G-2 Compliance Report
G-2 Compliance Report is designed to guide hospital, lab, and pathology professionals in developing, implementing and revising compliance programs to meet federal standards. In every issue, you’ll get practical advice and information you need to: Stay on top of fast-changing federal mandates Structure business arrangements to prevent fines Reduce exposure to whistleblower lawsuits Maintain public trust and thwart negative publicity And more With the continued emphasis on healthcare fraud by the Justice Department and HHS Office of Inspector General —and record-setting fines and settlements—don’t take the risk of being caught unprepared for an investigation and audit.
September 2010 - Table of Contents
The final rule on “meaningful use” of electronic health records is loose and flexible enough to make provider adoption easier, say experts.
Groups representing clinical laboratories are expressing concern over a proposal by the Centers for Medicare and Medicaid Services (CMS) to require the signature of a physician or nonphysician practitioner (NPP) on all requisitions for tests paid under the Part B lab fee schedule. The proposal would reverse longstanding Medicare policy.
As the events of the last couple of months have made clear, the Food and Drug Adminsitration (FDA) has decided to step up regulation of laboratory-developed tests (LDTs). What’s not so clear is just what approach the agency will take in its oversight.
On July 14, 2010, the Office for Civil Rights of the Department of Health and Human Services (OCR) published its notice of proposed rulemaking to implement various provisions of the Health Information Technology for Economic and Clinical Health Act (the HITECH Act) by revising the privacy, security, and enforcement rules that were previously issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
For more than 11 years, the American Association of Bioanalysts (AAB) has fought a court battle against the New York State Department of Health, claiming that it was intentionally overcharging clinical laboratories so that it could subsidize its many other research programs that had no relation to covering the necessary costs of regulating clinical labs and blood banks.
The latest nationwide crackdown on health care fraud has led to more than 90 people being charged in connection with alleged billing schemes involving more than $251 million in false Medicare claims.
The College of American Pathologists (CAP) recently submitted comments to the Food and Drug Administration (FDA) on regulating array-based cytogenetic tests, noting that this emerging technology should be no different from other laboratory tests introduced into medical practice.
Georgetown University Hospital in Washington, D.C., has shut down its molecular diagnostics laboratory amid allegations of inaccurate testing and a pending investigation by the federal government and the College of American Pathologists (CAP). According to an Aug. 6 article in the Washington Post, the lab received failing results from a quality-control assessment of its HER2 testing in January 2010.
The Department of Health and Human Services (HHS) has agreed to destroy the bid data that San Diego-area laboratories submitted to the Centers for Medicare and Medicaid Services (CMS) as part of CMS’s competitive bidding demonstration project. In a statement released by the American Association of Bioanalysts (AAB) and the National Independent Laboratory Association (NILA), administrator Mark Birenbaum, Ph.D., said that HHS has until Aug. 20 to destroy all the documents.
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