Sunshine Act Weekly Quiz #2

1. Payments under $____ in value do not need to be reported

5

10

100

1000

Payments under $10 do not need to be reported UNLESS they total more than $100 annually. Therefore, you could give 11 $9 payments and not have to report it, but if you give 12 payments of $9, you will go over the annual cap of $100 and have to report it

Explanation

Payments under $10 do not need to be reported UNLESS they total more than $100 annually. Therefore, you could give 11 $9 payments and not have to report it, but if you give 12 payments of $9, you will go over the annual cap of $100 and have to report it

2. True or False: hospitals, pharmacies, and labs that produce or manufacture products solely for their own use or use by their patients count as an applicable manufacturer and must report payments

True

False

The Sunshine Act excludes hospitals, hospital-based pharmacies and laboratories that manufacture a covered product solely for use within the entity itself or by an entity’s own patients.

Explanation

The Sunshine Act excludes hospitals, hospital-based pharmacies and laboratories that manufacture a covered product solely for use within the entity itself or by an entity’s own patients.

3. Will meals provided to office staff and nurses be reported?

Yes

No

Under the Sunshine reporting guidelines, meals provided to nurses and office staff will not be reportable and will not be attributed to physicians. However, some state disclosure laws do require reporting of payments to a broader group of recipients, including non-physician prescribers, nurses and office staff.

Explanation

Under the Sunshine reporting guidelines, meals provided to nurses and office staff will not be reportable and will not be attributed to physicians. However, some state disclosure laws do require reporting of payments to a broader group of recipients, including non-physician prescribers, nurses and office staff.

4. Manufacturers can delay publication for money paid to researchers for up to how many years?

1

2

3

4

Under the Sunshine Act, certain research payments or other transfers of value under a product research or development agreement may be delayed from publication on the website. “This provision seeks to balance the need for confidentiality of proprietary information with the need for public transparency of payments to covered recipients that could affect prescribing habits or research outcomes.”

Publication of a payment or other transfer of value is delayed when made in connection with the following instances:

(1) Research on or development of a new drug, device, biological, or medical supply, or a new application of an existing drug, device, biological, or medical supply.

(2) Clinical investigations regarding a new drug, device, biological, or medical supply.

Explanation

Under the Sunshine Act, certain research payments or other transfers of value under a product research or development agreement may be delayed from publication on the website. “This provision seeks to balance the need for confidentiality of proprietary information with the need for public transparency of payments to covered recipients that could affect prescribing habits or research outcomes.”

Publication of a payment or other transfer of value is delayed when made in connection with the following instances:

(1) Research on or development of a new drug, device, biological, or medical supply, or a new application of an existing drug, device, biological, or medical supply.

(2) Clinical investigations regarding a new drug, device, biological, or medical supply.

5. Which of these count as covered recipients who must report transfers of value or payments?

Teaching hospitals

HCP's employed by pharma companies

HCP's not employed by pharma companies

Medical residents

Manufacturers are required to report payments and transfers of value made to “Covered Recipients.” The term Covered Recipients refers to U.S. physicians and teaching hospitals.

The Sunshine Act defines a “physician” as any of the following types of professionals who are legally authorized to practice:

Doctor of Medicine
Doctor of Osteopathy
Doctor of Dentistry
Doctor of Dental Surgery
Doctor of Podiatry
Doctor of Optometry
Doctor of Chiropractic Medicine

Medical residents, nurse practitioners and office staff are NOT included in the definition of Covered Recipients.

CMS will annually publish a list of hospitals that meet the definition of a teaching hospital for Sunshine Reporting purposes.

Explanation

Manufacturers are required to report payments and transfers of value made to “Covered Recipients.” The term Covered Recipients refers to U.S. physicians and teaching hospitals.

The Sunshine Act defines a “physician” as any of the following types of professionals who are legally authorized to practice:

Doctor of Medicine
Doctor of Osteopathy
Doctor of Dentistry
Doctor of Dental Surgery
Doctor of Podiatry
Doctor of Optometry
Doctor of Chiropractic Medicine

Medical residents, nurse practitioners and office staff are NOT included in the definition of Covered Recipients.

CMS will annually publish a list of hospitals that meet the definition of a teaching hospital for Sunshine Reporting purposes.

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