1. Introduction

The provision of comprehensive medical care is essential in leading to the management of certain chronic ailments, prevention of complications, and improvement of the quality of life for those with chronic conditions. One such condition is peripheral arterial disease, or PAD. PAD is a condition in which fatty deposits clog arteries, and it most commonly affects the legs. It is a marker for widespread systematic atherosclerosis and is associated with other forms of cardiovascular disease and disease of the arteries. More especially with diabetics, it is a debilitating condition and if severe can lead to ulcers and gangrene in the legs and feet. Treatment options for PAD include lifestyle changes, medications, and/or surgical procedures or endovascular interventions aimed at lowering symptoms, improving function, and limb salvage. With a large number of older patients with diabetes on Medicare, it is more important than ever to define the morbidity and cost of treating PAD. Medicare is a complicated system, and this study was undertaken to see if PAD is addressed specifically or lost in the myriad diagnoses, and if treatment for this condition is successfully being translated to improved patient-centered outcomes. Medicare is a federal health insurance program for three specific populations in the United States: people aged 65 or older, people under 65 with certain disabilities, and people of all ages with End-Stage Renal Disease (ESRD). Given that PAD is a disease of the elderly described by our study population, Medicare, which is a payer for most chronic disease care in the United States, will be a major issue in better understanding the care and outcome for these patients. PAD is a degenerative and chronic disease, and this study will specifically examine the care of those patients with Medicare coverage for over 1 year. Understandings gleaned from studying Medicare coverage of PAD can be used to specifically define disease states and craft algorithms in the future for patients and physicians to understand the risk and benefit of treatments rendered for PAD. The data that Medicare collects is essential in understanding the translation of diagnosis and treatment to outcome in a population that is vastly underrepresented in clinical trials. This information is fundamental in understanding the care of the increasing geriatric population in the United States with PAD. (Keisler-Starkey & Bunch)

1.1 What is Pae?

PAE includes ‘home’ as well as the community locations and the services address an individual’s or a caregiver’s needs. This description is an expansion and clarification of the current Medicare Home Health benefit in an effort to move away from the fragmented and undefined interpretation of what it means to ‘stay out of an institution’. It is important to note that conceptually, PAE expands the focus from elders and advocates for populations with serious health conditions. During the public Affordable Care Act/Health Care Reform deliberations, it was recognized that creating ways to provide PAE for people enrolled in Medicaid (and/or Dual Eligible) waiver services and very low-income Medicare beneficiaries would be important, yet difficult to operationalize. Development of effective strategies to improve the status of the most at-risk populations in settings with limited resources is an ongoing national priority. (Jaramillo & Willging, 2021)

PAE is defined as: – Services aimed at maintaining or improving a person’s health or functional status – Services provided to delay or avoid institutionalization or to aid in the transition from an institutional setting back to the home – Services honoring patient choice regarding care during serious illness

The need for long-term care (LTC) is great, and spans all types of chronic illnesses, disabilities, and other disabling conditions among the elderly and younger population. Today, approximately 9 million elderly and disabled individuals in the United States need LTC. This number is expected to triple by 2040. Because individuals needing LTC are diverse, the settings are varied. LTC is provided in facilities (nursing homes, assisted living, board and care) as well as in private homes. PAE is an alternative to in-home, facility-based, and acute care and it is designed to provide an array of preventive, diagnostic, therapeutic, and support services in the home or community for people with chronic, disabling, or serious health conditions.

1.2 Importance of Medicare coverage

Chronic diseases have emerged as the most common source of illness in the United States. Many of these chronic diseases require careful monitoring and regular management to maintain an acceptable quality of life. One such chronic disease, end stage renal disease (often referred to as ESRD), has become increasingly more common in the United States. In fact, it has been estimated that there are currently around 400,000 persons in the United States who have ESRD and that this number is increasing by about 8% per year. ESRD is a condition characterized by a total and permanent kidney failure, which is only treatable through dialysis or kidney transplant. As of now, there is no cure for ESRD. If not treated, ESRD can be a life-threatening condition. However, with current methods of treatment, persons with ESRD can live for many years, even decades. Dialysis is the most common treatment for ESRD. It is a process that substitutes the normal function of the kidneys through a machine. A patient’s blood is cleaned in the machine and then returned to the patient’s body. Most patients with ESRD are able to take care of their regular daily activities for some time, but will eventually have to stop working due to the severe fatigue and other symptoms of their kidney disease. At this point, many will seek disability benefits, quit their jobs or take early retirement. In order to qualify for Medicare based on ESRD, a person must apply for Social Security or Railroad Retirement Board disability benefits, but no waiting period is required for persons who have received a kidney transplant or are receiving maintenance dialysis treatments. This is an important point since Medicare is one of the most common insurance types that covers people with ESRD. Therefore, it is essential to know if Medicare will cover expenses incurred by these persons. Pae is a condition caused by non-traumatic brain injury that results in long-term damage. This sort of brain damage can develop from high blood pressure or diabetes, which are common causes of ESRD. Pae usually results in cognitive impairments. These cognitive problems are often severe enough to affect the patient’s ability to think, concentrate, or remember. Cognitive impairments can cause great difficulty in completing even the simplest tasks, as well as emotional problems such as depression and personality changes. Cognitive function very much affects a person’s quality of life and ability to work, since many jobs require critical thinking, decision making, and problem solving. (Powers et al.2020)

2. Medicare Coverage for Pae

The title of this section introduces the concept of coverage by Medicare for various forms of pae. In this analysis, we are concerned with the ways in which Medicare does or does not pay for pae. The focus is on all types of pae; however, a comparison of pae types will be made when specific information is available. Step 2.1 explores the eligibility criteria for Medicare coverage of pae and provides important background information. Step 2.2 is the heart of this analysis where we learn which types of pae are covered by Medicare. Step 2.3 explains the limitations and restrictions on Medicare coverage and should be read in conjunction with Step 2.2. Note that this is a complex issue, and sometimes the specific terminology used by Medicare is difficult to understand. This analysis attempts to provide clear explanations, but consultation of Medicare resources may be required for a full understanding of some points.

2.1 Eligibility criteria for Medicare coverage

Meet the criteria for ongoing patient for Medicare. One of the most important criteria for Medicare coverage is that the service or item must be considered reasonable and necessary, and not experimental or specifically excluded by Section 1862 of the Social Security Act. Another important consideration is that the patient must meet the Medicare definition and coverage of a “Medicare beneficiary.” This is particularly important when considering patients who are not permanent residents or citizens. The differing classifications of temporary residents, refugees, and newly arrived migrants are not eligible for full Medicare benefits and must meet certain criteria in order to receive any cover. Eligibility for Medicare can be confirmed through the health provider hotline. Assuming the patient meets the eligibility requirements for Medicare, the type of cover and the extent to which Medicare will cover P&G services may differ. In the instance that the patient enrolled in PEGP and the service provided by the psychologist is to prepare a mental health care plan or to review the said plan, the patient will be eligible for a Medicare rebate each with a different level of cover. Utilizing allied health referrals including P&G services to help manage a chronic illness or mental health condition are covered under the Enhanced Primary Care (EPC) items. With a GP referral, patients who suffer from chronic and complex health conditions are eligible for a Medicare rebate on allied health services up to a maximum of five services a year. EPC is a type I service with a rebate currently set at $52.95. Patients may be referred by their GP to a psychologist for a clinical psychology assessment to determine what the patient’s mental health condition is and the most appropriate treatment. This type of assessment falls under the assessment and therapy item to which the patient can receive a Medicare rebate for sessions up to 60 minutes duration. Usually, assessments are not time-limited and are composed of multiple sessions. (Foo & Haddock, 2020)

2.2 Types of Pae covered by Medicare

Finally, there are instances where a physician is called to evaluate a poorly functioning dialysis access which requires no intervention. This constitutes a low complexity service, and a separate payment is often not well defined for such services.

Alteration of a dialysis access is another circumstance. This will likely be considered a separate procedure with its own payment. This applies to both peripheral and central access.

Once it has been established that a patient is eligible for Medicare coverage, there are several different scenarios of PAE creation that may take place. Medicare provides reimbursement for services pertaining to both the creation of a new access and maintenance of an existing access. The reimbursement for a new access generally falls under the global surgical payment mechanism. Global payments are designed to provide a single payment for a series of related services. This single payment is designed to cover all services provided in relation to the access creation over a 90-day period. This encompasses evaluation of the access, any interventions to maintain the access, and infusion of the access for any purpose.

Anchor: Does Medicare coverage differ among the different types of percutaneous arteriovenous access (PAE)?

2.3 Limitations and restrictions on coverage

There are several limitations and restrictions that could result in a PAE not being covered by Medicare. As the majority of the symptoms of BPH are not immediately life threatening, the age-based prevalence of BPH and its associated symptoms direct the majority of BPH treatment towards elderly men. PAE may not be an appropriate treatment for all patients, particularly those with very large prostates. PAE is generally most effective for prostates sized between 30-80g (Volumetric analysis of prostates in patients with benign prostatic hyperplasia in the Chinese population. Zhang et al. PLOS one 2015) and some urologists may consider this small prostate size an indication that the patient should seek medical treatment from other options. Unfortunately, PAE has only relatively recently emerged as a treatment for BPH, the future refinement of patient selection and long-term outcomes may hinder Medicare and insurance coverage. Co-development of this procedure with specialist SIR interventional radiologists, urologists, and industry representatives will be required to guide BPH patients to the appropriate management pathway, and it is possible that PAE may become less accessible should other newer treatments not covered by Medicare become the new standard of care. This will depend largely on cost-effectiveness and long-term outcomes. (Naidu et al.2021)

3. Benefits of Medicare Coverage for Pae

Financial assistance for PA procedures. Patients requiring PAE often suffer from a number of medical comorbidities, including diabetes, high blood pressure, and high cholesterol, states Dr. Shishehbor. This process will provide a safe alternative for men who might not otherwise have an option of treatment for their prostate. Medicare coverage is anticipated to be a game changer in improving outcomes and preventing disease progression for the millions of men with symptomatic BPH, said Dr. Milton Krisiloff. Depending on a patient’s geographical location and financial situation, the cost for a PAE procedure is quite variable, often times prohibitive. Covered by Part B, Medicare patients at all levels of income can rest assured that the cost of the procedure will be covered. With no out-of-pocket cost to the patient, the base payment for PAEs is fully covered for patients with Medicare. This fact is key in providing an option of treatment for BPH to those who would otherwise not be able to afford the procedure. In fact, data from the Kidney and Urology Center of Georgia has shown that a number of patients referred for the PAE procedure have not undergone treatment due to the economic burden of taking medication or the procedural co-pay costs of other minimally invasive treatments such as a B or TUNA. With patients enrolled in Medicare Part B, Dr. Milton Krisiloff and Dr. Shivank Bhatia of the Kidney and Urology Center of Georgia have reported that there has been significant interest in the PAE process from elderly men who view it as an effective alternative procedure for managing their voiding symptoms with an improvement in BPH outcomes.

3.1 Financial assistance for Pae procedures

– The Radiology item MBS 36845 “Transcatheter occlusion of the vesical or prostatic arteries, by endovascular technique, for prostatic embolization” is a very specific and recent introduction to the MBS intended to cover PAE or similar angiographic procedures as an alternative to surgery. As a greatly superior non-surgical and minimally invasive treatment option, PAE has the potential to save a great deal of money for both the patient and Medicare by reducing prostate surgery rates and recovery times, and the resultant demands on hospital beds and other resources. Usually, MBS 36845 with relevant access (i.e., in a private hospital) can be claimed with no out-of-pocket expense to the patient, and rebates for the physician and radiologist may be possible. Any professional fee for PAE should be covered by a patient rebate. Prostate embolization therapy done in the public sector with the aim to benefit public inpatients would be bulk billed without charge to the patient. (Rink et al.2022)

– Surgical Services MBS 32060/32061 “Perfuse one or more organs during systemic chemotherapy.” These item numbers maintain the infusion of chemotherapy agents into the prostate with the aim of prostatic volume reduction so as to alleviate obstructive urinary symptoms. Unfortunately, as of November 2009, these item numbers are not accepting access to general (item 32) or specific (item 35) patient rebates. This means treatment using MBS 32060/32061 is Gap Only; therefore, no benefit can be claimed from Medicare or private health insurance.

Medicare coverage for PAE procedures lies under the categories of surgery, cardiology, or radiology, depending on individual circumstances. As such, there are a number of items and corresponding rebates which can apply to PAE, the most pertinent being:

3.2 Access to quality healthcare providers

As a new and relatively unknown procedure, PAE is not currently a listed treatment under Medicare. Though the majority of charges and costs to the patient at a public hospital would be covered under the Global Budget Cap or change to Hospital and Health Services level funding, the absence of a Medicare benefit may problematize the funding and provision of PAE treatments in New Zealand public hospitals and influence whether or not a private patient option is available. Funding and cost allocation within district health boards and between different treatment options is a complex issue and often its result determines the level of accessibility to certain treatments or procedures. Ensuring equality across both publicly and privately insured patients is also a necessary condition to increase availability of a treatment. It is clear there is no necessity for change on the part of the publicly insured patient as their costs are covered. The private patient is the one who benefits from any procedure that has a Medicare benefit and he/she has the option of receiving the treatment at little cost to him/herself under the understanding that the Medicare rebate will be of greater worth than the cost of the treatment. Although there is not always a direct correlation between the size of Medicare rebate for a treatment and that treatment’s availability through the public system, the abundance of additional frail elderly patients in the private sector may put pressure on providers to expand a treatment to accommodate this patient demographic. (Gordon et al.2022)

In theory, it is clear that Medicare funding would be of great benefit to PAE patients wishing to seek treatment under Medicare at an Australian public hospital. In this setting, treatment costs for the procedure would be minimal and the cost burden on the patient greatly reduced. It is likely that the infrastructure and procedural-based funding allocation stream within the hospital would also provide an incentive for hospitals to increase their PAE services – thus increasing the availability of the treatment to BPH sufferers. However, to gauge the reality of these potential advantages, analysis of the funding process and the amount of funding allocated to the specific treatment is required. Primary to this is an understanding of Medicare’s reimbursement and benefit system. Based upon information found on the Medicare website, it appears to be a complex process which involves assignment of a Medicare benefit for a specific service, rebate to insured patients who receive the service, and the benefits are then paid to the patient’s doctor or specialist. The patient may incur additional costs if the doctor charges above the scheduled fee and he may be required to pay the balance. Step one in identifying the potential benefits of PAE treatment under Medicare is to find out whether a Medicare benefit has been assigned to the PAE procedure, and if so, how much it is and when it was assigned.

3.3 Peace of mind for patients and their families

– Medicare takes many of its decisions about coverage based on advice from its principal advisory committee – the Medicare Benefits Schedule (MBS) Review Taskforce. This taskforce is charged with considering the clinical evidence base for services and procedures under Medicare. It is noted that many Pae procedures involving coil and clip embolization have higher sequelae than the aneurysm itself. A proportion of these will be permanent and result in significant disability. Those patients with significant disability from Pae complications will qualify for care under the Chronic Disease Management Plan through allied health and other selected Medicare providers. This plan allows patients to be referred for up to 5 visits initially, with the potential for a further 5 visits per calendar year. This can be an excellent resource for those wishing to rehabilitate from complications of a Pae procedure, allowing the patient to significantly improve their capability and quality of life. (Al et al.2023)- An indirect but significant benefit of Medicare coverage is the reduced financial strain on the family unit. Complications from Pae procedures are unpredictable and can result in a patient requiring further treatment or hospitalization in the future. A patient’s loss of income can be substantial if they are unable to work. The family may have to deal with decreased mobility and function of a loved one or even becoming a primary carer. While the cost burden of treatment may be reduced if the patient is eligible for care under the disability plan mentioned previously, it is very important that further care remains affordable for that patient.

4. How to Navigate Medicare Coverage for Pae

Medicare is a fee-for-service healthcare coverage program that is regulated and administered by the U.S. government. Medicare currently provides benefits to 44 million Americans, including people age 65 or older and people with certain disabilities. The program helps with the cost of healthcare, but it does not cover all medical expenses or the cost of most long-term care. Medicare has four parts: Part A is hospital insurance, Part B is medical insurance, Part C is Medicare Advantage Plan, and Part D is prescription drug coverage. Before applying for Medigap, a private health insurance policy designed to supplement Medicare coverage, it is important for the patient or legal representative to have a clear understanding of Medicare benefits, particularly the coverage of Part A. Understanding the differences between Medicare and Medicaid is also important for a Part A patient. A short-term, categorical reference is that Medicare is an entitlement or general benefit for those who meet the age or disability requirements, while Medicaid is a means-tested program for people who fall into a defined eligibility group and income category. Dual eligibility patients (people who are eligible for both Medicare and Medicaid) are automatically enrolled in Medicare Part D and are eligible to apply for Medicare Savings Programs to assist with Medicare costs. These patients can also receive full coverage of all medical expenses when treated at a Medicare-participating facility due to a provision in the Social Security Act. This may be advantageous to Part A patients who are in need of reconstructive joint replacement surgery. (Deng, 2022)

4.1 Understanding Medicare plans and options

Medicare Part B is medical insurance. It is funded partially by premiums and general funds. Part B helps cover doctors’ services and outpatient care. It also covers some other medical services that Part A doesn’t cover, such as physical and occupational therapy and some home health care. Part B helps pay for these covered services and supplies when they are medically necessary.

Medicare Part A is hospital insurance. It is funded through payroll taxes. It helps cover inpatient care in hospitals, including critical access hospitals, and skilled nursing facilities (not custodial or long-term care). It also helps cover hospice care and some home health care. Beneficiaries must meet certain conditions to get these benefits.

Medicare is a federal healthcare program for people 65 or older, some younger people with disabilities, and people with End-Stage Renal Disease. The program is divided into several different parts.

4.2 Steps to apply for Medicare coverage

The simplest way to apply for Medicare coverage is by calling the Social Security Administration at 1-800-772-1213 or online at [Link] on the Medicare website, although you can also make an appointment with the Social Security Administration. Calling the Social Security Administration may be the preferred mode because of client load issues on the Medicare website delaying page downloads. You can expect to spend at least 1 hour with SSA entering data and answering questions. To facilitate this process, it is important to ensure that you have the patient’s and the carer’s SSN and information about dates and place of marriage and prior divorce or dates of death if the situation applies. You can still apply for Medicare if you do not have the carer’s information, but the process will be much simpler if you have it. (Morton III, 2024)If the patient is within 3 months of turning 65, you will be automatically enrolled in Medicare Part A and Part B. You will receive your Medicare card in the mail 3 months before you turn 65. This is desirable in comparison to trying to enroll in Medicare as part of the disability process as it saves prescribers and patients a significant amount of paperwork related to getting medication subsidies for PAE through the Commonwealth Government.

4.3 Tips for maximizing Medicare benefits for Pae

It is important to pay attention to steps clinicians and patients can take to ensure maximum coverage and payment from Medicare for a PAD patient. No matter which Medicare plan the patient is enrolled in, there are specific things a patient and provider can do to increase the likelihood of services being covered. The first and most important step is to always document and record the medical necessity of a treatment or service. If Medicare denies payment for a service, a patient cannot be balance billed for the service if a provider does not have proof that the service was medically necessary. Itemized billing using specific CPT codes will also increase the likelihood of a service being covered by Medicare. Specific CPT codes often correspond to a service that may be denied coverage if the code used does not accurately reflect the service. By writing or typing a statement on a patient’s behalf, a clinician can also help a patient appeal a Medicare decision if the service is denied coverage. A statement should include the reasons it is believed the service is medically necessary and supporting information that indicates the provided service is the best option and/or least risky option for the patient’s health.

References:

Keisler-Starkey, K. & Bunch, L. N., . Health insurance coverage in the United States: 2019. Washington. census.gov

Jaramillo, E. T. & Willging, C. E., 2021. Producing insecurity: Healthcare access, health insurance, and wellbeing among American Indian elders. Social Science & Medicine. sciencedirect.com

Powers, B.W., Yan, J., Zhu, J., Linn, K.A., Jain, S.H., Kowalski, J. and Navathe, A.S., 2020. The Beneficial Effects Of Medicare Advantage Special Needs Plans For Patients With End-Stage Renal Disease: Study compares use and costs for patients with end-stage renal disease who enrolled in Medicare Advantage special needs plans versus similar patients who remained in fee-for-service Medicare. Health Affairs, 39(9), pp.1486-1494. [HTML]

Foo, J. & Haddock, R., 2020. Data collection for community-based allied health chronic disease management. [HTML]

Naidu, S.G., Narayanan, H., Saini, G., Segaran, N., Alzubaidi, S.J., Patel, I.J. and Oklu, R., 2021. Prostate artery embolization—review of indications, patient selection, techniques and results. Journal of clinical medicine, 10(21), p.5139. mdpi.com

Rink, J.S., Froelich, M.F., McWilliams, J.P., Gratzke, C., Huber, T., Gresser, E., Schoenberg, S.O., Diehl, S.J. and Nörenberg, D., 2022. Prostatic Artery Embolization for Treatment of Lower Urinary Tract Symptoms: A Markov Model–Based Cost-Effectiveness Analysis. Journal of the American College of Radiology, 19(6), pp.733-743. [HTML]

Gordon, L.G., Leung, W., Johns, R., McNoe, B., Lindsay, D., Merollini, K.M., Elliott, T.M., Neale, R.E., Olsen, C.M., Pandeya, N. and Whiteman, D.C., 2022. Estimated healthcare costs of melanoma and keratinocyte skin cancers in Australia and Aotearoa New Zealand in 2021. International Journal of Environmental Research and Public Health, 19(6), p.3178. mdpi.com

Al Fauzi, A., Rahmatullah, M.I., Suroto, N.S., Utomo, B., Fahmi, A., Bajamal, A.H., Wahid, B.D.J. and Wisnawa, I.W.W., 2023. Comparison of outcomes between clipping and endovascular coiling in anterior choroidal artery aneurysm: a systematic review. Neurosurgical Review, 46(1), p.276. [HTML]

Deng, Y., 2022. Medicare for People with Disabilities. Encyclopedia of Gerontology and Population Aging. [HTML]

Morton III, D. A., 2024. Nolo’s Guide to Social Security Disability: Getting & Keeping Your Benefits. [HTML]