The Lymphedema Treatment Act: A Huge Win for Patients

But What Is the Future of CLTs in Outpatient Lymphedema Clinics?

 

We would like to thank Heather Ferguson and all those involved for the hard work over the years in successfully getting the Lymphedema Treatment Act to become federal law, taking effect on Jan. 1, 2024. This is monumental legislation and will change the lives of many people suffering from this progressive disease that has no cure.

The human body consists of multiple systems working together for the common good as they provide us with the ability to function effectively. The lymphatic system is one system that has been underrecognized and misunderstood over time.

The lymphatic system is responsible for transporting lymph and waste products from the tissues back into the blood as the lymphatic system maintains fluid homeostasis and has an immunological role. This system is vital and without it we could not live. If fluid is not removed adequately due to a lymphatic dysfunction and/or damage, then patients are prone to recurrent infections, progressive accumulation of fluid, skin changes, ulcers, and progressive swelling. 

Lymphatic dysfunction means the lymphatic system is working poorly or is sluggish, thus leading to fluid collecting in the tissues. If this dysfunction is not addressed in a timely manner, it can lead to accumulation of protein-rich fluid in the tissue, known as lymphedema. Lymphedema is a progressive disease with no cure, but it is manageable. Lymphedema can have multiple etiologies and is categorized as either primary or secondary. Primary lymphedema is a congenital condition that may show up at birth or later as an adult. This type of lymphedema may indicate that the patient has abnormal or absent structures from the lymphatic system. 

Secondary lymphedema occurs because of damage to the lymphatic system such as trauma, infections, chronic venous insufficiency (CVI), cancer, surgery, radiation, and trauma to name a few. It may affect the arms, trunk, genitalia, legs, head and/or neck.

The diagnosis is not based on the size of the extremity but rather by a good history and physical examination and ruling out of medical issues. There are invasive tests such as lymphoscintigraphy, magnetic resonance imaging (MRI), and computed tomography (CT) scans that the provider may choose to determine if the lymphatic system is involved. The standard of care for treatment does not change based on whether the patient has a diagnosis of primary or secondary lymphedema.

The Problem With Lymphedema and Its Economic Impact

The economic impact for taking care of patients with lymphedema continues to increase when looking at direct and indirect costs. There are potential cost savings if preventative strategies are utilized, and comprehensive treatment is initiated at early onset.

According to the Lymphedema Education & Research Network, up to 10 million Americans, and hundreds of millions of people worldwide, suffer from lymphedema and lymphatic diseases. In the US, 1 in 100,000 people may be diagnosed with primary lymphedema while 1 in 1000 may be diagnosed with secondary lymphedema. These numbers continue to increase not only for patients diagnosed with cancer and its related treatment but also as studies indicate a higher number of lymphedema due to CVI and obesity.¹ The American Lymphedema Framework Project (ALFP) recognized that the magnitude of this condition is unknown as prevalence studies are lacking.² Inaccurate ICD-10 coding of lymphedema also can misleadingly indicate a lower incidence of lymphedema than what is actually seen by practitioners. 

Dean and colleagues published an article discussing the long-term economic burden of breast cancer and lymphedema by looking at out-of-pocket expenses over a 12-month period.³ Their conclusion was that long-term cancer survivors with lymphedema may face up to 112% higher out-of-pocket costs than those without lymphedema, which influences lymphedema management. 

Sawers and Stillwaggon reported a 52% cost reduction where community-based limb care programs in Indian endemic areas existed.⁴ Gutknecht and colleagues in 2017 concluded that there is a high need for structured disease management programs in order to diagnose and treat lymphedema early and to avoid complications, thus limiting socio-economic burden.⁵

Cost savings with lymphedema-related complications such as cellulitis infections with associated hospitalizations were decreased with appropriate management based on a case study by Linnitt and colleagues in 2005.⁶ Stout and colleagues demonstrated that if this condition is treated early, there was a significant health care dollar cost savings versus treating patients in an advanced stage (cost of $693 vs. $3,212 per patient).⁷

Patients not treated with complete decongestive therapy (CDT) demonstrated a hospitalization rate on the average of 8.5 hospitalizations per year for lymphedema related cellulitis compared to an average 0.63 per year for those treated with CDT.⁸

Important Recent Findings on Lymphedema

The Starling Principle used to state that 80–90% of the fluid was removed by the venous system while the lymphatic system removed the remaining 10–20% of fluid. The recently modified Starling Principle demonstrates that the lymphatic system plays a much bigger role than initially expected. It postulated that the majority of capillary ultrafiltrate was reabsorbed on the venous side but in fact, nearly all of it is reabsorbed by the lymphatic system. Hettrick and Aviles define this in an article titled “All Edema is Lymphedema.”⁹ The message becomes that if edema is not treated properly then lymphatic dysfunction will occur and it may eventually lead to system failure or lymphedema.
 
As previously mentioned, Dean’s 2020 study demonstrated that a leading cause of secondary lymphedema lists patients with CVI.¹ This is worth mentioning because the numbers of patients with CVI will continue to rise in the US in the CVI population if the standard of care of compression is not utilized appropriately. CVI is a dynamic insufficiency that can be treated with adequate compression. If not addressed, then CVI will progress to a mechanical insufficiency, impacting the lymphatic system. The combination of CVI and lymphedema is termed phlebolymphedema. If a patient has phlebolymphedema, and it goes unrecognized, compression alone will not be successful thus increasing healthcare dollars. The skills of a certified lymphedema therapist with these populations will achieve better outcomes, decrease hospitalizations, and save health care dollars.

Who Provides Lymphedema Treatment?

While most clinicians from various disciplines claim to treat lymphedema with various treatment regimens, surgical approaches, and ideologies, the gold standard intervention to treat lymphedema remains complete decongestive therapy. The skilled interventions included in CDT are skin care, manual lymphatic drainage, multilayer short stretch bandaging, exercise, fitting of compression garments for long term management, and education.

Surgical approaches continue to advance in the US with CDT being a crucial part of the postsurgical rehabilitation program (refer to individual surgeon’s protocol). Many insurance companies (private and public) have significant restrictions for payment of these surgical techniques.   

Lymphedema clinics typically employ physical therapists, occupational therapists, physical therapy assistants, and certified occupational therapy assistants to provide CDT treatments for patients with public and private insurance policies. Therapists treating lymphedema pursue specialty certifications, which is an additional expense averaging $3,000 to $3,500 for the training course, but not including time off work or costs associated with travel. 

In outpatient clinics, therapists face multiple challenges with treating patients with public and private insurance as well as those who are uninsured. As stated earlier, the Lymphedema Treatment Act is a step forward in the right direction as it has great potential to help many patients afford the various garments needed for the rest of their lives.

How Lymphedema Clinics May Suffer

In our opinion, the reality is that outpatient lymphedema clinics may dwindle if reimbursement and payment reform does not occur. Lymphedema therapists provide one-on-one care of patients with treatment times ranging from 45 minutes to 2 hours based on the severity of the condition, thus limiting the numbers of patients that therapists can see in a day. A further limitation is the significant overhead costs involved with an outpatient therapy clinic and very limited availability of CLTs to provide the treatments. Lymphedema therapists are entrusted to treat patients with multiple comorbidities with or without wounds at an advanced stage, with no coverage for supplies (short stretch bandages in the first treatment phase, alternative bandages, garments in the second treatment phase, and difficulty with being able to afford a multiple array of wound dressings) with overall poor reimbursement for the level of service provided. These multiple issues overall affect the ability for a program to survive or even come to fruition. 

From our perspective, patients who suffer from lymphatic dysfunction and/or lymphedema have been indirectly neglected for years. The inability to properly diagnose patients with this progressive disease, the lack of coverage for needed supplies, the limited number of qualified health care providers who can treat this population, and the limited payment for those of us treating this population all cause a hardship for each patient with this disease.

The therapists who want to go through the rigorous and costly training to become a CLT, and the current CLTs in practice in the US continue to diminish due to limited reimbursement from CMS and private payors. With no specific CPT codes to properly reimburse for the skill sets of a certified lymphedema therapist, we will not see growth in the lymphedema therapy community. Our CLT colleagues continue to find employment in other settings across the continuum or begin working for industry for this same exact reason—limited payment/reimbursement.

From personal experience, most organizations and companies love the idea of starting lymphedema clinics as there’s a market to help this population. However, the plans run out of steam when reimbursement/payment and coding data is gathered and is found to be substandard for this labor-intensive skilled treatment. In rural areas in which we practice, the Medicare wage index is lower compared to our urban counterparts, thus lowering the reimbursement even further. Finding a CLT in rural America is often compared to finding a needle in a haystack. And as I travel across the country, I find patients will have an average waiting list of 4–6 weeks or longer to be treated by a CLT.

The Process of Becoming a CLT

The Lymphology Association of North America (LANA) is a national non-profit organization that certifies health care professionals who diagnose/treat lymphedema and related disorders. It was designated to create certification guidelines for various health care providers. Before sitting for this national examination, one must meet the criteria, which include having a minimum of 135 foundational course credit hours from didactic and lab work. 

Once you complete 135 hours in CDT from an approved training program, you are designated as a CLT and then you can sit in for the LANA national certification examination. Successful completion will allow the designation of CLT-LANA.

Currently there are no federal or state specific rules or laws that regulate the treatment of lymphedema patients. A therapist does not have to be lymphedema certified to bill the limited codes that are used when treating lymphedema, thus leading to substandard care for many patients that is ineffective and costly for private and public insurance companies. We feel that all clinics/programs must have at minimum one LANA approved training program CLT therapist per three practicing therapists. Lymphedema patients are very complex with multiple comorbidities and without the proper high level training a CLT obtains the treatment will not meet the needs of these patients.

Advanced Lymphedema Leads May Experience Hard to Heal Wounds

Patients not only encounter difficulty in finding a lymphedema therapist to treat their condition appropriately, but they also run into challenges with getting needed supplies. In advanced stages of lymphedema, a patient may often have wounds that can be life-altering. Lymphedema may become chronic, nonhealing, with copious amounts of drainage that likely will have an odor. These chronic lymphedema-related wounds significantly impair a patient’s daily and social functioning. We find patients become more reclusive and inactive as the lymphedema and wounds progressively get worse. A study found that patients with lymphedema have a higher rate of unemployment as well.¹⁰

Since 2016, we have noticed a disconnect between wound care centers and lymphedema clinics as if we all were working in silos. At first our efforts were directed at training wound care clinicians regarding lymphedema and vice versa. The idea was that each camp didn’t understand the other so education became our priority.

Now we realize there’s more to education for this population. If these patients are treated in outpatient lymphedema clinics, the already limited payment along with the cost of dressings will exceed the ability to cover expenses/overhead in providing standard of care.

The Lymphedema Treatment Act: What It Means and How It Can Help

The following is the authors' understanding and we must point out that the following sections do not apply to outpatient hospital based wound care centers. Hospital based centers are not eligible to have therapist treat and bill under current regulations.

The Lymphedema Treatment Act was created to advocate for payment of compression supplies for patients diagnosed with lymphedema. The LTA was initially introduced to Congress in 2010 by Rep. Larry Kissell. Many years of increasing congressional support have succeeded in the passing of the LTA on Dec. 23, 2022. The Omnibus Bill H.R 2617 includes the LTA in section 4133. The bill states:

• Standard and custom compression garments shall be furnished on or after January 1, 2024, to an individual with a diagnosis of lymphedema for the treatment of such condition. 
• These garments will primarily and customarily be used to serve a medical purpose and for the treatment of lymphedema. These garments must be prescribed by a physician (or a physician assistant, nurse practitioner, or a clinical nurse specialist). 
• The amount paid for these garments shall be equal to 80 percent of the lesser of the actual charge or the amount determined under the payment basis determined under section 1834(z), which states that garment rates will be based from state plans (or waivers of such plans) under title XIX, the Veterans Health Administration, group health plans and health insurance coverage, or other information as the Secretary determines appropriate. 
• No payment may be made under this part for lymphedema compression treatment items furnished other than at such frequency as the Secretary may establish.
• The payment basis under this sub section for such items furnished shall be the payment basis determined under a competitive acquisition program. 

The current legislation has good building blocks for constructing a plan for payment of compression garments. We acknowledge that standard and custom garments will be covered and the cost will be at 80% of the allowable for patients with a diagnosis of lymphedema. The garments will be furnished at an undetermined frequency and payments will be set under a competitive acquisition program. 
 
What we would like CMS to be aware of the following during their planning period if we were both their consultants and advocating for lymphedema patients:

The Lymphedema Treatment Act The (LTA) legislation set no specific listing of types of compression. We would like this list to include: 

• multilayer bandaging supplies (at minimum 2 sets per treatment regime, per body part);
• custom and/or off the shelf compression garments based on the patient’s needs (at minimum 1 to wear and 1 to wash every 6 months per body part); and
• nighttime garments (at minimum 1 per year per body part). 
• Consider lymphedema bandaging, when applied by a CLT, as a skilled procedure.
• Do not reduce reimbursement when a lymphedema is treated by a CLT that is a PTA/COTA.
• Provide reimbursement for preventative measures. Lymphedema disease is a progressive problem and addressed early will prevent complications found at an advanced stage.
• Lymphedema at an advanced stage may have wounds. Provide coverage for dressings to help these patients.

 
The legislation did not specify HCPCS codes for reimbursement and set no monetary reimbursement rates for any of these supplies and garments. Currently there are very limited HCPCS coding for compression bandaging supplies and custom compression garments; therefore, CMS is unable to set price limits based upon HCPCS codes. Creation of HCPCS codes for bandaging supplies and custom compression garments (including all styles, grades, and textiles) is crucial.
   
The legislation states patients with lymphedema will qualify for compression garments; however, it does not specify the ICD-10 codes for lymphedema. We would like to see the diagnosis codes specific to lymphedema include: I89.0 Other lymphedema acquired, Q82.0 Hereditary lymphedema, and I 97.2 Post-mastectomy lymphedema. These codes will need to be required for reimbursement of all compression bandages and garments. 
 
In addition, when considering national health policies, develop reimbursement and payment strategies for preventative programs while reassessing current payment structure.
 
Provide conditions such as phelbolymphedema and lipolymphedema with ICD-10 codes to be able to track these diagnoses and for appropriate payment.
 
What considerations we would like CMS to be aware of during their planning period for certified therapists and programs: 

CLTs in all settings currently utilize CPT-4 coding that is not specific to lymphedema. The primary code utilized by therapists for lymphedema treatment is 97140 (manual therapy) that encompasses only the manual lymphatic drainage component of CDT. There are no specific CPT-4 codes for lymphedema bandaging, skin care, lymphedema patient education, and measuring and fitting for compression garments. Therapists over time have utilized alternate CPT codes for the other components of CDT. However, such codes are not lymphedema specific, thus therapists frequently get denied and have to fight constantly for reimbursement.   

Lymphedema evaluations and treatments require treatment by a certified lymphedema therapist and are done as one on one sessions that average in length from 1 to 2 hours. The treatments are physically demanding and require frequent revisions of the treatment plan due to the complexity of this diagnosis. Lymphedema therapists’ current reimbursement is poor and limits the growth of programs and creation of new programs and clinics. We request that new CPT-4 coding be created specific to the treatment of lymphedema with reimbursement that will sustain and grow the lymphedema treatment community.

In Conclusion

The Lymphedema Treatment Act was a huge win for patients suffering from lymphedema. As we continue advocating education and treatment for this underrepresented population, we would like for policymakers to consider some of the barriers we face in the outpatient lymphedema clinics. If we work together, then this population will be taken care of and ultimately save healthcare dollars.

Frank Aviles Jr. is Wound Care Coordinator for Natchitoches (LA) Regional Medical Center and PT/wound care/lymphedema consultant at Cane River Therapy Services LLC, Natchitoches.
 
Brandy McKeown is the CEO of International Lymphedema and Wound Training Institute (ILWTI). She is director and treating therapist at RST Lymphedema Center in Tifton, Ga and Rehabilitation Services of Coffee in Douglas, GA.

References
1. Dean S. The clinical characteristics of lower extremity lymphedema in 440 patients. J Vasc Venous Lymphat Disord. 2020; 8(5):851–59.
2. Stout N, Weiss R, Feldman J, et al. A systematic review of care delivery models and economic analyses in lymphedema: health policy impact (2004-2011). Lymphology. 2013; 46(1):27-41.
3. Dean LT, Moss SL, Ransome Y, et al. "It still affects our economic situation": long-term economic burden of breast cancer and lymphedema. Support Care Cancer. 2019;27(5):1697-1708. doi:10.1007/s00520-018-4418-4
4. Sawers L, Stillwaggon E. Economic costs and benefits of community-based lymphedema-management programs for lymphatic filariasis in India. Am J Trop Med Hyg. 2020 Jul;103(1):295-302. doi: 10.4269/ajtmh.19-0898. PMID: 32653050; PMCID: PMC7356420.
5. Gutknecht M, Herberger K, Klose K, et al. Cost-of-illness of patients with lymphoedema. J Eur Acad Dermatol Venereol. 2017;31(11):1930-1935. doi:10.1111/jdv.14442
6. Linnitt N. Case study detailing treatment of bilateral lower limb lymphoedema. Br J Community Nurs. 2005; Suppl:S28-31.
7. Stout, NL, LA Pfalzer, B Springer, et al. Breast cancer-related lymphedema: Comparing direct costs of a prospective surveillance model and a traditional model of care. Phys Ther. 2012; 92(1):152-163.
8. Arsenault K, Rielly L, Wise H. Effects of complete decongestive therapy on the incidence rate of hospitalization for the management of recurrent cellulitis in adults with lymphedema. Rehab Onc. 2011; 29(3):14–20.
9. Hettrick H, Aviles F. All edema is lymphedema: progressing lymphedema and wound management to an integrated model of care. Wound Manag Prev. 2022; 68(1):8–15.
10.  Eneanya O, Garske T, Donnelly C. The social, physical and economic impact of lymphedema and hydrocele: a matched cross-sectional study in rural Nigeria. BMC Infectious Diseases. 2019;19(1):332.