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MR. BERENS: Good morning. My name is Donald Berens. I am the General Counsel of the Health Department.

MR. GRAZIANO: Iím Dennis Graziano. I am the Director of the Office of Professional Medical Conduct.

MR. MURPHY: I am Brian Murphy. I am Chief Counsel for the Bureau of Professional Medical Conduct.

MS. CUNNINGHAM: My name is Pat Cunningham and I am with the Office of Professional Medical Conduct.

ASSEMBLYMAN GOTTFRIED: I am sorry can you tell me your name again Pat.

MS. CUNNINGHAM: Pat Cunningham.

ASSEMBLYMAN GOTTFRIED: And your title at OPMC?

MS. CUNNINGHAM: I am the assistant to the director.

ASSEMBLYMAN GOTTFRIED: Okay go ahead. Are you all set? Mr. Murphy were you part of the oath taking?

MR. MURPHY: I will be if you want me to be.

ASSEMBLYMAN GOTTFRIED: Yes please.

MR. MURPHY: I didnít think I was going to testify.

ASSEMBLYMAN GOTTFRIED: You may, well you may be useful to answer questions at some point.

MR. GRAZIANO: I thank you for the opportunity to discuss the departmentís role in the disciplinary process of physicians and physician assistants. In your packages that we provided you should have copies of the 2000 annual report of the Board of Professional Medical Conduct, descriptive statistical information on program performance, written testimony from the Chair of the Board for Professional Medical Conduct, Dr. William P. Dillon and the departmentís oral and written testimony.

I would like to take a few moments to outline some of the important evolutionary changes that have occurred in the medical conduct system in New York State over the past ten years which have resulted in our national recognition as the premier leader of state medical boards.

As you know prior to 1991, the Health Department and the Board for Professional Medical Conduct were responsible for investigating complaints, conducting hearings and recommending disciplinary sanctions to the State Education Department. However, the Education Department and the Board of Regents were responsible for determining final sanctions in all physician discipline cases.

In 1991, the physician disciplinary process was modified by the state legislature when the Board for Professional Conduct was granted sole responsibility for determining final administrative sanctions in all physician discipline cases. The intent was to establish an independent peer review process for physicians. Only the Administrative Review Board also peers or the New York State courts and not the Commissioner of Health can overturn a decision of a board hearing committee.

Pursuant to legislative mandate, the Physician Discipline Process Evaluation Panel issued its final report in 1996 reviewing the structural and procedural aspects of the physician discipline process and assessing how well the goals and objectives of the new process were met.

It concluded the current physician discipline process results in fair and equitable decisions, which have been almost uniformly upheld by the courts. It stated that the physician discipline process in New York is one of the most professional and conscientious in the United States. The Department of Health through the Office of Professional Medical Conduct has made great improvements in its processing of disciplinary cases.

Despite these improvements the panel found that it took too long to adjudicate disciplinary cases. In 1996 Governor George Pataki and the legislature responded to the panelís report by enacting additional legislative reforms. Key to these statutory reforms was the decision to increase physician license registration fees which funded the OPMCís hiring of additional investigators and attorneys.

Since then a number of strategies have been employed by the board and its staff in the Office of Professional Medical Conduct to reduce the amount of time it takes to resolve cases.

I am pleased to report that over the past six years the percentage of complaints resolved within the same calendar year in which they were received has increased from 59% in 1996 to 75% in 2001.

It should be noted that 100% resolution of cases within the same calendar year cannot be achieved since OPMC receives complaints on an ongoing basis. This increase was accomplished despite a 34% rise in the overall number of complaints received by the department during the same period. Complaints rose from 5,151 in 1996 to 6,983 last year and the OPMC completed a record 6,854 investigations in 2001.

Equally impressive results have been achieved relative to the length of time required for actual case prosecution. Prior to 1996 the length of time required for actual case prosecution averaged fourteen months. Today, that average has been reduced to five months.

New York is recognized as a leader in the investigation and discipline of physicians and physician assistants. The Federation of State Medical Boards in their Summary of 2000 Board Actions places New York at the top in the most significant performance categories among large states.

After appropriate OPMC staff investigation, in 2001 nearly 6,300 cases were closed without presentation to a board panel. Also in 2001 about 650 cases were presented to investigation committees. Nearly 400 were determined appropriate for hearing and over 350 resulted in settlements or sustained charges for which discipline was imposed.

In its analysis of the data, the Public Citizens Health Research Group ranked New York tenth in the nation in taking serious disciplinary actions against physicians who commit misconduct. Ten years ago, Public Citizen ranked New York 49th in the nation for serious disciplinary actions.

A fair and efficient physician disciplinary process is not only in the interest of all consumers but is a fundamental importance to the medical profession itself. The objective has been to make sure that the physician disciplinary structure is qualitatively sound and that it is correctly perceived as fair and effective by both physicians and the public. That is why the board strives to maintain a fair process that is comprehensible to all who have a legitimate interest in its operation.

The medical community in New York has been assured that the disciplinary process is fair to the physicians who are subject of allegations of misconduct while at the same time assuring the public that physicians found guilty of misconduct are either removed from medical practice or appropriate safeguards have been put in place to protect the public from potential harm.

New York has invested substantial resources to ensure that the process involves strong elements of peer review at each stage of every investigation and prosecution and that physicians are provided with strong procedural do rights process. These peer elements include medical expert consultants, the physician members of the board and medical coordinators. At each stage of the process trained medical professionals are used to ensure that medical and professional issues are identified, properly investigated and judged appropriately.

MR. BERENS: The Office of Professional Medical Conduct provides staff to carry out the objectives of the board. Its mission is to protect the public from medical negligence, incompetence and illegal or unethical practices by physicians and physician assistants.

OPMCís primary goal is the fair, objective and professional investigation of complaints that result in the prompt resolution of groundless cases and the prosecution of meritorious cases.

The confidentiality of complaints is specified in statute to encourage reports from medical professionals and other sources. In many areas the legislature has determined that persons with necessary information, if they know they will be identified will be reluctant to come forward. This is particularly true in such proscribed conduct as patient abuse, child abuse and professional misconduct. Licensed professionals are currently required by law to report behavior, which might constitute this proscribed conduct.

ASSEMBLYMAN SULLIVAN: Excuse me for a second. If you are going to jump pages thatís fine, itís salutary. Could you let us know where you are jumping to because I am not following this in the testimony you have given us.

MR. BERENS: We have given you two versions of the testimony. One is longer and the complete written remarks. Another is oral and what we are presenting right now.

ASSEMBLYMAN SULLIVAN: Is this the oral one?

MR. BERENS: Yes.

ASSEMBLYMAN SULLIVAN: Thank you.

MR. BERENS: I am on page fifteen of the oral.

ASSEMBLYMAN SULLIVAN: Okay good.

MR. BERENS: I am sorry. I am told the pagination that you have may be different from mine.

ASSEMBLYMAN SULLIVAN: Okay.

MR. BERENS: Iím sorry.

ASSEMBLYMAN SULLIVAN: Perfectly okay. Thank you. Proceed. Iím sorry.

MR. BERENS: Licensed professionals are currently required by law to report behavior, which might constitute this proscribed conduct. Pursuant to statute OPMC does not disclose to a respondent the complaint of a person who does not testify. However, the issues in question are identified to the licensee. The courts have upheld this practice as sufficient due process.

Questions have been asked about the role of complainants, patients or other sources in disciplinary procedures. Should the report of a non-testifying source be disclosed to a licensee? Should a non-complaining patient be notified that his or her records are being reviewed by OPMC or that his or her case is the subject of charges? Answers to these questions turn on the nature of BPMC disciplinary procedures.

The purpose of the boardís disciplinary procedures is to identify and respond to licensee misconduct including negligence or incompetence so that licensee behavior which is potential, fraudulent or dangerous to patients is corrected, deterred or by revocation made impossible.

Civil tort and criminal procedures are available to provide compensation to patients who are actually harmed or to sanction wrongdoers.

Professional discipline serves its public purposes whether or not there has been actual harm. In fact many of our cases involve matters in which patient harm has not occurred yet there is a significant deviation from the standard of care. To wait for actual harm to occur would be a failure of both the letter and the spirit of our statutes.

In order to achieve its purposes, physician discipline need not and should not turn on whether a person who is often not medically trained believes that he or she has observed misconduct or been harmed. Instead, the state has committed to the board and the department responsibility to investigate, evaluate and where appropriate prosecute cases of suspected misconduct. An individual complainantís or patientís role in physician discipline is appropriately subordinate to that of the stateís obligation to the patient public.

Accordingly, it is unnecessary and inappropriate to disclose to a licensee the complaint or other report of a person the department has determined will not be a witness against the licensee. It is the credibility of witnesses not non-witnesses which is at issue. Indeed mandatory disclosure may discourage informantís from bringing suspected misconduct to OPMCís attention.

As in hospital oversight and other statutorily mandated programs to protect public health and safety, the department has authority to access medical records immediately without patient notice or approval. Patient names and records are never made public by the department.

A respondent physician may contact a patient and ask that patient to be a witness if that physician feels that there are pertinent facts to be elicited. The issue is whether the physician acted appropriately in the discharge of his or her medical duties and if failing to do so the state then has the obligation of proceeding with a process that will protect the public.

Generally cases addressed by the State Board for Professional Medical Conduct are factual disputes. They are primarily about whether specific behavior meets the standard of care. In most of these cases experts are not far apart on the standard of care but are disputing whether or not the facts in the specific case meet the minimal standard of care.

Many aspects of medical care are subject to examination in a medical negligence or incompetence case. Diagnosis, selection of treatment and subsequent monitoring are each potential issues but they may not all converge in a single case. For example there may be a reasonable difference of medical opinion about how to treat a particular condition once it is properly diagnosed. Particularly where new therapies are emerging. In such a case it might not be misconduct to select a treatment within the range of reasonable treatments.

However, in the same case even where an affirmative diagnosis is a combination of art and science there may be general professional agreement on the steps needed to rule out other possible causes of the signs and symptoms presented. Those steps would include taking an adequate history, performing a proper physical examination, ordering, interpreting and acting upon appropriate laboratory and other tests, keeping good records and obtaining necessary consultations. In such a case it might be misconduct to make a diagnosis consistent with those signs and symptoms and to select a form of treatment appropriate to the diagnosis without first ruling out other causes and ruling out the need for different treatments.

Finally, even where a differential diagnosis is properly made and an appropriate treatment selected it is still necessary for a physician to implement the treatment in accordance with medical standards including informed consent, infection control and monitoring of patient reactions to the selected treatment.

Infrequently there have been cases in which an element of the case involved a dispute in the medical community as to the scientific basis for the medical care and treatment rendered by the physician.

In some cases there is a dispute about whether there is a reasonable dispute in the profession about the standard of care. In such cases and in all cases involving patient care issues, the process provides for the physician under investigation to present expert medical opinion and testimony for consideration by the office and the board. Likewise, the office also obtains outside medical opinions from experts in the field.

In all cases this expert selection by the office is based upon a review of the expert physicians medical credentials in the disease or condition under consideration. The expert is almost always board certified in the specialty of interest and has been in practice for at least five years.

There are no classes of physicians or physicians assistants targeted for investigation or prosecution or exempted from OPMC review. The law provides that OPMC may investigate on its own any suspected professional misconduct and shall investigate each complaint received regardless of the source. All cases are subject to careful review from beginning to end. Persons experienced in law enforcement policies and procedures review case reports for factual accuracy.

It is interesting to note that over the past six years the Administrative Review Board has either sustained or increased the penalty determinations of hearing committees in over 90% of their decisions.

The issues of the Administrative Review Boardís authority have been reviewed many times by the courts of New York State. New Yorkís courts are nationally renowned as being solicitous and protective of the rights of the accused. The courts have reviewed whether the Administrative Review Boardís decisions were supported by substantial evidence. Whether the decisions were made in violation of lawful procedure. Affected by error of law. Were arbitrary or capricious. Or, were an abuse of discretion. Consistently the New York State courts have supported the substantive determinations of the board, which they have reviewed on the merits, upholding the probity and propriety of these determinations.

Due process is essentially the right to be heard in a timely and fair manner. These rights are fully expressed in this process. It allows for the state and the respondent to have their day in court and receive a full and fair airing of the issues of concern, before triers of fact that include representation by medical peers and the lay community. In no other state is this expression of a constitutional mandate more fully and completely carried out than it is in New York State. It is so structured so as not to protect or attack any particular physician or distinct class of physicians. It is so structured that each case is individually treated. It is structured so as to provide the patient public with their protection as mandated by the law. It is so structured that uniquely each side, the state and the respondent have the right of appeal.

The Department of Health and the Board for Professional Medical Conduct continually strive to improve and preserve the standards of quality medical practice we in New York have come to expect. We are proud of our accomplishments and are dedicated to exploring opportunities for improvements in the physician disciplinary process.

Thank you very much.

ASSEMBLYMAN GOTTFRIED: Thank you. I have a series of questions. Before I do though could you just tell me whether you would incorporate by reference the long version of your testimony into the oral version for inclusion in the record?

MR. BERENS: We would be happy to do so.

ASSEMBLYMAN GOTTFRIED: Okay. Thank you. A question that was not in the hearing notice in part because it did not arise until a few days ago. You made reference in your testimony to the license fee increase revenue being allocated by the legislature for the workings of OPMC. First of all can either of you tell me to what extent OPMCís budget is derived from physician license fee revenue versus the state general fund.

MR. GRAZIANO: 100% of the offices budget is derived from the physician fee.

ASSEMBLYMAN GOTTFRIED: The Governorís budget proposes to take $3 million from the physician fee account that the state maintains and to essentially just use that money for general budgetary purposes and to take it away from OPMC. I guess my first question would be how does it happen that OPMC can afford to give away $3 million in one yearís budget? How big a piece of your budget would $3 million represent?

MR. GRAZIANO: The short history if you would on the appropriations and expenditures on the OPMC budget has been that historically, historically meaning prior to I would say the last year and a half to two years, the OPMC was well below their approved fill levels which generated surpluses in the account.

ASSEMBLYMAN SULLIVAN: Excuse me I donít know what a fill level is.

MR. GRAZIANO: A fill level is our authorized level for staff. The number of staff that weíre allowed to hire. Essentially what the budget, what the appropriation will support, the dollar amount will support in terms of our full time equivalence.

ASSEMBLYMAN GOTTFRIED: What years was that the case?

MR. GRAZIANO: I am going to say and we can certainly provide particulars for you that up until a couple of years ago we were well below our funded fill levels and that generated surpluses.

The last two years you asked a question in terms of what our appropriation level are. I believe they are in the vicinity of $23, $24 million. We in OPMC are at our authorized fill levels and are essentially accruing expenses at the appropriated levels. In terms of the transfer we too are not prepared today to assess if you would what the details are behind that. We too have not had an opportunity to look at the particulars. I would suggest perhaps that we could have our fiscal folks follow up with the specifics.

ASSEMBLYMAN GOTTFRIED: When you say youíre now at your fill level as opposed to a couple of years ago is that because the number of authorized positions has been reduced or is that because youíve hired more people?

MR. GRAZIANO: Weíve hired more people.

ASSEMBLYMAN GOTTFRIED: Okay. But as to what the impact of this transfer of $3 million might have on your operations in the coming fiscal year, you are not in a position yet to comment?

MR. GRAZIANO: I would comment generally that it will not have any negative impact in the immediate upcoming state fiscal year.

ASSEMBLYMAN GOTTFRIED: Okay.

ASSEMBLYMAN SULLIVAN: Could I just clarify that?

MR. GRAZIANO: Sure.

ASSEMBLYMAN SULLIVAN: Youíre now, Iím not going to use the lingo because Iím not familiar with it. You now are using your appropriate like last year you used all of your appropriation to hire staff. Is that correct?

MR. GRAZIANO: Thatís correct.

ASSEMBLYMAN SULLIVAN: Okay. And now the number that you, the amount of money that you had last year will be reduced by $3 million. Is that correct?

MR. GRAZIANO: That is not correct. Essentially as I indicated earlier and it may not have been clear. In prior years we were well below our authorized levels for staff. In that generated surplus if you would Ė-

ASSEMBLYMAN SULLIVAN: I understand.

MR. GRAZIANO: In the special revenue account. The appropriation and the cash account if you would are two separate accounts. And our appropriation level draws from both the surplus account if you would and current registration fees that are coming into the state.

ASSEMBLYMAN SULLIVAN: So the $3 million that the Governor seeks to take from your office is from the surplus that was generated in previous years. Is that your testimony?

MR. GRAZIANO: That would be my understanding. Correct.

ASSEMBLYMAN SULLIVAN: Thank you.

ASSEMBLYMAN GOTTFRIED: Your testimony does not offer any suggestions or recommendations for change in the system or the statute. Do I take it that your conclusion is that no changes are called for?

MR. BERENS: As I indicated near the close of my remarks, we are open to the possibility of improvements. We have none to suggest. We think no major improvements are necessary but we would be happy to discuss with you any refinements that might be necessary.

ASSEMBLYMAN GOTTFRIED: Mr. Berens towards the end of your testimony you said the words to the affect that consistently the state courts have supported determinations of the board. By consistently I assume that you donít mean in every case.

MR. BERENS: I do not. I was unable to put together an exact percentage of cases in which the discipline has been affirmed. So, I did not give you any percentage cases. I know that it is not 100%. It is well over, well over 50%. Itís much closer to 100% than to 50%.

ASSEMBLYMAN SULLIVAN: Itís over 75%?

MR. BERENS: Yes.

ASSEMBLYMAN SULLIVAN: Not to get too esoteric.

MR. BERENS: Youíre right.

ASSEMBLYMAN GOTTFRIED: On the question of complainants. Does the office keep any record of what I will call the category of the complainant which is to say does it note down whether the complainant is an insurance company or a colleague of the licensee or a patient or a follow up treating practitioner, etc.?

MR. BERENS: I would like to split the response. First although the statute speaks of complainants or complaints we get much of our information from persons who in any ordinary sense of the word are not complaining but are simply reporting information. For purposes of todayís discussion I am happy to use the term source or the term complainant as long as it is understood that not every such person has an ax to grind. They may be simply reporting information or asking OPMC to look into something as to which they have drawn no conclusions.

ASSEMBLYMAN GOTTFRIED: Right.

MR. BERENS: With that having been said Iíll let Mr. Graziano tell you how that information is categorized.

ASSEMBLYMAN GOTTFRIED: Okay.

MR. GRAZIANO: We provided some descriptive information in your packages as well that I would point you to in partial response to the question.

In terms of indexing if you would a particular case we use broader categories such as whether it was a public complaint from the public, a complaint from a governmental agency or insurers. We do not categorize at the level of referring physician, patient, relative of the patient, etc. on a routine basis. That information would have to be manually extracted from our investigative files.

ASSEMBLYMAN GOTTFRIED: But if you looked in the investigative file would you be able to tell whether the report, what kind of person the report had come from?

MR. GRAZIANO: If in the initial complaint they identified themselves as a patient or a relative of the patient certainly. The complainants in most instances generally are interviewed. There are follow up interviews that are performed. In some instances that information is gathered as a result of that additional contact with the complainant.

ASSEMBLYMAN GOTTFRIED: Is such an inquiry as to the personís identity, is it a routine part of the follow up inquiry?

MR. GRAZIANO: I would say in most cases we certainly know what the relationship is yes.

ASSEMBLYMAN GOTTFRIED: Okay. I havenít looked at the chart thatís in the folder. It was just handed to me. Can you tell me either from that chart or from your experience how that tends to break down roughly to proportionately to what extent are the complaints or reports from insurance companies. To what extent from fellow practitioners and to what extent from patients.

MR. GRAZIANO: We certainly have that and it is included in one of the bar charts. 55% of the complaints are from the public. These by the way percentages (inaudible) relatively constant. They are based on the complaints that we received in the year 2001 but we do see a consistency across years. The number of physician, percentage of physician complaints in 2001 was 2%, insurers were 11%, out of state was 10%. If you need it all I can give you the rest of it.

ASSEMBLYWOMAN MAYERSOHN: Insurance company percentage Ė-

MR. GRAZIANO: Insurers are 11%.

ASSEMBLYMAN GOTTFRIED: And you said 2% from other physicians?

MR. GRAZIANO: Correct. There is also another chart that gives you a little further refinement if you would of the complaint information. And that second chart actually displays the percentage of complaints that were referred to an investigation committee and the sources of those complaints. For example overall physicians report at 2% of the complaints however, in the cases that were submitted to an investigation committee for their review that constituted 3% of the total complaints that an investigation committee heard.

ASSEMBLYMAN GOTTFRIED: In considering a complaint does the nature of the source of the report play any role in your evaluation of that report or its credibility or your thinking as to how to follow up on a report?

MR. BERENS: At the first level it plays no role whatsoever. If we get a complaint we are statutory bound to investigate it. At the next level the office seeks corroboration for every significant element of a case that might result in charges. It is a rare case I believe when the evidence provided by the original source or complainant is the sole evidence that the department has concerning that point.

But in those narrow areas where the point at issue can be proven only by evidence from the complainant at that point the credibility of the complainant is essential and the office, I believe Mr. Graziano will confirm this, the office does assess the credibility of each complainant on whom the department intends to rely.

ASSEMBLYMAN GOTTFRIED: What if anything would be the argument against disclosing to the licensee the category of the reporting party? In other words not necessarily disclosing the identity of the reporting party but letting the licensee know whether the report had come from an insurance company or another health care provider or a patient?

MR. BERENS: In some cases the nature of the complaint or issues are so unique to the physicians practice that is itís a small enough universe of people who have characteristics A, B, C and D so that when that case comes to the attention of the licensee because OPMC reveals it to the licensee naming the category of the original source might be enough to make a good guess or to actually deduce with certainty what or who exactly the complainant was. I am not saying that is true in all cases but there would be some cases in which that is true.

ASSEMBLYMAN GOTTFRIED: If there is, if the issue that is being reviewed is so narrow and I donít know how often that happens, wouldnít the licensee be able to make a pretty good guess in any event and actually might I suppose if there are only two or three possibilities the licensee might come to a conclusion as to which of them it was and might come to the wrong conclusion. But, in those what I assume are a relative minority of cases where it is so focused down how much harm could there be in disclosing the category at that point or how much differential or marginal harm could there be to simply saying what the category was?

MR. BERENS: I canít quantify the amount of that marginal harm but I am confident that in some cases there would be the ability to identify the particular complainant which would not otherwise exist in the absence of identifying the category of complainant. And, to some extent, if that is true, then to some extent those sources of information who might otherwise come forward to OPMC some of them would be dissuaded from doing so because they just would not want to be identified by the physician. Again I cannot quantify that but I am sure that to some extent that exists.

ASSEMBLYMAN GOTTFRIED: Are there states where that kind of disclosure is provided for do you know?

MR. GRAZIANO: Yes. The answer is yes. I donít have the specifics but we do know there are other states where that disclosure is provided for.

ASSEMBLYMAN GOTTFRIED: Okay. Do you know offhand whether in those states there have been negative consequences from providing that disclosure?

MR. BERENS: In one sense it would be impossible to know because how do you measure the complainants who do not come forward because they fear that they will be identified either directly or indirectly.

ASSEMBLYMAN GOTTFRIED: Okay. In terms of identifying the reporting party specifically, if the reporting party is not a patient or a colleague who works with the practitioner what would be the harm in not only disclosing the category of the complainant but of disclosing the identity of the complainant? Fro example if itís an insurance company. If itís another practitioner to whom the patient has gone on to. What would be the obstacle there? What would be the problem there with changing the law to allow disclosure in that case?

MR. BERENS: There is a wide range of human motivations that lead people to bring information to governments. Some of them hope to gain something personally from it and some do it out of a sense of civic obligation. Some do it because they are statutorily mandated to do it and take that mandate seriously. Depending on the motivation of a potential reporter, disclosure might or might not have an effect on their willingness to come forward.

And, identifying even a subsequent treating physician or an insurance company could in some circumstances dissuade people who are on the margin and not sure whether or not they want to bother to report could discourage them from doing so. The assessment of the significance of that effect I cannot quantify. But, I believe that it is a real effect in many cases.

ASSEMBLYMAN GOTTFRIED: My last question on the area of complainants is in March of 2000 as I wrote to you last week, in March of 2000 I had a meeting with Dennis Whalen and Ann Sale, I donít think any of you were at that meeting on the question of the ten pending cases involving what we can loosely call Lyme doctors, not a particularly good characterization but it will do for the moment. In that meeting Dennis Whalen assured me that in those cases all of the reporting parties were either patients or follow up health care providers.

Based on your knowledge of those cases as those currently stand and I donít know if any of them have come in since March of 2000 or whether the universe of those cases is the ones that were there in March of 2000 but based on your knowledge and I guess I say you plural of those cases, is that statement an accurate description of the origin of those cases?

MR. BERENS: It is not now accurate. What I now know is that cases that we have identified as relating to Lyme disease diagnosis or treatment involve a number of physicians and we have cases that were originated based on a variety of sources. In every one of those cases at least one of the complaints came from a patient or a subsequently treating physician. But, not all of the complaints originated from those two kinds of sources.

I know for example that there were insurance companies. Out of 21 sources concerning eight different Lyme doctors two of them were insurers. One of them did not actually make a report to the state, made a report to, a malpractice insurer made a report to the National Practitioner Data Bank which OPMC looked at. Thatís one of the cases that came from an insurance company and that case was closed without going to an investigation committee and certainly without charges. There is one other insurance company case, health insurance company has made a report to the state. That case is pending. There have been no charges filed.

ASSEMBLYMAN GOTTFRIED: Okay. Now there are a lot of other topics that I am going to be asking you about. If you would like we can take other questions relating to Ė-

ASSEMBLYMAN SULLIVAN: I just have two questions really. One of them do you keep records as to the local of the conduct that is alleged, that is involved in the complaint?

MR. GRAZIANO: Yes.

ASSEMBLYMAN SULLIVAN: That is to say you know a hospital and a clinic and a private office or whatever.

MR. GRAZIANO: Iím sorry no. We do not index by that category. No. Geographic location is Ė-

ASSEMBLYMAN SULLIVAN: Iím sorry?

MR. GRAZIANO: We do index by geographic location but not site of issue.

ASSEMBLYMAN SULLIVAN: Okay. Wouldnít it be interesting to know, get some statistics on how many cases of complaints, how many incidents of complaints took place in clinics or hospitals, what clinics, what hospitals or how many occurred in private offices or other locations? Wouldnít that be of interest to you statistically I mean?

MR. GRAZIANO: I certainly would agree. I will note that we are currently in the process of reviewing our case indexing procedures. We would expect within the next year to two years to have an automated updated system that will capture more and categorize and index on many more variables than we do today.

ASSEMBLYMAN SULLIVAN: If an extraordinary number of complaints that turned out to be valid took place in hospital x, I think it would be interesting to the State of New York. If an unusual number of cases that turned out to be invalid took place in hospital y I would think that would also be interesting to the Health Department. Something was going on in that hospital and they should know about it. It just seemed to me something Ė-

MR. BERENS: It is worth noting that the OPMC process for disciplining physicians is not the only way that the Health Department learns whatís going on in hospitals.

ASSEMBLYMAN SULLIVAN: I understand. But itís one of them?

MR. BERENS: Yes. And it may well be useful but we do have a hospital surveillance system that would pick up multiple cases in hospital x.

MR. GRAZIANO: Let me just qualify my statement because you did raise an interesting point. Night Ports is the hospital reporting, incident reporting system. We have modified, we at OPMC did modify our systems to integrate ourselves with the Night Ports reporting system earlier in 2001.

ASSEMBLYMAN SULLIVAN: Okay. Another thing you have a category here out of state on the chart that you gave us.

MR. GRAZIANO: Yes.

ASSEMBLYMAN SULLIVAN: What does that mean out of state and why should it be so, of the cases that were, hold on a second, bare with me for a moment here.

MR. GRAZIANO: Sure.

ASSEMBLYMAN SULLIVAN: Of the source of total complaints where the public is understandably 55% high and then you get complaints referred to the investigation committee. That is to say after the frivolous cases have been dispensed with now the public, understandable, comes down a little bit because those are non-professionals and the out of state sores at this point. It goes up to 24% and then of the cases referred to a hearing the out of state is now 35%, the largest category on your chart. What is out of state? What does that mean? And, why should it be such a large percentage of those cases referred to hearing?

MR. GRAZIANO: The out of state actions are what we commonly refer to as direct referral proceedings. They are actions that other states have taken against a licensee who is also licensed in New York State. Based on those actions in other states we are entitled under the law to take an action.

MR. BERENS: Those out of state actions might be administrative discipline or they also might be criminal convictions.

ASSEMBLYMAN SULLIVAN: So someone is licensed in two states and the other state other than New York, one of them, takes disciplinary action against the doctor and then informs you of it and thatís the category. Now as a citizen in New York State that over a third of the cases referred to hearing come from out of state actions, it just seems high to me and it would seem to hint at some inefficiency on the in state procedure of finding these doctors. These doctors apparently are doing something that is inappropriate and you know that a third of the cases referred to hearing come from out of state. It just seems extraordinarily high. Is there a reason?

MR. BERENS: If a physician is practicing in California and commits misconduct or a crime there, we donít have a process sin new York State to discover the conduct that lead to the discipline or to the conviction. So there is no likely case that we would get that information except from out of state. Itís a different situation when the physician practices in New York and also is licensed in California. There you can expect that we would have the primary responsibility and ability to discover any actual misconduct taking place within our borders.

ASSEMBLYMAN SULLIVAN: There is apparently a large number of doctors licensed to practice in New York State but actually licensed and practicing in other states.

MR. BERENS: Thatís correct. When you get a New York State license as a physician you are licensed for life. Whether or not you renew your registration and whether or not you leave to practice in another state.

ASSEMBLYMAN SULLIVAN: I see so even if you donít renew your license, that goes into the, your license at age I know 30 letís say and by age 40 you have moved to Florida and now you never even bother with New York State anymore you donít renew your license but what ever happens in Florida is part of these records?

MR. GRAZIANO: Thatís correct.

ASSEMBLYMAN SULLIVAN: Thank you.

ASSEMBLYMAN GOTTFRIED: It seems to me one reason why that proportion would sore when you go into the category of cases that go to investigation and cases that go to hearing is that these out of state cases are sort of prescreened for their validity. I mean as far as I understand it virtually every case you get from out of state is one where there has been an out of state criminal conviction or an out of state revocation and so the fact that those cases go all the way is not surprising.

MR. BERENS: Thatís exactly right. The chief issue, the reason why itís not 100% that go all way is sometimes there is a dispute about whether the offense in the foreign state has a comparable equivalent in New York. There can be arguments about that.

ASSEMBLYMAN SULLIVAN: One more. Then when you come to the disciplinary actions you drop that bar graph at that point. Do I guess correctly that the percentages involved in disciplinary actions would be roughly the same as complaints referred to hearing?

MR. GRAZIANO: Iím sorry Iím not following. Which particular chart are you looking at?

ASSEMBLYMAN SULLIVAN: Of the complaints referred to hearing 1/3 of them come from out of state, really out of state behavior that is referred to us because the doctor is licensed here. Is that correct?

MR. GRAZIANO: Thatís correct.

ASSEMBLYMAN SULLIVAN: Did I understand your testimony to say that? Okay. So now, I donít know because itís not here but if the disciplinary actions taken are reflective of the complaints referred to hearing, which is the title of your bar graph here. If thatís roughly similar do I deduct correctly that the disciplinary actions that over 1/3 of the disciplinary actions taken against doctors in New York State refer to actions performed out of state?

MR. GRAZIANO: Yes. Thatís correct.

ASSEMBLYMAN SULLIVAN: Okay. Thank you.

ASSEMBLYMAN GOTTFRIED: Other questions on the complainant issue?

ASSEMBLYWOMAN MAYERSOHN: I want to get back to the area of Lyme disease. Are you saying and I want to make sure I have the correct statistics. How many Lyme doctors have been charged? How many have been threatened with license removal? How many of these complaints were initiated by the insurance industry or the insurance industry is in some other way involved lie providing expert witnesses? Can you sort of give me a rundown on that?

MR. BERENS: Excuse me a moment. I think I can answer your questions and if I miss some of them please remind me and I will come back to them. First of all there is no precise board certification in Lyme disease treatment.

ASSEMBLYWOMAN MAYERSOHN: But we both know what we are talking about.

MR. BERENS: But we think, what we have done is we have identified eight physicians for whom diagnosis or treatment of Lyme disease was an issue or a potential issue. We received complaints from 21 sources. Now remember complaints in the sense that I described earlier does not necessarily mean that someone is evaluating the physicians conduct it may just be reporting information. In some cases they are evaluating the physicians conduct and asking us to do something about it.

ASSEMBLYWOMAN MAYERSOHN: That kind of opens the door, right? Then they go into the doctorís office and pull all records and find out what he did thirty years ago.

MR. BERENS: What we are getting at is we have these 21 sources. Thirteen of them were patients or family. Four of them were public officials, there were two doctors, two insurers and thatís the total of 21 sources. Making reports or complaints about eight physicians. Three of those physicians have been charged. Three of those physicians all matters have been closed without charges and in the cases of two physicians charges are still under investigation.

ASSEMBLYWOMAN MAYERSOHN: Has the insurance industry been involved in the cases themselves providing expert witnesses to OPMC?

MR. BERENS: Let me confer with my colleagues to be sure I get an accurate answer. I am told that we do not seek experts from insurance companies. That hey would have issues of credibility in the hearing that we donít want to deal with. They may be perfectly capable and professional but they come with a label that we would prefer not to have to deal with. When we seek experts we donít rule them out if they have done work for other entities including insurance companies. We evaluate the experts usefulness to us on the basis of his or her expertise and experience and although there may be incidental or coincidental connections to other entities they do not form a basis for our decision to select experts.

ASSEMBLYWOMAN MAYERSOHN: In a case where an expert witness is being at thee same time retained on a professional basis by the insurance company is there any investigation done to see that this does not happen?

MR. BERENS: We look into the qualifications and affiliations of the experts that we are considering for use. We do not have an inflexible rule that an expert physician that has work for an insurance company Ė-

ASSEMBLYWOMAN MAYERSOHN: Iím talking about current not work in the past, current.

MR. BERENS: We do not have rule that a physician who has either in the past or is in the past working for an insurance company is automatically disqualified form our further consideration. If we do select a physician for testimony the expert physicianís report is disclosed and the identity is disclosed to the licensee who has the opportunity to cross examine and they do take advantage of that opportunity at length. If there are affiliations past or present that the licensee feels it bear on the experts credibility they are free to bring it out and they do and then the hearing panels assess the credibility of all experts in the light of all of those factors that are brought to light.

ASSEMBLYWOMAN MAYERSOHN: Again in the area of Lyme disease and weíll take all of this a step further. Has there ever been an incident where the OPMC doctors attempts to solicit a complaint from a patient?

MR. BERENS: Again let me confer so that I donít leave out any information that I ought to know about. Nobody at this table has 100% knowledge of every action of every employee through all of time. What we do know is of an OPMC employee who returned a telephone call to a patient who had inquired seeking information. A patient who had been identified to the office by a public official as a patient whose case ought to be looked into. There was a discussion between that staff employee and that patient. No one at this table was present for that conversation. There apparently are differing reports of exactly what was said in that conversation. Our view of the matter from what we have been able to determine is that the patientís case had come to our attention before the staff member returned the call of the patient. Even if a discussion of a possible complaint from the patient did take place and I am not saying that it did because I don not know. I am not saying that it did not because I do not know.

ASSEMBLYWOMAN MAYERSOHN: We have a letter in our files that indicates the OPMC employee did attempt to persuade the patient to file a complaint.

MR. BERENS: So if that happened that is the only occasion we know of when it happened.

ASSEMBLYWOMAN MAYERSOHN: Can there have been others that you may not be aware of? Is that what you are saying?

MR. BERENS: I cannot know everything that happened in that office. No one possible could.

ASSEMBLYMAN MILLER: Before there seemed to be a considerable effort on the part of those of you who are testifying to indicate the severe consequences of in any way releasing information that might give the defendant in a case like this any knowledge at all who might be filing complaints against them. One of the reasons you cited was that it might discourage people from complaining.

You had over 7,000, over 7,000 people for whom you received complaints which according to your records 6,300 of them were basically closed without presentation to a panel indicating potentially that there were at least 6,300 cases of people reporting things that had no merit because itís such a great thing to be able to file a complaint against someone knowing no one will ever know that you did it. Sort of the anonymous bomb threats. The anonymous tip offs to the police. The anonymous almost anything. You donít like a physician colleague because theyíre doing something you donít like. You donít quite understand why they have a very successful practice and you donít so you file a complaint and no one will ever know. And, eventually that comes up and it could be one of the 6,300 cases. But of the 6,300 cases that you closed without any type of hearing what were those cases? Were those cases that had no merit at all? I mean weíre talking 6,300 out of 7,000. Thatís a substantial percentage no matter where the complaints came from. Why were those cases so easily gotten rid of?

MR. BERENS: One possibility is for what is sometimes referred to as simple negligence. That is not gross negligence or simple incompetence rather than gross incompetence, the statute does not permit a charge to be brought on a single instance. In other words a single instance of negligence or incompetence is not misconduct. The statute defines it as practicing with negligence or incompetence on more than one occasion. So we could in some number of those cases have identified a single instance of negligence or of incompetence but no other and closed the matter for that reason because there was no sustainable charge even though there was negligence or incompetence.

ASSEMBLYMAN SULLIVAN: Could you give me a description, forgive me, between, give an example of incompetence and then gross incompetence or negligence and gross negligence.

MR. BERENS: They are questions of degree when the conduct is so egregious that it goes beyond the bounds of any conceivable Ė-

ASSEMBLYMAN SULLIVAN: I understand what gross means. Could you just give me an example of the legal definition between you know negligence or incompetence on the one hand and gross negligence or gross incompetence on the other hand? If you choose to. You donít have to.

MR. BERENS: I will be happy to give you some actual examples after the hearing. I will send you a letter and give you some.

ASSEMBLYMAN MILLER: One of the things and it amazes me because one of the things that often happens when these hearings start, not with the hearing but when the investigation starts is that all of these patient records are taken into the Office of Medical Professional Conduct. They are reviewed and in many cases the complaint is poor record keeping. Yet when we ask a question there is never a direct answer. Your answer was not it could have been. The question is what was it really and you didnít answer that. You said well it could have been this as an example.

If youíre keeping the very type of records that you are demanding the physicians keep it should seem to me that you should have a record of the 6,300 cases, 100 were for this, 300 were for that, 400 were for this but it could have been is not an answer.

MR. GRAZIANO: If I may we do have additional information in terms of those 6,300 complaints. And, what types of dispositions resulted. For example matters that do not constitute misconduct such as billing disputes. We receive many calls, many complaints from patients regarding billing disputes between the patient and the physician. That does not constitute misconduct.

ASSEMBLYMAN MILLER: You donít have a percentage breakdown?

MR. GRAZIANO: I can get those for you if you need those. We have many complaints that are referred to other jurisdictions such as state ed. Complaints, individuals come in and will file a complaint regarding the nursing care, chiropractic care, what have you. We refer those directly to state ed and we certainly have statistically information that we can provide the committee.

ASSEMBLYMAN MILLER: (inaudible) a patient comes into a physicianís office they take a history. You stated before that in many cases you donít have the identity of the individual from a standpoint of how they relate to the person theyíre complaining against. And, you even said that in some cases the people who you are using in cases where you are actually proceeding with a case you donít have the information either. I mean the terms that you used were very vague. You said in some cases we have this information which implies in some cases you have people filing complaints that you are using an investigation and you never really check to see what their relationship was and yet you have statistical breakdown of 10% here, 3% here, 6% here.

Why are we and it seems to me in a mode where the most important thing is to encourage complaints no matter where they come from even to the point where you have someone on your staff soliciting complaints and it was our understanding that that person was disciplined. They couldnít possibly have been disciplined if no one really knew what they were doing. But thatís what we were told. So on the basis of letís get as many complaints as we can against people. We donít care who they are. We donít even know who they are and then if we donít get enough weíll solicit.

Then it seems very carefully crouched that there may have been one case. Well we know of at least one case. Why canít we say yes there is a case we know of one definitely? In fact we disciplined that person. Instead of you people who are running this organization are implying to us that youíre not really sure what your staff is doing and your not sure of the consequences. I mean it seems to me that we are working so secretly on where these complaints come from.

Enron was a big corporation. They used the biggest auditor they could find. Guess what no one was telling anyone anything until the company went bankrupt. At what point is the Office of Medical Professional Conduct going to function in the open so that the physicians know where the complaints are coming from. And, here this panel still wonít know where the complaints are coming from because youíre not sure you even know what certain people related in the weight of open people.

This should be an open process. This is not the former Soviet Union. This is not some strange dictatorship. This is an open society where we have foils. We have the internet.

I mean any physician no matter what they do, if it seems anyway negative their name appears on the internet. No one knows exactly what they did but everyone makes sure that that information is available. But everything you do still seems to be a secret in an open society. The IRS used to do that. The IRS had this system where you had to prove your innocence. The courts said well thatís really not the way it supposed to be. The government is supposed to prove their guilt. Yet you are not providing the same opportunity for these physicians to know whatís happening. It just seems to me that thatís part of the problem.

The reporting system in itself, the way you hide that information. You knew you were coming here today. You knew these were the type of questions that were going to be asked.

This reminds of a particular President who you know he defined sex in a certain way so he didnít have to talk about it. It just -- Iím only kidding about him you know that. But as the only republican here, but seriously. You knew that this hearing was happening and yet the information is only scathely available.

Let me go to another thing and itís only because you were questioned about this before. How the courts back up your findings and you talk about administrative review here. When you said that the Administrative Review Board has either sustained or increased the penalties the termination of hearing committees in over 90% of their decisions. The Administrative Review Board has what relationship to the health department or to your Office of Medical Professional Conduct?

MR. BERENS: Iíve counted at least four questions.

ASSEMBLYMAN MILLER: This is the only one Iím asking. (inaudible) rhetorical.

MR. BERENS: I do want to respond to those rhetorical questions. I think itís important that we do so.

The first one concerning the discipline of a physician. We did discipline, excuse me the discipline of a staff member. We did discipline that staff member but it was not for the contact with the patient. It was for another matter.

Number two you have I think unfairly accused us of sloppy record keeping. There is a, and compared it to the record keeping requirements that physicians have. I think we are talking apples and oranges here. There is a vast difference between the records that are required by sound medical practice to be kept by a physician concerning a specific patient and the specific things done in the course of treatment. It is essential to good medical practice that those records be kept so that a physician the same one or a different one knows what happened before. That is an entirely different matter from either of two things about the OPMC record keeping.

In any individual case we know who the complainant is if we are going to use that complainant to prove a point. We know what the relationship is. What we donít know today, because we donít keep track of it in the aggregate is the percentages of complainants who have this relationship or that relationship. It has not been necessary for us to gather that information and to report it in the aggregate. But, in the particular cases, we know.

ASSEMBLYMAN MILLER: Again the comment when we were talking about those individuals who file those complaints in cases that we use for prosecution. The answer was we know who they are in some cases. Didnít say all cases. I mean I am responding to the type of testimony you are giving us. I am not responding to the type of information you have hidden away in closets somewhere. If you have the information, be forthcoming with it. But, the idea of in some cases we do and in some cases we donít, and I would hate to think that when we are dealing with the elimination of an individuals livelihood and their professional standing in the community and the destruction of their entire life that we would be in a position where the records we keep for something like that are any less rigid than the records we would keep for someone who has provided health care for someone. So I donít see a distinction there.

MR. BERENS: The evidence that is offered in a case that is prosecuted is all recorded as a matter of record. There is no hiding that. It is recorded and it can be retrieved. The Appellate courts look at.

You spoke about the 6,300 complaints that do not result in discipline or even in the representation to an investigation committee. You mentioned that some people Ė- there is an important policy question to be asked and to be decided by the legislative process and that is in a field of physician discipline where the state has granted a license to physicians which enables them to cut into us. Which enables them to prescribe potentially poisonous medicines for us, in a field where so much power is given to the licensee itís an important policy question to determine whether you would rather have one too many complaints that result in no discipline or one too few that result in a patient death or serious injury. Thatís a judgment question.

Now exactly where the number should be 6,300, 6,200, 7,200. I donít know where that ought to be but the legislature has set a policy so far that encourages complaints. I think as a matter of patient safety thatís something that ought not to be changed cavalierly.

ASSEMBLYMAN MILLER: Okay even getting back to what you were saying before we go into something else. The ones that you discourage we are not suggesting that by having a patient come forward complaining against a doctor that they think should not be practicing medicine anymore that that person would be afraid to file the complaint because what they still want to continue going to that doctor? I mean that would be an interesting thing.

The physician in the hospital who has to work side by side with that doctor and has to constantly fix up what they have done, that doctor doesnít want to file a complaint because they donít want the (inaudible) to move ahead.

I mean the question is who is it that has a really substantial complaint, a really valid complaint that would be dissuaded from coming forward if in fact the only consequences someone might know who they are.

But you see suggesting on that basis alone you know that that person, that everything would be done to encourage, again to some extent even frivolous complaints, But all of it at the expense of the openness and the freedom that we constantly hear is being threatened by 9/11 but not by this board. I mean openness is openness. If we have an open society why donít we have this open process?

MR. BERENS: Remember that not every report is what a lay person would consider a complaint. Some people that OPMC ought to have information that they have even though that they donít see the whole picture. They are not prepared to make a judgment about whether what they have observed is misconduct. They leave that to OPMC and the board. Thatís an entirely appropriate. There may be people who say to themselves I do not want to share what I know with OPMC if my name is going to be dragged into it. I donít want to make an accusation. I donít have all the facts but I do have some facts that I am thinking about giving to OPMC but I sure donít want to give them to them if I am going to be upheld as an accuser and dragged into it. There are informants out there in that situation.

ASSEMBLYMAN SULLIVAN: Could I go back to a question before? When you spoke very clearly about the need for keeping medical records, did I infer correctly that that is what you would call, that the failure to keep medical records would be gross misconduct as contrasted with simple misconduct and therefore would come to the attention of the board?

MR. BERENS: The failure to keep adequate records could be either simple or gross negligence. Hereís an extreme example. The notation of the patients name and the date and time of visit but nothing else is more of a record than nothing at all. Nothing at all is certainly gross failure to keep adequate records. But, there is a whole continuum. How much information goes into the record I have never been to medical school but those who have and sit on these panels make judgments about how much information needed to be recorded for a record to be adequate.

ASSEMBLYMAN SULLIVAN: We are all familiar with the story that Al Capone was sent to prison not because of the many crimes he committed of murder and theft and whatever but because of his failure to pay his income taxes properly. And, it was often boasted of a clever trick on the part of the United States Government to get this malefactor away. I was never impressed by that. I mean if he didnít pay his income tax he should be punished like everybody else who doesnít pay their income tax. But, to send somebody to jail for life because they didnít pay their income tax just seemed to me a little bit strange. And a violation of the procedures. The procedures were if you want to send someone to jail get the evidence, bring them to trail and try them on that mater. Now if someone is mistreating patients they should be dealt with. Clear as a bell to me. If they are, if you suspect they are then it seems to me your job to gather the evidence and to present that evidence at the hearing. Am I wrong on that?

MR. BERENS: I agree with you.

ASSEMBLYMAN SULLIVAN: Okay. And to say well, I mean youíre not saying well we donít have any evidence that this person, that somebody x and Iím not as familiar with this as some of my colleagues are but I am just getting the drift here. Youíre not saying are you, that we donít have the evidence to prove that this person is mistreating patients so what we will do is well fine you must be doing something wrong, every doctor makes mistakes in keeping records or fails to do this or fails to do that so what we will do is weíll nail him on record keeping and that will accomplish the task. Youíre not doing that are you?

MR. BERENS: I donít believe we ever brought a case, which was solely based on record keeping. There was evidence of other misconduct which we presented in addition to record keeping.

ASSEMBLYMAN SULLIVAN: And there have been no conversations at OPMC that would be similar to the conversations that apparently took place in the FBI and the Justice Department back in the 30ís to the effect that well we canít get Al Capone for the St. Valentineís Day massacre so letís tighten the screws on the income tax thing. There has been no conversations in the OPMC to the effect that well we donít have the evidence to deal with the doctor, whoever on his mistreat or her mistreatment of patients so letís really focus on the record keeping aspect and see what we can do there. Has there been any conversations like that that have gone on in OPMC?

MR. BERENS: To my knowledge none at the management level or at the level where decisions to proceed with investigations and charges are made.

ASSEMBLYMAN SULLIVAN: Well why do you qualify it? It makes me nervous.

MR. BERENS: Because I am in the counselís office and Mr. Graziano is in OPMC. I will let him add.

MR. GRAZIANO: I certainly would support the statement that Don has made on the record.

ASSEMBLYMAN SULLIVAN: Which is what in your opinion?

MR. GRAZIANO: Which is that there has not been any discussions that I am aware of particularly at the management level. Now can I vouch for every staff member in the Office of Professional Medical Conduct? I cannot.

ASSEMBLYMAN SULLIVAN: How about in the operative level that is to say at the point where something moves forward because such a discussion took place?

MR. GRAZIANO: I would fell comfortable saying that a discussion of that sense has never taken place.

ASSEMBLYMAN SULLIVAN: Thank you.

ASSEMBLYMAN MILLER: Getting back to the other question I asked, the Administrative Review Board. What is its relationship to the Department of Health or to the Office of Medical Professional Conduct?

MR. BERENS: The board for Professional Medical Conduct consists of over 150 members. It does its work through a variety if committees and through the administrative review Board. So the ARB or Administrative Review Board is a unit of the board for Professional Medical Conduct. OPMC the Office for Professional Medical Conduct is the Department of Health staff which supports the work of the board for Professional Medical Conduct.

ASSEMBLYMAN MILLER: Now we had a case of a peer review in New York. Not peer review a utilization review where the HMOís had their own groups of people to review when patients ask them to reconsider a treatment and there of course well over 90% of the time surprisingly the HMOís own review board agreed with them. So we said well that doesnít work so we actually asked the HMOís to go out and hire what we called an external review board and son of a gun the external review board knowing that salary was dependent on the HMO that hired them they also agreed pretty much above 90% that the HMO was always right. So now we went to a situation in New York State where the review board is in no way connected to the HMOís. Itís a nice comment but basically what you are saying is that the Office for Professional Medical Conduct agrees with itself in 90% of the cases. I mean is that what that statement basically says?

MR. BERENS: Logically I agree with you. You can characterize it in a snide or other way if you choose to.

ASSEMBLYMAN MILLER: I mean but thatís what it is. They are agreeing with themselves.

MR. BERENS: And then the external review is the court system.

ASSEMBLYMAN MILLER: Okay and I wanted to get to that. You mentioned that and that sounded very good. The number of cases where a defense attorney will bring their defendants case into the court system outside the OPMC and you are saying that statistically the results are about the same or is between 75% and 100%. What is the chance that you have of having your case overturned if in fact you appeal to the court system if you are a physician convicted, not convicted but penalized under the administrative procedures of OPMC?

MR. BERENS: We donít have an exhaustive study but some preliminary work suggests that it might be a 15% chance that the penalty will be reduced or overturned entirely. About 85% of the time the courts agree that what the board has done with or without the involvement of the ARB is legally sustainable.

ASSEMBLYMAN MILLER: Was this the statistic we were kidding about before well over 50%, between 75%?

MR. BERENS: It is and the reason I qualify with lawyerly caution is because I am not certain how wide spread the sample was.

ASSEMBLYMAN MILLER: Okay. Thank you.

ASSEMBLYMAN GOTTFRIED: I have a series of other questions. In previous discussions on the subject of Lyme disease the department has made statements about following the Centers for Disease Control and Prevention Treatment Guidelines relating to Lyme disease. It is my understanding that CDC actually has no such treatment guideline. That all they have is a guideline as to what constitutes a reportable case. In my letter to you last week Mr. Berens I asked if you would submit to us either at or before this hearing any materials or specific citations to materials that the department including OPMC uses or relies on in considering the appropriateness of treatment for Lyme disease. Have you brought that material with you and can I have it?

MR. BERENS: I have not because it does not exist. Except to the extent of particular cases where I am prohibited by statute from giving it to you. Let me explain.

CDC has published case definitions for the Public Health Surveillance of Selected Diseases including Lyme disease. And for at least eleven years CDC has said that these case definitions are not appropriate for clinical diagnosis. On CDCís website they do refer to private publications which describe guidelines for the treatment, for the diagnosis and treatment of Lyme disease. But CDC itself does not endorse them. It simply describes them and refers to them.

So you are correct that CDC does not have official treatment guidelines for Lyme disease. OPMC does not rely on particular guidelines to determine whether or not to investigate or prosecute a physician. Instead the process works as follows.

OPMC using itís own staff or using outside consulting experts reviews the facts as they emerge in the investigation and the expert medical staff and consultants determine what is in their view the appropriate standard to apply to the case at hand. Either the diagnosis or the treatment if thatís an issue. Those experts may give differing weight to various standards or guidelines that are published privately. They may even give weight to the CDC surveillance guidelines. Other experts may differ including those retained by the respondents.

When a case goes to prosecution the department relies on one or more experts to provide testimony as to what the standard of care for diagnosis and treatment is. Thatís subject to cross examination. Another side provides its expert views which are in turn subject to cross examination. And then the board makes a decision about what the standard is and whether or not the physician departed from it. So in a particular case an expert report may be a document on which the department relies for presenting its case. But statute prohibits me from collecting those and distributing them to you. As a general matter there is no guideline that the department follows. In particular cases we take what the expert says is applicable to the case.

ASSEMBLYMAN GOTTFRIED: So if in a series of cases you were prosecuting or in a particular case you were proceeding against a physician for a particular mode of treatment letís say and your expert had said based on the following Journal articles or based on something else I believe that that mode of treatment is misconduct, it would seem to me that OPMC by proceeding in that case and by presenting that expert witness as its witness, OPMC is accepting that treatment guideline. And yet you are telling me that you canít tell me what, youíre not allowed to tell me what the form of treatment OPMC has decided is professional misconduct?

MR. BERENS: The standards evolved through time as new therapies are discovered to be effective or old ones are discovered to be less effective. So, there is not a single standard which is engraved in stone for all time. It changes.

The way that we resolve both medical malpractice cases in a civil litigation arena and disciplinary proceedings involving the clinic practice of medicine in our process necessarily has to turn on expert views about what is the standard. Not all standards are equally applicable to all cases. Not only do they change through time but certain aspects of the whole complex series of transactions that constitute medical care may or may not be subject to any particular standard. It is up to an expert to advise us what is an appropriate standard that applies to the facts of a particular case.

If it makes sense to the staff of OPMCD it will be presented to an investigation committee. If it makes sense to a majority of the investigation committee it may be voted to a hearing. If it goes to a hearing and it makes sense to the hearing committee misconduct will be found.

I donít know any other way to proceed in particular cases. And if that constitutes for that case the endorsement of a particular standard, then so be it. Thatís what it is.

ASSEMBLYMAN GOTTFRIED: But you feel then that a given medical practice is so bad that it requires taking away a physicianís license yet your not prepared to tell the public what that practice is?

MR. BERENS: Thatís true in the case of Lyme disease and every other condition. We do not publish guidelines. In fact we are prohibited from regulating physician practice. We are allowed to discipline it when misconduct occurs but we just had a court case Ė-

ASSEMBLYMAN GOTTFRIED: Iím not suggesting that the department should publish guidelines on physician office practice. Actually I am suggesting in another bill that the department be authorized to make regulations governing office based surgery but OPMC is proceeding against people on the basis of conclusions in medical literature and the like yet you are not prepared to tell the public and the profession what forms of treatment OPMC considers to be misconduct.

MR. BERENS: We cannot say what all of those cases of misconduct would be. We canít say that in advance. Itís too complex. It changes through time. What we can do is reveal to the physician who is charged the experts report on which we rely. So it is certainly made clear to the physician the standard to which we will contend he or she is held accountable. But the statute prohibits us from disclosing to the public an experts report.

ASSEMBLYMAN GOTTFRIED: Letís talk a little about the expert report. At what point in the proceeding is a physician entitled to see that report which is to say at what point in the proceeding is a physician entitled to know what he or she is being accused of?

MR. BERENS: Those are two different questions with two different answers. The physician is entitled to know what is the subject of the departmentís investigation before a case is presented to the investigation committee. They are not entitled at that time to a copy of any experts report. The courts have upheld that.

ASSEMBLYMAN GOTTFRIED: I think courts have probably said that that is what the statute says and the statute is not unconstitutional?

MR. BERENS: I agree.

ASSEMBLYMAN GOTTFRIED: Okay.

MR. BERENS: If the case is voted to hearing by the investigation committee then charges are drawn and when a hearing is scheduled there is a pre-hearing conference and the experts report is disclosed, the stateís expert report is disclosed to the physician and they have the opportunity to see what is coming.

ASSEMBLYMAN GOTTFRIED: Excuse me a second. What is going on over here? You may want to go somewhere else and do that. Iím sorry continue.

MR. BERENS: There are rules that require similar disclosure by the licensee who is charged of the expert reports on which the licensee will rely. But those are hardly ever in fact given to us until the middle of a hearing. There is asymmetrical disclosure of the expert reports in practice.

ASSEMBLYMAN GOTTFRIED: Asymmetrical disclosure is kind of enshrined in our constitution. We do say different things about what the government has to do versus what the defendant has to do. It is right that we do that. I may have been distracted at the point where you stated at exactly what point in the process does the physician get a copy of the expert report?

MR. BERENS: It happens at the pre-hearing conference.

ASSEMBLYMAN GOTTFRIED: That is after the charges have been filed by the investigative committee and sometime before the hearing?

MR. BERENS: The charges are not filed by the investigation committee but it does occur after the charges are filed by the department.

ASSEMBLYMAN GOTTFRIED: Well the investigation committee Ė-

MR. BERENS: The investigation committee votes to approve the filing of charges.

ASSEMBLYMAN GOTTFRIED: Okay. So the case goes all that length before the doctor knows essentially what the department feels he or she did wrong and until that point the doctor really has no ability to try to talk you out of prosecuting the doctor?

MR. BERENS: No that is an incorrect understanding.

ASSEMBLYMAN GOTTFRIED: You may up front tell the doctor we are prosecuting you because you are guilty of misconduct. So yes we have told you the nature of the charges. But the doctor doesnít know what it is about what he or she is doing you think is wrong and what the standard is that that doctor is being held up against so that that doctor might have an opportunity to say well you are relying on the November 20, 01 article in the New England Journal of Medicine about how to treat such and such infection but here is this other article that explains what I am doing. The doctor canít do that until the doctor know that you are relying on the November 20, 01 New England Journal of Medicine article.

MR. BERENS: I disagree. Let me explain why. At the interview we do not simply say you are being accused of negligence on more than one occasion. It gets much more detailed than that. We are looking in the patients A and B who would be known by name to the physician and we are concerned about what you did on such and such a date and such and such another date. If itís infection control these are the issues that we are looking into. The physician may not know at that point about the November 99 article of Journal A but the physician knows what the issue is and has the opportunity then to say well you want to look at Journal B from the year 2000. That opportunity occurs without the disclosure of the experts report to be sure. But that opportunity occurs before the investigation committee is convened.

ASSEMBLYMAN GOTTFRIED: What is the rationale for keeping the expert report secret through all that length of the proceeding?

MR. BERENS: The report may turn out not to be used. The case may turn out to be closed with or without presentation to the investigation committee. Until the experts report is sure to be used that is when the hearing is coming up you have the question again to be considered will experts cooperate and be fully candid and forthcoming with us if they are subject to disclosure in a case which may never reach a hearing?

ASSEMBLYMAN GOTTFRIED: That to me strikes me as an utterly unfounded concern. That you would find a shortage of experts who are willing to tell you what they think is the right form of practice and who would be willing to do so knowing that a month from now their name and report will be disclosed but will back out of doing it if their name and identify and content of their report gets disclosed today as opposed to a month or two from now. It just doesnít make sense to me.

MR. BERENS: You should also distinguish between a preliminary report based on information developed at the stage of an interview and a final report fully considered in the light of all the facts that come to light by the time a case gets through the investigation committee and is going to hearing. To disclose a draft if you will or a preliminary report is a problem. It then results in the focus on a not yet fully formed opinion. So the interview is designed to disclose what the issues are to hear what the licensees response is which can include expert reports or Journal articles or written or oral statements. And then the issues are refined. When they are refined to the point where the expert is ready to finalize a report on which the department wishes to proceed at hearing then itís disclosed.

ASSEMBLYMAN GOTTFRIED: So the licensee is put in the position of being invited to disclose information to the prosecutor and to explain himself or herself to the prosecutor while the prosecutor is not expected to share similar information with the licensee. I mean that seems to me kind of the opposite of being protected against being a witness against yourself and being entitled to confront your accusers.

MR. BERENS: The right to confront the accusers occurs when there is an accusation not when there is an investigation.

ASSEMBLYMAN GOTTFRIED: I would think most, I mean in a literal technical sense that may be correct. But I think in terms of the spirit that guides our system or is supposed to guide our system at the point in the proceeding we are talking about I think the physician certainly feels accused unless he or she is not paying attention and I think the physician, and I think that occasionally happens, but the physician is certainly at great peril. I think the department considers the physician in its heart of hearts to be under an accusation and under a charge. You may not have procedurally carried it to a given stage but it would be like saying at the point where the cop has you slammed up against the wall he shouldnít really have to give you miranda warnings because after all you havenít been indicted yet. You know the system doesnít go that way.

So I at this point donít understand why at the earliest possible moment the doctor would not be entitled to know who the expert is and thereby be able to figure what axes that expert may have to grind. And, why the doctor shouldnít be entitled to know what the feeling of the case is against him or her and what standard of care the doctorís practice is being held against so they know how to refute that standard of care. Or how to argue against it.

But let me move on. Does it ever happen that the department goes to a particular expert and that experts comes back with a report that exonerates the licensee and OPMC says well thank you very much but weíre going to go find ourselves a different expert until we find one that will find against this doctor. Does that ever happen?

MR. BERENS: I can agree with you up to a point in your description but not all the way. There are occasions when we receive an expert report and we are dissatisfied with it and we seek another until we are satisfied with it. The difference between what you described and what I have described is the focus on the result or the conclusion versus the focus on the reasoning. If we get an incompletely reasoned report that doesnít make sense to us. Weíll seek another one. The conclusion is not the issue for us itís the reasoning and the persuasiveness of the report. So yes we do seek reports where we are dissatisfied with the original report but it is not to seek it until we get the result that we have predetermined ought to apply.

ASSEMBLYMAN GOTTFRIED: Now thatís your judgment that the one that accuses the doctor is valid but the one that exonerated the doctor was reflected defective reasoning. Is the doctor allowed to have a copy at any point of the expert report that exonerated him or her?

MR. BERENS: Yes.

ASSEMBLYMAN GOTTFRIED: At what point does the doctor have an entitlement to that kind of exculpatory material?

MR. BERENS: At the pre-hearing conference.

ASSEMBLYMAN GOTTFRIED: Does the investigation committee before it approves charges get to know about exculpatory material like that?

MR. BERENS: Yes.

ASSEMBLYMAN GOTTFRIED: So an expert report that the department rejected shall we say or did not choose to go forward on is submitted to the investigation committee on the same time frame as the investigative report that you choose to go forward on?

MR. BERENS: Yes.

ASSEMBLYMAN GOTTFRIED: And both expert reports are presented to the physician at the same time?

MR. BERENS: Yes.

ASSEMBLYMAN GOTTFRIED: Is that also, what about other exculpatory material that OPMC may have in its possession or be aware of?

MR. BERENS: That is turned over to the physician as well again at the pre-hearing conference.

ASSEMBLYMAN GOTTFRIED: But not before.

MR. BERENS: I am told that it sometimes does happen before the pre-hearing conference.

ASSEMBLYMAN GOTTFRIED: At what point in the proceeding does the physician have an opportunity to present medical literature in his or her defense?

MR. BERENS: At any time during the proceeding when they are made aware that the proceeding exists. That is during the investigation stage. We donít have to wait for a hearing. Certainly at the hearing the physician is entitled to present such evidence but also prior to the investigation committee convening during the course of the investigation.

ASSEMBLYMAN GOTTFRIED: Does the physician have ht opportunity to present medical literature to the investigation committee?

MR. BERENS: Any information that the physician presents is presented to the investigation committee?

ASSEMBLYMAN GOTTFRIED: By whom?

MR. BERENS: By the department.

ASSEMBLYMAN GOTTFRIED: So when the investigation committee is judging whether charges should go forward against the doctor the doctorís side of the story is presented to the investigation committee by the prosecutor?

MR. BERENS: The materials that the physician has presented are delivered unedited to the investigation committee.

ASSEMBLYMAN GOTTFRIED: Does the physician have any opportunity to present his or her side or explanation directly to the investigation committee?

MR. BERENS: Not in person.

ASSEMBLYMAN GOTTFRIED: Okay. Is there any reason why this system should not be modified to give the accused an opportunity to communicate directly with the investigation committee?

MR. BERENS: I suppose itís a judgment call to be made about whether that additional right would slow down the process too much or whether the value of receiving that direct oral presentation is sufficiently valuable that you would extend the times and scheduling issues of getting everybody together in front of an investigation committee.

ASSEMBLYMAN GOTTFRIED: Understandable though that the accused physicianís sense as to the value of that delay might be different from the prosecutionís sides assessment of the value of that delay.

MR. BERENS: Of course prospective can differ. I might also point out that the department does not present live witnesses to the investigation committee either. The materials on both sides of the issue are presented in writing and the investigation committee looks at them.

ASSEMBLYMAN GOTTFRIED: But the department is there at the investigation committee to not only submit documents but to make an oral presentation?

MR. BERENS: They respond to questions yes. Yes the department staff is present.

ASSEMBLYMAN GOTTFRIED: Do they make an opening presentation? Who does make an opening presentation?

MR. BERENS: Excuse me a moment. The staff makes an oral presentation of a summary of the case to the investigation committee. The investigation committee has previously received all the documents in the case. And the summary which is presented is presented in writing first and then repeated orally to the investigation committee.

ASSEMBLYMAN GOTTFRIED: Now the investigation committee receives the expert report?

MR. BERENS: Report or reports.

ASSEMBLYMAN GOTTFRIED: Right. Does the physician have the opportunity to submit beyond a stake of Journal articles, does the physician have the opportunity to submit a report to the investigation committee setting forth the physicians side of the story comparable to the way the expert report sets forth the prosecution side of the story?

MR. BERENS: Yes the physician can submit a written statement compiled by the physician and his or her lawyer or compiled by an expert. Any written material from any source that the physician wants to submit is submitted, can be submitted and if it submitted to the investigators it is disclosed to the investigation committee.

ASSEMBLYMAN GOTTFRIED: Okay. Although there are I guess two critical differences. One is OPMC gets to make an oral presentation, number one. Number two OPMC gets to see what the physician is submitting in his defense but the physician at that point doesnít get to see what the prosecution is submitting.

MR. BERENS: That is true. Until later.

ASSEMBLYMAN GOTTFRIED: Okay. At the hearing stage if a physician wants to introduce medical literature for the purpose of, letís first focus on for the purpose of cross examining the prosecutionsí expert witness. What are the restrictions or what is the basis on which that medical literature can be introduced? I guess I am in particular focusing in on the question of who makes the determinations to whether medical literature, a given piece of medical literature offered up in cross examination and what is the standard?

MR. BERENS: The standard is similar to that in civil litigation to use an expert treatise to impeacher cross examine an opposing expert one must establish that the witness recognizes the treatise as authoritative. The ruling on whether that foundation has been established is made by the administrative law judge.

ASSEMBLYMAN GOTTFRIED: So if the expert witness thinks that a given form of treatment is bogus and the defense wants to introduce in cross examination medical literature that defends that treatment the admissibility at that stage of that literature is dependent on the judgment of the expert who has already decided that that position is bogus?

MR. BERENS: If it is to be used in the context of cross examination yes. If itís to be used on the defenses own case there are other evidentiary predicates used to establish what the standard is.

ASSEMBLYMAN GOTTFRIED: So the expert witness canít be asked to comment on another piece of literature or respond to criticisms of the experts viewpoint that are in that other piece of literature unless that expert witness chooses to accept that other sideís piece of literature as valid.

MR. BERENS: No that is no true. The expert can be cross examined on the basis of the standards set forth in the expert treatise that the cross examiner proposes is authoritative. But if the expert dos not concede the authoritative nature of the treatise than the treatise cannot be offered as evidence itself. At least at that point. There may be another foundational predicate that can be established when the physician presents his or here own case.

ASSEMBLYMAN GOTTFRIED: Okay. When the time comes for the physician to present his or her case what is the process and the standard by which medical literature at that point can be introduced?

MR. BERENS: Here the standard comes in a variety of ways. It could be offered without objection. It can be offered and admitted over objection if the physician wants to establish what authorities he or she relied on in determining what course of treatment to undertake.

ASSEMBLYMAN GOTTFRIED: Well there are I guess two uses for a piece of medical literature. One would be this is what I relied on. The other would be not only did I rely on it but it is valid. If the physician wants to introduce medical literature for letís say to defend the validity of his or her mode of treatment what does the physician have to go through to get that medical literature introduced at the hearing?

MR. BERENS: Without a live witness to vouch for the authoritativeness of the treatise there is no way to cross examine the authors of the treatise. So either the physician himself or herself who certainly is likely to be deemed an expert can testify as to the authoritative nature of the treatise or someone else other than the respondent licensee who is similarly expert can testify as to its authoritative nature and if that predicate is established the ALJ can admit it into evidence.

ASSEMBLYMAN GOTTFRIED: If the document is being introduced, if the physicianís defense is I did whatís in the textbook, if the textbook is wrong tell me but I did what was in the textbook and therefore I am not guilt of misconduct. And if the physician then is not introducing the textbook to prove its truth but simply to say this is the book I relied on does the physician have to do something to document the truth of the textbook or the truth of the Journal article?

MR. BERENS: He or she has to make a case that it is a reasonable thing to rely on the book. For example if it was a fifty year old text and the medicine had advanced substantially the ALJ might rule that there had been insufficient evidence that there was a reasonable reliance on the text.

If it was a text written by someone widely believed to be a quack which the licensee admitted was a quack but said this is the book I relied on it probably would not be admitted for its authenticity.

But in the absence of a reason to question the reasonableness of the reliance it would be admitted and of course it be subject to cross examination, the physicians reliance on it and a rebutting expert could say well yes that is admitted in evidence but here are the reasons why you shouldnít pay attention to it and then all of that would be then be evaluated by the panel of two physicians and a lay person.

ASSEMBLYMAN GOTTFRIED: Okay. I am going to come back to some other points but Iíll pause here and let Ė-

ASSEMBLYMAN SULLIVAN: I just want to back up a little bit. You said at the beginning of your testimony that you seemed to think or the beginning of the questioning put it that way that things seemed to be doing okay at the OPMC. That you were pleased with the way you operate. You thought you were doing the state a service and you quoted various indicators that nationally you were recognized as doing a good job. Am I Ė-

MR. BERENS: Thatís fair paraphrases of Ė-

ASSEMBLYMAN SULLIVAN: Is that a fair assessment? I am a legislator, we are all legislators up here so weíre supposed to decide, one of the purposes of the hearing is there any legislation needed to change the way you do things if something is not going well. You said that if you thought of something you would let us know but at the moment you donít; have any suggestions to make as to your procedures? Is that again a fair Ė-

MR. BERENS: Yes it is.

ASSEMBLYMAN SULLIVAN: Now I am looking at a situation here where you seem to be standing, I am neither a doctor nor a lawyer forgive me nor do I play one on television. I am just approaching this from maybe a naive standpoint. But it seems to me that a doctor is being put in the dark as it were and at that time during that procedure without going into the detail which I am not an expert, during that procedure that follows it will be determined what the standards are that that doctor violated. And, it seems that the doctor might have had no knowledge of what the standards are that he or she was expected to follow until itís determined during the procedure in which that doctorís license is being put in jeopardy that there is a standard and here is what it is and last month you didnít follow it. Although it didnít exist at that time and therefore we are going to find against you. Thatís whatís coming out here. Correct me where I am wrong.

MR. BERENS: If a physician has no idea what the applicable standard is there has been a massive failure in the medical education system. Thatís what professionalism is about.

ASSEMBLYMAN SULLIVAN: But didnít you say that the standards are determined during the process as a result of the expert witness that will be presented. The magazine articles, the other documents that will be presented and that the board will determine during the process what the standard is. Didnít you just say that? Didnít you just get finished saying that?

MR. BERENS: The standard which must apply is the one at the time of the act. The evidence which demonstrates what is the reasonable standard is presented at the time of the hearing.

ASSEMBLYMAN SULLIVAN: I am just going to stop you right there. That just seems to me to be a completely contradictory statement. How could this standard exist at the time of the act if the standard isnít determined until the hearing which is later.

MR. BERENS: The proof of the standard comes in at the hearing.

ASSEMBLYMAN SULLIVAN: The proof of the standard. What does that mean?

ASSEMBLYMAN GOTTFRIED: Let me just take a stab at this. I think the notion is that the standard if the act in question took place in November of 2000 at that time and place there was a standard or a range of permissible ways of either treating x or controlling infection or whatever. You and I might not have known what that standard was and it may not have been written down neatly in a code somewhere but there was a range of appropriateness and what OPMC should be doing in February of 02 when they are judging the conduct that took place in November of 2000 is not writing that standard but looking back and trying to discern what it was. The may be different views as to what it was back then.

ASSEMBLYMAN SULLIVAN: Let me go on. Let me go on and just indulge me for a minute. If the standard is well known by the doctor, the standard that the doctor should be following is well known then what is the point of the testimony saying what the standard is? There seems no point to that whole procedure. If the standard is well known and known by the doctor and presumably known by the people who are going to sit in the panel then the only question is did the doctor follow the standard or didnít the doctor follow the standard. That would be a legitimate inquiry. But why bring in testimony to determine what the standard is when in fact the standard is well known. You seem to be saying contradictory things.

MR. BERENS: I hope not. In most cases there is not a dispute about the standard. There is a question about whether the doctor did or did not meet it. But in some cases there is a question about what was the standard at the time of the relevant conduct.

For example letís suppose that somebody alleged that a physician was negligent for failing to prescribe drug purple in November of 99.

ASSEMBLYMAN SULLIVAN: Okay.

MR. BERENS: And everybody now knows that drug purple is the best treatment that you can have for this particular conduction but nobody remembers whether drug purple was on the market in November of 99 or December of 99 Ė-

ASSEMBLYMAN SULLIVAN: Iím not talking about that.

MR. BERENS: Well I use it as an example. You need expert testimony to determine what was the best practice. What was the acceptable practice at a given point in time for a given set of factual circumstances.

ASSEMBLYMAN SULLIVAN: But shouldnít that be publicly clear not only to the doctors but to the public at large so that a patient will know whether to make a complaint. How would a patient know the doctor did the best he could and your brother died. It happens. And the patient now not knowing whether the doctor did the best he could has no standard to refer to. Because you are going to determine that standard according to you during the hearing that will follow the complaint.

ASSEMBLYWOMAN MAYERSOHN: Can I just inject?

ASSEMBLYMAN SULLIVAN: Donít inform me. I just want this gentlemen to because heís (inaudible). Would you answer that question for me? Why is there any inquiry at all into what the standard is if you say that the doctor should have known what the standard was when eh performed the treatment?

MR. BERENS: Itís a function of education, training, skill, experience, science, art. Everything that goes into what is a profession. I am sorry sir I donít know what your profession may have been before.

ASSEMBLYMAN SULLIVAN: Legislator.

MR. BERENS: I am sure that the highest standards apply in that profession and they are well known and when you see a colleague who departs from them you can recognize it even if you didnít articulate it beforehand. In the skilled professions in health care itís the same sort of thing. Itís a vast area with enormous range of knowledge and just because one has a medical license does not mean you now know enough to practice. You have to indulge that skill and keep reading. Learn from others. The medicine changes. Hopefully for the better.

ASSEMBLYMAN SULLIVAN: Is there a procedure that you used when innovative treatments are propose or in the wind, you calling a hearing, nobody is in the dark. You call a hearing. You invite people to come and testify. They all give their opinion. Some will say this, some will say that. And you listen and you say weíve decided that either pill A, pill purple or pill green are acceptable or weíve decided that pill purple is acceptable but not pill green or whatever. Why wouldnít that be useful so that not only the doctors and you but also the public would know what the standard is if there is a standard.

MR. BERENS: I would be a massive undertaking and well beyond any conceivable resources that Ė-

ASSEMBLYMAN SULLIVAN: $3 million you got floating around there.

MR. BERENS: Public Health would ever have. Instead that process is done by the professionals in the medical schools, in the scientific research laboratories, in the journals. Thatís how the standard evolves.

ASSEMBLYMAN SULLIVAN: I get you. Iím not going to delay this any longer. Iím just saying as a citizen and as a legislator I am concerned about the fact that doctors are being brought for investigation and charged with violating standards of which are such inclarity, a lack of clarity in the standards. I think that that is not good for the patients of this state and its not good for innovation because people are nervous, would be naturally nervous to innovate because I am liable to be brought up on charges if I innovate in any way with no clearing house for innovation or is there. I donít know maybe there is.

MR. BERENS: On the other hand codification of a standard might inhibit innovation. Thatís a serious issue.

ASSEMBLYMAN SULLIVAN: If itís constantly revised it wouldnít. If itís ongoing. Maybe we need an Office of Professional Codification or Innovation. Iíll back off. Thank you.

ASSEMBLYMAN GOTTFRIED: Thatís an interesting question but I think itís a little fairer field from todayís Ė-

ASSEMBLYMAN SULLIVAN: I think itís right on target myself. In my opinion.

ASSEMBLYWOMAN MAYERSOHN: I just really want to comment. I have been involved with this issue for quite sometime and weíre talking about Lyme disease and what I have found is that there are no standards. There really are no standards. You have experts on both sides of the issue and I have seen the degrees that some of these doctors have. Some of the experience that they have. Some of the work that they have done in the field of Lyme.

You have experts on both sides of the issue debating the issue and my feeling was why are you injecting yourself into the debate. Let the debate play itself out in the scientific and in the medical community but we should not be getting involved and setting standards when itís an illusion. Right?

Now there are no standards. You can test positive for Lyme and be negative. You can test negative for Lyme and be positive. And read so much of the debate. Let it go on in a scientific community. Let it go on in a medical community. Let us stay out of it until we clearly know and even CDC hasnít issued standards because they donít know. We should not be involved in this debate.

MR. BERENS: There is not a single Lyme disease issue. It is a cluster of many issues. Even in those areas where there is a reasonable scientific and medical debate about what is the appropriate treatment, what is the appropriate way to diagnosis. There is nonetheless a substantial area of near universal agreement on the fundamentals of medical practice which surround the diagnosis and treatment of Lyme disease and many other diseases and conditions.

For example we all know that Lyme disease can present itself with a wide variety of symptoms and signs. Sometimes they are there. Sometimes they are not. But certain combinations of signs and symptoms which may be consistent with Lyme disease are also consistent with other diseases or conditions. In fact one example might be chest pain radiating down the left arm. That can be consistent with Lyme disease. If a physician fails to rule out the possibility of a heart attack that would be misconduct.

Even in areas where one might debate about how long antibiotic therapy ought to be administered in cases of suspected or confirmed Lyme disease it is near universally agreed that physicians ought to keep track in their records of what antibiotics are prescribed in what doses and what the reaction of the patient is so that if a particular selected antibiotic is not working there is a reassessment of what treatment should be used.

I have to disagree that Lyme disease cases should be totally exempt from review by OPMC. There are some aspects of the treatment, the diagnosis and treatment of Lyme disease which should be reviewed and judged by the near universally recognized standards. There are others where there is such a wide open range of debate about what is appropriate that it could not be considered misconduct to diagnosis Lyme disease if you have gone through all the other steps to rule out the other causes and if you keep good records and you give information so the patient can make a conformed decision about treatment and you monitor the results of those treatments and adjust them where itís necessary.

It is certainly possible for a Lyme disease physician to practice without committing misconduct. But it is also possible for a Lyme disease physician who is acting the realm of legitimate debate to be committing misconduct in some other area of the case where there is no legitimate debate.

ASSEMBLYWOMAN MAYERSOHN: I have seen some of the complaints against some of the physicians. There is a heavy emphasis on over treatment of Lyme disease, over treatment with antibiotics.

Again I have also been hearing from hundreds of patients who are so fearful that their doctors are going to lose their licenses that they are desperately concerned about where they go. Because theyíve come from other doctors that treated their symptoms very casually and said oh well there is nothing more we can do for you. They went to these doctors who they felt were paying attention to what their symptoms were and were treating their symptoms.

So, when you say that some of these doctors are not doing all the tests I also know that Lyme disease mocks a lot of symptoms and some of the doctors have taken, have gone through many of the tests and then theyíre accused of over testing. I donít know how they can win on this issue.

I really believe that I think that the OPMC really has to remove itself from this debate. I think we just have to let it go on. Let the scientists argue among themselves and we stay out of it. We are hurting so many people by what we are doing which is why I became involved in this issue.

ASSEMBLYMAN MILLER: I canít imagine how Dr. Lister would have faired under todayís times being the only person who thought cleanliness might be a good way to stop spreading infections. Certainly at the time he started there were no standards for cleanliness and while he was going on there were no standards for cleanliness. But we would have, according to what I hear today, brought in every single expert that filth was the way to go. Weíve used it forever and why shouldnít we just continue that way and obviously all of this stuff is bogus.

I mean the Office of Medical Professional Conduct is not supposed to stand in the way of progress. Now you claimed before that there was no standard that you were adhering to, that that was determined. Yet when it comes to the Lyme physicians you routinely go to that side of the debate which believes in twenty-eight days youíre cured and that has become your standard because those are your experts. The only thing your experts canít explain a way is why their patients donít get well or why bumble bees can fly.

We donít know exactly what the weather is right now. But if I had to determine the weather there is two things I can do. I can go to a scientific journal or I can have someone stick their head out the window. Now in many times I am listening to the radio and I hear the great scientist telling me that there is a 90% chance of rain. Itís going to rain from 9:00 to 10:00 at night. Meanwhile itís not raining.

You have and you have accepted as your standard a treatment outline that does not help every person. It doesnít help them. This room is filled with the discarded patients from that treatment regimen. If you continue to use the standards that you have adopted as your guidelines, the standards that you really have. You believe in them thatís where your experts come from. You progress from that point and as soon as you find a physician that has deviated from that thatís when they are subjected to the type of witch hunt will produce a document that may have left something out. A document which may be short in this area. That is the basis from which you are coming from but you refuse to admit it. But your actions clearly show that that is in fact the standard that you are using.

Not every patient who is subjected to the alternative treatment is going to get well. But certainly out of all of the people who are sick, many are getting well but you donít allow for that.

There are no, again with the testing, the complaint is the overuse of antibiotics without adequate testing to demonstrate their need. Basically what you are saying is if there is a micro-present and itís not just the micro that causes Lyme now we know that there are other co-infections and some of them are resistant to certain types of antibiotics.

But you are saying unless its easy because easy is the standard that you picked, the people that you are using are the easy standard people. Big bulls eye. You canít miss it. You can hit it with whatever you know from 1000 yards. That doesnít often occur.

The blood tests. We know that that has failed because years after the testing is started suddenly without any other exposure the person finally tests positive. The worse place to test positive is at your autopsy. At that point these standards that you are adhering to have not really worked at all.

I had a friend who was a chemical engineer. He was going for his Ph.D. He decided that he was going to use a particular form of osmosis for a dialysis machine but he could never get it to work. His professor said to him well if you canít get it to work, if you can prove that it canít work, thatís equally valid.

You have not been able to prove that the other treatments, the more extensive treatments, the long term treatments of Lyme, you have not been able to prove they donít work. There are people in this audience that are living proof that it does work. And so you have basically really started on a particular path and there is a problem.

You get the complaints and then you find the material to support it. Itís always for those doctors who didnít manage to stay on the side of the protocol that you have predetermined as correct. That is dangerous. That is dangerous because you really are preventing experimentation, advancement in medicine and these are not alternative treatments in the way that we are asking people to drink shark cartilage. These are treatments that expand what is currently known as legitimate medicine and trying to apply them in a way and thatís valid.

I mean there are times a patient comes to me and says I have a pain on the top and a pain on the bottom. I say well you know the chance of having two tooth headaches are kind of nil. Iíll look where I think the most logic place is and Iíll inject to see whether I can stop the pain. Iíll give a lower injection. Low and behold the upper pain stops as well. Thatís valid for a diagnosis. Sometimes you do things and see what the end result is.

Youíre scaring people. You really are. You are not giving them a fair shake. Youíre discouraging other physicians from joining the physicians that have protocols that work and youíre scaring the patient because you tried to remove their doctors. The bottom line is it all comes down to whether itís too much secrecy. Whether itís too much closeness or whether ti was too much anything. But why donít you just come out and say if you go past x number of days of treatment weíre going to come after you because thatís what you do.

Again if you use to determine the protocols, if you use to determine the approved treatment during the process in which you are still relying on the doctors who believe in the old way than thatís not a fair trial. Thatís not a fair process. I mean if weíre going to use everything old and nothing new then you canít ever convince these people that theyíre wrong and this wonít be admitted as evidence.

But, clearly the fact that we have this number of people here today and we certainly had at least twice this number of people in Albany, all of whom say the same thing. That it is only the extended use of antibiotics that have gotten them out of their wheelchairs or out of their beds and back into the street when no one else is treating them. The rumatologists donít treat them. The infectious disease people in many cases donít treat them. Some of the neurologists treat them. This is a disease that has significant neurological components and yet youíre denying this.

The other thing that you used about well if you have pain in your chest and your arm you should be tested. I grew up at a time when measles was common. We all got the measles. What happened when you got the measles? You were put into a room and the lights were turned way down and you listened to the radio. Why? Because your eyes hurt. Now if a doctor came and diagnosed you as having measles would they then be brought up before your board because they didnít send me to an ophthalmologist because my eyes hurt? I donít think so.

I mean when you look at a diagnosis you donít look at the little pieces you look at the entire overview. When there is enough things going on and the patient is running up the steps and they donít feel anymore pain running up the steps than walking down the steps even though their arm hurts and their chest hurts, Iím not quite sure theyíre having a coronary right then and there.

Some of this stuff is self, you seem to have set out a system which protects yourself but protects the status quo. Thatís not protecting these people. The fact hat you claim that under the law you are forced to do this. Thatís not true. You dismissed 6,300 cases out of 7,000 without having to worry about the fact that there was a complaint against them. You pick the people that you go after.

When I was in the service it was easy. If they wanted Miller to go to Vietnam they simply put it into the computer dentist, last name M-I-L-L-E-R, first name Joel. Hey Joel really surprised the computer picked you to go to Vietnam.

Youíre picking the people that you want to prosecute. Once you pick them you have no constraints on what you can do to gather the evidence to find out something totally unrelated to the complaints that now you are going to use against them.

Exactly as Ed Sullivan said, we are going to put you in jail for income tax evasion even though we know you killed forty people.

I am just saying that what you are doing and the way that itís being done is not at this point defending the position that we have to get rid of bad physicians. We agree with that. We would not want to tie your hands so you couldnít look at records. It seems to me for whatever political reasons or whatever monetary reasons with the insurance companies lingering back there this is whatís happening.

You said there were four elected officials. Now an elected official is just a conduit for information. That doesnít tell me whether it was the insurance companies that complained to those state officials or whether it was patients that complained to those officials. If in fact it was insurance companies that were complaining to officials somewhere in the state we should know that. That sort of taints whatís going on.

As much as I respect the work that you do to protect our public and as important as it is that you continue the work that you do to protect the public at some point in the middle of a controversy and thatís exactly what Nettie Mayersohn is saying. This is controversial. For you to have picked one side before anyone can prove it works or anyone has proved it doesnít work seems to me to be inappropriate. We should be waiting for science on this. This is as much anecdotal on your side as your side claims itís anecdotal on the other. Just let it run. Donít take these people away from their patients until you really have something to prove and say not just because of politics.

ASSEMBLYMAN GOTTFRIED: I donít know whether there was a necessity for a response to that but I do have some other questions. When transcripts are made of proceedings, I understand that the court reporter involved in transcribing the proceedings does so under a contract with the department?

MR. GRAZIANO: That is correct.

ASSEMBLYMAN GOTTFRIED: Is that contract a public a document? Just to say could I have a copy?

MR. GRAZIANO: I would defer to our fiscal management folks but I believe it is.

ASSEMBLYMAN GOTTFRIED: Okay. I would appreciate it if as soon as possible you could provide me with a copy of that contract. Are the fees paid to the court reporters for transcripts by the department the same or different from the fees that are paid by the licensee to get the same transcript.

MR. BERENS: I donít know. Weíll find out.

ASSEMBLYMAN GOTTFRIED: I would appreciate that information. The assignment of three of the 150 or so members of the board of Professional Medical Conduct to a particular investigation committee or a particular hearing committee. In the judicial system I donít know if itís an ironclad rule there is some form of either random or non-discretionary rotation in determining whether a particular judge handles a particular case. The system went to that to avoid the perception that you know "hanging judges were handling all of the particular kind of case." What is the mechanism for determining which three BPMC members will be assigned to a particular case?

MR. GRAZIANO: The written testimony that we provided provides a description in terms of the process for selection of committee members. I can sort of go through in detail or briefly describe it. Whatever your pleasure.

ASSEMBLYMAN GOTTFRIED: Well if you could briefly describe it.

MR. GRAZIANO: At the discretion of the board chair on an annual basis he will canvass the board members for interest in serving on investigation committees. Those individuals who so opt to participate on ICís are scheduled for a three year term. They are rotated based on availability, or selected based on availability.

Based on, in addition to availability they are also selected based on their particular expertise that the case may be presenting with. In other words if the physician has a specialty in cardiology we will certainly make every attempt to have at least a cardiologist on the IC.

But I think those are pretty much the two significant criteria specialty in terms of the area thatís being investigated. As well as, Iím sorry I am talking about hearing committees, as well as availability.

ASSEMBLYMAN GOTTFRIED: What if any protection is there for against the practice of selecting people maybe ostensively on the basis of their expertise but perhaps in reality on the basis of their consistency or lack of consistency in ruling with the staffís recommendations? How can you, and I donít know whether you would agree that it would be inappropriate for people to be either chosen for or excluded from committees based on their history of ruling for the prosecution as opposed to the defense. But I would think certainly many people would agree that that practice would be improper. What safeguard is there against that practice?

MR. GRAZIANO: We would agree. I think one of the safeguards we have in place is that we do not track the decisions of board members in cases to use that information if you would for what I would refer to as a bias selection. We do not track that information internally nor make decisions based on it.

ASSEMBLYMAN GOTTFRIED: You may not keep a statistical record of it but I would be surprising to me if you wouldnít, if somebody in OPMC didnít have a notion of who were the hanging judges and you werenít so to speak.

MR. GRAZIANO: I again in terms of the process that we utilize and the individuals that actually canvass board members for availability they are not primary staff that is associated if you would with the hearing process. I donít think they would have that type of information available to make those kinds of determinations. But I think it is Ed Hock in terms of the selection process.

ASSEMBLYMAN GOTTFRIED: When a licensee is dissatisfied with a ruling at some point in the process by the administrative law judge is there any mechanism in the course of the proceeding for getting any formal process for getting a review of that ruling either from a superior of the ALJ or elsewhere in the department other than letting the case run itís course and then taking it to court.

MR. BERENS: Only the latter alternative is available.

ASSEMBLYMAN GOTTFRIED: What would be your response to the notion of creating some procedure during a proceeding for appealing such rulings not to the courts but internally within the department whether it would be to a senior ALJ or to some review mechanism.

MR. BERENS: I would be wary of the additional time that that would add to proceedings.

ASSEMBLYMAN GOTTFRIED: Okay. But that would be your concern?

MR. BERENS: Iím sorry I didnít hear if you spoke at the same moment.

ASSEMBLYMAN GOTTFRIED: That would be your concern the delay that it might create?

MR. BERENS: I would be wary of that. There is also the issue of the independence of the ALJ to perform his or her role in the course of the hearings. They are certainly subject to review by the courts after the proceeding has been completed. I think the opportunity for the appearance or in some cases the actuality of interference with the ALJís independence would not be good for the objectivity of the process.

ASSEMBLYMAN GOTTFRIED: Okay. Last thing I want to raise is the question of efforts to divert cases from the full disciplinary system where alternative resolutions might be better.

For example in the case of so called impaired physicians. Physicians with a drug or alcohol problem. We have a power or mechanism that doesnít involve the department. It involves an impaired physician committee run by the medical profession that diverts such cases and helps get people into treatment etc.

It would seem to me it would make sense to divert appropriate cases early in the process for reeducation, retraining, monitoring, what have you. Is there, I donít believe there is, is there any mechanism for diverting case sin that way and how commonly is that done and could we not do more to divert cases early through a consensual process to some form of a merely irrational mediation rather than having it running them through the disciplinary process sand having retraining etc. only at the conclusion of that process.

MR. GRAZIANO: I think there is a number of instances where that in fact occurs through what is referred to as the administrative warning process. In many instances physicians will be strongly encouraged, strongly advised to seek some remediation, some additional education based on the information uncovered during the investigation and presented to an IC based on the recommendation from the investigative committee to the executive secretary of the board. That information is usually conveyed to the responded physician.

ASSEMBLYMAN GOTTFRIED: But that happens at the investigation committee stage?

MR. GRAZIANO: The investigation committee has to issue that recommendation.

ASSEMBLYMAN GOTTFRIED: Is there some reason why you might not be able to make such arrangements long before anything has gotten that formal?

MR. MURPHY: Sometimes if that is the situation we will bring the case very quickly because the use of the investigative committee in an administrative warning is supposedly a protection to the doctor. The director canít do it by himself but he needs their concurrence. Often times that case could rule very quickly through the process of saying we want to issue an administrative warning or a consultation.

The other thing we do have under the statute is a 237 team monitoring which is a non-disciplinary situation in which with the consent of a physician where the director can work out a monitoring situation. Itís not disciplinary so itís not public and I think thatís the kind of thing you were talking about. Possibly you got a physician whose skills were somewhat questionable, can we get him in, keep a look at this physician and get their skills back to a position where they should be able to practice.

ASSEMBLYMAN GOTTFRIED: But at what point in a process in case can that mechanism in the statute be brought to bear?

MR. MURPHY: It would probably depend upon where both the parties are in terms of the investigation is kind of played out that we know what it is and the physician is at a point where they will agree to that. So itís an agreement situation. We try in most of our cases to make contact, if there are attorneys involved to make contact with our attorneys, discuss cases and see if we can resolve them. We look to resolve, we resolve many of our cases and we try to do that in some kind of a negotiated fashion. We feel any lawsuit or any matter the negotiated situation is usually the best because everybody understands what they are going to get and in many, many cases particularly when we are talking about fashioning some particular discipline and remediation for a particular physician we put our physician monitoring people in place and they can often work out a much better situation on how this particular physician needs to be retrained. Needs to monitored. Maybe needs practice supervision. Or whatever that particular aspect of it is. We do that as often as we possibly can.

ASSEMBLYMAN GOTTFRIED: But itís your understanding of the statute that that can all be done early, at the earliest stages of the proceeding?

MR. MURPHY: We can do it by consent anywhere along the proceeding.

ASSEMBLYMAN GOTTFRIED: Okay.

MR. MURPHY: As long as there is consent amongst, in order to resolve a case from a consent point of view the director, the chair in the Division of Legal Affairs must agree to it. Thatís kind of a checkered balance on that.

ASSEMBLYMAN GOTTFRIED: Okay. Thatís the extent of my questions. Any other questions?

ASSEMBLYMAN SULLIVAN: I just have one. Just to sum up. If during a proceeding as a result of gathering together evidence it becomes clear that such and such a standard is expected of doctors in a certain situation than a doctor could rely upon that finding by OPMC in determining what he should or shouldnít do in a similar situation. Is that correct?

MR. BERENS: If the situation is indeed similar in time and as medical knowledge changes and as the particulars of the individual patient change. But yes if the cases are otherwise similar the physician should expect that that would be the standard that would apply to both.

ASSEMBLYMAN SULLIVAN: If the accused physician or the physician complained about cited that standard that would exculpatory, wouldnít it? Would it not? There wouldnít be any need to go further would there?

MR. BERENS: If the cases were indeed similar yes you are correct.

ASSEMBLYMAN GOTTFRIED: Okay. Thank you.

MR. BERENS: Thank you for the opportunity.

ASSEMBLYWOMAN MAYERSOHN: I have one more question. I really just want you to think about this. How many doctors have been disciplined who have dismissed patients and havenít given them enough treatment for Lyme disease? Itís really something that has been bothering me. I know the disciplinary actions that have been taken on the other side. I want you to think about the patients that have come to us and said my doctor dismissed my symptoms. My doctor said there is nothing more he could do about it. I would like you to think about whether those doctors should be disciplined or a message go out that thatís not good enough.

MR. BERENS: We will.

ASSEMBLYMAN GOTTFRIED: Thank you. Just a word or two about our process from here on. First I will assure you that I donít think any other group of witnesses will occupy us for almost three hours. I do think that the time that we spent with the department was well worth it.

Just to remind everyone both the witnesses and ourselves. We have got a lot more people whose testimony we need to hear. I would remind each of the witnesses that they should limit their initial presentations to not more than ten minutes. People who can edit their testimony down to less than that will get our heartfelt appreciation. Hopefully we will try to restrain ourselves in our questioning of each of you. If and when you testify and you are not blessed with an hour or so of questions you have to promise not to feel bad about that. That doesnít mean we didnít find your testimony interesting or valuable. That was going to be my next point.

Before we proceed with our next group of witnesses we are going to take a hopefully not more than five or ten minute break so we can all stand up and stretch our legs and do whatever else we would like to do.

(Whereupon at 1:17 P.M. the Public Hearing on the Disciplinary Process of Physicians and Physician Assistants was in recess.)

ASSEMBLYMAN GOTTFRIED: We are going to reconvene in a couple of minutes.

(Whereupon at 1:35 P.M. the State Assembly Hearing on Disciplinary Process of Physicians and Physicians Assistants was reconvened.)

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