urine drug screen. Tr. 400. A discussion needs to occur because the patient is starting a program of regular scheduled medications. Tr. 401. If, later, it is determined that the patient is still abusing drugs, it is clear the original discussion was not enough, and the doctor needs to revisit the issue with the patient.
Id.

68. Signed forms are not sufficient to constitute a treatment plan. Tr. 374.

69. A Patient Treatment Contract does not establish a physician/patient relationship. Tr. 304.

70. None of the patients' medical records in the Administrative Record contained sufficient documentation to support a prescription for Klonopin. Tr. 399-400.

The Patients

Patient AK

71. On January 16, 2017, AK signed a Patient Treatment Contract with Dr. Daniels. Tr. 161, 303-04; GE-6, at 30. In paragraph one of that contract, AK agreed to keep, and be on time, for all of his scheduled appointments, and in paragraph two he agreed to the payment policy of Dr. Daniels' office.
Id.
In paragraph 13 of the contract, AK agreed

to abstain from alcohol, opioids, marijuana, cocaine, and other addictive substances.
Id.
This contract was signed by Dr. Daniels on January 18, 2017. Tr. 162; GE-6, at 30.

72. Paragraph 10 of the Patient Treatment Contract that AK signed on January 16, 2017, reads as follows: “I understand that mixing buprenorphine with other medications especially benzodiazepines (for example, Valium, Klonopin, or Xanax), can be dangerous. I also recognize that several deaths have occurred among persons mixing buprenorphine and benzodiazepines (especially if taken outside the care of a physician, using a route of administration other than sublingual or in higher than recommended therapeutic doses).” GE-6, at 30.

73. On January 16, 2017, AK signed a Patient Agreement to Participate in Suboxone Treatment. Tr. 161, 308; GE-6, at 31. At the end of each paragraph is a space for the patient's initials, but there are no initials there. Tr. 308; GE-6, at 31.

74. On January 16, 2017, AK signed a Patient Information and Consent to Treatment with Buprenorphine and Suboxone. GE-6, at 41. The fourth paragraph of that information sheet advises that combining buprenorphine with alcohol or other sedating medications is dangerous, and that combining buprenorphine with benzodiazepines has resulted in deaths.
Id.

75. The prescription that Dr. Daniels wrote for AK on January 16, 2017, for 15 tablets of 8 mg Subutex predates any written documentation of Dr. Daniels actually seeing AK. Tr. 160-61; GE-9, at 10; Stip. 17. Because this prescription was written prior to Dr. Daniels initially seeing AK, this prescription was issued outside of the course of medical practice in the state of Louisiana, and it was not issued for a legitimate medical purpose. Tr. 162-63, 401-02.

76. The initial Physician Intake Note for AK, dated January 18, 2017, indicates that AK had a history of multiple fractures, secondary to a fight and a motor vehicle accident. Tr. 162, 511; GE-6, at 25. The Note also indicates that AK had an opioid addiction issue, and that he previously took prescriptions for 8 mg Subutex, three times a day, and for 2 mg Klonopin, once a day. Tr. 165, 302, 511; GE-6, at 25;
see also
GE-6, at 43. The treatment history indicated that AK had previously been treated by another provider. Tr. 165, 511; GE-6, at 25. It does not appear that Dr. Daniels obtained treatment records from that provider. Tr. 165-66; GE-6. The Authorization to Release Healthcare Information in AK's file was not completed. Tr. 167; GE-6, at 47.

77. Dr. Daniels testified that he was able to conclude that AK had an opioid addiction based on AK's medical history, the physical examination that Dr. Daniels described, and AK's urine drug screen. Tr. 515.

78. Dr. Daniels testified that, even though the documentation is limited, AK also had an anxiety disorder and pain, and that the pain was related to AK's fractures. Tr. 517-18. Dr. Daniels did not see pain recorded in AK's chart.
3

Tr. 517.

3
Assuming that AK was in pain, a physical examination should have included an examination of AK's body parts that had been fractured. Tr. 388-89, 492. No such examination, however, is documented in AK's medical record. GE-6.

79. Dr. Daniels testified that the Food and Drug Administration has advised that patients should not be denied Subutex simply because the patient is also taking a benzodiazepine. Tr. 518. In Dr. Daniels' opinion, he believed it was justified to prescribe Subutex and Klonopin to AK because he had pain and had taken opioids and Klonopin before. Tr. 518. Dr. Daniels acknowledged, however, that AK's chart does not document that AK had taken opioids before *[for a pain condition].
Id.

80. Dr. Daniels believed prescribing a higher dose of Subutex to AK was warranted because in addition to opioid addiction, AK also had pain and Subutex can be used to relieve pain. Tr. 517-19.

81. The initial Physician Intake Note for AK, dated January 18, 2017, contains a treatment plan that reads, “Monthly and random drug screens. Counseling with LW Medical Multi Care Clinic 801 Shreveport Rd. Minden, La. One group monthly 6:00-7:30 p.m. Meet with LPC 20 minutes prior to doctor visit.”
4

Tr. 169, 302-03; GE-6, at 25. The treatment plan also includes the medications prescribed, but it does not include a rationale as to why the medications were prescribed.
Id.
Dr. Daniels testified that AK's treatment plan developed on January 18, 2017, was to conduct monthly and random urine drug screens, provide AK counseling, prescribe Subutex 8 mg TID and Klonopin 2 mg, and have AK return to the Clinic in one month. Tr. 515, 518; GE-6, at 25.

4
This treatment plan will be referred to as the “boilerplate treatment plan” throughout the remainder of this Recommended Decision.

82. Contained in AK's medical file is a Physician Assessment form dated January 18, 2017. Tr. 164; GE-6, at 45-46. Although this assessment is contained in AK's patient file, his name is not on the form, and the form is not signed by a doctor.
Id.
The form also does not document that Dr. Daniels performed a physical examination of AK.
Id.

83. The only portion of a physical examination documented in AK's medical record for his first visit on January 18, 2017, was that AK appeared neat and clean, and that he had a depressed affect. Tr. 512; GE-6, at 25.

84. Dr. Daniels did not know whether the Klonopin AK reported he had been taking had been prescribed to him, or if he was taking it “off the street.” Tr. 511-12.

85. AK's PMP was not checked at the Clinic. Tr. 168, 597-99; GE-30.

86. On January 18, 2017, AK's urine drug screen was positive for benzodiazepines, methamphetamine, THC, and Subutex. Tr. 169-70, 514; GE-6, at 29. In his “MD Notes” for that day, Dr. Daniels wrote that AK's drug screen was positive for Subutex and negative for opioids.

5

Id.
at 26. This was an abnormal drug screen because it was positive for methamphetamine and THC (“marijuana”). Tr. 170-72. In that AK had indicated that he had not used crystal methamphetamine, the results of the urine drug screen should make a physician very suspicious that AK was lying. Tr. 171-72; GE-6, at 39. There is no indication in AK's medical record that Dr. Daniels took any action in response to AK's abnormal drug screen. Tr. 174.

5
This note makes little sense, however, because Subutex is an opioid. Tr. 177.

87. On February 23, 2017, and March 22, 2017, AK's urine drug screens were positive for benzodiazepines, THC and Subutex. GE-6, at 27-28. In his treatment notes for those days, Dr. Daniels wrote that AK's drug screen was positive for Subutex and negative for opioids.
Id.
at 26.

88. On a Pharmacy Prior Authorization Form, dated April 3, 2017, Dr. Daniels notes that AK had reported adverse reactions to Suboxone. GE-6, at 24.

89. On June 20, 2017, AK's urine drug screen was positive for benzodiazepines and Subutex. Tr. 309; GE-6, at 6.

90. On September 25, 2017, Dr. Daniels discharged patient AK for failing to keep agreed appointments every 28 days, and/or for not paying in full for his office visits in a timely manner. GE-6, at 6.

91. A review of Dr. Daniels' medical records of AK reveals no documentation that Dr. Daniels ever conducted a physical examination of AK, and those records provide no justification for Dr.

Daniels' prescription of Klonopin to AK. Tr. 396-97; GE-6, at 1-49.

92. The prescriptions that Dr. Daniels wrote for AK on January 18, 2017, for Klonopin and Subutex were not issued for a legitimate medical purpose because: action taken on the abnormal urine drug screen, if any, was not documented; the PMP was not checked; there were no past medical records; and there was no documentation of a significant physical examination. Tr. 177; GE-30.

93. A Physician Intake Note dated June 20, 2017, is contained in AK's patient file. Tr. 180; GE-6, at 12. This is the only other intake note contained in AK's patient file. Tr. 182; GE-6, at 12. Prior to this date, Dr. Daniels issued prescriptions to AK on six occasions, and after this date on two more occasions. Tr. 181; Stip. 17.

94. The Physician Intake Note of June 20, 2017, does not document: A physical examination; AK's response to prior treatment; a rationale for the prescriptions; or the response to abnormal drug screens. Tr. 182-84; GE-6, at 11, 12, 27-28.

95. Although the Physician Intake Note of June 20, 2017, is signed, it is not dated, and the signature is identical to that contained on an intake note of patient MN, dated June 28, 2017, and an intake note of patient CM, dated August 9, 2017, and the signatures on both of those intake forms are not dated. Tr. 186-89; GE-6 at 12; GE-14, at 14; GE-18, at 26.

96. Dr. Daniels also used identical copied handwritten “boilerplate” notes concerning patients' monthly counseling appointments. Tr. 193-95;
cf.
GE-6, at 26, and GE-10, at 57. Such notes are not credible in medical records. Tr. 196.

97. The prescriptions that Dr. Daniels issued to AK between January 16, 2017 and August 25, 2017, identified in Stipulation 17, were issued outside the course of acceptable medical practice and were not issued for a legitimate medical purpose because Dr. Daniels did not: conduct a sufficient medical history of AK; conduct a physical examination of AK; formulate a treatment plan with a rationale that supported the prescriptions; document resolution of abnormal urine drug screens; obtain prior medical records or conduct a review of AK's PMP; or maintain accurate medical records. Tr. 191-92.

Patient CA

98. On June 9, 2016, CA signed a Patient Treatment Contract with Dr. Daniels. GE-10, at 56. In paragraph 13 of the contract, CA agreed to abstain from alcohol, opioids, marijuana, cocaine, and other addictive substances.
Id.

99. Paragraph 10 of the Patient Treatment Contract that CA signed on June 9, 2016, reads as follows: “I understand that mixing buprenorphine with other medications especially benzodiazepines (for example, Valium, Klonopin, or Xanax), can be dangerous. I also recognize that several deaths have occurred among persons mixing buprenorphine and benzodiazepines (especially if taken outside the care of a physician, using a route of administration other than sublingual or in higher than recommended therapeutic doses).” GE-10, at 55.

100. On June 9, 2016, CA signed a Patient Information and Consent to Treatment with Buprenorphine and Suboxone. GE-10, at 76. The fourth paragraph of that information sheet advises that combining buprenorphine with alcohol or other sedating medications is dangerous, and that combining buprenorphine with benzodiazepines has resulted in deaths.
Id.

101. On June 9, 2016, CA's urine drug screen tested positive for only buprenorphine. GE-10, at 93-95. This was abnormal based on the medications that CA reported he was taking. Tr. 217-18.

102. The prescriptions that Dr. Daniels wrote for CA on June 9, 2016, for Klonopin and Subutex predate any written documentation of Dr. Daniels actually seeing CA. Tr. 204; Stip. 22. Because these prescriptions were written prior to Dr. Daniels initially seeing CA, these prescriptions were issued outside of the course of medical practice in the State of Louisiana, and they were not issued for legitimate medical purposes. Tr. 204, 401-02.

103. On June 22, 2016, an assessment was completed for CA. Tr. 196; GE-10, at 51-53. The assessment indicates that CA had an opioid (oxycodone) addiction, and that another doctor had given CA a prescription for Subutex. Tr. 197, 521; GE-10, at 51. The assessment indicates that CA became addicted to oxycodone while being treated for abdominal pain, a hand fracture, and arthritis. Tr. 196, 521; GE-10, at 51. The assessment also indicates that CA had a history of ADHD for which he was taking Adderall, and he was taking Klonopin for anxiety. Tr. 196, 521-22, 524; GE-10, at 51. CA also had a history of TMJ. Tr. 521; GE-10, at 51. The assessment does not document a physical examination that would support prescriptions for controlled substances. Tr. 196-97; GE-10, at 53. The assessment also does not document a rationale for the controlled substances that Dr. Daniels prescribed. Tr. 198-99; GE-10, at 51-53. Because CA's chart does not support a diagnosis of ADHD, there is nothing in CA's chart that justified a prescription for Adderall. Tr. 322, 377.

104. The comments' section of the June 22, 2016 assessment is a handwritten partial treatment plan.
6

Tr. 406-07; GE-10, at 51-53. What is missing is a notation of follow-up, anticipated reaction to things that may go wrong or if the patient needs more medication. Tr. 407;
see also
Tr. 503. In addition, Louisiana law details specific information that must be contained in a treatment plan.
See
La. Admin. Code tit. 46, Pt. XLV, § 6921(A)(3).

6
This partial treatment plan is the same plan that is preprinted on Physician Intake Forms-the boilerplate treatment plan.
See, e.g.,
GE-6, at 25; GE-10, at 23.

105. Although the June 22, 2016 assessment indicated that another doctor had treated CA, there are no prior medical records in CA's medical file, nor was there a request for those records in the file. Tr. 197-98.

106. Dr. Daniels viewed CA's history, his answers, and his demeanor as being consistent with ADHD. Tr. 523. Based on CA's history and Dr. Daniels' examination of CA, he diagnosed CA with an opioid addiction, anxiety disorder, and ADHD. Tr. 522.

When asked about the physical examination he conducted of CA, Dr. Daniels testified that he looked at CA's person, place, and orientation; noted that CA's affect was “blunted and flat”; and observed that he was “depressed and anxious.” Tr. 521. This information was obtained from CA's mental status examination, however, not from a physical examination. Tr. 582; GE-10, at 52.

107. Dr. Daniels' treatment plan for CA included monthly urine drug screens, counseling, Subutex at his current dosage, Klonopin 1 mg TID, and Adderall 30 mg. Tr. 523; GE-10, at 53. Dr. Daniels acknowledged, however, that the justification for these prescriptions is not contained in CA's medical records.
Id.
He further testified these prescriptions were written to treat CA's medical condition he had diagnosed: Opioid addiction, anxiety, chronic abdominal pain, TMJ, and ADHD. Tr. 524; GE-6, at 53.

108. CA's medical file contains a Physician Intake Note dated July 26, 2017. Tr. 199; GE-10, at 34. The intake note contains the boilerplate treatment plan. GE-10, at 34. The intake note does not document: A physical examination; CA's responses to past treatment; or a

rationale for the prescriptions that Dr. Daniels issued to CA. Tr. 199; GE-10, at 34. In addition, the length of time between this documented encounter with CA and the previous documented encounter (more than a year), during which CA continued to get the same three prescriptions every month, is not consistent with the standard of care. Tr. 205-06; Stip. 22.

109. CA's medical file contains a Physician Intake Note dated September 13, 2017. Tr. 200; GE-10, at 23. The intake note contains the boilerplate treatment plan. GE-10, at 23. The intake note does not document: A physical examination,
*E

or a rationale for the prescriptions that Dr. Daniels issued to CA. Tr. 201; GE-10, at 23. It does have a comment that CA reported zero problems with current meds.
Id.
That comment, however, does not provide sufficient follow-up or history of his prior treatment with Dr. Daniels. Tr. 201-202.

*E
Although vital signs were taken for CA, Dr. Kennedy testified that they are not adequate to support the provision of controlled substances. Tr. 376-77; GE-10, at 51.

110. On June 9, 2016, CA's urine drug screen was positive for only buprenorphine. Tr. 217; GE-10, at 93-94. This was an abnormal urine drug screen because it was inconsistent with the medications he told the doctor he had been previously prescribed. Tr. 217-18.

111. On September 29, 2016, CA's urine drug screen was positive for only Subutex. Tr. 212; GE-10, at 87. This was an abnormal urine drug screen because it was inconsistent with the medications he was prescribed, whereas earlier tests were positive for those same medications. Tr. 212-13.

112. On October 18, 2016, November 16, 2016, December 7, 2016, and January 4, 2017, CA's urine drug screens were positive for benzodiazepines, Subutex, and methamphetamine. Tr. 208-212; GE-10, at 72-74, 97. *[Although CA was taking amphetamines, Dr. Kennedy testified that this would not make the urine drug test positive for methamphetamines. Tr. 209. Additionally, he testified that “this is an inconsistent result and we have to send it out to disprove that notion.” Tr. 210.]

113. A treatment note of January 11, 2017, indicates that CA was receiving a prescription of Adderall for ADHD, and a prescription of Klonopin for anxiety. GE-10, at 64. Someone other than Dr. Daniels signed this note.
Id.

114. On May 2, 2017, CA's urine drug screen was positive for Subutex, but negative for Adderall and Klonopin. Tr. 216; GE-10, at 18. CA had received prescriptions for all of these medications on April 5, 2017. GE-10, at 6. The results of this urine drug screen were abnormal. Tr. 216. On May 3, 2017, an unsigned, handwritten treatment note for CA indicates that his drug screen was positive, but does not indicate what it was positive for. GE-10, at 57. The treatment note also incorrectly indicates that the drug screen was negative for opioids.
Id.

115. On July 26, 2017, CA's urine drug screen was positive for buprenorphine, but negative for amphetamines and benzodiazepines. Tr. 216-17; GE-10, at 28, 30. CA had received prescriptions for all types of these medications on June 29, 2017. GE-10, at 3. The results of this urine drug screen were abnormal. Tr. 216-17.

116. On August 23, 2017, CA's urine drug screen was positive for buprenorphine, but it was negative for amphetamines and benzodiazepines. Tr. 214; GE-10, at 11-12. CA had received prescriptions for all types of these medications on July 26, 2017. GE-10, at 2. The results of this test were not normal. Tr. 214-15.

117. A review of Dr. Daniels' medical records of CA reveals no documentation that Dr. Daniels ever conducted a physical examination of CA, and those records provide no explanation of why Dr. Daniels prescribed Klonopin to him, other than CA's claim that he had a history of ADHD and anxiety, which was unsupported by any records. GE-10, at 1-97, 51; Tr. 322. * [The record does contain vital signs for CA, which Dr. Kennedy described as “part” of the physical examination. Tr. 316; GE-10, at 51.]

118. There are no discussions of any abnormal urine drug screens in CA's medial file. Tr. 214-15, 220. The failure to respond or document that response to abnormal urine drug screens makes it very difficult to conclude that the physician is engaged in “legitimate medical management in a patient who's receiving scheduled medications for any reason.” Tr. 219.

119. Between June 2016 and September 2017, Dr. Daniels was issuing CA prescriptions for Subutex, Klonopin, and Adderall, an opioid, a benzodiazepine, and an amphetamine. Tr. 203; Stip. 22.

120. In Dr. Kennedy's opinion, all the prescriptions Dr. Daniels wrote for CA, identified in Stipulation 22, were issued outside the course of medical practice and were not issued for a legitimate medical purpose. Tr. 206-07, 220.

Patient MN

121. On May 2, 2017, MN presented to the Clinic needing help with withdrawal symptoms due to a history of opioid dependence. GE-14, at 19. She stated that she was addicted to Subutex, which she claimed to have been taking for two years.
Id.
MN also reported that she had taken Klonopin in the past for depression and anxiety and was requesting a refill.
Id.

122. On May 2, 2017, MN signed a Patient Treatment Contract with Dr. Daniels. Tr. 327-28; GE-14, at 43. In paragraph 13 of the contract, MN agreed to abstain from alcohol, opioids, marijuana, cocaine, and other addictive substances. GE-14, at 43. Although MN signed this contract, it was not signed by Dr. Daniels or anyone else.
Id.

123. Paragraph 10 of the Patient Treatment Contract that MN signed on May 2, 2017, reads as follows: “I understand that mixing buprenorphine with other medications especially benzodiazepines (for example, Valium, Klonopin, or Xanax), can be dangerous. I also recognize that several deaths have occurred among persons mixing buprenorphine and benzodiazepines (especially if taken outside the care of a physician, using a route of administration other than sublingual or in higher than recommended therapeutic doses).” GE-14, at 43.

124. MN's medical file contains an assessment completed by a licensed clinical social worker on May 2, 2017. GE-14, at 19-28, 31-39.

125. On May 3, 2017, MN's urine drug screen was positive for ecstasy, THC, and Subutex. Tr. 222, 327; GE-14, at 41. The presence of ecstasy and marijuana indicates that MN was abusing drugs. Tr. 222.

126. On May 3, 2017, Dr. Daniels entered a “very limited note”
7

in MN's medical record that Suboxone gave MN headaches. Tr. 527, 583-84; GE-14, at 29. The note does not include a subjective complaint, any objective findings, any assessment of MN's conditions, or a medical treatment plan. GE-14, at 29. That same day, Dr. Daniels wrote prescriptions to MN for 8 mg Subutex TID, and 2 mg Klonopin BID. Stip. 24; GE-14, at 5. Then on May 31, 2017, Dr. Daniels again wrote a prescription to MN for 8 mg Subutex TID, but he modified the prescription for 2 mg Klonopin to TID. GE-14, at 4; Stip. 24. Because these prescriptions were written prior to Dr. Daniels documenting sufficient information into MN's medical record, these prescriptions were issued outside of the usual course of professional practice in

the State of Louisiana, and not for a legitimate medical purpose. Tr. 163, 401-02.

7
Dr. Daniels explained that it was a limited note because “sometimes with interruptions in the clinic, you get limited information to put in the chart.” Tr. 527.

127. MN's medical file contains a Physician Intake Note dated June 28, 2017. Tr. 221; GE-14, at 14. The intake note contains the boilerplate treatment plan. GE-14, at 14. The intake note does not document: A physical examination; MN's responses to past treatment; or a rationale for the prescriptions that Dr. Daniels issued to MN. GE-14, at 14. The MD note of May 3, 2017, and this intake note are the only notes in MN's file that document an encounter between Dr. Daniels and MN. Tr. 221; GE-14.

128. When asked whether he had a physical encounter with MN, Dr. Daniels testified that he did not “see a document of physical encounter.” Tr. 527. Although there is no documentation of a physical encounter, he testified that he did see her and he did conduct a physical examination.
8

Tr. 527-28. Dr. Daniels also testified, however, that he diagnosed MN as having an opioid addiction based on her history. Tr. 528-29.

8
Earlier, however, Dr. Daniels testified that, “After looking at the notes, I just remember the encounter. I don't remember from just my memory though.” Tr. 525.

129. There is nothing in Dr. Daniels' medical record concerning MN that documents that Dr. Daniels diagnosed MN's medical condition. Tr. 582.

130. A treatment plan for MN would have included a discussion of how Dr. Daniels was going to wean MN off of Subutex, the substance she claimed she was addicted to. Tr. 408-09. As of May 3, 2017, Dr. Daniels' treatment plan for MN only included Subutex 8 mg TID and Klonopin. Tr. 529; GE-14, at 29.

131. On June 28, 2017, MN's urine drug screen was positive for only Subutex. Tr. 223; GE-14, at 10. This drug screen was abnormal because it should have been positive for a benzodiazepine, having received a prescription for Klonopin on May 31, 2017. Tr. 223-24; Stip. 24.

132. On July 28, 2017, MN's urine drug screen was positive for ecstasy, Subutex, and methamphetamines, and negative for benzodiazepines. Tr. 224; GE-14, at 8. This is a “wildly abnormal” drug screen. Tr. 224-25. * [Dr. Kennedy testified that “to have a drug screen like this, and to make absolutely no comment in the medical record, did not make any comment with addressing the patient about it, or what you plan to do about this, is in my view, inexcusable.” Tr. 226. Further, he stated that “to continue providing this patient with scheduled medications without comment, in my view, is not medically legitimate.”
Id.
]

133. On August 29, 201[7] *, MN received prescriptions for Subutex and Klonopin, written by Dr. Daniels, but there is no documentation in MN's medical file of an encounter with Dr. Daniels that day. Tr. 228; GE-14, at 1; Stip. 24. * [Dr. Kennedy testified that “every single prescription for a scheduled medication, in my opinion, must be accounted for.” Tr. 233. He clarified that when writing new prescription, there must be something documenting that prescription in the medical record.
Id.
]

134. There are no discussions of any abnormal urine drug screen in MN's medical file. Tr. 226-27; GE-14. The failure to respond or document a response to abnormal urine drug screens makes it very difficult to conclude that the physician is engaged in “legitimate medical management in a patient who's receiving scheduled medications for any reason.” Tr. 219.

135. A review of Dr. Daniels' medical records of MN reveals no documentation that Dr. Daniels ever conducted a physical examination of MN, and those records provide no explanation of why Dr. Daniels prescribed Klonopin to her, other than that she had been prescribed it in the past, and she had requested a refill. GE-14, at 1-47, 19.

136. In Dr. Kennedy's opinion, all the prescriptions identified in Stipulation 24, issued to MN, were issued outside the course of acceptable medical practice and were not issued for a legitimate medical purpose. Tr. 231. Dr. Kennedy's opinion was based upon: The absence of drug screening documentation; the absence of medical records; no documentation that MN's PMP was reviewed; no evidence of a credible physical examination; and the absence of any documented discussions with MN that would establish a valid doctor-patient relationship. Tr. 231-32.

Patient JD

137. On August 3, 2016, JD signed a Patient Treatment Contract with Dr. Daniels. GE-15, at 30. In paragraph 13 of the contract, JD agreed to abstain from alcohol, opioids, marijuana, cocaine, and other addictive substances.
Id.

138. Paragraph 10 of the Patient Treatment Contract that JD signed on August 3, 2016, reads as follows: “I understand that mixing buprenorphine with other medications especially benzodiazepines (for example, Valium, Klonopin, or Xanax), can be dangerous. I also recognize that several deaths have occurred among persons mixing buprenorphine and benzodiazepines (especially if taken outside the care of a physician, using a route of administration other than sublingual or in higher than recommended therapeutic doses).” GE-15, at 30.

139. On August 3, 2016, JD signed a Patient Information and Consent to Treatment with Buprenorphine and Suboxone. GE-15, at 32. The fourth paragraph of that information sheet advises that combining buprenorphine with alcohol or other sedating medications is dangerous, and that combining buprenorphine with benzodiazepines has resulted in deaths.
Id.

140. On August 3, 2016, JD signed a Patient Agreement to Participate in Suboxone Treatment. Tr. 332; GE-15, at 29. At the end of each paragraph is a space for the patient's initials, but there are no initials there.
Id.
Dr. Daniels did not sign the Agreement; a counselor signed it instead. GE-15, at 29.

141. On August 3, 2016, JD presented to Dr. Daniels with a history of back pain, and indicated that he had a prior prescription for Lortab. Tr. 235, 531; GE-15, at 22. JD also reported that he had taken Percocet and methadone off the streets, and that he had used Subutex for two years.
Id.
Dr. Daniels signed and dated this handwritten assessment on August 10, 2016. Tr. 235; GE-15, at 22-23. This is the only documented encounter between JD and Dr. Daniels. Tr. 235; GE-15.

142. A review of Dr. Daniels' medical records of JD reveals no documentation: That he obtained JD's prior medical records; that Dr. Daniels ever conducted a physical examination of JD;
*F

or that he developed an appropriate treatment plan for JD. Tr. 235-36; GE-15, at 1-35.

*F
The JD file does include vital signs, which Dr. Kennedy testified is part of the physical examination, but not adequate by itself to meet the standard of care and usual course of professional practice. Tr. 329; GE-15, at 22.

143. Dr. Daniels' assessment of JD does not document a treatment plan (other than the boilerplate treatment plan) and it does not provide a rationale for the controlled substances prescribed to JD. Tr. 236, 330, 532; GE-15, at 22-23.

144. On August 3, 2016, JD's urine drug screen was positive for only Subutex. Tr. 532; GE-15, at 26. A counselor signed this urine drug screen. Tr. 330; GE-15, at 26. A physician should have signed the urine drug screen. Tr. 331, 380-81.

145. Over the 13 months that Dr. Daniels treated JD, there is only one encounter note. Tr. 235, 237; GE-15. Dr. Kennedy testified that one encounter followed by a year's worth of the maximum dosage of buprenorphine, is clearly outside the course of acceptable

medical practice anywhere in the United States. Tr. 238-39.

146. In Dr. Kennedy's opinion, all the prescriptions Dr. Daniels issued to JD, identified in Stipulation 27, were issued outside the course of acceptable medical practice and were not issued for a legitimate medical purpose. Tr. 238. Dr. Kennedy's opinion was based upon the absence of follow-up care after the initial encounter.
Id.

Patient SB

147. On January 17, 2017, SB signed a Patient Treatment Contract with Dr. Daniels. Tr. 340; GE-17, at 17. In paragraph 13 of the contract, SB agreed to abstain from alcohol, opioids, marijuana, cocaine, and other addictive substances. GE-17, at 17.

148. Paragraph 10 of the Patient Treatment Contract that SB signed on January 17, 2017, reads as follows: “I understand that mixing buprenorphine with other medications especially benzodiazepines (for example, Valium, Klonopin, or Xanax), can be dangerous. I also recognize that several deaths have occurred among persons mixing buprenorphine and benzodiazepines (especially if taken outside the care of a physician, using a route of administration other than sublingual or in higher than recommended therapeutic doses).” GE-17, at 17.

149. On January 17, 2017, SB signed a Patient Agreement to Participate in Suboxone Treatment. Tr. 337-38; GE-17, at 18. At the end of each paragraph is a space for the patient's initials, but only half of the spaces were initialed.
Id.
A counselor signed this Agreement, rather than Dr. Daniels. GE-17, at 18.

150. On January 17, 2017,
*G

SB signed a Patient Information and Consent to Treatment with Buprenorphine and Suboxone. GE-17, at 31. The fourth paragraph of that information sheet advises that combining buprenorphine with alcohol or other sedating medications is dangerous, and that combining buprenorphine with benzodiazepines has resulted in deaths.
Id.

*G
It appears that the patient mistakenly marked this with the year 2016 and so I have edited the RD to reflect 2017. In GE-17, at 17, the patient's signature year of “16” is crossed out and hand-edited to state “17” and the physician's signature lists 2017.
See
GE-17, at 17 and 18. The record demonstrates that SB first came to the clinic in January 2017. It is logical, based on these other records, that the patient was simply confused about the new year in signing this form.

151. On a January 18, 2017 Physician Intake Note, Dr. Daniels noted that SB had a history of recreational drug abuse, heroin abuse, and severe panic attacks. Tr. 239, 333, 533-34; GE-17, at 15. The Note states that SB had previously been treated with Suboxone, but developed hives as a side effect. Tr. 534; GE-17, at 15. This Note is the only documentation of Dr. Daniels' assessment of SB, other than an undated, unsigned “Physician Assessment” in SB's medical file that does not bear the name of a patient. Tr. 239-40; GE-17, at 27-28. Neither the Note nor the Assessment documents a physical examination of SB. Tr. 240, 333; GE-17, at 15, 27-28. In addition, neither the Note nor the Assessment documents a rationale for the medications Dr. Daniels prescribed to SB. Tr. 243; GE-17, at 15, 27-28.

152. Although the Intake Note indicates that SB was treated with Suboxone in Dallas, the medical records request form was not completed and there are no prior medical records in SB's medical file. Tr. 241; GE-17, at 29.

153. On January 18, 2017, SB's urine drug screen tested positive for methamphetamine, THC and Subutex. Tr. 336, 534; GE-17, at 16. Dr. Daniels did not document any discussions with SB about this abnormal urine drug screen. Tr. 243. In light of this abnormal drug screen, Dr. Daniels should have provided a rationale for his decision to treat SB. Tr. 337. On July 14, 2017, SB's urine drug screen tested positive for Klonopin, Subutex, fluoxetine, norfluoxetine, and cTHC. GE-17, at 8, 10-11. The lab report indicates that a source for fluoxetine includes Prozac.
Id.
at 8. On her patient intake form, SB indicated that she had previously taken Prozac.
Id.
at 24-25.

154. While Dr. Daniels did not make a note of it in the file, he testified that the general recommendation for a drug screening that was positive for marijuana and methamphetamine would have been more frequent counseling.
9

Tr. 534-35.

9
The medical records in this case, however, do not document an instance where Dr. Daniels increased the frequency of counseling based upon an abnormal urine drug screen. Further, although SB had an abnormal urine drug screen on January 18, 2017, GE-17, at 13,
see supra
FF 154, SB's treatment plan with respect to counseling is identical to those of other patients who had not initially tested positive for marijuana or methamphetamines. GE-10, at 34; GE-17, at 15; GE-23, at 8. In fact, Dr. Daniels' medical records concerning SB do not document that she ever returned to the Clinic for follow-up treatment or counseling, though she did receive monthly prescriptions of Subutex and Klonopin for another six months after her initial appointment. GE-17; Stip. 29.

155. A review of Dr. Daniels' medical records of SB reveals no documentation that Dr. Daniels ever conducted a physical examination of SB, and those records provide no explanation of why Dr. Daniels prescribed Klonopin to her, other than that she had a history of severe panic attacks. GE-17, at 1-32, 15.

156. In Dr. Kennedy's opinion, all the prescriptions issued to SB, identified in Stipulation 29, were issued outside the course of acceptable medical practice and were not issued for a legitimate medical purpose. Tr. 244. Dr. Kennedy's opinion was based upon SB being a young woman of reproductive age, who had a history of heroin abuse, issues with alcohol, an abnormal drug screen, and an absence of documentation to explain treatment.
Id.
*[Dr. Kennedy testified that, “there was, in essence, in [his] view, no medical care here, simply the provision of scheduled prescriptions.”
Id.
]

Patient CM

157. On May 2, 2016, CM's urine drug screen tested positive for buprenorphine and cTHC. GE-18, at 34, 36.

158. On May 3, 2016, CM signed a Patient Treatment Contract with Dr. Daniels. GE-18, at 45. In paragraph 13 of the contract, CM agreed to abstain from alcohol, opioids, marijuana, cocaine, and other addictive substances.
Id.

159. Paragraph 10 of the Patient Treatment Contract that CM signed on May 3, 2016, reads as follows: “I understand that mixing buprenorphine with other medications especially benzodiazepines (for example, Valium, Klonopin, or Xanax), can be dangerous. I also recognize that several deaths have occurred among persons mixing buprenorphine and benzodiazepines (especially if taken outside the care of a physician, using a route of administration other than sublingual or in higher than recommended therapeutic doses).” GE-18, at 45.

160. On May 3, 2016, CM signed a Patient Information and Consent to Treatment with Buprenorphine and Suboxone. GE-18, at 41. The fourth paragraph of that information sheet advises that combining buprenorphine with alcohol or other sedating medications

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2021-24206. Public record. Not legal advice.