Tomorrow, the US House will vote on the "21st Century Cures Act" (HR 6). As the title suggests this bill deals with federal funding for medical research. H.R. 6 does contain some good provisions. For example, it streamlines the Food and Drug Administration approval process in order to get life-saving treatments to the market faster.
However, concerns have been raised about the bill's creation of a new National Institutes of Health "innovation fund." H.R. 6 authorizes spending approximately $8 billion over five years on this new fund. The funding is classified as "mandatory" which means it cannot be altered by Congressional appropriators. Since the innovation fund is classified as mandatory the spending is considered outside the sequester's spending caps.
Proponents of the bill point out that the spending is offset and the innovation fund "sunsets" after five years. The drafters of this act also point out that, since the innovation fund is largely offset from reductions in other mandatory spending, the savings from those reductions will end up dwarfing the among spent on the innovation fund.
However, even if the money is offset, the innovation fund is still extending government's role in medical research. Since goverment funding of medical research inevitably politicizes decisions on what will, and will not, be funded. It also introduces layers of bureaucracy into the research process. So expanding government's role in medical research may not be the best way to improve medical research.
There are also concerns about the precedent set by this bill. Congress should be using money saved form spending cuts to reduce the deficit, not to create new federal programs. It is also all well and good to sunset the fund, but does anyone really believe that Congress will not extend the fund? It is quite possible that the fund could end up increasing taxpayer spending by more than the offsets contained in HR 6.
In addition, CURE Act my further erode our medical privacy. Twila Brase, head of the Citizen's Council for Health Freedom, explains:
Consider H.R. 6, the “21st Century Cures Act” authored by Rep. Fred Upton (R-MI). The U.S. House Energy and Commerce Committee meets tomorrow to advance this bipartisan bill, which will: 1) hand over your private health data to millions of corporate and government outsiders for so-called “research”; and 2) prohibit electronic health records (EHR) from interfering with such research.
Your consent would not be required. As the bill says in the interoperability section: “health care providers do not need the consent of their patients to share personal health information of such patients with other covered entities, in compliance with the HIPAA privacy regulations…” (Subtitle A, Title III)....
The “Cures Act” would permit major new intrusions into private lives. As the American Hospital Association told Politico Pro, the bill “is too broadly encompassing in allowing access to patient data for undefined research purposes; this undermines the trusted relationship between providers and their patients.” Specifically, section 1124 reclassifies research in the following subsections:
The “Cures Act” also prohibits barriers to outsider access. Section 3001 mandates that electronic health record (EHR) companies, under threat of penalties, provide transfer of and access to “the entirety of a patient’s data form any and all health information technology for authorized use under applicable law.” As stated above, Section 1124 expands “authorized use” to unspecified “research.”
H.R. 6 also specifically includes the use of patient data for controversial “comparative effectiveness research” (CER) as established by Obamacare.A reporter from The Hill (Washington, D.C.) asked me yesterday about the dangers of allowing such broad access to private patient data. I included the following:
Read Twila's full analysis here.
Also read Twila'as 12 reason to oppose the 21 First Centrury Cures Act.
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PDFTags: Obamcare, medical privacy