Senate Finance Committee Chairman Max Baucus (D-MT) released his Chairman’s Mark on America’s Health Future Act of 2009. A Chairman’s Mark is a recommendation by committee chairman of a measure to be considered in a markup (A committee session where a bill is reviewed and amended).
The America’s Health Future Act of 2009 Physician Payment Sunshine Provision includes provisions for pre-emption of state laws, a $10 per event or $100 cumulative payment quota, and requires reporting of payments to physicians, group practice or hospitals with a medical residency program and does not include a small business exemption. The bill requires reporting on significantly fewer entities than the house version.
Below is an outline of the Physician Payment Sunshine Provisions within the chairman’s mark.
Reporting
The bill 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, a physician medical practice, a physician group practice, or a hospital with an approved medical residency training program to report annually, in electronic form, specified information on such transactions to the Secretary of HHS. The report would include:
· The transfer recipient‘s name, business address, amount of the payment;
· Date of the payment;
· A description of the form of the payment;
· A 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 the name of that product; and
· Any other category of information that the Secretary determines appropriate.
If the recipient requests a transfer of payment to another entity or individual at the request of the recipient the manufacturer should disclose that information.
Clinical Trials and Product Development
Delayed reporting requirements would apply for payments made pursuant to a product development agreement or clinical trial.
Exclusions
Information excluded from these reporting requirements include payments or transfers of $10 or less, unless the aggregate annual payments or transfers to a recipient exceeds $100. If the annual payments or transfers to a recipient exceed $100.
Other excluded information includes:
· Samples intended for patient use;
· Patient educational materials;
· Loan of a covered device for a short-term time period;
· Discounts and rebates;
· Payments made to a physician for the provision of health care to employees;
· Payments to a physician who is also a licensed, non-medical professional if the payment is solely related to non-medical services, payments to a physician solely for services related to a civil or criminal action or an administrative proceeding, and in-kind items used for charity care.
Timeline
This reporting requirement would begin on March 31, 2012 and continue on the 90th day of each subsequent calendar year.
The Chairman‘s Mark 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.
Penalties
Manufacturers or group purchasing organizations would be subject to a civil money 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.
Website
Beginning September 30, 2012 and on June 30 of subsequent years, submitted information will be available on an Internet website that will include information on enforcement actions during the preceding year, background information on industry-physician relationships, and a separate listing for payments related to clinical research, and other information that the Secretary deems appropriate.
Preemption
Effective January 1, 2011 the Chairman‘s Mark would preempt any state (or political subdivision of a state) law or regulation that requires manufacturers to disclose the type of information required under this provision regarding payments or transfers to covered recipients. The Mark would not preempt any state (or political subdivision of a state) law or regulation that requires the disclosure or reporting of
- Any information not required under this provision;
- The types of information excluded from reporting requirements under this provision, with the exception of the $10 de minimis/$100 aggregate reporting requirement;
- Information by any person or entity other than an applicable manufacturer or covered recipient described above; and
- Information reported to a Federal, state, or local government for public health purposes.
CME
The bill will require reporting of continuing medical education (CME) grants/payments to Medical Schools and Hospitals with approved medical residency training programs.
Other Transparency Sections
In addition to payments from manufactures, there are several other transparency measures addressed in the chairman’s mark.
Insurance Companies
· Beginning in 2010, to ensure transparency and accountability, health plans would be required to report the proportion of premium dollars that are spent on items other than medical care.
Hospitals
· Beginning in 2010, hospitals would be required to list standard charges for all services and Medicare DRGs.
Drug Samples
· Submit to the Secretary of HHS rather than make available (as the current law requires) data on drug samples including recipient, amount, theft and losses.
Nursing Homes
· Discloser of Ownership
· Staffing Data
· Results of State Facility Surveys
· Enforcement Actions
· Expenditures on Staffing Expenditures for Direct Patient Care
Imaging Services
For Imaging Services the referring physician must inform the individual at the time of the referral that:
· The individual may obtain the services from a person other than the referring physician; a physician who is a member of the same group practice as the referring physician; or an individual who is directly supervised by the physician or by another physician in the group practice.
· The individual must be provided with a written list of suppliers who furnish services in the area in which the individual resides.
· This new requirement would apply to services furnished after January 1, 2010.
Summary
The bill covers significantly fewer recipients than the House Version and the original Physician Payment Sunshine Act introduced in January
Overall the chairman’s version is very reasonable and a good test for transparency. It also takes into consideration time for manufactures to develop procedures to comply with the law.