Physican Payment Sunshine Provision
The Physician Payment Sunshine Provision falls under PPACA (Patient Protection Affordable Care Act) and basically requires reporting of payments made to physicians or physician-owned entities by manufacturers to the government starting 1/1/12. I wonder if this includes all of those lunches paid by pharmaceutical manfacturers! That has got to be a chunk of change. Seriously, Healthcare IT News and IBM are offering a free webinar on this..http://www.healthcareitnews.com/resource-central-web-seminars
|Applicable group purchasing organization’ means a group purchasing organization (as defined by the Secretary) that purchases, arranges for, or negotiates the purchase of a covered drug, device, biological, or medical supply which is operating in the United States, or in a territory, possession, or commonwealth of the United States.The term ‘applicable manufacturer’ means a manufacturer of a covered drug, device, biological, or medical supply which is operating in the United States, or in a territory, possession, or commonwealth of the United States.The term ‘manufacturer of a covered drug, device, biological, or medical supply’ means any entity which is engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply (or any entity under common ownership with such entity which provides assistance or support to such entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological, or medical supply).|
|Report on self-referral||a requirement that the referring physician inform the individual in writing at the time of the referral that the individual may obtain the services for which the individual is being referred from a person other than a person described in subparagraph (A)(i) and provide such individual with a written list of suppliers (as defined in section 1861(d)) who furnish such services in the area in which such individual resides.’’.|
|Form of Reporting||
|Included in Disclosure||
|Definition of Payment||
|Excluded from Reporting||A transfer of anything the value of which is less than $10, unless the aggregate amount transferred to, requested by, or designated on behalf of the covered recipient by the applicable manufacturer during the calendar year exceeds $100.
|Product Development||Payments under a product development agreement must be reported for services furnished in connection with the development of a new drug, device, biological, or medical supply, and must also be reported with the following information: The date of the approval or clearance of the covered drug, device, biological, or medical supply by the Food and Drug Administration; andPayments made four calendar years after this date|
|Clinical Investigations||Confidential until either:
|Penalties||A civil money penalty of not less than $1,000, but not more than $10,000, for each payment or other transfer of value or ownership or investment interest not reported.The total amount of civil money penalties will not exceed $150,000.Knowingly failing to submit payment information will result in a civil money penalty of not less than $10,000, but not more than $100,000, for each payment.
The penalty will not exceed $1,000,000.
|Third Party Payments||Reported if they are requested by or designated on behalf of a physician|
|Pre-emption||Pre-Empts State Laws that are similar or weaker than this provisionDoes not pre-empt more restrictive laws (lower limits of payments, gift bans….)|