Sunshine Act 2014

Question 1

Medical device and pharmaceutical companies are required to report: (2)

Answer 1

1. payments or other transfers of value

2. recipients

Question 2

What bill mandates that information be publicly available about physician (or immediate family members of a physician) ownership or investment interests in applicable manufacturers and group purchasing organizations (GPOs).

Answer 2

Section 6002 of the Affordable Care Act

Question 3

Payments and transfers of value under the Sunshine Act, the following 4 bits of information must be reported:

Answer 3

1. physician’s name and address
2. amount and date of the payment
3. form of the payment, such as cash or stocks
4. nature of the payment, such as consulting fees, gifts, or entertainment expenses

Question 4

On which date will information become publicly available

Answer 4

Sept 30, 2014

Question 5

14 exceptions to the rule or reporting.

Answer 5

1. “in-kind” items for charity
2. mutual funds?
3. self-insured plans
4. non-medical professional services.
5. civil or criminal action or an administrative proceeding.
6. value $100 in a calendar year
7. Certified CME
8. buffet, snacks, soft drinks or coffee available to large scale conference
9. Product samples not intended to be sold and are intended for patient use.
10. educational materials that directly benefit patient care. textbooks not excluded.
11. loan of a medical device for trial period <90 days
12. contractual items including replacement of a covered device.
13. when physician is a patient
14. discounts

Question 6

Manufacturer reporting categories: (14)

Answer 6

1. Consulting fees
2. Compensation for services other than consulting
3. Honoraria
4. Gift
5. Entertainment
6. Food
7. Travel
8. Education
9. Research
10. Charitable contribution
11. Royalty or license
12. Current or prospective ownership or investment interest
13. Direct compensation for serving as faculty or as a speaker for a medical education program
14. Grant

Question 7

Physicians have ____ days once CMS provides access to individual physicians’ consolidated industry reports via online portal to challenge reports

Answer 7

45 days

portal will allow physicians to contact the manufacturer/GPOs that submitted inaccurate, misleading, falst information in order to resolve disputed submissions

Question 8

If physician/manufacturer cannot resolve dispute, additional ____ days provided before report is made public

Answer 8

15 days

If still not reached, info will be flagged but report will be posted on public webpage CMS develops

Question 9

Physicians are able to seek correction or contest reports for _____ after access has been provided to a report with dispute info

Answer 9

2 years