Dedicated to Lymphedema Patients and the Therapists Who Treat Them
Dedicated to Lymphedema Patients and the Therapists Who Treat Them
10671 Baton Rouge Avenue
Porter Ranch, CA 91326-2905
November 24, 2015
Wilfred Mamuya, MD, PhD NHICDMEDraftLCDFeedback@eds.com
DME MAC, Jurisdiction E
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Hingham, MA 02043-1588
Stacey V. Brennan, M.D., FAAFP DMACDraftLCDComments@wellpoint.com
DME MAC, Jurisdiction F
National Government Services
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Robert D. Hoover, Jr., MD, MPH, FACP firstname.lastname@example.org
DME MAC, Jurisdiction G
CGS Administrators, LLC
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Eileen M. Moynihan, MD, FACP, FACR email@example.com
DME MAC, Jurisdiction H
Noridian Administrative Services
900 42nd Street South
Fargo, ND 58103-6727
Comments regarding LCD L33829 Pneumatic Compression Devices
effective Dec. 1, 2015.
Although there has been no public comment period on this release, I would like to send in a list of issues that should be considered concerning the accuracy of the information therein and the potential impact on Medicare beneficiaries. This version of the PCD LCD is, in this reviewer's opinion, a disaster for lymphedema patients that will increase significantly Medicare costs of treating beneficiaries with diagnosed lymphedema. Whereas current medical studies are demonstrating the value of early detection and intervention for lymphedema as a means of reducing treatment costs and improving patients' quality of life, this revision is forcing exactly the opposite to happen, with one valuable lymphedema treatment tool being placed out of reach of the patient most in need of it. PCD technology and lymphedema knowledge have advanced greatly in the 15 years since the last revision of PCD policy, but the benefits of this knowledge and new technology are not being reduced to practice in this version of the PCD LCD.
I urge you to not implement this LCD until an updated version can be developed that reflects the current state of PCD technology and that will be coordinated with current Medicare policies on the other modalities of lymphedema treatment. Only then will Medicare realize the potential for early management of lymphedema before it reaches the hard-to-treat Stage III with its concomitant risks for recurrent infection, hospitalizations, provider visits and ultimately disability.
General Comments on the subject LCD:
Lymphedema is a chronic, progressive condition. Evidence is emerging in the last few years that early treatment of pre-clinical lymphedema has the potential of preventing or slowing progression to more severe stages and avoiding the permanent tissue changes that result from long-standing lymph stasis (lymphedema). [Box 2002, Stout-Gergich 2008, Boccardo 2009, Torres-Lacomba 2010, Zimmermann 2012].
Hard evidence is also emerging that early treatment of lymphedema reduces adverse clinical outcomes and costs. Using insurance claims data on a population of 1,065 individuals with cancer-related lymphedema, it was shown that introduction of a sequential pneumatic compression device for the treatment of lymphedema decreased annual rate of hospitalization from 45 to 32%, outpatient hospital visits from 95 to 90%, cellulitis diagnoses from 28 to 22%, physical therapy use from 50 to 41%, and annual health care costs from $62,190 to $50,856 [Table 3 of Brayton 2014]. Similar data based on ten years of a lymphedema treatment mandate in Virginia will be forthcoming in a peer-reviewed paper [Weiss 2016].
The tools used by the trained therapist to treat lymphedema vary with the characteristics and severity of the patient's lymphedema and the patient's comorbidities and social needs. Tissue fluid content, skin fibrosis, fat content and skin condition are continually changing and must be managed through changing combinations of manual lymph drainage (MLD), compression, lymphatic decongestive exercises and meticulous skin care (together, known as complex decongestive therapy or CDT).
Current Medicare policy on pneumatic compression devices is governed by NCD 280.6 that was informed by references published between 1984 and 2000. It was last updated on January 14, 2002. On November 18, 2009 at a MEDCAC convocation of lymphedema specialists, it was determined with an intermediate level of confidence, that complex decongestive therapy (CDT) alone, CDT with adjuvant compression devices, compression bandaging/compression garments alone, and pneumatic compression devices alone "produce clinically meaningful improved health outcomes for patients with secondary lymphedema" [MEDCAC 2009].
Since the 2009 evaluation of the benefits of pneumatic compression devices (PCDs) there have been many additional clinical studies and peer-reviewed studies amplifying the beneficial role of PCDs in the treatment of lymphedema—both primary and secondary [e.g. Muluk 2013, Fife 2012, Adams 2010, Ridner 2010]. The importance of truncal clearance as a component of lymphedema treatment has been elucidated [Mayrovitz 2009].
The restriction of PCDs to severe lymphedema after irreversible tissue changes have taken place runs counter to all our current medical knowledge about the benefits of early detection and intervention for the prevention of late stage lymphedema. Under-treatment of lymphedema and allowing it to progress to later stages also places the patient under risk of recurrent cellulitis and accelerated tissue degradation [Stöberl C 1987, Al-Niaimi 2009].
Recent lymphedema treatment studies document the reduction of infections, hospitalizations and doctor visits resulting from lymphedema treatment [Bilar 2012, Box 2002, Brayton 2014, Karaca-Mandic 2015, Torres Lacomba 2010, Weiss 2016].
Comments concerning definition of secondary lymphedema (Page 3 of 18):
Among the causes of lymphedema is obesity, which may develop and be irreversible for patients with body mass index (BMI) greater than 50 [Greene 2015].
The last sentence in the description of secondary lymphedema is incorrect. Secondary lymphedema does not result from "compression of the lymphatic and venous channels resulting from leakage of fluid into interstitial tissues". It results from an inability of the lymphatic system to collect and transport the interstitial fluid.
Comments concerning definition of Chronic Venous Insufficiency (CVI)(Page 3 of 18)
Fluid does not "leak into the tissues from the venous system". Tissue fluid leaks into the tissue from the arterial system, but CVI impairs the venous system from performing its normal function of returning circulatory fluid to the heart.
Comments on the use of PCDs for the treatment of venous insufficiency (Page 3 of 18)
The medical rationale for only treating venous insufficiency with venous stasis ulcers is faulty. Venous ulcers can be prevented with use of compression upon appearance of edema, since it is the state of chronic edema (lymph stasis due to an overloaded lymphatic system) that causes tissue degradation leading to venous ulcers. These ulcers can largely be prevented by early use of compression!
Comments on the coverage of an E0652 PCD for the extremity alone (Page 4 of 18)
There may be a valid medical reason to require an E0652 PCD for treatment of an extremity with massive localized lymphedema [Fife 2014], localized fibrotic tissue, or lymphatic ulcers. In these cases manual programming of pressures and times may be required. The General Coverage Requirements of NCD 280.6 provides this flexibility, i.e. "The only time that a segmented, calibrated gradient pneumatic compression device (HCPCS code E0652) would be covered is when the individual has unique characteristics that prevent them from receiving satisfactory pneumatic compression treatment using a non-segmented device in conjunction with a segmented appliance or a segmented compression device without manual control of pressure in each chamber." This decision is best left to the treating physician and therapist, and not dictated as a rule.
Comments on the four-week trial for lymphedema (Pages 4-5 and 6-7 of 18)
This four-week trial imposes requirements for medical services that are not provided by Medicare. The trial requires four weeks of "regular and compliant use of an appropriate compression bandage system or compression garment...". Medicare Contractors regularly deny coverage of compression bandage systems and compression garments for lymphedema even though they meet the coverage criteria of CMS Pub. 100-02, Chap. 15, §120 for "prosthetic devices" (Pages 29-43 of Weiss 2013)
Manual lymphatic drainage (MLD) is held to be a key component of conservative treatment but it is not included in the required trial protocols. In any case, four weeks of MLD and compression bandaging is likely to exceed the annual therapy cap, and so could in all probability not be provided unless this trial justifies an exception to the Congressionally-imposed annual therapy cap.
There is no CPT Code for applying compression bandages by qualified lymphedema therapists (it is bundled with MLD CPT 97140). Four weeks of lymphedema bandaging would exceed the annual therapy cap.
The criteria for failure of the four-week trial is vague and unenforceable--improvement by what measure? Is there a "control" against which improvement is measured? Is there a threshold that defines "improvement" for purposes of this trial?
Comments on the requirements for an E0652 PCD (Pages 6-7 of 18)
"The only time that a segmented, calibrated gradient pneumatic compression device (HCPCs code E0652) would be covered is when the individual has unique characteristics that prevent them from receiving satisfactory pneumatic compression treatment using a non-segmented device in conjunction with a segmented appliance or a segmented compression device without manual control of pressure in each chamber." [NCD 280.6].
Lymphedema extending into the trunk, chest and/or abdomen clearly fits this criteria and is correctly included in the LCD. But this is by no means the only unique individual characteristic that would require an E0652 PCD, and the requirement "A PCD coded as E0652 used to treat lymphedema not extending onto the chest, trunk and/or abdomen or CVI is not eligible for reimbursement. Claims will be denied as not reasonable and necessary." is in conflict with NCD 280.6. Upper or lower lymphedematous limbs exhibiting localized fibrosis, significant scarring, sensitive skin or the presence of contracture with documentation of the need for a specified pressure to a localized area [BlueCross BlueShield 2015], local massive edema [Fife 2014], or non-healing ulcers might require a PCD with individually-adjustable pressures or durations at the direction of the treating physician or therapist which are not achievable with an E0650 or E0651 PCD. These special medical requirements are consistent with NCD 280.6 and should not be prohibited by a PCD LCD.
Pumps that offer programmability with calibrated gradient pressures allow for adjustability to address painful areas and some also provide programs that can retreat specific areas of fibrosis [Mayrovitz 2007]. Using specific E0652 pumps have proven to aid in tolerance, compliance with recommended treatment regimens and satisfaction with physical improvement in patient reported symptoms [Ridner 2008]
While existing pump research may not conclude that programmable pumps provide "superior" outcomes over traditional nonprogrammable pumps in terms of reducing volume, the published literature clearly raises concerns with injudicious use of nonprogrammable pumps in lymphedema treatment due to the significant risks and shortcomings associated with older generation pumps. Traditional (E0651) pumps may be safe and effective for some patients with "swelling", but clearly those devices are not clinically appropriate for many lymphedema patients due to potential complications and technology limitations [Weiss 2012]
Comments on the four-week trial for an E0652 PCD (Pages 6-7 of 18)
"Regular exercise" is too vague to be a mandatory trial condition for an E0652 PCD. While regular exercise has been found to be salutary for general health and wellbeing, there is little evidence that it is effective in reducing lymphedema of the breast, chest and trunk, and should not be included in the four-week trial of conservative therapy for lymphedema extending into the chest, trunk and/or abdomen.
There is no evidence that diet is effective in reducing lymphedema of the breast, chest and trunk, and should not be included in the four-week trial of conservative therapy for lymphedema extending into the chest, trunk and/or abdomen.
Although there is evidence that manual lymph drainage performed by a therapist trained in lymphedema therapy is effective in reducing lymphedema of the extremities or the breast, chest, trunk and/or abdomen, there is no evidence that self-manual lymphatic drainage is effective in reducing lymphedema of the extremities or of the breast, chest, trunk and/or abdomen, and should not be included in the four-week trial of conservative therapy for lymphedema extending into the chest, trunk and/or abdomen. [Wilburn 2006]
The criteria concerning compression bandage system or compression garment applies to lymphedema of the extremities, but is not appropriate for the determination of a PCD with truncal appliances for the treatment of lymphedema extending into the chest, trunk and/or abdomen. Compression bandage systems are typically not part of the conservative treatment of truncal lymphedema, and guidance on "graduated compression with a minimum of 30 mmHg distally" do not apply when dealing with the chest, trunk and/or abdomen. Also, Medicare does not provide coverage for these items or for their measurement or application.
Comments on Certificate of Medical Necessity (Page 14 of 18)
The current version of the Certificate of Medical Necessity (CMN) CMS-846 Pneumatic Compression Devices has not been updated to correspond with the coverage criteria of the LCD. This is a source of confusion in documenting the medical necessity for a PCD for treatment of secondary lymphedema which is not cancer-related, e.g. infection, joint replacement, physical trauma, obesity. Instructions on providing the appropriate information should be provided in the LCD, or the CMS-846 form should be updated.
Comments on in-clinic use of PCDs and patient training in the home use of PCDs
This writer would suggest a reiteration, in the LCD, of the billing rules and restrictions for use of a PCD in an outpatient clinic, and the therapist billing for patient training in the home use of a PCD.
Comments on Associated Documents
It is stated that: "This LCD version has no Related National Coverage Documents." Isn't NCD 280.6 an associated NCD?
Submitted by: Robert Weiss, M.S.
Independent Lymphedema Patient Advocate
Porter Ranch, CA
[Adams 2010] Adams KE, Rasmussen JC, Darne C, Tan I-C, Aldrich MB, Marshall MV, Fife CE, Maus EA, Smith LA, Guilloid R, Hoy S and Sevick-Muraca EM. Direct evidence of lymphatic function improvement after advanced pneumatic compression device treatment of lymphedema. Biomed Optics Express. 2010;1(1):114-25.
[Al-Niaimi 2009] Al-Niaimi F and Cox N. Cellulitis and lymphoedema: a vicious cycle. J Lymphoedema 2009;4(2):38-42.
[Bilar 2012] Bilir SP, DeKoven MP and Munakata J. Economic Benefits of BIS-Aided Assessment of Post-BC Lymphedema in the United States. Am J Manag Care 2012;18(5):234-41.
[BlueCross BlueShield 2015] BlueCross BlueShield of North Carolina. Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers, 5/2015. Accessed 9/06/2015 at BCBS of North Carolina
[Boccardo 2009] Boccardo FM, Ansaldi F, Bellini C, Accogli S, Taddei G, Murdaca G, Campisi CC, Villa G, Icardi G, Durando P, Puppo F and Campisi C. Prospective evaluation of a prevention protocol for lymphedema following surgery for breast cancer. Lymphology 2009;42:1-9.
[Box 2002] Box RC, Reul-Hirsch HM, Bullock-Saxton JE and Furnival CM. Physiotherapy after breast cancer surgery: results of a randomised controlled study to minimise lymphoedema. Br Cancer Res Treat. 2002;75:51-64.
Brayton 2014]. Brayton KM, Hirsch AT, O'Brien PJ, Cheville A, Karaca-Mandic P and Rockson SG. Lymphedema Prevalence and Treatment Benefits in Cancer: Impact of a Therapeutic Intervention on Health Outcomes and Costs. PLoS ONE 2014;9(12): e114597. doi:10.1371/journal.pone.0114597
[Fife 2010] Fife C & Carter M. Lymphoedema in Bariatric Patients. J Lymphoedema 2010;4(2):29-37.
[Fife 2012] Fife, CE, Davey S, Maus EA, Guilliod R and Mayrovitz HN. A randomized controlled trial comparing two types of pneumatic compression for breast cancer-related lymphedema in the home Support Cancer Care 2012;20:3279-86.
[Fife 2014] Fife C. Massive localized lymphedema a disease unique to the morbidly obese: a case study. Ostomy Wound Manage. 2014;60(1):30-5.
[Greene 2015] Greene AK, Grant FD and Maclellan RA. Obesity-induced lymphedema nonreversible following massive weight loss. Plast Reconstr Surg Glob Open June 2015;3(6):e426. Published online 2015 Jul 8. doi: 10.1097/GOX.0000000000000398
[Karaca-Mandic 2015] Karaca-Mandic P, Hirsch AT, Rockson SG and Ridner SH. The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. JAMA Dermatology Published Online October 7, 2015. http://archderm.jamanetwork.com/ Accessed on 10/07/2015
[Mayrovitz 2007] Mayrovitz HN. Interface pressures produced by two different types of lymphedema therapy devices. Physl Ther October 2007;87(10):1379-88.
[Mayrovitz 2009] Mayrovitz HN, Brown-Cross D, Mayrovitz BL and Gotta AH. Lymphedema: Roll of truncal clearance as a therapy component. Home Health Care Mgmt Pract. 2009;21:325-37.
[Muluk 2013] Muluk SC, Hirsch AT, Taffe EC. Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-reported Outcomes, European Journal of Vascular and Endovascular Surgery, October 2013, 46(4)480-7.
[MEDCAC 2009] MEDCAC Lymphedema Panel Score Sheets, MEDCAC Lymphedema Technical Panel, Question 6 https://www.cms.gov/faca/downloads/id51a.pdf
[Ridner 2008] Ridner SH, McMahon E, Dietrich M, Hoy S. Home-based lymphedema treatment in patients with cancer-related lymphedema or non cancer-related lymphedema. Oncol Nurs Forum. 2008;35:671-80.
[Stöberl 1987] Stöberl C and Partsch H. [Erysipelas and lymphedema—egg or hen?] (in German) Zeit Hautkrankheiten. 1987;62(1):56-62.
[Stout-Gergich 2008] Stout Gergich NL, Pfalzer LA, McGarvey C, Springer B, Gerber LH and Soballe P. Preoperative Assessment Enables the Early Diagnosis and Successful Treatment of Lymphedema. Cancer June 15, 2008;112(12):2809-19.
[Torres-Lacomba 2010] Torres Lacomba M, Yuste Sanchez MJ, Zapico Goñi A, Prieto Merino D, Mayoral del Moral O, Cerezo Téllez E and Minayo Mogollón E. Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial. BMJ 2010;340b5396 doi:10.1136/bmj.b5396.
[Weiss 2012] "All you need to know about Sequential Compression Devices" on LymphActivist's Site http://www.lymphactivist.org/sequential_compression_devices.php
[Weiss 2013] Weiss R. "How Are Compression Bandages, Garments, Devices and Supplies Coverable under the Social Security Act?" April 9, 2013 http://www.lymphactivist.org/prosthetic_devices-insert.pdf Accessed November 21, 2015.
[Weiss 2016]. Cost of a Lymphedema Treatment Mandate – 10 Years of Experience in the Commonwealth of Virginia. Health Econ Rev. (in press)
[Wilburn 2006] Wilburn O, Wilburn P and Rockson SG. A pilot, prospective evaluation of a novel alternative maintenance therapy of breast cancer-associated lymphedema. BMC Cancer 2006;6(1):84-9.
[Zimmermann 2012]. Zimmermann A, Wozniewski M, Szklarska A, Lipowicz A and Szuba A. Efficacy of manual lymphatic drainage in preventing secondary lymphedema after breast cancer surgery. Lymphology 2012;45:103-12.