Belinda R. Mori, N.P.; Decision and Order, 36582-36591 [2013-14447]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 78, Number 117 (Tuesday, June 18, 2013)]
[Notices]
[Pages 36582-36591]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14447]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 12-15]


Belinda R. Mori, N.P.; Decision and Order

    On November 17, 2011, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Belinda R. Mori, N.P. (Respondent), of Santa Fe, New 
Mexico. The Show Cause Order proposed the denial of Respondent's 
pending application for a DEA Certificate of Registration, on the 
ground that her ``registration would be inconsistent with the public 
interest.'' ALJ Ex. 1, at 1.
    The Show Cause Order specifically alleged that on March 18, 2011, 
Respondent applied for a Certificate of Registration as a mid-level 
practitioner, seeking authority to dispense controlled substances in 
schedules II through V. Id. The Order further alleged that Respondent 
had previously held a registration, which authorized her to dispense 
controlled substances in schedules II through V as a mid-level 
practitioner but that ``this registration expired on January 31, 
2011.'' Id.
    Next, the Show Cause Order alleged that ``[b]etween August 29, 2009 
and March 15, 2011, [Respondent] issued approximately thirty-three 
purported prescriptions for alprazolam (a [s]chedule IV controlled 
substance) to [her] daughter without conducting a medical examination 
and without creating a patient record,'' and that these prescriptions 
``were issued outside the usual course of professional practice, in 
violation of Federal and . . . state law.'' Id. (citing 21 CFR 
1306.04(a); N.M Admin. Code tit. 16, Sec. Sec.  12.2.7(V) and 
12.2.13(N)(5)(g)). The Order further alleged that ``[o]n or about March 
15, 2011, [Respondent] issued a purported prescription for alprazolam . 
. . to [her] daughter . . . while [she was] without a valid DEA 
Certificate of Registration, in violation of Federal and . . . state 
law.'' Id. at 2 (citing 21 U.S.C. 841(a)(1); N.M. Admin. Code tit. 16, 
Sec.  12.2.13(N)(5)(a)).
    On December 5, 2011, Respondent, through her counsel, requested a 
hearing on the allegations. ALJ Ex. 2. The matter was placed on the 
docket of the Office of Administrative Law Judges (ALJ), and assigned 
to an ALJ who proceeded to conduct pre-hearing procedures.
    On December 20, 2011, the Government filed its pre-hearing 
statement. Therein, the Government provided notice that it intended to 
elicit

[[Page 36583]]

the testimony of an Agency Diversion Investigator (DI) that ``on or 
about April 14, 2011, she spoke with Respondent about her application 
for a DEA Certificate of Registration'' and ``asked Respondent whether 
[she] used her previous DEA Certificate of Registration after it 
expired, and Respondent stated that she had not.'' Gov't Prehr'g 
Statement, at 3. The Government also provided notice that it intended 
to show that ``[o]n this same day, [the DI] ran a prescription 
monitoring report with the New Mexico Board of Pharmacy for the period 
of February 1, 2011, through April 14, 2011, and that the report showed 
that Respondent issued one prescription for controlled substances 
(alprazolam) after her previous DEA Certificate of Registration 
expired,'' and that the prescription was for her daughter and issued 
``on or about March 15, 2011.'' Id. Finally, the Government provided 
notice that the DI would ``testify that on or about May 3, 2011, she 
interviewed Respondent about the alprazolam prescription that was 
issued after her previous DEA Certificate of Registration expired,'' 
and that ``Respondent informed [the DI] that she issued the alprazolam 
prescription to her daughter because [she] did not have health 
insurance and therefore could not see her treating physician.'' Id.
    On May 1, 2012, the ALJ conducted a hearing in Albuquerque, New 
Mexico. At the hearing, the Government elicited the testimony of the DI 
and introduced various documents into the record; Respondent testified 
on her own behalf and also introduced various documents into the 
record. Following the hearing, both parties submitted briefs containing 
their proposed findings of fact, conclusions of law, and argument.
    On July 30, 2012, the ALJ issued her Recommended Decision (R.D.). 
Therein, the ALJ found that the Government had proved that Respondent 
violated federal law because she issued thirty-three prescriptions to 
her daughter and ``did not establish a good faith practitioner-patient 
relationship with [her] prior to issuing controlled substance 
prescriptions to her.'' R.D. at 16. Moreover, the ALJ found that 
Respondent ``violated federal law by issuing a prescription after the 
expiration of her DEA Certificate of Registration.'' Id. (citing 21 
U.S.C. 843(a)(2)). The ALJ thus concluded that ``in light of 
Respondent's serious and undisputed violations of the CSA and New 
Mexico law, . . . the Government has presented a prima facie case that 
supports the denial of Respondent's application.'' Id. at 16-17.
    The ALJ then addressed whether Respondent had rebutted the 
Government's prima facie case. R.D. at 17. The ALJ found that 
``Respondent has both taken responsibility for her actions and shown 
remorse for her unlawful conduct,'' noting that ``she demonstrated 
visible remorse for her misconduct'' and ``testified credibly and 
candidly about the circumstances surrounding the misconduct.'' Id. She 
also explained that Respondent's testimony regarding her ``health 
problems,'' the ``death of her son in a motorcycle accident, and her 
daughter's subsequent struggle with mental illness after losing her 
health insurance'' were ``appropriate mitigating factors'' which should 
be considered. Id. at 17-18.
    The ALJ further found that although Respondent had made a false 
statement to the DI in an April 2011 phone call when she denied writing 
any prescriptions after her registration had expired, the ALJ rejected 
the Government's contention that she did so deliberately. Id. at 18. 
Instead, the ALJ found ``that it is quite plausible that [Respondent] 
unintentionally made the false statement,'' reasoning that ``the 
Government's argument regarding [her] lack of candor is undercut by the 
extensive and voluntary disclosures [she] made to [the DI] during that 
April 2011 telephone conversation, namely that she had not prepared or 
maintained any treatment records regarding these prescriptions.'' Id. 
The ALJ thus reasoned that ``[i]n light of the totality of [her] 
interaction with [the DI] and her credible testimony at the hearing, . 
. . her statement, while admittedly false, does not negatively outweigh 
her overall candor with the Agency.'' Id.
    Next, the ALJ found ``that Respondent has demonstrated specific 
remedial measures which she has undertaken to prevent the reoccurrence 
of her unlawful conduct,'' including her completion of ``a continuing 
medical education class on prescribing for family members'' and that 
she ``has pledged to cease writing prescriptions for her daughter or 
any other family member.'' Id. at 19. The ALJ further noted that 
Respondent had discussed her daughter's treatment with her psychiatrist 
and confirmed that all of her daughter's prescriptions would henceforth 
be issued by him. Id.
    The ALJ thus concluded that the Government's proposed sanction of 
denial would be ``too severe.'' Id. While finding that Respondent's 
``misconduct was . . . serious,'' the ALJ recommended that Respondent 
be granted a restricted registration, concluding that she ``has now 
demonstrated that she understands the responsibilities and requirements 
of a DEA registrant.'' Id. at 19-20.
    Having considered the record in its entirety, I adopt the ALJ's 
findings of fact and conclusions of law except as discussed below. 
While I reject the ALJ's finding that Respondent violated the CSA's 
prescription requirement when she prescribed to her daughter as 
unsupported by substantial evidence, I adopt her finding that 
Respondent violated DEA regulations when she prescribed a controlled 
substance after the expiration of her registration. I further reject 
the ALJ's finding that Respondent unintentionally made a false 
statement to the DI when she denied having written any controlled 
substance prescriptions after the expiration of her DEA registration. 
Because Respondent has failed to accept responsibility for her 
misconduct, I reject the ALJ's recommended sanction and will order that 
Respondent's application be denied.

Findings of Fact

    Respondent is a Certified Nurse Practitioner licensed by the Board 
of Nursing for the State of New Mexico. GX 3, at 3. On June 23, 2010, 
the Executive Director of the Board of Nursing (Board) notified 
Respondent that she had reviewed evidence suggesting that Respondent 
had practiced on an expired license (and thus practiced without a 
license). GX 4, at 1. While the Executive Director noted that ``there 
is sufficient evidence for the Board to consider disciplinary actions 
against [Respondent's] nursing license,'' the Board offered Respondent 
a ``voluntary reprimand and fine.'' Id., see also GX 4, at 3. On July 
2, 2010, Respondent accepted the reprimand, id. at 2, and in December 
2010, the Board issued her a Voluntary Letter of Reprimand. GX 5.
    Respondent also previously held a DEA Certificate of Registration, 
which authorized her to dispense controlled substances in schedules II 
through V, as a mid-level practitioner, at the registered address of 
3715 Southern Blvd., Rio Rancho, New Mexico. GX 2, at 1. On January 31, 
2011, the registration expired. Id. Thereafter, ``no controlled 
substances could be obtained, stored, administered, prescribed, or 
dispensed under'' the registration. Id. Respondent did not submit a 
renewal application until March 18, 2011. Id.
    At some point not clear on the record, but after Respondent 
submitted her renewal application, Respondent called the DEA Office in 
Albuquerque regarding the status of her application. Tr. 16. The DI who 
was assigned the weekly duty of taking phone calls subsequently 
returned her call and

[[Page 36584]]

explained that her application had yet to be assigned to an 
investigator, but that it would be and that an investigator would 
contact her for further information. Id.
    The DI testified that before she returned Respondent's phone call, 
she had determined that Respondent had previously held a DEA 
registration.\1\ Id. at 17. The DI also testified that before she 
returned Respondent's call, she had queried the Board of Nursing's Web 
site and noted that Respondent had been reprimanded by the Board. Id.
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    \1\ According to the DI, at the time of her first phone call 
with Respondent, the matter had yet to be assigned to an 
Investigator. However, the matter was eventually assigned to the DI. 
The record is less than transparent regarding whether at the time of 
the DI's initial phone call with Respondent she had queried the 
State Board's Web site as well as determined that Respondent had 
previously been registered or whether she made these inquiries prior 
to a second phone conversation.
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    During the phone call, the DI verified with Respondent that she had 
previously held a registration. Id. The DI also told Respondent that as 
part of the pre-registration investigation, she would be contacting the 
Board for more information regarding the basis of the reprimand. Id. 
She then discussed with Respondent the reason for having to submit a 
new application. Respondent told the DI that her registration had 
expired because she had failed to renew it. Id. at 22.
    The DI asked Respondent if she had written any prescriptions past 
the expiration date; Respondent ``stated she had not.'' Id. The DI then 
told Respondent that she ``would be running a prescription monitoring 
program report [PMP]'' and ``explained to [her] what the PMP was and 
what it would show me.'' Id. The DI told Respondent that the PMP 
``would show the prescriptions that were filled pursuant to her DEA 
number for a certain time period,'' id, and ``explained that [she] 
would be querying that to verify the information she had provided of 
not writing any prescriptions with an expired DEA number.'' Id. at 23.
    Subsequently, the DI ran the PMP from August 1, 2009 through August 
5, 2011. Id. at 23; GX 6. The DI testified that ``the document shows . 
. . that Ms. Mori had self-prescribed a controlled substance in August 
of 2009, and also that there was a patient by the name of Mia Mori who 
had a prescription written and filled on March 15 of 2011.'' Id.; GX 6, 
at 1. The DI testified that the report listed additional prescriptions 
written by Respondent for Mia Mori, which were for two schedule IV 
controlled substances, alprazolam and zolpidem, and which were written 
between August 29, 2009 through March 15, 2011. Id. at 24-25; GX 6, at 
1-3. The PMP report also shows that on August 12, 2009, Respondent 
self-prescribed thirty tablets of zaleplon 10 mg, a schedule IV 
controlled substance. GX 6, at 1; 21 CFR 1308.14(c)(51).
    The DI then testified that Respondent's DEA registration had 
expired on January 31, 2011. Id. at 25. She also reiterated that 
Respondent had not told her about the March prescription when she spoke 
to her in April 2011. Id.
    Next, the DI testified regarding the process for renewing a 
registration and the procedures used by the Agency to notify a 
registrant regarding an impending expiration. More specifically, the DI 
explained that a DEA registration does not renew automatically, and 
that a ``renewal application . . . has to be submitted by the 
registrant, asking for a renewal of the number.'' Id. The DI further 
explained that the expiration date is printed on the face of the 
registration certificate, and that ``the [Agency's] registration unit . 
. . automatically generates two notices before the expiration, advising 
[the registrant that] you're coming close to the expiration date.'' Id. 
at 25-26. According to the DI, if a registration ``actually does expire 
before it is renewed . . . a delinquency notice is mailed out to the 
registered address of the registrant.'' Id. at 26.
    The DI testified that after she discovered the March 15, 2011 
prescription, she spoke again with Respondent by telephone. The DI 
explained to Respondent that she had run the PMP report and that there 
were three prescriptions filled after the expiration date which were 
written prior to the expiration date, and one prescription that was 
written after the expiration date that was also filled. Id. at 26. 
Regarding these prescriptions, the DI testified that Respondent told 
her ``that Mia Mori was her daughter and that she had written the 
prescription after her daughter had lost her health insurance, and that 
she had forgotten to advise me of that.'' Id. at 26-27. Respondent told 
the DI ``that her daughter had seen a psychiatrist'' and that she was 
``treating her daughter's anxiety and that was why she had prescribed 
the alprazolam to her.'' Id. at 27.
    The DI then asked Respondent to meet her and bring her daughter's 
patient chart for review. Id. Respondent told the DI that she had not 
created a patient chart for her daughter, and that she did not maintain 
any records regarding periodic evaluations of her daughter to determine 
whether her treatment was proceeding as it should. Id. at 27-28. 
Moreover, when asked by the Government's counsel if she knew if 
Respondent ``was conducting a medical examination of any sort,'' the DI 
answered that she did ``not know.'' Id. at 28.
    The DI ran another PMP report using Mia Mori's name; the report 
covered the period from January 2006 through December 8, 2011. GX 7. 
The report shows that Respondent first began prescribing to her 
daughter in April 2007; the first prescription was for hydrocodone with 
acetaminophen, a schedule III controlled substance. Tr. 29; GX 7, at 2.
    The report also shows that Respondent wrote multiple prescriptions 
for her daughter for both zolpidem and alprazolam. These include 
prescriptions for 90 tablets of zolpidem 10 mg on July 28 and October 
17, 2007, as well a prescription for 30 tablets of zolpidem 10 mg on 
August 29, 2009, which was refilled on September 26, 2009. GX 7, at 2.
    As for the alprazolam prescriptions, on October 23, 2009, 
Respondent wrote a prescription for 30 tablets of alprazolam 0.5 mg; 
this prescription was refilled on November 8, 18, and 29. Id. On 
December 9, 2009, Respondent wrote a prescription for her daughter for 
60 tablets of alprazolam 0.5 mg; this prescription was refilled on 
December 28 and January 14, 2010. Id. This was followed by a February 
3, 2010 prescription for 30 tablets of alprazolam 0.5 mg, which was 
refilled on February 12, 22, and March 3, 2010; as well as another 
prescription for 30 tablets of alprazolam 0.5 mg on March 14, 2010 
(which was not filled until March 25, 2010). Id.
    On April 15, 2010, Respondent wrote another prescription for 60 
tablets of alprazolam 0.5 mg, which was refilled on May 20, June 15, 
and July 2, 2010. Id. This was followed by prescriptions for 30 tablets 
of alprazolam 0.5 mg on July 28, 2010 (which was refilled on August 9, 
19, and 29), on September 8, 2010 (which was refilled on September 20, 
October 4, 15 and 27), and on January 14, 2011 (which was refilled four 
times through March 6, 2011). Respondent wrote a final prescription for 
30 alprazolam 0.5 mg for her daughter on March 15, 2011, which was 43 
days after her DEA registration had expired. Id.
    The DI testified that the 2007 prescriptions were noteworthy 
because Respondent's daughter turned twenty-two in 2009, and the DI's 
understanding was that she had lost her health insurance upon reaching 
this age. Tr. 29. The DI stated that ``based on the information that 
[Respondent] provided,

[[Page 36585]]

her daughter would have had health insurance'' in 2007. Id. at 29-30.
    The DI continued her investigation by contacting the pharmacies 
listed as having filled the controlled substances and asking them to 
pull the original prescriptions, the signature log, and the method of 
payment for those prescriptions. Id. at 31. Those documents indicated 
that each of those prescriptions was called in by Respondent for her 
daughter, and that Mia Mori had picked up the prescriptions. Id.
    The DI testified that Respondent issued her daughter a total of 
thirty-three controlled substance prescriptions. Id. Of these, eleven 
were original prescriptions; the other twenty-two were refills. Id.
    The DI testified that she provided a copy of her report to the New 
Mexico Board of Nursing, and that after the report was forwarded to the 
Board, it initiated a complaint and subsequently took action against 
Respondent's nursing license. Id. at 32. This resulted in a Settlement 
Agreement between the Board and Respondent in December 2011. Id. at 33-
34; RX 4, at 2. Under the Settlement Agreement, Respondent received a 
letter of reprimand and was required to complete a continuing education 
course in patient/physician/family caregiver relationships. RX 4, at 2. 
Respondent completed the course in December 2011. Id. at 5.
    Respondent testified that in 2004, after being released from active 
duty in the army, she had suffered a heart attack, and that about a 
year and a half later, her son was killed in a motorcycle accident. Tr. 
53. Shortly thereafter, her daughter complained that ``she was going 
crazy'' and ``needed to see a psychiatrist.'' Id. at 53-54. Respondent 
stated that she took her daughter to a psychiatrist, who diagnosed her 
with ``severe anxiety disorder with an OCD component.'' Id. at 54. 
Subsequently, the psychiatrist recommended that Respondent's daughter 
see a specialist in OCD, and so she began treating with a Dr. Summers. 
Id.
    When asked by her counsel as to why she had written her daughter 
prescriptions for Abilify (a non-controlled prescription drug) and 
alprazolam, Respondent testified that her daughter's OCD causes 
thoughts of self-harm, and she wanted to ensure that her daughter was 
mentally stable. Id. Respondent testified that she ``could not lose 
another child.'' Id.
    Respondent then testified regarding several other prescriptions she 
had issued for her daughter. Specifically, Respondent testified that 
she prescribed Ambien (zolpidem) for her daughter on two occasions, 
including on August 29, 2009 (as well as on another date which she did 
not recall) because ``she was unable to sleep at all.'' Id. at 55. See 
also GX 7, at 2 (zolpidem prescriptions issued on 7/28/07 and 10/16/
07). Respondent testified that Ambien had been prescribed for her 
daughter by her treating physicians, but did not state when or by whom 
specifically.\2\ Id. at 56. Respondent testified that she also wrote 
her daughter a prescription for Percodan on April 21, 2007, when she 
had inflamed tonsils. Id. at 58.
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    \2\ Other evidence corroborates Respondent's testimony that 
Ambien had been prescribed to her daughter on multiple occasions by 
a Dr. D.R., beginning in May 2006. GX 7, at 2.
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    Respondent stated that one of the reasons she wrote the 
prescriptions for her daughter was because she ``did not have insurance 
and the cost of the drugs,'' and ``to maintain her sanity, so that she 
would not commit suicide.'' Id. However, when the Government asked 
Respondent if her daughter had been diagnosed as suicidal, she stated: 
``I have not read her records.'' Id. at 61. Moreover, Respondent's 
evidence shows that her daughter resumed treatment with her 
psychiatrist on January 13, 2011. RX 3, at 11. Yet the next day, 
Respondent issued to her daughter another prescription for thirty 
alprazolam with four refills. GX 8, at 40. Moreover, on March 15, 2011, 
Respondent issued another prescription for thirty alprazolam, which 
also authorized multiple refills. GX 8, at 45. Respondent offered no 
explanation as to why she issued these prescriptions when her daughter 
had resumed seeing her psychiatrist.
    Respondent was also asked whether she looked into care alternatives 
when she knew her daughter would not be able to continue seeing her 
doctor. Id. at 62. Respondent first stated she did not, but then 
changed her response to ``yes.'' Id. Respondent then testified that 
there were neither free therapy services nor group therapy sessions 
available for her daughter, and that because she was stable, she 
decided to just continue her on the medication. Id. Respondent then 
admitted that when she informed the doctor that her daughter no longer 
had health insurance, he did not immediately cease all ties with her. 
Id. at 63. When asked whether she had developed a treatment plan with 
her daughter's psychiatrist for the period when her daughter did not 
have health insurance, Respondent replied that the psychiatrist had 
already created a treatment plan. Id.
    Regarding the prescriptions she issued her daughter, Respondent 
also introduced several exhibits. The first of these is an affidavit by 
her daughter's psychiatrist, who stated that he had treated her 
daughter from April 2006 through 2011, and that he had diagnosed her 
with ``an anxiety disorder and secondary depression due to obsessive 
compulsive neurosis.'' RX 1. The psychiatrist stated that he had 
prescribed Abilify and alprazolam to Respondent's daughter. Id. The 
psychiatrist further stated that it was his understanding that ``due to 
insurance concerns,'' Respondent had ``actually filled out 
prescriptions for her daughter from the time frame of August 2010 
through March 2011 \3\,'' and that ``[s]uch prescriptions would have 
been in conformance with my desired treatment including drugs ordered, 
strength indicated, and number of pills to be given.'' Id. Finally, the 
psychiatrist expressed his belief that the ``prescriptions were written 
in conformance with my treatment and do not indicate any prescription 
regime that was not recommended by me.'' Id. Yet, the psychiatrist did 
not address why Respondent had continued to prescribe alprazolam after 
her daughter had resumed treatment with him.
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    \3\ In a letter written by the psychiatrist to Respondent's 
counsel approximately one week before he executed his affidavit, the 
psychiatrist stated that ``[a]pparently, in 2009[,] she 
[Respondent's daughter] was unable to afford health insurance. She 
was lost to follow-up until January 2011.'' RX 2, at 1. In resolving 
the apparent conflict between the dates during which Respondent's 
daughter lacked insurance, I give no weight to the psychiatrist's 
letter (which is unsworn) and rely solely on the affidavit.
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    Regarding the prescribing class the Board required her to take, 
Respondent testified that ``it's common practice that is not well 
established to not prescribe for your family members, and that this is 
a real issue.'' Id. at 59. She further testified that she understood 
that she can never again prescribe to a family member. Id. And when 
asked by the ALJ if she had issued any prescriptions to her daughter 
since taking the class on prescribing to family members, Respondent 
answered ``absolutely not.'' Id. at 66.
    Respondent also acknowledged that in December 2010, the State Board 
issued her a reprimand for not renewing her state license in a timely 
manner. Id. at 64-65. When the Government asked if it was correct that 
she then let her DEA registration lapse in January 2011, Respondent 
replied:

    Well, I didn't let it. I just was unaware of the expiration, and 
I didn't know this until I started refilling my New Mexico pharmacy 
license, where they require you to put in the expiration of your 
DEA. At that point, I

[[Page 36586]]

called the DEA in El Paso, to ask them when that was, and that's how 
I found out. . . .

Id. at 64. Respondent admitted that notwithstanding having been 
reprimanded for not renewing her state license in a timely manner, she 
did not then check her DEA registration to determine if it was going to 
expire soon. Id. at 65. Indeed, she described herself as being ``very 
much'' scattered during the previous five years with regard to filing 
the renewals for her various licenses on time. Id. at 53. However, in 
response to a series of questions regarding whether she now understood 
the importance of keeping her licenses current, Respondent testified 
that she ``understood the gravity'' of the situation, id., and on 
cross-examination, she testified that she had recently renewed her 
pharmacy license and had ``sent it in early.'' Id. at 66.

Discussion

    Section 303(f) of the Controlled Substances Act (CSA) provides that 
the Attorney General ``may deny an application for [a practitioner's] 
registration if he determines that the issuance of such a registration 
is inconsistent with the public interest.'' 21 U.S.C. 823(f). In making 
the public interest determination, the CSA directs that the following 
factors be considered:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing . . . controlled 
substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.
    Id.

    ``[T]hese factors are . . . considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I 
``may rely on any one or a combination of factors, and may give each 
factor the weight [I] deem[] appropriate in determining whether a 
registration should be revoked.'' Id.; see also MacKay v. DEA, 664 F.3d 
808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 
2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while 
I am required to consider each of the factors, I ``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.\4\
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    \4\ In short, this is not a contest in which score is kept; 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, 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. Likewise, findings under a single factor can support the denial 
of an application.
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    The Government has ``the burden of proving that the requirements 
for . . . registration . . . are not satisfied.'' 21 CFR 1301.44(d). 
However, where the Government has met its prima facie burden of showing 
that issuing a new registration to the applicant would be inconsistent 
with the public interest, an applicant must then ``present sufficient 
mitigating evidence'' to show why she can be entrusted with a new 
registration. Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008) 
(quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. 
Miller, 53 FR 21931, 21932 (1988))).
    In this matter, while I reject the ALJ's conclusion that Respondent 
violated 21 U.S.C. 843(a)(2), I find Respondent violated DEA 
regulations when she issued a controlled substance prescription when 
she was not registered to do so. Accordingly, I agree with the ALJ's 
conclusion that factors two (Respondent's experience in dispensing 
controlled substances) and four (Respondent's compliance with 
applicable laws related to controlled substances) support the denial of 
Respondent's application. R.D. at 16-17. However, with respect to 
factor five, I reject the ALJ's conclusion that Respondent did not 
intentionally make a false statement to the DI when she denied having 
written any controlled substance prescriptions after her registration 
expired. Moreover, I reject the ALJ's conclusion that Respondent has 
``both taken responsibility for her actions and shown remorse for her 
misconduct.'' Id. at 17. Indeed, Respondent offered no remorse for her 
misconduct in prescribing to her daughter after her registration 
expired. Nor did she offer any testimony addressing the materially 
false statement she made to the DI when she denied writing controlled 
substance prescriptions after the expiration of her registration.\5\
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    \5\ As for factor one, I acknowledge that Respondent holds the 
requisite New Mexico certified nurse practitioner and controlled 
substance licenses. However, there is no ``recommendation'' one way 
or the other from the various state authorities as to whether 
Respondent's application should be granted.
     While the possession of state authority to dispense controlled 
substances is a prerequisite for obtaining and maintaining a DEA 
registration, the CSA vests this Agency with ``a separate oversight 
responsibility [apart from that which exists in state authorities] 
with respect to the handling of controlled substances.'' Mortimer B. 
Levin, 55 FR 8209, 8210 (1990). DEA has therefore long recognized 
that it has ``a statutory obligation to make its independent 
determination as to whether the granting of [a registration] would 
be in the public interest.'' Id. Thus, while Respondent satisfies 
this prerequisite for obtaining registration, this factor is not 
dispositive of the public interest inquiry. Id. (holding that 
practitioner's reinstatement by state board ``is not dispositive'' 
in public interest inquiry).
     As for factor three, while a history of criminal convictions 
for offenses involving the distribution or dispensing of controlled 
substances is a highly relevant consideration in the public interest 
inquiry, there are any number of reasons why a registrant may not 
have been convicted of such an offense, and thus, the absence of 
such a conviction is of considerably less consequence. Jayam 
Krishna-Iyer, 74 FR 459, 461 (2009). Accordingly, that Respondent 
has not been convicted of an offense related to the distribution or 
dispensing of a controlled substance is also not dispositive of 
whether granting her application ``is consistent with the public 
interest.'' 21 U.S.C. 823(f); Krishna-Iyer, 74 FR at 461.
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Factors Two and Four--Respondent's Experience in Dispensing Controlled 
Substances and Compliance With Applicable Laws Related to Controlled 
Substances

    Under a longstanding Agency regulation, ``[a] prescription for a 
controlled substance [is not] effective [unless it is] issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of [her] professional practice.'' 21 CFR 1306.04(a). This 
regulation further provides that ``an order purporting to be a 
prescription issued not in the usual course of professional treatment . 
. . is not a prescription within the meaning and intent of [21 U.S.C. 
Sec.  829] and . . . the person issuing it, shall be subject to the 
penalties provided for violations of the provisions of law relating to 
controlled substances.'' Id.; see also 21 U.S.C. 802(10) (defining the 
term ``dispense'' as meaning ``to deliver a controlled substance to an 
ultimate user by, or pursuant to the lawful order of, a practitioner, 
including the prescribing and administering of a controlled 
substance'') (emphasis added).
    As the Supreme Court recently explained, ``the prescription 
requirement . . . ensures patients use controlled substances under the 
supervision of a doctor so as to prevent addiction and recreational 
abuse. As a corollary, [it] also bars doctors from peddling to patients 
who crave the drugs for those prohibited uses.'' Gonzales v. Oregon, 
546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 
135, 143 (1975)).
    Under the Controlled Substances Act, ``it is fundamental that a 
practitioner must establish a bona fide doctor-patient relationship in 
order to act `in

[[Page 36587]]

the usual course of professional practice' and to issue a prescription 
for a legitimate medical purpose.'' Patrick W. Stodola, 74 FR 20727, 
20731 (2009) (citing Moore, 423 U.S. at 141-43). The CSA generally 
looks to state law and medical practice standards to determine whether 
a practitioner has established a valid practitioner-patient 
relationship. See United Prescription Services, Inc., 72 FR 50397, 
50407 (2007) (citation omitted); but see 21 U.S.C. 829(e).
    Under New Mexico regulations, a Certified Nurse Practitioner (CNP) 
who has ``fulfilled the requirements for prescriptive authority may 
prescribe and distribute dangerous drugs including controlled 
substances . . . within [her] clinical specialty and practice 
setting.'' N.M. Code Sec.  16.12.2.13N(5). These regulations further 
provide that a CNP ``may prescribe, provide samples of and dispense any 
dangerous drug to a patient where there is a valid practitioner-patient 
relationship as defined in'' N.M. Code Sec.  16.12.2.7. The latter 
provision defines a ``valid practitioner-patient relationship'' as:

a professional relationship between the practitioner and the patient 
for the purpose of maintaining the patient's well-being. At minimum, 
this relationship is an interactive encounter between the 
practitioner and patient involving an appropriate history and 
physical or mental examination, ordering labs or diagnostic tests 
sufficient to make a diagnosis and providing, prescribing or 
recommending treatment, or referring to other health care providers. 
A patient record must be generated by the encounter.
Id. Sec.  16.12.2.7.V.

    Based on this regulation, the Government argues that Respondent 
violated both federal and state law when she prescribed controlled 
substances such as alprazolam and Ambien (zolpidem) to her daughter 
because she ``kept no prescription records, kept no patient charts, and 
performed no physical or mental examinations.'' Gov't Br. 8. It further 
argues that ``[a] practitioner is not excused from establishing a valid 
[practitioner]-patient relationship simply because another practitioner 
has previously established a valid relationship and the course of 
prescribed controlled substances is the same as with the prior 
practitioner.'' Id. at 7 (citing Randall L. Wolff, 77 FR 5106 (2012)). 
With respect to the latter contention, the Government argues that the 
psychiatrist's ``post-approval of the program, [in] an attempt to bring 
validity to the prescriptions[,] instead reveals two New Mexico 
practitioners ignoring or unaware of the simple fact that a doctor-
patient relationship is not transferrable.'' Id. at 8 (citations 
omitted).
    As support for its contention that Respondent ``performed no 
physical or mental examinations,'' the Government cites the DI's 
testimony. Gov't Br. 4 (citing Tr. 27-28). However, while the DI 
testified that Respondent indicated ``that she had never made a patient 
chart for her daughter'' or provided her ``with any prescription 
records,'' id. (citing Tr. 27), on the issue of whether Respondent had 
examined her daughter, the DI's testimony lacked probative force.
    More specifically, when asked if Respondent told her ``about 
weekly, monthly sessions of meeting with her daughter to diagnose or to 
make sure the treatment was proceeding as it should,'' the DI 
testified: ``No, she did not.'' Tr. 27. When the Government followed up 
by asking the DI if she knew ``why [Respondent] didn't provide you with 
any of that information?'' the DI testified: ``Because she stated she 
had not maintained any of those documents.'' Id. And when asked ``do 
you know if she [Respondent] was conducting a medical examination of 
any sort?,'' the DI testified: ``No, I do not know.'' Id. at 28.
    Significantly, at no point did the Government ask the DI if she had 
specifically asked Respondent whether she had examined her daughter or 
had performed periodic evaluations of her and been told that she had 
not. Nor, during Respondent's testimony, did the Government ask her if 
she had examined her daughter or performed periodic evaluations of 
her.\6\
---------------------------------------------------------------------------

    \6\ There is evidence that Respondent practiced at a med spa. 
See GX 1 (Respondent's application); Tr. 52 (Respondent's testimony 
that in 2006, she had ``moved into the medical aesthetics 
industry''). However, while New Mexico's regulations limit a CNP's 
prescribing authority to ``their clinical specialty and practice 
setting,'' N.M. Code Sec.  16.12.2.13N(5), and it seems most 
unlikely that prescribing for psychiatric conditions was within 
Respondent's clinical specialty, the Government made no such 
contention.
---------------------------------------------------------------------------

    To be sure, there are cases in which evidence that a practitioner 
failed to create medical records has given rise to the inference that 
the practitioner failed to perform those tasks (such as taking the 
necessary history and performing an appropriate examination) which are 
essential for properly diagnosing and periodically re-evaluating her 
patient. Yet this case stands on a substantially different footing than 
those cases, because even if it is not within professional ethics for a 
Nurse Practitioner to prescribe to a family member,\7\ the evidence is 
undisputed that Respondent was intimately involved in her daughter's 
wellbeing and the decision to seek psychiatric care. Thus, while 
Respondent may not have documented a history of her daughter's 
psychiatric condition, she was obviously well aware of her daughter's 
condition. So too, she was well aware of her daughter's diagnosis and 
her response to treatment. And significantly, upon resuming active 
treatment of Respondent's daughter, her psychiatrist made the same 
assessment of her condition and continued to prescribe alprazolam to 
her. See RX 3, at 9-10.
---------------------------------------------------------------------------

    \7\ It is noted that the State Board required Respondent to take 
a course in ``patient/physician/family caregiver relationships.'' RX 
4, at 2. While it seems unlikely that the Board would have required 
Respondent to take this course if prescribing to a family member was 
not a violation of professional standards, the Board's Order 
contains no reference to any such standard. See generally RX 4. Nor 
does the Government cite to any New Mexico statute, board 
regulation, policy statement, or decision (of either the Board or 
state courts) holding that prescribing to family members exceeds the 
bounds of professional practice. It also did not sponsor any expert 
testimony on the issue.
     In her decision, the ALJ sidestepped the issue of the adequacy 
of the Government's proof, reasoning that ``[t]he parties 
acknowledge that [Respondent] violated both federal and state law 
when she issued the thirty-three prescriptions to'' her daughter. 
R.D. at 16 (citing, inter alia, Tr. 45). However, the cited portion 
of the transcript was simply the opening statement of Respondent's 
counsel and not testimony. Therein, Respondent's counsel stated: 
``Should she have written prescriptions for her daughter? The answer 
is, no, she shouldn't have.'' Tr. 45.
     Moreover, even were I to treat this statement as evidence, 
there are many things that people do that they shouldn't do. But 
that does not necessarily make the particular act a violation of a 
law or regulation. Given that the State Board required Respondent to 
take a course in prescribing to family members, Respondent may well 
have recognized that doing so was unethical or constituted 
malpractice. While Respondent testified that prescribing to family 
members ``is a real issue,'' Tr. 59, on cross-examination, the 
Government did not ask Respondent why she now recognized that doing 
so ``is a real issue'' or why she should not have written the 
prescriptions, and in any event, her acknowledgement does not 
constitute an admission that her ``actions completely betrayed any 
semblance of legitimate medical treatment'' and thus constituted 
drug dealing. United States v. Feingold, 454 F.3d 1001, 1010 (9th 
Cir. 2006).
---------------------------------------------------------------------------

    As noted above, the Government also cites the Agency decision in 
Wolff, to argue that a ``doctor-patient relationship is not 
transferrable'' and that Respondent ``ignor[ed] clear laws that make 
such transference of the doctor-patient relationship a violation.'' 
Gov't Br. 8. The Government ignores that the decision in Wolff 
specifically cited the testimony of an expert witness that it was not 
``within the standard of care'' in the State where Dr. Wolff practiced 
``for a physician to `perpetuate[] the issuance of controlled 
substances ordered by another doctor without first establishing his own 
valid doctor-patient relationship.' '' 77 FR at 5107 n.2. Contrary to 
the Government's

[[Page 36588]]

understanding, neither the CSA, nor Agency regulations, address the 
issue of whether, and under what circumstances, a prescriber-patient 
relationship is transferable. Rather, this is an issue which can be 
decided only by reference to the standards adopted by the New Mexico 
authorities and the accepted standards of professional practice. Here, 
however, the Government cites to no state authority (whether a statute, 
regulation, administrative or judicial decision, or policy statement) 
to support its contention that Respondent violated ``clear laws.'' Nor 
did it offer any expert testimony to this effect.
    Thus, while Respondent's failure to create a patient record for her 
daughter provides some evidence that Respondent lacked a legitimate 
medical purpose in prescribing alprazolam to her daughter, I conclude 
that the record as a whole does not support a finding that she violated 
the CSA's prescription requirement.\8\ As for whether her failure to 
create a patient record is, by itself, sufficient to establish that she 
prescribed without a valid practitioner-patient relationship under New 
Mexico law, I conclude that that was a matter for state authorities. In 
short, I conclude that the Government's evidence establishes only that 
Respondent did not create state-required medical records. See N.M. Code 
Sec. Sec.  16.12.2.7.V, 16.12.2.13.N(5)(g).
---------------------------------------------------------------------------

    \8\ It is also noted that the Government makes no claim that the 
drugs Respondent prescribed to her daughter were being abused or 
diverted to others.
---------------------------------------------------------------------------

    The Government's evidence does, however, establish that 
Respondent's registration expired on January 31, 2011, GX 2, and that 
on March 15, 2011, Respondent issued her daughter another prescription 
for alprazolam. See GX 7, at 1; GX 8, at 45. Under federal law, it is 
``unlawful for any person knowingly or intentionally . . . to use in 
the course of the . . . dispensing of a controlled substance, . . . a 
registration number which is . . . expired.'' 21 U.S.C. 843(a)(2).
    Regarding this violation, the DI testified that the expiration date 
of a registration ``is printed on the certificate'' and that the 
Agency's registration unit ``automatically generates two notices before 
the expiration'' advising a registrant of the impending expiration. Tr. 
25-26. The DI also testified that after the expiration of a 
registration, a delinquency notice is also mailed to the registrant. 
Id. at 26. Respondent's registration was not ``retired from the DEA 
computer system [until] March 1, 2011.'' GX 2, at 1. However, the 
Government offered no evidence that these notices were actually mailed 
to Respondent, let alone evidence as to what address they were sent.\9\
---------------------------------------------------------------------------

    \9\ According to the Government's evidence, Respondent was 
registered at the address of PMG GI, 3715 Southern Blvd., Rio 
Rancho, New Mexico. GX 2, at 1. However, on her application, 
Respondent listed her proposed registered address as Eden Medspa, 
405 Kiva Court, Santa Fe, New Mexico. GX 1, at 1. Under federal law, 
``[e]very registrant . . . shall be required to report any change of 
professional or business address in such manner as the Attorney 
General shall by regulation require.'' 21 U.S.C. 827(g); see also 21 
CFR 1301.51 (providing procedure for modifying address). While 
Respondent was required to inform the Agency that she had changed 
her address and modify her registration, no such allegation was 
raised by the Government. Moreover, no evidence was adduced as to 
whether her mail had been forwarded to her by the clinic listed on 
her expired registration.
---------------------------------------------------------------------------

    At the hearing, Respondent asserted that she ``was just unaware of 
the expiration'' of her registration, and ``didn't know this until 
[she] started refilling [sic] [her] New Mexico pharmacy license, where 
they require you to put in the expiration of your DEA.'' Tr. 64. She 
further asserted that notwithstanding the reprimand she had received in 
late December 2010 for practicing nursing without a license, she did 
not check her DEA registration to see if it was due to expire soon. Id. 
at 65. The Government did not, however, ask Respondent when she had 
filled out her pharmacy license application, or introduce any 
documentary evidence establishing the date on which she did this.
    Notwithstanding Respondent's testimony (which the ALJ found to be 
credible) that she was unaware of the expiration of her registration, 
the ALJ found that Respondent ``violated federal law by issuing a 
prescription after the expiration of her'' registration. R.D. at 16 
(citing 21 U.S.C. 843(a)(2)). However, as explained above, establishing 
a violation of section 843(a)(2) requires proof that Respondent 
knowingly issued the prescription after the expiration of her 
registration. As the D.C. Circuit has explained, to establish 
knowledge, the Government must either prove that when she wrote the 
March 15, 2011 prescription, Respondent had actual knowledge that her 
registration had expired or that she was willfully blind or 
deliberately indifferent to that fact that her registration had 
expired. Cf. United States v. Alston-Graves, 435 F.3d 331 (D.C. Cir. 
2006). However, if Respondent ``act[ed] through ignorance, mistake or 
accident,'' id. at 337, she did not act with the requisite knowledge.
    Here, the ALJ found Respondent's testimony credible that she was 
unaware of the expiration of her registration at the time she issued 
the prescription and did not become aware of its expiration until she 
filed her application for her state pharmacy license and was required 
to provide the expiration date. Notably, the Government adduced no 
evidence sufficient to support the rejection of the ALJ's credibility 
finding. As explained above, the Government produced no evidence 
establishing the date on which she filed her pharmacy license 
application. Nor did it establish when Respondent had last looked at 
her DEA registration. And while there is evidence that various notices 
regarding the expiration of her registration were likely sent to 
Respondent, there is no evidence that the notices were mailed to her 
new address, or forwarded from her registered address to either her new 
registered address or her mailing address. See GX 1. Thus, the 
Government has failed to prove that Respondent either had actual 
knowledge of, or was willfully blind to, the fact that her registration 
had expired. Rather, the evidence supports the conclusion that 
Respondent was simply ignorant of the fact that her registration had 
expired. Accordingly, the ALJ's conclusion that Respondent violated 21 
U.S.C. 843(a)(2) is not supported by substantial evidence.
    However, the Controlled Substances Act requires that ``[e]very 
person who dispenses . . . any controlled substance, shall obtain from 
the Attorney General a registration issued in accordance with the rules 
and regulations promulgated by him.'' 21 U.S.C. 822(a)(2). Agency 
regulations further provide that ``[a] prescription for a controlled 
substance may be issued only by an individual practitioner who is . . . 
[e]ither registered or exempted from registration. . . .'' \10\ 21 CFR 
1306.03(a). Cf. id. Sec.  1301.13(a) (``No person required to be 
registered shall engage in any activity for which registration is 
required until the application for registration is granted. . . .''). 
To establish a violation of 21 CFR 1306.03(a), the Government is 
required to prove only that Respondent issued a prescription for a 
controlled substance when she was not registered to do so; it is not 
required to prove that Respondent knew that she lacked a valid 
registration when she issued the prescription. Accordingly, I find that 
Respondent violated DEA regulations when she issued the March 15, 2011 
alprazolam prescription.\11\
---------------------------------------------------------------------------

    \10\ Respondent makes no claim that she was exempt from 
registration.
    \11\ While there was also evidence that Respondent self-
prescribed thirty tablets of zaleplon, see GX 6, at 1, the 
Government offered no further evidence or argument regarding the 
lawfulness of this prescription. I therefore do not consider it.

---------------------------------------------------------------------------

[[Page 36589]]

Factor Five--Such Other Conduct Which May Threaten Public Health and 
Safety

    In making the public interest determination, ``this Agency also 
places great weight on a registrant's candor, both during an 
investigation and in any subsequent proceeding.'' Robert H. Hunt, 75 FR 
49995, 50004 (2010); see also, e.g., The Lawsons, Inc., t/a The 
Medicine Shoppe Pharmacy, 72 FR 74334, 74338 (2007); Rose Mary Jacinta 
Lewis, 72 FR 4035, 4042 (2007) (holding that lying under oath in 
proceeding to downplay responsibility supports conclusion that 
physician ``cannot be entrusted with a registration''). As the Sixth 
Circuit has recognized, ``[c]andor during DEA investigations properly 
is considered by the DEA to be an important factor when assessing 
whether a . . . registration is consistent with the public interest.'' 
Hoxie, 419 F.3d at 483.
    The Government argues that Respondent knowingly made a false 
statement to the DI when the DI asked her if she had written any 
prescriptions after the expiration of her registration and Respondent 
denied doing so. Gov't Br. 11. The ALJ rejected the Government's 
contention, explaining that she found it ``quite plausible that 
[Respondent] unintentionally made the false statement to'' the DI. R.D. 
at 18. As support for her conclusion, the ALJ reasoned that ``the 
Government's argument regarding [Respondent's] lack of candor is 
undercut by the extensive and voluntary disclosures which [Respondent] 
made to [the DI] during that April 2011 telephone conversation, namely 
that she had not prepared or maintained any treatment records regarding 
these prescriptions.'' Id. (emphasis added). The ALJ thus concluded 
that ``[i]n light of the totality of [Respondent's] interaction with 
[the DI] and her credible testimony at the hearing, . . . her 
statement, while admittedly false, does not negatively outweigh her 
overall candor with the Agency.'' Id.
    I reject the ALJ's finding that Respondent unintentionally made the 
false statement. Indeed, the ALJ's conclusion clearly rests on a 
misreading of the record, which while not a model of clarity, 
nonetheless establishes that Respondent made the false statement in a 
phone call which occurred before the DI had run the PMP, and in fact, 
during this phone call, the DI specifically discussed with Respondent 
that her registration had expired and told her that she would be 
running a PMP report ``to verify the information [Respondent] had 
provided of not writing any prescriptions with an expired DEA number.'' 
Tr. 22-23. Moreover, the evidence clearly shows that what the ALJ 
characterized as Respondent's ``extensive and voluntary disclosures'' 
(regarding her failure to create and maintain treatment records for her 
daughter's prescriptions), were not made until a subsequent phone call 
which occurred after the DI had run the PMP report. Thus, contrary to 
the ALJ's understanding, it was only after Respondent was confronted 
with the evidence of her misconduct that she made the admissions 
regarding her failure to create records. And even then, she maintained 
that she had forgotten that she had written the March 15 prescription.
    Of further note, Respondent submitted her application three days 
after she wrote the prescription and clearly knew then that her 
registration had expired. Moreover, the phone call in which she denied 
having written any prescriptions after the expiration of her 
registration occurred in April 2011, approximately a month (more or 
less) after she had written the prescription.\12\ It simply defies 
credulity to suggest that Respondent did not remember having written 
the prescription in the preceding month, especially given that the 
prescription was written for her daughter.\13\
---------------------------------------------------------------------------

    \12\ In its brief, the Government asserts that the conversation 
occurred on April 14, 2011. Gov. Br. 11. Yet the record does not 
establish anything more than that it occurred in April 2011. See Tr. 
21 (testimony of DI: ``I had a phone conversation with [Respondent] 
in April, and we discussed the licensing information, and at that 
point, I also asked [her] if she had prescribed controlled 
substances to anyone after the expiration date of her prior 
registration.''); see also id. (Government counsel: ``And do you 
know the date of this phone call or approximate date?'' DI: ``It was 
in April . . . of 2011.'').
    \13\ In support of her contention that Respondent did not 
deliberately make the false statement, the ALJ also cited 
Respondent's ``credible testimony at the hearing.'' R.D. at 18. Yet, 
Respondent offered no testimony regarding the circumstances 
surrounding her statement. Thus, the ALJ's finding does not rest on 
a credibility determination.
---------------------------------------------------------------------------

    I therefore conclude that Respondent knowingly made the false 
statement to the investigator. I further conclude that the false 
statement was material in that it had ```a natural tendency to 
influence, or was capable of influencing, the decision of' the 
decisionmaking body to which it was addressed.'' Kungys v. United 
States, 485 U.S. 759, 770 (1988) (quoting Weinstock v. United States, 
231 F.2d 699, 701 (D.C. Cir. 1956) (other citation omitted)) (quoted in 
Samuel S. Jackson, 72 FR 23848, 23852 (2007)); see also United States 
v. Wells, 519 U.S. 482, 489 (1997) (quoting Kungys, 485 U.S. at 770). 
Most significantly for this proceeding, the Supreme Court has explained 
that ``[i]t has never been the test of materiality that the 
misrepresentation or concealment would more likely than not have 
produced an erroneous decision.'' Kungys, 485 U.S. at 771 (emphasis in 
original). Rather, the test is ``whether the misrepresentation or 
concealment was predictably capable of affecting, i.e., had a natural 
tendency to affect, the official decision.'' Id.
    ```[T]he ultimate finding of materiality turns on an interpretation 
of substantive law,''' id. at 772 (int. quotations and other citation 
omitted), and must be met ``by evidence that is clear, unequivocal, and 
convincing.'' Id. That standard is met here. As explained above, under 
federal law, a practitioner cannot lawfully dispense a controlled 
substance unless she possesses a registration or is otherwise exempt 
from registration.\14\ 21 U.S.C. 822(a)(2); 21 CFR 1306.03(a). So too, 
it is a violation of federal law for a practitioner to knowingly use an 
expired registration to dispense a controlled substance.\15\ 21 U.S.C. 
843(a)(2). Respondent's false statement denying that she had issued any 
controlled substance prescriptions after her registration expired was 
clearly material under the public interest standard, because the 
standard clearly directs the Agency to consider an applicant's 
``[c]ompliance with applicable . . . Federal . . . laws relating to 
controlled substances.'' Id. Sec.  823(f)(4).
---------------------------------------------------------------------------

    \14\ Respondent makes no argument that she was exempt from 
registration at the time she issued the prescription to her 
daughter.
    \15\ That in this matter, the Government did not ultimately 
prove Respondent knew that her registration had expired does not 
make her statement immaterial. Moreover, at the time of the 
statement, Respondent knew her registration had expired, and that 
when she issued the prescription, she did not have authority to do 
so. 21 CFR 1306.03(a).
---------------------------------------------------------------------------

    That the DI made clear that she intended to obtain a PMP report and 
verify the validity of Respondent's statement does not make her 
statement immaterial. As the First Circuit has noted with respect to 
the material falsification requirement under 18 U.S.C. 1001, ``[i]t 
makes no difference that a specific falsification did not exert 
influence so long as it had the capacity to do so.'' United States v. 
Alemany Rivera, 781 F.2d 229, 234 (1st Cir. 1985); see also United 
States v. Norris, 749 F.2d 1116, 1121 (4th Cir. 1984) (``There is no 
requirement that the false statement influence or effect the decision 
making process of a

[[Page 36590]]

department of the United States Government.'').
    To the extent the ALJ's opinion suggests that because Respondent, 
in a subsequent conversation, admitted to various other acts (but not 
to writing a prescription after her registration expired), and thus her 
overall candor excuses her false statement, I reject it. Indeed, 
adopting the ALJ's reasoning would create a perverse incentive to 
falsely deny the commission of acts which could result in the denial of 
one's application, in the hope that the Agency's investigator would 
simply take one at her word. Contrary to the ALJ's understanding, there 
is no free pass for those who make a false statement during the course 
of an Agency investigation, and those who seek registration from the 
Agency have an obligation to provide truthful answers to all material 
questions asked by Agency personnel, no matter the stage of the 
investigation. I therefore conclude that Respondent's false statement 
provides additional grounds to conclude that her registration would be 
inconsistent with the public interest.\16\
---------------------------------------------------------------------------

    \16\ Respondent's false statement has generally been considered 
under factor five, as other conduct which may threaten public health 
or safety.
---------------------------------------------------------------------------

Sanction

    As found above, while I reject the Government's contention that 
Respondent lacked a legitimate medical purpose and acted outside of the 
usual course of professional practice in violation of federal and state 
law when she prescribed to her daughter, I nonetheless find that 
Respondent violated federal law when she issued a controlled substance 
prescription after the expiration of her registration and then made a 
materially false statement to the DI when she denied having issued any 
such prescriptions after the expiration of her registration. Had the 
proven violations been limited to Respondent's issuance of a controlled 
substance prescription after the expiration of her registration, I 
would likely have concluded that denial of her application would be 
unwarranted. See Jacobo Dreszer, 76 FR 19386, 19387-88 (2011) (holding 
that even where the Government has made out a prima facie case under 
the public interest standard, a respondent can argue that ``his conduct 
was not so egregious as to warrant revocation''); Gregory D. Owens, 74 
FR 36751, 36757 n.22 (2009) (``in assessing what sanction to impose, 
the Agency . . . considers the extent and egregiousness of a 
practitioner's misconduct.'').
    However, I find that Respondent's act in making a materially false 
statement to the Investigator constitutes sufficiently egregious 
misconduct to support the denial of her application. I therefore hold 
that the Government has satisfied its prima facie burden of showing 
that issuing a new registration to the applicant would be inconsistent 
with the public interest.
    As DEA has repeatedly held, upon this showing, the applicant must 
then ``present sufficient mitigating evidence'' to show why she can be 
entrusted with a new registration. Medicine Shoppe-Jonesborough, 73 FR 
364, 387 (2008) (quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007) 
(quoting Leo R. Miller, 53 FR 21931, 21932 (1988))). ``Moreover, 
because `past performance is the best predictor of future performance,' 
ALRA Labs. Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), [DEA] has 
repeatedly held that where a registrant has committed acts inconsistent 
with the public interest, the registrant must accept responsibility for 
[her] actions and demonstrate that [she] will not engage in future 
misconduct.'' Medicine Shoppe, 73 FR at 387; see also Jackson, 72 FR at 
23853; John H. Kennedy, 71 FR 35705, 35709 (2006); Cuong Tron Tran, 63 
FR 64280, 64283 (1998); Prince George Daniels, 60 FR 62884, 62887 
(1995); Hoxie v. DEA, 419 F.3d at 483 (``admitting fault'' is 
``properly consider[ed]'' by DEA to be an ``important factor[]'' in the 
public interest determination). So too, in determining the appropriate 
sanction, the Agency has a substantial interest in deterring future 
acts of misconduct, both on the part of a respondent in a particular 
case and the community of registrants. See Joseph Gaudio, 74 FR 10083, 
10094 (2009) (quoting Southwood Pharmaceuticals, Inc., 72 FR 36487, 
36504 (2007)); see also Butz v. Glover Livestock Commission Co., Inc., 
411 U.S. 182, 187-88 (1973); Michael S. Moore, 76 FR 45867, 45868 
(2011).
    Here, the ALJ found that ``Respondent has both taken responsibility 
for her actions and shown remorse for her unlawful conduct.'' R.D. at 
17 (citing Tr. 53, 59). As to the first citation, Respondent testified 
regarding her having been reprimanded, for--in the words of her 
counsel--``not filling out things in a timely basis.'' Tr. 53. In this 
regard, Respondent testified that she was ``very much scattered'' and 
that she now ``absolutely understand[s] the gravity of this.'' Id. The 
issue, however, is not whether Respondent timely completed a renewal 
application but why she issued a prescription when she lacked legal 
authority to do so and then falsely denied doing so to the DI.\17\ 
Respondent simply offered no testimony acknowledging that she had 
violated federal law when she issued a prescription after her 
registration expired. Nor did Respondent even address the circumstances 
surrounding the false statement she made to the DI. Accordingly, I 
reject the ALJ's finding that Respondent has accepted responsibility 
for her misconduct.
---------------------------------------------------------------------------

    \17\ At Tr. 59, Respondent testified regarding what she had 
learned in the class about prescribing for family members. 
Respondent is not, however, required to acknowledge wrongdoing for 
unproven misconduct.
---------------------------------------------------------------------------

    In recommending that I grant Respondent's application, the ALJ also 
cited various mitigating factors which I should consider including 
Respondent's health problems (a 2004 heart attack), her son's death in 
a motorcycle accident (in 2006), and her daughter's struggle with 
mental illness after losing her health insurance. R.D. at 17. While the 
first two events are indisputably tragic, they do not mitigate 
Respondent's misconduct, which occurred years later.
    As for her daughter's struggle with mental illness after losing her 
insurance, because I find the allegation that Respondent acted outside 
of the usual course of professional practice in issuing prescriptions 
to her daughter to be unsupported by substantial evidence, I need not 
decide whether this mitigates her conduct. However, it clearly does not 
mitigate her misconduct in issuing the prescription after the 
expiration of her registration, as the evidence shows that Respondent's 
daughter had resumed treatment with her psychiatrist prior to the 
issuance of the prescription.
    Most significantly, it does not excuse her deliberate and material 
false statement to the Investigator. Because Respondent has failed to 
acknowledge her misconduct in making the statement, I conclude that her 
application should be denied. However, in the event Respondent is 
willing to acknowledge her misconduct in making this statement, 
favorable consideration should be granted to a new application made no 
earlier than six months from the date of this Order.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well 
as 28 CFR 0.100(b), I order that the application of Belinda R. Mori, 
N.P., for a DEA Certificate of Registration as a Mid-Level 
Practitioner, be, and it hereby is, denied. This Order is effective 
immediately.


[[Page 36591]]


     Dated: June 9, 2013.
Michele M. Leonhart,
Administrator.
[FR Doc. 2013-14447 Filed 6-17-13; 8:45 am]
BILLING CODE 4410-09-P