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10671 Baton Rouge Avenue
Porter Ranch, CA 91326-2905
September 26, 2016

Eileen M. Moynihan, MD, FACP, FACR
Medical Director, DME MAC JD
Noridian Administrative Services, LLC
P.O. Box 6727
Fargo, ND 58108-6727

SUBJECT: Comments on PROPOSED/DRAFT Local Coverage Determination (LCD): Surgical Dressings (DL33831) and FUTURE Local Coverage Article: DRAFT - Surgical Dressings - Policy Article - Effective XXXX-XXXX (A54563)

Dear Dr. Moynihan,

I am a patient advocate who has been assisting Medicare beneficiaries with lymphedema appeals of denials of their prescribed medically-required compression bandaging systems, stockings, sleeves and devices for over 10 years. The most frequent reason given for their denial is that they do not meet the statutory coverage requirements for surgical dressings. It is my belief that this is an incorrect interpretation of Medicare statutes and CMS policies, partly caused by wording in the LCD for Surgical Dressings, for reasons I will explain.

As stated in LCA A54563 "Surgical Dressings are covered under the Surgical Dressings Benefit (Social Security Act §1861(s)(5)). The CMS Benefit Policy Manual (IOM 100-02), CH 15, §100 [Surgical Dressings, Splints, Casts, and Other Devices Used for Reductions of Fractures and Dislocations] provides interpretive guidance to contractors for the implementation of this provision". The fact that an item may be covered or non-covered as a surgical dressing benefit has absolutely no bearing on whether it may or may not meet the coverage requirements of another benefit category, such as durable medical equipment, prosthetic devices, or prosthetics and orthotics, which are governed by the Social Security Act §§1861(s)(6), 1861(s)(8) or 1861(s)(9) and the CMS Benefit Policy Manual Chapter 15, §§110, 120 or 130 respectively.

Benefit category is defined in the Social Security Act (SSA) and in the CMS Benefit Policy Manual (BPM) in terms of medical function and not form. The benefit category of a bandage is determined by its medical function, and not its description (e.g. "used with parenteral nutrition", "included in a kit"). Likewise, its coverage is determined by its function (e.g. covered when "used as a primary or secondary dressing on a surgical or debrided wound", or non-covered when "used for wound cleansing".)

Table 1 shows the structure of Medicare policies and statutes and how they derive from Title XVIII of the Social Security Act (SSA), the governing law. The authority flows down by benefit category. Coverage is defined by the SSA and corresponding regulations in the Code of Federal Regulations. Coverage requirements are defined by CMS in a set of Internet Only Manuals, notably: the Medicare Benefit Policy Manual that defines the benefits; the Medicare National Coverage Determination Manual which interprets coverage issues and coverage policy; and the Medicare Claims Processing Manual which defines payment policy. Each benefit category has a unique definition and set of coverage and payment requirements. The coverage criteria are separately defined for each benefit category, and do not apply to other benefits.

STATUTORY DMEPOS BENEFIT CATEGORIES
BENEFIT CATEGORY AUTHORITYSURGICAL DRESSINGS, SPLINTS, CASTSDURABLE MEDICAL EQUIPMENTPROSTHETIC DEVICESPROSTHETICS AND ORTHOTICS
1. Title XVIII Social Security Act§1832(a)(1)
§1861(s)(5)		§1832(a)(1)
§1861(s)(6)
§1861(n)		§1832(a)(2)(I)
§1861(s)(8)		§1832(a)(2)(I)
§1861(s)(9)
2. Code of Federal Regulations 42 CFR§410.36(a)(1)§410.38
§414.202 DME		§410.36(a)(2)
§414.202 POD(1)		§410.36(a)(3)
§414.202 POD(3)
3. Medicare Benefit Policy Manual Pub. 100-02, Ch. 15, Covered Services§100§110
§110.1		§120§130
4. Medicare National CoverageDetermina-tions Manual Pub. 100-03, Ch. 1§270§280.1§§20, 50, 80, 160, 180, 230
5. Medicare Claims Processing Manual Pub. 100-04, Ch. 20 DMEPOS§10.1.1§10.1.2§10.1.3
6. HCPCS Code GroupA-Code,S-CodeE-CodeL-Code, S-CodeL-Code

Table 1 FLOW DOWN OF STATUTORY REQUIREMENTS

CMS Coverage policy is stated succinctly in the introductory section of the LCD DL33831:

CMS National Coverage Policy
CMS Manual System, Pub. 100-02, Benefit Policy Manual, Chapter 15, Section 100, 100-03, National Coverage Determinations Manual, Chapter 1, Sections 270.4 & 270.5

  1. Coverage Guidance
    Coverage Indications, Limitations, and/or Medical Necessity
  2. For any item to be covered by Medicare, it must:
  3. be eligible for a defined Medicare benefit category;
  4. be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member; and
  5. meet all other applicable Medicare statutory and regulatory requirements.

For the items addressed in this local coverage determination, the criteria for "reasonable and necessary", based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

...
Medicare provides reimbursement for surgical dressing under the Surgical Dressings Benefit. This benefit only provides coverage for primary and secondary surgical dressing used [on] the skin on specified wound types. Refer to the related Policy Article NONMEDICAL NECESSITY COVERAGE AND PAYMENT RULES for information about these statutory requirements.

The coverage policies stated are limited to surgical dressings and dressings and other items whose medical function is associated with treatment of wounds, burns, and fractures.

There are a number of "surgical dressings" described in the subject LCD and Policy Article that have other medical uses, and that may meet the coverage criteria and fall into other benefit categories. The fact that an item fails to meet the coverage criteria for surgical dressings does not mean that it is "statutorily non-covered". It means that it is non-covered as a surgical dressing benefit. Using this LCD and Policy Article to deny coverage for a prosthetic device benefit, for example, is not logical.

It is requested that statements as to the coverability of Light Compression Bandage (A6448-A6450), Moderate/High Compression Bandage (A6451, A6452), Self-Adherent Bandage (A6453-A6455), Conforming Bandage (A6442-A6447), Padding Bandage (A6441), Gradient Compression Wrap (A6545), and Gradient Compression Stockings (A6530-6549) be modified to reflect limitations of coverage to "surgical dressing benefits" and any references to "no benefit" be modified to indicate "not covered as a surgical dressing benefit".

Furthermore, in the discussion of other non-qualifying uses of bandages in the paragraphs LIGHT COMPRESSION BANDAGE (A6448A6450), MODERATE/HIGH COMPRESSION BANDAGE (A6451, A6452), SELFADHERENT BANDAGE (A6453A6455), CONFORMING BANDAGE (A6442A6447), PADDING BANDAGE (A6441) and in GRADIENT COMPRESSION STOCKINGS/WRAPS (A6531, A6532, A6545) on pages 3-4 of 7 of the LCA, the last sentences should be modified to read "Claims for these uses will be denied as non-covered as surgical dressing benefits, however, they may meet the statutory coverage criteria for other benefit categories."

This leaves open the task of determination of Medicare benefit category per Medicare statute consistent with item 1) in the LCD Coverage Guidance. Where the item or service is not mentioned at all in the CMS Manual System the Medicare contractor is to make the coverage decision, in consultation with its medical staff, and with CMS when appropriate, based on the law, regulations, rulings and general program instructions. [Medicare National Coverage Determination Manual, Chapter 1, Part 1, Section A]

It is not my purpose on this occasion to discuss why medically-required compression bandaging systems, stockings, sleeves and devices used in the compression therapy of lymphedema patients are prosthetic devices. If you are interested, and wish to consider a local or national coverage analysis leading to a Prosthetic Device LCD or NCD for Compression Items for Lymphedema, then please see "How Are Compression Bandages, Garments, Devices and Supplies Coverable under the Social Security Act?" at http://www.lymphactivist.org/prosthetic_devices-insert.pdf My purpose in this instance is to comment on policy extensions in the Surgical Dressing LCD and Policy Article that are not justified by statute and frequently lead to unreasonable denials of treatment coverage for Medicare beneficiaries with lymphedema-- denials which are frequently reversed by Administrative Law Judges.

Robert Weiss, MS, Independent Lymphedema Patient Advocate
LymphActivist@aol.com      www.lymphactivist.org

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