[Congressional Record (Bound Edition), Volume 148 (2002), Part 8]
[Senate]
[Pages 11315-11331]
[From the U.S. Government Publishing Office, www.gpo.gov]




          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

      By Mr. BROWNBACK (for himself and Mr. Conrad):
  S. 2674. A bill to improve access to health care medically 
underserved areas; to the Committee on the Judiciary.
  Mr. CONRAD. Mr. President, today I join Senator Brownback in 
introducing important legislation aimed at ensuring that a piece of the 
puzzle regarding adequate physician services in underserved communities 
is preserved.
  By all accounts, the Conrad State 20 J-1 Visa Waiver program has been 
a great success at bringing crucially-needed doctors to medically-
underserved areas. It has served as a wonderful resource for my State 
and for other States across our Nation. The bill we are introducing 
today eliminates the program's sunset date, thereby making sure that 
this much-needed program remains available.
  I created the Conrad State 20 program in 1994 to deal with the 
reality that many areas of the country, especially rural communities, 
have a very difficult time recruiting American doctors. These health 
facilities have had

[[Page 11316]]

no other choice but to turn to foreign medical graduates to fill their 
needs. J-1 visa waivers allow foreign physicians to practice in 
medically-underserved communities after their J-1 status has expired 
without first returning to their home countries. These waivers allow 
foreign physicians to receive nonimmigrant, H-1B status, temporary 
worker in specialty occupation, for 3 years. In order to receive the 
waiver, the physician must agree to serve the medically-underserved 
community for the full three years. If he or she fails to fulfill that 
commitment, the physician is subject to immediate deportation.
  Prior to the creation of my State 20 program, J-1 visa waiver 
exclusively involved finding an ``interested Federal agency'' to 
coordinate the request. This was found to be a long, cumbersome, and 
bureaucratic process. By allowing States to directly participate in the 
process of obtaining waivers, my program relieves some of the burdens 
on participating Federal agencies and allows decisions regarding a 
State's health care needs to be made at the State level by the people 
who know best.
  I have shepherded the Conrad State 20 program from its creation in 
1994 through a subsequent reauthorization and other improvements over 
the years. By now removing the program's sunset date, the bill that 
Senator Brownback and I are introducing today will ensure that this 
important program remains a part of a State's tool belt in dealing with 
physician-shortages in medically-underserved areas.
  Our bill also provides for a modest increase from 20 allowable Conrad 
State 20 visa waivers per State per year to 30. For some time, a number 
of States have been bumping up against the State 20 ceiling, and my 
hope is that this increase will help additional medically underserved 
communities throughout the country procure the physician services they 
need.
  I urge my colleagues to support this legislation.
                                 ______
                                 
      By Mr. SARBANES (for himself, Mr. Warner, Ms. Mikulski, and Mr. 
        Allen):
  S. 2675. A bill to amend the Elementary and Secondary Education Act 
of 1965 to establish a pilot program to make grants to eligible 
institutions to develop, demonstrate or disseminate information on 
practices, methods, or techniques relating to environmental education 
and training in the Chesapeake Bay watershed; to the Committee on 
Health, Education, Labor, and Pensions.
  Mr. SARBANES. Mr. President, today I am introducing legislation to 
establish an environmental education program for elementary and 
secondary school students and teachers within the Chesapeake Bay 
watershed. This measure would provide grant assistance to elementary 
and secondary schools, school districts and not-for-profit 
environmental education organizations in the six-state watershed to 
support teacher training, curriculum development, classroom education 
and meaningful Bay or stream outdoor experiences. It would also enable 
the U.S. Department of Education to become an active partner in the 
Chesapeake Bay Program. Joining me as co-sponsors of this legislation 
are my colleagues Senators Mikulski, Warner, and Allen.
  There is a growing consensus that a major commitment to education, to 
promoting an ethic of responsible stewardship and citizenship among the 
nearly 16 million people who live in the watershed, is necessary if all 
of the other efforts to ``Save the Bay'' are to succeed. The ultimate 
responsibility for the protection and restoration of Chesapeake Bay is 
dependent upon the individual and collective actions of this and future 
generations. As population growth and development continue to place 
enormous pressures on the Chesapeake Bay region's natural resource 
base, we must learn how to minimize the impacts that we are having on 
the Bay. Our future depends upon our ability to use the Bay's resources 
in a sustainable manner. This is as much a civic responsibility as 
voting. Developing an environmentally literate citizenry that has the 
skills and knowledge to make well-informed choices and to exercise the 
rights and responsibilities as members of a community is clearly one of 
the best ways to raise generations who can be contributors to a healthy 
and enduring watershed. In my judgment, this can best be accomplished 
by expanding assistance for environmental education and training 
programs in the K-12 levels.
  In addition to stewardship, there are other dimensions to expanding 
environmental education opportunities in the Chesapeake Bay region that 
are equally compelling. A number of recent studies have found that 
environmental education also enhances student achievement, critical 
thinking and basic life skills. A 1998 report by the State Education 
and Environment Roundtable, perhaps the most comprehensive study to 
date, documents how 40 schools in 12 States, including three schools in 
Maryland and four schools in Pennsylvania, achieved remarkable 
academic, attitudinal and behavioral results by using the environment 
as an integrating strategy for learning across all subject areas. 
According to the study, students performed better in science, social 
studies, math and reading. Classroom discipline problems declined and 
students demonstrated increased engagement and enthusiasm in learning 
in an environment-based context. Moreover, students' creative thinking, 
decision-making and interpersonal skills were enhanced by environment-
based learning.
  The report is replete with success stories, but I will just cite two 
examples from schools in the Chesapeake Bay watershed. According to the 
report, students in the 4th grade at Hollywood Elementary School in 
Maryland scored 27 percent higher on the Maryland State Performance and 
Assessment Program test than at other schools in their county and 43 
percent higher than the State as a whole after the school implemented 
the environmental based education program. The study also found 
behavior improvements and reduced discipline problems for 6th graders 
participating in the STREAMS program at Huntingdon Area Middle School 
in Pennsylvania compared to students not involved in the program. I ask 
unanimous consent that excerpts from this study regarding these two 
schools be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

          [From the State Education and Environment Rountable]

 Closing the Achievement Gap--Using the Environment as an Integrating 
                          Context for Learning

              (By Gerald A. Lieberman and Linda L. Hoody)


               HOLLYWOOD ELEMENTARY: A LIVING LABORATORY

       Adults in Saint Mary's County, Maryland, a wedge of 
     farmland bordering the Chesapeake Bay, had tried for 25 years 
     to start a community recycling program; for some reason the 
     idea just never caught on. But once the fifth graders at 
     Hollywood Elementary School decided to solve the problem it 
     did not take long for them to turn their campus into a 
     neighborhood recycling center.
       It was the children's enthusiasm more than anything that 
     motivated parents and neighbors to join their efforts. Soon, 
     Hollywood's hallways bulged with giant boxes of old 
     newspapers and the school's parking lot became a regular 
     Saturday-morning stop for residents eager to dump their cans 
     and glass. Teachers helped, but students ran the show. 
     Parents offered their vans, trucks, and even horse trailers 
     to help haul the goods to the nearest recycling station in 
     the next county. Eventually Saint Mary's County itself caught 
     on, set up a few recycling transfer stations of its own and 
     hired a recycling coordinator. But it all started at 
     Hollywood.
       ``It was just as grass-roots as anything can get,'' 
     remembers Betty Brady, the teacher who initiated the project. 
     ``We were a very small school at the time, less than 300 
     students, and we became a little place where people 
     rallied.''
       Hollywood Elementary is not such a little place anymore. 
     Enrollment is up to 600 now, housed in a spacious new 
     facility designed to accommodate the real-world teaching that 
     Brady and her colleagues practice. But the campus remains a 
     rallying point for parents, educators, and other area 
     residents dedicated to the task of maximizing individual 
     learning through integrated, environment-based education.
       During the past 15 years, aided by community volunteers and 
     funded through a series of small grants from the Chesapeake 
     Bay Trust, Hollywood's students have turned their 72-acre 
     campus into a living lab--blazing a nature trail, creating a 
     butterfly garden, planting a forest habitat for migrating

[[Page 11317]]

     birds, and transforming a drainage pond into a natural 
     wetland. Each project capitalized on the children's innate 
     attraction to the natural world while providing unique 
     opportunities to combine traditional subject areas in a 
     meaningful whole. The results? At Hollywood Elementary, 
     education works.
       ``As teachers, we always look at what works with and for 
     children, paying attention to what causes that learner 
     engagement that's so crucial to learning that lasts,'' 
     explained principal, Kathleen Glaser. ``We're very concerned 
     about not just teaching something so that students can pass a 
     test and then forget it a month later, but teaching something 
     that will be part of their knowledge base, something they can 
     work from to solve problems and enhance their lives.''
       Glaser and her staff, as well as the parents and students 
     of Hollywood Elementary, clearly believe the school's real-
     world emphasis produces that kind of learning. And recent 
     empirical evidence confirms it. Since 1992, the state of 
     Maryland has required a year-end performance assessment for 
     all students in grades three, five, and eight. It is a 
     demanding yardstick, build around a child's ability to 
     perform integrated tasks, such as life-science experiments 
     and writing research reports. But it is a perfect tool to 
     measure the effects of integrated education on real-world 
     problem-solving.
       Following five years of steady progress, Hollywood's 
     students turned in a bellwether performance in 1997. In 
     contrast to a statewide average of 38 percent, 67 percent of 
     Hollywood's third grades achieved satisfactory assessment 
     scores. At the fifth-grade level, Hollywood hit Maryland's 
     ideal 70th percentile, with 70 percent of students performing 
     in the satisfactory zone, as contrasted to 46 percent 
     statewide.
       Glaser attributes her school's stellar performance in large 
     part to her staff of hardworking and innovative teachers, 
     including Betty Brady and Julie Tracy.
       Tracy found Glaser's supportive leadership style reason 
     enough to choose Hollywood over another job offer when she 
     finished her master's certification program in 1990. ``I 
     think it was probably the teachers and Mrs. Glaser's 
     encouragement and her openness to suggestions,'' she said. 
     ``The other school was not as open to innovative ideas.''
       For instance, while partnering with a class in Costa Rica 
     during a Smithsonian-sponsored study on migratory birds, 
     Tracy's students learned that loss of habitat was causing a 
     decrease in the birds' population. Their solution? Creating a 
     habitat on the school grounds. Teaming up with other classes, 
     they identified likely planting areas, including a stand of 
     recently planted trees that still lacked native underbrush, 
     and filled in the area with berry shrubs chosen from the 
     birds' regular menu.
       Tracy believes allowing that sort of student initiative is 
     crucial to the learning. ``If you approach a project saying, 
     `we're going to go out and plant a tree,' then it's the 
     teacher's project,'' she said. ``But if the students are 
     engaged in real scientific inquiry, and they're the decision-
     makers directing the project, then it's authentic, and 
     they're engaged in meaningful learning.''
       With its integrated, environment-based curriculum now 
     expanding, and recognition of its effectiveness spreading. 
     Hollywood Elementary has become a living portrait of the 
     mature EIC school.
       Looking back, Hollywood's recycling program, begun in the 
     late 1980s, constitutes an important benchmark in an 
     evolutionary process that started in 1982 when Glaser became 
     principal of the school. From her own experiences first as a 
     classroom teacher and later as a resource teacher, Glaser 
     brought a dual focus to her new position: to encourage 
     individual learning and support innovative teaching.
       ``I think we communicated pretty early, after I became 
     principal, that what was most important was the individual 
     learner,'' Glaser said. ``I think it's also important for 
     teachers to grow professionally, so when they found a program 
     or a resource or a good working idea we began to try some of 
     those out.''
       As Brady and her fellow teachers continued to brainstorm 
     and experiment, they made two discoveries. First, they found 
     that students learned most effectively when previously 
     disjointed subjects came together in an integrated 
     curriculum. Second, they realized that the environment 
     provided a perfect integrating context for learning.
       Brady has a simple explanation for that: ``All things are 
     connected.'' Tracy agrees. ``All the subject areas are right 
     there,'' she said. ``You don't have to try to plug anything 
     in; it all just fits in naturally when you use the 
     environment.''
       Add to that children's innate love of animals and curiosity 
     about nature, and Hollywood had found a sure-fire recipe for 
     effective education. ``We saw children really engaging with 
     the real world in a way they weren't engaging with the 
     textbooks,'' Glaser explained, ``and we saw the learning 
     really lasting.'' ``They see the big picture,'' Tracy added. 
     ``They see the goal.''
       Encouraged by their early successes and Glaser's never-
     wavering support, Hollywood's teachers began to design more 
     and more environment-based projects and to tighten the 
     teamwork so crucial to integrated learning. In some 
     instances, teachers paired up based on their differing 
     preferences: a nature nut, unfazed by bugs and dirt, and a 
     bookworm, more comfortable juggling papers and pencils.
       ``We have such a spirit here of being a community of 
     learners and leaders that people welcome someone with a 
     different strength,'' Glaser commented. ``I'd like to think 
     that one of the things we do well is to blend the teaching 
     strengths we have available, then nuture not only the 
     students, but also support each other where we need it.''
       Hollywood's distinctive approach to teaching caught the 
     national limelight in 1996, when Julie Tracy's idea that 
     second and third graders could turn a drainage pond into a 
     natural habitat earned her a 1996 presidential award for 
     excellence in teaching. In a project that combined biology, 
     botany, ecology, math, and language arts, Tracy's students 
     explored the types of aquatic plants and animals they could 
     expect to thrive in the little pond, then drafted a planting 
     plan, calculating depths and distances for optimal growth, 
     and recruited parents and local college students to help with 
     the work. Today, the former drainage basin is home to fish, 
     birds, amphibians, and even a raccoon or two.
       Not surprisingly, with Hollywood's thriving EIC emphasis 
     drawing attention throughout Maryland and beyond, people are 
     beginning to take notice. Glaser has been fielding frequent 
     calls from other schools eager to duplicate Hollywood's 
     success. She is eager to respond. ``They want to know more 
     about the nature trail or the butterfly garden, how that sort 
     of thing gets organized,'' Glaser said. ``I'm getting more 
     interested in how to help other teachers integrate some of 
     these ideas. How can we help people benefit from our years of 
     experience?''
       ``I'm seeing lots of indicators that this kind of work is 
     growing,'' Glaser said. ``Hopefully, we can be a place people 
     can visit or know about, so they can learn more about how to 
     do it.'' If American education is indeed headed toward a new 
     paradigm of integrated, environment-based instruction, 
     Hollywood is already out front and eager to lead the way.


          huntingdon area middle school: streams of knowledge

       The students at Huntingdon Area Middle School are making 
     adults in their rural Pennsylvania community sit up and take 
     notice. Their active engagement in their community is an 
     outgrowth of an innovative, homegrown EIC program called 
     STREAMS--a regional grand-prize winner of the National Middle 
     School Association's Team-teaching Award.
       STREAMS, which stands for Science Teams in Rural 
     Environments for Aquatic Management Studies, is an 
     interdisciplinary program that aims to increase students' 
     awareness of and concern for their immediate environment and 
     to engage them in the community at large. As its name 
     suggests, the program focuses on water and emphasizes active 
     learning and real-world issues.
       Student enthusiasm for the program keeps building. Every 
     year, Huntingdon students clamor to begin projects earlier 
     and earlier. ``We used to start in January,'' said Fred 
     Wilson, social studies teacher. ``Then it was in November and 
     this year some kids were ready in September.'' The 
     accelerated schedule means more work for Wilson and his 
     colleagues. But there is a certain synergy created when 
     students are so eager, he said. And that is what gives him 
     the energy to keep up.
       The genesis of the STREAMS program occurred eight years ago 
     when the sixth-grade teaching team, including Wilson, began 
     looking for a new theme to incorporate across their existing 
     interdisciplinary curriculum. They decided a program tied to 
     the water studies presented in Tim Julian's science class 
     would be ideal because they could tie it into all the 
     disciplines.
       ``We wanted to examine problems in our community--such as 
     water quality, storm-water runoff and erosion--to make the 
     subject more meaningful to our students,'' Wilson explained. 
     It was a perfect choice. With four separate watersheds 
     converging within two miles of the school, he pointed out, 
     Huntingdon already had a phenomenal outdoor lab at its 
     doorstep.
       Wilson volunteered to develop the interdisciplinary program 
     and contacted a number of organizations in his search for 
     suitable learning projects. But, while he discovered lots of 
     suggestions for activities, there was no program that could 
     be ``plugged in'' to Huntingdon's existing curriculum. By 
     1991, the first year Wilson and his teammates taught the 
     STREAMS unit, he had developed his own instructional segments 
     dealing with storm-water runoff, erosion and sedimentation, 
     water quality monitoring, household pollutants, and community 
     involvement. At the same time, Julian expanded the portion of 
     his science curriculum that dealt with water to include the 
     study of local watersheds as well as water and wastewater 
     treatment facilities.
       Students response was overwhelming, so overwhelming that 
     the following summer Wilson and his colleagues developed more 
     STREAMS topics--wetlands, groundwater, acidity, and nutrient 
     enrichment--and added

[[Page 11318]]

     more water quality studies plus two additional watersheds to 
     monitor.
       The team effort regularly crosses disciplinary lines, with 
     each teacher contributing his or her expertise toward common 
     projects. In science class, for instance, Julian teaches the 
     students about the properties of water, purification 
     processes, and wastewater treatment. Before they go out on a 
     field trip to conduct tests, they also learn how to use the 
     proper monitoring equipment. ``Our kids don't go out unless 
     they are prepped,'' Wilson said. ``That's so they can 
     succeed.''
       Rose Taylor, Huntingdon's sixth-grade language arts 
     teacher, reinforces the vocabulary students need to know in 
     their studies and works with students on STREAMS-related 
     writing assignments. Math teacher Mike Simpson helps the 
     students learn to interpret statistics, construct charts and 
     graphs, and use computer database programs to report their 
     findings. He also incorporates the data they collect into 
     problems he uses to teach important math concepts such as 
     fractions and percentages. ``Rather than use cookbook 
     problems,'' he said, ``we use real field data.''
       Wilson's part of the curriculum emphasizes the consequences 
     of land use--residential, agricultural, and mining--on the 
     water supply, as well as various types of pollution and the 
     function of wetlands. Wilson's students also learn about the 
     effects of storm-water runoff, a significant problem in the 
     Huntingdon vicinity because of over-development in what was 
     once a wetland.
       Everything comes together out in the field, where all the 
     team members get their hands dirty. Their eagerness to dig 
     right in can be traced in large measure to their lengthy 
     history as a team. ``We've teamed together so long--15 
     years--that we can be frank and open,'' Wilson explained. 
     Another secret of the STREAMS staff is a willingness to step 
     outside the bounds of their own disciplines. ``You have to be 
     willing,'' he said, ``to wear different hats.''
       Indeed, STREAMS teachers seem entirely comfortable sharing 
     their teaching responsibilities all around. All the team 
     members, for example, teach reading. Tim Julian and Mike 
     Simpson capitalize on the interrelationships between science 
     and math; both, for instance, teach students to interpret 
     charts and graphs. ``Science uses a lot of math--averaging, 
     graphing, measuring speed,'' Julian pointed out. ``Sometimes 
     we work together; sometimes we handle it separately.'' Julian 
     also supports Rose Taylor's efforts in language arts by 
     having students write reports on their field activities. ``I 
     do correct their grammar,'' he said, ``but I don't lower 
     their science grade for mistakes.''
       The teachers are equally flexible about class time. ``I 
     could go into school tomorrow and say that I need a block of 
     time,'' Wilson said, ``and we'd revamp the schedule in a 
     minute.'' STREAMS team members synchronize and evaluate their 
     lesson plans and schedules in regular weekly meetings, but 
     they can also meet daily during a common planning period.
       Wilson conducts an annual formal assessment of what 
     students learned in the program. In the 1994/95 school year, 
     97 percent of STREAMS students failed a pre-test with an 
     average score of 38 percent. Two months after the program 
     concluded, the students' average score, on an unannounced 
     post-test, was 81 percent, with only a 2 percent failure 
     rate. In the 1996/97 school year, Wilson conducted the post-
     test five months after they completed the initial STREAMS 
     unit. Even after that lengthy interval, the students' 
     averaged 71 percent on the test. Those results, Wilson point 
     out, indicate that most students not only mastered the 
     content, but also retained that knowledge months after 
     completing the program.
       When Wilson and his colleagues started the STREAMS program, 
     no one dreamed how successful and far-reaching it would 
     become. Beyond the creativity and effort of the Huntingdon 
     team, Wilson said, another key reason for their success is 
     partnering with various organizations in the community.
       Parents are another valuable resource. Without them, Wilson 
     said, he could not accommodate all the students who want to 
     do independent work, often after school and on weekends. They 
     help transport and chaperone students giving presentations to 
     public groups, civic organizations, teacher conferences, and 
     workshops, as well as those taking special field trips or 
     traveling to the biotechnology lab at Penn State. Parents 
     also help with tree-planting projects and water-quality 
     monitoring.
       The students, too, have tapped into the partnering concept. 
     When they proposed creating a wetland near the school, for 
     example, they raised $1,000 and then found partners to 
     contribute the $3,000 needed to complete the project--proof 
     that they have learned to leverage their dollars and attract 
     broad-based support.
       The community that spawned these savvy students and 
     teachers is by some standards an unlikely one. Huntingdon, a 
     town of 7,000, is located in south central Pennsylvania, an 
     area that historically has reported the highest unemployment 
     figures in the state. The average family income here is 
     $20,000 annually. Only 9.4 percent of adults in the county 
     have earned a post-secondary degree, compared to 18 percent 
     statewide.
       Wilson also noted a dichotomy in the region's attitudes 
     toward education, with some residents very supportive and 
     others indifferent. Consequently, it has been exciting for 
     Huntingdon's teachers to watch a gradual shift in the 
     public's attitude toward the students' endeavors. ``At first, 
     they were taken rather lightly,'' Julian noted, ``but now the 
     community is coming and asking them for help.''
       Without a doubt, Wilson observed, the Huntingdon teachers' 
     decision to use the environment as an umbrella for 
     interdisciplinary study and hands-on instructional strategies 
     has produced tremendous results. ``I think that our students 
     are engaged in a meaningful learning experience that will 
     help to empower them to be critical thinkers and become more 
     independent learners,'' he said.
       As principal Jill Adams sees it, programs like STREAMS and 
     teachers like Wilson and his colleagues hold the key to 
     reshaping the entire educational process. ``The future of 
     education really depends on people like this,'' she said. 
     ``We cannot continue to teach the way that we were taught.''

  Mr. SARBANES. In the Chesapeake Bay region, the Governors of 
Maryland, Virginia, Pennsylvania and the Mayor of the District of 
Columbia have recognized the importance of engaging students in the 
protection of the Chesapeake Bay. The States have each enacted 
legislation to integrate environmental standards into the curriculum 
for particular grade levels. As signatories to the Chesapeake 2000 
Agreement, they have also committed to ``provide a meaningful Bay or 
stream outdoor experience for every school student in the watershed 
before graduation from high school'' beginning with the class of 2005.
  Likewise, several not-for-profit organizations including the 
Chesapeake Bay Foundation, and the Living Classrooms Foundation have 
spearheaded efforts to create long-term, cohesive education programs 
focused on the local environment. They have developed terrific 
partnerships with schools and are helping teachers develop and 
implement quality instruction, investigations and Bay or stream-side 
projects.
  Unfortunately, all these efforts and programs are only reaching a 
very small percentage of the more than 3.3 million K-12 students in the 
watershed. Classroom environmental instruction across grade levels is 
sporadic and inconsistent, at best, and relatively few students have 
had the opportunity to engage in meaningful outdoor experiences. Many 
of the school systems in the Bay watershed are only at the beginning 
stages in developing and implementing environmental education into 
their curriculum, let alone exposing them to outdoor watershed 
experiences. What's lacking is not the desire or will, but the 
resources and training to undertake more comprehensive environmental 
education programs.
  In 1970, the Congress enacted the first Environmental Education Act 
to authorize the then-U.S. Department of Health, Education, and Welfare 
to establish programs to support environmental education at the 
elementary and secondary levels and in communities. In its statement of 
findings and purposes, the Congress found ``that the deterioration of 
the quality of the Nation's environment and of its ecological balance 
is in part due to poor understanding by citizens of the Nation's 
environment and of the need for ecological balance; that presently 
there do not exist adequate resources for educating citizens in these 
areas, and that concerted efforts on educating citizens about 
environmental quality and ecological balance are therefore necessary.'' 
Grants for curriculum development, teacher training, and community 
demonstration projects were made available for several years under this 
Act, but the program expired and was not reauthorized.
  In 1990, the Congress enacted the National Environmental Education 
Act to renew the federal role in environmental education. The Congress, 
once again found that ``current Federal efforts to inform and educate 
the public concerning the natural and built environment and 
environmental problems are not adequate.'' Today, 32 years after the 
first Environmental Education Act was first authorized, those findings 
are still true. Last year, nationwide funding for the National 
Environmental Education Act administered by EPA was only $7.3 million. 
That averages to a little more than $140,000

[[Page 11319]]

for each of the 50 States, a sum that is totally inadequate for schools 
to incorporate environmental education as part of the K-12 curriculum.
  The legislation which I am introducing would authorize $6 million a 
year over the next three years in federal grant assistance to help 
close the resource and training gap for students in the elementary and 
secondary levels in the Chesapeake Bay watershed. It would require a 50 
percent non-federal match, thus leveraging $12 million in assistance. 
The funding could be used to help design, demonstrate or disseminate 
environmental curricula and field practices, train teachers or other 
educational personnel, and support on-the-ground activities or 
Chesapeake Bay or stream outdoor educational experiences involving 
students and teachers, among other things. The program would complement 
a similar initiative that I sponsored last year within the National 
Oceanic and Atmospheric Administration which is providing $1.2 million 
to support environmental education in the Chesapeake watershed.
  The Chesapeake Bay Program has pioneered many of the Nation's most 
innovative environmental protection and restoration initiatives. It has 
been a leader in establishing a large volunteer monitoring program; 
implementing pollution control programs such as the ban on phosphate 
detergents and voluntary nutrient reduction goals; and conducting an 
extensive habitat restoration program including the opening of hundreds 
of miles of prime spawning habitat to migratory fish. It is an ideal 
proving ground for demonstrating that strong and consistent support for 
environmental education, using the Chesapeake Bay and local environment 
as the primary instructional focus, will lead not only to a healthier, 
enduring watershed, but a more educated and informed citizenry, with a 
deeper understanding and appreciation for the environment, their 
community and their role in society as responsible citizens.
                                 ______
                                 
      By Mr. TORRICELLI (for himself and Mr. Hatch):
  S. 2676. A bill to amend the Internal Revenue Code of 1986 to allow a 
10-year foreign tax credit carryforward and to apply the look-thru 
rules for purposes of the foreign tax credit limitation to dividends 
from foreign corporations not controlled by a domestic corporation; to 
the Committee on Finance.
  Mr. TORRICELLI. Mr. President, today, Senator Hatch and I are 
introducing legislation to modernize and simplify the foreign tax 
credit. The legislation contains two meritorious provisions that we 
hope Congress will enact this year, in that they are both long overdue.
  The first provision addresses the problem of double taxation that 
results when foreign tax credits expire unused under current law. To 
enhance the international competitiveness of U.S. companies operating 
overseas, and to help avoid this unfair double taxation, our 
legislation simply extends the current 5-year foreign tax credit 
carryforward period for five additional years to a 10-year 
carryforward.
  The second provision reforms current law, which unduly hinders U.S. 
companies in their efforts to penetrate foreign markets by imposing the 
so-called 10/50 foreign tax credit rule. Due to legal and political 
realities, many U.S. companies are forced to operate through corporate 
joint ventures in partnership with local businesses. The 10/50 rule 
imposes a foreign tax credit limitation for each of these corporate 
joint ventures where a U.S. company owns at least 10 percent but not 
more than a 50 percent interest in a foreign company, and thus 
increases the cost of doing business for U.S. firms competing abroad.
  10/50 reform would restore parity in the tax treatment of joint-
venture income to other income earned overseas by U.S. companies by 
applying ``look-through'' treatment. Without this change, U.S.-based 
companies engaged in joint ventures overseas will continue to be 
disadvantaged vis a vis foreign competitors. Congress attempted to 
rectify this problem in a large tax bill that was ultimately vetoed in 
1999. The Clinton Treasury also recommended enactment of this crucial 
tax change in its FY 2000 budget package and similarly, the Joint 
Committee on Taxation endorsed this non-controversial provision in its 
2001 Simplification Study.
  As indicated earlier, these two changes are long overdue and we urge 
their expeditious enactment.
  Mr. HATCH. Mr. President, I am pleased to join with my friend and 
colleague from New Jersey in introducing a bill to improve the tax 
treatment of U.S.-based multinational companies.
  It is apparent that our international tax code is deeply flawed. The 
current wave of companies reincorporating in Bermuda, the foreign sales 
corporation debacle, and the trend of tax-motivated foreign takeovers 
all provide abundant evidence that Congress needs to act to make our 
international tax rules friendlier to American-based companies.
  The bill we are introducing today is one that I consider to be a 
down-payment on the fundamental reform that our international tax 
system demands. The bill will reduce, but unfortunately will not 
eliminate, the double taxation of international income that occurs far 
too often. This double taxation is just one of several serious problems 
with our international tax rules.
  The threat of double taxation, where an American corporation ends up 
paying corporate taxes to both the United States and to a foreign 
country on the same income, discourages U.S. firms from investing 
overseas. And since U.S. multinationals provide millions of America's 
best-paying domestic jobs, anything that discourages overseas direct 
investment ends up hurting the take-home pay of our nation's workers.
  Our bill has two provisions. The first would reform the carryforward 
treatment of foreign tax credits. The Internal Revenue Code was 
originally designed to make sure that U.S. corporations investing 
overseas are not subject to double taxation by a foreign nation and the 
U.S. on the same income. It does this through the availability of a 
foreign tax credit. If this system worked well, then American 
businesses would seldom or ever face this kind of double taxation.
  However, the system most emphatically does not work well. For 
example, American businesses are only allowed to use these foreign tax 
credits when their U.S. operations are profitable. As a result, when 
the U.S. side of the business is doing badly, firms are unable to 
immediately use the foreign tax credits. While the current tax law 
allows businesses to carry excess foreign tax credits forward for up to 
5 years, that timetable is unrealistic. An expanding business, with 
high domestic expansion costs and low domestic profits, can easily go 
through 5 years of losses, and never get a chance to use those tax 
credits. Once the 5-year period has expired, the credits are gone 
forever, and the result is double taxation, the threat of which 
discourages firms from taking on otherwise profitable overseas 
investment projects.
  If we want American businesses to take the long view, a 5-year 
carryforward just is not long enough. The legislation Senator 
Torricelli and I are introducing today will extend that horizon to 10 
years. If enacted, it would give U.S. firms a much better search 
throughout the world for profitable investment projects. And again, 
profits earned by U.S. companies throughout the world generally 
translates into more and better-paying jobs for Americans.
  Our second proposal would eliminate our tax code's inhospitable 
treatment of international joint ventures. In many developing countries 
with rules and restrictions on foreign ownership, joint ventures are 
the only way to get things done. Our current-law tax treatment of these 
joint ventures, known as 10/50 companies because between 10 and 50 
percent of the joint venture is owned by the U.S. company--is 
indefensible.
  Ordinarily, our tax code adds together tax attributes from different 
divisions of the same firm. For example, if one division of a company 
loses a hundred dollars and another division earns a hundred in 
profits, we offset the gain and the loss and assess no tax liability.

[[Page 11320]]

  Unfortunately, when it comes to these 10/50 companies, the tax law 
applies a separate foreign tax credit limitation to each venture. This 
increases the cost of doing business for the U.S. firms competing 
abroad because it makes it harder for firms to use their foreign tax 
credits and also adds a great deal of complexity. The result? Double 
taxation once again. And once again, our tax code discourages U.S. 
firms from jumping on profitable investment opportunities, because of 
the very real threat of double taxation.
  When American businesses are considered overseas investment 
opportunities, we do not want that decision to turn on the arcane 
details of U.S. tax law--we want a code that is fairer, simpler, and 
most of all, helps our companies better compete in the global 
marketplace. The bill we are introducing today will not fix all of our 
tax code's many problems in the international area, but it is an 
excellent start. I urge our colleagues to give their consideration to 
this important piece of legislation.
                                 ______
                                 
      By Mr. ROCKEFELLER:
  S. 2677. A bill to improve consumer access to prescription drugs, and 
for other purposes; to the Committee on Finance.
  Mr. ROCKEFELLER. Mr. President, I rise today to introduce a bill that 
affects all of our lives. This bill gets to the heart of an issue that 
Congress has been talking about for years, access to prescription 
drugs. As the name implies, the Consumer Access to Prescription Drugs 
Improvement Act of 2002 seeks to improve access to prescription drugs 
for every person who needs medication.
  Today, people rely on prescription drugs for several different 
reasons. For some people, prescription drugs make life more 
comfortable. Some would not survive without them. Prescription drugs 
have become an intricate part of modern medicine, replacing procedures 
that once required an inpatient stay. Ailments that once could not be 
treated can now be cured with a little pill. The innovation that has 
been displayed is amazing and must continue.
  The problem, however, is that prescription drug manufacturers have 
been distorting the market. Drug manufacturers are exploiting loopholes 
in existing laws to further extend their monopolies and keep generic 
drugs off the market. The result, after years of paying monopoly 
prices, consumers continue to be cheated out of cost-effective 
alternatives. We've all heard the horror stories of people going 
without their medications, splitting pills, or making the choice 
between food and drugs. However, the consequences of actions taken by 
drug manufacturers are actually more global. They are taking a terrible 
toll on State budgets, forcing Medicaid to severely scale back their 
coverage of our most needed population. They are causing employer 
health care premiums to go through the roof. These pressures will cause 
the number of uninsured to increase and will ultimately limit access to 
health care.
  The group that suffers the most due to drug cost growth is seniors. 
Millions of seniors have no drug coverage today. Over the past five 
years, the 50 prescription drugs most commonly used by seniors have 
increased in price by nearly twice the rate of inflation. In fact, over 
25 percent of these drugs increased in price by three or more times the 
rate of inflation over that time period. According to the Kaiser Family 
Foundation, the average retail prescription price for brand name drugs 
has increased more than 58 percent in 10 years. Brandeis University 
recently released a report on this issue. The major conclusion of the 
report is that greater and appropriate use of generic medications can 
achieve $50-$100 billion in savings for any new Medicare drug benefit. 
This legislation will make a Medicare drug benefit affordable and 
sustainable into the future. Senators should be aware that I plan to 
offer this legislation as an amendment to any Medicare prescription 
drug benefit that the Senate considers.
  This legislation will stop pharmaceutical companies from 
circumventing the law and open the door to competition so that every 
consumer from West Virginia to California has access to reasonably 
priced prescription drugs. However, this legislation will also go 
further. It will provide crucial information to physicians, consumers, 
and health care purchasers about the cost-effective generics that are 
equivalent to brand names. According to the Federal Trade Commission, 
generic drugs typically cost 25 percent less than brand-name drugs when 
they first enter the market. After two years, the price difference 
grows to 60 percent. Every patient should have access to the drug 
prescribed by their doctor, but if there is a drug out there that is 
equivalent to the brand name but will cost you half as much, don't you 
want your physician to know about it? This bill will shine a spotlight 
on the real costs and the effects of issues we hear so much about, 
direct-to-consumer advertising, drug detailing, and sampling. We can no 
longer afford to talk about these issues in broad, hypothetical terms. 
Congress and the public need to understand these issues better so that 
we can be more prudent purchasers. This legislation will create the 
correct incentives, to innovate rather than litigate.
  Finally, this legislation will expand access to drugs under existing 
programs which are so crucial to those who rely on them. This 
legislation will expand Medicare's current drug benefit to include all 
cancer drugs, regardless of the method by which they are administered. 
It will allow public hospitals access to the drug prices they need to 
be able to continue in their mission to provide care to our neediest 
citizens. It will help states with their drug utilization review 
programs which we all know are cost effective. I urge my colleagues to 
join me in this effort.
  My efforts are supported by the Service Employees International 
Union, the American Federation of State, County and Municipal 
Employees, the AFL-CIO, Families USA, the Generic Pharmaceutical 
Association, the National Association of Chain Drug Stores, and 
Representative Waxman, the author of the original legislation.
  Representative Waxman stated:

       Now more than ever, as the cost of prescription drugs has 
     skyrocketed, access to low-cost generics is essential. At a 
     time when the brand-name companies have few innovative 
     products in their pipelines, we are seeing a disturbing 
     trend: a growing number of companies are choosing to protect 
     their profits through legal maneuvers to delay generic 
     competition on their existing products. The price of this 
     anti-competitive behavior to our nation's health care bill 
     and to the health of Americans is shockingly high. It is time 
     that Congress acted to stop unnecessary delays in the 
     marketing of generic drugs. The bill that Senator Rockefeller 
     is introducing today makes a real contribution to the effort 
     to combat these problems.

  This legislation is a commonsense step we can take to increase access 
to prescription drugs for all consumers. I urge Congress to consider 
and pass this legislation. I ask unanimous consent that the text of the 
bill be printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2677

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``Consumer 
     Access to Prescription Drugs Improvement Act of 2002''.
       (b) Table of Contents.--The table of contents of this Act 
     is as follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings; purposes.

     TITLE I--EXPANSION OF ACCESS THROUGH EDUCATION AND INFORMATION

Sec. 101. Pharmaceutical Advisory Committee.
Sec. 102. Guidance for payer and medical communities.
Sec. 103. Study of procedures and scientific standards for evaluating 
              generic biological products.
Sec. 104. Institute of Medicine study.

      TITLE II--EXPANSION OF ACCESS THROUGH INCREASED COMPETITION

Sec. 201. Drug Reimbursement Fund.
Sec. 202. Patent certification.
Sec. 203. Accelerated generic drug competition.
Sec. 204. Notice of agreements settling challenges to certifications 
              that a patent is invalid or will not be infringed.

[[Page 11321]]

Sec. 205. Publication of information in the Orange Book.
Sec. 206. No additional 30-month extension.

        TITLE III--EXPANSION OF ACCESS THROUGH EXISTING PROGRAMS

Sec. 301. Medicare coverage of all anticancer oral drugs.
Sec. 302. Removal of State restrictions.
Sec. 303. Medicaid drug use review program.
Sec. 304. Clarification of inclusion of inpatient drug prices charged 
              to certain public hospitals in the best price exemptions 
              established for purposes of the medicaid drug rebate 
              program.
Sec. 305. Upper payment limits for generic drugs under medicaid.

                      TITLE IV--GENERAL PROVISIONS

Sec. 401. Report.

     SEC. 2. FINDINGS; PURPOSES.

       (a) Findings.--Congress finds that--
       (1) prescription drugs are a crucial part of modern 
     medicine, serving as complements to medical procedures, 
     substitutes for surgery and other medical procedures, and new 
     forms of treatment;
       (2) a lack of access to prescription drugs can not only 
     cause discomfort, but can be life-threatening to a patient;
       (3)(A) by all accounts, double-digit prescription drug 
     price increases are forecast annually for the next 3 to 5 
     years; and
       (B) such increases would result in prescription drug costs 
     that would be prohibitive for many Americans;
       (4) the Congressional Budget Office estimates that--
       (A) the use of generic prescription drugs for brand-name 
     prescription drugs could save purchasers of prescription 
     drugs between $8,000,000,000 and $10,000,000,000 each year; 
     and
       (B) generic prescription drugs cost between 25 percent and 
     60 percent less than brand-name prescription drugs, resulting 
     in an estimated average saving of $15 to $30 on each 
     prescription;
       (5) expanding access to generic prescription drugs can help 
     consumers, especially seniors and the uninsured, have access 
     to more affordable prescription drugs;
       (6) policymakers should be better informed about issues 
     relating to prescription drugs, particularly issues 
     concerning barriers to patient access to prescription drugs;
       (7) health care purchasers should be more aware of safe, 
     cost-effective alternatives to brand-name prescription drugs; 
     and
       (8) prescription drug coverage provided under existing 
     programs should be expanded to better reflect modern 
     technology and provide drugs to the people who rely on them 
     most, yet who increasingly find themselves uninsured or with 
     coverage that is becoming more expensive and less meaningful.
       (b) Purposes.--The purposes of this Act are--
       (1) to better educate policymakers, purchasers, and the 
     public about safe and cost-effective generic alternatives, 
     barriers to market entry, and upcoming issues in the 
     pharmaceutical industry;
       (2) to increase consumer access to prescription drugs by--
       (A) decreasing price through increased competition; and
       (B) expanding coverage under the medicare and medicaid 
     programs.

     TITLE I--EXPANSION OF ACCESS THROUGH EDUCATION AND INFORMATION

     SEC. 101. PHARMACEUTICAL ADVISORY COMMITTEE.

       Title XVIII of the Social Security Act (42 U.S.C. 1395 et 
     seq.) is amended by inserting after section 1805 the 
     following:


                  ``pharmaceutical advisory committee

       ``Sec. 1805A. (a) Establishment.--There is established, as 
     part of the Medicare Payment Advisory Commission established 
     under section 1805, a committee to be known as the 
     `Pharmaceutical Advisory Committee' (referred to in this 
     section as the `Committee').
       ``(b) Membership.--
       ``(1) Composition.--The Committee shall be composed of 11 
     members appointed by the Comptroller General of the United 
     States.
       ``(2) Qualifications.--
       ``(A) In general.--The Committee members shall be selected 
     from among--
       ``(i) individuals with expertise in and knowledge of the 
     pharmaceutical industry (brand name and generic), including 
     expertise in and knowledge of pharmaceutical--

       ``(I) development;
       ``(II) pricing;
       ``(III) distribution;
       ``(IV) marketing;
       ``(V) reimbursement; and
       ``(VI) patent law; and

       ``(ii) providers of health and related services;
       ``(B) Representation.--The members of the Committee shall 
     include--
       ``(i) physicians and other health professionals;
       ``(ii) employers;
       ``(iii) third-party payers;
       ``(iv) representatives of consumers;
       ``(v) individuals having--

       ``(I) skill in the conduct and interpretation of 
     pharmaceutical and health economics research; and
       ``(II) expertise in outcomes, effectiveness research, and 
     technology assessment; and

       ``(vi) patent attorneys.
       ``(C) Conflicts of interest.--The members of the Committee 
     shall not include any individual who, within the 5-year 
     period preceding the date of appointment to the Committee, 
     has been an officer or employee of a drug manufacturer or has 
     been employed as a consultant to a drug manufacturer.
       ``(D) Representation.--The members of the Committee shall 
     be broadly representative of various professions, geographic 
     regions, and urban and rural areas.
       ``(E) Limitation.--Not more than \1/2\ of the members 
     appointed under this subsection may be directly involved in 
     the provision, management, or delivery of items and services 
     covered under this title.
       ``(F) Public disclosure.--As soon as practicable after the 
     date of enactment of this Act, the Comptroller General of the 
     United States shall establish rules for the public disclosure 
     of financial and other potential conflicts of interest by 
     members of the Committee.
       ``(3) Terms; vacancies.--
       ``(A) Terms.--
       ``(i) In general.--Except as provided in clause (ii), a 
     member of the Committee shall be appointed for a term of 3 
     years.
       ``(ii) Initial terms.--Of the members first appointed to 
     the Committee under this subsection--

       ``(I) 4 shall be appointed for a term of 1 year; and
       ``(II) 4 shall be appointed for a term of 2 years.

       ``(iii) Carryover.--After the term of a member of the 
     Committee has expired, the member may continue to serve until 
     a successor is appointed.
       ``(B) Vacancies.--
       ``(i) In general.--A vacancy on the Committee--

       ``(I) shall not affect the powers of the Committee; and
       ``(II) shall be filled in the same manner as the original 
     appointment was made.

       ``(ii) Filling of unexpired term.--An individual chosen to 
     fill a vacancy shall be appointed for the unexpired term of 
     the member replaced.
       ``(4) Meetings.--The Committee shall meet at the call of 
     the chairperson.
       ``(5) Chairperson; vice chairperson.--The Comptroller 
     General shall appoint 1 of the members as chairperson and 1 
     of the members as vice chairperson.
       ``(c) Duties.--
       ``(1) In general.--The Committee shall--
       ``(A) review payment policies for drugs under titles XVIII 
     and XIX of the Social Security Act (42 U.S.C. 1395 et seq.); 
     and
       ``(B) make recommendations to Congress with respect to the 
     payment policies.
       ``(2) Inclusions.--The matters to be studied by the 
     Committee under paragraph (1) include--
       ``(A) the effects of direct-to-consumer advertising, drug 
     detailing, and sampling;
       ``(B) the level of use of generic drugs as safe and cost-
     effective alternatives to brand name drugs;
       ``(C) the barriers to approval of generic drugs, including 
     consideration of all of the matters described in paragraph 
     (3);
       ``(D) the adequacy of drug price metrics, including the 
     average wholesale price and the average manufacturers price;
       ``(E) the effectiveness of various education methods on 
     changing clinical behavior;
       ``(F) the effectiveness of common drug management tools, 
     including drug use review and use of formularies;
       ``(G) the perception of patients, physicians, nurses, and 
     pharmacists of generic prescription drugs as safe and 
     effective substitutes for brand-name prescription drugs;
       ``(H) the costs of research and development and the costs 
     of clinical trials associated with producing a drug;
       ``(I) the relationship between pharmacy benefit managers 
     and prescription drug manufacturers;
       ``(J) best practices to increase medical safety and reduce 
     medical errors; and
       ``(K) polypharmacy and underutilization.
       ``(3) Barriers to approval.--The matters for consideration 
     referred to in paragraph (2)(C) include--
       ``(A) the appropriate balance between rewarding scientific 
     innovation and providing affordable access to health care;
       ``(B) features of the communication process and grievance 
     procedure of the Committee that provide opportunities for 
     tactics that unduly delay generic market entry;
       ``(C) the use of the citizen's petition process to delay 
     generic market entry;
       ``(D) the use of changes to a drug product (including a 
     labeling change) timed to delay generic approval; and
       ``(E) the impact of granting patents on diagnostic methods 
     such as patents on genes and genetic testing systems on 
     access to affordable health care.
       ``(4) Report.--Not later than January 1 of each year, the 
     Committee shall submit to Congress a report on--
       ``(A) the results of the reviews and recommendations;

[[Page 11322]]

       ``(B) issues affecting drug prices, including use of and 
     access to generic drugs; and
       ``(C) the effect of drug prices on spending by government-
     sponsored health care programs and health care spending in 
     general.
       ``(d) Powers.--
       ``(1) Information from federal agencies.--
       ``(A) In general.--The Committee may secure directly from a 
     Federal department or agency such information as the 
     Committee considers necessary to carry out this section.
       ``(B) Provision of information.--On request of the 
     Chairperson of the Committee, the head of the Federal 
     department or agency shall provide the information to the 
     Committee.
       ``(2) Data collection.--To carry out the duties of the 
     Committee under subsection (c), the Committee shall--
       ``(A) collect and assess published and unpublished 
     information that is available on the date of enactment of 
     this Act;
       ``(B) if information available under subparagraph (A) is 
     inadequate, carry out, or award grants or contracts for, 
     original research and experimentation; and
       ``(C) adopt procedures to allow members of the public to 
     submit information to the Committee for inclusion in the 
     reports and recommendations of the Committee.
       ``(3) Additional powers.--The Committee may--
       ``(A) seek assistance and support from appropriate Federal 
     departments and agencies;
       ``(B) enter into any contracts or agreements as are 
     necessary to carry out the duties of the Committee, without 
     regard to section 3709 of the Revised Statutes (41 U.S.C. 5);
       ``(C) make advance, progress, and other payments that 
     relate to the duties of the Committee;
       ``(D) provide transportation and subsistence for persons 
     serving without compensation; and
       ``(E) promulgate regulations for the internal organization 
     and operation of the Committee.
       ``(e) Committee Personnel Matters.--
       ``(1) Compensation of members.--
       ``(A) In general.--A member of the Committee shall be 
     compensated at a rate equal to the daily equivalent of the 
     annual rate of basic pay prescribed for level IV of the 
     Executive Schedule under section 5315 of title 5, United 
     States Code, for each day (including travel time) during 
     which the member is engaged in the performance of the duties 
     of the Board.
       ``(B) Travel expenses.--A member of the Board shall be 
     allowed travel expenses, including per diem in lieu of 
     subsistence, at rates authorized for an employee of an agency 
     under subchapter I of chapter 57 of title 5, United States 
     Code, while away from the home or regular place of business 
     of the member in the performance of the duties of the Board.
       ``(2) Staff.--
       ``(A) In general.--The Committee may, without regard to the 
     civil service laws (including regulations), appoint and 
     terminate an executive director and such other additional 
     personnel as are necessary to enable the Committee to perform 
     the duties of the Committee.
       ``(B) Compensation.--The Chairperson of the Committee may 
     fix the compensation of the executive director and other 
     personnel without regard to the provisions of chapter 51 and 
     subchapter III of chapter 53 of title 5, United States Code, 
     relating to classification of positions and General Schedule 
     pay rates.
       ``(C) Employees of the federal government.--For the 
     purposes of compensation, benefits, rights, and privileges, 
     the staff of the Committee shall be considered employees of 
     the Federal Government.
       ``(f) Request for Appropriations.--
       ``(1) In general.--The Committee shall submit requests for 
     appropriations in the same manner as the Comptroller General 
     submits requests for appropriations.
       ``(2) Separate amounts.--Notwithstanding paragraph (1), 
     amounts appropriated for the Committee shall be separate from 
     amounts appropriated for the Comptroller General.''.

     SEC. 102. GUIDANCE FOR PAYER AND MEDICAL COMMUNITIES.

       (a) In General.--The Secretary of Health and Human Services 
     shall issue guidance for the payer community and the medical 
     community on--
       (1) how consumers, physicians, nurses, and pharmacists 
     should be educated on generic drugs; and
       (2) the need to potentially educate pharmacy technicians, 
     nurse practitioners, and physician assistants on generic 
     drugs.
       (b) Matters To Be Addressed.--The guidance shall include 
     such items as--
       (1) a recommendation for allotment of a portion of yearly 
     continuing education hours to the subject of generic drugs 
     similar to recommendations for continuing education already 
     in place for pharmacists in some States on pharmacy law and 
     AIDS;
       (2) a recommendation to all medical education governing 
     bodies regarding course curricula concerning generic drugs to 
     include in the course work of medical professionals;
       (3) a recommendation on how the Food and Drug 
     Administration could notify physicians and pharmacists when a 
     brand name drug becomes available as a generic drug and what 
     information could be included in the notification;
       (4) the establishment of a speaker's bureau available to 
     groups by geographic region to speak and provide technical 
     assistance on issues relating to generic drugs, to be 
     available to pharmacists, consumer groups, physicians, 
     nurses, and local media; and
       (5) the proposition of a survey on perception and awareness 
     of generic drugs at the beginning and end of an educational 
     campaign to test the effectiveness of the campaign on 
     different audiences.
       (c) Public Education.--The Secretary shall provide for the 
     education of the public on the availability and benefits of 
     generic drugs.
       (d) Notification of New Generic Prescription Drug 
     Approvals.--As soon as practicable after a new generic 
     prescription drug is approved, the Secretary shall--
       (1) notify physicians, pharmacists, and other health care 
     providers of the approval; and
       (2) inform health care providers of the brand-name 
     prescription drug for which the generic prescription drug is 
     a substitute.

     SEC. 103. STUDY OF PROCEDURES AND SCIENTIFIC STANDARDS FOR 
                   EVALUATING GENERIC BIOLOGICAL PRODUCTS.

       (a) In General.--The Institute of Medicine shall conduct a 
     study to evaluate--
       (1) the feasibility of producing generic versions of 
     biological products; and
       (2) the relevance of the source materials and the 
     manufacturing process to the production of the generic 
     versions.
       (b) Establishment of Process.--
       (1) In general.--If, as a result of the study under 
     subsection (a), the Institute of Medicine finds that it would 
     be feasible to produce generic versions of biological 
     products, not later than 3 years after the date of the 
     completion of the study, the Secretary, shall prescribe 
     procedures and conditions under which biological products 
     intended for human use may be approved under an abbreviated 
     application or license.
       (2) Application.--An abbreviated application or license 
     shall, at a minimum, contain--
       (A) information showing that the conditions of use 
     prescribed, recommended, or suggested in the labeling 
     proposed for the new biological product have been previously 
     approved for a drug subject to regulation under section 505 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
     or under section 351 of the Public Health Service Act (42 
     U.S.C. 262) (referred to in this subsection as a ``listed 
     drug'');
       (B) information to show that the new biological product has 
     chemical and biological characteristics comparable to the 
     characteristics of the listed drug; and
       (C) information showing that the new biological product has 
     a safety and efficacy profile comparable to that of the 
     listed drug.
       (3) Product standards.--The Secretary, on the initiative of 
     the Secretary or on petition, may by regulation promulgate 
     drug product standards, procedures, and conditions to 
     determine insignificant changes in a biological product that 
     do not affect the scientific and medical soundness of product 
     approval and interchangeability.

     SEC. 104. INSTITUTE OF MEDICINE STUDY.

       (a) In General.--The Institute of Medicine shall convene a 
     committee to conduct a study to determine--
       (1) whether information regarding the relative efficacy and 
     effectiveness of drugs (as defined in section 201 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) and 
     biological products (as defined in section 351(i) of the 
     Public Health Service Act (42 U.S.C. 262(i))) is available to 
     the public for independent and external review;
       (2) whether the benefits of drugs and biological products, 
     and particularly the relative benefits of similar drugs and 
     biological products, are understood by physicians and 
     patients; and
       (3) whether prescribing and use patterns are unduly or 
     inappropriately influenced by marketing to physicians and 
     direct advertising to patients.
       (b) Recommendations.--If problems are identified by the 
     study conducted under subsection (a), the committee shall 
     make recommendations to the Commissioner of Food and Drugs 
     for improvement, including recommendations regarding--
       (1) ways to better review the relative efficacy and 
     effectiveness of drugs approved for use by the Food and Drug 
     Administration;
       (2) the appropriate governmental or nongovernmental body to 
     conduct the review described under paragraph (1); and
       (3) ways to improve communication and dissemination of the 
     information reviewed in paragraph (1).
       (c) Authorization of Appropriations.--There are authorized 
     to be appropriated such sums as are necessary to carry out 
     this section.

      TITLE II--EXPANSION OF ACCESS THROUGH INCREASED COMPETITION

     SEC. 201. DRUG REIMBURSEMENT FUND.

       Subchapter A of chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 501 et seq.) is amended by adding at 
     the end the following:

[[Page 11323]]

     ``SEC. 524. DRUG REIMBURSEMENT FUND.

       ``(a) Definitions.--In this section:
       ``(1) Drug patent.--The term `drug patent' means a patent 
     described in section 505(b)(1).
       ``(2) Fund.--The term `Fund' means the Drug Reimbursement 
     Fund established under subsection (b).
       ``(b) Establishment.--There is established in the Treasury 
     of the United States a separate fund to be known as the `Drug 
     Reimbursement Fund'.
       ``(c) Comptroller.--The Secretary shall appoint a 
     comptroller to administer the Fund.
       ``(d) Regulations.--
       ``(1) In general.--The Secretary shall promulgate 
     regulations for the operation of the Fund, including the 
     method of payments from the Fund and designation of 
     beneficiaries of the Fund.
       ``(2) Administrative determinations.--The regulations under 
     paragraph (1) may permit the administrative determination of 
     the claims of health insurers, State and Federal Government 
     programs, and third-party payers or other parties that are 
     disadvantaged by the conduct of drug manufacturers that seek 
     to bring spurious civil actions for infringement of drug 
     patents in order to block the production and marketing of 
     lower-cost drug alternatives.
       ``(e) Contributions to the Fund.--
       ``(1) In general.--In any civil action under section 505 or 
     512 or in a civil action for infringement of a drug patent 
     (as defined in section 524(a)) under chapters 28 and 29 of 
     title 35, United States Code--
       ``(A) if the Court determines that the drug patent is 
     invalid or that the drug patent is not otherwise infringed, 
     but that the plaintiff obtained an injunction against the 
     defendant for the production or marketing of the drug to 
     which the drug patent relates, the Court shall order the 
     plaintiff to pay to the Fund the amount that is equal to--
       ``(i) the amount that is equal to the amount of net 
     revenues generated by the plaintiff from the production or 
     marketing of the drug during the period in which the 
     injunction was in effect, plus an additional period of 12 
     months; minus
       ``(ii) the amount of any special damages paid by the 
     plaintiff under section 524(m); or
       ``(B) if the defendant enters into a settlement agreement 
     or any other arrangement under which the defendant agrees to 
     withdraw an application under section 505 or 512, the Court 
     shall order the defendant to pay to the Fund the amount that 
     is equal to 50 percent of the amount (including the value of 
     any form of property) that the defendant receives from the 
     plaintiff under the arrangement.
       ``(2) Collection.--The United States may seek to enforce 
     collection of a contribution required to be made to the Fund 
     by bringing a civil action in United States district 
     court.''.

     SEC. 202. PATENT CERTIFICATION.

       (a) In General.--Section 505(j)(5) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) is amended--
       (1) in subparagraph (B)--
       (A) by striking ``(B) The approval'' and inserting the 
     following:
       ``(B) Effective date of approval.--Except as provided in 
     subparagraph (C), the approval''; and
       (B) by striking clause (iii) and inserting the following:
       ``(iii) Certification that patent is invalid or will not 
     otherwise be infringed.--

       ``(I) No civil action for patent infringement or 
     declaratory judgment, or no motion for preliminary 
     injunction.--Except as provided in subclause (II), if--

       ``(aa) the applicant made a certification described in 
     paragraph (2)(A)(vii)(IV);
       ``(bb) none of the conditions for denial of approval stated 
     in paragraph (4) applies;
       ``(cc)(AA) no civil action for infringement of a patent 
     that is the subject of the certification is brought before 
     the expiration of the 45-day period beginning on the date on 
     which the notice provided under paragraph (2)(B)(ii) was 
     received; or
       ``(BB) a civil action is brought as described in subitem 
     (AA), but no motion for preliminary injunction is filed 
     within 90 days of commencement of the civil action; and
       ``(dd) the applicant does not bring a civil action for 
     declaratory judgment of invalidity or other noninfringement 
     of the patent before the expiration of the 60-day period 
     beginning on the date on which the notice provided under 
     paragraph (2)(B)(ii) was received;

     the approval shall be made effective on the expiration of 60 
     days after the date on which the notice provided under 
     paragraph (2)(B)(ii) was received.
       ``(II) Civil action for patent infringement or declaratory 
     judgment.--If--

       ``(aa)(AA) a civil action for infringement of a patent that 
     is the subject of the certification is brought before the 45-
     day period beginning on the date on which the notice provided 
     under paragraph (2)(B)(ii) was received; or
       ``(BB) the applicant brings a civil action for declaratory 
     judgment of invalidity or other noninfringement of the patent 
     before the expiration of the 60-day period beginning on the 
     date on which the notice under paragraph (2)(B)(ii) was 
     received;
       ``(bb) the holder of the approved application or the owner 
     of the patent seeks a preliminary injunction prohibiting the 
     applicant from engaging in the commercial manufacture and 
     sale of the drug; and
       ``(cc) none of the conditions for denial of approval stated 
     in paragraph (4) applies;

     the approval shall be made effective on issuance by a United 
     States district court of a decision and order that denies a 
     preliminary injunction, or, in a case in which a preliminary 
     injunction has been granted by a United States district court 
     prohibiting the applicant from engaging in the commercial 
     manufacture or sale of the drug, a decision and order that 
     determines that the drug patent is invalid or that the drug 
     patent is not otherwise infringed.
       ``(III) Procedure.--In a civil action brought as described 
     in subclause (II)--

       ``(aa) the civil action shall be brought in the judicial 
     district in which the defendant has its principal place of 
     business or a regular and established place of business;
       ``(bb) each of the parties shall reasonably cooperate in 
     expediting the civil action;
       ``(cc) the court shall not consider a motion for 
     preliminary injunction unless the motion is filed within 90 
     days of commencement of the civil action; and
       ``(dd) the holder of the approved application or the owner 
     of the patent shall be entitled to a preliminary injunction 
     if the holder or owner demonstrates a likelihood of success 
     on the merits and without regard to whether the holder or 
     owner would suffer immediate or irreparable harm or to any 
     other factor.'';
       (2) by redesignating subparagraphs (C) and (D) as 
     subparagraphs (F) and (G), respectively; and
       (3) by inserting after subparagraph (B) the following:
       ``(C) Effectiveness on condition.--
       ``(i) Notice.--The applicant of an application that has 
     been approved under subparagraph (A) but for which the 
     approval has not yet been made effective under subparagraph 
     (B) (referred to in this subparagraph as the `previous 
     application') and with respect to which a preliminary 
     injunction has been issued prohibiting the commercial 
     manufacture or sale of the drug subject to the previous 
     application may submit to the Secretary a notice stating 
     that--

       ``(I) the applicant expects to receive, within 180 days, a 
     United States district court decision and order that vacates 
     the preliminary injunction and denies a permanent injunction 
     or determines that the patent is invalid or is otherwise not 
     infringed (referred to in this subparagraph as a 
     `noninfringement decision');
       ``(II) requests the immediate issuance of an approval of 
     the application conditioned on a noninfringement decision 
     within the specified time;
       ``(III) agrees that--

       ``(aa) the applicant will not settle or otherwise 
     compromise the noninfringement decision in any manner that 
     would prevent or delay the immediate marketing of the drug 
     under the approved application; and
       ``(bb) the applicant will notify the Secretary of the 
     noninfringement decision (or if a decision is rendered that 
     is not a noninfringement decision, will notify the Secretary 
     of that decision) not later than 5 days after the date of 
     entry of judgment; and

       ``(IV) consents to the immediate withdrawal of the 
     approval, without opportunity for a hearing, if the applicant 
     fails to comply with the agreement under subclause (III) or 
     if the noninfringement decision is vacated by the district 
     court or reversed on appeal.

       ``(ii) Approval.--On receipt of a notice under clause (i), 
     if none of the conditions for denial of approval stated in 
     paragraph (4) applies, the Secretary shall immediately issue 
     an effective approval of the application conditioned on the 
     receipt of a noninfringement decision within the specified 
     time, subject to immediate withdrawal if the applicant fails 
     to comply with the agreement under clause (i)(III).
       ``(iii) Effect.--If a noninfringement decision is rendered, 
     the date of the final decision of a court referred to in 
     subparagraph (B)(iv)(II)(aa) shall be the date of the 
     noninfringement decision, notwithstanding that the 
     noninfringement decision may be, or has been, appealed.
       ``(D) Civil action for declaratory judgment.--A person that 
     files an abbreviated application for a new drug under this 
     section containing information showing that the conditions of 
     use prescribed, recommended, or suggested in the labeling 
     proposed for the new drug have been previously approved for a 
     listed drug may bring a civil action--
       ``(i) against the holder of an approved application for the 
     listed drug, for a declaratory judgment declaring that the 
     certification made by the holder of the approved drug 
     application under subsection (b)(5)(C) relating to the listed 
     drug was not properly made; or
       ``(ii) against the owner of a patent that claims the listed 
     drug, a method of using the listed drug, or the active 
     ingredient in the listed drug, for a declaratory judgment 
     declaring that the patent is invalid or will not otherwise be 
     infringed by the new drug for which the applicant seeks 
     approval.''.
       (b) Conforming Amendments.--Section 505A of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended--

[[Page 11324]]

       (1) in subsections (b)(1)(A)(i) and (c)(1)(A)(i), by 
     striking ``(j)(5)(D)(ii)'' each place it appears and 
     inserting ``(j)(5)(G)(ii)'';
       (2) in subsections (b)(1)(A)(ii) and (c)(1)(A)(ii), by 
     striking ``(j)(5)(D)'' each place it appears and inserting 
     ``(j)(5)(G)''; and
       (3) in subsections (e) and (l), by striking 
     ``505(j)(5)(D)'' each place it appears and inserting 
     ``505(j)(5)(G)''.

     SEC. 203. ACCELERATED GENERIC DRUG COMPETITION.

       (a) In General.--Section 505(j)(5) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) (as amended by 
     section 203) is amended--
       (1) in subparagraph (B)(iv), by striking subclause (II) and 
     inserting the following:
       ``(II) the earlier of--
       ``(aa) the date of a final decision of a court in an action 
     described in clause (iii)(II) (from which no appeal has been 
     or can be taken, other than a petition to the Supreme Court 
     for a writ of certiorari) holding that the patent that is the 
     subject of the certification is invalid or not otherwise 
     infringed; or
       ``(bb) the date of a settlement order or consent decree 
     signed by a Federal judge that enters a final judgment and 
     includes a finding that the patent that is the subject of the 
     certification is invalid or not otherwise infringed;''; and
       (2) by inserting after subparagraph (D) the following:
       ``(E) Forfeiture of 180-day period.--
       ``(i) Definitions.--In this subparagraph:

       ``(I) Forfeiture event.--The term `forfeiture event' means 
     the occurrence of any of the following:

       ``(aa) Failure to market.--An applicant fails to market the 
     drug by the later of--
       ``(AA) the date that is 60 days after the date on which the 
     approval of the application for the drug is made effective 
     under subparagraph (B)(iii) (unless the Secretary extends the 
     date because of the existence of extraordinary or unusual 
     circumstances); or
       ``(BB) if the approval has been made effective and a civil 
     action has been brought against the applicant for 
     infringement of a patent subject to a certification under 
     paragraph (2)(A)(vii)(IV) or a civil action has been brought 
     by the applicant for a declaratory judgment that such a 
     patent is invalid or not otherwise infringed, and if there is 
     no other such civil action pending by or against the 
     applicant, the date that is 60 days after the date of a final 
     decision in the civil action, (unless the Secretary extends 
     the date because of the existence of extraordinary or unusual 
     circumstances).
       ``(bb) Withdrawal of application.--An applicant withdraws 
     an application.
       ``(cc) Amendment of certification.--An applicant, 
     voluntarily or as a result of a settlement or defeat in 
     patent litigation, amends the certification from a 
     certification under paragraph (2)(A)(vii)(IV) to a 
     certification under paragraph (2)(A)(vii)(III).
       ``(dd) Failure to obtain approval.--An applicant fails to 
     obtain tentative approval of an application within 30 months 
     after the date on which the application is filed, unless the 
     failure is caused by--
       ``(AA) a change in the requirements for approval of the 
     application imposed after the date on which the application 
     is filed; or
       ``(BB) other extraordinary circumstances warranting an 
     exception, as determined by the Secretary.
       ``(ee) Failure to challenge patent.--In a case in which, 
     after the date on which an applicant submitted an application 
     under this subsection, new patent information is submitted 
     under subsection (c)(2) for the listed drug for a patent for 
     which certification is required under paragraph (2)(A), the 
     applicant fails to submit, not later than 60 days after the 
     date on which the applicant receives notice from the 
     Secretary under paragraph (7)(A)(iii) of the submission of 
     the new patent information either a certification described 
     in paragraph (2)(A)(vii)(IV) or a statement that the method 
     of use patent does not claim a use for which the applicant is 
     seeking approval under this subsection in accordance with 
     paragraph (2)(A)(viii) (unless the Secretary extends the date 
     because of extraordinary or unusual circumstances).
       ``(ff) Monopolization.--The Secretary, after a fair and 
     sufficient hearing, in consultation with the Federal Trade 
     Commission, and based on standards used by the Federal Trade 
     Commission in the enforcement of Acts enforced by the Federal 
     Trade Commission, determines that the applicant at any time 
     engaged in--
       ``(AA) anticompetitive or collusive conduct; or
       ``(BB) any other conduct intended to unlawfully monopolize 
     the commercial manufacturing of the drug that is the subject 
     of the application.

       ``(II) Subsequent applicant.--The term `subsequent 
     applicant' means an applicant that submits a subsequent 
     application under clause (ii).

       ``(ii) Forfeiture event occurs.--If--

       ``(I) a forfeiture event occurs;
       ``(II) no action described in subparagraph (B)(iii)(II) was 
     brought against or by the previous applicant, or such an 
     action was brought but did not result in a final judgment 
     that included a finding that the patent is invalid; and
       ``(III) an action described in subparagraph (B)(iii)(II) is 
     brought against or by the next applicant, and the action 
     results in a final judgment that includes a finding that the 
     patent is invalid;

     the 180-day period under subparagraph (B)(iv) shall be 
     forfeited by the applicant and shall become available to an 
     applicant that submits a subsequent application containing a 
     certification described in paragraph (2)(A)(vii)(IV).
       ``(iii) Forfeiture event does not occur.--If a forfeiture 
     event does not occur, the application submitted subsequent to 
     the previous application shall be treated as the previous 
     application under subparagraph (B)(iv).
       ``(iv) Availability.--The 180-day period under subparagraph 
     (B)(iv) shall be available only to--

       ``(I) the previous applicant submitting an application for 
     a drug under this subsection containing a certification 
     described in paragraph (2)(A)(vii)(IV) with respect to any 
     patent; or
       ``(II) under clause (i), a subsequent applicant submitting 
     an application for a drug under this subsection containing 
     such a certification with respect to any patent;

     without regard to whether an application has been submitted 
     for the drug under this subsection containing such a 
     certification with respect to a different patent.
       ``(v) Applicability.--The 180-day period described in 
     subparagraph (B)(iv) shall apply only if--

       ``(I) the application contains a certification described in 
     paragraph (2)(A)(vii)(IV); and
       ``(II)(aa) an action is brought for infringement of a 
     patent that is the subject of the certification; or
       ``(bb) not later than 60 days after the date on which the 
     notice provided under paragraph (2)(B)(ii) is received, the 
     applicant brings an action against the holder of the approved 
     application for the listed drug.''.

       (b) Applicability.--The amendment made by subsection (a) 
     shall be effective only with respect to an application filed 
     under section 505(j) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355(j)) after the date of enactment of this 
     Act for a listed drug for which no certification under 
     section 505(j)(2)(A)(vii)(IV) of that Act was made before 
     June 7, 2002.

     SEC. 204. NOTICE OF AGREEMENTS SETTLING CHALLENGES TO 
                   CERTIFICATIONS THAT A PATENT IS INVALID OR WILL 
                   NOT BE INFRINGED.

       (a) Definitions.--Section 201 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 321) is amended by adding at the 
     end the following:
       ``(kk) Brand Name Drug Company.--The term `brand name drug 
     company' means a person engaged in the manufacture or 
     marketing of a drug approved under section 505(b).
       ``(ll) Generic Drug Applicant.--The term `generic drug 
     applicant' means a person that has filed for approval or 
     received approval of an abbreviated new drug application 
     under section 505(j).''.
       (b) Notice of Agreements Settling Challenges to 
     Certifications That a Patent Is Invalid or Will Not Otherwise 
     Be Infringed.--Section 505 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355) is amended by adding at the end 
     the following:
       ``(o) Notice of Agreements Settling Challenges to 
     Certifications That a Patent Is Invalid or Will Not Otherwise 
     Be Infringed.--
       ``(1) In general.--A brand name drug company and a generic 
     drug applicant that enter into an agreement regarding the 
     settlement of a challenge to a certification with respect to 
     a patent on a drug under subsection 505(b)(2)(A)(iv) shall 
     submit to the Secretary and the Attorney General a notice 
     that includes--
       ``(A) a copy of the agreement;
       ``(B) an explanation of the purpose and scope of the 
     agreement; and
       ``(C) an explanation whether there is any possibility that 
     the agreement could delay, restrain, limit, or otherwise 
     interfere with the production, manufacture, or sale of the 
     generic version of the drug.
       ``(2) Filing deadlines.--A notice required under paragraph 
     (1) shall be submitted not later than 10 business days after 
     the date on which the agreement described in paragraph (1) is 
     entered into.
       ``(3) Enforcement.--
       ``(A) Civil penalty.--
       ``(i) In general.--A person that fails to comply with 
     paragraph (1) shall be liable for a civil penalty of not more 
     than $20,000 for each day of failure to comply.
       ``(ii) Procedure.--A civil penalty under clause (i) may be 
     recovered in a civil action brought by the Secretary or the 
     Attorney General in accordance with section 16(a)(1) of the 
     Federal Trade Commission Act (15 U.S.C. 56(a)(1)).
       ``(B) Compliance and equitable relief.--If a person fails 
     to comply with paragraph (1), on application of the Secretary 
     or the Attorney General, a United States district court may 
     order compliance and grant such other equitable relief as the 
     court determines to be appropriate.
       ``(4) Regulations.--The Secretary, with the concurrence of 
     the Attorney General, may by regulation--
       ``(A) require that a notice required under paragraph (1) be 
     submitted in such form and contain such documentary material 
     and information relevant to the agreement as is

[[Page 11325]]

     appropriate to enable the Secretary and the Attorney General 
     to determine whether the agreement may violate the antitrust 
     laws; and
       ``(B) prescribe such other rules as are appropriate to 
     carry out this subsection.''.

     SEC. 205. PUBLICATION OF INFORMATION IN THE ORANGE BOOK.

       (a) Definition of Orange Book.--Section 201 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 321) (as amended by 
     section 205(a)) is amended by adding at the end the 
     following:
       ``(mm) Orange Book.--The term `Orange Book' means the 
     publication published by the Secretary under section 
     505(b)(1).''.
       (b) Publication of Information in the Orange Book.--Section 
     505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355(b)) is amended--
       (1) in the fourth sentence of paragraph (1), by inserting 
     before the period at the end the following: ``in a 
     publication entitled `Approved Drug Products With Therapeutic 
     Equivalence Indications' (commonly known as the `Orange 
     Book')''; and
       (2) by adding at the end the following:
       ``(5) Publication of information in the orange book.--
       ``(A) Definitions.--In this paragraph:
       ``(i) Interested person.--The term `interested person' 
     includes--

       ``(I) an applicant under paragraph (1);
       ``(II) any person that is considering engaging in the 
     manufacture, production, or marketing of a drug with respect 
     to which there may be a question whether the drug infringes 
     the patent to which information submitted under the second 
     sentence of paragraph (1) pertains;
       ``(III) the Federal Trade Commission; and
       ``(IV) a representative of consumers.

       ``(ii) Qualified patent information.--The term `qualified 
     patent information' means information that meets the 
     requirement of the second sentence of paragraph (1) that a 
     patent with respect to which information is submitted under 
     that sentence be a patent with respect to which a claim of 
     patent infringement could reasonably be asserted if a person 
     not licensed by the owner engaged in the manufacture, use, or 
     sale of the drug that is the subject of an application under 
     paragraph (1).
       ``(B) Duty of the secretary.--The Secretary shall publish 
     in the Orange Book only information that is qualified patent 
     information.
       ``(C) Certification.--
       ``(i) In general.--Information submitted under the second 
     sentence of paragraph (1) shall not be published in the 
     Orange Book unless the applicant files a certification, 
     subject to section 1001 of title 18, United States Code, and 
     sworn in accordance with section 1746 of title 28, United 
     States Code, that discloses the patent data or information 
     that forms the basis of the entry.
       ``(ii) Contents.--A certification under clause (i) shall--

       ``(I)(aa) identify all relevant claims in the patent 
     information for which publication in the Orange Book is 
     sought; and
       ``(bb) with respect to each such claim, a statement whether 
     the claim covers an approved drug, an approved method of 
     using the approved drug, or the active ingredient in the 
     approved drug (in the same physical form as the active 
     ingredient is present in the approved drug);
       ``(II) state the approval date for the drug;
       ``(III) state an objectively reasonable basis on which a 
     person could conclude that each relevant claim of the patent 
     covers an approved drug, an approved method of using the 
     approved drug, or the active ingredient in the approved drug 
     (in the same physical form as the active ingredients is 
     present in the approved drug);
       ``(IV) state that the information submitted conforms with 
     law; and
       ``(V) state that the submission is not made for the purpose 
     of delay or for any improper purpose.

       ``(iii) Regulations.--

       ``(I) In general.--Not later than 16 months after the date 
     of enactment of this paragraph, the Secretary, in 
     consultation with the United States Patent and Trademark 
     Office, shall promulgate regulations governing certifications 
     under clause (i).
       ``(II) Civil penalties.--The regulations under subclause 
     (I) shall prescribe civil penalties for the making of a 
     fraudulent or misleading statement in a certification under 
     clause (i).

       ``(D) Consultation.--For the purpose of deciding whether 
     information should be published in Orange Book, the Secretary 
     may consult with the United States Patent and Trademark 
     Office.
       ``(E) Publication of determination.--The Secretary shall 
     publish in the Federal Register notice of a determination by 
     the Secretary whether information submitted by an applicant 
     under the second sentence of paragraph (1) is or is not 
     qualified patent information.
       ``(F) Petition to reconsider determination.--
       ``(i) In general.--An interested person may file with the 
     Secretary a petition to reconsider the determination.
       ``(ii) Contents.--A petition under clause (i) shall 
     describe in detail all evidence and present all reasons 
     relied on by the petitioner in support of the petition.
       ``(iii) Notice.--The Secretary shall publish in the Federal 
     Register notice of the filing of a petition under clause (i).
       ``(iv) Response.--Not later than 30 days after publication 
     of a notice under clause (iii), any interested person may 
     file with the Secretary a response to the petition.
       ``(v) Reply.--Not later than 15 days after the filing of a 
     response under clause (iv), the petitioner may file with the 
     Secretary a reply to the response.
       ``(vi) Regulations.--The Secretary may promulgate 
     regulations providing for any additional procedures for the 
     conduct of challenges under this subparagraph.''.
       (c) Expedited Review of the Orange Book.--
       (1) Use of defined terms.--Terms used in this subsection 
     that are defined in the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 201 et seq.) (as amended by this section) having 
     the meanings given the terms in that Act.
       (2) Expedited review.--As soon as practicable after the 
     date of enactment of this Act, the Secretary shall--
       (A) complete a review of the Orange Book to identify any 
     information in the Orange Book that is not qualified patent 
     information; and
       (B) delete any such information from the Orange Book.
       (3) Priority.--In conducting the review under paragraph 
     (2), the Secretary shall give priority to making 
     determinations concerning information in the Orange Book with 
     respect to which any interested person may file a petition 
     for reconsideration under paragraph (5)(F) of section 505(b) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355(b)), as added by subsection (b).
       (d) Differences in Labeling.--Section 505(j)(2) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)) is 
     amended--
       (1) in subparagraph (A)(v)--
       (A) by striking ``subparagraph (C) or because'' and 
     inserting ``subparagraph (C), because''; and
       (B) by inserting after ``manufacturers'' the following: ``, 
     or because of the omission of an indication or other aspect 
     of labeling that is required by patent protection or 
     exclusivity accorded under paragraph (5)(D)''; and
       (2) by adding at the end the following:
       ``(D) Labeling consistent with labeling for earlier version 
     of listed drug.--For the purposes of subparagraph (A)(v), 
     information showing that labeling proposed for the new drug 
     that is the same as the labeling previously approved for the 
     listed drug, although not for the current version of the 
     listed drug, shall be deemed to be the same labeling as that 
     approved for the listed drug so long as the previously 
     approved labeling is not incompatible with a safe and 
     effective new drug.''.

     SEC. 206. NO ADDITIONAL 30-MONTH EXTENSION.

       Section 505(j)(5)(B)(iii) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355 (j)(5)(B)(iii) is amended by 
     inserting after the fourth sentence the following: ``Once a 
     thirty-month period begins under the second sentence of this 
     clause with respect to any application under this subsection, 
     there shall be no additional thirty-month period or extension 
     of the thirty-month period with respect to the application by 
     reason of the making of any additional certification 
     described in subclause (IV) of paragraph (2)(A)(vii) or for 
     any other reason.''.

        TITLE III--EXPANSION OF ACCESS THROUGH EXISTING PROGRAMS

     SEC. 301. MEDICARE COVERAGE OF ALL ANTICANCER ORAL DRUGS.

       (a) In General.--Section 1861(s)(2)(Q) of the Social 
     Security Act (42 U.S.C. 1395x(s)(2)(Q)) is amended by 
     striking ``anticancer chemotherapeutic agent for a given 
     indication,'' and all that follows and inserting ``anticancer 
     agent for a medically accepted indication (as defined in 
     subsection (t)(2)(B));''.
       (b) Conforming Amendment.--Section 1834(j)(5)(F)(iv) of the 
     Social Security Act (42 U.S.C. 1395m(j)(5)(F)(iv)) is amended 
     by striking ``therapeutic''.
       (c) Effective Date.--The amendments made by this section 
     shall apply with respect to drugs furnished on or after the 
     date that is 90 days after the date of enactment of this Act.

     SEC. 302. REMOVAL OF STATE RESTRICTIONS.

       (a) Therapeutic Equivalence.--Section 505(j) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is amended--
       (1) in paragraph (5)(A)--
       (A) by striking ``(5)(A) Within one hundred and eighty days 
     of the'' and inserting the following:
       ``(5) Time periods.--
       ``(A) Approval or disapproval.--
       ``(i) In general.--Not later than 180 days after the date 
     of''; and
       (B) by adding at the end the following:
       ``(ii) Finding regarding therapeutic equivalence.--When the 
     Secretary approves an application submitted under paragraph 
     (1), the Secretary shall include in the approval a finding 
     whether the drug for which the application is approved 
     (referred to in this paragraph as the `subject drug') is the 
     therapeutic equivalent of a listed drug.
       ``(iii) Therapeutic equivalence.--For purposes of clause 
     (ii), a subject drug is the therapeutic equivalent of a 
     listed drug if--

[[Page 11326]]

       ``(I) all active ingredients of the subject drug, the 
     dosage form of the subject drug, the route of administration 
     of the subject drug, and the strength or concentration of the 
     subject drug are the same as those of the listed drug and the 
     compendial or other applicable standard met by the subject 
     drug is the same as that met by the listed drug (even though 
     the subject drug may differ in shape, scoring, configuration, 
     packaging, excipients, expiration time, or (within the limits 
     established by paragraph (2)(A)(v)) labeling);
       ``(II) the subject drug is expected to have the same 
     clinical effect and safety profile as the listed drug when 
     the subject drug is administered to patients under conditions 
     specified in the labeling; and
       ``(III) the subject drug--

       ``(aa)(AA) does not present a known or potential 
     bioequivalence problem; and
       ``(BB) meets an acceptable in vitro standard; or
       ``(bb) if the subject drug presents a known or potential 
     bioequivalence problem, is shown to meet an appropriate 
     bioequivalence standard.
       ``(iv) Finding.--If Secretary finds that the subject drug 
     meets the requirements of clause (iii) with respect to a 
     listed drug, the Secretary shall include in the approval of 
     the application for the subject drug a finding that the 
     subject drug is the therapeutic equivalent of the listed 
     drug.''; and
       (2) in paragraph (7)(A)(i)(II), by striking ``and the 
     number of the application which was approved'' and inserting 
     ``, the number of the application that was approved, and a 
     statement whether a finding of therapeutic equivalence was 
     made under paragraph (5)(A)(iv), and if so the name of the 
     listed drug to which the drug is a therapeutic 
     bioequivalent''.
       (b) State Laws.--Section 505(j) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355(j)) is amended by adding at 
     the end the following:
       ``(10) State laws.--No State or political subdivision of a 
     State may establish or continue in effect with respect to a 
     drug that is the subject of an application under paragraph 
     (5) any requirement that is different from, or in addition 
     to, any requirement relating to therapeutic equivalence 
     applicable to the drug under paragraph (5).''.

     SEC. 303. MEDICAID DRUG USE REVIEW PROGRAM.

       (a) In General.--Section 1927(g)(2) of the Social Security 
     Act (42 U.S.C. 1396r-8(g)(2)) is amended by adding at the end 
     the following:
       ``(E) Generic drug samples.--The program shall provide for 
     the distribution of generic drug samples of covered 
     outpatient drugs to physicians and other prescribers.''.
       (b) Federal Percentage of Expenditures.--Section 
     1903(a)(3)(D) of the Social Security Act (42 U.S.C. 
     1396b(a)(3)(D)) is amended by striking ``in 1991, 1992, or 
     1993,'' and inserting ``(beginning with fiscal year 2003)''.
       (c) Effective Date.--The amendments made by this section 
     take effect on October 1, 2002.

     SEC. 304. CLARIFICATION OF INCLUSION OF INPATIENT DRUG PRICES 
                   CHARGED TO CERTAIN PUBLIC HOSPITALS IN THE BEST 
                   PRICE EXEMPTIONS ESTABLISHED FOR PURPOSES OF 
                   THE MEDICAID DRUG REBATE PROGRAM.

       Section 1927(c)(1)(C)(ii) of the Social Security Act (42 
     U.S.C. 1396r-8(c)(1)(C)(ii)) is amended--
       (1) in subclause (II), by striking ``and'' at the end;
       (2) in subclause (III), by striking the period and 
     inserting ``; and''; and
       (3) by adding at the end the following:

       ``(IV) with respect to a covered entity described in 
     section 340B(a)(4)(L) of the Public Health Service Act, 
     shall, in addition to any prices excluded under clause 
     (i)(I), exclude any price charged on or after the date of 
     enactment of this subparagraph, for any drug, biological 
     product, or insulin provided as part of, or as incident to 
     and in the same setting as, inpatient hospital services (and 
     for which payment may be made under this title as part of 
     payment for and not as direct reimbursement for the drug).''.

     SEC. 305. UPPER PAYMENT LIMITS FOR GENERIC DRUGS UNDER 
                   MEDICAID.

       Section 1927(e) of the Social Security Act (42 U.S.C. 
     1396r-8(e)) is amended by striking paragraph (4) and 
     inserting the following:
       ``(4) Establishment of upper payment limits.--
       ``(A) In general.--The Administrator of the Centers for 
     Medicare & Medicaid Services shall establish a upper payment 
     limit for each multiple source drug for which the FDA has 
     rated 3 or more products therapeutically and pharmaceutically 
     equivalent.
       ``(B) Public availability of national drug code.--The 
     Administrator of the Centers for Medicare & Medicaid Services 
     shall make publicly available, at such time and together with 
     the publication of the upper payment limits established in 
     accordance with subparagraph (A), the national drug code 
     (commonly referred to as the `NDC') for each drug used as the 
     reference product to establish the upper payment limit for a 
     particular multiple source drug.
       ``(C) Definition of reference product.--In subparagraph 
     (B), the term `reference product' means the specific drug 
     product, the price of which is used by the Administrator of 
     the Centers for Medicare & Medicaid Services to calculate the 
     upper payment limit for a particular multiple source drug.''.

                      TITLE IV--GENERAL PROVISIONS

     SEC. 401. REPORT.

       (a) In General.--Not later than the date that is 5 years 
     after the date of enactment of this Act, the Federal Trade 
     Commission shall submit to Congress a report describing the 
     extent to which implementation of the amendments made by this 
     Act--
       (1) has enabled products to come to market in a fair and 
     expeditious manner, consistent with the rights of patent 
     owners under intellectual property law; and
       (2) has promoted lower prices of drugs and greater access 
     to drugs through price competition.
       (b) Authorization of Appropriations.--There is authorized 
     to be appropriated to carry out this section $1,000,000.
                                 ______
                                 
      By Mr. BAUCUS (for himself, Mr. Crapo, Mr. Harkin, Mr. Warner, 
        Mr. Daschle, Mr. Craig, Mr. Bond, Mr. Graham, Mrs. Carnahan, 
        Mr. Reid, Mr. Thomas, Mr. Enzi, and Mr. Johnson):
  S. 2678. A bill to amend the Internal Revenue Code of 1986 to 
transfer all excise taxes imposed on alcohol fuels to the Highway Trust 
Fund, and for other purposes; to the Committee on Finance.
  Mr. BAUCUS. Mr. President, I rise today to introduce the MEGATRUST 
Act, the Maximum Growth for America Through the Highway Trust Fund.
  Next year, the Congress must reauthorize highway and transit programs 
and the system of Federal financing for them. This is a very important 
issue for our Nation. The highway and transit programs are very 
important in every State. Very few other pieces of legislation effect 
our country's citizens and businesses more directly than the highway 
bill. These are our ways for moving goods and people.
  They are key to our economy and our ability to connect to one 
another. This country needs good, safe highways in order to cross great 
distances, and highway and transit construction and maintenance is an 
important part of every State's economy.
  In order to facilitate our work in reauthorizing these programs, I 
plan to introduce a series of bills concerning important issues that 
Congress must address in that legislation.
  This will be the first of those bills, a proposal concerning revenues 
for the highway trust fund. But unlike other bills I will introduce, 
this one must pass more quickly because it sets the foundation for the 
other bills I will be introducing later. This bill will represent how 
this country will help pay for our highway and transit needs over the 
next several years.
  The MEGATRUST Act represents an important step in the effort to 
strengthen our Nation's economy, and improve its quality of life, by 
investing in transportation.
  It would increase revenues into the highway trust fund by several 
billion dollars annually by making some needed corrections in the way 
Federal revenues are credited to the highway trust fund.
  Nothing in this bill increases any tax. I repeat that. Nothing in 
this bill increases any tax.
  Federal dollars to help States and localities improve their highways 
and transit systems are derived largely from the Federal highway trust 
fund. Under the system today, revenues from highway user taxes are 
deposited into the highway trust fund, and, more specifically, into 
separate accounts within the fund for highways and for transit. Those 
are two separate accounts.
  These revenues are, in turn, distributed to States and localities for 
transportation investments that truly to improve our lives, create 
jobs, and make our economy better. This trust fund mechanism has been 
widely regarded as successful. But, as always, we must make adjustments 
to meet new challenges.
  This bill would improve and extend this important financing 
mechanism, principally by making sure that certain revenues not 
currently credited to the highway trust fund are, in fact, placed in 
that fund.
  The MEGATRUST Act does several things. First, it will ensure that 
taxes paid on gasohol are fully credited to the highway account of the 
highway trust fund. Today, when gasohol is taxed, the mass transit 
account of the

[[Page 11327]]

highway trust fund receives its full share of revenues, as if the fuel 
were gasoline. But 2.5 cents of the gas tax per gallon that is imposed 
on gasohol is credited to the general fund of the Treasury, not to the 
highway account. So the MEGATRUST Act ensures that those 2.5 cents per 
gallon go to the highway account.
  Second, the MEGATRUST Act will ensure that the highway system does 
not bear the cost of our national policy to develop and promote the use 
of gasohol. This tax rate preference is part of our national policy to 
advance the use of gasohol.
  I believe the ethanol subsidy is good energy policy, good agriculture 
policy, and good tax policy. Yet ironically, it is the highway trust 
fund that bears the burden of the subsidy. Since it is good general 
policy--that is, gasohol--I believe the general fund should bear the 
burden of the subsidy, not the highway trust fund.
  Gasohol, as a fuel, is taxed 5.3 cents per gallon less than gasoline. 
But gasohol-fueled vehicles cause the same wear and tear on roads as 
gasoline-fueled vehicles. That is obvious. They use the same roads, 
travel the same distances, et cetera.
  Ensuring necessary and affordable energy supplies is important to the 
quality of life and economic prosperity of all Americans. Policies to 
achieve these objectives, however, should not come at the expense of 
transportation infrastructure improvements.
  Accordingly, the MEGATRUST Act would leave the gasohol tax rate 
preference in place but credit the highway account of the highway trust 
fund with revenue equal to that forgone to the Treasury by the gasohol 
tax preference.
  Third, the MEGATRUST Act credits both the highway and mass transit 
accounts of the highway trust fund with interest starting in fiscal 
year 2004. Today, the highway trust fund is one of the few trust funds 
in the Federal budget that is not credited with interest on its unspent 
balance, which is highly inappropriate.
  The MEGATRUST Act would change this in order to make sure that 
collected highway user taxes are to be put to work for better 
transportation for our citizens.
  Fourth, the MEGATRUST Act would extend the basic highway user taxes 
and the highway trust fund so they do not expire.
  And last, the MEGATRUST Act would require the creation of an 
important commission concerning the future financing of the Federal 
highway and transit programs.
  Why is that important? While the current mechanism has worked well, 
we know that cars will become more fuel efficient and advancing 
technology will only bring us closer to increased fuel efficiency.
  Other changes are possible as well in our dynamic economy. While 
major changes will not occur overnight, we have to be ready for them. 
We have to understand what is likely to happen so we can consider 
making adjustments in the highway trust fund and its revenue streams, 
so we are not caught off guard and unable to adequately fund our 
transportation system.
  What am I saying? I am basically saying that the hybrid fuel 
vehicles--it could be fuels cells, other technologies for our 
automobiles of the future--they do not use gasoline, they do not use 
gasohol, therefore, revenue would not be placed in the highway trust 
fund. We have to anticipate all of those changes so our highways are 
adequately funded regardless of the types of cars and regardless of the 
type of energy that is used to propel those cars.
  I especially thank Senators Harkin, Warner, Crapo, Graham of Florida, 
Reid, Daschle, Carnahan, Bond, and Craig for working so closely with me 
on this legislation.
  In sum, through this highway trust fund proposal, I want to make 
clear to my colleagues that there are ways to increase revenue into the 
highway trust fund without raising taxes. We will need to increase 
highway trust fund resources to help us all structure a successful 
reauthorization bill next year, and I look forward to working closely 
with my colleagues to that end.
                                 ______
                                 
      By Mr. BAUCUS (for himself, and Mr. Smith of Oregon):
  S. 2679. A bill to amend the Internal Revenue Code of 1986 to provide 
for a tax credit for offering employer-based health insurance coverage, 
to provide for the establishment of health plan purchasing alliances, 
and for other purposes; to the Committee on Finance.
  Mr. BAUCUS. Mr. President, I rise today to introduce the ``Health 
Insurance Access Act'' of 2002.
  This bill addresses one of the most serious problems facing the 
United States. The problem of the uninsured.
  According to recent census data, 38 million Americans lack health 
insurance coverage. More than the population of twenty-three States. 
Plus the District of Columbia. And lack of coverage is an even greater 
problem in rural areas. In Montana, one in five citizens goes without 
health insurance. As premiums sky-rocket, I'm worried that this number 
may grow even higher.
  For America's uninsured, the consequences of going without health 
coverage can be devastating.
  Put plainly, uninsured Americans are less healthy than those with 
health insurance. They delay seeking medical care or go without 
treatment altogether that could prevent and detect crippling illnesses. 
Illnesses like diabetes, heart disease, and cancer. The uninsured are 
far less likely to receive health services if they are injured or 
become ill.
  These factors take an enormous personal toll on the lives of the 
uninsured. They are sicker and less productive in the workplace. Their 
children are less likely to survive past infancy. And they must 
struggle with the knowledge that a serious injury or illness in their 
family might push them to the brink of financial ruin.
  I just recently saw a statistic that women with breast cancer who 
lack health insurance are 49 percent more likely to die than women who 
have insurance. Unfortunately, this statistic is just one of countless 
other statistics about the effects that lack of health insurance has on 
peoples' health and their lives.
  But these personal struggles are not the only affect of America's 
uninsured problem. Because when the uninsured become so sick that they 
must finally seek emergency treatment, there is no one to pay for it. 
No insurance company. No government program.
  So who absorbs the cost of this uncompensated medical care? We all 
do. In the form of higher health care costs. Higher and higher premiums 
at a time when the cost of health care is already rising out of 
control.
  The situation is becoming critical. And I believe the time for 
talking has ended. It is time for us to examine solutions instead of 
talking about the problem.
  That is why I have joined with Senator Gordon Smith to introduce this 
important piece of legislation. Our bill would lift millions of 
Americans out of the ranks of the uninsured. It would give millions of 
families the peace of mind that comes from knowing they will receive 
the care they need, when they need it. And it would lighten the load of 
uncompensated care on our over-burdened health care system.
  Our bill attacks the problem of the uninsured on several fronts. As 
you know, the 38 million uninsured Americans are a diverse mix of 
people. Some work for small employers, who simply can't afford the high 
cost of health insurance. Others have pre-existing health conditions. 
These conditions translate into unaffordable, even astronomical, health 
care insurance premiums.
  Some uninsured Americans fall just beyond the eligibility levels for 
public programs like Medicaid. And many are near-elderly individuals, 
too young to qualify for Medicare, yet old enough that any health 
condition at all means expensive premiums or high deductibles. In fact, 
the fastest growing segment of the uninsured today is the near-elderly 
population.
  Our bill addresses each of these populations.
  The first part of our bill would target uninsured Americans who work 
for small businesses. It would give a tax

[[Page 11328]]

credit of up to 50 percent to small firms, those with 50 or fewer 
employees, for the cost of health insurance premiums for their 
employees. The credit is not limited only to employers who do not 
currently provide health benefits. It is available to all qualified 
small employers. The credit will give small employers the extra 
resources they need to extend, or continue to offer, health benefits to 
millions of hard-working Americans and their families.
  One thing I heard from my constituents traveling around the State, in 
addition to grief over increasing premiums, is that the health 
insurance options available to individuals and small employers are 
limited. If they could pool their resources together, even across State 
lines, they might be able to reduce their costs as a group.
  In response to these concerns, the second part of our bill would 
provide funding to states, private employer groups, and associations to 
create purchasing pools. These purchasing pools, or alliances, as we 
call them in this bill, would provide small employers with affordable 
health coverage options, which would, accordingly, allow them to take 
maximum advantage of their tax credits.
  For individuals with high cost health conditions, our bill would 
spend $50 million annually to support state high risk pools. These 
pools serve a dual purpose. They offer high-risk individuals a place to 
purchase affordable health coverage. And, by isolating the costs of 
high-risk individuals, they help lower premiums for those who are not 
considered high risk or high cost.
  Fourth, our bill would also allow states to expand health insurance 
coverage to the parents of children who are eligible for Medicaid and 
the Children's Health Insurance Program, or CHIP. This will reach an 
estimated four million low-income parents who do not currently meet 
eligibility levels for health insurance coverage under public programs. 
It will also help us cover even more kids under CHIP, kids who are 
eligible for coverage but not currently enrolled.
  Finally, our bill would allow uninsured Americans between the ages of 
62 and 65 to buy into Medicare. Under current law, Americans in this 
age group are stuck in a bind: not old enough to qualify for Medicare, 
but unable to afford the high cost of private health insurance options 
because of their age or health condition. This predicament explains why 
they represent the fastest-growing group of uninsured. Our bill would 
offer the near-elderly a more affordable, quality health care package 
to tide them over until they reach 65.
  All told, these efforts would expand access to health insurance 
coverage to 10 million Americans who are currently uninsured. It's not 
a panacea. But it's a start.
  I commend Senator Smith for his hard work on this issue. I believe 
our bipartisan efforts prove that covering the uninsured is not a 
Democratic issue. It's not a Republican issue. And it's not a Montana 
or an Oregon issue. It's an American issue.
  I hope my colleagues will join this fight by helping us pass this 
legislation, and taking a solid step towards providing quality, 
affordable health insurance to all Americans.
  Mr. SMITH of Oregon. Mr. President, I would like to thank my 
colleague from Montana for his leadership on the issue of the 
uninsured, and rise today in support of the Baucus-Smith Health 
Insurance Access Act. This bill will go a long way toward mending some 
of the holes in our nation's health care safety net.
  And make no mistake, the safety net is torn. Currently 40 million 
Americans, that's one in six,--live, work, and go to school among us 
without health insurance. That means that nationally, 17 percent of 
Americans do not have any health insurance. They are our friends, our 
neighbors, our children, our parents.
  And the problem is getting worse, not better. In 2001, two million 
Americans lost their health insurance, that's the largest one year 
increase in almost a decade.
  Many, more than 35 million of these uninsured Americans, are in low-
income working families. Many people who work in small businesses are 
not offered health insurance, and those who are often cannot afford the 
skyrocketing premiums.
  This is particularly true if an individual or a member of their 
family happen to have some kind of pre-existing or chronic condition 
that can make a simple policy totally unaffordable. Even relatively 
healthy Americans find that when they get older, they may be unable to 
afford health care premiums after they retire, but before they become 
eligible for Medicare.
  Some people say that insurance is irrelevant, that the uninsured can 
still get good care at public clinics and in emergency rooms. While it 
is true that public clinics do provide high quality care to millions of 
Americans, this is not the same as having health insurance with a 
regular source of care.
  Not having a regular source of care leads to needless delays in 
seeking care. According to a recent report by the Institute of 
Medicine, an estimated 18,000 people die every year because they don't 
have health insurance, and don't get the care they need in a timely 
fashion. Eighteen thousand deaths a year. Millions more people suffer 
unnecessarily due to delays in care.
  Millions of Americans are falling through the cracks in our health 
care system, and it is our moral obligation to help them get the care 
they need by providing access to affordable health insurance.
  The Health Insurance Access Act of 2002 provides a number of 
solutions to the growing crisis of the uninsured.
  It helps small businesses, which are often unable to offer affordable 
health insurance to their employees. Under this legislation, small 
businesses would get a significant tax break to subsidize their 
purchase of health insurance. The tax break is indexed to the size of a 
business, so the smallest employers get the most help if they choose to 
offer their employees health insurance. This is important because 
smaller businesses are much less likely to offer their employees health 
coverage.
  In order to avoid punishing small employers who are already doing the 
right thing, our tax credit is available to all qualified small 
employers, regardless of whether they currently offer health insurance 
to their employees.
  Another problem small businesses face in purchasing health insurance 
for their employees is finding an affordable policy with real benefits 
for their employees. By definition, small businesses are too small to 
provide a stable risk pool. This drives up the cost of premiums.
  The Baucus-Smith Health Insurance Access Act of 2002 offers employers 
some relief to this problem by providing funding for purchasing 
alliances, which lower premiums by sharing risk. This will provide new, 
more affordable options for millions of Americans, who have until now 
had limited health insurance choices.
  Our bill also provides grants to states to help fund high risk pools 
for people who have very limited health insurance options. It seems 
ironic to me that many of the people who need health insurance most, 
people with an expensive medical condition--are often unable to obtain 
insurance.
  For many people who have extensive health care needs and medical 
expenses, obtaining coverage in the individual insurance market is not 
a viable option. If they can find a policy to cover their illness--
often they cannot--they may not be able to afford the premium.
  However, in many cases, many of these individuals may not be able to 
buy health insurance at any cost, because insurers often turn down high 
risk individuals for coverage because of an existing or previous 
illness.
  High-risk insurance pools attempt to fill this gap in the insurance 
market. Oregon has had a high risk insurance pool for people who were 
unable to obtain health insurance because of health conditions for the 
past 15 years. Since its inception, more than 24,000 Oregonians have 
bought health care coverage through this high risk insurance pool, 
24,000 people who would otherwise have had no health care coverage.
  Operating a high risk pool in Oregon has had its costs, costs which 
are increasing every year. Our legislation

[[Page 11329]]

will help States assist people who are trying to do the right thing 
afford health insurance coverage that would otherwise be out of reach.
  While much of the policy discussion about the uninsured focuses on 
children, low income parents are substantially more likely than their 
children to be uninsured. The Health Insurance Access Act of 2002 would 
also allow states to offer Medicaid and SCHIP benefits to parents of 
low income eligible children.
  Encouraging States to offer Medicaid or SCHIP coverage to parents 
will significantly expand access to care for low income parents, and 
their children, because parents are more likely to enroll their kids in 
Medicaid or SCHIP when the family is eligible, rather than just certain 
family members.
  Finally, the Health Insurance Access Act of 2002 would address 
another hole in the insurance market: the near elderly. The near 
elderly, Americans aged 62-64, often do not have employer sponsored 
health insurance, because they have retired from the labor force, but 
are not yet eligible for Medicare.
  At the same time, insurance coverage is particularly critical for 
near-elderly Americans, as the risk of serious illness rises with age, 
and the prevalence of chronic disease is higher among this population. 
In addition, because many of the near-elderly have pre-existing 
conditions, private insurers often deny them coverage or charge 
unaffordable premiums.
  Allowing all Americans aged 62-64 to buy into the Medicare program 
would create a strong risk pool that would stabilize premiums, making 
them affordable to many who would otherwise have been unable to afford 
coverage. Researchers estimate that almost 40% of eligible Americans 
62-64 would buy into Medicare if allowed to do so.
  The number of uninsured people in America is an outrage. If 18,000 
Americans died in terrorist incidents each year, there would be 
widespread outrage. Yet, tens of thousands of uninsured Americans are 
at risk of dying each year from cancers diagnosed too late, or stroke 
from uncontrolled high blood pressure. These can be slow, painful 
deaths. They are preventable deaths. We can help prevent these deaths. 
We should help prevent these deaths.
  I urge you to join me and my colleague from Montana to support the 
Health Insurance Access Act of 2002. This legislation will touch 
millions of lives by making quality, affordable health insurance 
accessible to individuals and families who are living at risk.
  It is the right thing to do. It is the right time to do it.
                                 ______
                                 
      By Mr. BAUCUS:
  S. 2680. A bill to direct the Secretary of the Interior to evaluate 
opportunities to enhance domestic oil and gas production through the 
exchange of nonproducing Federal oil and gas leases located in the 
Lewis and Clark National Forest, in the Flathead National Forest and on 
Bureau of Land Management land in the State of Montana, and for other 
purposes; to the Committee on Energy and Natural Resources.
  Mr. BAUCUS. Mr. President, I am introducing a bill today that is 
extremely important to the people of my State of Montana. Why is it so 
important? Because I hope it will take us one step closer to achieving 
permanent protections for Montana's magnificent Rocky Mountain Front.
  The Front, as we call it back home, is part of one of the largest and 
most intact wild places left in the lower 48. To the North, the Front 
includes a 200 square mile area known as the Badger-Two Medicine in the 
Lewis and Clark National Forest. This area sits just south-east of 
Glacier National Park, one of our greatest national treasures. The 
Badger-Two Medicine area is sacred ground to the Blackfeet Tribe. In 
January of 2002, portions of the Badger-Two, known as the Badger-Two 
Medicine Blackfoot Traditional Cultural District, were declared 
eligible for listing in the National Register of Historic Places.
  South of the Badger-Two, the Front includes a 400 square mile strip 
of national forest land and about 20 square miles of BLM lands, 
including three BLM Outstanding Natural Areas.
  Not only the Front still retain almost all its native species, only 
bison are missing, but it also harbors the country's largest bighorn 
sheep herd and second largest elk herd. The Rocky Mountain Front 
supports one of the largest populations of grizzly bears south of 
Canada and is the only place in the lower 48 States where grizzly bears 
still roam from the mountains to their historic range on the plains.
  Because of this exceptional habitat, the Front offers world renowned 
hunting, fishing and recreational opportunities. Sportsmen, local land 
owners, hikers, local communities and many other Montanans have worked 
for decades to protect and preserve the Front for future generations.
  In short, a majority of Montanans feel very strongly that oil and gas 
development, and Montana's Rocky Mountain Front, just don't mix. The 
habitat is too rich, the landscape too important, to subject it to the 
roads, drills, pipelines, industrial equipment, chemicals, noise, and 
human activity that come with oil and gas development.
  Building upon a significant public and private conservation 
investment and following an extensive public comment process, the Lewis 
and Clark National Forest decided in 1997 to withdraw for 15 years 
356,000 acres in the Front from any new oil and gas leasing. This was a 
significant first step in protecting the Front from developing that I 
wholeheartedly supported.
  However, in many parts of the Rocky Mountain Front, oil and gas 
leases exist that pre-date the 1997 decision. These leaseholders have 
invested time and resources in acquiring their leases. Several 
leaseholders have applied to the federal government for permits to 
drill. These leases are the subject of my proposed bill.
  History has shown that energy exploration and development in the 
Front is likely to result in expensive and time consuming environmental 
studies and litigation. This process rarely ends with a solution that 
is satisfactory to the oil and gas lessee. For example, in the late 
1980's both Chevron and Fina applied for permits to drill in the Badger 
Two Medicine portion of the Front. After millions of dollars spent on 
studies and years of public debate, Chevron abandoned or assigned all 
of its lease rights, and Fina sold its lease rights back to the 
original owner.
  Therefore, I think we should be fair to those leaseholders. We want 
them to continue to provide for our domestic oil and gas needs, but 
they are going to have a long, difficult and expensive road if they 
wish to develop oil and gas in the Rocky Mountain Front.
  My legislation would direct the Interior Department to evaluate non-
producing leases in the Rocky Mountain Front and look at opportunities 
to cancel these leases, in exchange for allowing leaseholders to 
explore for oil and gas somewhere else, namely in the Gulf of Mexico or 
in the State of Montana. In conducting this evaluation, the Secretary 
would have to consult with leaseholders, with the State of Montana and 
the public and other interested parties.
  When Interior concludes this study in two years, the bill calls for 
the agency to make recommendations to Congress and the Energy and 
Natural Resources Committee on the advisability of pursuing lease 
exchanges in the Front and any changes in law and regulation needed to 
enable the Secretary to undertake such an exchange.
  Finally, in order to allow the Secretary to conduct this study, my 
bill would continue the current lease suspension in the Badger-Two 
Medicine Area for three more years. This lease suspension would only 
apply to the Badger-Two Medicine Area, not the entire Front.
  That's it, that's all my bill does. It doesn't predetermine any 
outcome, it doesn't impact any existing exploration activities or 
environmental review processes. It just creates a process through which 
the federal government, the people of Montana and leaseholders can 
finally have a real, open and honest discussion about the fate of the 
Rocky Mountain Front.

[[Page 11330]]

  We should look for ways to fairly compensate leaseholders for 
investments they've made in their leases if they decide to leave the 
Front rather than waste years and millions fighting to explore for 
uncertain oil and gas reserves. Because, a lot of Montanans don't want 
to see the Front developed, and they will fight to protect it. 
Including me.
  So, developers can wait years, or decades, or most likely never, for 
oil and gas to flow from the Front. Or we can look at ways to encourage 
domestic production much sooner, in much more cost effective, 
appropriate and efficient ways somewhere else.
  That is what I hope this legislation will accomplish, and I hope my 
colleagues in the Senate will support it.
                                 ______
                                 
      By Mr. GRASSLEY:
  S.J. Res. 38. A joint resolution providing for the designation of a 
Medal of Honor Flag and for presentation of that flag recipients of the 
Medal of Honor; to the Committee on Armed Services.
  Mr. GRASSLEY. Mr. President, today I am introducing a resolution to 
designate a Medal of Honor Flag to further honor those individuals who 
have gone above and beyond the call of duty in service to their country 
and to present that flag to each recipient of the Medal of Honor. This 
idea came from a constituent of mine, retired First Sergeant William 
Kendall of Jefferson, IA. Mr. Kendall had been thinking about another 
resident of Jefferson, Captain Darrell Lindsey, who was shot down while 
on a bombing mission over France during World War II. Captain Lindsey 
was able to keep his aircraft in the air long enough to allow the 
members of his crew to escape safely, but this action cost him his 
life. As a result of this selfless sacrifice, Captain Lindsey was 
awarded the Medal of Honor.
  A Medal of Honor monument commemorating this heroic Iowan now stands 
on the courthouse lawn in Jefferson, IA. It was partly this monument 
and the proud history of his fellow Iowan that inspired Bill Kendall to 
ponder the heroism of all recipients of the Medal of Honor. He then 
began to wonder why there was no official flag to honor recipients of 
the Medal of Honor. The Medal of Honor is the Nation's highest award 
for bravery he felt that a flag would help to show respect for this 
award as well as all those who have earned it through their service to 
the United States of America. I agree.
  The Medal of Honor is not given out lightly. To date, only 3,439 
individuals have been awarded the Medal of Honor and there are only 143 
living recipients of this award. Each of the armed services has very 
strict regulations for judging whether an individual is entitled to the 
Medal of Honor. The award is only given for acts of exceptional bravery 
or self-sacrifice above and beyond what is expected and must involve 
risk of life. The deed must be proved by incontestable evidence of at 
least two eyewitnesses.
  I should also add that there is an Iowa connection going back to the 
creation of the Medal of Honor. In 1861, during the Civil War, Iowa 
Senator James Grimes introduced legislation in the Senate to create a 
Medal of Honor for the Navy. This first Medal of Honor was followed by 
similar awards for the other services. It is appropriate that another 
Iowan, Sergeant William Kendall, should create the first Medal of Honor 
flag.
  It is indeed right and appropriate to honor those Americans to whom 
we owe so much. Bill Kendall's idea for a Medal of Honor flag is a good 
one and I am honored to do what I can to help see his vision realized. 
I am pleased that the House has already acted on a similar measure and 
I hope my colleagues in the Senate will join me in this important 
initiative.
  I ask unanimous consent that the text of this resolution be printed 
in the Record.
  There being no objection, the joint resolution was ordered to be 
printed in the Record, as follows:

                              S.J. Res. 38

       Whereas the Medal of Honor is the highest award for valor 
     in action against an enemy force which can be bestowed upon 
     an individual serving in the Armed Forces of the United 
     States;
       Whereas the Medal of Honor was established by Congress 
     during the Civil War to recognize soldiers who had 
     distinguished themselves by gallantry in action;
       Whereas the Medal of Honor was conceived by Senator James 
     Grimes of the State of Iowa in 1861; and
       Whereas the Medal of Honor is the Nation's highest military 
     honor, awarded for acts of personal bravery or self-sacrifice 
     above and beyond the call of duty: Now, therefore, be it
       Resolved by the Senate and House of Representatives of the 
     United States of America in Congress assembled,

     SECTION 1. DESIGNATION OF MEDAL OF HONOR FLAG.

       (a) In General.--Chapter 9 of title 36, United States Code, 
     is amended by adding at the end the following new section:

     ``Sec. 903. Designation of Medal of Honor Flag

       ``(a) Designation.--The Secretary of Defense shall design 
     and designate a flag as the Medal of Honor Flag. In selecting 
     the design for the flag, the Secretary shall consider designs 
     submitted by the general public.
       ``(b) Presentation.--The Medal of Honor Flag shall be 
     presented as specified in sections 3755, 6257, and 8755 of 
     title 10 and section 505 of title 14.''.
       (b) Clerical Amendment.--The table of sections at the 
     beginning of such chapter is amended by adding at the end the 
     following new item:

``903. Designation of Medal of Honor Flag.''.

     SEC. 2. PRESENTATION OF FLAG TO MEDAL OF HONOR RECIPIENTS.

       (a) Army.--(1) Chapter 357 of title 10, United States Code, 
     is amended by adding at the end the following new section:

     ``Sec. 3755. Medal of honor: presentation of Medal of Honor 
       Flag

       ``The President shall provide for the presentation of the 
     Medal of Honor Flag designated under section 903 of title 36 
     to each person to whom a medal of honor is awarded under 
     section 3741 of this title after the date of the enactment of 
     this section. Presentation of the flag shall be made at the 
     same time as the presentation of the medal under section 3741 
     or 3752(a) of this title.''.
       (2) The table of sections at the beginning of such chapter 
     is amended by adding at the end the following new item:

``3755. Medal of honor: presentation of Medal of Honor Flag.''.

       (b) Navy and Marine Corps.--(1) Chapter 567 of such title 
     is amended by adding at the end the following new section:

     ``Sec. 6257. Medal of honor: presentation of Medal of Honor 
       Flag

       ``The President shall provide for the presentation of the 
     Medal of Honor Flag designated under section 903 of title 36 
     to each person to whom a medal of honor is awarded under 
     section 6241 of this title after the date of the enactment of 
     this section. Presentation of the flag shall be made at the 
     same time as the presentation of the medal under section 6241 
     or 6250 of this title.''.
       (2) The table of sections at the beginning of such chapter 
     is amended by adding at the end the following new item:

``6257. Medal of honor: presentation of Medal of Honor Flag.''.

       (c) Air Force.--(1) Chapter 857 of title 10, United States 
     Code, is amended by adding at the end the following new 
     section:

     ``Sec. 8755. Medal of honor: presentation of Medal of Honor 
       Flag

       ``The President shall provide for the presentation of the 
     Medal of Honor Flag designated under section 903 of title 36 
     to each person to whom a medal of honor is awarded under 
     section 8741 of this title after the date of the enactment of 
     this section. Presentation of the flag shall be made at the 
     same time as the presentation of the medal under section 8741 
     or 8752(a) of this title.''.
       (2) The table of sections at the beginning of such chapter 
     is amended by adding at the end the following new item:

``8755. Medal of honor: presentation of Medal of Honor Flag.''.

       (d) Coast Guard.--(1) Chapter 13 of title 14, United States 
     Code, is amended by inserting after section 504 the following 
     new section:

     ``Sec. 505. Medal of honor: presentation of Medal of Honor 
       Flag

       ``The President shall provide for the presentation of the 
     Medal of Honor Flag designated under section 903 of title 36 
     to each person to whom a medal of honor is awarded under 
     section 491 of this title after the date of the enactment of 
     this section. Presentation of the flag shall be made at the 
     same time as the presentation of the medal under section 491 
     or 498 of this title.''.
       (2) The table of sections at the beginning of such chapter 
     is amended by inserting after the item relating to section 
     504 the following new item:

``505. Medal of honor: presentation of Medal of Honor Flag.''.

       (e) Prior Recipients.--The President shall provide for the 
     presentation of the Medal of Honor Flag designated under 
     section 903 of title 36, United States Code, as added by 
     section 1(a), to each person awarded the Medal of Honor 
     before the date of the enactment of this joint resolution who 
     is living as of that

[[Page 11331]]

     date. Such presentation shall be made as expeditiously as 
     possible after the date of the designation of the Medal of 
     Honor Flag by the Secretary of Defense under such section.

                          ____________________