On June 28, 2004, the Deputy Administrator, Drug Enforcement Administration (DEA), issued an Order to Show Cause/Immediate Suspension of Registration to James S. Bischoff, M.D. (Dr. Bischoff) who was notified of an opportunity to show cause as to why DEA should not revoke his DEA Certificate of Registration BB0377247 under 21 U.S.C. 824(a)(4) and deny any pending applications for renewal or modification of that registration under 21 U.S.C. 823(f). Dr. Bischoff was further notified that his registration was being immediately suspended under 21 U.S.C. 824(d) as an imminent danger to the public health and safety.
The Order to Show Cause alleged in relevant part, that Dr. Bischoff diverted controlled substances through larceny and fraudulent prescriptions, failed to maintain required records, could not account for 32,000 dosage units of controlled substances and dispensed controlled substances to individuals without a bona fide doctor-patient relationship or legitimate medical purpose. The Order to Show Cause also notified Dr. Bischoff that should no request for a hearing be filed within 30 days, his hearing right would be deemed waived.
On July 14, 2004, a DEA investigator personally served the Order to Show Cause/Immediate Suspension of Registration on Dr. Bischoff at the offices of the Ennis, Montana Police Department. Since that date, DEA has not received a request for a hearing or any other reply from Dr. Bischoff or anyone purporting to represent him in this matter.
Therefore, the Deputy Administrator of DEA, finding that (1) thirty days having passed since personal delivery of the Order to Show Cause/Immediate Suspension of Registration to the registrant and (2) no request for hearing having been received, concludes that Dr. Bischoff is deemed to have waived his hearing right. See David W. Linder, 67 FR 12579 (2002). After considering material from the investigative file in this matter, the Deputy Administrator now enters her final order without a hearing pursuant to 21 CFR 1301.43(d) and (e) and 1301.46.
The Deputy Administrator finds that Dr. Bischoff is registered with DEA as a practitioner under Certificate of Registration BB0377247. Dr. Bischoff's registered location is also his residence, which is located in Ennis, Montana.
In April 2003, Dr. Bischoff took “Patient B,” a 16-year-old high school student, to an out of town physician specialist for emergency treatment after the boy's had was cut in an accident. Dr. Bischoff was a friend of the boy's father and step-mother and would come to their home for social visits/dinners. They were both out of town at the time of the accident and Dr. Bischoff volunteered to take the boy to the specialist. While the specialist did not recommend any treatment with controlled substances, Dr. Bischoff wrote the boy a prescription for 100 tablets of Oxycontin, a Schedule II narcotic controlled substance, which he personally picked up a local pharmacy. However, he delivered only 20 tablets to the boy, unlawfully diverting the Start Printed Page 12735remaining 80 tables to his own use or that of someone else.
Around the same time Dr. Bischoff wrote a second prescription in the name of Patient B, for 120 tablets of the Schedule II controlled substance Adderall. He also picked that prescription up at a local pharmacy, supposedly on behalf of the boy, but never delivered it to the boy or his parents, diverting the controlled substance to his personal use or for that of another.
In September 2003, Dr. Bischoff wrote the boy another prescription for 120 tablets of Adderall, which was picked up by the boy's sister. However, the father and step-mother were unaware Dr. Bischoff had prescribed the medication, which the boy began taking, thinking he was supposed to. When his step-mother discovered the bottle a couple of weeks later, she found out for the first time that Dr. Bischoff was prescribing Adderall to the boy. After checking with the regular family physician, she was advised the dosage instructions and strength of the medication were excessive. Fortunately, the boy only took 12 of the tablets and stopped using them because of their effect.
She then checked with the pharmacy where the prescription was filled and discovered Dr. Bischoff had issued multiple fraudulent prescriptions for controlled substances in the names of family members, which he personally picked up, telling pharmacists he was a close friend and the purported patients were too busy to get to the pharmacy. She also discovered Dr. Bischoff had falsely told the pharmacy her stepson, then 16 years old, was 18, thus avoiding a requirement for a parent to sign when prescriptions were picked up.
Investigators subsequently determined Dr. Bischoff had written and filled seven prescriptions for controlled substances in the name of Patient B, along with multiple prescriptions in the names of other family members who were not his patients, all without their knowledge.
During the period January 2001 through January 2003, Dr. Bischoff ordered approximately 46,000 doses of Schedule III and IV controlled substances from a supplier, including various anti-depressants, anti-anxiety, sleep medications, amphetamines and narcotics. After Dr. Bischoff was served with a Notice of Inspection at his registered premises, he declined to permit an inspection or provide investigators with any of the records he was required to keep.
On March 10, 2004, Dr. Bischoff was served with an Administrative Inspection Warrant. Controlled substances were found in the basement of his home/registered location, but he had very few actual patient records and no records of receipt, inventory, dispensation or accountability for controlled substances, violating 21 U.S.C. 827(a) and 842(a)(5). Dr. Bischoff was unable to account for 32,000 dosage units of controlled substances and refused to provide any records or otherwise account for their distribution or whereabouts.
Additional investigation determined Dr. Bischoff had written fraudulent prescriptions for controlled substances to several other area pharmacies during 2003. Interviews with professionals at some of his previous clinic and hospital affiliations also indicated he was known to be involved in inappropriate dispensation and prescribing of controlled substances.
On February 29, 2004, Dr. Bischoff gave a Schedule II controlled substance to a woman he was having dinner with. She was on probation at the time for a controlled substance offense. This distribution was done without a legitimate medical purpose and was outside the usual course of professional practice.
Under Federal and Montana law, for a doctor to be acting in the usual course of professional practice, there must be a bona fide doctor/patient relationship. Investigative review of Dr. Bischoff's computer records indicated he was not maintaining patient records, yet was prescribing controlled substances for individuals, both inside and outside Montana. He prescribed drugs directly to individuals without the benefit of examination or clinical determination of a valid medical purpose and in many cases, there was no evidence Dr. Bischoff had established any actual doctor-patient relationship with these individuals. These controlled substances were dispensed either directly or by prescription, in violation of 21 CFR 1306.04.
Pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy Administrator may revoke a DEA Certificate of Registration and deny any pending applications for renewal of such registration, if she determines that the continued registration would be inconsistent with the public interest. Section 823(f) requires that the following factors be considered in determining the public interest:
(1) The recommendation of the appropriate state licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health or safety.
These factors are considered in the disjunctive; the Deputy Administrator may rely on any one or a combination of factors and may give each factor the weight she deems appropriate in determining whether a registration should be revoked or an application for registration denied. See Henry J. Schwartz, Jr., M.D., 54 FR 16,422 (1989).
As to factor one, the recommendation of the appropriate state licensing board or professional disciplinary authority, there is no evidence in the investigative file that the State of Montana has yet taken adverse action against Respondent's medical license. However, “inasmuch as State licensure is a necessary but not sufficient condition for a DEA registration * * * this factor is not dispositive.” See Edson W. Redard, M.D., 65 FR 30,616, 30,619 (2000).
With regard to factors two and four, Respondent's experience in handling controlled substances and his compliance with applicable controlled substance laws, the investigative file contains ample evidence Dr. Bischoff unlawfully distributed, prescribed and diverted controlled substances over an extensive period. He grossly failed to comply with accountability record keeping requirements or maintain minimally acceptable patient files documenting medical necessity for controlled substance prescriptions. He could not account for 32,000 dosage units of controlled substances delivered to his residence/office and wrote fraudulent prescriptions for controlled substances for non-patients, which he personally picked up and never delivered to their purported recipients. He also prescribed controlled substances to individuals without bona fide doctor-patient relationships and dispensed medically unnecessary or inappropriate drugs to a minor without his parents' knowledge.
While the evidence does not reveal whether Dr. Bischoff diverted controlled substances for personal use or for others, it is clear he failed abysmally to meet the rudimentary responsibilities of a physician and registrant. Thus, factors two and four weigh in favor of a finding that continued registration would be inconsistent with the public interest.
Factor three, the applicant's conviction record under Federal or State Start Printed Page 12736laws relating to the manufacture, distribution, or dispensing of controlled substances, is not relevant for consideration, as there is no evidence Dr. Bischoff has yet been convicted of any crime related to controlled substances. However, it is noted the investigation has been provided to local authorities for possible initiation of criminal charges.
With respect to factor five, other conduct that many threaten the public health and safety, Respondent's actions discussed above are also relevant under this factor. The Deputy Administrator is particularly troubled by Dr. Bischoff's abuse of the trust placed in him as a family friend and physician, both by the minor and his parents and by Dr. Bischoff's calculated efforts to obtain controlled substances through fraud and misrepresentation.
In sum, Dr. Bischoff's cavalier disregard for the law and regulations governing controlled substances and the abandonment of his responsibilities as a physician and registrant cannot be tolerated. They weigh heavily in favor of a finding that his continued registration would not be in the public interest.
Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in her by 21 U.S.C. 823 and 28 CFR 0.100(b), and 0.104, hereby orders that DEA Certificate of Registration BB0377247, issued to James S. Bischoff, M.D., be, and it hereby is, revoked. The Deputy Administrator further orders that any pending applications for renewal or modification of such registration be, and they hereby are, denied. This order is effective April 14, 2005.Start Signature
Dated: February 24, 2005.
Michele M. Leonhart,
[FR Doc. 05-5072 Filed 3-14-05; 8:45 am]
BILLING CODE 4410-09-M