Antitrust Criminal Penalties Enforcement and Reform Act of 2004 Extension Act

Mr. President, today I join my good friend and colleague, Senator Baucus, in introducing the Patient-Centered Outcomes Research Act of 2009. This proposal builds on the legislation we introduced during the last Congress. Our legislation is the product of months of careful deliberations regarding the best way to expand the quality and quantity of evidence available to patients, physicians, and other health care decision-makers about the comparative clinical effectiveness of health care services and treatments. We have met with dozens of key stakeholders and thought leaders to discuss various aspects of this legislation. People have come to us with many constructive suggestions, many of which are reflected in the bill that we are introducing today. I am proud of the result. This legislation lays the groundwork for improving health care quality and patient outcomes, enhancing patient safety, and reducing overall health care costs in the long run.

As Chairman of the Senate Budget Committee, I am acutely aware of the long-term budget challenges facing our Nation. Health care spending is growing at an unsustainable rate. Although demographic changes associated with the retirement of the baby boom generation contribute to this spending growth, the most significant factor is growth in health care costs in excess of per capita GDP growth. According to Congressional Budget Office projections, by 2050, Medicare and Medicaid spending alone will consume 12 percent of our Nation's gross domestic product.

But excess growth in per capita health care costs is not just a challenge for Federal health spending and the Federal budget. If we continue on the current trajectory, the private sector will also be overwhelmed by rising health care costs. In fact, total health care spending is projected to grow from about 17.6 percent of GDP in 2009-- which is far higher than in other industrialized countries--to more than 37 percent of GDP in 2050.

Clearly, we need to address the underlying causes of rising health care costs, not just in the Medicare and Medicaid programs, but in the overall health care system. Simply cutting Medicare and Medicaid without making other changes will do little to solve the larger problem we face. Skyrocketing health care costs are hurting families, businesses, and State and Federal budgets. In a speech before the

Business Roundtable on March 12th, President Obama emphasized this point: ``Medicare costs are consuming our Federal budget. Medicaid is overwhelming our State budgets. At the fiscal summit we held in the White House a few weeks ago, the one thing on which everyone agreed was that the greatest threat to America's fiscal health is not the investments we've made to rescue our economy. It is the skyrocketing cost of our health care system.''

Health care reform is about achieving three important goals: choice, quality, and affordability. To achieve these three goals, we must confront the fact that our health care system does not deliver care as effectively or efficiently as it should. There is widespread agreement that Americans are not getting good value for the money we are already spending on health care. According to work by the Dartmouth Atlas Project, nearly 30 percent of total spending in our health care system, or $700 billion per year, is wasteful and does nothing to improve health outcomes.

Despite our high level of health care spending, health outcomes in the United States are no better than health outcomes in the other OECD countries. Indeed, the U.S. spends twice as much as other OECD nations on health care, yet Americans have shorter average life expectancies and higher average mortality rates than residents of other OECD countries. OECD data show that the U.S. has one of the highest rates of medical errors among industrialized nations and that U.S. patients are more likely to receive duplicate tests and more likely to visit an emergency room for a condition that could have been treated in a regular office visit than most other nations in the comparison. Similarly, a 2008 Commonwealth Fund report found that the U.S. is last among 19 industrialized nations in preventable mortality, or deaths that could have been prevented if individuals had access to timely and effective care.

We can and must find ways to deliver health care more efficiently, reduce ineffective or unnecessary care, and get better health outcomes without harming patients.

One solution is to generate better information about the relative clinical effectiveness of alternative health strategies--and encourage patients and providers to use that information to make better choices about their health. Many health care services and treatments are absorbed quickly into routine medical care--yet there is little evidence that these services and treatments are any more clinically effective than existing treatments and services. Generating more comparative clinical effectiveness research is one of the keys to transforming our health care system away from a system based on volume toward a system that focuses on evidence-based medicine and improving patient outcomes.

The Federal Government currently funds some comparative effectiveness research through the Agency for Healthcare Research and Quality, AHRQ, the National Institutes of Health, NIH, and the Veterans Health Administration. For example, the Effective Health Care Program at AHRQ has been a successful initiative. But comparative effectiveness research is not the primary focus of any Federal agency--nor is this Federal funding occurring permanently on a large scale.

Provisions included in the American Recovery and Reinvestment Act, ARRA, temporarily expanded existing Federal efforts by providing $1.1 billion to AHRQ, NIH, and the Secretary of Health and Human Services, HHS, for such research through 2010. Important work is currently underway to develop recommendations for how best to utilize some of these resources. In particular, I would like to commend the work being done by the Institutes of Medicine, IOM, to convene a panel of experts that is tasked with making recommendations on how to spend the $400 million provided to the HHS Secretary through ARRA. The IOM panel has been doing extraordinary work in gathering ideas and input from a very broad group of stakeholders under a very tight timeline. I look forward to seeing the results of its work at the end of the month. It is this model of allowing for input from a broad set of stakeholders and of conducting priority-setting activities in a transparent way that we are hoping to advance in the legislation we are introducing today.

The Congressional Budget Office, CBO, the Medicare Payment Advisory Commission, MedPAC, and the IOM have all discussed the positive impact of creating a new entity charged solely with conducting research on the comparative effectiveness of health interventions, including pharmaceuticals, medical devices, medical procedures, diagnostic tools, medical services and other therapies.

In its June 2007 report to Congress, MedPAC issued a unanimous recommendation that ``Congress should charge an independent entity to sponsor credible research on comparative effectiveness of health care services and disseminate this information to patients, providers, and public and private payers.''

And the Congressional Budget Office agrees. In a report, entitled, ``Research on the Comparative Effectiveness of Medical Treatments: Issues and Options for an Expanded Federal Role,'' former CBO Director Peter Orszag wrote that, ``generating better information about the costs and benefits of different treatment options--through research on the comparative effectiveness of those options--could help reduce health care spending without adversely affecting health overall.''

The IOM also supports getting better information into the hands of patients and providers. As part of its report, ``Learning What Works Best: The Nation's Need for Evidence on Comparative Effectiveness in Health Care,'' the Institute concluded that, ``[a] substantially increased capacity to conduct and evaluate research on clinical effectiveness of interventions brings many potential opportunities for improvement across a wide spectrum of healthcare needs.''

This bill that Senator Baucus and I are introducing today represents an important step in creating a long-term vision for expanding comparative clinical effectiveness research. The bill would significantly expand the conduct of comparative clinical effectiveness research to get better information into the hands of patients and providers in the hopes of improving health outcomes and reducing unnecessary or ineffective care.

The purpose of this bill is to provide patients and physicians with objective and credible evidence about which health care treatments and services are most clinically effective for particular patient populations. The research conducted under our bill would evaluate and compare the clinical effectiveness of two or more health care interventions, protocols for treatment, care management, and delivery, procedures, medical devices, diagnostic tools, and pharmaceutical, including biologicals

Access to better evidence about what works best will help patients and health care providers make better-informed decisions about how best to treat particular diseases and conditions. Our hope is that the evidence generated by this research could lead to savings in the overall health care system over the long-term by empowering patients and doctors with information about treatments and services that may be clinically ineffective, while at the same time improving health care outcomes and quality.

Specifically, our bill creates a private, nonprofit corporation, known as the Patient-Centered Outcomes Research Institute, which would be responsible setting national research priorities and carrying out a comparative clinical effectiveness research agenda. In conducting the research, the Institute would contract with AHRQ, the VA, and other appropriate public and private entities and could use a variety of research methods, including clinical trials, observational studies and systematic reviews of existing evidence.

Many leading experts on this issue, such as MedPAC, have concerns that a large entity within the Federal government would be vulnerable to political interference that could hamper the Institute's credibility, and, therefore, limit the usefulness of its research. As a result, we chose a model outside of the Federal government, but subject to government oversight.

In order to ensure that the information developed is credible and unbiased, our bill establishes a 21-Member Board of Governors to oversee the Institute's activities. Permanent board members would include the HHS Secretary and

the Directors of AHRQ and NIH. The remaining 18 board members would be appointed by the Comptroller General of the U.S. and would include a balanced mix of patients, physicians, public and private payers, academic researchers, philanthropic organizations, quality improvement entities, and medical technology manufacturers.

To ensure further credibility, the Institute is also required to appoint expert advisory panels of patients, clinicians, researchers and other stakeholders that would assist in the development and carrying out of the research agenda; establish a methodology committee that would help create methodological standards by which all research commissioned by the Institute must be conducted; create a peer review process through which all primary research findings must be assessed; and develop protocols to help translate and disseminate the evidence in the most effective, user-friendly way.

Moreover, Senator Baucus and I want to ensure that the operations of the Institute are transparent and focused on the needs of patients. Therefore, we built in a strong role for public comment prior to all key decisions made by the Institute. For example, the bill requires public comment periods prior to the approval of research priorities and individual study designs. In addition, the bill calls for public forums to seek input, requires that all proceedings of the Institute be made public at least seven days in advance and be made available through annual reports, and requires that any conflicts of interest be made public and that board members recuse themselves from matters in which they have a financial or personal interest.

Because all health care users will benefit from this research, our legislation funds the Institute with contributions from both public and private payers. These contributions will include mandatory general revenues from the Federal Government, amounts from the Medicare Trust Funds equal to $2 per beneficiary annually, and amounts from a $2 fee per-covered life assessed annually on insured and self-insured health plans. Funding will ramp up over a series of years. By the 5th year, we expect the Institute's total annual funding to reach nearly $600 million per year and continue to grow thereafter.

The concept of an all-payer approach for comparative effectiveness research has been embraced by a number of health care experts. For example, on the subject of comparative effectiveness information in its June 2008 report, MedPAC stated: ``The Commission supports funding from federal and private sources as the research findings will benefit all users--patients, providers, private health plans, and federal health programs. The Commission also supports a dedicated funding mechanism to help ensure the entity's independence and stability. Dedicated broadly based financing would reduce the likelihood of outside influence and would best ensure the entity's stability . . .''

To ensure accountability for these funds and to the Institute's mission, our bill requires an annual financial audit of the Institute. In addition, the bill requires GAO to report to Congress every five years on the processes developed by the Institute and its overall effectiveness, including how the research findings are used by health care consumers and what impact the research is having on the health economy. Finally, the bill requires a review of the adequacy of the Institute's funding, which will include a review of the appropriateness and adequacy of each funding source.

Let me take a moment to address some of the criticisms that might be levied against this proposal. Some may say this Institute will impede access to care and will deny coverage for high-cost health care services. That is simply not the case. Our proposal explicitly prohibits the Institute from making coverage decisions or setting practice guidelines. It will be up to medical societies and patient groups to use the research findings as they see fit. Moreover, to the extent that high-cost health care services or new technologies are studied by the Institute and found to be clinically ineffective compared to other services and technologies, such evidence will be made public to consumers and providers so that they can make informed choices.

We have been working with colleagues on the other side of the aisle who have concerns about the impact this research could have on patient safety and access to health care treatments and services. For several months, we have been engaged in an active dialogue to address these concerns. While I am disappointed that those discussions did not result in co-sponsorships for this legislation at this time, I look forward to continuing that dialogue in a constructive manner as we work to include a long-term vision for comparative effectiveness research in a comprehensive health reform bill.

In the meantime, we have made a number of meaningful changes to our legislation that address the concerns voiced by our colleagues. For example, we have placed a greater focus on aspects of personalized medicine and included new patient safeguards to ensure that when CMS uses this research it does so through a process that is transparent, allows for public comment, and takes into account the benefits to particular subpopulations.

This bill is a balanced, carefully crafted proposal that has taken into consideration the recommendations of a broad range of stakeholders and thought-leaders. We welcome further discussion and suggested improvements. But we refuse to allow this proposal to get bogged down in political maneuvering or scare tactics. Our nation needs to immediately ramp up and sustain a major comparative clinical effectiveness research initiative to improve health outcomes and reduce ineffective and inefficient care.

Senator Baucus and I will work jointly to push for the expeditious enactment of this bill as part of a comprehensive health reform bill. I urge all of my colleagues to join our effort and cosponsor the Patient- Centered Outcomes Research Act of 2009. There is no time to waste.

Mr. President, I rise today to introduce the Fracturing Responsibility and Awareness of Chemicals, FRAC, Act along with my colleague, Senator Schumer, that protects drinking water and public health from the risks associated with an oil and gas extraction process called hydraulic fracturing. Specifically, our bill does two things. First, it repeals an exemption to the Safe Drinking Water Act that was granted to oil and gas companies four years ago. Second, it requires oil and gas companies to publicly disclose the chemicals used in hydraulic fracturing.

The regulation of hydraulic fracturing under the Safe Drinking Water Act is supported by 77 groups, including 14 groups from Pennsylvania.

The oil and gas industry uses hydraulic fracturing in 90 percent of wells. The process, which is also called ``fracking,'' involves injecting tens of thousands of gallons of water mixed with sand and chemical additives deep into the rock under extremely high pressure. The pressure breaks open the rock releasing trapped natural gas, which is then captured. Fracking often occurs near underground sources of drinking water. Unfortunately, a provision included in the 2005 Energy Policy Act exempted hydraulic fracturing from compliance with the Safe Drinking Water Act. The oil and gas industry is the only industry to have this exemption.

The Casey-Schumer legislation is extremely important to people living in Pennsylvania, especially those living in communities along a geological formation called the Marcellus Shale. The Marcellus is a geological formation covering 34 million acres extending from southern New York, through central and western Pennsylvania, into the eastern half of Ohio and across most of West Virginia. The deepest layer of the Marcellus formation--the Marcellus Shale--contains a significant amount of natural gas trapped in deep rock formations up to 9,000 feet below ground. Last year, a professor at Penn State estimated that there was 168 million cubic feet of natural gas in the Marcellus Shale. In the industry it is what is known as a ``Super Giant gas field.'' It is enough natural gas to provide for the entire country for 7 years. This vast amount of natural gas combined with a more complete knowledge of the natural fractures in the Marcellus Shale through which the gas can be easily extracted, has led to what Pennsylvanians are calling a gas rush.

As I have mentioned, fracking involves injecting water mixed with chemicals. My major concern is that the chemicals added to the water to create fracking fluids are highly toxic. We're talking about chemicals like formaldehyde, benzene, and toluene. These chemicals are injected right below underground drinking water. This is especially important to Pennsylvania because our state has the second highest number of private wells for drinking water in the nation, second only to Michigan. Three million Pennsylvanians are dependent on private wells to provide safe drinking water to their homes. So massive drilling to get to the natural gas in the Marcellus Shale is not required to comply with the Safe Drinking Water Act, but drilling is happening right next to drinking water supplies. You can see why Pennsylvanians are concerned about their future access to safe drinking water.

Now, the oil and gas industry would have you believe that there is no threat to drinking water from hydraulic fracturing. But the fact is we are already seeing cases in Pennsylvania, Colorado, Virginia, West Virginia, Alabama, Wyoming, Ohio, Arkansas, Utah, Texas, and New Mexico where residents have become ill or groundwater has become contaminated after hydraulic fracturing operations began in the area. This is not simply anecdotal evidence; scientists have found enough evidence to raise concerns as well. In a recent letter supporting our bill, 23 health professionals and scientists wrote the following:

. . . Oil and gas operations are known to release

substances into the environment that are known to be very

hazardous to human health, including benzene, arsenic,

mercury, hydrogen sulfide, and radioactive materials. The

demonstrated health effects caused by these substances

include cancers, central nervous system damage, skin and eye

irritation, and lung diseases. For example, fluids used in

the hydraulic fracturing process may contain toxic chemicals

such as 2-butoxyethanol, formaldehyde, sodium hydroxide,

glycol ethers, and naphthalene. For these reasons, we support

regulation of hydraulic fracturing under the Safe Drinking

Water Act and the disclosure of all chemical constituents in

hydraulic fracturing fluids to public agencies, including the

disclosure of constituent formulas in cases of medical need.

Moreover, we support full regulation of stormwater runoff,

which can pollute drinking water supplies, under the Clean

Water Act.

There are growing reports of individuals living near oil

and gas operations who suffer illnesses that are linked to

these activities, yet there has been no systemic attempt to

gather the necessary data, establish appropriate monitoring,

analyze health exposure or assess risk related to any of

these activities. This should be done, in addition to full

Health Impact Assessments to inform future planning and

policy efforts.

In Dimock, Pennsylvania, we have a recent example of the risks involved with hydraulic fracturing. On New Year's Day, Norma Fiorentino's drinking water well exploded. It literally blew up. Stray methane leaked and migrated upward through the rock and into the aquifer as natural gas deposits were drilled nearby. An investigation by the Commonwealth of Pennsylvania shows that a spark created when the pump in the well house turned on may have led to the explosion. The blast cracked in half the several-thousand-pound concrete slab at the drilling pad on Ms. Fiorentino's property and tossed it aside. Fortunately, no one was hurt in the explosion. But throughout the town, several drinking water wells have exploded and nine wells have been found to contain so much natural gas that one homeowner was advised to open a window if he plans to take a bath. Tests of the well water show high amounts of aluminum and iron, which leads researchers to believe that drilling fluids are contaminating the water along with the gas. So this is a real concern. We are talking about serious implications if we don't develop the Marcellus Shale carefully and responsibly.

I would point out that Pennsylvania has a long history of developing our natural resources to power the region and the nation. In fact, Pennsylvania is home to the Drake Well near Titusville, Pennsylvania, which celebrates its 150th anniversary this year. The Drake Well was the first commercial oil well in the United States and it launched the modern petroleum industry. In addition to oil, Western Pennsylvania has long produced natural gas. Pennsylvania also mines coal which we use to provide electricity to many of our neighboring states. Pennsylvanians are proud of the contributions we have made to the growth of our nation. Contributions that were made because we developed our abundant natural resources. But we also bear the burden of some environmental legacies, most created in previous generations when we were not as concerned with responsible development. We have old natural gas wells that were not capped and leak methane into homes in Versailles, PA. We have acid mine drainage that we spend millions of dollars every year to try and remediate. These examples are the lessons from which we need to learn.

Pennsylvania will develop the natural gas in the Marcellus Shale. We are doing it right now, and we will see more drilling over the next few years. But we must develop the Marcellus Shale using the best environmental practices to protect our communities and our state. That is why I am introducing the Fracturing Responsibility and Awareness of Chemicals Act. This legislation will ensure that hydraulic fracturing does not unnecessarily jeopardize our groundwater. There are affordable alternatives that oil and gas companies can use so that they are not risking contaminating drinking water wells with potentially hazardous chemicals.

I think Norma Fiorentino from Dimock, Pennsylvania, summed it up best when she told a reporter, ``You can't buy a good well.''

So I urge all of my colleagues to support this legislation and ensure that our groundwater is protected as we responsibly develop our natural resources.

Mr. President, I have sought recognition today to introduce The Patient Access to Critical Lab Tests Act. The legislation would modernize Medicare billing rules to improve beneficiary access to important, life-saving advanced diagnostic technologies.

Mapping the human genome has enabled revolutionary advances in understanding a wide variety of diseases, and ushered in an era where treatments can be tailored to individual patients based on their DNA and specific molecular character of their disease. Complex diagnostic laboratory tests make such ``personalized medicine'' possible. By understanding the molecular nature of

disease, these new technologies increasingly allow clinicians and patients to pick individualized treatment options, rather than basing treatment choices on broad assessments of what works best for a population.

Unfortunately Medicare payment, coding and coverage practices are harming Medicare beneficiary access to specialized diagnostic tests. In particular is the Centers for Medicare and Medicaid Services, CMS, Medicare ``date of service'' regulation. Under the regulation, any test furnished within 14 days after the patient's discharge from a hospital is deemed to have been performed on the day of collection, when the patient was in or at the hospital, even though the patient may no longer be at the hospital when the test is ordered, and the test is not used to guide treatment during the patient's hospital encounter. A laboratory test that is deemed to coincide with the date on which the patient was a hospital patient becomes a service furnished by the hospital, even though the hospital may have nothing to do with the ordering, performance, or use of the test.

The combination of these rules creates a host of administrative and financial disincentives for hospitals to embrace these tests.

Hospitals are required to exercise professional responsibility over these services, but are unwilling to do so for tests that are not offered by the hospital, and which are, in fact, offered by laboratories that are otherwise unaffiliated with and unfamiliar to the hospital.

Hospitals are required to bill for the service; the laboratories may not bill Medicare directly, and instead must bill the hospital for the services they provide, which means the hospital assumes the financial risk that the service is covered and that Medicare will pay for it.

In light of these administrative and financial disincentives, hospitals are encouraging physicians to delay ordering the tests until after the 14 days; others are cancelling orders altogether. These disincentives create obstacles for physicians and their patients, and genuine barriers to access these beneficial tests.

These rules also create substantial hardship for the laboratories that are seeking to develop these tests. In order for the tests to be covered, hospitals must enter into agreements with the laboratories furnishing the tests. It is administratively overwhelming for these small laboratories to seek to enter into agreements with all potential originating hospitals, which may number in the thousands when considering sites where tissue may be stored.

The legislation that I am introducing today with Senator Wyden would require CMS to take a small, but important step toward facilitating Medicare beneficiary access to innovative, life-saving diagnostic tests by updating the ``date of service'' regulation. Specifically, the Patient Access to Critical Lab Tests Act would permit independent laboratories offering complex diagnostic laboratory tests to bill Medicare directly for tests performed anytime following a patient's hospital stay, without forcing the hospital into an unnecessary middleman role.

Given the promise of these new technologies, it is important that all regulatory regimes keep pace with the rapidly evolving world of science and technology, and operate to promote innovation. Out-dated regulations and calcified regulatory agencies can stifle innovation and prevent new life-saving diagnostics and therapies from ever coming to market. They can also serve as a drag on our economy.

Fixing this rule is a matter of critical importance to Medicare beneficiaries, as well as to the laboratories developing these technologies.

I encourage colleagues to join Senator Wyden and me in cosponsoring this bill. I likewise urge Senators Baucus and Grassley to consider this important measure as part of health care reform.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, I have sought recognition today to introduce legislation that will help ensure Medicare beneficiaries' access to cancer drugs provided by community-based cancer clinics.

Cancer takes a great toll on our families, friends, and our Nation. On average, one American dies from cancer each minute and the overall cost of cancer to the U.S. is $220 billion annually. While these statistics are daunting, the rate of cancer deaths in the U.S. has decreased since 1993. This decrease is the result of earlier detection and diagnosis, more effective and targeted cancer therapies, and greater accessibility to quality care provided by oncologists. These vital services have allowed millions of individuals to lead healthy and productive lives after successfully battling cancer.

Leading the treatment against cancer, community cancer clinics treat 84 percent of Americans with cancer. Community cancer clinics are freestanding outpatient facilities that provide comprehensive cancer care in physician's office settings located in patients' communities. These clinics are especially critical in rural areas where access to larger cancer clinics is not available.

In 2003, the Medicare Prescription Drug Improvement and Modernization Act was signed into law. This legislation contained numerous provisions that were beneficial to America's seniors and medical facilities; however, it also provided a reduction in Medicare's reimbursement for cancer treatment. The new Medicare drug reimbursement rates, based on average sales price or ASP, are artificially lowered by the inclusion of prompt payment discounts. These discounts are provided by the pharmaceutical manufacturer to the distributor and are a financing mechanism between the manufacturer and the distributor for prompt payment of invoices. As such, they are not passed on to community oncology clinics, which purchase drugs from distributors. However, pharmaceutical manufacturers are required by statute to include all discounts and rebates in the calculation of ASP, including prompt payment discounts that are not provided to community oncology clinics. The inclusion of these prompt payment discounts results in the artificially lowering of Medicare drug reimbursement rates by approximately 2 percent. Community cancer clinics are reporting that they are finding more cancer drugs reimbursed by Medicare at a rate less than their cost.

The Congressional Budget Office estimated that Medicare reimbursements to oncologists would be reduced by $4.2 billion from 2004-2013. PricewaterhouseCoopers estimated that reductions will reach $14.7 billion over that time. This increased reduction will have a debilitating effect on oncologists' ability to provide cancer treatment to Medicare beneficiaries, especially those in the community setting.

This legislation will remove manufacturer to distributor prompt payment discounts from the calculation of ASP to provide a more appropriate Medicare drug reimbursement and will help ensure Medicare beneficiaries' access to community-based cancer treatment. I encourage my colleagues to work with me to move this legislation forward promptly.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, last year, America spent $2.4 trillion on health care. That is 1/6 of our economy. Yet we ranked last among major industrialized nations in the Commonwealth Fund's National Scorecard on Health System Performance, which ranks the number of deaths that could be prevented before age 75 through effective health care.

Some analysts estimate that as much as 30 percent of our spending is for ineffective, redundant, or inappropriate care. That's care that does nothing to improve the health of Americans.

Our system also leaves nearly 50 million Americans without health coverage and 25 million more with inadequate coverage. Most bankruptcies and foreclosures in America are related to medical costs.

Our system needs reform.

Today, along with Senator Conrad, the Chairman of the Budget Committee, I am proud to introduce a bill that would improve health care in America by helping doctors and patients to make better, more- informed health care decisions.

This legislation would increase the chances that Americans receive the right care. This bill would provide for research that can help physicians and patients know more about what works best in medicine, and what does not.

Some patients, receive medical treatments that work well. Some patients receive treatments that do not. In many cases, doctors simply don't have enough reliable evidence to decide which treatments are best for which patients.

Rapid innovation and advancements in medicine have led to an ever- changing array of new and sometimes expensive technologies. The age of personalized medicine and genetic engineering will provide even more choices for patients and their physicians. Indeed, both patients and physicians can face great difficulty in choosing among treatment options.

Patients and physicians need more credible information about how treatments for a specific condition compare to each other. Today, the vast majority of medical information shows how treatments work compared to placebos. Most medical information does not show how treatments work compared to each other.

For example, men with prostate cancer have a choice among 3 common treatments surgery, radiation, and chemotherapy. Each approach yields different outcomes in terms of survival, ability to return to work, and other measures of quality of life.

Comparative effectiveness research would compare each approach in a systematic way. That way, doctors and patients would have more information about how options work, and for whom. The bill that I introduce today would do just that.

This bill would facilitate comparisons across a broad spectrum of health care interventions and health care strategies that are used to prevent, treat, diagnose and manage health conditions. By evaluating and comparing what works best, patients and providers can make more informed decisions about care.

More specifically, this bill would create a nonprofit institute that would be responsible for setting national health care research priorities. The institute, called the Patient-Centered Outcomes Research Institute, would be a private

entity. It would be governed by a multi-stakeholder, public-private sector Board of Governors. It would not be an agency of the Federal Government.

Keeping the Institute a private, nonprofit entity would shelter it from potential political influence from both the executive and legislative branches of Government. The independence and expertise of the Institute would result in more credible and more useful research for Americans.

The Institute would set national priorities for comparative effectiveness research and facilitate studies that would help to answer the most pressing questions about what works, and what doesn't.

The Institute would have the authority to contract with experienced Federal agencies--such as the National Institutes of Health and the Agency for Health Care Research and Quality, or with private researchers--to carry out the actual research. The Institute would also be responsible for disseminating the findings of the research in ways that make sense to both patients and providers.

The Institute's work would not happen behind closed doors. The bill would provide opportunities for public input and scientific review of the integrity of the research being conducted. The Institute's meetings would be accessible to the public, and open forums would help to solicit and obtain input on the Institute's activities and agenda. Also, public comment periods would be made available to discuss research findings.

The Institute's work would benefit all Americans who receive health care. So both public and private payers would fund the Institute. After an initial investment from general revenues, the Institute would be funded by an all-payer system, drawing from both public and private sources.

Comparative effectiveness research would not be the ultimate decision maker. Instead, it would provide an additional tool to improve health quality. The Institute would be a health care resource, a scientific entity, a source of knowledge, and a provider of information.

According to the Institute of Medicine, this research would provide better evidence--objective information--so that doctors and patients could make better decisions.

If we are truly to reform our health care system, then we must get more evidence into the hands of the people making medical decisions. This research is not only about reducing health care costs. It is focused on addressing significant gaps in knowledge.

It is not just the academics and economists who agree. Patient advocates like the National Breast Cancer Coalition, provider groups like the American Medical Association, and consumer groups like AARP can see the benefits of this research quite clearly. They have all extended their support.

The American Recovery and Reinvestment Act made a significant investment towards this type of research. But that was just a first step. We must ensure that this research will be sustained in the years to come.

From cars to toasters, Americans are able to readily view and evaluate information about the quality and effectiveness of so many of the items that they buy. It seems only logical that they should have information on what works and what does not when it comes to their health, especially with one in every 6 of this country's dollars leing spent on health care.

It is time for Americans and their doctors to be wield the world's most advanced science, so that the most personal health care decisions, like so many of the other decisions we make, are made with access to the best available information.

I urge my colleagues to support this common-sense measure.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, I rise today with Senator McConnell to introduce a joint resolution renewing the ban on all imports from Burma for another year.

I regret that we must take this action once again.

I had hoped that since we last took up this resolution last year, the ruling military junta, the State Peace and Development Council, SPDC, would have, at long last, heeded the voices of the people of Burma and the international community and put Burma on a path to democracy, human rights, and the rule of law.

Sadly, the regime responded to these calls in true fashion, by trying yet again to break the will of Burma's democratic opposition and stifle any movement for change.

Just last month, the military junta arrested and detained Nobel Peace Prize Laureate and Burma's democratically elected leader Aung San Suu Kyi on trumped-up charges of violating her house arrest.

Currently standing trial--behind closed doors and without due process--she faces up to 5 years in prison if convicted. This will come on top of spending the better part of the past 19 years isolated and alone under house arrest.

The regime's actions should come as no surprise. They represent yet another attempt to hold on to power and crush any opposition.

Almost 20 years ago, it annulled parliamentary election results overwhelmingly won by Aung San Suu Kyi's National League for Democracy.

Six years ago government-sponsored thugs attempted to assassinate Suu Kyi and other members of her National League for Democracy by attacking her motorcade in northern Burma.

Two years ago, the regime brutally put down pro-democracy demonstrations of the Saffron Revolution led by Buddhist monks.

And last year, we saw the regime ignore offers made by the international community and international humanitarian organizations to help Burma respond to the devastation caused by Cyclone Nargis, leading to countless deaths of innocent civilians.

In addition, they imposed a new constitution on the people of Burma, one that was negotiated behind closed doors without the input of the democratic opposition and one that will entrench the military's grip on power.

The SPDC understands all too well that the vast majority of Burmese citizens embrace Suu Kyi's call for freedom and democracy and reject the junta's oppressive rule.

That is why they are trying once again to silence her voice.

We cannot allow this brutal dictatorship to succeed.

For those of my colleagues who are disappointed with the lack of progress in bringing freedom and democracy to Burma since we first enacted this ban in 2003, I share their disappointment.

But now is not the time to turn back. Now is not the time to reward the regime for its oppressive tactics by lifting any part of our sanctions regime on Burma.

It has not made ``substantial and measurable progress'' towards:

ending violations of internationally recognized human rights;

releasing all political prisoners;

allowing freedom of speech and press;

allowing freedom of association;

permitting the peaceful exercise of religion and;

bringing to a conclusion an agreement between the SPDC and the National League for Democracy and Burma's ethnic nationalities on the restoration of a democratic government.

By renewing the import ban we express our solidarity with Aung San Suu Kyi and the democratic opposition who bravely stand up to the regime and reject their abuses.

They understand that the import ban is not directed at the people of Burma, but at the military junta that dominates economic and political activity in their country and denies them their rights.

And I remind my colleagues that this import ban renewal is good for 1 year and we will have the opportunity to revisit this issue again next year.

I am hopeful that the United Nations Security Council and the international community will follow our example and put additional pressure on the SPDC to release Aung San Suu Kyi and all political prisoners immediately and unconditionally and engage in a true dialogue on national reconciliation, one that will lead to a truly democratic constitution.

I urge my colleagues to pass this Joint Resolution as soon as possible.