Sunday, August 24, 2014

If there is a clear winner in the health care field--in terms of increased efficacy and lower cost over the decades--it has to be cataract surgery.  I remember my grandmother's cataract removal in the 1960s. An expensive, laborious procedure requiring days of unmoving bed rest afterwards while the eye healed, and a lifetime of thick glasses.  Now, the procedure takes minutes, the costs have plummeted, and the patient leaves the outpatient procedure ready to drive herself home. As noted here, "The surgery has become fairly common: millions of people have cataracts removed every year, and 98% of the surgeries are successful and free of complications."  The societal benefit has been huge, according to the American Academy of Ophthalmology:

Cataract surgeries performed over one year eventually save $123.4 billion over 13 years and delivers a 4,567 percent financial return on investment to society according to the results of a cost-utility study.

The majority of the $123.4 billion savings are in patient cost savings and Medicare savings, which accounted for 39.4 percent 29.5 percent, respectively. Other gains included employment/productivity (20.6 percent), Medicaid (2.7 percent) and other insurers (7.8 percent).  For each cataract surgery on a single eye, which costs an average of $2,653, the savings will amount to $121,198.

The overall cataract surgery cost in 2012 was 34.4 percent less expensive than in 2000 and 85 percent less expensive than in 1985 after adjusting for inflation. Furthermore, the inflation-adjusted physician fee in 2012 was only 10.1 percent of what it had been in 1985.

Now, the trend may change. Recent developments indicate a possible shift towards a high-cost procedure that is being marketed by ophthalmologists as a way to improve their income. The impetus is a new medical device that, on its face, would be too expensive given the relative improvement in efficacy that it offers.  A loophole in the Medicare billing system makes it possible. Cooperation by the manufacturers and doctors in direct-to-consumer marketing is the key, persuading unsophisticated patients that the extra money they pay is worth it.

The femtosecond laser

There is a new medical device that has been introduced to make the initial incision for cataract surgery, called the femtosecond laser.  No one disputes that it adds a level of precision to the procedure. Here's one remark:

Eric Donnenfeld, MD, immediate past president of ASCRS, says the clinical benefits of femtosecond laser cataract surgery are fourfold:

1. The primary incision allows the surgeon to create a uniform and consistent three-plane incision with a self-sealing reverse side cut, which has the potential to reduce the incidence of endophthalmitis.

2. Incisions are more accurate, safer and reproducible.

3. Capsulotomies are more precise.

4. The procedure is safer.

But there are strong feelings in the profession:

Can the laser do anything that a well-qualified surgeon can't already do? Steven G. Safran, M.D., Lawrenceville, N.J., and Brad Oren, M.D., Lake Worth, Fla., don't seem to think so. "There is nothing that this technology can do for me that I need help with," said Dr. Safran. "I can make a perfect capsulorhexis 100% of the time with a bent needle and capsulorhexis forceps and in my opinion, it takes less time than it would if a femto laser was added to the mix." "In my hands, this machine doesn't benefit the patient at all," said Dr. Oren. "I haven't had a wayward capsulorhexis since I was a resident. Any good surgeon hasn't." Dr. Safran likens the assistance the femtosecond laser gives cataract surgeons to bathroom attendants in high-dollar nightclubs and restaurants: Thanks, but I can grab the towel and soap myself.

Another states:

It seems like one of the best reasons now to get a laser is to ‘keep up with the Joneses’ rather than for any outcome or safety issue,” said Thomas A. Oetting, MD, associate professor of clinical ophthalmology at the University of Iowa. 

All of this back-and-forth is anecdotal.  Is it clinically relevant? Where's the hard evidence? An article notes:

“The literature on vastly improved safety and visual outcomes is limited, with traditional cataract surgery being so successful and laser-assisted surgery still being relatively new in terms of mainstream use,” says J. Christopher Freeman, OD, clinical director at nJoy Vision in Oklahoma City and president of the Optometric Council on Refractive Technology.

Clinical results, peer-reviewed evidence and cost-effectiveness will ultimately determine the level at which femtosecond laser technology is clinically embraced in the years to come. Further prospective clinical trials are needed to evaluate femto’s impact on the quality of cataract surgery and outcomes.(Roberts T, Lawless M, Colin CK, et al. Femtosecond laser cataract surgery: technology and clinical practice. Clin Experiment Ophthalmol. 2013 Mar;41(2):180-6.)
Some articles supportive of the technology are written by doctors with a financial connection to the equipment manufacturer.

Increased costs

So, in scientific terms, the jury is still out.  And the machine is expensive:

The machine alone costs about a half-million dollars. Then there’s a usage fee that comes in between $150 and $400 per eye, and maintenance costs of between $25,000 and $50,000 per year after the initial warranty has expired. 

There are other kinds of payment plans.

You can lease the laser, lease to buy, or buy it, and some [femtosecond] companies give away the laser for a nominal sum and then charge a higher click fee. If you’re leasing the equipment and just paying per click, the fee could be $650 to $750 per treatment.

And it has ancillary costs:

The space the laser takes up; the cost of OR time; staffing costs not just in the OR, but also for the receptionists, preop nurses, recovery room nurses, and ancillary staff, all of whom will be at the surgery center longer because of increased surgical time; the cost of doctor’s time; and the opportunity costs.

Increased MD Revenues

Even if there is an improvement in clinical outcomes, is the improvement worth these extra costs?  From the doctor's point of view, only if there is more revenue to make the investment financially viable.  How could this be this possible?  An MD friend explains:

It is important to understand how cataract surgery is billed. We typically use two different codes. Medicare reimburses the same amount regardless of the way you remove the lens and implant it. If you use the laser, they still reimburse the same, no matter what. See reimbursement rates below:

Regular cataract extraction CPT 66984- $687.71 
Complex cataract extraction CPT 66982  $855.58

The ethical dilemma arises because we now have new technology that can assist with intra-operative imaging in ideal lens placement for "premium" or "presbyoptic" lenses or lenses that correct astigmatism, "toric lenses." Medicare, again, will not reimburse for these items. They are an out-of-pocket cost to the patient. 

The laser also happens to assist in removal of the cataract by
1. Making incisions
2. Performing the anterior capsuolotmy or "capuslorhexis"
3. Performing the initial portion of breaking up the nuclear part of the cataract.

Surgeons would like to bill for this separately I'm sure; however Medicare does not allow it. Again, no matter how you remove the lens, it is the same reimbursement. So, how they have gotten away with it is that CMS has already ruled that physicians can charge the patient an out-of-pocket fee to implant the premium IOL and toric IOL.With the advent of the femtosecond laser,  recently CMS has also ruled that physicians may bundle in an extra fee for using the femtosecond laser for "imaging" purposes to implant these premium and toric lenses. Most physicians will then still use the laser for the above parts of the surgery described (#1-3) but technically they are billing for the imaging part of the procedure used to implant the lens. 

Why consumers choose to pay

Why would consumers choose to pay extra out-of-pocket costs if Medicare already covers the normal costs of cataract surgery?  Because the industry convinces them that it's worth it.  Here's how it is advertised by the Cleveland Eye Clinic:

The Cleveland Eye Clinic is the third practice in the nation to offer their patients the Catalys laser refractive cataract surgery system. Laser refractive cataract surgery offers the patient a greater level of precision and a greater level of customization. Patients can benefit from a truly innovative solution that allows for customization in cataract surgery that was never attainable before. When you choose to have your surgery performed with this Catalys, OptiMedica laser, you’ll enjoy a truly innovative solution that allows for customization in cataract surgery. A bladeless, computer-controlled laser allows the surgeon to plan and perform your surgery to exact individualized specifications, not attainable with past cataract surgery methods.

 With the Catalys, OptiMedica laser, you can move forward with confidence knowing that you’ve chosen the most advanced technology available for this life-changing procedure, one that enables a customized cataract surgery experience. If you are seeking a Cleveland cataract surgeon consider choosing the most advanced cataract surgery technology available right here.

Here's a Boston-based ad. Here's an outtake from the ad's video testimonial:

The marketing people have been clever: Note the use of the term "bladeless." This preys on our inherent fear of being cut in the eye. A laser is just as "sharp" as a blade, but it sounds so much more benign.

My MD friend summarizes the situation:

Seems a bit shady to me. I have heard adds on the radio that say, "If you aren't getting laser cataract surgery you aren't getting the best!" So what does this mean for the medicare patient convinced by their unethical ophthalmologist to have a premium IOL or toric lens implanted? 

Well, they not only will be charged for that premium lens (many times around $800-1000 extra depending on the surgeon) but also they will be charged an "imaging fee" for use of the femotosecond laser. This imaging fee can essentially be whatever the surgeon wants it to be. The various device companies charge you for the laser and a "per-click" use as well. Some places around here charge an additional $1000 for use of the laser. So now the patient is paying $2000 per eye extra for their "premium" cataract surgery.

Your government makes it possible 

We've seen this kind of direct-to-consumer marketing before, e.g., with robotic surgery.  Here, as with proton beam machines, the commercial viability of the equipment is made possible by an explicit Medicare pricing policy.

CMS offered its pricing guidance on these matters in 2012.  As my friend noted, the convoluted language chosen permits the femtosecond laser out-of-pocket charges to be imposed on patients:

If the bladeless, computer controlled laser cataract surgery includes implantation of a PC-IOL or AC-IOL, only charges for those non-covered services specified above may be charged to the beneficiary. These charges could possibly include charges for additional services, such as imaging, necessary to implant a PC-IOL or an AC-IOL, but that are not performed when a conventional IOL is implanted. Performance of such additional services by a physician on a limited and non-routine basis in conventional IOL cataract surgery would not disqualify such services as non-covered services.

In the second and third sentences, CMS created a loophole a truck could drive through. I don't have the resources to investigate how this occurred.  Perhaps reporters with interest and wherewithal will do so.  I find it extremely odd that CMS put out this advisory in response to a single press release issued by someone's ophthalmology practice (perhaps this one?), one that honestly attempts to portray the costs consumers might pay. Since when does the biggest agency in the federal government respond to a press release in that way? If I had to guess, I would surmise that medical industry representatives and the trade association of ophthalmologists noticed the ad, didn't like its implications, and made sure the agency did something about it.

What's the end result of all this? The decades-long trend of lower cost cataract surgery is about to reverse. Consumers will pay the difference.  For some, it is worth it.  Others are paying for the attendant in the washroom.


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