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Opioid Legislation: Expanding the Sunshine Act

By Stephanie Willis & Alice Hall-Partyka on October 15, 2018
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On October 3rd, the United States Senate passed a bipartisan opioids package with a sweeping vote of 98 to 1, after the U.S. House of Representatives passed the final version of the bill with a vote of 393 to 8. One of its components, the “Fighting the Opioid Epidemic with Sunshine Act,” expands the scope of reporting requirements under the Physician Payment Sunshine Act (known as the “Sunshine Act”), which will have immense implications for the pharmaceutical and medical device and supply industries.

Enacted at section 6002 of the Affordable Care Act in 2010 to increase transparency around the financial relationships between health care providers and drug manufacturers, the Sunshine Act requires “applicable group purchasing organizations” and “applicable manufacturers,” including pharmaceutical and medical device or supply companies with operations in the United States, to track and report payments and transfers of value that they make to “covered recipients,” currently defined to include physicians and teaching hospitals. These transfers of value include items such as consulting fees, honoraria for speaking events, and research grants.

The opioids legislation package expands the definition of “covered recipients” to include other types of health care professionals: physician assistants, nurse practitioners, clinical nurse specialists, registered nurse anesthetists, and certified nurse midwives. The new legislation additionally sunsets a prohibition in the Sunshine Act that prevents the inclusion of the National Provider Identifier on the CMS Open Payments website.

Given the Administration’s focus on the opioid crisis, identified as a “national emergency,” the expansion of the Sunshine Act reflects the reality that prescriptions of opioids and other drugs to individuals may come from health professionals who are not physicians. State “sunshine laws” that imposed reporting requirements on payments to these professionals have existed for a number of years, but the changes passed in the opioids package would make this standard the baseline for reporting covered payments nationwide. By the time these changes would be effective on January 1, 2022, applicable group purchasing organizations and manufacturers will need to update their Sunshine Act compliance and monitoring activities to account for the greatly enlarged scope of individual health care professionals to whom they may be providing direct or indirect transfers of value.

The expansion of the Sunshine Act’s covered recipient definition was introduced in the Senate version of the opioids package, and remained in the overall legislation despite vigorous opposition. To become law, the bill requires the signature of President Trump.

Photo of Alice Hall-Partyka Alice Hall-Partyka

Alice Hall-Partyka is a counsel at Crowell & Moring’s Los Angeles office, where she is a member of the firm’s Health Care Group. She counsels payers, providers, and technology companies on a broad range of health care regulatory, corporate, and policy matters. Alice

…

Alice Hall-Partyka is a counsel at Crowell & Moring’s Los Angeles office, where she is a member of the firm’s Health Care Group. She counsels payers, providers, and technology companies on a broad range of health care regulatory, corporate, and policy matters. Alice uses her industry experience to help clients identify practical solutions and navigate complex regulatory frameworks.

Alice advises health care companies that are adapting to evolving laws and regulations, developing new products or services, or seeking to improve their regulatory compliance. She also strategizes with and represents clients that are responding to governmental inquiries and investigations. Alice’s areas of focus include Medicaid and Medicare program requirements, mental health parity, health reform, state regulation of payers and providers, digital health and innovative technologies, and health care fraud and abuse.

Read more about Alice Hall-PartykaEmail
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  • Posted in:
    Health Care
  • Blog:
    Health Law
  • Organization:
    Crowell & Moring LLP
  • Article: View Original Source

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