In March, President Obama signed the healthcare reform bill into law. As previously reported in IVD Technology, industry analysts believe that various provisions in the new law will promote and increase the use of IVDs and will benefit the IVD industry. For example, the law has a provision for value-based purchasing for hospitals, which will encourage them to follow quality standards, many of which involve broader use of selected IVD tests. The law also includes a focus on new forms of reimbursement (e.g., accountable care organizations, bundled payments) that put the whole healthcare bundle together rather than paying on a fee-for-service basis, and put a premium on providers to deliver care efficiently and do some cost reductions.

"We hope that providers will understand as they get into the healthcare reform that the more they use IVD tests, the better they can prevent disease, manage patient care, and target treatments, and the less extra or unnecessary expenditures theyíll be making," David Nexon, senior executive vice president at AdvaMed (Washington, DC).  "There is also going to be a stepped-up effort to do comparative effectiveness research. Thatís challenging to some degree for diagnostics. But if done properly, again because IVDs are so valuable, it will help move the field along. So we're bullish on these changes in the payment system in terms of their impact on diagnostics."

The law also has a provision that requires the Department of Health and Human Services (HHS) to hold a public meeting to look at mechanisms for payment specifically for new clinical laboratory tests. It requires the HHS Secretary to report to Congress on the public meeting and to make recommendations about what legislative and administrative reforms should be made.

"We think that there are long-standing concerns about the way that Medicare pays for new clinical laboratory tests, and that reforms in this area are critical," said Teresa Lee, vice president, payment and healthcare delivery at AdvaMed. "So we're very supportive of the Secretary taking a close look and of having a public airing of all of the issues involved so that we can achieve meaningful reform."

Another provision in the law makes healthcare-associated infections a specific measure in hospital value-based purchasing. AdvaMed believes this provision is going to generate an increased emphasis on clinical laboratory diagnostic tests that can identify whether an individual does or does not have a specific healthcare-associated infection, and generate interest generally in infection control. There is an upside potential in promoting such best practices, particularly for those IVD companies with products in this area.