CLN Article

Federal Insider

Reporting Genetic Data to Physicians, Patients

AACC called for the Food and Drug Administration (FDA) to work with laboratory medicine professionals, physicians, and others to ensure patients receive education about genetic testing as well as clear, understandable information about their genetic test results. The association responded with a letter to FDA’s request for comments after a public hearing in March on the issue.

Laboratories performing molecular testing are regulated under CLIA, an oversight model that should remain in place, according to the AACC letter. “Laboratory professionals work diligently to ensure the quality and efficacy of their tests. In addition, laboratory professionals work closely with their physician partners in selecting appropriate tests, interpreting test results, and determining the clinical utility of each selected test. This collegial relationship serves patients and the healthcare community alike and should continue,” the association wrote.

FDA should work with the healthcare community to develop guidance on patient education, and should also become more involved in translational research so that institutional review boards and researchers understand CLIA requirements, the letter said. AACC also recommended that trained healthcare professionals educate patients about the risks and benefits of genetic tests, as well as financial implications.

At the FDA workshop, Kathy Hudson, PhD, deputy director for science, outreach, and policy at the National Institutes of Health, framed this issue of how patients receive genetic test results as key to President Obama’s precision medicine initiative. This plan will involve some 1 million volunteers in research capturing genomic, environmental, and other health-related data. Hudson noted that participants may receive individual data, individual health information, ongoing study updates, and aggregated results, depending on their preferences.

AACC Joins March of Dimes in Push for Zika Funding

AACC, the March of Dimes, and 66 other major healthcare organizations are calling for Congress to provide immediate emergency funding to prepare for potential Zika virus outbreaks in the U.S. by strengthening laboratory testing and rapid response capabilities. Legislation to unlock funding for these efforts has stalled in the U.S. House of Representatives, even as a bipartisan group of lawmakers seem closer to a deal.

House Speaker Paul D. Ryan (R-Wisc.) has pushed for the Obama administration to use “pre-allocated funding” to fight Zika. The White House argues such funds will have to be taken from money set aside to fight Ebola virus, and not nearly enough to match President Obama’s $1.8 billion request for Zika. Leaders of the House Appropriations Committee promised to study Obama’s request further and “monitor the changing needs resulting from this unpredictable crisis.”

The letter from March of Dimes, AACC, and numerous other supporting organizations urges Congress to pass the supplemental funding requested by President Obama to boost laboratory testing, epidemiology, and surveillance capabilities.

Thirty Percent of Medicare Payments Tied to Quality Ahead of Schedule

According to the Centers for Medicare and Medicaid Services (CMS), an estimated 30% of Medicare payments are now tied to alternative payment models that reward the quality of care over quantity of services provided to beneficiaries, affecting some 10 million patients covered by the program. In January 2015, the Obama administration announced goals and a timeline for shifting Medicare reimbursements from quantity to quality, setting a goal of 30% of Medicare payments through alternative payment models by the end of 2016.

Currently, 477 Medicare Accountable Care Organizations represent about three-quarters of progress toward the CMS goal. Put another way, this means that roughly $117 billion out of a projected $380 billion Medicare fee-for-service payments are tied to CMS quality and value metrics.