In This Issue...
LDT Guidance Unlikely in Near Future
The Food and Drug Administration’s (FDA’s) Director of the Center for Devices and Radiological Health (CDRH), Alberto Guiterrez, PhD, mentioned at the AACC Annual Meeting that the agency has not, at this time, notified Congress of its intent to publish the long-awaited guidance documents regulating laboratory developed tests (LDTs). Under the medical device user fee law enacted last year, Congress stipulated that the agency notify the legislative body 60 days prior to releasing the LDT documents.
This issue has been in the news lately as FDA Commissioner Margaret Hamburg and the New York Times both called for the release of the guidance documents. In addition, the American Clinical Laboratory Association filed a Citizen’s Petition with the FDA questioning its authority to regulate LDTs. Also joining the debate was former CDRH Director Steve Gutman, MD, who posted a blog asserting that behind-the-scenes politics is the cause of the delay and the future issuance of the guidance is unclear. To view Dr. Gutman’s blog, please go to the Myraqa website.
Senators Hagan and Hatch Introduce Newborn Screening Measure
Senators Kay Hagan (D-NC) and Orrin Hatch (R-UT) recently introduced legislation, S.1417, the Newborn Screening Saves Lives Reauthorization Act, which would preserve recent advances in state newborn screening programs. Since the enactment of earlier legislation, the number of states testing for 29 of the 31 treatable core conditions has increased four-fold.
In addition to expanding access to newborn screening, S.1417 would:
- help state screening programs better assess and coordinate newborn treatments;
- continue research towards identifying treatments for conditions that can be detected through early testing;
- ensure the quality of testing provided by newborn screening laboratories;
- renew the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children; and
- Create a fast track process for reviewing conditions where drug treatment is available.
AACC recently endorsed the companion House legislation, H.R.1281. The Association’s Government Relations Committee is currently reviewing S.1417. A copy of the legislation is available on the congressional web site, THOMAS.
House Energy and Commerce Approves 'Doc' Fix
On July 31st, the House Energy and Commerce Committee unanimously passed a bill to repeal the sustainable growth rate (SGR) formula that annually mandates a deep cut in physician payments. Each year Congress enacts legislation preventing the reduction from taking place. The bi-partisan bill does not identify how Congress will pay for the $138 billion in lost revenue resulting from the repeal of the SGR. The proposal also permits nurse practitioners and physician assistants to manage medical homes without physician oversight. AACC will continue to monitor this measure as Congress decides how to pay for the costly change. To learn more about the legislation, please visit the committee website.