On October 3, 2007, the petitioner, the Board of Registration in Medicine, issued a Statement of Allegations ordering the respondent, Vernon S. Kellogg, M.D., to show cause why he should not be disciplined based on the conduct set forth in the Statement of Allegations. Respondent was charged with failing to maintain malpractice insurance while holding himself out as having an active malpractice insurance policy, falsely holding himself out as certified in emergency medicine after he had failed to renew that certification, failing to reveal to petitioner that he had been investigated on two occasions by DEA, and failing to indicate all these events and changes on his license renewal forms. He was also charged with failing to turn over the medical records of the persons he treated out of his home, and with dispensing inappropriate amounts of generic Vicodin to them without written prescriptions and in amounts that went beyond meeting an immediate treatment need. The Statement of Allegations sets forth the following legal bases for potential discipline:
• engaging in conduct calling into question respondent's competency to practice medicine;
• committing an offense against the provisions of various sections of M.G.L. c. 94C and related regulations;
• violating rules and regulations of petitioner;
• engaging in conduct with the capacity to deceive or defraud;
• committing misconduct in the practice of medicine;
• engaging in conduct showing a lack of moral character that undermines public confidence in the integrity of the medical profession;
• failing to respond to petitioner's subpoena or to furnish information petitioner is legally entitled to receive; and,
• fraudulently procuring the renewal of his registrations.
(Ex. A.) The matter was referred to the Division of Administrative Law Appeals (DALA) for hearing. (Ex. B.)
Also on October 3, 2007, petitioner issued an Order of Temporary Suspension of respondent's license to practice medicine pending the outcome of the hearing on the merits. This was issued in response to petitioner complaint counsel's Motion for Summary Suspension that provided in support of it, the information obtained from an investigation of respondent. (See Ex. A.) A hearing was scheduled for October 11, 2007 before DALA to permit respondent to challenge the Order of Temporary Suspension, but respondent decided not to challenge this order and the order has been in place through the present.
A pre-hearing conference was held April 25, 2008 at the DALA offices, 98 North Washington Street, 4th Floor, Boston, MA, and respondent was ordered to file an Answer to the Statement of Allegations by May 16, 2008. The Answer was filed May 29, 2008. Respondent denied engaging in any wrongful conduct. Thereafter, the parties engaged in discovery, but during the course of discovery respondent failed to respond to many of petitioner's requests. Petitioner filed motions to compel discovery which were allowed, but respondent continued to fail to respond. Hearing dates were scheduled for May 26, 27, 28 and 29, 2009. On May 19, 2009, respondent's counsel withdrew as counsel noting irreconcilable differences with respondent on the handling of his case. The hearing commenced, but was held on only May 26 and 27, 2009. The hearing was transcribed.
At the outset of the hearing, petitioner presented a Motion in Limine to limit the evidence respondent could present based on his failure to comply with petitioner's motions to compel discovery which had been allowed. Petitioner noted that the parties were under an order to end discovery by October 31, 2008, and that respondent had also failed to comply with that order. Petitioner sought a ruling that designated facts be established adversely against respondent, that respondent not be allowed to support or oppose claims or make defenses, and be subject to other specific orders regarding the evidence. This motion was denied and the hearing commenced. (Ex. E.)
Exhibits 1 - 31 are in evidence. (Exhibit 31 is admitted post-hearing and is petitioner's Standing Order on interlocutory appeals.) Petitioner's Motion to Impound Exhibits 24 and 25, the reports of Dr. Friedman, was allowed as these documents contain medical information concerning Dr. Kellogg. (Ex. F.) (Findings of Fact numbers 49-62 are also impounded as based on the information contained in these Exhibits.)
Before any witnesses testified, the parties made opening statements. In his opening, respondent claimed that his natural and constitutionally protected rights were being violated by petitioner, a consistently raised objection to petitioner from the time he was investigated. He claimed that petitioner failed to follow its own rules and never provided him with his due process rights as he never received any notice of any complaints against him. Respondent explained that his license to practice was suspended but the suspension was not based on evidence that he harmed or endangered any persons. He claimed he should not have had to undergo an evaluation by a psychiatrist based on an investigation conducted by persons who lacked medical training. Respondent contended that his natural and constitutional rights arguments should be addressed immediately because he should not be subject to petitioner's arbitrary and capricious actions against him. If this could not be done at the DALA hearing then he wanted to stop the proceeding and seek judicial review. He contended that:
The reason that any of the Statement of Allegations occurred is based on my belief in the fundamental law of the land and my possession of natural rights. Any of the items in the Statement of Allegations are there simply because of these reasons. I cannot defend anything that I did or did not do based on my belief in the natural rights.
(Hearing transcript of 5/26/09, volume I, page 60.)
Petitioner countered that if respondent fails to contest the Statement of Allegations at this hearing he is without a future right to contest these allegations. Petitioner argued that it has specific statutory and regulatory authority to issue a subpoena to a physician to secure certain records prior to the issuance of a Statement of Allegations. Petitioner also noted that respondent could have challenged the Order of Temporary Suspension at a hearing but chose not to do so and is therefore barred from now raising arguments to challenge it.
I ruled that no interlocutory appeal to petitioner board members would be permitted on the grounds raised by respondent of seeking to stop the hearing process and to throw out the Statement of Allegations, the Order of Temporary Suspension, and the Order to Undergo a Psychiatric Evaluation. I ruled that respondent would have to present these arguments on appeal in court after a hearing on the merits of the Statement of Allegations and a final decision by petitioner. Respondent was warned that there would be consequences to his failure to go forward with this hearing process on the Statement of Allegations, including not having another opportunity to contest these allegations.
Respondent continued to consider walking out of the hearing before any evidence or testimony was taken. In addition to lengthy explanations about the G.L. Chapter 30A hearing process and how the court on appeal would be the proper forum for presenting his constitutional and natural law arguments, respondent was given time to make his decision. He decided to go forward with the hearing. Discussions concerning this issue also occurred during the course of the hearing.
I did not find respondent's arguments to dismiss petitioner's Statement of Allegations and orders involving respondent satisfied the tests in petitioner's Standing Order No. 91-1 regarding matters acceptable for an interlocutory appeal to be brought before petitioner board before the adjudicatory hearing occurred.
Petitioner's Standing Order No. 91-1 reads in pertinent part as follows:
When any case is pending before the Division of Administrative Law Appeals (DALA), a party may file an Interlocutory Appeal of a ruling of an Administrative Magistrate with the Board if (1) the ruling involves an important question of law or policy concerning which there is substantive grounds for difference of opinion and an immediate appeal from the ruling may materially advance the ultimate termination of the proceeding or (2) subsequent review will be an inadequate remedy. (Ex. 31.)
The Standing Order goes on to provide:
Interlocutory appeal will not be permitted unless the Motion is allowed by the Administrative Magistrate or when the Board has determined that (a) vital public or private interests might otherwise be seriously impaired, or (b) the Board has not developed standards which the Administrative Magistrate can apply in determining whether interlocutory review is appropriate.(Ex. 31.) Respondent also failed to reduce his contentions into the form of a written motion as required by this Standing Order.
Respondent also sought to introduce evidence of good character. This was allowed over petitioner's objection to the specific letters presented by respondent after the close of the hearing and filed by June 29, 2009. (Ex. 30) Petitioner's objections go to the weight to be given the letters which are allowed in evidence only as character evidence to be available to petitioner board regarding disposition matters. (Ex. G.) The letters were not used to determine the findings of fact.
Petitioner presented the testimony of Anne Vacca, who investigated Dr. Kellogg for the Board, and Joe Zorola, head underwriter for ProMutual Insurance Group. (Counsel for Mr. Zorola was present for his testimony.) Mr. Zorola was sequestered. Petitioner also called Dr. Kellogg as its witness. Respondent presented no witnesses, but testified on his own behalf following his direct examination by petitioner. Both parties made closing arguments on the record.
1. Vernon Starr Kellogg, M.D., d.o.b. 11/23/46, graduated from medical school and became licensed to practice medicine in Massachusetts in 1975 under certificate of registration #38932. There has been no lapse in his licensure in Massachusetts. (Exs. A & C. Testimony.)
2. Dr. Kellogg worked from about 2002 until his suspension in the emergency rooms at both the Athol Memorial Hospital in Athol, MA and at the Henry Heywood Memorial Hospital in Gardner, MA. (Exs. A, C, 19 & 20. Testimony.)
3. Dr. Kellogg was affiliated with Tripler Army Hospital in Hawaii from
1972-1973; University of Massachusetts Memorial Health Center in Worcester, MA from 1983-2001; and, Burbank Hospital in Fitchburg, MA from 1976-1989. From about 1990, Dr. Kellogg was the director of three urgent care centers in Fitchburg, Leominster and Gardner, MA, all operating under his corporation called MCARE. The clinics were sold
in 1996, and he stayed on as director until 2000. (Exs. 19 & 20. Testimony.)
4. From 1985 through December 1995, Dr. Kellogg was a diplomat in emergency medicine of the American Board of Emergency Medicine holding certification #00830180. He did not renew this certification. (Exs. 8, 19 & 20. Testimony.)
5. Dr. Kellogg did not find a need to have the emergency medicine certification for his work in the two hospital emergency rooms or in the clinics where he worked, and he understood that there were other physicians working in the same hospital emergency rooms who did not have this certification. (Testimony.)
6. Dr. Kellogg worked with Bay State Emergency Medical, Inc., which contracted with the Athol and Heywood Hospitals to provide emergency room services coverage by physicians. Dr. Kellogg was one of those physicians. Bay State Emergency Medical provided its physicians with a stipend that was intended to be used to help them cover the costs of working at these emergency rooms, including helping to cover the annual premium for their malpractice insurance policy. These physicians, including Dr. Kellogg, were required to secure their own malpractice insurance at least as of 2003. (Exs. 19 & 20. Testimony.)
7. Dr. Kellogg held malpractice insurance policies through ProMutual Insurance Group. This insurance was arranged through insurance agent Heritage Insurance Agency, Inc. Dr. Kellogg had a malpractice insurance policy in his own name between October 1, 2003 and September 30, 2004. He did not timely renew this insurance policy. By letter of November 1, 2004, ProMutual Group informed Dr. Kellogg that he had an overdue balance on a renewal of his malpractice insurance for the next time period of October 1, 2004 through September 30, 2005, and that his policy was going to be voided effective September 30, 2004 if no payment was received by November 11, 2004. By letter of December 9, 2004, Heritage Insurance Agency, Inc. notified ProMutual Insurance Group that Dr. Kellogg's malpractice insurance policy should be cancelled as of September 30, 2004 as "he has gotten coverage elsewhere." In fact, Dr. Kellogg had not secured malpractice insurance elsewhere because he decided to stop carrying malpractice insurance. He decided he would simply be self-insured in the sense that if he was sued for malpractice he would pay any damage award out of his personal assets. In 1997, he was the subject of a malpractice claim in which the malpractice carrier made a $1,310,000 payment, and in 1999, he was the subject of a malpractice claim in which the malpractice carrier made a $25,000 payment. (Exs. 19, 20, 21 & 22. Testimony.)
8. Dr. Kellogg was required to have malpractice insurance in place in order to work at the two hospital emergency rooms. He did not inform either Athol or Heywood Hospitals that he was intending to be self-insured. He either directly falsified or had someone else at his direction falsify his expired malpractice insurance declaration to read that he held a renewed policy with ProMutual Insurance Group covering 2004-2005. He continued to do the same to show to the hospitals that he had coverage for 2005-2006 and 2006-2007. (Exs. 19, 20, 21, 22 & 26. Testimony.)
9. Dr. Kellogg has resided in Pepperell, MA from the early 1970's. Since then and once he became a licensed physician, he has operated a form of free medical clinic out of his home offering limited services. He has never had a sign of any kind or done any advertising to promote this home medical practice, including nothing in the telephone yellow pages or any informational listing of the practice on the internet. It has only been by word-of-mouth that people learned about this walk-in clinic. The hours of operation have been whenever he happened to be at home. In this practice, Dr. Kellogg only treats people he evaluates and decides are the "working poor." He understands these people to be those who do not purchase health insurance or see private physicians or visit emergency rooms due to the costs involved, and who do not seek government covered health services. He believes he may have treated 200 to 300 patients at his home practice. (Exs. A & C. Testimony.)
10. Dr. Kellogg's home clinic lacks any medical office or room with an examination table. He only treats the immediate care needs of the persons he accepts to evaluate. He does not establish with them in his view any on-going relationship such as becoming their primary care physician and only functions as a general physician for them. He provides some degree of physical examination and/or mental status evaluation. (Testimony.)
11. Dr. Kellogg may have produced and maintained written medical records on some of or even on most of the persons he has seen over the years at his home practice, but he will not show these records to any third party, including petitioner. He will not divulge the scope of information contained in them or provide any information that would suggest the name of the persons he has treated out of his home. He feels he should do this to protect their privacy, and believes he can do this because there is no third party insurer involved and because he charges no fees to the persons he treats at his home clinic. (Testimony.)
12. While he was the director of the three urgent care clinics, Dr. Kellogg used his DEA and Massachusetts Department of Public Health (DPH) registration numbers to order and then dispense drugs to patients seen at these clinics. He ordered the drugs directly from a distributor and received the drugs at his Pepperell home. They were delivered with no need for him to sign to receive them. They would usually be left inside his garage. He stored them in a safe in his basement that had a combination lock that only he knew how to unlock. He transported some of the drugs from his home to the three clinics to use them there. Only small quantities were stored at the clinic locations at any given time. During this time period, he ordered the drugs from Interstate Drug Exchange (IDE), which later became General Injectables and Vaccines, Inc. (GIV). He continued to order medications from GIV. For his home clinic patients, he ordered drugs this same way, had them delivered the same way, and stored them the same way. (Exs. A, C, 4, 5 & 6. Testimony.)
13. From about 2004 or 2005, Dr. Kellogg stopped routinely using prescription pads when prescribing medications for the home clinic patients. He primarily provided them only with verbal information on the use of the medications/ controlled substance drugs he dispensed to them. His practice was not to routinely call-in prescriptions to area pharmacies. He put the medications for his home clinic patients into prescription bottles he had on-hand that he had taken when he was in the U.S. Army, which bottles he understood were being thrown away at the time. (Testimony.)
14. Dr. Kellogg has dispensed different amounts of medications, including controlled substances , to various persons at his home clinic depending on their needs and depending on whether he felt they would be going to see another doctor about their condition. This could mean he provided a home clinic patient with a large quantity of a drug at one time. To Dr. Kellogg, treating a home clinic patient's immediate needs could encompass providing a large quantity of medication and not just a few days worth of the medication. This is in keeping with his assessment that he treats people who will not use emergency rooms or see other doctors due to the costs involved. Dr. Kellogg would still tell the patient receiving a large amount of a medication about the proper dosage to take each day. Dr. Kellogg was aware of the recommended daily dosage of the drugs he dispensed. (Testimony.)
15. Dr. Kellogg maintained dispensing logs for the medications he dispensed to his home clinic patients. These logs are in chronological order and contain a number he assigned to a home clinic patient, the date he dispensed the drug to the patient, the number of tablets of the drug dispensed, and a running total of the declining inventory of the drug to let him know when he needed to order more of the drug. The log does not contain the patient's name or address or any way to contact that person. Dr. Kellogg claims he can de-code the numbers he assigned to each patient into the patient's name using what he calls his "Rosetta Stone." Dr. Kellogg will not reveal the "Rosetta Stone" or explain how it works to any third party, including petitioner. (Exs. 1, 14, 15 & 16. Testimony.)
16. Dr. Kellogg dispensed the generic form of Vicodin called hydrocodone with acetaminophen (or Tylenol). He purchased it from GIV in a strength of 5mg, 500 mg in tablet form. This generic Vicodin is a schedule II controlled substance under DPH and DEA statutes, rules and regulations. He dispensed it to his home clinic patients for such conditions as pain involving toothaches, broken bones and backaches. (Exs. 1, 2, 14, 15 & 16. Testimony.)
17. Dr. Kellogg is aware that petitioner adopted guidelines that it expects its licensed physicians to adhere to called, Prescribing Practices Policy and Guidelines. Dr. Kellogg disagrees that he should have to conform his prescribing practices for his home clinic patients to the guidelines if in his medical opinion he is able to accomplish a proper patient treatment in a more informal way that avoids all the recordkeeping and other procedures set forth in the guidelines. As to his home clinic practice, Dr. Kellogg's prescribing practices and protocols do not comply with the principles, intent, or even the basic recordkeeping protocols of the Prescribing Practices Policy and Guidelines. (Ex. 18. Testimony.)
18. The Prescribing Practices Policy and Guidelines starts with the following warning to Massachusetts physicians:
The consequences of improper prescribing practices are matters of grave concern to the public, the medical community, law enforcement personnel, state and federal agencies and licensing boards that license and oversee health care professionals. Indeed, physicians who engage in improper prescribing practices, including direct diversion of drugs for non-medical use and indirectly contributing to such diversion by imprudent prescribing, account for a high percentage of Board [Board of Registration in Medicine] investigations and disciplinary actions.(Ex. 18.) This is followed by the following further instruction concerning the importance of the guidelines:
The Board believes that this Guide will advance [the delivery of competent, high quality health care] by informing physicians as to the legal requirements upon them and the standards the Board applies in reviewing their prescribing practices.(Ex. 18.) The explanations in the guidelines include statutory and regulatory
citations. (Ex. 18.)
19. These guidelines set forth the requirements for prescribing drugs to patients. The requirements assume a written prescription, and include: a signature line for the physician along with the print version of the physician's name; the physician's address in print form; the physician's registration numbers; the date the prescription is issued; the name of the drug and dosage and strength per dosage unit as well as the quantity of units; the patient's name and address; directions for use with cautionary statements; and the number of refills. (Ex. 18.)
20. These guidelines address verbal prescriptions, and explain that "Schedule II controlled substances cannot be prescribed without a written prescription except in emergency situations." Footnote 13 explains that such emergency situations are set forth in 247 CMR 5.03(1) which was "derived" from 21 CFR 290.10. The emergency criteria are:
(a) that the immediate administration of the controlled substance is
necessary for the proper treatment of the intended ultimate user, and
(b) that no appropriate alternative treatment is available, including
administration of a controlled substance which is not in Schedule II, and
(c) that it is not reasonably possible for the practitioner to provide a
written prescription to be presented to the person dispensing the
controlled substance prior to the dispensing.
(Ex. 18.) The footnote also explains that 21 CFR 1306.11(d)(1) prevents pharmacists from filling verbal prescriptions for schedule II drugs in amounts beyond what is "adequate to treat the patient during the emergency period." (Ex. 18.)
21. The guidelines address physicians dispensing controlled substances without a prescription, and explain that this can occur when "the drug is being delivered or administered to the patient for immediate treatment … in a single dose or in such quantity as is, in the opinion of the physician, essential for the proper treatment of the patient." The guidelines define immediate treatment in the context of a physician's private practice, which includes the practice Dr. Kellogg was running from his home. The definition is taken from M.G.L. c. 94C, § 9(b); "that quantity of a controlled substance which is necessary for the proper treatment of the patient until it is possible for him to have a prescription filled by a pharmacy." The guidelines also instruct:
Physicians who stock sample controlled substances should be aware that the Prescription Drug Marketing Act of 1987 imposes strict record-keeping requirements on physicians, restricts the manner in which drug samples may be acquired and authorizes heavy fines and prison sentences for violations of its provisions.(Ex. 18.)
22. These guidelines address what situations show a legitimate medical purpose for a prescription, and various factors that would not show "good faith in issuing the prescription:"
a) Failure to follow at least minimum professional procedures …;
b) The physician permitting the patient to name the drug he desires;
c) The physician expressing concern during a patient encounter as to how
and where a prescription would be filled in a manner that does not
indicate a good faith concern for his patient;
d) Repeated refills over relatively short periods;
e) General remarks of the physician indicating his or her experience with
non-therapeutic uses of the drug and of drug enforcement actions and
f) Failure to schedule appropriate additional appointments for return
visits, and other factors indicating a lack of interest in follow-up care; and
g) Conversations and other circumstances that demonstrate that the
physician knew that the drugs were not to be used for a therapeutic or
(Ex. 18.) The guidelines also address what is needed when issuing a prescription in the usual course of a physician's practice. The primary factor is to establish "a physician-patient relationship," and to "establish a proper diagnosis and regimen of treatment." On a first visit the guidelines describe basic steps the physician has
1) Take and record an appropriate medical history; and
2) Carry out an appropriate physical and/or mental status exam
and record the results.
(Ex. 18.) The guidelines explain it is of "paramount importance" to take "a complete medical history," and when that is not done and "an appropriate examination" is not given, there can be "serious consequences for the patient" and for the physician such as malpractice claims and investigations by petitioner. In addition, the guidelines caution that,
physicians must maintain medical records that are detailed enough in nature that the physician's clinical reasoning is implicit in his or her documentation. Treatment plans should be explicitly recorded.(Ex. 18.)
23. The guidelines endorse the general guidelines issued by the DEA, which guidelines have been endorsed by the American Medical Association. These best practices mirror the petitioner's prescribing guidelines. One practice highlighted is for the physician who has prescribed stronger drugs to "remain in close contact" with the patient, such as seeing the patient every six months or recording information in the medical record if that is not possible or practical or is inappropriate. The guidelines urge the physician at a minimum to "speak with the patient or the patient's primary care physician by telephone before issuing a new Schedule II prescription." If the patient is drug dependent, the guidelines explain there are "special reporting requirements under Massachusetts law and … limitations [in prescribing] imposed by federal law." M.G.L. c. 111E, § 1 defines a drug dependent person as,
a person who is unable to function effectively and whose inability to do
so causes, or results from, the use of a drug other than alcohol, tobacco
or lawful beverages containing caffeine, and other than from a medically
prescribed drug … proportioned to the medical need.
(Ex. 18.) Included among the federal limitations is a need to secure "separate registration" from DEA to treat drug dependent persons. (Ex. 18.)
24. The guidelines address pain management and prescribing drugs
for "patients who are in severe pain, both acute and chronic." The physician is instructed to provide a physical and take a history to address "the nature of the patient's pain," and address "the patient's risk of addiction." The guidelines refer to the Model Guidelines for the Use of Controlled Substances for the Treatment of Pain of the House of Delegates of the Federation of State Medical Boards of the United States, which the physician should review, and which guidelines are attached to petitioner's prescribing guidelines. (Ex. 18.)
25. Dr. Kellogg's practice when ordering drugs from IDE was to order large
amounts of a drug so that he would not need to re-order the drug so often. By letter of October 3, 1989, IDE informed Dr. Kellogg that it was "withholding [his] order since it contains a narcotic or controlled substance which is in excess of the normal purchases made by other doctors." IDE noted how DEA was asking IDE to "scrutinize such orders." As a result, IDE was seeking from Dr. Kellogg
a letter indicating uses for the product requested by you so that we may stay within the guidelines that have been recently "suggested" by the DEA … that inventory levels of all narcotic and controlled substances be kept to a minimum with the suggestion of approximately 3 months maximum … to avoid excess amounts of controlled or narcotic preparations getting into the black market if a
doctor's office should be burglarized. (Ex. 4.)
26. In response, Dr. Kellogg wrote to IDE on October 8, 1989 and explained:
My reason for ordering the amount of controlled substances that I did was for
convenience to me. I find it easier to order for the year, rather than every 3 months as you suggest. If you check your records, you will see that this has been my pattern for the last 15 years. Furthermore, I safeguard all controlled and other dangerous drugs in a 1,200 lbs. steel combination lock safe that is bolted to a concrete foundation. Only I have the combination. A well-trained locksmith would take hours to open this and only after the normal security system had been turned off or by-passed.I feel confident in my storage system, however, if you would rather return my order with all the forms and my check, then please do.(Ex. 5.)
27. The DEA did an inventory of Dr. Kellogg's drug orders and supplies at his home in the early 1990's. He understood as a result of this DEA inventory that he could not transport the drugs to the three clinics from his home, and that the DEA number permitting him to order the drugs had to be specific to one location. This led to Dr. Kellogg being issued a new DEA number linked to the Fitchburg clinic location. Dr. Kellogg believed the DEA permitted him to transport drugs between the three clinic locations. Dr. Kellogg was fined $10,000 by the DEA, which he understood was for improperly disposing of drugs used at the three clinics. The DEA explained that he needed to package the old medications with an inventory sheet and send them to the DEA office in Boston. The DEA would be responsible for their destruction and send back a receipt indicating that the drugs had been destroyed. By letter of June 11, 1991, Dr. Kellogg was instructed to return to the DEA his prior DEA number linked to his home or his new DEA number would be revoked. Dr. Kellogg returned his prior DEA number. He also learned how to inform DEA of a change of address in terms of ordering and receiving drugs in the future. There was never a time he lacked a DEA number in connection with this DEA investigation. (Ex. 6. Testimony.)
28. After the urgent care clinics were sold and at least by 2002-2003, Dr.
Kellogg had changed with the DEA the location for receipt of drugs he ordered back to his home for use in his home clinic practice. (Testimony.)
29. In 2007, Dr. Kellogg's practice for ordering and dispensing of drugs at his home clinic was investigated by DEA. The DEA went to Dr. Kellogg's home on July 17, 2007 and took an inventory of the drugs he was storing. The DEA contacted petitioner in and around April 2007 and explained that Dr. Kellogg had been ordering from GIV a large quantity of generic Vicodin, hydrocodone bit 5mg acetaminophen 500 mg. DEA's investigation determined that Dr. Kellogg had ordered 4,500 tablets of this drug between April 25, 2005 and April 25, 2007. Dr. Kellogg is not sure that he actually received all 4,500 tablets of the generic Vicodin he ordered, and that the actual amount he received might have been closer to 3,500. He attributes this discrepancy to problems he was having with the delivery of the medications he was ordering; that the deliveries would be left outside his home door or in his breezeway and not just placed inside his garage. He realized he might have paid for all 4,500 tablets. The drug was manufactured by Watson Pharmacies and an appropriate dosage per person per day was no more than eight tablets. (Exs. 1, 2 & 3. Testimony.)
30. Following its visit, the DEA issued a "formal notification" to Dr. Kellogg explaining that he failed "to maintain adequate records under the Code of Federal Regulations," and that this involved "violations of Title 21 of the United States Code (USC) § 827(a)(1), (3) and (b)." The DEA instructed him "to comply with the requirements of the Controlled Substance Act and Code of Federal Regulations, which were outlined by the Investigators ... on July 17, 2007." The DEA gave him thirty days to respond in writing with an account of "the action taken or planned to correct these violations." This notification set forth in detail in three numbered paragraphs the violations found:
1. Registrant had no initial inventory or biennial inventory on hand as
required by Title 21 United States Code §827(a)(1), (3) and (b), Title 21 Code of Federal Regulations (CFR) §1304.11(b) and (c). The registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is within two years of the previous biennial inventory date.
2. Registrant failed to have receipt records readily retrievable as required
by Title 21 Code of Federal Regulations (CFR) §1304(g) and Title 21
Code of Federal Regulations (CFR) §1304.22(c).
3. Registrant failed to maintain the number of units or volume of such
finished form dispensed, including the name and address of the person
to whom it was dispensed, the date of dispensing, the number of units or
volume dispensed, and the written or typewritten name or initials of the
individual who dispensed or administered the substance on behalf of the
dispenser as required by Title 21 Code of Federal Regulations (CFR)
31. Dr. Kellogg felt that this DEA investigation and inventory resulted in some recordkeeping concerns and that he was now going to adhere to what DEA recommended. He felt he always maintained accurate inventory information and that he viewed the supplier's invoices as something only the supplier had to maintain and not him. He felt he kept all required information regarding dispensing of medication, including the number of units given to a patient, the name of the person who received the medication, the date the medication was dispensed, and a running total of the amount of the particular medication he had left in his inventory at any given time. He also felt he has always been able to keep the medication and the records about the medication secure in his home. By letter of August 5, 2007, he reported all this to the DEA in response to their letter to him about what they found at their July 2007 visit to his home. (Ex. A at #5 & Ex. 14. Testimony.)
32. Dr. Kellogg never felt he needed to report to petitioner that his emergency medicine certification had stopped in 1995; that he was not continuing to hold a malpractice insurance policy; and that DEA had made two visits to do drug inventories. On his license renewal forms that he filed to maintain his Massachusetts license with petitioner, he never noted these changes and events. He either decided the forms contained no precise request for reporting the two DEA visits, or that leaving erroneous information about no current emergency medicine certification and that he was now self-insured, were minor matters. (Testimony.)
33. On his 1991 license renewal form, which Dr. Kellogg signed under the
pains and penalties of perjury on October 6, 1991, he did not provide any information concerning the DEA visit-investigation to his home practice. (Ex. 7. Testimony.) The form contained questions that were to be answered yes or no and to cover the prior four years. Detailed explanations were to be provided on Form 15A as to each question if needed to adequately explain the answer. Dr. Kellogg answered number 18 in the negative with no Form 15A explanation. It read:
Has your privilege to possess, dispense or prescribe controlled substances been suspended, revoked, denied, restricted, surrendered, or have you been called before or been warned by this state or any other jurisdiction including a federal agency?(Ex. 7.)
34. On his 1997, 1999, 2001 and 2003 license renewal forms, which Dr. Kellogg signed under the pains and penalties of perjury, he did not correct the information contained in question number 7 that listed him with the specialty of emergency medicine of the American Board of Medical Specialties. (Exs. 8, 9, 10 & 11. Testimony.)
35. On his 2005 license renewal form, which Dr. Kellogg signed under the pains and penalties of perjury, he did not correct the information contained in question number 6 that listed him with the specialty of emergency medicine of the American Board of Medical Specialties. Also, at question number 12, he checked the box to indicate that he held a medical liability insurance policy with ProMutual Insurance Group. He wrote in the policy dates as covering September 30, 2005 to September 30, 2006. He made no report to petitioner concerning the fact that he considered himself now self-insured as he had ceased holding any malpractice insurance policy after September 30, 2004. (Ex. 12. Testimony.) On the form at page 5, there was a list of certifications Dr. Kellogg was instructed to review. He signed-off on all of them. Among the certifications was number 6 which read:
I certify that I have complied with my obligations to report a physician to the Board of Medicine, pursuant to G.L. c. 112, sec. 5F, when I have a reasonable basis to believe that person violated any provisions of G.L.
c. 112, sec. 5 or any Board regulation.(Ex. 12.)
36. In April 2007, after petitioner learned about the July 17, 2007 DEA investigation of Dr. Kellogg, petitioner commenced an investigation of Dr. Kellogg. Petitioner investigated and received from GIV an itemized list of medications ordered by Dr. Kellogg between January 1, 2000 and September 28, 2007. (Exs. 1, 2 & 3. Testimony.)
37. Petitioner issued a subpoena to Dr. Kellogg on September 17, 2007
seeking various documents by September 20, 2007. The documents sought were:
1. The original and complete medical record for all patients that you
have seen at your property, located on 105 Jewett Street, Pepperell,
Massachusetts, from August 1, 2006 to the present.
2. The original dispensing logs that you provided to DEA agents on
July 17, 2007.
3. All original dispensing logs that you have created from January 1, 2005
to the present.
4. All original receipts for all controlled substances, including Schedule
VI substances, such as antibiotics, that you have purchased from
January 1, 2005 to the present.
38. Dr. Kellogg called petitioner's investigator on his case, Anne
Vacca, on September 18, 2007. After speaking with her, he wrote to her on September 19, 2007, explaining that he was sending her the records being asked for. He also wrote that he was,
not happy with the manner in which events have occurred and therefore must demand that you and your agencies respect all my God-given and Constitutionally protected rights. Specifically, but not limited to, I have the right to know of what I am accused and to face my accuser … you refuse to tell me the nature of the investigation. You mention "underlying allegations," but fail to enumerate. This violates my legal right to due process among others.
Therefore, I feel I have to be cautious in dealing with you and your agencies and I do not give you permission to look at my records until I am present and in possession of them …. (Ex. 29.)
39. On September 21, 2007, Dr. Kellogg wrote petitioner board chairman. He explained that he was finding it "uncomfortable to be attacked by one of your investigators, and treated with arrogance, distrust and dishonesty." He went on to describe his private practice as house calls and home visits. (Ex. 27. Testimony.) He explained:
[I]n my private practice there are only two private individuals contracting for medical consultation and care and the element of confidentiality is paramount … HIPAA doesn't apply to private medical contracts such as my records where there is no insurance, government or other third party payer of any kind. There is a Constitutionally protected right to privacy and confidentiality that your investigator should not violate, but she did. (Ex. 27.) Dr. Kellogg understood there were no patient complaints about him. He recounted his version of what he and Anne Vacca talked about during the September 18, 2007 telephone conversation. He wrote that she raised a zoning issue concerning his home office, and also asked if he was a pharmacist. He expressed his hope to "meet to discuss and resolve these issues at the [petitioner's] administrative level." (Ex. 27.)
40. At a September 27, 2007 interview with petitioner's investigator, Anne Vacca, and with petitioner's complaint counsel, Luz Carrion, Dr. Kellogg provided his drug dispensing logs, but would not provide names and addresses of the persons each entry pertained to. Although he maintained he knew who each entry referred to through use of his "Rosetta Stone," he only provided a computer disk that he claimed contained medical records on persons he treated at his home clinic. At the interview, he continued to claim his rights were being violated by the actions of petitioner's investigators. When Anne Vacca attempted to open the information on Dr. Kellogg's disk, her computer showed the disk to be empty. She then had the "IT" experts at her office open up the disk, but they also found the disk to be empty. Once confronted with this information, Dr. Kellogg never
provided a hard copy of the information he claimed was on the disk. (Ex. 17.
41. Petitioner's investigator, Anne Vacca and petitioner's complaint counsel, Luz Carrion, in response to Dr. Kellogg's constitutional challenges to how the investigation was being conducted, provided him with a copy of a Suffolk Superior Court decision, Board of Registration in Medicine v. Jane Doe, MD, SUCV-2007-01247 (May 9, 2007)(Riley, J.). He was asked to review this decision to appreciate why petitioner felt it had full authority to be conducting the investigation against him. One of the issues petitioner highlighted for Dr. Kellogg was the Court's acknowledgement that petitioner has the right to gain access to patient medical records of a physician it is investigating. Petitioner's investigators also made it clear to Dr. Kellogg that he had a right to secure
counsel during this investigation process. (Testimony.)
42. By letter to petitioner of October 1, 2007, Dr. Kellogg complained that the investigation process made him
feel as if I have been taken back to the pre-Constitutional times in Salem, MA. The analogy is like I have been accused of being a witch and now have to prove I am not. A negative is difficult to prove. (Ex. 28.) Dr. Kellogg further claimed that petitioner's investigator and complaint counsel lacked sufficient medical backgrounds to understand the terms he used during the "four hours" they questioned him. He felt they were not competent to be interviewing him. He also highlighted that at the start "of the interrogation," petitioner's complaint counsel "became visibly upset when I asserted my God-given and Constitutionally protected rights." He felt she did not take his
assertions seriously, and referred to what was going on as involving regulation of
his conduct that such arguments did not reach. Dr. Kellogg next wrote:
Every inhabitant, and indeed every lawyer, in this Commonwealth should know that the Supreme Being (God) grants us our rights. We the people then grant limited powers to the government in order to have a more peaceful and protected life. We then write a Constitution to give limits to the powers of government. People who choose to work for the government swear an oath to uphold the Constitution. It is from this Constitution that they derive any authority. If a lawyer, working for the government, states to me that the Constitution doesn't apply, I know that she has no more authority to do anything; her actions are null and void. She needs the Constitution to act in her capacity. My rights stem from God.(Ex. 28.)
43. On October 3, 2007, petitioner issued a Statement of Allegations against Dr. Kellogg. At the same time it also issued an Order to Undergo a Psychiatric Evaluation with a psychiatrist to be named by petitioner within the next forty-five days. The order provided that the results of the examination were to be provided to petitioner board members, and noted that the results "may be used as direct evidence in any proceeding conducted pursuant to G.L. c. 112, § 5." Petitioner explained in this order "that there are grounds to conclude that Dr. Kellogg may be unable to practice medicine with reasonable skill and safety because his ability to practice might be impaired due to mental disorder, and that the public health, safety and welfare necessitates this Order." Petitioner also issued, pursuant to 243 CMR 1.03(11)(a), an Order of Temporary Suspension of Dr. Kellogg's license to practice medicine, requiring that he cease his practice of medicine immediately as a matter of "the health, safety, and welfare of the public." This Order was in response to the petitioner complaint counsel's Motion for Summary Suspension that included documentary and affidavit support for issuing it and reflected the outcome of the investigation performed. The Order of Temporary Suspension required that Dr. Kellogg "immediately … surrender his wallet card and wall certificate to the Board forthwith." Although a hearing was scheduled for October 11, 2007 at DALA for Dr. Kellogg to contest this order, this matter did not go forward to hearing, and it has remained in place. (Ex. A.)
44. Included among the numbered paragraphs of allegations in the Statement of Allegations are claims that: Dr. Kellogg has practiced medicine while holding no malpractice insurance; has failed to provide petitioner any indication, including on his license renewal forms, that he lacked such insurance; has failed to report to petitioner, including on his license renewal forms, that his emergency medicine specialty certification expired in 1995; and that he has been investigated twice by the DEA, including not noting these investigations on his license renewal forms. In addition, the Statement of Allegations contains claims that Dr. Kellogg has violated statutes and regulations regarding his administering of drugs to his patients, and that he has failed to provide medical records on his home clinic patients to petitioner. None of the allegations involves his dispensing of medications to the patients he saw in his hospital practice. (Ex. A.)
45. The Statement of Allegations contains detailed references to the specific statutory and regulatory provisions the petitioner found were violated by
Dr. Kellogg's conduct. (Ex. A.)
46. Dr. Rohn S. Friedman is the psychiatrist appointed by petitioner pursuant to its order of October 3, 2007 to evaluate Dr. Kellogg. Dr. Friedman interviewed Dr. Kellogg in person on March 26 and April 24, 2008. Dr. Friedman also conducted telephone interviews with: petitioner's complaint counsel on February 1 and April 16, 2008; Dr. Kellogg's counsel at the time, W. Scott Liebert, Esq., on March 20 and April 24, 2008; Wayne Gavrick, M.D., PHS, on April 16, 2008; Carl Sorenson, M.D., Chief of Surgery at Heywood Hospital, on April 18, 2008; John Skrzypczak, M.D., owner of Bay State Emergency Medical, Inc., on April 28, 2008; and, Suzanne Kellogg, Dr. Kellogg's wife, on May 2, 2008. (Ex. 24. Testimony.)
47. Dr. Friedman explained to Dr. Kellogg that he was providing "a forensic psychiatric examination" which was not being done for treatment purposes, and that the results of the evaluation would not be kept confidential. He explained to Dr. Kellogg that petitioner wanted him "to evaluate psychiatric diagnosis, status, treatment, and prognosis, and to address the referral questions" he had received from petitioner board. He felt Dr. Kellogg understood this framework before the evaluation commenced. (Ex. 24.)
48. On February 13, 2008, Dr. Kellogg signed a consent form called Authorization and Waiver that was witnessed by his wife. By its terms, he acknowledged that petitioner could disclose to and discuss with Dr. Friedman information it had concerning Dr. Kellogg and his fitness to practice medicine, including information uncovered through petitioner's investigation. He also acknowledged that the results of the evaluation and any diagnoses would be provided to petitioner along with Dr. Friedman's discussion of his results. The form provided specific statutory and regulatory citations of rights and privileges Dr. Kellogg was waiving in terms of disclosures, and that he recognized that this information could be used "as evidence in any adjudicatory or Board proceeding." The form contained the statement:
The purpose of this consent is to allow the Board to carry out its function to protect the public health, safety, and welfare as determined in the Board's discretion, to the extent permitted by law.(Ex. 23.)
Findings of Fact #s 49 - 62 are impounded.
63. Dr. Friedman offered some recommendations for treatment for Dr. Kellogg, including,
individual therapy to address the personality issues … participate in a PHS physician group to provide feedback from his peers which may help him to understand other perspectives on some areas of his strongly held beliefs … neuropsychological testing to see whether there is evidence of neuropsychological contributions … If … found, then the testing will point to appropriate treatment and compensatory strategies.(Ex. 24.) Dr. Friedman also made recommendations for monitoring Dr.
Dr. Kellogg should enter into a behavioral contract with PHS … not see patients at his home or outside of formal clinic, hospital, or office sites … should not store or dispense any medications.
(Ex. 24.) Dr. Friedman's prognosis for Dr. Kellogg is "excellent" in terms of delivering patient care, but is a more difficult one in terms of "his willingness to conform his behavior to rules with which he may disagree." (Ex. 24.)
64. Dr. Friedman "found no evidence of intent [on the part of Dr. Kellogg] to harm patients or of actual patient harm; to the contrary, others described Dr. Kellogg as an excellent and well-respected clinician." (Ex. 25.)
65. Dr. Kellogg has a reputation in his community of being a good neighbor and member of the community, as well as a good family man. (Ex. 30.)
66. Dr. Kellogg has a good reputation as a physician in the medical community where he has been employed, Athol and Heywood Hospitals. (Ex. 30)
67. Dr. Kellogg has not pursued any of Dr. Friedman's recommendations in regard to treatments, therapies, or medical tests. Dr. Kellogg does not find Dr. Friedman presented clear goals for him involving the recommendations. He sees no need to pursue the recommendations such as the medical tests suggested. (Testimony.)
The Statement of Allegations contains eight legal bases to support wrongful conduct by respondent.
Basis A. refers to G.L. c. 112, § 5(c) and 243 CMR 1.03(5)(a)(3), that respondent's conduct calls into question his competency to practice medicine. Covered by these provisions are gross misconduct, fraudulently practicing, practicing beyond the physician's abilities, practicing with gross incompetence, and practicing with gross negligence on a particular and on repeat occasions.
There is no way to tell whether or not respondent caused injury to any of his home patients' health because he either does not have or will not turn over his home patients' medical records for petitioner to review his treatment of them. This failure to permit petitioner to properly monitor his practice of medicine with his home patients does not mean respondent can avoid being found in violation under Basis A. Certainly, a failure to follow petitioner's rules with respect to maintaining sufficient medical records on each home clinic patient is gross negligence and gross misconduct. See Board of Registration in Medicine v. Jabib Asmar, M.D., RM-96-124 (Final Decision and Order, August 28, 1996). A failure to follow petitioner's rules regarding the prescribing of controlled substances is gross negligence and gross misconduct. See Board of Registration in Medicine v. Michael A. Greenwald, M.D., RM-95-619 (Final Decision and Order, July 31, 1996). Practicing without malpractice insurance while holding oneself out as having that insurance is fraudulently practicing medicine as well as gross negligence and gross misconduct. See Board of Registration in Medicine v. Vladimir Shurlan, M.D., RM-01-780 (Final Decision and Order, January 22, 2002).
Basis B refers to G.L. c. 112, § 5(b) and 243 CMR 1.03(5)(a)(2), that respondent committed an offense against the provisions of the laws of Massachusetts or any rules or regulations promulgated under such laws regarding the proper practice of medicine. Petitioner cites G.L. c. 94C at various sections:
• Section 19(a) - dispensing medications without a legitimate medical purpose and outside the usual course of respondent's professional practice;
• Section 17(c) - dispensing schedule III controlled substances without a written or oral prescription;
• Section 9(a) - possessing more controlled substances than required for purposes of treating patients;
• Section 9(b) - dispensing controlled substances in amounts or quantities exceeding what is needed for immediate treatment;
• Section 9(d) - not keeping and maintaining records with names and quantities of schedule III controlled substances received by respondent with names and addresses of patients who he gave them to and including the date, name, dosage and strength per dosage unit of the controlled substance dispensed;
• Section 15 - not complying with federal record-keeping and inventory requirements of the comprehensive drug prevention and control act of 1970.
There is no way to know if respondent dispensed medications to any of his home clinic patients with no legitimate medical purpose and outside the usual course of his professional practice in violation of Section 19(a) because he would not reveal these patients' medical records, if he had any, to petitioner.
In terms of prescribing practices with his home patients, respondent may very well have prescribed controlled substances without a written prescription, and there is no way to know the extent of what he may have told the patient in terms of providing an oral prescription. His uncorroborated testimony is insufficient proof of having conducted himself properly in regard to his dispensing of controlled substances to his home clinic patients. If medical records would have shown what he did with any particular home patient who received the generic Vicodin, respondent never revealed them. He cannot escape being held in
violation of Section 17(c).
The same reasoning applies in regard to possessing and dispensing a greater amount of a controlled substance, i.e., generic Vicodin, than what the patient required or for addressing the patient's immediate treatment needs. Respondent presented no corroborative evidence concerning the examples he gave in his testimony of home patients given a large amount of generic Vicodin. All that he could establish is that he did not believe these patients were going to secure any more Vicodin or other medication from any other physicians because he decided they were the working poor. In this regard he did not require these patients receiving large amounts of the generic Vicodin at one visit to have to return to him after a few days to be re-evaluated to receive more of it. I conclude
this conduct shows a violation of Sections 9(a) and 9(b).
There is no evidence that respondent maintained sufficiently full records connecting the date of dispensing, the dosage and strength of the controlled substance, i.e., generic Vicodin, to a named patient with a particular address. His dispensing records along with his testimony about the Rosetta Stone he has that he claims permits him to de-code the dispensing records' numbers into patient names, is no substitute for keeping and maintaining proper records under the statutory provision regarding controlled substances. I conclude that he violated Section 9(d).
The findings show respondent failed to comply with federal record-
keeping and inventory requirements of the Comprehensive Drug Prevention and
Control Act of 1970. The findings show that, following the late 1990's investigation and inventory done by the DEA, the DEA found him in violation of this law but did permit him to submit a plan to show how he would come into compliance. There is insufficient proof in the record to show whether he did adequately address these violations. Even if he did, however, that does not eliminate the violations the DEA found. I conclude that he violated Section 15. (See Ex. 3.)
Basis C. refers to G.L. c. 112, § 5(h) and 243 CMR 1.03(5)(a)(11), that respondent violated a rule or regulation of petitioner:
• 243 CMR 2.07(5) - that a licensee violating G.L. c. 94C also violates petitioner's rules and regulations;
• 243 CMR 2.07(12) - that respondent has to make available to petitioner, any relevant records petitioner is authorized to review when petitioner is investigating the licensee's professional conduct; and
• 243 CMR 2.07(16) - that respondent has to obtain professional
malpractice insurance as a condition for rendering any direct or indirect patient care in Massachusetts.
The findings of fact show respondent violated all three of these regulations.
Basis D. refers to 243 CMR 1.03(5)(a)(10), that respondent has engaged in conduct that has the capacity to deceive or defraud. Basis E refers to 243 CMR 1.03(5)(a)(18), that respondent committed misconduct in the practice of medicine. These violations have been demonstrated by respondent's conduct in not maintaining proper records on his home patients. They are shown by respondent providing large amounts of controlled substances to some home patients without proper prescriptions and without monitoring those patients' use of large amounts of the controlled substance. These violations are shown by respondent's failure to have malpractice insurance for many years while holding himself out as having that insurance and by being responsible for altering expired insurance declarations to look like he was still carrying the insurance. These violations are shown by respondent's failure to correct the misleading information in his license renewal forms showing he continued to be certified in emergency medicine when he wasn't while being employed at two hospital emergency departments and operating a kind of walk-in clinic at his home. They are shown by his failure to reveal on his license renewal forms that he had been investigated by the DEA.
Basis F refers to the two Supreme Judicial Court cases of Levy v. Board of Registration in Medicine, 378 Mass. 519 (1979), and Raymond v. Board of Registration in Medicine, 387 Mass. 708 (1982), that respondent lacks good moral character and has engaged in conduct undermining public confidence in the integrity of the medical profession. These two grounds have been shown by the findings made, including by the conduct of respondent during the course of petitioner's investigation. He may have a reputation in his community as a good neighbor and in his hospital employment settings as a good emergency room physician, but his conduct with his home patients and his conduct with petitioner show an intentional disregard for the need to adhere to the rules petitioner has imposed in exchange for receiving a license to practice medicine in Massachusetts. Respondent also engaged in this conduct without informing petitioner he was ignoring certain of its rules, and filing untruthful, deceptive and incomplete license renewal forms to allow him to continue to conduct his home clinic the way he wanted to.
Basis G. - 243 CMR 1.03(5)(a)(16), that respondent failed to respond to
petitioner's subpoena to provide documents and information petitioner is legally
authorized to receive. The findings show respondent clearly violated this
regulation and was well aware that he did. He even failed to respond to the subpoena during the discovery phase of this adjudicatory proceeding.
Basis H. - G.L. c. 112, § 5, paragraph 10(a) and 243 CMR 1.03(5)(a)(1), that respondent fraudulently procured the renewal of his licenses to practice. This is shown clearly by respondent's intentional conduct in altering expired malpractice insurance declarations so that not only petitioner, but the general public, and the hospitals where he worked would all understand that he held a
malpractice insurance policy.