Introduction

The Physician Payment Sunshine Act (PPSA), which is part of the Affordable Care Act, was established to “shed light” on financial exchanges of $10 or greater or transfers that cumulatively exceed $100, between drug and medical device manufactures and physicians and teaching hospitals. These transfers can include but are not limited to: research funding, consulting fees, royalties, and speaking fees in addition to gifts, food, and entertainment. The American Medical Association (AMA) recently released an editorial expressing concerns about the PPSA. Under the act, the Centers for Medicare and Medical Services (CMS) will provide oversight and its Center for Program Integrity will take charge in carrying out all components of the act. Will the use of the Center’s antifraud unit create an environment of distrust and carry with it a stigma?

Background

Within the CMS, the Center for Program Integrity (CPI) was established in 2010 to prevent medical payment abuse and fraud within the Medicaid and Medicare programs. The CPI monitors for errors arising from medical billing mistakes; waste from unnecessary medical services being rendered; abuse from improper billing practices; and fraud arising from the billing of services not provided.

Additionally, in an effort to reduce fraud and abuse within the healthcare system, the CPI works closely with several state and federal law enforcement agencies including the Health and Human Services Office of Inspector General; The Department of Justice; and State Medicaid Fraud Control Units. The AMA has concerns regarding the public’s perception, believing that the reporting process, if carried out under the CPI, will lead to a stigma and possibly lead to a limitation in the advancement of medical research by limiting the interactions between physicians and pharmaceutical researchers.

Issue

If the CPI carries out the PPSA, will it create a public stigma and reduce physician researcher interactions?

Rule

The CPI should not be responsible for carrying out the PPSA if

  • There is a legitimate belief that CPI oversight will lead to a negative public perception of physician-manufacturer interactions

Or

  • The CPI oversight will hinder physician-pharmaceutical researcher interactions.

Analysis

There is a legitimate belief that CPI oversight of the PPSA will lead to a negative public perception of physician-manufacturer interactions. The AMA does support increased transparency of physician-manufacturer interactions. However, because the CPI is the antifraud unit of the CMS, the AMA asserts that reporting and public distribution of records under the CPI will lead to a stigma. The AMA believes that the affiliation with the antifraud unit will create a public perception that the physician-manufacturer interaction is somehow unethical or not legal. The AMA has stated a legitimate concern regarding public perception.

The CPI oversight will hinder physician-researcher interactions. Because of the proposed reporting of the PPSA under the control of the CPI, the AMA raised the concern that the public may perceive such interactions as unethical and negative. The public may not be aware that such collaborations between physicians and pharmaceutical researchers are vital to the advancement of medicine. Because of the possible negative public response, the AMA suggests that research collaborations may be limited under the direction of the CPI. If the public perceives physician-pharmaceutical researcher interactions as unethical, physicians will be pressured to avoid such interactions to avoid public stigma.

Conclusion

Because the AMA raised a legitimate concern regarding public perception of physicians, which may negatively impact the physician-research interaction, the CPI should not carry out the PPSA.

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