Surgeons and ambulatory surgery centers are feeling the effects of the Pharmaceutical Research and Manufacturers of America guidelines, now that free postop surgical kits have become a thing of the past. Manufacturers had supplied surgeons at ambulatory surgical centers with free kits, which often included a pair of sunglasses, saline rinse and antibiotic drops. However under the revised PhRMA guidelines, manufacturers are no longer supplying the kits gratis, and surgeons have been left with some decisions to make.

William L. Rich III, MD, FACS, American Academy of Ophthalmology medical director for health policy, says it is important that ophthalmologists and ASCs understand the changing environment. "The kits were often given for free along with sample of a steroid or NSAID in return for the quid pro quo of agreeing to write a prescription for a fourth-generation fluoroquinolone antibiotic. Under the new voluntary guidelines, which went into effect in January of this year, industry would no longer supply the surgical kits for free. As a result docs should have been putting together their own kits or paying fair market value to a company who supplied them," he says.

Michael A. Romansky, Washington counsel and vice president of corporate development for the Outpatient Ophthalmic Surgery Society, concurs that ASCs and surgeons must be vigilant to ensure that their buying practices comport with the Medicare anti-fraud and abuse laws, which prohibit a provider from receiving a kickback, rebate, bribe or other remuneration from a manufacturer in exchange for the commitment to purchase products that are paid for by the Medicare/Medicaid programs. "Over the past several years, manufacturers, their trade groups and many health lawyers, such as me, have become increasingly uncomfortable with the practice of manufacturers providing free postop kits to surgeons or ASCs, that are in turn sold to patients," he says.

Mr. Romansky advises:

   • To mitigate concern that the supplier is inappropriately providing a stream of revenue (money from the patient for the postop kit) in exchange for business, the ophthalmologist or ASC should purchase at fair market value, rather than accept for free, the supplies provided in a postop kit.

   • If the surgeon is purchasing the postop kit or materials from a manufacturer, it is acceptable to charge the patient the acquisition cost plus a reasonable handling fee.

Dr. Rich adds that surgeons should only hand out the samples (steroid and/or NSAID) in the office, not the ASC, because to do so would violate many states' pharmacy guidelines. "Do not charge patients for samples or the postop kits, but if you do, make sure you have paid fair market value for them," he says. "Otherwise it could be seen as an inducement to use a particular antibiotic product."

ASCs are complying with the new guideline in a variety of ways. Dr. Rich's group uses a zip-lock plastic bag, tape and an inexpensive pair of sunglasses. "We dispense the baggie and the samples in our office pre- or postop. We don't charge for them," he explains.

Elise Levine, practice administrator/director of clinical research, at North Valley Eye Medical Group in Mission Hills, Calif., notes that the change in policy feels like a punitive measure that could negatively affect patients. She points out that the patients need the postop kits, unlike the free pens, paper and paperclip holders that have also been eliminated under the guidelines.

"After a lot of thought, we made a decision that we were going to choose to purchase the kits from the pharmaceutical companies, and not pass on the cost of it to the patients," she says. "It just didn't seem cost-effective for us to put together our own kits when you look at manpower and ordering all the supplies individually."

She explains that the cost to purchase the kits is nominal, between $4 and $6 each. The practice decided not to pass the cost onto the patients because it would not be the right thing to do from a marketing perspective, she adds.

Finally, Dr. Rich advises surgeons to return any free postop kits that were obtained following the January 2009 deadline. "This is not a trivial issue," he says, noting that the Office of the Inspector General is looking into the situation.

Can Common Drug Thwart Diabetic Retinopathy?

AcCording to a report in ScienceDaily, a University of Minnesota Medical School researcher has found a treatment that significantly slows the progression of eye injury in people with type 1 diabetes. By administering an antihypertensive commonly prescribed to treat high blood pressure, Michael Mauer, MD, and colleagues were able to slow progression of diabetic eye damage in more than 65 percent of participants involved in the study.

Diabetes is the primary cause of acquired blindness in adults and accounts for nearly half of all new cases of chronic kidney failure in the United States each year, and people living with the disease often struggle with these complications as it progresses. Previous studies of people with type 1 diabetes who were already exhibiting symptoms of vision and kidney function loss showed that these types of antihypertensive medications slowed further function loss in the kidneys, but often could not prevent kidney failure.
Dr. Mauer and colleagues were interested in testing whether or not they could delay diabetic kidney injury in participants who had normal blood pressure and had not yet shown signs of kidney disease at the beginning of the study.

Three groups of participants were observed over the course of five years. Two groups were administered one of two antihypertensive medications, losartan or enalapril, and the last group, a placebo. The results were unexpected, but conclusive. Dr. Mauer's study demonstrated that these drugs did not protect the participants' kidneys from damage or from losing function. However, participants who were administered either enalapril or losartan experienced a significant slowing of the progression of diabetic eye injury, by 65 and 70 percent, respectively.

"The secondary results of this study showed that people taking these antihypertensive medications experienced a substantially positive effect in slowing diabetic eye injury," said Dr. Mauer, professor of pediatrics and medicine. "Although neither medication delayed early kidney tissue injury or early loss of kidney function, the advantage to a study with negative findings such as this one is that physicians now know that this treatment is ineffective for this purpose, and they can pursue other treatment options that may improve their patients' outcomes."

Although the data does not support the use of these types of antihypertensives to prevent kidney damage in people living with diabetes, Dr. Mauer and colleagues find it reasonable for physicians to consider prescribing these classes of medication to people with type 1 diabetes in order to slow the onset and progression of diabetic eye disease. He notes, though, that this also poses several other unanswered questions, such as at what age a person with diabetes should be prescribed this class of drug and how long they should continue taking it.

Telemedicine Improves ROP Diagnosis

A study examining retinopathy of prematurity diagnosis speed using traditional bedside indirect ophthalmoscopy versus telemedicine and remote medical consultation revealed that: 1) ROP diagnosis by the ophthalmologist is significantly faster via telemedicine, and 2) there are significant time requirements by ophthalmologists associated with ROP diagnosis at the neonatal intensive care unit bedside beyond ophthalmoscopy. In particular, additional time is taken for travel and communication with families and hospital staff.

To counteract these time requirements, the implementation of telemedicine for ROP management has the ability to decrease the time commitment for examining ophthalmologists. Previous studies have shown that telemedical ROP diagnosis is highly accurate and reliable compared with ophthalmoscopy, and future work is required to address workflow questions in more detail.

According to senior author Michael F. Chiang, MD, "Telemedicine has potential to improve the delivery and accessibility of care for infants with ROP by reducing geographical and logistical barriers. This study shows that it may also improve the efficiency of care for ophthalmologists."

Given the increased number of at-risk infants in the United States and worldwide, improved use of ophthalmology resources may help to prevent cases of avoidable childhood blindness. The study appeared in July's American Journal of Ophthalmology.
For more on ROP, please see p. 60.

Approval Expands Crystalens Options

Bausch & Lomb received FDA approval to market the Crystalens HD accommodating intraocular lens in quarter-diopter steps. Quarter diopters will be available for the Crystalens HD for the models HD500 and HD520 in the ranges of 18 to 22. B&L expects to have the diopters available in a wider range by the end of the year. The company began shipping the Crystalens HD in the additional diopter steps on July 16, 2009.