Daily Rules, Proposed Rules, and Notices of the Federal Government
On July 19, 2011, Administrative Law Judge (ALJ) Gail A. Randall issued the attached recommended decision. The Respondent did not file exceptions to the decision.
Having reviewed the entire record, I have decided to adopt the ALJ's recommended rulings, findings of fact, conclusions of law, and recommended Order except for her legal conclusions as to the initial visits of the two undercover officers (UCs) and her discussion in the first full paragraph at page 34 of her slip opinion.
More specifically, one week after the initial visit of David Hays (UC1), at which he was prescribed 150 Percocet, a drug which combines 10 mg of oxycodone with 325 mg of acetaminophen, Hays returned to Respondent complaining that the drug was causing digestive problems. Respondent then prescribed 150 Roxicodone (oxycodone) 30 mg, without any inquiry into Hays' pain level. Tr. 54, GX 3a, at 13. Respondent noted in the chart, however, that Hays "had no relief [from] pain." GX 12, at 14.
With respect to this prescription, the Government's Expert testified that the "[m]edication would not have been indicated given the complaints of the patient, [and] certainly not that particular agent and certainly not that dose or frequency." Tr. 54. Notably, this
Hays returned three weeks later (May 19, 2010) and saw Respondent's Physician Assistant (PA). While during the visit, the PA initially confused Hays with a patient whose name was spelled Hayes, upon recognizing his error he nonetheless noted that Hays was "too early." GX 4, at 14. During the visit, Hays asked the PA if he could increase the Roxicodone 30 mg prescription because he was probably going to be gone for three or four months working on a tugboat.
Approximately fifteen minutes later, the PA spoke with Hays and told him that Respondent "was very generous" but that the "the deal" was that Hays could not see the PA again until after the fourth of July.
While the progress note for this visit stated "Earliest pt. can be seen until 7/5/10,"
Respondent then noted that Hays' "pain level is only a two over ten" and that this was "pretty good."
Hays returned on July 20 and saw the PA. Hays told the PA that he was doing "pretty good" and that his back had improved. GX 6, at 3-4. During the visit, Hays told the PA that his girlfriend had gotten into his medicine (which according to the Government's Expert was indicative of "misuse and diversion," Tr. 65) and wanted to come to the clinic. GX 6, at 5. The PA told Hays that "we could only see her with a valid reason * * * like an MRI report" and "not just because [the drugs] made her feel good."
The PA then discussed giving Hays "this new medicine called Dilaudid, which is a morphine derivative" for his breakthrough pain. After discussing how Dilaudid (hydromorphone) was different from oxycodone, the PA and Hays resumed discussing where the latter could fill his prescriptions with the PA stating that because of the number of pills (210 Roxicodone), it was "extremely hard to believe that [Hays would] be able to get" the Oxycodone 30s from big chain drug stores such as CVS or Publix.
Later, the PA asked Hays if he was "satisfactory in the sleep department and in the anxiety department?"
Hays returned on August 18 and again saw the PA. Notably, on the Patient Comfort Assessment form, Hays indicated that the worst his pain had been in the last month was a "3" on a "0" to "10" scale, that his pain had averaged a "2" during the last month, and that it was currently a "1." GX 12, at 33. Hays also wrote that his pain "was in my lower back but feels better now" and circled that pain was "occasional" and not "continuous."
Hays told the PA that the Dilaudid made him "kind of dizzy and nauseous" and that he thought the oxycodone were "good for" him and asked if Respondent ever prescribed the 80s. GX 7, at 22-23. The PA stated that Respondent would "start out a little slower[,] like the 40's * * * but yes, we do, do the 80s."
Next, the PA asked Hays if his "lower back [was] okay this month?"
Hays asked if the stuff Michael Jackson had taken would work; the PA stated that that drug was only indicated to "put people out with and perform surgery."
Hays and the PA returned to discussing his use of Dilaudid, with the PA stating that he was going to discontinue it.
With respect to the Dilaudid prescription Respondent issued to Hays, the Government's Expert testified that there was no evidence that Hays was experiencing break-through pain "of any significant degree." Tr. 60. The Expert further explained that "[t]here was no history consistent with severe break-through pain and it appeared that [Hays'] pain was adequately--more than adequately managed, even based on the subjective history."
I therefore conclude that substantial evidence supports the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing the Dilaudid prescription to Hays. 21 CFR 1306.04(a). Moreover, for the same reasons that the Expert concluded that the Dilaudid prescription was not medically justified, I also conclude that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing the May 15 and June 16 prescriptions for Roxicodone 15mg, as well as the August 18 prescription for Percocet 10, all of which were purportedly issued for breakthrough pain.
As for the Valium prescription, the Government's Expert observed that the progress note "indicated that the patient had insomnia for the past month" but that Respondent did not explain "in his note why Valium [was] being added, although the prescription is to be taken one at bedtime only."
The Government's Expert further explained that before prescribing Valium for insomnia, "[t]he first reasonably standard thing to do would be to ensure that the patient wasn't doing anything that may be promoting insomnia" such as having "caffeine at night or excessive meals right before bedtime."
Here too, the testimony of the Government's Expert was unrefuted. I therefore conclude that substantial evidence supports the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing the Valium prescription to Hays. 21 CFR 1306.04(a).
As for the prescriptions issued to Eddie Martinez, the evidence showed that Respondent increased his prescription from 120 Percocet 10/325 at the initial visit (for a total daily dose of 40 mg of oxycodone) to 90 Oxycodone 30 mg (for a total daily dose of 90 mg of oxycodone) at the second visit. GX 13, at 16, 20. The Government's Expert opined that Martinez's complained-of pain level did not justify a prescription for Roxicodone 30, which was more than double the dosing of the previous prescription, as "[t]here wasn't any physical examination abnormality or focal neurological deficit * * * consistent with his MRI finding or even his complaints that * * * would have warranted those medications at that dose." Tr. 85. This testimony was unrefuted.
At the third visit, Martinez told Respondent that he had run out a week early and bought drugs on the street even though in Respondent's words "[y]ou changed from Percocet to Oxycodone, that's a much stronger medicine than what you were using" and "there's a significant increase in the total amount of medicine you're getting daily." GX 11, at 20;
According to the Government's Expert, that Martinez said he had run out early and complained of unrelieved pain was not a legitimate medical justification for increasing the dosing of oxycodone because it was "[n]ot based on the history, physical, and objective information available in this patient's file." Tr. 87. The Expert further opined that while it would be within the course of professional practice to prescribe analgesic medications "if the clinical justification existed," Martinez's "history and physical" did not meet the criteria for prescribing.
Here again, this testimony was unrefuted. Accordingly, I hold that substantial evidence supports the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing oxycodone prescriptions to Martinez at both his second and third visits. 21 CFR 1306.04(a). I thus conclude that Respondent violated Federal law in issuing numerous controlled substance prescriptions to both UCs.
This finding provides reason alone to conclude that Respondent has committed acts which render his registration inconsistent with the public interest.
Accordingly, I adopt the ALJ's recommended order that Respondent's registrations be revoked and any pending applications be denied. For the same reasons which led me to order the Immediate Suspension of Respondent's registrations, I conclude that the public interest requires that this Order be made effective immediately.
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 28 CFR 0.100(b), I order that DEA Certificates of Registration Nos. FP1312406, BP8477639, and BP3429835, issued to Zvi H. Perper, M.D., be, and they hereby are revoked. I further order that any pending applications of Zvi H. Perper, M.D., to renew or modify any of his registrations, be, and they hereby are denied. This Order is effective immediately.