Please keep in mind: These bills are complicated, vague and extremely lengthy (well over 2000 pages each). Both bills, HR 4872- The Reconciliation Act of 2010 and HR 3962- The Affordable Healthcare For America Act, have sections that deal with a National Medical Device Registry and implantable devices. Neither bill is technically a part of HR 3590, the bill known as "Obamacare". However, HR 4872 does contain the infamous Section 2521, seemingly 'cut & pasted' from the original bill known as "Obamacare", the unpassed HR 3200. To keep things as simple as possible, we will assume you have done your homework and printed out the following: HR 4872; Section 2521; Subtitle C-National Medical Device Registry-pg.1013 (www.housedocs.house.gov/rules/hr4872/111_hr4872_reported.pdf). The entire section must be read to make sense of it. Please take the time to do that before you continue. HR 3962, Section 2571, Section C begins on page 1501 and can be obtained by going to: www.housedocs.house.gov/rules/hr3962/111_hr3962_reported.pdf.
How did we come up with a "March 2013" implementation?
HR 4872, pg.1019; lines 4-12: "Effective date.- The Secretary of Health and Human Services shall establish and begin implementation of the registry under section 519(g) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph (1), by not later than the date that is 36 months after the date of the enactment of this Act, without regard to whether or not final regulations to establish and operate the registry have been promulgated by such date." Exact same wording is found on page 1508, beginning on line 17 in HR 3962.
- This bill was signed into law on 3/29/2010
- 36 months later = March 2013
For those of you unwilling to do the detective work required, this bill creates a National Medical Device Registry. The stated purpose of the Registry is to collect safety data on post-market medical devices: "a class III"; or "a class II device that is implantable, life supporting or life-sustaining" (HR 4872, pg.1014, lines 15-17; similar language is found in HR 3962, pg.1502, lines 16-17), and to put the safety data into a publicly accessible electronic database..."the term 'data' refers to information respecting a device described in paragraph (1), including claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of data from disparate data environments, electronic health records, and any other data deemed appropriate by the Secretary." (HR 4872, pg. 1017, line 3-9; HR 3962, pg. 1505, line 13-18).
The big question is: What exactly is "a class II device that is implantable, life supporting or life-sustaining? The innocuous definition is "pacemakers" and the like. If that's all they mean, then they will be tracking only devices and not patients. No problem. But the way these bills are written leaves another door open.
In 2004, the FDA approved "an implantable radiofrequency transponder system for patient identification and health information. A device intended to enable access to secure patient identification and corresponding health information. This system may include a passive implanted transponder, inserter, and scanner. The implanted transponder is used only to store a unique electronic identification code which is read by the scanner. The identification code is used to access patient identity and corresponding health information stored in a database." (www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance). The FDA goes on to say, "This guidance is issued in conjunction with a Federal Register notice announcing the classification (class II) of implantable radiofrequency transponder system for patient identification and health information."
Okay, back to the question of the day: Are the bills (HR 4872 & HR 3962) referring to pacemakers or RFID chips? There is a huge difference. One definition means they are collecting data about the device. The other means they are retrieving data accessible by the device. One is relatively harmless, while the other is an invasion of government into our private lives. We lay down our Christian (living-in-the-Last Days-bias) worldview with difficulty and do our best to read the bills as they are written. Verdict? You be the judge. Take the time to read them for yourselves. And then ask:
- Why remove the National Medical Device Registry from Obamacare when it came under scrutiny?
- Why not simply change the language of the bill (i.e. add words like: class II device NOT to include an implantable radiofrequency transponder for data collection)?
- Why did they feel it necessary to slip the Registry section into two separate bills and then pass them without fanfare, as is, despite the public's misgivings?
And while you're at it, read the February 2, 2012 post, "Power Grab Alert!" from our Archives for another example of a vague, but frightening bill.
Words to the Wise: "Behold, I send you out as sheep in the midst of wolves. Therefore, be wise as serpents and harmless as doves." (Matthew 10:16)
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