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Latest From Sue Darcey
Two House Committee leaders are asking HHS Secretary Tom Price about the current status of an overdue pandemic influenza preparedness plan, including diagnostic advancements, that was promised last August. The lawmakers say they are worried about a US return of the H7N9 avian influenza virus, which re-emerged in China earlier this year.
Rep. Ryan Costello, R-Pa., and Scott Peters, D-Calif., recently introduced legislation clarifying that the US FDA device center, rather than the drug center, will have primary authority to consider and clear new indications for imaging devices and technologies that use previously approved contrast agents.
Lawmakers emphasized the need for a swift reauthorization of a combined US FDA device and drug user-fee reauthorization bill before the end of July, and released a clean discussion draft April 14 that mirrors the agreements reached by industry and the agency last summer.
The clinical lab industry and IVD test-kit-makers appear ready to work with lawmakers on diagnostic reforms that would create a new category of regulated product for all lab tests that would undergo a mix of US FDA and CMS oversight. Meanwhile, key groups representing laboratory professionals remain fundamentally opposed to the concept.
Five Emory University-affiliated hospitals taking part in a Philips eICU program cut total costs by $4.6m – or $1,468 per average care episode – reduced discharges to nursing homes by 6.9%, and lowered inpatient readmission rates, according to a recent audit by CMS contractors.
A bill introduced by four US Senators to address and improve chronic illness care will increase reimbursements for telehealth care of home-based patients on Medicare Advantage plans, permit beneficiaries in several accountable care organizations (ACO) to be furnished telehealth service at home, and expand the use of telehealth for individuals with stroke.