Lymphedema Therapy Source

  

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Can You Cheat in Lymphedema? (part 2)

We’re continuing a patient story from last month. (Click here for part 1)

The patient we’ve been following received a daytime CCL 2 sleeve & glove (she also wanted to try a gauntlet). She also received her CCL 1 sleeve & glove which she wanted to try for night use (instead of the recommended protocol of bandaging or a foam sleeve).

What Happened?

Five weeks after getting her daytime sleeve/glove, she had issues with finger swelling & arm refilling. She wasn’t resting well at night either. She stopped using the CCL 1 garment & used the same CCL 2 sleeve at night. When she returned to see me, she seemed angry (with me) for her outcome. When there’s a deviation from the protocol, the outcome will be affected.

I noted the likelihood of using a CCL 2 daytime sleeve/glove at night, especially when sleeping with elbow bent, as contributing to her forearm swelling & worsening fibrosis. While resuming bandaging was the best idea, she was adamant she wasn’t going to do that again. I said the next best option would be to get a nighttime foam sleeve. It should help reduce the forearm fibrosis which would help reduce the swelling. She agreed.

(collaboration with a local garment rep on best night garment in this case)

Intervention

This patient chose to continue wearing her daytime CCL 2 sleeve/glove (23-32 mmHg) before being fit for the night garment. (She hadn’t been re-reduced with bandaging.) That meant, the nighttime garment would likely be bigger than it should be. The fitter tried to compensate for this by decreasing the circumferences. (I had the manufacturer’s local rep do the fitting.)

Outcome

It took several weeks for the nighttime garment to arrive. The patient continued wearing the CCL 2 sleeve & glove during this time. (She did come in for bandaging one session prior to the arrival of the night garment.) The night garment was a little short & a little big, but the patient agreed to try it at night. After a few nights, she felt she was doing well & seeing progress.

(photo sent by pt after removing the night garment in the morning; she had worn it several nights)

When she returned to see me, she was happy with her status. Because the night sleeve wasn’t quite as long as it could have been (or the patient hadn’t been able to keep it up near the shoulder because it was a too large around the upper arm), there was some refilling around the shoulder. But her other numbers were improved as her fibrosis softened with the chipped foam sleeve.

(final visit after wearing night foam sleeve: volume 26.3 cm)

Can You Cheat the System?

Short answer: No. The protocol for lymphedema treatment exists to maximize the best outcome by softening fibrosis & decongesting tissue. Once this process is complete, a patient is ready for their maintenance day & night garment fitting. They should remain bandaged until both garments are in place.

This patient’s course was prolonged & a bumpy ride to get to her conclusion. But in the end, she was happy with her status. That’s what matters most. Sometimes a patient’s goals aren’t solely to maximize reduction. Convenience or interference with daily routines may trump the “ideal outcome.” It’s important to ask a patient what their goal is & to monitor this goal during the course of therapy as it may change.

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Can You Cheat in Lymphedema? (part 1)

Many people are tempted to shortcut the therapy process in lymphedema. Instead of bandaging, they only want manual lymph drainage (MLD). Or instead of MLD, they only want to bandage. Or they may stop treatment early (or skip therapy & go right to a compression garment). Is it possible to “cheat” in therapy? Yes, it is. But just like shortcutting or changing a recipe, the outcome will be affected.

Protocol

The recommended protocol for lymphedema treatment (according to Foldi) is to bandage daily during the decongestion phase.1 Once volume plateaus & a patient is not expected to make further progress, they are fit with a custom, flat-knit, daytime sleeve/glove & they are to bandage at night for the maintenance phase.2 (Or, alternatively, a special nighttime garment like a foam sleeve might be used.)

A patient with left arm lymphedema due to breast cancer was tiring of bandaging & driving to appointments after ~10 sessions of daily treatment. Her arm fibrosis hadn’t maximized in reduction nor had the swelling, but she had made decent progress.

(evaluation – visit 1: total left arm volume 27.9 cm)

(after 10 sessions: total left arm volume 26.9 cm)

She wanted to proceed with getting fit for her custom, flat-knit sleeve & glove in a class 2 (23-32 mmHg). She would continue working on her arm fibrosis herself. In addition, she didn’t want to bandage at night (or get an alternative night garment like a foam sleeve which looked hot & bulky). She wanted to try using a daytime sleeve and glove at night in less compression instead – a class 1 (18-21 mmHg). I wasn’t wholly supportive of this idea, but I agreed to try it.

Waiting for the custom sleeve & glove

Custom garments can take 2-3 weeks to receive. During the waiting period, a person should remain bandaged. However, therapy sessions can usually reduce in frequency. In this case, the pt remained bandaged 3x/week until the daytime garments arrived.

What was the outcome? Find out next month.

References
1 Foldi, M, Foldi, E. (2006). Foldi’s Textbook of Lymphology (2nd ed.), p. 272. Germany: Urban and Fisher.
2 Foldi, M, Foldi, E. (2006). Foldi’s Textbook of Lymphology (2nd ed.), p. 273, 574-581. Germany: Urban and Fisher.

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Contraindications to Manual Lymph Drainage: Insights from Foldi’s Textbook of Lymphology (part 2 of 3)

Last month, we began a series on contraindications to MLD. This post will continue that topic, citing a few more contraindications.

3. Heart Failure

Patients with heart failure are at risk for fluid overload, and MLD could further strain their cardiovascular system. The technique’s effects on fluid mobilization may overwhelm the heart’s ability to manage the increased fluid load. Foldi underscores the importance of careful evaluation of a patient’s cardiac function before initiating MLD, especially in those with advanced heart conditions. MLD is not appropriate if heart failure isn’t controlled. And it’s not appropriate if the sole reason for swelling is heart failure as that is a medical condition requiring medical intervention (not lymphedema). Patients with combined edema (from heart failure or other organ dysfunction) and lymphedema require extra caution.

4. Renal Insufficiency

Patients suffering from severe renal insufficiency or kidney failure may experience difficulties in fluid regulation. In such cases, MLD could cause fluid retention and exacerbate symptoms like edema or ascites (according to Ai). (My position is that MLD increases lymphatic flow & ultimately cardiovascular return & renal load. But MLD is primarily not done as it would be of no benefit because lymph vessels are already working at maximum capacity due to the dynamic nature of the edema.) Patients with impaired kidney function should be closely monitored, and MLD should be avoided or used with extreme caution in individuals with compromised renal status. Again, patients with combined edema (from renal disease or other organ dysfunction) and lymphedema require extra caution.

5. Thromboembolic Disorders

Deep vein thrombosis (DVT) or other thromboembolic disorders are a significant contraindication for MLD. Manual lymph drainage can increase blood and lymphatic flow, potentially dislodging clots and causing a pulmonary embolism (PE) or other complications. Foldi’s Textbook emphasizes the critical importance of excluding thrombosis prior to MLD treatment and recommends that patients with active DVT or a history of thromboembolic events within 6 months not undergo MLD (with some exception). DVTs in the acute phase are at risk of dislodging & creating a PE which can kill a person. In the subacute phase (which occurs over the next several weeks), there is typically pain, redness and swelling. The body begins to break down the clot in a process known as fibrinolysis, where enzymes dissolve fibrin and other clot components. As this process happens, part of the clot is reabsorbed, while the remaining structure becomes more organized and fibrous. In the chronic phase (month 3-6), the clot typically becomes firm and organized (restructured with scar tissue) and has little risk of dislodging by month 6.

The exception to waiting 6 months is if a person has a filter and/or receives anticoagulation medication. After stabilization with anticoagulant therapy, MLD may be safely resumed after a 2 to 4-week period (if the physician approves MLD).

Generated by Ai (with edits by author)

References
Foldi’s Textbook of Lymphology

*****For Medicare garment coverage updates, click here.*****

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Billing for Compression (part 3)

We’ve been talking about how a therapist can bill for compression in light of the passage of the Lymphedema Treatment Act. Last month, we noted there were (3) models. The third model involved:

  • a therapist billing Medicare for compression as a supplier & for service as a provider for their own patients, and
  • the same therapist also billing for compression for people who are not their patients.

This gets tricky because the model gives rise to unique ownership concerns related to Medicare & Medicaid payments. (Government complicates things.) These concerns revolve around federal statutes & criminal liability. That’s the focus of this month’s blog.

Disclaimer: Information is not guaranteed to be comprehensive or accurate. Consult a healthcare law attorney for guidance.

Model 3

You would think billing for other people’s patients could be done in your therapy business. But that’s not the case – unless the individual is your patient. And would another therapist want to refer their patients to you – a competitor? Of course, there are several people seeking compression that aren’t wanting treatment. They just need someone who can bill insurance. But does billing for a supply item constitute someone becoming a patient?  Besides that, the 42 CFR has special considerations for therapists billing for compression for their own patients that doesn’t apply to therapists billing for individuals who are not their patients. (See April’s blog update.) A seemingly easy solution is to have a second business.

If you have a second business for DME, why not simplify things? Keep your therapy services in the therapy business & the DME in a DME business. You could have both businesses in the same location & save on costs (like rent). Additional benefits could include having a different taxonomy code (for potential better reimbursement rates), less confusion among insurance payors, & legal protection from financial losses.  You could refer your therapy patients to the DME business. Right? Wrong. (Why not? Well, government complicates things.)

Medicare Supplier Standards2

Anyone who plans to bill federal healthcare programs for DME must be mindful of the 42 CFR Supplier Standards. One of those standards states a supplier is prohibited from sharing a practice location with another Medicare provider or supplier. But there are a few exceptions. Two of these include:

  • a therapist (i.e. provider) who is billing DME for their own patients only
  • a DME supplier can be co-located with & owned by a Medicare provider (e.g. therapist), but the businesses must operate separately (separate phone lines, separate computers, separate staff, etc.). You must also meet the definition of a Medicare provider.7,8

It would seem you actually could separate the therapy business & refer your patients to your DME company. But that’s not the case. (Did I mention government complicates things?)

The Anti-Kickback Statute

The Anti-Kickback Statute is one of the fraud & abuse laws mentioned last month. It was an amendment added to the Social Security Act & first passed by Congress in 1972 as an effort to prevent fraud & abuse of federal healthcare programs (i.e. Medicare & Medicaid).6 It can be found in Title 42 of the U.S. code which covers public health & welfare. (These laws are broken down into titles, chapters, subchapters, parts & sections.)3,4 Specifically, Section 1320a-7b talks about the Anti-Kickback Statute. This amendment prevents giving or receiving anything of value (e.g. money, free rent or other perks) for generating healthcare business paid for by federal programs.

In other words, if you had two businesses that billed Medicare or Medicaid, & you wanted to refer patients from one to the other, you can’t. (Unless, of course, you don’t mind jail time & hefty monetary penalties. Most therapists try to avoid these.) There are a few “safe harbor” exclusions that will allow such business transactions.5 But all elements of a safe harbor must be met. (And these have pros & cons.)

Two notes: First, this only applies to providers/suppliers billing federal healthcare programs (clarification is needed as to whether the non-direct plans like the exchange programs provided by commercial plans are included in this). Second, you can still have a therapy business providing therapy services & DME to your own patients. You can also have a separate DME business for other people’s patients in addition. But these must operate entirely separately & cannot refer business between them if you bill federal healthcare programs unless you fall within one of the safe harbor exclusions. You would also be wise to consider other mitigating factors to prevent implication of Anti-Kickback Statute violation.

There’s one more question that comes to mind regarding billing. What if a Medicare patient wants to pay cash for an item? We’ll look at that next month.

References
1 https://oig.hhs.gov/compliance/physician-education/fraud-abuse-laws/
2 (supplier standards) https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-B/part-424/subpart-D/section-424.57
3 https://www.govinfo.gov/app/details/USCODE-2010-title42/USCODE-2010-title42-chap7-subchapXI-partA-sec1320a-7b
4 https://uscode.house.gov/
5 (safe harbors) https://www.ecfr.gov/current/title-42/chapter-V/subchapter-B/part-1001/subpart-C/section-1001.952
6 https://www.whistleblowerllc.com/anti-kickback-statute/#:~:text=Congress%20first%20enacted%20the%20AKS,physicians%20corrupt%20medical%20decision%2Dmaking.
7 (clinic definition) https://www.govinfo.gov/content/pkg/USCODE-2011-title42/html/USCODE-2011-title42-chap7-subchapXVIII-partE-sec1395x.htm, https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R5BP.pdf & https://www.ssa.gov/OP_Home/ssact/title18/1861.htm
8 (OTPP definition) https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R5BP.pdf

Attribution
Photo by Olia Danilevich Pexels

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Why Would Treatment Not Work (Part 3)

Reason 3 – Medical Staff or the Patient

In parts 1 & 2, we looked at two reasons CDT (complete decongestive therapy) may not work.

  • Combined edema & lymphedema
  • Inappropriate application of CDT (such as leaving one of the four components of treatment out, incorrectly applying technique or inadequate frequency).”

In part 3, we’ll look at the medical professionals & the patient’s role.

(photo by Pexels/Leeloo Thefirst)

Medical Doctors

A doctor may incorrectly diagnose a person with lymphedema, or they may overlook another condition causing swelling that is not lymphedema. And/or these other conditions causing swelling may not have been adequately treated. Additionally, compression garments recommended by a physician may not be the appropriate type or the right compression class.

Therapists

Therapists may also be a reason CDT doesn’t work. First, the therapist may not have actually gotten appropriate training (i.e. they may not have attended a 135-hour lymphedema training course in CDT yet say they “treat lymphedema”). Second, they may have attended an appropriate CDT program to treat lymphedema but may not have sufficient experience. According to Foldi,1 “Therapeutic success cannot be expected if errors are made in administering the treatment. The necessity of daily treatment has already been noted. Furthermore, we must again emphasize that a … therapist who has just received a certificate authorizing him or her to perform CDT is a novice & needs to get experience.” The text continues, “A “10-year rule” states that it takes approximately a decade of heavy labor to master any field!” The following are listed as the most common errors made by therapists.

  • Gross technical errors (such as failing to remove a bra which causes constriction)
  • Failure to treat the patient on a daily basis
  • Failure to apply bandages properly

Patients

Surprisingly, some patients may cause “artificial lymphedema” through constriction of a tourniquet or other means (& in some cases, deny it for reasons such as disability income). But in most situations (in my experience), failure on the part of a patient is due to non-compliance. Non-compliance can be not showing up for appointments, removing bandages to shower, not performing exercises prescribed, or not wearing a compression garment (including separate daytime & nighttime garments which are typically needed for pure lymphedema).

References
1 Foldi, M, Foldi, E. (2006). Foldi’s Textbook of Lymphology (2nd ed.), p. 281-282. Germany: Urban and Fisher. Foldi, M., & Foldi, E. (2012). Foldi’s Textbook of Lymphology (3rd ed.). Urban and Fisher.

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Why Would Treatment Not Work (Part 2)

Reason 2 – Inadequate Treatment

In part 1, we looked at one reason CDT may not work. In part 2, we’ll look at the important components of lymphedema treatment.

Complete Decongestive Therapy (CDT) involves (4) pillars of treatment:

1. Manual lymph drainage (MLD)
2. Multilayer compression bandaging
3. Skin Care
4. Exercise

If one of these is lacking (particularly 1, 2 & 4), a patient will not maximize their potential. Let’s look at each of these individually.

Manual Lymph Drainage

The purpose of MLD is to remove the protein in the interstitial tissue space. (The protein accumulation is due to damage of the lymphatic system – from a birth defect or a secondary cause.) Bandaging without MLD might squeeze the “water” from the tissue space, but it won’t remove the protein (neither will diuretics). That’s a specific function of MLD. And if protein attracts water, what will the result be? More swelling.

I’ve recently read & heard that there isn’t proof that MLD works. But there is research to back the efficacy of MLD.

  • In a 2017 study published in the Lymphatic Research and Biology Journal, near-infrared imaging was used to track a dye (indocyanine green) in nine healthy participants before & after a 15-minute period of MLD followed by a compression garment for 10 minutes applied to the arm. Images were taken at the forearm & elbow. There was a statistically significant improvement in the movement of lymph fluid & the speed of transport. At baseline, lymph transport speed was 6.7 millimeters per second (mm/s). This increased to 13.3 mm/s after MLD! Speed increased by 10.5 mm/s after use of a compression garment.3
  • Another study published in 2011 also used near-infrared imaging to assess the speed of lymph contractile function before & after MLD. Results showed lymph transport speed increased by 23% in symptomatic limbs (ones with lymphedema) & 25% in asymptomatic limbs (ones without lymphedema).4

Characteristics of MLD include a gentle, 2-way stretch of the skin (approximately 1 stretch per second8) that create a “pulling & shear force.”12 If too much pressure is applied, anchoring filaments of the initial lymphatic vessels close to the skin’s surface may be damaged. If MLD strokes are performed too fast or too firm, lymphangions may spasm.8  Frequency of MLD should be daily in Phase I (the decongestion phase).1 If MLD is not administered correctly or with less frequency than recommended, results will show it.

Multilayer compression bandaging

Compression is an essential part of CDT. According to Foldi’s Textbook,1 a study from the European Journal of Cancer assessed the outcome of MLD in breast cancer-related lymphedema. The study found that MLD reduces limb volume & dermal (skin) thickness in the upper arm.5 In contrast, the 9th edition of the Munich Cancer Center manual reported a deterioration in arms of women with lymphedema who received lymph drainage but did not wear compression sleeves.

The International Lymphoedema Framework publishes a best practice guideline for compression.6 The upper body guideline states, “The application of a compression garment results in constant pressure on the skin when the limb is at rest (resting pressure). When the muscles contract, expand and then relax (e.g. during exercise), they transiently press against the resisting garment and so the tissue pressure in the limb increases temporarily.” This pressure increase “compresses the adjacent dermal lymphatics and because the collecting and larger lymphatics are valved, these vessels pump passively so that lymph flows up the arm without the lymphatics having to contract.” In other words, the resistance provided by compression increases tissue pressure &, as a result, lymph movement.

Other benefits of compression include softening of fibrotic tissue & improving the venous pump function.10 Foldi states, “In lymphedema, one should always use the maximum compression that is tolerated by the patient.”7 (A 2016 study found 84 mmHg compression stopped lymphatic flow.8 This is extremely high pressure. Compression seldom goes above ~46 mmHg in lymphedema garments & limb size should be considered. Smaller circumferences like fingers & arms will not tolerate the same compression that legs might.)

Compression is an important component of CDT. If it is lacking in the treatment phase or maintenance phase, there will not be sufficient volume reduction or containment. If compression bandages are removed between sessions, refilling will occur. And if bandages are not applied correctly, there can be adverse consequences such as increased swelling or pressure wounds.

Skin Care

Good hygiene & using acidic products more like the skin’s natural pH level will reduce itching & improve skin texture. These will also help mitigate potential infections due to a compromised skin barrier.

Exercise

When the body is at rest, only a minor amount of lymph is formed.12 Movement is key to lymph creation. Exercise engages the muscle pump. Singing, deep breathing & laughing are excellent ways to engage the diaphragm & compress the most important lymph vessel in the body (the thoracic duct).11 Exercising with compression increases tissue pressure (& so lymph movement) & softens fibrosis in extremities (helping to reduce volume).

In summary, all aspects of CDT are important components. If one is overlooked or administered inadequately, CDT may fail at worst or results may be subpar at best.

References
1 Foldi, M, Foldi, E. (2006). Foldi’s Textbook of Lymphology (2nd ed.), p. 272. Germany: Urban and Fisher. Foldi, M., & Foldi, E. (2012). Foldi’s Textbook of Lymphology (3rd ed.). Urban and Fisher.
2 https://www.lympho.org/publications
3 Lopera C, Worsley PR, Bader DL, Fenlon D. Investigating the Short-Term Effects of Manual Lymphatic Drainage and Compression Garment Therapies on Lymphatic Function Using Near-Infrared Imaging. Lymphat Res Biol. 2017;15(3):235-240. doi:10.1089/lrb.2017.0001
4 Tan IC, Maus EA, Rasmussen JC, et al. Assessment of lymphatic contractile function after manual lymphatic drainage using near-infrared fluorescence imaging. Arch Phys Med Rehabil. 2011;92(5):756-764.e1. doi:10.1016/j.apmr.2010.12.027
5 Williams AF, Vadgama A, Franks PJ, Mortimer PS. A randomized controlled crossover study of manual lymphatic drainage therapy in women with breast cancer-related lymphoedema. Eur J Cancer Care (Engl). 2002;11(4):254-261. doi:10.1046/j.1365-2354.2002.00312.x
6 Moffatt, CJ, et al. International Lymphedema Framework. (p. 13)
7 Foldi, M, Foldi, E. (2006). Foldi’s Textbook of Lymphology (2nd ed.), p. 273. Germany: Urban and Fisher. Foldi, M., & Foldi, E. (2012). Foldi’s Textbook of Lymphology (3rd ed.). Urban and Fisher.
8 Foldi, M, Foldi, E. (2006). Foldi’s Textbook of Lymphology (2nd ed.), p. 526. Germany: Urban and Fisher. Foldi, M., & Foldi, E. (2012). Foldi’s Textbook of Lymphology (3rd ed.). Urban and Fisher.
9 Belgrado JP, Vandermeeren L, Vankerckhove S, et al. Near-Infrared Fluorescence Lymphatic Imaging to Reconsider Occlusion Pressure of Superficial Lymphatic Collectors in Upper Extremities of Healthy Volunteers. Lymphat Res Biol. 2016;14(2):70-77. doi:10.1089/lrb.2015.0040
10 Foldi, M, Foldi, E. (2006). Foldi’s Textbook of Lymphology (2nd ed.), p. 568-569. Germany: Urban and Fisher. Foldi, M., & Foldi, E. (2012). Foldi’s Textbook of Lymphology (3rd ed.). Urban and Fisher.
11 Shields, J. (1992). Lymphology, v25, n4, Dec. 1992, p. 147* & Foldi, M, Foldi, E. (2006). Foldi’s Textbook of Lymphology (2nd ed.), p. 550. Germany: Urban and Fisher. Foldi, M., & Foldi, E. (2012). Foldi’s Textbook of Lymphology (3rd ed.). Urban and Fisher.
12 Foldi, M, Foldi, E. (2006). Foldi’s Textbook of Lymphology (2nd ed.), p. 198. Germany: Urban and Fisher. Foldi, M., & Foldi, E. (2012). Foldi’s Textbook of Lymphology (3rd ed.). Urban and Fisher.
* https://lymphaticyoga.net/deep-breathing-and-the-lymphatic-system/ cites Dr. Shields as saying, “Deep diaphragmatic breathing stimulates the cleansing of the lymph system by creating a vacuum effect which pulls the lymph through the bloodstream.” I cannot find this statement in the cited article posted by the author. (https://journals.uair.arizona.edu/index.php/lymph/article/view/17643/17366)

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