We posted several stories analyzing the various aspects of the Final Rule to implement the Physician Payments Sunshine Act—Section 6002 of the Patient Protection and Affordable Care Act (PPACA). In light of the significant complexity the rule presents to many stakeholders, we decided to provide a condensed chart or quick reference guide for readers to know many of the key details for reporting.
|42 CFR Part 403|
|Start Date for Collecting/Tracking||August 1, 2013|
|Must Report to CMS by||March 31, 2014 (aggregate data)|
|Publication of Reports||September 30, 2014 and June 30th in future years|
|Who Reports||Applicable Manufacturers & Applicable Group Purchasing Organizations (GPO) (click here for definitions and here for limitations on applicable manufacturer reporting) must report payments made to “covered recipients”|
|What is Reported?||
|Nature of Payment||
|Payments for Research||(i) Name of the research institution, individual or entity receiving the payment or other transfer of value.
A. If paid directly to a physician covered recipient, all of the following must be provided:
(1) The physician’s name as listed in the NPPES (if applicable).
(2) National Provider Identifier.
(3) State professional license number(s) (for at least one State where the physician maintains a license) and State(s) in which the license is held.
(5) Primary business address of the physician(s).
B. If paid directly to a teaching hospital covered recipient, list the name and primary business address of teaching hospital.
C. If paid to a non-covered recipient (such as a non-teaching hospital or clinic), list the name and primary business address of the entity.
(ii) Total amount of the research payment, including all research-related costs for activities outlined in a written agreement, research protocol, or both.
(iii) Name of the research study.
(iv) Name(s) of any related covered drugs, devices, biologicals, or medical supplies (subject to the requirements specified in paragraph (c)(8) of this section) and for drugs and biologicals, the relevant National Drug Code(s), if any.
(v) Information about each physician covered recipient principal investigator (if applicable) set forth in paragraph (f)(1)(i)(A) of this section.
(vi) Contextual information for research (optional).
(vii) ClinicalTrials.gov identifier (optional).
|Payments for Pre-Clinical Research||For pre-clinical studies, applicable manufacturers only have to report: (i) Research entity name (as required in paragraph (f)(1)(i) of this section).
(ii) Total amount of payment (as required in paragraph (f)(1)(ii) of this section).
(iii) Principal investigator(s) (as required in paragraph (f)(1)(v) of this section), including
No requirement to report an “associated product, or study name.”
|Special rules for payments or other transfers of value related to continuing education programs.||Payments or other transfers of value provided as compensation
for speaking at a continuing education program are not required to be reported, if all of the following conditions are met:
i. The event at which the covered recipient is speaking meets the accreditation or certification requirements and standards for continuing education of one of the following:
ii. The applicable manufacturer does not pay the covered recipient speaker directly.
iii.The applicable manufacturer does not select the covered recipient speaker or provide the third party (such as a continuing education vendor) with a distinct, identifiable set of individuals to be considered as speakers for the continuing education program.
|Excluded from Reporting||
(click here for more information)
|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.
Combined, penalties may not exceed $1,150,000.
|Pre-emption||“State and local entities may require reporting of nonrequired of information for payments or other transfers of value reported to CMS, which are not required under Federal law. This includes payment categories excluded by the Federal law, with the exception of those that do not meet the minimum dollar threshold ($10). “States and localities may require reporting of payments or other transfers of value not required to be reported at all under the Federal law. For example, they may require the reporting of payments to non-covered recipients or by non-applicable manufacturers.|
Links to Additional Policy & Medicine’s Stories on Final Sunshine Act Regulations