Lymphedema Therapy Source

  

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Could MLD help Nerve Inflammation or Brain Congestion?

Researchers at Yale are studying the lymphatics discovered in the meningeal dura mater. Anne Eichmann, Professor of Medicine said, “Meningeal lymphatic vessels are potential targets to treat brain diseases.”1 This includes causes of intracranial hypertension like brain injury or stroke according to Foldi.2

Foldi had it going on

Years before Yale’s 2022 research, Foldi had written about this in the Foldi Textbook of Lymphology. In the chapter on lymphostatic diseases, Foldi notes lymphostatic failure can occur in the body’s organs – including the brain. Many people might consider this “lymphedema.” But lymphedema is referring to the lymphostatic condition that affects the skin & tissues. When it’s elsewhere in the body, it’s simply called “lymphostatic failure.” If it affects the nerves, it’s called, “lymphostatic neuropathy.” If it affects the brain, it’s called, “lymphostatic encephalopathy.” Etc. Foldi states, “Any organ requiring lymphatic drainage develops a lymphostatic disease under circumstances of low-output failure or combined [high & low output] failure.”2

What can give rise to congestion surrounding nerves? Inflammation, as occurs in trigeminal neuralgia (cranial nerve V is affected) & Bell’s Palsy (the facial nerve, cranial nerve 7, is affected). Cranial nerve V runs through the dural venous sinus (the cavernous sinus). Cranial nerve 7 passes through the temporal bone. There’s a head & neck MLD sequence that can address this.

On the right is the facial nerve involved in Bells’ Palsy. The picture shows it passing through the temporal bone. The nerve can swell, causing it to be compressed. This leads to the symptoms people experience.

Why direction matters

It’s important to be aware that dural venous sinuses don’t have valves or muscle like regular veins do.  As a result, blood can flow backwards. In fact, most brain veins (except for the larger pial veins) don’t have valves or muscle.3 (Spinal veins are also valveless & muscleless.4)

The Noted Anatomist describes the dural venous sinuses at minute 5 in this video.

The missing valves & muscle in these veins allows them to expand if intracranial pressure rises. But, as The Noted Anatomist states, “Veins that drain the eyes or nasal pages could flow backwards, back into the orbit or nasal area. This could transport infection into the brain.” That’s the downside. MLD may be able to help this backflow caused by congestion.

How MLD could help

Foldi notes that, “Immune deficiency develops in lymphedematous areas. This fact plays an important role in the pathophysiology of lymphostatic diseases.”5 In lymphedema, as inflammation continues, we see the changes characteristic of lymphedema tissue as the disease progresses (skin thickening, fat growth, scarring or fibrosis, skin papules & hyperkeratosis, etc.). Complete decongestive therapy (with MLD being one of the components of CDT) improves this condition by decongesting the tissue. It’s a proven fact that proper MLD speeds up lymphatic flow.6,7,8 Check out the below video of a person receiving leg MLD. It shows the movement of lymph fluid before & after MLD.

If MLD can increase lymph transport, it stands to reason that it could reduce swelling around nerves or congestion in the brain given what we’ve learned about anatomy. Foldi has already suggested that it does. Wolf Lüdemann (physician) treated patients with intracranial pressure due to brain injury using MLD. And the pressure reduced.9 (It’s important to note position can also play a role in intracranial pressure.)

Foldi highlighted patients with recurrent inflammatory nasal congestion & primary lymphedema (which caused dysplasia of the jaw & paranasal sinuses) who were treated with MLD. Their tonsils were often enlarged, leading to mouth-breathing. The kids often have trouble staying awake & concentrating in school. Colds were a common occurrence. MLD improved their symptoms.10

The start of modern MLD

It’s interesting to note that Dr. Emil Vodder (credited with being the founder of MLD) got his start in the south of France treating patients with colds, migraines & sinus problems.11

Conclusion

MLD has potential to help nerve inflammation & conditions causing intracranial pressure through head & neck MLD. In fact, “Földi’s concept of lymphostatic encephalopathy provides both a possible explanation of the wide spectrum of symptoms after these accidents [causing increased brain pressure] and a way to help heal the problems by using MLD.”12

References
1 https://medicine.yale.edu/news-article/the-brains-drainage-system-in-3-dimensions/
2 Földi, Michael; Földi, Ethel; Strößenreuther, Cornelia; Kubik, Stefan. Földi’s Textbook of Lymphology: for Physicians and Lymphedema Therapists (German Edition) (p. 515). Elsevier Health Sciences. Kindle Edition.
3 Hufnagle JJ, Tadi P. Neuroanatomy, Brain Veins. [Updated 2023 Jul 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. (https://www.ncbi.nlm.nih.gov/books/NBK546605/#:~:text=Structurally%2C%20the%20veins%20of%20the,a%20circumferential%20smooth%20muscle%20layer)
4 (Green K, Reddy V, Hogg JP. Neuroanatomy, Spinal Cord Veins. [Updated 2023 Jul 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. https://www.ncbi.nlm.nih.gov/books/NBK542182/)
5 Földi, Michael; Földi, Ethel; Strößenreuther, Cornelia; Kubik, Stefan. Földi’s Textbook of Lymphology: for Physicians and Lymphedema Therapists (German Edition) (pp. 515-516). Elsevier Health Sciences. Kindle Edition.
6 https://ltstherapy.com/blog/can-mld-slow-cognitive-decline-part-3/
7 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 (https://pmc.ncbi.nlm.nih.gov/articles/PMC3109491/)
8 https://www.movinglymph.com.au/post/update-on-icg
9 Földi, Michael; Földi, Ethel; Strößenreuther, Cornelia; Kubik, Stefan. Földi’s Textbook of Lymphology: for Physicians and Lymphedema Therapists (German Edition) (p. 716). Elsevier Health Sciences. Kindle Edition.
10 Földi, Michael; Földi, Ethel; Strößenreuther, Cornelia; Kubik, Stefan. Földi’s Textbook of Lymphology: for Physicians and Lymphedema Therapists (German Edition) (p. 712). Elsevier Health Sciences. Kindle Edition.
11 https://vodderschool.com/emil_vodder_life_work_article
12 (Földi, Michael; Földi, Ethel; Strößenreuther, Cornelia; Kubik, Stefan. Földi’s Textbook of Lymphology: for Physicians and Lymphedema Therapists (German Edition) (p. 1844). Elsevier Health Sciences. Kindle Edition.)

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Can MLD Slow Cognitive Decline (Part 3)

The last two months we learned the brain has lymphatics in the outer meningeal layer (which is just beneath the skull). We also learned an accumulation of waste in the CNS is the likely cause of neurological pathology.

The Disease Process

Specifically, two types of waste accumulate in the CNS during this neuropathology:

  1. amyloid beta peptide – a metabolic waste product in the brain created during neuronal activity &
  2. phosphorylated tau protein – tau protein that has become highly phosphorylated & insoluble. That is to say, when multiple phosphate groups are added to its structure, tau can detach from microtubules (the “highways” within neurons) & cause neurofibrillary tangles that block the neuron transport system. This causes cells to die.

To summarize, the accumulation of these waste products leads to inflammation, cell death & the symptoms seen in neurological diseases like Alzheimer’s (a form of dementia), multiple sclerosis, Parkinson’s & traumatic brain injury among others.1 The reason for this waste buildup is a disruption in drainage of fluid from the CNS. How does fluid drain from the CNS?

CNS fluid drainage

Fluid drains from the central nervous system through pathways similar to the rest of the body: veins & lymphatic pathways.2 The brain (cerebrum, cerebellum & brain stem) drain to the arachnoid (middle meningeal layer) & then to the dural venous sinus before emptying into the internal jugular veins.

The dural venous sinuses are formed by the outer dura mater when it separates to form two layers within the dura mater (one that lines the skull & one that continues around brain tissue).

Interesting fact: In Latin, “dura” means tough & “mater” means mother. Your dura mater is a tough mother!

The spinal cord drains to a network of veins along the spinal cord called the vertebral plexuses. This pathway is a bit more complicated.5,6 For example, the cervical (neck) portion drains to the vertebral veins before emptying to the brachiocephalic veins, the subclavian veins, the superior vena cava & the heart.3  Other spinal cord sections drain differently. But all blood eventually drains to either the superior vena cava or the inferior vena cava before entering the heart.

Lymph fluid drainage

In the last couple of months, we also learned that CNS fluid mixes with interstitial fluid before draining to lymph vessels in the outer meningeal layer (the dura mater). From there (focusing on the brain), fluid drains to the cervical lymph nodes in the neck.

Image depicting lymphatic drainage from the head & neck as it returns to the heart.

What CNS drainage & lymphedema have in common

As we’ve already learned, when CNS drainage is disrupted, it causes congestion & the accumulation of amyloid beta peptide & phosphorylated tau protein. This results in inflammation, cell death & the symptoms associated with neurological diseases.

A similar process happens in lymphedema. When lymphatic drainage is disrupted, it causes congestion & the accumulation of the lymphatic load (protein, in particular). This results in inflammation, tissue remodeling & symptoms (swelling, tissue hardening, skin changes, etc.) associated with lymphedema. Conservative treatment is complete decongestive therapy (CDT). One of the components of CDT is manual lymph drainage (MLD). And herein lies a key to the answer of our blog heading: Can MLD Slow Cognitive Decline?

Professor Michael Foldi

A medical doctor, Professor Foldi & his wife (also a physician) have spent years researching, collaborating, teaching, & treating patients with lymphedema. In 1966, Professor Foldi said, “The potential role of the lymphatic system should never be disregarded in any disease of the central nervous system.”7 In the chapter on lymphostatic diseases in the Foldi textbook, Wolf Lüdemann (physician) did a study in 2004 showing the positive influence of MLD on intracranial pressure in severe traumatic brain injury.8 A 2016 article showed cervical & cranial MLD improved intracranial pressure as well as did a 2023 study.9,10

How MLD could impact CNS drainage

Deeper lymph vessels called collectors have components called lymphangions. Lymphangions have a proximal & distal valve as well as muscle that moves lymph through the collectors. “During the systole of the lymphangion, the proximal valve is open and the distal valve is closed. The lymph is pumped into the next lymphangion, which is in its diastole at that moment. “A lymphangion responds to an increased load like the heart.”12 In fact, lymphangions are sometimes referred to “mini-hearts.” When at rest, the lymph flow (per unit of time) is low.  But when lymph flow increases, then the amount of lymph entering a lymphangion also increases. This causes the wall of the lymphangion to be stretched & lymph fluid to be transported. “Stretching the lymphangion wall from the outside through manual lymph drainage has the same effect!”13

Improving neurological conditions like dementia

In closing, MLD impacts the flow of lymphatic fluid. When there is congestion as can be seen in the CNS in neurological conditions like dementia, MLD may very well reduce this congestion by stimulating lymph drainage. In fact, Foldi’s Textbook states, “Fostering the lymphatic drainage of β-amyloid in older persons could prevent its accumulation in the brain, could sustain homeostasis, and could represent a treatment strategy to prevent the decline of mental faculties in Alzheimer’s disease.”11 I would caution that not all MLD is the same. Just because a technique is called “MLD” doesn’t mean it is. See also Guenter Klose’s presentation for LERN.

The original form of MLD (as developed by Dr. Vodder & taught by the Foldi’s) is a two-way stretch of the skin. There are specific characteristics of proper MLD in addition to being a two-way stretch of the skin. These characteristics include being slow (1 second per repetition) & rhythmical among other characteristics.

To learn more about other potential ways to slow cognitive decline, check out this podcast with Dr. Heather Sandison. To learn how microplastics could be contributing to inflammation, check out this interview. You know what else could benefit from MLD? Nerve inflammation. Find out how trigeminal neuralgia & Bell’s Palsy could be improved with MLD next month.

References
1 Bakker EN, Bacskai BJ, Arbel-Ornath M, et al. Lymphatic Clearance of the Brain: Perivascular, Paravascular and Significance for Neurodegenerative Diseases. Cell Mol Neurobiol. 2016;36(2):181-194. doi:10.1007/s10571-015-0273-8; link https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4844641/)
2 Adigun OO, Al-Dhahir MA. Anatomy, Head and Neck: Cerebrospinal Fluid. [Updated 2023 Jul 17]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459286/
3 https://www.kenhub.com/en/library/anatomy/vertebral-vein
4 https://www.youtube.com/watch?v=WTu31680f6s
5 https://www.physio-pedia.com/Spinal_Cord_Anatomy
6 Green K, Reddy V, Hogg JP. Neuroanatomy, Spinal Cord Veins. [Updated 2023 Jul 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. (https://www.ncbi.nlm.nih.gov/books/NBK542182/)
7 Földi, Michael; Földi, Ethel; Strößenreuther, Cornelia; Kubik, Stefan. Földi’s Textbook of Lymphology: for Physicians and Lymphedema Therapists (German Edition) (p. 715). Elsevier Health Sciences. Kindle Edition.
8 Földi, Michael; Földi, Ethel; Strößenreuther, Cornelia; Kubik, Stefan. Földi’s Textbook of Lymphology: for Physicians and Lymphedema Therapists (German Edition) (p. 774). Elsevier Health Sciences. Kindle Edition.
9 Roth C, Stitz H, Roth C, Ferbert A, Deinsberger W, Pahl R, Engel H, Kleffmann J. Craniocervical manual lymphatic drainage and its impact on intracranial pressure – a pilot study. Eur J Neurol. 2016 Sep;23(9):1441-6. doi: 10.1111/ene.13055. Epub 2016 May 30. PMID: 27238738.
10 Esparza WD, Aladro-Gonzalvo AR, Ruíz-Hontangas A, Celi D, Aguirre MB. The Effect of Craniofacial Manual Lymphatic Drainage after Moderate Traumatic Brain Injury. Healthcare (Basel). 2023;11(10):1474. Published 2023 May 18. doi:10.3390/healthcare11101474
11 Földi, Michael; Földi, Ethel; Strößenreuther, Cornelia; Kubik, Stefan. Földi’s Textbook of Lymphology: for Physicians and Lymphedema Therapists (German Edition) (pp. 717-718). Elsevier Health Sciences. Kindle Edition.
12 Földi, Michael; Földi, Ethel; Strößenreuther, Cornelia; Kubik, Stefan. Földi’s Textbook of Lymphology: for Physicians and Lymphedema Therapists (German Edition) (p. 450). Elsevier Health Sciences. Kindle Edition.
13 Földi, Michael; Földi, Ethel; Strößenreuther, Cornelia; Kubik, Stefan. Földi’s Textbook of Lymphology: for Physicians and Lymphedema Therapists (German Edition) (p. 450). Elsevier Health Sciences. Kindle Edition.

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Can MLD Slow Cognitive Decline? (Part 2)

Last month we learned the brain has lymphatic vessels in the outer meningeal layer (the dura mater). Fluid inside the brain (cerebral spinal fluid) mixes with interstitial fluid in the innermost meningeal layer (the pia mater) before draining to the outer dura mater & its lymphatic vessels. When things go awry, dementia enters the picture. How does this occur?

The Glymphatic System

Along the blood vessels in the brain are cells called astrocytes. Astrocytes are a type of glial cell (a specialized WBC that are helpers or support cells for neurons & coat neurons with myelin).1 They come from monocytes & reside in the CNS.

Astrocytes & microglial cells (another type of glial cell in the CNS) aid in nutrition, but they also help with immunity, waste clearance & maintaining homeostasis (just like the lymph system does). The perivascular channels containing these cells were named the “glymphatic system” because of their similarity to lymphatic system function.2,3,4

perivascular channels

The Cause of Dementia & Other Neurological Conditions

Previously, amyloid plaques were thought to be the cause of Alzheimer’s. Instead, they’re likely a by-product of the glymphatic system drainage disruption. More recent research is finding impairment in the glymphatic drainage is the likely cause of many neurological conditions, including dementia & Alzheimer’s (a form of dementia), by allowing a buildup of harmful waste to occur in the brain.  There seem to be two primary culprits.

The Culprits

One culprit is faulty clearance of the fibrillar form of the beta-amyloid protein (an imbalance in the production & clearing of the peptide that comes from the processed amyloid protein, in particular).5,6 Another culprit is faulty clearance of the phosphorylated tau protein.7,8

The Stars of the CNS

Glial cells found in the brain (astrocytes, oligodendrocytes & microglia) can be considered the stars of the CNS because of their important role in preventing inflammation & their job of coating neurons with myelin.9 Myelin is the fatty sheath that surrounds & protects nerve fibers. It allows nerve impulses to travel quickly & efficiently.

diagram showing myelin sheath

Brain inflammation (such as faulty clearance of substances mentioned above) causes this myelin sheath to break down, leading to the symptoms experienced in neurological diseases.10 How could MLD help? Find out in part 3.

References
1 https://my.clevelandclinic.org/health/body/23273-autonomic-nervous-system
2 https://www.nih.gov/news-events/nih-research-matters/new-brain-cleaning-system-discovered
3 https://www.researchgate.net/figure/Outline-of-the-glymphatic-system-This-figure-illustrates-that-perivascular-clearance_fig1_322688508
4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4636982/#:~:text=The%20glymphatic%20system%20is%20a,from%20the%20
central%20nervous%20system
5 https://www.medicalnewstoday.com/articles/if-amyloid-accumulation-is-part-of-normal-aging-what-causes-alzheimers#:~:text=The%20researchers%20showed%20that%20the,journal%20of%20the%20Alzheimer’s%20Association
6 https://www.ncbi.nlm.nih.gov/books/NBK459119/
7 Garland EF, Hartnell IJ, Boche D. Microglia and Astrocyte Function and Communication: What Do We Know in Humans?. Front Neurosci. 2022;16:824888. Published 2022 Feb 16. doi:10.3389/fnins.2022.824888 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8888691/)
8 https://www.nih.gov/news-events/nih-research-matters/lymphatic-vessels-discovered-central-nervous-system#:~:text=The%20lymphatic%20system%20carries%20white,was%20termed%20the%20glymphatic%20system
9 https://my.clevelandclinic.org/health/body/23273-autonomic-nervous-system
10 https://my.clevelandclinic.org/health/body/22974-myelin-sheath

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Can MLD Slow Cognitive Decline? (Part 1)

Until recently, it was thought the brain had no lymphatic vessels. Research in 2012 proved otherwise.

Lymphatics of the Brain

In this study, scientists injected tracer dye into the subarachnoid space of the brains of living mice.

Subarachnoid space showing CSF. Cerebral spinal fluid travels around the brain & spinal cord & in the ventricles of the brain providing nutrients & removing waste.3

The subarachnoid space is found within the membranes (called meninges) that cover the brain & spinal cord.

Meninges

There are three layers of protective meninges. The inner layer is called the pia mater. Between the inner layer & the middle layer (called the arachnoid meningeal layer) is the subarachnoid space that houses the cerebral spinal fluid (& blood vessels). The outside layer of meninges is called the dura mater.

Cervical lymph nodes & CSF

Researchers followed the dye they had injected during their study. They observed that CSF drained from the inner brain (the CNS or central nervous system) to lymphatic vessels in the outer brain (the dura mater meningeal layer) before draining to the cervical lymph nodes in the neck.4 So, this study showed lymphatic vessels were present in the brain – the outer dura mater meningeal layer in mice.1,2 (Turns out, they’re in humans, too, as well as the spinal cord meninges.)4

Perivascular channels

The pia mater meningeal layer contains spaces known as perivascular channels (also called “Virchow-Robin” channels). These channels are created by the space between blood vessel walls & the inner pia mater meningeal layer. Cerebral spinal fluid (CSF) mixes with interstitial fluid (fluid found within the tissue space between cells – the fluid we deal with in lymphedema) continuously within this perivascular space before draining to the lymphatic vessels in the outer dura mater.

Where does dementia come into the picture? Find out next time as we continue to part 2.

References
1 https://www.nih.gov/news-events/nih-research-matters/new-brain-cleaning-system-discovered
2 https://www.nih.gov/news-events/nih-research-matters/lymphatic-vessels-discovered-central-nervous-system#:~:text=The%20lymphatic%20system%20carries%20white,was%20termed%20the%20glymphatic%20system.
3 https://www.nih.gov/news-events/nih-research-matters/new-brain-cleaning-system-discovered
4 Hershenhouse KS, Shauly O, Gould DJ, Patel KM. Meningeal Lymphatics: A Review and Future Directions From a Clinical Perspective. Neurosci Insights. 2019;14:1179069519889027. Published 2019 Dec 31. doi:10.1177/1179069519889027 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7176397/#:~:text=They%20demonstrated%20lateral%20branches%20associated%20with%20spinal%20nerves%20and%20blood%20vessels.&text=The%20localization%20of%20the%20lymphatics,nonhuman%20primate%2C%20and%20human%20specimens.&text=Further%20anatomical%20evidence%20for%20this,meningeal%20arteries%20and%20venous%20sinuses.&text=However%2C%20this%20localization%20remains%20an,access%20from%20the%20dura%20mater

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Compression Billing Confusion

We’re resuming our educational blog about lymphedema. And we’re moving on from the last few posts about Medicare’s new coverage of lymphedema supplies & compression … almost. I had a recent incident worth mentioning.

Lymphedema Treatment Act Website

The Lymphedema Treatment Act (LTA) website has a list of durable medical equipment (DME) suppliers for lymphedema compression supplies & garments. It’s a good start, but it’s not entirely accurate. I’ve had a few inquiries from people who saw this business (Lymphedema Therapy Source) listed on the LTA website as a Medicare supplier. While this business just became an approved Medicare DME supplier this month, it can’t provide supplies or compression garments for people in states outside of Texas (not yet, anyway). That’s because most states (if not all) require a business to have a (DME) license in their state. And that usually requires a physical presence in that state.

The LTA advocacy team sent an email in Aug informing readers that Medicare has updated their online supplier search tool to include compression supplies. Unfortunately, Medicare (nor the Lymphedema Treatment Act website) contain an accurate list of businesses that can bill Medicare for lymphedema supplies.

August LTA newsletter. While both Medicare & the LTA lists include DME suppliers, Medicare’s list may not specialize in lymphedema products. And the LTA list may not include DME suppliers that can bill Medicare in your state (or at all).

How to Find a Billing Supplier

If you have insurance other than Medicare, your carrier may provide a list of suppliers for DME that are in-network. But like the Medicare list, they may not specialize in lymphedema products. The takeaway is: You should call before making a trip to visit a supplier to make sure they sell (on site) the item you’re seeking.

Here’s an example. A few weeks ago, a man came to my office building looking for an orthotic (with a doctor’s script in hand). His doctor had sent him to the building because another company (Accentus) is a local DME supplier who showed as in-network with his insurance. What the man didn’t know is the company specializes in diabetic supplies & that particular office is solely composed of backend office staff (i.e. it’s not a storefront). The girls in the office came looking for me assuming I could help him.

While this business can now bill insurance for DME, the specialty is lymphedema. Not orthopedic products like an ankle brace. I was able to read the script, explain the situation, & advise the man he needed to contact his insurance company again for a list of in-network suppliers. He then needed to call those companies to ensure they sold the ankle support he needed.

Conclusion

While it’s terrific that Medicare will now pay for lymphedema compression, treatment supplies & aids thanks to the efforts of the Lymphedema Treatment Act team, the downside is there’s a lot of confusion among beneficiaries as to how to find a supplier who can bill for their DME needs.

(First posted 09/16/24 for Aug.)

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Cash Pay for Medicare Compression?

Medicare will now pay for lymphedema compression supplies, aids & garments. But there may be an occasion when a patient wants to pay cash for an item. Simple, right? Well (as noted in last month’s post), government complicates things. (Next month, we’ll resume our normal educational blog about lymphedema.)

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

Image by Andrew Patrick / Pexels

In this post, “provider” will be used interchangeably with “supplier” except where noted.

Billing Medicare 1,2

Most patients will want to bill Medicare for anything Medicare will cover. In such cases, providers (i.e. therapists who add a DME supplier aspect to their provider therapy business for their own patients) must have a PTAN (provider transaction access number). This is obtained when enrolling with Medicare. There are three classifications: “participating,” “non participating,” & those who “opt out”.

Participating Providers 3, 4

A participating provider is an individual who contracts with Medicare. They have agreed to accept what Medicare will pay. They are required (by law) to submit a claim on behalf of a Medicare beneficiary for any service or item that’s a covered benefit. This now includes lymphedema compression (thanks to Heather Ferguson & team – see also the Lymphedema Treatment Act). Because they contract with Medicare, these providers cannot accept cash for an item sold to a Medicare beneficiary (other than the deductible, 20% coinsurance or upgrades). They also have other rules (such as issuing an ABN – advanced beneficiary notice – when certain services or items are not expected to be covered.) Some commercial insurance companies require therapists to be Medicare participants in order to become an in-network provider with them.

A Participating Provider can become a Non Participating Provider by notifying their regional national provider enrollment contractor during the enrollment period (mid-Nov to Dec 31 each year). There are currently two regional enrollment providers (NPE East & NPE West) that took the place of the prior National Supplier Clearing House (“NSC”).

Non Participating Providers 5-8

Non participating providers are individuals who accept Medicare payment but not necessarily in full. (They are still “contracted” providers & must have a PTAN in order to bill Medicare – whether they accept or do not accept Medicare’s payment amount in full.) If they choose not to accept Medicare’s payment in full, they can charge more than Medicare’s payment amount (similar to out-of-network providers), but they have a limit (by law) on what amount they can charge. However, this limit only applies to providers, not suppliers.

Non participating providers can require payment upfront but must still issue an ABN (like participating providers). They’re supposed to submit a claim to Medicare on behalf of a patient in order to collect any billed amount. (If a patient submits a claim, a “CMS 1490S” form can be used.) Can a “non participating provider” sell an item for cash to a Medicare beneficiary? Possibly – if a patient specifically states they don’t want Medicare to be billed. (see image below)

Opting Out 9,10

The Social Security Act Title 18 amendment (of the Balanced Budget Act of 1997, §4507) has a provision allowing a provider to opt out of Medicare. Opt-out providers have chosen not to work with Medicare at all. Instead, they privately contract with patients. This decision is valid for two years at a time. Opting out means a provider can legally bill a Medicare patient directly for services that would be covered. This is not an option for therapists or suppliers.

Non-Contracted Providers (Cash Practices or “retail”) 11,12

Can cash-only practices (without a PTAN) choose to sell compression to Medicare patients? According to CFR 42, section 1395m (j)(4)(A), no. One exception may be if the supplier informed the patient before any transaction took place that the supplier did not bill Medicare & the patient agreed to pay cash. And an ABN should be issued for signature as well.

What about internet sales? 12

Can a Medicare patient pay cash for an item now covered by Medicare? Not without the supplier having liability. According to one legal source, a supplier needs to ensure they have an obvious notice on their website (& at checkout) for all Medicare beneficiaries informing the buyer that the supplier does not have a PTAN & does not bill Medicare. They might even consider having an ABN form signed by each Medicare buyer.

Competitive Bidding

Items covered under the LTA are not currently subject to Competitive Bidding according to 42 U.S. Code § 1395m – Special payment rules for particular items and services.

References
1 Title 42 USC section 1395 m(j), https://www.cgsmedicare.com/jc/pubs/pdf/chpt2.pdf
2 https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/pim83c10.pdf
3 (Upgrades) CFR 1395m (19) Certain Upgraded Items https://www.law.cornell.edu/uscode/text/42/1395m
4 (Enrollment Providers) https://www.achc.org/blog/cms-replacing-nsc/)(https://www.cms.gov/medicare/provider-enrollment-and-certification/medicareprovidersupenroll/downloads/contact_list.pdf
5 (Limit not for Suppliers) https://www.medicareinteractive.org/get-answers/medicare-covered-services/outpatient-provider-services/participating-non-participating-and-opt-out-providers#:~:text=Non%2Dparticipating%20providers%20accept%20Medicare,care%20services%20as%20full%20payment
6 (CMS 1490S) https://www.cms.gov/medicare/cms-forms/cms-forms/cms-forms-items/cms012949
7 (paying cash) https://www.webpt.com/blog/times-a-medicare-patient-cant-pay-cash#:~:text=As%20a%20non%2Dparticipating%20provider,may%20reimburse%20the%20patient%20directly
8 https://www.medicareinteractive.org/get-answers/medicare-covered-services/outpatient-provider-services/participating-non-participating-and-opt-out-providers#:~:text=Non%2Dparticipating%20providers%20accept%20Medicare,care%20services%20as%20full%20payment
9 (opting out) https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00093112#P22_1451
10 (opting out) https://www.congress.gov/bill/105th-congress/house-bill/2015#:~:text=were%20not%20notified.-,(Sec.,shall%20receive%20no%20Medicare%20reimbursement
11 (CFR 42, subch 18, part B, section 1395m, (j)(4)(A)) https://www.law.cornell.edu/uscode/text/42/1395m
12 https://medtrade.com/news/billing-reimbursement/selling-dme-by-a-supplier-without-a-ptan/#:~:text=AMARILLO%2C%20TX%20%2D%20Certain%20disclaimers%20must%20be,does%20not%20have%20a%20Medicare%20supplier%20number%2C

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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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Billing for Compression (part 2)

Last month, we highlighted how therapists can bill insurance for compression for their own patients. It’s not exactly straight-forward. There are several federal & state laws that must be considered (among others). And if you want to bill compression for other people’s patients, well – that throws a wrench into the mix! This post will discuss how therapists can do that & what needs to be considered.

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

Billing Medicare

Let’s recap your options for billing for compression as a therapist. There are (3) models.

  1. You only bill Medicare for compression as a supplier (not for service as a provider). You still have to know the laws relevant to DME & pay related fees. But the model is simple.
  2. You bill Medicare for compression as a supplier & for service as a provider within your business. It’s still fairly simple but it is a bit more complex than the first model.
  3. You bill Medicare for compression as a supplier & for service as a provider – but you also want to bill compression for other people’s patients. Hmmm….that’s tricky. This model has unique ownership precautions that not only gets into federal statutes (as do the above options) but also criminal liability.

First, in order to bill for compression, you must have a DME license in your state & follow your laws (therapist or not). You must also credential with insurance companies (if you want to be in-network) & decide whether you’re going to bill yourself (using a software) or whether you’re going to use a third-party. (Each of these has their own learning curve.)

Second, if you want to bill for compression in other states (obviously for people who are not your patients), you must follow the same procedures as above. You also need to be prepared to open a physical location in each of those states. Third, if you plan to bill for your own patient’s compression & also bill for other people’s compression, you need to be aware of federal statutes pertaining to fraud & abuse as well as to business ownership.

Federal Statutes: Fraud & Abuse Laws1

The Office of Inspector General outlines five of the most important laws pertaining to medical professionals. These include:

1. False Claims Act – don’t lie, overcharge or provide poor-quality goods
2. The Anti-Kickback Statute – don’t give or take rewards (money or otherwise) for referrals or business involving federal funds
3. Stark (or self-referral) Law – a physician (or their family) can’t have a financial interest in a business & refer Medicare or Medicaid patients to it
4. The Exclusion Authorities – people or business convicted of certain crimes are automatically excluded from federal health care plan participation
5. Civil Monetary Penalties Law – you may be fined fees (ranging from $10k-$50k per violation) based on certain laws breached

Some of these laws are for physicians only (such as Stark Law), but others pertain to everyone. The most relevant to our discussion is the Anti-Kickback Statute. We’ll pick that topic up next time.

References
https://oig.hhs.gov/compliance/physician-education/fraud-abuse-laws/

Attribution
Pexels calculation photo by Tom Miroshnichenko
Pexels gavel photo by Katrin Bolovtsova

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Billing for Compression

It’s April Fools’ Day & do I have a hoax for therapists wanting to bill Medicare in light of the Lymphedema Treatment Act (LTA). Seems simple, right? Read on…

Applicable Laws

There are several federal & state laws you need to be aware of to bill for compression (which falls under DME or durable medical equipment). A non-comprehensive list of these laws includes the supplier standards in the Code of Federal Regulations (CFR), anti-kickback laws & state DME regulations. It’s also going to cost a fair amount of money to start. The good news is, if you’re a therapist who already bills insurance as a provider, you can also bill for DME as a supplier within the same business. (You do need to consider, however, how taxonomy codes may impact reimbursement for commercial payors in such case.) If you want to bill for your own patients, setting up is simpler. If you want to bill for other people’s patients, it’s tricky & potentially more expensive. Let’s look at the first scenario in this blog.

Billing Insurance for Your Own Patients

If you have a therapy practice which bills insurance as a provider for lymphedema treatment, you’ll need to establish a DME part to your business to be a supplier. You should already have an office space (hopefully, that’s no less than 200 sq feet as required by federal supplier standards). So, the next step is to familiarize yourself with the 42nd chapter of the Code of Federal Regulations. It says therapists in private practice can bill for their own patients & avoid some of the supplier standards that others must adhere to. Namely, you can avoid paying for a surety bond & having to keep the business open/staffed for a minimum of 30 hours/week. You still have to set up a separate land line that’s answered (no cell phones or call centers) & pay for accreditation, Medicare’s application fee & liability insurance (among other costs).

The second step is to contact your state’s DME licensing board to find out applicable laws. These laws may be under a different name such as “device distributors” for your purposes. Complete your state’s licensing paperwork & pay their fee.

Next, contact one of Medicare’s approved DME accreditation agencies. Medicare has a list of these agencies.1 After ensuring you’re in compliance with their rules, complete their application & pay that fee. (Many suggest you also retain a consultant to help with all the required policy & procedures that must be implemented & on-hand during site visits.)

Fourth, once all laws & fees are paid, you’re ready to credential with insurance (if you want to be in-network). Call the credentialing line for each insurance company you’d like to contract with & specify that you’re seeking to be a DME supplier in-network. They’ll send you the necessary paperwork & fee schedule once you’re approved. (Be prepared: There may be some confusion with insurance credentialing staff if you’re already credentialed as a provider. Again, you’ll need to specify you want to credential as a DME supplier. You can hire a 3rd party to assist with credentialing.) For Medicare, there’s an extra step. You’ll need to know your state’s local DMEPOS MAC (durable medical equipment, prosthetics, orthotics & supplies Medicare administrative contractor). These MACs have jurisdiction over specific regions in the United States. These jurisdictions are called A, B, C, & D. For example, Texas falls in jurisdiction C. The DMEPOS MAC for Texas is CGS Administrators (CGS Medicare).

Fifth, familiarize yourself with Medicare’s LTA billing requirements. If you’re already a provider billing insurance, you’ve got a leg up on understanding billing codes. For example, you know providers use CPT codes, but suppliers use HCPCS codes. You’ll also need to know about modifiers, when to use them & other billing requirements for the LTA.4  You can find out more about these requirements on your MACs site.

Conclusion

It’s important to note that just because you’re able to bill Medicare in your state doesn’t mean you can bill for DME for other states. We’ll cover that & billing DME for other people’s patients in the next post.

***UPDATE 06/11/24***

According to the National Provider Enrollment West (NPE West) division (granted to Palmetto GBA), therapists (billing for their own patients only) are no longer required to be accredited. But they must get a surety bond. (This is a change from the current rules.)2 In an email, the administrator said, “Per CMS, lymphedema items are a separate benefit under SSA 1861(s)(2)(JJ).  They are not orthotics, prosthetics, and supplies mentioned in 42 CFR 424.57(d)(15)(i)(D)(3), and any OT/PT wanting to update the enrollment to furnish lymphedema items would not be “only billing for orthotics, prosthetics, and supplies”, and would no longer qualify for the surety bond exemption. CMS also contacted the HHS Office of General Counsel, which confirmed CMS’ determination.“

References
1 (DME accreditation list) https://www.cms.gov/files/document/dmepos-accreditation-organizations.pdf
2 (CFR 42) https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-B/part-424/subpart-D/section-424.57
3 (DMEPOS MACs) https://www.cms.gov/medicare/coding-billing/medicare-administrative-contractors-macs/who-are-macs
4 (modifiers) https://www.cgsmedicare.com/jc/pubs/news/2023/12/cope147943.html

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Compression Garments & Insurance (part 5/5)

Because of the Lymphedema Treatment Act, Medicare will now cover lymphedema compression, supplies & aids with the appropriate diagnosis code & medical necessity. What items are covered & how do you get them?

Diagnosis Codes

A diagnosis code must be written on a physician order. Appropriate diagnosis codes1 to qualify for the new lymphedema benefit category are

  • I89.0 Lymphedema, not elsewhere classified
  • I97.2 Post-mastectomy lymphedema
  • I97.89 Other postprocedural complications & disorders of the circulatory system, not elsewhere classified
  • Q82.0 Hereditary lymphedema

Medical Necessity

A patient must have a medical necessity for the ordered item(s). Medical necessity is proven by physician order & supportive documentation. A physician order can be signed by a “treating practitioner,” meaning, a medical doctor, doctor of osteopathy, podiatrist, physician’s assistant (PA), nurse practitioner (NP), or clinical nurse specialist (CNS).2,3 The following must be on the “standard written order.”2

  • The name of the treating practitioner, their NPI (national provider identifier), their signature & the date
    • stamps can’t be used; signatures & dates can be electronic or handwritten1,4
  • The beneficiary’s name (the patient’s name) & Medicare number
  • Description of the item(s) (such as the HCPCS code1)
    • options or features constituting an upgrade above the basic item must be listed separately on the order (such as upgrading from an off-the-shelf hose to a custom hose or adding a lining, zipper or pocket to a custom garment, etc.)
    • supplies must be listed separately on the order (such as a donning frame, donning gloves, etc.)
  • The quantity to be dispensed.

Supportive documentation (if requested) would include medical or therapy notes. (Note: Some DME requires a face-to-face encounter with the treating practitioner within 6 months of an order.5 Lymphedema items are not currently on that list.)

Compression Supplies Covered

Phase 1 of lymphedema treatment (the reduction or decongestion phase) requires decongestion supplies. This typically includes a cotton liner, a padding layer & several short-stretch bandages. At times, a Velcro reduction garment or wound kit might be used instead.

For coverage, supportive documentation must include justification for the quantity & frequency of these items. In my experience, two sets of supplies are needed (one to use & one to wash). Each set can be laundered & reused each session. (Avoid bleach, fabric softener, Woolite, dryer use or placing items in the sun as these things can damage the elastic fibers.)

When it comes to billing, a supplier will need to line-item each compression bandaging supply, accessory, wrap or garment that doesn’t have a unique HCPCS code with one of the following best-matched HCPCS codes:

  • A6549 – Gradient compression garment, not otherwise specified
  • A6584 – Gradient compression wrap with adjustable straps, not otherwise specified
  • A6593 – Accessory for gradient compression garment or wrap with adjustable straps, not otherwise specified
  • A6609 – Gradient compression bandaging supply, not otherwise specified.

The supplier will also need to add:1

  • a description of the item (including the inch, foot or yard for supplies)
  • manufacturer name
  • product name & number
  • supplier price list
  • HCPCS of a related item.

Billing modifiers are needed as well (right, left, replacement – if an item is lost, stolen or damaged, etc.).

All therapists & patients should be good stewards & conservative in their utilization of this benefit. Abuse & waste will cause problems down the road (be it increased government debt, higher taxes or another outcome).

Compression Garments Covered

Phase 2 of lymphedema treatment is the maintenance phase. This is when compression garments are needed to maintain the volume loss attained in Phase 1. Medicare covers these garments which may include:

  • off-the-shelf or custom (for all body parts) (typically flat-knit, circular-knit or Velcro)
  • day &/or night garments (typically Velcro or foam garments).

Medicare allows for:

  • (3) daytime garments every 6 months
  • (2) nighttime garments every 24 months

    (Note: There are two situations in which additional compression may be covered. The first is if an item is lost, stolen or damaged. The second is if there is a change in the patient’s status or condition. Either situation will require a new order & the replacement clock will start over.1)

Garment Aids Covered

Many patients are not aware there are several donning & doffing aids available to help get compression on or to remove it. There are donning frames, slippery material, gloves & other tools your therapist may know about. Justification for the quantity of supplies & the frequency of dispensing must be supported by documentation.

YouTube
Check out the Lymphedema Savvy YouTube channel for an upcoming treatment vlog. Information about the Lymphedema Treatment Act & billing will be included in a future video.

*****UPDATE 07/22/24*****

The following educational handouts were provided by the Lymphedema Treatment Act:

Patients
Providers
Suppliers

*****UPDATE 02/19/25*****

The current list of HCPCS lymphedema compression billing codes can be found here. The US Medical Compression Alliance has noted Medicare approval of additional codes here (effective April 1, 2025). They are specifically listed in Medicare’s Final Rule here. Medicare Learning Network (MLN Matters publication) provides billing tips here.

References
1 (coverage) https://www.cgsmedicare.com/jc/pubs/news/2023/12/cope147943.html
2 (orders) https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=55426
3 (physician) https://www.ssa.gov/OP_Home/ssact/title18/1861.htm
4 (signatures) https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/pim83c03.pdf
5 (face to face) https://www.cms.gov/data-research/monitoring-programs/medicare-fee-service-compliance-programs/medical-review-and-education/dmepos-order-requirements or https://www.federalregister.gov/documents/2023/01/17/2023-00718/medicare-program-updates-to-face-to-face-encounter-and-written-order-prior-to-delivery-list#:~:text=For%20items%20on%20the%20F2F,of%20the%20written%20order%2Fprescription.

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