1. Introduction
Medicare is a publicly funded universal healthcare system in Australia. It is operated by the government authority, Medicare Australia. The objective of the Medicare system is to provide Australian residents with affordable, quality healthcare. This is a complex issue. Medicare provides a rebate for medical procedures in two ways. The patient can either claim the rebate back from the doctor who will refund the patient by relinquishing the rebate from the charge. This is known as bulk billing. Otherwise, the patient can claim the rebate back from Medicare itself. If the procedure is performed in a private practice or hospital, the patient is only entitled to 75% of the schedule fee common rebate. Therefore, patients who are treated with the Nanoknife system will receive a rebate from Medicare on the fees for the anesthetist, specialist, and hospital booking. This is advantageous in comparison to most other current elective procedures as the Medicare rebate usually covers over 90% of these costs.
The term “ablation” is used as the endpoint for this process. Ablation refers to removal of tissue by vaporization, charring, or scraping. Ideally, a 5 mm rim of ablated tissue will encompass the tumor and the only remaining task would be follow-up imaging to ensure complete success of the treatment. Usually, the series of imaging includes a PET scan performed 6 weeks later, if histologically confirmed.
Nanoknife is a novel technique in the treatment of unresectable solid tumors. This technique was introduced in April 2006. By means of a series of electrical pulses delivered through electrodes placed around a tumor, cells in the tumor are subjected to an electric field of sufficient intensity to cause permanent holes on the cell membrane. Once the cells in the mitotic phase are damaged during this process, it will be impossible for new viable cells to be produced. Apoptosis is initiated in these damaged cells. A foreign body response to remove the dead cells will be elicited. This entire process is selective to the tumor. The time and amplitude of electrical current can be controlled to minimize injury on adjacent critical structures. The Nanoknife system allows real-time tracking of and adjusting to changes in tumor impedance. This is important as the electrical field and hence the ablation effect is inversely related to tumor impedance. The electrodes are placed as pairs across the tumor and the electrical pulses are delivered between each pair for maximal coverage.
1.1 What is Nanoknife?
With the significant developments in treatment modalities and outcomes for cancer patients, comes an increased need for these newer therapies in the elderly population. However, many of these therapies are deemed “unproven” by Medicare carrier policies and are subsequently denied coverage for a large portion of individuals. Subsequently, leaving the patient and/or family responsible financially for the procedures. Irreversible Electroporation (NanoKnife) is a “new” therapy and is often denied coverage by Medicare carriers. The following is a detailed overview of how Medicare determines coverage, the findings in coverage for this specific therapy, and the implications of denial. In order to appreciate the complexities of coverage, a thorough understanding of what exactly NanoKnife is, and the implications of this will be discussed. This includes the technicalities of NanoKnife in comparison to other therapies, in terms of what it “is” and the implications on providing oncological surgical therapies to an elderly population. (Schofield et al.2024)
1.2 Importance of Medicare Coverage
Medicare is a health insurance program that is funded by the federal government and designed to help primarily those aged 65 and older offset the costs of health care. Coverage also extends to people with disabilities and end stage renal disease. It is broken down into four parts, each covering a specific portion of healthcare. Part A, the first and most common part, covers hospital visits and any follow-up care. Part B covers physician and outpatient care. Part C involves private companies administering health plans and Part D covers prescription drugs. Medigap is a type of private insurance designed to supplement Medicare. It is important to know that the question “Is Nanoknife Covered by Medicare?” mainly revolves around Medicare in the United States and coverage may differ in other countries.
2. Medicare Coverage for Medical Procedures
Medicare coverage determinations are made pursuant to a National Coverage Determination (NCD), a Local Coverage Determination (LCD), or an NCD or LCD Article. An NCD is a determination by the Centers for Medicare and Medicaid Services (CMS) that a particular item or service is covered nationally. A determination is made through an evidence-based process. Medicare non-coverage determinations can also be made through an NCD. A Local Coverage Determination (LCD) is a decision by a particular Medicare Administrative Contractor (MAC) as to whether a particular item or service is covered on a carrier-wide, intermediary-wide, or system-wide basis in accordance with section 1869(f)(2)(B) of the Social Security Act. An LCD becomes effective no sooner than 45 days from the date of its posting unless stated otherwise, and it is based on an extensive review process and public comments. An NCD or LCD Article is a comprehensive description of the evidence that CMS considered in making the NCD or of the rationale for disallowing coverage in an NCD issued on or after April 26, 1999.
Where private insurance is concerned, getting coverage for a medical procedure can be as simple and straightforward a matter as determining that the procedure is necessary and scheduling it. The situation becomes much more complex for patients with Medicare. This is because Medicare, as a federal health insurance program, has four parts and covers a wide range of medical expenses, usually to a lesser extent than a private insurer. This can make it difficult to determine whether a medical procedure is covered by Medicare and whether the patient will have to pay the out-of-pocket costs.
2.1 Overview of Medicare Coverage
Medicare is a government-funded health insurance for all Australians. The aim of the Medicare program is to provide affordable, accessible, and high-quality health care for all. Medicare provides access to a number of medical services such as free treatment in a public hospital, as well as access to cheaper or sometimes free medical care. Medicare will also provide rebates for certain types of medical services to a private health care on the basis of patients’ income. Among the services provided by Medicare, qualified health care professionals supply the best customer service and medical aids for patients who are thinking about going in for a procedure to resolve a health-related issue. They will provide the appropriate treatment details and check whether the procedure is needed to get a patient back to healthy living. Medicare will provide rebates for these services done by healthcare professionals. Although Medicare covers a wide range of medical services that medical practitioners and health care professionals supply, it does not cover all services. Medicare will only cover (provide rebates) for services that are listed under the Medicare Benefits Schedule (MBS). This means if the procedure the patient is thinking of acquiring is not listed under the MBS, they will not receive a Medicare rebate. In some cases, the patient may be required to provide written consent for private medical services in hopes to attain a Medicare rebate. This can sometimes cause confusion to patients on what Medicare covers for particular medical services. The consent states that the patient has been informed by the health care professional of the services needed and that it is understood what services Medicare will provide rebates for. Written consent ensures that the patient has a clear understanding of what medical services are provided and the cost, should there be any out-of-pocket expenses.
2.2 Criteria for Medicare Coverage
In the fall of 2009, Nanoknife treatment of prostate cancer was given a positive coverage decision by Medica insurance in Minnesota. Patient advocate Mike Scott has provided an audio interview with a detailed discussion of the process by which this decision was achieved and has information of similar decisions by private insurers, which serve as solid evidence that future private insurance coverage will likely be positive. Given that private insurance is basing coverage decisions on a comparison to surgery and that the coming treatment code and established Medicare coverage will guide them toward blanket coverage in the future, we can be reasonably confident that future private insurance coverage will be comprehensive.
So if we know that this is the process and considering that new treatment code will be developed in October 2010, it’s valuable to look at the positive coverage decision for Nanoknife that we expect to come forward in 2010. Right now the bulk of private insurance coverage decisions have been made on a case by case basis, wherein the patient’s physician seeks special approval or “override” of non-coverage to do the procedure and then the insurer provides an ad-hoc payment based on that single case. Usually these private insurers are comparing Nanoknife to the standard of surgical resection and are providing coverage based on the fee they’d pay for a comparable surgical case. (Roknsharifi et al.2021)
So, the big question is whether Nanoknife is reimbursed by insurance? Currently, this procedure is so new and still relatively rare that many insurance companies are not adequately appraised of the procedure and have not yet developed a specific reimbursement code for Nanoknife. But does that mean it’s not covered? No. As we’ve seen from the coverage determination process, when a given procedure doesn’t have an explicit code, it’s compared against similar procedures that do have codes and then coded as equal to the nearest analog.
2.3 Types of Medical Procedures Covered
This section has proved to be a useful tool in determining which types of procedures may be covered by Medicare. The section has significance because it is much easier to determine if Medicare will or may not cover a specific type of procedure. A favorable decision means that a local Medicare Administrative Contractor (MAC) has determined that the procedure is a reasonable and necessary medical treatment for the diagnosis or treatment of an illness or injury, and it is a statutory requirement that a National Coverage Determination or Local Coverage Determination be made by the MAC before the service can be covered by Medicare. Not always will a Decision Memo/Determination letter be easily accessible, due to the level of effort of bureaucracy Medicare has concerning coverage of services there may be an extensive amount of research and discussion without a public disclosure being made of the decision. Lastly, as to make even procedures without a Decision Memo easily found, the use of keywords can provide the technician with valuable information. The disadvantage is that the NCD/LCD document does not always have the procedure the technician is discussing or they may be too vague. Nonetheless, the overall types of various medical decision methods can provide a beneficiary effective knowledge on whether or not a service may be covered by Medicare and provide the technician a way to make Medicare track down a decision on an item in question. (Wang, 2023)
3. Nanoknife Coverage under Medicare
The plan includes decision making over a nine-month period, including public comment and internal review. If accepted, the NCD would extend Medicare coverage to patients nationwide and would largely impact the eligibility of patients for Nanoknife treatment.
The NCD originally released in 2015, with the proposal of adding irreversible electroporation to a list of non-covered procedures for Medicare patients. However, the scope of the decision was limited to a small number of malignancies of the pancreas. On December 10th, 2015, the Centers for Medicare & Medicaid Services (CMS) released a proposed decision that would extend the coverage of irreversible electroporation ablative treatment. This new plan involves the reconsideration of irreversible electroporation coverage throughout the entirety of Medicare, effectively rescinding the original NCD.
A crucial factor in the decision to perform irreversible electroporation (Nanoknife) is the coverage by medical insurance. The current status of Nanoknife coverage is that it is under scrutiny for broad coverage and considered investigational. Medicare has released a National Coverage Decision (NCD) for the use of irreversible electroporation.
3.1 Current Status of Nanoknife Coverage
Background: Irreversible electroporation (IRE) utilizing the brand new “Nanoknife” is an emerging technology in the treatment of solid tumor cancer. By applying a series of short, high-voltage electrical pulses to the tumor via microelectrodes, IRE creates nanoscale defects in the cell membranes, resulting in cell death. Recent clinical trials have suggested the effectiveness of IRE in destroying tumor cells without causing damage to connective tissue or vasculature, but the long-term effects of this modality are still being investigated. Healthcare coverage most often determines accessibility to new therapies, and many patients and physicians are likely to be considering whether IRE could be a recommended course of treatment. This commentary will focus on the current status of Medicare coverage for IRE, and will review whether current and potential future evidence-based information warrant its status as a covered procedure. (Zhang et al.2022)For the purposes of this article, published Medicare “Coverage Diagnosis” documents for individual indications will be referenced. Since these decisions differ by locality and are subject to change, discussion will be limited to a general overview of coverage. Available papers referring to coverage for IRE or Nanoknife are limited. Searches of the public Medicare website, CMS.gov, and private literature provided by Angiodynamics Inc. and Perseon Medical yielded no results. This suggests that coverage decisions for IRE are in line with the view of it as an experimental or emerging technology.
3.2 Factors Influencing Coverage Decision
The coverage decisions by both public and private payers are generally influenced by the strength of evidence supporting improved health outcomes when a new technology is compared with currently available alternatives. The conclusion whether a particular technology improves health outcomes often depends on interpretation of the available evidence. The majority of academic clinicians believe that RCTs provide the best way to generate such evidence. However, due to unique product characteristics and the relative slow pace of RCT-generated evidence, sponsors claim that a technology’s full real-world performance can never be captured by RCT data and is underrepresented in assessments based on RCT data. Another key consideration in coverage decisions is the economic impact of a new technology on a particular population. Medicare’s coverage decisions often include consideration of the Social Security Act Title XVIII definition of ‘reasonable and necessary,’ which states that only services that are considered to be safe and effective, not experimental or investigational, and are necessary for the diagnosis or treatment of an illness or injury, or to improve the functioning of a malformed body part are covered. This definition is interpreted with consideration of the wider economic impact of the technology. High-cost technologies with small marginal health benefits may de facto not be considered ‘necessary’ in comparison to currently available alternatives and therefore not be covered. Other technologies have relative cost-saving potential if they prevent future expensive procedures. This is considered, for example, in coverage decisions for preventive services with the reasoning that an ounce of prevention is worth a pound of cure.
3.3 Potential Benefits of Nanoknife Coverage
Although it has not yet received full Medicare coverage, Nanoknife therapy offers the potential of cost-savings in recurrent tumor ablation. This is because it is able to ablate tumors that were previously considered surgically unresectable without increasing the risk of serious complications. For these patients, the ability to ablate the tumor instead of relying on other palliative measures would increase life expectancy and quality of life. This in turn would help Medicare to realize the full benefits of covering these patients. As our population ages and the prevalence of cancer in the elderly rises, the ability of our healthcare system to care for these patients will be a great concern. With 40% of new cancer cases and 60% of cancer deaths occurring in the elderly, cancer is a disease that places a heavy burden on the Medicare system. By offering technologies that are able to extend life and improve quality of life in elderly cancer patients, such as Nanoknife therapy, Medicare is better able to meet the needs of this growing population.
4. Advocating for Nanoknife Coverage
Given the substantial monetary cost of the Nanoknife procedure, no patient will want to assume the full financial responsibility of the treatment should coverage be denied. So it is crucial for patients and their physicians to make a concerted effort to challenge an initial non-coverage decision and attempt to have it overturned. Understanding how to effectively navigate the Medicare appeals process can be the difference between success and failure in obtaining coverage. It is highly recommended that patients and physicians read the informative “Medicare Appeals Process” article provided on the American Urological Association website. This details the various stages of the appeals process, and offers advice on specific actions to take should the appeal decision be unfavorable. A key take home message from this article is that persistence is necessary when attempting to overturn an initial non-coverage decision. With an initial non-coverage decision and attempt to have it overturned. Understanding how to effectively navigate the Medicare appeals process can be the difference between success and failure in obtaining coverage. It is highly recommended that patients and physicians read the informative “Medicare Appeals Process” article provided on the American Urological Association website. This details the various stages of the appeals process, and offers advice on specific actions to take should the appeal decision be unfavorable. A key take home message from this article is that persistence is necessary when attempting to overturn an initial non-coverage decision. With the help of this platform from which patients and physicians can share and obtain information, the possibility of change in coverage policy for IRE may be achievable in a stepwise fashion. To this end, Ablation Alliance is currently gathering a comprehensive nationwide listings of all known IRE treatment sites. This information will be of great assistance when identifying other patients who have undergone IRE for interaction and information sharing on coverage experiences.
Cancer patients who have considered undergoing IRE with the Nanoknife are now faced with the decision of how to obtain coverage for this minimally invasive treatment. This is an extremely important endeavor when considering the still investigative nature of IRE, and the need to keep treatment costs reasonable. In general, acquiring Medicare coverage for a specific treatment or service is a difficult and uphill battle. This is due to the fact that Medicare has made it specifically challenging to overturn an initial non-coverage decision. This was made clear by a recent statement from the Centers for Medicare and Medicaid Services that “We cannot stress enough the importance of providing all necessary and relevant information in the written redetermination request. Reiteration of information already submitted with the initial determination or a general desire for change is not sufficient and will not constitute an error on the part of the contractor.”
4.1 Understanding the Medicare Appeals Process
When patients are denied coverage for Nanoknife as a treatment for their cancer, there are rights to appeal this decision. The appeals process can be lengthy, but if coverage is gained in the end, the battle will have been worth it. During an appeal, all decisions about whether or not care will be covered are based on whether or not the care is medically necessary. This is the case in all types of appeals in all states. The 4 levels of appeal are: redetermination, reconsideration, ALJ hearing, and a review by the Medicare Appeals Council. At each of these levels of appeal it is important to remain organized and keep copies of all letters and forms. This will make it easier to keep track of the status of the appeal, and will be beneficial if the patient needs to refer back to a previous step in the process. Although coverage was denied at first, there is much potential to gain coverage for Nanoknife during the appeals process. In the first 2 levels of appeal, redetermination and reconsideration, a request for the case to be reviewed without a hearing can be made. This is a simple written request. Then, a hearing and review will be held. These first 2 levels of appeal are the most difficult time to gain coverage. According to a Medicare Payment Advisory Commission report, only 13% of redeterminations and 6% of reconsiderations result in overturning the denial of coverage. The next two levels of appeal, hearing and review by the Medicare Appeals Council have much higher rates of success in gaining coverage. (Crocker, 2021)
4.2 Building a Strong Case for Coverage
Building a strong case requires that the patient and his or her healthcare professionals thoroughly document the patient’s course of treatment. This includes providing a detailed medical history, the progression of the disease state, diagnostic testing, and the rationale behind the treatment being advocated. It is best if this information is put into a concise and focused narrative. Most important are any documentation of the patient’s functional status or changes in functional status, and how these changes impact the patient’s quality of life. A strong case will often require the healthcare professionals to seek additional information from other healthcare professionals confirming the information provided and the treatment being sought. For an impact review, coverage is not the issue. The treatment is considered for coverage or not. An impact review addresses the significance of the treatment for the general progression of the disease state and improvement in patient outcomes. If a positive impact review deems a treatment unsafe or of low risk, it is usually not the basis for denial. Specific documentation requirements for submitting an impact review vary by contractor and some national coverage determinations now require an impact review as a part of the formal decision process. The patient’s representative can only request a formal impact review if a local coverage determination or national coverage determination decision was based on a non-coverage regarding the treatment’s impact.
4.3 Collaborating with Healthcare Professionals and Patient Advocacy Groups
In order to build more support for Nanoknife coverage, we have reached out to other healthcare professionals and health organizations to assess their willingness to our advocacy efforts. Our targeted stakeholders are those who specialize in treating cancers of the pancreas, liver, prostate and other difficult-to-treat cancers often deemed medically inoperable. This work being very much in line with the mission of the ACC to advance the cardiovascular care for patients; this success involved discussing our goals with prominent cardiologists who had been involved with successful efforts to attain Medicare coverage for other new technologies and a meeting with the President of the American College of Cardiology to determine the best strategy for change in Medicare policy. We received very beneficial advice including suggestions for building public and political support, pursuing a National Coverage Decision and seeking assignment to a DRG status which would provide adequate reimbursement. Through the SIR we have begun to develop a plan for obtaining a ND which will allow for optimal Nanoknife coverage and minimally invasive treatment of inoperable tumours at a fully government insured rate. Our discussion with the doctors using Nanoknife technology provided some very insightful comments as to Medicare’s disinclination to approve coverage for new medical technologies regardless of the potential benefit to patients. This has left many a physician “stuck between a rock and a hard place” having to choose between providing optimal care for the patient and keeping treatment cost within the patient’s financial means. Often the result is a less effective treatment or a referral to another physician for non-Medicare patients. With recent CMS initiatives to accelerate the use of certain new medical services by private Medicare plans, we hope that we a closer time when a coalition of patients and physicians can effect national policy towards improved Medicare coverage for new medical interventions. (Tuohy)
References:
Schofield, P., Hyatt, A., White, A., White, F., Frydenberg, M., Chambers, S., Gardiner, R., Murphy, D.G., Cavedon, L., Millar, J. and Richards, N., 2024. Co‐designing an online treatment decision aid for men with low‐risk prostate cancer: Navigate. BJUI compass, 5(1), pp.121-141. wiley.com
Roknsharifi, S., Wattamwar, K., Fishman, M.D., Ward, R.C., Ford, K., Faintuch, S., Joshi, S. and Dialani, V., 2021. Image-guided microinvasive percutaneous treatment of breast lesions: where do we stand?. Radiographics, 41(4), pp.945-966. rsna.org
Wang, Y., 2023. Agendia, Inc. v. Becerra: Imposing a Dangerous Assumption of Unworthiness to Local Coverage Determination. J. Health Care L. & Pol’y. umaryland.edu
Zhang, X., Zhang, X., Ding, X., Wang, Z., Fan, Y., Chen, G., Hu, X., Zheng, J., Xue, Z., He, X. and Zhang, X., 2022. Novel irreversible electroporation ablation (Nano-knife) versus radiofrequency ablation for the treatment of solid liver tumors: a comparative, randomized, multicenter clinical study. Frontiers in Oncology, 12, p.945123. frontiersin.org
Crocker, K. M., 2021. The Supreme Court’s Reticent Qualified Immunity Retreat. Duke LJ Online. wm.edu
Tuohy, C. H., . Anniversary Narratives of the Health Care State: Institutional Entrenchment in Retrospect. Journal of Health Politics. [HTML]
