Barring an asteroid or the biggest economic surprise in recent history, Friday's jobs report will be the 60th straight month that America's private sector has gained jobs. That's a new record — but another milestone this month arguably looms larger. March marks five years since the Affordable Care Act was passed … amid Republican cries that the ACA was a job-killer. To put that more plainly: The private sector hasn't lost jobs since Obamacare was officially created. Were Republicans wrong? The state of the debate: 2010 To understand that question — and the peculiar political implications when answering it — we need to revisit the heated months when the ACA was limping toward passage.
Although one of the duodenal endoscopes implicated in recent "superbug" infections was never cleared by the FDA, the agency says physicians should continue to use it because otherwise there wouldn't be enough devices available to meet patient needs. From MedPage Today.
Although one of the duodenal endoscopes implicated in recent "superbug" infections was never cleared by the FDA, the agency said Wednesday that physicians should continue to use it because otherwise there wouldn't be enough devices available to meet patient needs.
Also, the FDA pointed out that infections have occurred with other duodenoscopes that had been approved, reiterating that the designs of all these devices made them hard to disinfect thoroughly after use.
The problem came to the fore 2 weeks ago, when two deaths and several other infections at a UCLA hospital were attributed to duodenoscopes contaminated with carbapenem-resistant Enterobacteriaceae (CRE) bacteria. Afterward, the FDA acknowledged that it had received 135 reports of such infections in conjunction with duodenoscopic exams since January 2013 but hadn't taken action.
Since then, "FDA has received inquiries from healthcare providers about whether they should cancel ERCP [endoscopic retrograde cholangiopancreatography] procedures, based on the fact that one specific model duodenoscope manufactured by Olympus (the TJF-Q180V) does not currently have a 510(k) clearance," the agency said in an update posted Wednesday.
"FDA is not recommending that healthcare providers cancel ERCP procedures for their patients who need them," it said. "[W]e believe that that removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the U.S. of approximately 500,000 procedures per year."
Also, the FDA said, "the reported duodenoscope-associated infections have occurred in patients who have had procedures with duodenoscopes from all three manufacturers."
Olympus has applied for 510(k) clearance for the TJF-Q180V device, which the FDA is now reviewing, the agency said.
It said it planned no action against Olympus, although marketing a medical device without approval or clearance is a clear violation of FDA regulations.
For providers planning to perform ERCP procedures, the agency issued the following recommendations:
Thoroughly clean and disinfect duodenoscopes, pursuant to the manufacturers' instructions
Have a comprehensive quality program in place for reprocessing duodenoscopes
If you suspect that a duodenoscope may be associated with a patient infection, take it out of service and meticulously clean and disinfect it until it is verified to be free of pathogens
Inform patients of the benefits and risks associated with ERCP procedures, including the risk of possible infection
Discuss with your patients what they should expect following the ERCP procedure and what symptoms (such as fever or chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools) should prompt additional follow-up
Any infections that could be related to such procedures should be reported to the FDA via its MedWatch program.
As the nation awaits a Supreme Court ruling on Obamacare, lawmakers in many states are moving ahead with a range of Affordable Care Act bills, some of which seek to bolster the law and others that are bent on derailing it. The Supreme Court case, King v. Burwell, focuses on subsidies paid to millions of Americans who bought health insurance through exchanges set up under the Affordable Care Act. At issue: whether subsidies issued through exchanges operated by the federal government are legal. By the end of June, the justices are expected to issue a ruling, which could either uphold the law as it now operates or strike down those subsidies for good.
Whether Obamacare survives its latest trip to the Supreme Court surprisingly could come down to a question of the federal government's power over the states. After nearly 90 minutes of oral arguments Wednesday, there's generally agreement the expected ruling in the case -- questioning the legality of subsidies for millions buying health insurance through 34 federal-run exchanges -- is too close to call. Chief Justice John Roberts, the pivotal swing vote upholding the Affordable Care Act three years ago, gave away nothing that would show which way he's leaning. Justice Anthony Kennedy, who voted to strike down the entire law last time, asked tough enough questions of both the plaintiffs and the federal government that indicated his vote could be in play.
Management of HealthCare.gov isn't perfect, but it's far better off than it was a year-and-half ago. Much of a new report from the Government Accountability Officere hashed all the problems that caused the initial rollout of HealthCare.gov to be a mess. But it also pointed to the current state of the website as much improved. How so? In the immediate aftermath of the debacle, the Centers for Medicare and Medicaid Services doubled the number of servers for systems supporting HealthCare.gov, added virtual machines for the Enterprise Identity Management and Federally-Facilitated Marketplace, and replaced a virtual database with a high-capacity physical database, the GAO reported.
California lawmakers say they don't just want to reverse the 10 percent reimbursement cuts to doctors under Medi-Cal. Two identical bills, SB243 and AB366, would make some Medi-Cal payments equal to compensation under the federal Medicare program. In some cases, that would increase payments to as much as three times the current Medi-Cal rate for a typical doctor visit. "It's not just because we want to drive a Mercedes. I drive a Kia, a second-hand one," says Dr. Luther Cobb, President of the California Medical Association, with a laugh. Cobb says California's Medicaid rates are among the lowest in the nation.