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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
filling a prescription. Tr. 643. She indicated that she uses it daily and prior to every fill of a new prescription of her patients. Id. She even stated that E
FORCSE is the best system to resolve red flags, in her opinion. Id. at 645.
She made multiple comments about the usefulness of the EFORCSE system and how she uses it on a daily basis during her work in the pharmacy. Finally, she indicated that she uses it before she fills every controlled substance prescription.
Id. at 64546.
The Government introduced evidence of the EFORCSE searches conducted by Pharmacy 4 Less between January 1, 2015, and June 6, 2017, for the 10
charged patients in this matter. GX 38.
For the six patients previously mentioned, this exhibit shows that Pharmacy 4 Less conducted initial opioid fills for the six patients, but did not run a search on EFORCSE on the corresponding date of the fill. For example, Patient A.E. first filled a prescription on November 19, 2015, but Pharmacy 4 Less did not check E
FORCSE for Patient A.E. until April 7, 2016. GX 38, p. 11. Apart from being able to run checks through EFORCSE, Pharmacy 4 Less did not introduce any evidence that it otherwise completed or documented its resolution of any potential red flags for Patient A.E before doing an initial fill of the prescription.
The evidence shows this to be true for Patients A.E., B.F., K.E.D., R.R., R.V., and V.W. GX 38.
Therefore, the Government has met its burden of proof as to this allegation as to these six patients.
As to the remaining four subject patients, the EFORCSE records introduced reflect that either she or Mr.
Sprys checked the EFORCSE database for the first charged prescriptions for the following subject patients:LL A.R. on March 16, 2016; A.V. on April 21, 2016;
LL In its exceptions, the Government argued that merely running a name through EFORCSE was insufficient to resolve the opioid nave red flag, and that the pharmacist needed to affirmatively review the report, determine that the report addressed the red flag, and document the resolution. Govt Exceptions, at 910. I agree with the Governments position, but do not find that the ALJ erred. The ALJ
considered the EFORCSE records along with Ms.
Mincys testimony that she was using EFORSCE to resolve the red flag in exactly the manner the Government said was required. There are credibility issues with Ms. Mincys testimony, but ultimately, the ALJ in a different section of the RD found that Respondent Pharmacys failure to document resolution of this red flag demonstrated a violation of its corresponding responsibility. Infra section Failure to Document Resolution of Red Flags. I
have modified this section of the RD to clarify that the ALJ found that the Respondent Pharmacys failure to document resolution of this red flag demonstrated a violation of Respondent Pharmacys corresponding responsibility and was outside the usual course of pharmacy practice.

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B.N. on January 22, 2016; and K.Y.D. on February 4, 2016. See GX 38; RX 21, p.
4, RX 23, p. 3, RX 27, p. 3, RX 31, p.
7. Ms. Mincy conceded there was no documentary evidence that indicated that any of the subject ten patients started at lower doses of opioids, including oxycodone and hydromorphone, and worked their way up because they become opioid tolerant.
Tr. 81516. Consistent with Dr.
Hamiltons testimony, I find that Respondent acted outside of the usual course of professional practice and in violation of its corresponding responsibility when it failed to resolve and/or to document resolution of the opioid navete red flag as to each of the ten patients at issue in this case.MM
Cash Paid and Excessive Pricing NN
The Government has alleged that Pharmacy 4 Less routinely filled controlled substance prescriptions for patients who were paying cash at extremely high prices.
As previously discussed, I credit Dr.
Hamiltons opinion that Pharmacy 4
Less charged unusually high prices.
Using his calculations in relation to large and small pharmacies, and his findings as to average prices charged in the surrounding area, Dr. Hamilton determined that there is generally only a slight difference between large and small pharmacies prices, with the difference generally amounting to a few dollars per prescription. Id. at 19498.
However, the Governments evidence suggests that Pharmacy 4 Less was charging prices much higher than that expected by a pharmacy within the surrounding area, whether it be a small independent pharmacy or a large retail pharmacy. Most concerning, the patients at issue in this case were paying for these over-priced controlled substances with cash which created a red flag. When Dr. Hamilton was asked at the hearing what he meant by the red flag he labeled paid cash, extremely high prices in his report, see GX 28, at 6, Dr. Hamilton explained that absent diversion, there is no reason for a . . . patient to continue to go to a MM This replaces the ALJs original finding that the Government failed to carry its burden that the opioid navete red flag went unresolved for four of the ten patients.
NN Throughout the testimony in this case and in its Posthearing Brief, the Government emphasized the excessively high prices charged by the pharmacy. However, the Governments expert also opined that the customers cash payment at excessively high prices created red flags that were not resolved prior to dispensing. See also OSC, at 37; Govt Supp. Prehearing, at 715 GX 28, at 5
6; Tr. 19498. I have made modifications throughout this section as noted in brackets to account for the cash payment portion of the issue.

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pharmacy that has extremely high prices when there are pharmacies that would sell it for much less. Id. at 194.
While the Respondent put on evidence by Mr. Parrado as to the excessive pricing, I note that Mr.
Parrado did not reveal the actual reasons the Respondent charged such prices, nor reveal similar prices by pharmacies closer to the subject patients homes or physicians. Mr.
Parrado further testified that some pharmacies only take cash, they do not take insurance . . . its hard to get on some of these insurance networks,OO
then you are subject to their audits.
Tr. 450. I have found that his opinions on this allegation were more anecdotal and historical, and did not provide a sufficient basis to completely refute Dr.
Hamiltons more objective and timely analysis.
Therefore, I find that the Government has met its burden of proof as to this allegation. The record establishes that the Respondents patients at issue in this case paid cash at prices that were noticeably higher than market forces would explain and sufficient to create a red flag. However, the record does not support a finding that the Respondent prices were exorbitant to the extent those transactions represented knowing diversion by the Respondent.
I do not find that solely on the basis of the high prices charged by the Respondent that Pharmacy 4 Less knowingly issued the prescriptions without a legitimate medical purpose. In their Posthearing Brief, the Government argues that where a pharmacy is consistently charging exorbitant prices, DEA may properly draw the inference that the pharmacy is charging those prices because it knows it is supplying persons who are seeking the drugs to either abuse them or divert them to others. Jones Total Health Care Pharmacy, LLC, 81 FR 79,188, 79,199
200 2016. Govt Posthearing Brief at 3940. The Government argues that, while there may be some variance in pricing, which the Administrator in Jones Total Health Care acknowledged, exceeding the average retail price by more than 200% at times is not what one would expect to find at a legitimate pharmacy. Govt Posthearing Brief at 31. As noted in Jones Total Health Care, the view that prices charged by a OO In its exceptions, Respondent asserted that it takes almost 2 years for a new pharmacy to be accepted by all insurance companies.
Respondents Exceptions, at 3. Though this specific factual assertion lacks evidence in the record, I find it is in line with Mr. Parrados anecdotal testimony which was properly considered by the ALJ in reaching his decision.

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