CMS Releases Exceptions to ACO Rules for Rural Areas

The Centers for Medicare & Medicaid Services (CMS) has released a fact sheet titled “Medicare Shared Savings Program and Rural Providers” highlighting exceptions to the proposed regulations governing accountable care organizations (ACOs). On March 31, 2011, CMS released its proposed rules for ACOs. According to CMS, ACOs are supposed to help doctors, hospitals and health […]

US Supreme Court Rules in FCA, FOIA Case

On May 16, 2011 the US Supreme Court resolved a split among federal circuits and ruled in Schindler Elevator Corp. v. United States ex rel. Kirk that a federal agency’s response to a Freedom of Information Act (FOIA) request amounts to a “report” within the False Claims Act’s (FCA) pre-PPACA public disclosure bar and therefore […]

CMS Receives Failing Marks for HIPAA Enforcement

The Office of the Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) released a report on the oversight and enforcement actions conducted by the Center for Medicare and Medicaid Services (CMS) pertaining to hospitals’ implementation of the HIPAA Security Rule.  The OIG conducted its audits at CMS in Baltimore, Maryland, […]

GlaxoSmithKline In-House Attorney Acquitted of Obstruction of Justice Charges; Judge Criticizes Application of Crime Fraud Exception to Privileged Documents

In November 2010, a former in-house counsel for the pharmaceutical company GlaxoSmithKline, Lauren Stevens, was indicted on charges of making false statements and obstructing a federal investigation into illegal drug marketing with regard to the antidepressant Wellbutrin.  The federal investigation surrounded allegations that GlaxoSmithKline had illegally marketed Wellbutrin for weight-loss, a use for which had […]

CMS Reports $162 Million In Medicare Overpayments in First Three Months of 2011

Based on a recent report released by CMS, its Medicare Fee-for-Service Recovery Audit Program recovered $162 million in Medicare overpayments during the period of January through March 2011. This is a substantial increase in the amount of money recovered by the Recovery Audit Program (RAP) in that $162 million is more than double the amount […]

Supreme Court Rejects Virginia’s Request to Fast Track Challenge to PPACA

Yesterday, the United States Supreme Court rejected a request made by the Commonwealth of Virginia to fast track a challenge to the Patient Protection and Affordable Care Act (PPACA) passed last year. When a case is fast-tracked, it bypasses the regular federal appeals process, and the case goes directly to the Supreme Court Justices for review.  […]

OIG Finds Various State’s False Claims Acts, Including New York’s, To Be Noncompliant

The term “qui tam” comes from the latin phrase qui tam pro domino rege quam pro se ipso in hac parte sequitur, which means “[he] who sues in this matter for the king as [well as] for himself.”  In our legal system, qui tam actions are brought by private individuals, or whistleblowers, with knowledge of […]

Clinical Laboratories Recover over $5 Million in Landmark Victory over New York State Department of Health

Over $5 million is being refunded by the New York State Department of Health (NYSDOH) to 35 clinical laboratory members of the American Association of Bioanalysts (AAB), as a result of a lawsuit filed 12 years ago by O’Connell and Aronowitz.  The case was handled by Jeffrey J. Sherrin. As we previously reported, on February […]

Can you really patent a human gene? U.S. Appeals Court will soon decide

On Monday, the United States Federal Circuit Court of Appeals heard oral argument in Association of Molecular Pathology v. U.S. Patent and Trademark Office.  The court’s decision, expected in the coming months, could affect the validity of thousands of existing gene patents. Under the U.S. Patent Act, “[w]hoever invents or discovers any new and useful […]

CMS Will Change Physician Signature Requirement for Laboratory Requisitions

As we previously reported, on February 11, 2011, the Center for Medicare & Medicaid Services (CMS) informed various trade associations that it was pulling back a new rule requiring physician signatures on all laboratory requisitions. Although an official announcement to this effect was expected due to concerns expressed by lab associations and others, it appears […]