Federal Register - October 1, 2021

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Source: Federal Register

Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices Code under which the Government has raised allegations against the Respondent for failing to meet the minimum standard of care.
Requirement To Document Resolution of Red Flags Dr. Hamilton provided testimony that resolution of each red flag had to be documented somewhere in a patients file to demonstrate that the red flag had been resolved. He noted that this would be required under the Florida standard of care and that if it is not documented, theres no evidence that . . . it was resolved. Id. at 17981. Dr.
Hamilton conceded that although this requirement was not specifically written in the relevant Florida regulations, it was without question required in the context of the Florida regulations as part of the Florida standard of care. Id. at 100708.
Despite its obvious logic, Mr. Parrado disagreed with Dr. Hamiltons assertion that such documentation is required in Florida. Mr. Parrado conceded that documenting the resolution of red flags may represent best practice, including that he would also do it as a pharmacist, but that it is not required under Florida law or the standard of care. He provided that most pharmacists complete at least some kind of documentation to indicate resolution of red flags. He also stated that he had created a computer program called Red Flag Resolver to assist pharmacists in documenting the resolution of red flags in their own practice.
Omitted. Here both experts agree that documentation of red flag resolution is not explicitly required by Florida law. However, the regulations generally support the testimony of Dr.
Hamilton regarding the importance of documentation in the usual course of professional practice in Florida. See also Suntree Pharmacy and Suntree Medical Equipment, L.L.C., 85 FR
73,753, 73,772.HH thnsp;56
HH In Suntree, the Respondent implied that the Governments experts inability to draw a solid conclusion as to where the requirement to document the resolution of red flags is written somehow demonstrated that there is no such requirement in the standard of practice. Id. The Acting Administrator rejected that reasoning and found that Florida state law can be reasonably interpreted to support the Government experts testimony, but that her testimony was independently credible that documentation of the resolution of red flags is a requirement of the practice of pharmacy in the State of Florida. Id. I
find the same. Here, Dr. Hamilton clearly testified that the resolution of the red flag had to be documented in the file as part of the Florida Standard of Care, noting, if its not documented, theres no evidence that . . . it was resolved, or a phone call was made, or an answer was given. Id.
at 17980; see also id. at 306, 318, 337, 100611, 1016.

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Therefore, under Florida regulations and findings of the Agency on this issue, I credit Dr. Hamiltons testimony that pharmacists are required under the Florida standard of care to document the resolution of red flags.
Pricing of Prescriptions II
Dr. Hamilton expressed concerns that the patients willingness to pay cash for these JJ highly priced prescriptions was a red flag that should be addressed. Dr. Hamilton indicated that it does not make sense that a patient would continue to go to a pharmacy that is charging high prices when there are pharmacies that sell the same medications for much less. Tr. 194. For example, high prices were a red flag for Patient A.E. paying up to $500 a month because A.E. was paying up to $5.95 per pill in cash when he could have gotten the controlled substances elsewhere for 1.50 per pill. Tr. 199; GX
28, pp. 67. He opined that patients do not want to pay more than they have to, and if the same prescription was offered at a lower price at a different pharmacy, the patient would have gone to that other pharmacy. Tr. 199. Dr. Hamilton also noted he has observed different pricing schemes for the same prescriptions for the same person, paying cash for which he could not provide a rational explanation. Id. at 20304.
Mr. Parrado disagreed with Dr.
Hamiltons assertion that the prices on the prescriptions should be much lower than that charged by Pharmacy 4 Less.
He opined that every pharmacy can determine their own prices, which may be more expensive when filling a controlled substance prescription based on the added work load including checking EFORCSE, better maintenance of records, and additional inventories. Id. at 449. He stated that pharmacy pricing can be very competitive. Id. at 450. The only explanations Mr. Parrado could give for a pharmacy charging different prices for the same medication was a potential higher cost from a different wholesaler, the use of discount coupons, or indigent pricing programs. Id. at 45152. There was no evidence offered that these exceptional circumstances existed here.
As to Mr. Parrados claim that opioids had become scarce, difficult to locate, 56 Omitted text where original footnote was included.
II I have made modifications as indicated throughout this section to more directly address the issue in this casethat the patients identified in the OSC were paying cash, and excessively high prices at that, for controlled substances which created a red flag.
JJ See infra n. NN.

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and involved additional expense to the pharmacies, thus warranting higher prices, neither party introduced documentary evidence to support or to counter this claim. Id. at 45152, 539.
Mr. Parrado did not offer the actual reason the Respondent charged the prices they did, or whether the Respondent recognized their prices were significantly higher than other like-situated pharmacies. For example, we dont know if there was a pharmacy much closer to the patients homes or doctor offices charging less, from any direct evidence. We are left with conflicting, sometimes anecdotal, evidence by Mr. Parrado and Dr.
Hamilton.
Dr. Hamilton personally surveyed pharmacy prices in his area, near Fort Lauderdale, while Pharmacy 4 Less is located just north of Orlando. Id. at 178.
Dr. Hamiltons formula to determine average prices by large and small pharmacies involved a survey of wholesale prices of opioids sold to pharmacies, generally increased by 20%
for pharmacy mark up, does not rebut the justifying explanations given by Mr.
Parrado. To be more accurate, the survey should have been limited to small pharmacies. However, Dr.
Hamiltons reliance upon a GoodRx program to determine prices charged by pharmacies for opioids does provide objective support for his assertions that the prices charged by Pharmacy 4 Less for the various subject opioids were considerably in excess of what other pharmacies were charging. Id. at 177
78.
Based on a review of this record, I
find that Dr. Hamilton provided a more reliable basis in support of his opinion of unusually high prices of opioids charged by Pharmacy 4 Less than the uncorroborated and more anecdotal and historical explanations given by Mr.
Parrado. I do not discount the market forces cited by Mr. Parrado, although I
reject the extent to which he opined they affected the prices charged by the Respondent.
Having found that Respondents cash-paying patients at issue in this case were paying unusually high prices for the subject opioids, triggering a red flag, the next inquiry is whether the Respondent resolved the red flag. There was no evidence introduced that the Respondent performed any inquiry or investigation as to why the subject patients were willing to pay such high cash prices for the subject opioids.
Dr. Hamiltons opinion that this red flag repeatedly went unresolved is fully supported by this record.

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Federal Register - October 1, 2021

TitoloFederal Register

PaeseStati Uniti

Data01/10/2021

Conteggio pagine257

Numero di edizioni7797

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Ultima edizione17/06/2026

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