The Centers for Medicare & Medicaid Services (CMS) recently issued a Federal Register notice requesting comments related to the Sunshine Act, section 6002 of the Affordable Care Act. Specifically, CMS is requesting comments on the implementation of the registration process, attestation process, dispute and resolution processes, assumptions document, and data retention requirements for the Open Payments System.
Pharmaceutical, medical device and biotechnology manufacturers and group purchasing organizations (GPOs) should consider providing comments to CMS regarding: (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Comments must be submitted by September 20, 2013 using one of the following formats:
1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document related to Document Identifier/OMB Control Number CMS–10495.
2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number CMS–10495, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.