The FDA is finalizing guidance to accelerate the development of reliable sequencing-based tests. New research shows that immunotherapy, when used in conjunction with chemotherapy, helps lung cancer patients live longer, and the Trump Administration is taking steps to ease ACA essential health benefit requirements. This and more in this week’s Innovation Partners BioBlog.
FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests
The U.S. Food and Drug Administration today finalized two guidances that will assist with the development of technology that scans a person’s DNA to diagnose genetic diseases. Such disease are usually hereditary. The guidances provide recommendations for designing, developing, and validating tests that use the technology, called next generation sequencing (NGS), and will play an important role in the continued advancement of individualized, genetic-based medicine.
CMS has taken an important step towards covering the cost of diagnostic laboratory tests using Next Generation Sequencing for patients with advanced cancer. The company made the move after the FDA approved FoundationOne CDx (F1CDx), an NGS-based in vitro diagnostic test that is a companion diagnostic for 15 targeted therapies. Speculation rests on whether other insurers will follow CMS’s lead.
A recently unsealed lawsuit has revealed that CVS has been accused of false claims. Aetna’s Head Actuary for Medicare Part D, Sarah Behnke, claims the fraudulent claims cost Medicare and patients more than $1 billion, beginning as early as 2007. The company denies the charges.
On Tuesday, Humana completed the purchase of Family Physicians Group, which has 22 clinics in Florida and provides care for more than 40,000 Medicare Advantage and Medicaid patients. The move comes despite rumors that Walmart may purchase Humana.
A new drug that activates the immune system, when used in combination with chemotherapy, appears to help lung cancer patients live longer. These findings support the expert’s notion that immunotherapy should begin as early as possible and that chemotherapy alone is no longer the sole standard of care.
The Trump administration issued a new 522-page rule on Tuesday which will ease ACA essential health benefit requires. Under the new rule, states will be able to choose from 50 essential benefit benchmark plans, instead of 10, beginning in 2020. States will also have a choice in which benefits are included in their essential health benefit benchmark plan by drawing from plans used in other states.