This Open Payments User Guide (Guide) for Industry includes definitions, descriptions, screenshots, tables, tools, and tips designed to assist medical industry manufacturers and group purchasing organizations (GPOs) to better understand the rules and comply with Open Payments, including how to operationalize collecting and reporting data.
The website for the CMS that has links to templates and guidance on the Sunshine Act, or as it has been renamed, the "Open Payments Act".
This final rule will require applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children's Health Insurance Program (CHIP) to report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals ("covered recipients"). In addition, applicable manufacturers and applicable group purchasing organizations (GPOs) are required to report annually certain physician ownership or investment interests. The Secretary is required to publish applicable manufacturers' and applicable GPOs' submitted payment and ownership information on a public website.
The 4th Aggregate Spend and Sunshine Conference took place in June 2013. This event was created to help end some of the confusion, misinterpretations, and fear that has been plaguing the industry leading up to the final ruling by CMS.
The Physician Payment Sunshine Act final rule was released this past week. The final regulations will greatly affect the entire pharmaceutical and medical device industry. In general, the Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical supplies to report annually to the Secretary of HHS certain payments or other transfers of value to physicians and teaching hospitals. It also requires applicable manufacturers and applicable group purchasing organizations (GPOs) to report certain information regarding the ownership or investment interests held by physicians or the immediate family members of physicians in such entities.
While pharmaceutical and medical device companies have the heaviest weight to carry when it comes to collecting data under the Physician Payment Sunshine Act (PDF) beginning August 1, there are a few steps physicians can also take to prepare for the implementation of the rule.
The nearly 300-page document issued by the Department of Health and Human Services in February requires medical product manufacturers to report data annually on payments and gifts given to physicians. To (hopefully) prevent conflicts of interest, that data will become public in a searchable database on the web beginning in the fall of next year.
The new Physician Payment Sunshine Act (Sunshine Act) was created by Congress to ensure transparency in physicians’ interactions with the pharmaceutical, biologic and medical device industries as well as group purchasing organizations. Physicians elected to our House of Delegates have developed strong ethical standards and made clear that physicians’ relationships with these industries should be transparent and focused on benefits to patients.
The Patient Protection and Affordable Health Care Act (H.R. 3590) signed into law in March 2010 includes the Physician Payment Sunshine Act (section 6002) (PPSA), which requires pharmaceutical, medical device, biological, and medical supply manufacturers to report to Health and Human Services (HHS) any "payment or other transfer of value" to physicians and teaching hospitals. The first reports will be due March 31, 2013 for the calendar year 2012 reporting period.
PolicyMed is a blog that writes occasional articles about the Sunshine Act.
This is a very good resource from the Pew Prescription Project. The Pew Prescription Project conducts rigorous nonpartisan research related to federal oversight of drug safety to better illuminate problems and potential solutions.
Here, the Pew Prescription Project has compiled an excellent list of resources in PDF format to help organizations and stakeholders better understand the ramifications of the Physician Payments Sunshine Act.
A lot of organizations believe the Physician Payments Sunshine Act will help patients make better decisions and shed light on the relationships between doctors and medical manufacturers. This blog post talks about some of the organizations supporting sunshine acts in years past and this one as well.
To amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP.
A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP.