The Impact of Healthcare Reform (PPACA) On the U.S. IVD Industry
The "Patient Protection and Affordable Care Act" (H.R. 3590) is complex legislation that affects virtually every aspect of health care, and many of its provisions are beginning to take effect now. IVD manufacturers who have different needs and strategies are now considering the legislation and whether it will help or hurt business plans. The legislation contains a range of different provisions and while the law in a broad sense is expected to have a positive result in terms of net sales and procedure volume increases, it will also impose challenges, including cost containment initiatives and reimbursement cuts.
Kalorama has been analyzing IVD markets for decades and brings its knowledge of the market to this new law. This Kalorama Information report, The Impact of Healthcare Reform (PPACA) On the U.S. IVD Market. examines the effects of the Patient Protection and Affordable Care Act’s provisions on IVD sales, procedure volumes and profits. Analyst Alison Sahoo calculates the effects of the legislation good and bad in a way that business planners can utilize.
The overall objective of the PPACA is to expand access to health care coverage for most U.S. citizens and legal residents by requiring individuals to have coverage and employers to either provide coverage or pay a penalty that would support coverage from a pool of public funds. Approximately 46 million American residents had no health care insurance as of early 2010. Under the new law, insurance will be extended to as many as 32 million of these persons through a variety of methods taking effect through 2014. The PPACA utilizes the state-run Medicaid program, which was originally established in 1965 as an entitlement program for low income families and other persons who met eligibility requirements such as persons who are blind, disabled and/or pregnant, as a major vehicle to extend health care coverage. However, it also imposes cost containment requirements on Medicaid as well as Medicare, the federal health care program for persons age 65 and older.
The report examines the proposed positive developments for the IVD industry resulting from PPACA such as an expansion in the number of insured U.S. persons, increased utilization of tests related to nosocomial infections, product innovation resulting from value-based pricing, and new coverage of wellness and prevention programs. The report also examines legislation components that might present challenges, such as the medical device excise tax and changes to Medicare reimbursement. Finally, the report looks at the unresolved questions of the legislation.
In the course of its analysis, the report provides the following:
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