Life Science Compliance Update

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August 16, 2012

Physician Payment Sunshine Act: Senate Aging Committee Roundtable September 12th, and Letter from Stakeholders to CMS Requesting 180 Days for Implementation

There has not been much public activity regarding the Physician Payment Sunshine Act (“Sunshine Act”)—Section 6002 of the Affordable Care Act (ACA)—since the Centers for Medicare & Medicaid Services (CMS) announced back in May of this year, that it would delay data collection until 2013.  

In general, the Sunshine Act requires that all drug, medical device, and medical supply manufacturers disclose every payment or object above $10 allocated to physicians and teaching hospitals. 

This week, the Center for Business Intelligence (CBI) held its 6th Annual Forum on Sunshine and Aggregate Spend, which we attended.  The two-day event included experts across the entire healthcare industry discussing approaches and strategies for tracking aggregate spend and complying with U.S. and global transparency regulations.  

A representative from Centers for Medicare and Medicaid Services (CMS), who has been leading the effort at CMS to write the final Sunshine regulations, gave a brief update on the Sunshine Act regulations during the first day.  He noted that a lot of progress has been made and that CMS has been meeting and speaking with various stakeholders.  Though he gave no clear indication of when to expect the final regulations to be issued he did clarify that it would be well before December 2014 deadline to issue new draft guidance’s. 

Following the CMS presentation, was a presentation by a representative of the Special Committee on Aging in the U.S. Senate, which is chaired my Senator Herb Kohl (D-WI), who was co-author of the Sunshine Act, along with Senator Charles Grassley (R-IA).   Aging staff noted that the Aging Committee will be holding a 2-3 hour Roundtable Meeting to discuss the Sunshine Act on September 12, 2012, on Capitol Hill.     

The Roundtable will likely include members from CMS along with other affected stakeholders around technical issues regarding implantation of the Sunshine Act. They are limiting the roundtable participants in an effort to gain the best information from those participating.

The Senate Aging committee would like to gain insights on how to effectively collect post and explain context around the transparency data that the Sunshine Act collects.  

Aging staff noted that the meeting may address several specific questions including: 

  • Context in public interface:  so patients understand the purpose of the transfers of value of the relationships including research. 
  • What can they do better, what have they learned from implementing state laws and corporate integrity agreements. 
  • Questions around Continuing education and meals
  • How to do effective stakeholder outreach  

The Aging Committee has yet to publicize the exact details and information for the meeting, but we will be sure to post the information as soon as its published.  

The Senator is retiring this year and wants to see the Sunshine act implementation done well, and wants to see this as a workable system for patients and consumers. 

In addition to these announcements, CMS noted a recent letter that CMS had received from the Advanced Medical Technology Association (AdvaMed), Biotechnology Industry Organization (BIO), Medical Imaging & Technology Alliance (MITA), and Pharmaceutical Research and Manufacturers of America (PhRMA).  While the trade groups noted their commitment to transparency in the reporting of payments to physicians and teaching hospitals, they wrote “to encourage CMS to promptly publish the final rule implementing” the Sunshine Act.” 

The trade groups offered their appreciation for CMS’ attention to reporting details and its commitment for addressing over 300 comments the agency received.  Nevertheless, the companies asked that CMS release the final regulation so that companies have sufficient preparation time to implement the final rule.  The groups reiterated their comment that CMS provide applicable manufacturers 180 days after publication of the final rule before requiring data collection.  Companies will need this time for system development, implementation, testing, and training.

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The comment was obscure for a reason. The CMS rep mentioned that the administrative rules for making final rules in the government, require that you issue the final rule within three years of issuance of the proposed rule or you will have to issue another proposed rule. CMS issued the sunshine rule in December 2011, he kidded that the final rule would be issued before December 2014. They did not give any indication that the rule would be issued September of this year.

Thanks for the nice update but I am confused by the December 2014 date in paragraph 4 of your article. Do you mean September of 2012? and do you expect that the final bill will be out before the round table in Washington.

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