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

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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Ohio HealthCare Simplification Act creates a new Chapter 3963 in Ohio Revised Code.  ORC 3963.04 is the provision governing material amendments to a health care contract.  Under ORC 3963.04, if an amendment to a health care contract is not a material amendment, the contracting entity is only required to give providers a notice of amendment at least 15 days prior to the effective date of the amendment.   

For a material amendment, the contracting entity must provide the participating provider the material amendment in writing at least 90 days prior to the effective date of the material amendment. The notice shall be conspicuously entitled “Notice of Material Amendment to Contract.” 

The provider must object within 15 days if it does not accept the material amendment. If the parties cannot resolve the objection, either party may terminate the health care contract.  If the participating provider does not object to the material amendment in the manner described above, the material amendment shall be effective. 

The issue is whether the material amendment will become effective if the parties cannot reach a resolution on the provider’s objection. 

Some payors have taken the position that if the parties cannot resolve their differences, the proposed material amendment becomes effective.  

This has caused confusion to some providers. In some cases, it has even taken away the benefit of providers' original contract provision.  Nor is it clear if this interpretation is consistent with the legislative intent of ORC 3963.04.   Many in the industry agree that this issue would benefit from clarification from the Ohio Department of Insurance.

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The Department of Justice announced changes to its corporate charging guidelines for federal prosecutors.  The new guidance revises the Department's Principles of Federal Prosecution of Business Organizations, which governs how federal prosecutors investigate, charge, and prosecute corporate crime.  The changes address issues concerning the attorney-client privilege and cooperation credit. 

First, the revised guidelines state that credit for cooperation will not depend on the corporation's waiver of the attorney-client privilege or attorney work product protection.  Rather, credit will depend on a corporation's timely disclosure of relevant facts.  Corporations that timely disclose relevant facts may receive due credit for cooperation, regardless of whether they waive attorney-client privilege or work product protection in the process.

Second, prosecutors are instructed not to consider a corporation's advancement of attorneys' fees to employees when evaluating cooperativeness.  In addition, the mere participation in a joint defense agreement will not render a corporation ineligible for cooperation credit. 

The revised guidelines are located here.

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The American Health Lawyers Association recently released the results of its Voluntary Disclosure Survey.  The Survey provides data and observations regarding the experience of healthcare organizations with the government voluntary disclosure process.  There were 195 respondents.  Some of the important findings include:

• 71% of respondents had been involved in a voluntary disclosure to the government.
• 70% of the disclosures involved overpayment or billing/coding errors and 28% involved Kickback or Stark violations
• 70% of the disclosures were made by outside counsel.
• Most of the disclosures were made to OIG, followed by government contractors (e.g., fiscal intermediaries) and U.S. Attoney's Offices.
• Almost half (49%) of the disclosures were resolved within a year of the disclosure.
• 46% of the disclosures were resolved with a full overpayment refund; 12% resulted in a corporate integrity agreement.

The complete survey results are located here.

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An interesting Government Accountability Office report was posted recently regarding the problems that CMS and the SSA (Social Security Administration) have had with implementing systems to withhold Medicare Advantage ("MA") and Part D Plan ("PDP") premiums from social security checks. 

Amidst a chronicling of the difficulties and problems encountered, and the efforts of the government to address them, are the executive recommendations.  One of the GAO's suggestions is that CMS consider allowing plans to bill beneficiaries directly until the premium withholdings are processed.  If this suggestion is implemented, it could have a significant impact on managed care providers operating MA or PDP plans.

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