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The Expansion of the Federal Health Care Bureaucracy Bill

Eric
With the conference report available on the web, here are the references to the health care provisions in the conference report of the 'stimulus' bill. I have not gone into great detail on the privacy provisions (which are, in large part, dedicated to a new aggressive federal watchdog/ punishment regime to enforce the privacy standards– that have not been developed yet).

Nor have I done a complete look at the COBRA and Medicaid expansion provisions.

But, make no mistake, this may be called a 'stimulus' bill— but it is really a massive expansion of the federal health care bureaucracy.

Of the 1434 pages, pages 806-1251are dedicated to the expansion of the federal health care bureaucracy.  (That is, not including the COBRA, Medicaid, etc. expansion that begins on page 1278)

There is absolutely no doubt that the authority and power vested in federal agencies is a HUGE step toward complete government-mandated and government-run health care.  Or, as I call it— welcome to 'healthcare-by-lobbyist".

Page 806 line 13            400,000,000 to NIH for comparative effectiveness research

page 807 line 4            400,000,000 to HHS for comparative effectiveness research

page 811 ONCHIT 3,000,000,000

page 826 line 8            establishes There is hereby established a Federal9 Coordinating Council for Comparative Clinical Effective10ness Research

page 900 health information technology (HITECH ACT)

page 909 federal electronic record goals

page 910 : ''(viii) Specific plans for ensuring that populations with unique needs, such as children, are appropriately addressed in the technology design, as appropriate, which may include technology that automates enrollment and retention for eligible individuals.

Page 911: HARMONIZATION.—The Secretary may recognize an entity or entities for the purpose of harmonizing or updating standards and implementation specifications in order to achieve uniform and consistent implementation of the standards and imple6mentation specifications.

Pages 914-15: ''(7) ASSISTANCE.—The National Coordinator may provide financial assistance to consumer advocacy groups and not-for-profit entities that work in the public interest for purposes of defraying the cost to such groups and entities to participate under, whether in whole or in part, the National Technology Transfer Act of 1995 (15 U.S.C. 272 note).

Page 915: The National Coordinator shall establish a governance mechanism for the nationwide health information network.

Page 920: the HIT Policy Committee may consider the following additional areas:''(i) The appropriate uses of a nationwide health information infrastructure, including for purposes of—''(I) the collection of quality data and public reporting;''(II) biosurveillance and public health;''(III) medical and clinical research; and''(IV) drug safety.''(ii) Self-service technologies that facilitate the use and exchange of patient information and reduce wait times.

… ''(x) Any other technology that the HIT Policy Committee finds to be among the technologies with the greatest potential to improve the quality and efficiency of healthcare.

Page 923: puts Unions firmly at table in HIT Policy Committee— providers only get 1 member (same as labor), also one member shall have expertise in improving the health of vulnerable populations;

Page 935: HHS Secretary has complete authority over the implementation and decision to implement all HIT standards

Page 938: ONCHIT director can impose federal fees on private providers for implementation: ''(c) AUTHORIZATION TO CHARGE A NOMINAL FEE.The National Coordinator may impose a nominal fee for the adoption by a health care provider of the health information technology system developed or approved under subsection (a) and (b). Such fee shall take into account the financial circumstances of smaller providers, low income providers, and providers located in rural or other medically underserved areas.

Page 942: ONCHIT can require private entities to have approved electronic medical records         SEC. 13112. APPLICATION TO PRIVATE ENTITIES.Each agency (as defined in such Executive Order issued on August 22, 2006, relating to promoting quality and efficient health care in Federal government adminis11tered or sponsored health care programs) shall require in contracts or agreements with health care providers, health plans, or health insurance issuers that as each provider,plan, or issuer implements, acquires, or upgrades health information technology systems, it shall utilize, where available, health information technology systems and products that meet standards and implementation specifications adopted under section 3004(b) of the Public Health Service Act, as added by section 13101

Page 952: Subtitle C—Incentives for the Use of Health Information Technology

Page 955: Provide $300,000,000 to support regional or sub-national efforts towards health information exchange

Page 955: ''SEC. 3012. HEALTH INFORMATION TECHNOLOGY IMPLEMENTATION ASSISTANCE

Page 955-56: To assist health care providers to adopt, implement, and effectively use certified EHR technology that allows for the electronic exchange and use of health information, the Secretary, acting through the Office of the National Coordinator, shall establish a health information technology extension program to provide health information technology assistance services to be carried out through the Department of Health and Human Services. The National Coordinator shall consult with other Federal agencies with demonstrated experience and expertise in information technology services, such as the National Institute of Standards and Technology, in developing and implementing this program.

Page 958-9: This section is first real area where regional 'nonprofits' are beginning to get control over health data and best practices…HEALTH INFORMATION TECHNOLOGY REGIONAL  EXTENSION CENTERS

FOR EXAMPLE: ''(F) integration of health information technology, including electronic health records, into the initial and ongoing training of health professionals and others in the healthcare industry that would be instrumental to improving the quality of healthcare through the smooth and accurate electronic use and exchange of health information.

PAGE 968: HHS SECRETARY USING FUNDS for state grants CAN: (large and bold mine)

The Secretary shall annually evaluate the activities conducted under this section and shall, in awarding grants under this section, implement the lessons learned from such evaluation in a manner so that awards made subsequent to each such evaluation are made in a manner that, in the determination of the Secretary, will lead towards the greatest improvement in quality of care, decrease in costs, and the most effective authorized and secure electronic exchange of health information.

Page 984: PRIVACY
 essence:

1. Notification if 'breach' suspected2. patients can restrict access except as in other laws allowed and for collection of data on care3. no private group can sell data, but government and its approved organizations get it for free4. enormous verbiage dedicated to penalties for breaches5. but the government can just recommend 'corrective actions' instead of penalties6.hhs secretary can require audits from covered entities

primary health section ends page 1051

Eric Novack,MD, practices orthopedic surgery full time in Arizona. In addition to being an avid patient advocate, he has written for THCB and other blogs, he has published opinion pieces in many newspapers, and has made appearances on a variety of TV and radio shows. Dr. Novack hosted his own radio show for 2 1/2 years in Phoenix, and was the founder and chairman of the recent Proposition 101 campaign to amend the Arizona Constitution to add protections to keep individuals, not bureaucrats and lobbyists, in charge of their health and health care.

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8 replies »

  1. Could they at least have run the name “Federal Coordinating Council for Comparative Effectiveness Research” by a professional acronym writer? FCCCER

  2. Eric. My immediate concern was with the “competitive effectiveness” and “Health IT” part of the stimulus package.
    Competitive effectiveness research is not something for patients to be afraid of. It can help doctors and patients, through research, studies and comparisons, understand which drugs, therapies and treatments work and which don’t.
    Comparative effectiveness research is not intended to mandate coverage, reimbursement, or other policies for any public or private payer. The funding shall be used to conduct or support research to evaluate and compare the clinical outcomes, effectiveness, risk, and benefits of medical treatments and services that address a particular medical condition.
    There is nothing in the competitive effectiveness research provision that says what treatments, tests and therpies you can and cannot have, or what your doctor can prescribe for you. You will not be, and cannot be, denied end-of-life care or medicines.
    Government will not be in the examination room and will not be designing your treatment according to a government health care menu. You and your doctor decide what’s best.
    Health IT does not give the government access to your medical records. They remain confidential between you and your doctor. The government cannot monitor your care and then penalize you or your doctor for unapproved treatments.
    The funding for health information technology in the recovery package is projected to create over 200,000 jobs and a down-payment on broader health care reform. Converting an antiquated paper system to a computer system by making the health care system more efficient.
    The Congressional Budget Office has estimated that one-third of $2 trillion spent annually on health care in America may be unnecessary due to inefficiencies in the old system such as exessive paperwork. Investing in infrastructure like Health IT would help improve the quality of America’s health care.
    Currently, fewer than 25% of hospitals and fewer than 20% of doctor’s offices employ health information technology systems. Researchers have found that implementing Health IT would result in a mean annual savings of $40 billion over a 15-year period by improving health outcomes through care management, increasing efficiency and reducing medical errors.
    Investing in Health IT would also help primary care physicians who often bear the brunt of tech implementation without seeing immediate benefits, affording the infrastructure for expanison. Some PCPs are ahead of the IT curve but cannot afford the richness of its expansion. They need this important infrastructure.

  3. Peter- no, all we should ask of both parties is that adequate time (more than the 48hr rule the House just disregarded) is available before a vote on ANY bill.
    My fear is that a bill mandating that would not pass in either house of Congress due to overwhelming opposition from both parties…
    Someone once told me that “2 wrongs don’t make a right”… and I thought this was the ‘most ethical Congress ever”?

  4. “welcome to ‘healthcare-by-lobbyist”.
    If what you say is true then it’s business as usual.
    “(a) legislators must read the full bill (b) legislators read almost none of a bill’s language…”
    If you want them to do that then you’ll have to find a way for them to afford to stop dialing for dollars in readiness for the next election. Maybe this time legislators/staff wrote the bill, whereas before the Bush administration had the lobbyists write the bills.
    http://www.citizen.org/pressroom/release.cfm?ID=1733

  5. Greg-
    Have you read the bill?
    I have great respect for your opinions, but if you have not read the 250+ pages dedicated to expanding the federal health care bureaucracy’s power, your commentary rings hollow.
    I agree– political expediency is the order of the day for treatment guidelines, etc.
    “objective” data is and would be great— but that should take 1 page, not 250.
    If the bill simply said— $400,000,000 to NIH/CDC/FDA ‘earmarked’ for clinical trials to compare treatment approaches for diseases a,b,c,d— that would be one thing. But the bill DOES NOT say that at all.
    Unlike nearly all of the elected officials voting today (of both parties)— read the bill.
    Unless we need a study to demonstrate whether effective legislation is more likely to get passed if (a) legislators must read the full bill (b) legislators read almost none of a bill’s language…

  6. I have great respect for the members of the NeHC board. This is a quality group of representatives. Several I know personally, and I have had an opportunity to recognize and appreciate their areas of expertise.
    I thus have had opportunities to recognize that, for the most part, most of their hearts are in the right place, and they honestly seek to serve the common good. However, I am not aware that any of them have any significant first-hand experience working within small and independent medical practices. Small and independent practices deliver no less than 70% of current, direct patient care. Several of them think they have a grasp, but I can state with assurance that this has not proven to be accurate on many occasions. I have witnessed members of this group support policy decisions that made perfect sense to them, but were all but totally impractical in the trenches. I can promise this largely well-intended group will significantly err unless there is a stronger feedback mechanism involving the grassroots. My concern is thus related to my lack of evidence this group can adequately recognize the realities of their limitations. Paradoxically, their limitations are largely a product of their great expertise.
    Intent is meaningless unless there is a realistic capability to deliver.

  7. It can be a real challenge for people who are busy practicing medicine full time to stay abreast of the industry, this article seems to imply a real lack of knowledge about the intent of the legislation, the role of the ONC and the new National eHealth Collaborative (the public private non-profit that was stood up under the last administration to advise the ONC and HHS).
    One simple example. Page 938 Nominal Fee to implement an EMR is if a provider elects to use a national application like Vista. This is versus the typical cost of $50,000 for a private vendor application. In the past most high tech firms have discovered that if you simply give software or hardware away it isn’t used but everyone wants it.
    Charging a small fee seems rational to me.
    Other requirements that they have an approved system is meant to ensure that people aren’t all off building their own proprietary system and then showing up with their hand out to be reimbursed for it.
    I don’t think that when we built the Highway system in the country that people were worried that the Government was going to control the flow of travel.
    The ONC was established under the Bush administration, is headed up by a provider and the new advisory board (NeHC) has at least 8 physicians on it including many who post on this blog regularly. http://www.nationalehealth.org/ShowContent.aspx?id=86
    The chair of the board Dr John Tooker is the the CEO of the American College of Physicians, Matin Harris, MD is the Chairman of the Cleveland Clinic, Paul Tang, MD is the VP of the Palo Alto Medical Foundation, Simon Kohn is a VP at Kasier, Johnathan Perl, MD is the President of the Hospital Corp of America and on and on .
    The reason that ONC will provide funding to consumer groups is because they rarely have a line item in their budget that allows them to travel to DC or elsewhere for meetings and yet all of the drug companies have the ability to do this so it is an attempt to level the playing field for consumer groups not take over health care.
    This bill in fact has blocked the power of many lobbying groups (ie it isn’t a vendor dominated organization) and is only one small part of the total amount of money that needs to be implemented in health IT. The private sector has been catering to their clients (hospitals) and both providers and consumers have been left out of this process up until now.

  8. The Wall Street Journal reported how the drug makers put together a coalition, the Partnership to Improve Patient Care, which includes the lobbying arms of the drug, device and biotechnology industries as well as patient-advocacy groups, most of which accept pharmaceutical industry donations, and medical-professional societies, to lobby Congress to give the “industry” a major say over how provisions in the stimulus bill that would spend money on research comparing medical treatments.
    The research funding would be doled out to the National Institutes of Health, the Agency for Healthcare Quality and Research and the Centers for Medicare and Medicaid Services to focus on producing the best unbiased science possible. Comparative research has the potential to tell us which drugs and treatments are safe, and which ones work. This is not information that the private sector will generate on its own, or that the “industry” wants to share. Companies want to control the data, how it is reviewed, evaluated, and whether the public and government find out about it and use it. Just about the way they are controlling data now.
    Merrill Goozner, of the Center for Science in the Public Interest, reminds us, do publicly traded companies have a seat on the governing board of the Securities and Exchange Commission? Should Boeing and Airbus be given the right to determine the scope of the National Transportation Safety Board’s inquiry into airplane crashes? It is simply bad governance to give “industry” a seat at the table when officials decide what comparative effectiveness studies will get done.
    Sometimes clinical practice guidelines are questioned on the basis of profit conflicts. Specialty medical societies work to insure their specialist members get reimbursement for common procedures/treatments, the drug industry works to produce evidence statements that promote use of their drugs, so some questions arise that do not seem comfortable that many trials are unobjective and balanced.
    The entire premise upon which these societies base their evidence-based guidelines may be biased towards maintaining flow of their life blood-industry funded clinical trial dollars. Could it be that they focus on guidelines to both justify and feed the proposition that because cancer patients are probably going to die, then the FDA, CMS and taxpayers are supposed to pay for any combination of these wanna-be cancer drugs for any type of terminal cancer?
    Evidence-based medicine has morphed into pharma-based medicine and HMO-based medicine. Evidence is based on data from medical journal articles, epidemiology and economics, which relies on randomized clinical trials, which doesn’t even require a medical education. Nonphysicians trained in social science, science or even public policy analysis, have judgement over medicine. Where doctors defined the “standard of care,” now payers and purchasers of medical services redefine the standards for appropriate medical care, encouraging doctors to act in ways to promote their financial interest when they make medical decisions.
    The use of clinical trials to establish prescribing guidelines for evidence-based medicine is highly criticized because such trials have little relevance for the “individual” patient in the real world, the individuality and uniqueness of each patient. Comparative research is not rationing health care.

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