Federal Register - October 1, 2021
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Fuente: Federal Register
Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices between the Government and Respondent versions of the same records, Dr. Hamilton conceded that the Respondent versions could be updated versions of the Government versions. Id.
at 101920. Dr. Hamilton observed that updating medical records was required by the standard of care. Id. at 1020.
Turning to patient A.R., Dr. Hamilton noted a prescription for 112 tablets of 15
mg of oxycodone represented several red flags, citing significant dosage, high quantity, frequency of prescribed usage 4 times daily, and high price.31 Id. at 20405, 329; GX 8, pp. 1
2; RX 20. Dr. Hamilton was unable to find that these red flags were resolved on the face of the prescription or on the information sheet within the patient record. Tr. 20506; GX 7. Dr. Hamilton explained that, although the patients information sheet contained information relating to diagnoses and medical conditions, it did not include information justifying the long-term use of the subject oxycodone prescription.
Tr. 206, 32930; GX 28, pp. 1214. As relates to price per pill, Dr. Hamilton estimated the retail price to be approximately 90 cents. Tr. 33031. The next prescription for A.R. also involved 15 mg of oxycodone, but for 140 tablets at a directed frequency of 5 times per day at a price of $350. Tr. 20708; GX
8, pp. 34. Dr. Hamilton noted the distance between A.R.s residence and the prescribing doctors office and Pharmacy 4 Less. Tr. 208. Dr. Hamilton estimated A.R. lived approximately 40
miles from the prescribing doctor, and another 13 miles further to the subject pharmacy. Id. at 209. Dr. Hamilton indicated this distance represented a red flag, which went unresolved within the subject records. Tr. 20910, 33237; GX 7, GX 8, p. 3.
The next two prescriptions for A.R., which Dr. Hamilton indicated disclosed the same red flags were identical prescriptions for 15 mg of oxycodone, for 140 tablets, but at a price of $340.
Tr. 21214; GX 8, pp. 56, 3334.
31 Patient A.R. paid $280 for 112 pills of oxycodone in connection with this prescription, or $2.50 per pill. Later, Patient A.R. paid between $340 and $350 for 140 pills of oxycodone, or approximately $2.43$2.50 per pill. GX 8, at 36, 3334.
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Omitted based on further review of the record. Dr. Hamilton opined the subject oxycodone prescriptions for A.R.
remained unresolved within the records reviewed, and were thus below the standard of care in Florida. Tr. 21516;
GX 7.
On rebuttal, Dr. Hamilton compared versions of the same medical records as to A.R. See GX 7 and RX 20, 21. After pointing out differences in the two versions, and granting the reliability of the Respondents versions, Dr. Hamilton opined that considering the GX 20 and 21 version, his previous opinions as to A.R.s dispensing remained the same.
Tr. 96569.
As to Patient B.F., Dr. Hamilton reviewed a series of prescriptions for hydromorphone 8 mg, 84 count, 3 times daily. Tr. 21622; GX 12, pp. 1314, 17
18, 2122, 2526; RX 24. The red flags revealed included the controlled substance itself, the dosage at the highest available, the high quantity 84
tablets, the immediate release, the ongoing length of time it is being prescribed, and the high price $490.32
Tr. 21622.
On rebuttal, Dr. Hamilton evaluated the Respondents sponsored versions of medical records as to B.F., RX 24, 25.
Dr. Hamilton noted references to a discharge date of May 15, 2017, a reference to liver cancer, stage 3, and the last fill of the subject prescription on May 15, 2017. Tr. 97677. Even granting 32 Eighty-four tablets at $490 equals $5.83 per tablet. The ALJ then found that Dr. Hamilton estimated the expected retail price to be $0.90 per pill citing to Tr. 21822 and GX 28, p. 11, but the record does not support this finding. Dr. Hamilton originally testified that hydromorphone had an estimated retail price of $0.90, Tr. 218; however, after he refreshed his recollection with his expert report he stated, I might have misspoke at $0.90.
Its a little bit more expensive for Dilaudid, or hydromorphone . . . . Tr. 222. Dr. Hamiltons export report stated that the estimated retail price of hydromorphone was approximately $1.50 per pill. GX 28, at 11. Dr. Hamilton also testified elsewhere in the record that the market retail price for hydromorphone was $1.50 per pill. See e.g. Tr.
19597. Moreover, albeit in a different context, Dr.
Hamilton testified that to the extent numbers appearing in his expert report differed from numbers to which he was testifying based on his recollection, the numbers in the expert report would be more accurate. Tr. 209. Based on the entirety of the record, I find that Dr. Hamilton estimated the expected retail price of hydromorphone to be $1.50 per pill.
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the reliability of the records, Dr.
Hamilton stuck with his original opinions as to B.F.s dispensing. Id. at 97580.
As to Patient B.N., Dr. Hamilton identified red flags related to a series of prescriptions for hydromorphone. Id.
at 223. The first was of 8 mg, 90 count, priced at $580. Tr. 22223; GX 14, pp.
12; GX 13; RX 26. Dr. Hamilton reiterated the hydromorphone itself represented an unresolved red flag, as well as the dosage, quantity and cost.
Tr. 223, 226. The second and third prescriptions for hydromorphone, again with the same unresolved a red flags, involved 8 mg, 100 count, priced at $640. Tr. 22428; GX 14, pp. 36; GX
13. The fourth hydrocodone prescription, again with the same unresolved red flags, involved 8 mg, 100 count, priced at $600. Tr. 22930;
GX 14, pp. 1516. This prescription prompted an additional red flag as it represented ongoing prescribing of hydromorphone without demonstrated justification. Tr. 230. Dr. Hamilton reviewed a prescription for oxycodone, 30 mg the highest dosage available, 120 count, priced at $600. Id. at 23132.
Dr. Hamilton opined the medication itself represented a red flag, as well as the dosage, the quantity and the cost.
Id.; GX 14, pp. 1920, GX 13.
Additionally, transitioning from hydromorphone to oxycodone required an explanation, which was not contained within the records reviewed by Dr. Hamilton. Tr. 232. A second prescription for oxycodone for B.N., for 30 mg, quantity 40, had the same unresolved red flags. Tr. 233; GX 14, pp. 2122. As this represented the second consecutive prescription for oxycodone, an additional red flag was raised regarding the ongoing unjustified prescribing. Tr. 23334. The next two oxycodone prescription for B.N.
involving the same unresolved red flags, involved 30 mg, 120 count, priced at $600.K Tr. 23436; GX 13; GX
14, pp. 2324, 3738.
K Dr. Hamilton also testified that additional prescriptions falling between the November 11, 2016, and June 2, 2017, prescriptions had the same unresolved red flags. Tr. 236.
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