Medical Device Daily Washington Editor
FDA reported last week that it has undertaken a collaborative study with the Department of Defense (DoD) and the National Eye Institute (NEI) to "examine the potential impact" on quality of life (QoL) from laser-assisted in situ keratomileusis (LASIK), a procedure that is said to work exceedingly well for most patients, but which triggered a noisy advisory committee hearing for FDA last year (Medical Device Daily, April 29, 2008).
The Oct. 15 statement also disclosed that FDA has issued warning letters to 17 outpatient facilities that offer the procedure "after inspections revealed inadequate adverse event reporting systems at all the centers," according to the agency's statement. An FDA spokesperson told Medical Device Daily via e-mail that the letters were issued Oct. 9 and will be posted to the agency's web site on Oct. 27. The FDA statement notes that the inspections of the LASIK centers "did not identify problems with the use of the LASIK devices at these facilities."
Physicians have not always adhered to guidelines for the use of LASIK, sometimes using the technology on patients whose pupils were of a diameter larger than indicated in guidelines. A number of patients attended the ophthalmic devices advisory committee meeting last year, and the father of one patient alleged that an unsuccessful procedure drove his son to suicide. However, representatives of DoD at the meeting argued that proper adherence to guidelines has made the procedure a highly effective tool and in some cases, a lifesaver for American military personnel.
According to the FDA statement, the LASIK project will roll out in three phases, the first of which began in July. FDA, DoD and NEI will build and post "a web-based questionnaire to assess patient-reported outcomes and evaluate quality-of-life issues" for patients who have had the procedure. Some of the responses, FDA indicates, "may relate to the safety of the lasers used in the ... procedure."
The second phase will "evaluate the quality of life and satisfaction ... in a select, active duty population treated" at the Navy Refractive Surgery Center in San Diego. The final phase "will be a national, multi-center clinical trial and will study the impact of the procedure on quality of life," FDA says. Enrollment has commenced for both phase 2 and 3, and FDA indicates that the last phase will wrap up in 2012.
"This study will enhance our understanding of the risks of LASIK and could lead to a reduction in patients who experience adverse effects from the procedure," acting CDRH director Jeffrey Shuren, MD, said in the statement. He also said that adverse events reports are "critical to better understand the safety and effectiveness of ophthalmic lasers used in LASIK procedures and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements."
TENS promoted for surgical analgesia
Makers of transcutaneous electrical nerve stimulators sometimes demonstrate a sense of adventure where an expansion of indications is concerned, but the Sept. 3 letter to Pantheon Research (Venice, California) serves as yet another reminder that an expansion of indications without FDA's approval rarely equates to a good business strategy.
The warning letter says that the agency's review of the company's web site, which was not operational at press time Friday, disclosed that the firm was marketing several models of electro-stimulation products outside of cleared indications, including for treatment of "many syndromes including pain, addictions, and ... for analgesia during surgery." FDA reminded Pantheon that it had neither clearance nor approval for such indications and said that the agency "requests" that the company desist with the promotions, threatening seizure and civil money penalties.
John Hubacher, the company's president, told MDD "we have hired an FDA counsel to advise us and determine if we need to upgrade our regulatory filings."
AHRQ says costs for those age 45-64 up
Medicare costs will always be a topic it seems, but a recent report by the Agency for Healthcare Quality and Research indicates that costs for those who have hit middle age but are not yet eligible for Medicare have spiked pretty vigorously as well.
According to a recently published statistical brief, Americans between the ages of 45 and 64 generated $307 billion in healthcare expenditures in 2006, a sharp jump over the $183 billion in 1996, a figure adjusted to 2006 dollars (AHRQ does not give the pre-adjustment numbers for 1996).
The type of healthcare service did not seem to change much over that span. According to AHRQ's numbers, 75.7% of those in this cohort spent time at a physician's office in 1996, a number that nudged to only 77.6% a decade later. Prescription drug usage likewise held steady, rising about half a percentage point (73.6% to 74.1%).
On the other hand, the cost of those drugs as a share of all healthcare spending for this group expanded significantly, from roughly 15% to more than 25%. The driver for this increase was largely the per-prescription cost, which rose from $103 to $199. However, AHRQ does not isolate the effect of mail order pharmacy spending, which often provides three months of prescriptions in one fill.
AHRQ makes the claim that the distribution of total expenditures "by source of payment did not change significantly" between 1996 and 2006, with patients contributing 20.5% in 2006 vs. the 18.8% seen at the beginning of the studied period. Private payers also saw a slight bump in their contributions (from 54.4% to 56.3%).
As for government spending, Medicaid accounted for slightly less (7.8% to 7.2%) in 2006, but Medicare caught a larger slice of the pie, growing from 6.3% in 1996 to 8.8% ten years later.
The winner in this cost-shifting dynamic was the group of payers occupying the category titled "other." This group of payers, which includes state Medicaid and Children's Health Insurance Program funds as well as other state and local sources, got a reprieve via a share that fell from almost 13% to slightly more than 7%.
Mark McCarty, 703-268-5690