What's hot & what's not: Health law 

Posted: 1:00 am Mon, August 3, 2009
By Michelle Lore

Every time you turn on the news these days, you hear talk about health care reform. Questions around how to ensure coverage for everyone, who’s going to pay for coverage and how it will be administered and delivered are being bandied about by both political parties, often resulting in divisive debates.

How do health lawyers fit into this reform effort? What are they doing for their clients as the debate rages? What will they do if reform measures pass?

Lucinda Jesson, director of the Health Law Institute at Hamline University School of Law, recently sat down with Minnesota Lawyer to answer these questions and talk about some of the busy — and not so busy — areas in the field of health law today.

WHAT'S HOT:

Health care reform

Health care reform is occurring on two levels, according to Jesson. On one level is the federal government’s attempt to totally reconfigure the health care system. The other involves efforts by some health care providers in the private sector, such as Medica and Fairview Health Systems, to move toward a performance-based payment system.

The 1,000-plus page bill that was recently introduced in the House contains numerous new rules and expectations for health care payors and providers — which means a lot of work for lawyers, Jesson explained.

But even as Congress debates health care reform, she continued, lawyers are busy analyzing how the potential new laws will affect their health care clients and encouraging those clients to contact their representatives about provisions that may negatively affect them.

Attorneys are also working with health care clients to determine how the legislation, if passed, will affect those clients and the way they do business.

The other aspect of all this, according to Jesson, is the attempt to ensure that today’s rapidly changing health care delivery system is in compliance with statutes that are often quite old.

“Lawyers spend a lot of time figuring out how best to structure new health care payment systems and health care delivery systems to comply with laws that were written for health care delivery as it existed 30 years ago,” said Jesson. “That is challenging.”

E-health

The increasing use of technology in health care is also keeping lawyers busy. As more providers move towards electronic health records, for example, more privacy and security-related issues are arising.

“A lot of our laws were designed with the paper file holding our medical records in mind,” said Jesson.

She pointed out that the recent federal economic stimulus bill included a lot of money for improving health information technology and a lot of changes to the Health Insurance Portability and Accountability Act — the statute passed in 1996 to protect the confidentiality of medical records.

Changes to HIPAA include new rules for health care business associates, more notice to individuals if their private health care information is disclosed in a security breach and more enforcement of the law’s provisions.

“That is going to change the way everyone approaches things,” said Jesson, noting that to date there has not been a lot of enforcement by the federal government. “I think that will change. There are increased civil penalties for violating HIPAA privacy and security laws.”

Jesson added that the stimulus law also gives discretionary enforcement ability to the state attorneys general. “We’ve increased the security and privacy requirements and we’ve given more enforcement authority,” she said.

The use of videoconferencing to treat patients is another growing technology-related phenomenon.

UnitedHealth Group and Cisco recently announced a plan to create a telehealth network that would enable video medical imaging, audio communication and health record information to be exchanged between health care providers and patients from remote locations.

The idea is to “create an experience remarkably similar to an in-person visit with a doctor,” Jesson quoted from a recent UnitedHealth Group press release. Again, however, many of the applicable laws are outdated, such as licensure laws that “are written with house calls, not videoconferencing in mind,” she said.

Federal pre-emption

Federal pre-emption of state tort claims continues to be a hot area in health law. Rather than put the pre-emption issue to rest, two major decisions from the U.S. Supreme Court in the past year have actually created more questions.

In Wyeth v. Levine, the court determined that federal law does not automatically pre-empt state failure-to-warn claims involving the labeling of prescription drugs regulated by the FDA. But in Riegal v. Medtronic, the court found that federal law does pre-empt state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the FDA.

“[The decisions] leave a host of questions which the lower courts and lawyers are trying to sort out,” said Jesson.

Examples include whether pre-emption is appropriate in claims based on withholding or misrepresenting information to the FDA when seeking premarket approval of a device, claims involving a manufacturer that learns about a problem after FDA approval, and failure-to-warn cases dealing with the labeling of generic drugs.

WHAT'S NOT:

Antitrust enforcement

Antitrust enforcement in the health arena has been extremely quiet.

“We have seen very few big health care antitrust cases either in the state or by the federal government in the recent past,” said Jesson. “To the extent we’ve seen antitrust scrutiny it’s been in the pharmaceutical area. We’ve seen very little in the hospital or health-plan [merger] areas.”

Jesson predicts, however, that may change under the Obama Administration with the appointment of Christine Varney to head the DOJ’s antitrust division. Varney has been outspoken about inadequate antitrust oversight in recent years.

“It’s an area that really may be warming up,” said Jesson.

Arbitration agreements

Mandatory arbitration clauses in health care delivery contracts are becoming few and far between.

Jesson explained that three years ago these clauses began showing up in things like nursing home agreements, where someone entering the facility would agree to mandatory arbitration in case of a dispute.

Hospital systems outside of Minnesota were also starting to include those in admission agreements in nonemergency cases, Jesson explained. But they didn’t go over well.

“I think we have seen a real backlash against those types of arbitration agreements,” she said. “On the delivery side at least, I think we’ll be seeing far fewer of those. We’ll still see arbitration agreements, and appropriately so, in things like payer-provider contracts, however.”

Corporate medicine doctrine

The exceptions contained in the corporate practice in medicine doctrine have essentially swallowed the rule, ac
cording to Jesson.

Over the last 80 years or so, the doctrine — which says that corporations can’t practice medicine — has been adopted by the states either through caselaw or statute.

Jesson said that while the theory is nice — that it should be just the patient and the doctor in the room making decisions — in reality, a number of entities are present. The utilization review committee reviews whether the admission was appropriate, the insurer decides whether the visit or procedure is covered, and the government, if federal dollars are involved, also gets drawn in.

Jesson said she was surprised when the Minnesota Supreme Court affirmed the continued existence of the doctrine in 2005.

“Because of that [decision], Minnesota health lawyers still have to, when we set up agreements, draft with that in mind. … But [the doctrine] is out of touch with the reality of health care delivery today.”