HIPAA Regulatory Alert

Labs seek HHS transaction guidance and relief

ACLA president testifies before Senate

In testimony before the U.S. Senate Special Committee on Aging, the president of the American Clinical Laboratory Association (ACLA) said that although labs are committed to compliance with the transaction standards, the Department of Health and Human Services (HHS) needs to provide more specific guidance to assist providers struggling with implementation and also must streamline the mechanisms for development and maintenance of the transaction standards.

ACLA president Alan Mertz said that clinical laboratories are in a unique position with respect to implementation of the transaction standards because they typically have no direct patient contact and thus little opportunity to obtain much of the information that now is required to be submitted in compliant claims. "Clinical laboratories generally perform testing at the request of a physician, on a specimen they pick up from the physician, and they report test results back to the same physician," he said. "As a result, clinical laboratories must rely on physicians to provide patient information." But, he said, because of other demands on the time of physicians and their staffs, they often fail to provide the information initially and also may not be responsive when laboratories make a point of requesting it.

Mertz made particular reference to the problem of providing patient demographic information and also diagnosis coding, noting that physicians have little incentive to provide a laboratory with diagnosis codes because there is virtually no legal or financial consequences to them for transmitting incomplete information to a laboratory. While the laboratory has no ability to force physicians to give them the information, he said, they have to expend precious resources trying to do so.

"As a practical matter," according to Mertz, "a laboratory cannot refuse to perform testing ordered by a physician. Laboratory testing is a critical, and often time-sensitive, health care service. Most laboratories feel they are obligated to perform the testing that is ordered once they receive a specimen, and the laws of several states specifically require testing on all specimens that are submitted to a laboratory. Further, a laboratory could be held liable if a patient later suffers harm as a result of the laboratory’s failure to perform testing ordered by a physician. Thus, the practical reality is that if diagnosis information is required to electronically submit a claim, laboratories will be faced with filing paper claims or will end up doing testing for free when they cannot obtain the required information from a physician."

Mertz also raised questions about the HIPAA regulatory process, noting that the law generally requires the department to adopt a standard that has been developed, adopted, or modified by a standard-setting organization. But the law also requires that any standard adopted be consistent with the objective of reducing the administrative costs of providing and paying for health care and accommodate the needs of different types of health care providers.

Mertz said in addition to comprehensively evaluating the relevant regulatory processes, HHS should provide covered entities with additional guidance on compliance with the transaction standards, including a definition on what constitutes a compliant claim and recognition that less-than-perfect claims may be considered compliant initially.

(Contact Mertz at (202) 637-9466 or go to www.acla.org.)