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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices On rebuttal, Dr. Hamilton compared versions of the same medical records as to V.W. See GX 23 and RX 36, 37. After pointing out differences in the two versions, and granting the reliability of the Respondents versions, Dr. Hamilton opined that considering the RX 36 and 37 version, his previous opinions as to R.V.s dispensing remained the same.
Tr. 100104.
As to Patient A.V., Dr. Hamilton discovered a series of controlled substance prescriptions that were filled by Pharmacy 4 Less despite unresolved red flags. Tr. 26167; GX 10, pp. 1
2, 34, 56, 910, 1516, 3738, 4142, 4344, 4546, 4748, 5960; RX 22. The first such prescription involved 29
tablets of 8 mg of buprenorphine. Tr.
26162. The second prescription, filled 9 days after the buprenorphine was filled, involved 112 tablets of oxycodone, 20 mg each, priced at $290.
Tr. 262. The oxycodone prescription itself presented red flags, which needed to be resolved, as discussed earlier, including the drug itself, the large quantity, the relatively high dosage, and the price. Id. Additionally, Dr. Hamilton observed the 20 mg oxycodone was being prescribed in conjunction with the buprenorphine. Id.
at 263. Buprenorphine is used to wean someone off of an opiate, such as oxycodone. Id. The prescribing of buprenorphine along with an opioid prescription creates a red flag, which needs to be resolved. Id. at 26263. The acceptable protocol would be to introduce the buprenorphine as the dosage of oxycodone is reduced, until the oxycodone is completely replaced by the buprenorphine. Id. at 26265.
Here, the buprenorphine is introduced, yet nine days later the 20 mg of oxycodone was filled, which is inconsistent with the typical detoxification protocol, and can present some contraindication issues. Id. at 26667. Additionally, detoxification would require physician monitoring. Id.
at 265. Dr. Hamilton noted there was no indication in the reviewed records Q
that the red flag was resolved. Id.
at 26566. Another 8 mg buprenorphine prescription of 60 tablets was filled almost two months after the first buprenorphine prescription. Id. at 267
68. On the same day, a second identical prescription for 20 mg of oxycodone Q The ALJ found that Dr. Hamilton noted that there was no indication in the reviewed records that the physician was monitoring any attempted detoxification. I have omitted the finding because I do not see support for it in the record and find it to be irrelevant. The record is clear that Dr.
Hamilton did not see any documentation of resolution of the red flag, which is ultimately the fact at issue in this case.

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was filled, triggering the same set of red flags as previously described and, according to Dr. Hamilton, there was no documentation that those red flags were resolved. Id. at 26869.
This second prescription for oxycodone,R according to Dr.
Hamilton, raised the same unresolved red flags as the first one, and an additional unresolved red flag because the medication dosage and frequency remained unchanged and you would see a de-escalation of medication with a patient going through detox. Id. at 26869. The next month saw a repeat of an 8 mg buprenorphine prescription for 60 tablets, along with a 20 mg prescription for oxycodone, thus repeating the same unresolved red flags. Id. at 27172. Less than one month later, dual prescriptions for 8 mg of buprenorphine and 20 mg of oxycodone were filled, repeating the same unresolved red flags as described earlier. Id. at 27173.
Additionally, as to the oxycodone, the repeated prescribing created the unresolved red flag related to the length of time without a reduction in dosage. Id. at 27374. Dr. Hamilton addressed another set of dual prescriptions for 8 mg of buprenorphine and 20 mg of oxycodone, thus repeating the same unresolved red flags discussed earlier.S Id. at 27477.
On rebuttal, Dr. Hamilton evaluated the Respondents sponsored versions of medical records as to A.V. See RX 22, 23. Dr. Hamilton noted references to a consultation with Dr. Seaford, to tapering and to detox. Tr. 97072.
Even granting the reliability of the records, Dr. Hamilton stuck with his original opinions as to A.V.s dispensing. Id. at 97075.
Again on rebuttal, Dr. Hamilton confirmed that nothing in the testimony of Mr. Parrado or Ms. Mincy has caused Dr. Hamilton to change his previously offered opinions in this case. Id. at 100405. Dr. Hamilton did agree with Mr. Parrados observation that it was proper to fill a pain prescription up to a month after the patient was released from the hospital. Id. at 1017. Dr.
Hamilton further commended the Respondents practices of maintaining R The ALJ found that the second prescription highlighted the red flag relating to the absence of any evaluation as to the reduction in the dosage or frequency of the oxycodone. I have revised this finding to quote Dr. Hamilton.
S Dr. Hamilton testified collectively regarding the remaining prescriptions for buprenorphine and oxycodone in GX 10 issued between August 2, 2016, and February 13, 2017, and opined that each oxycodone prescription had the same red flags as the other oxycodone prescriptions discussed herein and that there was no documentation that these red flags were resolved. Tr. 276.

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medical records within their pharmacy files. Id. at 101516.
Respondents Case in Chief The Respondent presented its case through the testimony of two witnesses.
First, the Respondent presented the testimony of Ms. Amy Mincy Ms.
Mincy. Second, the Respondent presented the testimony of its expert, Robert M. Parrado Mr. Parrado.
Ms. Amy Mincy, R.Ph.33
Ms. Mincy testified to the following.
Several of Ms. Mincys claims were contested by the government and will be discussed later. As background, Ms.
Mincy graduated from Mercer University in Atlanta, Georgia, and has been a pharmacist since 1983. Tr. 569.
She is licensed in the State of Florida and has inactive licenses in Tennessee and Virginia. Id. She has worked for a number of pharmacies for varying lengths of time, including independent pharmacies, as a relief pharmacist, and as a pharmacy consultant, over the course of her career. Id. at 56976, 579
83; RX 1.34 She has also previously been disciplined by the Florida Board of Pharmacy for filling a prescription for her mother, was placed on probation, and successfully completed the terms of her probation in 1998. Id. at 57982.
She began working as a pharmacist at Pharmacy 4 Less in January 2016. Id. at 57677. She is one of two pharmacists that works at Pharmacy 4 Less, along with Mr. Sprys. Id. at 577. She works at Pharmacy 4 Less four days per week, Monday through Thursday, with Mr.
Sprys working on Friday. Id. at 822.
Ms. Mincy was working as the pharmacist on duty at Pharmacy 4 Less on June 6, 2017, when the DEA
conducted its on-site inspection at the pharmacy. Id. at 584. She testified that DI1 and another Diversion Investigator hereinafter DI2 arrived at the pharmacy sometime between 10:00
a.m.12:00 p.m. that day. Id. at 585. She did not know the DEA was planning to conduct the on-site inspection that day.
Id. at 58586. She was told that the inspection would take between 2030
minutes or up to an hour. Id. at 586.35
She related that Mr. Sprys son, William Sprys, was also in the pharmacy. Id. at 33 Ms. Mincy testified the entire day of November 7, 2018. She was recalled to the stand during the second portion of the hearing at the DEA Hearing Facility in Arlington, Virginia on February 25, 2019, for the remainder of her testimony.
34 Ms. Mincys CV was admitted over objection with the corrections noted through Ms. Mincys testimony. Tr. 584.
35 When asked, Ms. Mincy said that it was primarily DI1 that spoke to her and asked her questions during the inspection. Tr. 586. She stated that DI2 was primarily observing. Tr. 587.

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