In This Issue...
GOP Proposes Funds for KIDS Research
The House Republican leadership released its legislative agenda for the summer. One measure at the top of its list is the passage of H.R.2019, The Kids First Research Act. This measure would terminate the Presidential Election Campaign Fund and divert its $130 million to researching children’s medical disorders and diseases, such as autism, juvenile diabetes, Down syndrome and cancer. The bill has 112 cosponsors. No action has been scheduled.
New York Times Urges FDA Action on Regulation of LDTs
On July 7th, the New York Times published an editorial, “The Gap in Medical Testing,” urging the Food and Drug Administration (FDA) to release draft guidance documents that establish agency oversight over laboratory developed tests (LDTs). Currently, LDTs are developed in-house by clinical laboratories and subject to the CLIA’88 laboratory standards, but do not go through the FDA medical device review process.
Last month, FDA Commissioner Margaret Hamburg urged the agency to release the guidance documents. Advocates for LDTs assert that subjecting these tests to additional regulation will limit patient access to low volume tests, whereas opponents assert LDT developers have a competitive advantage, since they do not bear the costs of FDA review. Although the agency reportedly completed the guidance documents last year, they were not released.
At this point, all that is known is that the guidance documents will not be released this summer. A provision in last year’s medical device user fee statute requires the FDA to give the congressional oversight committees two months’ notice prior to the release the documents.
Medicaid Loophole May Deny Beneficiaries Preventive Services
A health study conducted by George Washington University and published in Health Affairs reports that some Medicaid beneficiaries may not qualify for preventive screenings as a result of a loophole in the 2010 Affordable Care Act (ACA). Under the ACA, all new Medicare and Medicaid beneficiaries, along with individuals in private plans, are eligible for free preventive services, such as colonoscopies and diabetes screenings. Unfortunately, a glitch in the health care law states that ACA will only pay for currently enrolled Medicaid beneficiaries if they reside in a state that has elected to expand its program. What wasn’t anticipated was that 21 states would decide against Medicaid expansion, while another six remain undecided. More information about the study is available on the Health Affairs website.