Sunday, February 10, 2019


Over 1 in 4 physicians say prior authorizations lead to serious adverse events, AMA survey finds

Fierce Healthcare (2/6, Finnegan) reports, “In a survey (pdf) by the American Medical Association” conducted online in December, “28% of 1,000 responding physicians said the prior authorization process required by health insurers for certain drugs, tests and treatments have led to serious or life-threatening adverse events for patients.” Physicians were specifically asked “if the prior authorization process ever affected care delivery and led to a serious adverse event, such as a death, hospitalization, disability or permanent bodily damage or other life-threatening event for a patient in their care.” In an announcement that released the result of the survey, AMA Chair Jack Resneck, Jr., M.D., said, “The AMA survey continues to illustrate that poorly designed, opaque prior authorization programs can pose an unreasonable and costly administrative obstacle to patient-centered care.” Dr. Resneck added, “The time is now for insurance companies to work with physicians, not against us, to improve and streamline the prior authorization process so that patients are ensured timely access to the evidence-based, quality healthcare they need.”


FDA issues 2019 update on BIA-ALCL

The American Society of Plastic Surgeons (ASPS)
 would like to make members aware of a Feb. 6
updating the number of adverse event
 reports submitted to the agency related to
 breast implant-associated anaplastic
 large cell lymphoma (BIA-ALCL).

The statement notes that as of September 2018, 
the agency has received 660 total medical
 device reports (MDR) regarding BIA-ALCL 
cases in the United States – an increase of
 246 new MDRs (59 percent) from the
 previous year’s update. Acknowledging
 that the nature of the MAUDE database’s
 reporting system is susceptible to duplicate 
reports, the agency’s analysis suggests
 there are only 457 unique cases,
 including nine deaths, of BIA-ALCL 
reported (since 2010). The FDA 
also notes that while the MDR 
system is a valuable source of information,
 it is a passive surveillance system with
 limitations, including incomplete,
 inaccurate, untimely, unverified or
 biased data in the reports. The
 incidence or prevalence of BIA-ALCL
 cannot be determined from this reporting
 system alone, due to potential under-
reporting, duplicate reporting and lack 
of information about the total number

 of breast implants.

The FDA update calls
 for no changes in recommendations
 regarding breast implants.
 For patients with breast implants, 
the FDA states there is no need to 
change routine medical care and
 follow-up, and there is no need to 
test asymptomatic patients.

BIA-ALCL is a rare condition that occurs
 most frequently in patients who have
 breast implants with textured surfaces.
 Patients should discuss with their
 health-care provider the benefits
 and risks of textured-surface
 versus smooth-surface implants. .