American Association for Clinical Chemistry
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October 2012 Clinical Laboratory News: Regulatory Profiles

Regulatory Profiles

 

ICD-10 Delay Becomes Official

The Centers for Medicare and Medicaid Services (CMS) officially set the new deadline for the transition to the new ICD-10 medical coding system to October 1, 2014. The most recent deadline was October 1, 2013, a 2-year deferral from the original 2011 date. ICD-10 will introduce more than 100,000 new diagnostic and procedure codes. Physician groups had complained about the 2013 deadline, making a case that too much was going on at once, including a transition to electronic health records and electronic prescribing.

The American Health Information Management Association (AHIMA) took a positive stance on the announcement. “ICD-10 implementation is inevitable, but today’s news gives the healthcare community the certainty and clarity it needs to move forward with implementation, testing, and training,” said AHIMA CEO Lynne Gordon.

Physician groups, such as the American Medical Association (AMA), had argued for at least a 2-year delay, if not scrapping the transition all together. “The implementation of ICD-10 will create more challenges for physicians when our Medicare system is broken and cannot provide adequate funding to cover the cost of these additional administrative burdens,” said Steven Stack, MD, chair of the AMA board of directors.

In the final rule, CMS said it would continue to work with stakeholders on ICD-10, but that it believed 1 year would be sufficient time for physicians to prepare.

The final rule is available from the Office of the Federal Register, online.

CMS Releases Final Rule for Stage 2 of EHR Incentive Program

The Centers for Medicare and Medicaid Services (CMS) issued a final rule laying out the requirements for stage 2 of its electronic health record (EHR) incentive program that will begin in 2014. Under the Health Information Technology for Economic and Clinical Health (HITECH) Act, physicians and hospitals can qualify for Medicare and Medicaid incentive payments when they adopt and meaningfully use certified EHR technology.

Physicians and hospitals will work through the program in three steps over time, but CMS has defined only stage 1 clearly in regulation until now. Stage 1 set the basic functionalities of EHR, but stage 2 increases health information exchange between providers and promotes patient engagement by giving patients secure online access to their health information, including lab results.

So far, more than 120,000 eligible health care professionals and more than 3,300 hospitals have qualified to participate in the program and receive an incentive payment since it began in January 2011, according to CMS. This includes more than half of all eligible hospitals and critical access hospitals and one out of every five eligible health care professionals.

A fact sheet on CMS’s final rule is available online.

National Human Genome Research Institute Reorganizes

The National Human Genome Research Institute (NHGRI) of the National Institutes of Health will complete a major reorganization to accommodate broad changes in its mission beginning this month. The reorganization includes dividing the institute’s Extramural Research Program into four new divisions and promoting to division status the office overseeing policy, communications, and education and the office overseeing administration and management.

“This reorganization reflects the expanding scope of genomics research, as described in NHGRI’s new strategic vision published in Nature last year,” said NHGRI director Eric Green, MD, PhD. “The mission of the institute has dramatically evolved from the singular focus on the Human Genome Project, for which NHGRI was created, to pursuing an exciting and broad set of opportunities for using genomics to advance medical science and improve human health. NHGRI needs an organizational structure concordant with this expanded mission.”

The reorganization will establish four divisions that will constitute NHGRI’s Extramural Research Program: the Division of Genome Sciences will oversee basic genomics research and technology development, as well as major activities such as large-scale genome sequencing; the Division of Genomic Medicine will promote the institute’s efforts to advance the application of genomics to medical science and clinical care, with the institute’s Office of Population Genomics subsumed into this division; the Division of Genomics and Society will be responsible for an expanded program related to societal issues relevant to genomics research, incorporating and extending the activities of the institute’s Ethical, Legal, and Social Implications research program and working to integrate the many NHGRI-wide activities in these areas; and the Division of Extramural Operations will manage grants management and scientific reviews, as well as other operational aspects of the institute’s Extramural Research Program.

More information about the reorganization is available online.

CMS Suspends Troponin Outpatient Quality Measure

The Centers for Medicare & Medicaid Services (CMS) announced the immediate removal of the troponin result quality measure from the Hospital Outpatient Quality Reporting (OQR) measure program set to begin in 2013. The measure, referred to as OP-16, required troponin results within 60 minutes of arrival in the emergency department for acute myocardial infarction patients or chest pain patients.

According to CMS, the troponin turnaround provision is being removed based on patient safety concerns. In July, the Food and Drug Administration issued a Class I recall on several point-of-care troponin testing kits that provide troponin results.

CMS will use OQR measures to determine payment for hospitals in 2013, with hospitals that measure up receiving extra payments under a new CMS value-based purchasing scheme.

More information is available from CMS online.