Updated on: October 7, 2019

LCDs and NCDs: Why the Difference is Often Misunderstood

Original story posted on: October 2, 2019

To understand the difference it is helpful to know the regulatory hierarchy.

Last week’s article describing how Local Coverage Determinations (LCDs) are not binding prompted a question: what about National Coverage Determinations (NCDs)? 

Are NCDs afforded more weight than LCDs? The answer is a resounding “yes.” NCDs are binding, but people often misunderstand how to apply them. 

Before exploring how people misunderstand NCDs, it is helpful to consider the regulatory hierarchy. The U.S. Constitution is the controlling authority, the ultimate “law of the land.” Since both Medicare and Medicaid are federal government programs, they must comply with all constitutional provisions, including the right to due process. It may not always feel this way, but the programs must be fair. Next come statutes, which we would typically call laws. For Medicare, the laws are generally found in the Social Security Act. Since Medicaid is a joint federal and state program, both federal and state laws apply. 

Immediately below statutes in the hierarchy are regulations. Federal regulations are found in the Code of Federal Regulations, while their state counterparts appear in something that’s usually called the “state administrative code,” but might also be called state rules, state regulations, or something similar. Regulations are the lowest level of authority that is still binding. Many people will refer to regulations as “rules.” I strongly encourage you to reserve the term “rule” for a regulation. Provisions of materials such as a “program manual” or “policy” should be called “guidance” rather than a rule, because they lack the legal authority conferred upon regulations/rules.

Regulations are typically going to be binding legal authority, while guidance will not. The only time a statute or rule is not authoritative is if it contradicts a higher authority. Statutes can’t violate the Constitution, and regulations can’t violate either the Constitution or a statute. Finally, there are all of the other guidance found in manuals, LCDs, the Medicare Learning Network, and other documents. They are not binding, and shouldn’t be treated as if they are.

Let’s return to NCDs. First, how do we know that NCDs are binding? A federal statute says so. 42 U.S.C. §1395hh(a)(1) says nothing other than an NCD may change benefits unless promulgated as a regulation. Under that statute, NCDs are treated as analogous to regulations. That makes some sense because they go through a comment period, similar to a regulation. This article opened with a claim that people misapply NCDs. What does that mean? People often read an NCD and conclude that particular treatments are not covered. However, unless it explicitly says otherwise, an NCD only extends coverage. It doesn’t limit coverage. If an NCD says “for condition A, treatments 1, 2, and 3 are covered,” that NCD is not limiting the overage of treatment 4. Instead, typical medical necessity rules apply to treatment 4. The NCD limits coverage only if it said something like “treatment 4 is not covered” or “no other treatment can be covered.” Absent that language, treatments or conditions not mentioned by an NCD remain covered. That principle is articulated in the Medicare National Coverage Determination Manual, CMS Pub. 100-03, Chapter 1. The foreword says “where coverage of an item or service is provided for specified indications or circumstances but is not explicitly excluded for others, or 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.” 

The bottom line is that NCDs are binding, but they are not nearly as limiting as most people think. Unless the NCD specifically states that a service is uncovered, or includes the statement that “all other services are uncovered,” the NCD does not prevent you from billing Medicare for a treatment that the patient’s physician believes is medically appropriate. 

Programming Note:

Listen to David Glaser live every Monday during Monitor Monday, 10-10:30 a.m. EST.

David M. Glaser, Esq.

David M. Glaser, Esq., is a shareholder in Fredrikson & Byron’s Health Law Group. David helps clinics, hospitals, and other healthcare entities negotiate the maze of healthcare regulations, providing advice about risk management, reimbursement, and business planning issues. He has considerable experience in healthcare regulation and litigation, including compliance, criminal and civil fraud investigations, and reimbursement disputes. David’s goal is to explain the government’s enforcement position and to analyze whether the law supports this position. David is a popular panelist on Monitor Mondays and a member of the RACmonitor editorial board.


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