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What is an Applicable Manufacturer? A Comprehensive Legal Overview
Definition & Meaning
The term applicable manufacturer refers to a company that produces covered drugs, devices, biological products, or medical supplies and operates within the United States or its territories. These manufacturers are required to report specific financial transactions involving covered recipients (CRs), such as healthcare providers who are not employees of the manufacturer, or teaching hospitals. The reporting occurs annually, detailing payments or transfers of value made to CRs, including their names, business addresses, specialties, and the nature of the transactions.
Table of content
Legal Use & context
This term is primarily used in healthcare law and regulations, particularly in compliance with the Affordable Care Act and the Physician Payments Sunshine Act. Applicable manufacturers must adhere to strict reporting requirements to ensure transparency in financial relationships with healthcare providers. This is relevant for legal practitioners in healthcare, compliance, and regulatory fields, as well as for organizations managing healthcare compliance.
Key legal elements
Real-world examples
Here are a couple of examples of abatement:
Example 1: A pharmaceutical company provides a $5,000 grant to a physician for research purposes. As an applicable manufacturer, the company must report this transaction, including the physician's name and specialty.
Example 2: A medical device manufacturer offers a free training seminar for doctors, valued at $2,000. This transfer of value must also be reported to comply with legal requirements.
Relevant laws & statutes
Major laws governing applicable manufacturers include:
Affordable Care Act (ACA)
Physician Payments Sunshine Act
State-by-state differences
Examples of state differences (not exhaustive):
State
Reporting Requirements
California
Requires additional disclosures beyond federal requirements.
New York
Has specific state laws regarding gifts and payments to healthcare providers.
Florida
Mandates annual reports on financial relationships with healthcare professionals.
This is not a complete list. State laws vary, and users should consult local rules for specific guidance.
Comparison with related terms
Term
Definition
Applicable Manufacturer
A manufacturer required to report payments to healthcare providers.
Covered Recipient
Healthcare providers receiving payments from applicable manufacturers.
Transfer of Value
Any payment, gift, or service provided to a covered recipient.
Common misunderstandings
What to do if this term applies to you
If you are an applicable manufacturer, ensure that you understand your reporting obligations under the law. Consider using US Legal Forms' templates to help you prepare the necessary documents. If your situation is complex, consulting with a legal professional may be beneficial to ensure compliance.
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