Federal Register - October 1, 2021
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Source: Federal Register
Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
54567
53. On November 30, 2015, Pharmacy 4 Less dispensed to Patient V.W. 84
tablets of oxycodone 15 mg without determining whether Patient V.W. was opioid nave. Tr. 25657; GX 28, p. 24;
GX 38, p. 9.
54. Between November 30, 2015, and May 31, 2017, Pharmacy 4 Less, on 21
separate occasions, dispensed oxycodone 15 mg tablets to Patient V.W.
at a price of approximately $2.54 to $3.57 per tablet, even though other retail pharmacies were selling oxycodone 15
mg at approximately $0.90 per tablet at the time. Tr. 25660; GX 28, pp. 2425.
55. Between January 25, 2016, and May 31, 2017, Pharmacy 4 Less, on 19
separate occasions, dispensed oxycodone to Patient V.W. without determining why oxycodone was being prescribed on a long-term basis without the presence of a long-acting pain medication. Tr. 25860; GX 28, pp. 24.
59. Pharmacy 4 Lesss records were inaccurate, and included shortages and overages. GX 4. Specifically, the shortages and overages are as follows a. Oxycodone 15 mg: Shortage of 73
tablets b. Oxycodone 20 mg: Shortage of 212
tablets c. Oxycodone 30 mg: Shortage of 731
tablets d. Hydromorphone 8 mg: Shortage of 149 tablets e. Methadone 10 mg: Overage of 1,488
tablets f. Suboxone 8 mg/2 mg: Overage of 224
tablets g. Carisoprodol 350 mg: Shortage of 526
tablets 60. Pharmacy 4 Lesss invoices FF
did not include the date the order was received for 84 invoices. Tr. 13738; GX
26.
Further, DI1 demonstrated a basic understanding of the relevant DEA
regulations as provided in the Code of Federal Regulations in order to properly perform his duties.46 He had some difficulty citing specific relevant provisions of the CFR when asked, which is quite understandable.
However, part of DI1s testimony involved an issue contested by the Respondent regarding the necessity of the date of receipt on invoices maintained by the pharmacy, which this Tribunal finds necessary to separately analyze and discuss.47 Tr. 13639.
Based on a complete review of DI1s presentation of testimony, ability to recall events, and comparison with the other evidence, I find his testimony to be credible and should be afforded considerable weight.
Recordkeeping 56. Pharmacy 4 Less did not have an initial inventory readily available during DI1s on-site inspection. Tr. 39
40.
57. According to DI1, the copy of Pharmacy 4 Lesss biennial inventory that he viewed in-person during the inspection on June 6, 2017, did not notate whether the inventory was completed at the opening or closing of business. Tr. 4142. DD
58. Pharmacy 4 Lesss biennial inventory apparently revised sometime after June 6, 2017 did not indicate whether it was conducted at the close or opening of business, instead listing the time that it was completed. Compare GX 37, p. 2 with RX 38, p. 1.
Specifically, the content appeared on a blank document that Ms. Mincy described as a cover page with handwriting stating Biennial Inventory; Completed April 26, 2017;
8AM and with signatures by both pharmacists. Id. The cover page was included in a fax to DI1 from Respondent pharmacy on June 7, 2017. EE
Analysis
Ms. Amy Mincys credibility presents more of a challenge for this Tribunal to address. During the first portion of the hearing in Orlando, Florida, Ms. Mincy appeared on the stand for the entire duration of the third day of testimony.
At the beginning of her testimony, Respondents counsel attempted to cover Ms. Mincys professional background and C.V. Ms. Mincy struggled greatly remembering details about pharmacies where she had previously worked, and other details about her own professional background.
While the transcript does not fully capture Ms. Mincys difficulties in discussing her background, there are indications within the transcript that demonstrate these issues.48
DD Finding
of fact modified for clarity.
is insufficient information in the record for me to conclusively determine whether or not the cover page was attached to the biennial inventory at the time of DEAs inspection. On the one hand, I fully credit DI1s testimony that the biennial inventory did not notate whether the inventory was completed at either the opening or closing of business. Tr. 4142. However, I cannot tell whether DI was testifying that the specific words opening or closing of business did not appear on the biennial inventory which I agree is true or if he was testifying that the cover page at GX 37, p.
2 was not included on the biennial inventory that DI1 was handed on the date of the inspection. If DI1s testimony meant the latter, it was unclear, and unfortunately, the biennial inventory was not seized during the inspection. Instead, the biennial EE There
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Credibility Analysis of Fact Witnesses Ability To Recall Events DI1
Generally speaking, individuals experiencing an event out of the ordinary, such as an on-site inspection as occurred here, are likely to have a better memory of those events than the Government Diversion Investigator, who performs similar inspections on any number of clinics. It seems to me, all other factors being equal, it would be easier for a DI to forget or confuse events than the person inspected. However, in this matter, DI1 presented an overall clear description of events surrounding the June 6, 2017, and June 21, 2017 onsite inspections of Pharmacy 4 Less.
DI1 occasionally had difficulty recalling the specific individual who responded to his questions. See, e.g., Tr.
9091. This cuts slightly against his reliability. However, he was generally able to recall the key events as to what had occurred during the on-site inspections and the substance of the relevant conversations. His testimony is also generally corroborated by the documentary evidence.
inventory was faxed to DI1 the following day and the cover page was included. Notably, Mr. Sprys was out of the country at the time of the inspection and subsequent fax. As Mr. Sprys signature appears on the biennial inventory cover page that was faxed, it does not seem implausible to conclude that the cover page existed prior to Mr. Sprys leaving the country and prior to the inspection. Therefore, I
cannot find substantial evidence to support the Governments allegation that the biennial inventory lacked the notation regarding whether it was conducted at the opening or closing of business.
FF Modified because he ALJ referred to these documents as 222 Forms, but I find that they are more accurately described as invoices.
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Ms. Amy Mincy
46 While this Tribunal heard testimony from DI1
about the regulations, it does not rely on DI1s understanding of the regulations in this Recommended Decision.
47 See infra at section Date of Receipt on Invoices.
48 MR. INDEST: And since shes having a little bit of difficulty remembering some of these, Id like the clerk to give her the hearing book and let her, if she needs to refer to the CV.
THE WITNESS: Im good.
MR. INDEST: No, lets have it in front of you so weve got the dates right and everything, okay? Tr.
571.
Q Okay, but where did you work next after that? Where did you work next? If youre having trouble remembering, if you need to refresh your recollection, please look at the CV because youre taking a long, long pause before you answer my questions. This might help speed things up. Tr.
57273.
Q Okay, and did you work as a pharmacy consultant after that?
A For some places, yes.
Q According to your CV, Ms. Mincy, listen, these are simple straightforward questions, and if you cant remember the answers. Tr. 573.
MR. INDEST: Your Honor, Id like the record to reflect Im asking the questions and shes taking a long, long pause. Tr. 574.
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