December 30, 2012

Advocates Call on HHS to Include Genetic Testing in ACA Benefits

As the Affordable Care Act (ACA) begins to shape some parameters of the health care system in the U.S., there are many details to be worked out. A centerpiece of the law is that states can set up health care exchanges for the purpose of pooling uninsured residents so they can obtain health coverage in an economically efficient manner. The goal is to provide a system that will facilitate access to comprehensive medical coverage and prescription drug benefits. However, several obstacles to the concept of the state exchanges are evident: states may decide not to set up a health care exchange or, alternatively states that do set up an exchange can define the contours of the coverage provided. Under the ACA, the concept of essential health benefits (EHB) has been central: the ACA mandates a set of guaranteed services that an insured can expect from any insurance plan covered by the ACA, including those provided through a health care exchange ("such as hospitalization, prescription drugs, and maternity and newborn care.") One of the ten categories of EHB is "laboratory services." In November, HHS issued proposed rules for covered insurance plans and state health care exchanges, detailing the EHB that are required to comply with the ACA. In a letter to The Centers for Medicare & Medicaid Services (CMS) (the laboratory-regulating agency in HHS) the College of American Pathologists (CAP) has called on HHS to clarify the definition of laboratory services, noting that some states are differentiating genetic testing from other tests, which will narrow the diagnostic options for those covered. 

The CAP strongly supports the inclusion of genetic and genomic testing, when medically necessary for clinically relevant diagnostic purposes, pre-disposition studies, and treatment, as a laboratory service required under PPACA for all qualified health plans in federal or state health insurance exchanges…..We therefore urge the agency to clarify that genetic and genomic testing, as a subset of laboratory services that are mandated for coverage under the Affordable Care Act, be included as a covered service offered by any qualified health plan under a state or federally operated health exchange. 

As the health care exchanges begin to take shape in 2013, the particular issue of genetic testing in the ACA mandate highlights how genomic medicine is taking a distinct profile in the health care system, but such individuation could be used to segregate new technologies due to concerns about cost. It is essential that any disparate treatment of genetic services be flagged early as the ACA begins to define health care access in the U.S.

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