In This Issue...

Senate Passes AACC-Backed Newborn Screening Legislation

On January 29, 2014, the Senate passed S.1417, the “Newborn Screening Saves Lives Reauthorization Act of 2013,” which would preserve recent advances in state newborn screening programs. Since the enactment of the initial legislation in 2008, the number of states testing for 29 of the 31 treatable core conditions has increased four-fold.  S.1417 would preserve these gains. 

According to the Centers for Disease Control and Prevention early screening has resulted in 12,500 babies receiving life-saving treatments and interventions annually.  This legislation has played a critical role in improving the lives of these children.  In addition to expanding access to newborn screening, S.1417 would:

  • assist state screening programs to better assess and coordinate newborn treatments;
  • continue research to identify treatments for conditions that can be detected through early testing; and
  • allow states to use government funds to improve the timeliness of newborn screening systems.

Attention will now focus on the House of Representatives, which has yet to take action on the bill.  AACC is a strong supporter of this measure and continues to urge its members to write their House Member and urge them to cosponsor the bill.  In addition, please send a thank you letter to your Senators (it is pre-written as well). For more information on the bill, please go to the House and Senate legislative website

Congress Examining Ways to Pay for SGR Fix

The House Ways and Means and Senate Finance committees are exploring options to repeal the physician sustainable growth rate (SGR).  The current SGR payment formula recommends deep cuts in physician reimbursement annually.  Only with congressional intervention have these reductions, often ranging between 20-30 percent, been forestalled. The House and Senate are now considering draft legislation that would replace the SGR with a new value-based performance system. 

The Congressional Budget Office estimates that replacing the SGR would cost approximately $121 billion to $150 billion.  If Congress decides to make this change, it will need to find cuts to pay for it.  Among the items under consideration is a $9.5 billion cut in laboratory payments.  This would be achieved by extending the annual 1.75 reduction in the laboratory consumer price index through 2023 (it is currently scheduled to expire in 2015).  AACC opposes additional cuts in laboratory reimbursement.  The Association urges you to contact your congressional representatives and oppose additional cuts in laboratory payments. 

HHS Releases Patient Access Final Rule

On February 3rd, the Department of Health and Human Services issued the Patients’ Access to Test Reports final rule that permits consumers to directly obtain their test results from a laboratory provider.  Currently, most states only permit the ordering provider to access the results.  The final rule supersedes these state laws.  Laboratories will have 30 days (60 days if they need an extension) to comply with a patient request.  Clinical laboratories are allowed to charge a “reasonable cost-based fee” for retrieving the data.  The final rule will take effect 60 days after it’s officially published in the Federal Register.

AACC/FDA Webinar on New Draft Blood Glucose Monitor Guidance

On March 19th, AACC is sponsoring a webinar on the new Food and Drug Administration (FDA) draft guidance on blood glucose monitors used in professional settings.  Although the intent is to improve patient care, the document, if implemented, could have far-reaching implications for device manufacturers, hospitals, long-term care facilities and other health care providers.  Join us for a 60-minute discussion with the FDA on this important topic.

Rep. Waxman to Retire

After nearly 40 years, Rep. Henry Waxman (D-CA), former Chair of the House Energy and Commerce Committee, and a leading advocate in the areas of health care and consumer protection, is retiring from Congress.  Rep. Waxman was a leading proponent of CLIA, medical device safety and user fee legislation.  In addition, the California Democrat was a passionate advocate for nursing home reform, the expansion of Medicaid, and the Affordable Care Act.  For a complete listing of Rep. Waxman’s legislative accomplishments, please do go to the House Energy and Commerce website.