[Congressional Record (Bound Edition), Volume 157 (2011), Part 4]
[SEN]
[Pages 4476-4477]
[From the U.S. Government Publishing Office, www.gpo.gov]




                               OBAMACARE

  Mr. KYL. Mr. President, last Wednesday marked the 1-year anniversary 
of the deeply flawed health care bill. The

[[Page 4477]]

worst aspect of that bill is that it will lead to health care rationing 
by the Federal Government. That is the delay and denial of care in 
order to control costs. The words ``ration,'' ``withhold coverage'' and 
``delay access to care'' of course are not found anywhere in the bill. 
But new Federal rules that aim to reduce health care costs will 
inevitably result in delayed or denied tests, treatments, and 
procedures deemed too expensive and in less innovation in the 
development of drugs, devices, and treatments. Many of the decisions 
will be based on information provided by a new entity called the 
Patient-Centered Outcomes Research Institute, sometimes referred to as 
the PCORI. That will conduct comparative effectiveness research.
  Comparative effectiveness research weighs the effectiveness of two or 
more health care services or treatments. The goal is to provide 
patients and doctors with better information regarding the risks and 
benefits of, for example, a drug versus a surgery for a particular 
situation. The problem is not with the merits of the research but 
whether the research should be used by the government to determine 
treatments and services covered by one's insurance. The health care law 
actually empowers the Secretary of Health and Human Services to do just 
that, to use this comparative effectiveness research when making 
coverage determinations.
  Section 6301 of ObamaCare states:

       The Secretary may [. . .] use evidence and findings from 
     research conducted [. . .] by the Patient-Centered Outcomes 
     Research Institute.

  That means the government, not patients and doctors, has the power to 
make health care decisions that affect you. A bureaucrat decides if 
your health care is an effective use of government resources without 
regard to the patient's individual needs and medical history. The end 
result is the government inevitably interferes with access to care. 
That is rationing, and it is wrong.
  While ObamaCare includes limited safeguards for how this research may 
be used--appreciating the dangers involved--there is nothing that 
prohibits the government from taking it into account when, for example, 
making Medicare coverage decisions.
  In fact, when asked whether the Federal CER agency should be involved 
in cost determinations, Donald Berwick, the President's recess-
appointed head of the Centers for Medicare and Medicaid, responded:

       The social budget is limited.

  Ask citizens in Britain how well the system is working in their 
country. Britain's National Institute for Health and Clinical 
Excellence--called NICE--routinely uses comparative effectiveness 
research to make cost-benefit calculations.
  Last year, NICE rejected a cutting-edge drug, Avastin, used to treat 
bowel cancer because it said the drug's limited effectiveness for 
extending life--they said 6 weeks; but up to 5 months according to the 
chief executive of the organization, Beating Bowel Cancer--they said it 
did not justify the cost. As Mike Hobday, head of policy at the 
charity, Macmillan Cancer Support, told Britain's Daily Telegraph:

       We think this is devastating news for cancer patients with 
     metastic colorectal cancer, especially as this drug could 
     have a significant impact on peoples' quality of life. 
     Although a few extra weeks or months might not sound much to 
     some people it can mean an awful lot to a family affected by 
     cancer.

  Likewise, in August 2008, NICE recommended against coverage of four 
expensive drugs for advanced kidney cancer. NICE considered the drugs 
clinically beneficial in specific situations but concluded they ``were 
not cost-effective within their licensed indications.''
  Health care in Britain is also routinely delayed. Several years ago, 
the country's National Health Service launched an ``End Waiting, Change 
Lives'' campaign--``End Waiting, Change Lives.'' The campaign's goal 
was to reduce a patient's wait time to 18 weeks from referral to 
treatment. That is 4\1/2\ months, and that is an improvement.
  Government-run health care systems that ration care are the reason 
many Europeans and Canadians come to the United States each year to get 
treatments denied to them in their own countries.
  Access to the highest quality care and the sacred doctor-patient 
relationship are the cornerstones of U.S. health care--the very things 
Americans value most and that the health care law jeopardizes.
  So I will join Senators Coburn, Barrasso, Roberts, and Crapo in 
introducing the Preserving Access to Targeted, Individualized, and 
Effective New Treatments and Services Act of 2011. That is also known 
as the PATIENTS Act.
  The PATIENTS Act does not prohibit comparative effectiveness 
research; rather, it is a propatient firewall that protects patients' 
access to high-quality care by prohibiting the Federal Government from 
using comparative effectiveness research to delay or deny care.
  Additionally, the bill would require comparative effectiveness 
research to account for differences in the treatment response and 
preferences of patients, genomics and personalized medicine and the 
unique needs of health disparity populations and it would clarify that 
nothing shall be construed as affecting the FDA Commissioner's 
authority to respond to drug safety concerns.
  All Americans deserve personalized treatment and should be able to 
get the care they and their doctors decide is best for them. No 
Washington bureaucrat should interfere with that right by substituting 
the government's judgment for that of a physician.
  The administration has repeatedly promised that the health care law 
will not result in rationing. Well, if that promise is true, they 
should have no problem supporting the PATIENTS Act.
  I urge my colleagues to join us in cosponsoring this important 
legislation.
  I suggest the absence of a quorum.
  The ACTING PRESIDENT pro tempore. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Ms. LANDRIEU. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.

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