You Just Can’t Talk to Some People.

In our daily practice routine, we encounter all sorts of individuals with all sorts of styles of communicating. One of our greatest challenges as clinicians is to develop our own style that provides a clear transfer of information in a caring tone that can fit this broad spectrum of individuals we treat.

Reading the personality type of our patient and understanding what methods of reasoning and communication are his or her best fit is an art in itself. I’ve long taken an interest in learning how best to communicate with different types of personalities because I continue to work at being a better communicator with patients.

Recently I met a patient who came for a consultation for cataract surgery. I read her to be highly intelligent, and I was very fortunately warned by the optometrist who referred her that she had a very stubborn personality and was not open to new ideas.

My discussions with the patient confirmed her stubbornness. When I brought up the subject of refractive lens implants, we talked about their limitations. As I always do, I was very clear that no option can guarantee a patient a life of true spectacle independence. The patient didn’t seem to accept this. Instead of nodding and understanding the limitations of technology, as most patients do, she ended our discussion by saying, “So if I pay all that extra money, doctor, I will never need to wear glasses again.”

Upon clarifying again the limitations of the lens, the patient repeated her position.

In the end I (fortunately) chose not to offer this patient any refractive option with her cataract surgery. I felt it would be a set-up for disappointment and conflict. Like other similar patients I’ve treated before, this patient illustrated to me the importance of identifying patients with whom I just can’t communicate. How many broken physician-patient relationships have occurred because of a gap in communication? How valuable is it to identify this potential gap before real conflict arises?

This is one of many reasons I feel that every surgeon should spend time personally talking through the consent process with patients prior to refractive cataract surgery. There are some important interactions that just can’t effectively be delegated.

FDA Approval of Surgical Treatment for Meibomian Gland Disease: A boon for patients and physicians alike.

North Carolina-based TearScience recently announced the FDA approval of its LipiFlow thermal pulsation system for treating meibomian gland disease. This device is designed to apply heat to the inside of the eyelids while simultaneously compressing them from both internally and externally in a pulsatile manner. It is designed not only to maximally express the sluggish meibomian glands in this disease, but also to stimulate their continued spontaneous flow to provide sustained relief of symptoms following the treatment. The fairly comfortable 12-minute procedure is performed in the ophthalmologist’s office, and patients treated in the FDA study were found to have at least several months of significant improvement in symptoms.

This new development is great news for dry eye sufferers and physicians alike for several reasons. First, the therapeutic device (LipiFlow) will be coupled with a diagnostic device (called LipiView by TearScience) that is designed to aid in patient selection. This will hopefully take much of the guesswork out of treating dry eye by defining what degree of lipid vs. aqueous secretion is present. Well-selected patients will hopefully be very satisfied with the results of treatment. Second, the system is designed to express the sludge from these stopped-up glands much more efficiently than is possible with manual methods. Expressing glands manually is a task that most ophthalmologists avoid because it is painful for the patient and highly unpleasant for the physician. Finally, this represents the only treatment for meibomian gland disease that has been specifically examined and approved by the FDA.

It is likely that LipiFlow treatment will not be covered by Medicare or third-party insurance carriers, at least in the beginning. Because it is a self-pay procedure, patients will be demanding of genuine relief. So far, the data looks very promising that this will be the case, at least in well-selected patients.

At this time in history when FDA approvals of new drugs and devices come about as frequently as an eclipse, we should all celebrate the approval of this important new treatment.

• Disclosure: Dr. Hovanesian is a consultant and member of the medical advisory board to TearScience, the maker of LipiFlow.

“What do you mean I don’t have enough astigmatism to have laser cataract surgery, Senator?”

There are many questions in physicians’ minds about the application of femtosecond lasers for routine cataract surgery. Among them is the degree of safety added and the amount of cost incurred with these procedures. Another is the reimbursement model. To defray the cost of a $500,000 laser and disposables that cost several hundred dollars per eye, there clearly must be a significant added cost to the patient or third-party payer, but Medicare’s rules do not allow us to charge more to complete the steps of cataract surgery, no matter how expensive the “scalpel” we use.

Currently, laser manufacturers are talking about charging patients added fees for astigmatism correction, which the same lasers can also accomplish, while the steps (capsulotomy, lens fragmentation, incisions) that are part and parcel of cataract surgery will not be charged to the patient.

This really makes no sense at all and is just a workaround for a payment system that currently fails to recognize the added value of laser cataract surgery.

What do we do for a patient who has exactly 0.5 D of astigmatism, steep at the horizontal axis where we routinely make our primary incision? After a routine incision, one would anticipate no residual astigmatism. Therefore, the lasers used cannot be justified because there are no additional limbal relaxing incisions to be made. Do we not offer these patients laser cataract surgery because they don’t have enough astigmatism?

Healthcare systems have to change in response to changing technology. Data on the benefits of laser cataract surgery is surely to accumulate and create a convincing case for the adoption of this technology. Limiting its use to patients with just the right amount of astigmatism just for reimbursement purposes just isn’t a long-term solution.

We as physicians will need to encourage patients to step forward and speak to lawmakers and insist that better technology be made available, even if the costs are out of pocket. This is exactly what happened with presbyopia-correcting implants in 2005, when CMS was forced to recognize that these lenses did more, cost more and could not be provided for in the meager allowance for IOL reimbursement in the cataract surgery facility fee schedule. Medicare’s free ruling allowed patients to receive these more modern lenses as an optional, self-pay upgrade from traditional cataract surgery. A similar ruling is needed for laser cataract surgery, distinguishing it as a “refractive cataract procedure” as opposed to a more traditional procedure.

An impending epidemic of lens/bag dislocations?

A number of peer-reviewed publications in the last 10 years have highlighted the frequency of delayed dislocations of IOLs and capsular bags in patients with pseudoexfoliation syndrome. This phenomenon appears to be related to progressive capsular shrinkage and contraction (phimosis) creating centripetal traction against the lens zonules, causing the already weak zonules to lose their support for the lens.

Pseudoexfoliation cases pose enough intraoperative risks that every surgeon breathes a sigh of relief at the end of a successful case. However, it appears that we need to think further into this matter to avoid long-term complications for these successfully implanted patients.

Fortunately, Lisa Brothers Arbisser, MD, has done much of the thinking for us. She recently produced an extremely informative video chock-full of surgical pearls for pseudoexfoliation cases that can be viewed here. Among my favorite techniques that Dr. Arbisser presents was the idea to capture the optic of the IOL through the capsulotomy to prevent future phimosis. This anecdotal evidence suggests that this technique has been successful in preventing at least extensive phimosis and may have saved some eyes. We owe Dr. Arbisser a collective thank you for putting this information in such a compact format and making it available to us, her colleagues. I invite readers to comment on their own experiences with lens/bag dislocations in pseudoexfoliation cases.

Generic ‘Equivalents’?

This three-part blog series has focused on generic medications in ophthalmology. In our first post, we explored how the withdrawal of samples for branded medications used perioperatively will affect prescribing patterns. In our second post, we looked at the economics of generic medications, particularly for Medicare beneficiaries.

Now, let’s talk about efficacy. Many eye surgeons around the country are moving toward generic medications for preoperative and postoperative treatment because of cost pressures from patients. In an ideal world, generic equivalents could perform the same job as branded medications for a fraction of the cost.

With this assumption in mind, and with the hope of lowering out-of-pocket costs to our patients, my own practice, Harvard Eye Associates in Laguna Hills, Calif., made a change about 18 months ago to an all-generic regimen for cataract surgery consisting of generic 0.3% ofloxacin, generic prednisolone acetate 1% and generic ketorolac 0.5%. Compared with our previous regimen of all-branded medications — Zymar (gatifloxacin 0.3%, Allergan), Durezol (difluprednate ophthalmic emulsion 0.05%, Alcon) and Xibrom (bromfenac ophthalmic solution 0.09%, Ista Pharmaceuticals), all twice daily — we knew we would lose some efficacy simply because of patient compliance going from a twice-a-day to a four-times-a-day regimen. We did not expect this to affect our clinical outcomes, however.

The generics were simply not equivalent.

Fortunately, we had no increase in infections relative to the prior period using branded medications. In other words, our anti-infective regimen, including topical Betadine (povidone iodine, Purdue Pharma) at the conclusion of surgery, seemed to do its job.

Inflammatory sequelae of surgery, though, occurred at a noticeably increased incidence with the generic regimen. Fortunately, relatively few patients had full-blown cystoid macular edema. However, prolonged postoperative uveitis occurred much more frequently with the generic medication. Patients frequently had to be switched to branded steroids and non-steroidals, and their experience with cataract surgery was clearly affected by this adverse event.

In our practice of four busy cataract surgeons, we learned a clear lesson from this: The term “generic equivalent” is an oxymoron. Since the beginning of 2011, we have switched back to a new branded regimen consisting now of Vigamox (moxifloxacin 0.3%, Alcon) four times a day, non-generic Pred Forte (prednisolone acetate 1%, Allergan) and Bromday (bromfenac 0.09%, Ista Pharmaceuticals) once daily.

We have further learned the following about generic medications:

• The FDA approval process for generic medications requires proof of bioequivalence. In other words, generic drugs must demonstrate similar concentrations of active ingredients. However, bioavailability in target tissues is not tested. Clinical studies on neither animals nor humans are conducted to demonstrate safety or efficacy.
• Inactive ingredients in generic medications may vary widely from their branded counterparts. In an ingested pill, this may not make as much difference as in an eye drop. Toxicity of those incipient ingredients on the eye is commonly seen and has been reported widely, although anecdotally.
• In the case of steroids and non-steroidals after cataract surgery and glaucoma medications, patients may be using these generic products and exposed to these toxic inactive ingredients for many weeks.

While we still firmly believe that generic medications have an important place in the treatment of patients, we now use them more selectively for situations in which we are less concerned about efficacy and tolerability. Our patients are doing much better with the branded regimen that we now use. Inflammatory complications of cataract surgery are virtually unseen. (We are preparing data for a peer-reviewed publication on our experience so that others may learn from it.)

As the economic climate of health care in our country continues to evolve, so too will our challenges as physicians trying to navigate the ever more complex landscape while protecting our patients from harm.

• Disclosure: Dr. Hovanesian is a consultant for Allergan and Ista Pharmaceuticals.

Femto Wars, Part 2: The Nitty-Gritty

While the interest in femtosecond cataract equipment from last fall’s AAO meeting continued at this year’s recently concluded ASCRS meeting (more than 1,400 people attended a live surgery session sponsored by Alcon), it is good to see the conversation turn more toward technical distinctions among the machines and their relative advantages. Alcon, with its tidy lead in cataract surgery equipment market share, has the greatest potential to gain market share by offering discounts on other equipment and disposables for prospective users of its LenSx laser. OptiMedica boasts a fluid interface that does not require applanation (and therefore distortion) of the cornea and other anterior segment tissues. LensAR promotes the demonstrated quality of its proprietary imaging system. And Technolas Perfect Vision suggests that its laser will be capable of assisting in cataract surgery as well as creating LASIK flaps.

Those are all features, but what about benefits? As commercial femtosecond lasers become more widely available and more patients are treated, benefits in safety and surgical and refractive predictability will undoubtedly alter this conversation and slowly eliminate surgeons’ collective suspicion about the value proposition of this new, expensive technology. As other technologies such as lens implants and surgical instruments evolve around the capabilities of these new, highly precise machines, we can expect the debate about their utility to slowly fizzle. Twenty years ago, this happened with phacoemulsification. More than 10 years ago, it occurred with excimer lasers, and soon it will happen with femtosecond lasers.

Still, there is no reason to rush out and buy a machine. It is a dubious competitive advantage to have the first femtosecond laser in the community. While the first adopters may get the first local television news features and have some bragging rights, it is unlikely to significantly shift future local market share in cataract surgery. After all, we are facing an aging population that is doubling in size and a population of cataract surgeons that is declining. Everyone is going to be very busy in the near future.

Lastly, as competition among the four (and maybe more) femtosecond companies continues to heat up, it will be interesting to see what conflicts might arise over intellectual property. The question of which company owns the rights to the various parts of femtosecond laser-assisted cataract surgery is still unclear. Much as it occurred with the excimer laser, we might expect some legal tangles between the companies over patent infringement.

One thing is clear: The idea of femtosecond laser-assisted cataract surgery is here to stay.

Generics, Part 2: The Real Cost of Generics — The hole in Medicare’s donut is bigger than it used to be.

This is the second in a series of blog posts about changing trends in the use of perioperative medications in cataract surgery.

For decades, physicians have become accustomed to pharmacies substituting generic medications for the brand name products that they prescribe. In general, this substitution saves money and does not present any greater side effects or loss of efficacy than the prescribed brand name product. There are notable exceptions in which generic substitution is not advisable, including thyroid hormone replacement medications and others. But most of the time, a generic medication is essentially equivalent to the brand name product. In treating eye disease with topical medications, however, we have a special pharmacologic environment — one in which the medicine (and its vehicle and all incipients) is placed directly on the very sensitive end organ, the eye. We will discuss more on the efficacy and side effects of generic substitutes in eye care in the last blog post in this series.

What about the cost of generics? Frequently, well-intentioned doctors prescribe generics for patients who are paying cash out of pocket or who are in the Medicare Part D donut hole — the period of time for each Medicare beneficiary where prescription coverage is theoretically absent. For these patients, generics are cheaper, right?

Not so fast.

A patient recently brought to my attention the following facts about what happens with generic vs. brand name medications for most Medicare patients in the so-called donut hole*:

• The donut hole will be phased out between 2010 and 2020 in a series of steps. In 2011, eligible Medicare beneficiaries in the donut hole will receive a 50% discount at the pharmacy on brand name drugs and a 7% discount on “equivalent” generics.
• The full Medicare-negotiated price of brand name products (not the 50% discount) will be counted toward the patient’s true out-of-pocket costs, which must reach $2,850 before the patient exits the donut hole.
• For generics, the actual amount paid for the generic, which is 93% of negotiated price, will apply toward the deductible.

So let’s say brand name Acme Pain, a prescription medicine, costs $200/month, and a generic is available for 70% less than the cost of Acme Pain, or $60/month. (According to the National Association of Chain Drug Stores, generic medications on average cost 30% to 50% less than their brand name counterparts, but I am assuming a much bigger 70% discount.) In the donut hole, a patient buying the brand name medication would get a 50% discount (per the rules above), or $100/month for this brand name medication. A patient buying the generic would pay 7% less per the same rules, or $55.80. There’s a savings of $44.20 for the generic, right? At first yes, but only $55.80 applies to the patient’s deductible with the generic vs. the full $100 with the brand name product. In other words, the $44.20 “saved” must now be spent before the patient gets past the $2,850 out-of-pocket cost to exit the donut hole.

Generics? Some savings.

In the old days when only efficacy and side effects mattered, it was easy to make decisions for patients’ best medication choices. Now, however, the increasingly confusing element of cost has entered into the equation, and the old “white knight” of generic medications does not appear always to be the good guy after all.

*This is not a complete description of Medicare Part D rules. Please consult the CMS website for full details.

Generics, Part 1: As samples disappear, what will we prescribe?

This is the first in a series of three blogs that will examine the changing climate affecting prescribing patterns for perioperative medications.

As samples disappear, what about those who can’t afford medications?

A sea change is happening in ophthalmology as it appears that market leaders in perioperative eye drops have begun limiting samples of the medications that are most commonly used in cataract postop “kits.” The perception by many surgeons is that the new policies are based upon concerns by the companies that providing a high volume of samples to physicians could be misconstrued as promoting the off-label use of these products in cataract surgery.

Macro-economically, this is good news because it allows market forces to determine which drops are prescribed rather than brand loyalty. No longer will the company with the highest budget for samples be able to dominate the postoperative kit market. Rather, physicians will choose products based upon perceived efficacy and price.

Micro-economically, we should all be concerned for our low-income patients. Those on fixed incomes sometimes have to choose between their medications. How many of them really consider eye drops to be “real medicines” anyway? We can hope that fear of postoperative complications will motivate most to comply. We can prescribe less expensive choices (more on this in the next part of this series). We can apply for assistance from the drug makers. It was just so much easier when we could reach into the cupboard and hand out samples to those who couldn’t afford to pay.

Remember when pharmaceutical companies could give us pens, pads and mousepads? Nobody misses those days. But I’m afraid we will miss the days when drug makers could provide enough samples to give a little help without fear of legal troubles.

In our next blog, we will examine some little-known truths about the costs of generic alternatives.

Amniotic Membrane a Useful Tool for Every Ophthalmologist.

A recent article by Tandon and colleagues in the British Journal of Ophthalmology described a study of 100 patients with moderate and severe ocular burns (both thermal and chemical) who were treated by conventional medical therapy with and without the adjunctive use of ocular surface transplantation with aminotic membrane (AMT). The study found that in patients in whom adjunctive amniotic membrane was applied as opposed to controls, epithelial healing time was substantially shortened. This is not surprising because AMT is routinely used to enhance epithelial healing in neurotrophic ulcers, diabetics with chronic epithelial defects and other ocular surface abnormalities.

What surprised me about the study was that the long-term outcome of these eyes was similar with and without AMT. However, the control and amniotic membrane groups were not equivalent, and I suspect that this skewed the study’s results against the benefits of aminotic membrane. Eyes in the amniotic membrane group had significantly larger epithelial defects and more limbal conjunctival destruction. Additionally, both groups were made up of mostly children and young adults, who bear the best prognosis following ocular burns because of their healthy, robust conjunctiva. In the short term, children tend to heal quickly and well. If the treatment and control groups in this study had been equal, and if the patients had been followed for a longer time, it seems quite likely that the results would show more uncomplicated healing in the amniotic membrane-treated groups.

Amniotic membrane has a long history of use in ophthalmology, dating back to the 1930s. Although it is primarily used in the treatment of pterygium, it has received global acceptance as a useful tool in almost every type of ocular surface surgery. Besides speeding ocular healing, amniotic membrane quiets inflammation and allows restoration of a healthy ocular surface. I commend the authors of this study for bringing forth another data set showing the value of this most useful material.

For Cataract Surgery in the Uveitic Eye: use the safest lens possible.

A recent study in the Journal of Cataract and Refractive Surgery by Abela-Formanek reviewed the biocompatibility of different lens materials and designs for use in uveitic eyes. The study concluded, by a somewhat narrow margin, that hydrophilic acrylic lenses performed slightly better than hydrophobic acrylic lenses. Furthermore, lenses with a square-edge design allowed less formation of Elschnig pearls and posterior capsule opacification.

We pay a good deal of attention to the medication regimen used in uveitic eyes and other complicated scenarios, but the choice of lens material is also important.* This article builds upon an existing fund of knowledge that hydrophilic acrylic lenses probably serve these patients best. In the U.S., the lenses that fit into the category of hydrophilic acrylic are the Akreos lenses (Bausch + Lomb), the series of STAAR Collamer lenses (STAAR Surgical), the Rayner C-flex IOLs (Rayner) and the Softec series of lenses (Lenstec). The increasing availability of hydrophilic acrylic lenses fills an important need in our surgical armamentarium.

It’s worth mentioning that two of the most common lenses in use in the United States are the hydrophobic acrylic AcrySof (Alcon) and the Tecnis (Abbott Medical Optics). With a track record of tens of millions of implants, these lenses are known to be safe in a wide variety of situations. In the patient with prolonged postoperative uveitis, however, the advantage probably goes to hydrophilic lens materials.

*There are no data showing that silicone or other lens materials are unsafe in patients with uveitis. This blog entry intends to clarify the findings of one published study. It does not intend to suggest that silicone or any other lens material is inherently unsafe.