At Press Time
Sustained-release Punctal Plugs Effective
New double-plug approach leads to improved results.
By Jerry Helzner, Senior Editor
■ In its continuing efforts to deliver the glaucoma medication Xalatan (latanoprost) via a sustained-release punctal plug system, QLT Inc. recently reported significant IOP lowering and higher plug retention using a new proprietary plug design in the phase 2 Latanoprost Punctal Plug Delivery System (L-PPDS) trial.
Highlights of the 95-patient study include a mean pressure reduction from baseline of -5.7 mm Hg at four weeks, with 60% of subjects at four weeks showing an IOP reduction of 5 mm Hg or greater. Mean IOP at baseline for the patient cohort was 28.5 mm Hg. Retention of QLT's proprietary punctal plug placed in the lower punctum was 95% at four weeks.
The phase 2 trial featured simultaneous placement of punctal plugs in both the upper and lower puncta for delivery of a daily drug load with a goal of enabling comparable clinical outcomes to that of daily administered Xalatan eye drops. The company's overall drug development objective was a mean reduction in IOP of 5 mm Hg or greater.
“Most if not all glaucoma specialists would agree that eye pressure-lowering should be taken out of the patients' hands and left in the hands of the physician,” said Alan L. Robin, MD, associate professor of Ophthalmology and International Health at Johns Hopkins University. “The results of the QLT study find that L-PPDS may offer a breakthrough in the way glaucoma medication can be delivered. The results suggest that the L-PPDS may have the ability to deliver long-lasting clinically significant eye pressure-lowering that is relatively well-tolerated by patients so that they do not have to worry about eye drop instillation. Adherence no longer becomes a factor in preventing the development of needless blindness. Additionally, the procedure appears to be relatively safe, minimally invasive and simple to perform. With further development success, this delivery system could potentially revolutionize our therapy of glaucoma.”
“We are very excited to see clinically meaningful data showing that a higher dose of latanoprost administered through a double-plug approach can successfully decrease IOP by more than 5 mm Hg,” said Bob Butchofsky, president and CEO of QLT Inc. “As a result, we plan to move forward with another phase 2 trial in glaucoma and broaden this delivery platform by accelerating plans for a second molecule in 2012.”
Cataract Complications in Decline
■ A large-scale, retrospective study of 221,594 Medicare patients who had initial cataract surgery between 1994 and 2006 indicates that patients who underwent the procedure in the later years of the study had significantly less chance of being diagnosed with a serious adverse event.
Results of the study, led by Joshua Stein, MD, MS, of the University of Michigan Department of Ophthalmology and Visual Sciences, were published in the September issue of Ophthalmology.
The researchers broke the huge patient base into three cohorts, with another covering the 1999-2000 time period and the third cohort spanning 2005-2006.
A key finding was that, after adjustment for confounders, patients having cataract surgery in the 1994-1996 time period had a 21% greater chance of being diagnosed with a severe postoperative complication than those who underwent surgery in the 2005-2006 period. Patients operated on in the 1999-2000 period had a 20% greater complication risk than individuals who had cataract surgery in 2005-2006.
In the study, severe complications encompassed such events as endophthalmitis, retinal detachment and suprachoroidal hemorrhage. In all, 1,086 serious adverse events were reported over the three cohorts studied, which translates to 0.5% of the 221,594 total patients.
Risk factors associated with severe adverse events included prior diagnosis of proliferative diabetic retinopathy and undergoing cataract surgery combined with another intraocular procedure on the same day. Surgeons operating on the most complication-prone case mix had higher numbers of patients with severe adverse events.
Make Year-end Equipment Purchases
It's not too late to bolster your Section 179 deduction.
By Samantha Stahl, Assistant Editor
■ As 2011 draws to a close, it's that time of year to finalize any last-minute decisions about making equipment purchases in order to cut down the practice's federal tax bill for this year. As was the case last year, the 2011 limit for the Section 179 deduction on business assets is $500,000 (double the $250,000 limit in 2009) with a $2 million overall property value limit. Under new tax laws passed in December 2010, the deduction limit in 2012 will be $125,000 — meaning that now is a highly advantageous time to buy those big-ticket items.
The generous deduction limit allows your practice to fully depreciate any new asset purchase in the given tax year, rather than over the course of several years, placing a larger percentage of the practice's value on its capital equipment.
Keep in mind that to qualify for the deduction, the purchased equipment must actually be placed in service by the practice before December 31, not just “delivered and put in a back room somewhere,” says Mark Kropiewnicki, Esq, LLM, of The Healthcare Law Associates in Plymouth Meeting, Pa.
Because the purchase needs to be up and running quickly, make a realistic timeline of how long the equipment will take to be ready to go. An EHR system, for example, will likely be too large a project to tackle before the end of December. But diagnostic equipment with a minimal learning curve, like imaging devices, may be a little more feasible.
“I encourage physicians to take advantage of the tax savings offered by Section 179, as it gives the ophthalmic community an opportunity to purchase state-of-the-art technology, such as SD-OCT, that will aid their practice in improving the diagnosis and therapy of ocular disease,” says Peter Naismith, Optovue's director of marketing.
Most basic diagnostic equipment, and potentially a femtosecond laser — one of the year's most hotly discussed systems — are other possibilities to meet the end of year deadline. “To maximize the deduction, purchase items that are true capital assets, rather than expenses like disposables, service contracts or training,” says Farrell Tyson, MD, FACS, of Cape Coral Eye Center in Florida. “Also pay attention to how your contracts are itemized, since most vendors like to bundle everything into a lump sum. A line-item contract will allow you to separate ‘expensible’ items to maximize your deduction and minimize tangible tax exposure.”
In order for the IRS to consider a payment made in 2011, the check must be dated, mailed or postmarked on or prior to December 31. Equipment purchased with a credit card qualifies for deduction as long as the date charged is before December 31, even if the bill isn't actually paid until after that date.
It's important to involve your practice accountant in these decisions so that he or she will be aware of any legitimate deductions, but anyone looking for more specific information about Section 179 can review the topic at www.section179.org.
Also consider donating equipment that your practice no longer needs after purchasing replacements. While the tax benefits may not be substantial (particularly for corporations) unless the device is personally owned, explains Mr. Kropiewnicki, there are many charities that would appreciate the equipment. OM
| In the News … |
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| ■ MedPac “doc fix” meets opposition. The Medicare Payment Advisory Commission (MedPac), which provides recommendations to Congress on Medicare reimbursement issues, has suggested that a potential 29.5% cut in Medicare physician fees scheduled to go into effect on Jan. 1 could be softened by instituting a 5.9% fee cut for specialists for the next three years followed by a seven-year freeze in payment levels. Physician organizations immediately rejected the plan. AMA President Peter Carmel, MD, called it a “misguided scheme.” Potential shortfalls in Medicare physician fees have been averted in recent years through last-minute “doc fixes” pushed through by Congress. It is likely that Congress will have to act again to set the 2012 physician fees. ■ Same-day surgery will be allowed. In a major victory for ASCs and advocates for ophthalmology, the Obama administration has reversed regulations that it described as “unnecessary, obsolete, or burdensome … to American hospitals and healthcare providers.” Among those repealed is the Medicare rule that prohibited the performance of surgery in an ASC on the same day as the diagnosis and referral to the facility. This regulation has, for the past two years, essentially precluded an ophthalmologist from seeing his patient in the clinic and performing a procedure such as a YAG on the same day, causing inconvenience to patients and their loved ones, especially the frail and those who had to travel long distances. A new final regulation, effective in December, will allow the ASC to provide the patient, the patient's representative or the patient's surrogate with the patient rights information prior to the start of the surgical procedure. Notice must be both verbal and in written form. ■ NY ends eye tests for driver's license renewals. In what has been called a move to streamline government, the New York state Department of Motor Vehicles no longer requires that people renewing their driver's licenses take a brief eye test. Drivers can now “self-certify” that they have uncorrected or corrected vision of 20/40 or better and no further proof will be required. The New York State Ophthamological Society is objecting to the new standard, with a spokesman telling the New York Times that, as we age, vision changes are usually subtle and thus most people will believe that they have normal vision. The Ophthalmological Society says the decision to end the eye tests for license renewals now puts the public at considerable risk. “Although the vast majority of New York drivers would provide an honest and valid account of their visual function, this decision is a dangerous one,” says Jason Slakter, MD, a retina specialist who practices in New York City. “It opens up the possibility for individuals to knowingly or unknowingly overestimate their ability to see well enough to drive safely. Without doubt, what appears to be a cost-savings measure by the Department of Motor Vehicles may put many drivers and pedestrians at risk.” The DMV says nine states allow drivers to self-certify. Anyone caught lying will face criminal prosecution. ■ Ametek buys Reichert. Ametek, a large multi-industry company with $3 billion a year in sales, has acquired Reichert Technologies, a manufacturer of analytical instruments and diagnostic devices for the eyecare market. The company was acquired for $150 million and has estimated annual sales of $55 million. Reichert is a leader and innovator in high-technology instruments used by ophthalmologists for vision correction and the screening and diagnosis of eye diseases such as glaucoma and macular degeneration. |
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