Quality Control And Patient Information
Before application, the patient must be informed in writing about the planned therapy, its experimental nature, the risks involved , and alternative methods of treatment. The patients informed consent should be obtained. If only a small amount of blood is taken mild anaemia or circulatory disorders need not be considered as contraindications. However, in order to minimise the danger of bacterial contamination, no blood should be taken from patients with suspected septicaemia, and to reduce the risk of viral transmission to others, patients testing positive for HIV, HBV, HCV, or syphilis should be excluded.
Bacterial contamination is a potential risk in the production and use of serum eye drops. Sterile manufacturing conditions, beginning with thorough skin disinfection, are of the utmost importance. It is preferable that further processing is performed in a closed system. A microbiological examination of the product should be performed before application in order to rule out bacterial contamination resulting from the production process. To minimise the risk of infection to third parties it is strongly recommended that the donor is tested for HIV, HBV, and HCV and a control system must be implemented to ensure that the product is only used when the microbiological and serological tests are clear.
Why It Is Important To Do This Review
The use of AS in severe dry eye treatment has gained widespread acceptance in the past decade. However, it continues to be a restricted area because the preparation of serum eye drops requires a well-equipped laboratory and trained personnel. Studies conducted recently are controversial with regard to the effectiveness of AS for dry eye symptoms . Therefore, we undertook a systematic review to determine the efficacy and safety of AS for the treatment of dry eye.
Best At Defending Claims
An ophthalmologist pays nearly half a million dollars in premiums over the course of a career. Premium paid is directly related to a carriers claims experience. OMIC has a higher win rate taking tough cases to trial, full consent to settle clause, and access to the best experts. OMIC pays 25% less per claim than other carriers. As a result, OMIC has consistently maintained lower base rates than multispecialty carriers in the U.S.
Ophthalmic Mutual Insurance Company Phone: 562-6642655 Beach Street | San Francisco, CA 94109-1336Fax: 771-7087PO Box 880610 | San Francisco, CA 94188-0610Email:
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Introducing Aseds: Dry Eye Drops Derived From Your Own Blood
If you suffer from dry eye syndrome, you may already be familiar with the frustration of trying to manage your symptom of a shortage of your own natural and vital tears.
Unfortunately, there are a number of patients who fail to obtain symptom relief despite trying one or more of artificial tears, ointments, eyelid hygiene regimens, collagen tear duct plugs, or laser treatment options of the lacrimal glands to boost their natural tear production.
If you are one of those patients who have failed to find long-lasting relief, we invite you to consider autologous serum eye drops .
The use of autologous serum eye drops dates back to 1975 when they were first used to treat chemical burns of the eye. ASEDs are made from serum — a component of your blood that is combined with sterile saline to create a lubricating fluid rich in certain nutrients and growth factors that may be missing in very dry eyes. The term autologous means that it comes from your own body.
Does Medicare Cover Lasik
Medicare covers the surgery only when a doctor declares it medically necessary. If a person could use corrective glasses or contact lenses instead of having LASIK surgery, it would mean their sight and health do not rely on the LASIK procedure and it would not be deemed medically necessary.
In addition, original Medicare does not cover routine eye care, although coverage may be available for medically necessary eye exams or surgery related to another medical condition. For example, Medicare may cover certain eye care services related to diabetes, glucose, or if a doctor states a person needs cataract surgery.
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Do You Wear Glasses Youll Want To See This
According to the Vision Council of America, approximately 75% of adults use some sort of vision correction.1 Whether its eyeglasses, contacts or cheater readers, thats a pretty big number.
Given that number, you may be surprised to learn that, unlike most Medicare Advantage plans, Original Medicare does not cover routine vision care.
It does, however, cover medically necessary treatments that may improve or cure chronic eye conditions like glaucoma or cataracts. But you’ll need to check with your doctor to see if your condition makes the cut. For example, Lasik surgery for vision correction is not considered a medical necessity, so its not covered by Medicare.
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What Are The Different Advantage Plans
A person with original Medicare can choose to switch to or enroll in an Advantage plan if the plan is offered in their area. Costs may include a plan premium, deductibles, and copays.
Generally, plans that offer in-network providers in a certain service area offer the lowest costs. Plans also have out-of-pocket limits, which can help a person avoid unexpected healthcare costs. Some plans may offer the choice of out-of-network coverage, although such plans may be more expensive.
Advantage Plans include:
A person can use this online tool to search for Advantage plans in their area.
Eyedrops Made From Autologous Serum As A Treatment For Dry Eye
Dry eye is a common disorder of the tear film, which is a layer of tears covering the surface of the eye. Dry eye affects many adults older than 40 years of age. One common treatment for dry eye is artificial tears, which provide lubrication to the surface of the eye. However, artificial tears lack the biologically active components found in natural tears that are critical to the maintenance of the tear film. Eye drops made by separating the liquid and cellular components of the patients blood, known as autologous serum eye drops, have been shown to possess many of the same biological nutrients found in natural tears. Because of this, autologous serum eye drops are believed to be a better tear substitute and have become a common treatment for dry eye.
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How Are Dry Eyes Treated
You should discuss treatment options with an ophthalmologist or optometrist . In some cases, dry eye is caused by another disease or condition, like rheumatoid arthritis or systemic lupus erythematosus. If this is the case, the systemic disease should also be treated in order to relieve the dry eyes.
Here are some common treatments for dry eyes:
Symptoms can be greatly improved by these treatment options.
What Causes Dry Eyes
The majority of patients with dry eye have chronic inflammation in the tear glands that line the eyelid and in the conjunctiva . Just like inflammation in a knee, lungs or liver, this chronic inflammation can permanently damage the tear gland tissue to the point that treatment becomes ineffective.
In addition to an imbalance in the tear-flow system of the eye, dry eye can be caused by the drying out of the tear film. This can be made worse by dry air created by air conditioning, heat or other environmental conditions.
Many patients also have ocular rosacea , an abnormality of the glands on the edge of the eyelid that are supposed to produce the oil to prevent evaporation of the tears. When a patient has both dry eye and ocular rosacea, not only does he or she produce too few tears, but the tears that are made evaporate too quickly.
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Why Use Autologous Serum Tears
In our professional experience, patients who use autologous serum in conjunction with other dry eye treatment therapies have a significant and faster improvement of signs and symptoms, due to the serums ability to mimic their natural tears. Unlike artificial tears, these drops have antibacterial and antiinflammatory properties, and, because they are derived from the patients own body, they also provide an increased benefit to the population of patients who are opposed to the use of artificial substances.
We typically prescribe serum tears for acute and chronic phases of dry eye. Patients with persistent epithelial defects can typically stop using the autologous serum once they have healed, but patients with more persistent ocular surface disease, such as those with dry eye with associated Sjögren syndrome, will often need to use the autologous serum drops long term or possibly for the rest of their lives.
What Are The Costs For Lasik Surgery
LASIK surgery costs depend on several factors, including where the surgery is done, the surgeons experience, and the technology used for the procedure.
However, if a person needs cataract surgery, it may be done as out-patient surgery, and Medicare Part B would cover the cost. Medicare Advantage plans generally also provide coverage for cataract surgery.
Although Medicare does not generally cover eyeglasses and contact lenses, it does provide coverage for one set following cataract surgery. The beneficiary must pay 20% of the Medicare-approved amount.
If the individual requires a more advanced lens implant, they may have to cover some costs.
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I Will Be Offering Autologous Serum Tears To Our Patients And Will Draw Blood And Produce The Drops Onsite Does My Omic Policy Cover This
Yes, coverage will apply to both the preparation as well as the prescription and use of autologous serum eye drops by insured ophthalmologists. The use of autologous serum tears is widely utilized and accepted in the management and possible treatment of difficult clinical conditions that do not respond to other treatments. While the OMIC policy, like most medical professional liability policies, contains a product exclusion that excludes coverage for the designing, producing, manufacturing, assembling, distributing, marketing or selling of any medical device or other product, we consider the preparation of autologous serum tears for the insureds own patients to be a component of direct patient treatment rather than the production of a product. As such, the product exclusion does not apply to this activity.
One concern regarding this therapy is the possibility of contamination, which could result in serious infection. Technical procedures such as sterile manipulation of the bottles and the blood, as well as clear instructions to the patient about the need to keep the bottles refrigerated and about possible symptoms of discomfort or blurred vision, are helpful and are recommended to enhance the safety of this therapy. For additional advice or assistance in minimizing your liability exposure relating to the use of autologous serum eye drops, please contact an OMIC risk management representative by calling 562-6642, option 4.
What Do Autologous Serum Eye Drops Cost
One of the reasons that ASEDs arent widely used is because they are not covered by most health insurance since this treatment does not have FDA approval. And this treatment is costly because it requires the preparation of a custom medication using each patients blood.
The blood must be drawn by a technician, prepared using special equipment, and then stored frozen. Most ophthalmology practices refer patients to get blood drawn at an outside facility that sends the blood to a compounding pharmacy which then prepares the eye drops. This adds more inconvenience and expense to the process. Finally, after starting the eye drops, you need to return to your eye doctor’s office for follow-up visits to see how your treatment is progressing.
At AEI we simplify the process by doing the blood draws and preparing the eye drops on-site so that our patients can get everything done in one visit. Many of our dry eye patients who’ve had limited relief from other treatment modalities have had life-changing symptom improvement from serum drops and feel that keeping their eyes healthy is a worthwhile investment.
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What You Should Know
One negative factor of this type of treatment is frequent and inconvenient blood draws that must be made to prepare the serum, especially in people who require long-term treatment. Outside serum is being studied but it poses the risk of transmitting disease and causing hypersensitivity reactions. Of course, there are other ethical and legal issues that are present when preparing another humans serum for treatment for another.
In addition, autologous serum eye drops are expensive. Insurance companies do not typically cover this type of treatment. Costs for compounding the serum for patients will most likely range from $175 to $300 for a two-month supply.
Severe Dry Eye And Superior Limbal Keratoconjunctivitis
In 1984 Fox et al reported that a 3 week course with serum diluted 1:2 with 0.9% NaCl solution was able to improve the signs and symptoms in 30 eyes of 15 patients. When this medication was replaced by serum diluted 1:200 or pure diluent the discomfort increased again. Fifteen years later Tsubota et al reported that symptoms, fluorescein, and rose bengal staining of dry eyes in Sjögrens syndrome were significantly decreased after 4 weeks of 20% serum eye drops 610 times daily. Similar findings were described in patients with dry eye because of graft versus host disease, with symptoms improving within days, but punctate epithelial staining improving only after months. In 14 patients with moderate keratoconjunctivitis sicca in graft versus host disease the improvement lasted more than 6 months, but six patients required additional punctal occlusion. In a prospective study by Poon et al an improvement of subjective and objective criteria of severe dry eyes . was found in all eyes receiving 100% serum , but only in three out of eight eyes on 50% serum. The efficacy may be dose dependent since in a study by Takamura 94% of patients receiving eight applications reported reduced symptoms compared to only 58% of those receiving four drops.
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What Are Autologous Serum Eye Drops
ASEDs are highly effective, well-tolerated and have ingredients that artificial tears just cant replicate, but which promote healthy growth and healing of the ocular surface . Some of the ingredients in ASEDs that are found in natural tears but which arent available in artificial tears include antibodies, albumin, Vitamin A, and special growth factors important for healthy eyes known as epidermal growth factors.
Note that ASEDs are not tear substitutes and are often used in conjunction with other treatment modalities such as artificial tears, DELIT laser, punctal plugs, in patients requiring more advanced eye treatment.
Should You Close Your Eyes After Eye Drops
Once the drop is on the eye, do not blink your eye or move it around to spread the drop. Instead, gently close your eyes just once, place the pad of your most sensitive finger at the inside corner of the eyelid by the nose and press gently. Leave the eyelids closed and the finger pressing gently for 2 full minutes.
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Does Medicare Advantage Cover Lazik
A Medicare Advantage plan must provide the same level of coverage as original Medicare parts A and B. Most Medicare Advantage plans also offer additional benefits, including routine vision care, such as annual eye examinations, corrective glasses, or contact lenses.
However, Advantage plans do not always cover LASIK surgery, and a person would need to contact their plan provider to determine the exact coverage details.
Minor Salivary Gland Auto
Wakamatsu and colleagues stated that the use of salivary glands as a source of lubrication to treat severe cases of dry eye has been proposed by different authors. The first reports proposed parotid or submandibular gland duct transplantation into the conjunctival fornix. However, complications limited the functional outcomes. Minor salivary gland auto-transplantation together with labial mucosa has been used as a complex graft to the conjunctival fornix in severe dry eye with a good outcome. These investigators demonstrated significant improvements in BCVA, Schirmer I test score, corneal transparency, and neovascularization after using this technique. A symptoms questionnaire applied to these patients revealed improvements in foreign body sensation, photophobia, and pain. Similar to tears, saliva has a complex final composition comprising electrolytes, immunoglobulins, proteins, enzymes, and mucins. The authors demonstrated the viability of minor salivary glands transplanted into the fornix of patients with dry eye by performing immunohistochemistry on graft biopsies with antibodies against lactoferrin, lysozyme, MUC1, and MUC16. They noted that these findings revealed the presence of functional salivary gland units, indicating local production of proteins, enzymes, and mucins.
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Autologous Serum Eye Drops Safe Effective For Dry Eyes
Laurie Barclay, MD
Autologous serum 50% eye drops appear to be safe and effective for dry eye disease in the long term, especially in patients with severe disease refractory to conventional treatment, according to findings of a retrospective cohort study in the December issue of Cornea.
“Standard treatments for dry eye disease include the use of artificial tears and lubricating ointments, topical cyclosporine 0.05%, topical corticosteroids, and punctal occlusion,” write Munira Hussain, MS, CCRP, from the Department of Ophthalmology and Visual Sciences, W.K. Kellogg Eye Center, University of Michigan Medical School, Ann Arbor, and colleagues. “However, none of these treatments supply epithelium-promoting growth factors or other essential components present in natural tears. Similar to tears, human serum contains immunoglobulins, vitamin A, fibronectin, and growth factors that promote epithelial health.”
In the current study, the authors examined the outcomes of long-term use of 50% AS eye drops in patients treated at the study authors’ institution between June 2008 and January 2013, using medical record review and ocular surface evaluation. This included Schirmer testing with topical anesthesia, fluorescein staining, and ocular surface disease index examined at baseline, 1 month, and every 3 to 6 months during AS treatment.
The authors have disclosed no relevant financial relationships.
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