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Technology: Changes ahead for clinical trials

Anticipating the Sunshine Act

The Center for Medicare & Medicaid Services (CMS) recently announced that it will delay implementing the Physician Payment Sunshine Act and will not begin collecting data until 2013. Despite this delay, many U.S. drug and medical device manufacturers have focused sharply on tracking and analyzing their payments to physicians and teaching hospitals—and on tackling the unique challenges of doing so in the clinical research context.

Under the Sunshine Act, which is part of the health care reform law, “applicable manufacturers” of drugs, devices, biologicals and medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program must report annually to the Secretary of Health and Human Services certain payments or transfers of value to physicians and teaching hospitals as well as certain information regarding ownership or investment interests held by physicians in such manufacturers. CMS must then publish the reported data on a public website.

Issues that those involved in clinical research should consider while awaiting the Final Rule include the following:

Will payments by drug, device and biologic startups to physician researchers for early-stage development work be reportable? Under the proposed rule, reporting requirements are limited to applicable manufacturers of a “covered drug, device, biological or medical supply.” Covered drugs and biologicals are limited to those that require a prescription to be dispensed, and covered devices are limited to those that require premarket approval by or notification to the Food and Drug Administration (FDA).

Contributing Author

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Robyn Shapiro

Robyn Shapiro is a partner in the Health Care Practice and co-chair of the Life Sciences group at Drinker Biddle & Reath. Her practice focuses...

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