Physician Payment Sunshine Act: CMS Proposed Rule – Links to Legal Resources and Questions

The February 17th deadline is quickly approaching for individuals and stakeholders to submit comments for the proposed regulations from the Centers for Medicare and Medicaid Services (CMS) that will implement the Physician Payment Sunshine Act (Section 6002 of the Patient Protection and Affordable Care Act). 

The proposed rule will require manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program to report to CMS payments or other transfers of value they make to physicians and teaching hospitals.  The proposed rule would also require manufacturers and group purchasing organizations (GPOs) to disclose to CMS physician ownership or investment interests.  

Comments are due on February 17, 2012 by 5:00pm EST.  In submitting comments, include file code CMS-5060-P.  The proposed rule can be downloaded here.   Comments can be submitted by clicking here. 

The rule covers all payments to physicians of $10.00 or more or any combination of payments that total more than $100.00 in a given year.  This increased transparency is intended to help reduce the potential for conflicts of interest that physicians or teaching hospitals might face as a result of their relationships with manufacturers. 

Violators of the reporting requirements will be subject to civil monetary penalties (CMPs), capped at $150,000 annually for failing to report, and $1,000,000 for knowingly failing to report.  Data collection will not begin until CMS issues a final rule.  Depending on the timing of the final rule, CMS is proposing that manufacturers and GPOs will be required to submit a partial year on Mar. 31, 2013.  

Once the data has been submitted, CMS will aggregate manufacturer submissions at the individual physician and teaching hospital level, provide them with a 45-day period to confidentially review and, if necessary, correct the data, and make the data publicly available by Sep. 30, 2013.  

Here are some links to summaries we have written on various sections of the proposed regulations: 

• Transparency Reports, Definitions, Payment Categories, Exclusions
• Delayed Publication for Payments for Research; Penalties; Annual Reports; Preemption
• Report Submission and Correction; Report Format; 45-Day Review Period;
• Impact on Third Parties, including CME Providers 

We have put together a list of questions that CMS is asking input on from companies and healthcare providers on the proposed rule.

• List of CMS Questions

In addition to our materials, we have collected a wide array of articles and client updates from law firms, as well as a few presentations: 

• Sunshine Presentation from Morgan, Lewis & Bockius LLP
• Sunshine Phone Call from Sidley Austin LLP
• Cooley  LLP Alert
• Cooley LLP Comments
• Reed Smith
• Webinar Upcoming on February 15 – Prozio, Bromberg & Newman, PC
• Bloomberg BNA
• McGuire Woods
• National Pharma Audioconferences
• HaynesBoone
• Latham & Watkins LLP
• EpsteinBeckerGreen
• Skadden Arps
• Perkins Coie
• Hogan Lovells

 some important primary source documents you should take into consideration, especially with respect to CME providers and third parties: 

• FDA Final Guidance on Industry-Supported Scientific and Educational Activities
• AMA Code of Medical Ethics Opinion 9.011 – CME
• AMA Code of Medical Ethics Opinion 8.061 – Gifts to Physicians from Industry
• ACCME Standards for Commercial Support
• OIG Compliance Program Guidance for Pharmaceutical Manufacturers
• US Senate Finance Committee Staff Report
• PhRMA Code on Interactions with Healthcare Professionals
• 2009 OIG Testimony from U.S. Senate Aging Committee  

Once the CMS docket is closed, we will be providing summaries and analysis of the comments submitted.  Consequently, CMS is asking for comments on pretty much the entire proposed regulation, so it should be interesting to see how many comments CMS must go through and how difficult it will be to align stakeholders.