Senators Baucus (D-MT) and Grassley (R-IA) released their outline for Healthcare Reform (Transforming the Health Care Delivery System: Proposals to Improve Patient Care and Reduce Health Care Costs), in the document they lay out their revised vision for the Physicians Payment Sunshine Act, which apparently, will be incorporated into the Health Care Reform Bill of 2009.
The option includes a realistic time frame of starting the reporting program in 2012, a four year delay of reporting pre-approval activities.
The Committee is seeing input in four areas:
· Whether the reporting of payments and other transfers of value should include additional individuals and entities
· Whether a de minimis threshold for payments and transfers of value should be implemented or an annual aggregate reporting threshold of $100 per recipient.
· Whether small business entities should be exempted from reporting or if all manufacturers, regardless of size, should be required to comply with the reporting requirements.
· The extent to which these provisions would preempt state laws or regulations.
The white paper tracks closely with the Physicians Payment Sunshine Act of 2009, the questions they are considering are good ones and organizations should consider responding.
Transparency Proposal Details
Proposed Option
This proposal would amend part A (General Provisions) of title XI of the Social Security Act to provide for transparency in the relationship between physicians and applicable manufacturers with respect to payments and other transfers of value and physician ownership or investment interests in manufacturers.
It calls for the submission of payment and ownership information and procedures to make this information public.
Reporting
The proposal would require any manufacturer of a covered drug, device, biological, or medical supply that makes a payment or another transfer of value to a physician to report annually, in electronic form, specified information on such transactions to the Secretary of Health and Human Services.
The Committee seeks input on whether the reporting of payments and other transfers of value should include additional individuals and entities.
The report would include:
· The transfer recipient’s name, business address,
· Value of the payment, date of the payment,
· Description of the form of the payment,
· Description of the nature of the payment,
· If the payment is related to marketing, education, or research specific to a covered drug, device, biological or medical supply and its name,
· National Provider Identifier,
· Any other category of information that the Secretary determines appropriate.
If the recipient requests a transfer of payment to another entity or individual, the manufacturer should disclose that information.
Pre-Approval
For payments made pursuant to a product development agreement or clinical trial, payments would not be published until the earlier of:
(1) the date of approval or clearance by the FDA, or
(2) four calendar years after the date of payment.
Exclusions
Some information would be excluded from these reporting requirements:
· including payments or transfers of $10 or less,
· samples intended for patient use,
· patient educational materials,
· loan of a covered device for a short-term time period,
· discounts and rebates,
· in-kind items used for charity care,
· profit distributions from publicly traded companies.
Timing
· The reporting requirement would begin on March 31, 2012
· Remain in effect on the 90th day of each subsequent calendar year.
De Minimis
The Committee seeks input on whether a de minimis threshold for payments and transfers of value should be implemented or an annual aggregate reporting threshold of $100 per recipient.
Physician Ownership
The proposal also requires any such manufacturer or related group purchasing organization to report annually to the Secretary, in electronic form, certain information regarding any ownership or investment interest (other than in a publicly traded security and mutual fund) held by a physician (or an immediate family member) in the manufacturer or group purchasing organization during the preceding year.
Small Business Exclusion
The Committee seeks input on whether small business entities should be exempted from reporting or if all manufacturers, regardless of size, should be required to comply with the reporting requirements.
Penalties
· Manufacturers or group purchasing organizations would be subject to a civil monetary penalty (CMP) of not less than $1,000 but not more than $10,000 for each payment or transfer not reported.
· The total amount of the penalties for any annual submission shall not exceed $150,000.
· Any manufacturer or group purchasing organization that knowingly fails to submit information would be subject to a CMP of not less than $10,000 but not more than $100,000 for each payment or transfer not reported.
· The total amount of the penalties for this failure to report category of submissions shall not exceed $1,000,000 annually.
Administrative Procedures
The proposal would require the Secretary to establish procedures no later than June 1, 2010 to ensure public availability of this information.
Beginning September 30, 2012, and on June 30 of subsequent years, submitted information would be available on an Internet website that meets formatting, search, and usability requirements.
In addition to the payment and value transfer information, the website would include information on:
· Enforcement actions during the preceding year,
· Background information on industry-physician relationships,
· Separate listing for payments related to clinical research,
· Other information that the Secretary deems appropriate.
Corrections
The Secretary would also allow recipients, manufacturers, and group purchasing organizations an opportunity to submit corrections to their information.
Input from Effected Parties
This reporting procedure would be established after consulting the Office of the Inspector General (OIG), affected industry, consumers and other parties in order to ensure that the information is presented in an appropriate context.
Reporting to Congress
The Secretary would be required to submit an annual report summarizing the payment and value transfer information to Congress and the states beginning April 1, 2012.
Preemption
Effective January 1, 2011, these provisions would preempt any state law or regulation that requires manufacturers to disclose information regarding payments or transfers.
This preemption does not affect information that is not required under this proposal.
The Committee seeks input on the extent to which these provisions would preempt state laws or regulations.
The Secretary should consult with the OIG on the implementation of this section.
For the other recommendations listed in the white paper: Transforming the Health Care Delivery System: Proposals to Improve Patient Care and Reduce Health Care Costs