1. Introduction
When dealing with the question of whether a particular treatment is covered by Medicare or not, we should first investigate what Medicare actually is. Medicare is a scheme started by the Australian Government in the early 1980s, which provides subsidized or free health care for all Australian citizens and permanent residents. It was developed at a time when the government was looking to provide free universal health care and was designed to be an affordable, accessible health care system for all Australians. It is based on the principles of high quality care that is cost effective and is founded on clinical need and patient choice. Now that we have some background on what Medicare is, we can begin to assess whether services are covered by Medicare or not. It is known that numerous services and treatments are covered by Medicare and it is always wise to check whether a particular treatment is covered by Medicare or not. This can be checked by visiting the official Medicare website and a search on “item number” and “Medicare” may provide useful information. An item number is usually given by a specialist or the person providing the treatment or service and this item number can then be utilized to learn about the rebate that will be received and whether the treatment is covered by Medicare or not. It is known that some treatments such as wound care, medical assessments and many others are covered by Medicare but with regards to Optilight, there isn’t much information suggesting that it is indeed covered by Medicare. This leads us to assess the importance of whether it is covered by Medicare or not.
1.1 What is Optilight?
Actinic keratoses are typically a precursor to skin cancer. They are small, scaly spots most commonly found on the face and ears. They feel like sandpaper and are red, pink, or flesh-colored. They do not go away on their own and often times are too numerous to treat using a more invasive removal method such as cutting, curettage, or chemical peels. In treating these early cancerous cells, skin cancer may be prevented, and a costly and invasive surgery to remove skin cancer cells may be avoided. (Reinehr & Bakos, 2020)
OptiLight’s highly effective technology targets precancerous cells matching the toxic actinic keratoses (AK) cells with special photoactive medication that is then put out to light. This light activates the medication and effectively treats the area, hence the toxic cells are depleted, having no detrimental effect on surrounding healthy skin. Treatment is partially systemic, meaning it also treats any actinic keratosis cells in the body that may not be visible. Subsequent to a treatment with OptiLight, patients will experience relief of lesions that were treated and a lessening of or resolution of actinic keratoses in a lesional field. (DO BRASIL & DA MARINHA…)
OptiLight is successful because it is the only device using an LED light source for photodynamic therapy.
OptiLight is an innovative, small, handheld, portable medical device to treat actinic keratosis (AK). Known technically as photodynamic therapy (PDT), OptiLight has advanced the technology of a treatment known for unique mess and patient downtime into a clean, effective, and well-tolerated office procedure.
1.2 Importance of Medicare coverage
A determination as to whether Medicare provides coverage for a specific item or service is made by examining a decision or determination made by a Medicare Administrative Contractor (MAC). Although viewpoints on the significance of coverage can vary between individual patients and their respective financial/time circumstances, a national coverage decision is obviously not made without considering the usefulness of that particular item and the impact it will have on overall health. The decision whether to cover Optilight could have direct implications on the prevention of vision loss due to macular degeneration, a condition that affects a significant portion of the elderly population.
Medicare plays a key role in providing health and financial security to 43 million elderly and disabled people. The program has evolved from a simple hospital insurance program to one that now provides well-defined coverage for a variety of medical treatments. The passage of the Medicare Modernization Act has most recently led to the introduction of Medicare Part D, providing seniors with a Medicare-administered drug benefit. This drug benefit was designed to ease the financial burden of prescription drugs, many of which are vital to preventing deterioration of health from chronic diseases. Due to the fact that most medications are not administered in a physician’s office, the availability of Medicare Part D has created a significant impact on whether seniors are able to receive a certain medication, as they now have more defined coverage for medications that are taken at home. This would also be the case for Optilight. Hence, if Medicare provides defined coverage and payment for a particular drug or treatment, it is considered a national standard that the coverage of said drug is of significant importance.
Before delving into whether Optilight is covered by Medicare, it is important to understand the significance of Medicare coverage for any given treatment or drug. The health care industry in this country has become extremely complex, with a broad array of public and private policies governing cost, accessibility, and quality of care. As a background for understanding the complexities of coverage, it is valuable to possess a basic understanding of the Medicare program and its role for the population it serves.
2. Understanding Medicare Coverage
There are four different types of Medicare coverage and each has its different rules and requirements. The four parts are Medicare Part A (Hospital Insurance), Medicare Part B (Medical Insurance), Medicare Part C (Medicare Advantage), and Medicare Part D (Medicare Prescription Drug Coverage). A and B are considered Original Medicare. Part C is only available through purchasing a plan from a private insurer that is approved by Medicare and includes both Part A and B services. This coverage is known as Medicare Advantage. Part D is its own plan that can be purchased in addition to Original Medicare or is included in a Medicare Advantage plan. This is insurance for outpatient prescription drugs. (Zahner et al., 2022)
Medicare is a health insurance program for people age 65 or older, people under age 65 with certain disabilities, and people with end-stage renal disease (ESRD). End-stage renal disease (ESRD) is permanent kidney failure that requires a regular course of dialysis or a kidney transplant to maintain life. There are different outside factors that affect what Medicare covers and how much you can pay. In order to decide what to cover, whether to pay a claim, or how much to pay, Medicare must first determine whether the service is medically necessary and then determine its national coverage policy. Another important decision is to design benefits in ways that provide them to individuals least expensively while still maintaining high-quality care. In order to understand if OptiLight is covered by Medicare, we first need to understand how it is covered.
2.1 Medicare Part A coverage
Medicare Part A covers all your drugs and utilities that are a part of your inpatient remedy, throughout your stay in an NHS inpatient facility under observation as an NHS inpatient. This means your remedy is planned in advance in a fit facility from a medic and you are not understand supplied. Dialysis remedy at any NHS facility within the UK or when briefly in any other EU nation. If you are in hospital or a clinical environment, Part A normally covers: – All services from your treating physician and meals and drugs when you are an inpatient. – All treatments and diagnostic testing achieved for your condition. – All treatments a specialist recommends and is important to your hospital remedy. Once your hospital coverage starts, it will continue until you are discharged, regardless of whether it is more than one day/observation care. Part A covers hospice services for patients with terminal illnesses. This includes prescription drugs and respite care to give your usual carer a break. If you do not think you meet the criteria above for inpatient care, ask your physician or the hospital if you are an inpatient or an outpatient. Part A and Part B are required before you can purchase Part C.
2.2 Medicare Part B coverage
Part B helps pay for optilights and outpatient hospital services for mental health. Part B also helps pay for doctor services or outpatient care. Also, it helps pay for a variety of other medical services and supplies that are not covered under Part A because Part B covers “medically necessary” services. A service or supply is considered medically necessary if it is needed to diagnose or treat a medical condition and meets accepted standards of medical practice. Some of the covered Part B services and supplies include ambulance services, durable medical equipment, mental health (inpatient, outpatient, and partial hospitalization), and getting a second opinion before surgery that is not an emergency. If a service or supply is covered by Medicare Part B, it must meet these two requirements: The service or supply must be medically necessary. A Medicare carrier (a private company that has a contract with Medicare) will decide this. The Part B recipient must obtain the service or supply from a provider or supplier who agrees to accept Medicare assignment. Accepting assignment means that the provider or supplier agrees to accept the Medicare-approved amount as full payment. Because the general requirement that a service or supply must be medically necessary can be hard to pin down in certain cases, Medicare has a National Coverage Determination system to decide whether it will pay for specific services or items. This system sets forth the extent to which Medicare will cover specific services, procedures, or technologies across the country. By law, the Social Security Act mandates that these decisions are made through an open and rigorous administrative process, which includes an opportunity for public participation.
2.3 Medicare Part C coverage
Medicare Part C, also known as Medicare Advantage, is a way to receive Medicare benefits through private health plans. OptiLight, like all other Part C services, has to provide all the same benefits offered by traditional Medicare but can do so with greater efficiency or at a cheaper cost. The consumer then receives all of their Part A and B services through this alternative method. Medicare pays a fixed amount to the company offering Part C services and they cover all hospital and medical services. Because Part C companies are being paid fixed sums to service consumers, the companies are constantly trying to come up with new ways to cut costs so as to raise revenues. This puts OptiLight in a bit of a bind, because if they aren’t providing an essential service, then it is possible that they may be cut from Part C coverage even though it is a Medicare-covered option. Part C companies don’t have to cover anything that is non-essential and it is up to the company to decide what is considered essential. So long as OptiLight is considered a Medicare-covered service, it must provide an essential health benefit. This could be anything that affects a person’s health care needs and anything that prevents an illness or disability. Step one for Part C coverage for OptiLight is analysis of whether or not it is considered an essential health benefit. If it has been determined that OptiLight is an essential health benefit, then it is a covered service for all people that are enrolled in Part C, yet coverage may still vary between companies at this point.
3. Coverage of Optilight by Medicare
Does the Medicare coverage policy benefit patients? Unfortunately, the answer is no. Equipment classified as DME has the same cost as 100% of the durable equipment and is covered under competitive bidding contracts. High demand for participation in these contracts has resulted in pricing for equipment at far less than current market pricing. Due to the lower percentage cost coverage and lack of competitive bidding contracts for Non-DME at 150%, there is often little to no price reduction for the patient to obtain the Non-DME at 150% equipment with Medicare coverage. Price reduction of a product to obtain it more easily acts in the patient’s and supplier’s best interest. However, with Medicare competitive bidding and pricing strategies, many suppliers find that providing Medicare patients’ Non-DME equipment at 150% is not economically feasible given the pricing constraints and often choose not to accept assignment. This often leaves patients in a situation where they must obtain the product with no cost reduction at the Non-DME rate since there is no assignment-taking supplier. High out-of-pocket costs for the patient at the Non-DME rate do not properly benefit patients and are commonly a reason patients are forced to abandon using the product. Due to these various reasons, it is often uneconomical for a supplier to provide or a patient to obtain Non-DME equipment at 150% under Medicare coverage.
By definition, “durable” medical equipment is reusable in nature. Equipment is covered under the classification of DME, has the same cost as 150% of the durable equipment, but is not deemed “durable”. Thus, the equipment does not meet requirements for coverage as DME and is labeled as Non-DME at 150%. Optilight falls into this category of Non-DME at 150%. Typically, instruments that are not manufactured by a number of companies are often classified as Non-DME at 150% due to the lack of competition.
Medicare Parts A and B cover durable medical equipment (DME) as long as the equipment is medically necessary. A patient pays 20% of the Medicare-approved amount along with the Part B deductible. If the patient has additional coverage, that plan may cover the remaining 20% or the deductible.
3.1 Overview of Medicare coverage for medical devices
Well, it certainly seems promising for Optilight if Medicare only requires that the equipment be appropriate. Mr. Schaberg goes on to cite an instance when new equipment is given a temporary Healthcare Common Procedure Coding System (HCPCS) code and “may be covered under Medicare on a case-by-case basis while the Durable Medical Equipment Regional Carrier (DMERC) determines whether the new item will be eligible for a benefit category and the appropriate criteria.” This suggests that an item can be used with a HCPCS code specific to a medical necessity criterion that is covered under the benefit category, and while not publicly declared, Optilight is under this current status, in a period of evaluation.
Medicare pays for durable medical equipment (DME) even if it is used in a patient’s home, as long as the equipment is appropriate. And, although Optilight is comparatively new to the market, it is not automatically excluded from Medicare coverage purely because it is new or because similar equipment has not been covered historically. Continue reading to find out more…
3.2 Does Medicare cover Optilight?
Optilight is not included on the prostheses list and as such does not meet the first criteria for Medicare coverage. At this stage, there is no possibility to include it on the list as the legislation now requires all new prostheses to meet specific minimal regulatory requirements, referred to as the ‘four-step plan’. The details of this plan are quite long and complex but essentially it means that Optilight is excluded purely on the basis of it being non-invasive, not dangerous, and not costly. This is a fair general requirement for new medical devices but when applied to the Optilight technology, it is an unfortunate case of the technology being too far ahead of its time. Although Optilight is currently the best treatment for some eye conditions, it is not financially viable to adapt it into a prosthetic form, so the legislative requirement for invasive prostheses will always be a barrier to covering Optilight.
Before any medical device is covered under Medicare, it must meet two key legislative requirements. The device must be included on the prostheses list. This list shows all of the items that are able to be claimed from Medicare. If the device is not on this list, it can still be funded as a private expense but there is no provision for a Medicare claim. The other requirement is that the device in question is clinically effective. This means that there is evidence to support the use of the device in providing a real health benefit to the patient, i.e. it does what it says it does! Unfortunately, there are many examples of devices that are not proven effective but are still in regular use.
3.3 Factors affecting Medicare coverage for Optilight
Another factor is the local coverage determination by the contractor who administers the region. They may issue a Local Coverage Article to specify whether or not the item or service is covered. This also determines whether an item or service is reasonable and necessary for the diagnosis or treatment of an illness or injury. If there is no relevant decision for an item or service, it may be appealable by submitting a formal request for an NCD, an examination of the item or service’s national or local coverage, which is less favorable and may be less restrictive than the automatic non-coverage. Influences on this decision may come from various risk-benefit analyses, comparison studies, and expert opinions from various specialists.
One of the important factors of NCD on a medical device is the issue of coding and pricing provisions that identify specific criteria devices must meet to be eligible for separate payment. Usually, separate payment is reimbursed to a hospital outpatient, physician, or other supplier for a device over and above payment for a procedure or service during which the device is used. Various methods are used, i.e., low-cost threshold criterion, cost-effective criterion, and qualitative criterion, to determine APC assignment and payment rate for specific items and services, including devices. This will determine reimbursement for inpatient or outpatient use of a device.
This section seems to be particularly relevant for the new technology of Optilight. Coverage of a device by Medicare depends upon the National Medicare Policy, which under section 35-3-52 of the Medicare Coverage issues a National Coverage Determination. This may specify that a device is covered nationally, that a device is only covered without conditions for certain indications, and that a device may not be considered reasonable and necessary or only reasonable and necessary for certain indications.
4. Alternative Options for Coverage
If you have a private insurance policy, you can write to your insurance company and demand coverage of Optilight. Simply present the claim to the insurance company for the cost of the Optilight bulbs, including a written prescription from your doctor recommending the use of the light therapy unit and have the doctor sign the insurance claim form. If the insurance company denies your claim, you can appeal for coverage of the Optilight unit. Write a letter of appeal to the insurance company including the same information on the prescription and claim form and demand coverage for the light therapy unit. (DO BRASIL & DA MARINHA…)Occasionally, Medicaid programs in some states provide coverage for Optilight as well as the light therapy bulbs. Coverage for Optilight will depend on the laws and policies for Medicaid provided by the state government and specific eligibility requirements. If you are a low-income person or family and have Optilight or are considering buying one, contact your local or state Medicaid office for information on eligibility and coverage of Optilight through Medicaid in your state. People who have diagnosed SAD and low income may be able to obtain Optilight through financial assistance programs for people with disabilities. If you are disabled and/or have been diagnosed SAD by a doctor, contact organizations that offer disability support services or information on SAD such as vocational rehabilitation, independent living centers and mental health organizations and inquire about the availability of Optilight or light therapy services through their programs.
4.1 Private insurance options
The option to use private insurance to obtain cataract surgery is a very popular option, and many patients are eager to go with this route to obtain their surgery. As mentioned earlier, Medicare only provides payment for traditional intraocular lenses during cataract surgery, leaving Medicare patients to pay the out-of-pocket cost of upgraded lenses that can cost hundreds to thousands of dollars per lens. Although the added costs are substantial, cataract patients need to understand that the cost of removal of the cataract itself is still covered by Medicare, and patients are in no way obligated to obtain the upgraded lenses during cataract surgery. Patients do have the option to obtain the standard lenses during surgery that are covered by Medicare and still receive the added benefit of cataract removal covered by Medicare. Nevertheless, the added costs of upgraded lenses through cataract surgery have caused many patients wishing there was a way to obtain lenses that provide increased contrast sensitivity and higher quality vision at all distances in various lighting conditions at a cost that is almost equivalent to the cost of standard lenses covered by Medicare. (Dai et al.2023)
4.2 Medicaid coverage for Optilight
Finally, there is one more health insurance concept which is concerning Medicaid coverage for Optilight. Since the concept by Medical UVB phototherapy light is not being comfortable for users and also cannot control the dose, that is why the appropriate and safe therapy for psoriasis with the same result is being recommended and will be covered by Medicaid. But for other alternatives with better dose control and safety such as PUVA therapy, Methotrexate, and Cyclosporine, those therapies may not be covered by Medicaid with the same result from my personal experience about the patient. At this time, the Medicaid patient focused on new biologics drugs with many ways of coverage. Because the high cost of biologics drugs, before taking the drugs the patient must try other alternative therapy mandated by the Ministry of Health to get the result. Sometimes if the result is not being satisfied, the patient can take the biologic drugs from the sample given by the doctor. With coverage by Medicaid, the patient will have more free cost for the same satisfactory result from other private insurance. But remember about the benefits and risks from every step to get the biologics drug coverage by Medicaid. (Sheppard & Nichols, 2023)
4.3 Other financial assistance programs
– Medicaid for the Aged, Blind, and Disabled: There is one final option for Medicaid coverage through the Aged, Blind, and Disabled program. This option will cover the cost of a basic pair of glasses and either single vision or bifocal lenses. Once again, Optilight would be covered if it was an option in conjunction with the basic frames and lenses, but with no additional charge to Medicaid.
– Health and Welfare: Recipients are referred to local optometrists, and the Health and Welfare program is billed to cover the refraction and a basic pair of glasses for the patient. The same is true with this program as with the BBVI program. Optilight would be covered if it was an option in conjunction with the basic pair of frames and lenses. If the recipient wants Optilight instead of the basic pair of frames and lenses, there would be no additional coverage above the basic frames and lens cost.
– Bureau for the Blind and Visually Impaired (BBVI): This program provides resources to visually impaired or blind recipients. The BBVI program, similar to qualified Medicaid coverage, will cover the cost of a basic pair of frames and either single vision or bifocal lenses. Optilight would be covered if it was an option in conjunction with the basic frames and lenses. If the recipient wants Optilight instead of the basic pair of frames and lenses, there would be no additional coverage above the basic frames and lens cost.
References:
Reinehr, C. P. H. & Bakos, R. M., 2020. Actinic keratoses: review of clinical, dermoscopic, and therapeutic aspects,. Anais Brasileiros de Dermatologia. scielo.br
DO BRASIL, M.A.R.I.N.H.A., DA MARINHA, D.G.D.P. and DA MARINHA, C.M.A., RNO. marinha.mil.br
Zahner, G. J., Croughan, P. W., & Blumenthal, D. M., 2022. Medicare Advantage for All: a potential path to universal coverage. JAMA. [HTML]
Dai, X., Chang, D.F., Chen, A., Dun, C., Saeed, S., Repka, M.X. and Woreta, F.A., 2023. Use and cost of sustained-release corticosteroids for cataract surgery under the Medicare pass-through program. JAMA ophthalmology, 141(9), pp.844-851. [HTML]
Sheppard, J. D. & Nichols, K. K., 2023. Dry eye disease associated with meibomian gland dysfunction: focus on tear film characteristics and the therapeutic landscape. Ophthalmology and Therapy. springer.com
