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National Drug Codes (NDCs) Test Study Guide
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National Drug Codes (NDCs) TestStudy Guide
Centers for Medicare and Medicaid Services (CMS) - Answer The Department of Health
and Human Services agency responsible for Medicare and parts of Medicaid.
Historically, CMS has maintained the
UB-92 institutional EMC format specifications, the professional EMC NSF specifications,
and specifications for various certifications and authorizations used by the Medicare
and Medicaid pro grams. CMS is responsible for the oversight of HIPAA administrative
simplification transaction and code sets, health identifiers, and security standards. CMS
also maintains the HCPCS medical code set and the Medicare Remittance Advice
Remark Codes administrative code set (CMS 2013).
Department of Health and Human Services (HHS) - Answer A cabinet-level agency that
oversees all the health and human services-related activities of the federal government
Drug Listing Act 1972 - Answer In 1972, the Food, Drug and Cosmetic Act (FDCA) was
amended to make submission of information on all commercially marketed drugs
mandatory. Under its new name, the Drug Listing Act of 1972 required all domestic and
foreign firms (manufacturers, repackagers, and labelers) marketing drug products in
the US to list with the FDA prescription drug products manufactured, prepared,
propagated, compounded, or processed for commercial distribution in the US.
Food and Drug Administration (FDA) - Answer The federal agency responsible for
controlling the sale and use of pharmaceuticals, biological products, medical devices,
food, cosmetics, and products that emit radiation, including the licensing of medications
for human use (FDA 2013). See Federal Food, Drug and Cosmetic Act.
Food, Drug and Cosmetic Act (FDCA) - Answer The basic authority intended to ensure
that foods are pure and wholesome, safe to eat, and produced under sanitary
conditions; that drugs and devices are safe and effective for their intended uses; that
cosmetics are safe and made from appropriate ingredients; and that all labeling and
packaging is truthful, informative, and not deceptive.
Labeler - Answer Any firm that manufactures, repacks, or distributes a drug product.
Labeler code - Answer The first segment of the National Drug Code (NOC); assigned by
FDA to a firm
National Drug Code (NOC) - Answer Codes that serve as product identifiers for human
drugs and biologics. The NOC system was originally established as an essential part of
an out-of-hospital drug reimbursement program under Medicare and has since found
wider application. The NOC system is the Health Insurance Portability and
Accountability Act (HIPAA) standard medical data code set for reporting drugs and
biologics for retail pharmacy transactions.
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