The LASIK Blog

Medicare Appears to be Reversing Avastin Ruling

In my October 12 Blog post I wrote about Medicare's foolish decision to reimburse retinal specialists less than their costs for treating macular degeneration with the much- less expensive drug, Avastin.  This decision would cost our government millions of dollars annually.  I questioned how this system could ever manage healthcare.

I received an e-mail from both Dr. Joel Eichler (EyeCare 20/20's Retinal specialist) and the AAO today:

Kohl Indicates CMS Will Reverse Avastin Reimbursement Decision

The Academy is encouraged by an announcement today from Sen. Herb Kohl, D-Wis., chairman of the Senate Special Committee on Aging, who indicated CMS intends to reverse its Oct. 1 implementation of a new reimbursement code (Q2024) created for physicians (including ophthalmologists) who use smaller doses of Avastin for patient treatments. The Academy, along with the American Society of Retina Specialists, the Macula Society and the Retina Society, had challenged the new code’s implementation because it poses significant challenges for members’ practices and our patients’ access to care.

While the Academy is pleased by Kohl’s announcement, we await official word from CMS and details of its reversal, which are expected later this week.

I am hopeful this reversal will go into effect ASAP, the cost savings are enormous.  I will keep you all posted!

Newest Trends in Eye Care From Annual AAO Meeting I

This week is the Annual Meeting of the American Academy of Ophthalmology (AAO).  Over the next few days I will report on a few of the latest trends being presented at the meeting in San Francisco.  Many of these short synopsises will be taken from "Academy Live" an e-mail; alert from the AAO.  Each synopsis will be followed by some of my personal commentary.

LASIK safe for Form Fruste Keratoconus?  Damien Gatinel, MD, went back and looked at outcomes after LASIK and PRK when they were performed inadvertently in patients with suspected keratoconus.  “Three years later, the results are so far satisfactory,” Dr. Gatinel said, “There was no topographical sign of ectasia in these patients.  Even if it’s not recommended, he concludes that refractive surgery seems safe in topographically diagnosed keratoconus suspect eyes with a good biomechanical profile. When the audience was polled as to whether they would perform surgery on patients with forme fruste keratoconus, 77 percent said they would not.  Even after hearing this evidence, I personally feel that it would be foolish to do LASIK on a suspected keratoconus patient, the risks are just too high!

New Phakic IOL from Alcon holds promise.  Ronald R. Krueger, MD, medical director of Refractive Surgery at Cole Eye Institute, evaluated safety outcomes from clinical trials of the AcrySof Phakic Angle-Supported IOL.  Vision increased by two or more lines for 20 percent of subjects, one line for 44.6 percent and unchanged for 33.8 percent.  Phakic IOLs are an excellent method of providing superb vision in high myopes.  I currently use the Visian IOL, a posterior chamber IOL manufactured by Starr.  The Alcon lens will allow more ophthalmologists to provide this technology to their patients once it is approved, as it will be a much simpler IOL to implant.

Avastin vs Lucentis Trials underway:  Avastin and Lucentis are competing in a hefty schedule of six head-to-head randomized clinical trials directly comparing their use in AMD patients, said Daniel F. Martin, MD.   Initial study results are expected to be available in early 2011.

Here’s the status of each of the studies:

• The NEI-sponsored CATT (Comparison of AMD Treatments Trial) study began enrolling an estimated 1,200 wet AMD patients at 44 sites in the United States in February 2008. The four-arm study comparing bevacizumab and ranibizumab on fixed and variable schedules is proceeding well, according to Dr. Martin, with one-year results targeted for 2011.

• In April 2008, researchers in the United Kingdom began enrolling an anticipated 600 patients at 17 sites in the IVAN (Inhibit VEGF in Age-related choroidal Neovascularization) study. This four-armed study compares monthly bevacizumab 1.25 mg and ranibizumab 0.5 mg injections given over two years with three monthly injections followed by PRN dosing.
• The four-site German VIBERA study started enrolling 360 AMD patients in 2008 to receive three monthly bevacizumab 2.0 mg or ranibizumab 0.5 mg injections and additional injections as needed.
• The Austrian MANTA study began assigning an anticipated 320 AMD patients in June 2008 to three monthly bevacizumab or ranibizumab injections, with additional treatment as needed.
• Researchers in Norway began enrolling an anticipated 450 patients in the 12-site LUCAS study in March. Subjects receive bevacizumab 1.25 mg or ranibizumab 0.5 mg monthly as needed until dry, with intervals between doses decreasing over time.
• French investigators opened enrollment this fall in the 600-patient, 20-site GEFAL study. Subjects are randomized to receive three initial monthly injections of one of the two drugs.

I am anxiously awaiting the results of these studies, as I am a strong advocate for the use of Avastin as a primary therapy in the treatment of SMD.

FDA Announces Plans for LASIK Quality of Life Project

In an October 15 press release, The FDA announced its plans to implement a 3 pronged initiative to evaluate "quality of life" issues associated with LASIK.  This study will be implemented in collaboration with the National Institute of Health and the US Department of Defense.  The goal of this initiative is to "determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems."

The 3 phases of the initiative will be:

1. Design and implement a Web‑based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure.
2. Evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center.
3. A national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population. Patient enrollment in Phases 2 and 3 have yet to begin but plans are under.

According to the release: "The results of the project will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome. If any of these factors are related to the safety or effectiveness of the lasers used in LASIK surgery, the FDA will evaluate whether any action is necessary. The project is part of the FDA’s ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery."

I think that this FDA initiative is a wonderful idea.  An organized study such as this can only improve our understanding and outcomes for this incredible procedure.  Once the online survey is made available, EyeCare 20/20 intends to forward the link to all our past LASIK patients so that they may participate in it.  We will also implement a "modified" online survey of our own to compare national results with those of EyeCare 20/20.

Avastin vs Lucentis: Why our Gov't Will Never Manage Healthcare Efficiently!

There have been several articles in the New York Times discussing how the current health care proposals currently being debated will do little to control health care costs.  In my opinion government control of health care and health care cost control are mutually exclusive!  A case in point:  the Avastin vs Lucentis controversy.

I have previously discussed the Avastin vs Lucentis controversy in this blog.  Basically, there are 2 medications used to treat certain types of macular degeneration: 

• Avastin, a cancer medication, is used as an of label use to treat macular degeneration at a cost of about $50 per injection

• Lucentis, approved for the treatment of macular degeneration at a cost of about $2000 per injection

These drugs need to be used every 2 to 3 months to control macular degeneration.  Both drugs are made by a Roche subsidiary, Genentech.  In my opinion, both drugs are equally efficacious in the treatment.  In the past a doctor could make more money by using the more expensive Lucentis, as the law allows a percentage mark up on injectables.

The New York Times reported on October 1 a change in the Medicare rule concerning these medications.  Medicare will continue to fully reimburse the doctor who uses the $2000 Lucentis , but will only reimburse the doctor $7.20 for using Avastin, which costs the doctor $50!  So now there is a double incentive for using the $2000 treatment every few months:

1. Ability to make more money ( a percentage of the more expensive medication)
2. Using the less expensive medication will cost the treating doc $42.80 out of his own pocket.

Do the math, with over 1.7 million people suffering from macular degeneration, this myopic policy will cost the tax payer hundreds of millions of dollars annually.  It will also cost the patients an additional $400 per treatment, the 20% that Medicare does not cover.

In the past I have stopped referring my patients to retinal surgeons who use Lucentis before Avastin.  Now, with this change in policy, I can't blame them for not wanting to "pay" to treat these patients!

What I do know is that our health care system is a mess.  I don't trust the Democrats, I don't trust the Republicans, I don't trust Obama, and I don't trust the insurance industry!  Who do you trust??

US Healthcare run Amok: Conjunctivitis treated for a mere $2500!

I was on call this past week for my local hospital.  This means that I cover the hospital for all eye problems including emergency visits and in patient consults.  Since I do all my surgical procedures in an Ambulatory Surgical Center (ASC), and since my hospital call obligations are only once a year, I have very little contact with the present day hospital environment.

Saturday afternoon, I received a call from an attending at the hospital, requesting a consult for one of his patients.  He stated that the patient had left eye pain and needed to be seen that day.  After dinner, I went to see this patient.

The patient was a 52 year old woman.  She was in the hospital bed, hooked up to an IV, receiving pain medication for her eye pain.  A brief history revealed that she had been experiencing some eye pain and light sensitivity for the past 3 days.  She decided to go to the ER when her condition had not improved on Saturday.  She was admitted to the hospital thru the ER for this eye pain!

Exam revealed hat this patient had a simple conjunctivitis with some inflammation in the front if her eye,  Treatment was simply some antibiotic and steroid eye drops.  I called the attending doc the next day REAL early, before my Sunday bike ride, knowing I would wake him up.  I told him what I found and what I recommended.  He said he would discharge the patient and have her follow up at my office this week.  I than asked him why she was admitted to the hospital.  I was hoping there might be another reason, other than the eye pain.  Wrong, she was admitted for unexplained eye pain!  I conveyed my displeasure with the attending and said goodbye.

On would think that this patient had no insurance.  It would less "expensive" for her to go the the ER and be treated for "free" than to spend $125 at an eye doctor's office and another $75 at the pharmacy for the eye drops.  But this patient did have insurance through an HMO!  The HMO will now incur the ER costs of around $500 to treat this patient, but to make matters worse was the hospital admission.  I would estimate that the total cost to the HMO to treat this woman's conjunctivitis will be in excess of $2500 as opposed to the $200 it would have cost as an out patient!   This translates into higher premiums for you and me...

I have no answers... Something is drastically wrong with the system, and it needs to be fixed fast!  What do you think??

New Advisory for Cataract Patients taking Flomax Issued: Not Strong Enough!

I have been advocating a change in practice patterns concerning Flomax patients who have cataracts.  I received an e-mail from the American Academy of Ophthalmology (AAO) containing an Advisory on this subject, which I will share with everyone: 

Academy, ASCRS Update Previous Advisory Following New Findings About Link Between Flomax and Post-Cataract Surgery Complications

The Academy and the American Society of Cataract and Refractive Surgery (ASCRS) have issued an update to their previous joint patient advisory regarding eye surgery and patients’ past, current or planned use of alpha-blockers, particularly Flomax® (tamsulosin). Recently, the lead article in the Journal of the American Medical Association reported that during a five-year study period, tamsulosin doubled the risk of serious postoperative complications following cataract surgery. No increased risk with non-selective alpha-blockers was seen. The findings of this study were widely reported in the press. The Academy and ASCRS believe this is an opportunity to reinforce and update their advice to the public about alpha-blockers and Intraoperative Floppy Iris Syndrome (IFIS).

The advisory recommends the following:

1) A patient should advise his or her ophthalmologist if he or she currently uses, or previously took, an alpha-blocker such as Flomax.

2) A patient should not decide to discontinue these drugs without first consulting his or her prescribing physician.

3) If he or she already has cataracts, the patient may wish to consult with his or her ophthalmologist before starting an alpha blocker for the first time.

The patient advisory emphasizes that if the ophthalmologist is made aware of the drug history, the success rate is still excellent and there is no need to delay or avoid cataract surgery that has been recommended.

View the Information statement.

This advisory recommendation is certainly a step in the right direction.  However, I still feel the policy has not gone far enough!  I repeat my recommendation: 

any patient being placed on Flomax or another alpha blocker should have an exam with their ophthalmologist prior to starting the medication.  If a cataract is found during this examination, the cataract should be removed before starting the medication!

The Flomax-Cataract Controversary, Continued

In this week's issue of JAMA is an article titled:  Association Between Tamsulosin and Serious Ophthalmic Adverse Events in Older Men Following Cataract Surgery.  The study looked at a group of 96,128 men, ages 66 and older, who had cataract surgery. Among those who had taken Flomax in the two weeks before surgery, 7.5 percent had a serious complication like retinal detachment or inflammation of the eye. Only 2.7 percent of patients who hadn't recently taken Flomax experienced such complications.  The authors concluded that:

Flomax exposure is associated with an increased risk of postoperative complications concurs with prior studies of intraoperative adverse events. We believe that this is the first large study with an adequate study design to describe this effect and provide a population-based risk estimate (something that can only be done using population-based observational research). It is unclear whether drug discontinuation prior to surgery reduces this risk. Because the combination of cataract surgery and tamsulosin exposure is relatively common, patients should be properly appraised of the risks of drug therapy and preoperative systems should focus on the identification of tamsulosin use by patients. In this way, surgeons can plan and prepare for a potentially more complicated procedure or refer to someone with more experience.

This article was also discussed in the New York Times and US News & World Report, among others.

I have already posted two blog posts concerning the problems associated with Flomax use before cataract surgery.  I find that discontinuing the Flomax prior to surgery does not decrease the risk of a more difficult surgery.  I have seen floppy iris syndrome (IFIS) in patients who have been off Flomax for more than 1 year!

In this month's issue of EyeNet, I have a letter to the editor,  Remove Cataracts Before Starting Flomax, published.  Here is a copy if my letter:

I read with interest the article “The Latest Wisdom on Managing Floppy Iris” (Clinical Update, March). Although we are better equipped for handling intraoperative floppy iris syndrome (IFIS) with the aid of the Malyugin ring, we are going about its prevention all wrong.

We may argue about whether to stop tamsulosin prior to cataract surgery or to have the urologist prescribe a different alpha blocker, but we are missing the point. The use of alpha blockers does cause an increased incidence of IFIS and, with it, an increased morbidity during routine cataract surgery! It is time to follow the guidelines for patients who are about to be prescribed chloroquine: a baseline ophthalmic exam prior to the initiation of therapy.

If the urologist is considering starting a patient on an alpha blocker to treat urinary symptoms, a baseline exam from the ophthalmologist should be considered prior to treatment. If a cataract is detected, it might make sense to treat the cataract prior to the initiation of alpha antagonist therapy. This would go a long way toward minimizing the morbidity in these patients.

Cary M. Silverman, MD

East Hanover, N.J

Download May09_Letters

I firmly believe that Flomax and other alpha agonists may have a severe adverse effect on cataract surgery.  I will be making it my mission to advocate for the above protocol when contemplating the start of this therapy.

OBSERVING MEMORIAL DAY: Honoring Our Fallen Heroes

This Memorial Day, we at EyeCare 20/20 would like to take this time to reflect and remember all the brave men and women of the United States who have given their lives while defending our freedom and country. We extend our deepest gratitude for their courage and dedication to preserving peace.

 

Memorial Day Facts:

• Memorial Day is celebrated every year on the last Monday of May.

• Memorial Day was first observed to honor Union soldiers who had perished during the American Civil War. It has since been expanded to observe casualties of all American fought wars and actions.

• Memorial Day was first declared a national holiday in 1971.

• In November 1918, while working at the YMCA Overseas War Secretaries Headquarters, Monina Michael wrote the poem We Shall Keep The Faith and vowed always to wear a red poppy as a sign of remembrance. Today, poppy flowers are used to represent Memorial Day. They are worn to remember those who died for our country.

    

    We Shall Keep The Faith

  “We cherish too, the poppy red
That grows on fields where valor led,
    It seems to signal to the skies
 That blood of heroes never dies."

 

• One tradition on Memorial Day is to fly the American flag at half staff from dawn until noon.

• A national moment of remembrance is observed at 3:00pm on Memorial Day.

• Memorial Day is often referred to as the unofficial start of summer.

 

Nat'l Foster Care Month: Giving Back Is Easy, It's In The Bag

Did you know that 496,000 American children and youth are in the foster care system? 

 

Each May, National Foster Care Month provides an opportunity to focus public attention on the plight and potential of children in foster care. The child welfare community is calling on every citizen to do something positive that will change a lifetime for a child or young adult in foster care -- as foster parents, volunteers, mentors, employers or in other ways.

According to to the website Fosterclub.com, if nothing changes in the United States between now and the year 2020:

• Nearly 11 million children confirmed cases of abuse and neglect will be reported;
• 8,000 children will die of abuse or neglect;
• 7.2 million children will experience the foster care system;
• 240,000 youth will age out of foster care with inadequate support and resources to compete in the workforce and build successful lives.

Thousands of individuals and families already support young people in foster care, now it’s your turn!

Foster youths often come into care and move homes unexpectedly with their belongings stuffed in trash bags. You can help comfort them during these times of turmoil. Just one bag filled with all the necessary items (see list below) to get through the first days of care is all is takes.

            *  A toothbrush and tootpaste

            *  A Hair Brush or Comb

            *  Deodorant and a small travel kit filled with amenities

            *  Socks and Underwear

            *  Small stuffed animal

            * A blanket

Children First For Oregon is currently holding a duffle bag drive. By donating just $35.00 you can provide a child with a bag filled with the items above. For more information on Children First For Oregon Duffle Bag Drive or to make a monetary contribution, visit them online.

To learn more about National Foster Care Month, visit www.fostercaremonth.org

Searching For That Special Gift This Mother's Day?

We know that finding the perfect gift for Mother’s Day can be a challenge. If you’re shopping for your mother, wife or girlfriend and you’re looking for answers to that age-old question of what to buy, here are some “eye-opening” gift ideas:

THE GIFT OF SIGHT- She’s always been the one to look after everyone. Say “Thanks Mom” by giving her LASIK. She’ll get the crisper, clearer vision she needs and deserves. Many mothers stress about the worries of taking care of their children in the home or while out should they lose their glasses or contacts. The piece of mind of knowing you can see without correction, as well as the convenience factor makes LASIK a worthy investment.  It’s the gift that can be opened every day and can help her focus on what’s really important.

A LITTLE “SCENT-SABILITY”-Gifts such as scented candles or aromatherapy essential oils can be great for the stressed-out Mom and the calm alike. Or maybe she has a favorite perfume or cologne?

A SPA DAY- Surprise and indulge your mother with a great massage or a day at the spa. It may be just what she needs to escape from life’s ups and downs.

MEMBERSHIP HAS ITS PERKS- A season pass or membership is the perfect gift that continues giving year round. How about a pass to her favorite museum, her local zoo or aquarium or that new yoga studio she’s been dying to try?

IT’S IN THE BAG- Find the perfect bag for the woman in your life and fill it with all her favorite things. Does your mother like to garden? Perhaps a bag filled with seeds and gardening tools. Does your wife really like to spend time in the kitchen? Kitchen gadgets, hand towels and a cookbook all make great gifts for the at home chef. How about a personalized photo diaper bag for the new mom?

When selecting a gift, remember it’s really the thought that counts. So whether it’s a simple gesture, a well-selected card, a box of candy or a bouquet of her favorite flowers, she’ll be sure to love it as long as she knows it came from you.