Posts
Written by Alexis Stroud - Manager, Regulatory Compliance at QPharma
In response to growing concerns of potential conflict of interest between physicians and the pharmaceutical and medical device industries, Section 6002 Transparency Reports and Reporting of Physician Ownership or Investment Interests (commonly known as the Physician Payment Sunshine Provision) was included in the Patient Protection and Affordable Care Act (PPACA) signed into law on March 23, 2010, by President Barack Obama.
QPharma has prepared a fact sheet and guidance highlighting the key elements to help our industry better understand this provision and its requirements.
Beginning in 2013, Section 6002 requires that all manufacturers of a drug, device, biological or medical supplies report any transfers of value or payments exceeding $10 (or an aggregate of $100 or more) to physicians and/or teaching hospitals to the Secretary of Health and Human Services on an annual basis. This information will be available on a public, searchable website.
What Information is Required to be Reported?
QPharma has prepared a fact sheet and guidance highlighting the key elements to help our industry better understand this provision and its requirements.
Beginning in 2013, Section 6002 requires that all manufacturers of a drug, device, biological or medical supplies report any transfers of value or payments exceeding $10 (or an aggregate of $100 or more) to physicians and/or teaching hospitals to the Secretary of Health and Human Services on an annual basis. This information will be available on a public, searchable website.
What Information is Required to be Reported?
- Name of covered recipient (if a payment is made to an entity or individual at the request of or designated on behalf of a covered recipient, the payment must be disclosed under the covered recipient)
- Business address
- Physician specialty
- National provider identifier
- The value of the payment or transfer of value
- Date of payment
- The name of the related drug, device, or supply, if available; to the level of specificity available
- Form of payment
- Cash or cash equivalent
- In-kind items or services
- Stock or stock option (or any other return on investment)
- Nature of payment
- Consulting fees
- Compensation for services other than consulting
- Honoraria
- Gift
- Entertainment
- Food
- Travel or trip
- Education
- Research
- Charitable contribution
- Royalty or license
- Ownership or investment interest;
- Direct compensation for serving as faculty or speaker for medical education program
Does this Law Preempt State Law?
This law does indeed preempt state law, starting in 2012. States are prohibited from collecting the same information required to be reported under this section. States may continue to collect other types of data not captured or excluded from reporting (with the exception of threshold limits), as well as data for public health purposes or legal proceedings.
Federal preemption would not occur for State or local laws that are beyond the scope of this section. Currently, 8 states have enacted unique laws regarding the financial arrangements between drug and/or device companies and healthcare professionals and as of Jan 2010, there are 14 states with pending disclosure bills and 8 states with pending bills that prohibit or restrict health care professionals from accepting certain items of value.
Other states, such as CA, MA, and NV, require companies to adopt a marketing code of conduct, which is not addressed at all in the PPACA. There are also state laws on representative licensing (e.g. - DC) and lobbying laws (e.g. - FL (Dade County), CO, LA). This means that companies will have to continue to report certain expenditures and ensure compliance to state authorities.
This law does indeed preempt state law, starting in 2012. States are prohibited from collecting the same information required to be reported under this section. States may continue to collect other types of data not captured or excluded from reporting (with the exception of threshold limits), as well as data for public health purposes or legal proceedings.
Federal preemption would not occur for State or local laws that are beyond the scope of this section. Currently, 8 states have enacted unique laws regarding the financial arrangements between drug and/or device companies and healthcare professionals and as of Jan 2010, there are 14 states with pending disclosure bills and 8 states with pending bills that prohibit or restrict health care professionals from accepting certain items of value.
Other states, such as CA, MA, and NV, require companies to adopt a marketing code of conduct, which is not addressed at all in the PPACA. There are also state laws on representative licensing (e.g. - DC) and lobbying laws (e.g. - FL (Dade County), CO, LA). This means that companies will have to continue to report certain expenditures and ensure compliance to state authorities.
No comments:
Post a Comment