What is OMIC’s position regarding use of intravitreal anti-VEGF (IVAV) agents for treatment of ROP?

By Betsy Kelley, VP Product Management

Laser surgery remains the current standard treatment for ROP; however, other means of arresting ROP are sometimes needed. Some babies are too sick to tolerate the anesthesia needed during the surgery. In others, the abnormal vessels are in an area that the laser cannot safely reach, or the view is obstructed by blood or a persistent tunica vasculosis lentis. Some infants have disease that persists despite laser treatment.  In these situations, intravitreal injection of anti-VEGF agents (“IVAV”) may be indicated.

Adult patients with retinal conditions due at least in part to VEGF have been successfully treated for many years now with intravitreal injections of anti-VEGF agents such as Avastin^TM (bevacizumab), Macugen^TM (pegaptanib), Lucentis^TM (ranibizumab), and Eylea^TM (aflibercept). ROP is similar to certain retinal conditions in adults, prompting clinical trials on the use of IVAV in neonatal populations. Published reports of IVAV from both clinical trials and “off-label” use suggest  that it can be effective and does not—so far—appear to produce many serious short or long-term side effects. However, the efficacy, safety, and long-term consequences have not yet been definitely proven, and cases of late recurrence of ROP have been reported. Concerns about IVAV both as primary or salvage therapy have been addressed in the literature and at eye society meetings. In addition, many questions are currently being studied and debated, such as agent, dosage amount, volume, timing of injections, length of follow-up, and contraindications. Despite these uncertainties, when faced with aggressive or refractive ROP, ophthalmologists at times feel there is no other prudent choice but to treat ROP with IVAV.

Because off-label use of approved drugs and devices is a necessary and legal part of the practice of medicine and use of non-approved drugs and devices is also appropriate in certain situations, OMIC’s policy does not contain any provisions or exclusions that would prohibit coverage for such activities outside of clinical trials. Additionally, OMIC’s policy does not contain any exclusions regarding the treatment of ROP, either traditionally or with IVAV. However, given the potential liability concerns with this new treatment modality, OMIC carefully underwrites physicians who administer intravitreal anti-VEGF agents for the treatment of ROP.

To further manage the potential liability concerns associated with the off-label use of IVAV for the treatment of ROP, OMIC has developed risk management recommendations and a sample consent form for anti-VEGF treatment of ROP. OMIC policyholders who administer anti-VEGF medications for ROP are strongly encouraged to call OMIC Risk Manager Anne M. Menke, RN, PhD at 1.800.562-6642, extension 651 to discuss this treatment modality. This is a confidential call.

Workers’ Compensation Coverage and the Law

By Jillian Brandt, CIC
OMIC Insurance Agency and Group Products Manager

[Digest, Winter 1998]

Loss of income due to accidents on the job has been a major problem for workers since the industrial revolution. Employers’ liability laws, adopted first by Britain in 1880 and later by most other European nations, held employers responsible for injuries caused by defective machinery or by negligence on the part of management. In the United States, workers’ compensation coverage increased greatly after Congress passed the Federal Employees’ Compensation Act of 1916, which provided benefits for certain federal civilian workers or their survivors in connection with injuries or death on the job. Today, most states require employers, including ophthalmic practices, to provide compensation coverage if they employ more than a minimum number of workers (usually three).

Who is Covered?

Employers are required to provide workers’ compensation coverage for all full-time permanent employees and for leased temporary and contract employees, unless separate insurance is provided elsewhere. Usually the leasing or temporary employment agency will provide coverage for employees they lease and charge the employer an inclusion fee. Contract workers can be treated either as a consultant in which the worker is responsible for his or her own coverage, or as a short-term employee in which the employer provides the protection. Additionally, executive officers of a corporation (defined as the president, vice president, secretary, treasurer or spouse) are covered under workers’ compensation laws unless, as some states allow, they elect not to be. On the other hand, a sole proprietor or partner is usually not subject to the law but can elect to be covered in most states.

What is Covered?

The purpose of workers’ compensation coverage to provide pay and medical benefits to workers who suffer an occupational injury or to their dependents in cases where death occurs. “Occupational injury” is defined in many statues as an injury “arising out of and in the course of employment.” Generally translated, this means that for an injury to be compensable, it must arise out or a risk reasonably related to employment or occur while the employee is at work, during work hours and while engaged in work he or she has been employed to do. Injuries that are deliberately self-inflicted or the result of deliberate failure to use safety equipment or of intoxication are not compensable. Claims alleging any type of discrimination are also excluded, as such coverage would be provided under an Employment Practices Liability Insurance policy.

There are four categories of compensation benefits payable to the injured worker or the workers’ dependent: medical, disability, rehabilitation and death. Each state has its own valuation method to determine coverage benefits; however, all states share one common goal: to return the injured worker to health and work as quickly as possible. Injured workers normally receive about two-thirds of their salary while disabled and may be eligible for job training if their injury makes it impossible to return to their previous line of work.

Hazards in the Medical Office

Although medical offices present fewer occupational hazards then many other workplaces, certain types of on-the-job injuries do tend to recur and to constitute the basis of most claims. Typically, these involve repetitive stress injuries such as carpal tunnel syndrome (CTS), back strains, slips and falls, and needle stick injuries. CTS occurs when there is chronic pressure on the median nerve in the wrist area and is most common in workers whose work involves repetitive hand movements such as computer keyboard operators. Because computers are an integral part of the office environment, it is important to take steps to safeguard workers from injury:

• Make sure each computer terminal and workstation is ergonomically designed.
• Educate employees on the importance of posture while sitting at the computer.
• Rotate job duties to allow breaks from data entry.

Most back strain injuries and slips and falls can be avoided if the office is kept clean, organized and free of clutter. Make sure supplies are easily accessible. Stacking items on top of file cabinets might work for long-term storage but is not a good idea for daily supplies. Minimize opportunities for slips and falls by putting everything in a designated place – stress organization so workers are not injured because of carelessness. Needle stick injuries are usually the result of haste. Allow adequate time and care during these procedures to ensure employee and patient safety.

How are Rates Determined?

Insurance companies determine rates for workers’ compensation coverage on the basis of an employers’ estimated payroll, claims history and anticipated exposure during the current policy period. This information allows the carrier to establish an estimated premium at the beginning of the year. At the policy’s expiration, the insured’s actual payroll records are audited to determine the final premium, and the insured either pays an additional premium or receives a refund. In most states, payroll is defined to include all remuneration, which means all wages, salaries, commissions, bonuses and paid time off. The average ophthalmic practice spends an amount equal to less than 2% of its payroll.

When employers of like kind come together to insure the exposures of all the group’s members, it is called group self-insurance. Group plans are subject to stringent regulatory requirements and can be arduous to set up. An alternative, known as a safety group, also provides group self-insurance but is easier to structure because it requires nothing more than participation of the group’s members. OMIC is currently developing a workers’ compensation safety group for ophthalmologists through The Hartford Insurance Group. If the group gains wide enough participation among ophthalmologists, it may be able to set rates based on the group’s experience along, resulting in lower average premiums than most ophthalmologists now pay.

In 1997, OMIC and the American Academy of Ophthalmology teamed up with The Hartford Insurance Company to offer the first workers’ compensation program for ophthalmologists. The program provides coverage for workers’ compensation and employers’ liability plus loss prevention and claims cost containment services.

For information on OMIC’s program, please contact OMIC at (800) 562-6642 or via email, omic@omic.com.

BOP Packages Property and Liability Coverage

By Jillian Brandt, CIC
OMIC Insurance Agency and Group Products Manager

[Digest, Spring 1998]

Purchasing property and general liability insurance for an ophthalmic practice used to mean sorting through a laundry list of optional coverages to supplement the basic policy. In addition to the base policy premium, a practice could expect to spend hundreds of dollars on individual supplemental policies and still not be sure it was covered for all daily operating exposures. Relief arrives in the 1960s in the form of a commercial package policy that allowed two or more property and liability coverage lines to be combined within a single policy. What later became known in the insurance industry as a BOP (Business Owners Policy) made it possible for carriers to charge a single premium for a broad range of coverages at rates that were usually lower than what those coverages would cost if purchased separately. Ophthalmic practices and other small businesses could obtain coverage for exposures they otherwise might not be able to afford with fewer gaps and overlaps in coverage.

Who Needs this Coverage?

Anyone operating a business who could be held legally, financially or professionally liable for losses resulting from damage to the building housing the business and the property within it (such as that caused by fire, theft, vandalism or water damage) or from the illegal actions of persons employed by that business needs business owners insurance. Most ophthalmologists carry business owners insurance because they are legally required to do so: building landlords require it under the terms of a lease, medical equipment companies require it in their contracts, banks require it as part of loan agreements. Under the terms of a BOP, coverage extends to an individual (and the individual’s spouse) in the conduct of business of which that individual is the sole owner. It also extends to partnerships, joint ventures, limited liability companies and any other organization with executive officers and/or stockholders.

What is Covered?

Under a BOP, property exposures are covered for loss, damage or destruction, property being any item of value that is owned, leased, used or depended upon as source of income or service. Examples of insurable property include medical equipment, office furniture, computers and office record systems. Coverage can be extended to such items as property in transit, valuable papers, computer programs and data, and personal property.

General liability exposures also are covered under a BOP. In an ophthalmic practice, liability exposures can arise from a number of situations: automobile liability exposures caused by or to their parties, premises operations (slips and falls), and personal injuries caused by false or misleading advertising, among other things.

More than other lines of insurance, BOPs tend to vary considerably from one carrier to the next as insurance companies have tailored their BOP programs over the years to meet the specific coverage needs of the businesses they insure. The office form BOP allows for protection of almost anything in an ophthalmic practice from almost any peril. Special form perils coverage covers all causes of loss unless specifically excluded by the policy. This is the broadest coverage form available in the marketplace today and is the form available to members of the American Academy of Ophthalmology through OMIC and The Hartford Insurance Company.

How are Rates Determined?

BOP rates are determined by the amount of coverage selected and the value of the property insured. Underwriters look at a number of factors when developing a premium: amount of property to be insured, office location and building construction. They also consider an organization’s overall management and risk classification, taking into account past loss experience, employee selection, training and supervision, and housekeeping and safety procedures. Ophthalmic practices have a better than average risk classification for office programs.

In 1997, OMIC and the American Academy of Ophthalmology teamed with The Hartford to offer a Spectrum BOP program for ophthalmologists. This program provides the most comprehensive property and general liability package available for the ophthalmic practice. Included are 15 coverages especially packaged for office building owners and occupants, including coverage for losses associated with accounts receivable, computers and media, employee dishonesty, forgery and alterations, and property off premises and in transit. Through the Spectrum BOP, these coverages are available at a cost of hundreds of dollars less than if they were purchased separately.

For information on this program, please contact the Underwriting Department at (800) 562-6642, extension 639 oromic@omic.com.

Fraud Busters – Who You Going to Call?

By Kimberly Wittchow, JD

Ms. Wittchow is an associate with OMIC’s insurance and group products department.

[Digest, Winter 1999]

It was a whistle-blower who triggered the 1996 criminal investigation of an ophthalmologist on charges that he faked laser surgery and defrauded Medicare. Shining a light into their eyes, the ophthalmologist told patients he was performing laser surgery. Without access to any of the instruments necessary to perform such procedures, he billed for 37 trabeculoplasties, 63 iridotomies/iridectomies, 12 photocoagulations, and 1 other retinal procedure. Between 1995 and 1997, he fraudulently billed Medicare and his patients nearly $118,000 for services that either were not necessary or not performed. Last year, he pleaded guilty to three criminal charges, including mail fraud and submitting false claims to Medicare. A related civil suit was settled for $700,000, $105,000 of which was rewarded to the whistle-blower. The ophthalmologist surrendered his state license to practice, was banned from all Medicare/ Medicaid and federal health care plans for five years, and had his hospital staff privileges revoked.

Flagrantly fraudulent reimbursement claims such as this one are the target of the federal government’s stepped-up Medicare/Medicaid fraud and abuse enforcement efforts. In the war against fraud and abuse, however, inadvertent billing errors are also being discovered and punished. Investigations typically begin when a third party payor detects an anomaly in billing patterns or when a competitor, patient or employee lodges a complaint. Some investigations are the result of random samplings. Both criminal and civil investigations may ensue, involving on-site visits, employee interviews, document reviews and accounting audits.

Even practitioners who comply with Medicare and Medicaid regulations to the best of their knowledge and ability are susceptible to devastating enforcement repercussions. In one case, an employee who was terminated by a physician retaliated by contacting the state department of insurance and local law enforcement agency regarding the physician’s alleged fraudulent billing practices. The ex-employee alleged that the physician was submitting false claims for nonexistent patients. The police took over the physician’s office, removed all of her files, and turned her patients away at the door. After much personal trauma and $20,000 in legal fees, the innocent physician was vindicated. However, she is still attempting to recover her confiscated medical files and repair the damage to her reputation and business.

Sometimes a clinical event may give rise to a complaint that becomes a compliance issue, and often there are parallels between the documentation required by the government for Medicare reimbursement and that which might be useful in malpractice risk management. In fact, CPT coding requirements can be a helpful reminder to the physician of the importance of thorough documentation, both to avoid potential liability suits and, ultimately, to benefit the patient.

Compliance Plans: Why have one?

Since the passage of the Health Insurance Portability and Accountability Act (HIPAA) in 1996, a plethora of new laws, fines, penalties and other sanctions have been added to the government’s stepped-up attack on health care fraud. No segment of health care is immune from these enforcement initiatives. Because of the escalating pace of legislative and administrative reform activities, virtually all providers are likely to be in technical violation of at least one law at any given time no matter how scrupulous and thorough their billing procedures.

An appropriate corporate compliance program, besides facilitating the prevention and detection of health care fraud and abuse in the first place, is invaluable if an organization nevertheless runs afoul of health care fraud and abuse laws. The compliance program must be in place at the time the violation occurs, however. Hastily instituting a program after notification of a violation will not help your case.

What are the benefits of having a compliance program in place during an investigation?

• It is the best means of convincing regulators not to exclude you from a federally funded program.
• It is the single most important factor in influencing a prosecutor not to proceed with a criminal prosecution when Medicare/Medicaid violations have occurred. (Prosecutors will have difficulty convincing a jury of fraudulent intent if a compliance plan is in place.)
• It may help you negotiate a less damaging civil settlement.

What is a Compliance Plan?

A compliance program is a bundle of policies and procedures used to identify legal and regulatory problems, correct identified deficiencies, prevent future violations and assure regulatory compliance. The Office of the Inspector General (OIG) has developed several model compliance programs for different types of providers (download at www. dhhs.gov/progorg/oig). The degree of formality required depends on the size and structure of the organization. The OIG emphasizes a strong organizational commitment to the detection, reporting and resolution of wrongful conduct. Additionally, the existence of benchmarks that demonstrate implementation and achievement are essential to any effective compliance program.

To be effective, a compliance plan must be legitimately implemented; otherwise, it is simply window dressing and worse than no plan at all. A practice may be required to present auditing logs and meeting minutes from compliance committee sessions to demonstrate implementation.

AMA 7-point System

The AMA Division of Health Law has developed the following 7-point system that serves as a skeleton for an effective compliance program:

1. Written compliance standards and procedures. The compliance program development team must create written standards and procedures that are reasonably capable of promoting the group’s commitment to compliance and that are to be followed by all employees and other agents.
2. Oversight responsibilities. It is no longer enough for doctors and hospitals to rely on internal billing clerks and bookkeepers to find mistakes. Specific, trustworthy individuals in high-level positions must be assigned overall responsibility for operating and monitoring the compliance program. A chief compliance officer and other appropriate oversight bodies should be designated.
3. Employee training and education. The compliance team must effectively communicate the compliance standards and procedures to all employees and agents. This will require the development and implementation of regular, effective education and training programs and materials for all affected employees and agents.
4. Monitoring and auditing claims. The compliance program must be reasonably designed to detect errors or criminal conduct by employees and other agents. Thus, claims development and submission must be monitored and evaluated by audit or other techniques.
5. Internal communications process. A reporting system, such as a confidential hotline, must be in place and publicized whereby employees and other agents can report criminal conduct by others without fear of retribution.
6. Investigation and enforcement. A system should be developed to respond to and investigate allegations of improper activities. Standards and procedures should be enforced through meaningful and consistent disciplinary mechanisms, including discipline of individuals responsible for failure to detect the offense.
7. Response and prevention. All reasonable steps must be undertaken to respond appropriately to the offense and to prevent similar offenses from occurring in the future. This includes necessary corrective action such as modifications to the compliance program.

If You Are Investigated

If you have fraud and abuse insurance, notify your carrier at once when a governmental proceeding is instituted against you or your entity. OMIC provides Medicare/ Medicaid Fraud and Abuse Legal Reimbursement Insurance coverage free of charge to all its professional liability insureds. (See Policy Issues.) OMIC will provide expert attorneys to assist insureds in responding to the government’s investigation or suit. Even if a governmental proceeding has not been instituted, OMIC will provide risk management services on other fraud and abuse liability questions or concerns. These services will include preliminary assessments of fraud and abuse liability issues by one of the leading health care law firms in the country. Please call (800) 562-6642, extension 652 to initiate these services.

Resources for Compliance Planning

American Academy of Ophthalmology’s Compliance Program Planner for the Ophthalmic Practice available from OMIC, (800) 562-6642.

Compliance Program for Physician Practices developed by Arent, Fox, Kintner, Plotkin & Kahn, PLLC law firm, available from the American Society of Ophthalmic Administrators, (800) 451-1339.

Medical Group Management Association’s Compliance Programs: A Resource Guide for the Small Group Practice available for $10 through the American Academy of Ophthalmology, (415) 561-8540.

Academy Web site, www.eyenet.org, provides coding information and resources to assist with coding compliance planning.

AMA Web site, www.ama-assn.org.

Medicare Web site on Fraud and Abuse, www.hcfa.gov.

Fraud and Abuse Coverage Options

By Kimberly Wittchow, JD

[Digest, Fall 2000]

For several years, the government has unwaveringly pursued physicians for alleged Medicare and Medicaid fraud and abuse. New emphases arise, from intra-practice consultations to dispensing services, but the outcomes seem to be the same. The government almost invariably finds the physician at fault in some way and assesses a reimbursement with little supporting explanation for remediation by the perplexed provider.

Many times when these issues arise, the physician will argue that “the carrier said I could bill this way.” The unfortunate truth is that, unless you have carrier guidance in writing, federal law enforcement agencies will refuse to listen to your supposed defense. Health care law attorney William A. Sarraille (see Lessons from the Fraud and Abuse Wars) advises writing to the carrier to confirm the advice given, specifying the date and time that you spoke to the carrier representative. Tell the carrier that you will act in reliance on the information provided unless it informs you in writing within 14 days that this information is not correct. Send the letter by certified mail (otherwise the carrier may deny receiving it) and keep a copy in a central binder so you can retrieve it if it is ever needed.

The federal government has at least proffered a little more general guidance. HCFA recently published its long-awaited voluntary compliance plan for individual and small physician practices, available online at www.dhhs.gov/oig/new.html.

Meanwhile, huge settlements still are being drafted and the government continues to bar doctors from billing the government for services rendered to elderly and poor patients. New studies show that in response doctors may be downcoding their billing to ensure that they are not targets of investigation. While most reports of such intentional downcoding are anecdotal, statistics show that physician coding for all levels of evaluation and management services declined in 1998 after a shift toward higher level codes between 1993 and 1997.

Expense, Fines & Penalties

To address this ongoing problem, OMIC now offers two types of insurance coverage for billing errors: Fraud & Abuse Legal Expense Reimbursement and Comprehensive Fraud & Abuse(including fines & penalties) coverage. Coverage under both policies pays for attorneys’ fees and associated expenses rendered in the defense of a covered proceeding.

The Legal Expense policy is available at three limits: $25,000, $50,000 and $100,000. The Comprehensive coverage is available at limits of $250,000, $500,000 and $1,000,000. In addition to attorneys’ fees, this coverage provides reimbursement for audit expenses and for fines or penalties assessed resulting from alleged billing errors. The actual overpayment by the payor, however, must be reimbursed to the payor by the insured.

Third Party Payors and Whistleblowers

In addition, OMIC has enhanced coverage under both forms to cover not only civil governmental proceedings alleging Medicare or Medicaid Fraud and Abuse, but also third party payor actions; in other words, claims made by commercial health insurance companies alleging billing errors.

The policy language also has been broadened to include qui tam, or whistleblower, actions. These are lawsuits filed by witnesses to the alleged wrongful practices brought on behalf of the government alleging Medicare or Medicaid fraud and abuse.

OMIC provides coverage at the basic Legal Expense limit of $25,000 per insured free of charge to its medical professional liability insureds ($50,000 effective January 1, 2011). Members of the American Academy of Ophthalmology may purchase these various billing error coverages for themselves, their employed optometrists, and business entities. Premiums vary depending on the coverage and limits selected. Discounted rates for groups may be available for practices comprising ten or more physicians.

For more information on OMIC’s Fraud & Abuse insurance, please contact Kim Wittchow at (800) 562-6642, ext. 653 or kwittchow@omic.com.

OMIC Fraud & Abuse Coverage

• Pays attorney’s fees and associated expenses
• Covers civil proceedings and third party payor or whistleblower actions.
• Optional comprehensive coverage for audits, fines & penalties.
• Limits of $25,000, $50,000 and $100,000 for Legal Expense coverage only.
• Limits of $250,000, $500,000 and $1,000,000 for Comprehensive Fraud & Abuse coverage.