Diagnostics & Imaging Week

While the economy is surely at the top of President-elect Barack Obama's to-do list, industry experts are hopeful that healthcare is right up there with it.

Healthcare reform and "changes in a new political environment" were among the many panel topics at the 4th annual Nasdaq OMX Healthcare Forum, co-sponsored by Leerink Swann, Monday in New York. Panelists speculated on what changes we may see under an Obama administration, with particular focus on such areas as comparative effectiveness, NIH funding, and healthcare IT.

"The one thing everyone agrees with is that this $1 trillion-plus industry in transition will probably go through more change in the next four years than it has since the inception of Medicare," said panelist Steve Klasko, CEO of the University of South Florida Health (USF Health; Tampa).

"From an academic perspective," Klasko said, "nothing has been more depressing than the decrease in NIH funding, especially since a good part of our recruiting and hiring in the '90s was consistent with the NIH doubling." He said many in the academic arena expect that the new administration through the Congress will approve a 3% to 3.5% increase in NIH funding, with a possible $1 billion or so stimulus package. But what's most important, he said, is where Congress and the new administration will try to focus those dollars, which he believes will be predominately in three areas - comparative effectiveness and evidence-based medicine, genomic research and personalized medicine (which he noted that in 2006 then-senator Obama sponsored the genomic and personalized medicine act that boosted funding to those areas), and "thirdly, what is expected to be an immediate repeal of the embryonic stem cell ban." This last one, Klasko added, should stimulate research and partnerships as long as it is accompanied by an increase in stem cell funding.

Another area of interest, especially for Klasko who earlier in the day participated in a panel discussion about healthcare IT, is the $50 million that the President-elect has pledged for a universal implementation of interoperable electronic health records (EHR).

"Remember that to this date, only 10% of physicians in groups and only 5% of solo doctors have any type of EHR," Klasko said. He added that seamless transitions in care between providers would be crucial, especially from the patient's perspective. So, he said, things like e-prescribing, electronic billing and claims, and aligning incentives through pay for performance should come to the forefront.

Another panelist, Joe Ferrara, president of Boston HC Partners, offered his predictions of what changes lay ahead, from the perspective of his clients. Boston HC Partners is a consulting firm focused on reimbursement, market access, and pricing strategies for pharmaceuticals, medical device and diagnostics.

Ferrara said that the topic of healthcare reform typically gets divided up into two broad issues: universal access, and cost control and value. "Our industry clients are most concerned with the latter ... how will cost control impact our product or our portfolio, what kinds of initiatives are being developed at the government level that will have an impact. Not questioning value, but [asking] how will value be determined by stakeholders with such a range of interests, motivations and objectives," he said.

Discussions of value often lead to conversations about evidence, Ferrara added. "What kind of evidence is available, what kind of evidence is needed and when and what kind of evidence will yield a return on our investment."

John McManus, president of The McManus Group (Washington) and the panel moderator, acknowledged that one issue that seems to be gaining traction in Washington is comparative effectiveness. He asked the panelists how they view the issue in the long term from the perspective of the drug and device industry.

Ferrara said he sees comparative effectiveness as increasing the amount of evidence required and also the cost of development, but on the other hand he said he believes it will also increase the value of new technologies along the way.

"The devil is always in the details," said panelist Steve Tilton, VP of federal affairs at the Pharmaceutical Research and Manufacturers of America (Washington). Tilton emphasized that his remarks were from his own perspective and not on behalf of the organization. He said it would depend on how well the comparative effectiveness legislation is drafted and subsequently implemented.