American Association for Clinical Chemistry
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November 2010 Clinical Laboratory News: Regulatory Profiles

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November 2010: Volume 36, Number 11

FDA and CMS Seek Public Input on Parallel Reviews

The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) announced a proposal to create a parallel process for reviewing products subject to FDA pre-market reviews and making Medicare coverage decisions related to those products. Simultaneously tackling both regulatory processes has the potential to encourage more device and test applications and increase patient access to new services, the agencies said.
The agencies plan to create a pilot program to test this concept after both have reviewed public comments. According to their Federal Register notice, the agencies want comments on questions such as: whether anyone other than the product sponsor should be able to initiate a request for parallel review; what criteria FDA and CMS should use to decide whether to grant a request for parallel review; whether FDA and CMS have access to the same data and information about the product during parallel review; and, once FDA and CMS have opened a parallel review, how a sponsor would terminate or withdraw the request for parallel review.

CMS said it has found that developers of new technology often fail to recognize the differences between the regulatory requirements of FDA and CMS. As a result, these firms undertake clinical studies that are designed to address FDA questions but which do not adequately address issues of importance to CMS such as the impact the technology will have on Medicare beneficiaries. This can slow the developer’s quest for Medicare coverage. Parallel review could also create incentives for venture capitalists and companies to increase their investment in innovative medical products by reducing the time to return on investment for those products eligible for parallel review.

FDA and CMS will accept comments on their proposal through December 16, 2010. A copy of the notice is available on the Federal Register website.


CMS Advises Providers to Prepare for New Electronic Transaction Standards

The Centers for Medicare and Medicaid Services (CMS) is warning healthcare providers and vendors about approaching compliance dates for a new generation of diagnosis and procedure codes, as well as updated standards for electronic healthcare transactions. The first compliance milestone for transition to the Accredited Standards Committee (ASC) X12 Technical Reports Type 3, Version 005010 (Version 5010) electronic healthcare transaction standards is quickly approaching. Beginning in January 2011, entities covered under the Health Insurance Portability and Accountability Act (HIPAA) must be ready to test with their partner organizations the functionality of both entities’ practice management and other related software featuring Version 5010 standards.

Use of the Version 5010 standards for HIPAA electronic health care transactions, including claims, remittance advice, eligibility inquiries, referral authorization, and other administrative transactions, will become mandatory on January 1, 2012. The Version 5010 standards also provide the framework needed for use of the revised medical data code sets (ICD-10-CM and ICD-10-PCS), that must be implemented on October 1, 2013. The ICD-10 code sets will also link to the standards and certification criteria for demonstrating “meaningful use” of certified electronic health record (EHR) technology under the Medicare and Medicaid EHR incentive program.

More information is on the agency’s ICD-10 website.


HHS Announces $30M in New Money for HIV Prevention

The Centers for Disease Control and Prevention (CDC) announced that it has allocated $30 million of the Affordable Care Act’s Prevention and Public Health Fund to expand HIV prevention efforts under the President’s National HIV/AIDS Strategy. This includes $21.6 million in grants to state and local health departments. The funding will help to further focus HIV prevention on high risk populations and communities, as well as fill gaps in data and understanding of the epidemic. 

Grants totaling $11.6 million will support demonstration projects to identify and implement a “combination approach” to enhance effective HIV prevention programming in 12 hard-hit areas across the country. These efforts will both supplement existing programs in these communities and help jurisdictions to better focus efforts on key at-risk populations and fulfill unmet needs. 

More than $4 million from the Affordable Care Act will allow CDC to further expand its HIV testing initiative. The initiative began in 2007 to increase knowledge of HIV status primarily among African Americans, and was recently expanded to reach more hard-hit communities and populations at risk, including Latinos, men who have sex with men, and injection drug users. In the first 2 years of the program more than 1.4 million were tested, and more than 10,000 individuals were newly diagnosed.

The 12 jurisdictions funded in the first year of these efforts include Chicago, the District of Columbia, Florida, Georgia, Houston, Los Angeles, Maryland, New York City, Philadelphia, Puerto Rico, San Francisco, and Texas. The average award is approximately $960,000.

More information is available from the CDC website.


State Health IT Dashboard Offers Quick Information

Healthcare Information and Management Systems (HIMSS), a not-for-profit organization focused on the optimal use of healthcare information technology (HIT) and management systems, has launched a State HIT Dashboard to provide healthcare professionals, policy makers, and other stakeholders a snapshot of major HIT initiatives underway across the nation.

According to HIMSS, the dashboard was designed to be an easy and comprehensive online tool for timely access to credible and comprehensive state-centric information about technology resources, health information exchanges, and state-based HIT policy. The HIMSS State HIT Dashboard includes a color-coded, visual interface that tracks current HIT programs across the country, including AHRQ HIT Grants, DOQ-IT, MHS, RHIOs, Health Information Exchanges, Bridges to Excellence, and Private HIT Projects.

The site is accessible from the HIMSS website.


Kaiser Donates HIT Terminology System to Government

Kaiser Permanente (KP) announced it has donated its Convergent Medical Terminology (CMT) to the International Healthcare Terminology Standards Development Organization for U.S. distribution through the Department of Health and Human Services (HHS).

CMT serves as the foundation of concept definitions and terminology cross-maps for all codes used within the organization, and it provides a consistent structure and access method to all codes. CMT enables greater interoperability: CMT concepts are mapped to lab, radiology, immunization, pharmacy, and EKG order and result codes within each KP region. This enables data comparison across regions and across applications. CMT concepts are mapped to HL7 vocabulary concepts as well as administrative billing codes for exchange of standard HL7 messages and a semi-automated translation from clinician documentation.

More information about the donation is available from the HHS’s online newsroom.