1. Introduction

Most healthcare providers, including podiatrists, chiropractors, and physical therapists, often have patients ask, “Is shock wave therapy a covered benefit?” With increasing frequency, patients are interested in trying shock wave therapy and at the same time seeking assurance that it will be a covered service. Luckily, there are actually a few shock wave therapy procedures that are within the Medicare benefit schedule. Unfortunately, it is not practical to say “yes” or “no” to the overall question of coverage. Usually, patients want to know if their treatment is covered before they receive it. But again, shock wave therapy is a general term, and it is difficult for practitioners to determine precisely what type of treatment will be most appropriate for the patient. Because it is difficult to compare all forms of shock wave therapy to one model, an accurate answer to the coverage question is elusive. The present article attempts to clarify the issue by outlining the types of shock wave therapy, defining the various levels of coverage, and discussing which types of treatment are covered or likely to be covered. With a better understanding of the process, patients can make a more informed decision about treatment options. (Nägele et al.2022)

1.1 What is Shock Wave Therapy?

Shockwave therapy is suggested for sufferers with chronic shoulder pain. Shockwave therapy isn’t advised for individuals with certain health conditions. It is a non-invasive alternative to surgery. It is a non-surgical therapy that can help in reducing symptoms associated with tennis elbow. Extracorporeal shockwave therapy (ESWT) is very good at curing chronic calcific tendinitis. It can be an effective conservative treatment for painful shoulder. There are several types of shockwave therapy. It may also increase the production of various substances involved in the healing process. It has been shown to be effective 70-80% of the time for patients and is one of the most effective therapy options for chronic conditions. Low-intensity shockwave therapy is supposed to work on aging skin to increase the creation of new collagen. While many people might believe that shockwave therapy is just one form, it in fact isn’t. Radial shockwave therapy is a powerful way of giving treatment for tendon and tendon insertional pain. High-energy shockwave therapy is most suitable for patients that have a particular point of pain and would love to decrease the chance of going through surgery.

1.2 Benefits of Shock Wave Therapy

Shock wave therapy has countless benefits outside the scope of the conditions it is commonly recognized for. While the majority of literature details its effectiveness for conditions such as chronic plantar fasciitis and calcific shoulder tendonitis, the capability to improve local blood circulation and metabolism is also well documented. Improvement in circulatory status in the treatment of slow healing wounds and various soft tissue conditions is beneficial. Numerous studies have identified the potential for shockwave to improve blood perfusion and carry more oxygen to the affected tissues. This has positive implications for the management of various soft tissue conditions for many patients. From a functional perspective, patients’ rehabilitation times and successful outcomes are always a key focus for a busy musculoskeletal practice. Recent studies have shown positive effects with shock wave treatment for quicker return of function after injury. High energy extracorporeal shockwave therapy significantly accelerated recovery of hip abductor tendonitis and allowed for a quicker return to activity. This effect is advantageous not only for athletes but also for any patients with pain or dysfunction due to tendonitis. The ability for shock wave to improve tendon regenerative potential might also suggest a beneficial effect in reducing the likelihood of recurrence for certain tendon conditions. (Al-Abbad et al.2020)(Simplicio et al.2020)

1.3 Importance of Medicare Coverage

In 2009, after being bombarded with countless questions about ESWT, The Centers for Medicare & Medicaid Services (CMS) finally issued a local coverage determination (LCD) concerning ESWT’s medical treatment of plantar fasciitis. Though some ESWT advocates believed this was a good step forward for Medicare coverage of ESWT, the ruling has had little to no effect on convincing private insurance companies to cover ESWT for this condition. Due to a lack of private insurance coverage and patients’ inability to afford the high cost of ESWT, many patients undergoing ESWT will choose to pay for the treatment out-of-pocket. In many cases, patients cannot afford the complete treatment regimen and are forced to stop after only a few sessions. This greatly reduces the likelihood of a successful outcome. ESWT is also being used to treat various soft tissue conditions at a higher frequency than in the past but the current support for insurance coverage is weak.

Medicare is a federally managed insurance program that primarily covers individuals aged 65 and over, and promotionally some who are entitled to social security disability benefits. Medicare provides many different types of coverage and has a large number of rules and regulations concerning those who are eligible and the types of services that are covered. When it comes to the medical treatment of conditions, many elderly individuals find that it can be difficult to determine if a particular treatment will be covered and many times the individual is unsure if they can afford the cost of the treatment through Medicare. If the individual is forced to pay for the treatment out-of-pocket and it’s not cheap, the treatment can make it difficult to maintain a decent standard of living and this can lead to alternative health complications.

2. Medicare Coverage for Shock Wave Therapy

Medicare Part B (Medical Insurance) covers a procedure called shock wave therapy for the treatment of plantar fasciitis. Shock wave therapy is a non-invasive surgical procedure performed in a healthcare provider’s office. The Extracorporeal Shock Wave Treatment (ESWT) Program LCD (L8699) implemented on April 1, 2003 also removed the non-coverage policy for shock wave therapy in the treatment of chronic proximal plantar fasciitis. Consequently, when provided in conjunction with a physician service for the treatment of chronic proximal plantar fasciitis, Medicare will now cover the technical costs associated with ESWT and the physician performing the procedure will bill and be reimbursed for providing the service provided it meets the criteria as indicated in the LCD. This decision memorandum states that “Medicare contractors shall make payment for this item for the services that are provided under the conditions that have been established as being safe and effective and use of this item for conditions other than those described will not be considered reasonable and necessary” (42 CFR 405.204b, social security act 1862(a)(1) and title XVIII, section 1862(a)(15)(2)(A)). (Chen et al.2023)

2.1 Medicare Part B Coverage

The Medicare program is divided into several parts, each covering different aspects of the medical services. Medicare Part B specifically provides coverage for medical services and supplies that are necessary to treat or diagnose a medical condition. Part B coverage will provide a reimbursement for the use of shock wave therapy to treat a condition but only if specific conditions are met. The first condition to satisfy is the most basic one: the provider of the shock wave therapy must be enrolled in the Medicare program and must also have the facility at which the therapy takes place enrolled in Medicare as well. If this condition is not met, Medicare will not provide reimbursement for the therapy regardless of the status of the patient receiving the therapy. Assuming this condition is satisfied, the provider’s next step is to diagnose the patient with a condition that shock wave therapy has been scientifically or clinically proven to effectively treat. In the absence of such evidence, Medicare will not consider the therapy to be a necessary medical service for treatment of the condition and thus will not provide coverage for the therapy. Suppose the condition has been diagnosed and the decision has been made to move forward with shock wave therapy. The next condition is that the cost of the therapy must not, in aggregate, exceed the cost of alternative treatments that provide comparable results for the same condition. This is dependent on the specific case that the patient’s condition is in. If this condition is met, the therapy is then subject to utilization management. (Brimley et al.2021)

2.2 Conditions for Coverage

At the time of the 2004 coverage decision, it was mused that if there was a change in the category of ESWT for chronic heel pain, based on available knowledge and technology, further studies would potentially demonstrate instead of divergent results, substantial improvement by patients with proper administration of the treatment to correct said compelling and safe technology.

In the first section, there was discussion if Medicare should cover Extracorporeal Shock Wave Therapy (ESWT) for the treatment of chronic plantar heel pain. This derived from a National Coverage Decision in 2004, which placed ESWT for this indication in a category of “not reasonable and necessary”. The National Coverage Decision followed a presentation in the same year that evaluated a request to change the category status from “not reasonable and necessary” back to a coverage decision.

Discussion regarding shock wave therapy continued with a report from the Coverage and Analysis Group. The report was divided into two major sections: Questions Pertaining to Effectiveness, and Questions of How to Treat?

Ada CDT2011 lists the following conclusion: Extracorporeal shock wave therapy is a covered service according to the previous MEDCAC meetings. There is adequate evidence that demonstrates positive results with patients who suffer from plantar fasciitis; however, the evidence is not substantial enough to change the category status back to one of medical necessity.

2.3 Limitations and Restrictions

So from that limitation and restrictions, we can conclude that there are few indications that are excluded from the coverage of ESWT therapy which is already covered by Medicare if it is a reasonable and necessary indication.

But Medicare only issued a limitation and restriction for ESWT therapy either in Global period for a surgical service or in to treat a condition that is no longer immediate; known as LCD for ESWT for Any Indications in a Musculoskeletal Category Number CAG-00048R3, CMS stated that coverage of ESWT in both conditions is non-covered.

Limitations and restrictions are also issued by Medicare in NCD for Standard Coverage and Local Coverage Determination. In any type of musculoskeletal indication, it may be covered, but this therapy is non-covered for plantar fasciitis, any type of epicondylitis, or rotator cuff tendonosis or calcific tendonitis. For the other indications of musculoskeletal, the determination for ESWT still depends on the coverage issued in LCD, so the therapy still may be covered for those indications.

This coverage applies only to ESWT, and only for musculoskeletal indications, the limitation only applied from the effective date. It means the ESWT will not be covered by Medicare anymore even though it is used for a reasonable and necessary indication from that date. The coverage for the indication of wounds that are no longer treated by ESWT for musculoskeletal indications also lasts until the effective date.

I already mentioned that shock wave therapy is a procedure of radiating the wound which is covered by Medicare if it is reasonable and necessary for the indication. But in the National Coverage Determination and the Local Coverage Determination issued by CMS, some limitations and restrictions of the shock wave therapy are published. According to LCD for Extracorporeal Shock Wave for Musculoskeletal Indications; Number CAG-00094R2, CMS stated that “ESWT to treat musculoskeletal indications in any anatomic region is not reasonable and necessary per s.1862(a)(1)(A)” and “For services performed on or after 01/05/2006, ESWT to treat all musculoskeletal indications, in any anatomic region, is non-covered”.

3. Alternatives to Medicare Coverage

While Medicare Part B does not cover ESWT, seeking additional insurance is one way to get treatment paid for. Although this is often costly and not available to all patients, private insurance is becoming more progressive in covering treatments that are both clinically effective and cost-effective. This was the case in a recent policy supported by the American Urological Association that recommended extracorporeal shockwave lithotripsy (ESWL) as the treatment of choice for kidney stones over more invasive surgical procedures. This resulted in increased coverage of ESWL by many private insurers. Step one is to contact your provider and find out what treatments are covered in your particular plan. Unfortunately, many insurers may consider ESWT an investigational treatment and will not cover it, while others have stipulations that it must be done in combination with other treatments which may or may not be beneficial to the patient. Private insurance may be the most efficient route of coverage for treatment, but only by contacting your provider can you find the best information for your specific case.

3.1 Private Insurance Options

4.1.3 Medicare Advantage Plans People with Medicare can choose to join a Medicare Advantage Plan. These plans are private health plan options, such as an HMO or PPO, approved by Medicare. If you join a Medicare Advantage Plan, you’ll still have Medicare but you’ll get most of your Medicare Part A (Hospital Insurance) and Medicare Part B (Medical Insurance) coverage from the Medicare Advantage Plan and not Original Medicare. Many Medicare Advantage Plans include prescription drug coverage. These plans have a limit on out-of-pocket costs for services covered by Part A and B and also provide coverage for services that Original Medicare does not cover. Members of Medicare Advantage Plans could also have lower out-of-pocket costs for ESWL treatment. This coverage may be helpful for some people, but this option may also have hidden costs and limit the flexibility of choosing your healthcare providers.

4.1.2 Private Medigap Alternatives Some Medicare recipients who are under 65 and receiving Social Security disability benefits have been able to purchase private Medigap insurance at a lower cost than the currently available Medigap policies to those under age 65. However, this is not a possibility for everyone and is only available in some states.

4.1.1 Medigap Insurance Medigap policies will pay partially for your health care costs. The amount of coverage Medigap offers will depend on which plan you have. At this time, Medigap insurance companies are only required to offer Medigap Plans A, C, D, and F to people under 65. However, these designations will change June 1, 2010. Medigap Plan F offers the most coverage for the price. With any other plan other than Plan A, insurance companies are not required to offer the same premium to everyone in your age group, meaning when you get older your premium will increase. It should be noted that after 2014, Medigap Plans C and F will no longer be available to newly eligible Medicare recipients.

3.2 Out-of-Pocket Expenses

Out-of-pocket expenses (what you pay) There is a gap between what your provider charges (the Medicare rebate) and the amount covered by either private insurance or financial assistance program, commonly known as “the out-of-pocket” expense. This is often substantial in ‘gap’ providing an impediment to treatment. There is a significant variation in out-of-pocket expenses dependent upon the practitioner and type of EPAT®/ESWT® treatment. Some users have reported being charged more than $100 per session, with a course of treatment ranging from $600-$2500. This is much higher than the recommended fees and treatment courses proposed by key medical associations and clinical guidelines such as The Royal Australian College of General Practitioners. NHI is currently conducting a study into the costs associated with ESWT® treatments and the level of user charges.

3.3 Other Financial Assistance Programs

There are many regional and national financial assistance programs for health care, medications and medical supplies. Some examples offer a set series of treatments for a certain ailment while others offer a variety of services and medications to low-income households. Qualifications vary greatly between programs based on your location, income and the treatment needed. Many assistance programs are localized and small in size and may not be well publicized. The social worker at your urologist’s office, possibly even at this program, may very well not know about ESWL coverage by their program. He or she should make some inquiries especially if this treatment is of little cost to you out-of-pocket. To facilitate the process between health care provider and social worker, be sure to obtain the procedure and diagnosis codes from the provider for use in identification and qualification of coverage. Due to the variability between programs, it is worthwhile to search even if you are not in immediate need. What may not be obtainable today may very well be available in the near future.

4. Conclusion

In contrast, in a 2008 study also in the AJPMR titled “Cost-Effectiveness of Custom Orthotics for Plantar Fasciitis,” authors T. C. Royer et al conclude that cost of orthoses is comparable to that for other forms of medical treatment or therapy, which suggests that it might be possible to justify insurance coverage for ESWT if use of custom orthoses (which is covered by some insurance providers) is an unsuccessful treatment for the condition. This study provides ESWT as a possible topic for future research on orthotic-refractory cases of plantar fasciitis, but despite its high quality, it still lacks a prevalent amount of evidence, giving a very general view on the topic.

For example, in a 2005 study in the American Journal of Physical Medicine and Rehabilitation titled “Extracorporeal shock wave therapy for plantar fasciitis: randomised controlled multicentre trial,” G. D. Rompe notes that despite the positive results of the study, Medicare and other insurance companies still do not cover the treatment. However, no insurance providers are specified, and the only mention of Medicare gives a statement by Dr. Lowell Weil Jr., the editor of the journal “utilization of shock wave therapy would be more easily justified if it were FDA approved and covered by insurance.” No explanation or evidence is given to support Weil Jr.’s claim, leaving the passage to be ambiguous and uninformative.

After reviewing the information obtained from the sources detailed in this paper, the importance of properly researching the topic of shock wave therapy and its coverage by Medicare becomes very clear. The researchers who wrote articles and studies on the issue were very split on their opinions, and most did not provide enough information to back up their claims.

4.1 Importance of Research and Consultation

Many patients may be disappointed by the finding that electrotherapy is not currently covered by Medicare. However, this does not mean that those without supplementary health insurance cannot afford the treatment. It is feasible that changes to insurance coverage may be made in the future. But whether or not this will occur largely depends on the results of research on the effectiveness of ESWT for various conditions, and cost-benefit analyses that compare ESWT to other treatments for the same conditions. As with clinical trials that test the efficacy of certain treatments, it is ultimately patient participation that will lead to the development of better therapy coverage. If patients consult their doctors, write to Medicare, or to their local political representative about access to electrotherapy, it is more likely that research on the treatment and insurance coverage will receive the attention it requires. Patient action has been shown to be quite effective in the past. For example, at the time of the insurance coverage review, the American Academy of Orthopaedic Surgeons sent a letter to Health and Human Services Secretary Tommy Thompson, stating that there are few treatments that are as successful as ESWT, and requesting that Medicare delay its decision on discontinuing coverage and conduct a comprehensive review of the treatment. Patients who ultimately wish to gain access to effective treatment for their condition should try to positively influence changes to ESWT insurance coverage in a fashion similar.

4.2 Making an Informed Decision

You should also ask your doctors if they have experience with shockwave therapy and what kind of success rate they have had treating patients similar to yourself. This will assist you in deciding if this is possibly the best doctor and/or form of treatment for your condition.

1. What benefits can I expect from this procedure? 2. What is the success rate of this procedure for my type of condition? 3. How many treatments will I need? 4. What are the potential side-effects or complications and how common are they? 5. What if the treatment doesn’t work? 6. How will I know if the treatment is working? 7. Is it safe to have this treatment if I am pregnant? 8. Does this treatment have FDA clearance for my condition? 9. How does this compare to other similar treatments and is it a better option for me?

The type of questions you should be ready to ask the shockwave therapist and your doctor range from general treatment questions to specific questions about the type of shockwave therapy being recommended. Here are some questions that AROC suggests you may use:

References:

Nägele, F., Pölzl, L., Graber, M., Hirsch, J., Mayr, A., Pamminger, M., Troger, F., Theurl, M., Schreinlechner, M., Sappler, N. and Dorfmüller, C., 2022. Safety and efficacy of direct cardiac shockwave therapy in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial): study protocol for a randomized controlled trial—an update. Trials, 23(1), p.988. springer.com

Al-Abbad, H., Allen, S., Morris, S., Reznik, J., Biros, E., Paulik, B. and Wright, A., 2020. The effects of shockwave therapy on musculoskeletal conditions based on changes in imaging: a systematic review and meta-analysis with meta-regression. BMC Musculoskeletal Disorders, 21, pp.1-26. springer.com

Simplicio, C.L., Purita, J., Murrell, W., Santos, G.S., Dos Santos, R.G. and Lana, J.F.S.D., 2020. Extracorporeal shock wave therapy mechanisms in musculoskeletal regenerative medicine. Journal of Clinical Orthopaedics and Trauma, 11, pp.S309-S318. journal-cot.com

Chen, R.F., Lin, Y.N., Liu, K.F., Lee, C.C., Hu, C.J., Wang, C.T., Wang, C.J. and Kuo, Y.R., 2023. Compare the effectiveness of extracorporeal shockwave and hyperbaric oxygen therapy on enhancing wound healing in a streptozotocin‐induced diabetic rodent model. The Kaohsiung Journal of Medical Sciences, 39(11), pp.1135-1144. wiley.com

Brimley, S., Natale, C., Dick, B., Pastuszak, A., Khera, M., Baum, N. and Raheem, O.A., 2021. The emerging critical role of telemedicine in the urology clinic: a practical guide. Sexual Medicine Reviews, 9(2), pp.289-295. nih.gov