Congressman Says HHS Rules Promote Medical 'Piracy'
Jeff Johnson, CNSNews.com
Tuesday, Aug. 20, 2002
Capitol Hill - A senior Democrat on the House Energy and Commerce Committee plans to introduce legislation next month to block new federal rules he says would eliminate patient privacy in America.
Rep. Edward Markey plans to introduce the "Do Not Use My Medical Information for Marketing Act," to countermand new policies of the Department of Health and Human Services (HHS) set to take effect Oct. 15. The Massachusetts Democrat says the proposed change to federal medical privacy rules "shreds a patient's right to consent."
"This misguided proposal turns the final medical records privacy rule into a medical records piracy rule," Markey wrote in April, before the changes had been adopted. "The American public deserves the strongest health information privacy protections possible."
HHS Secretary Tommy Thompson had a much different take on the regulations when he announced them Friday.
"Patients now will have a strong foundation of federal protections for the personal medical information that they share with their doctors, hospitals and others who provide their care and help pay for it," he said.
"The rule protects the confidentiality of Americans' medical records without creating new barriers to receiving quality health care," Thompson continued. "It strikes a commonsense balance by providing consumers with personal privacy protections and access to high quality care."
The new rules reverse regulations that went into effect in April of 2001 requiring that health care providers and other associated parties subject to federal jurisdiction obtain a patient's consent prior to releasing their medical information to anyone for any reason other than an emergency.
Thompson says the changes were necessary to improve the efficiency of health care delivery.
"The prior regulation, while well-intentioned, would have forced sick or injured patients to run all around town getting signatures before they could get care or medicine," he claimed. "This regulation gives patients the power to protect their privacy and still get efficient health care."
Opponents believe the efficiency issue is a "red herring."
"Dispensing with the need to obtain a warrant would be much more efficient for the police and law enforcement if they could just roar into your house anytime they wanted and search," said Jim Pyles, an attorney for the American Psychoanalytic Association. "But under our Constitution, they're not allowed to do it without either your consent or some sort of good cause identified in a warrant to waive that."
The new rules are, in Pyles' estimation, taking the right to consent or not away from patients.
'Blanket Permission'
"The federal government is, essentially, stepping in and providing consent or permission on your behalf, regardless of your wishes," he said. "Even if you don't want the information to go out, this is a blanket regulatory permission."
Pyles spoke at a briefing Friday for House staff members and other interested parties sponsored by Markey's office.
"What could be more intrusive in the doctor-patient relationship than the federal government stepping in between and saying, 'Regardless of what the doctor says, regardless of what the patient says, this information is going out'?" he asked rhetorically.
HHS estimates that some 600,000 physicians, pharmacists, hospitals, mental health workers and other "covered entities" - including insurance companies, health maintenance organizations, pharmacy benefit managers, and "business associates" of those entities - would have access to personally-identifiable medical information.
Pyles warned that the amended rules would also apply retroactively. Any information provided under an assumption of privacy prior to the mandatory compliance date of April 2003 would become available at that time.
The new rules provide that private medical information must be shared without a patient's knowledge or consent if it is needed for:
Providing health care treatment and services;
Paying for such services;
Facilitating "health care operations; or
Law enforcement, public health, or oversight purposes.
It is the third category that concerns Pyles.
"Many of these purposes, particularly health care operations activities, are related to the business operations of covered entities rather than the need to provide health care to an individual," he argued.
"Health care operations" include marketing alternative treatments to patients; determining eligibility for, and costs of insurance coverage; the sale, transfer, or merger of the entity possessing the medical records; and fundraising among others.
Pyles said physicians, pharmacists, and hospitals would be hurt only a little less than patients by the regulations.
"They are the repositories of the identifiable health information. Those are the folks who are going to be inundated with demands for information that previously was protected," he explained. "There is just going to be a wholesale mining of those medical records by clearinghouses, health plans, [and] HMOs."
Another concern is that the rules leave patients with no individual legal recourse should they believe their information has been improperly disclosed. Complaints can be filed with HHS, but lawsuits are forbidden by the rules.
"When you have no ammunition, you can't shoot," Pyles said, noting that the amended rules allow covered entities to share information freely, but have no tracking requirements. "There's no way to enforce this rule."
Markey will introduce his proposal to block enactment of the amendments when the House returns from the August recess. Markey's bill is co-sponsored by Rep. George Miller, D-Calif. Kristen Kulinowski, congressional science fellow in Markey's office said Markey expects "broad bipartisan support" for the bill.
Pyles noted that all of the members of the House and two-thirds of U.S. Senators are up for re-election in less than two months.
"We would hope that every person running to represent the folks of this country would be asked the simple question," he concluded. "Do you believe the citizens of this country should have the right to consent for the use and disclosure of their health information?"
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