SZD Health Law Scan : Health Care Lawyers & Attorneys : Schottenstein Zox & Dunn Law Firm : Strategic Planning, Managed Care, Insurance : Columbus, Cleveland, Cincinnati, Central Ohio

On September 20, 2008, the Department of Health and Human Services, Office of Inspector (the "OIG") published in the Federal Register a supplemental compliance guidance for Nursing Facilities ( the "Guidance"). The purpose of the Guidance is to supplement its prior compliance program guidance for nursing facilities issued in 2000. According to the OIG:

"The new CPG emphasizes the importance of submitting accurate claims and discusses issues related to reporting resident case-mix data, therapy services, screening for excluded individuals and entities, and restorative and personal care services. The guidance also urges nursing facilities to consider the risks of improper kickback payments associated with their business arrangements including those involving free goods and services, as well as those with physicians and suppliers."

The OIG's expanded discussion in the Guidance of fraud and abuse risks present in a nursing facility environment illustrates its increased enforcement focus on relationships between nursing homes and their referral sources, such as hospices. The Guidance includes, for example, a list of questions for a nursing home to ask itself when identifying potential kickback risks. The Guidance also contains a list of "potentially aggravating considerations" for a nursing home to look for when trying to determine arrangements at greatest risk of prosecution, such as whether the arrangement has a "potential to interfere with, or skew, clinical decision-making."

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The U.S. Department of Health and Human Services, Office for Civil Rights, recently released guides to providers and patients on when health care providers may communicate with a patient's family, friends, or others involved in the patient's care under the HIPAA privacy regulations.  The guides include frequently asked questions on this subject.  The provider's guide also notes that it is intended to clarify HIPAA requirements so that health care providers do not unnecessarily withhold a patient's health information from family, friends, and other health care providers.  

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A Philadelphia Common Pleas judge has ruled that the Vaccine Act, a federal law that governs the liability of pharmaceutical companies for drug vaccines, pre-empts state law tort claims that a vaccine design was defective or that there was a failure to warn the patient of risks associated with the vaccine.

In Wright v. Aventis Pasteur, Jared Wright, an eleven year-old boy with autism, was administered vaccines during his infancy that contained "thimerosal," a mercury-based preservative that Wright's parents contend was the cause of Wright's autism. 

Wright argued that Aventis Pasteur Inc., Merck & Co. Inc., and Wyeth were negligent because they failed to warn the medical community about the potential hazards of mercury in the vaccines, and also argued that the defendants failed to use ordinary cases in designing the vaccines because of the risks toxic mercury poses to infants and children.

Judge Arnold L. New, however, ruled that the Vaccine Act pre-empts Wright's state law tort claims. Specifically, Judge New discussed Congress' intent to avoid instability in the vaccine market that would result from state-law tort liability for vaccine injuries. Judge New also cited Congress's actions in creating the National Vaccine Injury Compensation Program as evidence that Congress intended the Vaccine Act to pre-empt state law tort claims.

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The FDA, as part of its Sentinel Initiative to better monitor FDA approved medical products, has announced its intention to create a national database of orthopedic implant registries. This database would track and monitor the progress of various orthopedic implants in an attempt to detect early troubles with the implants. The FDA proposes to create its database through the use of, and by querying, government databases, private and public medical claims databases, and electronic health record systems.

The following article provides a good summary of the FDA's proposed registry:

www.govhealthit.com/online/news/350502-1.html

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The FDA recently announced that it will begin posting a list of approved drugs that it is investigating due to safety concerns. The list will be available on the FDA's website, and the FDA will update it on a quarterly basis. 

The FDA receives, through its Adverse Event Reporting System, thousands of complaints each year about FDA approved drugs. The list that the FDA will post, however, will feature only those drugs that the FDA has chosen to investigate from the numerous complaints submitted.

While the FDA acknowledges that the list may create a type of false panic among consumers, the list may also serve to protect and inform conscientious consumers who are experiencing health complications from drugs that are on the FDA's quarterly list.

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This may well be the strangest Presidential Election Campaign in U.S. history, but excuse me, what happened to any meaningful discussion of health care reform?  Obviously, the economy and energy issues have caused health care to drop below the radar screen (see Modern Healthcare, Sept. 8, 2008, page 9), but how can this really be an election about "change" if we sweep health care under the rug?  Neither of the major candidates gave any prominence to this issue in his acceptance speech.  Does that mean we have to wait another four years to begin an honest discussion about something as vital as the health and well being of our citizenry?

While others may be tuned into the Gaffe of the Day, it is worth studying what the candidates (or more accurately their campaigns) have said about health policy reform.  This entry and the next two will focus on three aspects of reform:  1) cost, 2) quality and 3) fairness.  Let's begin with cost.

Barack Obama proposes to lower costs by modernizing the U.S. Health Care System. John McCain proposes to lower costs by restoring control of the system to patients and their families.

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