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Wherefore Goes the Laboratory?

Larry H. Bernstein, MD, FCAP

Writer and Curatorthat both public and private payers develop clear and consistent evidence criteria for payment of

http://pharmaceuticalintelligence.com/2015/7/17/larryhbern/Wherefore_Goes_the_Laboratory?

Pharmaceuticals and Diagnostics are becoming more integrated in terms of payment initiatives

We have already seen the impetus for targeted-design of drugs. However, how this plays out in the complex world of personalized-medicine remains to be seen.  Certainly, the genomics of cancer and other diseases has been a matter of continuing investigation, and is not clear with respect to patient management.  The American Association for Clinical Chemistry (AACC) has issued a position statement on Personalized Medicine, emphasizing the role of laboratory medicine in the delivery of Personalized Medicine (PM).  The AACC stresses the need for Congressional funding for basic and clinical research in the field of PM tests. Important in this view is  the need to develop evidence based criteria for the reimbursement of companion diagnostics. In addition, the recommendation urges that laboratory professionals become more engaged in educating physicians about the availability of and limitations of PM tests, and to partner with other  healthcare professionals.

The Centers for Medicare and Medicaid (CMS) has issued new data on the cost savings of accountable care oganizations (ACOs).    The American Hospital Association Senior Vice President Linda Fishman calls attention to the need for the CMS to make the program more attractive to new and current participants. CMS announced in May that the Office of the Actuary found the Pioneer ACO model geberated more than $384 million in savings to Medicare over the first two years of the program while continuing to provide high-quality care.

An important issue, quite easily overlooked, is the importance of the restructuring of the electronic health record (EHR) to accomplish this task. There are unresolved issues that need serious attention:

1. The EHR needs to be functionally more than just a repository for data.

It has to be linked to multivariable algorithms that parse the data in real time, and thereby assist physicians in decision-making.  This would be essential for a population-based model for value-based payments by Medicare and all providers in the next several years, in accordance with the Affordable Care Act.

2. The EHR has to be accessible to all of the providers of care to the patient, and the information also protected from intrusion.  This means that if a patient has cancer, and is also diabetic, and has for example, rheumatoid arthritis, the data has to be available to all providers actively engaged in treatment. This might be the endocrinologist, a primary care physician, a rheumatologist, radiologist, and oncologist. This is not by any means a consideration in the current design of the EHR.

3. The access to laboratory and pharmacy data must be seamless, which has not been the case.

If these considerations were considered in a patient-focused design of the EHR, the benefits would almost certainly accrue.  I call attention to the fact that there are ongoing medical studies and pertinent findings that could also contribute to the quality of care, but these might take some time to be incorporated into an evidence-based program going forward.

Clin Lab News July 2015; 41(7). AACC
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