Floor Statements

Mr. President, I ask for the yeas and nays.

Mr. President, I feel compelled to take a moment to respond to remarks of my colleague from New York on the nomination of Mr. Wolski and the status of the Court of Federal Claims. My colleague from New York has stated that we should not fill the judgeships that Congress itself created. This eleventh- hour attack on the court of claims and Mr. Wolski is simply a thinly veiled effort to stall action on more of President Bush's judicial nominees. Let's give the President a break and be honest.

I would like to respond to allegations that Mr. Wolski is not qualified to serve on the court of claims. These allegations are simply unfounded. I agree with my colleague that, in print, Mr. Wolski's statement in his 1999 National Journal profile raised questions about how he would view his role as a judge. But Mr. Wolski was indeed thoroughly questioned about this statement at his hearing. His response to those questions has convinced me that this statement should not be any bar whatsoever to his confirmation. Mr. Wolski testified at his hearing that he understands that the role of a judge is not political. He understands that the role of a judge--especially a trial court judge--is to follow the law and not to consider personal beliefs or positions argued as an advocate in determining how to rule. Mr. Wolski explained during his hearing that this statement was meant to reflect that his decision to work for our former colleague, Senator Connie Mack, was consistent with his commitment to public service. Mr. Wolski emphatically stated on several occasions throughout his hearing that his statement was meant to clarify the point that he has been not motivated by the money throughout his career, and he does not consider himself an ideologue.

Mr. Wolski has also been criticized about some of the clients that he has represented. It is important to remember that the clients Mr. Wolski has represented have been on both sides of the issues. He has represented property owners in takings cases, but he has also represented municipal and State governments. For example, he is presently a member of the litigation team representing the State of Nevada, Clark County, and the city of Las Vegas in their opposition to the location of a nuclear waste repository at Yucca Mountain. He represented a group of municipal governments challenging a commercial development that would have caused environmental, traffic, and other urban sprawl problems. So plainly, Mr. Wolski has represented a broad range of clients, including some whom a die-hard conservative ideologue would not represent. Instead, Mr. Wolski's clients indicate to me that he has done his best to act as an advocate on behalf of his clients' positions, regardless of his personal beliefs, just as every good lawyer should do.

I know that some of my colleagues have expressed concern about Mr. Wolski's brief in the case of Cargill v. United States. The first thing that I want to point out is the obvious: Mr. Wolski was acting in this case as a lawyer on behalf of his employer and had to perform his duties as assigned to him. In this case, his job was to submit an amicus brief. Second, it is important to note that Mr. Wolski was not challenging Congress's ability to protect migratory birds in general. Rather, his argument specifically addressed the scope of the Clean Water Act, which does not incorporate findings about migratory birds. Mr. Wolski clearly testified that he believes that the Clean Water Act is constitutional.

Finally, in regard to Mr. Wolski's comments in the San Francisco Examiner, I agree that they were a bit passionate, but Mr. Wolski's hearing testimony reflects that he has matured in the 11 years since he penned that letter. In fact, Mr. Wolski testified that he wrote that letter before he worked as a congressional staffer. He testified that had he worked on the Hill before he wrote that letter, he probably wouldn't have written it at all. So I believe that this letter can easily be chalked up to youthful indiscretion, and nothing more. I have every reason to believe that, as a judge, he will act consistently with his past practice by following the law regardless of his personal beliefs.

Now, I would also like to take a moment to respond to some of the allegations regarding the Court of Claims. It is clear that the Court of Claims is a necessity, especially with the current backlog of cases in our Federal district courts. The Court of Claims and the district courts have overlapping jurisdiction. This allows the Court of Claims to ease the heavy caseload in the district courts. As such, the Court of Claims is a mainstay of the system.

A letter to the editor in the Washington Post on April 9, 2003, from the president of the Court of Claims bar association made the point well. He said that the docket of the court ``consists of more than 4,000 cases. Opinions by the judges are recognized as well-written and well-considered and reflecting

of the complexity of the caseload. Those practicing before the Court know that its judges are busy.'' This letter, drafted by a lawyer who actually practices before the court, took direct issue with the Post's recommendation to abolish the court, saying it ``missed the central point.''

The editorial by Professor Schooner in the Washington Post on March 23, 2003, suggesting that the current cases pending before the Court of Claims can be easily divided among the district courts is troubling to me. Eliminating the Court of Claims would add nearly 5,000 additional cases to the district courts at a time when they are unable to keep up with the pace of cases being filed. Professor Schooner's academic analysis also fails to take account of the considerable work and learning that district judges do in order to handle complex patent, antitrust, environmental or civil rights cases.

I must admit that I was surprised to learn how inaccurate the statistics of my colleague from New York were after I did some research regarding the caseloads of the Federal district courts and the Court of Claims. These misleading numbers allege that the district court judges have an average caseload of 355 cases per judge, whereas Court of Claims judges would have an average caseload of 19 cases if the four pending nominees were confirmed. After reviewing statistics from both the Federal courts' legislative affairs office and the Court of Claims, however, it is clear that Senator Schumer's figures are erroneous. If we take the current caseload of the Court of Claims and suppose that the court was at its fully authorized number of 16 judges, the average caseload per judge would be 309. This is in sharp contrast to the 19 my colleagues would have us believe and not much less than the average caseload per district judge.

This campaign against Mr. Wolski and the Court of Claims is just the newest tactic in an organized effort to prevent President Bush's well- qualified judicial nominees from being confirmed and it must stop. It is obvious to me that the criticism of the court's necessity is borne more of political opportunity than any serious merit. We shouldn't be in the business of creating more rationales for delay. The lack of any functional problem in litigation between sovereign and citizen, or problem with the court structure, makes the solution of elimination of the Court of Claims a solution in search of a problem.

Madam President, I rise today in support of Victor Wolski, one of the four nominees for the Court of Federal Claims who have been awaiting votes on their nominations by the full Senate since March.

When Mr. Wolski was first nominated to the Court of Claims in September 2002, he joined three other well-qualified nominees to the same court who had been pending even longer. Charles Lettow had been nominated a month earlier, in August 2002, while Susan Braden and Mary Ellen Coster Williams had been nominated, respectively, in May and June 2001. None of them received a hearing in the 107th Congress.

So I am pleased that we have at last reached an agreement for an up- or-down vote on the nominations of Mr. Wolski and the other Court of Claims nominees. But getting to this point was not simple. We had to file a motion to invoke cloture on Mr. Wolski's nomination. Now, I am pleased that our Democratic colleagues agreed to vitiate this motion. But the fact still remains that we were almost forced to resort to a cloture vote simply to secure an up-or-down vote on Mr. Wolski's nomination. Mr. Wolski would have been the first Court of Claims nominee in the history of the Senate to be forced through a cloture vote. This would have been a historic but sad precedent that we came dangerously close to setting. As I said, I am pleased that we did not go down this path and that we are proceeding to an up-or-down vote on Mr. Wolski's nomination.

Mr. Wolski will make a fine addition to the Court of Claims. His nomination has bipartisan support, having been reported favorably to the full Senate by all 10 Judiciary Committee Republicans and Senator Feinstein. He is an accomplished trial attorney who has represented clients on both sides of the issues, including a number of clients on what many consider to be the so-called liberal side. For example, Mr. Wolski has represented a group of municipal governments challenging a commercial development that would have caused environmental, traffic, and other urban sprawl problems. He presently represents a class of Medicare beneficiaries who are suing the tobacco industry to try to recover reimbursement to the Medicare system. And he represents the State of Nevada, Clark County, and the City of Las Vegas in their opposition to the location of a nuclear waste repository at Yucca Mountain. Clearly, this is not the work of an ideologue but the work of an accomplished lawyer who recognizes his duty to represent his clients' interests to the best of his ability.

Mr. Wolski's breadth and depth of experience will be a true asset to the Court of Claims. After graduating from the University of Virginia Law School, Mr. Wolski clerked for Judge Vaughn Walker of the U.S. District Court for the Northern District of California. He has a fine record in public service, including 5 years as a litigator with a public interest law firm. During his tenure there, he represented clients in cases presenting significant issues of constitutional and property rights law. He continued his public service by serving as General Counsel and Chief Tax Advisor in the Congress with the Joint Economic Committee for Senator Connie Mack. As the first person to attend college in his family, Victor Wolski feels it is important to give back to the community and felt a strong commitment towards the public sector. This commitment is quite evident in his professional background.

In 2000, Mr. Wolski transitioned from the public sector to private practice, joining the prominent Washington, DC, law firm Cooper, Carvin & Rosenthal. He now practices with its successor firm, Cooper & Kirk. He has a reputation for being a thoughtful and hard-working legal professional who will be a stellar addition to the Court of Federal Claims, and I commend President Bush for nominating him.

Mr. President, we find ourselves at an important point. We have two eminent and well-qualified circuit court nominees, Miguel Estrada and Priscilla Owen, currently being blocked by a minority of Senators from an up-or-down vote on the Senate floor. History will show that this minority group of Senators was not asking for a full and open debate. They were not asking for meaningful deliberation on these well- qualified nominees. Rather, this minority group of Senators was committed to subverting precedent and reworking the meaning of advice and consent.

I think we can agree that the confirmation process is broken. I certainly hope we can find a constructive way to restore the process, but recent talk does not lead me to be overly optimistic--not when we hear injudicious talk about plans for three, four, or more planned filibusters. I hope that is not the kind of history we want to write. Instead, I hope that my colleagues will see today's up-or-down vote on Mr. Wolski's nomination as an opportunity to put a stop to the obstruction and delay by giving all the rest of our nominees the courtesy of a simple vote on their nominations. That is all we ask.

Madam President, I rise today in support of the confirmation of Susan Braden, who has been nominated to serve as a judge on the U.S. Court of Federal Claims. Ms. Braden has the breadth of experience and accomplishment we look for in a Federal judge, and I commend President Bush for nominating her.

After graduating from law school, Ms. Braden served for 7 years as a trial attorney, and then as a senior trial attorney, for the Department of Justice Antitrust Division. She then worked at the Federal Trade Commission for 5 years as a senior attorney advisor and senior counsel to Chairman David Clanton and Chairman James Miller III. In this capacity, she assumed responsibility for special policy and legislative projects, such as drafting a potential set of guidelines concerning interlocking directorates and issues concerning enforcement of the antitrust laws to professionals.

Ms. Braden has worked in the private sector for the past 18 years, where she has focused on antitrust law, complex civil litigation, international trade matters for industrial clients, and computer software litigation. Her experience will serve her well on the bench. I am confident that she will execute her duties on the bench with integrity, intelligence, and fairness. I ask my colleagues to join me in my unqualified support for her nomination.

nomination of mary ellen coster williams

Madam President, I am pleased today to speak in support of Mary Ellen Coster Williams, who has been nominated to the U.S. Court of Federal Claims.

Judge Williams has served with distinction on both sides of the bench. Upon her graduation from Duke University Law School in 1977, she worked in private practice with Fulbright & Jaworski and with Schnader, Harrison, Segal & Lewis.

Judge Williams then left private practice in 1983 to work in the Civil Division of the United States Attorney's Office in Washington, DC. She returned to private practice in 1987 as a partner with Janis, Schuelke & Wechsler.

During her 8 years in private practice and 3\1/2\ years as an Assistant United States Attorney, Judge Williams gained valuable experience handling matters involving Government contracts, employment law, torts, and commercial litigation. Since 1989, she has served as an administrative judge on the General Services Administration Board of Contract Appeals.

Judge Williams was named a Life Fellow by the American Bar Association and is currently the vice chair of the ABA Section on Public Contract Law. She also has been active in the District of Columbia Bar Association. Since 1997, she has served on the U.S. Court of Federal Claims Advisory Council, so she has much more than simply a passing familiarity with the court to which she has been nominated.

With her wealth of experience and dedication, Judge Williams is well equipped to serve on the Court of Federal Claims. I urge my colleagues to join me in supporting her nomination.

Nomination of Charles F. Lettow

Madam President, I rise today to express my full support for the confirmation of Charles F. Lettow, who has been nominated to the U.S. Court of Federal Claims.

Mr. Lettow is an excellent selection to join the Court of Federal Claims. He has a strong academic background and more than 30 years of litigation experience in constitutional and administrative law matters. A graduate of Stanford Law School, Mr. Lettow clerked for both the Ninth Circuit Court of Appeals and the U.S. Supreme Court before taking a position in 1970 as Counsel to the Council on Environmental Quality, which was established by Congress a year earlier. His responsibilities included drafting legislation and Executive orders and working to negotiate bilateral agreements.

In 1973 Mr. Lettow joined the firm of Cleary Gottlieb as a litigation associate, became a partner three years alter, and has remained with the firm since that time, focusing on Federal litigation and environmental cases. Cases he has handled over his career have presented often difficult questions of constitutional and administrative law, and he has handled them with expertise.

Mr. Lettow has argued before the U.S. Supreme Court three times and in the U.S. Courts of Appeals in more than 40 cases, as well as litigated in numerous Federal district courts and the U.S. Court of Federal Claims. I cannot imagine someone who is better prepared to sit on the Court of Federal Claims. I urge my colleagues to vote for his confirmation.

I suggest the absence of a quorum.

Mr. President, I rise today to express my strong support for the confirmation of David G. Campbell to serve as a judge of the United States District Court for the District of Arizona.

David Campbell is an extremely well-qualified nominee with a significant amount of litigation experience, and he will make an excellent addition to the federal bench.

He received his undergraduate degree magna cum laude, as well as his law degree, from the University of Utah--which, in my view, is a reliable and persuasive indication of his excellent judgment.

Upon graduation from law school, Mr. Campbell clerked for Ninth Circuit Judge Clifford Wallace, and for then Associate Justice William Rehnquist on the United States Supreme Court.

He joined the Phoenix law firm of Meyer, Hendricks, Victor, Osborn & Maledon in 1982 and became a partner there in 1986. Since 1995, Mr. Campbell has been a partner at its successor firm, Osborn Maledon, where he practices in the area of general civil litigation. The American Bar Association bestowed on Mr. Campbell its highest rating of unanimously well qualified in recognition of his outstanding legal skills and reputation.

In addition to his distinguished legal career, Mr. Campbell has been a great asset to his community and has donated many hours of pro bono service and volunteer time to help individuals and families in need in his community. His volunteer service has included building homes for the homeless in Mexico, providing Christmas supplies to crises nurseries, and providing back to school clothing for disadvantaged children. He was also named Professor of the Year in 1991 by the J. Rueben Clark Law School at Brigham Young University for his service as a visiting civil procedure professor.

I am confident that David Campbell will be a model jurist, and I urge my colleagues to join me in supporting his confirmation.

Madam President, I rise to speak about the medical liability and medical crisis threatening our great Nation. Over the years, I have pressed for legislation to protect our health care delivery system from the ravages of an out-of-control medical liability system.

Many times we have come close to enacting legislation, and a giant opportunity stands before us today. I hope we do not let it slip through our fingers once more.

I remember as a young lawyer in the early days of my practice in Pittsburgh, PA, the law basically was, if you met the standard of practice in the community, there was no case because everybody knew that medical science is not an exact science. Once they adopted the doctrine of informed consent in its various forms, it meant that every case goes to the jury, regardless; every case that has a bad result, even though the doctor did everything in his or her power to effectuate a decent result. And we have had this medical liability catastrophe upon our hands ever since.

I can remember as a defense lawyer, my advice to some doctors was that they needed to do everything they possibly could to make sure there was absolutely no way they overlooked anything with regard to any person's complaint. If a person came in to them with a common cold, they could no longer say: Take two aspirin every 6 hours, drink all the liquids you can, and in 7 days you will be better. Or: Don't do anything and in 7 days you will be better. No, they have to give vascular and respiratory examinations, blood tests, et cetera. As a result, what used to be a $5 bill in those days, or at most $15 or $20, is far more today. Of course, I believe unnecessary defensive medicine such as that has driven our country to its knees from a medical liability standpoint.

Today, defensive medicine increases health care costs by $60 to $108 billion per year according to the Department of Health and Human Services report of last year.

As I have noted previously, out-of-control medical liability litigation is needlessly increasing the cost and decreasing the quality of health care for every American. It is preventing patients from accessing high-quality health care or, in some cases, any care at all because doctors are being driven out of practice.

I was pleased that President Bush announced his desire to address medical liability legislation reform last summer when he spoke of the need for reform in his State of the Union Address and when he called on us to pass meaningful medical liability reform legislation in this Congress. I am pleased that our majority leader, Dr. Frist, has brought the Patients First Act forward to be debated today.

Our colleagues, Senator Ensign from Nevada, who introduced this bill, and Senator McConnell from Kentucky, deserve special recognition and thanks for their work on this bill as well.

Of course, this was not the first time we have addressed this issue. As many of us will recall, we passed medical litigation relief language with the Commonsense Product Liability and Legal Reform Act in 1995. Unfortunately, it was stripped from that bill in conference.

I am sorely disappointed that in the ensuing 8 years we have not addressed this problem. As a result, the problem has continued to fester like an infection that will not heal. Worse yet, this infection is spreading to all parts of our country.

This map which has been utilized throughout this debate, and I think properly so, with data supplied by the American Medical Association, shows the States that currently are experiencing a medical liability crisis and those that are showing signs of a developing crisis. The 19 red States are crisis States. Nineteen of the 50 States are crisis States. The 26 yellow States are showing problem signs. Only 5 States are currently OK. The red ones are in crisis. The yellow ones are about to be in crisis. The white States are currently OK generally because they have passed medical liability litigation reform legislation like

Madam President, I want to take a minute to say a few words in honor of Strom Thurmond, our friend and former colleague, who has passed away.

From the moment Strom Thurmond set foot in this Chamber in 1954, he has been setting records. He was the only person ever elected to the U.S. Senate on a write-in-vote. He set the record for the longest speech on the Senate floor, clocked at an astounding 24 hours and 18 minutes. He was the longest-serving Senator in the history of the U.S. Senate. He was also the oldest serving Senator. Many of my colleagues will recall the momentous occasion in September of 1998 when he cast his 15,000th vote in the Senate. With these and so many other accomplishments over the years, he has appropriately been referred to as ``an institution within an institution.''

In 1902, the year Strom Thurmond was born, life expectancy was 51 years--and today it is 77 years. Strom continued to prove that, by any measure, he was anything but average.

He was so much in his life. To provide some context, let me point out that during his lifetime, Oklahoma, New Mexico, Arizona, Alaska and Hawaii gained Statehood, and 11 amendments were added to the Constitution. The technological advancements he witnessed, from the automobile to the airplane to the Internet, literally spanned a century of progress. Conveniences we have come to take for granted today were not always part of Strom Thurmond's world. Perhaps this explains why, during Judiciary Committee hearings, he was often heard asking witnesses who were too far away from the microphone to ``please speak into the machine.''

The story of his remarkable political career truly could fill several volumes. It began with a win in 1928 for the Edgefield County Superintendent of Schools. Eighteen years later, he was Governor of South Carolina. Strom was even a Presidential candidate in 1948, running on the ``Dixiecrat'' ticket against Democrat Harry Truman.

I must admit that he came a long way in his political career, given that he originally came to the Senate as a Democrat. I was happy to say that wisdom came within a few short years when Strom saw the light and joined the Republican Party.

When I first arrived in the Senate in January of 1977, he was my mentor. As my senior on the Judiciary Committee, it was Strom Thurmond who helped me find my way and learn how the committee functioned. He was not only a respected colleague, but a personal friend.

During his tenure as chairman of the Judiciary Committee, Strom Thurmond left an indelible mark on the committee and the laws that came through it. He became known and respected for many fine qualifies and positions--his devotion to the Constitution, his toughness on crime, his sense of fairness.

He was famous for his incredible grip. Many of us in this Chamber had the experience of Strom Thurmond holding our arm tightly as he explained a viewpoint and asked for our support. I might add that this proved to be a very effective approach.

Strom was also known to have a kind word or greeting for everyone who came his way, and for being extremely good to his staff. Despite his power and influence, he never forgot the importance of small acts of kindness. For example, whenever he ate in the Senate Dining Room, he grabbed two fistfuls of candy. When he returned to the floor of the Senate, he handed the candy out to the Senate Pages. Unfortunately, it was usually melted into a kaleidoscope of sugar by then! I have a feeling that the Pages preferred it when Strom took them out for ice cream.

Strom Thurmond was truly a legend--someone to whom the people of South Carolina owe an enormous debt of gratitude for all his years of service. Clearly, the people of South Carolina recognize the sacrifices he made and are grateful for all he did for them. In fact, you cannot mention the name Strom Thurmond in South Carolina without the audience bursting into spontaneous applause. He truly was an American political icon.

Abraham Lincoln once said that ``The better part of one's life consists of friendships.'' With a friend like Strom Thurmond, this sentiment couldn't be more true. I am a great admirer of Strom Thurmond, and I am proud to have called him my friend.

One final note about Strom Thurmond: He was a great patriot. A decorated veteran of World War II who fought at Normandy on D-Day, Strom Thurmond loved this country. Let me close by saying that this country loved him, too.

I ask for the yeas and nays.

Mr. President, I move to reconsider the vote.

Mr. President, I ask unanimous consent that amendment 1102, which was just agreed to, be modified with the changes that are the desk.

Mr. President, I ask unanimous consent that the next three votes be 10 minutes in length each.

Mr. President, I rise in opposition. I want to stress my opposition is not because I do not understand or am not sympathetic to the difficult situation beneficiaries who are afflicted with cardiovascular disease, cancer, or Alzheimer's disease experience.

But I also recognize there are millions and millions of other seniors who suffer from diseases just as debilitating and life-threatening as the ones my colleague has identified here. Under this proposal they would be treated as second-class citizens because they do not suffer from the right disease.

The most basic, and really the most important, tenet of the Medicare program is to provide a universal benefit to all seniors. We have done that under S. 1.

We crafted a prescription drug benefit that helps every senior and also targets the most help to those who are less able to afford the appropriate care.

While I am sympathetic to my colleagues' desire to enhance the benefit, I can't support a proposal that pits one group of seniors against the other based solely on this disease.

I urge my colleagues to vote against this amendment so we can remain faithful to the most basic tenet of the Medicare program, a universal benefit, and to ensure that the Senate does not discriminate against seniors based on their disease.

I move to table the amendment, and I ask for the yeas and nays.

Mr. President, I strongly support Senator Kyl's sense of the Senate resolution to S. 1. His resolution asks Congress to rectify problems with the formula that is used to update Medicare physician reimbursement.

Due to flaws in this formula, payment rates for physicians and other practitioners are predicted to fall by 4.2 percent in 2004. This cut in physician compensation would be the fifth since 1991 including a 5.4 percent decrease in 2002. According to Medicare's own conservative estimates, between the years 1991 and 2003, reductions for physicians and other health professionals resulted in Medicare physician reimbursement that equates to 14 percent below their actual practice costs. The 2004 reduction would decrease Utah physician income by $13 million which translates to $3003 per physician in 2004. And this is in addition to the $9 million decrease in reimbursement that Utah physicians received in 2002. Furthermore, unless we correct this formula, it is estimated that more cuts will occur in 2005, 2006, and 2007.

The Medicare Payment Advisory Commission, MedPAC, has stated that these reimbursement reductions are the result of a problem with the Sustained Growth Rate that is used as part of the calculation to adjust rates each year. The SGR expenditure target is linked to gross domestic product. Therefore, the formula may decrease Medicare reimbursement for physicians and other practitioners when health care volume increases outstrip increases in the gross domestic product. The problem is magnified when gross domestic product decreases. Essentially, the formula penalizes physicians for factors over which they have no control.

It is true that as the population of our country ages, the volume of Medicare health care services consumed increases. However, physicians have no control over this and our Medicare system penalizes them because of it. As a result, some physicians no longer take new Medicare patients, some decline to participate in the Medicare program altogether, and young people are considering other professions.

I would submit that as the baby-boomer generation ages and increasing numbers of Americans become Medicare beneficiaries, we need physicians and other health care providers more than ever. If anything, we should be rewarding our physicians, not penalizing them.

An additional problem with the Sustained Growth Rate calculation is that it does not account for many changes in health care that improve quality but increase physician work also. The federal government actively promotes new coverage decisions, quality improvement activities and other initiatives that benefit patients but are not taken into account by the Sustained Growth Rate calculation.

MedPAC's recommendation to Congress is that annual updates in physician payments should reflect increases in the Medicare Economic Index or MEI rather than the gross domestic product. Using the Medicare Economic Index would eliminate the penalty that physicians and other practitioners currently experience when the volume of health care services increases due to factors that they are unable to control.

What we have before us is a flawed formula that is threatening the health of Americans and the future of our country. Congress has addressed this problem before, but it seems that we were only putting a bandage over the wound; we never cured the disease that caused it. The wound continues to fester and it will continue to do so until we cure the problem. And the cure, it seems, is to revise the formula.

I for one, am tired of applying bandages to this wound. I believe that it is time to address this problem directly and definitively. I urge my colleagues to join with me in supporting this resolution and in working to correct this problem.

Mr. President, I rise to speak on the Gregg-Schumer amendment which was adopted last week. This amendment was based on a piece of legislation, S. 1225, the Greater Access to Affordable Pharmaceuticals Act of 2003, reported by the HELP Committee on June 11th.

I want to take this opportunity to explain why I cast the lone vote against this amendment. It is my hope that when my colleagues consider my explanation that they may be open to making additional changes to this very important amendment as the process moves forward.

Let me start by commending Senators Gregg, Schumer, McCain, and Kennedy for their work in developing this provision which I believe is a significant improvement on legislation that was adopted by the Senate last Congress, S. 812.

The Gregg-Schumer amendment relates to a complex and often admittedly confusing law I coauthored with my friend, Representative Henry Waxman of California in 1984 the Drug Price Competition and Patent Term Restoration Act.

I chaired a hearing of the Senate Judiciary Committee in May of 2001 that helped document some abuses that were occurring in the law. Since our last hearing on this issue, much has happened.

Both the Federal Trade Commission and the Food and Drug Administration played a constructive role in attempting to end several mechanisms by which some research-based and generic

drug firms were attempting to game the system put in place by the 1984 and subsequent court decisions to avoid competition in the marketplace.

The FTC succeeded in achieving several widely-publicized consent decrees with a variety of offending firms under the existing antitrust statutes.

In addition, the FTC conducted an exhaustive survey and study of how certain provisions of the 1984 Waxman-Hatch Act affected competition in the pharmaceutical industry.

The FTC study contained two major recommendations. The first addressed the use of the statutory 30-month stay granted by the 1984 law in situations where patents are challenged by generic competitors. The FTC recommended that the law:

Permit only one automatic 30-month stay per drug product

per ANDA to resolve patent infringement disputes over patent

listed . . . prior to the filing date of the generic

applicant's ANDA.

This was precisely the position that I suggested in testimony before the HELP Committee on May 8, 2002 and argued for last year during the Senate debate on the Edwards-Collins substitute amendment to the McCain-Schumer legislation.

I would note that the 30-month stay provision in the McCain-Schumer bill last year, S. 812, and in the Edwards-Collins substitute, were both at variance with this central recommendation of the FTC report.

The second major FTC recommendation responds to those situations in which R&D and generic firms were entering into agreements not to impede generic competition. The FTC recommended that Congress:

Pass legislation to require brand-name and first generic

companies applicants to provide copies of certain agreements

to the Federal Trade Commission.

Senator Leahy, working very closely with the FTC, developed legislation, the Drug Competition Act, S. 946, that squarely addressed this second recommendation.

During the 107th Congress, I worked with Senator Leahy on refining that bill. I supported it in committee, and worked with him to pass it through the Senate late last year. I supported his efforts to have it attached to the Medicare vehicle earlier this week. I expect that the 108th Congress will adopt this measure.

The FTC study served an important purpose of cataloging the facts surrounding certain abuses of the 1984 act. In formulating public policy, the facts should matter and a legislative or regulatory response should be tailored to fit the problem.

Unfortunately, the timing of the issuance of FTC study did not allow the report to get the attention it deserved by the Senate. The FTC report was published only one day before the Senate adopted S. 812, the Greater Access to Affordable Pharmaceuticals Act of 2003, last July 31st.

The GAAP Act, developed by Senators McCain and Schumer, was substantially altered by the Edwards-Collins substitute, with active involvement of Senator Kennedy.

While there is no question my colleagues were motivated by their goal of making drugs more affordable for seniors and all Americans, and despite the fact that it garnered 78 votes in the Senate, there were significant shortcomings in the bill.

Let me briefly review a few of the most troublesome provisions of the Edwards-Collins substitute to S. 812. The proposed legislation would have created for the first time a private right of action in the Federal Food, Drug, and Cosmetic Act. The last thing the already overburdened FDA staff needs is a bunch of trial lawyers bringing the agency to a screeching halt by second-guessing its judgment calls.

The bill that passed last year would have resulted in the waiver of patent rights apparently against even third parties--if pioneer drug firms did not file its patents with the FDA and, if challenged by a generic drug applicant, pursue expensive litigation within tight time frames.

In sharp contrast to the FTC recommendation, S. 812 basically made any patents listed with the FDA after a month from the date the pioneer drug application was approved by the FDA ineligible for the 30-month stay. In most cases, this is at least four years earlier than what I and the FTC recommended--freezing the Orange Book to patents listed before a generic drug application was filed.

The American Intellectual Property Law Association opposed S. 812. The patent-dependent biotech industry worked against the bill. The Patent and Trademark Office found that ``S. 812 would forfeit unnecessarily the core right of patent holders--the right to exclude others from practicing the inventions for the entire patent term. After years of research and development and significant investment, the patent right is extinguished for the mere failure to satisfy an administrative task or respond in a timely manner.''

Here is what the July 18, 2002 Statement of Administration Policy said about the Edwards-Collins-McCain-Schumer legislation:

. . . the Administration opposes S. 812 in its current form

because it will not provide lower drug prices. S. 812 would

unnecessarily encourage litigation around the initial

approval of new drugs and would complicate the process of

filing and protecting patents on new drugs. The resulting

higher costs and delays in making new drugs available will

reduce access to new breakthrough drugs. Moreover, the new

cause of action is not necessary to address patent process

abuses. Clearly, the bill would benefit from consideration by

the Senate's experts on Hatch-Waxman law on the Judiciary

Committee, the proper committee of jurisdiction for this

bill.

While S. 812 passed by a very wide margin, it was certainly not without its critics.

Comes now S. 1225. This bill emerged from the HELP Committee. Once again, it is entitled the Greater Access to Affordable Pharmaceuticals Act. Once again, it is cosponsored by Senators McCain, Schumer, and Kennedy.

Due in large part to the leadership of Chairman Gregg, there are significant changes in the bill compared with last year's legislation.

While I have significant concerns over certain aspects of S. 1225 as adopted in its amended form on June 19, 2003, I must acknowledge Chairman Gregg and Majority Leader Frist for their roles in working with the cosponsors of last year's bill to make substantial improvements in the legislation.

Likewise, I commend Senators Schumer, McCain and Kennedy for abandoning many of the troublesome features of a bill that garnered 78 votes last Congress.

I can only believe that the factual presentation, analysis, and recommendations contained in the FTC report and subsequent public notice and comment process surrounding the recently-issued FDA final rule on patent listings and the application of the statutory 30-month stay both played a constructive role in helping to form the basis of the Gregg-Schumer legislation.

It is appropriate to recognize the efforts of the Bush administration for tackling the problem of multiple, successive 30-months stays through rulemaking. Secretary Thompson, Commissioner McClellan, and FDA Chief Counsel Dan Troy, should be saluted for their roles in so promptly completing a rulemaking regarding patent listing that generally embraced the one-and-only-one 30-month stay policy recommended in the FTC Report. Chairman Muris and the FTC staff deserve credit for a report that helped shape a more carefully targeted policy response.

There can be no doubt that this year's vehicle, S. 1225, is superior to S. 812. This new Gregg-Schumer bill, S. 1225, embraces exactly the type of one-and-only-one 30-month stay policy that I suggested to the HELP Committee last May, argued for on the floor last July, and was ultimately recommended by the FTC.

The Gregg-Schumer legislation, S. 1225 in the form adopted by the Senate, also addresses some problems that the FDA rule perhaps did not resolve satisfactorily. As FDA Chief Counsel Dan Troy stated at the June 17th Judiciary Committee hearing:

We tried as best we could to cut down on all opportunities

for gaming. We did not succeed in cutting down all

opportunities for gaming, because nothing, no legislation is

so good, no rule could be so good as to cut down all

opportunities for gaming, because there are unforeseen

circumstances and unintended consequences.

I think Mr. Troy is correct about the nature of the inherent limitations of regulatory and legislative fixes for complex problems where there are powerful incentives to game the system to gain financial advantage. We need to

keep this in mind as we analyze further the amendment the Senate adopted last week.

As I stated at the June 17th hearing, it was unfortunate that the PTO was unable to present a witness. Admittedly, the invitation was issued on short notice. I have asked PTO for its formal comments on the Gregg- Schumer amendment. I would also be interested in the PTOs comments on whatever language the House adopts. We would also be wise to hear from the Office of the United States Trade Representative if USTR finds that the legislation raises any concerns for international trade and intellectual property under the TRIPS provisions.

It is my understanding that FDA and FTC staff provided a great deal of what is known as ``technical assistance'' on the Gregg-Schumer amendment, a good deal of it between the markup on June 11th and the time the amendment was offered on June 19th. I am not aware whether PTO or USTR were consulted.

PTO and USTR should understand that this is a fast moving train, so they should be prepared to give us any comments they may have in short order. President Bush and the congressional leadership have made it plain that they expect the conference report on the Medicare bill to be completed as soon as possible.

One special area of concern to me as Chairman of the Judiciary Committee is that one provision of the amendment overwhelmingly adopted by the Senate raises significant issues with respect to civil justice policy, including a constitutional concern. Specifically, proposed section 271(e)(5) of title 35, would make the failure of a patentee to file a patent infringement action within a specified time frame sufficient to establish ``an actual controversy'' for the purpose of establishing subject matter jurisdiction for a declaratory judgement action by a generic drug firm challenging a patent.

Whether the Congress can, or should, by statute grant subject matter jurisdiction for a declaratory judgment based on the failure to bring a suit raises some interesting questions, particularly in light of manner in which the U.S. Courts of Appeals, including the Federal Circuit, have developed and applied the ``reasonable apprehension'' test. At our June 17th hearing, DOJ did not present the Judiciary Committee with its final opinion on the matter but Mr. Sheldon Bradshaw, Deputy Assistant Attorney General, Office of Legal Counsel, noted, ``that the actual case of controversy requirement is constitutionally compelled rather than statutorily required. And as a result, Congress can't simply create a case or controversy by statute but the plaintiffs must establish the constitutional requirement for bringing the case.'' The committee has received a spirited correspondence that takes differing views on the case or controversy provision of the Gregg-Schumer amendment.

I have requested the Department of Justice for its formal views on this language. At this point, I think it premature to embrace this language. It is my understanding that the bill that the House will take up does not contain the controversial case or controversy language. I stand prepared to work with the sponsors of the amendment, DOJ and others on this important issue.

Yet another improvement of S. 1225 over the bill adopted by the Senate last year relates to the manner in which the 180-day rule is addressed. In short, I am pleased that the policy embraced last year, the rolling exclusivity policy, was replaced in favor of a ``use it or lose it'' approach. I have long stated a preference for the consumer friendlier ``use it or lose it'' rule over the too open-ended rolling exclusivity.

The Waxman-Hatch law provides an incentive for generic firms to challenge patents. To encourage generic competitors to pursue patent challenges in a vigorous fashion, the 1984 law provided 180 days of marketing exclusivity in situations where a generic drug firm could show the pioneer's patents were invalidated or not infringed. For many years it was thought, as intended, that this valuable 180-day period of exclusive marketing would be granted to the first generic firm to successfully invalidate or invent around the pioneer's patents.

FDA regulations issued in 1994 required that the first generic applicant had to defend successfully against a patent claim made by a brand name company to receive the 180-day exclusivity. In a 1998 D.C. Circuit case, Mova v. Shalala, the court construed the plain language of the statute to strike down the successful defense requirement. As a result FDA now makes 180-day exclusivity decisions by applying the literal words of the statute. This results in a system that rewards first filers, not necessarily successful challengers.

The Gregg-Schumer amendment retains the preference for first filers. I believe that re-instating the successful defense requirement may prove preferable than intentionally sanctioning a first filer regime.

Frankly, I am uncertain of the policy justification for S. 1225's retention of granting the 180-day reward to the first filer rather than the first successful defendant. I believe that there is a lot to be said for giving the reward to the actual winner in court or the first not to be sued, not just the first one to enter the Parklawn Building with an application.

The amendment places a high premium on being a first filer. At our hearing last week, FTC Chairman Muris characterized the rush to be a first filer as ``the shantytown problem of people in line to file.'' FDA Chief Counsel Troy described that ``. . . right now, there are sometimes limousines, sometimes vans, sometimes cars, sometimes even tents in the Metro North parking lot that come days, weeks, and in some cases even months in advance of a particular date. Why we should reward someone because they camp out longer in the parking lot is a good question?''

I am concerned that the language that passed the Senate could allow some unintended and, in fact, counterproductive, results. Changes in current law with respect to the court decision and commercial marketing triggering mechanisms for the 180-day exclusivity provision demand careful attention and analysis. The amendment does not appear to adopt all the FTC recommendations in this area.

Other questions should be raised. What if, for example, the generic applicant that successfully challenges the validity of the patent is not also a first filer? Why should such a non-first filing but successful invalidity challenger not be granted the 180 days exclusivity? Stated another way, why should the first filer--or in Chairman Muris' ``shantytown'' situation, a whole group of first-day, exclusivity-sharing, first-filers, gain while the actual successful challenger waits out the 180-days? I am not sure that such an outcome is fair or even rational. Moreover, such a system may not result in the most efficient or aggressive pursuit of patent challenges.

One thing is for sure: You can expect a lot more first filers to appear at the door of the FDA building on the first day that successful drugs become eligible for patent challenges. As I pointed out at the Judiciary Committee hearing, some have already suggested that the first to file system might result in an increase in willful infringement cases. In fact, there was a decision last month by a Federal court in Chicago that ruled against a generic firm which filed a generic drug challenge before obtaining the opinion of outside counsel on either non-infringement or invalidity.

Another type of potential problem could arise, and frankly I am not certain how it can be avoided, if a non-first filing generic drug challenger wins a court decision on grounds of non-infringement. Unless I am wrong in my understanding of the Gregg-Schumer amendment, a generic challenger that prevailed on a non-infringement theory would have to wait for the 180-days granted the first filer, or a group of first-day, first-filers, to expire before the non-infringing firm could enter the market. Such an outcome only hurts consumers by needlessly delaying introduction of the non-infringing generic product for 180 days.

Unlike a determination of patent invalidity, a finding of non- infringement does not accrue to third parties. It is important to understand that there are two ways for a generic firm patent challenger to be awarded the 180-day exclusivity under the law. First, the generic challenger can show that the pioneer's patent is invalid. And second, the generic challenger can demonstrate

that its product will not infringe a pioneer's patent.

These are two very different theories. Al Engelberg, a highly successful and highly respected attorney engaged by generic drug firms to attack pioneer patents, has made the following observation about the difference between invalidity and non-infringement challenges:

In cases involving an assertion of non-infringement, an

adjudication in favor of one challenger is of no immediate

benefit to any other challenger and does not lead to multi-

source competition. Each case involving non-infringement is

decided on the specific facts related to that challenger's

product and provides no direct benefit to any other

challenger. In contrast, a judgment of patent invalidity or

enforceability creates an estoppel against any subsequent

attempt to enforce the patent against any party. The drafters

of the 180-day exclusivity provision failed to consider this

important distinction.

As one of the drafters of the 1984 law, I must accept a measure of responsibility for this problem. It is not clear, however, that S. 1225 has addressed this issue in a satisfactory fashion. The language adopted in the Gregg-Schumer amendment does not appear to solve the problem created by the 1998 Mova decision that effectively eliminated the successful defense requirement.

Frankly, I think we need further thought on how best to address the implications of the distinction between invalidity and non-infringement claims in the context of Hatch-Waxman patent challenges and 180-day exclusivity awards. Specifically, I question the appropriateness of continuing to group together patent invalidity and patent non- infringement challenges, particularly in light of the fact that the latter may in practice extend longer than the purported 180-day award. From what I know now, there are strong arguments to prefer the reinstatement of the successful defense requirement over the establishment of a new system based on first filing.

Let me close by once again commending Senators Gregg, Schumer, McCain, and Kennedy for all their hard work in reaching the compromise amendment that was so overwhelmingly adopted by the Senate. The Gregg- Schumer amendment represents significant improvement over the legislation passed by the Senate last year. I am pleased that the amendment adopts the one-and-only-one 30-month stay policy that I, and the FTC, advocated last year.

I am also pleased that the Senate has adopted Senator Leahy's Drug Competition Act, which also addressed a major recommendation of the FTC. I have worked with Senator Leahy to perfect and pass this measure.

As a co-author of the 1984 Drug Price Competition and Patent Term Restoration Act, I support efforts to bring affordable and innovative drugs to the American public. While I support the spirit and much of the letter of the Gregg-Schumer amendment, for the reasons I have set forth, I was unable to fully support this measure at this time.

Mr. President, I wish to take a minute to say a few words in

honor of Strom Thurmond, our friend and former colleague, who passed away today.

From the moment Strom Thurmond set foot in this Chamber in 1954, he has been setting records. He was the only person ever elected to the U.S. Senate on a write-in vote. He set the record for the longest speech on the Senate floor, clocked at an astounding 24 hours and 18 minutes. He was the longest serving Senator in the history of the Senate. He was also the oldest serving Senator. Many of my colleagues will recall the momentous occasion in September of 1998 when he cast his 15,000th vote in the Senate. With these and so many other accomplishments over the years, he has appropriately been referred to as ``an institution within an institution.''

In 1902, the year Strom Thurmond was born, life expectancy was 51 years--and today it is 77 years. Strom continued to prove that, by any measure, he was anything but average.

He saw so much in his life. To provide some context, let me point out that during his lifetime, Oklahoma, New Mexico, Arizona, Alaska and Hawaii gained Statehood, and 11 amendments were added to the Constitution. The technological advancements he witnessed, from the automobile to the airplane to the Internet, literally spanned a century of progress. Conveniences we have come to take for granted today were not always part of Strom Thurmond's world. Perhaps this explains why, during Judiciary Committee hearings, he was often heard asking witnesses who were too far away from the microphone to ``please speak into the machine.''

The story of his remarkable political career truly could fill several volumes. It began with a win in 1928 for the Edgefield County Superintendent of Schools. Eighteen years later, he was Governor of South Carolina. Strom was even a Presidential candidate in 1948, running on the ``Dixiecrat'' ticket against Democrat Harry Truman.

I must admit, he came a long way in his political career, given that he originally came to the Senate as a Democrat. I was happy to say that wisdom came within a few short years when Strom saw the light and joined the Republican Party.

When I first arrived in the Senate in January of 1977, he was my mentor. As my senior on the Judiciary Committee, it was Strom Thurmond who helped me find my way and learn how the committee functioned. He was not only a respected colleague, but a personal friend.

During his tenure as chairman of the Judiciary Committee, Strom Thurmond left an indelible mark on the committee and the laws that came through it. He became known and respected for many fine qualities and positions--his devotion to the Constitution, his toughness on crime, his sense of fairness.

He was famous for his incredible grip. Many of us in this Chamber had the experience of Strom Thurmond holding our arm tightly as he explains a viewpoint and asked for our support. I might add that this proved to be a very effective approach.

Strom was also known to have a kind word or greeting for everyone who came his way, and for being extremely good to his staff. Despite his power and influence, he never forgot the importance of small acts of kindness. For example, whenever he ate in the Senate dining room, he grabed two fistfuls of candy. When he returned to the floor of the Senate, he handed the candy out to the Senate pages. Unfortunately, it was usually melted into a keleidoscope of sugar by then. I have a feeling that the pages preferred it when Strom took them out for ice cream.

Strom Thurmond was truly a legend--someone to whom the people of South Carolina owe an enormous debt of gratitude for all his years of service.

Clearly, the people of South Carolina recognize the sacrifices he made and are grateful for all he did for them. In fact, you cannot mention the name Strom Thurmond in South Carolina without the audience bursting into spontaneous applause. He truly was an American political icon.

Abraham Lincoln once said that ``The better part of one's life consists of friendships.'' With a friend like Strom Thurmond, this sentiment could not be more true. I am a great admirer of Strom Thurmond, and I am proud to have called him my friend.

One final note about Strom Thurmond. He was a great patriot. A decorated veteran of World War II who fought at Normandy on D-day, Strom Thurmond loved this country. Let me close by saying that this country loved him, too.

Mr. President, I rise in strong support of the Bingaman- Snowe-Hatch amendment. This amendment addresses an important issue for both Medicare beneficiaries and community health centers by ensuring that

Medicare beneficiaries, regardless of their Medicare health coverage choice, would receive seamless coverage if they choose to receive services from a community health center. And, it provides the Community Health Centers the ability to give the Medicare beneficiaries that they serve seamless health coverage as well.

I have been a strong supporter of community health centers for many years. These health centers provide care to over 13 million people annually; nearly one million are low-income Medicare beneficiaries. These health centers receive funding under the Public Health Service Act in order to provide quality care to their uninsured and low-income patients. To ensure those dollars are used only to provide health care to health center patients, Congress has taken action to ensure that both the Medicare and Medicaid programs are reimbursing health centers for the costs associated with care to Medicare and Medicaid beneficiaries. Therefore, community health centers are reimbursed by Medicare and Medicaid under a cost-based system.

In 1997, Congress allowed States to increase greatly the number of patients enrolled in Medicaid managed care by requiring the Medicaid program to provide a ``wrap-around' payments for the difference between the managed care organization's payment and a health center's reasonable costs.

This amendment ensures that we do the same thing for Medicare beneficiaries in the MedicareAdvantage program. More specifically, the amendment ensures that community health centers are provided with a ``wrap-around'' or supplemental payment equal to the difference between the payments they now receive under Medicare through the cost-based system and the payment they would receive from MedicareAdvantage plans.

Officials at the Centers for Medicare and Medicaid Services and the Congressional Budget Office estimate that nine to 43 percent of Medicare beneficiaries will enroll in private health plans offered through the MedicareAdvantage program. If these estimates are accurate, then health centers will lose their guarantee of cost-based reimbursement for up to 43 percent of their Medicare patients. This could result in centers having to dip into their Federal funding received through the Public Health Service Act. This funding is intended to provide care to the uninsured--not to fill in the gaps for certain Medicare health center patients.

The Bingaman-Snowe-Hatch amendment would not only protect the vital role of health centers but would also ensure that these health centers would continue to provide seamless health coverage to one million low- income Medicare beneficiaries. I urge my colleagues to support this amendment.

I suggest the absence of a quorum.

Mr. President, I rise today to address an issue of importance to all Americans, the quality and safety of health care in the United States.

Numerous studies have identified serious shortcomings in the quality and safety of health care. However, addressing these shortcomings and improving health care outcomes in a complex health care system requires long-range strategies and specific goals.

The Medicare program, as one of the largest purchasers of health care, is ideally situated to take a leadership role in encouraging quality improvement. Currently, however, Medicare's payment methods and regulations provide few incentives to pursue innovative quality improvement strategies and to reward those who achieve exemplary performance.

Traditional Medicare pays most physicians according to a fee schedule and pays hospitals according to a DRG-based payment system. Medicare+Choice plans are paid a capitated rate and, in turn, pay physicians using a range of approaches, from salary to capitation to fee-for-service, none of which directly reward enhanced quality.

Attempts to adjust Medicare payments to reward performance improvements in safety and quality have been hampered, in part, by the lack of measures and data for assessing performance. Although the Centers for Medicare and Medicaid Services recently began an initiative to develop voluntary consensus performance measures for 10 clinical conditions for hospitals, standardized measures of quality for hospitals and providers do not otherwise exist.

As the Senate considers a new Medicare prescription drug benefit and additional measures to reform the Medicare program, it is more important than ever that we consider also measures to ensure that these new benefits are provided as safely and effectively as possible.

That is why I am today introducing a bill charging the Institute of Medicine with performing a study to evaluate leading health care performance measures and options to implement policies that align performance with payment in Medicare.

We have learned much about health care quality in the last several years. The Institute of Medicine, in its studies entitled ``To Err Is Human,'' and ``Crossing the Quality Chasm,'' has identified the health care safety and quality shortcomings that exist and the need for improvement. In a recent study performed at the request of Congress, ``Leadership by Example,'' the Institute of Medicine identified the leadership role that Government can take in improving health care quality in government sponsored health care programs and those in the private sector.

The bill that I am introducing today, and the study that will result, represents the next step toward improving health care quality and safety in the United States. It is an important step and one that we must take in order to ensure that Medicare beneficiaries receive the highest quality health care services available. I urge my colleagues to join me in supporting this legislation.

Mr. President, there is no question that our need to improve the Medicare program by adding prescription drug coverage for beneficiaries is extremely important, as this debate indicates.

But, our discussions would not be complete if we neglected another major Medicare improvement which is also long overdue, and that is the need to improve the climate in which providers strive to provide high quality services to patients.

Medicare's anticipated regulations--three times longer than the U.S. tax code--prevent providers from delivering health care efficiently and beneficiaries from receiving the care they need.

Complex Federal regulations and reams of paperwork require physicians to spend hours each day filling out government forms rather than caring for their patients. The array of Federal Medicare rules with which physicians must comply is overwhelming. Doctors are required to complete claims forms, advance beneficiary notices, certify medical necessity, file enrollment forms, and comply with code documentation guidelines. Indeed, these rules and mandates are not only extensive, they are constantly changing and they may be interpreted differently in different regions of the country.

The complexity of the rules and the variation in their interpretation has prompted outcries from all centers of our country. In fact, I have heard loud and clear from the physicians in my home State of Utah about the severity of the problem.

Leon Sorensen, Executive Vice President of the Utah Medical Association, recently wrote to me and said:

``The Utah Medical Association has long been concerned

about the unnecessary burdens placed upon physicians by the

voluminous regulations of Medicare. Not only does compliance

with these regulations take physicians' time away from

patients, but also the regulations contribute to the high

cost of medical care while contributing little of value. They

discourage physicians from participating fully in Medicare.

They are often punitive in nature rather than an educational.

They use tactics that would not be tolerated by businesses or

government if applied to them.

An example is the practice of extrapolating a small sample

of billing errors over the physician's entire practice,

making the physician liable for payback of thousands of

dollars of ``overpaid'' claims when demonstrated over

billings may amount only to a few dollars. If this process

were used by the IRS in a tax audit, the public outcry would

be deafening.

Medicare also requires that alleged ``overpayments'' to

physicians by repaid within 60 days, even if a physician

chooses to appeal Medicare's allegations. When assessed a

Medicare overpayment, the only way physicians can appeal is

to subject their practices to another audit, using a

``statistically valid random sample.'' Statistical sample

audits can shut down a physician's practice for days,

preventing physicians from treating patients. Physicians are

forced to settle with Medicare rather than be subjected to

such unfair scrutiny.

Any defense against this kind of administrative abuse is

extremely costly, time consuming and often ineffective.

Indeed, failure to follow Medicare's complex rules--or just the perception of such failure--can result in an audit of a physician's billing records, withholding of payments and crippling of a physician's practice.

And, physicians are not the only individuals affected by these rules. Medicare beneficiaries are affected--both directly and indirectly--by Medicare's onerous rules and burdensome paperwork. Both patients and providers are confused by obscure paperwork and apparently conflicting rules. Physicians have difficulty understanding how to bill for their services and beneficiaries find it difficult to understand the forms and billing information that they receive. Indeed, the administrative costs associated with managing this paperwork and the fear of harsh consequences in response to clerical errors has led some providers to consider whether they should continue to participate in the Medicare program.

The problem has not escaped the attention of the administration and addressing it is a priority for President Bush and it should be for Congress also. Secretary Thompson has said, ``Patients and providers alike are fed up with voluminous and complex paperwork. Rules are constantly changing. Complexity is overloading the system, criminalizing honest mistakes and driving doctors, nurses, and other health care professionals out of the program.''

Congress has considered legislation over the past few years to provide relief from this regulatory burden. Former Senator Frank Murkowski should be given great credit for drafting S. 452, the ``Medicare Education and Regulatory Fairness Act of 2001''--legislation that he introduced in the Senate on March 5, 2001 but which never came to a vote.

The legislation that I am introducing today, the ``Medicare Education Regulatory Reform and Contracting Improvement Act of 2003,'' MERCI, builds on that initiative. It will improve the Medicare program for beneficiaries and providers alike by clarifying regulations, rewarding quality and by enhancing services. I am introducing this legislation today because the need for Medicare regulatory reform remains. In fact, the need for Medicare regulatory reform has never been greater. In addition, the regulatory reform that I am proposing in MERCI fits hand in glove with the reforms that we have

proposed in S. 1, the ``Prescription Drug and Medicare Improvement Act of 2003.'' The reformed Medicare program must include reformed regulations if it is to provide efficient service to beneficiaries.

Let me take a moment to review a few of the important provisions in this bill. The educational provisions of the MERCI Act are designed to decrease Medicare billing and claims payment errors by improving education and training programs for Medicare providers. It includes also provisions that will improve communication between the Department of Health and Human Services and Medicare providers. Furthermore, the bill will improve communication with Medicare beneficiaries by providing for central toll-free telephone services to require free, appropriate referrals to individuals seeking information or assistance with Medicare.

The MERCI Act includes regulatory reform provisions that are designed to reduce waste, fraud and abuse in Medicare; provisions that are just and fair for beneficiaries, contractors, and providers. Among other things, the bill eliminates retroactive application of regulatory changes and expedites the appeals processes for beneficiaries, providers, and suppliers of Medicare services.

Finally, the MERCI Act will improve Medicare contracting; increasing competition, improving service and reducing costs by providing for a competitive bidding process for Medicare contractors that takes into account performance quality, price and other factors that are important to beneficiaries.

Medicare beneficiaries and Medicare providers have been suffering from burdensome and confusing regulations for too long. It is time that they received some mercy. The time for Medicare regulatory reform has come and the bill that I am introducing today provides that mercy. MERCI, the ``Medicare Education, Regulatory Reform and Contracting Improvement Act of 2003'' takes a common sense approach to providing relief for the Medicare beneficiaries and providers who have been suffering this burden for so long.

I believe that MERCI will improve the delivery of health care services to Medicare beneficiaries by enhancing the efficiency of the Medicare program for all concerned.

Finally, I would be remiss if I did not thank Chairman Grassley and Senator Baucus for working with me to include the MERCI legislative language in S. 1, the ``Prescription Drug and Medicare Improvement Act of 2003.'' Senators Grassley and Baucus have worked for many years to reform Medicare's complex regulations, as have I, and their agreement to include this language is appreciated greatly.

And so, it is with a great appreciation for my colleagues who have worked with me on this legislation and for those who have worked on similar legislation in the past, that I urge my colleagues in the Senate today to join me in addressing the needs of Medicare beneficiaries and providers by supporting this legislation.

I move to lay that motion on the table.

The motion to lay on the table was agreed to.

Amendment No. 984, as Modified

Mr. President, I rise to oppose the Dorgan amendment on drug importation.

Frankly, given the history of this amendment, I feel a little like we are in the movie, Groundhog Day. We have been there and done that. And like the Bill Murray movie, we appeared to have gone there and done that again last night. When I woke this morning, I had the feeling of deja vu all over again.

Each time the same thing happens. First we consider a flawed drug reimportation amendment. Then we adopt a second degree amendment that virtually guarantees the amendment can never be implemented. We did it in the 106th Congress, and Secretary Shalala--the Clinton administration's Secretary of Health and Human Services--could not certify the safety of reimported drugs. We did it in the 107th Congress again last year when the Senate adopted a reimportation amendment during the debate on the ill-fated vehicle, S. 812. And now last night we did it in the 108th Congress. The same dynamic played out yet again with the Dorgan amendment and the second degree amendment thereto.

Let me remind my colleagues. Here is what the Bush Administration's Secretary of Health and Human Services, Tommy Thompson, said about this idea last year: ``Opening our borders to reimported drugs potentially could increase the flow of counterfeit drugs, cheap foreign copies of FDA-approved drugs, expired and contaminated drugs, and drugs stored under inappropriate and unsafe conditions. In light of the anthrax attacks of last fall, that's a risk we simply cannot take.''

I agree with Secretary Thompson that reimportation was not ever a good idea. But, it could be even more deadly after September 11th. Although I am not a betting man, I can guess what Secretary Thompson will say if this unfortunate amendment survives the conference committee.

This year's version of the Dorgan amendment contains a new section relating to the effective date of the amendment. This modification attempts to make the proposal effective prior to the Secretary determining that the benefits of this law outweigh the risk.

Fortunately, the Cochran amendment we adopted last night by voice vote makes it clear that nothing in the Dorgan amendment can take effect unless the Secretary finds that the provision: first, poses no additional risk to the public health and safety; or, second, will result in a significant reduction in the drug costs.

My preference is for no Dorgan amendment at all. But if his language is adopted, it is essential that we have the Cochran correcting proviso so that the American public can be protected against unsafe drugs.

I agree with my friend, John Dingell, the Dean of the House of Representatives, and author of the 1988 Prescription Drug Marketing Act, PDMA, that helped put rigorous safety controls in the U.S. drug distribution system. Mr. Dingell said, ``the very existence of a market for reimported goods provides the perfect cover for foreign counterfeits.''

Representative Dingell's Energy and Commerce Committee produced a report that succinctly explained why the PDMA was needed: ``[R]eimported pharmaceuticals threaten the public health in two ways. First, foreign counterfeits, falsely described as reimported U.S. produced drugs, have entered the distribution system. Second, proper storage and handling of legitimate pharmaceuticals cannot be guaranteed by U.S. law once the drugs have left the boundaries of the United States.''

This view is consistent with the testimony that the experts at FDA have given before Congress numerous times.

As the FDA's senior associate commissioner for policy, planning, and legislation, Bill Hubbard, has warned: ``Even if the Canadian system is every bit as good as ours . . . the Canadian system is every bit as good as ours . . . the Canadian system is open to vulnerabilities by people who will try to enter the U.S. market . . . because that is where the money is.''

A bipartisan group of some 10 former FDA Commissioners have voiced their concern about the safety of reimported pharmaceuticals. So has the Drug Enforcement Administration.

We are told by the experts that the number of counterfeit cases is on the rise. FDA has opened more than 70 counterfeit drug cases since October 1998, including 26 arrests and 20 convictions through last June. In the last two months, FDA has issued alerts on counterfeit Lipitor. In March, the FDA found that doctored EPO--a product vital to patients fighting cancer and other deadly diseases--has been the target of counterfeiters in previous instances.

Let us remember the sage counsel we were all taught in elementary school--safety first. Unfortunately, the Dorgan amendment conflicts with this important lesson.

To summarize, my primary reason for opposing this amendment is a concern expressed by many public health and safety experts: Opening up the current closed U.S. drug distribution system to products of unknown pedigree will result in disaster down the road.

I know that Senator Dorgan and the other cosponsors of the amendment are motivated only by their desire to do right by their constituents and other Americans trying to obtain affordable pharmaceuticals. We all share in that goal. This is why we are working in a bipartisan fashion to craft a $400 billion Medicare drug benefit program. Let us focus on the Medicare drug benefit during this debate and not get sidetracked on ill-conceived measures like the Dorgan reimportation amendment.

Let me close by saying this to my friend from North Dakota, with whom I serve on the Finance Committee: We have worked together on several trade issues involving Canada. We have struggled with how to respond effectively to the problems associated by the influx of protected Canadian softwood lumber and the actions of the less-than transparent Canadian Wheat Board.

My friend from North Dakota does not like it when the actions of the Canadian government unfairly benefit Canadian producers of wood and wheat relative to American loggers and farmers. This is so even if the preferentially-treated Canadian products can undercut the prices offered by American producers to American consumers.

In this debate on drugs, we often hear heart-wrenching stories of seniors being forced to choose between paying for drugs or paying for food or paying the rent. When it comes to weighing

the interests of loggers and farmers versus the lowest cost goods, my friend from North Dakota carefully, and appropriately, factors in the long term interests of preserving vital U.S. industries. He does not automatically support policies that result in U.S. consumers, particularly our seniors, paying the lowest possible prices for such essential products as bread and wood.

Not so with price-controlled Canadian drugs. First, the Canadian government ratchets down the prices of drugs for its citizens. Comes now the Dorgan amendment that acts to pass on these controlled prices to U.S. consumers. If passing on Canadian government-controlled prices is such a good policy for drugs, then I ask why it is so bad when the Canadian government acts to artificially hold down the price of wheat and lumber and pass these savings along to the American consumer?

Let us face facts. Money is fungible. If the proper response to easing the choice among food, medicine and shelter is always to end up with the lowest prices then why should we not applaud equally the Canadian Wheat Board and the Canadian drug price control agency?

My answer is that government price controls, subsidy programs, and preferential treatment are never the preferred policy option--whether we are talking about food, medicine or the mortgage.

Let me close by saying that my fundamental objection to the Dorgan amendment is the safety risks it would engender. In addition, I have concerns over embarking on a policy that has the effect of imposing government price controls on a product highly dependent on investment capital, and let the Canadian government do the price controlling to boot.

I only hope that we can some day break the cycle of passing a piece of legislation with a circuit breaker provision that will always be tripped and ensure the underlying language, thankfully, will never take effect. Enough of Groundhog Day.

Mr. President, I rise in support of the Senate's confirmation of the nomination of C. Stewart Verdery, Jr. to be Assistant Secretary for Border and Transportation Security Policy at the Department of Homeland Security. At a time when the new Department of Homeland Security needs to have all vacancies filled, having Mr. Verdery confirmed will fill a vital position from which he will develop policy related to immigration, customs and trade, transportation security and international security issues.

As a counsel working for me on the Senate Judiciary Committee and working with me and my staff when he served for the Senate leadership, Mr. Verdery demonstrated superior political and legal skills which will serve the Department of Homeland Security and the country well.

After working for me as unit head of the Crime and Drug Policy Unit, which handles all matters related to law enforcement, including Federal crime and drug legislation and terrorism, Stewart has an invaluable knowledge of the issues which may confront him in the Border and Transportation Security Directorate. Mr. Verdery served with distinction for me and the committee at large and I know he will take his talents to the Department.

In sum, I believe that Mr. Verdery will be a valuable assistant to the President and to the Secretary for Homeland Security, and the administration will be well served by his confirmation. I thank my colleagues for their support of this nomination.

Mr. President, I rise to speak on the Gregg-Schumer amendment. This is a revised and improved version of S. 1225, the Gregg-Schumer bill, ``The Greatest Access to Affordable Pharmaceuticals Act of 2003.'' The HELP Committee reported S. 1225 just last week.

This bipartisan amendment was authored by Senators Gregg, Schumer, McCain, and Kennedy. I commend all of them for their hard work which, I believe has resulted in a bill that is vastly improved over legislation that passed the Senate last July, S. 812. Additionally, substantial improvements have been made between the version reported by the HELP Committee last week and the new draft of the amendment that I understand was only completed early this morning after an all night drafting session.

While I am supportive of the efforts and leadership of Senator Gregg and his prime cosponsors, Senators Schumer, McCain, and Kennedy, I am not in position to support this extremely important but complicated amendment at this time.

While I am mindful that the underlying bill is an attractive vehicle for this amendment, my experience teaches me that it is good to let the dust settle a bit, or at least let the ink dry, before making an informed judgment on an amendment that works at the complex intersection between the patent code and the Federal Food, Drug, and Cosmetic Act.

I can say this for certain: Senators Gregg, Schumer, McCain, and Kennedy deserve credit for their effort to make drugs more affordable for the public without undermining the existing incentives for developing new medicine.

On Tuesday, the Senate Judiciary Committee held a hearing on the issue of competition in the pharmaceutical industry. This hearing focused on the July 2002 Federal Trade Commission Study: Generic Drug Entry Prior to Patient Expiration, the recently-finalized Food and Drug Administration rule on patent listings and the statutory 30-month stay available in certain circumstances, and the new bipartisan Gregg- Schumer legislation, S. 1225.

At that hearing, I requested the Department of Justice to give us its opinion on the constitutionality of a provision of the legislation and asked the Patent and Trademark Office for their views on the patent- related provisions of the bill. I want to learn more from DOJ and PTO and others about their views on this only recently developed piece of legislation.

As well, at the hearing I discussed with the Chairman of the Federal Trade Commission, Tim Muris, and the Chief Counsel for Food and Drugs at the Department of Health and Human Services, Dan Troy, problems that may arise from the manner in which the bill addresses the granting of the 180-day marketing exclusivity incentive when patents are successfully challenged. The amendment appears to retain a feature of the current system that grants the 180-day marketing exclusivity period to first filers of generic drug applications rather than those applicants actually successful in defeating the patents of pioneer drug firms.

I look forward to working with the proponents of this legislation and once again commend them for their efforts to bring innovative and affordable drugs to the American public.

Mr. President, I rise in opposition to the amendment offered by the minority leader, Senator Daschle. This amendment would mandate a nationwide cap on the premium for the stand-alone prescription drug plans.

Although at first this amendment might seem attractive, a closer look reveals blemishes and flaws in this approach, flaws that would spell disaster for the stand-alone prescription drug benefit and for Medicare beneficiaries were we to adopt this amendment.

S. 1 provides for a stand-alone prescription drug plan premium that would average $35 nationwide. The amendment offered by Senator Daschle would cap the premium at $38.50.

Although it may sound trivial, the difference between these two approaches is an important distinction to make if we are to implement a successful program.

S. 1 provides for at least two, and perhaps many more, private entities to bid for and provide stand-alone prescription drug coverage in each region. The plans may provide either the standard drug benefit or a drug benefit that is actuarially equivalent to the standard drug benefit.

The actuarially equivalent plans will have some flexibility in determining the specific prescription drugs that they provide and how they provide those drugs to beneficiaries. Some plans may be more efficient. These plans may find that they are able to provide prescription drugs at a lower cost and charge a premium that is less than $35. Others may choose to offer enhanced coverage or use delivery systems that require a premium that is higher than $35. It may be 5 percent higher. It may be 10 percent higher. It may be 15 percent higher. Or, it could also be lower.

So why should we lock ourselves in? We would be negating the very flexibility around which S. 1 was designed.

The point is that by providing for an average nationwide premium and stipulating that the plans may be actuarially equivalent, we allow plans to offer choices. And that is what Americans and particularly Medicare beneficiaries want.

S. 1 provides Medicare beneficiaries with the opportunity to choose plans based on price, service, and within certain mandated limits, the prescription drugs that are provided.

Let me mention something that I addressed also a few days ago in my opening remarks. This pertains to the provision in the bill ensuring that Medicare beneficiaries will have affordable prescription drug coverage.

S. 1 gives the Secretary of Health and Human Services the discretion to make adjustments in geographic regions so there will not be a large discrepancy in Medicare prescription drug premiums across the country.

This is very important to me, because I do not want Utahns paying significantly higher premiums than Medicare beneficiaries living in Miami or New York.

That being said, I believe it is better to give the Secretary of HHS the discretion to make those important decisions. If we cap the monthly premium in legislation, we are taking away plan flexibility--one of the fundamental principles of S. 1.

If we adopt the Daschle amendment and cap the stand-alone drug plan premium nationwide, Medicare beneficiaries will lose choices. The plans will not have the flexibility to offer improved service; they may find that they are unable to offer different services at all. There could be little to distinguish plans from each other. And beneficiaries may not be able to find a plan that offers the services or the particular brand of drug that they prefer.

This is not what Medicare beneficiaries want and it is certainly not what we in the Senate should offer them. My Finance Committee colleagues and I have worked hard during the last several months to provide Medicare beneficiaries with choices; choices that allow them to determine which prescription drug plan works best for them.

My colleague from South Dakota is concerned also about the complexity of variable premiums in S. 1. He has claimed that differences between plans will be confusing to our Nation's seniors.

I share Senator Daschle's desire that our seniors understand the terms of the plans that they are offered. However, I must disagree that the stand-alone prescription drug plans provided for in S. 1 will confuse seniors because the choices offered to them will be clear. Differences between plans will be obvious; seniors will choose a plan based on the factors that are important to them. It seems to me that this promotes the kind of transparency in public policy that a democratic, open society is all about.

Let me mention another problem that will certainly occur if the Senate were to mandate a national prescription drug premium.

If we mandate a specific, nationwide premium dollar amount, Congress will be back here every year debating whether that amount reflects the true cost to deliver prescription drugs. Since we all know how quickly the Government moves, this seems like a decidedly inefficient process.

This is not how the American people want their elected officials to spend our time, and it certainly is not how I think we can best use our time. This is an instance when Congress should trust the American people to determine what is best for them by making choices in the marketplace.

Furthermore, providing for a nationwide average premium allows plans the flexibility to design prescription drug benefit packages that reflect modern health care--not just what makes sense today, but what will make sense in 10 to 20 years.

If plans do not have this flexibility, we may in 10 years find ourselves in the same situation that we are in today, needing to revise a system that no longer provides the up-to-date options that Medicare beneficiaries need and deserve.

The private health insurance market and the Federal Employees Health Benefit Plans operate in this manner.

These plans provide benefits that have evolved over time in response to enrollees' needs to keep pace with modern health care innovations. Flexibility enables these plans to adjust quickly to meet their enrollees' needs and flexibility will allow the stand-alone prescription drug plans to meet Medicare beneficiary needs quickly and efficiently over time.

It is important also that we recognize that the Congressional Budget Office has said that prescriptive benefits, those spelled out in statute, will cost more and will provide lower quality and less efficient health care. Setting limits usually means that plans provide the minimum benefit at the lowest cost. Providing flexibility enables plans to be innovative and to offer multiple coverage options that reflect what Medicare beneficiaries want.

I urge my colleagues on both sides of the aisle to resist the temptation to vote for this amendment. Although it may sound enticing, capping the prescription drug premium will result in an outcome that none of us desire and that no one intended.

Capping the prescription drug premium will result in a one-size-fits- all approach, an approach that will leave us in a few years with a tired old prescription drug plan that doesn't meet anyone's needs.

This bill, S. 1, is about providing people with choices--choices that are affordable, but choices that also provide Medicare beneficiaries with what they need and want.

When the Government limits prices, Americans lose choices. In establishing a national average premium, not a nationwide premium, S. 1 will provide Medicare beneficiaries with the prescription drugs that they need and the choices that they want today and in the future. That is what Medicare beneficiaries tell us that they want and that is what my Finance Committee colleagues and I have worked so hard to provide. And that is why I will oppose this amendment and why I urge my colleagues to do the same.