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CMS plans to open drug data to researchers

Medicare officials say physician-specific prescribing information would be invaluable for an eventual pay-for-performance system.

By David Glendinning, amednews staff. Nov. 20, 2006.

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Washington -- Now that Medicare has been processing prescription drug claims for nearly a full year, federal officials are setting up a plan for scientists to learn from all the information. But some experts worry about researchers learning a little too much.

The Centers for Medicare & Medicaid Services recently unveiled a proposed rule that would allow government agencies and approved outside researchers to access portions of the claims data to conduct studies. Statute currently prohibits even government scientists from using the information until the administration finalizes regulations that open the door for them.

Once access is granted, researchers could begin using the vast resource presented by the hundreds of millions of prescription drug claims for people with disabilities and seniors that the government processes over the course of a year. Such a move would benefit the health care system, said then-CMS Administrator Mark McClellan, MD, PhD, who left the agency in October.

"We have seen great improvements in the quality of health care based on identifying opportunities for better care based on Medicare information," he said. "Through the appropriate use of the new prescription drug claims data, we have an unprecedented resource to help us learn more about prescription drug usage by seniors and how we can help seniors get the most benefit from prescription drugs."

Investigators could examine drug claims alongside hospital admission numbers for signs of previously undetected side effects or harmful drug interactions -- information that could be passed along to the Food and Drug Administration. Alternatively, researchers could crunch the data to determine which drug therapies for certain conditions improved the health of patients and saved Medicare money in the long run.

Medicare already has taken similar steps to open access to physician and hospital claims for the same purposes. Once the drug claims are added to the list, researchers would be able to cross-reference the data to create a powerful tool for improving health care and lowering costs, CMS officials said.

Academic institutions that have received approval in the past to access Medicare claims data are eager for the administration to allow them to delve into the prescription drug area, said David Korn, MD, senior vice president of the Assn. of American Medical Colleges' division of biomedical and health sciences research. The tens of millions of seniors enrolled in the program and filing claims for their medications present a potential gold mine for researchers, he said. Seniors could provide more useful information about drug therapies, since they tend to take more medications at higher doses to combat chronic conditions that have worsened with age.

"You have here a very large, heterogeneous group that's a good population of people taking these drugs," he said. "It would be an extremely powerful database."

Dr. Korn said the ability to access such important data could help prevent or more quickly detect patient safety issues, such as the increased risk of heart attacks and other cardiovascular events associated with the painkiller Vioxx (rofecoxib) before its withdrawal from the market in 2004. If scientists looking at the claims notice a spike in emergency department visits or hospitalizations associated with a certain type of medication, the FDA or drugmaker could take action based on the warning flag, he said.

Privacy concerns

CMS officials said the agency would go to great lengths to protect confidential patient and physician data in the drug claims from inappropriate discovery or use. For instance, investigators would need to demonstrate that the information would serve a legitimate research purpose before they could see it. Medicare also would redact any data, such as beneficiary or physician identifiers, when they are not absolutely necessary to conduct the study in question.

Physicians need to know that personal information about them would be subject to discovery, just as it is through claims data mining by private interests, said Deborah Peel, MD, a psychiatrist and chair of the Patient Privacy Rights Foundation, a watchdog group based in Austin, Texas.

"Physicians are just waking up to the fact that they're being surveilled as well," she said.

CMS acknowledges that physician-specific data would be invaluable for an eventual Medicare pay-for-performance system.

"We need to know who prescribed the drug for studies that assess appropriate prescribing practices, such as those that would link physician payment to quality measures," the agency writes in the rule. "We are exploring value-based purchasing initiatives, in which we may collect data on the extent to which physicians are appropriately prescribing needed medications."

Dr. Korn said Medicare had done an excellent job of scrubbing physician and hospital claims data of sensitive information before it opened them up to researchers. But others are worried that the increased access sends the government down a dangerous path.

Prescription drug claims, even when "de-identified" for investigators, contain a large amount of information that could be used to reveal details about patients, Dr. Peel said. Many patients do not realize that private payers and pharmacies already share such data with drug companies and employers, and some seniors likely would be uncomfortable knowing that the government is planning to release even more information about them, she said.

The foundation is planning to call on CMS to obtain beneficiaries' consent before it makes their drug claims available to researchers. It also will ask the government to put more stringent safeguards in place to protect the security of claims information that is transmitted outside of federal agencies.

The proposed rule specifically asks if special limitations on external investigators are necessary to prevent nonresearch or commercial use of the released data.

CMS will accept comments on the proposed rule until Dec. 18.

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