At the Bethesda offices of eye doctor Mark E. Whitten, the influence of government regulation is pervasive but barely noticed.
It's visible in the brightly lit exit signs and the prominently positioned fire extinguishers, the boxes of rubber gloves in the examination rooms, the state wage-and-hour fact sheet posted in the lunchroom. It's even evident in the placement of the lunch area, well removed from all sterile equipment.
Yet for the most part, regulations fade into the background as office procedures become routine.
"I can honestly tell you . . . I don't have a problem," said Michael J. Fagnilli, chief financial officer for the Mark E. Whitten MD PC medical practice, which has three locations and 33 employees.
"It's almost like second nature to us," Fagnilli said. "These are things we do anyway."
Some requirements are more conspicuous than others. Whitten performs laser eye surgery at the TLC Rockville Laser Eye Center, where he is participating in a federally regulated clinical trial of an experimental laser. The surgeon must take care to inform patients about the experimental equipment, and he must monitor their progress to help the Food and Drug Administration assess the device's safety and effectiveness.
"The benefit is that we're going to have a product that everyone agrees is safe," Whitten said.
Medicare, the federal health insurance program for the elderly and disabled, covers many of the patients, and fulfilling its billing requirements can be a chore. Compliance isn't as simple as entering CPT code 99244 on a claim for an "office consultation" or code 92083 on the claim for an "extended examination." To avoid trouble with the government, the doctors must thoroughly document the services they perform.
When claiming reimbursement for a comprehensive exam, Whitten said, doctors ask patients about their smoking history and alcohol intake even though those questions may be irrelevant to the treatment at hand.
Many of the precautions Whitten's staff observes are prompted by OSHA, the federal Occupational Safety and Health Administration -- as well as a healthy dose of common sense. Certain waste is deposited in plastic bags marked "BIOHAZARD," and sharp disposable objects such as needles and scalpels are collected in plastic safety containers after use. Doctors wash their hands between patients.
To comply with OSHA standards, the practice had a consultant prepare a safety manual, which notes that certain employees should get vaccinated against hepatitis or at least sign a form saying they have knowingly declined to be vaccinated.
To comply with the Americans With Disabilities Act, which protects the rights of the handicapped, the office installed an extra-large bathroom capable of accommodating a wheelchair. One wall had to be moved six inches after the space was found to be too small.
Like any small business, the medical practice is subject to myriad payroll requirements related to Social Security, income tax, unemployment insurance and the like. But Whitten's office cuts through the tangle by using a specialized firm to handle those tasks.
Keeping track of all the state and federal regulations that employers are required to display for their workers has become so complicated that businesses such as G. Neil Cos. in Sunrise, Fla., make money by furnishing offices such as Whitten's with legal posters. Along with vacation snapshots, the bulletin board in Whitten's lunchroom is adorned with notices about the Employee Polygraph Protection Act and the Maryland Workers' Compensation Commission.
Much of the regulatory burden Whitten's office encounters involves not the government, but rather the private bureaucracies of health insurance and managed-care companies. Whitten said he's fortunate that most of the work he does isn't covered by insurance, limiting his exposure to red tape.
Dr. Mark E. Whitten
Regulators: OSHA, Food and Drug Administration, state licensing board