General Medical Policy Information
Medical policies are a combination of national and regional decisions. The Centers for Medicare & Medicaid Services (CMS) defines national policy in the CMS Internet Only Manual (IOM) Publication 100-03, Medicare National Coverage Determinations Manual , and the CMS IOM Publication 100-08, Medicare Program Integrity Manual . The durable medical equipment Medicare administrative contractor (DME MAC) is required to follow national policy where it exists. However, when there is no national policy on a subject, the DME MAC has the authority and responsibility to establish regional policy.

A local coverage determination (LCD), as established by Section 522 of the Benefits, Improvements & Protection Act (BIPA) of 2000, is a decision by a fiscal intermediary or carrier on whether to cover a particular service on a fiscal intermediary-wide or carrier-wide basis in accordance with Section 1862(a)(1)(A) of the Social Security Act (i.e., a determination as to whether the service is reasonable and necessary). The Final Rule establishing LCDs was published in the Federal Register on November 7, 2003.

Medical policies are published as two related documents: the LCD and a policy article (PA).

The major sections of the LCD are:

• Indications and Limitations of Coverage and/or Medical Necessity—This section defines coverage criteria based upon a determination of whether an item is reasonable and necessary. It includes information from national coverage determinations (NCDs) when applicable. When an item does not meet these criteria, it will be denied as “not medically necessary.”
• HCPCS Codes and Modifiers
• ICD-9 Codes and Diagnoses That Support Medical Necessity
• Documentation Requirements
• Revision History
• Attachments—Certificate of Medical Necessity (CMN) or DME Information Form (DIF), if applicable; other suggested forms if applicable

The major sections of the policy article are:

• Nonmedical Necessity Coverage and Payment Policy—This section identifies situations in which an item does not meet the statutory definition of a benefit category (e.g., durable medical equipment, prosthetic devices, etc.) or when it doesn’t meet other requirements specified in Regulations. It also identifies situations in which an item is statutorily excluded from coverage for reasons other than medical necessity. In these situations, the policies will continue to identify the denial as “noncovered.” This section may also include statements defining when an item will be denied as “not separately payable” or situations in which claim processing for the item is not within the Jurisdiction B DME MAC geographical area.
• Coding Guidelines
• ICD-9 Codes That are Covered
• Revision History

Note: The term policy article will have a very specific meaning and will be used in the title of the article to define the document that is related to the LCD.

The LCD and policy article taken together will be referred to as the “medical policy.” On the CMS Medicare Coverage Database (MCD), at the end of each LCD, there is a link to the related policy article and at the end of each policy article is a link to the related LCD. New or revised policies are generally released on a quarterly basis: March, June, September, and December. Posting of new and revised policies will be announced in a Listserv message from National Government Services and posted to the “What’s New” section of the Web site.

Medical Policy Development
The DME MACs shall ensure that the LCDs are developed and revised in accordance with the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.1.4 . CMS requires that all LCDs developed by the DME MACs be identical for each jurisdiction to ensure uniformity for durable medical equipment posthetic, othotics, and supplies (DMEPOS) suppliers that operate nationally.

Durable medical equipment Medicare administrative contractor medical policies are administrative and educational tools designed to inform suppliers and medical professionals about Medicare coverage requirements and to assist suppliers in submitting correct claims for payment. Medical policies are developed as a collaborative effort led by the medical directors of the four DME MACs. The intent of the policy development process is to provide the opportunity for input from the supplier and medical community, to enhance the understanding of the policy by those individuals, and to assure that the final policy is consistent with sound medical practice.

The initial stage of the LCD development process is to write a draft policy based on a review of current medical literature and medical practice relating to the item. The medical directors seek input from various individuals and groups during the drafting phase of policy development.

Drafts of new medical policies or revised policies that propose more restrictive medical necessity coverage criteria are sent for comment to a wide spectrum of national and regional organizations representing manufacturers, suppliers, physicians and other healthcare professionals. These draft medical policies can be found on the Coverage>Local Coverage Determinations (LCD) page of the National Government Services Web site.

At least 45 days are allowed for comments to draft policies after they are published.

The DME MAC encourages written comments to the draft policies. Commenters that disagree with any aspects of the policy should offer specific alternative wording and support their suggestions with references from the published medical literature. Comments on new or substantially revised draft medical policies may be submitted by e-mail to the National Government Services Jurisdiction B DME MAC “comments mailbox” at DMACDraftLCDComments@wellpoint.com.

Written comments may be submitted to:

National Government Services, Inc.
DME MAC Medical Director
Attn: Adrian Oleck, MD
P.O. Box 6036
Indianapolis, Indiana 46206-6036

DME MAC medical directors review all comments received and make revisions to the draft medical policies as appropriate. The medical directors summarize comments and provide a written response indicating agreement or disagreement with suggestions and reasons for their decision. The “comment and response” document is posted on the DME MAC Web sites when the final policy is published.

Local coverage determinations and PAs are to be published on the CMS MCD and the DME MAC contractors’ Web sites. Jurisdiction B DME MAC medical policies are published on the Coverage> Local Coverage Determinations (LCD) page of the National Government Services Web site. A link to all DME MAC medical policies on the CMS MCD is also provided on the Web site.

Note: Final medical policies are published on the Coverage> Local Coverage Determinations (LCD) page of the National Government Services Web site.

Local Coverage Determination Reconsideration Process
The LCD Reconsideration process is a mechanism by which interested parties can request a revision of an LCD. In order to be considered a valid request, the following requirements must be met:

• Requestor must be qualified
• Subject must be appropriate
• Information submitted must be adequate
• Process for submission must be followed

Any request for LCD reconsideration that, in the judgment of the DME MAC, does not meet these requirements is invalid.

Requestor
The DME MAC will consider all LCD reconsideration requests from:

• beneficiaries residing in their jurisdiction, or
• suppliers doing business in their jurisdiction

The DME MAC may consider LCD reconsideration requests from any other interested party doing business in their jurisdiction.

Subject
The LCD Reconsideration Process is available only for final LCDs. The whole LCD or any part of the LCD may be reconsidered. Requests are not accepted for other documents including:

• National Coverage Decisions (NCD)
• Coverage provisions in interpretive manuals, e.g., the CMS IOM
• Draft LCDs
• Retired LCDs
• Individual claim determinations
• Bulletins, articles, training materials
• Any instance in which no LCD exists, i.e., requests for development of an LCD

If modification of the LCD would conflict with an NCD, the request is not valid. Refer to the NCD reconsideration process on the CMS Web site.

Information to be Submitted
The request must identify the language that the requestor wants added to or deleted from an LCD. Requests must include a justification supported by new evidence, which may materially affect the LCD’s content or basis. When articles or textbooks are cited, copies of the published documents must be included.

The level of evidence required for LCD reconsideration is the same as that required for new/revised LCD development. As described in the CMS IOM Publication 100-08, Medicare Program Integrity Manual , LCDs are to be based on the strongest evidence available. In order of preference, LCDs are based on the following:

• Published authoritative evidence derived from definitive randomized clinical trials or other definitive studies
• General acceptance by the medical community (standard of practice), as supported by sound medical evidence based on:
  • Scientific data or research studies published in peer-reviewed medical journals, or
  • Consensus of expert medical opinion (i.e., recognized authorities in the field), or
  • Medical opinion from medical associations or other health care experts

Acceptance by individual health care providers, or even a limited group of health care providers, normally does not indicate general acceptance by the medical community. Testimonials indicating such limited acceptance, and limited case studies distributed by sponsors with financial interest in the outcome, are not sufficient evidence of general acceptance by the medical community. The broad range of available evidence will be considered and its quality will be evaluated before a conclusion is reached.

Submission Process
In order to be valid, the request for LCD reconsideration must be in writing and must include the name and mailing address of the requestor. Inclusion of a telephone number and/or email address is optional. If the requestor is a supplier, the Provider Transaction Access Number (PTAN) or National Provider Identifier (NPI) must be included. If the requestor is neither a beneficiary nor a supplier, the requestor must identify the nature of their business and who they represent (if applicable).

Requests may be submitted by mail, e-mail or fax to:

National Government Services, Inc.
DME MAC Medical Director
Attn: Adrian Oleck, MD
P.O. Box 6036
Indianapolis, Indiana 46206-6036

-Or-

DMACLCDReconsideration@wellpoint.com

-Or-

Fax: 317-841-4600

DME MAC Response
Within 30 days after the request is received, the DME MAC will determine whether the request is valid or invalid and will notify the requestor of that determination. If the request is invalid, the DME MAC will explain why it was invalid.

If the request is valid, within 90 days after the request is received, the DME MAC will make a reconsideration decision and will notify the requestor of the decision with its rationale. Decision options include:

• No revision
• Revision to a less restrictive policy
• Revision to a more restrictive policy, or
• Retiring the policy

Any revision to the policy will then be published in a future update and posted to the DME MAC Web site.

Scope of Policies
The LCDs and policy articles address many of the most frequently ordered DMEPOS items and services, but clearly not all. If coverage criteria for an item are not defined in a policy, then it means that only general coverage criteria apply, i.e. the item must fall within a benefit category, it must not be excluded by statute or by national CMS policy as described in the CMS IOM Publication 100-03, Medicare National Coverage Determinations Manual and CMS IOM Publication 100-08, Medicare Program Integrity Manual , and it must be reasonable and necessary in the individual case for the diagnosis or treatment of illness or injury, or to improve the functioning of a malformed body member.

When coverage is addressed in the medical policy, it only refers to coverage of claims processed by the DME MAC under specific benefit categories. (Refer to the Medicare Benefit and Denial Categories Chapter for more information.) The items described in the policies may be covered under other provisions of the law, e.g., as part of institutional care in a hospital or nursing facility, as an item incident to a physician’s service, etc. However, in these circumstances, the claim would not be submitted to the DME MAC and the coverage statements in the DME MAC policy may not apply.

Individual Consideration
In the medical policies, the stated coverage criteria represent the circumstances under which Medicare usually covers the item. However, the policies do not include every possible acceptable indication. Other indications can be considered for coverage if the denial or potential denial is based on a medical necessity decision by the DME MAC. (If the denial/potential denial is based on a benefit coverage determination—i.e., the policy states the item is “noncovered”—or on a national medical necessity policy, then an exception cannot be considered.) Other indication will be covered only if there is detailed documentation of the medical necessity for the item in the individual case.

The nature and extent of the documentation required would have to be individualized based on the item in question. Some of the following information would likely be pertinent:

• The diagnosis relating to the need for the item
• Complicating medical conditions
• Functional abilities and limitations (e.g., the ability to ambulate or transfer, the amount of time in a bed, chair or wheelchair, the type and frequency of activities outside the home)
• The duration of the condition
• The overall course (improving or worsening)
• Rehabilitation potential (including recent prior functional level)
• Prognosis
• Description of and response to prior treatment
• Experience with similar items
• Physical examination findings, test results, etc.

Documentation can be provided either with the initial claim or with an appeal. If it is provided with the initial claim, the supplier should include as much information as possible in the NTE (Note) segment of the electronic claim.

For additional information regarding the LCD process, please refer to the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13 .

Current DMEPOS Medical Policies
The DMEPOS medical policies are no longer included in the Jurisdiction B DME MAC Supplier Manual. All DMEPOS medical policies can be located on the Coverage> Local Coverage Determinations (LCD) page of the National Government Services Web site.