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The Medical Device User Fee and Modernization Act (MDUFA) authorizes the Center for Devices and Radiological Health (CDRH) to collect user fees from medical device manufacturers. [1] It is reauthorized every 5 years.
The Sunshine Act requires manufacturers of drugs, medical devices, biological and medical supplies covered by the three federal health care programs Medicare, Medicaid, and State Children's Health Insurance Program (SCHIP) to collect and track all financial relationships with physicians and teaching hospitals and to report these data to the Centers for Medicare and Medicaid Services (CMS).
Some Medicare Advantage programs may cover medical alert devices, says Holt. In addition, some Medicaid programs may cover what they call Personal Emergency Response Services (PERS) devices. You ...
Stakeholders have raised significant questions about health benefits of currently covered items or services; New evidence, or re-interpretation of previously available evidence indicates that current policies may need to be changed; Local coverage policies are inconsistent or conflicting, to the detriment of beneficiaries; For new items or services
Retiree Drug Subsidy (RDS) is a program that provides financial assistance to employers who offer prescription drug coverage to their retirees. The subsidy is a feature of Medicare Part D, designed to help retirees access affordable prescription medications.
The ICD-10 Procedure Coding System (ICD-10-PCS) is a US system of medical classification used for procedural coding.The Centers for Medicare and Medicaid Services, the agency responsible for maintaining the inpatient procedure code set in the U.S., contracted with 3M Health Information Systems in 1995 to design and then develop a procedure classification system to replace Volume 3 of ICD-9-CM.
Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.
The 340B Drug Pricing Program is a US federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices. The intent of the program is to allow covered entities to "stretch scarce federal resources as far as possible ...