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Physician Payment Sunshine Act - Collection of Data Starts August 1, 2013

August 2, 2013

On August 1, 2013, pharmaceutical manufacturers and group purchasing organizations (GPOs) must begin collecting data to comply with the requirements of the Physician Payments Sunshine Act (PPSA). The PPSA resulted from the Affordable Care Act and sets forth reporting requirements that affect teaching hospitals, physicians, pharmaceutical manufacturers and GPOs. The purported purpose of the PPSA is to ensure transparency of financial relationships between manufacturers/GPOs and providers by making these relationships public on CMS’s website.

Background

The PPSA requires that pharmaceutical manufacturers report payments and items of value given to physicians and teaching hospitals and certain ownership interests held by physicians and their families. GPOs have similar requirements in connection with payments and items of value given to physicians who are owners or investors in the GPO. These reports (for the initial time period August 1, 2013 through December 31, 2013) are due to Centers for Medicare & Medicaid Services (CMS) by March 31, 2014. The reports will then be made publicly available on September 30, 2014 by CMS. Data collecting and reporting is an ongoing obligation of the pharmaceutical manufacturers and GPOs, and the public reports will be updated annually by CMS. 

If you are a hospital, click here.

If you are a physician, click here.

If you are a pharmaceutical manufacturer, click here.

If you are a group purchasing organization, click here.


I am a hospital, what should I do?

1.     Determine whether your hospital is subject to the PPSA.

        • CMS published a list of the teaching hospitals subject to the PPSA for the 2013 reporting year.

2.     If your hospital is on the list, we recommend that your hospital keeps its own records of payments or items of value received from pharmaceutical manufacturers.

        • CMS posted three data collection templates to help pharmaceutical manufacturers comply with the PPSA. The templates can be used as a guide to keep your hospital’s records. They are available here.

3.     Ask each pharmaceutical manufacturer (from which your hospital received payments or items of value) for a pre-submission review and seek corrections as needed to the pharmaceutical manufacturer’s report beforeit is submitted to CMS.

4.    Review CMS’s Open Payment website to review a consolidated report of payments or items of value received by your hospital that were reported by manufacturers, and if needed, make objections.

        • Before the report is made public, CMS will provide hospitals 45 days to review the report and object to it.
        • To view this report, you must register on CMS’s Open Payments website. Registration is scheduled to begin in 2014.

I am a physician, what should I do?

1.     Update your financial and conflict of interest disclosures and your National Provider Identifier information.

2.    We recommend that you keep your own records of payments or items of value from pharmaceutical manufacturers. If you or your family members are an owner or investor in a GPO, keep your own records of payments or items of value from the GPO.

        • CMS posted three data collection templates to help pharmaceutical manufacturers and GPOs comply with the PPSA. These templates can be used as a guide to keep your own records. They are available here.

3.     Ask pharmaceutical manufacturers and GPOs (from which you received payments or items of value) for a pre-submission review and seek corrections as needed to their reports beforeit is submitted to CMS.

4.    View CMS’s Open Payment website to review a consolidated report of payments or items of value received by you that were reported by manufacturers and GPOs, and if needed, make objections.

        • Before the report is made public, CMS will provide physicians 45 days to review the report and object to it in advance.
        • To view this report, you must register on CMS’s Open Payments website. Registration is scheduled to begin in 2014.

I am a pharmaceutical manufacturer, what should I do?

1.    Evaluate whether the PPSA applies to your company.

        • The PPSA applies to manufacturers of at least one covered drug, device, biological or medical supply that participate in U.S. federal health care programs, such as Medicare

2.     If the PPSA applies to your company, begin collecting the required data on August 1, 2013:

        • Ownership interests held by physicians and their immediate family members in the company (various exceptions exist).
        • Payments and items of value given to physicians and teaching hospitals.
        • Seek advice on detailed requirements and standards.

3.     CMS posted three data collection templates to help pharmaceutical manufacturers comply with the reporting requirements of PPSA. They are available here

4.     All pharmaceutical manufacturers must register on CMS’s Open Payments website. Registration is scheduled to begin in 2014.

5.    To facilitate efficient and accurate reporting, pharmaceutical manufacturers should provide physicians and teaching hospitals the opportunity to review the data before submitting their reports to CMS.

6.     If pharmaceutical manufacturers do not comply with the PPSA requirements, monetary penalties may be levied.

I am a GPO, what should I do?

1.     Evaluate whether the PPSA applies to your company.

        • The PPSA applies to GPOs that purchase, arrange for purchase or negotiate the purchase of a covered drug, device, biological or medical supply for a group of individuals or entities

2.     If the PPSA applies to your company, begin collecting the following data on August 1, 2013:

        • Ownership interests held by physicians and their immediate family members in the company (various exceptions exist).
        • Payments and items of value given to physicians who are owners or investors.
        • Seek advice on detailed requirements and standards.

3.     CMS posted three data collection templates to help GPOs comply with the reporting requirements of PPSA. They are available here

4.     All GPOs must register on CMS’s Open Payments website. Registration is scheduled to begin in 2014.

5.    To facilitate efficient and accurate reporting, GPOs should provide physician owners and investors the opportunity to review the data before submitting their report to CMS.

6.     If GPOs do not comply with the PPSA requirements, monetary penalties may be levied on this alert.

The PPSA final regulations are available here.

If you have any questions regarding this important issue, please contact one of our Health Care Department attorneys.