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What to excpect in the Lame Duck: Cures and Creates?

Tuesday, October 18, 2016 13:07
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(Before It's News)

In addition to spending increases and the Obamacare bailout, another issue that may come up in the Lame Duck is the “Cures Act”. As I wrote when the Cures Act was passed in 2015, 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:
  • Defining Health Data Research as Part of Health Care Operations
  • Treating Disclosures of Protected Health Information for Research Similarly to Disclosures of Such Information for Public Health Purposes.
The details of your medical records will be available for any “research” related to public health (PH) or health care operations (HCO), including profiling, tracking, and analysis of patients and doctors. The federal definition of HCO is an astonishing 390 words long! And “public health” can be whatever the government says it is. HCO and PH could include experimentation at the bedside…without your consent. This is sometimes called Continuous Quality Improvement (CQI or QI). As the Hastings Center reports:
Federal agencies with responsibilities in this area have disagreed on where the interface between medical research and QI lies and how it should be handled. … The current state of uncertainty about what is ethically and legally required to safeguard participants in QI activities has already become a disincentive to engage in QI…
By reclassifying health data research, the “Cures Act” would make patient data available for undefined research purposes, including CQI, to more than 2.2 million entities plus government agencies.
This is a dramatic shift away from today’s protections for human subjects. Under today’s federal “HIPAA privacy rule,” researchers have specific de-identification requirements and limitations on access and use. However, HIPAA requires no patient consent for access or use under “health care operations” (HCO) or “public health activities.”
Only people living in states with true (anti-HIPAA) medical privacy laws would be protected – but those states are rare.

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:
  1. The end of the confidential patient-doctor relationship.
  2. Health care rationing as outsiders profile patients and doctors and use patient data to dictate treatment and conduct rationing-based research.
  3. Poor care as patients avoid the frank disclosures necessary for accurate and timely medical care.
  4. Inaccurate research findings as patients falsify data to protect themselves.
  5. Loss of public support for medical research and health care institutions as patients realize the research enterprise and the health care system do not respect their privacy rights, are interfering in treatment decisions, and are using their data for purpose they have no agreed to.

Read Twila’s full analysis here. Also read Twila’as 12 reason to oppose the 21 First Centrury Cures Act.

Rumors on Capitol Hill are that not only will Congress finish work on Cures Act in the lame duck, but it will make the bill worse by adding the “Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act) in order to pay for the CURES’s acts new spending. The CREATES Act (S. 3056) addresses what may be a legitimate problem with Food and Drug Administration (FDA) policies, but in a way that violates property rights. Under current law, the FDA can require generic drug manufacturers to perform risk evaluation and mitigation strategies (REMS), in cases where the agency determines that the additional safety measures are needed before the generic version can be marketed. In order to develop these REMS, the companies holding the patients on drugs must turn over samples of their products to the generic manufacturers. Concerns have been raised that some manufacturers are manipulating this requirement to make it difficult for generic drug manufactures to compete with their products by refusing to turn over samples of the drugs to their competitors. These concerns are highlighted by the Turing Pharmaceuticals manipulation of the regulatory process to obtain and maintain a monopoly or the drug Daraprim. The company was able to charge a 500% mark-up. Obviously, this system needs changing. The logical solution is to get the government out of their business of approving drugs and allowing free competition in pharmaceuticals. Instead of moving in the direction of more freedom, the CREATES Act imposes new mandates and government-imposed costs on the drug development process. Under CREATES a generic drug manufacturer has the power to sue a patent holder to force the holder to manufacture samples of their product for the use of their competitors. It also empowers courts to force companies to turn over safety protocols they have developed to their competitors. No matter what one’s views on the legitimacy of intellectual property, all libertarians should oppose giving any branch of government the power to force companies to turn over their product to their potential competitors. If government can force drug companies to share their products with their competitors, than why shouldn’t I be able to force Coke to turn over their formulas to me for “Norm’s Cola?” I have heard that some are proposing to fix this problem by changing the FDA’s rules. This is far from ideal. It is better than giving the federal courts new powers to violate property rights. The best solution is to get rid of the unconstitutional FDA and let all drug manufacturers compete in a free-market. Campaign for Liberty members who oppose further government spending, erosion of medial privacy, and “fixing” the problems with the FDA’s regulations of pharmaceuticals should call their Senators and Representatives to tell them to oppose the CURES Act and the CREATES Act. For more on how government regulations grants large pharmaceutical companies de facto monopoly powers that are responsible for the high prices of drugs like Daraprim, see here.    

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