Floor Statements

Mr. President, I thank my very good friend from Iowa. Senator Grassley is a true gentleman and I deeply appreciate the courtesy he is offering me, as well as my colleague Senator Tester.

A few moments ago, the House voted to override the President's veto by a vote of 361 to 54--361 to 54--clearly overriding the President's veto on the WRDA bill. I stand here today asking the Senate to do the same. We too should have a very strong vote to override the President's veto. If the House can vote to override, certainly the Senate can too.

This conference report, as we all know, provides authority for the Army Corps of Engineers to move forward on many very long overdue water resource projects. Let's not forget the West's battle with drought and the coasts' recurring struggles against Mother Nature's harsh storms that highlight the pressing need to address our water resource needs. I saw a very alarming article not too long ago, 2 or 3 weeks ago, about the effects of climate change and global warming. It is not just the ice sheets melting and the coastlines rising; there is also increased drought--increased drought in the Southeast and in the Southwest, especially the Southwest. It is tough enough for my part of the country where the average precipitation is about 13 inches a year. That is all it is. I think in Washington, DC, the average precipitation is around 40 inches. In the northern high plains States where we desperately need these projects, the annual precipitation is again about 13 to 14 inches a year. We need help.

I must say too it is important to keep in mind that since 1986, Congress enacted legislation known as the Water Resources Development Act, otherwise known as WRDA. Every 2 years since then, Congress has received a WRDA bill from the administration, seeking authorization for water resources projects. These requests provided the Corps and local sponsors with a regular planning schedule.

It is kind of like the highway bill. We have people in our country-- the highway bill clearly is the contractors and the States--some ability to plan for the future. That is why we have 5- or 6-year bills. The same is also true with the Water Resources Development Act. We need to give some sense of predictability and some sense of certainty to people so they can plan for projects, in this case the Corps.

I must say, however, that the administration has not requested one update of the program--not one--since the year he has been President. So the question is, Why? Why has the President not suggested an update in the program? Well, according to the President, this is not a priority. He says the Congress is not being fiscally responsible. I have to disagree. He is not accurate. Why? Well, one reason is the costs in this legislation reflect an accumulation of projects that need to be authorized because we have not had a WRDA bill for over 6 years. It stands to reason that if we haven't had an authorization for over 6 years, clearly the costs are going to go up a little bit.

Investing in our water infrastructure is a cost we cannot afford to put off. I submit it doesn't make any sense to turn our backs on all of these water projects because otherwise they continue to crumble, they continue to erode, and it does not make a lot of sense. In fact, many people are worried about America's competitiveness, and I am one who thinks we do not pay enough attention to our infrastructure; that is, if we are going to compete in the future, we have to have strong highways, we have to have a power system, a telephone system, and we need to have a very good water resource system. We have to get water where it is needed because if we don't, there are going to be huge costs not just in the immediate term but also in the long term.

It is very important that this legislation, in my judgment, pass. There are several projects in this bill in the State of Montana, my home State. One is the Yellowstone River and Tributaries Recovery project, and another is called the Lower Yellowstone project at Intake, MT; third, the Missouri River and Tributaries Recovery project; the Upper Basin of the Missouri River project, and a riverfront revitalization project in Missoula, MT. These projects will all improve and protect our valuable water resources.

The old saying about whiskey and water: You fight over water. Whiskey is for drinking, water is for fighting over. It is because water is such a precious and valuable resource.

There is also an important authorization for a very important project in my State of Montana, and that is the rehabilitation and improvement of an aging water project we call the Hi-Line. If you look at the State of Montana, it is a highway that goes across northern Montana. We call it Hi-Line. It is as though we are high above the Earth because we go across northern Montana and up there, there is something called the St. Mary Diversion. It is a Federal project built years ago. It is a mess. It is dilapidated and crumbling. I have been up there not too long ago. I have been up there a couple of times. I am embarrassed that the U.S. Government has not kept up the system, not kept up the operation, and not kept it going. I am embarrassed and I feel bad, and in fact I am angry that half of the people in the area--it is an Indian reservation as well, and a lot of people have moved off the reservation, and we have to address this. This legislation does address it. It is very important. Without it, I might add, the Lower Milk River, which falls out of the Diversion, would go dry 6 out of every 10 years. Without this St. Mary Diversion, the Milk River would go dry 6 out of every 10 years. That is 60 percent of the time. This affects thousands of Montana families.

If you have been up on the Hi-Line, if you have been on the Milk River, you will get a sense and a feel for how valuable this is. It is our lifeblood. The President might not think these projects are a priority. I certainly do.

This conference report authorizes projects that will provide needed flood and storm damage protection, as well as a lot of navigation improvements and a lot of environmental restoration. There is also authority here that is so important for rebuilding and restoring the coast of Louisiana devastated by Hurricanes Rita and Katrina, and authority for modernizing the lock and dam system on the Mississippi River, and authority for ecosystem restoration projects from New Jersey to Florida to Colorado--all vitally important.

The 1986 comprehensive WRDA bill was enacted after a 16-year deadlock between the Congress and the executive branch. The deadlock we see today between the Congress and the President is about priorities. What are our priorities? What are America's priorities? What are the priorities of our country? The Congress has set priorities and enacted this legislation. The American people clearly value--and it goes without saying--the water resources of our country and our need to invest in them. The American people see this as a priority.

Again, the conference report passed the Senate by a strong 81-to-12 vote, clearly enough votes to override a Presidential veto, and the House voted moments ago very strongly to override the President's veto 361 to 54. So let's not delay any longer. Let's get this conference report enacted with a very strong vote and override the President's veto. We already did it in the House. Let's do it in the Senate when the time comes--I think it is tomorrow--and then we can get on with developing these projects, and we can be very proud of doing something in the Congress that is very worthwhile.

Mr. President, I yield the floor.

Mr. President, I am pleased to join with my colleague Senator Grassley, as well as Senators Alexander, Biden, Bingaman, Bond, Cantwell, Corker, Crapo, Domenici, Graham, Kerry, Levin, Lincoln, Murkowski, Roberts, Salazar, Schumer, Smith, Stabenow, Tester, and Thune in submitting a resolution designating November 2007 as National Methamphetamine Awareness Month.

It is the sense of the Senate to increase awareness of methamphetamine and call upon the people of the U.S. to observe this month with appropriate methamphetamine educational programs and outreach activities.

Methamphetamine is devastating families and communities across the Nation.

It has been more than 1 year since enactment of the Combat Methamphetamine Epidemic Act. Methamphetamine lab seizures declined 42 percent nationwide last year, as a result of regulations on the sale of pseudoephedrine and ephedrine. These are the over the counter drugs which are often used in the production of methamphetamine.

But our work is not done. Methamphetamine is still the number one law enforcement problem. The National Association of Counties found that methamphetamine is the number one illegal drug problem for 47 percent of the counties in the country.

Four out of five county sheriffs report that while local methamphetamine production is down, methamphetamine abuse is not.

Methamphetamine users are changing. Three-fifths of the Nation's sheriffs report increased methamphetamine use by women. Half of the Nation's sheriffs report increased use by teens.

Surveys on methamphetamine abuse among teens show that many of the respondents said the drug was easy to get, and believed there was little risk in trying it. Methamphetamine is still far too readily available.

As a result, local social service and health care resources are stretched thin, and more and more children are being sent to foster homes.

These issues are even more apparent within tribal communities. I am very concerned that the highest rates of methamphetamine use among all ethnic groups occur within the Native American communities.

Last year, Carl Venne, Crow Tribal Chairman, testified before the Finance Committee. Chairman Venne told of the grave effects of meth on the Apsaalooka Nation. He said, ``There is no entity or organization on the Crow Reservation that is exempt from the devastating destruction of Meth.''

And while the regulations under the Combat Meth Act have stifled meth production here in the United States, the production has shifted to keep up with the ever-growing demand. Most illegal methamphetamine available in the U.S. is produced in large clandestine laboratories in Mexico and smuggled into this country. We must do more to break the meth supply chain at the border.

We must do more to end the demand for this devastating drug. We need to redouble our efforts and intensify methamphetamine education, prevention, and treatment. In this way, we show our resolve to bring to an end the problem of meth.

Thus, I stand here today, asking my fellow colleagues on both sides of the aisle to join us in support of designating November 2007 National Methamphetamine Awareness Month.

Conducting educational programs and outreach activities in November will give us an opportunity to talk with folks at home and focus on ways to fight methamphetamine across America.

I urge everyone to join us in support of this legislation.

Mr. President, reserving the right to object, I am wondering whether the Senator would amend his consent request to allow, instead, the following; namely, that when the Senate receives from the House its bill to extend the expiring tax provisions, the Senate would proceed to that bill, consider a Baucus amendment to extend the expiring tax provisions and prevent the AMT from hitting any additional taxpayers, agree to that amendment, and pass the bill, all without any intervening action or debate.

Hearing the comments of my good friend from Oklahoma, I have no alternative but to object.

Mr. President, again reserving the right to object, would the Senator again amend his consent request to instead allow the consent request I requested just previously?

Hearing his response, Mr. President, I must object.

Mr. President, reserving the right to object once again, I ask the Senator if he would again modify his request along the lines I outlined earlier?

Mr. President, I object.

Reserving the right to object, once again, I would ask my friend from Oklahoma if he would amend his consent request along the lines I earlier suggested.

Objection.

Mr. President, reserving the right to object, I make the same request of the Senator from Oklahoma.

Hearing the Senator's response to this long litany of requests of tax measures, which the Senator knows can in no way be passed in the Senate in this way, but also knows that many will be acted upon later this year, I must object.

Mr. President, I can short-circuit this charade. I object.

Reserving the right to object, I might say to my good friend that this is another measure that will be considered in due course later this year. I must object.

Mr. President, again, these are measures which will be considered in due course this year. I laud my good friend, but as he knows, Senator Grassley is ranking member of the committee, and there is a process in which to deal with these measures. This is not the process to be engaged in at this moment. So I must object.

Mr. President, just a few words to explain what just happened.

On behalf of many Senators, I am calling for swift passage of a full tax extenders package, which contains many of the measures that have been referred to in the preceding 4 or 5 minutes. These measures are called tax extenders, and we will pass tax extender legislation later this year.

I want quick action on them, including the college tuition deduction, the sales tax deduction, as mentioned by two Senators, and also we must move on provisions to prevent the alternative minimum tax from hitting more taxpayers and the complete set of expiring tax provisions when the House sends that legislation to the Senate.

We are all working on this issue. Senator Grassley and I have talked with Chairman Rangel on the other side of Capitol Hill, as well as those on this side of Capitol Hill, to get these measures enacted. I, myself, drafted many of these provisions in the first place. Senator Grassley and myself have advanced, as we always do in working together, in trying to get them all extended.

Mr. President, we want to get this done, and I am confident we will get it done, and I urge a little forbearance of my colleagues. We are working expeditiously to get it done. It may not be tomorrow, on Friday, but we are working very expeditiously to get it done, and I am confident it will be done later this year.

Mr. President, I yield the floor, and I suggest the absence of a quorum.

Madam President, what is the regular order?

We have 14 minutes remaining and we are going to have to use it, unless the Senator can use 1 or 2 minutes.

It is possible the Republicans might yield the Senator some time.

Madam President, I ask unanimous consent that the 20 minutes immediately prior to the cloture vote at 4:45 be equally divided and controlled between the leaders, or their designees, and that the majority leader will control the final 10 minutes prior to the vote; further, that the mandatory quorum required under rule XXII be waived.

Madam President, in 1997, Congress enacted the Children's Health Insurance Program--10 years ago. From the beginning, it has been about kids. It has been about trying to give the parents of low-income working families the peace of mind that comes from knowing that health care is there for their children. That is all this is, it is about health care for kids. These are kids in working families, not kids in wealthy families, not kids in middle-income families--kids in working families.

These are kids who, through no fault of their own, were born into families having had a hard time buying medical insurance in America, and we are trying to help these kids.

A large number of Senators on both sides of the aisle have worked together to try to reach a consensus. Both sides of the aisle--Senator Grassley, Senator Rockefeller, Senator Hatch, and I--met together and worked things out. And when the House failed to muster enough votes to override the President's veto, we worked together with House Republicans to help kids. All four of us--Senator Grassley, Senator Rockefeller, Senator Hatch, and I--met repeatedly with moderate House Republicans to try to find a middle ground.

We have made progress. We made a lot of progress, and I believe a compromise is very close, is within reach. I believe given a little more time, Congress could pass a CHIP bill that could achieve the support of more than two-thirds of both Houses of Congress. Unfortunately, today some objected to giving us that time, and I regret that objection.

But we met again, all of us--that is, Senator Hatch, Senator Rockefeller, Senator Grassley, and I--with House Republicans at 2 o'clock. We agreed to continue meeting. We will meet again next Tuesday. We will reach an agreement soon. I don't think I will be telling tales out of school to say that the majority leader visited our meeting and he said: If we get a deal, the Senate will take it up. I think we are close to getting that deal. There are only a couple of issues that are outstanding, and we will work through those issues.

I regret that the opponents of the Children's Health Insurance Program--and let us be clear, they are truly fighting not just the bill but the Children's Health Insurance Program--that those opponents of CHIP have made it impossible for us to offer an amendment to the bill before us today to get this done. They have succeeded in stopping us today. I am disappointed. I am not discouraged, I am disappointed. We will keep working. Even if the President once again vetoes health care for kids, we will work to get it done.

We are still left with a good bill before us. It is a better bill than the one the President vetoed. Before us today is a bill that addresses many of the concerns Senators expressed with the first CHIP bill. The bill before us today focuses more on kids. It focuses more on low-income families. It is a good bill.

There is no reason why anyone who supported the first bill on September 27 would not do so again today. It is improved. There is every reason why those who objected to the first bill would support this bill today.

I urge my colleagues to join in voting for cloture and then voting for the bill. I urge them to do so because this is still about health care for kids. That is what this is all about, it is for kids. We have a lot of peripheral issues, but they are peripheral; it is noise. We say: Keep our eyes on the ball. It is about helping low-income kids, health care for kids and working families. Measures such as this are why we came to work in public service. Measures such as this are why people for whom we work sent us here. Let us not let them down.

Madam President, I yield 3 minutes to my friend from Connecticut.

Madam President, I suggest the absence of a quorum.

Mr. President, it is hard to believe that it was 5 years ago today we lost our dear friend and colleague--Paul Wellstone.

On a cold Minnesota morning, his life, along with his wife, daughter, three staff members, and two pilots, was cut tragically short. It was a day that is burned into our memories, a day we will never forget.

Paul was a good man. He was a man who truly loved being a Senator. It wasn't the power and prestige that he loved, it was his ability to serve the people, to help those in need--especially those who otherwise wouldn't have had a voice.

He was a fighter. He fought for the underprivileged. For the downtrodden. For those who otherwise had been forgotten. He fought for the underdog--the little guy. And most of all he fought for what he believed in to be right and true.

Paul loved life and lived each day to the fullest. He always had a kind word and a smile to whom ever he came across. And he came to work determined to make our country and world a better place.

The Senate has changed a lot since Paul's death. The halls are a little quieter. There is a little less fire and brimstone on the Senate floor. Paul was known for going to the floor and giving an impassioned speech about how we had to provide better health care coverage for the mentally ill, assistance for domestic violence victims, better benefits for our veterans, or education for our children.

While Paul was a hard-working, dedicated public servant, he was also a family man who loved his wife, children, and grandchildren very much. His best friend and companion in his life was his wife Sheila. She inspired him, was his constant companion, and she calmed him. Their love was one of a kind. In many ways it is fitting they left this Earth together.

While Paul is not here, his spirit lives on. He inspired all of us to be better people. And his memory lives on. Paul's work is continued through his two sons Mark and David, Wellstone Action, and through his staff--many of whom can still be seen in the halls today.

Like many of my colleagues in Congress, I miss my Paul. So let us remember him today and honor all of the work he did to make this country a better place for all of us.

Mr. President, I would like to acknowledge the service of Representative David Tawei Lee, who has given nearly 3 years of exceptional service as Taiwan's principal representative to the United States. Representative Lee recently departed Washington, DC, to take on his next assignment as Taiwan's Representative to Canada. He leaves behind a legacy of friendship, prosperity, and understanding.

When Representative Lee arrived in Washington, he came equipped with a wealth of experience and insight. A foremost expert on U.S.-Taiwan relations, Mr. Lee has studied, written, and published on U.S.-Taiwan political and economic ties, including the development of the Taiwan Relations Act. I believe Representative Lee will be remembered not only for his excellent knowledge of history but also for his accomplishments.

While serving in Washington, Representative Lee dedicated his energy, intelligence, and spirit to expanding Taiwan-American ties. He raised the cultural and political profile of Taiwan and its people with cultural and education programs. To enhance our economic ties, Representative Lee oversaw the successful acceleration of our bilateral Trade and Investment Agreement talks. And he worked tirelessly to raise awareness of the benefits of a potential U.S.-Taiwan Free Trade Agreement. In these areas alone, he has left a legacy of which he should take pride.

Representative Lee's dedication and efforts were also felt far beyond our Nation's Capital. Three years ago, I was delighted to personally welcome Mr. Lee to my home State of Montana. There he witnessed Big Sky Country in all of its glory, making friends with hospitable and generous Montanans. But together we also saw the deep and healthy roots of the Montana-Taiwan economic relationship. At its core are Montana's finest agricultural products, which have long found their way to Taiwanese dinner tables and bakeries. Today, Taiwan purchases over 30 million bushels of Montana wheat annually. Our fine Montana beef is also in demand. This relationship benefits families in both Montana and Taiwan. And I hope it will continue to grow stronger.

It has truly been a pleasure to work with Representative Lee. His personal touch to everything he did will not be forgotten. And the value of his contributions will be remembered for many years to come. I wish him luck in all of his future endeavors.

Mr. President, today I am introducing a joint resolution to disapprove of the Medicare National Coverage Decision on cancer care announced by the Centers for Medicare & Medicaid Services on July 30, 2007. I am taking this action out of concern for America's seniors who are afflicted with cancer, a terrible disease that affects thousands of Medicare beneficiaries each year.

At the outset, I want to make very clear that Congress should not wantonly second-guess the scientific processes at CMS. The National Coverage Decision process is a very important component of the agency's governance of the Medicare program and its mission to protect the safety of beneficiaries. The agency makes several National Coverage Decisions each year that are implemented without any congressional involvement. Several more coverage determinations are made by regional Medicare carriers at the local level. When scientific evidence supports doing so, CMS clearly has authority to limit Medicare coverage for drugs and other medical products and services to an extent less than the Food and Drug Administration label would otherwise allow. In fact, I am working on a proposal that may provide more clinical evidence to guide CMS in making these decisions.

There are some rare occasions, however, when CMS makes a decision that intrudes on the clinical judgment of doctors without the support of scientific evidence, prompting virtually unanimous opposition from the clinicians who treat the patients whose care is at stake. In these cases, I believe that Congress not only may but must intervene. This National Coverage Decision regarding the use of erythropoiesis- stimulating agents, or ESAs, for Medicare beneficiaries with cancer and cancer-related conditions is precisely such an instance.

Mr. President, when a cancer patient receives an ESA, the goal is not to manage a person's hemoglobin back to the level of a healthy, non- anemic person. That is because there can be health risks associated with raising the hemoglobin to such a level through ESA use. The FDA label makes it clear that patients may only be administered enough of an ESA to avoid a transfusion, and that ESAs should never be used to bring a patient's hemoglobin level above 12 grams per deciliter. So there can be risks when a patient does not get enough of an ESA, including severe anemia and the need for blood transfusions. And there are

risks when a patient gets too much of an ESA. The FDA label establishes parameters to guard against under-utilization and over-utilization of these products.

Now let us compare the FDA label with the National Coverage Decision announced by CMS. The National Coverage Decision limits ESA treatment to hemoglobin levels less than 10 grams per deciliter. This cap fails to recognize the natural fluctuations in a patient's hemoglobin. This cap is simply incongruous with the FDA label, which recommends that patients should not be treated over 12. I should note that the FDA label was recently changed, with the addition of new ``black box'' warnings and recent safety information. If the FDA believes that scientific evidence warrants changing the label yet again, then clearly Medicare should not cover treatments that are not consistent with that new label.

Furthermore, there are other aspects of the CMS National Coverage Decision that are contrary to accepted standards of care and scientific evidence. CMS imposed 4-week dose limitations that are not based on the clinical needs of patients. The FDA labels allow ESAs to be administered three times a week, every week, every 2 weeks, or every 3 weeks. Also, for patients who are slow to respond to ESAs or do not respond, CMS has created a one-time dose escalation rule of 25 percent of the initial ESA dose. This limitation is contrary to FDA-approved dosing instructions. For instance, the FDA approved labeling allows doubling the dose for some regimens.

Mr. President, over the past months, I have seen an outpouring of concern with this National Coverage Decision by patients, providers, and the professional scientific community for many reasons. The American Society of Clinical Oncology, the world's leading professional organization representing physicians of all oncology subspecialties who care for cancer patients, wrote this to CMS:

Under the new CMS policy, a patient's hemoglobin could

repeatedly fall below 10 following termination of coverage at

the end of 4-week periods. This consequence would be

inconsistent with the FDA-approved labeling, which, as noted

above, states that ESA dosing should be titrated to the

individual patient to maintain the hemoglobin level. . . . We

strongly urge CMS to reconsider these restrictions in light

of the concerns detailed above.

The current NCD does not allow for interpretation

consistent with clinical practice, national guidelines, or

the FDA-approved labels in this area. This reopening [of the

National Coverage Decision] should occur as soon as possible

to avoid continued confusion and uncertainty [for] both

physicians and patients. Until these issues are clarified, we

also strongly recommend that CMS delay the effective date for

the entire NCD.

The American Society of Hematology, the leading clinical authority on disorders affecting the blood, bone marrow, and the immunologic, hemostatic, and vascular systems, has stated:

Consequently, the clinical scenario that is problematic is

when a patient's hemoglobin goes above 10 g/dL after 4 weeks

of treatment because the physician would then need to

discontinue the ESA treatment entirely. This is of concern

because some patients might then drop below 10 g/dL

justifying a renewal of the ESA treatment and leading to a

`roller coaster' of treatment potentially involving stopping

and starting ESA treatment several times. This is extremely

difficult for both the patient and the physician.

The Leukemia and Lymphoma Society wrote this in a recent letter to

Mr. President, today I am introducing a joint resolution to disapprove of the Medicare National Coverage Decision on cancer care announced by the Centers for Medicare & Medicaid Services on July 30, 2007. I am taking this action out of concern for America's seniors who are afflicted with cancer, a terrible disease that affects thousands of Medicare beneficiaries each year.

At the outset, I want to make very clear that Congress should not wantonly second-guess the scientific processes at CMS. The National Coverage Decision process is a very important component of the agency's governance of the Medicare program and its mission to protect the safety of beneficiaries. The agency makes several National Coverage Decisions each year that are implemented without any congressional involvement. Several more coverage determinations are made by regional Medicare carriers at the local level. When scientific evidence supports doing so, CMS clearly has authority to limit Medicare coverage for drugs and other medical products and services to an extent less than the Food and Drug Administration label would otherwise allow. In fact, I am working on a proposal that may provide more clinical evidence to guide CMS in making these decisions.

There are some rare occasions, however, when CMS makes a decision that intrudes on the clinical judgment of doctors without the support of scientific evidence, prompting virtually unanimous opposition from the clinicians who treat the patients whose care is at stake. In these cases, I believe that Congress not only may but must intervene. This National Coverage Decision regarding the use of erythropoiesis- stimulating agents, or ESAs, for Medicare beneficiaries with cancer and cancer-related conditions is precisely such an instance.

Mr. President, when a cancer patient receives an ESA, the goal is not to manage a person's hemoglobin back to the level of a healthy, non- anemic person. That is because there can be health risks associated with raising the hemoglobin to such a level through ESA use. The FDA label makes it clear that patients may only be administered enough of an ESA to avoid a transfusion, and that ESAs should never be used to bring a patient's hemoglobin level above 12 grams per deciliter. So there can be risks when a patient does not get enough of an ESA, including severe anemia and the need for blood transfusions. And there are

risks when a patient gets too much of an ESA. The FDA label establishes parameters to guard against under-utilization and over-utilization of these products.

Now let us compare the FDA label with the National Coverage Decision announced by CMS. The National Coverage Decision limits ESA treatment to hemoglobin levels less than 10 grams per deciliter. This cap fails to recognize the natural fluctuations in a patient's hemoglobin. This cap is simply incongruous with the FDA label, which recommends that patients should not be treated over 12. I should note that the FDA label was recently changed, with the addition of new ``black box'' warnings and recent safety information. If the FDA believes that scientific evidence warrants changing the label yet again, then clearly Medicare should not cover treatments that are not consistent with that new label.

Furthermore, there are other aspects of the CMS National Coverage Decision that are contrary to accepted standards of care and scientific evidence. CMS imposed 4-week dose limitations that are not based on the clinical needs of patients. The FDA labels allow ESAs to be administered three times a week, every week, every 2 weeks, or every 3 weeks. Also, for patients who are slow to respond to ESAs or do not respond, CMS has created a one-time dose escalation rule of 25 percent of the initial ESA dose. This limitation is contrary to FDA-approved dosing instructions. For instance, the FDA approved labeling allows doubling the dose for some regimens.

Mr. President, over the past months, I have seen an outpouring of concern with this National Coverage Decision by patients, providers, and the professional scientific community for many reasons. The American Society of Clinical Oncology, the world's leading professional organization representing physicians of all oncology subspecialties who care for cancer patients, wrote this to CMS:

Under the new CMS policy, a patient's hemoglobin could

repeatedly fall below 10 following termination of coverage at

the end of 4-week periods. This consequence would be

inconsistent with the FDA-approved labeling, which, as noted

above, states that ESA dosing should be titrated to the

individual patient to maintain the hemoglobin level. . . . We

strongly urge CMS to reconsider these restrictions in light

of the concerns detailed above.

The current NCD does not allow for interpretation

consistent with clinical practice, national guidelines, or

the FDA-approved labels in this area. This reopening [of the

National Coverage Decision] should occur as soon as possible

to avoid continued confusion and uncertainty [for] both

physicians and patients. Until these issues are clarified, we

also strongly recommend that CMS delay the effective date for

the entire NCD.

The American Society of Hematology, the leading clinical authority on disorders affecting the blood, bone marrow, and the immunologic, hemostatic, and vascular systems, has stated:

Consequently, the clinical scenario that is problematic is

when a patient's hemoglobin goes above 10 g/dL after 4 weeks

of treatment because the physician would then need to

discontinue the ESA treatment entirely. This is of concern

because some patients might then drop below 10 g/dL

justifying a renewal of the ESA treatment and leading to a

`roller coaster' of treatment potentially involving stopping

and starting ESA treatment several times. This is extremely

difficult for both the patient and the physician.

The Leukemia and Lymphoma Society wrote this in a recent letter to