1.OIG has authority to perform PATH audits
2.Florida doctor accused of fraudulently collecting $320,000
3.Pay-per-view article: Watch private payer mandates, as HIPAA court ruling proves
4.CCI edits deemed effective
5.Tip: Non-consensual use of human tissue

The U.S. Third Circuit Court of Appeals filed a ruling October 17th upholding the Office of Inspector General's (OIG) authority to perform Physicians at Teaching Hospitals (PATH) audits at teaching hospitals. The ruling focused on the OIG's planned audit of the University of Medicine and Dentistry of New Jersey. ("The University of Medicine and Dentistry of New Jersey v. Corrigan", 3d Cir., No. 03-1268, 10/17/03).

After the OIG notified the hospital of its plan to perform the PATH I audit, the hospital instead opted to pay for a PATH II audit from an independent entity. However, the hospital never commissioned the PATH II audit. Instead it filed an action to enjoin the OIG's audit request.

The OIG issued administrative subpoenas for documents relevant to the proposed audit. The hospital refused to comply with the subpoenas and contended that the subpoenas were illegitimate because the OIG lacks authority to audit without proof of fraud or abuse. The OIG then filed a motion for the district court to enforce the subpoenas. The court upheld the OIG's right to perform the audit. The university hospital then appealed the district court's decision.

The appeals court supported the district court's decision on the OIG's authority to perform PATH audits and reaffirmed the enforcement of the subpoenas. The decision found, in accordance with the Supreme Court, that an agency "can investigate merely on suspicion that the law is being violated, or even just because it wants assurance that it is not." United States v. Powell, 379 U.S. 48, 57 (1964); United States v. Morton Salt co., 338 U.S. 632, 642-643 (1950) (FTC).

The OIG has not found any instances of fraud involving the hospital or other plaintiffs; furthermore, the Inspector General has not commenced any enforcement actions.

A federal jury in Fort Pierce, Florida, indicted Paul Elliot, D.O., on 23 counts of Medicare fraud and one count each of money laundering and obstruction of justice. Elliot received $320,000 in fraudulent billings to Medicare and Blue Cross of Florida between 1998 and 2002, according to the indictment.

Elliot allegedly ran basic magnetic resonance imaging tests (MRI). However, on 240 occasions he billed the MRIs as more invasive and more expensive procedures. The indictment also alleges that Elliot received payments for 200 electromyography (EMG) tests that he never performed.

The additional charges of laundering and obstruction of justice refer, respectively, to Elliot's attempt to transfer $10,000 in fraudulent funds and his attempt to mislead Florida Secret Service investigators with forged records, said the indictment.

Elliott faces potential penalties of up to 10 years imprisonment for the health care fraud, 20 years for obstruction of justice, and a $250,000 fine for each of the 25 counts.

Informed consent is about more than explaining the risks of a research study and having a subject read and sign a consent form. Unique issues can arise to complicate the process-for example, your subjects might be children, elderly patients with dementia, or non-English speakers.

To ensure that your consent process is adequate, especially when dealing with trials or subjects that present ethical complexities, it's critical to keep your focus on two main issues, according to Kevin Gleeson, MD, professor of medicine in the pulmonary/critical care division at the Penn State College of Medicine in Hershey, PA.

The Office of Inspector General (OIG) found that Medicare carriers pay for "nearly all" of the services that the Correct Coding Initiative (CCI) edits target appropriately, according to a recent audit. The OIG found that carriers correctly apply the edits and prevent 98% of inappropriate payments.

The OIG shared its data on the small percentage of services that met the criteria for denial based on CCI edits. CMS should replicate the OIG's analysis ensure that the services continue to be paid appropriately, says the OIG.

Developers who use human tissue to research and develop commercial products should ensure that they compensate tissue donors for their contributions. Failure to do this can lead to lawsuits, such as the Greenberg v. Miami Children's Hospital (MCH), et al case. The lawsuit, filed in Federal District Court in Chicago on October 30, 2000, alleges that MCH and the physician committed a breach of informed consent, breach of fiduciary duty, unjust enrichment, fraudulent concealment, conversion, and misappropriation of trade secrets.

In the Greenberg case, parents and not-for-profit organizations asked researchers to develop accessible and affordable prenatal and carrier testing for Canavan disease. The suit alleges that a physician and his employer, MCH, received a patent for the Canavan disease gene they discovered, using the family's genetic information and the organization's financial resources. The researchers informed neither the families nor the organization of their actions. They then began charging royalties, which limited the availability of testing and contradicted the families' original hopes for the research.

The plaintiffs claimed they would not have provided genetic material to isolate the gene if they had known the defendants would use their discoveries to profit. This lawsuit may not have been necessary if the families' contract with the researchers limited the researchers' use of the information collected during the study to the original research protocol.

To safeguard against potential litigation, it is important for you to review and compare the terms of your organization's clinical trial agreement (CTA) and the information provided to subjects during the consent process. For example, compare the terms in the CTA regarding the sponsor's right to use the results in the to the terms told to the subject.