Here Comes the Sun(shine Act)

As pharmaceutical, biotechnology, and medical device manufacturers of every kind are discovering in the wake of March 2010's Patient Protection and Affordable Care Act (PPACA), big legislation can mean big change in the world of drug development and clinical trials.

As the healthcare industry initially mobilized to comply with dozens of immediately enforceable changes, even those able to wade through the 2,000-page act may have initially deferred preparation for less urgent provisions—those to be made compulsory eventually, but "not for a few years."

But time moves quickly, and just a few months from now a tiny little statute comprising about 1 percent of the PPACA's text and receiving even less attention from policy analysts will become increasingly prominent in the clinical trials community.

As 22 short pages tucked neatly into the mammoth PPACA, the Physician Payments Sunshine Provision—The Sunshine Act—mandates that drug, biological supply, and medical device manufacturers track all payments of over $10 made to investigators and research sites on an annual basis, beginning on January 1, 2012. This payment information will be reported beginning on March 31, 2013, with records becoming publicly available on September 30, 2013.

Facing penalties of up to $10,000 per payment omission means that pharmaceutical, biotechnology, and medical device companies need robust methods to track and report physician, vendor, and site payments, now more than ever.

Sponsors may deliver payments to research sites directly or, as is increasingly the norm, outsource their payment management to CROs for service charges of between $100 and $200 per payment. Given the scale of modern clinical trials, delivering, tracking, and reporting thousands of these transactions can turn into a substantial administrative burden and drive significant costs. In light of the Sunshine Act, payment management is also emerging as a regulatory liability.

Whether opting for an in-house or outsourced payment management strategy, the process of delivering, recording, tracking, and reporting site, vendor, and investigator payments has traditionally been undertaken manually, with limited use of automated, web-based resources. But just as technology has emerged to enhance so many other aspects of the clinical trials environment (think CTMS, EDC, IVRS, IWRS, ePRO, etc.), clinical technology developers have recently shifted their focus towards streamlining payment delivery and management processes. By centralizing all payment activity through a web-based system, technology enables detailed tracking and reporting across multiple CROs, vendors, sites, and investigators, where manual processes would be prohibitively costly and alarmingly unreliable.

Efficiently and accurately tracking and reporting site, investigator, and vendor payments is no longer the purview of only internal accounting and finance departments; soon, conformity with Sunshine Act provisions will demand the attention of compliance, regulatory, and top management for pharmaceutical corporations of all sizes and types.

In advance of the Sunshine Act's upcoming commencement, forward-thinking executives should recall the technological innovations now shaping the modern clinical environment and capitalize on the emergence of technology-based solutions for clinical payments.

CEO Greenphire E-mail: [email protected]