CBI Scene Blog

How to Prepare for Public Disclosure of Sunshine Data

Posted by Logan Fleck on Jun 9, 2014 10:14:00 AM


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The March 31, 2014 deadline for submitting reports reflecting the financial relationships between biotech companies, group-purchasing organizations (GPOs), pharmaceutical companies and medical device manufacturers passed. Physicians now have 45-days to review the reports for errors before the Centers for the Medicare and Medicaid Services (CMS) database goes online.

Physician Concerns

Registration on the Center for Medicare and Medicaid Service (CMS) Enterprise Portal began June 1 and in July, registration on the CMS’ Open Payments System begins. Many concerns surround the Sunshine Act as steps 1 and 2 begin.

Doctors express concern over:

  • Patient’s negative reactions to the reporting
  • Losing patient trust due to the government’s stricter regulations
  • The loss of autonomy in their fields

Patients put their health in the hands of professionals who practice under an oath of ethical behavior and misunderstanding the information in the database can turn patients away.

Other doctor and group purchasing organization reactions include:

  • The need to solidify relationships with the reporting industries
  • Acknowledgement of the problems with Medicare and Medicaid billing by some physicians
  • Dislike of regulations in the Sunshine Act that have existed in other laws for a long time
  • Frustration with the CMS’s disorganization and missed deadlines

The CMS database remains under construction even after submission of the required data by drug and device companies. Physicians concerned with the functioning of the database continue asking for more time to register and review the information the companies submit for accuracy. Doctors have 45-days to dispute information given to the CMS, but the requests for an extension during this first reporting year were denied.

Dispute Management Solutions

Organizations do not expect a large number of disputes as the doctors begin registering on the Open Payments portal provided by CMS. The website allows doctors to view reports submitted about them and to dispute information before its publication in September.

Preparing for disputes regarding small payments, like a $20 luncheon, have taken an exorbitant amount of time to settle, however. To date, claims for small amounts have taken an average of 14-days to resolve.

Organizations may reduce dispute resolutions time by:

  • Take information gathering from compliance departments and give them to sales
  • Setup a webpage with detailed dispute instructions and online filing opportunities
  • Using checklists for gathering proof of transactions

Compliance departments tend to employ fewer people than sales departments and the sales representatives know the faces behind the names. If the physician says he did not attend a $20 lecture, the sales representative will have access to the sign in sheet showing the signature.

Inaccurate doctor information presents another problem area for organizations reporting to the CMS. Using outdated information like:

  • A doctor’s specialty
  • Office location
  • Medical degrees
  • Years in practice

Physicians, advised to update their information by the AMA, may not do so. The AMA offers a toolkit to help doctors find and correct their information before publication. The information available may come from an outdated source. All attempts at finding the most current information for each physician or teaching hospital must be made to avoid disputes.

Disputes and Evidence Harvesting

Opening the way for Qui-Tam whistleblowers to harvest evidence for litigation also concerns doctors as the online publication date nears. The availability of this information may:

  • Provide evidence of conflict of interest where none exists
  • Support allegations of off-label marketing
  • Through manipulation, falsely implicate physicians who break no laws

The disclosure bar will stop qui-tam litigation when relators have no other evidence to support their claims. Public information cannot fuel a lawsuit unless the relator proves knowledge of the evidence before publication or has supporting evidence from a non-public source.

The intended purpose of the act, creators say, never bent toward exposing unethical or illegal transactions between pharmaceutical companies and physicians. Transparency of Medicare and Medicaid billing practices, the intended purpose of the Sunshine Act, sits in the background as confusion about the type of transactions CMS requires builds.

Changing Relations Between Doctors and Life Science Organizations

To avoid litigation, fines and losing their practices, doctors will consider free equipment and other gifts more carefully. Manufacturers will also have to look at their sales departments to find lower cost promotional services and sales techniques. The Sunshine act can further separate manufacturers and physicians by creating barriers sales representatives cannot cross without risking patient’s trust in their health care choice. Pre-disclosure to physicians, which many organizations refuse to do now, can ease the tension and open lines of communication.

To learn more about how you and your team can better prepare for public disclosure of Sunshine data, join us at CBI's 8th Annual Transparency & Aggregate Spend conference, taking place August 18-20, 2014 in Washington, DC. To learn more about this timely event, click on the button below!

Transparency and Aggregate Spend 2014

Topics: Compliance