News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Update on New Federal Regulations Affecting Clinical Pathology Laboratories: Stage 2 ‘Meaningful Use’ Rules Top the List

Final Stage 2 rules give providers another year to meet Stage 1 ‘meaningful use’ criteria and shorten Stage 2 requirements from one-year to just 90 days

Clinical laboratory managers and pathologists may be interested to know that, over the fall months, the U.S. Department of Health and Human Services (HHS) released three new rules that affect users of health information technology (HIT).

One rule covers Stage Two of Meaningful Use and includes guidance on how providers should address the need to encrypt patient data. The second rule updates eligibility criteria that providers implementing electronic health record (EHR) systems must meet to qualify for federal incentives. Because medical laboratories and pathology groups maintain ongoing electronic interfaces with hospitals and office-based physicians, it is useful to know some of the key elements of these three recently issued federal regulations. The third rule establishes a date for conversion to ICD-10.

The new regulations were contained in a 1,354-page document published in the Federal Register. These rules represent “a tsunami of change” for providers, observed Patricia B. Wise, RN, MS, MA, COL (USA ret’d), Vice President for healthcare information systems for the Chicago-based Healthcare Information Exchange and Management Systems Society (HIMSS). Wise was quoted in a Modern Healthcare story. (more…)

HHS and CMS Team Up to Propose New Rule to Give Patients Direct Access to their Clinical Pathology Laboratory Test Results

Draft language of new rule would change existing requirements on access to medical laboratory test results as defined in CLIA and HIPAA laws

Big changes lie ahead in how clinical laboratories and pathology groups must give patients access to their medical laboratory test results. Last week, federal agencies published a draft rule that specifies how patients or their authorized representatives are to be given direct access to their medical laboratory test results.

This draft rule was made public on September 12 by the Department of Health and Human Services (HHS), along with the Centers for Medicare and Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), and the HHS Office for Civil Rights. Two days later, on September 14, the proposed rule was published in the Federal Register. There will be a 60-day period from the date of this publication for public comment on the proposed rule. (more…)

Clinical Laboratories and Pathologists Dodge a Bullet as CMS Publishes Proposed Repeal Rule Dealing with Physician Signature Requirement on Paper Requisitions for Lab Tests

Proposed repeal rule was published in yesterday’s Federal Register

Yesterday, pathologists and clinical laboratory managers got an early Fourth of July present. That’s because the federal Centers for Medicare and Medicaid Services (CMS) published the proposed rule that repeals the requirement that paper requisitions for medical laboratory tests must have the physician’s signature.

This rule had been mandated by the 2011 Medicare Physician Fee Schedule Rule that was to take effect on January 1, 2011. In response to the negative response to this rule from important sectors of healthcare, including laboratory medicine professionals, hospital groups, and physician associations, as well as both Houses of Congress, CMS deferred implementation of the rule for the first 90 days of 2011. (See Dark Daily, “Good News for Clinical Laboratories as CMS Delays Physician’s Signature Requirement, December 22, 2010.

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