At a press briefing Wednesday sponsored by Health Law Foundation, a not-for-profit legal organization, representatives of three health policy groups said they were concerned that the rules, as written, would have unexpected consequences for patients, doctors, hospitals and pharmacies.
"Most importantly, we are very concerned about a new provision requiring providers to obtain consent for routine health care delivery activities," said Mary Grealy, president of Healthcare Leadership Council, a coalition of chief executives of the leading U.S. health care organizations and institutions.
The consent rules could swamp the health care system with red tape, keep doctors from making emergency decisions and prevent pharmacies from getting prescriptions filled timely, she said.
The new consent requirement requires providers such as hospitals, pharmacies, doctors and others to obtain written consent from patients before using or disclosing identifiable information for routine health care.
"I already wait in line to fill a prescription," Grealy said. "Imagine the line if everyone in it has to read and sign a consent document."
A model consent document drafted by American Hospital Association is 10 pages, she noted.
"We are very reassured that this administration intends to make sure that doctors and hospitals will have access to the information they need to treat patients, and that patient care will not be undermined by unnecessary and excessive bureaucracy, but that there remain provisions in the regulations in their current form that undermine these goals," she said.
Donald Moran, a Bush health care policy adviser and president of Moran Co., a consulting firm, agreed that changes will be needed.
"Failure could cause a collapse of the health care industry and concrete damage to the individual patient," he said. "Within 100 yards of us are power lines down which health care information is being passed. Whether it is possible for us to put our arms around it to protect this information is the issue, and for 99.6 percent of the population, this isn't a problem."
To change the rules within the two-year implementation window will first require a decision on how to balance preventing abuses and punishing abusers, he said.
"The question is whether and how much will it cost," he noted. "Is it necessary to protect a system that does not pose a risk to most people?" he asked. "This is the classic regulatory dilemma: prophylaxis or remediation - which is best?"
Consent and disclosure provisions in the rules will have to be re-examined, Moran said, as will the issues of the federal law's effect on civil action under state privacy laws.
Chris Hoofnagle, counsel for Electronic Privacy Information Center at Georgetown University, said advocates of medical privacy also saw problems with the rules, notably provisions that may allow access to marketing firms unless patients opt out and the lack of a mechanism for people who want to sue abusers of the rules.
"There's no private right to action in the rule like there is with junk faxes and telephone soliciting," he said. "The weaknesses of the regulations on police access and marketing also need to be amended."
Moran said the rule needed administrative mechanisms for enforcement.
"I can see a lot of litigation without this being resolved, with the health care system suing itself into oblivion," Moran said.
Grealy said it was necessary for the administration to make any changes soon so that they could be put in place early when it was easy to do so.
"Hospitals, health systems and pharmacies nationwide are going to be developing expensive, complex new systems to comply with these regulations. In order to ensure that they do not encounter excessive delays and billions of misspent health care dollars on the path to progress, it is essential that the administration act swiftly in spelling out how it will fix the flaws in these regulations," she said.
This new consent requirement is considerably stricter than any state law of which we are aware," Grealy said. State laws generally allow information to be used and disclosed for treatment, payment and many administrative activities related to health care treatment and payment.
"We don't have to speculate on what the unintended consequences of such a provision would be," she said.
"Maine enacted a requirement in 1999 that required specific patient authorization to disclose identifiable information. Maine suspended the law within 12 days of its taking effect due to serious unintended consequences for patients, hospitals, and pharmacies."
According to Grealy, the suspended Maine law was, in some important respects, less stringent than the final HHS "privacy" rule because the HHS rule prohibits either disclosure or use without prior consent. She said pharmacies were predicting "chaos at the counter" when the rule is implemented, as no states require prior consent for the more than 3 billion prescriptions filled annually in the United States.
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