FDA
Seeks Input on Post-LASIK Experiences
The Academy is presenting on LASIK at a
briefing tomorrow of the FDA’s Ophthalmic
Devices Panel. The meeting provides an
opportunity for the FDA to hear from the
public and experts about LASIK satisfaction
issues; several unhappy patients are
expected to testify. The Academy and The
International Society of Refractive Surgery
will be represented by Steven Schallhorn,
MD, former director of cornea service and
refractive surgery at the Naval Medical
Center San Diego and the refractive surgery
program manager for the U.S. Navy, and Peter
McDonnell, MD, director and William Holland
Wilmer professor of ophthalmology at the
Wilmer Ophthalmological Institute. While
multiple studies have documented that LASIK
is safe and effective with an excellent
satisfaction rate and has benefited millions
of patients, regulators are interested in
finding out more about quality-of-life
issues following LASIK surgery. To that end,
the Academy is co-funding and supporting a
new LASIK study with the FDA, NEI and the
American Society of Cataract and Refractive
Surgery.
CMS Meets with
Academy, Others About DMEPOS Quality
Standards
March 1 was the deadline for Medicare
Durable Medical Equipment, Prosthetics,
Orthotics and Supplies (DMEPOS)
accreditation for any new physician
practices or new office locations, including
ophthalmologists’ offices that supply
post-cataract eyewear. The Academy strongly
disagrees with the necessity of such
accreditation for any physician practices
and met with CMS on April 16, along with the
AMA and several other health care provider
groups. CMS agreed that the DMEPOS standards
are primarily aimed at larger licensed
retail suppliers, and the coalition was
offered an opportunity to provide
suggestions on how CMS might lessen the
burden for physician suppliers. CMS
stressed, however, that the law that
initiated accreditation for DMEPOS
specifically requires physicians and other
health care providers to be included.
Typically, physician practice accreditation
costs about $3,000, a rate that makes it
untenable for ophthalmology practices.
Existing providers who are currently
Medicare enrolled, have their National
Provider Information number and have an
existing National Supplier Clearinghouse
number, have until September 2009 to become
accredited.
IOM
Highlights Health Care Workforce Challenges
as Baby Boomers Loom
As nearly 80 million baby boomers begin to
become Medicare-eligible, health care
workforce and access issues rise to the top
of policy makers’ agenda, coinciding with
the Academy’s own initiatives. An Institute
of Medicine (IOM) report released this month
points to a shortage of practitioners
serving older people. To improve
ophthalmologists’ ability to keep up with
the growing eye health needs of society, an
Academy-produced white paper series
(member login required) considers the best
practices for high patient throughput in
three practice types:
The challenge
isn’t unique to ophthalmology.
The IOM study calls for higher pay, more
training and changes in care delivery to
avert a crisis.