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When the Government Comes Knocking on Your Door
Preventative measures can help reduce the likelihood of a government investigation into your cataract practice.
BY ERIC MILLER, ESQ.

The federal government acquired over $1 billion in settlements and fines relating to Medicare and Medicaid fraud and abuse in 2004, according to the Ophthalmic Mutual Insurance Company. Claims of unnecessary cataract surgery continue to be a main target of state and federal abuse allegations, investigations and fraud cases. It is therefore important that cataract surgeons understand the implications of governmental fraud investigations and the steps they can take to minimize the chances of being unfairly targeted by state and federal regulators.  

This article will discuss some of the tactics available to the government for its use during a legal investigation, as well as risk management strategies surgeons can employ to protect themselves against fraud or malpractice allegations.

A Wealth of Governmental Investigative Resources

The government has a wealth of investigative resources to bring to bear upon a surgeon who is accused of performing unnecessary cataract surgery, all of which can destroy a practice before the physician has had an opportunity to present a defense. The following list identifies some of the actions the government can take against a doctor during an investigation:

►Under certain circumstances, most state medical boards can summarily suspend a doctor's license without first conducting a hearing.

►State and federal governments are allowed to impound patient records through the use of search warrants, making it virtually impossible for a practice to operate during the investigative period.

►Regulators and prosecutors can engage the press inorder to publicly air allegations of unnecessary surgery before the physician is prepared to tell his or her side of the story.

►State and federal regulators are able to utilize dozens of lawyers and investigative agents to help perform the investigation. The sheer number of prosecution personnel can overwhelm even the best-financed defense team.

Government Investigational Missteps

Despite these resources, the government does not always get it right. Regulators who make decisions about which physicians should be investigated and prosecuted are often not doctors. These regulators usually base their decisions on the medical advice they receive from others, and the government cannot always be relied upon to seek the advice of good, unbiased physicians.

In one recent case, the government relied upon an expert witness who advised prosecutors that cataract surgery is never justified unless the patient sees 20/40 or worse on a standard Snellen chart, without glare. This criminal prosecution occurred even though the American Academy of Ophthalmology (AAO) and the American Society of Cataract and Refractive Surgery (ASCRS) had abandoned a purely Snellen-based standard for cataract surgery long ago. While the doctor was ultimately exonerated, the mistaken allegations permanently destroyed his practice. (For more about this case, read "Medical Fraud Case in Point" on page 80).

Protective Measures to Avoid Investigation and Litigation

Because the government has abundant resources, but limited medical knowledge, ophthalmologists must implement procedures in their practices to reduce the risk of a long, tedious, public and unwarranted investigation. There are numerous ways for ophthalmologists to improve their legal risk-management strategies.

Set forth below are a few measures that have proven helpful for physicians wrongfully charged of performing unnecessary cataract surgery.

►Initial consultation: Lifestyle questionnaires. Modern ophthalmology recognizes that it is the patient's complaint of disability and desire to improve vision that determines the necessity of surgery. Yet, studies have shown that, more often than not, postoperatively, patients do not accurately recall the symptoms that led them to choose cataract surgery.

This phenomenon makes doctors vulnerable to patient allegations of unnecessary surgery and legal charges that the medical record improperly overstated the patient's symptoms prior to surgery. It is therefore important to document the patient's preoperative symptoms in a manner that reduces the exposure to these sorts of allegations.

The most effective way to document patient symptoms is through the use of a detailed lifestyle questionnaire that is completed and signed by the patient. This questionnaire makes it impossible for a patient to dispute postoperatively their initial preop complaint of visual disability. Studies have also shown these lifestyle questionnaires, such as the VF-14 or a more streamlined equivalent, help identify good surgical candidates.

For all of these reasons, it is strongly recommended
surgeons use a questionnaire that allows the patient to identify real life visual problems, including: glare, night driving impairment and visual difficulty in low light.

►Supplemental vision tests: Contrast sensitivity and glare. Doctors have the ability to use vision tests that can be more comprehensive than Snellen, such as contrast sensitivity and glare testing. Although the AAO has long endorsed the use of these types of testing in evaluating cataract patients, these tests are not universally accepted or understood by doctors, insurers and regulators.

Therefore, doctors using these tests must take particular care in documenting the results so that others examining the chart will immediately understand the type of test performed, the prevailing testing conditions and what the results represent.

►Informed consent: Patient choice. Prosecutors and some patients may not understand that nearly all cataract surgery is elective. Rather, they tend to mistakenly view cataract surgery as they would an appendectomy — the patient either needs it or not.

As a result, it is important for practices to document that the decision to proceed with cataract surgery is made by the patient and based on the patient's own visual symptoms. It is not sufficient to verbally inform patients of these facts. Patients cannot be counted upon to recall accurately such conversations. It is important the patient acknowledges this choice by signing an informed consent document that clearly articulates the elective nature of the surgery.

Join Forces to Educate Regulators

Litigation-avoidance practices by ophthalmologists will not bring an end to unwarranted investigations and prosecutions. However, the ophthalmic community can do more to educate policymakers, insurers and regulators to help them understand the value of new diagnostic testing tools available to surgeons, as well as the medical necessity and benefit of cataract surgery.

As long as state and federal governments misunderstand or misapply the factors governing the decisions made by ophthalmologists and their patients, even the most careful and conservative physicians are at risk for malpractice suits.

Until there are positive changes in the laws, the number of medical fraud cases will continue to rise. The good news is that some of those prosecuted in ophthalmology have invested the time and money to dispute the allegations and to prove their innocence. Such cases can help set a precedent for questioning current standards and operations between the ophthalmic market and governmental affairs.

Eric Miller, Esq., is principal in Sheehey, Furlong and Behm, P.C., in Burlington, Vt. He specializes in state and federal civil and criminal litigation.

Medical Fraud: Case In Point BY ERIC MILLER, ESQ.

David Chase, M.D., a Burlington, Vt., ophthalmologist, was charged with recommending and performing unnecessary cataract surgery on his former patients and billing their insurers for that surgery. Dr. Chase performed cataract surgery on patients with a wide range of acuity scores, including patients with 20/40 or better. All of Dr. Chase's surgical patients had significant visual complaints and decreased contrast sensitivity due to cataracts. A number of Dr. Chase's patients had received second opinions regarding the need for surgery. Some of the doctors who provided the second opinions, none of whom utilized contrast sensitivity testing, felt that the patients' cataracts were not sufficient to warrant surgery. One patient filed a complaint with the Vermont Medical Practice Board. Upon learning of the patient's complaint, the federal government examined the medical necessity of the cataract surgeries that Dr. Chase offered to the complaining patient and others. Consequently, the U.S. Attorney in Vermont confiscated Dr. Chase's patient records and soon indicted him on 71 counts of criminal health care fraud. The indictment focused on Dr. Chase's decisions to recommend and/or perform allegedly unnecessary cataract surgery in 34 patient cases. The federal government then went on to prosecute the longest criminal case in Vermont history against Dr. Chase, calling over 60 witnesses and presenting thousands of pages of documents during the 3-month trial. The Practice's Safeguards Dr. Chase knew that many of his cataract patients had significant visual complaints, despite good acuity scores. In addition to a thorough written description of the patients' subjective complaints, Dr. Chase documented the patients' vision loss using glare and contrast sensitivity testing. Nearly every patient over age 45 was tested with the CSV-1000 (Vector Vision, Greenville, Ohio) contrast sensitivity test while viewing the instrument through a brightness acuity test on its high setting. Each patient's contrast sensitivity score was recorded on the Vector Vision recording form and placed in the patient's medical folder. The Government's Allegations During the trial, many of the patients who were implicated in the indictment testified that they had not been having visual problems due to cataracts and had not told Dr. Chase about any significant complaints. Ultimately, the government case revolved around several key points. One point was proper documentation of the patient scores in the record. Dr. Chase had some idiosyncrasies in his patient record keeping, and the government tried to show that this inconsistent record keeping led purposely to unnecessary surgery. The government also focused heavily on documentation of cataract patients' functional vision using glare and contrast sensitivity testing. The government called on several local ophthalmologists who testified that they did not use contrast sensitivity for cataract evaluation. These ophthalmologists also stated that acuity, subjective questioning of the patients and a slit lamp examination were the only requirements necessary to determine the necessity of surgery. The Defendant's Response Dr. Chase and his legal team presented a multi-pronged defense response. First, the patients' recent statements regarding their lack of visual complaints were in direct contradiction to their previous complaints noted in the patients' records. Furthermore, they presented overwhelming scientific evidence demonstrating that a high Snellen score alone is often not an accurate or sufficient measurement for vision loss related to cataracts. In fact, there are volumes of research supporting the scientific validity of contrast sensitivity for measuring cataract-induced vision loss. It was particularly important to the defense that the AAO's Preferred Practice Pattern and the ASCRS' White Paper both state that acuity alone is a poor predictor of functional vision associated with cataracts. Traditional visual acuity along with contrast sensitivity and glare testing are recommended. The expert witnesses that we called showed the 30-year track record of clinical contrast sensitivity testing and demonstrated that acuity alone is often a poor predictor for visual capability for cataract patients. Ultimately, the defense's presentation convinced the jury that Dr. Chase only recommended and performed cataract surgery that was medically necessary. Of the 71 counts in the indictment, the judge dismissed 56, the jury acquitted Dr. Chase on 23, and the government dismissed the remaining two. In December 2005, the federal government lost an extensive criminal health care fraud case against Dr. Chase, and he was completely exonerated.