OMIC Increases Coverage Limit on Policy Benefits
We are pleased to announce that your standard policy benefit limits for regulatory and cyber exposures will be increased from $50,000 to $100,000 per policy year effective January 1, 2015. OMIC has monitored the exposures related to administrative practice activities, such as billing reimbursements for services and electronic storage and transmission of protected health information. In response to an expected rise in the number of Recovery Audit Contractor requests and an increase in the number of reported breaches, including lost and stolen laptops and devices, OMIC’s Board decided to increase your coverage benefit to help reimburse for unexpected costs associated with these and similar events.
OMIC was one of the first malpractice carriers to cover its policyholders for proceedings related to billing errors and other regulatory exposures. Over the years, the coverage has been continually expanded and enhanced to meet the changing exposures of our insureds’ medical practice, including the rapid move to electronic medical records. OMIC’s standard professional liability policy now provides protection for 14 related events and proceedings.
Broad Regulatory Protection (BRP) reimburses insureds for legal expenses relating to regulatory proceedings, including billing errors, DEA, EMTALA, HIPAA, covered licensing, and STARK proceedings, and peer review. BRP also covers audit expenses related to billing errors proceedings and fines or penalties (where allowed by state law) related to billing errors, EMTALA, HIPAA, and STARK proceedings.
Cyber (eMD®) protection covers insureds for electronic media exposures and breaches. These include multimedia, security and privacy liabilities, privacy regulatory defense and penalties, security and privacy breach response costs, notification expenses, and support and credit monitoring expenses. eMD® also covers network asset protection and cyber extortion and terrorism.
For more information on your coverage benefits included within OMIC’s standard professional liability policy, please visit www.omic.com/policyholder/benefits or call your underwriting representative.
Adverse Events in Clinical Research
Anne M. Menke, RN, PhD, OMIC Risk Manager
Just as with care provided outside of research, subjects who participate in clinical trials can experience complications from the study intervention. Federal regulations use the term “adverse events” to describe these outcomes and define them in intentionally broad terms. In drug trials, for example, an adverse event would include any adverse change from the patient’s baseline condition, including any abnormal clinical laboratory test value, which occurs during the course of the study, whether related to the study medication or not. Management of adverse events in clinical research raises questions about who provides and pays for care when adverse events occur.
Q When is an investigator required to provide care for adverse events?
A The FDA issued a guidance document for investigators that contains non-binding recommendations.1 It states that investigators should provide reasonable care for any adverse events related to trial participation. If the investigator does not possess the necessary expertise, the investigator should make sure that the subject is able to obtain the needed care from a qualified practitioner. The care should continue until any emergency condition related to the study intervention is resolved, whether the condition develops during the study or after it ends. The claimant in the Closed Claim Study alleged that the principal investigator (PI) abandoned her by referring her to a hospital after an adverse event occurred instead of performing the needed surgery herself. The PI was a retinal specialist and had the requisite expertise to perform the vitrectomy. The subject, however, was unemployed and without insurance, and the PI, who was an employee of the research center, did not have the authority to provide care in these circumstances. Since endophthalmitis was a foreseeable risk of an intravitreal injection, the PI should have clarified in advance with the research center and the study coordinating center what care she would be authorized to provide in the case of an adverse event. Once she learned that the care she could provide was limited to office-based interventions, she should have identified retina specialists and hospitals willing to provide further care.
Q Who pays for the care in the case of an adverse event?
A Federal regulations governing informed consent stipulate that subjects who face more than minimal risk should be told what compensation and medical treatments, if any, are available for injuries arising from study procedures and where more information may be obtained. The claimant in the Closed Claim Study complained that the consent form contained conflicting information about what care would be provided. The form stated that tests related to the study would be free, but that the subject or subject’s insurance company would be responsible for the costs of study-related treatment, office visits, and general eye care. The consent form then went on to explain that some costs and treatment might not be covered by the subject’s health plan, but if they were not, they would be covered by the study. The claimant informed the investigator at the outset that she had no insurance, and it appears that she believed the study would pay for her care. Her complaint letter did not reference a later section of the consent form, which stated that, in the event of an injury, she would receive medical treatment but would be responsible for the costs and that no money was available to compensate her for an injury. The form did not explain whether the risks detailed in the document were considered an injury. Consent forms can be confusing. The National Cancer Institute developed a research consent form template that meets federal requirements but uses simplified language. It states, in part, “The study sponsors will not pay for medical treatment if you are injured or hurt because you took part in this study. Your insurance company may not be willing to pay for injury from the study. If you have no insurance, you will be responsible for any costs [related to an injury].” The template further explains that if subjects feel an injury was a result of medical error, they keep all of their legal rights to seek payment for an injury even though they were in a study.2 Ophthalmologists may benefit from using similar language to ensure that information about adverse events is clearly communicated in the protocol, consent form, and consent process.
- FDA. “Guidance for Industry: Investigator’s Responsibilities—Protecting the Rights, Safety, and Welfare of Study Subjects.” http://www.fda.gov/downloads/Drugs/…/Guidances/UCM187772.pdf.
- National Cancer Institute. NCI Consent Form Template. http://www.cancer.gov/clinicaltrials/conducting/simplification-of-informed-consent-docs/.
Fraudulent Enrollment of Patient in Clinical Trial
Ryan Bucsi, OMIC Senior Litigation Analyst
Allegation:
Manipulating screening data for study eligibility, failure to supervise technician, and abandonment.
Disposition:
Case settled for $250,000.
Case summary:
An OMIC insured was the principal site investigator (PSI) at an OMIC-insured research center during a clinical trial comparing the effectiveness of an anti-VEGF drug, focal laser photocoagulation, and steroids for the treatment of diabetic macular edema. Enrollment criteria included at least one eye showing definite retinal thickening involving the center of the macula due to diabetic macular edema on clinical exam and OCT central subfield ≥ 250 microns. A technician completed the OCT study; the PSI noted that it was off-center but assumed the subject could not keep her head still. Since the PSI’s exam showed macular edema, the PSI accepted the subject for the trial, obtained informed consent, and proceeded to administer an intravitreal injection of an anti-VEGF medication in the right eye and a sham injection in the left. The patient was instructed to use an antibiotic drop as prophylaxis against infection. Two days later, the patient returned to the PSI complaining of a pressure ache in the right eye and decreased vision. The PSI noted CF vision and diagnosed endophthalmitis, which was treated with a vitreous tap and intravitreal and subconjunctival antibiotic injections. The patient’s condition worsened the next day and surgical intervention was needed. As the patient did not have health insurance, the PSI called the study coordinating center (SCC) to see if it would pay for the treatment. When the PSI learned that no funds were available, the PSI referred the patient to a county facility for further treatment. A culture ultimately grew out a heavy growth of strep viridans. Despite a vitrectomy, the patient was left with LP vision in the right eye.
The insureds reported the adverse event to the SCC. A year later, the research center discovered and fired an employee for embezzlement. One year after that, the SCC conducted a review and noticed a significant number of off-center OCTs, all apparently manipulated or substituted by the fired employee. The research center did its own investigation and clarified to the SCC that it did not offer bonuses for enrolling subjects but suspected that the employee falsified the OCT scans in order to enroll as many subjects as possible as part of her embezzlement scheme. The SCC’s review also concluded, based upon a review of the OCTs and fundus photos, that many of the subjects did not have macular edema, thus calling into question the PSI’s clinical skills. The owner of the research center wrote to all affected subjects. The letter to the injured patient stated that the fired employee had intentionally altered the testing to increase eligibility for the study, that the right eye did not require an injection, and that, if the injection had not been performed, the eye would not have developed an infection. The patient sent a written claim to the research center expressing an intent to file suit.
Analysis
OMIC’s retained expert opined that the claimant did not meet the criteria for either the study or off-label use of the drug. He also felt that the failure of the PSI to obtain a second OCT when the first was clearly off-center was below the standard of care. While the claimant alleged abandonment because the PSI did not provide all care needed for the endophthalmitis, the expert supported the PSI’s management of the complication itself (see Hotline for a discussion of what care must be provided by an investigator). The claimant ultimately accepted a settlement on behalf of the research center for $250,000.
Risk management principles
Ensuring that research subjects meet enrollment criteria protects the research subject, the investigator, and the data. The trial developers in this case built safety into the protocol for enrollment through redundancy: findings of edema were required on both clinical exam and OCT, so either a competent exam or an accurate OCT would have excluded this subject from the trial. A more cautious approach when faced with a questionable test result, such as repeating the OCT scan, may have helped the PSI determine that the patient was not qualified for the study. Improved employee oversight may also have helped the insureds ferret out the fraudulent actions of the employee and uncover the falsification of the OCT scans.
Message from the Chair
The Bean. Magnificent Mile. Deep dish pizza.
There are a lot of things to like about my home town of Chicago. But for doctors, the inhospitable malpractice environment is not one of them. Perennially cited as one of the nation’s “judicial hellholes,” Cook County is a notoriously plaintiff-friendly venue with often unpredictable and seemingly unjustifiable jury awards. OMIC premiums for those of us practicing here reflect this increased liability exposure, averaging $17,000, well above the national average of $9,500. Attempts at tort reform in Illinois have been about as successful as our Cubs in postseason.
To see the power of tort reform in action, one need only look west. California enacted what is now recognized as the gold standard for malpractice reform in 1975. This legislation, the Medical Injury Reform Compensation Act (MICRA), limits pain and suffering damages to $250,000. It puts no caps on economic damages, which have continued to outpace inflation by more than double. Despite these increases, malpractice premiums for California physicians have stayed below the national average, thus helping to keep healthcare costs down and retaining access for patients. Several other states have adopted similar legislation with correspondingly good results.
MICRA is now under attack. Californians will go to the polls in November to vote on an initiative that, among other things, proposes to more than quadruple the cap on pain and suffering damages to over $1,000,000. Raising caps alone is not widely popular with voters, in part because it is expected to raise healthcare costs and limit access. To sweeten the deal, the plaintiff attorney bar has added two seemingly unrelated provisions: random and post-adverse event physician drug testing, and mandatory use of a cumbersome and non-secure statewide database of patient prescription information (CURES) in order to cut down on prescription drug abuse. Focus groups have shown these issues resonate with voters. And why shouldn’t they? An informal poll of my own physician colleagues finds little resistance to drug testing. While most did not relish the thought of submitting to such scrutiny, few could offer compelling arguments why physicians should be exempt from the same workplace drug testing as other high-stakes professions, such as pilots, police officers, or school bus drivers.
One can argue the pros and cons of physician drug testing, but we feel any such debate and vote should address this issue independently and not be a Trojan Horse for dismantling the nation’s oldest and most successful initiative in tort reform.
OMIC insures 484 California ophthalmologists, over 10% of our entire insured base. As a nationwide carrier, we clearly see the impact MICRA has had on minimizing frivolous lawsuits and stabilizing malpractice premiums in California. For that reason, OMIC has chosen to support Californians Allied for Patient Protection (CAPP), a broad coalition of California-based physicians, hospitals, and other providers fighting to keep the provisions of MICRA in place.
Watch for this battle to spill over nationally in the coming weeks. The decision on Prop 46 will impact tort reform everywhere. We hope California voters will see through the smoke screen.
Tamara R. Fountain, MD, Chair of the Board
