Physician Payment Sunshine Act: House American’s Affordable Health Choices Act of 2009, Physician Payment Sunshine Provision
While the Senate Finance Committee is projected to release their health care reform bill by Friday (almost two weeks passed their deadline), the House formally released their version of healthcare reform H.R 3200, the America’s Affordable Health Choices Act of 2009.
The bill is scheduled for mark up by the House Energy and Commerce Committee beginning tomorrow, and all through next week. The news around the bill has focused almost exclusively on increasing taxes on the wealthy to pay for the trillion dollar plus health care reform package.
Within the released bill, there is an updated section regarding the Physician Payment Sunshine Provisions, different from the previously reported summary.
The differences between the original bill and this version include :
- Preemption language based on Grassley-Kohl (S. 301) to preempt States from collecting info that is collected at the Federal level. It does not preempt States from requiring reporting of:
- Information that is not collected at the federal level;
- Information required to be reported to a federal state or local governmental agency for public health surveillance, investigation, or other public health purposes or health oversight purposes; and
- Does not affect the discovery or admissibility of information described in this section in a criminal, civil, or administrative proceeding. The previous House draft had no preemption.
- Discounts and rebates that are now explicitly excluded from reporting. Previous draft required reporting of discounts and rebates.
- Removal of language from the previous draft that required manufacturers to report payments made “directly, indirectly, or through an agent, subsidiary, or other third party” to covered recipients.
- Delayed reporting for product development and for clinical trials until the date that the trial is registered on clinicaltrials.gov or 2 years after the payment was made, whichever is earlier. The previous version only had delayed reporting for product development agreements.
- A new provision that says product development and clinical trial payment info are considered confidential and are not subject to disclosure under FOIA until or after the date on which the info is made public.
- A new provision that says the accuracy of information is the responsibility of the manufacturer, and the Secretary must establish procedures to ensure that covered recipients have the opportunity to submit corrections to the manufacturer, and under such procedures, the corrections must be transmitted to the Secretary.
- A new provision that National Provider Identifiers must not be made public but can be made available by the Secretary for research or legitimate business purposes pursuant to data use agreements.
- Removal from the previous version language within the annual report to Congress, to include a report on a description of the types and prevalence of financial arrangements between hospitals and physicians.
- The definition of “clinical investigation” as “materials derived from human subjects” has been added.
- Group Purchasing Organizations (GPO’s) have been added to the list of “covered recipients”.
- A special rule for drug samples, in which there is no requirement to make public information regarding drug samples.
- Penalties for any defined entity that does not comply with reporting, 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; with an annual penalty not to exceed $150,000;
- Penalties for knowingly failing to report will result in a civil money penalty of not less than $10,000, but not more than $100,000, for each payment or other transfer of value or ownership or investment interest not reported; with an annual penalty not to exceed $1,000,000 or, if greater, 0.1 percent of the total annual revenue;
- The ability for State Attorney Generals to enforce this provision.
- Exclusions from reporting such as payments under $5; the loan of a covered device not exceeding 90 days; services provided under a contractual warranty of a device or product;
For CME this version has the same language as the draft, in that all grants to CME providers by companies will be reportable, but reporting attendees and expenses will not be required.
The Senate Version, due this week (Thursday or early next week), may be very similar to the original bill posted this year with some minor changes. Physician Payment Sunshine Act 2009 Introduced.
U.S. House of Representatives
House Democrat American’s Health Choices Act of 2009 7-14-09