Section 6002 of the Affordable Care Act added section 1128G to the Social Security Act (Act), which requires applicable manufacturers and applicable group purchasing organizations (GPOs) of covered drugs, devices, biologicals, or medical supplies to report annually to CMS certain payments or other transfers of value to physicians and teaching hospitals, as well as, certain information regarding the ownership or investment interests held by physicians or the immediate family members of physicians in such entities. Specifically, applicable manufacturers of covered drugs, devices, biologicals, and medical supplies are required to submit on an annual basis the information required in section 1128G(a)(1) of the Act about certain payments or other transfers of value made to physicians and teaching hospitals (collectively called covered recipients) during the course of the preceding calendar year. Similarly, section 1128G(a)(2) of the Act requires applicable manufacturers and applicable GPOs to disclose any ownership or investment interests in such entities held by physicians or their immediate family members, as well as information on any payments or other transfers of value provided to such physician owners or investors. Applicable manufacturers must report the required payment and other transfer of value information annually to CMS in an electronic format. The statute also provides that applicable manufacturers and applicable GPOs must report annually to CMS the required information about physician ownership and investment interests, including information on any payments or other transfers of value provided to physician owners or investors, in an electronic format by the same date. This information collection request includes the Registration, Attestation, Assumptions Document and Data Retention Requirements this program.
In an effort to keep all aspects of the same data collection under one OMB control number, CMS is proposing to combine OMB control number 0938-1173 and OMB control number 0938-1237 under the same OMB control number. The total number of hours (3,925,518) in the existing 0938-1173 will decrease significantly as a result of decreasing the number of respondents and the time associated with the Open Payments Portal. The existing ICR overestimated burden considerably; however, due to more reliable data provided by the Open Payments system, CPI has been able to provide more accurate data versus relying on best guest assumptions. Start-up burden has been removed from 0938-1173 (Registration, Review and Disputes) and from 0938-1237 (Open Payments Portal) as well. CMS is proposing to decrease the overall burden hours by -1,956,056 hours.
The burden estimates related to registration (Applicable Manufacturer, Applicable GPO, Physician and Teaching Hospital) has decreased as the initial registration process has already been completed by the majority of Applicable Manufacturers and GPOs and physicians and hospitals interested in reviewing data. Once the initial registration is completed, no repeated registration is required. Thus registration is a one-time burden and does not recur on an annual basis; however, some registration burden is still included due to the fact that some new entities may need to register. Additionally, since the program inception, Open Payments has made a number of improvements to the system interface and user materials that streamline the registration process for users. Those improvements have significantly decreased the registration burden on users. The estimated number of such entities is much smaller than in the initial years of the program.
The estimated burden of record retention, dispute resolution and correction (teaching hospitals and physicians) has been revised as it was discovered that participation in the review, dispute, and correction process by physicians and hospitals was much lower than originally estimated. Participation in this process is entirely voluntary for physicians and hospitals. The number of records disputed during the first 3 years of the program, was also much lower than originally estimated. Lastly, the burden of the review, dispute and correction process was decreased for those who participate in it by usability refinements to the system and user documentation making the process less burdensome.
Estimates of burden for attestation and assumptions document for applicable manufacturers and GPOs changed due to methodology refinements based on the actual operational program data rather than best guest projections used in the previous set of estimates developed before the programâs start and also due to technical system refinements that streamlined the attestation and assumptions document submission process.
$0
No
No
No
Yes
No
No
Uncollected
Jamaa Hill 301 492-4190
Reginfo record details
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Form CMS-10495 AM and Applicable GPO (Data submission)
CMS-10495 - 2016-Data-Submission-Data-Mapping-Doc.xlsx
CMS-10495 - Open-Payments-User-Guide 2018.pdf
CMS-10495 - Supporting Statement AFinal.docx
AM and Applicable GPO (Data submission)