Mark Fenzl, D.O.; Decision and Order, 17520-17524 [2024-05099]

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All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.3 This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission’s Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)). By order of the Commission. Issued: March 5, 2024. Lisa Barton, Secretary to the Commission. [FR Doc. 2024–05041 Filed 3–8–24; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 22–51] Mark Fenzl, D.O.; Decision and Order On August 11, 2022, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) and Immediate Suspension Order (ISO) to Mark Fenzl, M.D. (Respondent), of Florida immediately suspending and seeking to revoke his DEA Certificate of Registration, Control No. FF7471840, and alleging that his ‘‘continued registration is inconsistent with the public interest.’’ OSC, at 1 (citing 21 U.S.C. 823(g)(1) 1). A hearing was held before DEA Administrative Law Judge Teresa A. Wallbaum (the ALJ). On April 10, 2023, the ALJ issued her Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision (RD), which recommended that the Agency revoke Respondent’s registration. RD, at 40. Respondent did not timely file exceptions to the RD.2 Having reviewed 2 All contract personnel will sign appropriate nondisclosure agreements. 3 Electronic Document Information System (EDIS): https://edis.usitc.gov. 1 Effective December 2, 2022, the Medical Marijuana and Cannabidiol Research Expansion Act, Public Law 117–215, 136 Stat. 2257 (2022) (Marijuana Research Amendments or MRA), amended the Controlled Substances Act (CSA) and other statutes. Relevant to this matter, the MRA redesignated 21 U.S.C. 823(f), cited in the OSC, as 21 U.S.C. 823(g)(1). Accordingly, this Decision cites to the current designation, 21 U.S.C. 823(g)(1), and to the MRA-amended CSA throughout. 2 On May 8, 2023, after the deadline to file exceptions passed and the ALJ certified the record to the Administrator, Respondent submitted a document entitled ‘‘Appeal to the Drug Enforcement Agency Administrator.’’ Respondent’s document appears to be an untimely attempt to file exceptions to the RD. See 21 CFR 1316.66(a), 1316.67. On that basis, they were not considered in this Decision. Further, even if these exceptions had PO 00000 Frm 00149 Fmt 4703 Sfmt 4703 the entire record, the Agency, except as noted below,3 adopts and hereby incorporates by reference the entirety of the ALJ’s rulings, credibility findings,4 findings of fact, conclusions of law, and recommended sanction in the RD and summarizes, expands upon, and clarifies portions thereof herein. I. Findings of Fact The Agency finds from clear, unequivocal, and convincing evidence that Respondent committed numerous failures in his prescribing conduct that fell below the standard of care in Florida. Specifically, the Agency finds that from June 2020 through April 2022, Respondent issued controlled substances to Patients J.H., C.K., G.K., and J.K. without a legitimate medical purpose, outside the usual course of professional practice, and beneath the standard of care in Florida. See RD, at 17–30. Florida Standard of Care Dr. Lynch provided expert testimony on the applicable standard of care for prescribing controlled substances in Florida.5 RD, at 6–7, 11–17; Tr. 141– been timely submitted, they contain arguments raised by Respondent in earlier filings that were addressed by the ALJ, lack the required specific and complete citations to the record, are contradicted or unsupported by the record, and/or otherwise lack merit. Accordingly, the Agency finds these untimely exceptions to be unpersuasive. See Yogeshwar Gill, M.D., 88 FR 55,076, 55,076 n.3 (2023). 3 See footnote 14, infra. 4 The Agency adopts the ALJ’s summary of each of the witnesses’ testimonies as well as the ALJ’s assessment of each of the witnesses’ credibility. See RD, at 3–11. The Agency agrees with the ALJ that the testimony by the Diversion Investigator (DI), which focused on the investigative steps completed in the case and establishing the foundations for many of the exhibits received into the record, was sufficiently detailed, plausible, and internally consistent to be afforded full credibility. See id. at 5–6. The Agency also agrees with the ALJ’s assessment that Dr. Paul Lynch, M.D., the Government’s expert witness, was reliable and persuasive. See id. at 6. His testimony was based on extensive relevant experience and consistent with applicable Florida law, and Respondent was unpersuasive in his efforts to challenge Dr. Lynch’s objectivity and reliability. See id. at 7. Regarding Respondent’s testimony, the Agency adopts the ALJ’s assessment that although Respondent testified candidly, his recollection was unreliable and at times contradicted by documentary evidence. See id. at 11. Therefore, the ALJ appropriately gave his testimony limited weight. See id. at 11. As the ALJ noted, Respondent’s testimony on Florida’s standard of care was vague, and he characterized pain management as an ‘‘area of weakness’’ for him. See id. at 11 (quoting Tr. 516–17). Accordingly, consistent with the ALJ’s findings, to the extent that Respondent disagreed with Dr. Lynch’s testimony regarding the Florida standard of care governing pain management, the Agency gives controlling weight to Dr. Lynch’s testimony. See id. at 11. 5 The Agency adopts and incorporates by reference the entirety of the ALJ’s findings regarding the standard of care in Florida and the related summary of Dr. Lynch’s expert testimony. E:\FR\FM\11MRN1.SGM 11MRN1 ddrumheller on DSK120RN23PROD with NOTICES1 Federal Register / Vol. 89, No. 48 / Monday, March 11, 2024 / Notices 473. According to Dr. Lynch, the standard of care stems from state statutes and additional, established practices that supplement, or expand upon, those statutes. RD, at 11; Tr. 149, 263–64. The standard of care requires the pain management practitioner to take a ‘‘complete medical history.’’ RD, at 13; Fla. Stat. § 456.44(3)(a). A thorough medical history should include a review of prior treatments and tests and a social history regarding possible substance abuse or mental health issues. RD, at 13; Tr. 157–59. The Florida standard of care also requires a physical examination before prescribing controlled substances and at each subsequent visit where controlled substances are prescribed. RD, at 13; Tr. 165–66, 349; see also Fla. Stat. § 456.44(3)(a). For any visit, the standard of care requires taking and recording vital signs. RD, at 13; Tr. 308. The physician must document and discuss abnormal vital signs, and failing to follow up on a patient with higherthan-normal vital signs is ‘‘significantly outside the standard of care.’’ RD, at 13– 14; Tr. 310, 345–48, 394–95. For pain management, the physical examination must involve a targeted examination of the area of pain and a ‘‘neurologic or behavioral interaction with the patient’’ to look for signs of intoxication. RD, at 13; Tr. 166, 437–38. When patients have a spinal issue, the standard of care includes an examination of all four extremities for strength, sensation, reflexes, and range of motion. RD, at 13; Tr. 166. The failure to even touch a patient in a physical exam for more than two years ‘‘is considerably outside the standard of care.’’ RD, at 13; Tr. 312. While the standard of care ‘‘is pretty broad on how frequent imaging should be,’’ it typically requires new images every two to three years. RD, at 13; Tr. 321. It is not, however, sufficient to simply order imaging; the patient must obtain the image. RD, at 13; Tr. 339–40. In this case, the physical examinations often stated simply that a patient was ‘‘Alert, Responsive, Interactive, which means they’re just there, that they showed up, that they’re alive.’’ RD, at 13; Tr. 261– 62. Such a physical examination is ‘‘not an appropriate exam,’’ and does not satisfy the requirement in Florida Statutes Section 456.44 that a physician must conduct a physical examination sufficient to establish an appropriate diagnosis that justifies prescribing controlled substances. RD, at 14; Tr. 262. The Florida standard of care requires a pain management physician to engage in regular patient visits and ongoing monitoring ‘‘to look for risk factors of VerDate Sep<11>2014 18:24 Mar 08, 2024 Jkt 262001 abuse or misuse or diversion of the medications.’’ RD, at 14; Tr. 164–65; see also Fla. Stat. § 456.44(3)(d). One method of monitoring is the legal requirement to check the Prescription Drug Monitoring Program (PDMP) each time a practitioner writes a controlled substance prescription, which allows a practitioner to determine if the patient is obtaining the same drugs from another doctor or frequenting different pharmacies. RD, at 14; Tr. 169–70. Another method of monitoring is urine drug screening and testing with documentation of the results in the patient’s record. RD, at 14; Tr. 216–18, 223–24. If there are signs of an abnormal or aberrant drug test result, Florida law establishes the steps a practitioner must take to address that aberrant result. RD, at 15; Tr. 169, 224, 247–48; see also Fla. Stat. § 456.44(3)(g). Evidence of diversion exists if a patient fails to test positive for a controlled substance that is currently being prescribed. RD, at 15; Tr. 224. If there are signs of diversion, Florida Statutes Section 456.44 requires that the practitioner stop prescribing the controlled substance and discharge the patient. RD, at 15; Tr. 169, 247–48; see also Fla. Stat. § 456.44(3)(g). Evidence of abuse exists if a patient tests positive for a substance that is not prescribed or for an illicit substance. RD, at 15; Tr. 224– 25, 370–71. If there is evidence of abuse, Section 456.44 requires the practitioner to refer the patient to an addiction medicine specialist.6 RD, at 15; Tr. 169, 224–25; see also Fla. Stat. § 456.44(3)(g). While there is a gray area on whether it could be acceptable to continue to prescribe opioids when there are signs of abuse, in ‘‘most cases of abuse of cocaine [and] methamphetamine’’ the continued prescribing would not be within the standard of care because of the risk of death. RD, at 15; Tr. 248–50. Prescribing doses of opioids with a high Morphine Milligram Equivalent (MME) 7 caries significant risks, including risk of death. RD, at 16; Tr. 257–58. Moreover, prescribing a combination of an opioid, a benzodiazepine, and a muscle relaxant (here, carisoprodol) is dangerous 6 An addiction medicine specialist is defined as a board-certified psychiatrist with a subspecialty certification or eligible for certification in addiction medicine, an addiction medicine physician certified or eligible for certification by the American Society of Addiction Medicine, or an osteopathic physician who holds a certificate of added qualification in addiction medicine through the American Osteopathic Association. RD, at 15 n.16; Fla. Stat. § 456.44(1)(b). 7 MME is a standard that determines how powerful a particular medication is by comparing the prescribed medication and dosage to the original standard of morphine, historically used to manage pain. RD, at 16; Tr. 257–58. PO 00000 Frm 00150 Fmt 4703 Sfmt 4703 17521 because together they produce a risk of synergistic respiratory depression; this ‘‘leads to a patient that’s heavily sedated and is [at] high risk for overdose and death.’’ 8 RD, at 16 (quoting Tr. 256–57). The combination, known as ‘‘the cocktail, the Houston cocktail, the trinity, [or] the holy trinity,’’ is ‘‘sought after’’ due to the ‘‘particularly powerful high to the patient.’’ RD, at 16 (quoting Tr. 256). Documentation is a requirement under the Florida standard of care. RD, at 17; Tr. 160–61. ‘‘The medical record shall . . . document the presence of one or more recognized medical indications for the use of a controlled substance.’’ Fl. Stat. § 456.44(3)(a); RD, at 17; see also Fl. Stat. § 456.44(3)(f); Tr. 160–61. In addition to documenting the physical examination, ‘‘the medical record must, at a minimum, document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, a review of previous medical records, previous diagnostic studies, and history of alcohol and substance abuse.’’ RD, at 17 (quoting Tr. 160); Fla. Stat. § 456.44(3)(a). Documentation is also important for the purposes of periodic review of the plan and continuation of treatment by another physician. RD, at 17; Tr. 159–60. Generally, having a ‘‘clear and complete and accurate’’ medical record ‘‘is really important for the practice of medicine.’’ RD, at 17 (quoting Tr. 171). The Florida standard of care does not create a separate standard for practitioners who ‘‘inherit’’ patients on controlled substance prescriptions. RD, at 12; Tr. 298–99. In other words, regardless of whether a patient is currently on controlled substance medications prescribed by another doctor, the Florida statute and standard of care require any practitioner to take a medical history and conduct an appropriate physical examination before prescribing and require practitioners to revisit prior plans on a regular basis to see if the controlled substance prescriptions are effective. RD, at 12; Tr. 213, 298–99. The Patients Patient J.H. Regarding Patient J.H., the Agency finds that Respondent issued controlled substance prescriptions for morphine, 8 The Food and Drug Administration (FDA) has issued a warning—the so-called ‘‘Black Box Warning’’—regarding the risks of prescribing opioids and benzodiazepines in combination. RD, at 16; Tr. 173–80, 182; GX 15–17. E:\FR\FM\11MRN1.SGM 11MRN1 17522 Federal Register / Vol. 89, No. 48 / Monday, March 11, 2024 / Notices oxycodone, carisoprodol,9 and diazepam 10 from July 2020 through February 2022 without a legitimate medical purpose, outside the usual course of professional practice, and beneath the standard of care in Florida. See RD, at 17–21; GX 6, 20; Tr. 200, 262–63. Based on Dr. Lynch’s testimony and the record as a whole, these prescriptions were issued without a legitimate medical purpose, outside the usual course of professional practice, and beneath the standard of care because Respondent failed to (1) establish an appropriate diagnosis to justify the controlled substance prescriptions (RD, at 17–18; GX 6, 20; Tr. 199, 201–03, 207, 211–14, 252, 255– 56, 262); (2) establish an appropriate medical justification for high-risk combination prescriptions with highrisk MMEs (RD, at 20–21; GX 6, 20; Tr. 250, 253–54, 256–57, 259–61); (3) appropriately address potential signs of abuse and diversion, despite at least seven aberrant drug test results (RD, at 18–20; GX 6; Tr. 204, 217, 219, 221–25, 227–31, 233–35, 238, 246–48); and (4) maintain adequate medical records with sufficient documentation 11 (RD, at 21; GX 6; Tr. 261–62). ddrumheller on DSK120RN23PROD with NOTICES1 Patient C.K. Regarding Patient C.K., the Agency finds that Respondent issued controlled substance prescriptions for hydrocodone,12 carisoprodol, and alprazolam 13 from July 2020 through April 2022 without a legitimate medical purpose, outside the usual course of professional practice, and beneath the standard of care in Florida. See RD, at 9 Carisoprodol is a Schedule IV controlled substance sold under the brand name Soma. Prehearing Ruling, at 2. The generic name (carisoprodol) is used in this decision. 10 Diazepam is a Schedule IV controlled substance sold under the brand name Valium. Prehearing Ruling, at 2. The generic name (diazepam) is used in this decision. 11 Respondent asserted that some documentation related to the four patients was missing from the medical files produced through the Government’s administrative subpoenas and admitted into evidence as Government Exhibits 6, 8, 10, and 12. RD, at 36; Tr. 496–97, 500–07. The Agency has considered Respondent’s claims regarding missing documentation. In agreement with the ALJ, any missing documentation does not change the outcome of this Decision. See RD, at 36–37. As Dr. Lynch reliably testified, any missing documents relate to only portions of the patients’ treatment, and there are numerous other examples of prescribing that fell well below the standard of care. RD, at 37. 12 Hydrocodone is a Schedule II controlled substance. Prehearing Ruling, at 2. Norco is a brand name medication that contains hydrocodone. Id. The generic name (hydrocodone) is used in this decision. 13 Alprazolam is a Schedule IV controlled substance sold under the brand name Xanax. Prehearing Ruling, at 2; Tr. 182. The generic name (alprazolam) is used in this decision. VerDate Sep<11>2014 18:24 Mar 08, 2024 Jkt 262001 22–24; GX 8, 21; Tr. 312–15. Based on Dr. Lynch’s testimony and the record as a whole, these prescriptions were issued without a legitimate medical purpose, outside the usual course of professional practice, and beneath the standard of care because Respondent failed to (1) establish an appropriate diagnosis to justify the controlled substance prescriptions (RD, at 22; GX 8, 21; Tr. 269–74); (2) adequately address signs of potential abuse and diversion, despite at least two aberrant drug test results (RD, at 22–23; GX 8; Tr. 277–86, 502–03); (3) appropriately address C.K.’s dangerous vital signs (RD, at 23; GX 8; Tr. 300–01, 303–07, 309); (4) establish an appropriate medical justification for high-risk combinations (RD at 23–24; GX 8, 21; Tr. 311–12); and (5) maintain adequate medical records with sufficient documentation (RD, at 24; GX 8; Tr. 308–09, 311–12). Patient G.K. Regarding Patient G.K., the Agency finds that Respondent issued controlled substance prescriptions for morphine, oxycodone, carisoprodol, and alprazolam from June 2020 through April 2022, without a legitimate medical purpose, outside the usual course of professional practice, and beneath the standard of care in Florida.14 See RD, at 25–27; GX 10, 22; Tr. 353–54. Based on Dr. Lynch’s testimony and the record as a whole, these prescriptions were issued without a legitimate medical purpose, outside the usual course of professional practice, and beneath the standard of care because Respondent failed to (1) establish an appropriate diagnosis to justify the controlled substance prescriptions (RD, at 25; GX 10, 22; Tr. 322–23, 325–26, 328–29, 331–37); (2) appropriately address G.K.’s dangerous vital signs (RD, at 25–26; GX 10; Tr. 344–47, 350–52); (3) establish an appropriate medical justification for high-risk combination prescriptions with high-risk MMEs (RD, at 26; GX 10, 22; Tr. 340–43, 352–54); and (4) maintain adequate medical records with sufficient documentation (RD, at 26; GX 10; Tr. 352–54). Patient J.K. Regarding Patient J.K., the Agency finds that Respondent issued controlled substance prescriptions for morphine, 14 The ALJ noted that Respondent also issued prescriptions to G.K. for the Schedule V controlled substance pregabalin (sold under the brand name of Lyrica). RD, at 25–26. As Respondent’s prescribing of pregabalin was not included in the OSC/ISO, the Agency does not make any findings on the prescribing of this controlled substance. PO 00000 Frm 00151 Fmt 4703 Sfmt 4703 oxycodone, and lorazepam 15 from August 2020 through April 2022 and carisoprodol from July 2020 through January 2022 without a legitimate medical purpose, outside the usual course of professional practice, and beneath the standard of care in Florida. See RD, at 27–30; GX 12, 23; Tr. 397– 98. Based on Dr. Lynch’s testimony and the record as a whole, these prescriptions were issued without a legitimate medical purpose, outside the usual course of professional practice, and beneath the standard of care because Respondent failed to (1) establish an appropriate diagnosis to justify the controlled substance prescriptions (RD, at 27–28; GX 12, 23; Tr. 359–67, 387–89); (2) adequately address signs of potential abuse and diversion, despite at least two aberrant drug test results (RD, at 28; GX 12; Tr. 370–78, 385, 496–97); (3) appropriately address J.K.’s dangerous vital signs (RD, at 29; GX 12; Tr. 391–96); (4) establish an appropriate medical justification for high-risk combination prescriptions with high-risk MMEs (RD, at 29; GX 12, 23; Tr. 389–90); and (5) maintain adequate medical records with sufficient documentation (RD, at 29–30; GX 12; Tr. 396–97). II. Discussion Under the CSA, ‘‘[a] registration . . . to . . . dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined under such section.’’ 21 U.S.C. 824(a). The CSA requires that the Agency consider the following factors for the public interest determination: (A) The recommendation of the appropriate State licensing board or professional disciplinary authority. (B) The [registrant]’s experience in dispensing, or conducting research with respect to controlled substances. (C) The [registrant]’s conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances. (D) Compliance with applicable State, Federal, or local laws relating to controlled substances. (E) Such other conduct which may threaten the public health and safety. 21 U.S.C. 823(g)(1). 15 Lorazepam is a Schedule IV controlled substance sold under the brand name Ativan. Prehearing Ruling, at 3; Tr. 355. The generic name (lorazepam) is used in this decision. E:\FR\FM\11MRN1.SGM 11MRN1 Federal Register / Vol. 89, No. 48 / Monday, March 11, 2024 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 The Agency considers these public interest factors in the disjunctive. Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each factor is weighed on a caseby-case basis. Morall v. Drug Enf’t Admin., 412 F.3d 165, 173–74 (D.C. Cir. 2005). Any one factor, or combination of factors, may be decisive. David H. Gillis, M.D., 58 FR 37507, 37508 (1993). The inquiry is ‘‘focuse[d] on protecting the public interest.’’ Jayam Krishna-Iyer, M.D., 74 FR 459, 462 (2009). The Government has the burden of proof in this proceeding. 21 CFR 1301.44. While the Agency has considered all of the public interest factors in 21 U.S.C. 823(g)(1), the Government’s evidence in support of its prima facie case for revoking Respondent’s registration is confined to Factors B and D. See RD, at 31 n.50 (finding that Factors A, C, and E do not weigh for or against the sanction sought by the Government). Factors B and D Evidence is considered under Public Interest Factors B and D when it reflects compliance (or non-compliance) with laws related to controlled substances and experience dispensing controlled substances. See Sualeh Ashraf, M.D., 88 FR 1095, 1097 (2023); Kareem Hubbard, M.D., 87 FR 21156, 21162 (2022). DEA regulations require that for a controlled substance prescription to be effective, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. 21 CFR 1306.04(a). Based on Dr. Lynch’s reliable and persuasive expert opinion, the Agency finds that Respondent issued controlled substance prescriptions outside of the usual course of professional practice and beneath the Florida standard of care in violation of federal law. See supra Section I. Further, the Agency finds that Respondent violated Florida Statutes Section 456.44(3) with regard to Patients J.H., C.K., G.K., and J.K., by failing to take proper medical histories and conduct adequate medical examinations that supported prescribing controlled substances and/or failing to monitor the patients’ medication compliance and address signs of abuse and/or diversion.16 RD, at 34. The Agency also finds that for each of the four patients at issue, Respondent failed to maintain sufficiently detailed medical records that properly documented a diagnosis 16 While Respondent argued that the patients were being treated by a drug and alcohol counselor, that counselor was not a psychiatrist or an addiction medicine specialist under Florida law. RD, at 34; Tr. 586; see Fla. Stat. § 456.44; see also Tr. 168–69. VerDate Sep<11>2014 18:24 Mar 08, 2024 Jkt 262001 for each patient that supported prescribing controlled substances, thereby violating Florida Statutes Section 456.44(3) and Florida Administrative Code Rule 64B8–9.003. Respondent’s arguments fail to refute the evidence of unlawful and inappropriate prescribing. Although Respondent testified to his positive behavior of discharging approximately forty percent of one clinic’s patients, such positive behavior cannot outweigh the evidence of prescribing contrary to the public interest. RD, at 33; Tr. 486, 489–90; see, e.g., Ester Mark, M.D., 86 FR 16760, 16771 (2021); Randall L. Wolff, M.D., 77 FR 5106, 5153 (2012). Nor do his broad arguments on the effects of the Government’s enforcement decisions on pain clinics and the populations they serve undermine the Government’s prima facie case. RD, at 34–35; see Stephen E. Owusu, D.P.M., 87 FR 3343, 3351 n.21 (2022) (‘‘the Agency has consistently held that community impact is not a relevant consideration under the public interest factors’’); George Pursley, M.D., 85 FR 80162, 80188 n.82 (2020); Frank Joseph Stirlacci, M.D., 85 FR 45229, 45239 (2020). Regarding the Florida standard of care, Dr. Lynch credibly and reliably refuted Respondent’s various suggestions that he met that standard, including the arguments that (1) titrating patients off opioids creates a risk of suicide, especially if the patient has been on opioids or benzodiazepines for a considerable period of time and/or has comorbid conditions such as anxiety disorder 17 (Tr. 29–30, 36–40, 628–29); (2) the standard of care is different for patients who cannot afford testing or alternative treatments (Tr. 30– 32, 45, 429–30, 564); and (3) the standard of care is different when a practitioner ‘‘inherits’’ patients who are already on opioids (Tr. 41–44). RD, at 35. Moreover, Respondent’s version of the standard of care is not supported by the applicable Florida statutes. RD, at 35; see Fla. Stat. § 456.44(3). 17 Dr. Lynch referenced Respondent’s own exhibits and other sources to discuss that there is also an association with a higher likelihood of suicide for patients who start taking opioids, patients who continue taking opioids, patients taking opioids at a high MME level, patients with signs of abuse or misuse of substances, and patients with mental health issues. RD, at 35; Tr. 458–61. Similarly, Dr. Lynch explained that while stopping a benzodiazepine prescription is associated with a higher likelihood of suicide, so too is prescribing benzodiazepines in the first instance and maintaining benzodiazepines. RD, at 35; Tr. 459, 461, 463. Moreover, Respondent’s numerous other failures, including his lack of appropriate documentation of the justifications for continued prescribing, violated federal and Florida law. PO 00000 Frm 00152 Fmt 4703 Sfmt 4703 17523 In sum, and in agreement with the RD, the Agency finds that the record contains substantial evidence that Respondent prescribed and dispensed controlled substances in violation of both federal and state law. See RD, at 34; 21 CFR 1306.04(a); Fla. Stat. § 456.44(3); Fla. Admin. Code r. 64B8– 9.003. In weighing Factors B and D, the Agency finds that the Government has established a prima facie case that Respondent committed acts that render his registration inconsistent with the public interest and support revocation of his registration. See 21 U.S.C. 823(g)(1). III. Sanction Where, as here, the Government has established grounds to revoke Respondent’s registration, the burden shifts to the respondent to show why he can be entrusted with the responsibility carried by a registration. Garret Howard Smith, M.D., 83 FR 18882, 18910 (2018). When a respondent has committed acts inconsistent with the public interest, he must both accept responsibility and demonstrate that he has undertaken corrective measures. Holiday CVS, L.L.C., dba CVS Pharmacy Nos 219 and 5195, 77 FR 62316, 62339 (2012). Trust is necessarily a fact-dependent determination based on individual circumstances; therefore, the Agency looks at factors such as the acceptance of responsibility, the credibility of that acceptance as it relates to the probability of repeat violations or behavior, the nature of the misconduct that forms the basis for sanction, and the Agency’s interest in deterring similar acts. See, e.g., Robert Wayne Locklear, M.D., 86 FR 33738, 33746 (2021). Here, Respondent has failed to fully accept responsibility or offer any basis for the Agency to trust him, despite his past misconduct, with the responsibility of a registration. RD, at 37–39. Respondent did not accept responsibility for most of the areas where his prescribing history fell short of both the standard of care and his obligations under federal and Florida law. RD, at 38. Although Respondent acknowledged that he could have kept better notes and been more diligent at detailing patients’ care, this limited acceptance of responsibility was inadequate in light of his repeated insistence that the prescriptions were justified and issued within the standard of care. RD, at 38, 40; Tr. 511, 518–20, 524, 529–30, 567, 600. Additionally, Respondent’s attempt to shift blame for his misconduct to other employees of the clinic was unpersuasive and further highlighted the insufficiency of his E:\FR\FM\11MRN1.SGM 11MRN1 ddrumheller on DSK120RN23PROD with NOTICES1 17524 Federal Register / Vol. 89, No. 48 / Monday, March 11, 2024 / Notices limited acceptance of responsibility. RD, at 38; Tr. 503–04, 515, 590, 606–08. While a respondent may present evidence of remedial measures taken to prevent reoccurrence of behavior inconsistent with registration, it is not necessary for the Agency to consider remedial measures when a respondent lacks unequivocal acceptance of responsibility. Ajay S. Ahuja, M.D., 84 FR 5479, 5498 n.33 (2019); Daniel A. Glick, D.D.S., 80 FR 74800, 74801, 74810 (2015). The Agency need not consider remedial measures given the lack of acceptance of responsibility, nevertheless Respondent did not present any evidence of remedial measures for consideration. See RD, at 39; Ahuja, 84 FR at 5498 n.33; Glick, 80 FR at 74801, 74810. In addition to acceptance of responsibility, the Agency looks to the egregiousness and extent of the misconduct, Garrett Howard Smith, M.D., 83 FR at 18910 (collecting cases), and considers both specific and general deterrence when determining an appropriate sanction. Glick, 80 FR at 74810. Here, Respondent’s inappropriate and unlawful prescribing of controlled substances was egregious and warrants a sanction. See RD, at 39. The record contains substantial evidence that Respondent improperly issued an extensive number of prescriptions to four patients at two clinics over the course of nearly two years. RD, at 9, 17–30; Tr. 490–91; see supra Section I. Respondent prescribed controlled substances to patients without taking appropriate action to address clear and repeated signs of diversion and abuse. RD, at 39; see supra Section I. Even when patients arrived at their appointments with vital signs indicating a medical crisis or emergency, Respondent failed to address their dangerous medical situations and continued the same prescribing in violation of the applicable standard of care. RD, at 39; see, e.g., Tr. 303, 345–46, 392. In this case, the Agency believes that revocation of Respondent’s registration would deter Respondent and encourage the general registrant community to properly manage patients’ treatment under the requirements of the CSA, including when faced with evidence of abuse and diversion. See RD, at 39. In light of the above considerations, there is insufficient evidence that Respondent’s behavior is unlikely to recur in the future such that the Agency can entrust him with a registration. In sum, Respondent has not offered sufficient mitigating evidence on the record to rebut the Government’s case for revocation of his registration. RD, at VerDate Sep<11>2014 18:24 Mar 08, 2024 Jkt 262001 37–40. The public interest factors weigh in favor of revocation. RD, at 40. Accordingly, the Agency will order that Respondent’s registration be revoked. Order Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. FF7471840 issued to Mark Fenzl, M.D. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I hereby deny any pending applications of Mark Fenzl, M.D., to renew or modify this registration, as well as any other pending application of Mark Fenzl, M.D., for additional registration in Florida. This Order is effective April 10, 2024. Signing Authority This document of the Drug Enforcement Administration was signed on February 20, 2024, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register. Heather Achbach, Federal Register Liaison Officer, Drug Enforcement Administration. [FR Doc. 2024–05099 Filed 3–8–24; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [OMB Number 1121–0147] Agency Information Collection Activities; Proposed eCollection eComments Requested; Reinstatement, With Change, of a Previously Approved Collection for Which Approval Has Expired: Census of State and Federal Adult Correctional Facilities Bureau of Justice Statistics, Department of Justice. ACTION: 60-Day notice. AGENCY: The Bureau of Justice Statistics (BJS), Department of Justice (DOJ) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in SUMMARY: PO 00000 Frm 00153 Fmt 4703 Sfmt 4703 accordance with the Paperwork Reduction Act of 1995. DATES: Comments are encouraged and will be accepted for 60 days until May 10, 2024. FOR FURTHER INFORMATION CONTACT: If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Laura Maruschak, Bureau of Justice Statistics, 810 Seventh Street NW, Washington, DC 20531, (email: laura.maruschak@usdoj.gov; telephone: 202–598–0802). SUPPLEMENTARY INFORMATION: Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Bureau of Justice Statistics, including whether the information will have practical utility; —Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Abstract: The Census of State and Federal Adult Correctional Facilities (CCF) is part of the larger Bureau of Justice Statistics’ (BJS) portfolio of establishment surveys that inform the nation on the characteristics of adult correctional facilities and persons sentenced to State and Federal prisons. The CCF collects data at the facility level. Data obtained are intended to describe the characteristics of confinement and community-based adult correctional facilities that are operated by (1) State correctional and BOP authorities or (2) private entities that primarily house inmates for State correctional or BOP authorities. The data collected inform issues related to E:\FR\FM\11MRN1.SGM 11MRN1

Agencies

[Federal Register Volume 89, Number 48 (Monday, March 11, 2024)]
[Notices]
[Pages 17520-17524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05099]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 22-51]


Mark Fenzl, D.O.; Decision and Order

    On August 11, 2022, the Drug Enforcement Administration (DEA or 
Government) issued an Order to Show Cause (OSC) and Immediate 
Suspension Order (ISO) to Mark Fenzl, M.D. (Respondent), of Florida 
immediately suspending and seeking to revoke his DEA Certificate of 
Registration, Control No. FF7471840, and alleging that his ``continued 
registration is inconsistent with the public interest.'' OSC, at 1 
(citing 21 U.S.C. 823(g)(1) \1\).
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    \1\ Effective December 2, 2022, the Medical Marijuana and 
Cannabidiol Research Expansion Act, Public Law 117-215, 136 Stat. 
2257 (2022) (Marijuana Research Amendments or MRA), amended the 
Controlled Substances Act (CSA) and other statutes. Relevant to this 
matter, the MRA redesignated 21 U.S.C. 823(f), cited in the OSC, as 
21 U.S.C. 823(g)(1). Accordingly, this Decision cites to the current 
designation, 21 U.S.C. 823(g)(1), and to the MRA-amended CSA 
throughout.
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    A hearing was held before DEA Administrative Law Judge Teresa A. 
Wallbaum (the ALJ). On April 10, 2023, the ALJ issued her Recommended 
Rulings, Findings of Fact, Conclusions of Law, and Decision (RD), which 
recommended that the Agency revoke Respondent's registration. RD, at 
40. Respondent did not timely file exceptions to the RD.\2\ Having 
reviewed the entire record, the Agency, except as noted below,\3\ 
adopts and hereby incorporates by reference the entirety of the ALJ's 
rulings, credibility findings,\4\ findings of fact, conclusions of law, 
and recommended sanction in the RD and summarizes, expands upon, and 
clarifies portions thereof herein.
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    \2\ On May 8, 2023, after the deadline to file exceptions passed 
and the ALJ certified the record to the Administrator, Respondent 
submitted a document entitled ``Appeal to the Drug Enforcement 
Agency Administrator.'' Respondent's document appears to be an 
untimely attempt to file exceptions to the RD. See 21 CFR 
1316.66(a), 1316.67. On that basis, they were not considered in this 
Decision. Further, even if these exceptions had been timely 
submitted, they contain arguments raised by Respondent in earlier 
filings that were addressed by the ALJ, lack the required specific 
and complete citations to the record, are contradicted or 
unsupported by the record, and/or otherwise lack merit. Accordingly, 
the Agency finds these untimely exceptions to be unpersuasive. See 
Yogeshwar Gill, M.D., 88 FR 55,076, 55,076 n.3 (2023).
    \3\ See footnote 14, infra.
    \4\ The Agency adopts the ALJ's summary of each of the 
witnesses' testimonies as well as the ALJ's assessment of each of 
the witnesses' credibility. See RD, at 3-11. The Agency agrees with 
the ALJ that the testimony by the Diversion Investigator (DI), which 
focused on the investigative steps completed in the case and 
establishing the foundations for many of the exhibits received into 
the record, was sufficiently detailed, plausible, and internally 
consistent to be afforded full credibility. See id. at 5-6. The 
Agency also agrees with the ALJ's assessment that Dr. Paul Lynch, 
M.D., the Government's expert witness, was reliable and persuasive. 
See id. at 6. His testimony was based on extensive relevant 
experience and consistent with applicable Florida law, and 
Respondent was unpersuasive in his efforts to challenge Dr. Lynch's 
objectivity and reliability. See id. at 7. Regarding Respondent's 
testimony, the Agency adopts the ALJ's assessment that although 
Respondent testified candidly, his recollection was unreliable and 
at times contradicted by documentary evidence. See id. at 11. 
Therefore, the ALJ appropriately gave his testimony limited weight. 
See id. at 11. As the ALJ noted, Respondent's testimony on Florida's 
standard of care was vague, and he characterized pain management as 
an ``area of weakness'' for him. See id. at 11 (quoting Tr. 516-17). 
Accordingly, consistent with the ALJ's findings, to the extent that 
Respondent disagreed with Dr. Lynch's testimony regarding the 
Florida standard of care governing pain management, the Agency gives 
controlling weight to Dr. Lynch's testimony. See id. at 11.
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I. Findings of Fact

    The Agency finds from clear, unequivocal, and convincing evidence 
that Respondent committed numerous failures in his prescribing conduct 
that fell below the standard of care in Florida. Specifically, the 
Agency finds that from June 2020 through April 2022, Respondent issued 
controlled substances to Patients J.H., C.K., G.K., and J.K. without a 
legitimate medical purpose, outside the usual course of professional 
practice, and beneath the standard of care in Florida. See RD, at 17-
30.

Florida Standard of Care

    Dr. Lynch provided expert testimony on the applicable standard of 
care for prescribing controlled substances in Florida.\5\ RD, at 6-7, 
11-17; Tr. 141-

[[Page 17521]]

473. According to Dr. Lynch, the standard of care stems from state 
statutes and additional, established practices that supplement, or 
expand upon, those statutes. RD, at 11; Tr. 149, 263-64. The standard 
of care requires the pain management practitioner to take a ``complete 
medical history.'' RD, at 13; Fla. Stat. Sec.  456.44(3)(a). A thorough 
medical history should include a review of prior treatments and tests 
and a social history regarding possible substance abuse or mental 
health issues. RD, at 13; Tr. 157-59. The Florida standard of care also 
requires a physical examination before prescribing controlled 
substances and at each subsequent visit where controlled substances are 
prescribed. RD, at 13; Tr. 165-66, 349; see also Fla. Stat. Sec.  
456.44(3)(a). For any visit, the standard of care requires taking and 
recording vital signs. RD, at 13; Tr. 308. The physician must document 
and discuss abnormal vital signs, and failing to follow up on a patient 
with higher-than-normal vital signs is ``significantly outside the 
standard of care.'' RD, at 13-14; Tr. 310, 345-48, 394-95.
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    \5\ The Agency adopts and incorporates by reference the entirety 
of the ALJ's findings regarding the standard of care in Florida and 
the related summary of Dr. Lynch's expert testimony.
---------------------------------------------------------------------------

    For pain management, the physical examination must involve a 
targeted examination of the area of pain and a ``neurologic or 
behavioral interaction with the patient'' to look for signs of 
intoxication. RD, at 13; Tr. 166, 437-38. When patients have a spinal 
issue, the standard of care includes an examination of all four 
extremities for strength, sensation, reflexes, and range of motion. RD, 
at 13; Tr. 166. The failure to even touch a patient in a physical exam 
for more than two years ``is considerably outside the standard of 
care.'' RD, at 13; Tr. 312. While the standard of care ``is pretty 
broad on how frequent imaging should be,'' it typically requires new 
images every two to three years. RD, at 13; Tr. 321. It is not, 
however, sufficient to simply order imaging; the patient must obtain 
the image. RD, at 13; Tr. 339-40. In this case, the physical 
examinations often stated simply that a patient was ``Alert, 
Responsive, Interactive, which means they're just there, that they 
showed up, that they're alive.'' RD, at 13; Tr. 261-62. Such a physical 
examination is ``not an appropriate exam,'' and does not satisfy the 
requirement in Florida Statutes Section 456.44 that a physician must 
conduct a physical examination sufficient to establish an appropriate 
diagnosis that justifies prescribing controlled substances. RD, at 14; 
Tr. 262.
    The Florida standard of care requires a pain management physician 
to engage in regular patient visits and ongoing monitoring ``to look 
for risk factors of abuse or misuse or diversion of the medications.'' 
RD, at 14; Tr. 164-65; see also Fla. Stat. Sec.  456.44(3)(d). One 
method of monitoring is the legal requirement to check the Prescription 
Drug Monitoring Program (PDMP) each time a practitioner writes a 
controlled substance prescription, which allows a practitioner to 
determine if the patient is obtaining the same drugs from another 
doctor or frequenting different pharmacies. RD, at 14; Tr. 169-70. 
Another method of monitoring is urine drug screening and testing with 
documentation of the results in the patient's record. RD, at 14; Tr. 
216-18, 223-24. If there are signs of an abnormal or aberrant drug test 
result, Florida law establishes the steps a practitioner must take to 
address that aberrant result. RD, at 15; Tr. 169, 224, 247-48; see also 
Fla. Stat. Sec.  456.44(3)(g). Evidence of diversion exists if a 
patient fails to test positive for a controlled substance that is 
currently being prescribed. RD, at 15; Tr. 224. If there are signs of 
diversion, Florida Statutes Section 456.44 requires that the 
practitioner stop prescribing the controlled substance and discharge 
the patient. RD, at 15; Tr. 169, 247-48; see also Fla. Stat. Sec.  
456.44(3)(g). Evidence of abuse exists if a patient tests positive for 
a substance that is not prescribed or for an illicit substance. RD, at 
15; Tr. 224-25, 370-71. If there is evidence of abuse, Section 456.44 
requires the practitioner to refer the patient to an addiction medicine 
specialist.\6\ RD, at 15; Tr. 169, 224-25; see also Fla. Stat. Sec.  
456.44(3)(g). While there is a gray area on whether it could be 
acceptable to continue to prescribe opioids when there are signs of 
abuse, in ``most cases of abuse of cocaine [and] methamphetamine'' the 
continued prescribing would not be within the standard of care because 
of the risk of death. RD, at 15; Tr. 248-50.
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    \6\ An addiction medicine specialist is defined as a board-
certified psychiatrist with a subspecialty certification or eligible 
for certification in addiction medicine, an addiction medicine 
physician certified or eligible for certification by the American 
Society of Addiction Medicine, or an osteopathic physician who holds 
a certificate of added qualification in addiction medicine through 
the American Osteopathic Association. RD, at 15 n.16; Fla. Stat. 
Sec.  456.44(1)(b).
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    Prescribing doses of opioids with a high Morphine Milligram 
Equivalent (MME) \7\ caries significant risks, including risk of death. 
RD, at 16; Tr. 257-58. Moreover, prescribing a combination of an 
opioid, a benzodiazepine, and a muscle relaxant (here, carisoprodol) is 
dangerous because together they produce a risk of synergistic 
respiratory depression; this ``leads to a patient that's heavily 
sedated and is [at] high risk for overdose and death.'' \8\ RD, at 16 
(quoting Tr. 256-57). The combination, known as ``the cocktail, the 
Houston cocktail, the trinity, [or] the holy trinity,'' is ``sought 
after'' due to the ``particularly powerful high to the patient.'' RD, 
at 16 (quoting Tr. 256).
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    \7\ MME is a standard that determines how powerful a particular 
medication is by comparing the prescribed medication and dosage to 
the original standard of morphine, historically used to manage pain. 
RD, at 16; Tr. 257-58.
    \8\ The Food and Drug Administration (FDA) has issued a 
warning--the so-called ``Black Box Warning''--regarding the risks of 
prescribing opioids and benzodiazepines in combination. RD, at 16; 
Tr. 173-80, 182; GX 15-17.
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    Documentation is a requirement under the Florida standard of care. 
RD, at 17; Tr. 160-61. ``The medical record shall . . . document the 
presence of one or more recognized medical indications for the use of a 
controlled substance.'' Fl. Stat. Sec.  456.44(3)(a); RD, at 17; see 
also Fl. Stat. Sec.  456.44(3)(f); Tr. 160-61. In addition to 
documenting the physical examination, ``the medical record must, at a 
minimum, document the nature and intensity of the pain, current and 
past treatments for pain, underlying or co-existing diseases or 
conditions, the effect of the pain on physical and psychological 
function, a review of previous medical records, previous diagnostic 
studies, and history of alcohol and substance abuse.'' RD, at 17 
(quoting Tr. 160); Fla. Stat. Sec.  456.44(3)(a). Documentation is also 
important for the purposes of periodic review of the plan and 
continuation of treatment by another physician. RD, at 17; Tr. 159-60. 
Generally, having a ``clear and complete and accurate'' medical record 
``is really important for the practice of medicine.'' RD, at 17 
(quoting Tr. 171).
    The Florida standard of care does not create a separate standard 
for practitioners who ``inherit'' patients on controlled substance 
prescriptions. RD, at 12; Tr. 298-99. In other words, regardless of 
whether a patient is currently on controlled substance medications 
prescribed by another doctor, the Florida statute and standard of care 
require any practitioner to take a medical history and conduct an 
appropriate physical examination before prescribing and require 
practitioners to revisit prior plans on a regular basis to see if the 
controlled substance prescriptions are effective. RD, at 12; Tr. 213, 
298-99.

The Patients

Patient J.H.
    Regarding Patient J.H., the Agency finds that Respondent issued 
controlled substance prescriptions for morphine,

[[Page 17522]]

oxycodone, carisoprodol,\9\ and diazepam \10\ from July 2020 through 
February 2022 without a legitimate medical purpose, outside the usual 
course of professional practice, and beneath the standard of care in 
Florida. See RD, at 17-21; GX 6, 20; Tr. 200, 262-63. Based on Dr. 
Lynch's testimony and the record as a whole, these prescriptions were 
issued without a legitimate medical purpose, outside the usual course 
of professional practice, and beneath the standard of care because 
Respondent failed to (1) establish an appropriate diagnosis to justify 
the controlled substance prescriptions (RD, at 17-18; GX 6, 20; Tr. 
199, 201-03, 207, 211-14, 252, 255-56, 262); (2) establish an 
appropriate medical justification for high-risk combination 
prescriptions with high-risk MMEs (RD, at 20-21; GX 6, 20; Tr. 250, 
253-54, 256-57, 259-61); (3) appropriately address potential signs of 
abuse and diversion, despite at least seven aberrant drug test results 
(RD, at 18-20; GX 6; Tr. 204, 217, 219, 221-25, 227-31, 233-35, 238, 
246-48); and (4) maintain adequate medical records with sufficient 
documentation \11\ (RD, at 21; GX 6; Tr. 261-62).
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    \9\ Carisoprodol is a Schedule IV controlled substance sold 
under the brand name Soma. Prehearing Ruling, at 2. The generic name 
(carisoprodol) is used in this decision.
    \10\ Diazepam is a Schedule IV controlled substance sold under 
the brand name Valium. Prehearing Ruling, at 2. The generic name 
(diazepam) is used in this decision.
    \11\ Respondent asserted that some documentation related to the 
four patients was missing from the medical files produced through 
the Government's administrative subpoenas and admitted into evidence 
as Government Exhibits 6, 8, 10, and 12. RD, at 36; Tr. 496-97, 500-
07. The Agency has considered Respondent's claims regarding missing 
documentation. In agreement with the ALJ, any missing documentation 
does not change the outcome of this Decision. See RD, at 36-37. As 
Dr. Lynch reliably testified, any missing documents relate to only 
portions of the patients' treatment, and there are numerous other 
examples of prescribing that fell well below the standard of care. 
RD, at 37.
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Patient C.K.
    Regarding Patient C.K., the Agency finds that Respondent issued 
controlled substance prescriptions for hydrocodone,\12\ carisoprodol, 
and alprazolam \13\ from July 2020 through April 2022 without a 
legitimate medical purpose, outside the usual course of professional 
practice, and beneath the standard of care in Florida. See RD, at 22-
24; GX 8, 21; Tr. 312-15. Based on Dr. Lynch's testimony and the record 
as a whole, these prescriptions were issued without a legitimate 
medical purpose, outside the usual course of professional practice, and 
beneath the standard of care because Respondent failed to (1) establish 
an appropriate diagnosis to justify the controlled substance 
prescriptions (RD, at 22; GX 8, 21; Tr. 269-74); (2) adequately address 
signs of potential abuse and diversion, despite at least two aberrant 
drug test results (RD, at 22-23; GX 8; Tr. 277-86, 502-03); (3) 
appropriately address C.K.'s dangerous vital signs (RD, at 23; GX 8; 
Tr. 300-01, 303-07, 309); (4) establish an appropriate medical 
justification for high-risk combinations (RD at 23-24; GX 8, 21; Tr. 
311-12); and (5) maintain adequate medical records with sufficient 
documentation (RD, at 24; GX 8; Tr. 308-09, 311-12).
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    \12\ Hydrocodone is a Schedule II controlled substance. 
Prehearing Ruling, at 2. Norco is a brand name medication that 
contains hydrocodone. Id. The generic name (hydrocodone) is used in 
this decision.
    \13\ Alprazolam is a Schedule IV controlled substance sold under 
the brand name Xanax. Prehearing Ruling, at 2; Tr. 182. The generic 
name (alprazolam) is used in this decision.
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Patient G.K.
    Regarding Patient G.K., the Agency finds that Respondent issued 
controlled substance prescriptions for morphine, oxycodone, 
carisoprodol, and alprazolam from June 2020 through April 2022, without 
a legitimate medical purpose, outside the usual course of professional 
practice, and beneath the standard of care in Florida.\14\ See RD, at 
25-27; GX 10, 22; Tr. 353-54.
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    \14\ The ALJ noted that Respondent also issued prescriptions to 
G.K. for the Schedule V controlled substance pregabalin (sold under 
the brand name of Lyrica). RD, at 25-26. As Respondent's prescribing 
of pregabalin was not included in the OSC/ISO, the Agency does not 
make any findings on the prescribing of this controlled substance.
---------------------------------------------------------------------------

    Based on Dr. Lynch's testimony and the record as a whole, these 
prescriptions were issued without a legitimate medical purpose, outside 
the usual course of professional practice, and beneath the standard of 
care because Respondent failed to (1) establish an appropriate 
diagnosis to justify the controlled substance prescriptions (RD, at 25; 
GX 10, 22; Tr. 322-23, 325-26, 328-29, 331-37); (2) appropriately 
address G.K.'s dangerous vital signs (RD, at 25-26; GX 10; Tr. 344-47, 
350-52); (3) establish an appropriate medical justification for high-
risk combination prescriptions with high-risk MMEs (RD, at 26; GX 10, 
22; Tr. 340-43, 352-54); and (4) maintain adequate medical records with 
sufficient documentation (RD, at 26; GX 10; Tr. 352-54).
Patient J.K.
    Regarding Patient J.K., the Agency finds that Respondent issued 
controlled substance prescriptions for morphine, oxycodone, and 
lorazepam \15\ from August 2020 through April 2022 and carisoprodol 
from July 2020 through January 2022 without a legitimate medical 
purpose, outside the usual course of professional practice, and beneath 
the standard of care in Florida. See RD, at 27-30; GX 12, 23; Tr. 397-
98. Based on Dr. Lynch's testimony and the record as a whole, these 
prescriptions were issued without a legitimate medical purpose, outside 
the usual course of professional practice, and beneath the standard of 
care because Respondent failed to (1) establish an appropriate 
diagnosis to justify the controlled substance prescriptions (RD, at 27-
28; GX 12, 23; Tr. 359-67, 387-89); (2) adequately address signs of 
potential abuse and diversion, despite at least two aberrant drug test 
results (RD, at 28; GX 12; Tr. 370-78, 385, 496-97); (3) appropriately 
address J.K.'s dangerous vital signs (RD, at 29; GX 12; Tr. 391-96); 
(4) establish an appropriate medical justification for high-risk 
combination prescriptions with high-risk MMEs (RD, at 29; GX 12, 23; 
Tr. 389-90); and (5) maintain adequate medical records with sufficient 
documentation (RD, at 29-30; GX 12; Tr. 396-97).
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    \15\ Lorazepam is a Schedule IV controlled substance sold under 
the brand name Ativan. Prehearing Ruling, at 3; Tr. 355. The generic 
name (lorazepam) is used in this decision.
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II. Discussion

    Under the CSA, ``[a] registration . . . to . . . dispense a 
controlled substance . . . may be suspended or revoked by the Attorney 
General upon a finding that the registrant . . . has committed such 
acts as would render his registration under section 823 of this title 
inconsistent with the public interest as determined under such 
section.'' 21 U.S.C. 824(a). The CSA requires that the Agency consider 
the following factors for the public interest determination:
    (A) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (B) The [registrant]'s experience in dispensing, or conducting 
research with respect to controlled substances.
    (C) The [registrant]'s conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (D) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (E) Such other conduct which may threaten the public health and 
safety.

21 U.S.C. 823(g)(1).

[[Page 17523]]

    The Agency considers these public interest factors in the 
disjunctive. Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each 
factor is weighed on a case-by-case basis. Morall v. Drug Enf't Admin., 
412 F.3d 165, 173-74 (D.C. Cir. 2005). Any one factor, or combination 
of factors, may be decisive. David H. Gillis, M.D., 58 FR 37507, 37508 
(1993). The inquiry is ``focuse[d] on protecting the public interest.'' 
Jayam Krishna-Iyer, M.D., 74 FR 459, 462 (2009).
    The Government has the burden of proof in this proceeding. 21 CFR 
1301.44. While the Agency has considered all of the public interest 
factors in 21 U.S.C. 823(g)(1), the Government's evidence in support of 
its prima facie case for revoking Respondent's registration is confined 
to Factors B and D. See RD, at 31 n.50 (finding that Factors A, C, and 
E do not weigh for or against the sanction sought by the Government).

Factors B and D

    Evidence is considered under Public Interest Factors B and D when 
it reflects compliance (or non-compliance) with laws related to 
controlled substances and experience dispensing controlled substances. 
See Sualeh Ashraf, M.D., 88 FR 1095, 1097 (2023); Kareem Hubbard, M.D., 
87 FR 21156, 21162 (2022). DEA regulations require that for a 
controlled substance prescription to be effective, it must be issued 
for a legitimate medical purpose by an individual practitioner acting 
in the usual course of professional practice. 21 CFR 1306.04(a).
    Based on Dr. Lynch's reliable and persuasive expert opinion, the 
Agency finds that Respondent issued controlled substance prescriptions 
outside of the usual course of professional practice and beneath the 
Florida standard of care in violation of federal law. See supra Section 
I. Further, the Agency finds that Respondent violated Florida Statutes 
Section 456.44(3) with regard to Patients J.H., C.K., G.K., and J.K., 
by failing to take proper medical histories and conduct adequate 
medical examinations that supported prescribing controlled substances 
and/or failing to monitor the patients' medication compliance and 
address signs of abuse and/or diversion.\16\ RD, at 34. The Agency also 
finds that for each of the four patients at issue, Respondent failed to 
maintain sufficiently detailed medical records that properly documented 
a diagnosis for each patient that supported prescribing controlled 
substances, thereby violating Florida Statutes Section 456.44(3) and 
Florida Administrative Code Rule 64B8-9.003.
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    \16\ While Respondent argued that the patients were being 
treated by a drug and alcohol counselor, that counselor was not a 
psychiatrist or an addiction medicine specialist under Florida law. 
RD, at 34; Tr. 586; see Fla. Stat. Sec.  456.44; see also Tr. 168-
69.
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    Respondent's arguments fail to refute the evidence of unlawful and 
inappropriate prescribing. Although Respondent testified to his 
positive behavior of discharging approximately forty percent of one 
clinic's patients, such positive behavior cannot outweigh the evidence 
of prescribing contrary to the public interest. RD, at 33; Tr. 486, 
489-90; see, e.g., Ester Mark, M.D., 86 FR 16760, 16771 (2021); Randall 
L. Wolff, M.D., 77 FR 5106, 5153 (2012). Nor do his broad arguments on 
the effects of the Government's enforcement decisions on pain clinics 
and the populations they serve undermine the Government's prima facie 
case. RD, at 34-35; see Stephen E. Owusu, D.P.M., 87 FR 3343, 3351 n.21 
(2022) (``the Agency has consistently held that community impact is not 
a relevant consideration under the public interest factors''); George 
Pursley, M.D., 85 FR 80162, 80188 n.82 (2020); Frank Joseph Stirlacci, 
M.D., 85 FR 45229, 45239 (2020).
    Regarding the Florida standard of care, Dr. Lynch credibly and 
reliably refuted Respondent's various suggestions that he met that 
standard, including the arguments that (1) titrating patients off 
opioids creates a risk of suicide, especially if the patient has been 
on opioids or benzodiazepines for a considerable period of time and/or 
has comorbid conditions such as anxiety disorder \17\ (Tr. 29-30, 36-
40, 628-29); (2) the standard of care is different for patients who 
cannot afford testing or alternative treatments (Tr. 30-32, 45, 429-30, 
564); and (3) the standard of care is different when a practitioner 
``inherits'' patients who are already on opioids (Tr. 41-44). RD, at 
35. Moreover, Respondent's version of the standard of care is not 
supported by the applicable Florida statutes. RD, at 35; see Fla. Stat. 
Sec.  456.44(3).
---------------------------------------------------------------------------

    \17\ Dr. Lynch referenced Respondent's own exhibits and other 
sources to discuss that there is also an association with a higher 
likelihood of suicide for patients who start taking opioids, 
patients who continue taking opioids, patients taking opioids at a 
high MME level, patients with signs of abuse or misuse of 
substances, and patients with mental health issues. RD, at 35; Tr. 
458-61. Similarly, Dr. Lynch explained that while stopping a 
benzodiazepine prescription is associated with a higher likelihood 
of suicide, so too is prescribing benzodiazepines in the first 
instance and maintaining benzodiazepines. RD, at 35; Tr. 459, 461, 
463. Moreover, Respondent's numerous other failures, including his 
lack of appropriate documentation of the justifications for 
continued prescribing, violated federal and Florida law.
---------------------------------------------------------------------------

    In sum, and in agreement with the RD, the Agency finds that the 
record contains substantial evidence that Respondent prescribed and 
dispensed controlled substances in violation of both federal and state 
law. See RD, at 34; 21 CFR 1306.04(a); Fla. Stat. Sec.  456.44(3); Fla. 
Admin. Code r. 64B8-9.003. In weighing Factors B and D, the Agency 
finds that the Government has established a prima facie case that 
Respondent committed acts that render his registration inconsistent 
with the public interest and support revocation of his registration. 
See 21 U.S.C. 823(g)(1).

III. Sanction

    Where, as here, the Government has established grounds to revoke 
Respondent's registration, the burden shifts to the respondent to show 
why he can be entrusted with the responsibility carried by a 
registration. Garret Howard Smith, M.D., 83 FR 18882, 18910 (2018). 
When a respondent has committed acts inconsistent with the public 
interest, he must both accept responsibility and demonstrate that he 
has undertaken corrective measures. Holiday CVS, L.L.C., dba CVS 
Pharmacy Nos 219 and 5195, 77 FR 62316, 62339 (2012). Trust is 
necessarily a fact-dependent determination based on individual 
circumstances; therefore, the Agency looks at factors such as the 
acceptance of responsibility, the credibility of that acceptance as it 
relates to the probability of repeat violations or behavior, the nature 
of the misconduct that forms the basis for sanction, and the Agency's 
interest in deterring similar acts. See, e.g., Robert Wayne Locklear, 
M.D., 86 FR 33738, 33746 (2021).
    Here, Respondent has failed to fully accept responsibility or offer 
any basis for the Agency to trust him, despite his past misconduct, 
with the responsibility of a registration. RD, at 37-39. Respondent did 
not accept responsibility for most of the areas where his prescribing 
history fell short of both the standard of care and his obligations 
under federal and Florida law. RD, at 38. Although Respondent 
acknowledged that he could have kept better notes and been more 
diligent at detailing patients' care, this limited acceptance of 
responsibility was inadequate in light of his repeated insistence that 
the prescriptions were justified and issued within the standard of 
care. RD, at 38, 40; Tr. 511, 518-20, 524, 529-30, 567, 600. 
Additionally, Respondent's attempt to shift blame for his misconduct to 
other employees of the clinic was unpersuasive and further highlighted 
the insufficiency of his

[[Page 17524]]

limited acceptance of responsibility. RD, at 38; Tr. 503-04, 515, 590, 
606-08.
    While a respondent may present evidence of remedial measures taken 
to prevent reoccurrence of behavior inconsistent with registration, it 
is not necessary for the Agency to consider remedial measures when a 
respondent lacks unequivocal acceptance of responsibility. Ajay S. 
Ahuja, M.D., 84 FR 5479, 5498 n.33 (2019); Daniel A. Glick, D.D.S., 80 
FR 74800, 74801, 74810 (2015). The Agency need not consider remedial 
measures given the lack of acceptance of responsibility, nevertheless 
Respondent did not present any evidence of remedial measures for 
consideration. See RD, at 39; Ahuja, 84 FR at 5498 n.33; Glick, 80 FR 
at 74801, 74810.
    In addition to acceptance of responsibility, the Agency looks to 
the egregiousness and extent of the misconduct, Garrett Howard Smith, 
M.D., 83 FR at 18910 (collecting cases), and considers both specific 
and general deterrence when determining an appropriate sanction. Glick, 
80 FR at 74810. Here, Respondent's inappropriate and unlawful 
prescribing of controlled substances was egregious and warrants a 
sanction. See RD, at 39. The record contains substantial evidence that 
Respondent improperly issued an extensive number of prescriptions to 
four patients at two clinics over the course of nearly two years. RD, 
at 9, 17-30; Tr. 490-91; see supra Section I. Respondent prescribed 
controlled substances to patients without taking appropriate action to 
address clear and repeated signs of diversion and abuse. RD, at 39; see 
supra Section I. Even when patients arrived at their appointments with 
vital signs indicating a medical crisis or emergency, Respondent failed 
to address their dangerous medical situations and continued the same 
prescribing in violation of the applicable standard of care. RD, at 39; 
see, e.g., Tr. 303, 345-46, 392. In this case, the Agency believes that 
revocation of Respondent's registration would deter Respondent and 
encourage the general registrant community to properly manage patients' 
treatment under the requirements of the CSA, including when faced with 
evidence of abuse and diversion. See RD, at 39.
    In light of the above considerations, there is insufficient 
evidence that Respondent's behavior is unlikely to recur in the future 
such that the Agency can entrust him with a registration. In sum, 
Respondent has not offered sufficient mitigating evidence on the record 
to rebut the Government's case for revocation of his registration. RD, 
at 37-40. The public interest factors weigh in favor of revocation. RD, 
at 40. Accordingly, the Agency will order that Respondent's 
registration be revoked.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. 
FF7471840 issued to Mark Fenzl, M.D. Further, pursuant to 28 CFR 
0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I 
hereby deny any pending applications of Mark Fenzl, M.D., to renew or 
modify this registration, as well as any other pending application of 
Mark Fenzl, M.D., for additional registration in Florida. This Order is 
effective April 10, 2024.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
February 20, 2024, by Administrator Anne Milgram. That document with 
the original signature and date is maintained by DEA. For 
administrative purposes only, and in compliance with requirements of 
the Office of the Federal Register, the undersigned DEA Federal 
Register Liaison Officer has been authorized to sign and submit the 
document in electronic format for publication, as an official document 
of DEA. This administrative process in no way alters the legal effect 
of this document upon publication in the Federal Register.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-05099 Filed 3-8-24; 8:45 am]
BILLING CODE 4410-09-P

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