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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices pharmacy in excess of average prices can support an inference that the pharmacy knew the prescriptions were not being issued for a legitimate medical purpose. Jones Total Health Care, 81 FR
at 79,200 citing United States v. Leal, 75 F.3d 219, 223 6th Cir. 1996; United States v. Cooper, 868 F.2d 1505, 1512
6th Cir. 1989; United States v. Hayes, 595 F.2d 258, 261 5th Cir. 1979.
Here, no direct evidence was offered by either party regarding the prices actually charged by alternate pharmacies near the patients homes or physicians offices. Absent additional and more specific evidence,PP I find that an inference based solely on the higher prices charged herein omitted that Pharmacy 4 Less knowingly filled the prescriptions without a legitimate medical purpose, would not be warranted. Still, as I found above, the record establishes that the Respondents patients at issue in this case paid cash at prices sufficiently high to create red flags, which were not resolved. And there is sufficient evidence to support a finding that the pharmacists who filled those prescriptions without documenting resolution of those red flags violated their corresponding responsibility due to their willful blindness to the prescriptions potential illegitimacy. See Suntree, 85 FR at 73,770.
Long-Term Fill for Immediate Release Pain Medication The Government has alleged that Pharmacy 4 Less routinely filled controlled substance prescriptions for immediate release pain medication over long periods of time.
Dr. Hamilton testified that a patient receiving short-acting medications over a long period of time is a red flag that must be resolved before the prescription is filled. He stated that immediaterelease medication should not be taken over long periods of time, with the medication being immediate-release for a reason. Tr. 193. He further testified that if it is prescribed over a long period of time, there needs to be documentation from the physician about the patient as to why a long-acting medication failed or other circumstance that would demonstrate why a shortacting medication was being prescribed over a long-period of time. Id. at 194.
The Respondent did not present evidence to directly counter the Governments evidence. Mr. Parrado agreed that this was a red flag that needed to be resolved. He only generally asserted that the physician determines what medication the patient will be on, PP Original
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that many insurance companies will not pay for extended release medication, and the charged patients may have had insurances that did not cover them. Id.
at 447. However, he did counter that oxycodone can be used for extended periods of time, based upon academic literature, and that there was no set duration of time which oxycodone should stop being used. Id. at 447. He did concede that as a pharmacist, he questioned whether a short acting versus a long acting prescription was properly prescribed. Id. at 44748.
Without evidentiary corroboration,QQ
Mr. Parrados testimony in this regard is little more than speculation. It does not meaningfully counter Dr. Hamiltons subject opinion.
Therefore, I find that the Government has met its burden of proof as to this allegation. Specifically, I find that Respondent pharmacy acted outside of the usual course of professional practice and in contravention of its corresponding responsibility when it failed to resolve and/or document resolution of the red flag arising from long-term use of immediate-release pain medications.
Long Distance Traveled by Patient A.R.
The Government has alleged that Pharmacy 4 Less filled prescriptions for Patient A.R., who traveled long distances fifty miles from his home to fill his prescriptions.
Both Dr. Hamilton and Mr. Parrado agreed that long distances traveled by patients to fill their prescriptions at Pharmacy 4 Less was a red flag that needed to be resolved before the prescription was filled. Id. at 20910, 453. As previously discussed, while there appears to be no dispute that long distances traveled can constitute a red flag, Dr. Hamilton and Mr. Parrado did disagree about the potential for resolution of the red flag in this matter as to Patient A.R. However, Mr. Parrado again gave general opinions on this matter as to why Patient A.R. may have been traveling such long distances to fill his prescriptions at Pharmacy 4 Less.
Without proper documentation to show if Pharmacy 4 Less even attempted to resolve such a red flag, Mr. Parrados assertions remain speculative and QQ In its Exceptions, Respondent asserted that patients are on immediate release because the price of long term is 3 to 5 times as much and their insurance does not pay for it. Almost all patients had forms that we filled out and signed for reimbursement from their insurance companies.
Resp Exceptions, at 2. This factual assertion, again without evidence in the record to support it, fails to qualify as the evidentiary corroboration needed to establish Dr. Parrados testimony as anything other than speculation.

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cannot be definitively shown.57 Further, I find that the distances traveled by Patient A.R. were long enough that Dr.
Hamiltons opinion is to be credited that this is a red flag that needed resolution, which Pharmacy 4 Less has failed to do.
Therefore, I find that the Government has met its burden of proof as to this allegation. Specifically, I find that Respondent pharmacy acted outside of the usual course of professional practice and in contravention of its corresponding responsibility when it failed to resolve and/or to document resolution of the red flag arising from the long distance A.R. traveled to fill his prescription.
Drug Combination Prescriptions The Government has alleged that Pharmacy 4 Less filled prescriptions for drug combinations that needed to be questioned. In particular, the Government has alleged that Pharmacy 4 Less improperly filled prescriptions for Patient A.V. that combined buprenorphine along with oxycodone.
Dr. Hamilton testified that buprenorphine issued with oxycodone presents a red flag that needs to be resolved. Id. at 26376. He explained that buprenorphine is a medication used for opiate withdrawal, and issuing it along with oxycodone, an opioid, would present a red flag because the opioid would no longer be of any use. Id. at 263. He testified that when these combinations are used, it would be expected to see that the patient, would within a few days to a few weeks, Id.
at 974 be weaned off of the opioid and it would be substituted with the buprenorphine. Id at 263. Dr. Hamilton indicated that he did not see any evidence that Pharmacy 4 Less had resolved this red flag before issuing the prescriptions to Patient A.V. Id. at 266.
When confronted with the Respondent sponsored PRM file, which included references to tapering the patient off of opioids, Dr. Hamilton opined that such cryptic reference was insufficient to resolve the red flag or be sufficient documentation within the pharmacy record. Id. at 972. Specifically, Dr.
Hamilton testified that the note says that the . . . physician is tapering the patient off of medications that he is addicted to, but there is a continuation of the oxycodone fill in the same amounts, same quantity, same timeframe. It continues over the course of the whole year. Id. It is clear from 57 Mr. Parrado testified that all of the red flags were resolved to his satisfaction by his speaking with Ms. Mincy and Mr. Sprys, as their explanations resolved all of the charged red flags.
Without more specificity, I cannot attribute significant probative value to this blanket opinion.

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