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Articles Posted in Health Law

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U.S. Western District Court of Michigan Dismisses False Claims Act Claim for Failure to State a Claim with the Required Particularity

Earlier this month, the U.S. District Court for the Western District of Michigan granted a defendant’s motion to dismiss a qui tam action against it. The court held that the relator failed to state a claim with the required particularity. Robert Lauricia filed the qui tam action under the False…

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Professional Medical Organizations Adopt New Ethics Codes

In the same vein as the Healthcare Reform legislation’s vendor-providing reporting requirements known as the “sunshine law,” several leading professional medical organizations have adopted the new ethics codes, including: the American College of Physicians, the American College of Cardiology, and the American Society of Clinical Oncology. The ethical codes require…

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Healthcare Reform Results in Amendments to the Anti-Kickback Statute

The Health Reform bill, also known as the Patient Protection and Affordable Care Act, includes amendments to the Anti-Kickback Statute (AKS), including a relaxation of the “specific intent” requirement. The Health Reform bill amended Section 1128B of the Social Security Act to add the following statement: “with respect to violations…

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Healthcare Reform’s Changes to Home Health Certification and DME Certification

The healthcare reform legislation included changes for home health and DME providers. First of all, DME or home health services may only be ordered for Medicare beneficiaries by Medicare enrolled physicians or eligible professionals. In addition, Medicare enrolled physicians are required to have a face-to-face encounter with a patient prior…

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Changes in CLIA Requirement for Processing Personnel

The College of American Pathologists (CAP) recently announced that it is changing its accreditation checklist for CLIA accreditation in response to an interpretation communicated by the Centers for Medicare and Medicaid Services (CMS) with regard to the qualifications for “processing” personnel. Previously CAP treated “processing” personnel different from “grossing” personnel…

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Healthcare Reform Adds Reporting Requirements for Vendor-Provider Relationships

The Healthcare Reform legislation includes vendor-provider reporting requirements, also known as the “sunshine law.” The law requires manufacturers of drugs, medical devices, medical supplies, and biologics to report financial arrangements with certain “covered recipients.” “Covered recipients” include physicians or teaching hospitals. The manufacturer must make the report to the U.S.…

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The Healthcare Reform Bill Amends Civil Monetary Penalties Law

The Health Reform bill, or the Patient Protection and Affordable Care Act, amended the definition of remuneration in the Civil Monetary Penalties Law. The amendment clarifies that certain charitable activities are not prohibited under the law. The amended law excludes the following from qualifying as remuneration: Any remuneration which promotes…

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The Patient Protection and Affordable Act of 2009 strengthens the False Claims Act (FCA)

Yet another way that the Patient Protection and Affordable Care Act (the Act), otherwise known as the Health Reform bill, impacts health care providers is the strengthening of the Federal False Claims Act (FCA). For example, Section 6402 of the Act amends Section 1128 B of the Social Security Act…

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