August 2010 Clinical Laboratory News: Regulatory Profiles

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August 2010: Volume 36, Number 8 

IOM Considers FDA 510(k) Reform

The Institute of Medicine (IOM) recently completed the last two of its public meetings intended to gather information for its highly anticipated report on FDA’s 510(k) premarket notification program, the regulatory review that clears more than 90% of diagnostic tests. Test manufacturers have worried about more demanding regulation, while at the same time other stakeholders inside and outside FDA are pushing for more dramatic changes.

The IOM committee heard presentations on differences between the U.S. and European medical device review models; the regulatory and infrastructure costs associated with bringing a new device to market; the different levels of evidence required for 510(k) versus premarket approval applications, post-market surveillance systems, and more. The final report is due to Congress by mid-2011.

Presentations and other information about the meetings are available from the IOM website.


CMS Explains Voluntary Accountable Care Organizations

CMS recently published an online document outlining the new voluntary Accountable Care Organizations (ACOs) created under the healthcare reform law. Under the statute, providers can join together to coordinate patient care across healthcare settings, and rather than paying each provider separately, CMS will pay the ACO a single fee. 

ACOs that meet quality performance goals will also have a share in the government savings, estimated by the Congressional Budget Office to be at $5 billion over 10 years.  CMS says it expects to have the program in place by January 1, 2012.

The document is available on the CMS website.


Senator Proposes PGx Bill

Senator Orrin Hatch (R-Utah) is circulating a draft bill among stakeholders that would create a new center within the FDA devoted solely to evaluating advanced diagnostic tests, whether developed as a kit or by a laboratory.

The draft "Better Evaluation and Treatment through Essential Regulatory Reform for Patient Care Act," would create a Center for Advanced Diagnostics Evaluation and Research focused only on "advanced personalized diagnostics.” The bill would also establish an advisory committee for the new center.

Under Hatch's draft bill, these advanced tests would be registered in a database and require manufacturers to submit tests to the new center to see whether the test fits the advanced personalized diagnostics category.


Proposed CMS Rule Expands Medicare Preventive Services

CMS announced proposed regulations that will implement the new preventive health benefits created under the health reform law, the Patient Protection and Affordable Care Act (PPACA). The new rule proposes two significant changes to preventive care benefits under Medicare that will expand access to lab services: Beginning January 1, 2011, Medicare will cover annual wellness visits aimed at helping doctors and patients develop personalized prevention plans that takes a comprehensive approach to improving patients’ health.  Also beginning January 1, 2011, Medicare beneficiaries will no longer have to pay any out-of-pocket costs for most preventive services, including annual wellness visits.

To help ensure that Medicare beneficiaries have access to primary care doctors, the rule would also boost payments for primary care services. The proposed regulation would also increase access to services by creating payment incentives for general surgeons as well as expand access to other types of healthcare providers.

CMS will accept comments on the proposed rule until August 24, 2010, and will respond to them in a final rule to be issued on or about November 1, 2010 that sets forth the policies and payment rates effective for services furnished to Medicare beneficiaries on or after January 1, 2011.

The proposed rule is available in the Federal Register.

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