Source: http://www.lymphactivist.org/pcd_lcd_updated.php
Timestamp: 2018-03-20 21:04:43
Document Index: 698428320

Matched Legal Cases: ['§60', '§280', '§6407', '§280', '§280', '§280', '§6407', '§1861', '§120']

UPDATED PNEUMATIC COMPRESSION DEVICES LCDS AND POLICY ARTICLES GO INTO EFFECT NOVEMBER 1, 2014 rev 2014-10-26 ver4
Pneumatic Compression Devices LCD Implementation Delayed
Joint DME MAC Publication October 16, 2014
"The Pneumatic Compression Devices Local Coverage Determination (LCD) and related Policy Article (PA) scheduled to take effect for dates of service on or after November 1, 2014 are being delayed. Additional clinical information published since the release of the draft policy is being reviewed. No future effective date for the draft policy is available at this time. The current LCD and related PA will remain in effect."
I hope that my comments on this upcoming revision at the end of this article are being incorporated into the rewrite of the LCD. [RW]
In 2001, as a result of National Coverage Analysis CAG-00016N, the rules for coverage of pneumatic compression devices (PCDs) for lymphedema treatment were separated from the rules governing treatment of venous insufficiency, and the new rules were documented in Coverage Issues Manual §60-16, and later as National Coverage Determination (NCD) §280.6. Since 2001 there has been significant development of pump designs specifically for superficial lymphatic decongestion, distinct from pumps originally developed to aid venous circulation. For a primer on the subject of PCDs for lymphedema treatment I recommend reading "All You Need to Know About Sequential Compression Devices" on this web site at http://www.lymphactivist.org/sequential_compression_devices.php
Scientific knowledge of the function and pathology of the human lymphatic system has also advanced in the intervening 12 years, knowledge that could guide the referring physician and treating lymphedema therapist in the specifying of an appropriate sequential compression device, its set-up and clinical and patient use. The importance of decongesting adjacent regions before draining the affected limb has led to development of breast, trunk and abdominal appliances and associated clinical protocols for the use of pneumatic sequential compression in the treatment of lymphedema.
Local Coverage Determinations for Pneumatic Compression Devices
Types of Local Coverage Determinations (LCDs)
Proposed/Proposed Draft LCD: Draft under development, not yet released for comment
Draft LCD: Preliminary LCD released to elicit comments during a defined comment period
Future LCD: Final LCD approved and awaiting date of effectivity
Active LCD: LCD that is currently in effect
Retired LCD: Formerly Active LCD which is no longer effective, but available for reference
In the last ten years the technology for PCDs for lymphedema has advanced, but changes were not made in the coverage of these devices pending accumulation of adequate evidence of the efficacy of these technological changes. The four Durable Medical Equipment (DME) Medicare Administrative Contractor (MAC) Medical Directors published a "Proposed LCD for Pneumatic Compression Devices (PCDs)" in 2011. Since then the Centers for Medicare and Medicaid Services (CMS) has received many comments and requests for changes to the published coverage of PCDs. CMS-accepted changes were documented in four revised LCDs and policy articles scheduled to become effective on November 1, 2014. It is these Future LCDs that are the subject of this paper.
In spite of the advances in lymphedema treatment knowledge and technology, coverage of a truncal appliance has been explicitly denied in LCDs issued since 2009 in all jurisdictions (i.e. Active LCDs L11503, L27028, L5017 and L11492 for Jurisdictions A, B, C and D respectively). It is puzzling that in 2009 the same revisions which added trunk and chest appliances to the HCPCS code list introduced a statement of the non-coverability of these items. The coverage criteria for trunk and chest appliances in the "Proposed Draft LCDs for Compression Devices", available for comment since August 2011, were never added to the 2013 and 2014 Active LCDs.
In July 2013 all four DME MACs added changes to their LCDs that were mandated by the Affordable Care Act (ACA) §6407 for a face-to-face interaction between the beneficiary and their treating physician prior to prescribing a pneumatic compression device and appliances, with specific documentation that states that the beneficiary was evaluated and/or treated for a condition that supports the need for the item(s) of DME ordered, and an explicit description of the required compression device and appliances.
The PCD LCDs becoming effective on November 1, 2014 will spell out in detail the requirements for coverage of a pneumatic compressor with chest, trunk or abdomen appliances for treatment of lymphedema of the limbs that extends to the chest, trunk or abdomen.
Pneumatic Compression Device LCDs and Coverage Articles
LCD ID ARTICLE
(AND CONTRACT NUMBER)
A37216 DME MAC A NHIC, Corp. (16003) Effective: 10/1/1993
Revision: 7/1/2013
Rev 4: 11/01/2014
A47127 DME MAC B National Government Services, Inc. (17003) Effective: 10/1/1993
A24141 DME MAC C CGS Administrators, LLC (18003) Effective: 10/1/1993
L11492
A37075 DME MAC D Noridian Healthcare Solutions, LLC (19003) Effective: 10/1/1993
Revision: 11/1/2013
Rev 5: 11/01/2014
CMS's Responses to Comments on the 2011 Draft
This section includes excerpts from the DME MAC advisories "Pneumatic Compression Devices (PCD) —Response to Comments Summary" dated September 11, 2014, which address CMS's responses to comments they received on the 2011 Proposed LCD. See the full advisory, for example, at: http://cgsmedicare.com/jc/pubs/news/2014/0914/cope26841.html
Only those issues relating to the treatment of lymphedema, and not to the use of PCDs for treatment of venous insufficiency or peripheral arterial disease have been abstracted.
Several commenters recommended allowing coverage of an E0652 PCD for secondary lymphedema of any etiology, with or without ulcers, when diagnostic criteria are met and the E0650 or E0651 has been ineffective at controlling the lymphedema. It was recommended that documentation of trained and supported daily use of a carefully-fitted E0650 or E0651 for a minimum of 4 weeks without significant clinical response should be sufficient to evidence the need for the E0652 device. It was recommended the documentation include a detailed description of the therapies recommended in conjunction with the pump as well as providing objective clinical details of why E0650/E0651 device and adjunct therapies were not effective.
Response: The CMS National Coverage Decision (NCD) §280.6 has determined, "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."
Review of the clinical literature indicates that the only consistently documented clinical need for an E0652 is for the treatment of lymphedema extending onto the chest, trunk and/or abdomen past the limits of a standard compression sleeve, where the lymphedema has failed to improve with a continued, carefully-performed, good-faith trial of the E0650/E0651 device coupled with other more conservative therapy.
Commenters indicated a need to use an E0652 where an E0650/E0651 was simply incapable of the task due to conditions of severe obesity, chronicity, fibrosis, number of wounds or other reasons, but there was no literature provided to enable a systematic way to identify these rare situations. The absence of such clinical literature prevents development of criteria to identify individual clinical circumstances and they must therefore continue to be addressed at appeal by individual consideration of a record which must establish that all other more conservative approaches including the continuous, regular use of E0650/E0651 over time have proven insufficient, whereas a trial of the E0652 has been successful.
Several commenters raised a concern that the draft LCD conflicts with NCD §280.6 for PCDs by being more restrictive that the NCD in the coverage afforded to causes of lymphedema.
Response: The revised LCD broadens the allowed indications and thereby specifically addresses any concern in this area. There is no conflict with the revised LCD and the NCD.
Several commenters recommended that PCDs should be covered for chronic venous insufficiency even in the absence of ulcers.
Response: This is not an option for the DME MACs under NCD §280.6. However, the coverage of lymphedema from various causes has been broadened which will likely accomplish much of what these commenters desire.
One commenter felt the language "...has failed to improve with a period of at least four weeks of regular daily home use of the E0650 or E0651 with careful, in-person fitting, overview and training by a technician skilled in and regularly, successfully using the appliances prescribed..." is unclear.
Response: The language and formatting have been clarified.
One commenter recommended that an E0652 be allowed for unilateral limb edema, documented to be unresponsive to use of E0651/E0650 coupled with other more conservative measures, on a prior authorization basis.
Response: This recommendation is beyond the scope of the current LCD and Policy Article revisions.
One large manufacturer of PCDs recommended that part of the current focus in the NCD and LCD about usage of the E0650 and E0651 was because of price differential and that with improvements in technology and cost-efficiencies in recent years, Medicare should reduce the reimbursement for E0652 and relax requirements for use of this code.
Several commenters indicated podiatrists should be an eligible provider type to order PCDs, rather than have ordering providers limited to physicians (MD, DO) and physician extenders (NP, PA & CNS).
Response: Podiatrists (DPM) and other providers are excluded because applicable state scope-of-practice or other license requirements limit management of systemic conditions. Treatment of peripheral artery disease, lymphedema, chronic venous insufficiency with ulceration and complications related to the treatment of these conditions by use of PCDs, require consideration of diagnoses and management of systemic conditions that fall outside of these practitioners' license limitations.
Two commenters pointed out that the Certificate of Medical Necessity (CMN) for pneumatic compression pumps, CMS Form 846 (DME Form 04.04B), does not track with the NCD and LCD requirements which causes confusion in submitting claims.
Response: We agree and are hopeful the CMN may at some point be revised to correct these issues, but this is currently beyond the scope of this LCD and Policy Article revision.
Lymphedema-Related Provisions from LCDs for Pneumatic Compression Devices (PCDs) Effective 11/1/2014
The following abstracts from the subject LCDs are those provisions I feel are important because they are either new, or are provisions not widely understood or are important to stress to avoid denials of reasonable and medically necessary claims for pneumatic compression devices for lymphedema treatment. These abstracts are not complete! The current version of the LCD for your DME MAC jurisdiction must be used for every Medicare transaction.
The revised LCD which becomes effective on November 1, 2014 may be accessed at the Medicare Coverage Database at http://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx To access before November 1, enter the LCD number as "Document ID", then enter "11/01/2014" when asked for the "Date of Service".
The appearance of a code for an item to be covered by Medicare, a detailed written order (DWO) must be received by the supplier before a claim is submitted.
Pneumatic compression devices are covered in the home setting for the treatment of lymphedema if the beneficiary has undergone a four-week trial of conservative therapy and the treating physician determines that there has been no significant improvement or if significant symptoms remain after the trial. The trial of conservative therapy must include use of an appropriate compression bandage system or compression garment, exercise, and elevation of the limb. The garment may be prefabricated or custom-fabricated but must provide adequate graduated compression.
For either lymphedema or CVI with venous stasis ulcers, pneumatic compression devices are covered only when prescribed by a physician and when they are used with appropriate physician oversight, i.e., physician evaluation of the beneficiary's condition to determine medical necessity of the device, assuring suitable instruction in the operation of the machine, a treatment plan defining the pressure to be used and the frequency and duration of use, and ongoing monitoring of use and response to treatment.
The determination by the physician of the medical necessity of a pneumatic compression device must include (1) the beneficiary's diagnosis and prognosis; (2) symptoms and objective findings, including measurements which establish the severity of the condition; (3) the reason the device is required, including the treatments which have been tried and failed; and (4) the clinical response to an initial treatment with the device. The clinical response includes the change in pre-treatment measurements, ability to tolerate the treatment session and parameters, and ability of the beneficiary (or caregiver) to apply the device for continued use in the home.
When a pneumatic compression device is covered, a non-segmented device (E0650) or segmented device without manual control of the pressure in each chamber (E0651) is generally sufficient to meet the clinical needs of the beneficiary. A non-segmented compressor (E0650) with a segmented appliance/sleeve (E0671- E0673) is considered functionally equivalent to an E0651 compressor with a segmented appliance/sleeve (E0667-E0669). When a segmented device with manual control of the pressure in each chamber (E0652) is ordered and provided, the claim will be denied as not reasonable and necessary, unless there is clear documentation that the individual has unique characteristics that prevent satisfactory pneumatic compression treatment using a non-segmented device (E0650) with a segmented appliance/sleeve (E0671- E0673) or a segmented device without manual control of the pressure in each chamber (E0651).
Appliances used for pneumatic compression of the chest or trunk (E0656, E0657, E0670) will be denied as not reasonable and necessary.
At least four weeks of regular, daily, multiple-hour home usage of the E0650 or E0651 after careful, in-person fitting, training and supervision by a technician who is skilled in and who regularly and successfully uses the appliance provided;
Use of an appropriate compression bandage system or compression garment to provide adequate graduated compression;
The garment may be prefabricated or custom-fabricated but must provide adequate graduated compression;
Dietary change;
Medications as appropriate (e.g. diuretics and/or other treatment of congestive failure, etc.);
Correction (where possible) of anemia and/or hypoprotenemia.
At the end of the four-week trial, if there has been improvement of the lymphedema extending onto the chest, trunk and/or abdomen, then reimbursement for an E0652 is not justified. Where improvement has occurred, the trial of conservative therapy must be continued with subsequent reassessment at four-week intervals. When and only when no further improvement occurs and the coverage criteria above are still met, an E0652 is eligible for reimbursement.
CPT/HCPCS Codes in this section does not necessarily indicate coverage.
Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider". It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.
ACA §6407 contains provisions that are applicable to certain specified items in this policy [all of above except E0670]. These items require an in-person or face-to-face interaction between the beneficiary and their treating physician prior to prescribing the item, specifically to document that the beneficiary was evaluated and/or treated for a condition that supports the need for the item(s) of DME ordered. A dispensing order is not sufficient to provide these items. A Written Order Prior to Delivery (WOPD) is required. Refer to the related Policy Article NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section for information about these statutory requirements.
The only products that may be billed to the DME MACs using codes E0650, E0651 and E0652 are those for which a Coding Verification Review has been made by the Pricing, Data Analysis, and Coding (PDAC) contractor and subsequently published on the appropriate Product Classification List. Information concerning the documentation that must be submitted to the PDAC for a Coding Verification Review can be found on the PDAC web site or by contacting the PDAC.
LymphActivist's Comments
CMS has been presented with the formidable task of defining rational coverage criteria for a class of DME that has been the subject of tremendous fraud, inadequate prescription by providers and aggressive sales tactics by some suppliers. CMS has wisely placed responsibility for the determination of the medical necessity and the specification of the proper device and its use on the referring physician—exactly where it belongs.
Unfortunately this imposes a greatly increased documentation burden on the provider and the supplier, with face-to-face evaluations with the patient, certification of medical necessity and detailed written orders to be provided before delivery. The burden has been made somewhat easier in that the LCD and associated coverage article clearly describe the required content of the documentation that will assure coverage of the compression device. Detailed documentation requirements have been abstracted from the Medicare Program Integrity Manual and repeated in the LCDs. Specific requirements are given for filling out the "Certificate of Medical Necessity (CMN) for Pneumatic Compression Devices".
The test for qualifying for a PCD is the same as it has been for the last 12 years:
Pneumatic compression devices are covered in the home setting for the treatment of lymphedema if the beneficiary has undergone a four-week trial of conservative therapy and the treating physician determines that there has been no significant improvement or if significant symptoms remain after the trial. The trial of conservative therapy must include use of an appropriate compression bandage system or compression garment, exercise, and elevation of the limb.
Absent from this qualifying test is the one modality most likely to negate the need for a PCD in reducing lymphedema, i.e. manual lymph drainage (MLD). Furthermore, the costs of "an appropriate compression bandage system or compression garment" are not covered by Medicare, thus forcing the beneficiary to bear the cost of the qualifying test for a PCD. MLD by a qualified lymphedema therapist (i.e. a therapist who has completed supplementary training and certification in lymphedema management), a covered Medicare benefit, should be added to the required components of "conservative therapy" and CMS must add coverage of compression bandage systems and compression garments for the treatment of lymphedema. See "How Are Compression Bandages, Garments, Devices and Supplies Coverable under the Social Security Act" on this web site at http://www.lymphactivist.org/prosthetic_devices-insert.pdf
While coverage of an E0652 controller and breast, chest and abdomen appliances has been added to this newly revised LCD, the conditions for justification will be impossible to implement or to document. A "four-week trial of conservative therapy" is called for which includes ALL of the following:
At least four weeks of regular, daily, multiple-hour home usage of the E0650 or E0651;
Medications as appropriate (e.g. diuretics and/or other treatment of congestive failure, etc.) ;
The test calls for four weeks of daily, multiple-hour usage of the E0650 or E0651 pump which may be medically-inappropriate for the patient, in order to demonstrate that the pump is not appropriate, before obtaining the proper medically-necessary E0652 device. This use of a potentially ineffective device for four weeks at best delays effective treatment and at worst may produce a condition of breast, truncal or abdominal lymphedema where one did not exist before. I question the ethics of such a test, particularly if the treating physician knows a priori based on the patient's medical record that an E0652 is medically required.
The test requires use of an appropriate compression bandage system or compression garment, presumably on a daily basis. But Medicare does not cover the cost of a compression bandage system in the absence of a debrideable wound, and they do not cover the costs of compression garments for lymphedema. Furthermore, the cost of manual lymphatic drainage and compression bandaging by a trained therapist for a four-week period will certainly exceed the annual therapy cap, and not be justifiable to a Recovery Audit Contractor performing the required mandatory audit.
Dietary change has not been found to improve lymphedema except possibly in the case of an obese patient. But it is being required as a condition for all beneficiaries, regardless of whether there is a diagnosed condition requiring dietary change, in order to obtain treatment of breast, truncal or abdominal lymphedema.
In my layman's opinion, making treatment of anemia, hypoproteinemia (misspelled in the LCD), congestive (heart) failure, obesity, and etc. necessary preconditions for covering the treatment of lymphedema is medically illogical. A simpler solution is to require a documented diagnosis of "lymphedema" with comorbidities, which would put the medical responsibility of a differential diagnosis and treatment of swelling in the hands of a physician, and which should eliminate other non-lymphatic causes of swelling.
The intent of requiring limb elevation is to determine whether this conservative protocol is sufficient to reverse swelling of the limb in the very earliest stages of lymphedema or in the presence of venous insufficiency and dependent edema. But what is the value of this protocol in determining whether compression is needed for lymphedema of the breast, trunk or abdomen?
In summary, Medicare beneficiaries with diagnosed lymphedema, and whose physicians have determined requirements for a pneumatic compression device of a specific type and with appropriate appliances, have been waiting for an LCD that would allow them to obtain the appropriate device, and take advantage of recent technological improvements and medical knowledge. What they will be getting on November 1, 2014 seems to be based on a complete lack of understanding of the condition of lymphedema, its treatment and of patient needs, and will be a great disappointment to these beneficiaries.
Ellen asks: Are they including changes for venous insufficiency lymphedema?
That is a good question, Ellen, insofar as many of the cases of lower extremity lymphedema are believed to be caused by venous insufficiency. "Long-standing CVI also may lead to the development of lymphedema, representing a combined disease process." [Eberhardt, "Chronic Venous Insufficiency" Circulation 2005] "The more severe the venous chronic stasis, the more lymphoscintigraphic abnormalities were observed, corroborating the association between venous and lymphatic disease and between chronic venous stasis and secondary lymphedema." [Silva, "Venous-lymphatic disease: lymphoscintigraphic abnormalities in venous ulcers" J. Vasc. Bras., 2009]
It is becoming increasingly evident that early treatment of lymphedema, before the condition becomes clinically evident (>10% excessive lymph volume), can retard the progression of the condition as well as prevent permanent changes in the affected tissue. Prevention of lymphedema with early MLD soon after breast cancer treatment has been demonstrated by Zimmermann "Efficacy of manual lymphatic drainage in preventing secondary lymphedema after breast cancer surgery" Lymphology 2012, and retardation of progression through preclinical intervention has been demonstrated by Stout-Gergich, "Preoperative assessment enables the early diagnosis and successful treatment of lymphedema" Cancer 2008.
In view of the above demonstrations it is inexcusable to demand, as a condition for the use of a sequential compression device as a component of the treatment of lymphedema or venous insufficiency, that skin breakdown or venous stasis ulcer must have existed for at least 6 months. For certain patients, use of the proper compression device as a part of their early treatment might very well avoid skin breakdown caused by lymphedema in the first place. Medical treatment protocols should be the responsibility of the primary physician and the specially-trained therapist, not driven by a rigid and unrealistic set of trials.
It is important for the patient's primary care physician to determine the proper treatment because of the newfound interactions of the lymphatic system with other body systems. Old concepts of lymphedema based on the "plumber's analogy" persist, e.g. the definition of lymphedema by the Mayo Clinic Staff "Lymphedema is most commonly caused by the removal of or damage to your lymph nodes as a part of cancer treatment. It results from a blockage in your lymphatic system, which is part of your immune system. The blockage prevents lymph fluid from draining well, and the fluid buildup leads to swelling." [http://www.mayoclinic.org/diseases-conditions/lymphedema/basics/definition/con-20025603]
Contrast this to the description of the lymphatic system from Mortimer & Rockson "New developments in clinical aspects of lymphatic disease" J. Clin. Invest., (2014): "The lymphatic system is fundamentally important to cardiovascular disease, infection and immunity, cancer, and probably obesity — the four major challenges in healthcare in the 21st century. ... new knowledge of lymphatic genes and molecular mechanisms has demonstrated that lymphatic dysfunction should no longer be considered a passive bystander in disease but rather an active player in many pathological processes and, therefore, a genuine target for future therapeutic developments. The specific roles of the lymphatic system in edema, genetic aspects of primary lymphedema, infection (cellulitis/erysipelas), Crohn's disease, obesity, cancer, and cancer-related lymphedema are highlighted."
In Pneumatic Compression Devices (PCD) - Response to Comments Summary, September 11, 2014, CMS responded to a question similar to yours: Question: "Several commenters recommended that PCDs should be covered for chronic venous insufficiency even in the absence of ulcers. Response: This is not an option for the DME MACs under NCD 280.6. However, the coverage of lymphedema from various causes has been broadened which will likely accomplish much of what these commenters desire."
NCD 280.6 (Formerly Coverage Issue 60-16, 1995?) was most recently changed in 2001 to reflect the National Coverage Analysis (NCA) on lymphedema pumps CAG-00016N. This NCA, based on studies from 1984-1998, changed the NCD to create two different coverage criteria in recognition of the difference between the use of pumps for lymphedema treatment and pumps for venous disease treatment. No further updates have been made based on the last 16 years of clinical knowledge and technological advances.
If it takes a change to the NCD, then CMS should perform another National Coverage Analysis on lymphedema treatment and update their policies based on new medical knowledge and new technologies. [I actually submitted a strawman LCD in 2000, which CMS was not ready for—RW] But meanwhile, while it may be true that "the coverage of lymphedema from various causes has been broadened", the requirement for "documented persistence over a period of at least six months of 'chronic and severe' lymphedema as identified by the documented presence of at least one of the following clinical findings [of non-reversible skin breakdown]" very effectively precludes access to a pneumatic compression device for the majority of Medicare lymphedema patients.
As far as the intent to force the use of "conservative" treatment methods for four weeks to show that they can be effective without using a PCD—the core of that conservative treatment, daily compression with short stretch bandages and compression garments, is not covered by Medicare. [It is my belief, and that of dozens of Administrative Law Judges who have reviewed the evidence, that these items are coverable by Medicare, authorized by the Social Security Act §1861(s)(8) as interpreted by the Medicare Benefit Policy Manual, CMS Pub. 100-02, Chap. 15, §120 Prosthetic Devices. See http://www.lymphactivist.org/prosthetic_devices-insert.pdf
So we are left with a mandatory healthcare system that covers limb elevation and exercise after a limited number of sessions of MLD for the treatment of chronic progressive lymphedema. Is there a clinical guide that supports the long-term adequacy of these lymphedema treatment protocols?
But there is a bright side. Medicare pays for limited rehabilitation when the Medicare beneficiary becomes disabled from the lymphedema, and for hospitalization for the Medicare beneficiary who is hospitalized with recurrent cellulitis, and extensive wound care for the non-healing stasis ulcer.
We read that "CMS is committed to promoting the appropriate use of Medicare preventive benefits. Medicare now covers a broad range of services to prevent disease, detect disease early when it is most treatable and curable, and manage disease so that complications can be avoided." [https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/] So much for "prevention".
I would like nothing more than to put my 20 years of study and expertise to use to help CMS write new and comprehensive policies for the treatment of lymphedema.