Sunshine provisions and poll

The following are key provisions of Sunshine rule. Take the poll and see what other industry stakeholders have to say.

Who would have to report?

 

Manufacturers of devices (including medical supplies) that require premarket approval by or notification to the Food and Drug Administration. (This would exclude many Class I devices and certain Class II devices, which are exempt from premarket notification requirements.)

 

Any manufacturer that sells or distributes at least one covered drug, device, biological, or medical supply would be considered an applicable manufacturer, and hence, be subject to reporting requirements, even though it may also manufacture products that do not fall within the category (that is, Class I or certain Class II devices).  Under the proposed rule, such a manufacturer would have to report all payments or transfers of value to a physician or teaching hospital, regardless of whether the particular payment or other transfer of value is associated with a covered drug, device, biological, or medical supply.

 

What would have to be reported?

 

•  Consulting fees.

•  Compensation for services other than consulting.

•  Honoraria.

•  Gifts.

•  Entertainment.

•  Food.

•  Travel (including the specified destinations).

•  Education.

•  Research.

•  Charitable contribution.

•  Royalty or license.

•  Current or prospective ownership or investment interest.

•  Direct compensation for serving as faculty or as a speaker for a medical education program.

•  Grant.

•  Any other nature of the payment or other transfer of value (as defined by the Secretary of Health and Human Services).

 

The name of the covered drug, device, biological, or medical supply associated with any payment, if the payment is related to the “marketing, education or research” of a particular covered drug, device, biological, or medical supply, would have to be reported. For example, if a sales representative takes a physician to dinner to explain the benefits of the applicable manufacturer’s new product, the name of the product would be included. The CMS rule adds, “We are considering, as an alternative, allowing applicable manufacturers to report multiple covered drugs, devices, biologicals, or medical supplies as related to a single payment or other transfer of value.”

 

What would be excluded?

 

• Transfers of value less than $10, unless the aggregate amount transferred to, requested by, or designated on behalf of the covered recipient exceeds $100 in a calendar year.
• Product samples that are not intended to be sold and are intended for patient use.
• Educational materials that directly benefit patients or are intended for patient use.
• The loan of a covered device for a short-term trial period, not to exceed 90 days, to permit evaluation of the covered device by the covered recipient.
• Items or services provided under a contractual warranty, including the replacement of a covered device, where the terms of the warranty are set forth in the purchase or lease agreement for the covered device.
• A transfer of anything of value to a covered recipient when the covered recipient is a patient and not acting in the professional capacity of a covered recipient.
• Discounts, including rebates.
• In-kind items used for the provision of charity care.
• A dividend or other profit distribution from, or ownership or investment interest in, a publicly traded security or mutual fund.
• In the case of an applicable manufacturer who offers a self-insured plan, payments for the provision of health care to employees under the plan.
• In the case of a covered recipient who is a licensed non-medical professional, a transfer of anything of value to the covered recipient if the transfer is payment solely for the non-medical professional services of the licensed non-medical professional.
• In the case of a covered recipient who is a physician, a transfer of anything of value to the covered recipient if the transfer is payment solely for the services of the covered recipient with respect to a civil or criminal action or an administrative proceeding.
• Transfers of value made indirectly to a covered recipient through a third party in cases when the applicable manufacturer is unaware of the identity of the covered recipient.

 

To view the CMS proposed rule, go to https://s3.amazonaws.com/public-inspection.federalregister.gov/2011-32244.pdf.