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This sort of device would be implanted in the majority of people who opt to become covered by the public health care option. . .With a name like CHIP it would seem consistent to have the chip implanted into a child.
Whoever wrote this is a liar and, frankly, (with that CHIP comment) an imbecile. There's no polite way to say it.
The section of the bill referenced here is dedicated to creating a National Medical Device Registry. What is the
purpose of this registry?
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The registry would list devices by type, model and serial number or other unique identifier. It is intended to help HHS assess the post-market safety and effectiveness of all class III devices, and all class II devices that are implantable, life-supporting or life-sustaining, according to the bill.
The registry, to be established by HHS, would link data provided by manufacturers to FDA with outcomes data from multiple sources.
The outcomes data would be drawn from Medicare claims data, patient survey data, electronic health records, and standardized analytic files maintained by CMS and the Department of Veterans Affairs. It could also come from private databases, such as pharmaceutical purchase and insurance claims data.
The registry data and analyses would be made available to the public without revealing private patient data or proprietary information, the bill states.
The bill also authorizes HHS to require device makers to submit "such other information as is necessary to facilitate post-market assessments of device safety and effectiveness and notification of device risks."
It might help to understand what Class II and Class III devices
actually are. The FDA gives these designations to show where exactly in the regulatory scheme a device lies.
(1) Class I means the class of devices that are subject to only the
general controls authorized by or under sections 501 . . . A device is in class I if (i) general
controls are sufficient to provide reasonable assurance of the safety
and effectiveness of the device . . .
(2) Class II means the class of devices that is or eventually will
be subject to special controls. A device is in class II if general
controls alone are insufficient to provide reasonable assurance of its
safety and effectiveness and there is sufficient information to
establish special controls . . .
(3) Class III means the class of devices for which premarket
approval is or will be required in accordance with section 515 of the
act. A device is in class III if insufficient information exists to
determine that general controls are sufficient to provide reasonable
assurance of its safety and effectiveness . . .
(d) Implant means a device that is placed into a surgically or
naturally formed cavity of the human body. A device is regarded as an
implant for the purpose of this part only if it is intended to remain
implanted continuously for a period of 30 days or more, unless the
Commissioner determines otherwise in order to protect human health.
(e) Life-supporting or life-sustaining device means a device that is
essential to, or that yields information that is essential to, the
restoration or continuation of a bodily function important to the
continuation of human life.
I've bolded the parts of the definition that explain why HHS would want to evaluate the post-market safety and effectiveness of certain Class II and all Class III devices.
H.R. 3200
does not say anywhere that anyone (in the public option or not) has to get some sort of implant. It merely says that medical devices have to be registered. That's a pretty enormous difference.
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So will everyone be covered by the public option eventually??????
No. The point of the public option is encourage private insurers to lower or at least control their "outrageous rates." They will do so to remain competitive and so they will still retain a good share of the market. The Congressional Budget Office estimates that in a few years about 11-12 million people will be in the public option. Everyone else will either be obtaining private insurance in the individual insurance markets or they will be getting it through their employer.
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And does that mean everyone will be chipped?????
Of course it doesn't. Here's a tip to assist you in thinking critically: if someone makes a claim about a bill and quotes part of the text of the bill
and the quoted bit
doesn't support their claim, they're probably lying. Nowhere does the bill suggest anyone has to be chipped.
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Finnaly some people are reading the Health care bill. It's bad.
It really isn't. People are just going crazy attempting to distort what's in the bill (see: this thread). If you want to know what's really in there, check the links in
this thread.
Edited by Startraveler, 31 August 2009 - 05:40 PM.