NO._______
`
`_____________________________________
`
`IN THE
`
`SUPREME COURT OF THE UNITED STATES
`_____________________________________
`
`GEORGE P. NAUM III,
`
`Petitioner-Appellant,
`
`v.
`
`UNITED STATES OF AMERICA,
`
`Respondent-Appellee.
`_____________________________________
`
`On Petition for Writ of Certiorari to the
`United States Court of Appeals for the Fourth Circuit
`_____________________________________
`
`PETITION FOR WRIT OF CERTIORARI
`_____________________________________
`
`
`
`RONALD W. CHAPMAN II
`CHAPMAN LAW GROUP
`Counsel of Record for Petitioner-Appellant
`1441 W. Long Lake Rd., Ste. 310
`Troy, Michigan 48098
`(248) 644-6326
`
`
`

`

`QUESTION PRESENTED FOR REVIEW
`
`Justice Potter Steward’s concerns raised at oral argument in United States v.
`
`Moore, 423 U.S. 122 (1975) over 40 years ago have become a reality.
`
`And is it not true that historically most, if not all of the great
`breakthroughs and advances in medical science are made by people who
`did not follow the conventional way of doing things. They followed a new
`way, their way, and most of the conventional physicians of their day
`would have disagreed with them because this is not the way it has
`always been done . . . it bothers me that this kind of evidence . . . is the
`basis for criminal liability. This man was a physician, he was not a
`fraud.
`
`United States v. Moore, 423 U.S. 122 (1975); Oral Argument in United States v. Moore,
`
`Oyez, https://www.oyez.org/cases/1975/74-759 (last visited Jan 27, 2021).
`
`As a result of what this Court has declared as ambiguous language in 21 U.S.C.
`
`§841 and 21 C.F.R. §1306.04, physicians in the United States are being convicted for
`
`professional disagreements and violations of the “standard of care” when prescribing
`
`opioids. United States v. Moore, 423 U.S. 122, 135; 96 S. Ct. 335, 345 (1975). The
`
`Circuits are widely split on their interpretation of 21 U.S.C. §841 and 21 C.F.R.
`
`§1306.04 and it is time for this Court to revisit United States v. Moore.
`
`Petitioner-Appellant, George P. Naum III was convicted of violations of 21
`
`U.S.C. §841(a)(1) and 21 U.S.C. §846 for prescribing Suboxone, a drug used to treat
`
`opioid use disorder. The central issue at trial was his use of nurses to expand the
`
`availability of patient care consistent with SAMHSA regulations. At trial, the trial
`
`court held that the elements of 21 U.S.C. §841(a)(1) as applied to a physician can be
`
`applied in the disjunctive thereby permitting the Government to procced on a theory
`
`that prescriptions were issued either “beyond the bounds of professional practice” or
`
`i
`
`

`

`“for other than a legitimate medical purpose.” This permitted the Government to
`
`prosecute and convict Dr. Naum solely for violating professional standards. Further,
`
`the trial court prohibited expert testimony regarding the medical legitimacy of the
`
`prescriptions and hospital programs that operated in the same manner as Defendant.
`
`The question presented is: Can the elements of 21 U.S.C. §841(a)(1) as defined
`
`in United States v. Moore, 423 U.S. 122 (1975) requiring the Government to prove
`
`unlawful distribution of a controlled substance “outside the usual course of
`
`professional practice” and “for other than a legitimate medical purpose” be applied in
`
`the disjunctive permitting the Government to prove only that a prescription was
`
`prescribed “outside the usual course of professional practice” or “outside the bounds
`
`of professional practice” solely for violation of a professional standard without regard
`
`to the medical legitimacy of the medication?
`
`
`
`ii
`
`

`

`LIST OF PARTIES
`
`All parties to the proceeding are identified in the style of the case.
`
`iii
`
`

`

`CORPORATE DISCLOSURE STATEMENT
`
`Pursuant to Supreme Court Rule 29.6, Petitioner-Appellant, George P. Naum
`
`III discloses the following. There is no parent or publicly held company owning 10%
`
`or more of Petitioner-Appellant’s stock.
`
`
`
`iv
`
`

`

`LIST OF PROCEEDINGS
`
`
`Trial Court
`United States of America, Plaintiff, v. George P. Naum III, Defendant
`United States District Court for the Northern District of West Virginia
`Case No.: 1:18-cr-00001
`Date of Judgment: February 11, 2020
`
`Direct Appeal
`United States of America, Plaintiff-Appellee, v. George P. Naum III, Defendant-
`Appellant
`United States Court of Appeals for the Fourth Circuit
`Case No.: 20-4133
`Date of Judgment: October 13, 2020
`
`Petition for Rehearing and Rehearing En Banc
`United States of America, Plaintiff-Appellee, v. George P. Naum III, Defendant-
`Appellant
`United States Court of Appeals for the Fourth Circuit
`Case No.: 20-4133
`Date of Judgment: November 24, 2020
`
`
`
`
`
`v
`
`

`

`TABLE OF CONTENTS
`
`
`QUESTION PRESENTED FOR REVIEW .................................................................... i
`
`LIST OF PARTIES ....................................................................................................... iii
`
`CORPORATE DISCLOSURE STATEMENT .............................................................. iv
`
`LIST OF PROCEEDINGS ............................................................................................. v
`
`TABLE OF CONTENTS ............................................................................................... vi
`
`TABLE OF AUTHORITIES ....................................................................................... viii
`
`PETITION FOR A WRIT OF CERTIORARI ................................................................ 1
`
`OPINION BELOW ......................................................................................................... 1
`
`JURISDICTION ............................................................................................................. 1
`
`STATUTES, ORDINANCES AND REGULATIONS INVOLVED .............................. 1
`
`STATEMENT ................................................................................................................. 3
`
`REASONS FOR GRANTING THE PETITION .......................................................... 11
`
`The Fourth Circuit has decided an important federal question in a way that
`A.
`conflicts with this Court’s holdings in Moore and Gonzales. .................................. 11
`
`a. Overview ......................................................................................................... 11
`
`b. Circuit Court interpretations of Moore have shifted significantly since the
`decision .................................................................................................................. 12
`
`c. The Fourth Circuit’s holding in Naum is not grounded in the CSA, Moore,
`OR Gonzales, creating further ambiguity disruptive to the state’s right to
`regulate the practice of medicine .......................................................................... 17
`
`d. Various Circuits have interpreted the vague language of 21 U.S.C.
`§841(a)(1) and 21 C.F.R. §1306.04 to permit physicians to be prosecuted for
`professional disagreements, which has a dangerous impact on medical
`advancement.......................................................................................................... 23
`
`e. There is no generally accepted standard for prescribing controlled
`substances in the U.S. ........................................................................................... 31
`
`CONCLUSION ............................................................................................................. 35
`
`CERTIFICATE OF WORD COUNT ........................ Error! Bookmark not defined.
`
`PROOF OF SERVICE .............................................. Error! Bookmark not defined.
`
`
`
`
`
`
`
`vi
`
`

`

`INDEX TO APPENDIX
`
`Unpublished Per Curium Opinion of the Fourth Circuit Court of Appeals, October 13,
`2020
`A1
`
`Opinion in United States v. Naum, 2020 U.S. App. LEXIS 32248 (4th Cir. 2020)
`
`A19
`
`Order Denying Petition for Rehearing and Rehearing En Banc, November 24, 2020
`
`A28
`
`Order in United States v. Naum, 2020 U.S. App. LEXIS 37150 (4th Cir. 2020)
`
`A29
`
`Judgment in a Criminal Case, Northern District of West Virginia, February 11, 2020
`
`A30
`
`Transcript, Testimony of Dr. Standiford Helm II
`
`A38
`
`United States’ Motion in Limine on Standards of Governing Prescriptions for
`Suboxone [ECF No. 166]
`A93
`
`United States’ Motion in Limine [ECF No. 273]
`
`Order Following Motion Hearing [ECF No. 299]
`
`
`
`
`
`A768
`
`A774
`
`vii
`
`

`

`
`Cases
`
`TABLE OF AUTHORITIES
`
`Gonzales v. Oregon, 56 U.S. 243, 271 (2006) ..................................................................
`4, 9, 10, 11, 12, 15, 16, 17, 19, 21, 22, 23, 24, 34
`
`In Re Wesley Pope, M.D., 82 Fed. Reg. 14944 (Drug Enf’t Admin. Mar. 23, 2017) ... 29
`
`United States v. Alerre, 430 F.3d 681 (4th Cir. 2005).................................................. 25
`
`United States v. Armstrong, 550 F.3d 382 (5th Cir. 2008) .......................................... 26
`
`United States v. Bartee, 479 F.3d 484 (10th Cir. 1973) ............................................... 22
`
`United States v. Birbragher, 576 F. Supp. 2d 1000 (N.D. Iowa 2008) ....................... 31
`
`United States v. Brickhouse, No. 3:14-CR-124, 2016 U.S. Dist. LEXIS 59821, 2016
`WL 2654359 (E.D. Tenn. Mar. 30, 2016) ................................................................. 30
`
`United States v. Chube, 538 F.3d 693 (7th Cir. 2008) ............................... 19, 22, 27, 28
`
`United States v. Collier, 478 F.2d 268 (5th Cir. 1973)................................................. 30
`
`United States v. Darji, 609 F. App’x 320 (6th Cir. 2015) ............................................. 30
`
`United States v. Enmon, 686 Fed. Appx. 796 (11th Cir. 2017) ................................... 26
`
`United States v. Feingold, 454 F.3d 1001, 1008 (9th Cir. 2006) ..................... 19, 22, 28
`
`United States v. Hitzig, 63 Fed. Appx. 83 (4th Cir. 2003) ....................................... 3, 18
`
`United States v. Hurwitz, 459 F.3d 463 (4th Cir. 2006) .............................................. 13
`
`United States v. Ignasiak, 667 F.3d 1217 (11th Cir. 2012) ......................................... 20
`
`United States v. Johnson, 71 F.3d 539 (6th Cir. 1995) ................................................ 20
`
`United States v. Kholi, 847 F.3d 483 (7th Cir. 2017) ................................................... 22
`
`United States v. Lague, 971 F.3d 1032 (9th Cir. 2020) ............................................... 33
`
`United States v. Moore, 423 U.S. 122 (1975) ..................................................................
`i, ii, 4, 9, 10, 11, 12, 13, 14, 15, 16, 17, 19, 21, 22, 23, 24, 28, 31, 34
`
`United States v. Nelson, 383 F.3d, 1227 (10th Cir. 2004) ..................................... 29, 30
`
`viii
`
`

`

`United States v. Newman, No. 3:19-CR-59-TAV-DCP, 2020 U.S. Dist. LEXIS 221891
`(E.D. Tenn. Sep. 8, 2020) .......................................................................................... 33
`
`United States v. Orta-Rosario, 469 F. App’x 140 (4th Cir. 2012) ................................ 30
`
`United States v. Prejean, 429 F. Supp. 2d 782 (E.D. La. 2006) .................................. 31
`
`United States v. Quinones, 536 F. Supp. 2d 267 (E.D.N.Y. 2008) ............................. 30
`
`United States v. Rosenberg, 585 F.3d 355 (7th Cir. 2009) ........................................... 19
`
`United States v. Singh, 54 F.3d 1182 (4th Cir. 1995) .......................... 10, 11, 17, 19, 20
`
`United States v. Smith, 573 F.3d 639 (8th Cir. 2009) ........................................... 28, 29
`
`United States v. Tran Trong Cuong, 18 F.3d 1132 (4th Cir. 1994) ..... 10, 11, 17, 20, 25
`
`United States v. Vamos, 797 F.3d 1146 (2nd Cir. 1986) .............................................. 27
`
`United States v. Volkman, 736 F.3d 1013 (6th Cir. 2013) ........................................... 27
`
`Statutes
`
`18 U.S.C. §2 .................................................................................................................... 8
`
`21 U.S.C. §801 .......................................................................................................... 4, 10
`
`21 U.S.C. §802(21) ......................................................................................................... 2
`
`21 U.S.C. §802(6) ........................................................................................................... 3
`
`21 U.S.C. §821 .............................................................................................................. 13
`
`21 U.S.C. §822(b) ......................................................................................................... 13
`
`21 U.S.C. §823(g)(2) ....................................................................................................... 5
`
`21 U.S.C. §841 ..................................................................................................... i, 26, 30
`
`21 U.S.C. §841(a) ............................................................... 3, 8, 9, 12, 15, 19, 21, 23, 28
`
`21 U.S.C. §841(a)(1) .......... i, ii, 1, 8, 9, 13, 14, 15, 17, 18, 20, 23, 24, 28, 29, 30, 31, 34
`
`21 U.S.C. §846 ......................................................................................................... i, 3, 8
`
`28 U.S.C. §1254(1) ......................................................................................................... 1
`
`42 U.S.C. §290bb-2a................................................................................................... 3, 4
`
`ix
`
`

`

`Rules
`
`81 Fed. Reg. 45603 ....................................................................................................... 32
`
`Regulations
`
`21 C.F.R. §1301.01 ....................................................................................................... 23
`
`21 C.F.R. §1306.04 .............................................................. i, 2, 3, 23, 24, 29, 30, 31, 34
`
`21 C.F.R. §1306.04(a) ................................................................................... 9, 13, 19, 30
`
`42 C.F.R. §8.2 ................................................................................................................. 5
`
`42 C.F.R. §8.610 ............................................................................................................. 5
`
`Other
`
`American Medical Association, AMA Urges CDC to Revise Opioid Prescribing
`Guidelines, June 18, 2020, https://www.ama-assn.org/press-center/press-
`releases/ama-urges-cdc-revise-opioid-prescribing-guideline, accessed Jan. 19, 2021
` ................................................................................................................................... 34
`
`Andrew Rosenblum et al., Opioids and the Treatment of Chronic Pain:
`Controversies, Current Status, and Future Directions, 16(5) EXP. CLIN.
`PSYCHOPHARMACOL, 405 (2018) ........................................................................ 32
`
`Andy Baker-White, A Look at State Legislation Limiting Opioid Prescriptions,
`ASTHO (Feb. 23, 2017), http://www.astho.org/StatePublicHealth/A-Look-at-State-
`Legislation-Limiting-Opioid-Prescriptions/2-23-17/ ............................................... 33
`
`Centers for Disease Control and Prevention, CDC Guidelines for Prescribing
`Opioids for Chronic Pain, (last updated Aug. 29, 2017),
`https://www.cdc.gov/drugoverdose/prescribing/guideline.html .............................. 32
`
`CMS, Advance Notice of Methodological Changes for Calendar Year (CV) 2019 for
`Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies
`and 2019 Draft Call Letter, (Feb. 1, 2018)............................................................... 33
`
`Doug Campos-Outcalt, M.D., M.P.A., Opioids for Chronic Pain: The CDC’s 12
`Recommendations, 65(12) J. FAM. PRACT. 906-909 (Dec. 2016) .......................... 33
`
`H.R. Rep. No. 91-1444 ................................................................................................... 4
`
`John J. Mulrooney II & Katherine E. Legel, Current Navigation Points in Drug
`Diversion Law: Hidden Rocks in Shallow, Murky, Drug-Infested Waters, 101
`Marq. L. Rev. 333 (2017) .......................................................................................... 29
`
`x
`
`

`

`R.K. Portenoy & K.M. Foley, Chronic Use of Opioid Analgesics in Non-Malignant
`Pain: Report of 38 Cases, 25(2) PAIN, 171-86 (May 1986) ..................................... 32
`
`
`
`
`
`xi
`
`

`

`PETITION FOR A WRIT OF CERTIORARI
`
`Petitioner-Appellant, Dr. George P. Naum III, respectfully prays that a writ of
`
`certiorari be issued to review the judgment below of the Fourth Circuit Court of
`
`Appeals.
`
`OPINION BELOW
`
`The opinion of the U.S. Court of Appeals for the Fourth Circuit appears in the
`
`Appendix to this Petition and can be found at United States v. Naum, 2020 U.S. App.
`
`LEXIS 32248 (4th Cir. 2020).
`
`JURISDICTION
`
`On October 13, 2020, a three-judge panel of the Fourth Circuit Court of
`
`Appeals entered its opinion in United States v. Naum, 2020 U.S. App. LEXIS 32248
`
`(4th Cir. 2020). Defendant filed a Petition for Panel Rehearing, or alternatively, for
`
`En Banc Rehearing, and this rehearing was denied. United States v. Naum, 2020 U.S.
`
`App. LEXIS 37150 (4th Cir., Nov. 24, 2020). This Court has jurisdiction pursuant to
`
`28 U.S.C. §1254(1).
`
`STATUTES, ORDINANCES AND REGULATIONS INVOLVED
`
`“Except as authorized by this subchapter, it shall be unlawful for any person
`
`knowingly or intentionally . . . to manufacture, distribute, or dispense, or possess with
`
`intent to manufacture, distribute, or dispense, a controlled substance . . . .” 21 U.S.C.
`
`§841(a)(1).
`
`1
`
`

`

`“A prescription for a controlled substance to be effective must be issued for a
`
`legitimate medical purpose by an individual practitioner acting in the usual course of
`
`his professional practice.” 21 C.F.R. §1306.04.
`
`“The term ‘practitioner’ means a physician . . . or other person licensed,
`
`registered, or otherwise permitted, by the United States or the jurisdiction in which
`
`he practices . . . to distribute, dispense, . . . , administer, or use . . . a controlled
`
`substance in the course of professional practice . . . .” 21 U.S.C. §802(21).
`
`
`
`
`
`2
`
`

`

`STATEMENT
`
`Defendant was a registered practitioner with the Drug Enforcement
`
`Administration and authorized to prescribe controlled substances per 21 U.S.C.
`
`§802(6). Defendant was indicted for violations of 21 U.S.C. §841(a) and §846 for
`
`knowingly and willfully distributing and dispensing controlled substances outside the
`
`usual course of medical practice and for other than a legitimate medical purpose.
`
`Prior to trial, the Government filed a motion in limine seeking to clarify its
`
`standard of proof, arguing its burden of proof is to show that Defendant prescribed
`
`controlled substances “for other than a legitimate medical purpose or not within the
`
`bounds of professional practice.” U.S.’s Motion in Limine at 3, United States v. Naum,
`
`No. 18-cr-00001 (N.D. W.Va. filed Apr. 15, 2019), ECF No. 273; see United States v.
`
`Hitzig, 63 Fed. Appx. 83 (4th Cir. 2003). The trial court granted the Government’s
`
`motion. Order Following Motion Hearing, United States v. Naum, No. 18-cr-00001
`
`(N.D. W.Va. filed Apr. 23, 2019), ECF No. 299. The court’s order permitted the
`
`Government to sever the standard outlined in 21 C.F.R. §1306.04 and proceed only
`
`on the theory that Defendant’s prescriptions were issued not within “the bounds of
`
`professional practice.”
`
`Defendant was charged with unlawful distribution of Suboxone. Suboxone is
`
`regulated differently than other medications because it can be used to treat patients
`
`suffering from opioid-use disorder. The Federal Government pre-empted the field of
`
`Opioid Treatment Standards and delegated the creation of treatment standards to
`
`Health and Human Services. 42 U.S.C. §290bb-2a. This statute specifically pre-
`
`3
`
`

`

`empted state governance of addiction treatment and the creation of methods of
`
`professional practice. See Gonzales v. Oregon, 56 U.S. 243, 271 (2006) (holding that
`
`42 U.S.C. §290bb-2a is the only area in which Congress set general uniform standards
`
`of medical practice). In Gonzales, the Court noted: “[t]his provision strengthens the
`
`understanding of the CSA [Controlled Substances Act, 21 U.S.C. §801] as a statute
`
`combating recreational drug abuse, and also indicates that when Congress wants to
`
`regulate medical practice in the given scheme, it does so by explicit language in the
`
`statute.” Id. at 272. The reason Congress sought to pre-empt state regulation of
`
`addiction treatment is exactly why the type of prosecution levied against Defendant
`
`should be disfavored for very strong public policy considerations:
`
`The practicing physician has ... been confused as to when he may
`prescribe narcotic drugs for an addict. Out of a fear of prosecution many
`physicians refuse to use narcotics in the treatment of addicts except
`occasionally in a withdrawal regimen lasting no longer than a few
`weeks. In most instances they shun addicts as patients.
`
`United States v. Moore, 423 U.S. 122, 143-44 (1975) (internal citations omitted). The
`
`Court found that this Congress-created national standard “was designed to clarify for
`
`the medical profession ... the extent to which they may safely go into treating narcotic
`
`addicts as patients.” Id. at 144 (quoting H.R. Rep. No. 91-1444, at 14). Under this
`
`scheme, “[t]hose physicians who comply with the recommendations made by the
`
`Secretary will no longer jeopardize their professional careers ... .” Id. (quoting H.R.
`
`Rep. No. 91-1444, at 15).
`
`Traditionally, patients could only be treated for addiction in a traditional
`
`“methadone clinic setting.” However, in 2000, providers were permitted to treat
`
`patients in an office-based setting but were required to obtain a separate DEA
`
`4
`
`

`

`registration in accordance with 21 U.S.C. §823(g)(2). In an effort to expand addiction
`
`treatment and make it more widely available to areas suffering from the opioid
`
`epidemic, the Federal Government later increased patients’ limit from 100 to 275. 42
`
`C.F.R. §8.610 and 42 C.F.R. §8.2.
`
`Given the unique application of medications like Suboxone for treating
`
`addiction, and to aid providers in how they may safely expand their reach to treat
`
`addiction medicine patients, the Substance Abuse and Mental Health Services
`
`Administration (“SAMHSA”) created publications and training designed to assist
`
`doctors with “best practices.” Unlike traditional medicine, nurses play a larger role
`
`in medication-assisted therapy so that patients can receive more access to care.
`
`Exhibit 2 to United States’ Motion in Limine on Standards Governing Prescriptions
`
`for Suboxone at 41, United States v. Naum, No. 18-cr-00001 (N.D. W.Va. filed Jan.
`
`29, 2019), ECF No. 166-2. In its 140-page guide for assisting nurses in this new role,
`
`SAMHSA permitted a nurse to perform all follow-up care and relapse prevention
`
`functions. Id. (“Nurses must continuously monitor urine drug testing or other
`
`toxicology testing, the number of pills in the patient’s supply, medication dosage, and
`
`pharmacy checks to help prevent relapse”).
`
`At trial, Defendant called Dr. Sandiford Helm, a board-certified addiction
`
`medicine and pain management physician and past president of the American Society
`
`of Interventional Pain Physicians. Helm testified that Suboxone is a drug designed
`
`to block the effects of opioid withdrawal; patients suffering from opioid use disorder
`
`should be put on a long-term, stable dose of Suboxone indefinitely until patient and
`
`5
`
`

`

`provider agree the patient is ready to “wean” off it. A central issue at trial was
`
`Defendant’s using a registered nurse to see patients after initial induction and to
`
`refill prescriptions for Suboxone without Defendant’s presence. Defendant would
`
`review the treatment of each patient and provide notes for subsequent follow-up,
`
`instructing the nurse to increase, decrease, or keep the dose the same upon next visit.
`
`Helm testified that after a patient has seen a provider for initial intake, subsequent
`
`monitoring and follow-up can be delegated to nurses, but the physician must
`
`determine how much medication the patient gets. Transcript of Trial Testimony by
`
`Dr. Standiford Helm at 14, United States v. Naum, No. 18-cr-00001 (N.D. W.Va. Apr.
`
`29, 2019). Helm described Defendant’s process: “The nurse would go in and perform
`
`the follow-up exam and — as I described it, and get the appropriate monitoring and
`
`then would issue the prescription, based upon the previous order provided by the
`
`physician.” Id. at 24.
`
`Helm testified that he believed Defendant established a physician-patient
`
`relationship with patients treated at his clinic during initial intake, and it was
`
`medically appropriate to assign follow-up care to a nurse under SAMHSA Guidelines.
`
`Id. at 19. He also testified that Defendant ensured compliance and properly prevented
`
`diversion in accordance with “best practices” by requiring frequent urinalysis tests
`
`and prescription drug monitoring report checks. Id. at 21. Helm opined it being
`
`permissible for a physician to simply review the care of a nurse in a Suboxone
`
`program by signing off on the charts. Id. at 23.
`
`6
`
`

`

`Helm was then asked by Defendant’s counsel if he had seen other examples of
`
`Defendant’s treatment model being used, which was met by the trial court’s sua
`
`sponte objection. Id. at 27. In a subsequent sidebar proceeding, the court refused to
`
`permit Helm to testify about a model similar to the treatment model used by
`
`Defendant, permitting nurses to treat patients upon follow-up and call-in physician-
`
`issued medication orders. “And to the extent that there are other models out there
`
`that are not relevant to this because they’ve been permitted by special regulation in
`
`the states and are funded by state funds, that is not this model. It will confuse the
`
`jury. We are not doing it.” Id. at 27.
`
`After preventing Defendant from introducing evidence about a state-funded
`
`model permitting nurses to provide follow-up care (in accordance with SAMHSA
`
`guidelines) and call-in prescriptions, the court, sua sponte, instructed the jury as
`
`follows:
`
`Ladies and gentlemen, I just want to make clear to you that we’ve
`had a discussion at the bench about anticipated testimony from Dr.
`Helm regarding a state-approved and funded model in Massachusetts
`that is a very different approach protocol-wise in the office, and,
`actually, in the kind of team put together, than what was utilized at
`Advance Healthcare. That doesn’t mean one is right and one is wrong.
`But it’s been my prior ruling in this case, and during this case, that that
`is — that model is not a relevant discussion to what happened here and
`the questions that are before you here.
`
`Id. at 27-28.
`
`Later during testimony, Helm began to explain that a prescription for a
`
`particular patient was written in the bounds of professional practice because the
`
`patient had a legitimate medical need. Prosecution objected, saying the Government
`
`7
`
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`need only prove a prescription was written “outside the bounds of professional
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`practice” and therefore the medical legitimacy of the prescription is not relevant. Id.
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`at 37. In open court, the trial judge stated:
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`I don’t think the question of whether it was for a legitimate medical
`practice has ever been raised by the Government. It’s not part of the
`case-in-chief. And it’s not an issue in this case and, therefore, is not
`helpful to the jury in determining the issues in the case. So his opinion
`is, it’s not outside the bounds of medical practice. You asked him why.
`He’s explaining. And that’s that.
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`After excluding the medical purpose of a medication from the inquiry into
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`whether a prescription was issued “in the bounds of professional practice,” the court
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`offered no guidance about its definition of “bounds of professional practice.”
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`
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`The jury convicted Defendant of conspiracy to distribute Suboxone “outside the
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`bounds of professional medical practice” from 2008-2016 in violation of 21 U.S.C.
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`§841(a)(1) and §846, and four counts of aiding and abetting distribution of Suboxone
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`outside the bounds of professional medical practice in violation of 21 U.S.C. §841(a)
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`and 18 U.S.C. §2. The court sentenced Defendant to six months’ incarceration
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`followed by six months’ home detention.
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`Section 841(a) of Title 21 of the U.S. Code provides, in relevant part: “(a) ... it
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`shall be unlawful for any person knowingly or intentionally — (1) to ... distribute, ...
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`a controlled substance ....” 21 U.S.C. §841(a)(1). Thus, to secure a conviction under
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`this section, the Government must prove beyond a reasonable doubt that a defendant
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`knowingly or intentionally distributed the controlled substance alleged in the
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`indictment, and at the time of such distribution, the defendant knew the substance
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`distributed was a controlled substance under the law. There is no dispute that the
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`8
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`prescriptions written by Defendant were controlled substances under the CSA and
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`therefore could not be lawfully distributed other than as provided by law.
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`
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`In 1971, the Attorney General promulgated a regulation requiring every
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`controlled substance prescription “be issued for a legitimate medical purpose by an
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`individual practitioner acting in the usual course of his professional practice.” See
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`Gonzales (citing 21 C.F.R. §1306.04(a) (2005)). In 1975, this Court gave its only
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`guidance on what it means for a practice to issue a prescription for a legitimate
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`medical purpose in the usual course of professional practice: “the scheme of the [CSA],
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`viewed against the background of the legislative history reveals an intent to limit a
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`registered physician’s dispensing authority to the course of his ‘professional
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`practice.’” Moore, 423 U.S. at 140. Therefore, a licensed physician who prescribes
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`controlled substances outside the bounds of his professional medical practice is
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`subject to prosecution and is no different than “a large-scale ‘pusher.’” Id. at 143. The
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`Moore court was careful to emphasize that Moore had so wantonly ignored the basic
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`protocols of the medical profession, “he acted as a large-scale ‘pusher’ — not as a
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`physician.” Id. The court further described §841(a) as prohibiting “the significantly
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`greater offense of acting as a drug ‘pusher.’” Id. at 138. These statements show that
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`the Moore court based its decision not merely on the fact that a doctor committed
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`malpractice, or even intentional malpractice, but rather that his actions betrayed any
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`semblance of legitimate medical treatment.
`
`
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`The only other opportunity this Court has had to analyze the conduct required
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`of a physician to be convicted of a violation of 21 U.S.C. §841(a)(1) mirrored the
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`9
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`language of Moore, again emphasizing that Federal Jurisdiction under the CSA is not
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`triggered upon a showing of malpractice, which is left up to the states. Gonzales. In
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`explaining that the CSA did not authorize the U.S. Attorney General to bar
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`dispensation of controlled substances for assisted suicide in the face of a state medical
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`regime permitting such conduct, this Court said:
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`The Controlled Substances Act (CSA), 21 U.S.C. §801 et seq., and case
`law amply support the conclusion that Congress regulates medical
`practice insofar as it bars doctors from using their prescription-writing
`powers as a means to engage in illicit drug dealing and trafficking as
`conventionally understood. Beyond this, however, the statute manifests
`no intent to regulate the practice of medicine generally.
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`Gonzales, 546 U.S. at 269-70.
`
`
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`Since Moore and Gonzales, Circuit decisions have varied widely in interpreting
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`the limited language in both cases. In the instant case, the Fourth Circuit upheld the
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`trial court’s ruling that prevented Defendant from presenting evidence that his
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`treatment of patients was “for a legitimate medical purpose.” Naum at *11. The
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`Fourth Circuit held that the “Government may meet its burden by establishing that
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`the physician’s actions were not for legitimate medical purposes in the usual course
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`of professional medical practice or were beyond the bounds of professional medical
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`practice.” Naum at *10. United States v. Singh, 54 F.3d 1182, 1187 (4th Cir. 1995); see
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`also United States v. Tran Trong Cuong, 18 F.3d 1132, 1141 (4th Cir. 1994). The
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`Fourth Circuit also held that the Government is not required to prove “both prongs”
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`(i.e.,