NADAC pricing is the approximate invoice price pharmacies pay for medications. This benchmark is compiled from a voluntary survey of pharmacies.  Though voluntary self-reporting can result in market distortion, due to the limited number of (mostly independent) pharmacies that participate in the survey, this benchmark was originally developed for use   as the basis for pharmacy reimbursement (with an added dispensing fee) for drugs in Medicaid. Note NADAC does not reflect off-invoice rebates or discounts the pharmacies may receive on the drugs from wholesalers.

 

A not-for-profit standards development organization that creates and promotes consensus standards for the transfer of data related to medications, supplies, and services within the health care system. Pharmacy systems use NCPDP standards for claims processing, electronic prescribing, ePA, and other technology requirements.

A unique 11-digit, three-segment code assigned by the FDA that identifies the manufacturer, active ingredient with strength, and package size of a drug. The NDC is used to identify the medication in prescription drug claims.

A 10-digit unique identification number issued by CMS to providers, pharmacists, and others for HIPAA standard transactions (see HIPAA standard transactions).

 

(See Pharmacy Networks)

Established standards set by the government, a health plan accrediting body, or a plan sponsor that require a specific ratio of pharmacies per population and within a specific geographic radius. CMS pharmacy network adequacy standards build on TRICARE (the uniform services health care program for active-duty service members, family members, and others) standards for retail access for Medicare Part D. For more information, go to https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/downloads/HPMSMEMORetailHIAccess.pdf

 

When the sponsor of a new drug believes that it has obtained enough evidence on the drug’s safety and effectiveness to meet FDA’s requirements for marketing approval, the sponsor submits an NDA to FDA. The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States. For internal tracking purposes, all NDAs are assigned an NDA number.