Physicians Under Siege: Navigating the Legal Hurdles
Breakfast With the Experts
Michael Goldstein, M.D., J.D.
115 East 61 st Street
New York, N.Y. 10065
Most of us who practice medicine are concerned with two main aspects of our professional lives. The first being the providing of quality 21 st century medical care. The second is to maintain an adequate cash flow to run our offices and support our families. Everything else is of secondary importance.
By ignoring these secondary factors we have both allowed for their expansion and have sometimes become thrust unexpectedly into a hostile world whose rules we don't understand and with potentially devastating consequences.
As a physician who has recently become an attorney I have been involved in defending doctors from the external forces that place their livelihoods, liberty and reputation at jeopardy.
Physicians must understand that they can be the subject of attack from their patients, licensing agencies, Hospital Boards, insurance companies, the Inspector General of the United States, and the FBI.
Surviving attacks from these powerful entities requires both pre-emptive defensive strategies and aggressive and competent immediate legal advice. The other side knows the rules and knows a lot about you before they ever contact you. You can easily be blindsided and manipulated into un-defensible positions.
The first step is to understand the nature of the entities that can impact your license, liberty and economic survival.
The second step is to understand the ground rules by which these entities operate.
The third step is to re-engineer your practices to protect yourself in the event you become a target.
The third step is when investigated or sued to mount the most aggressive pro active defense as soon as possible.
The subject of this course could easily be the topic of an entire seminar. Unfortunately we only have one hour to enlighten you. We will do so by presenting an overview, give you specific examples of what can happen and share some of our own personal experiences.
It is our hope that you will never need the information taught in this course. But if you do we believe that this course will help you survive against the types of attacks described in the course material.
Michael t. Goldstein, M.D., J.D.
PHYSICIAN DISCIPLINE BY STATE LICENSING BOARDS
State licensing boards are overwhelmed with complaints. For example New York and California each receive over seven thousand complaints per year. Of that seven thousand approximately four hundred result in charges. Of those that are charged approximately one third loose their license. Any disciplinary action can result in you being removed from your hospital staff and being delisted from all insurance companies which you have participation agreements. Being disciplined can put you out of business. The goal of anyone being investigated is to be among the over 90% who are never charged. To some extent it depends on the nature of the complaint but it also can depend on you.
Some of the complaints are absurd. People will file complaints if they have waited too long in your office. They will file complaints because they were charged a fee for something that they felt should have been covered by their insurance.
In the first stage the absurd complaints are thrown out. The investigators then need to look more carefully at the claims that warrant further investigation. It is a manpower issue. Investigators have produce results and wasting their time on weak complaints diverts them from focusing on the complaints that will lead to charges.
The main sources of complaints are: patients, insurance companies, malpractice settlements or verdicts, self initiated complaints, discipline in another state, convictions for a felony or misdemeanor, and colleagues.
Tip: Never talk to an investigator from a regulatory agency without a lawyer. You can inadvertently box yourself into an indefensible position.
Tip: There are three things you must avoid when talking to an investigator.
Do not say any stupid including things that will expand the scope of the investigation. If you are being investigated for the care and treatment of one patient do not volunteer that you gave the same treatment to 100 other patients.
Never lie to an investigator. They will ask you questions that they know the answer to and if they catch you lying your credibility and license are in trouble.
Do not alter medical records. They probably already have a copy and if you change them you are going to be disciplined. It is impossible to defend against altered records but you can defend bad records.
DISCIPLINE BY ANOTHER STATE
If you have been disciplined in another state you are presumed guilty of the charges for which you have been disciplined. The only issue is whether or not the state will charge you and what will be the punishment. If you do not like the punishment being offered you will have to hire a lawyer to plea bargain a better deal.
Tip: If you have medical licenses that you obtained from states where you no longer practice and no longer intend to practice arrange to get rid of them.
Every conviction by every state is a reportable event which goes to the National Practitioner Databank and must be reported to every state where you have a license, every hospital where you have privileges and every insurance company who has credentialed you.
CONVICTION OF FELONY OR MISDEMEANOR
If you have been convicted of a felony or misdemeanor you are obligated to report the conviction to every state where you have a license, every hospital where you have privileges and every insurance that has credentialed you. Failure to do so can result in you being charged not only for professional misconduct because of the conviction but also for failure to notify these other entities.
In these cases guilt is not the issue the only thing you can do is hire the best lawyer you can obtain. Explain the circumstances of your conviction in the most favorable way possible. Try to explain that it was an aberration due to so extraordinary circumstances and negotiate the best deal possible.
Every malpractice case that you loose or settle is reported to the state licensing agencies. You also have a duty to report it to hospital staffs and insurance companies.
The good news is that loosing or settling a malpractice case is not proof of professional misconduct.
Tip: There are different legal considerations in a malpractice case than there are in a professional discipline case. Some malpractice lawyers do not know this distinction. If yours does not know the difference then use a different lawyer for your licensure case.
Once your case has attracted the attention of the licensing board you must engage in an effective self defense.
Your goal is to convince the licensing agency to close your case and move on.
In some states there is an opportunity to meet with the investigators and possibly give written responses to the areas of inquiry.
Prior to such meetings or responses you must be well prepared. If it is an issue of patient care, know the chart cold. You should know the relevant medicine cold. You should do literature searches and read the latest literature on the subject. You should have literature based defense for your clinical actions. If you know more medicine than those are investigating you then your chances are much better.
You must be proactive in your defense. Do not rely on your lawyer. The know the law but not necessarily the medicine. You must know the medicine and teach it to the lawyer who is aiding in your defense.
Tip: If you have actually done something wrong at some point you will have to admit it. You and your attorney will have to develop a strategy to minimize your mistake. You should also pro-actively tell the investigator of your plan to prevent the same problem from happening in the future.
Tip: Licensing agencies do not apply the law equally to everyone who has committed the same misconduct. For committing the same misconduct one doctor will not be charged, another will be disciplined and another could have their license revoked. This is called prosecutory discretion.
EXAMPLE: CASE OF NY CATARACT SURGEON
1998 Surgeon enters into a plea bargain agreement essentially admitting that he improperly worked up two patients for cataract and improperly recommended surgery to two patients.
His plea bargain agreement was a two year stayed suspension with a practice monitor.
In October, 2007 he was charged for a similar offense regarding one patient. He had followed the patient for a period of time and recorded a worsening of vision and the progression of cataracts. He treated this patient from January, 1992-May, 2005. He recommended cataract surgery and performed an A Scan. The patient was referred to a internist who did not see a cataract with his direct ophthalmoscope and referred the patient to another ophthalmologist for a second opinion. The second doctor found a spectacle corrected visual acuity of 20/20 and did not find a cataract.
This hearing panel articulated a standard of care for the diagnosis and treatment of cataracts. According to their findings cataracts can only be determined by dilated exam (except of course by the internist who can do it with a direct ophthalmoscope). If a patient has 2+ nuclear sclerosis and their vision cannot be improved by refraction then other causes of vision loss must be explored.
The doctor was convicted of negligence in more than one occasion. One of those occasions is the performance of an unnecessary test the A Scan.
The Hearing Panel concluded that the doctor flouted the standard of care and set an unacceptably low threshold for cataract surgery. Their penalty was a $20,000 fine and the doctor was barred from performing cataract surgery for one year.
The prosecutor appealed the case and requested that the doctors license be revoked. In New York the appeal goes to an Administrative Review Board. In some other states it goes directly to the Board. It is not uncommon for these boards to meet out harsher sentences that the hearing panel or hearing judge.
In this case the Administrative Review Board revoked this doctors license. The basis of the revocation was twofold first the protection of the public from a doctor who they believed was doing unnecessary surgery and second was their belief that since he had done this before and was a repeat offender he deserved no mercy.
This case is disturbing for several reasons. Some of the evidence that was accepted is absurd. An ophthalmologist needs to perform a dilated exam to diagnose a cataract while an internist can do it with a direct ophthalmoscope. The second problem in this case is that the doctor, according to his website, determined that the patient had a 20/20 spectacle corrected acuity is a LASIK surgeon. He does not even mention that he does cataract surgery on his website. The hearing panel seems to imply that if there is a change in vision a refraction must be done. Refractions are not covered by Medicare and there becomes a cost issue and the possibility of patients complaining of unnecessary treatment. There is a need to look for other causes if the vision declines. This can be a two edged sword. The testing for these other causes is reimbursable but only if necessary. Here the licensing agency is saying that it is necessary but the insurance company or Medicare could disagree. This puts the doctor in an uncomfortable situation. The final problem is that visual acuity measurements are subjective and testing conditions vary.
The panel consisted of a internist who obtained his medical license in 1963 , an ophthalmologist who finished his residency in 1982 and became board certified in 1990 and a layman.
The most absurd part of this case is that in New York you can only be disciplined if there are at least two instances of professional misconduct. In this case the second incident of professional misconduct which enabled this case to prosecuted was the A scan which was described as an unnecessary test. Without the A scan this doctor could not have been charged. Draw your own conclusions.
Administrative law is not like the courts that you see on television. The law is divided into civil law and criminal law. In criminal law the defendant has the most rights. The standard of conviction is "beyond a reasonable doubt". There are special rules that exclude evidence that is generally considered hearsay. You have the right to confront witnesses.
Administrative Law is civil law but with even less rights.
In civil law you must be proven guilty or responsible with a "preponderance of evidence" . This means that there is a greater than 50% chance that you are responsible. If there is a jury you help pick it. Hearsay evidence is excluded.
In administrative law the government conducts the investigation, the prosecutor and the judge all work for the government. There is an appeal process that can be used by both the prosecutor and defendant. The appeal board can overturn or enhance the conviction and the punishment. These appeal boards are more favorable to the prosecutor than the physician.
The standard of evidence is low, hearsay and other garbage evidence can be admitted. You do not necessarily have the right to confront your accuser. If a patient files a complaint against you that patient may or may not testify.
The judge or other decision maker is biased in favor of the agency. Even though it is the responsibility of the prosecution to prove the case in reality it becomes your obligation to prove your innocence. You are supposedly presumed innocent but in reality your are assumed to be guilty.
Frequently you are better off avoiding a trial. The goal is to plea bargain the best deal possible. If you cannot live with the plea bargain then go to trial but do not be surprised if you loose.
There are three types of appeals.
The conviction was wrong
The government misinterpreted the law or violated legal rules
The punishment is too severe.
Convictions are divided into "Findings of Facts", "Conclusion of Law" and "Penalty".
FINDING OF FACTS
If you believe that the Administrative Law Judge misinterpreted the facts or that he/she came to the wrong conclusion regarding the quality of care that you provided your chances of appeal are slim. This type of appeal is based on the fact that there was an error in the "finding of facts" portion of the decision. Courts will almost never change the finding of facts. Their argument is that the Judge was there. He could see the witnesses, their faces and body language and know who to believe. If it is a standard of care issue the courts will defer to the agency who has expertise in the standard of care and not claim that they have superior knowledge.
CONCLUSIONS OF LAW
In this portion of the conviction the Judge is applying the law to the facts. If the judge applies the law incorrectly or misinterprets the law you can appeal to the courts. If the judge improperly admitted into evidence, pieces of evidence that affected the outcome of the trial this too can be appealed. These are the main areas that an appellate court will overturn a conviction.
Courts will almost never overturn a penalty unless it is so shocking to justify modification. It doesn't matter that 90 other people convicted for the same act received lighter penalties. The standard is not one of comparing yourself against others.
CONSEQUENCES OF DISCIPLINARY ACTIONS
You have lost your license to practice medicine. You cannot see patients you cannot earn a living as a physician. If you are licensed in other states they will be notified of your conviction. Each state will them accept the conviction and decide its own penalty. Not all states will revoke your license if they have stricter standards for revocation.
For a limited time you cannot practice. During that time you must have coverage for your patients. You must notify all hospitals, all states where you are licensed and all insurance companies of your suspension. Most likely they will revoke your privileges and de list you from their panels. Each state where you are licensed will look at your conviction and decide what to do. Some states will impose harsher penalties and some will impose lighter penalties. Once your suspension is over and perhaps before you should try to get re-instated by insurance companies and hospitals. You will need expert legal advice. Every reinstatement has to be fought separately and you could loose. You could wind up with a license but not hospital privileges and de-listed from every insurance company.
Your license has been suspended but part or all of the suspension is stayed. During the portion of the stayed suspension you can still practice. There might be conditions imposed on your practice. You may have to take courses. You may have a practice monitor. You may be restricted from providing certain services, ie. no surgery for one year. You must notify all the insurance companies, all states where you are licensed and all insurance companies. Here too your hospital privileges will be revoked and you will be delisted from all insurance companies. Because this penalty is less severe you have a better chance of being restored to insurance panels and hospital staffs. You need a good lawyer and each insurance company and hospital must be dealt with separately.
LETTER OF REPRIMAND
This is the lightest of penalties. You do not loose you ability to practice medicine. You must notify all the insurance companies, all states where you are licensed and all insurance companies. Here too your hospital privileges will be revoked and you will be delisted from all insurance companies. Because this penalty is even less severe you have a better chance of being restored to insurance panels and hospital staffs. If you are lucky, some insurance companies and hospitals may not revoke or de-list you.
These are usually private, non published letters that in at least some states are not considered disciplinary in nature. You may not have to disclose this and your career may not be affected. However if you are ever investigated for the same misconduct for which you have been given a pass they will not give you a second pass.
THE CIRCLE OF PAIN
You must disclose everything to all concerned parties. If you have been removed from a hospital staff or de-listed from an insurance company you must notify every state where you have a license. You must notify all hospitals where you have privileges. You must notify all insurance companies. If you fail to do any of this then you could be charged for failing to do so.
Malpractice is the dark side of patient care. Every patient is a potential malpractice litigant. The value of a malpractice case can be in the millions and bears no relationship to the fees charged by the physician. An exceedingly large malpractice verdict can exceed the policy limits of the insurance and create devastating financial hardships for the physician. In the 21st century physicians must factor malpractice risk into their diagnostic and treatment decisions.
ELMENTS REQUIRED FOR MALPRACTICE
In order for a plaintiff to be successful in wining a malpractice suit all of the following elements must be met.
Breach of Duty
Causation in Fact
If all these elements are not met the malpractice suit cannot be one. As a defendant all you have to do is prove that at least one of these elements have not been met.
Each physician who treats a patient had the duty of care of a reasonable physician under the circumstances. The care does not have to average or above average it only has to be reasonable. However if you hold yourself out as being an expert then you are held to the standard of an expert.
BREACH OF DUTY
The care that you have rendered is not what a reasonable physician would have done under the circumstances. That can include the failure to perform tests that a reasonable doctor should have done. It can be failing to properly do pre-surgical evaluation, or operating on a person who should not have had surgery. It can include surgery that was performed so poorly that it falls below the standard of a reasonable physician. You do not have to be the best or even average. You can be below average otherwise below average physicians which constitute an large number of physicians would always be committing malpractice.
However experts are held to the standard of an expert. If you are an expert you are held to a higher standard. If you are not an expert do not represent yourself as being one.
CAUSATION IN FACT
But for your actions the damages would not have occurred.
Your actions are the cause of the damages. If something else caused the damage you are not guilty. For example if on the way home from surgery you patient is shot in the eye and the patient is now blind from the shot you are not the proximate cause of the patient's blindness.
As a consequence of your actions the patient is harmed and all of the above elements are met then you are liable for damages. Sometimes you get lucky. For example due to negligence and not due to a complication you drop a nucleus into the vitreous. Before the surgery is finished a vitreoretinal surgeon joins you and removes the dropped nucleus. You successfully implant an IOL and the patient has an uncorrected vision of 20/20 you are ok. You were negligent, and met all the elements except damages. The patient was not harmed and there is no malpractice.
ANATOMY OF A LAWSUIT
Long before you receive any legal papers pertaining to a lawsuit a lot of events have taken place without your knowledge. Your disgruntled patient, who may or may not have a lawsuit has consulted an attorney.
Malpractice attorneys are not good Samaritans they are in the litigation business. The first question that they ask themselves, is that if everything the patient has told them is true what is the economic value of the lawsuit. Malpractice attorneys typically charge 1/3 of the value of the case , after expenses, provided that they win. The second question they ask is how much money do I have to spend on this case. If the value of the case is too low or the amount needed to pursue the case is too high the attorney will refuse to take the case. In large cities where the costs of litigation are high the threshold value of a case to a good attorney is between $500,000 and $1,000,000. Less skilled and less experienced attorneys will take cases that are worth considerably less than that.
If the attorney believes that he might be interested in the case he will obtain a copy of the records and send the records to be reviewed by a physician expert.  If it is necessary the attorney will have the patient examined by his expert. Based on the expert's analysis the attorney now knows the true damages. The attorney from his conversations with the plaintiff knows about the other damages, pain and suffering and economic loss. The attorney can now, based on personal experience and case searches know the value of the case. If it is too low then the attorney will decline the case. If the case has promise the attorney will go forward.
Another deciding factor in pursuing the case is venue. Venue is where the case can be filed. Cases can be filed where the doctor's office is located or where the patient lives. The outcome of case can depend on where it is filed. Some courts are very conservative and physician friendly and others view malpractice litigants as lottery winners. As the doctor you want case tried in a conservative pro physician court.
Based on all the above information the attorney looks at costs, probability of wining and the value of damages. If the numbers work the attorney goes forward if not he withdraws.
If the attorney has decided to roll the dice and sue you it is your responsibility to develop the most pro active aggressive defense that is possible.
The first step in the litigation is legal paperwork. You are served with a summons and complaint. Your attorneys respond with an answer, which must be filed within the statutory limitations.
The next step is the deposition process. This is part of what is called the discovery process. Your attorney has the opportunity to question the plaintiff. You need to know the nature of the injuries being claimed and why you caused them. It is then your turn to be deposed by the plaintiff's attorney. They want to size you up. They want to know what kind of witness you will be. They want to know whether or not the jurors will like or hate you. They want you to make dumb statements that they can use against you. The want you to make statement of facts or opinion that are not in your interests. You must be well prepared by your attorney for the deposition. Your attorney must be able to anticipate the questions you will be asked and prepare you to answer these questions. If you feel that the attorney is not spending enough time to prepare you or is not doing a good job you should replace your attorney. Depositions will also be taken of the experts in the case (except New York and a few other states).
Once the discovery process is complete both sides should have a good idea of the value of the damages, the causation and the probability that each side has of winning.
Based on that evidence the case is either dropped, settled of scheduled for trial. If you go to trial you need to be there every day. You need to show the jurors that you are concerned. You must come across as a caring concerned physician who did the best you could. Do not come across as arrogant or obnoxious or angry. According to many trial lawyers if the jury likes the doctor his chances of winning are much better.
LASIK malpractice is a good example to understand the problems and pitfalls of our malpractice system. The plaintiffs are usually young the damages can small or huge. There are structural problems with the procedure. These include the fact that the surgeon is frequently not doing the preoperative work up, co-management is common, underlying diseases can be missed and the marketing can misrepresent the procedures benefits without adequately disclosing the risks.
On the internet you can find; postings by attorneys who have won large malpractice settlements in LASIK case; blogs from unhappy patients; and supposedly consumer friendly pages linking websites about bad outcomes. Below are examples of attorney posted malpractice "victories". 
In the past few years alone, our New Jersey malpractice attorneys have had extensive success in Lasik malpractice cases, recovering millions of dollars for our clients. In fact, we won what is believed to be one of the largest Lasik malpractice recoveries in New Jersey history, a $2.1 million Lasik malpractice settlement. The following are other examples of our Lasik recoveries:
"Often, a person who was not a proper candidate for the surgery to begin with, due to factors such as the shape or condition of the cornea (i.e., keratoconus, pellucid marginal degeneration), high levels of myopia (nearsightedness), or large pupil size, was not carefully evaluated or told the true surgical risks. Poor outcomes can also result from a lack of proper attention to post-surgery issues, such as inflammation, infection, and uneven corneal tissue.
If you or a loved one has been the victim of Lasik malpractice, please contact New Jersey Lasik malpractice attorney... and... he will contact you within twenty-four (24) hours to discuss your Lasik malpractice case. "
More examples of internet posted cases will appear in the discussion.
OMIC is a nationwide malpractice carrier that is associated with the American Academy of Ophthalmology. Their website posts a large amount of information about LASIK malpractice. OMIC breaks LASIK malpractice suits into four categories: Clinical Issues, Systems Issues, Provider Issues, and Patient Issues. 
Clinical issues were present in 42% of all the claims. Of the clinical issues, 79% involved preoperative issues. These consisted mostly of contraindications to surgery, including, form fruste keratoconus, pellucid corneal degeneration, other corneal problems dry eyes and pupil size. 
In fact according to OMIC 50% of the LASIK settlements in 2006-2007 involved ectasia. This is caused by forme fruste keratoconus, pellucid degeneration or leaving too thin a posterior corneal bed.
An example of a internet posted LASIK ectasia case appears below.
"Dr. ... Successfully Sued for Medical Malpractice
Westmoreland Man Wins in Eye Surgery Lawsuit
A North Huntingdon man won more than $1 million in a malpractice lawsuit in which he contended his laser eye surgery was botched.
A jury in Allegheny County Common Pleas Court on Wednesday ordered Dr W., of Rockville, Md., to pay $850,000 to David N. Cantalupo, on whom the doctor performed surgery in 2001 at The Laser Center in Wexford. Mr. Cantalupo also received settlements from three other defendants named in the suit --The Laser Center and two optometrists -- bringing the total he is to receive to more than $1 million.
According to the lawsuit, the surgery left Mr. Cantalupo with permanent eye damage.
In his lawsuit, Mr. Cantalupo said he has unusually thin corneas, which makes LASIK surgery, in which the cornea is reshaped by a laser, more risky. The lawsuit contended that doctors knew about Mr. Cantalupo's thin corneas but never told him of the risk.
Dr. W. is best known for performing laser surgery on golfer Tiger Woods." 
Co-management combined with failure to diagnose pellucid degeneration can lead to malpractice.
In this OMIC case a patient had multiple visits to an optometrist who performed multiple corneal topographies as part of his evaluation of the patient. The patient was eventually referred to an ophthalmologist for LASIK and the optometrist only sent the last topography. The ophthalmologist performed his own topography and it was normal. Post LASIK ectasia developed and litigation followed. During the discovery phase of the lawsuit the ophthalmologist for the first time became aware of the optometrist's other topographies which, although normal, showed a pattern of progressive steepening of the inferior cornea. Had the ophthalmologist seen all the topographies pre-operatively he would have been able to diagnose pellucid degeneration. 
Altered records and a failure to diagnose forme fruste keratoconus.
"$5.6 MILLION LASIK EYE MEDICAL MALPRACTICE VERDICT. On Wednesday, June 10, 2009, a jury in New York City returned a verdict of nearly $5.6 million against Dr. N ., for LASIK malpractice. The verdict consisted of an award of: $2,360,000 for the patient's loss of income; $3,100,000 for the patient's pain and suffering, including loss of life's enjoyment; and $120,000 for the patient's wife's claim for loss of her husband's services and consortium. This is the second largest verdict ever for LASIK malpractice...
The plaintiff, Johnson Devadas, is a pharmacist who lives and works in Queens, New York. On March 25, 2004, Dr. N. concluded that Mr. Devadas was a suitable candidate for LASIK surgery. However, plaintiff's medical expert testified that he was not. Paul Donzis, M.D., and ophthalmologist and cornea specialist from Los Angeles, California, testified that prior to the elective surgery, the plaintiff had a contraindication to LASIK surgery, forme fruste keratoconus...
In addition to Dr. Donzis, plaintiffs called Albert Lyter, Ph.D., from Raleigh, North Carolina. Dr. Lyter is a former federal agent trained in ink dating analysis. Dr. Lyter testified that Dr. N. intentionally artificially aged a note in his chart concerning his purported conversation with the patient and his wife concerning the risks, benefits, and alternatives to LASIK surgery."
INTRA-OPERATIVE AND POST-OPERATIVE ISSUES
Intra-operative issues are events that occur during the surgery they include: flap creation issues, wrong settings, decentration and equipment malfunction. The most common intra-operative issue were related to flap creation (49/101 cases) and misidentification or laser setting issues ( 18/101 cases). Flap creation can be a technique related problem, a complication or a result of equipment malfunction. Programming the wrong settings or programming the settings for the wrong patient is the result of carelessness. It is important to remember that regardless of who enters the operative data into the computer it is still the surgeon's responsibility to make sure that the information is correct.
Post-operative clinical issues are events that occur after the surgery and include: corneal complications (79%), negligent diagnosis and treatment of post LASIK ectasia, infections and inflammations, flap issues, epithelial defects, epithelial ingrowths and central islands. It is important to emphasize that it is the surgeon's responsibility to ensure that the patient is properly managed post-operatively. If that surgeon delegates post-operative management to someone else the surgeon is still responsible for the damages resulting from the mismanagement of the patient's condition. Surgeons should not release a patient to the care of another until they feel that it is medically, not economically, appropriate to do so.
Systems issues include: medical device and equipment issues, equipment malfunction during flap creation 30%, informed consent 28%, co-management 23%, and patient misidentification 11%. Flap creation issues can be both intra-operative issues and systems issues. When it is due to malfunction of the equipment it is more likely a systems issue. Obtaining proper informed consent is required before all surgical procedures. It is the responsibility of the surgeon to ensure that proper informed consent is obtained and documented. Surgeons should not be so busy as to not have the time to ensure that proper informed consent is obtained, that the patient's questions are answered and that everything is properly documented.
Of all the systems issues, co-management is the most problematic. One of the many problems with co-management is that busy surgeons rely on others to do the pre-operative work up. However, regardless of who did the work up the surgeon is still responsible for the misdiagnosis of a pre-existing condition. An example of improper preoperative work up performed by someone other than the surgeon involves Dr. B.
"TLC Pays $900,000 to Settle Malpractice Lawsuit Against Dr. ...
Using assembly-line-like procedures, TLC-employed optometrists oversaw initial testing procedures, pre-qualified patients for surgery, and then lined up surgical candidates upon whom Dr. B. would fly in to operate. Surgery was performed on both of Judge Hoch's eyes on the same occasion.
By all accounts, Dr. B's surgical technique was flawless. By Dr. B's own candid admission, however, Judge Hoch never should have been operated on at all. The screening tests conducted by TLC and provided to Dr. B. for review before surgery showed that Judge Hoch had a condition called keratoconus - irregularly shaped corneas - that disqualified him for LASIK surgery. Instead of improving Judge Hoch's vision, the surgery triggered a series of worsening vision problems that led to legal blindness in one eye that could only be improved - though not completely cured - by a corneal transplant. The need for at least one additional corneal transplant in the other eye is expected.
TLC agreed to pay $900,000 to settle the portion of the case directed against it. Trial preparation for the case against Dr. B. continued until a separate negotiated settlement was reached with Dr. B's liability insurance carrier." 
The AAO and the ASCRS have issued a joint position statement on co-management. The ophthalmic surgeon has primary responsibility for the preoperative management and post operative care of his/her patient regardless of the type of surgery performed. The decision to co-manage should be the result of a determination of what is best for the patient and not economic considerations. 
In the event that the ophthalmologist needs to co-manage with an optometrist the ophthalmologist should verify and document that the optometrist(s) has the appropriate, education, training and skills to follow the patient post-operatively. 
This statement is not officially the standard of care but raises important legal considerations. It can be hard to argue that it is in the best interests of the patient not to have his surgeon manage him/her post-operatively but instead to have the care delegated to an Optometrist. In addition to this policy statement there are other problems with the co-management arrangement.
In a trial juries will look at the co-management arrangement. Of concern is the fee arrangement. If the co-management fee is higher than average it could be viewed as an incentive to refer the patient to the higher paying doctor. The staff of both the Optometrist and the Ophthalmologist can questioned during discovery. The entire chart of the co-managing Optometrist can be discovered. Is there information in the Optometrists chart that you should have been aware of before surgery which you are now discovering for the first time during litigation. Finally the co-management arrangement could be viewed as a joint venture. Co-management could if it also involves cataract referrals could violate Stark Anti Kickback laws.
Physicians must incorporate malpractice issues in all their clinical decision making and be aggressive pro active defendants.
All malpractice settlements and verdicts must be reported to, state licensing agencies, hospitals and insurance companies that you contract with.
PRIVATE INSURANCE COMPANIES
Recovery audits are actions by insurance companies to recover monies paid to physicians in error. The two most common reasons for recovery demands are that the procedures performed were not medically necessary or that there is insufficient documentation to prove that the procedure was ever performed.
The audit usually begins with the insurance company requesting a representative sampling of charts that can vary between 25 and 100 charts or perhaps more. The charts are sent to an auditing company for review. This company which has been selected by the insurance company conducts the audit on their behalf. They send a copy of their report to the insurance company which then analyzes the report. The report will take each procedure code in question and generate statistics with regard to what percentage of those procedures were not medically necessary or inadequately documented.
The insurance company then calculates the number of times that procedure was performed during the look back period and calculates the number of claims that should not have been paid and asks for a refund. For example if there were 2000 claims for service during the look back period and 50% were not medically necessary or not sufficiently documented the insurance company would determine that 1000 of those claims should not have been paid. The insurance company would then multiply the 1000 claims by the free for example $100 and then ask for a $100,000 refund plus interest.
The last thing that you should do at this point is write a check to the insurance company for $100,000. If you were to pay the full recovery amount without various legal disclaimers the insurance company could then notify the medical board and if there are federal funds involved they could also notify the Inspector General and or the Department of Justice. This would also open the door for further investigation into other procedures that you perform
Your next step should be to hire a lawyer with expertise in audits and recoveries. Legal advice is not free but with a good lawyer you will be better off. The first issue is the look back period. If it is a state issue then the look back period is governed by state law. For example in New York the look back period is 2 years. If it is a federal issue the look back period is 6 years. The next step is to have the same charts reviewed by you own expert. There is always a difference in opinion between a physician friendly and an insurance company friendly chart audit. If there is a claim that a procedure has not been documented , see if there is any other evidence in the chart that you performed the procedure. Is there a letter to a referring doctor that describes the findings of that procedure. Once all that is done the next step is negotiation. You are negotiating both for the dollar amount and the terms. Specifically you do not want to admit that you have committed fraud. You also want, if not barred by statute to have a confidentially agreement.
If you cannot come to an agreement the next step depends on whether you are a participating or non participating physician. If you are a non participating physician the insurance company has to sue you and go to a real court. You have a judge, you might have a jury. Real courts tend to be fairer than arbitration. If you are a participating physician you are forced to go to arbitration. In arbitration the insurance company picks which arbitration organization they use. Insurance companies can generate a lot of business for an arbitration organization. In a subtle way the arbitration organization wants the insurance company to keep using them. This can result in a subtle bias in favor of the insurance companies. We have seen this problem with objectivity being skewed in the financial industry with "independent" rating companies. Arbitration is also expensive there are hourly fees that are split or paid by the looser. All of this is governed by your provider contract. You should have your provider contracts reviewed by an attorney . As a general rule audit cases , when the parties are close, should be settled and not arbitrated.
Another tool that insurance companies can use against you, is reporting you to your state licensing agency for doing unnecessary procedures. This is a no cost option for them and a big cost , big risk option for you. For example in Foong v. Empire Blue Cross, the insurance company reported the doctor to the NYS OPMC to have him investigated for unprofessional conduct for doing unnecessary GI procedures. 
Another tool insurance companies will use is to remove you from their panel without due process. For example after Foong prevailed with the OPMC the insurance company tried to delist him from the insurance panel without due process. Foong prevailed and the court determined that in New York a physician is entitled to due process before de-selection from an insurance panel. 
Another attempt to remove a physician from a panel was Potvin v. Metropolitan Life.  Potvin was an OB Gyn who had three malpractice cases and settled one for $713,000. Metropolitan de-listed him and he sued. Case went to the California Supreme Court which held that because Metropolitan by de-listing him was depriving him from earning a living he was entitled to due process before this could happen.
De-listing is a real risk and your rights vary by state. In California the Cal. Bus. & Prof. Code 2056 protects physicians for retaliation by an MCO for advocating medically appropriate healthcare. Unfortunately many states do not offer physicians due process rights before de-listing.
FEDERAL RECOVERY AUDITS
Stark Antikickback is a complex law that prevents physicians and other healthcare entities from entering into business arrangements that in all other financial endeavors make good business sense and are perfect legal. Since this issue is too complex to cover in this short course I am and quoting a presentation made at American Bar Association, Health Law Section11th Annual Conference on Emerging Issues in Healthcare Law and published in their course outline.
" Imagine, for a moment, that you operate a business. Imagine that your customers all come to you through being referred by others. Imagine that, in order to increase your business volume, you offer to pay $10 per customer visit to each person who refers you a customer. What happens if you do that?
>>> You go to jail for five years.
Imagine that you need a piece of equipment. Imagine that your business partner owns that piece of equipment and is willing to lease it to you. Imagine that your business partner proposes that the rent you pay for that piece of equipment should increase if your business partner sends more customers to your door. What happens if you make that deal?
>>> You have to pay back three times the money you receive from those customers, plus $11,000 for each unit of service you billed them for.
Imagine that you own a building in a neighborhood where space rents for $20 per square foot. Imagine that building is next to your main business location. Imagine that, in order to make it more likely that your business partners will send you business, you lease them space in your building for $12.00 per square foot. What can you expect then?
>>> Your main revenue source says it won't pay you anymore, you get fined $25,000 AND you go to jail.
At this point, you say to yourself, "What kind of fool would go into business facing those kinds of risks?" The answer, of course, is
• Nursing homes.
• Clinical laboratories" 
This is the nutshell summation of Stark Anti-Kickback. Obviously it is much more complicated but this brief description covers a lot of ground.
RECOVERY AUDIT CONTRACTORS 
Recovery audit contractors are bounty hunters who are assigned a geographic area to audit on behalf of CMS. There purpose is to detect overpayments and underpayments under Medicare and on behalf of the government obtain refunds. Their bounty for recovery is approximately 10%. There is a three year look back date and the maximum look back date is October 1, 2007. There is a complex and multi layered appeals process.
The qui tam process is where a whistleblower sues on behalf of the government to obtain recovery of funds that have been illegally obtained from the government. This is authorized by 31 USC3730(b)
(b) Actions by Private Persons.-
(1) A person may bring a civil action for a violation of section 3729 for the person and for the United States Government. The action shall be brought in the name of the Government. The action may be dismissed only if the court and the Attorney General give written consent to the dismissal and their reasons for consenting.
The whistleblower is someone who has direct knowledge of illegal acts but is not a participant. They usually hire an attorney who works with them. The government can take over the case if it has merit. The whistleblower gets a percent of the recovery.
FALSE CLAIMS ACT (31 USC 3729-33)
The false claims act was initially written under President Lincoln to protect the government from being defrauded. Penalties for violating the Federal False Claims Act can be up to three times the value of the False Claim, plus from $5,500 to $11,000 in fines, per claim. Each HCFA 1500 form is a claim. If you are ever accused of violating this act you can quickly see how fast the dollars add up. Qui tams can be filed under this statute. Run don't walk to the office of the best attorney that you can find.
FRAUD AND ABUSE
Fraud and abuse is a criminal statute where the penalties include imprisonment. In fraud and abuse your actions have become so egregious that they are considered criminal. It is not unusual for there to be both a criminal and civil prosecution occurring simultaneously against you. You desperately need very experienced legal help under these circumstances.
•1. I am a good doctor and I do not have to worry
•2. Hospital Boards that are calling me in for an interview are my friends and colleagues
•3. If I am disciplined or removed from a hospital staff the courts will correct the injustice
•4. If a state licensing agency calls me and wants to chat I should just start talking without legal advice
•5. State licensing agencies are my friend
•6. The doctors on state licensing agencies are my colleagues
•7. The investigators for state licensing agencies are on my side
•8. If I am charged by a state licensing board I have the same legal rights as if I were in a courtroom
•9. If the licensing agency makes a mistake and they revoke my license the courts will rectify the problem
•10. I can change my records anytime I want to and nobody will know about it
•11. My patients love me they would never sue me for malpractice
•12. I am a great doctor who provides wonderful care therefore I could never loose a malpractice case
•13. If I am sued I should call the patient and discuss the suit with them
•14. If I hire a good lawyer I can then forget about the case
•15. If I go to trial I do not have to show up except to testify
•16. The jury doesn't understand any medicine they will believe whatever I tell them.
•17. The legal process is fair and justice will prevail
•18. Once I settle a case it is over and I no longer have think about or do anything about it
•19. One lost or settled lawsuit does not invite other patients to sue me for the same thing
•20. If I am a LASIK surgeon I am not responsible for the quality of the preoperative work up or post operative care
•21. Co-management with an Optometrist is risk free
•22. Co-management arrangements regarding LASIK surgery never violates the federal anti-kickback statutes
•23. The settlement value of a malpractice case has nothing to do with the age of the patient at the time of the injury or their income
•24. If I have overbilled a federal healthcare program I am only responsible for the amount I overbilled
•25. Billing issues can never result in imprisonment
•26. When an FBI agent comes to my office and asks questions I do not need a lawyer
•27. My disgruntled employees cannot turn me in and get a percentage of the recovery
•28. When an insurance company is requesting my records it is just usual business practices
•29. When an insurance company requests 25 or more records they are not conducting an audit
•30. Outside chart reviewers for insurers conduct un biased reviews
•31. If an insurance company asks for money back the prudent thing is just to simply send them a check
•32. You cannot be investigated by state licensing agencies or the federal government because you returned money to an insurance company
•33. If I have legal issues regarding the practice of medicine my friend the real estate or corporate lawyer can effectively represent me
 He refers to he/she since attorneys can be of either gender.
 The names of the doctors in these cases have been redacted.
 Available at www.mazielaw.com/lasikmalpractice.htm
 OMIC Digest, Fall 2008, v.8#14, 4-5.
 Available at www.lasikfraud.com/news/archives/000207.html
 Richard F. Calloway Jr., Charting the Perils of Lasik Comanagement , OMIC Digest Fall, 2002, 1-2.
 Available at www.lifeafter lasik.com/lasiklawsuitwins.html
 Available at AAO.org/aaoesite/promo/compliance/joint_position.cfm
 Foong v. Empire Blue Cross and Blue Shield, 762 N.Y.S.2d 348(N.Y.S. Ct. App. Div. 2003)
 Potvin v. Metropolitan Life, 22 Cal.4 th 1060(2000).
 FUNDAMENTAL CONCEPTS IN HEALTH LAW - HIPAA, STARK AND REIMBURSEMENT
THROUGH A GLASS, STARKLY: FUNDAMENTAL CONCEPTS IN STARK LAWAND
HEALTHCARE FRAUD ANALYSIS ,WILLIAM W. HORTON ,HASKELL SLAUGHTER YOUNG &REDIKER, LLC presented at the AmericECan Bar Association, Health Law Section
11th Annual Conference on Emerging Issues in Healthcare Law, February 17-19, 2010
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