Data From Medicare Drug Benefit Eyed for Rx Safety Project

Ten years from now, if the federal government’s time table is on target, every living soul in America will have an electronic medical record file, instantly accessible via the Internet no matter where a patient seeks care.

Instead of a clipboard hanging at the end of the bed with a chart showing what’s happened to a patient so far at General Hospital, Dr. Kildare and Nurse Nightingale will fire up a computer where a comprehensive, lifelong look at the patient’s history will be waiting in cyberspace.

It probably will take more than a decade to make that scenario commonplace, but there’s no question we’re headed in that direction. The first steps were taken in the past few weeks by federal health officials, following the lead of private providers — many of them in California — who already have embarked on the journey.

Earlier this month, HHS Secretary Mike Leavitt announced the formation of a commission to usher the nation into a new era of electronic medical information sharing, a public-private partnership to be known as the American Health Information Community.

A couple weeks before that, CMS Administrator Mark McClellan proposed what will probably be the first national foray into electronic data collecting and sharing: linking billing information from Medicare’s new prescription drug benefit — which begins Jan. 1, 2006 — with data collected when Medicare users submit claims for hospital and doctors’ care. McClellan proposes putting the new cross-referenced database online, making the information accessible to doctors, pharmacists and patients anywhere, any time.

The advantages of electronic information sharing are clear, abundant and for the most part undisputed: Comprehensive electronic records could save money and lives. The more providers know about a patient’s history, the better the treatment should be. Recognizing larger trends also should be easier when data are all in one place and can be manipulated with specific results in mind.

Improved Drug Surveillance?

McClellan hopes electronically linking Medicare prescription data with patient records will make it easier for health officials to spot adverse side effects in new drugs.

FDA’s current system of logging voluntary reports on newly approved drugs catches only about 10% of drug reactions classified as “serious.” Problems such as heart attacks in patients using the arthritis medication Vioxx and vision loss linked to Viagra might show up more quickly and obviously with a larger, more diligently attended database, according to McClellan, economist, physician and former administrator of FDA.

“As we start providing the Medicare drug benefit, we want to find new ways to make progress toward better care, to make the most of this unique opportunity,” McClellan told the Pharmaceutical Care Management Association in a speech outlining his electronic plans for Medicare.

“We’re really at a crossroads in our health care system,” McClellan said, “How we proceed from here will mean the difference between supporting patients and health professionals in a way that promotes and fosters safe effective use of the latest medical treatments to help our beneficiaries stay well — instead of continuing to spend more on preventable complications and avoidable health care costs.”

Last week, FDA endorsed McClellan’s plan.

Paul Seligman, director of the FDA Office of Drug Safety predicts the new system will help the FDA meet its mission of monitoring drugs. “Medicare beneficiaries … take more medications and more combinations of medications for longer periods than people of any other ages,” Seligman said.

The system will monitor four of every 10 prescriptions written in the United States and could help health officials determine the most cost-effective medications and treatments as well as problematic side effects.

California Efforts Influencing the Effort

Both CMS and HHS will look closely at several California efforts to get the health care information technology ball rolling.

Kaiser Permanente, Sutter Health, the WellPoint Foundation and other providers joined forces two months ago to start the California Regional Health Information Organization, a San Francisco-based collaborative effort to develop a statewide health care data exchange network linking hospitals, doctors and patients electronically.

Other California organizations have embraced electronic record-keeping for years. Since 2002, the Palo Alto Medical Foundation, a 600-doctor network, has offered patients access to their health records through the Internet.

Privacy Concerns Remain

Although there’s little debate about the advantages and inevitability of electronic data collecting and sharing in health care, there is a potential down side to putting all this information in cyberspace: patient privacy becomes much harder to guard.

“We’ll have to get to a point that nobody needs to worry about privacy issues or else the system won’t work,” Peter Ashkenaz, deputy director of public affairs for CMS, said.
Leavitt and McClellan, in announcing their respective initiatives, assured patient information will remain private and secure.

In his speech to PCMA outlining plans for the new Medicare Part D benefit, McClellan said the government would follow “strict guidelines that meet all HIPAA privacy protections.”

Paul Appelbaum — past president of the American Psychiatrists Association, an organization with a tradition for protecting patient privacy — is skeptical.

“Proposals for computerized databases of medical information are typically offered with the justification that they will save lives and money but the evidence that such savings will result is weak, while the countervailing risks to patient privacy are clear,” Appelbaum said.

“This is not an argument for abandoning the putative gains of computerization, but rather a reason to look skeptically at proposals that will encroach on patients’ privacy,” Appelbaum added. “Privacy protections need to be maximized as medical information is aggregated, and before privacy is traded for other ends we ought to have substantial reason to believe that those gains will occur and will outweigh the harms that may accrue to patients.”

Jerry Flanagan, consumer advocate with Santa Monica-based Foundation for Taxpayer and Consumer Rights, also sees potential problems with putting prescription records in cyberspace.

“You’re opening up a Pandora’s box of possible problems with identity theft at the top of the list,” Flanagan said. “Usually personal data — Social Security numbers, addresses, payment plans, information like that — is bundled with drug data. How hard is it going to be to unravel those bundles?”

There’s also a commercial consideration.

“Can’t you see the drug companies just salivating over the prospect of getting a hold of data for 41 million people?” says Jamie Court, president of FTCR. “That’s an incredibly valuable resource from a business perspective. Is the government going to charge for that data? Will consumers share in the profit?” Court asked.

Court adds, “There’s no question that information sharing is an important advance in health care and medicine, but we should question how it’s done and who is going to profit from it.”

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