Introduction

The January 1, 2013 deadline that the Centers for Medicare and Medicaid Services has set for pharmaceutical companies, medical device manufacturers, and biotechnology companies to begin data collection under the Physician Payment Sunshine Act is fast approaching.  While physicians and pharmaceutical companies will feel the effects of the act soon, the question remains: how will patients be affected?

Background

The Physician Payment Sunshine Act aims to enhance transparency among drug makers, physicians, and the public by requiring accurate reporting of all financial transactions between pharmaceutical companies and healthcare providers. The act applies to manufacturers of drugs, medical devices, biologics, and medical supplies, along with group purchasing organizations. All gifts and payments greater than $10 made to physicians and hospitals must be reported, while gifts greater than $100 will be public record and published online. While some argue that the resulting published online record will hold corrupt individuals and companies accountable, how will the Physician Payment Sunshine Act impact patients?

Issue

Will the Physician Payment Sunshine Act negatively impact patients?

Rule

The Physician Payment Sunshine Act will negatively impact patients if:

  • The act will negatively impact continuing medical education, or
  • The act will negatively impact medical research

Analysis

The act will negatively impact continuing medical education

A letter written by House of Representatives physicians and nurses stated that the proposed regulations of the Physician Payment Sunshine Act will “negatively impact patient care and the practice of medicine.” The letter stated that inclusion of continuing medical education (CME) events in the act would result in an end to participation in CME events, especially in cases where the seminar focus is medical technology advancement.

A Deloitte/Forbes survey shows that 57% of physicians consider industry-supported CME events as the best source for learning about new medications and treatments. If physician participation does indeed come to an end due to the Physician Payment Sunshine Act, patients will no longer receive the best care available with new medication and treatments.

The act will negatively impact medical research

In a September 12, 2012 Statement for the Record, Executive Director of the Association of Clinical Research Organizations Doug Peddicord referred to a survey that showed that 24% of physicians in the US who conduct clinical research would be less likely to participate in their research if payments were disclosed. He believes this to be because of the potential for this information to be misconstrued by the public. In this case he believes that the country could potentially lose one quarter of its clinical investigators, thus slowing innovation and its delivery to the patient population.

Conclusion

Since the Physician Payment Sunshine Act will negatively impact continuing medical education and negatively impact medical research, it will negatively impact patients.

For more information on this issue, contact the Kulkarni Law Firm.