Life Science Compliance Update

February 21, 2013

Physician Payment Sunshine Act: CMS Launches National Physician Payment Transparency Program Website, Forms and Templates

Open Payment System

This week, the Centers for Medicare & Medicaid Services (CMS) launched a website which will host the National Physician Payment Transparency Program—known as OPENPAYMENTS.  The website will be used for information for stakeholders regarding the Physician Payment Sunshine Act—Section 6002 of the Affordable Care Act (ACA).   

CMS’ Center for Program Integrity will implement and administer OPENPAYMENTS.  The group is led by Shantanu Agrawal, MD.  

“The National Physician Payment Transparency Program or OPENPAYMENTS makes the financial relationships between manufacturers, group purchasing organizations, physicians, and teaching hospitals transparent and publicly available,” the website says.   

“Physicians, teaching hospitals, and industry manufacturers working together can design and deliver life-saving drugs and devices. While working together can be beneficial, payments from manufacturers to physicians and teaching hospitals can also set up conflicts of interest,” CMS adds. 

CMS said it is in the process of defining business requirements based on the final rule with a technical RFP release soon for system. 

CMS Presentation at the Disclosure Summit

Niall Brennan the Director, Office of Information Products and Data Analytics, Centers for Medicare and Medicaid Services presented at the Fifth Annual Summit on Disclosure, Transparency and Aggregate Spend for Drug and Device Companies.  At the session he outlined CMS’s role in implementation of the Sunshine provisions and a overview of the final regulation including who reports and what is reported on.  He commented that they made a number of changes including changes to research reporting.  In describing nature of payment, one of the big changes was their treatment of Continuing Medical Education including multiple categories for CME (Accredited and non accredited).   

According to Mr. Brennan in the final rule accredited CME is generally excludable from reporting as long as it is accredited, the payment is not made directly from the manufacture, and the speakers are not affirmatively selected or suggested by the applicable manufacture.  He was later asked about this exclusion and CMS felt there were significant reforms and sufficient firewalls to exclude accredited CME from reporting.

To download the CMS presentation:  CMS Sunshine presentation Feb 19 2013

To order presentations from: Fifth Annual Summit on Disclosure, Transparency and Aggregate Spend for Drug and Device Companies

What OPENPAYMENTS will do 

  • Facilitate transparency into the financial relationships between industry and physicians and teaching hospitals
  • Help reduce the potential for conflicts of interest that physicians or teaching hospitals could face as a result of their relationships with manufacturers
  • Empower informed decision-making for consumers of healthcare 

How OPENPAYMENTS works 

Applicable manufacturers (AMs) and applicable group purchasing organizations (AGPOs) will tell us every year about:

1.  Payments or other applicable transfers of value made to physicians or teaching hospitals by an AM of drugs, devices, biologics, or medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP)

2.  Ownership or investment interests held by physicians or their immediate family in AMs or AGPOs 

AMs and AGPOs will start collecting financial relationship data on August 1, 2013 as specified in the CMS-issued data templates.  They need to register on CMS’ website and submit the data to CMS starting in 2014.  In 2014, physicians and teaching hospitals will be able to: 

  • Register with us to review data about them before public posting
  • Dispute data they believe is incorrect
  • Work with AMs and AGPOs to resolve disputes to correct mistakes 

To further ensure that the data is accurate and complete, CMS will conduct audits and when appropriate CMS will collect civil monetary penalties from AMs and AGPOs that fail to submit all of their data or submit data that is inaccurate. 

CMS will publicly post data on its Internet site in September of 2014.  CMS said it will “strive for OPENPAYMENTS to be an accurate and complete national resource of this information for beneficiaries, consumers, and providers to better understand relationships between doctors, teaching hospitals, and industry.”   

How this site can help 

This site tells you what you need to know about OPENPAYMENTS and Section 6002 of the Affordable Care Act.  CMS said to check back frequently for:  

  • General information
  • Fact sheets
  • Tools and instructions
  • Resources
  • Dates of webinars, calls and meetings
  • Frequently asked questions 

In addition, stakeholders can e-mail your questions about OPENPAYMENTS to openpayments@cms.hhs.gov. 

CMS Forms/Templates for Sunshine 

In addition to opening this website, CMS also recently posted the Templates for AMs and AGPOs to use for reporting purposes.  CMS said that “the data templates will provide detailed information about the data to be collected including the data element name, format, allowable values, required versus optional fields, and other associated rules intended to aid the applicable manufacturers and applicable group purchasing organizations as they prepare for and participate in data collection.” 

Comments on the templates can be submitted to CMS through the email noted above.  

It is interesting to note that in the proposed template for non-research payments, CMS has indicated that for the “contextual information” that AM’s may provide, the limit is only 200 characters—hardly any space to provide sufficient contextual information.  CMS provide four (4) separate templates: 

1.  Non-research payment template

2.  Physician ownership template

3.  Supporting Statement

4.  Research Payment Template

CMS said that if it intends to make changes to the data templates, it will provide them at least 90 days prior to first day of data collection for the next reporting year.  In providing revised templates, CMS will also comply with the requirements of the Paperwork Reduction Act to seek public comments on the proposed changes to the information collections, as required by law.  This will allow applicable manufacturers and applicable GPOs to make any necessary changes to prepare for the next reporting year. This is the same time as the date by which CMS will publish the list of teaching hospitals. 

Non-research payment template 

This template has six (6) columns and forty-six (46) rows.  In the columns are the following information: 

  • Row#
  • Data Element Name (e.g. physician specialty)
  • Definition/Description
  • Values (e.g. Text, Alphanumeric)
  • Required?
  • Data element size (e.g. 10 characters); and
  • Public display (Yes or no)

The forty-six rows correspond with all the various data element requirements, such as physician address, NPI #, etc. (see our quick reference guide for the payment categories.  For more in-depth analysis, see our stories about reporting requirements and nature of payment categories).   

The research payment template is similar in most respects, however, it has sixty-six (66) rows of data entry.  This is due to the different data elements required to be reported for research payments (see our story here).

All files have a common Submission File header.  For the research and non-research payments, if recipient is outside the US, a separate Province and Postal Code are required information.

Resources

To sumbit comments on the proposed templates:  openpayments@cms.hhs.gov

Link to proposed templates

Thanks to good folks at Polaris for finding the link to the CMS Forms and Documents... we realize it was not a simple task.

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