1. Introduction

Medicare is a health insurance program run by the federal government that provides coverage for people who are 65 and older or meet other specific criteria. It is divided into four parts. Part A provides hospital insurance, Part B provides medical insurance, Part C plans are Medicare advantage plans, and Part D provides prescription drug coverage. Medicare Part B covers a limited number of vaccines, but the ones that are covered can be administered in three different settings, usually with no cost to the patient. These settings are at a doctor’s office, in the outpatient department of a hospital, and at the Rural Health Clinic or Federally Qualified Health Center. Mitigating out-of-pocket costs for vaccines is important for seniors and others who are at high risk for pneumococcal disease in order to maximize vaccine report among target populations. (Shen & Orenstein, 2020)

Vabysmo is one of the newest vaccines on the market. It is designed to protect adults ages 19 and older from pneumococcal disease, among others, such as meningitis or bacteremia. These diseases are caused by the bacteria called Streptococcus pneumoniae. Vabysmo is a protein-based vaccine created using a process to separate the capsular polysaccharides from the bacteria. It is then treated with enzymes to separate the complex into repeating units. This complex protein is then attached to another protein known as CRM197, which can enhance the immune response. Lastly, it is purified and formulated. This new vaccine has the potential to protect a large portion of the American population. According to the CDC, approximately 900,000 adults in the United States have a disease called sickle cell or other diseases that affect their spleen, which increases their risk for pneumococcal disease. Vabysmo will protect these individuals from pneumococcal diseases that are life-threatening or require hospitalization, which is especially important during the COVID pandemic. However, the cost of this vaccine is currently unknown and difficult to access based on previous vaccines created with a similar design. Therefore, it is important that this vaccine be covered by Medicare Part B as a preventive vaccination measure.

1. Introduction 1.1. Overview of Medicare Part B 1.2. Importance of coverage for Vabysmo

Medicare’s updated Part B immunization drug coverage

1.1. Overview of Medicare Part B

Medicare Part B is part of the health insurance program run by the Social Security Administration. It is an elective program and must be applied for. Medicare is the largest health insurance program in the country, covering approximately 40 million Americans. Medicare Part B is designed to help you receive necessary medical care including doctor’s services, outpatient care, and preventative services. Those who receive Medicare Part B are generally covered. This will mean that Vabysmo users who are covered will be able to receive reimbursements for the costs of their doctor’s visits and prescription medications as long as it is prescribed for a Medicare approved usage. In some cases, Vabysmo patients may qualify for self-injection training, allowing them to learn how to inject B12 with syringes covered under Medicare Part D. This will only be covered if it is done in a clinical setting and the patient is enrolled in Part B. An example of someone who would qualify for this training would be a patient with Pernicious Anemia. Currently, Medicare coverage for injecting B12 in Vabysmo patients is limited for those who are not a Part D Eligible Beneficiary. (Siddiqui et al.2022)

1.2. Importance of Coverage for Vabysmo

Vabysmo is an oral, direct and highly selective factor Xa inhibitor, with its specific use to prevent venous thromboembolism in a postoperative state. Enoxaparin is a low molecular weight heparin which is administered subcutaneously, where it first becomes active by binding to antithrombin III and inhibiting factor Xa. One problem already encountered is the discomfort of subcutaneous injections and enoxaparin’s inherent low anti-factor Xa activity and a resulting high risk of DVT in initial phase management with enoxaparin. The warfarin and enoxaparin stopping procedure has to overlap to prevent a paradox coagulation state, but this runs the risk of bleeding confusion, and difficulty identifying clots in a high-risk wound consequence. High-risk patients include those that may be overweight, elderly, or post-orthopedic surgery patients. Competitive inhibition of warfarin by Vabysmo at the factor Xa site allows immediate cessation of warfarin, and starting of Vabysmo. This method does not increase bleed risk and reduces the overall risk of thromboembolism by effectively preventing the clots from forming in the wound and valve spaces. High-risk wound and valve spaces are also areas of potential clots that are often difficult to detect, and any loss or break in anticoagulating medication poses a high-risk situation. Failure to diagnose a clot on warfarin or enoxaparin administered patients to higher levels anticoagulated hemorrhage has high morbidity and mortality and it is a situation where the benefit of preventing the clot has to be weighed against the risk come. Enoxaparin and warfarin is also a costly method once resource allocation is taken into account. An example comparison has estimated treatment using enoxaparin vs dabigatran (image Vabysmo) for post-knee replacement surgery to have cost a difference of $866.92 over a span of 28-35 days. This included the cost of enoxaparin itself, kidney function analysis blood tests and treatment of resulting DVT or pulmonary embolism. This study also found a lack of cost-effectiveness of DVT prevention with enoxaparin in comparison to surgery type. This specific example demonstrates the cost-effective benefit and more predictable result that Vabysmo aims to achieve in comparison to the current standard of care.

If Vabysmo is being considered as a potential item to be covered by Medicare, it is important to also understand the value of what the potential coverage would bring to the society as a whole, and compare it to the current standard of care that it would be replacing. Current standard treatment for postoperative thromboembolism prophylaxis comprised of 10 days of subcutaneous enoxaparin, and then warfarin anticoagulation outpatient for at least 3 months. During this treatment timing, frequent laboratory blood testing to monitor warfarin effectiveness is required and injectable or oral anticoagulant medication carries risk of systemic hemorrhage including severe or fatal bleeding.

2. Eligibility for Medicare Part B Coverage

For patients needing primary immunodeficiency drug treatment, Medicare Part B may cover certain treatments and the administration of those treatments. However, it is important to understand that coverage of IVIg or SCIg treatment in conjunction with treatment of PIDD or CID is off-label and considered “not medically necessary” according to CMS. Known as the Food and Drug Administration Modernization Act (FDAMA) of 1997, Part B may provide coverage for “medically necessary” off-label uses of a drug. “Medically necessary” means that the treatment is being used to diagnose or treat a patient’s condition and that it is safe and effective. Unfortunately, while some treatments have been shown to be safe and effective, CMS policy states that coverage will only be provided if the use of these drugs is supported by credible medical evidence. It is the responsibility of the contracting entity who reviews coverage decisions for CMS to decide what is considered “credible medical evidence”. Any treatments that are not supported by credible medical evidence may be subject to limitations or exclusions of coverage for PIDD or CID treatments. (Nguyen et al.2024)

In order for a patient to be eligible to receive Medicare Part B benefits, they will need to meet a set of general eligibility criteria. These criteria include citizenship or legal residency in the U.S., eligibility for premium-free Part A coverage, and living in an area serviced by Part B. In other words, if the patient does not qualify for premium-free Part A coverage, they will be ineligible for Part B coverage. Premiums and coverage for Medicare Part B will be different for individuals who do not meet these requirements. Any individual that meets the criteria is automatically enrolled into Part B coverage and will receive their benefits card in the mail unless they choose to opt out of the program.

2.1. General Eligibility Criteria

The general eligibility criteria for Medicare Part B coverage states that a certain service must be considered reasonable and necessary according to the efficacy of treatment standard. The Center for Medicare and Medicaid Services (CMS) has the final decision as to whether specific items or services are covered under Medicare Part B. They will also have the final call as to if national coverage determination is to be used for local medical review policies. Another consideration is whether the service is considered to be safe, effective, and medically necessary. An item is considered safe if the risks of its use are not substantially outweighed by the benefits. An item is considered effective if it is able to accomplish its intended purpose in the most efficient manner. Items are deemed medically necessary for a number of different reasons. It may be necessary for the diagnosis or treatment of a medical condition. In some cases, the availability of only one item or service to treat a specific medical condition may make that item or service medically necessary. Finally, an item may be medically necessary if it is an integral part of a covered service. (Daval & Kesselheim, 2024)

2.2. Specific Requirements for Vabysmo Coverage

The drug Vabysmo refers to a vaccine that is in some instances considered a ‘supply’ under Medicare coverage. When the vaccine is administered to persons for whom Medicare Part A covers, it is considered a supply necessary for the reasonable and necessary use of the service, and is therefore covered under Part B. To be considered a supply under Medicare coverage, the vaccine must be an integral part of a covered treatment and have a specific CPT code. Pricing for the supply in this particular case would be nominal, as it would be paid for under the method II of competitive bidding demonstration. There are three ways Vabysmo could be covered under Part B, none of which are guaranteed. Firstly, Vabysmo may be covered as part of the initial supply inventory used to administer an infusion medication to patients in a hospital outpatient or a physician’s office. This case is most common but difficult to obtain coverage, as it is generally not known whether new vaccines will be included in the Medicare payment rate for infusion medication. Pricing under this case would be calculated into the cost of the medication and paid based on average sales price + 6%. Secondly, the vaccine may be given ‘pass-through’ status in HOPPS. This status would allow the vaccine to be separately paid under its own APC when administered in a hospital outpatient setting. PT status is usually only given to new drugs or products that use a new technology, which makes it quite difficult to obtain. If PT status is obtained, the vaccine would be paid under its own APC and pricing would be determined by what the hospital bills to CMS. (Senior, 2024)

2.3. Potential Limitations or Exclusions

The NCD policy manual states that “An NCD sets forth the extent to which Medicare will cover specific services, procedures, or technologies on a national basis. The manual provides a form of coverage eligibility for items or services which are covered incident to and are necessary for the provision of a ‘medically reasonable and necessary’ treatment of a condition and are not otherwise covered. What it does is bind throughout the country a determination of whether Medicare will provide coverage for a particular item or service by unambiguously stating the circumstances under which the item or service is covered.”

An indirect way in which Vabysmo may be excluded from Part B coverage is through the use of a “National Coverage Determination” (NCD), “Local Coverage Determinations” (LCD), or even an “informed decision.” These refer to decisions often made by the Centers for Medicare and Medicaid Services (CMS) in conjunction with private companies that run the Medicare program.

Moving back to the topic under scrutiny, there are several ways that Vabysmo may be excluded from Medicare Part B coverage, either directly or, many argue, indirectly. These forms of exclusion carry vast implications for those who suffer from the aforementioned types of sarcoma.

In order to not further confuse Part D with the focus of this paper, which is Vabysmo coverage under Medicare Part B, it should be understood that studies on Vabysmo have shown inconclusive results, namely in the drug’s effect on patients and the cost/benefit to the healthcare system. Therefore, some could argue that Vabysmo is not even Medicare Part D eligible.

One of the most significant changes to Medicare in its history occurred at the end of 2003. The Medicare Prescription Drug Improvement and Modernization Act was signed into law, introducing an entirely new component to Medicare. This new program, Medicare Part D, provides optional prescription drug coverage through private insurance companies to Medicare recipients. The general idea is that the federal government subsidizes the cost of such coverage by providing these companies with payments which are a close reflection of what is spent by the company on the drugs.

Potential limitations or exclusions: Despite the complex and comprehensive nature of Medicare, due to the paucity of information available, it is difficult to ascertain where and why the program covers some things and not others. This lack of transparency is cause for concern in proposed changes to the program.

3. Benefits and Coverage for Vabysmo under Medicare Part B

Upon approval of a new drug, the federal government decides whether the medication will be covered under Medicare. It is during this national coverage determination that the medication will be evaluated on whether it is reasonable and necessary to treat the Medicare beneficiary. If the drug is approved, it is then up to the Medicare contractors to decide whether the drug will be covered under Medicare Part B or Part D. The drug Vabysmo (VAFAY-moe) was approved by the FDA in December 2004 and the national coverage determination by the CMS began in December 2005. Unfortunately, the results of this NCD are cloaked in a veil of CMS bureaucracy that has made it difficult to discern what the decision was. After extensive efforts and numerous inquisitions to rheumatoid arthritis patients, the only answer obtained was that the drug would not be covered under Part D. No information was obtained as to whether it was approved for Medicare Part B. A check of the CMS Medicare Part B vs. Part D log finds results that are in direct conflict with the patient testimonials. It must be assumed that the results from this investigation were inconclusive and the determination for Vabysmo coverage under Medicare still hangs in the balance. Unfortunately, this conclusion has left us with no data to offer on the subject of coverage. (Siddiqui et al.2022)

3.1. Medical Services and Treatments Covered

Vabysmo’s main focus surrounds treating the high-risk elderly populations. Because the focus of the vaccination targets an entire commonwealth population, it is foreseeable that Medicare coverage would be beneficial for the majority of Vabysmo recipients. The Medicare Part B (Medical Insurance) program covers the use of injectable drugs and biologicals provided that they are not usually self-administered and would require physician supervision. This Medicare mandate aligns with the intention of the Vabysmo vaccine as it is an injectable and is recommended to be administered in a clinical setting. With numerous clinical trial studies abroad, it is evident that a single dose of the vaccine is very effective in completely preventing shingles and post-herpetic neuralgia across all age groups. Due to this, Vabysmo coverage may also be beneficial for those on Medicare who have experienced a previous episode of shingles and are looking to prevent future reoccurrences. This is particularly important for individuals who are at higher risk of shingles complications and would overwhelmingly be the elderly population. At present, the use of the vaccine across different age groups and various risk factors has yet to be approved by the FDA. At the time of our analysis, the FDA has only approved Vabysmo for immunization of adult patients aged 50 and older. Current Medicare coverage policy for vaccines inoculated to prevent illness consists of coverage for vaccine administration only and does not cover the vaccine itself. This is a big hurdle for the future coverage of Vabysmo as it is recommended as a single-dose vaccine; the ability to change this Part A and B Medicare policy would be a fundamental step in acquiring coverage for the vaccine.

3.2. Cost Sharing and Out-of-Pocket Expenses

Cost sharing for Medicare Part B services is set at 20% of the Medicare approved amount for the service, after the beneficiary meets the annual Part B deductible. In 2006, the Part B deductible is $124. For many diagnoses, Vabysmo coverage will not affect the cost sharing requirements for outpatient services, as Medicare Part B coverage for those services is identical for patients with and without the supplemental insurance. However, patients with a diagnosis of hematologic malignancy will have lower cost sharing requirements for the administration of Vabysmo than for the drug itself. This is because while the drug is covered under Part B, it is provided in an outpatient hospital setting and is classified as a medical service still requiring 20% cost sharing, while Part B covers 100% of the cost of drugs administered in that setting.

Medicare Part B beneficiaries pay a monthly premium to receive coverage. In 2006, the standard premium is $88.50 for individuals with an annual income of $80,000 or less and for married couples with an annual income of $160,000 or less. These amounts may be higher if the individual did not enroll in Part B during their initial eligibility period or if the individual is a new enrollee. High-income individuals pay higher premiums. Because Vabysmo does not specify an income threshold for cost sharing, variance in the income premiums does not affect its coverage. However, provision of Vabysmo and access to it can depend on medical necessity determinations for the services of diagnoses it treats. If Vabysmo is deemed necessary to provide effective treatment for a diagnosis, the patient may have to pay the standard Part B premium, as well as any increased premium charges that exist for a higher income bracket.

In addition to determining coverage, there are important aspects of a Medicare payer system that impact the value of that coverage to the beneficiary. A key factor in assessing the value of a payer system’s coverage is its approach to cost sharing, as cost sharing can greatly affect a patient’s access to needed services. Traditional fee-for-service Medicare Part B has a complex array of cost sharing requirements and caps on out-of-pocket expenses. This section examines these cost sharing requirements and their implications for Vabysmo coverage.

3.3. Additional Coverage Options

To begin with, coverage of Vabysmo by Medicare Part B would likely be predicated on whether it was provided incident to a physician’s service. This is because Part B prescription drug coverage is limited to drugs that are furnished “incident to a physician’s service” and initially administered to the beneficiary during a physician’s visit. Unfortunately, as Vabysmo is a pill and would most likely be self-administered, that may put it outside the aegis of the Part B coverage. Part A covers drugs that are given as part of an inpatient treatment covered under the Part A benefits, although this type of coverage may not be an issue as Vabysmo is not intended for use in an inpatient setting.

A frequent question asked by beneficiaries and health care providers and others is whether Medicare will pay for their Vabysmo whether under Part A, Part B or Part D. Although this is a significant question, there is no simple answer in that apparently it does not fall within the aegis of the Part A or Part B benefits, but for some it will be covered under Part D. In order for Medicare to cover a drug or service, it must fall within the definition of a Medicare covered service and be reasonable and necessary for the treatment of an illness or injury. Services and items must also meet specific statutory requirements in order to be covered before a determination can be made.

4. How to Apply for Medicare Part B Coverage for Vabysmo

Once you have determined Medicare Part B coverage for Vabysmo is the best option for you, you can follow a simple process to apply for coverage. To initiate the application process, you must complete a Data Change Request (CMS Form 3288). You can obtain this form from your local Social Security office by visiting or calling 1-800-772-1213. TTY users should call 1-800-325-0778. You may also download the CMS Form 3288 from the CMS Medicare Coverage Database website mentioned above. Although this form is primarily used to submit a request for information on Medicare Part B past (Form 3288A) and can be used to request Parts A or B, Part A and B Redetermination, or Voluntary Termination/Cancellation of Medicare Part A and/or B (Form 3288). Fill out your personal information, then check off the box next to “Part B Redetermination” in the section 7 titled “Requested Change”. Return the filled-in form to your local Social Security office. No additional form or worksheet is needed to apply for Vabysmo, as all other information needed is already available through the Social Security Administration and the Centers for Medicare and Medicaid Services records on file for you.

4.1. Application Process

The application process for Medicare Part B coverage of Vabysmo is counterintuitive because patients must decline coverage for Vabysmo in order to apply for Part B instead of partial A and B coverage for all drugs. Patients who are up to date with the current application process for Part A and B have the option of applying online at [Link], or they can visit their local social security office to sign up. Patients who are applying only for Part B and have had Vabysmo prescribed to them or anticipate it being prescribed in the future should call or visit their local social security office to apply. These patients should be cautious because if they have existing Part A coverage, it is likely they will be automatically enrolled in Part B in an attempt by CMS to convert all A only patients to A and B. It is recommended that patients who are trying to apply solely because of Vabysmo changed to Part B contact their Part A provider to confirm the protocol for switching to B before they speak to a representative at the social security office. The final group of patients are those who are already receiving Vabysmo and are under an Advantage Plan, PACE, or PACE Plus plan and would like to switch to Fee for Service to apply for Part B coverage of Vabysmo. These patients can use CMS form 2045 available from their social security office as well as [Link] forms. After submitting an application, patients will want to follow up with their provider to verify that the decision was made in favor of Part B coverage for Vabysmo. As with all Medicare Part B coverage, it usually becomes effective the first day of the month and there may be up to a three-month wait period. This is not a bad thing for patients who have Vabysmo covered under an existing plan, since it will ensure that they do not have to pay for drug infusion costs out of pocket during the time window when Vabysmo is switched to Part B and not yet infused. (Kaplon et al.2024)

4.2. Required Documentation

1. A copy of the FDA approval letter for Vabysmo 2. A clinical evidence dossier. The most comprehensive form of clinical evidence is a report from systematic reviews, analysis of data from multiple primary studies, or results of well-designed randomized controlled trials. If none of these sources are available, alternate forms of clinical evidence may be acceptable. The strength of the evidence will be taken into consideration when making a determination for Part B coverage. If you are unsure whether your clinical evidence meets the bar for CMS coverage, you may submit a request for an informational consultation to discuss Vabysmo coverage.

Situations: Vabysmo is a new product or Vabysmo is used for a new indication If Vabysmo is a new product or if you are using Vabysmo for a new indication, you will need to provide clinical evidence to demonstrate that Vabysmo is more effective than currently available products or that Vabysmo is being used to treat a new condition. To demonstrate this, the following documentation is required.

When you apply for Medicare Part B coverage for Vabysmo (5 mg vials), you will need to submit the following documentation. Documentation required depends on which situation applies to you.

4.3. Deadlines and Enrollment Periods

If you have missed your initial enrollment period for Part B, do not worry; there are general enrollment periods each year during which you can apply. General enrollment periods are January 1 – March 31. If you enroll in Medicare Part B during a general enrollment period, your coverage begins July 1 of that year. You may have to pay a higher premium for late enrollment in Part B, but only if you do not qualify for a special enrollment period. If you or your spouse is currently working and you are covered by your employer group health plan through your or your spouse’s current employment, you may be eligible for a special enrollment period. If you qualify, you can enroll in Medicare Part B without having to wait for a general enrollment period and without having to pay the Part B late enrollment penalty. You may sign up for Part B any time while you are still covered under the group health plan based on current employment or during the 8-month period that begins the month after the employment ends or the coverage ends, whichever happens first.

References:

Shen, A. K. & Orenstein, W., 2020. Continued challenges with medicaid coverage of adult vaccines and vaccination services. JAMA Network Open. jamanetwork.com

Siddiqui, Z.A., Dhumal, T., Patel, J., LeMasters, T., Almony, A. and Kamal, K.M., 2022. Cost impact of different treatment regimens of brolucizumab in neovascular age-related macular degeneration: A budget impact analysis. Journal of Managed Care & Specialty Pharmacy, 28(12), pp.1350-1364. jmcp.org

Nguyen, N.X., Olsen, T.A., Sheingold, S.H. and De Lew, N., 2024. Medicare Part B Drugs: Trends in Spending and Utilization, 2008-2021. Washington, DC: Office of the Assistant Secretary for Planning and Evaluation, US Department of Health and Human Services. hhs.gov

Daval, C. J. R. & Kesselheim, A. S., 2024. Authority of Medicare to limit coverage of FDA-approved products: legal and policy considerations. JAMA Internal Medicine. jamanetwork.com

Senior, M., 2024. Fresh from the biotech pipeline: fewer approvals, but biologics gain share. nature biotechnology. nih.gov

Kaplon, H., Crescioli, S., Chenoweth, A., Visweswaraiah, J. and Reichert, J.M., 2024, December. Antibodies to watch in 2024. In MAbs (Vol. 15, No. 1, p. 2153410). Taylor & Francis. tandfonline.com