Proposal on access to lab tests should be revised, doctors say

Proposed federal rules that would override laws in 20 states and require laboratories to send test results directly to patients upon request drew an array of objections from physician organizations, labs and hospitals.

The Dept. of Health and Human Services proposal, filed in September, does not require labs to ensure that physicians get test results before patients so they can help them understand the results. The proposal also does not distinguish between routine test results and those that deliver news of a potentially life-altering diagnosis, saying patients should have direct access to all test results.

The proposed regulation could lead to patient confusion and undermine the relationship with the physician, said Glen Stream, MD, president of the American Academy of Family Physicians.

"If you do enough tests on any healthy person, some of them are going to be abnormal, so one concern is that people are going to misinterpret insignificant values," said Dr. Stream, a family physician from Spokane, Wash. "This creates undue apprehension on the patient's part, and here the doctor's telling them, 'You don't need to worry about that.' That creates uncertainty in that doctor-patient relationship. The greater concern is that the result might be truly abnormal, but looking up that result yourself as a patient is not the way to get potentially bad news."

These concerns were echoed in comments submitted by the American Medical Association, the American College of Physicians and the American Academy of Pediatrics. They called for some kind of disclaimer attached to lab results to inform patients that they should consult the ordering doctor for interpretation.

"Lab reports ... should contain standard language emphasizing both the limitations of the lab data alone in confirming or ruling out a diagnosis, and the importance of the patient discussing their lab results with their physician," AMA Executive Vice President and CEO James L. Madara, MD, said in a comment submitted Nov. 10. "A critical part of the lab testing and results process is physician-patient communications."

Many trade groups representing clinical labs asked the government to add such disclaimer language, fearing liability exposure from patients who wrongly interpret their results and suffer adverse consequences. The labs, along with hospitals that operate laboratory facilities, asked HHS for extra time to comply with potential new requirements.

The labs also asked for guidance on how to verify patients' identity before handing out results. HHS estimates the rule will affect more than 22,000 labs, 6.1 million tests and impose $56 million in annual laboratory compliance costs.

Physicians want results first

In the AMA's comment, Dr. Madara said labs should be required to give test results to doctors at least at the same time as they give them to patients. Many of the 90 comments to HHS called for a time lag between when doctors receive results and when patients do.

"I think having a time lag is really important, because then physicians have adequate time to address the issue before expecting a patient's call," said Hardeep Singh, MD, MPH, assistant professor of medicine at Baylor College of Medicine in Houston.

According to a Sept. 28, 2009, Archives of Internal Medicine study co-written by Dr. Singh, office-based physicians fail to follow up on clinically meaningful abnormal test results 7.7% of the time.

Dr. Singh said it is difficult to predict whether the HHS proposal would improve patient safety. He co-wrote an online commentary about the rule published Nov. 28 in The Journal of the American Medical Association.

One of the premises of the regulation is that it will help prevent missed test results, but he said that might not happen.

"Do we know that if we leave it up to patients that they will then take more action and be more proactive?" he said, noting that few of the patients who already have access to test results through personal health record systems use the functionality.

HHS is examining the comments and, should it decide to proceed with the regulatory process, will issue a final rule that takes the comments into consideration. No date has been announced regarding when a final rule might be issued.

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States have varying access to lab results

The Dept. of Health and Human Services' proposed rule would set a nationwide legal standard to govern how labs communicate test results to patients. While a few states now allow results to be sent directly to patients, most either have no rules on the matter or require involvement of health care professionals.

Lab results are sent only to physicians or authorized health care entity: Arkansas, Georgia, Hawaii, Illinois, Kansas, Maine, Missouri, Pennsylvania, Rhode Island, Tennessee, Washington, Wisconsin, Wyoming

Lab results may be sent to patients with physician approval: California, Connecticut, Florida, Massachusetts, Michigan, New York, Virginia

Lab results may be sent directly to patients without physician approval: Delaware, Maryland, New Hampshire, New Jersey, Nevada, Oregon and West Virginia, the District of Columbia and Puerto Rico

No state law governs patients' access to lab results: Alabama, Alaska, Arizona, Colorado, Idaho, Indiana, Iowa, Kentucky, Louisiana, Minnesota, Mississippi, Montana, Nebraska, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah, Vermont, Guam, Northern Mariana Islands and the Virgin Islands

Source: "CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports: A Proposed Rule by the Centers for Medicare & Medicaid Services," Federal Register, Sept. 14 (www.federalregister.gov/articles/2011/09/14/2011-23525/clia-program-and-hipaa-privacy-rule-patients-access-to-test-reports)

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