Design Piracy Prohibition Act

Mr. President, I am pleased to join my good friend and colleague Senator Baucus to introduce the Continuing the Advancement of Quality Improvement Act.

The purpose of this legislation is to reform Medicare's troubled Quality Improvement Organization, QIO, program. QIOs and their predecessor organizations have long been responsible for ensuring that the care Medicare beneficiaries receive is medically necessary, meets recognized standards and is provided in appropriate settings. They are currently tasked with a wide variety of important roles ranging from investigating beneficiary complaints of poor quality care to giving technical assistance to Medicare providers for improving health care quality.

I have been an advocate of reforming the QIO program for quite some time. About 2 years ago, I initiated an investigation into a number of the QIOs. Those investigations revealed a program that is in desperate need of reform. This program was running with little or no oversight, and it was expending more than $1 billion every 3 years with little measurable results. In other words, I found trouble. Let me elaborate on a few disturbing things that I discovered. I found that one QIO leased residential properties for board members and a CEO. That same QIO also used Federal funds to lease automobiles for its top executives. I also found other QIOs who had board members and staff attend conferences, many at lavish resorts.

I was not the only one to identify serous concerns with the QIOs. Others identified concerns too. Specifically, the Institute of Medicine, IOM, the General Accountability Office, GAO, and the Department of Health and Human Services, HHS, Office of the Inspector Geheral (OIG) all identified numerous concerns about the effectiveness of this program. These independent organizations also voiced their concerns with the manner in which it is operated and have made recommendations for major reform. Their findings clearly show the need to hold the Centers for Medicare and Medicaid Services, CMS, and the organizations that serve as QIOs accountable for the important tasks they must perform.

The Continuing the Advancement of Quality Improvement Act will ensure that the QIO program is not only effective in improving the quality of care provided to our Medicare beneficiaries, but also that it operates in an effective, efficient and accountable manner. Much of this legislation is based on the investigations that I conducted and the troubling findings that I came across and on the work of the IOM, the GAO, and the HHS OIG.

First, the Continuing the Advancement of Quality Improvement Act would focus the mission of the QIO program on quality improvement. QIOs currently have many diverse responsibilities. As a result, they served conflicting roles of both ``regulator'' and ``technical assistant.'' This conflict poses significant barriers to QIOs effectively serving either role, and we have come to learn that they really don't perform either function particularly well.

The legislation would also address this conflict by following the IOM's recommendation to make the sole purpose of QIOs to be technical assistants for quality improvement and performance measurement. The HHS Secretary would be required to transfer all other QIO: responsibilities to other entities called Medicare Provider Review Organizations, MPROs, in a manner that will support the needs of beneficiaries and be accountable to them.

Second, the legislation would improve the beneficiary complaint review process that I think is in desperate need of reform. You may recall that in 2006 we read about the plight of Mr. Schiff. Mr. Schiff went to a QIO and filed a complaint about the care provided to his wife, who died. The QIO in that case was unresponsive to Mr. Schiff. He was forced to take legal action to learn what the QIO found out about his wife's death. He should not have had to do that. After all, he was the one who filed the complaint with the QIO in the first place because he thought that someone did something wrong that lead to his wife's death. It was at that juncture that I learned that the beneficiary complaint review process was too opaque and ineffective. More importantly, beneficiaries were not being properly served. In fact, I came to learn that complainants often do not receive the findings of the investigation conducted by the QIO. Now I ask; what sense does that make?

The Continuing the Advancement of Quality Improvement Act would require MPROs to report the investigational findings to the complainant and refer the provider to a QIO for technical assistance and/or the appropriate regulatory body for sanctions. In other words, this part of the bill would bring transparency to a process now shrouded in a cloud of silence.

Third, the Continuing the Advancement of Quality Improvement Act would ensure that limited resources go to providers that need them the most. The GAO recently found that QIOs prioritized their assistance to providers who would be easiest to help rather than the providers who were most in need of help. In other words the QIOs decided it was easier to take a B plus student and make them into an A student rather than putting their resources into the D student to bring them up to par. I guess that way they thought that they would look better and more successful. But if you ask me; that is not the best way to spend limited taxpayer resources. Now, this bill will insure that if demand for technical assistance exceeds available resources, the QIOs would give priority to providers that are in rural or underserved areas, in financial need, have low performance measures or have a significant number of beneficiary complaints. In other words the help is going to go to those who need it most.

Fourth, the Continuing the Advancement of Quality Improvement Act would make QIO data more available to CMS and providers for quality improvement and patient safety purposes. Amazingly enough, QIOs are currently restricted from sharing such data despite the obvious value of this data for improving health care quality. This legislation would permit the sharing of QIO data with providers for quality improvement and patient safety purposes and require CMS to make recommendations on how to improve the data sharing process.

Fifth, the Continuing the Advancement of Quality Improvement Act would promote competition in the QIO program. This is a giant leap forward. These organizations are currently not subject to significant competition because of limitations on who can be a QIO and the availability of noncompetitive contract renewals. This lack of competition has led to a gross lack of accountability and stagnation in the QIO program. This legislation would promote competition by allowing other types of organizations to serve as QIOs and eliminate noncompetitive renewals.

Sixth, the Continuing the Advancement of Quality Improvement Act would enhance governance at the QIOs. During the course of my investigations I identified repeated failures in governance. I exposed board members who were more interested in helping themselves than helping others.

This bill will also address board member conflicts of interest. My investigations identified numerous incidents of questionable QIO governance practices and board member conflicts of interest. Since the QIO program receives over $400 million in taxpayer funding every year, it is reasonable for us to expect not only that QIOs are governed in an ethical manner free of conflicts of interest, but also that CMS appropriately oversees the program. This

legislation would require QIOs to comply with board governance requirements and would require CMS to establish procedures to address conflicts of interest and follow those procedures.

Finally, the Continuing the Advancement of Quality Improvement Act would increase much needed accountability in the QIO program. The I0M, the GAO and the HHS OIG have all questioned the effectiveness of the QIO program. This legislation would require the Secretary to perform interim and final evaluations of program effectiveness not only at the individual QIO level, but at the overall QIO program level as a whole. Also, high performing QIOs would receive financial rewards while low performing QIOs would receive financial penalties. Finally, the Secretary would be required to submit a more detailed annual report showing performance results of QIOs and MPROs and details on how taxpayer dollars are spent.

We have been placing more emphasis on the quality of care that our Medicare beneficiaries receive from providers. You see this as we require more transparency in the Medicare program with the public reporting of provider quality measures. You also see this as we transform Medicare from being a passive payer of services of any quality to a value-based purchaser. These are important reforms that will help improve the quality of care provided in the Medicare program and work toward ensuring that limited resources are used more efficiently and wisely.

As we move toward a payment system based on quality, the reforms in this bill will position the QIO program to support that transformation in Medicare to a quality-based purchaser by making the tools and assistance available to help Medicare providers improve the quality of the care they provide. The Continuing the Advancement of Quality Improvement Act would ensure the QIO program's ability to provide this assistance in an effective, efficient and accountable manner and correct the problems currently plaguing the program.

Mr. President, I am pleased to join my good friend and colleague Senator Baucus, as well as Senators Lincoln, Roberts, Conrad, Enzi, Schumer, Cochran, Salazar, Smith, Bingaman, and Snowe, to introduce the Pharmacy Access Improvement Act.

I am pleased with how well the Medicare Part D program is working. It has demonstrated how effectively private sector competition can work in delivering an entitlement benefit. The program has defied official predictions and come in under budget by $113 billion compared to the baseline projected in 2006. Premiums, initially estimated at $37 for 2006, in fact averaged $23; in 2007 they fell to an average of $22. We understand that this year's bids are even lower and that premiums are expected to fall again next year. The vast majority of Medicare beneficiaries have enrolled in the program, and while there were some troubling start-up problems initially, beneficiaries are very pleased with their plans.

At the same time, the first years of implementation of the Part D program have revealed some areas in which the program can be improved. One is related to pharmacy participation in the program. Changes are needed to ensure that Part D treats pharmacies as Congress intended and to make the program friendlier to pharmacists and independent pharmacies.

As Senator Baucus, Senator Lincoln, and my other colleagues and I talked to beneficiaries, pharmacists, pharmacy owners and prescription drug plans about changes that would make Medicare Part D work better, many of our discussions centered around how to make sure that Part D works not just

for the beneficiaries, the chain drug-stores, and the plans, but also for the local, independent pharmacies, the long-term care pharmacies, and the safety net pharmacies that many beneficiaries rely on. That is exactly what this bill is intended to do.

My colleagues and I hope with this bill to improve contracting for pharmacies, increase CMS's and prescription drug plans' customer service, and give beneficiaries better access to pharmacies. Let me give you some of the specifics of the bill.

First, the Pharmacy Access Improvement Act would strengthen standards for ensuring convenient beneficiary access to pharmacies. During the first two years of implementation, CMS has permitted some plans to meet the pharmacy access requirements in the law by counting non-preferred and out-of-network pharmacies. The plans charge higher cost-sharing at these pharmacies to discourage their use and drive utilization to preferred pharmacies. Counting non-preferred and out-of-network pharmacies to meet the access requirements is clearly not what Congress had in mind in establishing the beneficiary access guarantees in the law. To correct this problem, this bill would require that plans, with certain exceptions, count only ``open'' pharmacies, those that are accessible to the general public, in meeting the Medicare pharmacy access standard.

It also would require plans to count only their preferred in-network pharmacies, not the non-preferred pharmacies, in determining whether they meet the access standard.

The bill would allow pharmacies to initiate negotiations with plans under the ``any willing pharmacy'' provision regardless of whether they had already rejected, or failed to act on, previous offers from the plan.

The bill also would help ensure the inclusion of safety-net pharmacies in a prescription drug plan's network by preventing plans from specifically excluding 340B entities in the terms of their contracts. 340B entities include federally qualified health centers, migrant health centers, health centers for residents of public housing, school health centers, as well as black lung clinics, entities receiving grants for early intervention for HIV under the Ryan White Act, disproportionate share hospitals, and others. They serve more than ten million people.

Many of these entities operate their own pharmacies, which operate under different constraints than other retail pharmacies. They may have abbreviated hours or be available only to patients of the 340B entity. If 340B entities' pharmacies are not available as in-network pharmacies in Part D, these patients may have difficulty getting their prescription drugs.

The Model Safety Net Pharmacy Addendum was developed by the Centers for Medicare and Medicaid Services and the Health Research and Services Administration to facilitate 340B entities' participation in Medicare Part D. Because it takes the 340B entities' special circumstances into account, it has appropriate contract language for Part D plans to use when contracting with safety net pharmacies. Under the bill, plans would have to apply the Model Safety Net Pharmacy Addendum to their contracts if a 340B entity so requests.

The bill also would require plans to include a contract provision to allow these safety net pharmacies to waive cost-sharing if the entity so requests. Many safety-net pharmacies waive cost-sharing for their patients, but the Part D plan contracts typically prohibit this. Given that 340B entities serve low-income and poor populations, we believe those entities should be able to waive cost sharing for drugs, and our bill would facilitate that.

We have found that long-term care pharmacies similarly operate under conditions different from those of retail pharmacies serving the general population. For institutionalized populations, each resident's daily drugs must be specially packaged to help ensure that each gets the drugs meant for her, not for other residents. Long-term care pharmacies specialize in this, but the Part D rules to date do not adequately reflect how long-term care pharmacies work with long-term care facilities, which affects residents' access to these pharmacies. Our bill would require the Secretary to establish rules that include pharmacy access standards for long-term care residents.

Another problem that has arisen in the implementation of Part D concerns the ability of beneficiaries to obtain extended supplies of their drugs from a local pharmacy. Our bill therefore would ask the Secretary to establish standards for access to pharmacies that dispense extended supplies of covered drugs.

We have also heard from our local independent pharmacies that many, despite contract terms, face delayed payments from prescription drug plans. Given that the pharmacies must pay for their drugs on a more abbreviated schedule, these delays have created cash-flow crises for some pharmacies and put some at risk of closing. As much as I hate to legislate contract terms, I would hate more for the independent pharmacies in my State to close and my beneficiaries to be left without a pharmacy. In our bill, we would require plans to pay most pharmacies within 14 days upon receipt of an electronically submitted clean claim. For paper claims, they would have 30 days. If they were late, the prescription drug plans would have to pay the pharmacies interest. If a pharmacy submitted claims electronically and requested electronic payment, the plan would have to pay electronically.

Because long-term care pharmacies operate under unusual circumstances compared with retail pharmacies, our bill would allow pharmacies in long-term care facilities, or that contract with long-term care facilities, at least 30 days but no more than 90 days to submit their claims for reimbursement to the plans.

Another problem involves how plans use maximum allowable prices as the upper limit of what they will pay a retail pharmacy for the cost of a drug. What has come to light is that some plans will not disclose to the contracting pharmacies exactly what the maximum allowable prices are either when the contract is proposed to them or even after they sign the contract.

It seems unconscionable to me that a pharmacy would be expected to sign a contract where the price term is hidden and not disclosed. In the Medicare program, no other health care providers are subject to signing a contract in which they don't know what they will get paid.

Another abusive practice by some plans occurs when they do not update their maximum allowable prices in a timely manner. When a pharmaceutical company raises its price for a drug the pharmacy has to pay that new higher price right away. But the plan might not update what it pays for weeks. That leaves the pharmacy to absorb the difference. The plans that do this know exactly what they are doing. They know they are making the pharmacies eat the higher cost while they delay updating their payment rates. To address these concerns, the bill would require plans to disclose to pharmacies their ``maximum allowable cost'' pricing, and also to update those prices as they change, through an Internet website and a toll-free phone number.

Similarly, the bill would require plans to update their prescription drug pricing standard at least every seven days. The drug pricing standard changes frequently, and the price the pharmacy is paid is based on that standard, and so it seemed fair to us that the prescription drug plans' payments should reflect recent changes.

Our bill is intended to improve CMS's and prescription drug plans' service to pharmacies. It would require the HHS Secretary to establish a pharmacists' toll-free hotline. Prescription drug plans would have to establish separate pharmacists' and physicians' toll-free hotlines, and would have to comply with customer service standards established by the Secretary. We hope this will prevent pharmacists being placed on long holds when they have customers standing at the counter waiting for their drugs.

We have some questions about pharmacists' average dispensing fees, and under the bill the HHS Inspector General would conduct a study of dispensing fees, including studying whether the pharmacist is dispensing a standard prescription or an extended one; whether the pharmacist is in a chain store or an independent pharmacy; whether the pharmacy dispenses specialty pharmacy products, or is a

long-term care pharmacy. The Inspector General's report would be due October 1, 2008.

I believe that with these changes, the Medicare Part D program will work even better for beneficiaries and for the pharmacies that serve them. As we refine the Medicare Part D program, we want to build on its success even as we hope to make it fairer to all the stakeholders involved, the beneficiaries, the pharmacies, the PDP plans, and the manufacturers. I believe this bill does just that.

Mr. President, I rise to introduce legislation to reauthorize the U.S. Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003, known as the Leadership Act, the largest international health initiative in history dedicated to a single disease.

Five years ago, there was little hope in Africa and the developing world of an effective response to HIV/AIDS. Tragically, many of the nations hardest hit by this disease are among those with the fewest resources to draw on for a response. There appeared to be little basis for hope.

Today, the pandemic continues. Yet there has been a change, and the American people have led that change.

The original Leadership Act authorized $15 billion in appropriations over 5 years. And in a significant departure from earlier approaches to development, it linked that funding to accountability for goals: support for treatment of 2 million people, prevention of 7 million new infections, care for 10 million people, including orphans and vulnerable children.

As many Senators will recall, when this legislation was first enacted in 2003, it was done with a certain amount of haste and after a request from the President for quick action. The G-8 summit was fast approaching, but even more importantly, rapid Senate action meant that the program could be established quickly, so that money could start to flow quickly to the fight. Given this, the Senate acted swiftly, passing the bill almost without amendment.

Now we are approaching the expiration of that 5-year authorization at the end of fiscal year 2008. Whatever our misgivings about the Leadership Act as we enacted it in 2003, at this point we need to judge it by the results it has enabled us to deliver. Those results are simply remarkable.

At the time the Leadership Act was announced, only 50,000 people in all of sub-Saharan Africa were receiving antiretroviral treatment. Yet through March of this year, the act has supported treatment for over 1.1 million men, women and children, over a million of them are in Africa, in those 15 countries where AIDS was on the verge of wiping out whole generations. In addition to these focus countries, we are working with one hundred other countries as well touching millions of other lives. Five years ago, HIV was a death sentence. Now there is hope.

During the first 3\1/2\ years of the act, U.S. bilateral programs have supported services for pregnant women to avoid transmission of HIV to their babies during more than 6 million pregnancies. In over 533,000 of those pregnancies, the women were found to be HIV-positive and received antiretroviral prophylaxis, preventing an estimated 101,000 infant infections through March 2007.

Before the advent of the Leadership Act, there was little concerted effort to meet the needs of those orphaned by AIDS, or of other children made vulnerable by it. We have now supported care for more than 2 million orphans and vulnerable children, as well as 2.5 million people living with HIV/AIDS, through September 2006.

Effective prevention, treatment and care all depend to a large extent on people knowing their HIV status, so they can take the necessary steps to stay healthy. The U.S. has supported 18.7 million HIV counseling and testing sessions for men, women and children.

Across the act's programs, the majority of services have been provided to women and girls, and a growing number of services are reaching children.

Our financial investment in this fight has been critical to our success, and thanks in large part to the flexibility of the Leadership Act, we have been able to obligate over 94 percent of its available $12.3 billion appropriated through this fiscal year.

In addition to support for the U.S. bilateral programs, the Leadership Act has also authorized support for the Global Fund to Fight AIDS, Tuberculosis, and Malaria. The Global Fund provides an important avenue for the rest of the world to substantially increase its commitment, as we have done. The U.S. is the largest supporter of the Global Fund, having provided some $2 billion so far. It is important for the American people to understand and for the rest of the world to remember, that the American people are responsible for approximately \1/3\ of all the funding received by the fund.

As we survey the results achieved by this legislation, it is apparent that our efforts have been exceptionally successful. But to build on that success, we must reauthorize the legislation for another 5 years. As we consider how to accomplish that reauthorization task, it is important to note that the vast majority of the authorities needed for the next phase of our effort are already contained in the current Leadership Act.

The necessity for new authorities is in the eye of the beholder. Many Senators may wish to enhance issues such as TB/HIV, gender, nutrition, human capacity, infrastructure and health systems, and education. But the current law already articulates and authorizes activities in these very same areas, as evidenced by the many activities in these areas that the act has undertaken under existing authorities.

In this case, I believe we should follow the old adage, ``If it ain't broke, don't fix it.'' We have a good, if not perfect, law that is succeeding. In lieu of drafting an entirely new bill, today I introduce a reauthorization which preserves the bulk of the authorities that have enabled the program succeed and makes only minor modifications.

The U.S. Global AIDS Coordinator has interpreted the existing authorities well and has listened to the Congress and many stakeholders. As the Institute of Medicine recently said, the Global Leadership Act is a ``learning organization.'' The Coordinator is the first to admit, as he has before Congressional committees, that we can do better in every area of implementation. But new authorities are not needed; these are issues of implementation. In short, rather than absorbing the time of Congress, the coordinator, as well as stakeholders in drafting an entirely new bill, we should empower them to continue the work they are doing to improve upon program implementation utilizing the experience of these past 3\1/2\ years.

Let me highlight the basic changes I am suggesting to the existing legislation. First, it would increase to $30 billion the authorization for the next five fiscal years 2009-2013, a doubling of the initial commitment. I recognize that Senators may wish to revisit that funding level, and I trust that there will be opportunities for them to do so, in committee and on the floor.

Second, as the Institute of Medicine and others have argued, I believe we need to keep the bill as free of funding directives as possible in order to ensure maximum flexibility for implementation. I am proposing that only two funding directives be included, one modified from its current form, the other maintained as is.

The first modification would seek to address the abstinence directive in current law. The current Leadership Act requires that 33 percent of all prevention funding be spent on abstinence-until-marriage programs. The problem with this directive is that some countries need to focus their efforts not on abstinence per se but on, for example, mother-to- child transmission, an activity which is considered to be nonsexual transmission of HIV/AIDS. The original directive thus forced theses countries to either spend money in areas where they did not necessarily need to spend it or to divert funds from areas where they truly needed to.

The administration had interpreted and implemented this provision so as to include both abstinence and faithfulness programs, the `AB' of `ABC,' which stands for Abstinence, Be faithful, and the correct and consistent use of condoms. The directive has been helpful in ensuring an evidence-based, comprehensive approach to prevention. The ABC paradigm for prevention was developed in Africa by Africans, in order to address the wide range of risks faced by people within their nations, particularly in the context of generalized epidemics where HIV is widespread throughout the population. Recent evidence from a growing number of African countries shows a correlation between the adoption of all three of the ABC behaviors, and a clear association with declining HIV prevalence.

Before the creation of the U.S. Global Aids Coordinator, the U.S. Government had relatively little experience implementing behavior change programs for global HIV/AIDS that included the whole array of ABC behavior change. This was the rationale for the directive, and I believe it has served a useful purpose. However, I agree with many others that we can improve upon it as we look to the future.

The language I propose would provide that 50 percent of funding for prevention of sexual transmission of HIV, a sub-set all prevention funding, be dedicated to abstinence and faithfulness. This will enable greater flexibility to countries whose situation mirrors the one just described.

At the same time, the language would ensure the continuation of funding for abstinence and faithfulness programs as part of comprehensive, evidence-based ABC activities. I think this compromise approach is the right one that can win support from across the political spectrum and provide increased flexibility while ensuring continued support for comprehensive, evidence-based prevention.

There are a number of other directives in the current law that need no longer be maintained and the new bill does not contain them. The one other directive that I believe must be maintained is that 10 percent of funding be devoted to programs for orphans and vulnerable children, or ``OVCs''. As I have noted, there were few programs focused on the needs of these children before the Leadership Act of 2005 and we remain in the early stages of the essential effort to serve them. This is one of the aspects of our effort that is most strongly supported by the American people, the maintenance of this directive will help to ensure that this effort remains focused on those who need our support the most. The directive will also help ensure the success of the Assistance for Orphans and Other Vulnerable Children in Developing Countries Act of 2005, a bill I drafted, one cosponsored by eleven of my Senate colleagues, and which the Congress passed in October 2005.

Finally, let me describe some new language proposed for the inclusion regarding the Global Fund, an organization that enjoys wide support here in Congress. The Global Fund is a critically important partner of the U.S. in our fight against HIV/AIDS. Our contributions are not only financial, we are also active on its board, and our U.S. personnel overseas provide the technical assistance needed for the Global Fund's grants to work.

However, the fund is subject to pressures from many donors and in many directions. It has become clear that it would benefit from greater transparency and accountability. In keeping with my concerns with transparency and accountability of international organizations that receive U.S. funding, including the World Bank and International Monetary Fund, my proposed language would establish similar benchmarks for U.S. funding for the Global Fund. I don't believe any of these proposed benchmarks will be controversial, but if Senators have concerns about any of them, I look forward to working with them to address them.

It is also worth noting that the bill would maintain the limitation in the existing Leadership Act that U.S. contributions to the fund may never exceed 33 percent of its funding from all sources. This limitation has proven to be a valuable tool for increasing contributions to the fund from other funding sources, such as other governments, and I believe there is wide agreement that this provision should be maintained as we move forward.

In closing, let me turn to the issue of legislative timing. It is critical to the contents of my approach to reauthorization. It is critically important to reauthorize this bill during 2007, as opposed to awaiting its expiration September 2008.

The US Global Aids Coordinator depends on his implementing partners, including host governments and nongovernmental organizations, including faith- and community-based organizations, to scale up programs rapidly to reach as many people as possible. They have been a critical part of programs success to date.

But HIV and AIDS are different from many diseases: once HIV-positive persons are provided treatment or orphans enrolled in care programs, their treatment and care become ongoing commitments for program partners. Thus, for partners to continue to scale up programs in 2008, they need assurances of a continued U.S. commitment beyond 2008. These partners recognize that at this point, they have only a Presidential proposal, not actual reauthorization.

In fact, some of my staff on the Foreign Relations Committee have recently returned from countries receiving our assistance and verified this concern. Various ministries of health are refusing to expand the number of patients currently receiving antiretroviral medication for fear that they will not receive enough money in the years to come to purchase next year's doses for these new patients.

Without reauthorization in 2007, partners have indicated that they will be unable to scale up programs in 2008, and as my staff have confirmed, there is already evidence that some have begun to slow enrollment in programs. Without continued rapid scale-up this year and next, we may not achieve the ambitious goals for the first phase of PEFPAR, treatment for 2 million, prevention of 7 million new infections, care for 10 million, including orphans and vulnerable children. However, time will be needed to develop sustainable programs with commitments from our partner countries as we move into the next 5- year commitment from the American people.

Thus it is essential that we act before we go out of session this year. I recognize that we face a crowded calendar. But we can do it if we will take the most direct path to passage, a clean bill.

This body can be proud of its contribution to the remarkable turnaround on the issue of global HIV/AIDS, from concern to action. We have represented well the compassion and generosity of the American people and the demand for accountability by the American taxpayer. I call on my colleagues to join me in sponsoring this bill to reauthorize the Leadership Act in 2007, and to extend the authorities that have enabled the American people to make such a difference in the lives of others.

I have no pride of authorship. But we need to start the reauthorization process now. I welcome the involvement

and inputs of my colleagues. We should let the mark-up and amendment process work. Secondly, I would welcome the assistance of other Committees and their memberships. Thirdly, I look for strong support and guidance from the NGO and faith-based communities. These organizations will be key to the reauthorization effort. We will require the constructive engagement of the administration in this reauthorization effort.

If we pull together and display the spirit of compromise necessary for good legislation, we can complete the job in 2007.

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

Mr. President, today I introduce the Co-Teaching Educator Professional Development Act of 2007 to help improve the education of children with disabilities.

A result of the enactment of the No Child Left Behind Act, NCLB, and the 2004 reauthorization of the Individuals with Disabilities Education Act, IDEA, is that States, districts, and schools in Rhode Island and nationwide have increasingly begun utilizing a ``co-teaching'' model to make sure that students with disabilities have the highest quality teachers. Co-teaching is a term that describes a general education teacher and a special education teacher jointly teaching students with and without disabilities in the same classroom. Co-teaching ensures that students with disabilities receive not only the special instruction, supports, and services they are entitled to under IDEA, but also are taught the same rigorous academic content as any other students.

However, achieving this is no easy task. Successful co-teaching requires that educators truly work together so their knowledge and skills truly complement one another. At the end of the day that requires that specialized professional development is provided to these teachers.

As such, the Co-Teaching Educator Professional Development Act of 2007 would amend Title II of the No Child Left Behind Act to award competitive grants to school districts to provide high-quality professional development opportunities for general education teachers, special education teachers, principals, and administrators to ensure that these educators have the necessary pedagogical, collaborative, planning, and interpersonal skills to successfully implement a co- teaching model and increase the achievement of students with disabilities. Such professional development training would help teachers, principals, and administrators address diverse learning and student needs; clearly define classroom, teaching, and decision-making responsibilities; develop effective communication, problem-solving, classroom management, and conflict resolution skills; and jointly develop and plan a student's IEP and overall classroom curriculum.

In short, this bill provides teachers, principals, and administrators with the skills and tools to help ensure that children with disabilities receive the

educational assistance and support they need and deserve. I urge my colleagues to cosponsor this legislation and work for its inclusion in the reauthorization of the Elementary and Secondary Education Act.

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

Mr. President, today I introduce the School Improvement through Teacher Quality Act of 2007, to foster the development of a highly skilled and effective teacher workforce capable of improving student achievement in this country.

We are slated to reauthorize the Elementary and Secondary Education Act this Congress for the first time since 2001. The key to this reauthorization will be ensuring that states, districts, and schools are given the resources, tools, and support to improve student learning, including targeted, high-quality efforts to improve a school when it is identified as in need of improvement under the law.

Improving teacher quality is the single most effective step we can take to increase student achievement and turnaround failing schools. Studies have found that 40 to 90 percent of the difference in student test scores can be attributed to teacher quality. Unfortunately, new teachers, not just those in hard-to-staff schools, face such challenging working conditions that nearly half leave the profession within their first 5 years, one-third leave within their first 3 years, and 14 percent leave by the end of their first year.

However, research has shown that offering new teachers comprehensive, multi-year mentoring and guidance cuts attrition rates in half, and helps these teachers become high-quality professionals who improve student achievement. At the same time, we know that experienced teachers also need effective, sustained professional development to maintain and improve their teaching skills.

For these reasons, I am introducing the School Improvement through Teacher Quality Act of 2007, cosponsored by Senators Murray, Obama, and Brown. This legislation amends Title II of the No Child Left Behind Act to create a new $500 million formula-based program for school districts to provide targeted assistance so teachers in low-performing, high- poverty schools get comprehensive, high-quality multi-year guidance and mentoring for new teachers and systematic, sustained professional development for experienced teachers.

First, this legislation would direct funding to districts with failing schools to help implement a high-quality induction program for teachers throughout at least their first two years of full-time teaching. This intensive support for beginning teachers would incorporate proven strategies such as: rigorous mentor selection; ongoing mentoring with school-protected release time; research-based professional development for mentors and school leaders; and research- based teaching practices, formative assessments, and teacher portfolios. Research has demonstrated that such mentoring for beginning teachers at institutions like the New Teacher Center at University of California, Santa Cruz provides a return on investment, $1.66 for every $1

spent; increases the new teacher retention rate, to 88 percent after 6 years in some California districts; and strengthens beginning teacher effectiveness to such an extent that their students demonstrate learning gains similar to those students of their more veteran counterparts.

Second, the School Improvement through Teacher Quality Act of 2007 would offer funding for struggling schools to provide their veteran teachers with ongoing professional development and training, including helping such schools develop and implement rigorous curricula aligned to State standards and student needs; design and evaluate assessments; implement strategies to improve student achievement and teacher effectiveness; train teachers, principals, and administrators in effective coaching strategies, analyzing school and student data, and strategies for teaching students with disabilities and English Language Learners; and utilize teacher leaders, coaches, or content experts to support learning and model effective collaboration skills.

This assistance would be tied to a modified definition of professional development based on successful nationwide models such as the National Staff Development Council, with an increased focus on collaboration among teachers, including engaging established teams of teachers to plan and develop instruction across grade level and content area and to evaluate and analyze data on student achievement and learning goals. This professional development would occur multiple times per week during the regular work day, and be supported by school principals through school-based coaches, mentors, or lead teachers who allocate time, resources, and structured facilitation to the learning teams or cohorts.

Lastly, this legislation requires that an external evaluation be conducted of the mentoring and professional development programs authorized and supported under this act. Outcomes would be based on measures such as teacher retention, student learning gains, teacher instructional practice, and parent, family, and community involvement.

We must act on this bill and continue to push for increased Federal investment in improving schools through enhanced teacher quality and professional development. The stakes are too high, not just in terms of meeting the current highly qualified requirements of the No Child Left Behind Act, but to take the next step and ensure that each and every classroom in America is taught by an effective teacher. Teachers are the key to student success and student success will in turn keep our country competitive in today's global economy.

I urge my colleagues to cosponsor this legislation and work for its inclusion in the reauthorization of the Elementary and Secondary Education Act.

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

Mr. President, today I am introducing the No Child Left Inside Act of 2007, which will provide new support for environmental education in our Nation's classrooms. Given the major environmental challenges we face today, teaching our young people about their natural world should be a priority, and this legislation is an important first step.

For more than three decades, environmental education has been a growing part of effective instruction in America's schools. Responding to the need to improve student achievement and prepare students for the 21st century economy, many schools throughout the Nation now offer some form of environmental education. Mr. President, 30 million students and 1.2 million teachers annually are involved in these programs.

Yet, environmental education is facing a significant challenge. Many schools are being forced to scale back or eliminate environmental programs. Fewer and fewer students are able to take part in related classroom instruction and field investigations, however effective or popular. State and local administrators, teachers, and environmental educators point to two factors behind this recent and disturbing shift: the unintended consequences of the No Child Left Behind Act and a lack of funding for these critical programs.

The legislation that I am introducing today would address these two causes. It would provide funding to States to train their teachers in the field of environmental education, and it would provide support for outdoor environmental education programs for children and a model environmental education curriculum. The bill would also create incentives, through new funding, for states to develop environmental literacy plans to make sure students have a solid understanding of our planet and its precious natural resources. Finally, the legislation would reestablish the Office of Environmental Education within the U.S. Department of Education to oversee critical environmental education activities. This legislation has broad support among national and state environmental groups and educational groups.

The American public recognizes that the environment is already one of the dominant issues of the 21st century. In 2003, a National Science Foundation panel noted that ``in the coming decades, the public will more frequently be called upon to understand complex environmental issues, assess risk, evaluate proposed environmental plans and understand how individual decisions affect the environment at local and global scales. Creating a scientifically informed citizenry requires a concerted, systemic approach to environmental education ...'' In the private sector, business leaders also increasingly believe that an environmentally literate workforce is critical to their long-term success. They recognize that better, more efficient environmental practices improve the bottom line and help position their companies for the future.

Climate change, conservation of precious natural resources, maintaining clean air and water, and other environmental challenges are pressing and complex issues that influence human health, economic development and national security. Finding widespread agreement about the specific steps we need to take to solve these problems is difficult. Environmental education will help ensure that our Nation's children have the knowledge and skills necessary to address these critical issues. In short, the environment should be an important part of the curriculum in our schools.

I know my constituents in Rhode Island, as well as the residents of other States, want their children to be environmentally literate and have a connection with the natural world. I am proud to sponsor this important legislation. I look forward to working with my colleagues to enact the No Child Left Inside Act of 2007. I ask unanimous consent that the text of the bill and a letter of support be printed in the Record.

Mr. President, today I am pleased to join Senator Grassley in introducing the Continuing the Advancement of Quality Improvement Act of 2007.

This bill represents another step in our commitment to improving the quality of care provided for Medicare beneficiaries and all Americans.

The Medicare program funds Quality Improvement Organizations, known as QIOs, in part to work with health care providers to help them improve the quality of care they provide.

QIOs have played an evolving role in Medicare. Recently, the QIO program has received a great deal of attention. Not only did Senator Grassley and I have the Senate Finance Committee look into aspects of QIO operations, but the Institute of Medicine, the Government Accountability Office, and the Health and Human Services' Inspector General have all opined about QIOs as well. It seems there is a consensus that the QIO program could be doing more to help improve the quality of care.

That is not to say that QIOs have not been doing good work and providing valuable services up until now. Quite the opposite. However, over the course of time, QIOs have been tasked with a number of responsibilities and the program's mission has become blurred.

What Senator Grassley and I found, as well as the IOM, the GAO, and the HHS, OIG, is that the QIO program needs a sharper focus. Its mission to improve quality must be clear and unambiguous. Therefore, the Continuing the Advancement of Quality Improvement, or CAQI, Act would focus QIOs on providing technical assistance for quality improvement and performance measurement.

The bill would separate the beneficiary complaint process from QIOs and give this responsibility to Medicare Provider Review Organizations, which will be required to report to the complainant and refer the provider to a QIO for technical assistance and/or the appropriate regulatory body for sanctions. This will make the complaint review process stronger.

The CAQI Act would ensure that QIOs devote their attention to the health care providers that need help the most. It would also permit sharing QIO data with providers for quality improvement and patient safety purposes.

The Finance Committee investigation of the QIO program led Senator Grassley and I to include certain provisions we believe will enhance the integrity of the program. So, the CAQI Act would promote competition by allowing other types of organizations to serve as QIOs and eliminating noncompetitive renewals.

To ensure ``corporate'' integrity, the CAQI Act would establish requirements for governance and boards of directors at the QIOs, as well as requiring CMS to establish ways to avoid conflicts of interest.

The CAQI Act aims to ensure greater accountability for individual QIOs, and the QIO program as a whole. It would require the Secretary to perform evaluations of the effectiveness of each QIO and the whole program. QIOs would be evaluated on consistent measures that are based on nationwide priorities for quality improvement. The Secretary would be required to report to Congress annually on QIO performance, including how program funds were spent.

The QIO program is an asset to the Medicare program and the health care system in general. We have an opportunity to improve its effectiveness. We can make it a more useful tool as we continue advancing toward quality improvement. We have a duty to make the Medicare program as strong and robust as it can be. The Continuing the Advancement of Quality Improvement Act presents an opportunity to do just that. Senator Grassley and I urge our Colleagues to support it.

Mr. President, today I am introducing the Pharmacy Access Improvement Act of 2007. This is an updated version of a bill I introduced last year, and I am proud to bring it back.

I am excited that this year's bill is bipartisan. I am happy that Senator Grassley has joined me in introducing this bill. Given all of our work together on the Medicare prescription drug benefit, I am glad he is a cosponsor. I also am pleased to have our Senate colleagues join us on this important piece of legislation.

The Medicare prescription drug benefit got off to a bumpy start last year. A lot of the problems have been fixed, and the benefit is providing millions of seniors with access to affordable prescription drugs. Unfortunately, a number of the problems facing pharmacists remain. We need to help them.

The Medicare drug benefit brought about big changes to the pharmacy business. Dual eligible beneficiaries switched from Medicaid to Medicare drug coverage. Many more seniors have drug coverage. Dozens of new private drug plans are available.

I have heard from pharmacists in Montana who are struggling. They are trying to help their patients. But they face great difficulty. The success of the Medicare drug benefit depends on the pharmacists who deliver the drugs. So we have to help them. We must act now, before pharmacists find that they are no longer able to provide drugs to Medicare beneficiaries, or to provide drugs at all.

The Pharmacy Access Improvement Act would do several things to help pharmacies. First, it would strengthen the access standards that drug plans have to meet. It is important that the drug plans contract with broad and far-reaching networks of pharmacies. This bill would ensure that the pharmacies that drug plans count in their networks provide real access to Medicare beneficiaries.

It would also help safety net pharmacies to join drug plan networks. These pharmacies serve the most vulnerable patients and should be able to continue to do so. Drug plans should not be allowed to exclude safety net pharmacies. Excluding them does a huge disservice to needy beneficiaries. This bill would rectify the problems that safety net pharmacies have encountered in participating in the Medicare drug benefit.

The Pharmacy Access Improvement Act would speed up reimbursement to pharmacies. The delays in receiving payment from drug plans have forced pharmacies to seek additional credit, dip into their savings, or worse, as they try to continue operations. This bill would require drug plans to pay promptly. Most claims would be reimbursed within 2 weeks. And the bill would impose a monetary penalty on plans that pay late.

One of the most common complaints from beneficiaries has been how confusing the practice of co-branding is. Co-branding is when a drug plan partners with a pharmacy chain and then includes the pharmacy's logo or name on its marketing materials and identification cards. This is confusing, because it sends the message that drugs are available only from that pharmacy. That is not true. To help end this confusion, the Pharmacy Access Improvement Act would prohibit drug plans from placing pharmacy logos or trademarks on their identification cards and restrict other forms of co-branding.

This bill would also require that plans provide pharmacists with more accurate and updated information about reimbursement rates. Currently, some plans do not divulge to pharmacists how much a particular prescription will be reimbursed prior to dispensing. This bill would require disclosure before a pharmacist dispenses. It would require regular updating and disclosure of pricing standards.

The problems that pharmacists are facing are real. And they are not going away. We must act on the Pharmacy Access Improvement Act before it is too late for many pharmacists and the beneficiaries whom they serve. We have a duty to make the Medicare drug benefit as strong and robust as it can be. And the Pharmacy Access Improvement Act presents an opportunity for us to do just that. My cosponsors and I urge our colleagues to support it.

Mr. President, I want to begin my remarks by commending the thousands of case workers, foster families, neighbors and friends across the country that work to provide safety, stability, and love for the more than half a million children in the Nation's foster care system. More than a third of foster children in Montana are Native American. Across America, most of the Native American children in foster care are under the jurisdiction of tribal courts. But Native American tribes that want to administer their own child welfare systems are not eligible for Title IV-E funds to run their own foster care and adoption programs.

Today I am proud to introduce with Senators Domenici, Bingaman, Smith, Stabenow, McCain, and Cantwell the Tribal Foster Care and Adoption Act of 2007. This legislation is a demonstration of the commitment on both sides of the aisle to provide tribes with the opportunity to care for their own children. Children that need foster care and adoption services because of the abuse and neglect that they have already suffered. This bill provides tribes with the ability to serve their children directly with culturally appropriate care and understanding. The legislation also recognizes the good work of states and their collaborative efforts with tribes on behalf of tribal children.

This legislation has had a long history in the Senate and I am pleased to have been a part of that history since the 107th congress. It has been introduced in every Congress since then always with bipartisan support. This bill's time has come.

We have worked very hard to fine tune this legislation in away that is fair to states and finally gives Tribes direct access to the child welfare system. We want a system set up to protect those that need our protection the most not to exclude the most vulnerable members of our society from direct participation.

The child welfare system is languishing because of inadequate funding. And the system also suffers from a lack of culturally- appropriate approaches to help tribal children to find loving, permanent homes. I am further committed to working on behalf of our child welfare system with Chairman Grassley and with Senator Rockefeller who have always been dedicated to child welfare issues. The Tribal Foster Care and Adoption Act provides a pivotal opportunity to ensure that tribes across our country have the ability to access the child welfare system. I see this as a first step in making much needed improvements to the country's child welfare system, without significant costs or new federal programs.

We owe the first inhabitants of this great Nation and their children a child welfare system that works for them. We must do all we can to provide help.

Mr. President, the spread of nuclear weapons and related technology and the possibility that a nuclear weapon could fall into the hands of terrorists constitute the most urgent threat to our national security. As experts on this issue such as Henry Kissinger, George Shultz, Bill Perry, and Sam Nunn have all warned, our current policies to deal with the threat posed by nuclear weapons are simply not adequate.

We know al-Qaida has made it a goal to acquire a nuclear weapon. At the same time, significant quantities of the material necessary to make one remain vulnerable to theft in various parts of the world. And, to make matters worse, the world may be on the brink of a new and dangerous era with a growing number of nuclear-armed states, as illustrated by North Korea's nuclear test last year and Iran's refusal to halt its uranium enrichment program.

So today, along with Senator Hagel, I am introducing the Nuclear Weapons Threat Reduction Act, which provides for sustained U.S. leadership in a global effort to prevent nuclear terrorism, reduce global nuclear arsenals, and stop the spread of nuclear weapons around the world.

Securing nuclear weapons and weapons-usable material at their source is the most direct and reliable way to prevent nuclear terrorism. Thanks to the leadership of Senators Nunn and Lugar in creating the Cooperative Threat Reduction program at the Department of Defense, there is no question that we have made significant progress in securing nuclear stockpiles. But there are still significant quantities of weapons-usable nuclear material that remain vulnerable to theft. In the civilian sector alone, there are an estimated 60 tons of highly enriched uranium, enough to make over 1,000 nuclear bombs, spread out at facilities in over 40 countries around the world. Many of these facilities do not have adequate physical security, leaving the material vulnerable to theft.

The insecure storage of nuclear stockpiles has already led to an alarming number of attempted exchanges of small quantities of dangerous nuclear materials. The International Atomic Energy Agency, IAEA, confirmed 16 incidents between 1993 and 2005 that involved trafficking in relatively small amounts of highly enriched uranium and plutonium. That is 16 incidents too many, in my opinion, and 16 incidents that should not have been allowed to happen.

Experts believe that a sophisticated terrorist group could potentially construct a crude nuclear bomb if it obtained the necessary amount of plutonium or highly enriched uranium. The 9/11 Commission concluded that a trained nuclear engineer with an amount of highly enriched uranium or plutonium about the size of a grapefruit or an orange could make a nuclear device that would level Lower Manhattan. Simply put, our ability to secure nuclear stockpiles around the world is what stands between the safety of the American people and a terrorism incident of almost unimaginable horror.

It is imperative that we build and lead a truly global effort to secure all stockpiles of nuclear weapons and weapons-usable material to the highest standards to prevent them from falling into the wrong hands. It is also essential that we make preventing nuclear terrorism a top presidential priority--with the resources, diplomatic effort and funding to match the threat. We need to work with other countries to ensure effective and sustainable security of nuclear stockpiles and to ensure that the highest priority is placed on security of those weapons and materials that pose the greatest risk.

The Nuclear Weapons Threat Reduction Act requires the President to submit to Congress a comprehensive threat reduction plan for ensuring that all nuclear weapons and weapons-usable material at vulnerable sites are secure by 2012. The plan must clearly designate agency responsibility and accountability, specify program goals and metrics for measuring progress, and outline estimated schedules and budget requirements.

To meet this ambitious goal, the bill calls for accelerating U.S. programs to secure, consolidate, and reduce stocks of nuclear weapons and weapons-usable material, including highly enriched uranium at civilian nuclear facilities worldwide. Additional funding is authorized for the Department of Energy's Global Threat Reduction Initiative, an important program that secures and removes high-risk nuclear materials from vulnerable locations around the world.

The bill calls for the United States to work cooperatively with other countries and the International Atomic Energy Agency, IAEA, to develop and implement a comprehensive set of standards and best practices to provide effective physical protection and accounting for all stockpiles of nuclear weapons and weapons-usable material.

The bill also authorizes additional funding to improve our ability to trace the origin of nuclear material that might be transferred or used in a terrorist attack so that responsible parties can be held accountable.

Given the nature of the threat we face from nuclear terrorism, we can't succeed if we act alone. Indeed, the danger of nuclear proliferation and nuclear terrorism reminds us of how critical global cooperation will be to U.S. security in the 21st century. America must lead in rebuilding the alliances and partnerships necessary to meet common challenges and confront common threats. And this legislation seeks to provide the tools to do just that.

While nuclear terrorism remains a dire threat to our security, it is only one part of the overall threat posed by nuclear weapons. The Nuclear Weapons Threat Reduction Act also addresses the need to reduce global arsenals and prevent the emergence of additional nuclear-armed nations. In all too many respects, the essential bargain that stands at the core of the nuclear nonproliferation regime is unraveling. Countries like North Korea and Iran are demonstrating that nuclear technology acquired for ostensibly civilian purposes can provide the basis for producing nuclear weapons. At the same time, established nuclear powers retain large arsenals and are reemphasizing the importance of nuclear weapons to their security.

At the end of the Cold War, many had hoped and believed that the world was moving in the right direction to reduce the threat of nuclear weapons. America and Russia agreed to significant reductions in their massive nuclear arsenals. Belarus, Kazakhstan, and Ukraine were persuaded to give up their post-Soviet nuclear arsenals. The U.S.- Russian Cooperative Threat Reduction or Nunn-Lugar program was established. In 1994, North Korea agreed to halt its plutonium production program. And in 1995, over 180 nations agreed to take further steps to strengthen the Nuclear Nonproliferation Treaty, NPT, and agreed to extend the treaty indefinitely.

In the last 6 years, however, these positive trends have stalled--and in some cases regressed. While promising to leave the Cold War behind, President Bush abandoned the very policies his successors had pursued to bring the Cold War weapons competition to a peaceful and successful end. He unilaterally withdrew the U.S. from the Anti-Ballistic Missile Treaty. He refused to support ratification of the 1996 Comprehensive Nuclear Test Ban Treaty. He opted for an arms reduction agreement with Russia in 2002 that does not include new verification provisions, does not require the dismantling of warheads or missiles, and allows each side to stockpile thousands of nondeployed weapons. And after ignoring the findings of U.N. weapons inspectors on the ground and launching a preemptive war against Iraq, President Bush lost much of the international goodwill that is required to mobilize global support to strengthen the beleaguered nuclear nonproliferation regime.

The Nuclear Weapons Threat Reduction Act calls for a balanced and comprehensive set of initiatives that would strengthen the global nonproliferation regime. The bill authorizes $50 million to support the creation of a low enriched uranium reserve administered by the IAEA that would help guarantee the availability of fuel for commercial nuclear reactors. This international fuel bank can play an important role in dissuading countries from building their own uranium enrichment facilities. Additional funding is also authorized for the IAEA's Department of Safeguards to improve its ability to conduct effective inspections.

To win the struggle against nuclear proliferation, we must also have the courage to lead by example. The bill calls for talks with Russia to reduce the number of nonstrategic nuclear weapons and further reduce the number of strategic nuclear weapons in Russian and U.S stockpiles in a transparent and verifiable fashion, and in a manner consistent with the security of the United States. It also calls for considering changes in the alert status of U.S. and Russian forces to reduce the risk of an accidental, unauthorized, or mistaken launch of nuclear weapons.

Other initiatives called for in the bill include reaffirming support for and strengthening the Nuclear Non-Proliferation Treaty, taking steps to reconsider and ratify a global ban on nuclear testing, pursuing a long-overdue global agreement to verifiably halt the production of fissile material for weapons, and fully implementing the Lugar-Obama initiative that strengthens the ability of friendly foreign countries to stop the transfer of weapons of mass destruction and related material.

With a bold, comprehensive approach and strong U.S. leadership, we can--and must--make significant strides in reducing the threat posed by nuclear weapons. America must lead the way again by marshalling a global effort to meet the challenge that rises above all others in urgency securing, destroying, and stopping the spread of weapons of mass destruction. This bill, I believe, makes a significant contribution toward that goal, and I urge my colleagues to support this legislation.