A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Centers for Medicare & Medicaid Services within the Department of Health and Human Services relating to Medicare coverage for the use of erythropoiesis stimulating agents in cancer and related neoplastic conditions.

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

Mr. President, I rise today to introduce S. 2213, the Cyber-Crime Act of 2007. I am joined in this effort by my colleague and good friend Senator Biden. This bipartisan legislation makes important, appropriate and necessary changes to federal law relating to computer fraud.

Continuous innovation in technology provides remarkable benefits to individuals throughout the world. In the United States, the integration of computer networks has allowed for increased efficiency of American businesses and provided greater access to

services and information for individuals. The ability of individuals and businesses to store vast amounts of data on computer networks has led to innumerable advantages including increased productivity and financial savings.

However, these same networks have proven to be prime targets for criminals seeking to utilize malicious computer code for illicit gain. Criminals are using viruses to exploit technological weaknesses in computer networks. These collections of compromised computers are called ``botnets'', and serve as zombie networks which can be remotely controlled by an attacker and used for numerous crimes, including identity theft and attacks on critical computer systems. Botnets can consist of hundreds of thousands of computers, and most victims are unaware their computer equipment has been compromised. An underground market has developed for these botnets, as criminals are renting these compromised networks to carry out different types of attacks. Botnets have the ability to grow exponentially and the potential damage from these networks grows accordingly.

Botnets pose a tremendous threat to our national infrastructure, economy, and security. Portions of the federal law relating to computer crime, written in a pre-Internet era, are inadequate and leave several unaddressed loopholes in our criminal code. For example, under current federal law a creator of a botnet can only be charged if the financial loss to one or more persons during one year passes a certain dollar threshold. It can be very difficult to put a price tag on the losses experienced by computer users, as it is not easy to calculate how much money an individual's time is worth in terms diverted from work or in trying to fix a malicious bot. In addition, it is possible for a criminal to create large botnets that can be utilized for future denial of service attacks and other violations, and still not violate this section of law.

In order to address this, the legislation we offer today modifies the Federal criminal code by criminalizing willful damage to 10 or more computers in any one year period. This change will allow the prosecution of criminals who covertly install malicious bots on protected computers with the purposes of making a botnet.

Also, S. 2213, will make other necessary changes to the Federal code, including expanding the definition of cyber extortion, and permit law enforcement seizure of computer equipment and other property used to perpetrate computer crimes. As well, the bill includes a directive to the U.S. Sentencing Commission to consider many highly relevant factors in its review of appropriate sentences for cyber crime.

All of the changes contemplated by this legislation, if aggressively enforced by law enforcement, will have a positive impact on our security. In this information age, it will not take long for potential criminals to hear about the new tools available to law enforcement personnel and many will be deterred from perpetrating illegal activity over the Internet.

As criminals continue to adapt their tactics to exploit technological changes and loopholes in the law, it is imperative that Congress pass legislation that allows Federal law enforcement to maintain vigorous and tireless efforts in the investigation of cyber crime activity. I am confidant that this legislation, once enacted, will provide for the tools needed to pursue those who choose to inflict such harm to our society.

Mr. President. I rise to introduce a bill that would formally establish and enhance the Protective Security Advisor Program Office within the Department of Homeland Security.

The PSA program, which operates under the DHS Office of Infrastructure Protection, has proven its worth on many occasions. For example, when the Interstate 35-W bridge in Minneapolis collapsed in August of this year, PSAs provided valuable support to the Minnesota Department of Public Safety, providing assessments of infrastructure impacts relating to emergency services, postal and shipping operations, public transit, fuel deliveries, public utilities, and rail operations.

DHS has deployed more than 70 PSAs in major metropolitan areas around the country. These are skilled and savvy people, averaging more than 20 years of law-enforcement, military, or counter-terror experience. They regularly interact and develop working relationships with Government agencies at all levels and with private-sector entities, and they can be among the first on the scene when disaster strikes.

Critical infrastructure is not, however, confined to large urban areas. Yet, 10 States--Delaware, Idaho, Maine, Montana, New Hampshire, North Dakota, Rhode Island, South Dakota, Vermont, and Wyoming--do not have a resident PSA dedicated to serving the interests and protecting the citizens of those States.

The bill I introduce today will enhance our national preparedness, response capability, and security by providing a minimum Protective Security Advisor presence in every State, while preserving the risk- based principle that provides extra coverage in areas of dense population or concentrated critical infrastructure.

The bill will also enhance the PSA program by providing for 10 supervisory PSAs for regional coordination and management, and by authorizing additional PSAs at DHS headquarters. These headquarters PSAs will help manage participation in training and exercises, PSA training and certification programs, and day-to-day operations that help our Nation prevent, respond to, and limit the consequences of terrorist attacks and natural disasters.

This bill also will advance the goals of the National Infrastructure Protection Plan. It will promote governmental and private-sector efforts to assess risks to and vulnerabilities of critical infrastructure, help stakeholders share information and coordinate activities, assist with multi-jurisdictional planning, and provide counsel to any designated Principal Federal Official when a joint field office must be established.

State emergency managers recognize the importance of this legislation. The Maine Emergency Management Agency has already provided a letter of support. Its bipartisan list of cosponsors--Senators Pryor, Sununu, Johnson, Coleman, Biden, Thune, Enzi, and Carper--includes three other members of the Senate Homeland Security Committee. These facts attest to the bill's merit.

Mr. President, 300 million Americans live in a society that depends on a complex and tightly interrelated network of critical infrastructure and services including food supply, finance, energy, sanitation, transport, and communications.

The DHS Protective Security Advisors have demonstrated that they are a critical element of our homeland-security defenses. This bill will expand their numbers, extend their coverage, strengthen their organization, and make all of us safer.

I urge my colleagues to support this measure.

Mr. President, I rise today to introduce the Federal Emergency Management Advancement Act of 2007, a bill to establish the Federal Emergency Management Agency, FEMA, as an independent agency. After a series of winter storms and summer flooding caused extensive damage in Oklahoma, the State encountered problems with FEMA as they sought disaster assistant due to the levels of bureaucracy and a lack of communication. When other natural disasters struck Oklahoma prior to the placement of FEMA under Homeland Security, the State did not encounter the same bureaucratic delays and other problems. Therefore, I support making FEMA an independent agency again in an effort to grant FEMA more autonomy by removing that added layer of bureaucracy. Additionally, after Oklahoma experienced troubles establishing an accurate incident period for the 2007 summer flooding, I have also included in my bill language stating that the administrator should give deference to State documentation when determining disaster incident periods.

Oklahoma first encountered problems with FEMA and lack of communication and information when wildfires ravaged the state in 2005 and 2006. These devastating wildfires swept through the entire state leading to declarations for Public Assistance, Individual Assistance and hazard mitigation funding. All 77 counties in the State of Oklahoma qualified for Public Assistance while all counties were also eligible to apply for the Hazard Mitigation Grant Program. These wildfires were wide spread and deadly to my State.

More recently, Oklahoma encountered severe winter storms with devastating results in January 2007. These storms led to prolonged loss of power and extensive building damage for many of my constituents. In Muskogee County alone, an estimated 16,000 power company customers experienced loss of electricity for days at time with temperatures remaining below freezing.

This summer, Oklahoma was hit by heavy rain, tornadoes, and flooding from May through September. The State made a number of disaster declarations during these periods. While I appreciate these declarations and aid, the process it took the state to get to this point was filled with unnecessary difficulty. Oklahoma particularly struggled with FEMA on the dates of the incident periods which is why I have included language in my bill to give deference to the State's documentation regarding the dates of such incidents. It makes sense that the State would be the one to have the most accurate information available regarding the disasters and the cause.

I believe this is an extremely important bill that will free FEMA from additional levels of bureaucracy and allow it to work in a more effective manner.

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