Proficiency Testing Improvement Act of 2005

Mr. Speaker, by direction of the Committee on Rules, I call up House Resolution 623 and ask for its immediate consideration.

Mr. Speaker, for the purpose of debate only, I yield the customary 30 minutes to the gentleman from Florida (Mr. Hastings), my friend, pending which I yield myself such time as I may consume. During consideration of this resolution, all time yielded is for the purpose of debate only.

Mr. Speaker, this resolution provides that certain specified measures may be considered under suspension of the rules at any time on the legislative day of Saturday, December 17, 2005.

Mr. Speaker, the Republican leadership of this House has set forth a positive legislative agenda for the remainder of this week and the balance of the first session of the 109th Congress. The goal of this plan is to address a number of outstanding issues remaining on Congress's calendar before we adjourn that maintain our commitment to improving America's economy and national security.

Over the past year, we have passed a number of important new education, health care, tax, trade and national security bills that will keep Americans safer and healthier, create new jobs and improve our economy. This rule will allow the House to consider a number of additional bills today under suspension of the rules that will ensure that Congress can complete some additional important work before we adjourn for the holidays.

This rule makes in order the consideration of nine bills under suspension

of the rules. These bills accomplish necessary and noncontroversial goals, such as extending funding for the operation of State high-risk health insurance pools, providing for collection of human cord blood stem cells for medical treatment and research, and improving the proficiency testing of clinical laboratories.

The suspension authority will also allow us to consideration legislation to authorize appropriations for the Department of Justice, improve medical benefits for patients, extend important educational programs and help NASA to continue its human space flight, aeronautics and science programs.

Perhaps most notably, it provides for consideration of the conference report to extend the applicability of the Terrorism Risk Insurance Act. Extending TRIA is a goal upon which I have worked very closely with my friends and fellow House conferees, Chairman Mike Oxley and Chairman Richard Baker, and I commend them for their hard work in preparing this bill for President Bush's signature.

This legislation represents a fiscally responsible response to the threats that acts of terrorism pose to the American economy. It also includes important taxpayer protections and will ensure that this important program does not expire and leave the marketplace for terrorism insurance in uncertainty.

After the tragedy of September 11, the marketplace for terrorism insurance largely disappeared. This lack of terrorism coverage terminated or delayed billions of dollars in commercial property financing, threatening business operations and development and job creation and our overall economy.

TRIA has proven its ability to stabilize the market, and it will continue to provide essential protection for businesses of all sizes in our country. I urge my colleagues to take the opportunity later today to follow up on this program's successful record and to reauthorize TRIA so that the program does not lapse and hurt businesses and policyholders around this great Nation.

Like TRIA, all of the bills scheduled for consideration by the Republican House leadership on behalf of all Americans enjoy broad support from Members of both the majority and the minority parties. This rule simply provides us with the tools needed to ensure that all of the important work is completed before we adjourn to our families and communities to celebrate for the holidays.

Mr. Speaker, I encourage my colleagues on both sides of the aisle to support this uncontroversial and balanced rule.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I, like my wonderful colleague, Mr. Hastings, am here doing the work of the American people. We are proud of what we are doing. It is just 1 week before Christmas, and we have a lot of work left to do. That is why we are here. We are here to work.

There are a number of my colleagues who showed up for work today prepared and ready. We know they miss their family and friends. Nathan Deal of Georgia, Tom Price of Georgia, and John Shimkus of Illinois are just an example of three Members of Congress who, even on a weekend and even a week before Christmas, show up.

So it is my hope that this same spirit we all talk about today, of accomplishing our work on behalf of the American people, the importance of completing our work because we said we would do it, to be responsible to the people of this whole country, all the people, that that spirit will carry through because that is why we are here today.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, the gentleman from Massachusetts has very appropriately talked about this important act, this TRIA legislation; and I would like to take time to thank the ranking member of the Financial Services Committee (Mr. Frank of Massachusetts) for not only his work for a long time on this bill but for working clearly and closely with industry and consumer groups to make sure that what we had control over of here in the House that we passed.

I do admit that there is frustration. There is frustration on my part, too, as the gentleman is well aware. And I will tell you that the process that has taken place may not be perfect, but I want to thank the gentleman not only for his support of the work that we were able to accomplish but for sticking with it.

The good part is there will be a process here today and the gentleman will be able to speak very clearly about his thoughts on that, and we will move forward.

Mr. Speaker, I continue to reserve the balance of my time.

Mr. Speaker, I offer an amendment.

Mr. Speaker, I want to thank my colleagues on both sides of the aisle for their thoughtful comments this morning about the circumstances, as we are here on December 17, almost a week before Christmas. I would like to thank all my colleagues for coming down and speaking clearly.

There is a lot of frustration, but I believe the process is important for us to follow through. I am proud of what we are doing. We can accomplish it all together.

Mr. Speaker, I yield back the balance of my time, and I move the previous question on the amendment and on the resolution.

The previous question was ordered.

Mr. Speaker, I yield myself such time as I may consume.

Joining my friend from Georgia, Mr. Deal, I rise in support of H.R. 4568, the Proficiency Testing Improvement Act.

It makes perfect sense to take steps to ensure that women are receiving accurate results after they have had a Pap test. But it makes no sense to take false steps in that direction. Proficiency testing can be extremely useful, or it can make a bad situation worse. If the proficiency test itself is inaccurate, then both competence and incompetence get lost in the shuffle. It is almost worse than not knowing.

H.R. 4568 gives the Secretary of Health and Human Services authority to revise a 13-year-old regulation that CMS has only recently acted on. The regulation calls for a Federal program to test the proficiency of individual laboratory individuals who read Pap tests.

Since this rule was first proposed in 1992, significant advances, such as computer-assisted screening, location-guided screening, digital imaging, have made a positive impact on screening for cervical cancer.

The proficiency testing system embedded in the agency's rule has not been modified to reflect these significant advances. As a result, the system is rooted in outdated and obsolete medical standards and practices. In fact, the testing scheme adopted 13 years ago but just implemented by the Federal Government this year is based upon standards that go back to the late 1960s.

H.R. 4568 delays implementation of this testing program for 1 year so the agency can review and revise the program to reflect current medical practice. One can look at it from a quality perspective, a safety perspective, an access perspective or a fiscal perspective. From any of those angles, it is in no one's best interest to use the wrong test to evaluate proficiency. All they end up with are more questions.

I want to make clear the bill does not repeal this testing program. It simply puts the program on pause while the agency makes changes to reflect valid and up-to-date medicine and laboratory working conditions.

In September, I joined over 100 Members of the House, from both parties, in sending a letter to Secretary Leavitt, urging him to update the testing program before implementing it. The Secretary of HHS, for whatever reason, has not responded.

In February, the Clinical Laboratory Improvement Advisory Committee, which advises the Department of Health and Human Services, unanimously recommended that the agency revise and update this 13-year-old regulation; yet the agency continues to move forward with a January 1, 2006, implementation date.

If we are serious in this body about promoting quality health care, we should ensure that the Federal Government's regulations are keeping pace with 21st Century medicine. This bill will help do that. I urge my colleagues to support it.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield 3 minutes to the gentlewoman from South Dakota (Ms. Herseth), who has been a terrific advocate for women's health in our country.

Mr. Speaker, I yield 3 minutes to the gentleman from Maryland (Mr. Cummings).

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I was just looking through the CMS informational supplement on this whole issue, and I just wanted to read the reason that CMS could not get its act together through Secretary Thompson and now Secretary Leavitt, that they have delayed this so much longer than it needed to, and this is their sort of double speak, if you will:

``Implementation of cytology proficiency testing has taken an extended period of time due to the absence of qualified national proficiency testing organizations and insufficient number of reference cytology testing materials and significant technical difficulties. Currently, there are two CMS-approved cytology proficiency testing programs in the country for 2005, and we anticipate the approval of additional programs in 2006.''

So the last 5 years both Secretary Thompson and Secretary Leavitt have not been able to get this whole program up and running. Now we have this same cast of characters telling the country that we have got to implement the Medicare bill right now when plenty of people in this body, led by Ms. Schakowsky of Illinois and Mr. Stark from California, it said on the Medicare bill that we should push back the deadline for people who want to benefit from the Medicare prescription drug benefit program, who want to benefit but cannot yet make their minds up because of the complexity of it. And they will be actually financially penalized if they do not make that decision more quickly than many seniors feel that they are capable of making.

At the same time, we are also doing nothing to allow the Secretary of CMS to bring down the price of prescription drugs. In fact, this institution, this body, prohibited the government from negotiating lower prices. So while Secretary Thompson and now Secretary Leavitt could not get their act together on this, they seem to want to move forward too quickly on Medicare, forcing seniors to make a choice prematurely in the minds of many seniors or pay an economic financial penalty for every month they delay, and at the same time doing nothing to bring the price of prescription drugs down.

It all fits together in a peculiar way, Mr. Speaker. That does not mean this bill is not important. I join my colleague, Mr. Deal, in support of it. As always, there is a little bigger picture here.

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, I thank the subcommittee chairman for his leadership on this issue.

I am not an OB/GYN, but as a general internist, I performed numerous Pap smears. I was not here in 1992 when this statute was put in place. If I had been, I would have voted against it. I do not think the Federal Government has any business being in this process.

I have to ask everybody in the Chamber a question: Why do we want to have a special test only for the pathologists? Why not a Federal test for the doctor performing the Pap smear? I frequently did breast exams at the same time. Why not a special test, a Federal test, for that? What about the mammogram? Why not a Federal exam for a mammogram?

We obviously do not do that for obvious reasons. Professional societies govern these issues. State statutes govern them, and this is just a huge area.

Physicians of various specialties perform a multitude of different tests. They review and do a multitude of different procedures, and it would virtually be impossible; it would involve a colossal expansion of the Federal Government into essentially an area traditionally of commerce.

Now, understanding, as I do, that this is in the law, another reason why this is a bad law is just the way it has played out. Thirteen years for the regulatory agency to finally bring regulations to the process, to put them forward, and, lo and behold, surprise, surprise, they are completely outdated. They are completely inconsistent with what has been going on.

Litigation forces and the College of American Pathology's policies have changed the landscape, and now you essentially have many pathologists, as my physician colleague Dr. Price said earlier, and I commend him for his leadership on this, many pathologists have abandoned this. And you literally have certain pathologists who are specializing in this. They read them all the time. They go to seminars all the time. When they get difficult smears, they take them to the university. They bring their colleagues in the room.

To me, this is a wasteful and inappropriate involvement of the Federal Government, and I am very, very pleased that the other side of the aisle is willing to go along with this 1-year delay. Hopefully, the Senate will approve this.

What I hope is, ultimately, we repeal this, because I believe it is completely unnecessary, and it is inserting the Federal Government in a place that I do not think the American public would really want us to be, and that is into the details of the practice of medicine, carving out one specific area of pathology. Why are we not credentialing pathologists who read thyroid biopsies? That can be very, very important. What about breast biopsies? So to single this out, to me it is almost bizarre.

Mr. Speaker, I commend the chairman of the subcommittee. I am certainly looking forward to working with him in the year ahead. I certainly commend the ranking member for his willingness to allow this to move forward, and I do hope the Senate concurs, and we are able to pass this.

What the bill does?

In 1992 CMS, HCFA, proposed regulations that would require proficiency testing of pathology labs for pap tests.

Those regs sat on the shelf for the past 13 years, until earlier this year CMS decided to implement these 13-year-old regs.

This bill simply delays for one more year the implementation of these regulations and asks CMS to update their regulations to reflect the practice of medicine today both within the pathology labs and in how clinicians respond to those lab tests.

Why is this bill necessary?

CMS dusted off 13-year-old regs that do not reflect the current practice of medicine.

CMS is requiring that pathologists examine these test exams in a vacuum; however, pathologists and cytologist practice in a team today. The CMS regulations don't reflect this change in practice; they are testing in a manner that does not reflect how a pathology is practiced today.

The test asks pathologists/cytologists to distinguish between high- and low-grade lesions.

In 1992 the standard of practice for low-grade lesions was to continue repeat cytology testing while colposcoply and biopsy were ordered for high-grade lesions.

The standard of practice today is to order colposcopy and biopsy for both high- and low-grade lesions.

The exam also applies a double standard for scoring--one test for cytologists and another higher standard for pathologists.

Who Has Asked CMS to Delay These Regs

Ten national pathology and cytology organizations; 49 State pathology medical societies; over 120 Members of Congress wrote CMS in October asking CMS to delay this testing; even CMS's own Clinical Laboratory Improvement Advisory Committee, CLIAC, unanimously moved that CMS revise the cytology PT regulations to reflect current practice, evidence based guidelines and antipated changes in technology.

Conclusion

This bill will provide for only a 1-year delay of these regulations so that CMS can update the regulations that they left sitting on the shelf for the past 13 years.

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 4568) to improve proficiency testing of clinical laboratories, as amended.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and include extraneous material on the bill.

Mr. Speaker, I yield myself such time as I may consume.

Each year, the licensed physicians and cytotechnologists who screen and interpret Pap tests save the lives of thousands of women by detecting the

earliest signs of cervical cancer, a common cancer in women. Without question, these professionals serve a vital role in the health care delivery system of this Nation, and we owe them our sincere admiration and appreciation for the services they perform.

However, our Federal bureaucracy has let these professionals and their patients down by neglecting to develop an effective and appropriate proficiency test for these individuals as required by the Clinical Laboratory Improvement Amendments of 1998, commonly referred to as CLIA. Instead, the Centers for Medicare and Medicaid Services have recently chosen to implement an outdated and flawed testing system that was finalized over 13 years ago.

This situation is unacceptable, and these professionals who are performing vital services deserve better.

And that is why I have introduced this legislation. H.R. 4568 will place a hold on the current CMS testing system and require that a new rule be developed that accomplishes the following four goals: First, to reflect the collaborative clinical decision-making of laboratory personnel involved in screening or interpreting cytological preparations; second, to revise grading or scoring criteria to reflect current practice guidelines; and, third, to provide for such testing to be conducted no more often than every 2 years; and, fourth, to make such revisions to the standards for such testing as may be necessary to reflect changes in the laboratory operations and practices since the standards were promulgated originally in 1992.

This is the least we can do for these professionals. And I want to thank my colleagues Sue Myrick, Tom Price, John Shimkus and Sherrod Brown for joining me in sponsoring this legislation.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield 2 minutes to the gentleman from Illinois (Mr. Shimkus), a member of the Energy and Commerce Committee that has jurisdiction over this issue.

(Mr. SHIMKUS asked and was given permission to revise and extend his remarks.)

Mr. Speaker, I am pleased to yield 4 minutes to my colleague, the gentleman from Georgia (Mr. Price), and to thank him for his efforts in shepherding this bill to the floor today.

(Mr. PRICE of Georgia asked and was given permission to revise and extend his remarks.)

Mr. Speaker, I am pleased to yield 4 minutes to the gentleman from Florida (Mr. Weldon), a physician familiar with this issue.

(Mr. WELDON of Florida asked and was given permission to revise and extend his remarks.)

Mr. Speaker, I yield myself 15 seconds just to respond to the gentleman and assure him that we understand his concerns with the whistleblower, but this is a situation in which government does have a role, but we are trying to make sure that government does not impose outdated regulations that are 13 years old and do not associate themselves with the current realities of the practice.

Mr. Speaker, I yield 2 minutes to the gentleman from Pennsylvania (Mr. Shuster).

Mr. Speaker, I yield 2 minutes to the gentleman from Texas (Mr. Burgess), my colleague on the Health Subcommittee of Energy and Commerce.

Mr. Speaker, I yield myself such time as I may consume.

While my colleague, Mr. Brown of Ohio, is my copartner in the issue of health care and he and I share many things in common, this bill being one of them, and I would disagree with his comments with regard to Medicare part D, I for one am pleased that we are finally offering senior citizens of this country the opportunity to have a prescription drug benefit plan.

We can disagree on that, and we will probably have some disagreements in the future; but I do want to thank Mr. Brown of Ohio and his staff and the others on the minority side for their cooperation in dealing with this issue that is before us today on pathology licensure.

I think that it is a bill that we need to act on quickly, and hopefully our colleagues across the way will do likewise.

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, I have to say I was struck by the gentleman from Texas crediting his fellow Republicans for showing up. Because if it were not for the combination of institutional incompetence and ideological extremism that dominates the Republican Party, none of us would have had to be here. So I guess we all deserve recognition as victims of that.

I actually think this motion should have been retitled. It should have been called Subversion of the Rules, not Suspension of the Rules, because that is what is happening. We are being at almost gunpoint, the metaphorical, parliamentary equivalent of gunpoint, being asked to debate under very restrictive measures bills that deserve more.

Let me talk about one, the terrorism risk insurance. I think it is an important bill, and I agree substantively with what the gentleman from Texas said. Unfortunately, the right wingers who dominate this administration and much of the congressional leadership in both Houses do not agree. They tried to kill this thing, until finally, at the overwhelming insistence of people who are involved in the economy of this country said that that would be irresponsible, they did the next best thing. They have forced us to deal with it in a constricted and inappropriate way.

We did take it up in the House, and we had a full markup in our committee, and we voted on it on the floor. In the Senate, and let us praise the rule change that now allows us to tell the truth about what goes on in the Senate, the Senate passed a very restricted version of this. The Senate chairman of the banking committee then refused to appoint conferees.

Interestingly, we are going to have to amend this rule, because the rule, reasonably, said let us take up on suspension the conference report on TRIA. And then the Rules Committee had to be reminded that there is no conference report on TRIA, because the Republican Senate chairman, knowing that he would have been outvoted in the conference, refused to allow one and, instead, individually dictated what would be in it.

So we are going to have to amend it, because if we had a vote on a conference report on TRIA, we would have no TRIA. They would not have a conference. The regular order has been totally subverted. Unfortunately, we have to accommodate it because we are up against a December 31 extension.

By the way, if the House Republican leadership had not delayed consideration of this bill, we could have done it months ago and not been vulnerable to that kind of extortion.

What we have now is a bill that leaves out, for example, the commission on how to deal with terrorism insurance that the families of September

11 have asked for. We will go into that further when we debate it, but the families of September 11 asked for a commission. We included it in the House bill. Chairman Oxley and Chairman Baker accommodated that reasonable request. It is not in the Senate Bill. And because of this outrageously high-handed legislative procedure, we do not have a chance to include it.

An important provision was adopted here in the House, sponsored by the gentlewoman from Florida, to prevent people who are traveling to what some insurance companies think are dangerous areas, like Israel, from being denied life insurance. That is not in the bill. Maybe some people do not like it, but we should have been able to have had a forum in which it could be debated and decided.

Instead, we have the right wing that controls the executive branch and both Houses of Congress grudgingly allowing a bare bones and, I think, inadequate form of extension. It is better than nothing. It is important to the economy, and the gentleman from Texas is right. But here is a combination of ideological extremism and a refusal to recognize the legitimacy of a democratic process here.

As we salute democracy in Iraq, and I am glad we saw it yesterday, I guess I am starting to get jealous of the Iraqis, because as of now there is more democracy being practiced under American auspices in Iraq than the leadership here in the House of Representatives is allowing on the floor of this body.

Mr. Speaker, if the gentleman will yield for just a moment, I want to thank the gentleman for his graciousness on that, and I appreciate that.