Local Coverage Determinations (LCD's) specify under what clinical circumstances a service is covered and correctly coded. As both an administrative and educational tool, a LCD assists providers in submitting correct claims for payment and outlines how claims will be reviewed to ensure that they meet Medicare coverage and coding requirements. Each LCD must be consistent with all statutes, rulings, regulations and national coverage, payment and coding policies. Highmark Medicare Services publishes LCD's at www.highmarkmedicareservices.com to provide guidance to the public and medical community within our specified geographic jurisdiction, the Commonwealth of Pennsylvania.

Reasons for developing LCD's include but are not limited to the following:

• The existence of a validated widespread problem demonstrating a significant risk to the Medicare trust fund;
• When there is a need to assure beneficiary access to care;
• The issuance of frequent claims denials for a particular service(s);
• Through the use of national data, Highmark Medicare Services is identified as an outlier in the reimbursement of a specific service;
• The availability of new technology which has a high potential of Medicare trust fund risk due to cost.
• For an item or service that is never covered under certain circumstances.

A service may be covered in an LCD if it meets all of the following conditions:

It is one of the benefit categories described in title XVIII of the Social Security Act (SSA). A list of Medicare benefit categories can be found at http://www.cms.hhs.gov/manuals/downloads/pim83c13.pdf.

• It is not excluded by title XVIII of the SSA other than 1862(a)(1). Such exclusions include, but are not limited to, routine physical checkups, cosmetic surgery, hearing aids, eyeglasses, and most dental care.
• It is reasonable and necessary under 1862(a)(1) of the SSA. A service is considered reasonable and necessary if it is:
  1. Safe and effective;
  2. Not experimental or investigational; and
  3. Appropriate, including the duration and frequency that is considered suitable for the service.

LCD's must be based on the strongest evidence available. The initial action in developing an LCD is a search of published scientific literature for all available evidence pertaining to the item/service on which the policy is focused. LCD's are based on:

• 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;
  • Consensus of expert medical opinion;
  • Medical opinion derived from consultations with medical associations or other health care experts.

In the course of developing a policy, contractors must provide a 45-day comment period in the following situations:

• Each new policy;
• A revised LCD that restricts an existing policy;
• A revised LCD that makes a substantive correction.

For Highmark Medicare Services, the required 45-day comment period transpires prior and post to the Carrier Advisory Committee (CAC)meeting with the policies being posted to the "draft LCD" status page (via the "Draft Policies" link) of www.highmarkmedicareservices.com. (The CAC process is discussed in more detail below.) Concurrently a copy of each LCD is provided to the CAC membership. Draft LCD's are also distributed to appropriate groups of health professionals, representatives of specialty societies, other contractors, Quality Improvement Organizations (QIO's), etc. During this 45-day comment period, there are three formal mechanisms available through which comments can be received.

1. A link is provided on the "draft LCD status" page allowing respondents to comment regarding individual policies on-line directly to Highmark Medicare Services.
2. An Open Session meeting is scheduled prior to the CAC meeting.  The intent of the  Open Session is to provide an opportunity for interested parties to make formal comments and present pertinent scientific information on issues related to any of the draft policies. There is a link available prior to the Open Session and CAC meeting for where, when and how to register on our Draft Open Sessions page.
   
   At the CAC meeting itself, members communicate their opinion of the contents of draft policies to the Highmark Medicare Services Contractor Medical Director and to the staff of Highmark Medicare Services's Medical Policy unit.

All comments received during the 45-day period are considered and the draft policies are changed appropriately.

After all comments are considered and the policy is changed as needed, a minimum notice period of 45 days is required prior to implementation. Notice is provided through publication of the full-text version of the policy on Highmark Medicare Services's website via the "Notice of Final Policies" link. A summary of the policies scheduled for implementation is printed in the Highmark Medicare Services newsletter, Medicare Report. When draft policies are finalized, become effective and are implemented, they are posted to the website via the "Current Policies" link.

Carrier Advisory Committee

The establishment of a Carrier Advisory Committee (CAC) is mandated by the Centers for Medicare and Medicaid Services (CMS). The purpose of the CAC is to provide:

• A formal mechanism for physicians in the contractor's geographical jurisdiction to be informed of and participate in the development of an LCD in an advisory capacity;
• A mechanism to discuss and improve administrative policies that are within carrier discretion;
• A forum for information exchange between carriers and physicians.

The focus of the CAC is LCD's and administrative issues. It is not a forum for peer review, discussion of individual cases or individual providers. While the CAC must review all draft LCD's, the final implementation decision about LCD's rests with the CMD. The CAC is co-chaired by the carrier CMD and one physician selected by the committee. Each quarterly meeting includes a discussion and presentation of comparative utilization data that has undergone preliminary analysis by Highmark Medicare Services and that relates to discussion of one or more of the draft LCD's.

While the CAC is comprised mainly of physicians, other members include a Medicare beneficiary representative and a member to represent independent clinical laboratories. In addition, carriers invite representatives from the CMS Regional Office to attend and participate as well as appointees from the State Hospital Association, the QIP Medical Director, and the Intermediary Medical Director, etc.