[Federal Register Volume 90, Number 107 (Thursday, June 5, 2025)]
[Notices]
[Pages 23955-23960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10237]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Lee S. Altman, M.D.; Decision and Order
I. Introduction
On September 6, 2024, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registration (OSC/ISO) to Lee S. Altman, M.D., of Stoughton,
Massachusetts (Respondent). Request for Final Agency Action (RFAA),
Exhibit (RFAAX) 1, at 1. The OSC/ISO informed Respondent of the
immediate suspension of his DEA Certificate of Registration, No.
BA4429684, pursuant to 21 U.S.C. 824(d), alleging that Respondent's
continued registration constitutes ``an imminent danger to the public
health or safety.'' RFAAX, at 1 (quoting 21 U.S.C. 824(d)). The OSC/ISO
also proposes the revocation of Respondent's registration, No.
BA4429684, pursuant to 21 U.S.C. 824(a)(1) and (a)(4), and 823(g)(1),
alleging that Respondent materially falsified an application for
renewal of his registration and his continued registration is
inconsistent with the public interest. RFAAX 1, at 1.
The OSC/ISO notified Respondent of his right to file with DEA a
written request for a hearing. RFAAX 1, at 11 (citing 21 CFR 1301.43).
The OSC/ISO also notified Respondent that if he failed to file such a
request or file an answer, he would be deemed to have waived his right
to a hearing and be in default. Id. On September 10, 2024, Respondent
timely requested a hearing in this matter. RFAAX 3.\1\ The matter was
placed on the docket of DEA Administrative Law Judge Teresa Wallbaum
(ALJ).
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\1\ Based on the Government's submissions in its RFAA, the
Agency finds that service of the OSC/ISO on Respondent was adequate.
According to the Notice of Service of Order to Show Cause and
Immediate Suspension Order, Respondent was personally served with
the OSC/ISO on September 10, 2024. RFAAX 2, at 1.
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Then on October 4, 2024, Respondent, through his attorney,
submitted a letter stating that he was withdrawing his request for a
hearing and that he would ``not contest the suspension of his DEA
registration.'' \2\ RFAAX 4, at 3-5. On October 7, 2024, Respondent
filed a motion to terminate proceedings based on his voluntary
withdrawal of the request for a hearing. RFAAX 4, at 1. On the same
day, the ALJ granted the motion to terminate proceedings and canceled
the hearing. RFAAX 5. After the ALJ terminated the proceedings, the
Government requested final agency action based on Respondent's default
pursuant to 21 CFR 1301.43(c), (f). RFAA, at 1-10.
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\2\ In the letter, Respondent asserted that on September 11,
2024, he submitted an Answer ``with a categorical denial of the
factual allegations contained in the OSC/ISO'' and that he ``st[ood]
by his earlier denial of the factual allegations.'' RFAAX 4, at 3-4.
However, DEA's rules do not permit ``categorical denials.'' 21 CFR
1301.37(d)(3). Instead, ``[f]or each factual allegation in the order
to show cause, the answer shall specifically admit, deny, or state
that the party does not have and it unable to obtain sufficient
information to admit or deny the allegation in the ISO/OSC.'' Id.
Respondent admitted that he did not specifically address the
allegations in the OSC/ISO, and therefore, Respondent's purported
``Answer'' was not an answer filed in compliance with the rules. See
RFAAX 4, at 3-4; 21 CFR 1301.37 (d)(3).
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Pursuant to 21 CFR 3101.43(e), ``[a] default, unless excused, shall
be deemed to constitute a waiver of the registrant's/applicant's right
to a hearing and an admission of the factual allegations of the
[OSC].'' Further, ``[i]n the event that a [registrant/applicant] . . .
is deemed to be in default . . . DEA may then file a request for final
agency action with the Administrator, along with a record to support
its request. In such circumstances, the Administrator may enter a
default final order pursuant to [21 CFR] Sec. 1316.67.'' Id.
1301.43(f)(1). In this case, the Agency finds that Respondent's
voluntary withdrawal of the request for a hearing constitutes a
default.\3\ See Salman Akbar, M.D., 89 FR 82259 (2024) (finding that a
voluntary withdrawal of a hearing request displayed a failure to defend
one's case and therefore the respondent was deemed to be in default).
Accordingly, in light of Respondent's default, the Agency finds that
the factual allegations in the OSC/ISO are deemed admitted.
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\3\ Respondent stated that he wished to ``waiv[e] his right to a
hearing[] without any admission of guilt.'' RFAAX 4, at 4. While
Respondent's waiver does not result in an admission that he is
``guilty'' of violating the Controlled Substances Act, it does
result in ``an admission of the factual allegations of the order to
show cause.'' 21 CFR 1301.43(e).
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II. Applicable Law
The OSC/ISO alleges that Respondent violated multiple provisions of
the Controlled Substances Act (CSA) and its implementing regulations.
As the Supreme Court stated in Gonzales v. Raich, the ``main objectives
of the CSA were to conquer drug abuse and to control the legitimate and
illegitimate traffic in controlled substances. Congress was
particularly concerned with the need to prevent the diversion of drugs
from legitimate to illicit channels.'' 545 U.S. 1, at 12-13 (2005). The
Supreme Court further explained that, to accomplish its objectives,
``Congress devised a closed regulatory system making it unlawful to . .
. dispense[ ] or possess any controlled substance except in a manner
authorized by the CSA.'' Id. at 13. Accordingly, the Supreme Court
stated, the ``CSA and its implementing regulations set forth strict
requirements regarding registration, . . . drug security, and
recordkeeping.'' Id. at 14.
The OSC/ISO's allegations concern the CSA's ``statutory and
regulatory provisions . . . mandating . . . compliance with . . .
prescription requirements'' and, therefore, go to the heart of the
CSA's ``closed regulatory system'' specifically designed ``to conquer
drug abuse and to control the legitimate and illegitimate traffic in
controlled substances,'' and ``to prevent the diversion of drugs from
legitimate to illicit channels.'' Id. at 12-14, 27.
A. The Allegation That Respondent Materially Falsified His DEA
Application
The OSC/ISO alleges that Respondent materially falsified his May 6,
2022, application to renew his DEA registration. RFAAX 1, at 4.
Pursuant to the CSA, the Attorney General is authorized to suspend or
revoke a registration ``upon a finding that the registrant . . . has
materially falsified any application filed pursuant to or required by
this subchapter.'' 21 U.S.C. 824(a)(1); see RFAAX 1, at 4.
B. The Allegation That Respondent Issued Prescriptions Outside the
Usual Course of Professional Practice
The OSC/ISO also alleges that Respondent improperly issued
controlled substance prescriptions to an undercover law enforcement
officer and
[[Page 23956]]
four other individuals. RFAAX 1, at 5-10. According to the CSA's
implementing regulations, a lawful prescription for controlled
substances is one that is ``issued for a legitimate medical purpose by
an individual practitioner acting in the usual course of his
professional practice.'' 21 CFR 1306.04(a); see Gonzales v. Oregon, 546
U.S. 243, 274 (2006), United States v. Hayes, 595 F.2d 258 (5th Cir.
1979), rehearing den., 598 F.2d 620 (5th Cir. 1979), cert. denied, 444
U.S. 866 (1979); RFAAX 1, at 2.
Massachusetts state law similarly requires that ``[a] prescription
for a controlled substance to be valid shall be issued for a legitimate
medical purpose by a practitioner acting in the usual course of his
professional practice,'' \4\ and ``[a]n order purporting to be a
prescription issued not in the usual course of professional treatment
or in legitimate and authorized research is not a prescription within
the meaning and intent of section one . . . .'' Mass. Gen. Laws ch.
94C, sec. 19(a); see RFAAX 1, at 2. A physician practicing in
Massachusetts must ``maintain a medical record for each patient that is
complete, timely, legible, and adequate to enable the licensee or any
other health care provider to provide proper diagnosis and treatment .
. . .'' 243 Mass. Code Regs. sec. 2.07(13)(a); see RFAAX 1, at 3.
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\4\ The Supreme Judicial Court of Massachusetts explained that
the ``usual course of professional practice'' can be interpreted
``to mean the routines customarily expected in the context of the
medical profession.'' Commonwealth v. Stirlacci, 137 NE3d 375, 384
(Mass. 2020) (`` `usual course of professional practice' refers to
`generally recognized and accepted medical practices' '' (quoting
United States v. Smith, 573 F.3d 639, 647-648 (8th Cir. 2009))).
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Under Massachusetts law, effective December 2014, a physician
``must utilize the prescription monitoring program prior to
prescribing, to a patient for the first time . . . a benzodiazepine,''
\5\ and in addition, effective June 2019, a physician must access the
prescription monitoring program ``each time the practitioner issues a
prescription to a patient for any . . . benzodiazepine.'' 105 Mass.
Code Regs. 700.012(G)(1)(b) \6\; see RFAAX 1, at 3. Moreover, effective
August 9, 2019, a physician must ``obtain and record a patient's
written informed consent before diagnostic, therapeutic, or invasive
procedures, medical interventions or treatments.'' 243 Mass. Code Regs.
2.07(26).
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\5\ From December 5, 2014, until June 14, 2019, the state of
Massachusetts required the physician to utilize the PMP prior to
prescribing benzodiazepine to a patient for the first time. 105
Mass. Code Regs. 700.012(H)(1)(b) (2014). Effective June 14, 2019,
the provision was amended and redesignated as 105 Mass. Code Regs.
700.012(G)(2), and the amended version required a physician to
utilize the PMP every time a prescription for benzodiazepine was
issued to a patient. See infra note 6.
\6\ In 2023, the provision was redesignated from 105 Mass. Code
Regs. 700.012(G)(2) to its current designation, 105 Mass. Code Regs.
700.012(G)(1)(b), but the substance of the provision remained the
same.
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III. Findings of Fact
In light of Respondent's default, the Agency finds that the factual
allegations in the OSC/ISO are deemed to be admitted. 21 CFR
1301.43(e).
A. Material Falsification
The Agency finds clear, unequivocal, and convincing record evidence
for each of the following facts, which are deemed admitted. Respondent
admits that on August 8, 2019, the Massachusetts Medical Board (Medical
Board) initiated a disciplinary proceeding against Respondent, and on
March 25, 2021, the Medical Board amended its allegations. RFAAX 1, at
4. On May 6, 2022, while the state disciplinary proceeding was ongoing,
Respondent applied to renew his DEA registration. Id. The renewal
application asked whether ``the applicant [has] ever surrendered (for
cause) or had a state professional license or controlled substance
registration revoked, suspended, denied, restricted, or placed on
probation, or is any such action pending?'' (Liability Question 3). Id.
(emphasis added). Respondent answered ``no'' to Liability Question 3 on
his renewal application, representing that he was not undergoing a
state action at that time. Id. On May 9, 2024, the Medical Board issued
a final decision regarding Respondent's disciplinary proceeding and
found that Respondent's misconduct warranted an indefinite suspension
of his state medical license.\7\ RFAAX 1, at 4-5.
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\7\ The OSC/ISO noted that the Medical Board stayed Respondent's
suspension for 60 days to consider a `` `standard, five-year Board
Probation Agreement.' '' RFAAX 1, at 4. The OSC/ISO also noted the
Medical Board's finding that Respondent demonstrated a lack of
candor to state officials when he, among other things, failed to
report his termination by a former employer, failed to report a
prior disciplinary action, and failed to disclose a search warrant
executed at his medical office. RFAAX 1, at 4-5.
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B. Prescriptions Issued Outside the Usual Course of Professional
Practice
The Agency finds substantial record evidence for each of the
following facts, which are deemed admitted. For about a decade, from
2013 through 2024, Respondent issued numerous controlled substance
prescriptions to five individuals, including an undercover law
enforcement officer (UC), outside the usual course of professional
practice. RFAAX 1, at 5-10. For example, Respondent admits that he
issued prescriptions without establishing diagnoses, preparing proper
documentation, addressing red flags of abuse and diversion, and
obtaining informed consent. RFAAX 1, at 5-10.
1. Prescribing to UC
Respondent admits that on five occasions between March 2019 and
July 2019 he issued controlled substances prescriptions to UC that
lacked a legitimate medical purpose. RFAAX 1, at 5-6. Specifically,
Respondent admits that on March 28, 2019, he issued to UC a
prescription for dextroamphetamine-amphetamine \8\ without a proper
diagnosis and without properly documenting the encounter. RFAAX 1, at
5. Respondent further admits that he ignored evidence of diversion when
UC stated that he/she was requesting the prescription after taking
unprescribed dextroamphetamine-amphetamine obtained from one of
Respondent's patients. RFAAX 1, at 5-6. Respondent admits that he
prescribed UC dextroamphetamine-amphetamine on four additional
occasions between April 29, 2019, and July 24, 2019, without addressing
evidence of abuse and diversion and without properly documenting the
encounter.
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\8\ Respondent prescribed 30 tablets of Adderall 30 mg, which is
a brand name for dextroamphetamine-amphetamine. RFAAX 1, at 5.
Amphetamine, its salts, optical isomers, and salts of its optical
isomers are Schedule II stimulants. 21 CFR 1308.12(d)(1).
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Respondent admits that on June 25, 2019, he issued to UC a
prescription for alprazolam \9\ without addressing evidence of abuse or
diversion and without properly documenting the encounter. RFAAX 1, at
6. Respondent admits that he ignored evidence of diversion by
prescribing despite UC stating that he had taken unprescribed Xanax
that he received from one of Respondent's patients. RFAAX 1, at 6.
Respondent also ignored evidence of abuse, which he acknowledged during
the encounter by stating that he believed UC was `` `gonna drink
anyways,' '' and that `` `I'm basically giving you Xanax to combine
with alcohol.' '' RFAAX 1, at 6. Respondent admits that throughout his
treatment of UC, he falsified medical records by describing events,
statements and/or diagnoses that never occurred. RFAAX 1, at 6.
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\9\ Respondent prescribed 10 tablets of Xanax 2 mg, which is a
brand name for alprazolam, a Schedule IV depressant and
benzodiazepine. RFAAX 1, at 6; see 21 CFR 1308.14(c)(2).
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2. Prescribing to J.G.
Respondent admits that from April 6, 2017, through February 1,
2024, he issued to J.G. monthly prescriptions for
[[Page 23957]]
dextroamphetamine-amphetamine and alprazolam that lacked a legitimate
medical purpose. Specifically, Respondent admits that he issued these
controlled substance prescriptions without establishing a proper
diagnosis and conducting periodic reassessments, without obtaining
informed consent, and without properly reviewing J.G.'s record in the
prescription monitoring program (PMP) before prescribing a
benzodiazepine.\10\ RFAAX 1, at 6-7. Respondent also admits that he did
not consistently monitor J.G.'s drug consumption through urine drug
screens and pill counts or resolve aberrant results; or address
evidence of abuse and diversion, such as J.G.'s alcohol abuse and use
of multiple pharmacies to fill prescriptions. RFAAX 1, at 6-7.
Respondent further admits that he cut-and-pasted documentation in the
medical records, he increased doses of controlled substances without
recording a new assessment, and he issued duplicative prescriptions for
dextroamphetamine. RFAAX 1, at 7.
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\10\ Respondent first documented his review of the PMP three
years after J.G. became his patient. RFAAX 1, at 7.
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3. Prescribing to D.B.
Respondent admits that from August 28, 2015, through February 2,
2024, he issued to D.B. monthly prescriptions for dextroamphetamine-
amphetamine and alprazolam that lacked a legitimate medical purpose.
RFAAX 1, at 7. Specifically, Respondent admits that he issued these
controlled substance prescriptions without establishing a proper
diagnosis and conducting periodic reassessments, without obtaining
informed consent, and without properly reviewing D.B.'s record in the
PMP prior to prescribing benzodiazepines.\11\ RFAAX 1, at 7-8.
Respondent also admits that he ignored evidence of potential abuse and
diversion, including D.B.'s report that he had been incarcerated for
drug trafficking and had a significant history of abusing alcohol,
cocaine, and heroin. RFAAX 1, at 8. Respondent further admits that he
cut-and-pasted documentation in the medical records, and he increased
doses of controlled substances without recording a new assessment.
RFAAX 1, at 8.
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\11\ Respondent first documented his review of the PMP on March
4, 2020, which was more than four and a half years after D.B. became
his patient. RFAAX 1, at 8.
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4. Prescribing to T.S.
Respondent admits that from October 10, 2013, through January 15,
2015, and again from August 3, 2018, through January 16, 2024, he
issued to T.S. monthly prescriptions for dextroamphetamine-amphetamine,
and on August 4, 2022, issued to T.S. one prescription for
diazepam,\12\ that lacked a legitimate medical purpose. RFAAX 1, at 8-
9. Specifically, Respondent admits that he issued these controlled
substance prescriptions without establishing a proper diagnosis,
without obtaining informed consent, and without properly reviewing
T.S.'s record in the PMP prior to prescribing a benzodiazepine. RFAAX
1, at 8-9. Respondent also admits that he ignored evidence of potential
abuse and diversion, including that T.S. had a history of being
arrested for selling and possessing drugs and driving under the
influence of drugs and alcohol, and historically abused opiates and
heroin. RFAAX 1, at 8. Respondent further admits that he cut-and-pasted
documents in the medical record, and that he increased doses and
changed medication at T.S.'s request and without recording a new
assessment. RFAAX 1, at 8-9.
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\12\ Respondent prescribed 30 tablets of diazepam 20 mg, which
is a Schedule IV depressant and benzodiazepine. RFAAX 1, at 9.
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5. Prescribing to T.P.
Respondent admits that from March 21, 2013, through February 16,
2024, he issued to T.P. monthly prescriptions for dextroamphetamine-
amphetamine and alprazolam. RFAAX 1, at 9. Respondent also admits that
from May 6, 2015, through May 27, 2021, he issued to T.P. monthly
prescriptions for modafinil,\13\ and that from May 6, 2019, through
February 16, 2024, he issued monthly prescriptions for clonazepam.\14\
RFAAX 1, at 9. Respondent admits that all these prescriptions were
issued without a legitimate medical purpose. RFAAX 1, at 9. More
specifically, Respondent admits that he issued these controlled
substance prescriptions without establishing a proper diagnosis,
without obtaining informed consent, and without properly reviewing
T.P.'s record in the PMP prior to prescribing benzodiazepines. RFAAX 1,
at 9-10. Respondent also admits that he ignored signs of potential
abuse and diversion, including an unexplained early refill for
clonazepam; and that he increased doses and changed medication at
T.P.'s request and without recording a new assessment. RFAAX 1, at 9-
10. Finally, Respondent admits that he cut-and-pasted documentation in
the medical records and that he issued controlled substance
prescriptions on March 6, 2023, and on March 22, 2023, with no
corresponding documentation in T.P.'s medical chart. RFAAX 1, at 9-10.
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\13\ Provigil, which is a brand name for modafinil, is a
Schedule IV stimulant. RFAAX 1, at 9; see 21 CFR 1308.14(f).
\14\ Klonopin, which is a brand name for clonazepam, is a
Schedule IV depressant and benzodiazepine. RFAAX 1, at 9; see 21 CFR
1308.14(c).
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6. Expert Review
DEA consulted with an independent medical expert who reviewed
Respondent's medical records and controlled substance prescriptions
issued to each of the five individuals identified above. RFAAX 1, at
10. Respondent admits that DEA's medical expert concluded that each of
``the controlled substance prescriptions violated the minimal medical
standards applicable to the practice of medicine in Massachusetts.''
RFAAX 1, at 10. Based on the expert's uncontroverted opinion and
Respondent's admissions, the Agency finds substantial record evidence
that each of the controlled substance prescriptions referenced above
were issued without a legitimate medical purpose and/or outside the
usual course of professional practice. RFAAX 1, at 10.
III. Discussion
A. Material Falsification
Pursuant to the CSA, the Administrator is authorized to suspend or
revoke a registration ``upon a finding that the registrant . . . has
materially falsified any application filed pursuant to or required by
this subchapter.'' 21 U.S.C. 824(a)(1); see also Farmacia Yani, 80 FR
29053, 29058 (2015) (``materially falsifying an application provides a
basis for revoking an existing registration without proof of any other
misconduct''). Agency decisions have repeatedly held that false
responses to the liability questions on an application for registration
are material. Kevin J. Dobi, APRN, 87 FR 38184, 38184 (2022)
(collecting cases).
Regarding proof of material falsification, the Government must
prove an allegation of material falsification ``by evidence that is
clear, unequivocal, and convincing.'' Richard J. Settles, D.O., 81 FR
64940, 64946 (2016) (quoting Kungys v. United States, 485 U.S. 759, 772
(1998)). The Government need not show that an applicant actually knew
that his response to a liability question was false. Rather, it is
sufficient that the Government shows that an applicant should have
known that his response to a liability question was false. Narciso A.
Reyes, 83 FR 61678, 61680 (2018) (citing Samuel S. Jackson, D.D.S., 72
FR 23848, 23852 (2007)). When the Government has made such a showing,
i.e., that an
[[Page 23958]]
applicant should have known that his response to a liability question
was false, an applicant's claim that he misunderstood a liability
question, or otherwise inadvertently provided a false answer to a
liability question, is not a defense. Id. (citing Alvin Darby, M.D., 75
FR 26993, 26999 (2010)). Indeed, the applicant bears the responsibility
to carefully read the liability questions and to answer them honestly;
``[a]llegedly misunderstanding or misinterpreting liability questions
does not relieve the applicant of this responsibility.'' Zelideh I.
Cordova-Velazco, M.D., 83 FR 62902, 62906 (2018) (internal citations
omitted).
As found above, Respondent submitted an application to renew his
DEA registration on May 6, 2022. RFAAX 1, at 4. Respondent answered in
the negative to the third Liability Question asking whether he had
``ever surrendered (for cause) or had a state professional license
revoked, suspended, denied, restricted, or placed on probation, or
whether any such action was pending.'' RFAAX 1, at 4; see supra section
III.A. The Agency finds that there is clear, unequivocal, convincing
and uncontroverted evidence that at the time Respondent answered in the
negative, there was a disciplinary proceeding involving Respondent's
professional license pending with the state Medical Board. RFAAX 1, at
4. In fact, the proceeding had been pending since August 9, 2019, and
the Medical Board amended the allegations on March 25, 2021, just over
a year from Respondent's renewal application. RFAAX 1, at 4.
Accordingly, the Agency finds clear, unequivocal, convincing and
uncontroverted evidence that Respondent knew or should have known that
his answer to the third Liability Question was false. See Robert L.
Carter, 90 FR 9631, 9633 (2025); Frank Joseph Stirlacci, M.D., 85 FR at
45237-40 (collecting cases).
Regarding materiality, the Supreme Court explained decades ago that
``the ultimate finding of materiality turns on an interpretation of
substantive law.'' Kungys, 485 U.S. at 772 (citing a Sixth Circuit case
involving 18 U.S.C. 1001 and explaining that, even though the instant
case concerned 8 U.S.C. 1451(a), ``we see no reason not to follow what
has been done with the materiality requirement under other statutes
dealing with misrepresentations to public officers''). The Supreme
Court also clarified that a falsity is material if it is ``predictably
capable of affecting, i.e., had a natural tendency to affect, the
official decision.'' Kungys, 485 U.S. at 771.
Respondent's false answer is material under the Supreme Court's
materiality analysis because it is ``capable of affecting . . . the
[Agency's] official decision.'' Id. Indeed, Respondent's falsification
relates to two of the five factors that the Agency must consider in
determining whether an application is consistent with the public
interest and should be granted or denied: Factors A and D. 21 U.S.C.
823(g); see Frank Joseph Stirlacci, M.D., 85 FR at 45234-35. Therefore,
Respondent's falsification directly implicates the Agency's CSA
mandated analysis and final decision by depriving it of legally
relevant facts needed to decide whether to grant Respondent's
application. Universal Health Servs., Inc. v. United States ex rel.
Escobar, 579 U.S. 176, 193 (2016) (``Under any understanding of the
concept, materiality `look[s] to the effect on the likely or actual
behavior of the recipient of the alleged misrepresentation.' '');
Maslenjak v. United States, 582 U.S. 335, 348 (2017) (concluding that
when ``there is an obvious causal link between the . . . lie and . . .
[the] procurement of citizenship,'' the facts ``misrepresented are
themselves disqualifying'' and the fact finder ``can make quick work of
that inquiry''). In other words, there is no doubt that Respondent's
false answer was ``predictably capable of affecting, i.e., had a
natural tendency to affect, the official decision'' the CSA instructs
the Agency to make. Kungys, 485 U.S. at 771.
Consequently, based on the CSA and the analysis underlying multiple
Supreme Court decisions involving materiality, the Agency finds that
Respondent's false response on the registration renewal application in
2022 is material. Accordingly, the Agency finds that the Government has
presented clear, unequivocal, and convincing record evidence
establishing a prima facie case for revocation of Respondent's
registration pursuant to 21 U.S.C. 824(a)(1).
B. Public Interest Determination
Pursuant to the CSA, ``[a] registration . . . to . . . distribute[
] or 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 . . . [21
U.S.C. 823] inconsistent with the public interest as determined by such
section.'' 21 U.S.C. 824(a)(4). In the case of a ``practitioner,''
Congress directed the Attorney General to consider five factors in
making the public interest determination. 21 U.S.C. 823(g)(1)(A-E).\15\
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\15\ The five factors of 21 U.S.C. 823(g)(1)(A-E) are:
(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.
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The five factors are considered in the disjunctive. Gonzales v.
Oregon, 546 U.S. 243, 292-93 (2006) (Scalia, J., dissenting) (``It is
well established that these factors are to be considered in the
disjunctive,'' citing In re Arora, 60 FR 4447, 4448 (1995)); 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. Penick Corp. v. Drug Enf't Admin., 491 F.3d 483, 490 (D.C.
Cir. 2007); Morall, 412 F.3d. at 185 n.2; David H. Gillis, M.D., 58 FR
37507, 37508 (1993).
According to Agency decisions, the Agency ``may properly rely on
any one or a combination of factors and give each factor the weight
[it] deems appropriate'' in determining whether to revoke a
registration. David H. Gillis, M.D., 58 FR at 37508; see also Jones
Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823, 830
(11th Cir. 2018) (citing Akhtar-Zaidi v. Drug Enf't Admin., 841 F.3d
707, 711 (6th Cir. 2016)); MacKay v. Drug Enf't Admin., 664 F.3d 808,
816 (10th Cir. 2011); Volkman v. U. S. Drug Enf't Admin., 567 F.3d 215,
222 (6th Cir. 2009); Hoxie v. Drug Enf't Admin., 419 F.3d 477, 482 (6th
Cir. 2005).
Moreover, while the Agency is required to consider each of the
factors, it ``need not make explicit findings as to each one.'' MacKay,
664 F.3d at 816 (quoting Volkman, 567 F.3d at 222); see also Hoxie, 419
F.3d at 482. ``In short, . . . the Agency is not required to
mechanically count up the factors and determine how many favor the
Government and how many favor the registrant. Rather, it is an inquiry
which focuses on protecting the public interest; what matters is the
seriousness of the registrant's misconduct.'' Jayam Krishna-Iyer, M.D.,
74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has
recognized, findings under a single factor can support the revocation
of a registration. MacKay, 664 F.3d at 821.
[[Page 23959]]
In this matter, while all the 21 U.S.C. 823(g)(1) factors have been
considered, the Agency finds that the Government's evidence in support
of its prima facie public interest revocation case regarding
Respondent's violations of the CSA's implementing regulations is
confined to Factors B and D. RFAAX 1, at 4. Moreover, the Government
has the burden of proof in this proceeding. 5 U.S.C. 556(d); 21 CFR
1301.44.
Evidence is considered under Factors B and D when it reflects
compliance or non-compliance with laws related to controlled substances
and experience dispensing controlled substances. See Kareem Hubbard,
M.D., 87 FR 21156, 21162 (2022). In the current matter, the Government
has alleged that Registrant has violated federal and state law
regulating controlled substances. RFAAX 1, at 1-2; see supra Section
II.
1. Violation of Federal Law
Here, the Agency finds substantial record evidence that Respondent
violated federal law, namely 21 CFR 1306.04(a), when he repeatedly
issued prescriptions for controlled substances outside the usual course
of professional practice and not for legitimate medical purposes. See
RFAAX 1, at 5-10. Specifically, Respondent admits that he issued these
prescriptions without establishing a proper diagnosis, documenting the
encounters, and/or obtaining informed consent. RFAAX 1, at 5-10.
Respondent also admits that he repeatedly ignored evidence of abuse and
diversion, cut-and-pasted medical records, and increased dosages
without proper assessments. RFAAX 1, at 5-10. An independent medical
expert obtained by DEA concluded that Respondent's ``controlled
substance prescriptions violated the minimal medical standards
applicable to the practice of medicine in Massachusetts.'' RFAAX 1, at
10. Based on the Respondent's admissions, the Agency finds that from
2013 through 2024, Respondent issued prescriptions for controlled
substances to five individuals, including one undercover law
enforcement officer, that lacked legitimate medical purposes. RFAAX, 5-
10; see supra, Section III.B.
2. Violation of State Law
For the same reasons that the Agency found that Respondent violated
federal law, the Agency finds substantial record evidence that
Respondent violated state law when he repeatedly issued prescriptions
for controlled substances outside the usual course of professional
practice and not for legitimate medical purposes. See RFAAX 1, at 5-10;
Mass. Gen. Laws ch. 94C Sec. 19(a); see also Section III.B.
Furthermore, the Agency finds substantial record evidence that
Respondent violated 243 Massachusetts Code Regulations 2.07(13)(a),
when Respondent failed to maintain complete and adequate treatment
records. Specifically, Respondent admits that in prescribing to UC, he
failed to document the encounters and falsified medical records by
describing events, statements and/or diagnoses that never occurred.
Additionally, Respondent admits that in prescribing to the other four
individuals, he cut-and-pasted documentation, failed to document proper
diagnoses and failed to record new assessments when increasing dosages.
RFAAX 1, at 5-10.
The Agency finds substantial record evidence that Respondent
violated state law when Respondent failed to utilize the PMP prior to
issuing relevant prescriptions for benzodiazepine to four individuals,
J.G., D.B., T.S., and T.P.\16\ RFAAX 1, at 5-10; see 105 Mass. Code
Regs. 700.12(G)(1)(b). The Agency also finds substantial record
evidence that Respondent violated state law, 105 Mass Code Regs.
2.07(26), when Respondent issued controlled substances prescriptions to
four individuals (J.G., D.B., T.S., and T.P.) without obtaining
informed consent.\17\ RFAAX 1, at 5-10.
---------------------------------------------------------------------------
\16\ Only the benzodiazepine prescriptions issued after December
2014, the date the relevant state law went into effect, are relevant
to the Agency's finding that Respondent's prescribing violated 105
Massachusetts Code Regulations 700.12(G)(1)(b). See supra notes 5-6.
\17\ This applies only for the consent forms that Respondent
failed to obtain after August 9, 2019, the date the relevant state
law went into effect. See 243 Mass. Code Regs. 2.07(26).
---------------------------------------------------------------------------
Based on Respondent's admissions, the Agency finds substantial
record evidence that Respondent violated federal and state laws
involving controlled substances and issued prescriptions outside the
usual course of professional practice. See RFAAX 1, at 1-11; see also
21 CFR 1306.04(a); Mass. Gen. Laws ch. 94C sec. 19(a); 243 Mass. Code
Regs. 2.07(13)(a); 105 Mass. Code Regs. 2.07(26), 700.12(G)(1)(b).
Accordingly, the Agency finds that Factors B and D weigh in favor of
denying Respondent's registration and thus finds that Respondent's
registration is inconsistent with the public interest in balancing the
factors of 21 U.S.C. 823(g)(1). The Agency further finds that
Registrant failed to provide any evidence to rebut the Government's
prima facie case.
IV. Sanction
Here, the Government has met its prima facie burden of showing that
Respondent's existing registration should be revoked because of his
material falsification and because his continued registration is
inconsistent with the public interest. The burden then shifts to
Respondent to show why he can be entrusted with a registration. Morall,
412 F.3d. at 174; Jones Total Health Care Pharmacy, 881 F.3d at 830;
Garrett Howard Smith, M.D., 83 FR 18882, 18904 (2018).
The issue of trust is necessarily a fact-dependent determination
based on the circumstances presented by the individual respondent.
Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019); see also Jones Total
Health Care Pharmacy, 881 F.3d at 833. Moreover, as past performance is
the best predictor of future performance, DEA Administrators have
required that a registrant who has committed acts inconsistent with the
public interest must accept responsibility for those acts and
demonstrate that it will not engage in future misconduct. Jones Total
Health Care Pharmacy, 881 F.3d at 833; ALRA Labs, Inc. v. Drug Enf't
Admin., 54 F.3d 450, 452 (7th Cir. 1995). A registrant's acceptance of
responsibility must be unequivocal. Jones Total Health Care Pharmacy,
881 F.3d at 830-31. In addition, a registrant's candor during the
investigation and hearing has been an important factor in determining
acceptance of responsibility and the appropriate sanction. Id. Further,
the Agency has found that the egregiousness and extent of the
misconduct are significant factors in determining the appropriate
sanction. Id. at 834 & n.4. The Agency has also considered the need to
deter similar acts by the respondent and by the community of
registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.
Regarding these matters, there is no record evidence that
Respondent takes responsibility, let alone unequivocal responsibility,
for the founded violations meaning, among other things, that it is not
reasonable to believe that Respondent's future controlled substance-
related actions will comply with legal requirements. Accordingly,
Respondent did not convince the Agency that he can be entrusted with a
registration.
Further, the interests of specific and general deterrence weigh in
favor of revocation. Given the foundational nature and vast number of
Respondent's violations, a sanction less than revocation would send a
message to the existing and prospective registrant community that
compliance with the law is not a condition precedent to maintaining a
registration.
[[Page 23960]]
In sum, Respondent has not offered any evidence on the record that
rebuts the Government's case for revocation of his registration, and
Respondent has not demonstrated that he can be entrusted with the
responsibility of registration. Accordingly, the Agency will order the
revocation of Respondent's registration.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a) and 21 U.S.C. 823(g)(1), I hereby revoke DEA Certificate
of Registration No. BA4429684 issued to Lee S. Altman, M.D. Further,
pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C.
824(a) and 21 U.S.C. 823(g)(1), I hereby deny any pending application
of Lee S. Altman, M.D., for registration in Massachusetts. This Order
is effective July 7, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
May 30, 2025, by Acting Administrator Robert J. Murphy. 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. 2025-10237 Filed 6-4-25; 8:45 am]
BILLING CODE 4410-09-P