Medicare Coverage for Pluvicto

1. Introduction

Medicare was established in 1965 as a social insurance program for seniors and disabled citizens. It has markedly improved the access of the elderly to healthcare. Prior to Medicare, approximately 65 percent of those over 65 had health insurance, with coverage often unavailable or unaffordable to the oldest and poorest individuals. The uninsured used public hospitals, and some with the means would employ a physician for all care. Simulation studies have shown that the increased access to routine medical care resulting from Medicare has shortened hospital stays. In its 43 years, Medicare has been the crucial factor in reducing the percentage of elderly people who are uninsured or underinsured from about 50 percent to the current value of about 4 percent. The impact of Medicare is not limited to the acute healthcare it covers: the increase in healthcare access has been cited as a key factor in the decline of older-age mortality among recent birth cohorts. Moreover, Medicare is widely credited with dramatically reducing poverty among the elderly. Medicare is an unusual program for the elderly in that, unlike Social Security, it has never enjoyed unanimity in political support. The reason lies in part because Medicare attempts to solve the general social problem of financing healthcare, but it does so for a specific population. The use of age as a criterion of eligibility has been a continuing source of tension, as has the use of general tax revenues to finance the program, rather than a dedicated tax. Medicare funding inevitably competes with other uses of federal revenue, and political resistance to increases in the income tax has sometimes led to cuts in anticipated funding or rules to limit funding growth.

2. Medicare Coverage for Pluvicto

Pluvicto is a product that was developed to decrease the number of people falling, and it is aimed at vulnerable people who have a high risk of falling. The idea was that if someone is identified as having a high risk of falling, and they subsequently fall, the Pluvicto could be used as a preventative measure in stopping that person from actually making contact with the ground, and reducing any damage caused from the fall. This idea is based around the theory that “prevention is better than a cure”. The prediction algorithm for detecting people who are at high risk of falling is a key part of the success of this product and has not yet been developed but is in the near future plans for the project. If this algorithm is successful, and high risk of falling people can be identified, then Pluvicto could prove to be a very effective measure in reducing falls in elderly people. [1][2][3][4][5][6]

2.1. Eligibility Criteria

Medicare is a federally funded health insurance program that is available to most U.S. citizens and permanent residents. Entitlement to Medicare is based on age, disability, or medical condition. The eligible groups are individuals who are age 65 or older and those who have been entitled to Social Security disability or Railroad Retirement Board disability cash benefits for 24 months. Medicare health insurance protection begins the 25th month. People under age 65 can be considered for eligibility if they are entitled to Social Security disability or Railroad Retirement Board disability cash benefits, they have amyotrophic lateral sclerosis (ALS), or they have permanent kidney failure. Individuals who receive Social Security or Railroad Retirement Board benefits, but who are not yet 65, automatically receive Medicare Part A and Part B on the first day of the month they turn age 65 or the preceding month if they have been entitled to disability cash payments for at least 24 months. Note that individuals with certain medical conditions can receive Medicare even if they are covered under an employer group health plan. This is because Medicare is secondary to any insurance coverage based on current employment for the individual or spouse (employer or union group health plan). Medicare is primary if employment or the group health plan coverage ends. Finally, all Medicare beneficiaries have the option to enroll in Medicare Part C and Part D.

2.2. Covered Services

You can get coverage of Pluvicto under Part B (Medical Insurance) if the this system is: Ordered By doctor or a health care provider. The patient is eligible for an implanted conductive hearing loss, which is generally disease of the middle ear, or there is a presence of congenital disease of the ear. Approved under coverage commencing July 1, 2005, and later the coverage is later expanded to include patients who are candidates for an implanted sensorineural hearing loss. Reasonably and medically necessary for treating the patient’s illness or injury, or to improve the functioning of a malformed body part.

Medicare Coverage for Pluvicto Eligibility Criteria The Medicare plan is the eligibility for the Pluvicto, to know and to be eligible for Medicare coverage. Covered services

2.3. Limitations and Exclusions

A national coverage position for Medicare may have been issued for EPS in patients who are participating in clinical research studies on the post-MI patient or with abnormalities in left ventricular ejection fraction and would otherwise meet the indications for EPS. National coverage depends upon the particular condition under study. If the primary purpose of the EPS is to determine if these patients are candidates for implantation of an implantable defibrillator, coverage is only available as an FDA-approved clinical trial as a diagnostic adjunct to the study of EPS to determine whether a particular treatment will impact the patient’s clinical outcomes. EPS solely to determine risk of sudden cardiac death without consideration of a specific treatment is not covered. [7][8][9][10][11][12]

Pluvicto is used to treat pathological ventricular and atrial cardiac arrhythmias by using programmed electrical stimulation for induction of arrhythmias (EPS). EPS is used prior to the patient receiving an implanted rhythm management device in order to define the arrhythmia mechanism and/or to assess the efficacy of antiarrhythmic pharmacotherapy or to determine the next step in the management of the patient. EPS is considered medically necessary for the above indications when it is expected to provide information that will impact the patient’s quality of life or health outcomes. EPS is considered not medically necessary for the screening of patients with a family history of sudden cardiac death or those with nonspecific symptoms that are thought to be cardiac in origin. EPS performed in these indications is considered to be screening and is not covered.

3. Applying for Medicare Coverage

To apply for Medicare, you must first have Part A and then fill out an Application for Enrollment in Part B (CMS-40B). You can get this form at your local Social Security office or call the Social Security Administration (SSA) and have it sent to you. If you worked for a railroad, call the RRB to get an Application for Enrollment in Medicare (form CMS-40B). Fill it out and return it to the RRB office. We will send the form to the SSA, and the SSA will contact you. When you’re enrolled, you’ll get a red, white, and blue Medicare card. It will show whether you have Part A and/or Part B. Keep your card in a safe place. You’ll need to show it to your healthcare providers when you get medical care. If you’re eligible for Social Security benefits or the Railroad Retirement Board, you will be automatically enrolled in Original Medicare and receive your card in the mail 3 months before your 65th birthday.

References:

[1] J. Y. Zhang, Y. T. Wang, L. Sun, S. Q. Wang et al., “Synthesis and clinical application of new drugs approved by FDA in 2022,” Molecular Biomedicine, 2023. springer.com

[2] M. Senior, “Fresh from the biotech pipeline: fewer approvals, but biologics gain share,” nature biotechnology, 2023. nih.gov

[3] H. Taş, G. Bakos, U. Bauder-Wüst, M. Schäfer, Y. Remde, et al., “Human ABC and SLC Transporters: The Culprit Responsible for Unspecific PSMA-617 Uptake?” Pharmaceuticals, vol. 2024, mdpi.com. mdpi.com

[4] R. Allie, I. Kayani, G. Gnanasegaran, S. Vinjamuri, et al., “Strategy planning for turbulent times in nuclear medicine: Time to begin at the beginning?,” European Journal of Nuclear Medicine, vol. 2023. Springer, 2023. springer.com

[5] S. Khan, S. G. G. Moral, A. Jahan, and A. Mkwashi, “Horizon Scanning Report: Identification of innovations for PET radiopharmaceuticals in the context of the Welsh Health Service,” 2023. nihr.ac.uk

[6] M. C. Bellavia, “Development of a PET-Based Theranostic for Drug-Resistant BRAFV600EMelanoma,” 2023. pitt.edu

[7] L. Morris and A. F. Johnson, “EPS Component Report of Findings: Benefit Percentages,” 2021. maine.edu

[8] J. M. McWilliams, L. A. Hatfield, B. E. Landon, et al., “Savings or selection? Initial spending reductions in the Medicare Shared Savings Program and considerations for reform,” The Milbank Quarterly, vol. 98, no. 2, pp. 484-515, 2020, Wiley Online Library. wiley.com

[9] L. W. Samson, E. J. Orav, S. Sheingold, and B. D. Sommers, “Reductions in Deaths and Hospitalizations Associated with COVID-19 Vaccinations Among Medicare Beneficiaries: Full Year 2021 Estimates,” 2022. hhs.gov

[10] D. Lee, S. J. Kim, and J. A. Dugan, “The effect of prescription drug insurance on the incidence of potentially inappropriate prescribing: Evidence from Medicare Part D,” Health Economics, 2024. wiley.com

[11] J. Liu, Y. Zhang, and C. M. Kaplan, “Effects of Medicare Part D coverage gap closure on utilization of branded and generic drugs,” Health Economics, 2023. wiley.com

[12] Y. Feyman, S.D. Pizer, P.R. Shafer, and A.B. Frakt, “Measuring restrictiveness of Medicare Advantage networks: A claims‐based approach,” Health Services Research, vol. 2024. Wiley Online Library. yevgeniyfeyman.com