Thank you for the opportunity to submit comments to the National Committee on Vital and Health Statistics Committee on Standards and Security, regarding the HIPAA Transaction and Code Set Standards and the urgent need for a contingency plan that will facilitate a smooth transition to the use of standard electronic transactions. In addition to the following comments, we add our strong support to the comments offered by the American Clinical Laboratory Association (ACLA), of which we are a member.
Laboratory Corporation of America Holdings (LabCorp) is one of the world's largest clinical laboratories, with annual revenues of $2.5 billion in 2002. Headquartered in Burlington, North Carolina, LabCorp has more than 24,000 employees and offers more than 4,000 clinical tests ranging from routine blood analyses to the most sophisticated molecular diagnostics. LabCorp tests more than 300,000 specimens daily for over 200,000 clients nationwide. LabCorp is committed to implementing the Health Insurance Portability and Accountability Act of 1996 (HIPAA). We have invested significant resources to create the capacity to submit compliant claims. LabCorp recognizes the potential future cost savings to the health care industry that can be achieved through administrative simplification and we support the Department's efforts to these ends.
As the October 16, 2003 compliance date nears and covered entities begin to test and validate their systems, the likelihood of implementation failure and the need for a contingency plan is becoming more evident. Although many health care providers will use the standard 4010 format, some providers, and laboratories in particular, will not be able to assure that all required data elements are present in every claim submitted. First, laboratories as indirect providers are unable to obtain certain required elements. Second, payers are interpreting the requirements of the implementation guides differently. Even after testing, it is unclear exactly which data elements individual plans will require on the compliance date. Providers and payors are at times taking divergent views of what a claim must look like in terms of content to qualify as a standard transaction, and therefore of which claims may be lawfully submitted and processed.
To ensure uninterrupted service and payment related to lab services, a contingency plan must be put in place. In the United States alone, clinical laboratories perform millions of tests each year for physicians and other health care professionals. Difficulties faced by clinical laboratories will ultimately have an effect on both patients and physicians.
The most significant problem faced by laboratories is the inability to secure certain required data elements. Laboratories will likely be unable to file compliant electronic claims because they do not always have access to the following information: diagnosis codes, patient and subscriber demographic information, and provider identifiers. There are several reasons laboratories are unable to secure these data elements. Clinical laboratories typically have little or no contact with the patient - generally laboratories perform testing on a specimen collected by the physician's office and test results are reported back to the physician. As a result, the lab must rely upon physicians to provide diagnostic information and patient demographic information. In fact, laboratories are generally not permitted to submit diagnosis codes that are not supplied by the physician or the physician's staff, unless a particular payer agrees to allow the laboratory to use a non-specific diagnosis code such as V72.6 (laboratory examination). Encounter information, which involves a payment system other than fee-for-service, is particularly problematic because the payment structure is not designed to capture demographic data. Therefore this data is commonly missing.
The physician identifier or UPIN is often unavailable to laboratories because a lab cannot know which physician ordered a test unless the physician provides the information. It is common for a laboratory account to be held in the name of only one of the physicians in a practice group. Therefore laboratories must rely upon physicians to provide the UPIN of the requesting provider. However, physicians frequently fail to include their own UPIN, even though they are prompted to do so by the test requisition form. Laboratory test requisitions are not covered transactions and physicians have little incentive to provide the UPIN. Even when patients present at a LabCorp service site, patients cannot provide the physician UPIN because they do not have that information.
Requiring these data elements on a laboratory claim places the burden to obtain this information on the party least able to obtain it. This information often has no bearing on the processing of the claim for payment. These structural impediments will prevent laboratories from consistently using electronic transactions and may force them instead to resort to paper claims.
LabCorp urges the Department to take the following steps to enable and facilitate laboratory use of electronic transactions. First, HHS should clarify that at least for the first phase of enforcement, claims sent in the standard format and using appropriate code sets are considered standard transactions, even if they lack certain data elements required by the implementation guides. The transaction rule requires that covered entities conduct transactions as standard transactions. Sending or accepting a claim that utilizes the proper format and code sets should be acknowledged by the Department as sufficient to meet this baseline requirement. Covered entities that are required to accept standard transactions could not reject such claims on the grounds that they are non-standard. This is clearly consistent with the goal of encouraging and facilitating the use of electronic health care transactions.
Second, these structural impediments outlined above should also be addressed in the Implementation Guide itself. The Implementation Guide for professional health care claims should be modified such that the data elements described above are situational rather than required. These elements should be required only when the information is necessary for adjudication of the claim.
Thank you for your consideration.