Pennsylvania Health Law Lawyer & Attorney : Fox Rothschild LLP : serving Philadelphia, Pittsburgh, Allentown, Erie, Upper Darby Twp

Medtronic (and by default, all medical device manufacturers) scored a huge win on Wednesday when the U.S. Supreme Court held that medical device manufacturers cannot he held liable in tort actions for medical devices that have gone through FDA pre-market approval.  The case in question was brought by the estate of a man injured when a balloon catheter manufactured by Medtronic burst.  While the issue of preemption of tort liability under the federal Medical Device Amendments of 1976 have been the subject of debate in the federal courts, the Supreme Court's action will likely end that debate for the time being.

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According to an article in the Los Angeles Times, a dispute is brewing in California over what one insurer is calling an “outreach effort” but others are calling an attempt to pit physicians against their patients. Specifically, Blue Cross of California has sent letters to physicians with a copy of patient insurance coverage applications, asking the physicians to identify patients who had pre-existing conditions at the time insurance coverage was extended to them. Presumably Blue Cross of California would use the information to rescind coverage for patients deemed to have pre-existing conditions. While Blue Cross of California says physician participation in the survey is voluntary, many physicians are concerned that enlisting physicians as moles in the effort could cause patients to withhold critical clinical information from their physicians. While HIPAA would likely permit the disclosure of this information, physicians considering making such disclosures should also check their participation contracts carefully to determine whether they have any duty to provide the data to an insurer.

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If you have a question about Medicare coverage or how a particular service is to be billed, who do you call? Many physician practices don’t hesitate to pick up the phone and call their Medicare carrier provider representative for guidance. While this can be an effective way of getting certain kinds of questions answered, practices should be aware that their calls to the carrier are being tracked and can be used by the carrier for a variety of things, including initiating audits. A recent Medicare carrier transmittal, Instructions Related to the CMS Standardized Provider Inquiry Chart for FY 2008, updates instructions to carriers on tracking provider inquiries and increases the level of specificity with which those inquiries are to be tracked. To avoid landing on the carrier’s radar screen with potential compliance or billing concerns, therefore, it is generally advisable, with the assistance of legal counsel, to make Medicare inquiries only in writing and on an anonymous basis.

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