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Partly cloudy for Sunshine Act start

Pharmaceutical and medical device companies still laboring to adapt to the regulation's requirements, which go into effect Aug. 1

In advance of August 1, when drug, device and biological companies, medical supply manufacturers and group purchasing organizations will be required to collect and document marketing expenses under the Physician Payments Sunshine Act, pharmaceutical and medical device companies have been preparing but they’re still laboring to adapt.

“The pharmaceutical guidelines that's been around for a while pretty much foresaw what was coming down the road, which was more and more transparency and sharing information with the public,” said Randy Vogenberg, PhD, RPh, principal of the Institute of Integrated Healthcare, a healthcare consulting organization.

[See also: CMS releases Sunshine Act final rule]

But even though these companies have been collecting data for some time now, it was for internal use – not tailored to public reporting, Vogenberg said.

Now that they must publicly report data in particular ways, these companies are incurring expenses to put the Sunshine Act’s reporting requirements in place, said Daniel Gilman, founder and chief information officer of RxVantage, a cloud-based technology platform interfacing physician practices with pharmaceutical and medical device representatives. “It’s a significant requirement and if you have hundreds or thousand of reps across multiple brands – and big Pharma companies do – you’ve got a lot to do.”

The Centers for Medicare & Medicaid Services estimates first year costs to companies totaling $269 million in compliance costs, with subsequent years costing $180 million to the broader industry. Manufacturers will assume approximately $183 million in costs the first year and an additional $1.15 million in infrastructure costs ($194 million total), while the remainder of the costs will be borne by GPOs, third parties, physicians and teaching hospitals.

The restrictions imposed by the Sunshine Act also impact how pharmaceutical and medical device companies’ sales forces do their work.

According to a recent AccessMonitor report from ZS Associates, 45 percent of physicians already restrict access to sales reps.

Pratap Khedkar, managing principal at ZS Associates, said that pharmaceutical companies have been trying to adapt to such access restrictions by eliminating work that representatives would have planned, but even that technique is no longer feasible given the new access restraints.

Khedkar said another way sales reps are adapting to the restrictions is by making the most of their decreased time with doctors by changing their approach to allow for longer and more impactful interactions.

“One way reps may enhance their conversations is by displaying content on their iPad or tablet devices,” Khedkar said. “Their content may be revamped to include more engaging and interactive content compared to a paper detail aid.”

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