The Physician Payments Sunshine Act (Sunshine Act) – a provision of the Patient Protection and Affordable Care Act – aims to govern certain physician-industry interactions. According to the Center for Medicare & Medicaid Services (CMS), the goal is to increase transparency in the health care system by increasing public awareness of financial relationships between drug and device manufacturers and healthcare providers. Read the proposed rule
Once the proposed rule goes into effect, industry will be required to publicly report any gift or payment greater than $10 made to physicians and teaching hospitals. While originally scheduled to go into effect on January 1, 2012, CMS delayed implementation of the Sunshine Act and is accepting comments on the proposed rule until February 17, 2012. How to submit comments
Although a specific date for implementation is uncertain, the new rules will eventually impact all physicians, regardless of specialty.
What You Need to Know
- Drug and device manufacturers will be responsible for reporting data on cash payments and other “transfers of value” made to physicians and other covered entities.
- CMS will issue final regulations 90-180 days after the commenting period ends on February 17, 2012, at which time industry will be required to begin data collection.
- Once the data has been submitted, CMS will provide a 45-day review period for physicians to contest any data with which they do not agree, after which time the data will be made publicly available.
- Industry will be required to report the following information:
- Physician name(s), business address, specialty and National Provider Identifier number(s)
- Date and amount of payment
- Form and nature of payment, including: consulting fees, compensation for services other than consulting, honoraria, gifts, entertainment, food, travel, education, research, charitable contributions, royalties or licenses, direct compensation for serving as faculty or as a speaker for a medical education program (including CME), and grants.
To submit comments on the proposed rule:
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. Eastern Standard Time on February 17, 2012. In commenting, please refer to file code CMS-5060-P.
You may submit comments in one of four ways (please choose only one of the ways listed):
1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.
2. By regular mail. You may mail written comments to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5060-P, P.O. Box 8013, Baltimore, MD 21244-8013.
*Please allow sufficient time for mailed comments to be received before the close of the comment period.
3. By express or overnight mail. You may send written comments to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5060-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments only to the following addresses prior to the close of the comment period:
a. For delivery in Washington, DC— Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.
(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-1066 in advance to schedule your arrival with one of our staff members.
*Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.