By Lisa Seachrist

Washington Editor

WASHINGTON ¿ With an Aug. 21 deadline looming, the Senate began to consider several different versions of medical privacy legislation.

The federal preemption of state laws and law enforcement access to medical records appear to be the biggest hurdles facing the Committee on Health, Education, Labor and Pensions as it attempts to reach consensus on legislation before it goes to the Senate floor.

The committee has three different versions of medical privacy legislation to consider: a bill sponsored by committee chairman Jim Jeffords (R-Vt.) and Christopher Dodd (D-Conn.), another by Edward Kennedy (D-Mass.) and Patrick Leahy (D-Vt.), and a bill introduced Monday by Bob Bennett (R-Utah) and Connie Mack (R-Fla.).

¿It¿s a challenge to have six different senators working on this issue,¿ Jeffords said. ¿But I hope to take the best protections of the three and have a bill ready for mark-up next month.¿

Congress is under the gun in getting medical privacy legislation passed. If Congress fails to enact federal privacy legislation by Aug. 21, the secretary of Health and Human Services (HHS) is required by the Health Insurance Portability and Accountability Act of 1996 to promulgate regulations establishing electronic privacy standards on Feb. 21, 2000.

Congress clearly stated its desire to weigh in on the issue in September 1997, when Secretary Donna Shalala outlined the federal privacy protections that HHS would put into place. They would provide easy access to medical records for law enforcement and no preemption of state laws. (See BioWorld Today, Sept. 15, 1997, p.1.)

Federal Preemption A Key Argument

The three bills before the committee call for varying degrees of limits to access by law enforcement officers, ranging from requiring summonses and administrative subpoenas to grand jury subpoenas and court orders. In general, the Leahy-Kennedy measure provides the most stringent hurdles to law enforcement access.

However, the pharmaceutical and biotechnology industries are more concerned with researcher access to medical information and uniform privacy protections across the country, rather than having a patchwork of state measures that researchers would need to navigate. The federal preemption of these state laws looks to be the source of the biggest battle in the committee.

¿Preempting state consumer protections legislation is not the way Congress has dealt with this type of issue in the past,¿ Leahy said. ¿For instance, consumer protections in financial and communications law set a federal floor ¿ not a preemptive ceiling. The legislation we enact should not change this precedent.¿

However, Bennett sees the issue in a different light. Acknowledging that he is a staunch conservative Republican and a champion of states¿ rights, he argued that the issue was a managerial one.

¿People keep asking me, How can you comp out for federal preemption?¿¿ Bennett said. ¿From a straight managerial point of view, federal preemption of state laws is vital. Health services very often straddle state lines, and this confusing, contradictory and complex patchwork of state laws doesn¿t work.¿

While acknowledging that setting a federal floor will ensure that all Americans have at least some guarantee of medical privacy protections, Bennett said, ¿A federal floor only offers temporary relief from this confusing patchwork of state laws.¿

In addition to providing federal preemption of laws, the Bennett bill provides for criminal and civil sanctions for wrongful disclosure of protected health information, including criminal penalties ranging from $50,000 to $250,000 and civil penalties ranging from $500 to $100,000.

¿The Bennett bill is very strong,¿ said Carl Feldbaum, president of the Biotechnology Industry Organization. ¿It balances the need to protect research interests with the need to ensure medical privacy and focuses on punishing the misuse of protected health information. It may be one of the few bills that we can get behind wholeheartedly all year.¿

Bennett Bill Favored By Industry

Feldbaum also noted the Bennett bill provided the complete federal preemption of state laws that would ensure all research sites around the nation comply with the same privacy standard, which is vital in the age of far-flung multicenter clinical studies.

¿This is the one bill that is completely balanced,¿ Jeff Trewhitt, media spokesperson for the Pharmaceutical Research and Manufacturers of America, said of the Bennett bill. ¿We are pleased with the fact that he has federal preemption of state laws. It is the right bill.¿

However, Sen. Paul Wellstone (D-Minn.) pointedly told Bennett that while he appreciated the work the senator had done, he was opposed to such preemption.

¿In the state of Minnesota we have a very strong medical privacy law,¿ Wellstone said. ¿I would find it difficult to preempt what we¿ve done there.¿ n