1. Overview
The scope of Medicare services is quite broad and includes various diagnostic and treatment services, inpatient and outpatient hospital care, skilled nursing facility care, home health care, hospice care, and in some cases dental. This is great news for those who suffer from the multitude of ailments that come with old age. Medicare coverage is, however, limited for the more advanced technologies of medical treatment, and very often the more recent alternative therapy options such as the rebuilder. An understanding of these limitations is crucial to avoid the planning of a treatment only to find that it is not covered by Medicare. In the case of a disallowed service, the patient is faced with the decision of scrapping the treatment that may be the only one of its kind for a long-term condition, or withstanding the financial burden of the entire cost. This is a tough decision that many patients and families are faced with, and it is often fueled by a lack of knowledge regarding what exactly is covered by Medicare. (Giest & Samuels, 2020)
First and foremost, Medicare is health insurance for people age 65 or older, under age 65 with certain disabilities, and any age with End-Stage Renal Disease (permanent kidney failure). The program helps with the cost of health care, but it will not cover all medical expenses or the cost of most long-term care. Medicare has four distinct parts: A, B, C, and D. It is funded by the American taxpayers, and it is designed to promote the health and welfare of the American people. In the year 2006, Medicare implemented a Prescription Drug Plan; this is designed to lower the costs of prescription drugs for Medicare beneficiaries. At this moment in time, we will not address the specifics of the drug plan due to its complexity and the fact that it is still in its implementation phase.
1.1. Introduction to Medicare coverage
The medical device type known as the rebuilder can be classified as a muscle stimulator and has been correlated to the desire for more conservative (less invasive) medical treatment for muscle pain. Use of the rebuilder device would fall under home health care. With Part A coverage, Medicare has some restrictions and limitations to what it covers. Since Part A coverage is broad and covers a wide range of services, this does not imply that Medicare insurance will cover everything. However, Medicare Part B can be used in conjunction with Part A for additional coverage of medical services or medical supplies. This would take form as an added insurance and it too has a premium which would be paid monthly. Physical therapy and more importantly the device itself and its supplies can be covered with Part B Medicare insurance. Since rebuilding and less invasive treatment is a goal, it may be more costly and one may wish to seek the more alternative or conservative forms of treatment. At this point, we know that some Medicare insurance coverage can be used for help in obtaining this medical cost. But one must ask, how much of it will be covered and how easy can it be obtained? (Mantovani et al.2023)
Medicare is a coverage of health mainly for the elderly or disabled individuals. It is not something easily understood. Most people assume that when they turn 65 years of age they will qualify for Medicare insurance coverage, this assumption is somewhat truthful. It has been previously stated that 65 years of age is considered elderly; Medicare begins to cover health insurance at age 65. Although for individuals under the age of 65, you may qualify for Medicare insurance under certain circumstances. This insurance allows for better access to medical care and medical technology. However, this is not an insurance plan that will cover everything. Usually a deductible or a monthly insurance premium is paid for by an individual receiving Medicare. Medicare also works on a patient co-pay system, which is similar to most private insurance plans. One must understand that Medicare has many sub sections. It starts with Part A and ends with Part D. Usually an individual will qualify for Part A if they are over the age of 65. This is insurance that is used to cover in-patient hospital stays, skilled nursing, hospice care or home health.
1.2. Importance of understanding coverage for medical devices
The rebuilder is a “durable medical equipment” (DME) used to treat foot pain for diabetic peripheral neuropathy patients through relaxing foot muscles, reducing muscle spasm, and increasing blood flow to speed the healing process. Typically, Medicare benefits will cover DMEs. However, it is important to understand whether the device is covered under Medicare Part B and if Medicare will cover rental or purchase of the device. Maintenance of the rebuilder is also an important matter to take into account when assessing if it is covered under Medicare. If Medicare determines that the maintenance is not an essential or necessary part of the device, it will not be considered a Medicare benefit even though the device is covered. It is essential for patients to understand that they should contact their Medicare carrier for information about coverage and that they may have to sign an advanced beneficiary notice if it is believed that Medicare will not provide reimbursement. Understanding that can help the patient make an informed decision on using the rebuilder as a treatment option. (Burt, 2023)
1.3. Relevance of the rebuilder in Medicare coverage
“But now we get to the point,” you’re thinking, “will Medicare cover my purchase of a rebuilder?” The answer is generally no. This is not because it is not often an appropriate device for someone to use, but because the goal of using it and the condition it would be billed under are not covered services. A rebuilder is used to treat symptomatic peripheral neuropathy, which involves pain, numbness or tingling in the extremities, such as hands or feet. While these symptoms are quite common in diabetes, the condition of Diabetes Mellitus itself (250.00-250.90) is not a peripheral neuropathy, rather it is a systemic disease. Therefore, treating a patient with diabetes to try to relieve symptoms in their feet, for example, using a rebuilder would actually be treating the systemic disease of diabetes and rebuilder services would have to be billed under a diabetic code. Services for treatment of diabetes under any diagnosis related to it are non-covered services by Medicare, per §1862.(a)(1)(A). Another reason why rebuilder services would not be covered is because it is something that can be done effectively in the home. In today’s Medicare climate, there is an increasing trend to reduce what is considered “maintenance” a treatment for a given condition, to a covered service. This is seen in the reduced coverage for physical therapy services, which has greatly impacted the incoming college graduates seeking to become physical therapists. Gaining knowledge of this, physical therapy for self-care is still an effective tool for someone with an affected extremity, to help increase circulation and relieve pain. Physical therapy is a covered service under a plethora of diagnoses, for an even wider range of symptoms, but the idea of using PT to “maintain” a level of function has a tenuous future at best for being considered a covered service. PT can still be an effective method of treatment and is not being removed from the realm of covered services, but the shifting of burden to the patient in an environment that is cost friendly for Medicare has direct relevance to the coverage of rebuilder services in the future. (BAUER et al.)
2. Medicare Coverage Criteria
Eligibility for Medicare coverage can be limited to certain Medicare beneficiaries who have a specific diagnosis or meet other specific requirements. When determining whether an item or service is covered, a beneficiary’s personal medical condition and the Medicare coverage requirements are considered. Items or services must meet all general and specific coverage requirements in order to be eligible for coverage. If an item or service falls within a National Coverage Determination (NCD) or a Local Coverage Determination (LCD), the item or service must meet the coverage requirements specified in these decisions. An NCD sets forth the extent to which Medicare will cover specific services, procedures, or technologies on a national basis. An NCD encompasses a determination of whether the item or service is reasonable and necessary, and the conditions for coverage. A decision memorandum is the primary mode of informing the public of these decisions. Collectively the NCD and decision memorandum are the formal record of the determination. If an NCD does not exist, the coverage an item or service is determined by what is reasonable and necessary with consideration of available evidence and pertinent to the health and/or treatment of an illness or injury. In this case, the item or service is evaluated under the general coverage decision process. This is also the same as services that are being reconsidered. A coverage decision made through an NCD or under the reconsideration process are binding throughout the appeals process for a specific medical claim regarding the item or service in question. An LCD contains coverage and benefit category determination issues and decisions based on whether the item or service is medically necessary or experimental. The LCD is a binding decision a carrier makes through a formal process and is approved by CMS to define whether a particular item or service is covered on a MAC (Medicare Administrative Contractor) jurisdiction by jurisdiction. If there is no NCD or when an item or service is new technology, a study can be made to have an NCD or if there is sufficient local interest, a request can be made for a LCD. New technologies will be evaluated under the same process as a National Coverage Decision. Local coverage decisions the record of the determination. If an NCD does not exist, the coverage an item or service is determined by what is reasonable and necessary with consideration of available evidence and pertinent to the health and/or treatment of an illness or injury. In this case, the item or service is evaluated under the general coverage decision process. This is also the same as services that are being reconsidered. A coverage decision made through an NCD or under the reconsideration process are binding throughout the appeals process for a specific medical claim regarding the item or service in question. L34395 (Schwartz et al.2021)(Burd et al.2020)(Lees et al.2020)
2.1. Eligibility requirements for Medicare coverage
To be eligible for coverage by Medicare, the device in question must meet all necessary requirements determined within the Factors of Coverage section of the NCD. This section is too lengthy to include in its entirety, so the author has selected only the points which are most relevant to the rebuilder.
In making the coverage decision, Medicare looks at a variety of factors. It may consider a comparison of the benefits of using the item versus not using it. It will consider whether the device is a proven treatment, or whether it is experimental. Often the decision is based on clinical evidence consisting of published reports and conclusions based on scientific studies. Ideally, there will be multiple studies identifying the use of the device for the same indication. Economic factors and the impact of the decision on the health status of the Medicare population would also be taken into account.
Congress has determined that Medicare will cover certain types of medical equipment. These are devices that are considered “reasonable and necessary” for the treatment of an illness or injury (and considered effective). The decision can be found within these Local Coverage Determinations. It can also be made at the national level through a National Coverage Determination. At this point in time, the decision regarding coverage of the rebuilder has only been made in the DMERC LCD for Jurisdiction A. It is important to note that consumers should check the policy for their own state, as it may differ from the national decision.
2.2. Specific criteria for coverage of medical devices
In 2003, Palmetto Government Benefits Administrators published “Local Coverage Determination for Transcutaneous Electrical Nerve Stimulators”, outlining the specific criteria for coverage of TENS devices and electrical stimulation devices. Overall, the policies outlined by this document represent Medicare’s coverage criteria for the rebuilder with just a few exceptions. A TENS device operates using the same principles as the rebuilder and the two devices are similar in nature. The following is a breakdown of the LCD’s criteria and how it relates to coverage of the rebuilder. A and B. The LCD states that these devices are reasonable and necessary for treatment resulting from acute post-operative conditions. Coverage of these conditions is fairly straightforward as stated in section 1862 of the Social Security Act. Although the act strictly prohibits payment for services that are not considered medically necessary, elective procedures and the resulting treatment services are excluded from Medicare coverage. Any services or devices used during treatment for conditions resulting from non-covered services are also not covered. Finally, there are multiple statutory or regulatory exclusions to Medicare coverage including but not limited to services provided by immediate relatives or live-in caregivers. Evidently coverage of this act excludes treatment stemming from a wide variety of conditions. However, recent research has shown that TENS is effective at reducing post-operative pain and morphine use, indicating that it may be a better alternative to painkillers for these conditions. While at the current time there is no coverage determination specific to TENS devices aimed at post-operative pain, it is quite possible that this would be the first step in coverage of electrical stimulation devices. This could in turn lead to an expansion in coverage of devices used for treatment of other conditions mentioned in future.
2.3. Evaluation of the rebuilder against Medicare coverage criteria
The CMS has outlined the 2001 National Coverage Determination for external infusion pumps. This provides an 8-step coverage outline. These steps range from defining what is included under an external infusion pump through to special payment rules for suppliers. At present, there is no NCD for TENS devices. A TENS device is defined as a device delivering low-frequency electric current and is used for a medical purpose. TENS devices must meet the following general requirements in order to be covered by Medicare. First, they must be reasonable and necessary for the treatment of the patient’s condition. They must be safe and effective, they must not be considered experimental or investigational, and they must meet all other applicable Medicare statutory and regulatory requirements. Devices meeting step 2 of the coverage outline for an external infusion pump must meet an additional 11 specific criteria which are defined under section 60-16 A-M (12).
2.4. Potential limitations or restrictions on coverage
(b) Effective for items or services furnished on or after July 1, 1995, a transcutaneous electrical nerve stimulator (TENS) will also be covered for the treatment of chronic intractable pain. (1) TENS will be covered as an ongoing therapy if the patient experiences documented and sustained functional improvement due to the TENS therapy.
(a) Effective for items or services furnished on or after July 1, 1995, a transcutaneous electrical nerve stimulator (TENS) will be covered at the initial onset of an episode of acute post-operative pain. (1) A TENS trial period of at least 30 days must be completed to demonstrate meaningful documented improvement in functional status due to the effects of the TENS therapy. (2) At the conclusion of the 30-day trial period, if no improvement is demonstrated, further TENS treatment would not be considered reasonable and necessary. A potential new episode of acute post-operative pain would require demonstration of a new TENS trial with similar documented improvement and would only allow a total of 60 days of TENS therapy.
Conditions for coverage (42 CFR 410.71) of TENS for acute post-operative pain or chronic intractable pain are listed below and are required to be met should TENS be considered as reasonable and necessary treatment. These conditions are a reflection of the statutory requirements that TENS therapy must be considered as reasonable and necessary for coverage to be met.
According to Section 1862(a)(1) of the Social Security Act, no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury. Section 1862(a)(1) of the Act establishes that HHS will supply guidance in determining whether specific services are considered as reasonable and necessary. However, no criteria has been specifically developed to determine when TENS is considered as reasonable and necessary, yet HHS has made indications on specific conditions for coverage that support TENS therapy.
3. Alternative Coverage Options
The Medicare program was not designed to cover all medical or health care costs. Medicare is, instead, intended to act as only a partial insurance program. In addition to the gaps in the traditional Medicare program, it is also important to note that Medicare Advantage Plans (or Medicare Part C) may have different coverage rules. For those interested in varying or adding coverage, the information provided in this essay is equally applicable to persons covered by Medicare Part C. It is also important to note that persons who are eligible for Medicare but are not currently covered by Medicare (for example because they are still working) may be eligible for Medicare coverage of the procedure if it is performed while they have Medicare. The information provided in this essay might also be applicable, whether to a person with traditional Medicare, or to a person considering whether to become a Medicare beneficiary.
3.1. Exploring alternative insurance plans
There are three alternative insurance options outside Medicare coverage: private fee-for-service Medicare Advantage plans; regular private health insurance; and Medicaid. It is difficult to find a private insurance plan that is marketable because most insurance companies do not want to sell a plan that duplicates the benefits of Medicare. Hastening the Senate policy debates regarding the revision of the Medicare program, Sections 237 and 238 of the Benefits Improvement and Protection Act of 2000 allowed Medicare beneficiaries to enroll in private fee-for-service Medicare Advantage plans and receive preventive care benefits not otherwise covered by the traditional Medicare program. However, medical providers and healthcare professionals are skeptical about treating patients who have a private Medicare plan because they have heard that reimbursement rates will be even lower than the traditional Medicare program. Thus, it may be even more difficult to find a physician who will administer the therapy. High premiums and lack of or limited benefits rules out regular private health insurance as an implausible alternative for coverage of the rebuilder therapy. Thus, those elderly and disabled individuals who are determined to receive superior quality of care for their medical treatments are most likely to opt for a private Medicare plan. However, the previously mentioned doubts with regards to physician participation may be further exacerbated by the passing of the Balanced Budget Act of 1997. The BBA led to a reduction in physician fees and significant cuts in Medicare program spending. This in turn could create less incentive for medical providers to treat patients with a private Medicare plan. High-risk patients and those who have depleted their lifetime savings are very likely to be eligible for Medicaid as a supplemental insurance to their Medicare coverage. Although Medicaid coverage is a definite opportunity, restrictions on the coverage of Medicaid in certain states and dual enrollment in Medicaid managed care programs can hinder the fulfillment of their goal to receive the best quality medical treatment available. Any changes in Medicaid coverage for the duration of this study may be important to monitor, especially compared with the recent trends of healthcare eligibility for low-income or disabled individuals.
3.2. Private insurance coverage for the rebuilder
For those with a Medicare supplement (Medigap) insurance policy issued on or after January 1, 2006, the non-coverage policy of the rebuilder by Medicare creates more favorable results. With Medicare making the decision to no longer pay for any expenses incurred for DME no longer considered “reasonable and necessary,” costs for copayments, coinsurance, and deductibles are left uncovered for Medigap policyholders. The shift in responsibility for these costs of Medicare to the patient makes it more reasonable for some to consider an attempt to file a private insurance policy claim or seek an alternative therapy into treating CLBP due to the expenditure for TENS now succession.
Understandably, it can be confusing or overwhelming to learn that Medicare typically will not provide coverage for the tens unit due to it being classified as a DME that is ‘not reasonable and necessary’ for use (CPT 64550). Medicare Part B (which covers DME) will cover TENS for only the treatment of chronic low back pain (CLBP) and with stipulations making it an unlikely option for many patients due to the restrictions of it qualifying as medical necessity for treatment and the limited duration and success of TENS on CLBP. TENS treatments must be 30 mins for 6 days a week with no more than a month-long trial to prove efficacy. Physiological effects and duration of relief provided by TENS therapy are not always satisfactory, and those who wish to seek an alternative treatment for pain management such as the rebuilder could potentially find better results at a faster rate. Due to these reasons, alternatives to funding the rebuilder are recommended.
3.3. Medicaid coverage for the rebuilder
Some formularies prevent the ReBuilder from being an option for Medicaid patients, as an Advantage plan is required. Medicaid Advantage is a program within the Medicare/Medicaid system that allows patients to gain additional benefits for a potential increased monthly premium. The Advantage plan works independently of the regular Medicaid billing, and private insurance companies are approved by Medicare to offer benefit packages to patients who are dual eligible (Medicare and Medicaid beneficiaries). Patients are still responsible for the use of a primary physician who can re-evaluate prescriptions given by subpar physicians in the past. A copayment may be necessary to once again visit the physician or the hospital. If the patient does not wish to involve a formulated product, they may have the ability to buy back a traditional Medicare plan and potentially self-pay for certain physician-given treatments with the ReBuilder out of pocket. A doctor’s support will ultimately be required to identify a way to achieve coverage of the ReBuilder for a Medicaid patient.
4. Advocating for Medicare Coverage
In order to have the ReBuilder covered by Medicare, it is important to understand and utilize the appeals process that will be initiated if the initial claim for coverage is denied. This process includes four levels: Redetermination, Reconsideration, ALJ Hearing, Medicare Appeals Council Review, and Federal Court Review. Although most changes to Medicare coverage are made at the national level, there is a process available to request a local coverage determination. An LCD is a decision by a fiscal intermediary or carrier whether to cover a particular service on an intermediary-wide or carrier-wide basis in accordance with section 1869(f)(2)(B) of the Social Security Act. This process requires the gathering and submission of extensive evidence and documentation. If an LCD is favorable, the decision can be made to cover or change the coverage for a service. This process is quite involved and will likely require assistance from healthcare providers and professionals. If an initial claim for coverage is denied, the beneficiary will receive a notice of denial in which there will be details on how to request a redetermination. The request must be filed within 120 days of receiving the notice. This level of appeal is somewhat informal and it is often helpful to discuss the reasons for the denial with the Medicare contractor prior to submitting the request. An important note is that at this level and at the reconsideration level, if the decision is unfavorable, the provider or beneficiary may be responsible for repaying the denied claims to Medicare. (Brammer, 2022)(Hanel2024)(Outland et al.2022)(Noll & Revesz, 2022)
4.1. Understanding the appeals process for denied coverage
Step two of the appeals process is a reconsideration and is the first level of appeal requiring the patient to submit the request within a specific time frame. This includes equipment providers who are seeking reconsideration on behalf of a patient. The request must be submitted in writing to the QIC within 180 days of receiving the notice of redetermination. The request must outline the specific items contested and reason for disagreement with the redetermination. Step two is not concluded with the form completion. Patients or providers may participate in a phone call discussing the case with the QIC and are also encouraged to submit additional written statements and new evidence. New evidence is an item or statement, citing specific information not included in the case file at the time of the redetermination.
If a patient has been denied an item of services and the patient believes it is in his or her best interest to obtain the equipment and/or service, he or she may file a request for redetermination. Step one of the appeals process requires the patient or the provider to file the request in writing to the contractor within 60 days of receiving the notice of the denial. The specific reason or reasons for the request should be included. Step one is the only level of appeal which does not require the patient or provider to submit the request within a specific time frame. The case file and pertinent information should be kept in a safe place.
Understanding the appeals process for denied coverage. Under rare circumstances, a patient may not realize that a contractor has made a decision to deny coverage of a service until after the service has been completed. The patient, or the provider on behalf of the patient, may request an advance determination to establish whether a service is covered and what the patient would be expected to pay by providing the contractor with a decision as to whether to request the determination using the standard or expedited process. The patient will receive a notice if the request is denied.
4.2. Gathering necessary documentation and evidence
Step by step guide: Write a specific letter requesting an appeal and stating the reasons for it to Medicare including the client’s name, the identification number found on the Medicare Summary Notice, the service in question and why the service is being denied, and the signature of the client or person representing the client. Make a copy of this letter and mail the original via certified mail with a return receipt requested. Keep a record of the certified mail number. Fill out a waiver form to have the Medicare service for the rebuildre considered and keep a copy for the client’s records. This can be found on Medicare’s website under the specific service in question. Attend a Medicare hearing if this waiver is denied. This waiver should generally be accepted if the only reason for denying the waiver was that the service was not deemed medically necessary. This hearing will be confirmed with a notice of hearing letter from the office of Medicare hearings and appeals and will usually take place by telephone. Failure to request this waiver within 60 days of the denial will result in having to start the appeal process over. Make a call to Medicare to stay informed with the status of the waiver. A positive waiver will result in a pending status inquiry.
Rationale: Have the client gather any and all relevant medical documentation that could help provide evidence for the medical necessity of a the rebuildre. This includes notes from any and all healthcare professionals that may have been involved in the decision for the rebuildre up to the doctor that wrote the prescription. This also includes any letters or notes given in the explanation for denial of the rebuildre from Medicare. Have the client gather any functional or occupational assessments that have been completed that relate to the medical necessity of the rebuildre. Include any and all Medicare summaries that show whether the rebuildre was denied as well as any Medicare summaries or medical notes that may serve as evidence for the medical necessity of the rebuildre. Include any notes or letters from a healthcare professional that might suggest the medical necessity of the rebuildre.
4.3. Seeking assistance from healthcare providers and professionals
Based on your doctor’s assessment, you may be able to enlist the help of a healthcare professional when seeking Medicare coverage for your rebuilder. Healthcare professionals, including doctors, nurse practitioners, physical and occupational therapists, and other individuals who specialize in Medicare’s rules and regulations, can help you to demonstrate that your rebuilder is a necessary and reasonable medical treatment. They can also help you to keep detailed records of your rebuilder usage, including any changes in your overall health and any out-of-pocket costs incurred during rebuilder use. These records will be useful when completing future appeal or reconsideration requests. In addition, you may want to consider obtaining a signed statement from a physician or healthcare provider confirming that the use of the rebuilder effectively treats your specific medical condition and is therefore deemed medically necessary.
References:
Giest, S. & Samuels, A., 2020. ‘For good measure’: data gaps in a big data world. Policy Sciences. springer.com
Mantovani, A., Leopaldi, C., Nighswander, C.M. and Di Bidino, R., 2023. Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: current scenario and challenges. Frontiers in Medical Technology, 5, p.1101476. frontiersin.org
Burt, E., 2023. Growing Pains: A Needs-Based Assessment of Aging in Place in the Twin Cities. augsburg.edu
BAUER, M., Ac, L., & MCDONALD, J., . Acupuncture is “Reasonable and Necessary” for Peripheral Neuropathy. acunow.org. acunow.org
Schwartz, A.L., Brennan, T.A., Verbrugge, D.J. and Newhouse, J.P., 2021, May. Measuring the scope of prior authorization policies: applying private insurer rules to Medicare Part B. In JAMA Health Forum (Vol. 2, No. 5, pp. e210859-e210859). American Medical Association. jamanetwork.com
Burd, C., Gruss, S., Albright, A., Zina, A., Schumacher, P. and Alley, D., 2020. Translating knowledge into action to prevent type 2 diabetes: Medicare expansion of the National Diabetes Prevention Program lifestyle intervention. The Milbank Quarterly, 98(1), pp.172-196. nih.gov
Lees Haggerty, K., Epstein‐Lubow, G., Spragens, L.H., Stoeckle, R.J., Evertson, L.C., Jennings, L.A. and Reuben, D.B., 2020. Recommendations to improve payment policies for comprehensive dementia care. Journal of the American Geriatrics Society, 68(11), pp.2478-2485. escholarship.org
Brammer, B., 2022. Elder Law. osbar.org
Hanel, A., 2024. The Pain of Prior Authorizations: Consequences of the De-Prioritization of Human Life in Favor of Cost Containment. Houston Journal of Health Law & Policy, 23(2), pp.43-77. scholasticahq.com
Outland, B.E., Erickson, S., Doherty, R., Fox, W., Ward, L. and Medical Practice and Quality Committee of the American College of Physicians*, 2022. Reforming physician payments to achieve greater equity and value in health care: a position paper of the American College of Physicians. Annals of Internal Medicine, 175(7), pp.1019-1021. acpjournals.org
Noll, B. A. D. & Revesz, R. L., 2022. Presidential Transitions: The New Rules. Yale J. on Reg.. yalejreg.com
