Life Science Compliance Update

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July 22, 2013

Physician Payment Sunshine Act: CMS Requests Comments on Open Payments System due September 20, 2013

Today in the Federal Register was posted a notice for interested parties to submit comments on the Open Payments System (Physician Payment Sunshine Act) implementation. For those who missed it, the notice was included within another notice for request for comments for the Nationwide Consumer Assessment of Healthcare Providers and Systems.

CMS is interested in receiving comments on the registration, attestation, dispute and resolution, assumptions document, and data retention requirements for Open Payments. Responses are due Friday September 20, 2013.

CMS is seeking input into the:

(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.

The Sunshine Act 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 their immediate family members in applicable manufacturers or applicable GPOs.

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.

Applicable manufacturers and applicable GPOs are subject to civil monetary penalties (CMPs) for failing to comply with the reporting requirements of the statute. CMS is required by statute to publish the reported data on a public Web site. The data must be downloadable, easily searchable, and aggregated. In addition, CMS must submit annual reports to the Congress and each state summarizing the data reported. Finally, section 1128G of the Act generally preempts state laws that require disclosure of the same type of information by manufacturers.

CMS published a final rule in 2013 to implement this program, which included several information collections subject to the Paperwork Reduction Act. This information collection request is to inform the public about information collected that is necessary for registration, attestation, dispute resolution and corrections, record retention, and submitting an assumptions document within Open Payments.

To submit comments:

When commenting, please reference the document identifier CMS-10493 and CMS -10495 or OMB control number (OCN). To be assured consideration, comments and recommendations must be submitted in any one of the following ways:

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(s) that are accepting comments.

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 ______, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.Show citation box

To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.

2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov.

3. Call the Reports Clearance Office at (410) 786-1326.

For policy questions regarding this collection contact Melissa Heesters at 410-786-0618.).

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This sunshine act is a huge waste of taxpayer money and will not result in significant elimination of undue influence because a) there is not a material amount of undue influence, b) there will be so much data to review that it will be unwieldy and virtually impossible to digest into actionable problems, c) it is likely to be very inaccurate because of unclear and inconsistent data collection methods.

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