National coverage determination (NCD) – means a decision that CMS makes regarding whether to cover a particular service on a national basis. An NCD does not include a determination of what code, if any, is assigned to a service or a determination with respect to the amount of payment to be made for the service-it merely decides the basis upon which Medicare will cover a particular service. In areas of fraud concern, NCD’s have been issued to clarify coverage conditions in order to avoid further fraud and abuse.
National Drug Code (“NDC”) -The NDC is a unique number made up of three distinct segments. The first portion is the labeler code. All drug manufacturers or repackagers are required to register with the FDA. The first segment of this unique 11-digit number is assigned by the FDA to each registrant. The second and third segments of this number are related to the product identity and package size or type. The manufacturers are allowed to assign whatever numbers they wish for each product and package configuration, but they must conform to the established format and must provide to the FDA all the required all information relating to that specific product. This knowing failure to list an NDC with the FDA is fraud. Although it has rarely if ever historically been enforced.
NDA Fraud – See New Drug Application Fraud in this Glossary.
New Drug Application (NDA) Fraud – Fraud involving the integrity of a new drug application submitted to the FDA by a pharmaceutical company. See Clinical Trial Fraud in this Glossary.
New Drug Application 505(b)(2) Fraud – a New Drug Application (NDA) submitted under section 505(b)(1) of the Federal Food Drug, and Cosmetic Act for a drug for which one or more of the investigations relied on by the applicant for approval of the “application” were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted” (21 U.S.C. 355(b)(2)). See New Drug Application (NDA) Fraud in this Glossary.
Non-Innovator Multiple Source Drug – relevant to both Medicaid and Medicare outpatient prescription drug coverage, this term means a drug that is not an original drug (but rather a generic) and is available from more than one source.
Nursing and Allied Health Education Payments Fraud – hospitals receive government funding for health education in proportion to their Medicare patient days and other factors. When fraud occurs, the provider includes costs that are not related to its nursing and allied health education programs.
Nursing Home False Claims – See LTACH Fraud in this Glossary
Nursing Home Fraud – See LTACH Fraud in this Glossary
Nursing Home Medicare Fraud – See Long Term Care Hospitals in this Glossary.