[Congressional Record Volume 145, Number 98 (Tuesday, July 13, 1999)]
[Senate]
[Pages S8335-S8367]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                  PATIENTS' BILL OF RIGHTS ACT OF 1999


                           Amendment No. 1237

  Mr. NICKLES. Mr. President, for the information of our colleagues, we 
were in the process of debating the Robb amendment dealing with 
mandatory length of stays for mastectomies. That is a second-degree 
amendment to an amendment I offered on behalf of myself, Senator Gramm, 
and Senator Collins that had a limitation on the cost. The cost of the 
underlying bill cannot exceed 1 percent, nor could it increase the 
costs or increase the number of uninsured by over 100,000 or the bill 
would not be in effect.
  Senator Robb's amendment strikes the amendment that limits the 1-
percent cost. It is our intention to finish the debate on the Robb 
amendment. We will vote on the Robb amendment, and it will be our 
intention for the Republican side to offer a second-degree amendment. 
We will debate that amendment and vote on it and work our way through 
the amendments that have been stacked today.
  I ask the Parliamentarian how much time remains on the Robb 
amendment?
  The PRESIDING OFFICER. The majority has 46 minutes remaining and the 
minority has 28 minutes remaining.
  Mr. NICKLES. I yield the floor.
  Mr. KENNEDY. I yield 5 minutes to the Senator from Maryland.
  The PRESIDING OFFICER. The Senator from Maryland is recognized for 5 
minutes.
  Ms. MIKULSKI. Mr. President, what does a woman do in a few days 
before she is scheduled to have a mastectomy? How should she spend her 
time? What should she be doing? Should she be on the phone calling her 
HMO, trying to figure out what will happen to her after surgery? Who 
will take care of her, how long will she be in the hospital? Should she 
be on the phone, dealing with bureaucracy? Should she be dealing with 
paperwork? Should she be on the phone, dealing with an insurance 
gatekeeper?
  No, I do not think that is what she should be doing and I think the 
Senate will agree with me. I think she should be with her family. I 
think she should be talking with her husband, because he is as scared 
as she is. He is terrified that she might die. He is wondering how can 
he support her when she comes home.
  She needs to talk to her children so that they understand that even 
though she is going in for an operation, they know their mother will be 
there when she comes back home but she might not be quite the same. She 
needs to be with her family. She needs to be with her clergyman. She 
needs to be with those who love her and support her.
  This is what we are voting on here today. Who should be in charge of 
this decision? When a woman has a mastectomy she needs to recover where 
she

[[Page S8336]]

can recover best. That should be decided by the doctor and the patient. 
We hear about these drive through mastectomies, where women are in and 
out in outpatient therapy. They are dumped back home, often sent home 
still groggy with anesthesia, sometimes with drainage tubes still in 
place or even at great risk for infection.
  Make no mistake, we cannot practice cookbook medicine and insurance 
gatekeepers cannot give cookbook answers. An 80-year-old woman who 
needs a mastectomy needs a different type of care than a 38-year-old 
woman. And a 70-year-old woman whose spouse himself may be 80 might 
have different family resources than a 40-year-old woman.
  Even the board of directors of the American Association of Health 
Plans states this: ``. . . the decision about whether outpatient or 
inpatient care meets the needs of a woman undergoing removal of a 
breast should be made by the woman's physician after consultation with 
the patient.''
  As I said earlier, we go out there and we Race for the Cure. Now we 
have to race to support this amendment. Let's look at what we have done 
with our discoveries. We in America have discovered more medical and 
scientific breakthroughs than any other country in world history. It is 
America who knew how to handle infectious diseases. It is America who 
comes up with lifesaving pharmaceuticals.
  We have been working together on a bipartisan basis to double the NIH 
budget. We have joined together on a bipartisan basis to have mammogram 
quality standards for women. Now we have to join together on a 
bipartisan basis and pass this amendment.
  We must continue our discovery, we must continue our research, and we 
must continue to make sure that we have access to the discoveries we 
have made.
  This is what this amendment is all about. It allows a woman and her 
physician to make this decision.
  Some time ago very similar legislation was offered by the former 
Senator of New York, Mr. D'Amato. People on the other side of the aisle 
had cosponsored this bill. What we are saying here is, if you 
cosponsored it under Senator D'Amato, vote for it under the Robb-
Mikulski-Boxer-Murray amendment. This should not be about partisan 
politics.
  Let's put patients first. Let's understand what is going to happen to 
a woman. Let's understand what is going to happen to her family. And 
let the doctors decide. I told my colleagues a few weeks ago--I 
recalled a few months ago I had gall bladder surgery. I could stay 
overnight because it was medically necessary and medically appropriate. 
Surely if I can stay overnight for gall bladder surgery a woman should 
be able to stay overnight when she has had a mastectomy.
  I yield the floor.
  The PRESIDING OFFICER. The time of the Senator has expired.
  Mr. KENNEDY. I yield 5 minutes to the Senator from California.
  The PRESIDING OFFICER. The Senator from California is recognized for 
5 minutes.
  Mrs. BOXER. Mr. President, I thank Senator Kennedy for his work on 
this, and Senator Mikulski for her inspirational talk, and Senator Robb 
for offering an amendment that I think is crucial to the women of this 
country. I am eternally grateful to him for putting this amendment 
together.
  Earlier, Senator Smith made a very eloquent talk about the need to 
set aside politics and do what is right for the people. I think we have 
an extraordinary opportunity to do that on this Patients' Bill of 
Rights. It is really very simple to do. Whether we are Democrats or 
Republicans or Independents, we can set all that aside and follow this 
simple rule, asking every time we vote: What is best for the people of 
our Nation? That is it, the simple question: What is best for the 
children? What is best for the women? What is best for the men? What is 
best for the families, the old or the young, et cetera.
  The Robb amendment is good for American women. As a matter of fact, 
the Robb amendment is crucially needed. It is desperately needed. The 
Senator from Maryland was eloquent on the point. Think about finding 
out you have breast cancer and learning you have to have a mastectomy. 
You do not need to be a genius to understand that you want a doctor 
making the decision as to how long you stay in the hospital.
  It is very simple: Mastectomies are major surgery. Cancer is life-
threatening and difficult. It is physical pain. It is mental anguish 
for you and your family. You don't want an accountant or a chief 
operating officer in an HMO telling you to leave after a few hours, 
with tubes running up and down you and being sick as a dog and throwing 
up and all the rest. I hate to be graphic about it, but we have to come 
to our senses in this debate. What is the argument against this? It is 
going to cost more? We know the CBO says it is maybe $2 a month to 
obtain all the benefits in the Patients' Bill of Rights. I think it is 
worth $2 a month to know a doctor makes the decision.
  I want to talk about the CEOs of these HMOs. They make millions of 
dollars a year. They are skimming off the top, off of our health care 
quality, and putting it in their pockets. They make $10 million a year, 
$20 million a year, $30 million a year--one person. If his wife comes 
down with cancer and needs a mastectomy, do you think he is going to 
leave the decision to an accountant in an HMO? You know he is not. He 
is going to dig into his pocket, into his $30-million-a-year pocket, 
and pay for her to obtain good care.
  What about the average woman? What about our aunts and our uncles and 
our neighbors? They deserve the same kind of attention and care. That 
is what the Robb amendment will do.
  It will do something else. Again, I am so grateful to the Senator 
from Virginia on this point. Senator Murray had offered the mastectomy 
amendment in committee, and even Senators who were on the original 
Feinstein-D'Amato bill, Republican Senators, voted against her 
amendment in the committee. She is on the floor fighting for this.
  Senator Snowe and I, in a bipartisan way, introduced a bill that 
would require your OB/GYN, your obstetrician/gynecologist, to be your 
basic health care provider. Senator Robb has included that in his 
amendment.
  The reality is that a woman does consider her OB/GYN as her primary 
care physician. Let's make it a guarantee that her OB/GYN can refer her 
to a specialist. You do not have to jump through hoops.
  Mr. President, 70 percent of the women in this country use their OB/
GYN as their only physician from the time they are quite young. So the 
Robb amendment recognizes the reality.
  Let me tell you why we should come together, both parties, on this 
amendment. Let's look at what happens to women who regularly see an OB/
GYN. A woman whose OB/GYN is her regular doctor is more likely to have 
a complete physical exam, blood pressure readings, cholesterol test, 
clinical breast exam, mammogram, pelvic exam, and Pap test.
  This is why it is so important. These are the threats to women.
  The PRESIDING OFFICER. The Senator's 5 minutes have expired.
  Mrs. BOXER. I ask unanimous consent for 1 additional minute.
  Mr. KENNEDY. I yield 1 minute.
  Mrs. BOXER. So you can see that the women who use their OB/GYN on a 
regular basis get what is necessary for them to stay healthy, to avoid 
the traumas, to avoid the problem of missing, for example, a breast 
cancer because they do not have that regular mammogram.
  In conclusion, we have Senator Robb who has long been a champion for 
women's health, and I can tell you chapter and verse that I have worked 
with him over these years and he has taken the most important issues to 
the women of this country and has rolled them into one, plus an 
additional part that deals with the deductibility of premiums if you 
are self-employed.
  This is a wonderful amendment. This is not an amendment that responds 
to Democrats, Republicans, or any other party. It is for American women 
and their families. I urge us to support this fine amendment.
  I yield back my time.
  Mr. KENNEDY. Mr. President, I take 30 seconds to note that on Tuesday 
afternoon at 3:30 on the Patients' Bill of Rights, on an issue that is 
so basic and fundamental and important to American women, we have our 
Members who are prepared to debate this issue, an issue on which, if my 
colleagues on the other side have a difference, we ought to be 
debating. We

[[Page S8337]]

cannot even get an engagement of debate on this.
  I do not know if that means they are willing to accept it. I would 
have thought they would have the respect at least for the position of 
several Members, led by our friend and colleague from Virginia, to 
speak to this issue.
  I yield the Senator from Arkansas 3 minutes.
  The PRESIDING OFFICER. The Senator from Arkansas is recognized.
  Mrs. LINCOLN. I thank my colleague.
  Mr. President, I rise today to make clear my position on such a very 
important issue. In the forefront of the managed care debate in the 
early nineties, I diligently supported the concept of trying to manage 
care, to control the cost of health care in this country in order to 
provide more health care to more Americans. When we did that, we in 
Congress never envisioned that medical decisions would be taken away 
from medical professionals or that an insurance company would 
circumvent a patient's access to specialists.
  Again we are debating this issue of how to provide better health care 
for more Americans. Today we are talking about the Robb amendment which 
is absolutely essential to women across this country.
  Managed care has been a very necessary and useful tool in our 
nationwide health care network. It has helped us cut the costs, 
especially in Medicare. But the issue of making sure women have the 
opportunity to choose as their primary care giver an OB/GYN is 
absolutely essential. Most women in this day and age go from a 
pediatrician to an OB/GYN. To have to go back through a primary care 
giver in order to see an OB/GYN is absolutely ridiculous.
  It is so important to do more to see that women have access to 
quality care. The Robb amendment takes us in the right direction with 
three very important provisions. It provides women with direct access 
to an OB/GYN. They should not have to obtain permission from a 
gatekeeper. I have had staffers in the past who had awful experiences 
of having to go to a primary care giver and not even bothering to see 
their OB/GYN to get the speciality care they needed because it took so 
much time to go through a primary care giver. That is absolutely 
inexcusable in this day and age with the kind of speciality care, 
research, and knowledge we have in our medical professionals.

  A great example: A lump is discovered in a woman's breast during a 
routine checkup. The OB/GYN ought to be able to refer that woman for a 
mammogram rather than sending her back to the primary care physician. 
The Robb amendment would designate the OB/GYN as the primary care 
giver. Most women try to do that already. They already view their OB/
GYN as their primary physician.
  It is especially important for women in rural areas. They are limited 
in their access and capability to get to their physicians, and if they 
cannot see an OB/GYN from a rural area, then they likely are never 
going to get the speciality care they need and deserve.
  Most important, we have to make sure our physicians are able to make 
those medical decisions. One of the most frustrating comments I ever 
heard from my husband, who is a physician, is when he spent 1 hour 45 
minutes on the telephone with an insurance adjustor after seeing one of 
his partner's patients who had come through surgery. She was still 
running a fever, and the nurse called him and said: We have to send 
this woman home because the insurance company said we had to.
  He spent 1 hour 45 minutes on the phone with that insurance adjustor, 
and at the end of that conversation he finally said: If you can send me 
your medical diploma and if you will sign an affidavit that you will 
take complete responsibility for this woman's life, then, and only 
then, should I be able to discharge her from this hospital, because she 
is sick.
  Yet they were not going to pay for it. He said: We are going to keep 
her in the hospital, and you are going to be responsible, you are going 
to pay for that bill, and we are going to ensure the woman is well 
taken care of.
  It is so important for the women across this country to know they 
will have the primary care they need through their OB/GYN.
  I appreciate my colleagues' involvement.
  Mr. REID. Mr. President, will the Senator yield?
  Mr. KENNEDY. I yield.
  Mr. REID. Mr. President, I say to the Senator, the manager of the 
bill, can he indicate to me why no debate is taking place on the most 
important amendment we have had to the Patients' Bill of Rights in the 
2 days we have been here? What has happened?
  Mr. KENNEDY. The Senator raises a good question. We are not going to 
take advantage of the absence of our Republican colleagues. We are 
asking where they are. We know they are someplace. I can understand why 
they do not want to engage in this debate. We have a limited period of 
time. We are ready to debate. Our cosponsors are here and ready to 
debate this basic, very important issue. I believe they have made a 
very strong case.
  I guess what they are waiting for is for us to run through the time 
and perhaps they will come out. Wherever they are, they will come out 
perhaps at least to try to defend their indefensible position on their 
legislation.
  I note the Senator from Minnesota is here and wants to speak for 5 
minutes.
  The PRESIDING OFFICER. The Senator from Minnesota is recognized for 5 
minutes.
  Mr. WELLSTONE. Mr. President, I did not rise to defend the Republican 
Party position. I am sorry to disappoint my colleagues. I say to the 
good Senator from Virginia, I am not here to speak against his 
amendment.
  I do find it interesting. I do not think I can repeat with the same 
eloquence and power what my colleagues have said about what this debate 
is about in personal terms when we are talking about women. But we 
could also be talking about a child having to get access to the 
services he or she needs. This is really a life-or-death issue. It is 
very important for people to make sure their loved ones, whether it be 
a wife, a husband, or children, get the care they need and deserve. 
That is what this debate is all about.
  I notice that the insurance industry is spending millions and 
millions of dollars on all sorts of ads talking about how we are going 
to have 1.8 million more people lose coverage.
  All of a sudden, the insurance industry is concerned about the cost 
of health care insurance. All of a sudden, the insurance industry in 
the United States of America is concerned about the uninsured. My 
colleague from Massachusetts says: Where are our colleagues on the 
other side of the aisle? Not too long ago, just a couple of hours ago, 
I heard colleagues come out on the Republican side and talk about how 
this patient protection was too expensive, families would lose their 
insurance company, the poor insurance industry--which is making record 
profits--cannot afford to provide this coverage. Where are they now?
  As I look at the figures, 10 leading managed care companies recorded 
profits of $1.5 billion last year. United Health Care Corporation, $21 
million to its CEO; CIGNA Corporation, $12 million to its CEO; and the 
figures go on and on. Yet we have colleagues coming out to this 
Chamber--apparently not now--trying to make the argument, even though 
the Congressional Budget Office says otherwise, even though independent 
studies say otherwise, that we cannot provide decent patient protection 
for women because it will be too expensive.
  It is not going to be too expensive. What will be too expensive and 
what will be too costly is when women and children and our family 
members do not get the care they need and deserve and, as a result of 
that, maybe lose their lives, as a result of that they are sicker, as a 
result that there is more illness.
  Where do the patients fit in? Where do the women fit in? Where do the 
children fit in? Where do the families fit in?
  I say to Senator Kennedy, we know where the insurance industry fits 
in. Here are their ads: Sure, the Kennedy-Dingell bill will change 
health care; people will lose coverage.
  This is outrageous. The insurance industry thinks that by pouring 
$100 million, or whatever, into TV ads and scaring people, they are 
going to be able to defeat this effort. They are wrong. The vote on 
this amendment, and on other amendments, and on this

[[Page S8338]]

legislation, will be all about whether Senators belong to the insurance 
industry or Senators belong to the people who elected us. We should be 
here advocating for people, not for the insurance industry.
  I yield the floor.
  Mr. KENNEDY. How much time remains?
  The PRESIDING OFFICER. The Senator has 7 minutes 14 seconds.
  Mr. KENNEDY. I yield the Senator from Virginia 2 minutes.
  The PRESIDING OFFICER. The Senator from Virginia.
  Mr. ROBB. Mr. President, I thank you. And I thank our distinguished 
colleague from Massachusetts for his leadership on this whole bill.
  I use this moment to simply commend our colleagues, who happen to be 
women, who have made the most passionate, persuasive case for this 
particular amendment that could be made.
  Frankly, in listening to my colleague from Maryland about the agony 
women go through before they have to make a decision about a 
mastectomy, talking about the difficult choices that women have to 
make, and adding to it the bureaucracy, where we bounce them back and 
forth, and talking about money--for this particular amendment, I have 
heard one estimate that it will be 12 cents a year for the increased 
cost--we will probably, I suggest, save more money in the lack of 
administration and bureaucracy than it would cost if we allow women to 
have as their designated primary care provider their obstetrician or 
gynecologist. This is the person they go to right now to receive their 
health care, as pointed out so eloquently by the Senator from 
California.
  As the Senator from Arkansas has noted, this is a very real problem. 
Her husband happens to practice this particular form of medicine. She 
gave us a compelling reason as to why we should not subject the women 
of America to this kind of burden.
  I am very grateful to my colleague from Washington, who has long led 
the fight on this particular issue, and my colleague from Minnesota, 
and others who have spoken out.
  I, frankly, do not understand the argument against this particular 
proposal. There is no one here to make that argument. I am, frankly, 
surprised. This makes sense for the women of America.
  The PRESIDING OFFICER. The time has expired.
  Mr. ROBB. Mr. President, with that, I yield back my time to the 
Senator from Massachusetts so we might hear again from the Senator from 
Washington.
  Mr. KENNEDY. I yield 3 minutes to the Senator from Washington.
  The PRESIDING OFFICER. The Senator from Washington.
  Mrs. MURRAY. Thank you, Mr. President,
  Again, I thank my colleague from Virginia, Senator Robb, and all of 
the women and men on the Democratic side who have come out to speak for 
the Robb-Murray-Mikulski-Boxer amendment, which is so essential to 
women in this country.
  I am astounded that the Republicans have fled the Chamber and have 
not returned to either agree with us in fighting for women's health or 
to explain why they are going to vote no.
  I was astounded in committee when I offered this amendment and it was 
defeated on a partisan vote. Where are our colleagues on the Republican 
side who have come before us so many times and said that they are going 
to be there at the Race for the Cure? Where are the men of the Senate, 
when they have been there so many times, saying: You bet we stand for 
women's health.
  This is a women's health issue. Young girls go to a pediatrician 
until they are 12, 13, or 14. At that time, they change doctors, not a 
primary care physician but an OB/GYN. Why should they be subjected now 
to HMO rules that say: We are going to change this, and you are going 
to have to go to a primary care physician in order to be sent to an OB/
GYN? OB/GYNs are our primary care physicians.
  As I stated this morning, if you are pregnant and have a serious cold 
or ear infection, or any other challenging problem that develops when 
you are pregnant, you will be given a different medication, a different 
procedure that you need to go through than if you are not pregnant.
  Your OB/GYN is your primary care physician from the time you are a 
teenager until the time you reach menopause, whether you are there 
because you are pregnant or there because a physician is examining you 
to determine treatment. But you are there. The OB/GYN is your primary 
care physician. This amendment will guarantee it.

  As Senator Mikulski so eloquently stated, a woman who has a 
mastectomy should not be sent home too soon whether she is 25 years old 
or 80 years old. In this country, on a daily basis, women are sent home 
too soon because it is considered, by HMOs, to be cosmetic surgery. 
This is not cosmetic surgery. A mastectomy is serious surgery. Women 
should be sent home when their doctor determines they are able to go 
home. That is what this amendment is about.
  We urge our colleagues on the other side to vote with us, to join 
with us in being for women's health care.
  I thank my colleagues who have been here to debate this issue. I 
especially thank Senator Robb, who has been a champion for all of us. I 
look forward, obviously, to the adoption of this amendment since no one 
has spoken out against it.
  The PRESIDING OFFICER. The Senator's side has 2 minutes remaining.
  Mr. KENNEDY. Mr. President, we are reaching the final moments for 
considering this amendment. We, on this side, who have been strong 
supporters of the Patients' Bill of Rights, think this is one of the 
most important issues to be raised in the course of this debate. It is 
an extremely basic, fundamental, and important issue for women in this 
country.
  Our outstanding colleagues have presented an absolutely powerful and 
indisputable case for our positions. We are troubled that we have had 
silence from the other side.
  We listened yesterday about how beneficial the Republican bill was--
when it refuses to provide protections to the millions of Americans our 
colleagues have talked about.
  We are down to the most basic and fundamental purpose of our bill; 
that doctors and, in this case, women are going to make the decision on 
their health care needs, not the bureaucrats in the insurance industry.
  This is one more example of the need for protections. Our colleagues 
have demonstrated what this issue is really all about. That is why I 
hope those Members on the other side that really care about women's 
health will support this amendment.
  Mr. President, we are prepared to move ahead and vote on this 
amendment.
  The PRESIDING OFFICER. Who yields time?
  If neither side yields time, time runs equally against both sides.
  Mr. KENNEDY. Do I have 1 minute left?
  The PRESIDING OFFICER. Seventeen seconds.
  Mr. JEFFORDS addressed the Chair.
  The PRESIDING OFFICER. The Senator from Vermont.
  Mr. JEFFORDS. How much time do we have?
  The PRESIDING OFFICER. Twenty-five minutes 15 seconds.
  Mr. JEFFORDS. Mr. President, I know that my worthy opponents have 
made note of our absence. We are not ignoring this issue. We have a 
better answer. There will be a Snowe-Abraham amendment presented, 
probably tomorrow, that will handle this issue. I think the Members 
will agree that the approach we take will be preferable to the one 
being taken right now.
  I would like to address my colleagues generally on the situation at 
this time. The Patients' Bill of Rights Act addresses those areas of 
health quality on which there is broad consensus. It is solid 
legislation that will result in a greatly improved health care system 
for all Americans.
  The Committee on Health, Education, Labor, and Pensions, the HELP 
Committee, has been long dedicated to action in order to improve the 
quality of health care. Our commitment to developing appropriate 
managed care standards has been demonstrated by the 17 additional 
hearings related to health care quality. Senator Frist's Public Health 
and Safety Subcommittee held three hearings on the work of the Agency 
for Health Care

[[Page S8339]]

Policy and Research, sometimes referred to as AHCPR. Each of these 
hearings helped us to develop the separate pieces of legislation that 
are reflected in S. 326, the Patients' Bill of Rights Act. People need 
to know what their plan will cover and how they will get their health 
care.

  The Patients' Bill of Rights requires full disclosure by an employer 
about health plans it offers to employees. Patients also need to know 
how adverse decisions by a plan can be appealed, both internally--that 
is, within the HMO--and externally, through an independent medical 
reviewer. Under our bill, the reviewer's decision will be binding on 
the health plan. We are talking about an external, outside reviewer, 
and it is binding. There is no appeal. It is binding. They have to do 
it. However, the patient will retain his or her current rights to go to 
court.
  Timely utilization decisions and a defined process for appealing such 
decisions are the keys to restoring trust in the health care system. 
Our legislation also provides Americans covered by health insurance 
with new rights to prevent discrimination based on predictive genetic 
information. This is a crucial provision. It ensures that medical 
decisions are made by physicians in consultation with their patients 
and are based on the best scientific evidence. That is the key phrase. 
We want to remember that one because you won't see it on the other 
side.
  It provides a stronger emphasis on quality improvement in our health 
care system with a refocused role for AHCPR, taking advantage of all 
the abilities we have now to understand better what is going on with 
respect to health care in this country, to sift through the information 
that comes through AHCPR and make judgments on what the best medicine 
is.
  Some believe that the answer to improving our Nation's health care 
quality is to allow greater access to the tort system, maybe a better 
lawsuit. However, you simply cannot sue your way to better health. We 
believe that patients must get the care they need when they need it. 
They ought not to have to go to court with a lawsuit. They ought to get 
it when they need it. It is a question of whether you want good health 
or you want a good lawsuit.
  In the Patients' Bill of Rights, we make sure each patient is 
afforded every opportunity to have the right treatment decision made by 
health care professionals. In the event that does not occur, patients 
have the recourse of pursuing an outside appeal to get medical 
decisions by medical people to give them good medical treatment. 
Prevention, not litigation, is the best medicine.
  Our bill creates new, enforceable Federal health standards to cover 
those 48 million people of the 124 million Americans covered by 
employer-sponsored plans. These are the very same people that the 
States, through their regulation of private health insurance companies, 
cannot protect. We will protect them.
  What are these standards? They include, first, a prudent layperson 
standard for emergency care; second, a mandatory point of service 
option; direct access to OB/GYNs and pediatricians--that has not been 
recognized by the opposition--continuity of care; a prohibition on gag 
rules; access to medication; access to specialists; and self-pay for 
behavioral health.
  It would be inappropriate to set Federal health insurance standards 
that duplicate the responsibility of the 50 State insurance 
departments.
  Mr. KENNEDY. Will the Senator yield on that issue?
  Mr. JEFFORDS. I am happy to yield.
  Mr. KENNEDY. Can the Senator show us one State that has the patient 
protections included in our proposal? Is there just one State in this 
country, one State that provides those types of protections?
  Mr. JEFFORDS. I believe Vermont does.
  Mr. KENNEDY. All of the protections for the patients? I know the 
Senator understands his State well, but does the Senator know of any 
other State that provides these kinds of protections?
  Mr. JEFFORDS. We are going to provide them with better protections.
  Mr. KENNEDY. The scope of your legislation only includes a third of 
all the people who have private health coverage.
  Mr. JEFFORDS. Well, in some areas we go beyond that, as the Senator 
well knows.
  Mr. KENNEDY. No, I don't know. I don't know, because you talk about 
self-insured plans, and there are only 48 million Americans in those 
plans. You don't cover the 110 million Americans who have other health 
insurance plans.
  Does the Senator know a single State that provides specialized care 
for children if they have a critical need for specialty care--one State 
in the country? We provide that kind of protection. Does the Senator 
know a single State that has that kind of protection?
  Mr. JEFFORDS. I tell you, we have a better health care bill. That is 
all I am telling you. It will protect more people at less cost. Your 
bill is so expensive that you are going to affect a million people, and 
those people are the ones we want most to protect. Those are the people 
who are working low-income jobs and who will be torn off and removed 
from health care protection by your bill. We will not do that. We are 
going to protect those people who need the protection the most from 
being denied health insurance.
  I take back the remainder of my time.
  It would be inappropriate to set Federal health insurance standards 
that duplicate the responsibility of the 50 State insurance 
departments. As the National Association of Insurance Commissioners put 
it:

       We do not want States to be preempted by Congressional or 
     administrative actions. . .Congress should focus attention on 
     those consumers who have no protections in the self-funded 
     ERISA plans.

  Senator Kennedy's approach would set health insurance standards that 
duplicate the responsibility of the 50 State insurance departments. 
Worse yet, it would mandate that the Health Care Financing 
Administration, HCFA, enforce them, if the State decides otherwise. It 
would be a disaster--HCFA can't even handle the small things they have 
with HIPAA, the Medicare and Medicaid problems--to get involved in the 
demands that would be placed upon them by the Democratic bill.
  This past recess, Senator Leahy and I held a meeting in Vermont to 
let New England home health providers meet with HCFA. It was a packed 
and angry house, with providers traveling from New Hampshire, 
Massachusetts, and Connecticut. That is who the Democrats would have 
enforce their bill. It is in no one's best interests to build a dual 
system of overlapping State and Federal health insurance regulation.
  Increasing health insurance premiums causes significant losses in 
coverage. The Congressional Budget Office, CBO, pegged the cost of the 
Democratic bill at six times higher than S. 326. Based on our best 
estimates, passage of the Democratic bill would result in the loss of 
coverage for over 1.5 million working Americans and their families.
  Now, why do you want to charge forward with that plan? To put this in 
perspective, this would mean they would have their family's coverage 
canceled under the Democratic bill--canceled. Let me repeat that. 
Adoption of the Democratic approach would cancel the insurance policies 
of almost 1.5 million Americans, CBO estimates. I cannot support 
legislation that would result in the loss of health insurance coverage 
for the combined population of the States of Virginia, Delaware, South 
Dakota, and Wyoming--no coverage.
  Mrs. MURRAY. Will the Senator yield for a question?
  Mr. JEFFORDS. Fortunately, we can provide the key protections that 
consumers want, at a minimal cost and without the disruption of 
coverage, if we apply these protections responsibly and where they are 
needed.

  In sharp contrast to the Democratic alternative, our bill would 
actually increase coverage. With the additional Tax Code provisions of 
S. 326, the Patients' Bill of Rights Act, our bill allows for full 
deduction of health insurance for the self-employed, the full 
availability of medical savings accounts, and the carryover of unused 
benefits from flexible spending accounts.
  Mrs. MURRAY. Will the Senator from Vermont yield for a question?
  Mr. JEFFORDS. With the Patients' Bill of Rights Plus Act, we provide 
Americans with greater choice of more affordable health insurance.

[[Page S8340]]

  Mrs. MURRAY. Will the Senator from Vermont yield for a question?
  Mr. JEFFORDS. Yes.
  Mrs. MURRAY. I thank the Senator.
  I was listening to his discussion about the Republican bill. The 
current pending amendment, the Robb-Murray amendment, allows women 
access to OB/GYNs as their primary care physicians. Will the bill the 
Senator is discussing provide direct access for all of those women who 
are not in self-insured programs in this country?
  Mr. JEFFORDS. We will have an amendment which will deal with that 
problem.
  Mrs. MURRAY. All women in this country who are not in self-insured 
programs will have access under the amendment you are going to be 
offering?
  Mr. JEFFORDS. First of all, we defer to the States in that regard.
  Mrs. MURRAY. Then I can assume that the women who are not in self-
insured programs will not be covered by the Republican amendment.
  Mr. JEFFORDS. Our bill covers, as we intended to cover, those who 
need the coverage now who have no coverage and get the protection to 
those who need the protection. We will have an amendment that will take 
care of the problems that are----

  Mrs. MURRAY. Not the self-employed. That is the answer.
  Mrs. BOXER. Will the Senator yield for a question?
  Mr. JEFFORDS. I think the Senator has her own time.
  Mrs. BOXER. I wanted to ask the Senator one question.
  Mr. JEFFORDS. Yes.
  Mrs. BOXER. Is the Senator aware that when he talks about people 
losing their insurance, there is a $100 million effort going on by the 
HMOs to scare people into thinking that if the Democratic Patients' 
Bill of Rights passes--which is supported by all the health care 
advocate groups in the country--they will lose their insurance?
  Is the Senator aware that his own Congressional Budget Office has 
clearly stated the maximum cost of the Democratic Patients' Bill of 
Rights is $2 a month?
  And further, is the Senator aware that the President, by executive 
order, gave the Patients' Bill of Rights to Federal employees, and 
there has been no increase in the premium?
  So what I am asking the Senator is, is he aware of this campaign by 
the HMOs? Has he seen the commercials? Does he believe the HMOs that 
who have an interest in this, the CEOs of which are getting $30 million 
a year, really have the interests of patients in their heart?
  Mr. JEFFORDS. I say that the Senator was successful in stealing some 
time from me. Let me say that we have differences of opinions on these 
bills. There is no question that your bill is much more expensive, that 
it is going to cost 6 percent, and that CBO estimates 1.5 million 
people--all of which you say you care most about, I say to the Senator 
from California, the low-income people, the people who are just barely 
able to have plans right now, and small businesses that won't be able--
1.5 million people will lose their health insurance if your plan is put 
in.
  Mrs. BOXER. I say to the Senator----
  The PRESIDING OFFICER. The Senator from Vermont has the floor.
  Mr. JEFFORDS. S. 326, the Patients' Bill of Rights Plus Act, provides 
necessary consumer protections without adding significant new costs, 
without increasing litigation, and without micromanaging health plans.
  Our goal is to give Americans the protections they want and need in a 
package they can afford and that we can enact. This is why I hope the 
Patients' Bill of Rights we are offering today will be enacted and 
signed into law by the President.
  Mr. President, I yield to the Senator from Tennessee.
  The PRESIDING OFFICER. The Senator from Tennessee is recognized.
  Mr. FRIST. Mr. President, I want to take a few minutes to return to 
the underlying amendment. It has taken me a while to read through the 
amendment. The first time I saw the amendment was 30 minutes ago. I 
have just read through the amendment offered by Senator Kennedy and 
others which relates to certain breast cancer treatment and access to 
appropriate obstetrical and gynecological care.
  I apologize for not being able to participate directly on in this 
issue earlier. At the outset, I will say that about 2 years ago, 
Senator Bradley from New Jersey and I had the opportunity to 
participate in writing an amendment that actually eventually became law 
which addressed the issue of postmaternity stay, postdelivery stay. We 
wrote that particular piece of legislation because we felt strongly 
that managed care had gone too far in dictating how long people stayed 
in the hospital and pushing them out after deliveries, and it was a 
little controversial, although I think a very good bill for the time, 
because it sent a message very loudly and clearly to the managed care 
industry that you need to leave those decisions, as much as possible, 
at the local level where physicians and patients, in consultation with 
each other, determine that type of care.

  The amendment on the floor is different in that it focuses on another 
aspect of women's care and that is breast cancer treatment. As to the 
debate from the other side of the aisle, I agree with 98 percent of 
what was said in terms of the importance of having a woman be able to 
access her obstetrician and gynecologist in an appropriate manner, the 
need for looking at inpatient care, to some extent as it relates to 
breast disease. Yet I think the approach that Senator Kennedy and 
others have put on the floor is a good start but has several problems. 
Therefore, I urge all of my colleagues to vote against that amendment, 
with the understanding we can take the good efforts from that 
amendment, correct the deficiencies, and address the very same issues 
that have been identified so eloquently by my colleagues across the 
aisle.
  Now, in looking at the Kennedy-Robb amendment, on page 2, they talk 
about:

       . . . health insurance coverage, that provides medical and 
     surgical benefits shall ensure that inpatient coverage with 
     respect to the treatment of breast cancer is provided for a 
     period of time as is determined by the attending physician, 
     in his or her professional judgment. . . .

  So far, I agree wholeheartedly. But where I cannot vote in good 
conscience, or allow my colleagues to, without fully understanding the 
implications, is where they continue and say:

       . . . consistent with generally accepted medical standards, 
     and the patient, to be medically appropriate following--(A) a 
     mastectomy; (B) a lumpectomy; or (C) a lymph node dissection.

  I agree with all of that and inpatient care. The part that bothers me 
is the ``consistent with generally accepted medical standards.'' This 
goes into the debate we will go into tomorrow, or the next day, on 
medical necessity and what medical necessity means.
  When we talk about what is medically appropriate and medically 
necessary, you are going to hear me say again and again that we should 
not try to put that into law, Federal statute. We should not define 
``medical necessity'' as generally accepted medical practices or 
standards. The reason is, as exemplified in this chart, nobody can 
define generally accepted medical standards. You will go up to a 
physician and a physician will say: That is what I do every day.
  Well, that is not much of a definition, I don't think. Therefore, I 
am not sure we should use those terms and put them into a law and pass 
it as an amendment and make it part of the Patients' Bill of Rights.
  This chart is a chart that shows the significant variation of the way 
medicine is practiced today, and that generally accepted medical 
standards has such huge variations that the definition means nothing. 
Therefore, I am not going to put into a Federal statute a definition 
that means very little because I think, downstream, that can cause some 
harm because maybe a bunch of bureaucrats will try to give that 
definition.
  Mr. SANTORUM. If the Senator will yield, he is arguing that it 
doesn't mean anything. It means everything. Really it is sort of the 
opposite of that. It has such an expansive character to it that it can 
include inappropriate medicine, which is, I think, the point the 
Senator is making.
  Mr. FRIST. I think that is right. My colleague said it much more 
clearly than I. The definition itself of ``medically necessary and 
appropriate'' is so important that we should not lock the definition 
into something that is so

[[Page S8341]]

small, so rigid, that we can't take into consideration the new advances 
that are coming along. That is why when we say generally accepted 
medical standards or practices, it leaves out the best evidence, the 
new types of discoveries that are coming on line. That decision should 
be made locally and should not be definitions put into a statute. 
Therefore, I am going to oppose this amendment.
  Mr. ROBB. Will the Senator yield?
  Mr. FRIST. Let me try to get through my presentation.
  Mr. ROBB. Will the Senator yield?
  Mr. FRIST. I will not yield.
  Let me go through for my colleagues why the variation in medical 
practice has implications that may be unintended and therefore we 
cannot let the amendment pass.
  Reviewing regional medical variations for breast-sparing surgery--
basically for breast cancer today--I don't want to categorize this too 
much because the indications change a little bit. In a lumpectomy--
taking out the lump itself and radiating because it is the least 
disfiguring--the outcome is equally good as doing a mastectomy and 
taking off the whole breast.
  In my training--not that long ago, 25 years--the only treatment was 
mastectomy. As we learned more and more and radiation therapy became 
more powerful, we began to understand there are synergies in doing 
surgical operations and radiation therapy and chemotherapy. We didn't 
have to remove or disfigure the whole breast. The new therapy ended up 
being better for the patient but was not generally accepted medically. 
That sort of variation is shown in this chart.
  In this chart, the very dark areas use lumpectomy versus mastectomy. 
Comparing the two, the high ratio of around 20 to 50 percent, versus 
going down to the light colors on the chart where this procedure is not 
used very much, there is tremendous variation. The different patterns 
of color on the chart demonstrate that a procedure generally accepted 
in one part of the country may be very different in another part of the 
country.
  For example, in South Dakota, using this ratio of lumpectomy versus 
mastectomy, the ratio is only 1.4 percent.
  In Paterson, NJ, the generally accepted medical standards in that 
community go up almost fortyfold to 37.8 percent--the relative use of 
one procedure, an older procedure, versus a newer procedure.
  Which of those are generally accepted medical standards? That shows 
the definition itself has such huge variation that we have to be very 
careful when putting it into Federal statute. We will come back to that 
because it is a fundamentally important issue. Medicine is practiced 
differently around the country. Therefore, the words ``generally 
accepted medical standards'' have huge variations. We have to be 
careful what we write into law.
  What I am about to say builds on the work of Senators Snowe and 
Abraham.
  How much time do I have remaining?
  The PRESIDING OFFICER. The Senator has 20 minutes 50 seconds.
  Mr. FRIST. Again, Senators Snowe and Abraham will talk more about 
this a little bit later.
  Instead of using language such as ``generally accepted medical 
standards,'' it has a built-in inherent danger because it defines what 
``medical necessity and appropriate'' are.
  We should be looking at words as follows: That provides a group 
health plan and a health insurance issuer providing health insurance 
coverage, that provides medical and surgical benefits, shall ensure 
that inpatient coverage--just like the Kennedy-Robb amendment with 
respect to the treatment of breast cancer--is provided for a period of 
time as determined by the attending physician, as the Kennedy-Robb 
amendment does, in consultation with the patient. I think this is ``in 
consultation with the patient.''

  No, they do not have in their bill ``in consultation with the 
patient.'' I suggest ``in consultation with the patient'' should be 
part of their amendment.
  We would put in ``in consultation with the patient'' to be 
``medically necessary and appropriate,'' instead of using their words 
``generally accepted medical standards,'' which has such huge 
variation.
  Why not use the better terminology, ``medically necessary and 
appropriate''?
  Use the same indications. Mastectomy is what we will propose, what 
they propose. Lumpectomy is what we propose, what they will propose. 
Lymph node dissection, we will use that language.
  But ``generally accepted medical standards'' is dangerous. We ought 
to use such words as ``medically necessary and appropriate.'' Then we 
are not locked into the variation where there is a fortyfold difference 
in mastectomies versus lumpectomy, which shows the importance of being 
very careful before placing Federal definitions of what is ``medically 
necessary and appropriate'' in Federal law.
  Mr. LEAHY. Mr. President, I was going to make a unanimous consent 
request.
  Mr. FRIST. I yield to the unanimous consent request.


                         Privilege Of The Floor

  Mr. LEAHY. I ask unanimous consent that Alex Steele of my office be 
granted privilege of the floor today.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. FRIST. In the Kennedy-Robb amendment is the issue of access.
  Again, my colleagues on the other side hit it right on the head: 
Women today want to have access to their obstetrician. They don't want 
to go through gatekeepers to have to get to their obstetrician or 
gynecologist. That relationship is very special and very important when 
we are talking about women's health and women's diseases.
  In the Kennedy-Robb amendment, the language is that the plan or 
insurer shall permit such an individual who is a female to designate a 
participating physician who specializes in obstetrics and gynecology as 
the individual's primary care provider.
  It is true that in our underlying bill we don't say the plan has to 
say that all obstetricians and gynecologists are primary care 
providers. That is exactly right. The reasons for that are manyfold.
  Let me share with Members what one person told me. Dr. Robert 
Yelverton, chairman of the American College of Obstetricians and 
Gynecologists' Primary Care Committee, stated:

       The vast majority of OB/GYNs in this country have opted to 
     remain as specialists rather than act as primary care 
     physicians.

  He attributes this to the high standards that health plans have for 
primary care physicians, saying:

       None of us could really qualify as primary care physicians 
     under most of the plans, and most OB/GYNs would have to go 
     back to school for a year or more to do so.

  You can argue whether that is good or bad, but it shows that 
automatically taking specialists and making them primary care 
physicians and putting it in Federal statute is a little bit like 
taking Bill Frist, heart and lung transplant surgeon, and saying: You 
ought to take care of all of the primary care of anybody who walks into 
your office.

  Mrs. BOXER. Will the Senator yield?
  Mr. FRIST. I will finish my one presentation, and we will come back 
to this.
  Mrs. BOXER. Will the Senator yield?
  The PRESIDING OFFICER. The Senator does not yield.
  Mrs. BOXER. Why do you not yield?
  The PRESIDING OFFICER. The Senator did not agree to yield.
  Mr. FRIST. I simply want the courtesy of completing my statement. I 
know people want to jump in and ask questions, but we have listened to 
the other side for 50 minutes on this very topic. I am trying to use 
our time in an instructive manner, point by point, if people could just 
wait a bit and allow me to get through my initial presentation of why I 
think this amendment must be defeated with a very good alternative.
  I want to get into this issue of access to obstetricians and 
gynecologists. In our bill that has been introduced, we take care of 
this. I believe strongly we take care of it. We say, in section 723: 
The plan shall waive the referral requirement in the case of a female 
participant or beneficiary who seeks coverage for routine obstetrical 
care or routine gynecological care.
  We are talking about routine women's health issues. We waive the 
referral process. There is not a gatekeeper. A patient goes straight to 
their obstetrician and gynecologist. That is what women tell me they 
want in terms of access to that particular specialized, trained 
individual.

[[Page S8342]]

  It is written in our bill. Let me read what is in our bill.

       The plan shall waive the referring requirement in the case 
     of a female participant or beneficiary who seeks routine 
     obstetrical care or routine gynecological care.

  Therefore, I think the access provisions in the Kennedy-Robb 
amendment are unnecessary and are addressed in our underlying bill. 
Plus, they go one step further in saying that this specialist is the 
individual's primary care provider. I am just not sure of the total 
implications of that, especially after an obstetrician who is the 
chairman of the American College of Obstetrics and Gynecology very 
clearly states that merely assuming that a specialist is a good primary 
care physician is not necessarily correct.
  Also, in our bill, beyond the routine care--this is in section 725 of 
our bill where we address access to specialists--we say:

       A group health plan other than a fully insured health plan 
     shall ensure that participants and beneficiaries have access 
     to specialty care when such care is covered under the plan.

  So they have access to specialty care when obstetrics care and 
gynecological care is part of that plan.
  So both here and in the earlier provision of section 723, where we 
talk about routine obstetrical care, there is no gatekeeper; there is 
no barrier; a woman can go directly to her obstetrician and her 
gynecologist, which is what they want. Or, if you fall into the 
specialty category in provision 725, you have access to specialty care 
when such care is covered under the plan.
  As I go through the Kennedy-Robb plan, and this is obviously the 
amendment that we are debating on the floor, there are a number of very 
reasonable issues in there. Again, I think the intent of the amendment 
is very good. I do notice secondary consultations in the amendment. I 
think, as we address the issue of women's health, obstetrical care, 
breast cancer treatment, access to appropriate care, which we plan on 
addressing and we will address, I believe, this is the amendment 
Senators Snowe and Abraham have been working on so diligently, the idea 
of secondary consultations.
  About 2 months ago we did a women's health conference. It was 
wonderful. It was in Memphis, TN. It was on women's health issues. 
Maybe 200 or 300 people attended, focusing on women's health issues. We 
talked about the range of issues, whether it was breast cancer, 
cervical cancer, osteoporosis, diseases of the aging process, but an 
issue which came up was the issue of secondary consultations. Because 
it is dealing with something that is very personal to them, women say: 
Is there any way we can reach out in some way with health plans to 
lower the barriers for us to get a second opinion?
  Why is that important? Part of that is important because of this huge 
variation. If you go to one doctor and he says do a mastectomy, which 
is very disfiguring, it is very clearly indicated--there are clear-cut 
indications for mastectomy or lumpectomy today. If you hear two 
different versions, you may want to get a secondary opinion or a 
secondary consultation.
  What we are looking at in that regard is language similar to this: to 
provide coverage with respect to medical and surgical services provided 
in relation to the diagnosis and treatment of cancer shall ensure that 
full coverage is provided for secondary consultations by specialists in 
the appropriate medical fields.
  ``Medical fields,'' I think we need to go a little bit further and 
focus on whether it is pathology or radiology or oncology or surgery to 
confirm--and I think it should be part of the language--to confirm or 
to refute the diagnosis itself. That is full coverage by the plan for 
secondary consultations for cancer as it deals with women's health 
issues.
  I think that will be an important part to include as we address this 
very specific field. It is totally absent in the Kennedy-Robb 
amendment. I propose offering an amendment which does much of what they 
say in terms of inpatient care, changing this terminology from 
``generally accepted medical standards,'' which I think is potentially 
dangerous, and move on to the language which I think should be used, 
which is ``medically necessary and appropriate.''
  The access issue, I believe, we have developed. There are other 
issues in the bill that I will work with Senators Abraham and Snowe to 
address, in a systematically and well-thought-out way, so we can do 
what is best for women in this treatment of cancer, breast cancer, 
mastectomy, and access to obstetricians and gynecologists. That is 
something about which we need to ensure that no managed care plan says: 
No, you cannot go see your obstetrician; or, no, you cannot go see your 
gynecologist; or, no, you have to hop through a barrier; or, no, you 
have to go see a gatekeeper before you can see your obstetrician/
gynecologist. We are going to stop that practice, and we are going to 
stop that in the Republican bill we put forward.
  I have introduced the concept today--again, it is very important--of 
medical necessity and how we define what is medically necessary and 
appropriate. It is something critical. It is something we are going to 
come back to. I think with all the issues we are discussing, if we try 
to put in Federal law, Federal statute, a definition of what is 
medically necessary and appropriate instead of leaving it up to a 
physician who is trained in the field, a specialist, we are going in 
the wrong direction and have the potential for broadly harming people.
  I urge defeat of this amendment with the understanding we are going 
to come back and very specifically address the issues I have talked 
about today.
  I yield the floor.
  Mr. LIEBERMAN. Mr. President, I rise today to express my support for 
the Robb-Murray amendment, which provides our mothers, wives, daughters 
and sisters with direct access to OB/GYN care and strengthens the 
ability of a woman and her doctor to make personal medical decisions.
  The sponsors of this amendment, along with most women and most 
Americans, believe that a woman should have the choice and the freedom 
to select an OB/GYN physician as her primary care provider and to 
determine, in consultation with her doctor, how long she should stay in 
the hospital following surgery.
  Those critical and deeply personal judgments should not be trumped by 
the arbitrary guidelines of managed care companies. The women in our 
lives deserve better than drive-by mastectomies. With the Robb-Murray 
amendment, we will say so in law, and ensure that women receive the 
services they need and the respect they are owed.
  Studies show that when women have a primary care physician trained in 
OB/GYN, they receive more comprehensive care and greater personal 
satisfaction when they are treated by doctors trained in other 
specialties.
  We should consider, too, that breast cancer is the second leading 
killer of women in this country. New cases of this disease occur more 
than twice as often as second most common type of cancer, lung cancer. 
More than 178,000 women in this country were diagnosed with breast 
cancer in 1998. I have no doubt we will someday find the origin and 
cure for this terrible malady. Until then, though, we have a duty to 
make the system charged with treating these women respectful and 
responsive to their needs.
  Sadly, the evidence suggests we have a long way to go. We continue to 
receive disturbing reports about the insistence of some insurance 
companies to force women out of the hospital immediately after 
physically demanding and emotionally traumatic surgeries. We have been 
shocked by stories of women being sent home with drainage tubes still 
in their bodies and groggy from general anesthesia. This is distressing 
to me not just as a policy-maker, but as a son, father, and husband.
  Now, some critics of the Robb-Murray Amendment want to sidestep this 
problem, and suggest that we are legislating by body part. To that, I 
say:
  Those who oppose this provision are wasting a valuable opportunity to 
increase the quality of physical health care for over half the 
population of the United States.
  Those who oppose are ignoring the suffering and inconvenience of 
women throughout this country trying to receive the basic health care 
that they have every right to expect.
  Those who oppose are failing to right a wrong that we have tolerated 
for too long.

[[Page S8343]]

  Mr. President, women are being denied the quality of care they are 
paying for and to which they have a moral right. And this Senate has a 
chance today to begin fixing this inequity. I urge my colleagues to 
look beyond the rhetoric and see the very simple and fair logic that 
calls for the passage of this amendment, and join us in supporting it.
  Several Senators addressed the Chair.
  The PRESIDING OFFICER. Who yields time? The Senator from Oklahoma.
  Mr. NICKLES. Mr. President, how much time remains on this amendment?
  The PRESIDING OFFICER. There are 7 minutes and 26 seconds on the side 
of the Senator from Oklahoma. The other side has used all its time.
  Mr. NICKLES. Mr. President, let me make a couple of comments. I heard 
my friend and colleague from Massachusetts say: Where is everybody in 
the debate? We have just received the amendment. I would like to look 
at it, and I had a chance to look at it while some of the debate was 
going on. I would like to make a couple of comments on it.
  I found in the amendment--
  Mr. KENNEDY. On that point, will the Senator yield?
  Just on the point of the representation you just made. It is 
virtually the same amendment that was offered in the committee.
  The PRESIDING OFFICER. Does the Senator yield?
  Mr. NICKLES. No, I do not.
  Mr. KENNEDY. It is not a surprise. It is the same amendment, 
effectively.
  Mr. NICKLES. The Senator from Massachusetts says it is the same 
amendment offered in committee, but that is not factual. The Senator 
can correct me if I am wrong, but this amendment deals with Superfund. 
This amendment deals with transferring money from general revenue into 
Social Security. That was not offered in committee. There are few tax 
provisions in here. I asked somebody: What is this extension of taxes 
on page 17? My staff tells me it is a tax increase of $6.7 billion on 
Superfund. I don't know what that has to do with breast cancer, but it 
is a tax increase on Superfund.
  I know we need to reauthorize Superfund. I didn't know we were going 
to do it on this bill. I stated in the past we are not going to pass 
the Superfund extension until we reauthorize it. We should do the two 
together. Why are we doing it on this bill?
  So there are tax increases in here that nobody has looked at. They 
did not do that in the Labor Committee or the health committee, I do 
not think. I asked the Chairman of the committee. I don't think they 
passed tax increases on Superfund. That does not belong in the HELP 
Committee.
  Certainly transferring money from the general revenue fund, as this 
bill does, into the Social Security trust fund, was not done in the 
HELP Committee, I do not think. It should not have been done. My guess 
is the Finance Committee might have some objections. Senator Roth is 
going to be on the floor saying: Wait a minute, what is going on?
  So there is a lot of mischief in these amendments. Some of us have 
not had enough time. One of the crazy things about this agreement is we 
are going to have amendments coming at us quickly. We have to have a 
little time to study them. Sometimes we find some things stuck in the 
amendments which some of us might have some objections with.
  I want to make a couple of comments on the amendment. In addition to 
the big tax increases hidden in the bill, this amendment also strikes 
the underlying amendment that many of us have proposed on this side 
that says, whatever we should do we should do no harm. If we are going 
to increase premiums by over 1 percent; let us not do a bill. Maybe 
people forgot about that, but that is an amendment we offered earlier. 
This amendment, the Robb amendment, says, let's strike that provision. 
We do not care how much the Kennedy bill costs.
  Some of us do care how much it costs. We do not want to put millions 
of people into the ranks of the uninsured. We do not want to do harm. 
Unfortunately, the amendment proposed by Senator Robb and others would 
do that. It would strike that provision. It would eliminate that 
provision.
  On the issue of breast cancer and mastectomy and lumpectomy and so 
on, Senator Frist has addressed it a little bit. Senator Snowe and 
others will be offering an amendment that is related and, I will tell 
you, far superior to the amendment we have on the floor.
  I do not know if we will get to it tonight. Certainly, we will get to 
it tomorrow. It is a much better amendment. It is an amendment that has 
been thought out. It is an amendment that does not have Superfund taxes 
in it. It is an amendment that includes, as this bill does, transfers 
from the general revenue fund into the Social Security trust.
  I urge my colleagues at the appropriate time to vote ``no'' on the 
Robb amendment, and then let's adopt the underlying amendment which 
says we should not increase health care costs by more than 1 percent; 
let's not do damage to the system; let's not put people into the ranks 
of uninsured by playing games, maybe trying to score points with one 
group or another group. Let's not do that. Let's not make those kinds 
of mistakes.
  If people have serious concerns dealing with breast cancer and how 
that should be treated, again, Senator Snowe, Senator Abraham, and 
Senator Frist have an amendment they have worked on for some time that 
I believe is much better drafted. It does not have Superfund taxes in 
it. It does not have a transfer of general revenue funds into the 
Social Security trust fund. It does not make these kinds of mistakes 
that we have, unfortunately, with this pending amendment.
  Mr. GREGG. Will the Senator yield for a question?
  Mr. NICKLES. I ask how much time we have?
  The PRESIDING OFFICER. The Senator has 2\1/2\ minutes.
  Mr. GREGG. As I understand it, by repealing the underlying amendment, 
which would limit the cost increase to 1 percent and would say, in the 
alternative, if 100,000 people are knocked off the rolls of insured, 
the bill will not go forward. If we repeal that and those 100,000 
people are knocked off the rolls, they are not going to have any 
insurance for mastectomies; right?
  Mr. NICKLES. The Senator is exactly right.
  Mr. GREGG. Basically, the proposal of the Senator from Virginia, 
supported by Senator Kennedy, uninsures potentially 100,000 women from 
any mastectomy coverage as a result of their amendment or any other 
coverage.
  Mr. NICKLES. The Senator makes a good point, but probably not 
100,000. Estimates would probably be much closer to 2 million people 
would be uninsured and have no coverage whatsoever in any insurance 
proposal if we adopt the underlying Kennedy amendment.
  Mr. GREGG. Of those 2 million people, we can assume potentially half 
would be women. So we have approximately 1 million women who would not 
have insurance as a result of this amendment being put forward on the 
other side.
  Mr. NICKLES. The Senator is correct.
  Mr. SANTORUM. Mr. President, will the Senator from Oklahoma yield for 
a question? As a matter of fact, we have some information just provided 
to us that under the Kennedy legislation, S. 6, with 1.9 million people 
no longer being insured, you would have 188,595 fewer breast 
examinations. If people had their routine breast examinations, of those 
1.9 million, a certain percentage would be women, that would be the 
number of breast exams that would no longer take place if this 
legislation passed.
  We hear so much talk about ``in human terms,'' and they say this 
argument does not cut. These people are going to lose insurance. They 
will lose insurance. They will not get coverage so you do not have to 
worry about covering them for a mastectomy. They are going to find out, 
in many cases, unfortunately, far too late for even those kinds of 
treatments to be helpful. That is what we are trying to prevent in not 
passing a bill that drives up costs dramatically which drives people 
out of the insurance area.
  Mr. NICKLES. I appreciate my colleague's comment. I yield back the 
remainder of my time and ask for the yeas and nays on the amendment.

[[Page S8344]]

  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.
  Mr. KENNEDY. I yield myself 2 minutes on the bill.
  The PRESIDING OFFICER. The Senator is recognized.
  Mr. KENNEDY. Mr. President, the more we debate, the more confused our 
good colleagues on the other side, quite frankly, become. The 
underlying amendment dealing with the OB/GYN is the amendment that was 
offered in committee and that is no surprise.
  The other provision the Senator from Oklahoma talks about is funding 
the self-insurance tax deduction introduced by the Senator from 
Oklahoma without paying for it. This would subject the bill to a point 
of order if it was carried all the way through. He did not pay for it.
  It is a red herring. Time and time again we have put in the General 
Accounting Office document which states that the protections in this 
bill will enhance the number of people insured, not reduce the number.
  Does the Senator from Pennsylvania actually believe we are 
endangering breast cancer tests for women, reducing Pap tests, reducing 
examinations for breast cancer and yet the breast cancer coalition 
supports our proposal? Is he suggesting any logic to his position?
  Mr. President, I yield back the remainder of the time and look 
forward to the vote.
  The PRESIDING OFFICER. The Senator from Oklahoma.
  Mr. NICKLES. Mr. President, I yield myself 1 minute on the bill.
  The Senator from Pennsylvania is right. The whole essence of the 
second-degree amendment is to kill the underlying amendment because the 
Senator from Massachusetts does not want to say we will not increase 
costs by more than 1 percent, because, frankly, he wants to, and 
expects to, increase costs by 5 or 6 percent. The net result of that 
will be to uninsure a couple million people, half of which could be 
women, half of which will not get those exams, half of which will not 
get those screenings, half of which will not get the care they need. 
That is the purpose of the amendment.
  In the process, he also increases Superfund taxes and also comes up 
with general transfers of money from the general revenue fund to the 
Social Security fund. That is a mistake.
  I urge my colleagues to vote no and keep in mind that in dealing with 
breast cancer, Senator Snowe, Senator Frist, and Senator Abraham will 
offer a much better proposal later in this debate. I yield the floor.
  The PRESIDING OFFICER. All time having been yielded back, the 
question is on agreeing to amendment No. 1237. The yeas and nays have 
been ordered. The clerk will call the roll.
  The legislative assistant called the roll.
  The result was announced--yeas 48, nays 52, as follows:

                      [Rollcall Vote No. 198 Leg.]

                                YEAS--48

     Akaka
     Baucus
     Bayh
     Biden
     Bingaman
     Boxer
     Breaux
     Bryan
     Byrd
     Chafee
     Cleland
     Conrad
     Daschle
     Dodd
     Dorgan
     Durbin
     Edwards
     Feingold
     Feinstein
     Graham
     Harkin
     Hollings
     Inouye
     Johnson
     Kennedy
     Kerrey
     Kerry
     Kohl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lincoln
     Mikulski
     Moynihan
     Murray
     Reed
     Reid
     Robb
     Rockefeller
     Sarbanes
     Schumer
     Specter
     Torricelli
     Warner
     Wellstone
     Wyden

                                NAYS--52

     Abraham
     Allard
     Ashcroft
     Bennett
     Bond
     Brownback
     Bunning
     Burns
     Campbell
     Cochran
     Collins
     Coverdell
     Craig
     Crapo
     DeWine
     Domenici
     Enzi
     Fitzgerald
     Frist
     Gorton
     Gramm
     Grams
     Grassley
     Gregg
     Hagel
     Hatch
     Helms
     Hutchinson
     Hutchison
     Inhofe
     Jeffords
     Kyl
     Lott
     Lugar
     Mack
     McCain
     McConnell
     Murkowski
     Nickles
     Roberts
     Roth
     Santorum
     Sessions
     Shelby
     Smith (NH)
     Smith (OR)
     Snowe
     Stevens
     Thomas
     Thompson
     Thurmond
     Voinovich
  The amendment (No. 1237) was rejected.
  Mr. NICKLES. Mr. President, I move to reconsider the vote.
  Mr. BOND. I move to lay that motion on the table.
  The motion to lay on the table was agreed to.


                Amendment No. 1238 to Amendment No. 1236

 (Purpose: To make health care plans accountable for their decisions, 
          enhancing the quality of patients' care in America)

  Mr. NICKLES. Mr. President, I send an amendment to the desk on behalf 
of Senator Frist, Senator Jeffords, and others, and ask for its 
immediate consideration.
  The PRESIDING OFFICER (Mr. Hagel). The clerk will report.
  The assistant legislative clerk read as follows:

       The Senator from Oklahoma [Mr. Nickles], for Mr. Frist, for 
     himself and Mr. Jeffords, proposes an amendment numbered 1238 
     to amendment No. 1236.
  Mr. NICKLES. Mr. President, I ask unanimous consent that reading of 
the amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (The text of the amendment is printed in today's Record under 
``Amendments Submitted.'')
  Mr. NICKLES. Mr. President, for the information of our colleagues, we 
have now disposed of the Democrats' second-degree amendment to the 
first-degree amendment proposed by the Republicans, which first-degree 
amendment would limit the cost of the Kennedy health care bill to 1 
percent. Now I have sent a second-degree amendment up under the 
unanimous consent agreement. Each side could offer a second-degree.
  The amendment I sent to the desk on behalf of Senators Frist, 
Jeffords, and others, is a very important amendment, so I hope all of 
our colleagues will listen to it. The amendment would strike the 
medical necessity definition that was in the Kennedy bill and replace 
it with the grievance/appeals process we have in our bill. In other 
words, it is a very significant amendment, one that we had significant 
discussion on last week. Some of our colleagues said they really wanted 
to vote on it last week. We will get to vote on it, depending on the 
majority leader's intention. If the time runs on this amendment, all 
time would be used, and we would probably be ready for a vote at about 
6:40. Of course, it would be the majority leader's call whether or not 
to have a vote.
  The amendment deals with medical necessity. It replaces the 
definition in the Kennedy bill with the grievance and appeals process 
that we have in the Republican package, which I think is a far superior 
package as far as improving the quality of care. I compliment Senator 
Jeffords, Senator Frist, and others for putting this together.
  I yield the floor.
  The PRESIDING OFFICER. Who yields time?
  Mr. JEFFORDS. Mr. President, this is an extremely important 
amendment. I think everyone ought to understand exactly what we are 
trying to do.
  We are entering into a new era with respect to the availability of 
health care, good health care, excellent health care. We have seen 
pharmaceuticals being devised which would do miraculous things. We are 
also having medical procedures designed and devices created. But what 
we have not seen is their being available everywhere, or a standard 
that will make them available in areas where they ought to be 
available.
  What we are trying to do today is establish that every American is 
entitled to the best medical care available, not that which is 
generally available in your area; not be different from one end of the 
country to the other but that everyone is entitled to that health care, 
especially if you are in an HMO. They should be, and must be, aware of 
what is the best health care that would serve you to make you a well 
person.
  For a couple of days now, we have heard many tragic stories about 
children who were born with birth defects or who were injured because 
the private health care system failed them in some manner. I know my 
colleagues on the other side of the aisle have a bill they believe 
would address these situations. The Republican health care bill 
addresses the concerns people have about their health care without 
causing new problems.
  Americans want assurance that they will get the health care they need 
when they need it. I am going to describe exactly how the Republican 
bill does just that. I am also going to describe how the Republican 
bill will create new patient rights and protections which

[[Page S8345]]

would have prevented the tragic situations described by my colleagues 
on the other side of the aisle.

  Finally, I want to talk about how the Republican bill achieves these 
goals in an accountable manner, without increasing health care costs, 
without a massive new Federal Government bureaucracy, and without 
taking health care insurance away from children and families. It 
doesn't cost money to increase your ability to make sure you are aware 
of what is available. The heart of the Republican Patients' Bill of 
Rights Plus Act is a fair process for independent external review that 
addresses consumer concerns about getting access to appropriate and 
timely medical care in a managed care plan.
  The Republican bill establishes gateways that ensure medical disputes 
get heard by an independent, external reviewer. The plan does not have 
veto power in these decisions. Denials or disputes about medical 
necessity and appropriateness are eligible for review, period. If a 
plan considers a treatment to be experimental or investigational, it is 
eligible for external review. The reviewer is an independent physician 
of the same specialty as the treating physician. In addition, the 
reviewer must have adequate expertise and qualifications, including 
age-appropriate expertise in the patient's diagnosis.
  So, in other words, a pediatrician must review a pediatric case and a 
cardiologist must review a cardiology case. In the Republican bill, 
only qualified physicians are permitted to overturn medical decisions 
by treating physicians. The reviewer then makes an independent medical 
decision based on the valid, relevant scientific and clinical evidence. 
This standard ensures that patients get medical care based on the most 
up-to-date science and technology.
  The Kennedy bill describes medical necessity in the statute. It does 
not define it in a manner that ensures that patients will get the 
highest quality care and the most up-to-date technology.
  The Republican bill ensures that physicians will make independent 
determinations based on the best available scientific evidence. That is 
the standard, the best available scientific evidence. It is that 
simple. Health plans cannot game the system and block access to 
external review. To ensure this is the case, I have asked the private 
law firm of Ivins, Phillips & Baker to analyze the Republican external 
review provision, asking two key questions: First, could a plan block a 
patient from getting access to external review in a manner that is 
inconsistent with the intent of our provision?
  Second, is there any factor that would prevent the external reviewer 
from rendering a fair and independent medical decision?
  I request that the letter be printed in the Record.
  There being no objection, the letter was ordered to be printed in the 
Record, as follows:


                                     Ivins, Phillips & Barker,

                                    Washington, DC, July 12, 1999.
     Hon. James M. Jeffords,
     Chairman, Committee on Health, Education, Labor and Pensions, 
         U.S. Senate, Washington, DC.
       Dear Mr. Chairman: You have asked us to provide you with 
     our opinion on the outcomes of certain medical claims denials 
     under the bill reported out of your Committee, The Patients' 
     Bill of Rights Act of 1999, S. 326 (the ``Bill'').
       In each of these examples, a claim is made for coverage or 
     reimbursements under an employer-provided health plan, and 
     the claim is denied. You have specifically asked us to 
     comment on whether the claims would be eligible for 
     independent external review under the Bill, which provides 
     the right to such review for denials of items that would be 
     covered under the plan but for a determination that the item 
     is not medically necessary and appropriate, or is 
     experimental or investigational.
     A. Bill's provisions for independent external review
       If a participant or beneficiary in an employer-provided 
     health plan makes a claim for coverage or reimbursement under 
     the plan, and the claim is denied, the Bill amends the 
     Employee Retirement Income Security Act of 1974 (ERISA) to 
     provide that he or she has the right to written notice and 
     internal appeal of the denial within certain time-frames set 
     forth by statute.\1\ If the adverse coverage determination is 
     upheld on internal appeal, the Bill provides that the 
     participant or beneficiary in certain cases has the right to 
     independent external review.\2\
---------------------------------------------------------------------------
     Footnotes at end of letter.
---------------------------------------------------------------------------
       The right to independent external review exists for denial 
     of an item or service that (1) would be a covered benefit 
     when medically necessary and appropriate under the terms of 
     the plan, and has been determined not to be medically 
     necessary and appropriate; or (2) would be a covered benefit 
     when not experimental or investigational under the terms of 
     the plan, and has been determined to be experimental or 
     investigational.\3\
       A participant or beneficiary who seeks an independent 
     external review must request one in writing, and the plan 
     must select an entity qualified under the Bill to designate 
     an independent external reviewer. Under the Bill's standard 
     of review, the independent external reviewer must make an 
     ``independent determination'' based on ``valid, relevant, 
     scientific and clinical evidence'' to determine the medical 
     necessity and appropriateness, or experimental or 
     investigational nature of the proposed treatment. \5\
     B. Fact patterns
       You have asked us to review whether the following fact 
     patterns would be eligible for external review under the 
     terms of the Bill. You have also asked for our judgment on 
     whether any factor in these examples would compromise the 
     reviewer's ability to make an independent decision.
       Fact Pattern 1: An employer contracts with an HMO. The HMO 
     contract (the plan document) states that the ``HMO will cover 
     everything that is medically necessary'' and that the ``HMO 
     has the sole discretion to determine what is medically 
     necessary.''
       Question 1: Would any denial of coverage or treatment based 
     on medical necessity be eligible for external review?
       Answer: All claims denials would be eligible for 
     independent external review under the Bill.
       The hypothetical employer who drafted this plan may have 
     thought that, by covering all ``medically necessary'' items, 
     the plan incorporates medical necessity as one of the plan's 
     terms. Under this apparent view, any coverage denial by 
     the HMO at its sole discretion, would be a fiduciary act 
     of plan interpretation, rather than a medical judgment. 
     Under this view, then, all claims denials would be 
     contract decisions rather than medical ones, and no 
     denials would be eligible for independent external review.
       The terms of the Bill clearly prevent this end-run around 
     its intent. The Bill provides that the right of external 
     review exists for any denial of an item that is covered but 
     for a determination based on medical necessity, etc., ``under 
     the terms of the plan.'' That is, the statutory language 
     provides for external review of any determination of medical 
     necessity, etc., even when that determination is intertwined 
     with an interpretation of the plan's terms.
       The report of your Committee clarifies that intent. The 
     report explicitly notes that ``some coverage discussions 
     involve an element of medical judgment or a determination of 
     medical necessity.'' After walking through an example of a 
     coverage decision which involves such a judgment, the report 
     concludes that your Committee intends that such ``coverage 
     denials that involved a determination about medical necessity 
     and appropriateness'' would be eligible for independent 
     external review.\5\
       That is, under the Bill any interpretation of the plan's 
     terms triggers independent external review when that 
     interpretation involves an ``element of medical judgment.''
       To further remove any ambiguity on this point, the 
     Committee report states that any determination of medical 
     necessity is eligible for independent external review, even 
     if the criteria of medical necessity are partly included as 
     plan terms requiring contract interpretation: ``The committee 
     is interested in ensuring that, in cases where a plan 
     document's coverage policy on experimental or investigational 
     treatment is not explicit or is linked to another policy that 
     requires interpretation, disputes arising out of these kinds 
     of situations will be eligible for external review.'' \6\
       Thus, even assuming that the HMO's determinations in this 
     example are plan interpretations by a fiduciary, they are not 
     saved from independent external review under your bill. Any 
     coverage determination by the HMO in this example involves 
     ``an element of medical judgment or a determination of 
     medical necessity,'' and is therefore eligible for 
     independent external review under the Bill and Committee 
     report. Moreover, the standard used by the HMO in this 
     example for determining medical necessity is not 
     ``explicit,'' and is therefore eligible for independent 
     external review under the Bill and Committee report.
       In short, under the hypothetical plan of this example, all 
     claims would involve determinations of medical necessity, and 
     all denials would be eligible for independent external 
     review.
       Question 2: Is there any factor that would prevent the 
     reviewer from rendering an independent decision?
       Answer. No. The reviewer's decision must be independent. 
     Under the Bill, the reviewer shall consider the standards and 
     evidence used by the plan, but is intended to use other 
     appropriate standards as well. It is expressly intended that 
     the review not defer to the plan's judgment under the 
     deferential ``arbitrary and capricious'' standard of review.
       Under the Bill, the independent external review must make 
     an ``independent determination'' based on ``valid, relevant, 
     scientific and clinical evidence,'' to determine medical 
     necessity, etc. In making his or her determination, the 
     independent external reviewer must ``take into consideration 
     appropriate and available information,'' which includes any 
     ``evidence based decision making

[[Page S8346]]

     or clinical practice guidelines used by the group health 
     plan,'' as well as timely evidence or information submitted 
     by the plan, the patient or the patient's physician, the 
     patient's medical record, expert consensus, and medical 
     literature.\7\
       That is, under the Bill the reviewer is instructed to 
     consider standards and evidence used by the plan, but is 
     intended to include other standards and evidence as well. The 
     Committee report clarifies this by stating that the external 
     review shall ``make an assessment that takes into account the 
     spectrum of appropriate and available information.'' \8\ 
     Fleshing out the above-cited list set forth in the statute, 
     the report further clarifies that such information can 
     include, for example, peer-reviewed scientific studies, 
     literature, medical journals, and the research results of 
     Federal agency studies.\9\
       Moreover, the reviewer is not bound by the standard or 
     evidence use by the plan, but must rather ``make an 
     independent determination and not be bound by any one 
     particular element.'' \10\ The Committee report further 
     states that the independent reviewer should not use an 
     ``arbitrary and capricious'' standard in reviewing the plan's 
     decision.\11\ That is, the reviewer is specifically 
     prohibited from using the deferential standard now used by 
     federal courts in reviewing certain coverage determinations 
     by ERISA plan fiduciaries.
       In short, the Bill provides that the reviewer shall use not 
     only the standards and evidence considered by the plan, but 
     other appropriate standards as well, in rendering its 
     independent judgment.
       Fact Pattern 2: A plan covers medically necessary 
     procedures but specifically excludes cosmetic procedures. An 
     infant born to a participant is born with a severe cleft 
     palate. The infant's physician contends that plastic surgery 
     to correct the cleft palate is necessary so the child can 
     perform normal functions like eating and speaking. The plan 
     denies the request on the grounds that it does not cover 
     cosmetic surgery. The participant appeals the decision, 
     arguing that the procedure is medically necessary. The 
     treating physician provides supporting documentation that the 
     procedure is medically necessary.
       Question 1: Is the denial of surgery in this example 
     eligible for external review?
       Answer: Yes, the denial of surgery in this example is 
     eligible for independent external review under the Bill.
       The plan in this example covers surgery generally, but 
     excludes ``cosmetic'' surgery. As with many plans, the term 
     ``cosmetic'' is not defined. There is therefore no express 
     basis in the plan's terms for inferring that ``cosmetic'' is 
     defined as a procedure that is not ``medically necessary and 
     appropriate.'' Does this mean that the claims denial in this 
     example is merely an act of plan interpretation, without any 
     determination of medical necessity? And if so, does this mean 
     that the denial is not eligible for external review?
       No. Under the terms of the Bill, any denial based on 
     medical necessity, etc., is eligible for external review. 
     This is so even if the denial is based on plan terms that do 
     not expressly incorporate a reference to medical necessity, 
     as long as interpretation of those terms involves ``an 
     element of medical judgment.''
       This intent is spelled out in the report of your Committee, 
     which, as already noted, states that ``The committee 
     recognizes that some coverage determinations involve an 
     element of medical judgment or a determination of medical 
     necessity and appropriateness.'' \12\ The report goes on to 
     give an example: ``For instance, a plan might cover surgery 
     that is medically necessary and appropriate, but exclude from 
     coverage surgery that is performed solely to enhance physical 
     appearance. In these cases, a plan must make a determination 
     of medical necessity and appropriateness in order to 
     determine whether the procedure is a covered benefit.''
       The report concludes that, ``It is the committee's 
     intention that coverage denials that involved a determination 
     about medical necessity and appropriateness, such as the 
     example above, would be eligible for external review.''
       In the example discussed here, the plan's denial is based 
     on its determination that the procedure is ``cosmetic'' under 
     the terms of the plan. This interpretation of the plan 
     includes a significant element of medical judgment. This is 
     so despite the fact that plan uses the term ``cosmetic'' 
     without an express reference to medical necessity. The 
     essential element of medical judgment is evidenced in part by 
     the fact that the treating physician provides documentation 
     for his or her judgment that the treatment is necessary for 
     certain basic life functions.
       In short, the coverage dispute in this example turns on 
     whether the procedure is cosmetic under the plan's terms. 
     Under the Bill as amplified by the report of your Committee, 
     this determination includes an ``element of medical judgment 
     or determination of medical necessity.'' Therefore, the 
     denial is eligible for independent external review under the 
     Bill.
       Question 2: Is there any factor that would prevent the 
     reviewer from rendering an independent decision?
       Answer: No, the reviewer's decision is independent, for the 
     reasons set forth in our answer to this question in the above 
     Fact Pattern 1. That is, under the Bill the reviewer shall 
     use not only the standards and evidence considered by the 
     plan, but other appropriate standards as well, in 
     rendering its independent, nondeferential judgment as to 
     whether the requested treatment is medically necessary and 
     appropriate or experimental and investigational.
       Fact Pattern 3: The employer contracts with an HMO that has 
     a closed-panel network of providers which includes 
     pediatricians. A baby born to a participant is born with a 
     severe and rare heart defect. The infant's own network 
     pediatrician, who is not a pediatric cardiologist (i.e., a 
     pediatric sub-specialist), recommends that the infant be 
     treated by such a specialist. The network does not include a 
     pediatric cardiologist. The plan denies coverage for a non-
     network pediatric sub-specialist, saying that one of the 
     plan's network pediatricians can provide any medically 
     necessary care for the infant.
       Question 1: Is the denial in this case eligible for 
     independent external review?
       Answer: Yes, the denial of pediatric sub-specialist care in 
     this example is eligible for independent external review 
     under the Bill.
       The Bill requires that participants have access to 
     specialty care if covered under the plan.\13\ The report of 
     your Committee explains that a health plan must ``ensure that 
     plan enrollees have access to specialty care when such care 
     is needed by an enrollee and covered under the plan and when 
     such access is not otherwise available under the plan.'' \14\
       The bill defines specialty care with respect to a condition 
     as ``care and treatment provided by a health care 
     practitioner . . . that has adequate expertise (including age 
     appropriate expertise) through appropriate training and 
     experience.'' \15\
       In short, the Bill defines specialty care in terms of 
     whether the care is ``needed'' by the enrollee, and by 
     reference to whether the care is ``adequate,'' and the 
     expertise ``appropriate.''
       Under the terms of the Bill, then, a physician's 
     determination that specialty care is required is by its terms 
     a judgment based on the medical necessity and appropriateness 
     of that care. Therefore, the treating physician's 
     recommendation in this example that the infant be treated by 
     a pediatric subspecialist is a judgment of medical necessity. 
     The plan's denial of such specialty care is a denial of an 
     otherwise covered service, based on a judgment of the medical 
     necessity or appropriateness of that service. The denial is 
     eligible for independent external review under the terms of 
     the Bill.
       Question 2: Is there any factor that would prevent the 
     reviewer from rendering an independent decision in this case?
       Answer: No, the reviewer's decision is independent, for the 
     reasons set forth in our answer to this questions in the 
     above Fact Patterns 1 and 2. That is, under the Bill the 
     reviewer shall use not only the standards and evidence 
     considered by the plan, but other appropriate standards as 
     well, in rendering its independent judgment as to whether the 
     requested treatment is medically necessary and appropriate or 
     experimental and investigations.
       Fact Pattern 4: A participant calls the plan to report that 
     the participant's infant is very sick, and inquiries about 
     emergency services. The plan representative pre-authorizes 
     coverage in a participating emergency facility, which is 20 
     miles away. Alarmed by the infant's various severe symptoms, 
     the participant instead takes the infant to a nearby 
     emergency facility which is only 5 minutes away. Shortly 
     after arrival, the baby is diagnosed as having spinal 
     meningitis, and goes into respiratory arrest. The baby is 
     immediately treated and stabilized, and tissue damage that 
     might otherwise have resulted is avoided. The participant 
     submits a claim to the plan for reimbursement of the 
     emergency treatment. The claim for reimbursement is denied on 
     the grounds that coverage was preauthorized only if provided 
     in the more distant, in-network, emergency facility specified 
     by the plan representative.
       Question 1: Would the denial of reimbursement in this case 
     be eligible for independent external review?
       Answer: Yes, under the Bill the denial of reimbursement 
     would be eligible for review by an independent external 
     reviewer.
       The Bill requires that if a plan covers emergency services, 
     it must in some cases cover such services without pre-
     authorization, and without regard to whether the services are 
     provide out-of-network.
       Specifically, such coverage must be provided for 
     ``appropriate emergency medical screening examinations'' and 
     for additional medical care to ``stabilize the emergency 
     medical condition,'' to the extent a ``prudent layperson who 
     possesses an average knowledge of health and medicine'' would 
     determine that an examination was needed to determine 
     whether ``emergency medical care'' is needed.\16\ 
     ``Emergency medical care'' is defined as care to evaluate 
     or stabilize a medical condition manifesting itself by 
     ``acute symptoms of sufficient severity (including severe 
     pain)'' such that a ``prudent layperson who possesses an 
     average knowledge of health and medicine'' could 
     reasonably expect the absence of medical care to endanger 
     the health of the patient or result in serious impairment 
     of a bodily function or serious dysfunction of any bodily 
     organ or part.\17\
       That is, under the Bill, reimbursement for the services in 
     this example must be provided if the services satisfy the 
     ``prudent layperson'' standard of the bill. The prudent 
     layperson standard is met if an individual without 
     specialized medical knowledge could reasonably reach the 
     decision, based on the patient's symptoms, that lack of 
     medical care could possibly result in severely worsened 
     health or injury, and that expert medical observation is 
     therefore necessary.

[[Page S8347]]

       A determination made by the ``prudent layperson'' is 
     therefore a determination of medical necessity or 
     appropriateness--albeit one made under a nontechnical, 
     nonexpert, standard. Under the Bill, a plan is required to 
     incorporate this lower, non-expert or ``prudent layperson'' 
     standard in evaluating whether to cover non-pre-authorized, 
     out-of-network emergency medical care.
       In this example, the participant's judgment, based on the 
     baby's symptoms, that the baby should be observed as quickly 
     as possible by medical experts at the nearer facility, is a 
     judgment of medical necessity and appropriateness, made under 
     this lower, non-expert standard. Likewise, the plan's denial 
     of coverage in this case is based on the plan's determination 
     that the participant's judgment concerning medical necessity 
     was in error even under this lower standard.
       In short, the coverage dispute in this case involves a 
     judgment of medical necessity and appropriateness under the 
     ``prudent layperson'' standard mandated by the Bill, and is 
     therefore eligible for independent external review under the 
     Bill.
       Question 2: Is there any factor that would prevent the 
     reviewer from rendering an independent decision?
       Answer: No, the reviewer's decision is independent, for the 
     reasons set forth in our answer to this question in the above 
     Fact Patterns 1, 2 and 3. That is, under the Bill the 
     reviewer shall use not only the standards and evidence 
     considered by the plan, but other appropriate standards as 
     well, in rendering its independent judgment as to whether the 
     requested treatment is medically necessary and appropriate or 
     experimental and investigational.
       I hope this letter has been responsive to your request. 
     Please do not hesitate to have your staff contact me for any 
     questions with respect to the points here discussed.
           Very truly yours,
                                                 Rosina B. Barker.


                               Footnotes

     \1\ ERISA Sec. Sec. 503(b), (d), as added by S. 326 
     Sec. 121(a).
     \2\ ERISA Sec. 503(e), as added by S. 326 Sec. 121(a).
     \3\ ERISA Sec. 503(e)(1)(A), as added by S. 326 Sec. 121(a).
     \4\ ERISA Sec. 503(e)(4), as added by S. 326 Sec. 121(a).
     \5\ S. Rep. No. 82, 106th Cong., 1st Sess. 46 (1999).
     \6\ Id. at 47.
     \7\ ERISA Sec. 503(e)(4), as added by S. 326 Sec. 121(a).
     \8\ S. Rep. No. 82, 106th Cong., 1st Sess. 48 (1999) 
     [emphasis supplied].
     \9\ Id. at 49.
     \10\ Id. at 48.
     \11\ Id. at 48.
     \12\ Id. at 46 [emphasis supplied].
     \13\ ERISA Sec. 725(a), as added by S. 326 Sec. 101(a).
     \14\ S. Rep. No. 82, 106th Cong., 1st Sess. 32 (1999).
     \15\ ERISA Sec. 725(d), as added by S. 326 Sec. 101(a).
     \16\ ERISA Sec. 721(a), as added by S. 326 Sec. 101(a).
     \17\ ERISA Sec. 721(c), as added by S. 326 Sec. 101(a).

  Mr. JEFFORDS. Let me provide examples of how our external review 
provisions ensure that patients and children get medical care.
  Chart 1 illustrates under the Republican bill that the health plan 
cannot ``game the system'' by blocking access to external review or 
using some cleverly worded definition of ``medical necessity.'' The 
Republican provision ensures that people get the medical care they 
need.
  Here is an example of an HMO that has a planned contract which says 
the HMO will cover ``medically necessary care'' but the HMO has the 
sole discretion to determine what is ``medically necessary.''
  Of course, this is an extreme example. Let's see if it holds up under 
our external review provision. In this example, the patient and 
physician may not know the plan's rationale for denying a claim since 
it is the HMO's sole discretion to determine medical necessity. This 
can be frustrating for both the patient and the physician.
  Under the Republican bill, a denied claim would be eligible for an 
outside independent medical review. In fact, all denied medical claims 
under this example would be eligible for review under our provision. 
This is confirmed by the outside legal analysis which I have submitted 
for the Record. The legal opinion says:

       The statutory language provides for external review of any 
     determination of medical necessity and appropriateness, even 
     when that determination is intertwined with an interpretation 
     of the plan's terms.

  The external reviewer would make an independent medical 
determination. There is nothing in the HMO contract or in the 
legislative provision that prevents the reviewer from making the best 
decision for the patient. If the patient needs the medical care, the 
reviewer will make this assessment. They will get the care. The 
independent reviewer's decision is binding on the plan.
  Chart 2 is an example of a cleft palate. This chart illustrates that 
patients, and especially children, will get necessary health care 
services. Plans will not be able to deem a procedure as ``cosmetic'' 
and thus block access to external review. Only physicians can make 
coverage decisions involving medical judgment.
  An example we have heard many times from our colleagues on the other 
side of the aisle is of an infant born with a cleft palate. The 
infant's physician recommends surgery so the child can perform normal 
daily functions, such as eating and speaking normally. The treating 
physician says this surgery is medically necessary and appropriate. In 
this example, the HMO planned contract states: ``The plan does not 
cover cosmetic surgery.'' It was denied as a claim, saying the child's 
surgery is not a covered benefit because it is a cosmetic procedure, 
despite the recommendations of the treating physician.
  What does this mean? Does this mean this is the end of the road for 
this child's family? No. Under the Republican bill, this denial of 
coverage would be eligible for appeal because the decision involves an 
``element of medical judgment.'' Under the Republican bill, medical 
decisions are made by physicians with appropriate expertise. In this 
case, it means an independent reviewer would be required to have 
pediatric expertise.
  Finally, the independent medical reviewer would look at the range of 
appropriate clinical information and would have the ability to overturn 
the plan's decision. The child would receive the surgery to correct the 
cleft palate, and the plan would cover this procedure because the 
reviewer's decision is binding on the plan.

  The next chart is on emergency room coverage. The primary point of 
this chart is that under the prudent layperson standard, parents can 
use their judgment and take their sick child to the nearest emergency 
room without worrying about whether the plan will deny coverage.
  Another example we are all familiar with is of little Jimmy whose 
tragic story has been told by Senator Durbin. His parents called the 
HMO when their baby fell ill. The HMO nurse recommended the parents 
take their sick child to a participating hospital an hour's drive away. 
During their long drive, the family passed several closer hospitals 
along the way. The child's symptoms grew worse and the baby went into 
respiratory arrest. By the time they got to the hospital, the one that 
the HMO said was covered by a plan, it was too late. The tissue damage 
resulted in the loss of a limb and little Jimmy had to endure a 
quadruple amputation. This is a horrible situation.
  Let's look at what the Republican bill would do to address this type 
of tragic and unnecessary situation. First, under our prudent layperson 
standard, a parent would not have to call the HMO to get permission to 
go to the nearest emergency room. In this case, the parents could have 
gone to the closest emergency room and little Jimmy would not have gone 
into respiratory arrest. This tragedy would have been averted under the 
Republican provision because our bill ensures that emergency room 
services must be provided without preauthorization and without regard 
to whether the services are provided out of network.
  Say for the sake of argument that the plan denies reimbursements 
after the hospital has provided the treatment. Under the Republican 
bill, little Jimmy's family would not be stuck with the hospital 
charges. They could appeal this decision to an outside reviewer because 
the decisions about whether care is medically necessary are eligible 
for external review.
  The law firm of Ivins, Phillips & Baker says that under our 
provision:

       The coverage dispute in this case involves a judgment of 
     medical necessity and appropriateness under the prudent 
     layperson standard mandated by the bill, and therefore is 
     eligible for independent external review under the bill.

  This is a quote from the letter that has been previously printed in 
the Record.
  Mr. SCHUMER. Will the Senator yield?
  Mr. JEFFORDS. The independent medical reviewer can make an 
independent decision and overturn the plan denying reimbursement. This 
decision is binding on the plan and not appealable.
  Mr. SCHUMER. Would the Senator from Vermont yield for a question?
  Mr. JEFFORDS. Let me finish.
  Mr. SCHUMER. I thank the Senator.
  Mr. JEFFORDS. As Members can see from the examples on these charts, 
the

[[Page S8348]]

Republican Patients' Bill of Rights ensures patients get the medical 
care they need, that parents can be assured their children will be 
cared for by appropriate specialists, and that people can go forward to 
emergency rooms when they are sick, when the children are sick, and can 
do so with the assurance that their health plan will cover these 
services.
  Establishing these important rights will help families avoid illness, 
injury, and improve the quality of health care. I believe this is why 
we are debating this issue today. You can't sue your way to health 
care. Congress can't create a definition of ``medical necessity'' that 
is better than letting physician experts make decisions on the best 
available science. They must practice the best available science.
  However, we can improve access to health care services and ensure 
that people get timely access to the medical care they need. We can 
ensure that health care we provide is high quality health care. Most 
important, we can do all these things without increasing health care 
costs and causing more Americans to lose their coverage.
  We accomplish all these goals with the Republican Patients' Bill of 
Rights.
  I yield the floor.
  The PRESIDING OFFICER. Who yields time? The Senator from 
Massachusetts.
  Mr. KENNEDY. Mr. President, I yield myself 5 minutes.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, this amendment goes to the heart of the 
issue. I urge our colleagues to pay attention to the exchange we are 
going to have on the floor of the Senate.
  Let us look, first, at what is in the Democratic bill. In the 
Democratic bill, ``medical necessity,'' as defined on page 86, is 
``medically necessary or appropriate.'' That is the standard definition 
medicine has used for 200 years. It is the standard recommended by none 
other than the Health Insurance Association of America itself, on page 
269:

       Medical necessity. Term used by insurers to describe 
     medical treatment that is appropriate and rendered in 
     accordance with generally accepted standards of medical 
     practice.

  Our legislation does what the Health Insurance Association of America 
recommended. This is the standard that has been used for 200 years. 
This is the standard that is supported by the medical profession.
  The Republican plan knocks that standard out. It knocks it out. What 
do they put in as a substitute? As a substitute, on page 148, they say 
``medical necessity'' used in making coverage determinations is 
determined ``by each plan.'' ``By each plan.'' The plan can define 
medical necessity any way it wants.
  In their appeals procedure we find that medical necessity issues can 
be appealed, but medical necessity is defined by the HMO.
  That sounds complicated. What does it mean in real terms? Let me read 
you a few examples of how HMOs have defined medical necessity. Here is 
a company--I will not give its name--and their definition. The company:

       . . . will have the sole discretion to determine whether 
     care is medically necessary. The fact that care has been 
     recommended, provided, prescribed or approved by a physician 
     or other provider will not establish the care is medically 
     necessary.

  In other words, medical necessity is whatever the HMO says. Whatever 
the HMO says.
  Here is an example of Aetna U.S. Health Care, the provision in their 
Texas contract:

       The least costly of alternative supplies. . . .

  Here is another HMO:

       The shortest, least expensive, or least intensive level. . 
     . .

  They throw out the medical necessity standard used for 200 years and 
say, medical necessity will be whatever the HMO wants it to be. That is 
the heart of this issue.
  What do we find when the HMO uses their own medical necessity 
definition? Who makes the judgment? It is an insurance company 
bureaucrat. That is what this amendment is all about.
  Finally, when you see the appeals procedures which will be addressed 
by my other colleagues, all you have to do is look at the Consumers 
Union and many other consumer groups. The consumer groups believe their 
appeals procedure does not provide adequate protections.
  The American Bar Association believes basic consumer protections are 
not met. The American Arbitration Association makes the same judgment.
  This is a status quo amendment. If you want to do nothing about the 
pain and injury being experienced by children, women, and family 
members in our country, go ahead and support this program. It is an 
industry protection amendment. It will protect the profits of the 
industry; it puts the profits of the industry ahead of protecting 
patients.
  I yield 5 minutes to the Senator from California.
  The PRESIDING OFFICER. The Senator from California.
  Mrs. FEINSTEIN. Mr. President, the Senator from Massachusetts is 
absolutely correct. This amendment essentially puts into the bill the 
basic premise of the Republican plan, which is to let the HMO define 
what is medically necessary, decide what the treatment should be, what 
the length of hospitalization should be for a patient, not based on 
that patient, not based on medical necessity, but based on standards 
that individuals who have not even seen the patient determine.
  I must tell you I have a very real problem with that. The insurance 
plan would determine medical necessity, not the physician who sees the 
patient. It would substitute an independent review process for the 
knowledge and the skill of the independent physician who is actually 
seeing the patient, who has done the diagnosis, who knows the patient, 
the patient's history the patient's problems.
  This past week I spent a good deal of time in California talking with 
physicians and patients up and down the State. I probably talked with 
more than 50 people, including patients, hospital administrators, 
county medical societies of many different counties as well as the 
California Medical Association. What I found was a dispirited, 
demoralized medical profession because medical decisionmaking was being 
taken out of their hands. I learned that a physician would prescribe 
medication, the patient would go to the druggist to have the medication 
filled and the druggist would make a substitution, often without even 
the doctor knowing. The patient would say: I cannot take this drug. And 
the pharmacist would have to say: We cannot furnish what your physician 
prescribed because it was not on your plan's list. This is what we mean 
by medical necessity --the most appropriate medical treatment for that 
particular patient in the judgment of the treating physician.
  I contend there is not anyone who has not seen a patient, who doesn't 
know what patient is all about, who can adequately prescribe for that 
individual. That, in fact, is what is happening.
  Let me read a statement by someone who testified before a 
congressional House committee a couple of years ago in a hearing. This 
individual was the reviewer for an HMO. As an HMO reviewer, she 
countermanded a physician. Let me read her words:

       Since that day I have lived with this act and many others 
     eating into my heart and soul. For me, a physician is the 
     professional charged with the care of healing of his or her 
     fellow human beings. The primary ethical norm is, `Do no 
     harm.' I did worse. I caused death.
       Instead of using a clumsy weapon, I used the simplest, 
     cleanest of tools, my words. This man died because I denied 
     him a necessary operation to save his heart. I felt little 
     pain or remorse at the time. The man's faceless distance 
     soothed my conscience. Like a skilled soldier, I was trained 
     for this moment. When any moral qualms arose I was to 
     remember I am not denying care, I am only denying payment.

  That is why this Republican amendment is so fallacious. Let me read 
the actual language in the bill:

       A review of an appeal under this subsection relating to a 
     determination to deny coverage based on a lack of medical 
     necessity and appropriateness, or based on a experimental or 
     investigational treatment, shall be made only by a physician 
     with appropriate expertise including age appropriate 
     expertise, who was not involved in the initial determination.

  My father, chief of surgery at the University of California, would 
turn over in his grave with this kind of language. That is not what 
someone goes to medical school and does a residency, does a surgical 
residency, does graduate school work for, to get overturned

[[Page S8349]]

by an insurance company reviewer who has not even seen the patient. 
This amendment, I contend, is in the worst of medical practice because 
it allows a panel that has never seen the patient to make the 
determination of whether a patient gets a lifesaving operation, gets a 
drug that might make them well, gets a treatment from which the 
physician thinks they might benefit.

  The PRESIDING OFFICER. The time of the Senator has expired.
  Mrs. FEINSTEIN. I yield the floor.
  The PRESIDING OFFICER. The Senator from Vermont.
  Mr. JEFFORDS. Mr. President, I would like to answer my good friend 
from California. I do not believe she was listening to my explanation 
of what this bill does. In fact, we do throw out 200 years of law 
practice. That shakes the legal community up a bit because they have to 
learn what is going on in modern medical situations. They have to 
become aware of how they find out what the best medicine is, not 
necessarily what is used in that area. It is the best medicine 
available.
  We set a higher standard, and that is why the legal profession is a 
little bit upset. They do not want to have to learn all this medical 
stuff. They want to go back to the good old days when they could just 
call the local doctor and say: What is the general medical practice? 
And whatever that doctor does is the general medical practice. That is 
the present standard. We say that is not good enough now.
  We are going to make sure that every person in an HMO has the right 
to the best medical care available, and that is what we explained with 
chart 1, chart 2, and chart 3. The decision is made by the external 
reviewer who says: Look, you can use this treatment now, you can use 
this pharmacy prescription, and that can be cured. You did not use it, 
you are not going to use it--that is wrong. Give them that care.
  Mrs. FEINSTEIN. Will the Senator yield for a question?
  Mr. JEFFORDS. Certainly.
  Mrs. FEINSTEIN. Does the Senator from Vermont really believe the best 
treatment can be provided by a reviewer who has never seen the patient?
  Mr. JEFFORDS. There is nothing that says the reviewer never sees the 
patient. The reviewer is an expert. He is the one who is qualified in 
that profession to know, who reviews the records. There is nothing that 
says he cannot also see the patient and interview the patient. This is 
not going to be a judgment done in some courthouse with a jury 
determining something. This is going to be done by an expert in the 
field who is dealing with a patient to make sure that patient gets the 
best available health care, the best of medicine that is available.
  Mrs. FEINSTEIN. Will the Senator yield to me a moment?
  I met some of the reviewers this past week. They did not see the 
patient. They made the decisions based on their insurance companies' 
definitions of medical necessity, not based on the particular needs of 
the individual patients.
  Mr. JEFFORDS. This is new. This does not exist anywhere. We are 
creating a new policy to ensure the best health care possible for every 
American.
  Mr. President, I yield the floor.
  The PRESIDING OFFICER. Who yields time?
  The Senator from Massachusetts.
  Mr. KENNEDY. I want to ask the Senator from California a question. 
Where in the earlier response does it say they will use the best 
practices?
  Mrs. FEINSTEIN. It does not.
  Mr. KENNEDY. It does not say that. To the contrary, does the Senator 
not agree that we have example after example where HMOs have used 
definition based on lowest cost?
  Mrs. FEINSTEIN. As a matter of fact, I can read terminology right out 
of insurance contracts, which I was going to read had my amendment been 
able to come to the floor. As the Senator knows, the purpose of this 
amendment is essentially to defeat the amendment I was going to offer, 
that I did offer to the Agriculture Appropriations bill and that I said 
last week that I was going to offer to this bill, to allow the 
physician to give the treatment and prevent the HMO from arbitrarily 
interfering with or altering the treating physician's decision, whether 
it be the treatment or the hospital length of stay.
  Mr. KENNEDY. I yield 5 minutes to the Senator from New York.
  The PRESIDING OFFICER. The Senator from New York.
  Mr. SCHUMER. Mr. President, I thank the Senator from Massachusetts.
  There are two pernicious parts to this amendment. One is removing the 
accurate definition of medical necessity, as the Senators from 
Massachusetts and California have pointed out, and the second is 
putting in an appeals process that is nothing short of bogus in a whole 
variety of ways. When you look at the appeals process that is being 
substituted by the Senator from Vermont, you understand how grudging it 
is, how imperfect it is, how it will not do the job. Let me give a few 
examples.
  First, there is no timeliness. The HMO can initiate the appeals 
process whenever it wants. It could wait 3 months or 6 months or 9 
months before review. Our amendment, which the Senator from North 
Carolina and I will offer, requires the review process to start when 
the patient asks.
  Second, there is no requirement that the appeals process, after it is 
finished, be implemented. The HMO can appeal and appeal and appeal.
  The two I want to focus on this afternoon are these: First, it is 
much more limited in scope. I say to my friends and my fellow Americans 
who are watching this debate, this is not two competing bills; this is 
one bill that does the job and one bill that seeks to please the 
insurance industry and still make it look as if the job is being done.
  One of the main issues is scope: 160 million covered versus 48 
million covered for emergency room, for medical necessity, and for 
other things. Thirty-eight million people would be included in the 
Schumer-Edwards amendment who are excluded by this amendment.
  Perhaps the greatest area where this amendment is a false promise, is 
a hoax, is the independent review. The Senator from Vermont said the 
review is independent. Not so. In the amendment offered by the Senator 
from Vermont, the reviewer is appointed by the HMO. The reviewer is not 
even required to have no financial relationship with the HMO. 
Theoretically, under this proposal, the HMO could pay an 
``independent'' reviewer. If we want an independent external review, 
why shouldn't that reviewer have no ties to the HMO?
  How can we tell people that an independent review is independent when 
the insurer selects the reviewer? If you have ever heard of the fox 
guarding the chicken coop, here it is. An independent review, as in the 
amendment we will be voting on in the next few days, requires that the 
HMO not pick the reviewer. I know the Senator from Vermont has stressed 
that a pediatrician would review a child's case. I say to my 
colleagues, if I were a member of an HMO, I would not want a 
pediatrician who has a financial relationship with the HMO to review 
the case.
  Mr. JEFFORDS. Will the Senator yield for a question?
  Mr. SCHUMER. The Senator did not yield to me. I will wait until his 
time to answer a question.
  What I am saying is this: If you want a real review, and hundreds of 
thousands of Americans want such a review, then vote against this 
amendment, wait for the Schumer-Edwards amendment, and you will get a 
true independent review.
  In conclusion, this is not so different from the gun debate we had a 
month and a half ago, where we had a powerful special interest on one 
side and the American people on the other side, and there were a series 
of proposals put forward that the powerful special interests liked but 
were intended to make the American people believe we were making 
progress.
  I cannot tell you how or where or when, but just as in the gun 
debate, the American people will not be fooled. They want, they demand, 
a real Patients' Bill of Rights, one that covers 160 million Americans, 
not 48 million, one that has a real review process, not a sham review 
process where the reviewer can be paid by the HMO. Please vote down 
this amendment.
  The PRESIDING OFFICER. The Senator's 5 minutes has expired.
  Who yields time to the Senator from Pennsylvania?
  Mr. JEFFORDS. I yield the Senator from Pennsylvania 10 minutes.
  The PRESIDING OFFICER. The Senator from Pennsylvania.

[[Page S8350]]

  Mr. SPECTER. I thank the Chair.
  Mr. President, it is extraordinarily complex to work your way through 
the various provisions. Representations are being made on both sides of 
the aisle which are contradictory.
  The Senator from New York has just made a contention that the 
independent reviewer is not independent at all. My reading of the 
provisions in S. 326 at page 177 set forth the qualified entities as 
the reviewers and the designation of independent and external reviewer 
by the external appeals entity which specifies independence.
  I will not take the time now to read it. But that reference, I think, 
would establish the true independence of the reviewer.
  My principal purpose in seeking recognition was to deal with the 
comparison of the standards for ``medical necessity,'' which is the 
core of the argument at the present time.
  The pending amendment seeks to strike the language of the Kennedy 
amendment, which defines medical necessity as ``medical necessity or 
appropriate means with respect to a service or benefit which is 
consistent with generally accepted principles of professional medical 
practice.''
  The language of the pending amendment, which would be substituted, 
provides for a standard of review as follows, at pages 179 and 180:

       In General.--An independent external reviewer shall--
       (I) make an independent determination based on the valid, 
     relevant, scientific and clinical evidence to determine the 
     medical necessity, appropriateness, experimental or 
     investigational nature of the proposed treatment; and
       (ii) take into consideration appropriate and available 
     information, including any evidence-based decision making or 
     clinical practice guidelines used by the group health plan or 
     health insurance issuer; timely evidence or information 
     submitted by the plan, issuer, patient or patient's 
     physician; the patient's medical record; expert consensus; 
     and medical literature . . .

  The accompanying report amplifies ``expert consensus'' as ``including 
both what is generally accepted medical practice and recognized best 
practice'' so that the language of the statute itself is more expansive 
in defining ``medical necessity.'' The commentary goes on to include 
generally accepted medical practice and adds to it: the recognized best 
practice.
  There is no doubt that in the articulation of these competing 
provisions, an effort is being made by one side of the aisle to top the 
other side of the aisle. It is a little hard, candidly, to follow the 
intricacies of these provisions because, as is our practice in the 
Senate, an amendment can be offered at any time, and to work through 
the sections and subsections is a very challenging undertaking.
  Mr. SCHUMER. Would the Senator from Pennsylvania yield?
  Mr. SPECTER. No, I will not, but I will yield in a minute. I will not 
now because I am right in the middle of my train of thought. I will be 
glad to yield in a moment and respond to whatever question the Senator 
from New York may have.
  I supported the Robb amendment, the last vote, because the Robb 
amendment had provided a standard for medical necessity, generally 
accepted medical principles, important operative procedures. At this 
stage of the record, without that definition of the requirement, as 
articulated in the Robb amendment, I thought that was improvement.
  Now we are fencing. To say that the air is filled with politics in 
this Chamber today would be a vast understatement. But in at least my 
effort to try to understand what is going on and to make an informed 
judgment, I am prepared to make a judgment for the Robb amendment or 
the Kennedy amendment or the Schumer amendment contrasted with the 
Nickles amendment or the Jeffords amendment. It requires a lot of 
analysis.
  But as I read these plans, I believe that Senator Jeffords, Senator 
Frist, and Senator Nickles are correct, that when you take a look at 
the language they are substituting, it places a higher standard on the 
HMO, the managed care operation, than does the provision in the Kennedy 
amendment which they are striking.
  Now I would be glad to yield to the Senator from New York on his 
time.
  Mr. SCHUMER. I thank the Senator for yielding.
  Mr. SPECTER. I am yielding for a question.
  Mr. SCHUMER. I appreciate the Senator searching to come up with the 
right solution here. I would ask him--he is an excellent lawyer, far 
better than I am--on page 179 of the bill, (iv), says:

       receive only reasonable and customary compensation from the 
     group health plan or health insurance issuer in connection 
     with the independent external review . . .

  It seems to me--and I ask the Senator the question--that the plan 
proposed in the substitute envisions the insurer paying the reviewer. 
That seems to me not to be an independent review.
  Mr. SPECTER. I ask the Senator, where are you reading from?
  Mr. SCHUMER. This is S. 326, page 179. That is, as I understand it, 
the exact language of the amendment offered by the Senator from 
Vermont.
  Mr. SPECTER. Would the Senator restate the question?
  Mr. SCHUMER. Yes. My question is, given that the amendment envisions 
the insurer paying the reviewer, as listed in little number (iv) on 
page 179, how can we say the review in the Jeffords amendment is 
independent?
  Mr. SPECTER. The fact that the insurer pays the reviewer does not 
impugn or impinge upon the reviewer's objectivity when there are 
specific standards for the selection of the reviewer and specific 
standards that the reviewer has to follow.
  If I could use an analogy from a practice that I engaged in for a 
long time as district attorney of Philadelphia, the State paid the fee 
for the defendant in first-degree murder cases. But there was no doubt 
that notwithstanding the fact that the Commonwealth of Pennsylvania 
paid defense counsel, the defense counsel worked in the interests of 
the defendant.
  When you have a determination as to what the HMO ought to be doing, 
that is something they ought to pay for. But there ought to be a 
structure to guarantee objectivity by the decisionmaker.
  Similarly, if I can amplify, if you have a Federal judge paid by the 
Federal Government, and the Federal Government is a party to the 
process, nobody would say that Federal judge is going to be biased 
toward the Federal Government simply because the Federal Government 
pays his salary.
  Mr. SCHUMER. Would the Senator yield for a question?
  Mr. SPECTER. I do.
  Mr. SCHUMER. If we could give these reviewers lifetime appointments 
and salary, I might agree with the analogy of a federal judge. But, of 
course, these reviewers could be immediately----
  Mr. SPECTER. The defense lawyers do not have lifetime appointments.
  Mr. SCHUMER. I understand.
  The second question: On page 175, this reviewer is selected by the 
HMO, whereas in our plan there is an independent selection process. 
Again, I rely on the Senator's much greater knowledge of the law. If 
the reviewer were not selected by the HMO, they would obviously be more 
independent. That is on page 175.
  Mr. SPECTER. If I may respond, on page 177, the qualified entities 
are defined, and they are the ones that make the determination of the 
independent reviewer. And a qualified entity is defined to be:

       (I) an independent external review entity licensed or 
     accredited by a State;
       (II) a State agency established for the purpose of 
     conducting independent external reviews;
       (III) any entity under contract with the Federal Government 
     to provide independent external review services;
       (IV) any entity accredited as an independent external 
     review entity by an accrediting body recognized by the 
     Secretary for such purpose; or
       (V) any other entity meeting criteria established by the 
     Secretary for purposes of this subparagraph.

  I think that language answers the question of the Senator from New 
York about independence and expertise.
  Mr. SCHUMER. I ask the Senator, wouldn't we be better in guaranteeing 
independence by having the selection of the review panel be made 
independently of the HMO, given that the HMO--I understand there are 
some criteria here, but if we are trying to get a truly independent 
process, it strikes me that it would be a lot better to have the 
selection be made truly independently, not by the HMO, which obviously 
has an interest, albeit, as the Senator certainly recognizes and 
pointed out, with a bunch of criteria.

[[Page S8351]]

  Mr. SPECTER. Mr. President, if I may respond, I don't understand the 
question. The reason I don't understand the question is that the 
specification of independence here is so comprehensive that it 
guarantees independence.
  Mr. SCHUMER. I thank the Senator.
  Mr. KENNEDY. Mr. President, I yield 8 minutes to the Senator from 
North Carolina.
  Mr. EDWARDS. Mr. President, if the Senator from Pennsylvania will 
respond to a question.
  Mr. SPECTER. I am glad to respond to a question at this time.
  Mr. EDWARDS. I am looking at page 30 of the actual amendment that has 
been offered. Looking under subsection (B)(ii), this is the designation 
of independent external reviewer, which goes to the very heart of 
whether the review is independent or, in fact, is not independent. In 
subsection (ii) it says there is a requirement that the reviewer ``not 
have any material, professional, familial, or financial affiliation 
with the case under review.''
  My question to the Senator is--and I would like to see the language 
in the actual amendment, if he could point to it--what is it that 
requires that the reviewer not have an ongoing financial relationship 
with the health insurance company or with the HMO, which would in fact, 
as the Senator I am sure would recognize, make them not independent?
  Mr. SPECTER. Well, I believe that that is provided by the high level 
of independence specified in the preceding section (3)(A)(ii) which 
establishes the independence of the qualified entity which selects the 
independent reviewer.
  Mr. EDWARDS. My question is, Can you point to specific language in 
the bill that requires that the reviewer, in order to be independent, 
not have an ongoing financial relationship with the health insurance 
company?
  Mr. SPECTER. Well, there is no suggestion that there would be that 
kind of a relationship. The language which the Senator from North 
Carolina cited takes care of one category of potential conflict of 
interest, that they will not have any material, professional, familial, 
or financial affiliation with the case under review, the participant or 
beneficiary involved, the treating health care professional, the 
institution where the treatment would take place, or the manufacturer 
of any drug, device, procedure, or other therapy proposed for the 
participant or beneficiary whose treatment is under review.
  If your question is, Would there be a triple firewall if you also 
specify the HMO? I would be inclined to have all the firewalls I could, 
as I do when I draft documents, as my distinguished colleague did when 
he practiced law.
  Mr. EDWARDS. I thank the Senator very much, and I reclaim the 
remainder of my time.
  Mr. President, there are two fundamental problems with this amendment 
that go to the very heart of this debate. First, as my colleague from 
New York pointed out, this review is not an independent review. It is 
not an independent review by any definition of independence. The reason 
is, No. 1, the health insurance company, the HMO, chooses the entity 
which chooses the reviewer. I want to be precise here. That is exactly 
what the bill provides. The health insurance company chooses an entity; 
that entity chooses the reviewer. So the health insurance company has 
control over who ultimately does the review.
  No. 2, the only requirement with respect to financial independence or 
professional independence is the requirement that I just read to the 
Senator from Pennsylvania, that the reviewing entity not have a 
financial or professional relationship with the very specific case 
under review, which means there is nothing to prohibit a reviewer, the 
so-called independent reviewing body under their amendment, from being 
somebody who has a longstanding, ongoing relationship with the health 
insurance company or with the HMO.
  Nobody in America, certainly none of my colleagues in the Senate, 
would believe that an independent review could be conducted by somebody 
who has an ongoing contractual relationship and receives money from the 
health insurance company. There is absolutely nothing in this bill 
which prohibits that. That is why the Senator from New York and I have 
proposed an amendment that makes it very clear that there is a truly 
independent reviewing body. That independence is critical and to the 
very heart of the review process. It is why we need it.
  I notice both the junior and the senior Senators from Pennsylvania 
are on the floor now. In Pennsylvania, these reviews are conducted by a 
State regulatory body. They are not conducted by some person chosen by 
an HMO or a health insurance company. Second, in terms of what can be 
reviewed under the State law of Pennsylvania, any consumer grievance 
can be reviewed. It is not, as this bill is, limited to what 
constitutes medical necessity.
  Third, under the law of the State of Pennsylvania, the review is de 
novo, which is absolutely not what this amendment provides.
  Let me go back and summarize where we are. No. 1, we don't have, 
under this amendment, an independent review. We don't have it for two 
fundamental reasons: No. 1, the health insurance company, the HMO, is 
allowed to select the body that picks the reviewer. No. 2, the 
reviewing body is allowed to have a longstanding professional or 
financial relationship with the HMO that has denied the claim. There is 
absolutely nothing to prohibit that under this bill. Our amendment, 
which will be considered at a later time, would not allow that. So 
there is no independent review.
  The second problem is--and this goes to the amendment offered by my 
colleague from California--this review process is meaningless so long 
as the reviewing body is bound by the definition of medical necessity 
contained and written by the HMO. It is absolutely bound by the 
language of the HMO.
  I will add, in committee--I see my colleagues from Massachusetts and 
Tennessee are here--Senator Kennedy asked a question to Senator Frist. 
The question was:

       Would the Senator accept language that mentions that the 
     decision would be made independent of the words of the 
     contract?

  The question Senator Kennedy posed was: Would you agree that in the 
appeals process, the determination could be made without regard to the 
HMO-written definition of medical necessity?
  Senator Frist's answer was: ``No, sir,'' in the committee. So he 
would not concur to not be bound by the language in the HMO or health 
insurance contract.
  So there are two fundamental problems, and they work in concert to be 
devastating and to make this amendment devastating to the whole concept 
of the Patients' Bill of Rights.
  No. 1, there is no independent review. The people are picked by the 
HMO, and they are allowed to have an ongoing financial relationship 
with the HMO. No. 2, they are bound by an HMO-written definition of 
medical necessity. That is the very heart of the amendment of my 
colleague from California, because what this debate is ultimately about 
is whether health care decisions are going to be made by medical 
professionals, doctors, or whether they are going to be made by 
insurance company bureaucrats.
  Mrs. FEINSTEIN. Will the Senator yield?
  The PRESIDING OFFICER. The Senator's 8 minutes have expired.
  Who yields time?
  Mr. KENNEDY. Mr. President, I yield 10 minutes to the Senator from 
Rhode Island.
  Mr. CHAFEE. I thank the Chair.
  First of all, it is with deep regret that I find myself on the 
opposite side of an issue from my good friend, the senior Senator from 
Vermont.
  The question before us this afternoon is medical necessity. I believe 
this medical necessity provision is one of the most widely 
misunderstood issues in this entire debate.
  I think what we want to make clear is what we are not talking about 
this afternoon. We are not talking about erasing the gains managed care 
has made in bringing down costs. We are not talking about forcing plans 
to cover unnecessary, outmoded, or harmful practices. We are not 
talking about forcing plans to pay for any service or treatment which 
is not already a covered benefit. This is absolutely not about giving 
doctors a blank check. What we are talking about is making sure that 
patients get what they pay for with their premium dollars. It is

[[Page S8352]]

about ensuring that an objective standard of what constitutes prudent 
medical care is used to guide physicians and insurers in making 
treatment and coverage decisions.

  This provision is about making sure that an infant suffering from 
chronic ear infections gets drainage tubes to ameliorate his or her 
condition. It is about making sure that a patient with a broken hip is 
not relegated to a wheelchair in perpetuity but, rather, given the hip 
replacement surgery that prudent medical practice dictates.
  Although some would have us believe that ``medical necessity'' would 
undo managed care by giving doctors the power to dictate what 
treatments and services insurers must cover, this isn't accurate. The 
real issue is, how will questions of coverage and treatment be decided?
  S. 1344--a bipartisan bill that I have had the privilege of 
introducing earlier this year with Senators Graham, Lieberman, Specter, 
Baucus, Robb, and Bayh--would codify the professional standard of 
medical necessity.
  As defined, medically necessary services are those ``services or 
benefits which are consistent with generally accepted principles of 
professional medical practice.'' This means the care that a prudent 
practitioner would give. The medical necessity standard is a well-
settled principle of legal jurisprudence which has been used by the 
courts to adjudicate health law cases for nearly a century.
  Many insurance contracts in force today contain some version of this 
standard. In fact, remarkably similar language is found in contracts 
written by Prudential and Blue Cross and Blue Shield, to name a few. 
The contractual definition of medical necessity from a Blue Cross 
contract is care which is ``. . . consistent with standards of good 
medical practice in the U.S.''
  One of the reasons managed care plans are so adamantly opposed to 
putting this standard into the law is that some in the industry are 
beginning to move in a very troubling direction, away from this 
standard. Here is how an insurance regulator in the State of Missouri 
explained this very alarming trend:

       Increasingly, insurance regulators in my State are finding 
     that insurers are writing ``sole discretion'' clauses into 
     their contracts--meaning that it is solely up to the insurer 
     to determine whether treatment is medically necessary. 
     Therefore, without an objective standard of what constitutes 
     medically necessary care, and a requirement that treatment 
     and coverage decisions are supported by credible medical 
     evidence, any external appeals process is meaningless.

  If an insurance contract gives the plan sole discretion to determine 
what constitutes medically necessary care, an external review panel's 
hands are tied; it will have no choice but to enforce the terms of the 
contract, even if the coverage decision in question is completely 
irresponsible. Thus, if we don't codify the professional standard, any 
external review provision we pass in the Senate could be entirely 
meaningless.
  I have a chart here. This includes the actual medical necessity 
provision from an insurance contract in force today. I have eliminated 
the company's name, but this tells the whole story. If a plan has the 
sole discretion to determine what is medically necessary care, it can 
ignore the doctor's recommendations, the patient's medical record, and 
any other evidence it cares to overlook in making its determination. 
You will see it here. Here is the name of the company. That company 
will have the sole discretion to determine whether the care is 
medically necessary. The fact that the care has been recommended, 
provided, described, or approved by a physician or other provider will 
not establish that care is medically necessary. In other words, talk 
about putting the fox in charge of the chicken coop. This is it. Here 
we have the company deciding whether care is medically necessary, and 
they have the final decision.

  Let me give you a real world example of what can happen when a plan 
has an imprudent definition of medical necessity. A child named Ethan 
Bedrick was born with cerebral palsy and needed physical therapy to 
maintain some degree of mobility. The insurer paid for the physical 
therapy for a while but one day cut off payment for the services--
which, by the way, were covered as an unlimited benefit under the 
plan's contract. The child's doctor thought the care was medically 
necessary to prevent further deterioration in Ethan's condition, and 
physical therapy is routinely provided to patients with cerebral palsy.
  When the plan was questioned in court as to why the care had been 
denied, the response was given that it was not medically necessary 
because, under the plan's definition, medically necessary care is that 
which will restore a person to ``full normalcy.'' Well, this child has 
cerebral palsy and he is not going to be restored to full normalcy.
  If we do not include an objective standard of medical necessity in 
this legislation, insurers will be able to bait and switch when it 
comes to the delivery of services, just as they tried to do with Ethan 
Bedrick.
  The professional objective standard--and not an insurer's practice 
guidelines or opinions--should be used to determine if care is 
medically necessary. Without the objective standard, what measure would 
an appeals body use to determine whether a treatment or coverage 
decision was accurate or appropriate? Let me deal with two arguments 
used by those against this medical necessity provision.
  First, they say it will prevent ``best practices'' and will force 
plans to practice substandard care. I have trouble with that. Since the 
professional standard of medical necessity has been the standard used 
by the courts for over a hundred years and it is a feature of many 
insurance contracts today, why hasn't this already had the effect of 
preventing ``best practice'' medicine? In other words, I don't get the 
argument that somehow you are not going to practice the best medicine 
because you have to use what is medically necessary. The fact is that 
this standard does not lock in the state of medical practice today. Why 
do we make these giant strides forward? Because we are not locked in, 
as has been suggested.
  Second, it is suggested that adopting this standard is tantamount to 
giving doctors a blank check and will force plans to cover a whole 
array of services which are not covered benefits, such as aromatherapy.
  The plain fact is, if a plan excludes aromatherapy, or any other 
service, that is the end of the story. It excludes it. It is out. There 
is no fuss after that. If it is written in there, it is out. A patient 
would have no basis for an external appeal in a case where a denied 
service was clearly excluded.
  In summary, I urge colleagues not to be swayed by the health 
insurance industry. Both Democrats and Republicans alike acknowledge 
the need for an external appeals process. But make no mistake about it, 
without a provision to ensure that plans are held to an objective 
standard of professional medical practice, legislation giving patients 
access to the external process will be ineffective.
  I thank the Chair and the managers of the legislation.
  The PRESIDING OFFICER. Who yields time?
  Mr. FRIST. Mr. President, I yield myself 5 minutes, and then I will 
yield 5 minutes to the Senator from Maine.
  My amendment is pending. I will review where we are today. My 
amendment does two things. No. 1, it strikes certain provisions that we 
believe will be harmful to the quality of health care, and it goes back 
to medical necessity and defining medical necessity in Federal statute. 
We will come back and talk about that. My colleagues will talk further 
about that shortly. We also strike certain provisions that will 
increase cost and ultimately reduce access to health insurance 
coverage. Again, people have heard me again and again going back to the 
patients. We can simply not do anything. I believe it diminishes 
quality and at the same time diminishes access to make ourselves feel 
good.
  Now, what we have done, we struck that and we replaced that part of 
the bill--the accountability provisions, the provisions on internal 
appeal, on external appeal, the issues we have been talking about in 
the last 15 or 20 minutes--although there is a lot of misconception 
that we need to straighten out before we actually vote on this bill, 
because the internal appeals process and external appeals process, 
which in many ways are the heart of the Patients' Bill of Rights bill, 
are important to ensure that patients do get the medical care they need 
and ensure that

[[Page S8353]]

ultimately it is physicians, not trial lawyers, not bureaucrats, who 
make the coverage decisions regarding medical necessity. That is what 
this amendment is all about. I want to steer the discussion right 
there.
  To simplify things, so we will know how the process works, if you are 
a doctor and you are a patient, and you say that a particular procedure 
should be covered, and your plan for some reason says no, well, you 
need an appeals process if that is what you really believe is 
appropriate to get that sort of care. What you do under our bill is go 
to an internal appeals process and work through. That is something in 
the managed care network. It might be going to another physician within 
the network. It is a process that has to be set up by each and every 
managed care plan. That is what we call an internal appeals process.

  The bill on the other side of the aisle also had an internal appeals 
process. If the doctor and patient and the managed care internally 
could not come to an agreement after going through a specified process, 
at that point the doctor and patient can go outside the plan. This is 
where the accountability is so important: Should my plan cover what is 
medically necessary and appropriate? Outside the external appeals 
process is where much of the discussion has taken place.
  Our bill has that final decision of whether or not something is 
covered, whether or not it is medically necessary or appropriate, made 
by a medical specialist--these are words actually in the bill--
independent medical specialist, physician making the final decision, 
not some bureaucrat, not some health care plan, not some trial lawyer. 
An independent medical specialist is making the final decision in this 
external process.
  Mr. President, 20 minutes ago we had discussed that the external 
reviewer has to be independent--it is written into the bill that way--
has to be a medical person from the same field, a specialist, if 
necessary. Are they part of the Health Maintenance Organization? Does 
the Health Maintenance Organization actually hire that person to make a 
decision?
  We have not talked about what our bill does. Our bill says in this 
external review process there has to be a designated entity. Nobody has 
talked about that today. Words such as ``unbiased, external entity'' 
are in the bill. This unbiased entity is regulated by either the 
Secretary of Health and Human Services in Washington, DC, by the 
Federal Government, or by the State government. They regulate that 
entity, not the plan itself.
  What about the independent reviewer? Where do they come from? The 
impression which I have heard again and again is the independent 
reviewer has ties to the medical care plan and will give a biased view. 
No; the independent medical specialist making the binding final 
decision is appointed by the third party entity--not the plan itself 
but this third party entity regulated by the Federal Government, State 
government, or signed off for by the Secretary of Health and Human 
Services. This independence from plan to entity has to be unbiased. 
That is No. 1, to assure independence.
  No. 2, the entity is regulated by the Federal Government or the State 
government or the Secretary of Health and Human Services.
  No. 3, it is written in the bill that that entity does the 
appointment of the independent medical specialist who makes the final 
decision.
  What information does that medical specialist use to make the final 
decision? We don't limit the information. In fact, we encourage them to 
consider all information. It is very specifically written in the bill 
that the ``independent medical specialist will make an independent 
determination based on the valid relevant scientific and clinical 
evidence to determine the medical necessity, appropriateness, 
experimental or investigational nature of the proposed treatment.'' 
They will take into consideration ``all appropriate and available 
information, including any evidence-based decisionmaking or clinical 
practice guidelines.''
  The point is this external review person is independent and separate 
from the entity and separate from the HMO.
  I yield 5 minutes to the Senator from Maine.
  Ms. COLLINS. First, I commend the Senator from Tennessee for his very 
lucid explanation clearing up a lot of the misinformation about what is 
in the Republican package with regard to the independent, impartial, 
unbiased external review.
  This is a very complicated issue. On the surface, the Kennedy bill 
appears to have a great deal of appeal. It sounds so simple. It reminds 
me of that expression by H.L. Mencken when he said that for every 
complicated problem there is a solution that is simple, easy, and 
invariably wrong.
  That fits the Kennedy bill on medical necessity.
  Physicians clearly must play a central role in care decisions. No one 
disputes or wants to minimize the critical role of treating physicians 
in the process of determining what is medically appropriate and 
necessary care. However, the very same patient can go to different 
physicians, be told different things, and receive markedly different 
care.
  This chart illustrates the problem. The Washington Family Physicians 
Collaborative Research Network studied how physicians treat bladder 
infections for adult women. This is the second most common problem seen 
in a physician's office. Mr. President, 137 treating physicians were 
asked to describe their treatment recommendations for a 30-year-old 
woman with a 1-day history of the infection and an uncomplicated 
urinary tract infection. They responded with 82 different treatment 
options.
  Which of these is the prudent physician? Which of these 82 different 
treatments is the generally accepted principle of medical practice as 
provided by the Kennedy bill? The Kennedy bill would require health 
plans to cover all 82 different treatments without any thought being 
given to what is the best treatment, what is the most effective 
treatment, what is the newest treatment based on the latest in medical 
research.
  Even if something is consistent with generally accepted principles 
and professional practice, it may not necessarily be the medically best 
treatment for that patient. Dr. Jack Wennberg is Dartmouth's premier 
expert in studying quality and medical outcomes. He testified before 
our committee recently that medical necessity in one community is 
unnecessary care in another.
  Let me give an example from my home State of Maine. The Maine Medical 
Assessment Foundation conducts peer review and studies area variations 
in practice patterns in an effort to identify cases in which too many 
procedures being performed, unnecessarily putting patients at risk. 
They did a study that showed that physicians in one city in Maine were 
performing a disproportionately high rate of hysterectomies. They 
counseled the physicians in that city and were able to lower the rate, 
thus saving women from being exposed to unnecessary risks of surgery.
  I ask my friends on the other side of the aisle, wasn't that review 
appropriate? Wasn't that review necessary? Wasn't that review a good 
idea to save these women from undergoing unnecessary hysterectomies?
  Let me give some other examples. The Centers for Disease Control 
estimates that physicians performed 349,000 unnecessary C sections in 
1991. Again, these women were placed at risk for unnecessary surgery. 
Isn't it a good idea to question in some of these cases the decision of 
the physician to order this unnecessary surgery?
  Let me give yet another example. Despite solid evidence that women 
who undergo breast-sparing surgery followed by chemotherapy or 
radiation and women who undergo total mastectomies have similar 
survival rates, regional preferences--as opposed to medical necessity--
still prevail in determining treatment.
  There was a recent article in the New York Times which showed that 
the rate of mastectomies was 35 times higher for Medicare patients in 
one region of the country than in another. According to another study 
at Dartmouth, women in Rapid City, SD, were 33 times less likely to 
have breast-sparing surgery than women in a similar city in Ohio.
  Yet another example involves children. Today, treatment for frequent 
ear infections includes the implantation of tubes. I have a nephew who 
had this procedure, and I am sure many of

[[Page S8354]]

my colleagues have children who have gone through this as well. In 
fact, almost 700,000 children in the United States have had this 
procedure. According to a 1994 study published in the Journal of the 
American Medical Association, however, this treatment is inappropriate 
for more than a quarter of these children.
  The PRESIDING OFFICER. The Senator has used her time.
  Mr. FRIST. Mr. President, I yield an additional 3 minutes.
  The PRESIDING OFFICER. The Senator from Maine is recognized for an 
additional 3 minutes.
  Ms. COLLINS. In another 41 percent of the cases reviewed, the 
clinical indications for having the tubes implanted were inconclusive 
at best.
  A 1997 study showed that only 21 percent of elderly patients were 
treated with beta blockers after a heart attack, despite evidence that 
mortality rates are 75 percent higher for those not receiving 
treatment.
  I would note, in contrast, that HMO members in plans that submit data 
to the National Committee on Quality Assurance are 2\1/2\ times more 
likely than members of fee-for-service plans to receive beta blockers.
  I could go on and on and on. Perhaps the President's own commission 
said it best. It concluded that excessive procedures--procedures that 
lack scientific justification--could account for as much as 30 percent 
of our Nation's medical bills.
  Not to mention posing unnecessary risks as well as pain an suffering 
for those who undergo these unnecessary procedures.
  As we can see by these examples and countless more, there may well be 
valid, indeed, very worthwhile. In fact, there may be very good reasons 
for the health plan, in some cases, to suggest an alternative treatment 
to the one the treating physician has initially selected. It may be far 
better for the patient than the initial recommendation of his or her 
physician. These examples show that, even if something is consistent 
with generally accepted principles of professional medical practice, it 
is not necessarily appropriate high quality care. That should be our 
goal. Our goal should be to put the patient first and to provide the 
best quality care to that patient.
  The Republican bill deals with the issue of medical necessity through 
a strong, independent, external appeals process. That is the way to 
deal with disputes about medical coverage. A Federal statutory 
definition of medical necessity is unwarranted and unwise.
  I yield the floor, and I reserve the remainder of our time.
  The PRESIDING OFFICER. Who yields time? The Senator from Oklahoma.
  Mr. NICKLES. Mr. President, how much time remains on both sides?
  The PRESIDING OFFICER. The Senator has 5 minutes 30 seconds; the 
Senator from Massachusetts has 13 minutes 30 seconds.
  Mr. NICKLES. Mr. President, that means there is about 20 minutes 
remaining. Just for the information of our colleagues, I think they can 
expect a rollcall vote on this and subsequent amendments to begin at 
about 6:45. So those offices should notify their Senators to expect 
rollcall votes beginning about 6:45.
  The PRESIDING OFFICER. Who yields time?
  Mr. KENNEDY. Mr. President, I yield 5 minutes to the Senator from 
California.
  The PRESIDING OFFICER. The Senator from California is recognized for 
5 minutes.
  Mrs. FEINSTEIN. Mr. President, if this definition, the definitions we 
have been debating on what is medical necessity--if the Republican 
definitions were supported by medical organizations, I might think they 
are pretty good. But there is virtually no physician-oriented 
organization anywhere in the United States that I know of that supports 
this particular definition of medical necessity. Every single one of 
them supports the definition in the Daschle bill.
  I think the Senator from Rhode Island and the Senator from North 
Carolina spoke eloquently as to why. Since the Senator from North 
Carolina remains on the floor, I would like to ask him this question. 
The Senator from Rhode Island read the definition from a particular 
insurer. Let me reread it:

       [This company] will have the sole discretion to determine 
     whether care is medically necessary. The fact that care has 
     been recommended, provided, prescribed or approved by a 
     physician or other provider will not establish that the care 
     is medically necessary.

  Then, in view of that, if you read on the top of page 180, in the 
bill, which sets out the guidelines for the standard of review for the 
independent reviewer, at the top of the page and the bottom of page 
179:

       The independent reviewer will take into consideration 
     appropriate and available information including any evidence-
     based decisionmaking or clinical practice guidelines used by 
     the group health plan or insurance issuer.

  How would an independent reviewer make a decision?
  Mr. EDWARDS. Under the definition the Senator has just read--and I 
might point out the appeals process that is contained in this amendment 
is completely controlled by the HMO or health insurance company's 
definition of medical necessity. Throughout the process it is totally 
controlled by it.
  Mrs. FEINSTEIN. Then if I understand you correctly, if an insurer had 
in its plan that they will use the least costly alternative available, 
the independent reviewer would have to find for the least costly 
alternative?
  Mr. EDWARDS. That is absolutely correct.
  Let's suppose we had a young child who needed a particular kind of 
care and every physician who had treated that child recommended the 
care for the child. But there was a less costly procedure that could be 
used, so the care was denied. Throughout the appeals process, the 
determination of whether it ought to be reversed or not would be based 
on what is the least costly, because it is totally controlled by the 
definition written by the HMO.
  In the language the Senator from California has just read to me, 
where it says it shall be within the ``sole discretion,'' what that 
ultimately means is whatever appealing body is deciding, which is bound 
by that definition, which they are by this amendment--if they are bound 
by that definition, every appealing body would be left with no 
alternative but to affirm the decision because the contract says it is 
left within the sole discretion of the HMO.

  It goes to the very heart of the Senator's amendment. It goes to the 
very heart of this debate. The whole question is, Are health insurance 
bureaucrats going to make health care decisions or are health care 
decisions going to be made by doctors and health care professionals?
  Mrs. FEINSTEIN. I just read the language. There is no language in 
this that says the independent reviewer, even in a case of life or 
death, would necessarily see the patient.
  Mr. EDWARDS. That is absolutely correct. There is nothing that 
requires the independent reviewer to see the patient. You could have 
some doctor who is nothing but a bureaucrat, who has not seen the 
patient, does not know what the patient needs, making the decision.
  If I could add one thing, another problem with this so-called 
independent review process is the HMO, the health insurance company, 
are the ones that are determining. Remember, they choose this entity 
that chooses the reviewer. They determine who is biased or unbiased.
  Mrs. FEINSTEIN. And the entity pays the reviewer as well.
  Mr. EDWARDS. They pay the reviewer. We have said it now five 
different times, but talk about putting the fox in charge of the 
chicken coop. What we need to be doing is to have some truly 
independent body making these determinations. They need to be able to 
make the determination based upon what the patient, in my example the 
child, really needs, based on what the doctor says the child needs.
  Mr. NICKLES. Will the Senator yield?
  Mr. EDWARDS. No, I will not.
  It is not based on what some insurance company has written into a HMO 
or health insurance contract.
  Mrs. FEINSTEIN. So, in other words----
  Mr. NICKLES. Mr. President, regular order.
  Mrs. FEINSTEIN. I believe I have the floor, Mr. President.
  Mr. NICKLES. Parliamentary inquiry. Aren't Senators supposed to go 
through the Chair?

[[Page S8355]]

  Mr. KENNEDY. Regular order. Senators are permitted to inquire and ask 
questions. That is the regular order, Mr. President. I insist on the 
regular order, not the interruption of the Senator from North Carolina. 
Whose time is this on, Mr. President?
  Mr. NICKLES. The Senator from North Carolina----
  The PRESIDING OFFICER. The time right now, at this point, is not 
being charged. The Senator from California had 5 minutes that she was 
controlling after it was allotted by the Senator from Massachusetts.
  Mr. KENNEDY. Parliamentary inquiry. Can the Senator be inquired of by 
a Member of the Senate and answer a question?
  The PRESIDING OFFICER. The questions are most appropriately addressed 
through the Chair.
  Mr. KENNEDY. But the Senator is entitled, the Senator from North 
Carolina, to inquire of the Senator from California, is he not?
  Mrs. FEINSTEIN. Or vice versa.
  The PRESIDING OFFICER. If he does so through the Chair.
  Mr. KENNEDY. I thank the Chair.
  Mrs. FEINSTEIN. I inquire of the Senator from North Carolina, through 
the Chair, if I were a woman suffering from ovarian cancer and I have 
this policy that I read from, and my physician said there is a small 
chance a bone marrow transplant might help you----
  The PRESIDING OFFICER. The time of the Senator has expired.
  Mr. KENNEDY. I yield an additional 3 minutes.
  Mrs. FEINSTEIN. But there is a small chance a bone marrow transplant 
might help you, I would advise that you have it, and if the health plan 
with this language turned it down, I would have no opportunity to have 
that bone marrow transplant?

  Mr. EDWARDS. You would have absolutely no opportunity and no 
opportunity to have the decision reversed. I might add, there is a 
double whammy in this amendment. The double whammy is that the only 
thing that can be appealed is the determination of what is medically 
necessary, and what is medically necessary, under the language of their 
bill is--and I am reading now from the bill--``when medically necessary 
and appropriate under the terms and conditions of the plan,'' which is 
what the HMO and the health insurance company's contract says.
  People are getting whammied twice: No. 1, you cannot appeal but one 
thing, which is: Is it medically necessary? No. 2, that determination 
is based on what the health insurance company or the HMO wrote into the 
plan.
  Mrs. FEINSTEIN. In other words, if I may, through the Chair, if this 
amendment were to be adopted, every enrollee of an HMO plan would have 
to read the fine print very carefully, because all an HMO would have to 
do is put in a disclaimer, either medical necessity based on least cost 
or medical necessity based on the fact that the plan would have the 
ultimate say on how medical necessity is defined.
  Mr. EDWARDS. The Senator is correct, and the patient would be stuck 
with that decision initially by the HMO and would be stuck with it 
throughout the entire appeals process and would have absolutely--it 
goes to the very heart of this debate: Do we want health insurance 
companies deciding what is medically necessary, or do we want health 
care providers, doctors, and patients making the decisions?
  Mrs. FEINSTEIN. Who have seen the patient.
  Mr. EDWARDS. Absolutely, doctors who have seen the patients. We 
believe doctors ought to make the decisions.
  Mrs. FEINSTEIN. I thank the Senator very much. This has been a 
helpful clarification. I yield the floor.
  The PRESIDING OFFICER. Who yields time?
  Mr. NICKLES. Mr. President, I yield myself 5 minutes on the bill.
  The PRESIDING OFFICER. The Senator from Oklahoma is recognized for 5 
minutes on the bill.
  Mr. NICKLES. Mr. President, I was trying to make sure our colleagues 
understand the procedure in the Senate. When you have colloquies, you 
go through the Chair. I have noticed some colloquies on this side have 
bypassed the Chair. Some colloquies on that side have bypassed the 
Chair. That is not the rule of the Senate. It is important we have 
discussions according to the rules of the Senate. That is the way we 
should do it. That way, we do not freeze out other colleagues who want 
to participate in colloquies. I was not trying to get under my 
colleagues' skin. It is important we follow the rules of the Senate.
  I want to point out that a couple of the statements made by our 
colleagues are actually very inaccurate. Actually who pays for the 
plans and entities are very similar in both bills. Under the Democrat 
bill, S. 6, on page 66: A plan or insurer shall be conducted under 
contract between the plan or insurer in one or more qualified external 
appeals entities.
  That is page 66.
  Under the Republican bill, it is the same thing, the plan selects the 
entity. They do not select the person who does the review, they select 
the entity. The entity is licensed by the State, or it is a State 
agency established for that purpose, or it is an entity with a contract 
with the Federal Government and they have the reviewers.
  My point is, both the Democrat plan and the Republican plan select 
the entities. They are the same. For them to say, oh, the Republican 
plan selects the reviewer is false. The Democrat plan, as well as the 
Republican plan pay for the entities, they select the entities, and the 
entities themselves are independent, and the entities select the 
individual reviewer.

  There is a little--I do not want to use the word ``hypocrisy''; it is 
not a word I often use on the floor. But to be railing against the 
Republican plan, not stating the facts, and then say, oh, by the way; 
oh, the Democrat plan, the plan selects the entities as well, I just 
find it to be very inconsistent.
  I urge my colleagues to see that in the Republican plan, the proposal 
we have before us, we say the plans select the entity, and the entity 
is a qualified entity if it is an independent external reviewer and 
credentialed by the State or a State agency established for the purpose 
of conducting the external review, or it is an entity under contract 
with the Federal Government, or it is an entity accredited as an 
independent external review entity by an accrediting body recognized by 
the Secretary of HHS.
  I just mention that. It is important we be consistent and that people 
understand on both sides, the Democrat proposal selects an entity very 
similar to that of the Republican proposal.
  I yield the floor.
  The PRESIDING OFFICER. Who yields time?
  Mr. KENNEDY. I yield 1 minute to the Senator from California and then 
1 minute to the Senator from North Carolina.
  Mrs. FEINSTEIN. Mr. President, I must respond to the Senator from 
Oklahoma because he mischaracterizes the Democratic plan. His statement 
might be correct if it were taken in an isolated sense. But if you take 
it with the medical necessity definitions on page 85 of the Democratic 
plan, you will see that ``a group health plan and a health insurer, in 
connection with a provision of health insurance coverage, may not 
arbitrarily interfere with or alter the decision of the treating 
physician regarding the manner or setting in which particular services 
are delivered if the services are medically necessary or appropriate 
for treatment.''
  Then it goes on to define medical necessity as a service or benefit 
which is consistent with generally accepted principles of professional 
medical practice. It does not give the plan the opportunity in its fine 
print to throw out medical necessity.
  The PRESIDING OFFICER. The Senator's time has expired.
  Mr. KENNEDY. I yield the Senator 2 minutes.
  The PRESIDING OFFICER. The Senator from North Carolina is recognized 
for 2 minutes.
  Mr. EDWARDS. Mr. President, I say respectfully in response to my 
colleague from Oklahoma that there are two things about which I 
fundamentally disagree with him. No. 1, under our proposal, the State--
totally independent--chooses the reviewing body. If my colleagues are 
really looking for an independent review, I ask them whether they would 
agree to allow the State to choose the reviewing body instead of the 
health insurance company, instead of the HMO choosing the entity that 
chooses the reviewing body. I cannot imagine how they would disagree

[[Page S8356]]

with that if they are looking for a truly independent review.
  Secondly, the entire issue revolves around what is medical necessity. 
I say to my colleagues, would they agree to change the language of this 
amendment so that the initial decision and every appeals decision of 
the appeals deciding body is not bound by the definition of ``medical 
necessity'' contained in the insurance written contract? Because so 
long as the appeals process is controlled by what the HMO wrote, what 
the health insurance company wrote at the beginning and all the way 
through the process, the patient does not have a chance. They will 
never have a chance. My question is to my colleagues----
  Mr. GREGG. Will the Senator yield?
  Mr. EDWARDS. I will give the Senator an opportunity to respond. My 
question is whether they will agree, No. 1, with the State choosing a 
truly independent reviewing body, and, No. 2, whether they will agree 
that the reviewing body is not bound by a definition written by the 
health insurance or HMO company.
  I yield for a question.
  The PRESIDING OFFICER. The Senator's time has expired.
  Who yields time?
  Mr. GREGG. We have no time.
  Mr. FRIST. We have 5 minutes.
  Mr. KENNEDY. I yield 1 minute to the Senator for a question.
  Mr. GREGG. I appreciate that.
  Mr. KENNEDY. Does the Senator still have time left?
  The PRESIDING OFFICER. The majority side controls 5 minutes 20 
seconds, the minority side, 5 minutes 4 seconds.
  Mr. GREGG. Mr. President, I have a question for the Senator from 
North Carolina which is in reference to the Kennedy bill, section 133, 
subsection (1)(ii), on page 67:

       If an applicable authority permits--

  That will be the State authority--

       more than one entity to qualify as a qualified external 
     appeals entity with respect to a group health plan or health 
     insurer issuer, then the plan or issuer may select among such 
     qualified entities the applicable plan.

  So basically if the State picks two or three different reviewers, 
under your plan, then the plan gets to choose; isn't that correct?
  Mr. FRIST. Whose time is this on?
  The PRESIDING OFFICER. On the majority side.
  Mr. FRIST. I yield another 30 seconds.
  Mr. GREGG. So there is an option under your proposal where plans 
would have a choice because that is what the language says?
  The PRESIDING OFFICER. Who yields time?
  Mr. EDWARDS. Am I allowed to respond?
  Mr. KENNEDY. I yield the Senator 1 minute.
  The PRESIDING OFFICER. The Senator is recognized for 1 minute.
  Mr. EDWARDS. My response is very simple.
  The language on the preceding page requires that the independent 
external review entity be designated by the State. That is, if I am 
reading the language correctly, contained on the preceding page. That 
is designated by the State. In fact, we say--this is at page 11, I say 
to the Senator--that ``No party to the dispute shall be permitted to 
select the entity conducting the review.''
  So there are two things operating, I think, in combination in our 
bill. No. 1, the State has to designate an independent body, and, No. 
2, we specifically require that no party to the dispute be involved in 
designating the reviewing entity.
  I might add to that, I think it is also critically important who 
determines what is medically necessary and what the appeal decision 
body is bound by in terms of what is medically necessary because I 
think all of this becomes meaningless if they are bound by what the HMO 
or health insurance company wrote.
  The PRESIDING OFFICER. The time has expired.
  Mr. GREGG. Will the Senator yield me another 30 seconds?
  Mr. FRIST. How much time do we have?
  The PRESIDING OFFICER. Four minutes 20 seconds. The minority has 4 
minutes.
  Mr. FRIST. I yield 30 seconds to the Senator.
  Mr. GREGG. I, therefore, take it in the Kennedy plan, when it says, 
``the plan or issuer may select among such qualified entities,'' that 
that language is not operative, that that does not exist, that that 
language is a nonfactor.
  Let's get serious. This is what your bill says. It says the plans can 
be selected from the qualified entities. You can pick two or three 
plans, that the States have chosen to qualify two or three plans, and 
the people pick the plans. So you are totally inconsistent with your 
argument.
  Mr. EDWARDS. May I respond?
  The PRESIDING OFFICER. Who yields time?
  Mr. KENNEDY. I yield the Senator 30 seconds.
  The PRESIDING OFFICER. The Senator from North Carolina is recognized 
for 30 seconds.
  Mr. EDWARDS. There is a very simple, straightforward answer to the 
question. I understand the Senator is reading the old bill. He is not 
reading the bill that is presently before the Senate.
  The PRESIDING OFFICER. Who yields time?
  Mr. FRIST. Mr. President, I yield 4\1/2\ minutes--how much time is 
remaining?
  The PRESIDING OFFICER. The majority side controls 4 minutes on the 
amendment.
  Mr. FRIST. Mr. President, I yield the remaining time to the Senator 
from Wyoming.
  Mr. GREGG. Would the Senator yield me 10 seconds? Because a 
misstatement was made.
  Mr. FRIST. I yield another 30 seconds to the Senator from New 
Hampshire.
  Mr. GREGG. I am reading from S. 6. That is the bill that was laid 
down. That is the bill we are debating.
  The PRESIDING OFFICER. Who yields time?
  Mr. FRIST. I yield 4\1/2\ minutes to the Senator from Wyoming.
  The PRESIDING OFFICER. There are only 3 minutes 50 seconds remaining 
on the majority side. The Senator from Wyoming is recognized for that 
time.
  Mr. ENZI. Mr. President, I rise in strong support of improved, 
reliable quality care for all Americans. To that end, I am pleased to 
join my colleagues in debating the dangerous concept of putting into 
law a definition of medical necessity.
  The minority argues that putting a definition of medical necessity 
into the law would assure health care providers absolute autonomy in 
making all treatment decisions for their patients. They say that is 
exactly what they want. It is their prescription for high quality 
health care.
  Well then, when asked what patients and providers would use as a 
guide for the choice of treatment options and delivery of care, 
particularly in such a dynamic and constantly innovating field such as 
health care, the minority relies squarely on ``generally accepted 
medical practice.''
  The Democrat plan is a trial lawyer's dream. ``Generally accepted 
medical practice'' is lawsuit bait. But I can tell you that with the 
Democrat plan ``medical necessity'' would be absolutely necessary 
because it is the only way to bridge the bureaucracy.
  This is the bill we are looking at from the Democrats. Who can follow 
the lines? Each one of those lines represent a lawsuit trap. This is 
lawsuit bait.
  Unfortunately, for patients, ``generally accepted medical practice'' 
is the strict application of medical opinion versus the combination of 
your doctor's good judgment or opinion and the prevailing evidence-
based practice of medicine. The minority approach turns its back on the 
scientific foundation of medicine. But what other solid ground is there 
upon which we could build greater quality into our health care system?
  The minority, for the first time in Federal law, wants to carve this 
variability into law, and that law will be followed by rule and 
regulation--more lawsuit bait. This is a Federal one-size-fits-all 
budget-busting bureaucracy with lots of lawsuit bait and difficulty in 
following the whole process.
  Let me share with my colleagues the language from the minority bill. 
Under the subtitle of ``Promoting Good Medical Practice,''--a good 
title--lies a provision which, in my estimation, would have the exact 
opposite effect. The bill reads:

       A group health plan, and a health insurance issuer in 
     connection with the provision

[[Page S8357]]

     of health insurance coverage, may not arbitrarily interfere 
     with or alter the decision of the treating physician 
     regarding the manner or setting in which particular services 
     are delivered if the services are medically necessary or 
     appropriate for treatment or diagnosis to the extent that 
     such treatment or diagnosis is otherwise a covered benefit.

  Now, let me loop through the rest of their proposal to demonstrate 
how they essentially ``ban'' the use of trustworthy science and 
evidence-based medicine. At the end of the same subtitle, we are 
offered a definition of medical necessity or appropriateness. It reads, 
``medically necessary or appropriate means, with respect to a service 
or benefit, a service or benefit which is consistent with generally 
accepted principles of professional medical practice.''
  To recap the minority policy proposal, they've suggested that doctors 
make decisions about their patients based just on opinion, and that 
health plans would, by law, have to cover any and every treatment 
opinion prescribed by providers. The minority may argue that their 
proposal limits what plans must pay for to the terms of the contract. 
However, their plan requires plans to cover all treatments deemed 
medically necessary, so this provision would, in fact, encompass the 
universe of health care, heedless of quality and contract alike.
  It's my opinion, and a major thrust of the Republican bill, that we 
should be doing everything we can to help health care providers in 
their efforts to provide the highest possible quality of care to 
patients. The minority tells doctors, who are now busier than ever and 
doing their best to stay atop the innovations in medicine, that ``it's 
all on you.''
  Mr. President, since there has been an effort to infuse real life 
examples into this debate, it might be helpful for all of the health 
care consumers at home if we talk about how medical science versus 
``generally accepted practices'' actually translates into real life. In 
the following examples, you'll begin to understand that ``generally 
accepted practices'' vary from town to town, and the gap gets wider 
from state to state. This basically means that the quality of your 
health care may depend more on where you live than on what the 
prevailing best medical science is on your illness.

  Here's an example where I can use my home state of Wyoming. The 
average number of days spent in the hospital during the last 6 months 
of life for people living in Wyoming was between 4.4 days and 8 days. 
In contrast, the average number of days spent in the hospital for the 
last 6 months of life for people living in New York was between 12 and 
22 days. This means that there is nearly a 250 percent variation among 
States for hospital length-of-stay at the end of life. Who's 
responsible for this variation and what does it mean about the quality 
of care we're receiving?
  More importantly, how does this jibe with legislating a definition of 
medical necessity? Remember, the minority want us, for the first time, 
to carve this variability into law. The law will be followed by rule 
and regulation. Does this mean that for health plans that have 
beneficiaries in Wyoming and in New York that what might be determined 
a medically appropriate treatment for a New Yorker would be deemed 
medically inappropriate for a patient in Wyoming?
  This variation is comprehensive, going beyond hospital lengths-of-
stay, from the use of drug therapies to surgical practices. One of the 
most disheartening and horrifying statistic is regarding women with 
breast cancer. Despite the solid evidence that women who undergo 
breast-sparing surgery followed by chemotherapy or radiation and women 
who undergo radical mastectomies have similar survival rates, it is 
regional preferences, that is, the general practices of a region, that 
still prevail in determining a woman's course of treatment. In 1996, 
women with breast cancer in Rapid City, SD were 33 times less likely to 
have breast-sparing surgery than women in Elyria, OH. How can anybody 
look at these variations and view them as the only answer to good 
medicine?
  These inconsistencies in the medical care Americans receive are 
something we all need to address; that includes health plans and 
doctors, and ourselves. Make no mistake about our potential as Congress 
to derail the efforts at quality improvement in American's health care 
if we're not very careful and very thoughtful about what it is we're 
doing here today.
  On a positive note, we are seeing signs of improvement when it comes 
to doctors and health plans working together to improve the consistency 
and overall quality of health care. For example, according to a 1997 
Quality Compass report by the National Committee on Quality Assurance, 
over 50 percent of elderly heart attack patients in HMOs that submitted 
data were treated with beta blockers, which can reduce mortality rates 
by 75 percent in those patients. In the same year, patients in regular 
fee-for-service plans received beta blocker only 21 percent of the 
time. This is almost a three-fold difference when you compare a 
coordinated approach to care with a ``generally accepted practices'' 
approach.

  I am very concerned that we need to pass a proposal that responds to 
these ``consistent inconsistencies'' in the quality and practice of 
medicine in this country, while also guarding the doctor-patient 
relationship. After all, outside of family, many of us view our 
relationship with our doctor as our most trusted.
  The solution lies in building on the doctor-patient relationship and 
infusing our health care system with evidence-based medicine. Our bill 
does that. Our bill does not turn a blind eye to either the strengths 
or the weaknesses of today's health care system. Our bill takes a look 
at what we need to preserve and what we need to improve upon, and 
offers a responsible solution to enhancing quality and ensuring access.
  Our bill will provide patients and their doctors with a new, iron 
clad support system that will insure access to medically necessary 
care. An independent, external appeals process will be available for 
patients whose plan has initially denied a treatment request that the 
patient and doctor have decided is necessary. In other words, our bill 
gets patients the right treatment, right away. And it's based on the 
independent decision of a medical professional who is expert in the 
patient's health care needs. In rendering a decision on the medical 
necessity of the treatment request, the expert review will consider the 
patient's medical record, evidence offered by the patient's doctor and 
any other documents introduced during the internal review. This covers 
the ``generally accepted practice'' standard that the minority offers 
as a singular solution.
  Our bill goes further, capturing the other half of good quality 
health care, which is the evidence-based medicine rooted in science 
that I spoke about earlier. We would require the expert reviewer to 
also consider expert consensus and peer-reviewed literature and 
evidence-based medical practices. Let me say that again; evidence-based 
medicine, not the varied, town-by-town, tried but not necessarily true, 
general practice of medicine.
  Because we feel so strongly about preserving the trusted relationship 
between doctors and patients by providing them with the best evidence-
based medicine in making treatment decisions, we've included another 
lynchpin in our bill. We establish the Agency for Healthcare Research 
and Quality, whose purpose it is to foster overall improvement in 
health care quality, firmly bridging the gap between what we know about 
good medicine and what we actually do in health care today. The Agency 
is built on the platform of the current Agency for Health Care Policy 
and Research, but is refocused and enhanced to become the hub and 
driving force of Federal efforts to improve the quality of health care 
in all practice environments.
  The Agency will assist, not burden physicians, by aggressively 
supporting state-of-the-art information systems for health care 
quality. This is in stark contrast to the minority proposal, which 
would require the Secretary of Health and Human Services to Mandate a 
new, onerous data collection bureaucracy. The Agency would support 
research in primary care delivery, priority populations and, critical 
to my state of Wyoming, access in underserved areas. Most important 
with regard to this research, is that it would target quality 
improvement in all types of health care, not just managed care. The 
Agency would also conduct

[[Page S8358]]

statistically and scientifically accurate, sample-based surveys, using 
existing structures, to provide high quality, reliable data on health 
outcomes. Last, the Agency would achieve its mission of promoting 
quality by sharing information with doctors, health plans and the 
public, not tying it up in the knots of an expanded Federal 
bureaucracy. We need to assist the providers on the front lines. Their 
job is to make clinical decisions. We need to give them the tools to 
make these medical decisions based on the proven medical advances made 
every day through our investment in medical research. It would be a 
huge mistake to put the Secretary and a Federal bureaucracy between 
doctors and patients.
  Clearly, medical necessity is a long and complicated issue. It is 
also where the rubber meets the road on improving the quality of 
medicine in the purest sense. This is where we all must pony up on the 
true intent of our proposals regarding medical necessity. This is where 
we peel away the rhetoric and reveal the true implications of our 
vastly different standards regarding the quality of care we are willing 
to demand for Americans. I, for one, am demanding that my constituents 
get the best care possible, with a solid basis in proven, quality, 
evidence-based medicine and timely access to the advancements and 
innovations in health care.
  Mr. President, I understand and greatly respect the role of doctors 
and all health care providers in this country. It is for that very 
reason that I support the creation of a new, independent appeals 
mechanism to support their efforts in treating their patients. This, in 
conjunction with strengthening the health care system through strong 
Federal support for access to evidence-based medicine.
  Mr. President, I reserve the remainder of my time.
  The PRESIDING OFFICER. Who yields time?
  Mr. KENNEDY addressed the Chair.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, much of this debate may seem technical, 
but the definition of medical necessity and a fair and independent 
appeals process are at the heart of any serious effort to end insurance 
company abuse. Our plan has it; their program does not. That is why 
Consumers Union--the outfit that publishes Consumer Reports--calls the 
Republican program ``woefully inadequate'' and ``far from 
independent.''
  No one supports their program but the insurance companies and the 
HMOs, the very organizations that profit from the abuses of the status 
quo. Their program is opposed by the American Cancer Society, and 
virtually every cancer organization in the country. It is opposed by 
the American Heart Association. It is opposed by the disability 
community. It is opposed by the women's community, and the people who 
represent children. These are the patient groups that have the most to 
lose from low quality and the most to gain from high quality. And they 
lose under the Republican program.
  This amendment will determine whether Senators stand with the 
patients or with the HMOs.
  We yield back the remainder of our time and are prepared to vote.
  Mr. NICKLES addressed the Chair.
  Mr. KENNEDY. I reserve my time.
  Mr. NICKLES. Just to clarify, I think my colleague from Massachusetts 
spoke incorrectly. The insurance industry does not support our 
amendment. I think he said that they do. He happens to be factually 
wrong. I would like to have the Record be clear. We ought to be stating 
facts and we ought to be stating the truth. What he said was not 
correct. They do not like our bill, either. They have not supported our 
bill.
  My colleague from Massachusetts earlier said they wrote our bill. He 
is absolutely wrong. I just want to make sure people have the facts.
  Mr. President, I will yield back the remainder of our time.
  First, I ask unanimous consent that at the expiration of debate time 
on the pending amendment, votes occur on the following pending 
amendments: amendment No. 1238, medical necessity, that is the pending 
amendment; the next amendment would be amendment No. 1236, which is the 
cost cap, limiting it to 1 percent; the next amendment would be 
amendment No. 1235 which deals with emergency rooms, by Senator Graham; 
the next amendment would be amendment No. 1234, deductibility for the 
self-employed; and the next amendment would be amendment No. 1233, 
dealing with the scope.
  I further ask unanimous consent that following the first vote, there 
be 4 minutes equally divided for closing remarks prior to the beginning 
of each vote.
  Mr. KENNEDY addressed the Chair.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Reserving the right to object, and I will not object, 
just in response to the Senator's earlier statement, I wonder why the 
insurance companies are spending more than $2 million opposing our 
program.
  Mr. NICKLES addressed the Chair.
  The PRESIDING OFFICER. Is there objection?
  Mr. KENNEDY. Mr. President, I reserve the right to object. Unless I 
am entitled to speak, I will object, Mr. President.
  Mr. CHAFEE addressed the Chair.
  Mr. KENNEDY. Mr. President, I withdraw my objection.
  The PRESIDING OFFICER. Is there objection?
  Without objection, it is so ordered.
  Mr. CHAFEE. I wonder if we could have an agreement that on the 
successive votes the Senator from Oklahoma outlined there be a 10-
minute break, or whatever he suggests, in there.
  Mr. NICKLES. I think our friend from Rhode Island has made a good 
suggestion. I suggested possibly doing that. I think we will possibly 
do that after the first vote.
  The PRESIDING OFFICER. Is there an objection to the request? Without 
objection, it is so ordered.
  Mr. NICKLES. For the information of all of our colleagues, we are now 
getting ready to begin a series of votes, beginning with the first vote 
dealing with medical necessity. We expect there will be four votes 
tonight, so I encourage all our colleagues to come to the floor to 
vote.
  I encourage all of our colleagues to stay on the floor because it is 
our intention to reduce the time allotted to each vote to 10 minutes 
after the first vote.
  Mr. REID. Reserving the right to object----
  Mr. NICKLES. I did not make a UC.
  Mr. REID. Are we going to allow a minute of explanation? Is that in 
the unanimous consent request?
  Mr. NICKLES. Under the unanimous consent that has already been agreed 
to, we have 4 minutes equally divided.
  Mr. REID. I missed that. I apologize.
  The PRESIDING OFFICER. Does the Senator from Massachusetts yield back 
the remainder of his time?
  Mr. KENNEDY. Just 30 seconds of the time to point out, in response to 
the comments of the Senator from Oklahoma, the insurance industry has 
just spent $2 million in opposition to our program, which basically 
includes the provisions so eloquently commented on by the Senators from 
California and North Carolina. Zero has been spent by the insurance 
companies in opposition, to my best understanding, to the Republican 
proposal. If it looks like a duck and quacks like a duck, it is a duck.
  This is the insurance company's proposal, the HMO proposal. They are 
the ones that will gain if this amendment of the Republicans is 
accepted. There is no question about that. It is the disabled, the 
cancer groups, and the children who will gain if our proposal prevails.
  I yield back the remainder of the time.
  Mr. NICKLES. Mr. President, I yield back the remainder of my time.
  The PRESIDING OFFICER. The question is on agreeing to amendment No. 
1238.
  The yeas and nays have not been ordered.
  Mr. NICKLES. Mr. President, I ask for the yeas and nays on the 
amendment.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.
  The PRESIDING OFFICER. The question is on agreeing to amendment No. 
1238. The yeas and nays have been ordered. The clerk will call the 
roll.
  The result was announced--yeas 52, nays 48, as follows:

[[Page S8359]]

                      [Rollcall Vote No. 199 Leg.]

                                YEAS--52

     Allard
     Ashcroft
     Bennett
     Bond
     Brownback
     Bunning
     Burns
     Campbell
     Cochran
     Collins
     Coverdell
     Craig
     Crapo
     DeWine
     Domenici
     Enzi
     Frist
     Gorton
     Gramm
     Grams
     Grassley
     Gregg
     Hagel
     Hatch
     Helms
     Hutchinson
     Hutchison
     Inhofe
     Jeffords
     Kyl
     Lott
     Lugar
     Mack
     McCain
     McConnell
     Murkowski
     Nickles
     Roberts
     Roth
     Santorum
     Sessions
     Shelby
     Smith (NH)
     Smith (OR)
     Snowe
     Specter
     Stevens
     Thomas
     Thompson
     Thurmond
     Voinovich
     Warner

                                NAYS--48

     Abraham
     Akaka
     Baucus
     Bayh
     Biden
     Bingaman
     Boxer
     Breaux
     Bryan
     Byrd
     Chafee
     Cleland
     Conrad
     Daschle
     Dodd
     Dorgan
     Durbin
     Edwards
     Feingold
     Feinstein
     Fitzgerald
     Graham
     Harkin
     Hollings
     Inouye
     Johnson
     Kennedy
     Kerrey
     Kerry
     Kohl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lincoln
     Mikulski
     Moynihan
     Murray
     Reed
     Reid
     Robb
     Rockefeller
     Sarbanes
     Schumer
     Torricelli
     Wellstone
     Wyden
  The amendment (No. 1238) was agreed to.
  Mr. LOTT. I move to reconsider the vote.
  Mr. NICKLES. I move to lay that motion on the table.
  Mr. LOTT. Mr. President, I ask unanimous consent that remaining votes 
in this series be limited to 10 minutes in length. I urge Senators to 
stay in the Senate Chamber or not to go any farther than the cloakrooms 
so we can actually hold these next three votes to 10 minutes. Please do 
so. Senator Daschle and I intend to cut off the vote after about 10 or 
11 minutes. Please stay in the Chamber.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                           Amendment No. 1236

  The PRESIDING OFFICER. There are 4 minutes equally divided.
  Mr. NICKLES. Mr. President, I yield the Senator from Texas 1 minute.
  Mr. GRAMM. Mr. President, the Kennedy Patients' Bill of Rights drives 
up health care costs by 6.1 percent. It causes 1.8 million Americans to 
lose their health insurance. It raises the cost of health care for 
those who don't lose their health insurance by $72.5 billion. By 
driving up labor costs, it would destroy 194,041 jobs in the American 
economy by the year 2003. These are not our numbers. These are numbers 
based on estimates done by the CBO and private research firms that have 
used those numbers to project the economic impact.
  Our amendment simply says if the Kennedy bill drives up health care 
costs by more than 1 percent when it is fully implemented, or if it 
pushes more than 100,000 Americans off the private insurance rolls by 
driving up cost, then the law will not go into effect; it will be 
suspended.
  The PRESIDING OFFICER. Who yields time?
  Mr. REID. The Senator from Rhode Island is yielded 2 minutes.
  The PRESIDING OFFICER. The Senator from Rhode Island.
  Mr. REED. Mr. President, once again we hear the same old misestimate 
of the costs associated with the legislation. The true cost calculated 
by the Congressional Budget Office is 4.87 percent over 5 years. That 
is exactly what Senator Lott said on ``Meet The Press'' on July 11. In 
his words, ``By the way, the Democratic bill would add 4.8 percent 
cost. That is less than 1 percent a year.''
  Mr. GRAMM. Mr. President, may we have order. I can't hear the 
Senator.
  The PRESIDING OFFICER. The Senate will be in order. Those of you who 
have conversations, please take them to the Cloakroom. This is 
important debate.
  The Senator from Rhode Island.
  Mr. REED. I thank the Chair.
  As I indicated, the true cost is 4.8 percent over 5 years. ``That is 
less than 1 percent a year.'' That is what Senator Lott said on ``Meet 
The Press.'' Indeed, if you calculate that down to a monthly cost, it 
is about $2 extra a month to the average family paying health care 
premiums. It is not going to cause a huge eruption of costs.
  It is also to me somewhat disconcerting to think that the insurance 
industry is worried about people losing their health care coverage. 
They raise costs every day. They will raise costs to protect their 
profits.
  What this legislation wants to do is guarantee that there is quality 
in the American health care system.
  Make no mistake, this amendment is calculated and designed to 
undercut all the protections in the Patients' Bill of Rights. It is 
calculated within 2 years to undercut and remove all of the protections 
that are so necessary to the American family, which we are fighting 
for.
  This would be a recipe also to reward those companies that have 
excessive costs, and it would be virtually impossible to figure out 
what costs are associated with their need for profits versus what costs 
are associated with the increase in quality in the system. They would 
be doing the audits. They would essentially be exempting themselves. We 
are giving them a key to let them out of the responsibilities to their 
patients and to their consumers. We can't do that.
  This is just another red herring, another ruse, and another device to 
prevent the American people from achieving what they definitely want--
rights in the health care system.
  The PRESIDING OFFICER. The Senator's time has expired.
  The Senator from Oklahoma.
  Mr. NICKLES. Mr. President, just to correct my colleague from Rhode 
Island, he said the cost of the Kennedy bill is about $2 a month. That 
is not correct. That is not in CBO's report. CBO says most of the 
provisions would take full effect within the first 3 years, not 5 
years; not 1 percent, but a total of 6.1 percent. That is S. 6. That is 
what we are debating. That is what we are amending.
  We are saying that costs shouldn't increase by more than 1 percent.
  The Congressional Budget Office says the total costs would be $8 
billion in lost Social Security taxes and total lost wages would be $64 
billion. That is not a McDonald's hamburger. That is $64 billion in 
lost wages, according to the Congressional Budget Office. That is not a 
Republican insurance study. That was the Congressional Budget Office 
that said people would lose $64 billion in lost wages.
  They also said as a result of the Kennedy amendment that people would 
drop insurance entirely; would reduce the generosity of health benefit 
packages; they would increase cost sharing by beneficiaries.
  I urge my colleagues to vote for this amendment.
  The PRESIDING OFFICER. The Senator's time has expired.
  Mr. NICKLES. I ask for the yeas and nays on the amendment.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.
  The PRESIDING OFFICER. The question is on agreeing to Amendment No. 
1236, as amended. On this question, the yeas and nays have been 
ordered, and the clerk will call the roll.
  The legislative clerk called the roll.
  The PRESIDING OFFICER. Are there any other Senators in the Chamber 
who desire to vote?
  The result was announced--yeas 52, nays 48, as follows:

                      [Rollcall Vote No. 200 Leg.]

                                YEAS--52

     Abraham
     Allard
     Ashcroft
     Bennett
     Bond
     Brownback
     Bunning
     Burns
     Campbell
     Cochran
     Collins
     Coverdell
     Craig
     Crapo
     DeWine
     Domenici
     Enzi
     Frist
     Gorton
     Gramm
     Grams
     Grassley
     Gregg
     Hagel
     Hatch
     Helms
     Hutchinson
     Hutchison
     Inhofe
     Jeffords
     Kyl
     Lott
     Lugar
     Mack
     McCain
     McConnell
     Murkowski
     Nickles
     Roberts
     Roth
     Santorum
     Sessions
     Shelby
     Smith (NH)
     Smith (OR)
     Snowe
     Stevens
     Thomas
     Thompson
     Thurmond
     Voinovich
     Warner

                                NAYS--48

     Akaka
     Baucus
     Bayh
     Biden
     Bingaman
     Boxer
     Breaux
     Bryan
     Byrd
     Chafee
     Cleland
     Conrad
     Daschle
     Dodd
     Dorgan
     Durbin
     Edwards
     Feingold
     Feinstein
     Fitzgerald
     Graham
     Harkin
     Hollings
     Inouye
     Johnson
     Kennedy
     Kerrey
     Kerry
     Kohl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lincoln
     Mikulski
     Moynihan
     Murray
     Reed
     Reid
     Robb
     Rockefeller
     Sarbanes
     Schumer
     Specter
     Torricelli
     Wellstone
     Wyden
  The amendment (No. 1236), as amended, was agreed to.

[[Page S8360]]

  Mr. NICKLES. Mr. President, I move to reconsider the vote.
  Mr. CRAIG. I move to lay that motion on the table.
  The motion to lay on the table was agreed to.


                           Amendment No. 1235

  The PRESIDING OFFICER. The question is on the Graham of Florida 
amendment. There are 4 minutes equally divided.
  The Senator from Florida is recognized.
  Mr. GRAHAM. Mr. President, most of us here have already voted in 
favor of the amendment which is before us. In 1997 we adopted virtually 
this identical language as it relates to the 70 million Americans who 
are covered either by Medicare or Medicaid. So the question before us 
is, Should we adopt a different standard of emergency room care for the 
rest, for the other 190 million Americans?
  There are two principal differences between the current law for 
Medicare and Medicaid and what the Republican alternative would 
propose. First, as to access to the nearest available emergency room, 
the current Medicare/Medicaid law says you have the right to go to the 
nearest emergency room without any additional charge. That is the same 
provision that is in this amendment. The Republican provision says that 
a differential charge can be made so you would have to pay more if it 
happened that the closest emergency room was not an emergency room 
affiliated with your health maintenance organization.
  The second difference is poststabilization care. What is 
poststabilization care? I quote the language from the Medicare 
regulations:

       Poststabilization care means medically necessary 
     nonemergency services needed to assure that the enrollee 
     remains stabilized from the time that the treating hospital 
     requests authorization from the health maintenance 
     organization.

  Medicare and Medicaid beneficiaries get the benefit of 
poststabilization care. Our amendment would make that benefit available 
to all 190 million non-Medicare/Medicaid Americans. The Republican bill 
would not. It would not say that you are entitled to medically 
necessary services to continue you in a stabilized condition after you 
had contacted your HMO and received authorization to do so.
  The PRESIDING OFFICER. The time of the Senator has expired.
  Mr. GRAHAM. Mr. President, there is no reason why all Americans 
should not have the same benefits that we voted less than 3 years ago 
to make available to the 70 million Medicare and Medicaid 
beneficiaries.
  Mr. NICKLES. Mr. President, may we have order in the Senate.
  The PRESIDING OFFICER. The Senate will come to order.
  Mr. NICKLES. I yield 2 minutes to the Senator from Arkansas.
  The PRESIDING OFFICER. The Senator from Arkansas.
  Mr. HUTCHINSON. Mr. President, I say to my colleagues, in the area of 
emergency group services, both bills eliminate prior authorization, and 
they should. You should not have to call your insurance company before 
you go to the emergency room. Both bills establish a process for timely 
coordination of care, including services to maintain stability of the 
patient.
  I will be offering an amendment that will make it perfectly clear in 
the Republican bill that there can be no greater costs charged for 
those going to an out-of-network emergency room as those going to an 
in-network emergency room. There should not be a differential. I will 
make very certain in my amendment that there is no such differential.
  The Graham amendment is flawed, and it is seriously flawed because it 
uses language that is confusing for patients, confusing for plans and 
providers, it is vague and ambiguous, and it does not ensure that 
poststabilization services are related to the emergency condition. That 
is a gaping loophole. It is a blank check to say you have to provide 
services for a condition that is absolutely unrelated to the reason you 
went to the emergency room.
  My amendment I will be offering will fix that vague and ambiguous 
language to be sure that what is provided in the emergency room for 
poststabilization services are related to the condition for which the 
patient went to the emergency room.
  This is a very dangerous amendment in that it is vague and ambiguous 
and leaves a blank check, a gaping loophole that needs to be fixed. I 
ask my colleagues to reject the Graham amendment.
  Mr. NICKLES. Mr. President, I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.
  The PRESIDING OFFICER. The question is on agreeing to amendment No. 
1235. The yeas and nays have been ordered. The clerk will call the 
roll.
  The legislative clerk called the roll.
  The PRESIDING OFFICER. Are there any other Senators in the Chamber 
desiring to vote?
  The result was announced--yeas 47, nays 53, as follows:

                      [Rollcall Vote No. 201 Leg.]

                                YEAS--47

     Akaka
     Baucus
     Bayh
     Biden
     Bingaman
     Boxer
     Breaux
     Bryan
     Byrd
     Chafee
     Cleland
     Conrad
     Daschle
     Dodd
     Dorgan
     Durbin
     Edwards
     Feingold
     Feinstein
     Graham
     Harkin
     Hollings
     Inouye
     Johnson
     Kennedy
     Kerrey
     Kerry
     Kohl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lincoln
     Mikulski
     Moynihan
     Murray
     Reed
     Reid
     Robb
     Rockefeller
     Sarbanes
     Schumer
     Specter
     Torricelli
     Wellstone
     Wyden

                                NAYS--53

     Abraham
     Allard
     Ashcroft
     Bennett
     Bond
     Brownback
     Bunning
     Burns
     Campbell
     Cochran
     Collins
     Coverdell
     Craig
     Crapo
     DeWine
     Domenici
     Enzi
     Fitzgerald
     Frist
     Gorton
     Gramm
     Grams
     Grassley
     Gregg
     Hagel
     Hatch
     Helms
     Hutchinson
     Hutchison
     Inhofe
     Jeffords
     Kyl
     Lott
     Lugar
     Mack
     McCain
     McConnell
     Murkowski
     Nickles
     Roberts
     Roth
     Santorum
     Sessions
     Shelby
     Smith (NH)
     Smith (OR)
     Snowe
     Stevens
     Thomas
     Thompson
     Thurmond
     Voinovich
     Warner
  The amendment (No. 1235) was rejected.
  Mr. NICKLES. I move to reconsider the vote.
  Mr. HUTCHINSON. I move to lay that motion on the table.
  The motion to lay on the table was agreed to.


                           Amendment No. 1234

  The PRESIDING OFFICER. The question is on amendment No. 1234 by 
Senator Nickles for Senator Santorum. There are 4 minutes equally 
divided. Who seeks recognition?
  Mr. NICKLES. Mr. President, I yield the principal sponsor of the 
amendment, Senator Santorum, 1 minute.
  The PRESIDING OFFICER. The Senator from Pennsylvania is recognized.
  Mr. SANTORUM. Mr. President, I rise in strong support and encourage 
all my colleagues to support this amendment. The amendment does 
basically two things. No. 1, it establishes 100-percent deductibility 
for the self-employed, something for which I know many Members of both 
sides of the aisle have been striving. One of the things we have said 
about our health care proposal is that ours is much more comprehensive 
than the Democratic plan. It looks at the issue of access.
  Mr. NICKLES. Could we have order?
  The PRESIDING OFFICER. The Senate will please come to order. Again, 
this is an important debate.
  The Senator from Pennsylvania is recognized.
  Mr. SANTORUM. As I said, our bill is much more comprehensive. We 
looked at the question of access and making health insurance more 
affordable to cover more people, to bring them into the insurance 
market. Our bill, with this amendment, does that.
  The other thing we do is we emphasize that we do not want the Federal 
Government, the Health Care Financing Administration, to oversee State-
regulated plans. Almost all 50 States have passed a Patients' Bill of 
Rights. They traditionally regulate health insurance. They are doing a 
very good job. We do not need to impose HCFA regulations and HCFA 
control over every State insurance department. It is the wrong 
approach. It is Washington getting its teeth into the State pie. That 
is unnecessary.
  The PRESIDING OFFICER. The Senator's time has expired.

[[Page S8361]]

  Mr. DASCHLE. I yield 1 minute to the distinguished Senator from 
Massachusetts.
  The PRESIDING OFFICER. The Senator from Massachusetts is recognized.
  Mr. KENNEDY. Mr. President, this vote is directly related to whether 
the Senate is really interested in covering all Americans who have 
insurance or whether whatever passes applies to only the 48 million 
persons who are included in the Republican bill.
  In the House of Representatives, all of the leading Republican 
legislation applies to all patients with insurance through their 
private employers--the whole 123 million here. The proposals put 
forward by the House Republicans who happen to be doctors also cover 
the people in the individual market. But not the Senate Republican 
bill.
  It is an extraordinary irony, but HMOs are found in all of these 
other categories--under the 75 million, the 15 million, the 25 
million--not in self-funded employer plans. So the Republican bill does 
not even cover the individuals who first raised the whole question of 
whether their current coverage is adequate. Whatever we are going to 
do, Republican program or Democrat, let's make sure we provide 
protections to all patients. Every category here on this chart. That is 
what our amendment does.
  But their amendment would leave out more than 100 million Americans 
like Frank Raffa, a fire fighter for the city of Worcester, 
Massachusetts. He puts his life on the line every day, but he and 
millions of others are left out and left behind with the Republican 
program. Let's make sure we are going to cover all of them, all the 
workers in this country.
  The PRESIDING OFFICER. The time has expired.
  Who yields time?
  Mr. NICKLES. Mr. President, I yield 1 minute to the Senator from 
Missouri, Senator Bond.
  The PRESIDING OFFICER. Before the Senator from Missouri starts, the 
Senate will be in order.
  The Senator from Missouri.
  Mr. BOND. Mr. President, the opponents of this amendment overlook the 
fact that the States are involved. The States do regulate health 
insurance. The States are taking care of those they can cover.
  This amendment says we should not wipe out State regulation. It also 
completes the job of ending the tremendous inequity in our health care 
system which said formerly that self-employed people could only deduct 
25 percent of their health insurance premiums. Thanks to the bipartisan 
support we have had, we say now, by 2003, that there will be 100-
percent deductibility. Right now, however, there are 5.1 million 
uninsured, 1.3 million children. For the woman who is starting a new 
business, the fastest growing sector of our economy, she starts up an 
information technology business and she is not able to deduct 100 
percent of health care insurance for herself and her family until 2003. 
She cannot afford to wait to get sick until 2003.
  I urge my colleagues to support immediate deductibility.
  The PRESIDING OFFICER (Mr. Gorton). The distinguished minority leader 
is recognized.
  Mr. DASCHLE. Mr. President, I think the distinguished Senator from 
Pennsylvania had it right. We all support 100-percent deductibility for 
the self-employed. We just voted for it an hour or so ago. There is no 
question all of the Senate supports it. We are on record in support of 
it. The question is whether we should accelerate it. We just voted to 
accelerate it on this side on the Robb amendment. That isn't the 
question on this amendment. This amendment is about whether or not we 
offer 100 million additional Americans the patient protections under 
the Patients' Bill of Rights.
  In order to clarify that, I ask unanimous consent that the 
deductibility language be added to both the Republican bill, S. 1344, 
and the Daschle substitute.
  Mr. NICKLES. I object.
  Mr. DASCHLE. I ask unanimous consent that at least the deductibility 
amendment be allowed as part of the Kennedy amendment as well.
  Mr. NICKLES. I object.
  The PRESIDING OFFICER. Objection is heard.
  Mr. DASCHLE. That makes it very clear. This vote is about denying 
millions of Americans the right to patient protections, not about 
health and deductibility for self-employed businessmen.
  I yield the floor.
  The PRESIDING OFFICER. All time has expired.
  Mr. NICKLES. Mr. President, I ask for the yeas and nays on the 
amendment.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.
  The PRESIDING OFFICER. The question is on agreeing to amendment No. 
1234. The yeas and nays have been ordered. The clerk will call the 
roll.
  The assistant legislative clerk called the roll.
  The result was announced--yeas 53, nays 47, as follows:

                      [Rollcall Vote No. 202 Leg.]

                                YEAS--53

     Abraham
     Allard
     Ashcroft
     Bennett
     Bond
     Brownback
     Bunning
     Burns
     Campbell
     Cochran
     Collins
     Coverdell
     Craig
     Crapo
     DeWine
     Domenici
     Enzi
     Fitzgerald
     Frist
     Gorton
     Gramm
     Grams
     Grassley
     Gregg
     Hagel
     Hatch
     Helms
     Hutchinson
     Hutchison
     Inhofe
     Jeffords
     Kyl
     Lott
     Lugar
     Mack
     McCain
     McConnell
     Murkowski
     Nickles
     Roberts
     Roth
     Santorum
     Sessions
     Shelby
     Smith (NH)
     Smith (OR)
     Snowe
     Stevens
     Thomas
     Thompson
     Thurmond
     Voinovich
     Warner

                                NAYS--47

     Akaka
     Baucus
     Bayh
     Biden
     Bingaman
     Boxer
     Breaux
     Bryan
     Byrd
     Chafee
     Cleland
     Conrad
     Daschle
     Dodd
     Dorgan
     Durbin
     Edwards
     Feingold
     Feinstein
     Graham
     Harkin
     Hollings
     Inouye
     Johnson
     Kennedy
     Kerrey
     Kerry
     Kohl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lincoln
     Mikulski
     Moynihan
     Murray
     Reed
     Reid
     Robb
     Rockefeller
     Sarbanes
     Schumer
     Specter
     Torricelli
     Wellstone
     Wyden
  The amendment (No. 1234) was agreed to.
  Mr. NICKLES. Mr. President, I move to reconsider the vote.
  Mr. LOTT. I move to lay that motion on the table.
  The motion to lay on the table was agreed to.


                     Amendment No. 1233, As Amended

  The PRESIDING OFFICER. The question now is on agreeing to amendment 
No. 1233, as amended.
  The amendment (No. 1233), as amended, was agreed to.
  Mr. DODD addressed the Chair.
  The PRESIDING OFFICER. The Senator from Connecticut is recognized.


                Amendment No. 1239 To Amendment No. 1232

(Purpose: To provide coverage for individuals participating in approved 
      clinical trials and for approved drugs and medical devices)

  Mr. DODD. Mr. President, I send an amendment to the desk and ask for 
its immediate consideration.
  The PRESIDING OFFICER. The clerk will report.
  The legislative clerk read as follows:

       The Senator from Connecticut [Mr. Dodd] for himself, Mrs. 
     Boxer, Mr. Harkin, Mr. Kennedy, Mr. Reid, Mrs. Murray, Mr. 
     Durbin, Mr. Rockefeller, Mr. Feingold, Mrs. Feinstein, and 
     Mr. Daschle, proposes an amendment numbered 1239 to amendment 
     No. 1232.

  Mr. DODD. Mr. President, I ask unanimous consent that reading of the 
amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (The text of the amendment is printed in today's Record under 
``Amendments Submitted.'')
  Mr. DODD. Mr. President, I offer this amendment on behalf of myself, 
Senators Harkin, Boxer, Feingold, Feinstein, Johnson, Rockefeller, 
Kennedy, Murray, and Reid of Nevada.
  As I understand it, we will debate it briefly this evening, and then 
it will be one of the first orders of business tomorrow morning.
  This amendment has two parts to it. It would ensure that patients 
have access to the best possible care in two areas--cutting edge 
clinical trials and medically necessary prescription drugs.
  Until recently, health plans routinely paid for the doctor and 
hospital costs associated with clinical trials, and many still do. But 
a growing number of insurance plans are now refusing to pay, disrupting 
an arrangement that

[[Page S8362]]

immediately benefited individual patients and advanced our ability to 
treat future patients.
  As my colleague from Vermont will recall from our debate in the 
Health and Education Committee, which he chairs, this amendment is a 
moderate one. It would require insurance plans to cover the costs of a 
patient's participation in clinical trials in only those circumstances 
that meet the following criteria: One, the clinical trial must be 
sponsored or funded by the National Institutes of Health, the 
Department of Defense, or the Veterans' Administration; two, the 
patient must fit the trial protocol; three, there is no other effective 
standard treatment available for the patient; four, the patient has a 
serious or life-threatening illness.
  It seems to me that if a patient's situation meets those criteria, 
insurance plans ought not to deny access to clinical trials. This ought 
not to be a controversial proposal.
  Let me lastly add that the plan's obligation is to pay only for the 
routine patient costs, not for the costs of running the trial that 
ought to be paid for by the sponsor of the trial--such as the 
experimental drug or medical device.
  The cost of providing coverage for clinical trials is negligible. 
After all, similar routine patient costs for blood tests, physicians' 
visits, and hospital stays are covered for standard treatment anyway.
  The Congressional Budget Office found that this patient protection 
would increase premiums a mere four-tenths of a percent over the next 
10 years. That is less than 12 cents per person per month.
  Many researchers believe even this minuscule amount is a dramatic 
overstatement of the cost. In fact, when the Memorial Sloan-Kettering 
Cancer Center, and the MD Anderson Cancer Center compared the cost of 
clinical trials to standard cancer therapies, both of these world-
renowned cancer centers found that the average cost per patient 
actually was lower for those patients enrolled in clinical trials. So 
it actually can save money to give patients access to clinical trials, 
if you believe Sloan-Kettering and the Anderson Cancer Center.
  The American Association of Health Plans--the trade association for 
the managed care plans--has urged its members to allow patients to 
participate in clinical trials and to pay the associated doctor and 
hospital costs. Let me quote from a news release of the American 
Association of Health Plans. They said:

       AAHP supports patients having access to NIH-approved 
     clinical studies, and supports individual health plan 
     linkages with NIH-sponsored clinical trials. AAHP also 
     believes that it is appropriate for health plans choosing to 
     participate in NIH research studies to pay the routine 
     patient-care costs associated with these trials.

  This is the very trade association of the insurance plans urging its 
members to allow access to clinical trials and suggesting they ought to 
pick up the cost
  The release goes on to cite the benefits of participating in clinical 
trials for patients and for the advancement of medicine.
  We are asking that health plans do nothing more than what they 
already said they want and they intend to do.
  The Republican proposal? What do they say about the clinical trials? 
They say the managed care bill should study this issue further. With 
all due respect, further studies will only cause unnecessary delays. We 
already have answers to many of the questions they want to study. We 
know what hinders a patient's participation in clinical trials. It is 
the plans' refusal to pay for them. We know what the costs are. They 
are minuscule. And plans presumably have figured out how to 
differentiate between costs of running the trials and costs of patient 
care since many of them already are doing it.
  All we would get from another year of delay is more patients with 
life-threatening conditions being denied access to research that can 
save their lives.
  I know this does not have to be a partisan issue. Republicans have 
not only supported related legislation but some--including Senator 
Mack, and my colleague, Senator Snowe who is on the floor, and Senator 
Frist--have been leaders on this issue. Our good friend and colleague 
from Maine, Senator Snowe, has authored excellent legislation widely 
supported, I might add, by patient groups which would broadly provide 
access to almost all clinical trials for all privately ensured 
patients. I commend her for that bill. Thirteen of our Republican 
colleagues have cosponsored the Mack-Rockefeller bill that would 
require Medicare to cover the cost of cancer clinical trials. The 
Representative from my State, Republican Congresswoman Nancy Johnson, 
has introduced a companion bill with several Republican cosponsors.
  What I am offering has broad bipartisan support in a variety of 
legislative proposals. All we are saying is this Patients' Bill of 
Rights ought to include it.
  Clearly, there is bipartisan interest in making sure patients all 
over this country with breast cancer, colon cancer, liver cancer, 
congestive heart failure, lupus, Alzheimer's, Parkinson's, diabetes, 
AIDS, along with a host of other deadly illnesses, have access to 
cutting-edge treatments. To allow a plan to deny a patient access to 
clinical trials is an outrage.

  I hope this body will find it in its good judgment to adopt this 
amendment tomorrow when it comes up for a vote and to allow people to 
have access to these critical clinical trials.
  The second part of this amendment deals with prescription drugs.
  Nearly all HMOs and other insurance plans use a preferred list called 
a formulary to extract discounts from drug companies and to save on 
drug costs. Many of the best plans already take steps to ensure these 
formularies aren't unreasonably rigid by putting processes in place 
that allows patients access to nonformulary medicines when their own 
doctors say those drugs are absolutely needed. In fact, the HMO trade 
association supports this practice as part of its Code of Conduct for 
member plans.
  Why would a patient need a drug that is not in the plan's formulary? 
Patients have allergies in some cases to drugs on the formulary. They 
may be taking medications that would have bad interactions with the 
plan's preferred drugs, or simply have a medical need for access to 
some product that is not listed in the formulary--rather commonsensical 
reasons.
  Without access to a reasonable process for making exceptions to the 
formulary, patients may be forced to try two or three different types 
of older, less effective medications and demonstrate that those drugs 
don't work or have negative side effects before the plan would allow 
access to offer formulary prescription drugs.
  No patient, in my view, should be exposed to dangerous side effects, 
or ineffective treatment, just because the cheaper drug in their plan 
that was chosen does not work as well as the one their doctor would 
recommend.
  I was pleased that during our committee markup our chairman, who is 
on the floor, and our Republican colleagues agreed to support a portion 
of the protection in the Democratic Patients' Bill of Rights plan that 
relates to access to prescription drugs. I will point out that, as with 
the majority of provisions in the Republican bill, even its limited 
protection would be denied to more than 100 million Americans whose 
employers don't self-insure their own health care coverage.
  In addition, their provision contains a significant loophole that 
needs to be corrected. The Republican proposal requires plans to 
provide access to drugs off the formulary. However, it also says that 
the insurers can charge patients whatever they want to get those off-
formulary products, even if they are medically necessary, and even if 
the drug is the only drug that can save that patient's life.
  This subverts the purported intent of the very provision the 
Republican bill proposes; and that is to ensure that patients have 
access to medically necessary care. If a determination has been made by 
a doctor and the plan that a patient needs that specific drug and no 
other, why should that patient be subjected to higher costs--
conceivably even a 99-percent copay?
  The issue is not about patients simply preferring one brand over 
another. Our concern is for patients for whom a certain product is 
medically necessary. It is inconceivable they should be charged more 
for the care they need just because it doesn't make the plans 
formulary. This amendment would remedy that situation.

[[Page S8363]]

  Lastly, our amendment would also address another roadblock that 
patients encounter trying to get life-saving prescription drugs. That 
is the practice of a plan issuing blanket denials on the ground that a 
drug is experimental even when it is an FDA-approved product.
  If there is any question in your mind why the plans would resort to 
such a practice, I think it's useful to listen to their own 
explanation. In a letter to the majority leader in July of last year, 
the American Association of Health Plans, Blue Cross and Blue Shield, 
and the Health Insurance Association of America wrote:

       If health plans are not allowed to deny coverage on the 
     basis that the device is investigational, the health plans 
     would have to perform a much more costly case-by-case review 
     on the basis of ``medical necessity''.

  They state the case for me.
  In other words, according to the health plans themselves, their fear 
is that if they are prevented from issuing blanket, unfounded denials 
they might actually have to look at an individual patient's medical 
needs.
  These two provisions of this amendment are critically important. 
Patients need access to clinical trials and they need access to 
prescription drugs. It doesn't get more basic than that.
  Denying access to clinical trials doesn't just deny good care to the 
patient today who is desperately in need of a cure, but it denies state 
of the art health care to future patients as well, by impeding the 
development of knowledge about new therapies.
  Senator Mack, Senator Snowe, and many others have strongly supported 
legislation in this area. Some of their bills go further than my 
amendment does.
  I hope tomorrow when the vote occurs we will have the support of a 
broad bipartisan coalition.
  Mr. REID. Will the Senator yield?
  Mr. DODD. I am happy to yield to the Senator.
  Mr. REID. I say to my friend from Connecticut, isn't it true we spend 
billions of dollars at the National Institutes of Health, the Veterans' 
Administration, and the Department of Defense on medical research that 
can only be made effective if they have clinical trials?
  Mr. DODD. That is correct. The process of finding cures starts with 
an unknown product first being tested in the laboratory. The second 
place it is tested is with animals. Third is the clinical trial before 
it is on the market for general use.
  If insurers impede enrollment in clinical trials that phase of 
research development will be adversely affected and valuable, life-
saving products will be delayed from getting on the market for general 
use by the public.
  It is an excellent question.
  Mr. REID. I say to my friend, all the money, the billions and 
billions of dollars, spent by the entities I previously talked about, 
the money we spend is basically worthless unless we can have clinical 
trials.
  Mr. DODD. To answer my colleague from Nevada, the Senator is 
absolutely correct. This is a tremendous waste of taxpayer money. There 
are those, I suppose, who are only concerned about that issue. I 
appreciate the Senator raising the point because it is indeed a waste 
of money.
  It is also a waste of human lives. I think that people watching this 
debate here on the floor of the Senate will ask the question: What did 
the Senate do when it had a chance to protect my family, my child, my 
wife or my husband, to give them access to the cutting edge 
technologies when my insurer says no. I think they will be outraged if 
we don't provide them this protection.
  In addition to the monetary cost issue, which our distinguished 
friend from Nevada has raised, to cause a human life to be lost because 
we denied access to clinical trials, I argue, is an even greater loss.
  Mr. REID. There have been some who say it is too expensive. The 
Senator is aware of plans that have cut off clinical trials because it 
is ``too expensive.''
  What I hear my friend saying is, the real expense is in the pain and 
suffering of the families who suffer from Parkinson's, Alzheimer's, 
lupus, and all the other diseases that the Senator has outlined so 
clearly.

  Is it not true that is where the real suffering comes and that is 
where the expense comes--in the pain and suffering to those people--if 
we don't allow the clinical trials?
  Mr. DODD. I appreciate the question of my colleague.
  He is absolutely correct. I will make a dollars-and-cents case. The 
cost is 12 cents per patient per month, a negligible cost.
  As I mentioned in earlier remarks, when Sloan-Kettering Cancer 
Institute and the MD Anderson Cancer Center examined the issue of 
cost--two world-class cancer research centers--their conclusion was 
that clinical trials are actually less costly than the standard care 
that will be used in the absence of clinical trials. ``Less costly'' is 
their conclusion.
  If your argument is we cannot do this because it costs too much, one 
estimate suggests 12 cents per patient per month, and two of the world-
class cancer centers in the world think it is actually a lower cost 
using the clinical trials.
  Mr. REID. The final question I ask my friend from Connecticut: Isn't 
it true that huge amounts of money will be saved if these clinical 
trials are proved effective? The Senator knows that half the people in 
our rest and extended care facilities are there because of Parkinson's 
and Alzheimer's.
  Assume, for example, that these clinical trials would delay the onset 
of one of these two diseases or if some miracle would occur we could 
cure those diseases. Would that save this country money?
  Mr. DODD. The cost in savings would be astronomical.
  When we delay a product going from the research phase to general use 
because patients are shut out of clinical trials, not only do patients 
today suffer, but future patients suffer, and the costs to the health 
care system as a whole go up.
  AIDS is a wonderful example of this--the AIDS clinical trials have 
saved literally thousands of lives. People are working today who would 
not have been able to do so had it not been for clinical trials that 
helped to develop powerful new drugs. Imagine if the treatments that 
exist today existed a few years ago, what a different world it would be 
and how many lives would not have been lost--productive citizens today 
who would make a contribution to our society.
  I reserve the remainder of our time.
  Mr. JEFFORDS. Mr. President, I commend my good friend on the 
committee for the work he has done in this area. This is an area where 
we have joined together. It will ensure that we have a change, a 
positive change in the clinical trial aspect. I want to work together 
with the Senator in that regard.
  I also want to say this bill is not finished yet. We have places to 
go and time to spend to bring it to a better form than it is now. I 
look forward to continuing to work to improve the bill.
  I reserve the remainder of my time.
  Mr. DODD. How much time remains?
  The PRESIDING OFFICER. The Senator from Connecticut has 29 minutes 33 
seconds, and the Senator from Vermont has 49 minutes 15 seconds.
  Mr. REID. Mr. President, I think we are ready to do wrap-up.
  Mr. JEFFORDS. That is my intention.
  Mr. REID. The time has stopped running on the bill for both the 
majority and minority.
  Mr. McCAIN. Mr. President, this evening I cast several difficult 
votes regarding core principles facing this body as we work to ensure 
the health care rights of Americans are protected.
  I voted for an amendment creating an external appeals process for 
patients who are denied medical care by their health plan. While I 
strongly support this initiative, I am concerned that this specific 
proposal needs further strengthening ensuring that the individual 
health care rights of Americans are the priority. I will be working 
with my colleagues on both sides of the aisle to strengthen the 
external appeals process, including access to reasonable legal remedies 
while ensuring that the external review process is conducted by 
unbiased and independent entities whose sole purpose is to protect the 
rights of American patients.
  In addition, I support guaranteeing an individual medical care in an 
emergency room without prior approval from their HMO if the person 
believes that it is an emergency situation. However, I was forced to 
vote against an

[[Page S8364]]

amendment which provided this protection but then superseded state 
rights and created an opportunity for emergency rooms to begin 
providing a litany of treatments outside of the realm of the perceived 
emergency which could have negative financial repercussions.
  Finally, I support providing American women with direct access to OB/
GYNs and ensuring they receive quality health care while battling 
breast cancer. However, I was forced to vote against an amendment 
providing this critical access because it eliminated an important 
provision ensuring that health care costs do not skyrocket thereby 
causing thousands, if not millions of new Americans to lose their 
health care coverage.
  Mr. CAMPBELL. Mr. President, today I take this opportunity to comment 
on the pending bill.
  In my view, what we are discussing today is the most costly big-
government health care plan since the Clinton health care reform plan 
was debated earlier this decade. We all know the fate of that attempt, 
and it is my hope we might now allow common sense to play a part in 
creating a Patients' Bill of Rights.
  The demands on our health care system have changed dramatically in 
the past decade. So has our health care system. But, those changes have 
not affected all people evenly, and it's clear many people have had 
unfortunate experiences.
  Going from the traditional doctor-patient relationship into a system 
where all aspects of care are subject to approval and authorization is 
understandably difficult. But, as the cost of quality care became an 
obstacle to access, the concept of managing care has evolved as the 
predominate method of insured medical service.
  While health care in America, and our advances in medical technology 
remain the envy of the world, it would be a serious mistake to pretend 
that all are well-served by our present health care system.
  The Federal Government, in an effort to give all Americans access to 
affordable care, has, in fact, encouraged participation in managed care 
plans. All federally-sponsored health care, which includes Medicare, 
Medicaid, the Federal Employees Health Benefit program and military 
health care, has experienced the emergence of managed care. Now we must 
deal with the issue of ensuring health care quality as a first 
priority. And we must do it in a way that will not raise costs of care 
or cause employers to stop offering health insurance.
  While managed care has become the dominant delivery method of cost-
effective healthcare in our nation, what is missing are standards that 
will ensure fairness to both patients and providers, and clarify what 
are often confusing medical and legal terms and hidden rules for both 
parties. The question before us now is how best to protect these 
patients while giving the health care industry incentives for finding 
efficient methods of delivering care.
  All of us expect the highest quality health care for the citizens of 
this country, but, that care must be affordable. Anyone that believes 
having Congress dictate a costly, one-size-fits-all mandate will make 
health care more affordable or more available is, I believe, severely 
out of touch with reality.
  That is why I am concerned about the pending legislation. This bill 
mandates new regulations which would increase premiums by 6.1 percent, 
not including inflation. It could raise the cost of a typical family's 
health insurance policy by more than $300 per year. That is not 
logical, responsible or acceptable. We have been down this road before 
with the ``catastrophic health'' bill of 10 years ago. The Senate 
passed it because people were told premium increases would be minimal. 
Then people got their bill. This pending bill will drive up the number 
of uninsured Americans. In my State of Colorado, it is estimated that 
this legislation would add more than 32,000 persons to the rolls of the 
uninsured. Our biggest health care problem already is that there are 
currently 43.5 million uninsured Americans. Who pays for their 
inevitable medical care? You, I, and every other taxpayer. It is clear 
that increased mandates increase costs, and that those increased costs 
reduce coverage.
  It is no secret that higher health insurance premiums will force 
employers to drop optional medical coverage they offer employees. That 
should not be the intention of this legislation, but it is the reality. 
Every time a mandate raises the cost of insurance by one percent, more 
than 200,000 Americans lose their coverage.
  Small businesses would drop coverage if exposed to the pending bill's 
liability provisions. Canceling coverage leaves patients exposed to 
expensive medical bills. That's not patient protection. We cannot pass 
legislation that forces employers to provide health care. They will 
close shop, because they can't afford it. The pending bill will lead to 
government-run health care. The bill's mandates could cost the private 
sector more than $56 billion, greatly exceeding the annual threshold 
established in the Unfunded Mandates Reform Act, which most Members of 
this body voted for.
  Many States are currently developing patient-protection legislation 
through their State legislatures and assemblies. My State of Colorado 
has already established mandates concerning an independent external 
review process for denied claims, a ban on gag clauses, and direct 
access to OB-GYN services.
  Despite that fact, the pending bill, in an attempt to tighten federal 
control over the entire U.S. health system, applies federal mandates to 
all health insurance products.
  Mr. President, I believe it is time to put the brakes on the runaway 
one-size-fits-all mandates which are inflicting hardship on our most 
vulnerable citizens and legitimate health care providers. The time to 
protect patients and providers is before costly mandates are enacted 
into law.
  Let us think ahead. We have already seen through our experience with 
the Balanced Budget Act of 1997, that well-intentioned solutions 
enacted by Congress can turn into unworkable, burdensome regulations 
when imposed on the entire health care system. We are discussing 
sweeping legislation which, if passed and enacted, will have 
significant consequences for all Americans and their health care. I 
believe we can best protect these Americans by making reasonable 
changes which give them more choices. Let's provide access to 
affordable, quality care without inventing unnecessary new federal 
mandates for an already top-heavy health care structure.
  I believe the Republican Patients' Bill of Rights Plus will do just 
that. It will improve quality of care and expand consumer choice as 
well as protect patients' rights.
  It will hold HMOs accountable for providing the care they promised. 
It places treatment decisions in the hands of doctors, not lawyers. 
And, patients have the right to coverage for emergency care that a 
prudent lay-person would consider medically necessary.
  The purpose of our bill is to solve problems when care is needed, not 
later after harm has occurred. Common sense demands we act reasonably. 
More importantly, the future health care of hundreds of millions of 
Americans demands we act with their interests in mind.
  I thank the Chair.
  Mr. ALLARD. Mr. President, in the 1970s, the State of Colorado 
adopted a well-child care law, legislation concerning the treatment of 
alcoholism and mental health, as well as legislation concerning 
insurance coverage of psychologists. In the 1980s home health care, 
hospice care, and mammography screening legislation was passed into 
law. In the 1990s, those who represent the people of Colorado in the 
State House saw fit to pass laws concerning the coverage of nurses, 
nurse midwives, nurse anesthetists, nurse practitioners, psychiatric 
nurses, the continuation of coverage for dependents and employees, and 
conversion to non-group health care.
  This decade the Colorado Legislature also passed consumer grievance 
procedures, children's dental anesthesia and general dental provisions, 
direct access to OB-GYN, direct access to midwives for OB-GYN, 
emergency room services legislation, a ban on gag clauses, prostate 
cancer screening, breast reconstruction, maternity stay, and mental 
health parity legislation. Last, but certainly not least, among State 
laws enacted in my home State is a law concerning independent external 
appeals

[[Page S8365]]

for patients and a comprehensive Patients' Bill of Rights, passed in 
1997.
  I am proud to have served in the Colorado State Senate, and I am 
proud to say that today I represent a state that has been responsive 
and aggressive in addressing health care issues and patients' rights.
  At the same time, Mr. President, I am deeply troubled that there are 
those in this body who are advocates of Senator Kennedy's Patients' 
Bill of Rights that would preempt a number of the laws that I just 
mentioned in the State of Colorado. In this country of 260 million 
Americans throughout the fifty states I believe that the people of 
those States are in the best position to make these specific decisions. 
I come from our nation's 8th largest State with a population of just 
3.9 million people. I will not assume that any federal entity is more 
prepared to develop policy for Colorado than the people of Colorado, 
nor would I impose the policies unique to Colorado's needs on another 
State.
  Something I find equally troubling is that in addition to infringing 
on the laws of the State of Colorado, the legislation that Senator 
Kennedy and the Democrats have developed has the potential to increase 
health care costs, deprive 1.9 million Americans of health insurance 
who are currently covered, and cast heavy mandates down on individual 
states who are in a far better position to make these decisions for 
themselves.
  I will speak today about a number of things I believe will enhance 
the quality of health care, increase access to care, and provide 
important protections for patients without unnecessarily placing 
mandates on individual states. These provisions are all part of a 
comprehensive package called the Patients' Bill of Rights Plus Act, 
which I feel properly addresses the needs of America's patients, 
physicians and health care providers.
  The Patients' Bill of Rights Plus Act establishes consumer protection 
standards for self-funded plans currently governed by the Employee 
Retirement and Income Security Act (ERISA). 48 million Americans are 
currently covered by plans governed by ERISA--these are American health 
care consumers who are not under the jurisdiction of state laws.
  Our bill would eliminate gag rule clauses in providers' contracts and 
ensure that patients have access to specialty care. The legislation 
also requires that health plans that use formularies to provide 
prescription medications ensure the participation of doctors and 
pharmacists in the construction of the formulary. Further addressing 
patient choice and access, health plans would be required to allow 
women direct access to obstetricians and gynecologists, and direct 
access to pediatricians for children, without referrals from general 
practitioners.
  These provisions are important steps in removing barriers that may 
prevent patients covered under ERISA from receiving necessary and 
proper treatment in a timely manner.
  As a former small business owner I have a keen understanding of the 
issues that confront the self-employed. I also have experience in 
balancing the wages and benefits you extend to an employee with a 
healthy bottom line. I think it is important that we remember 
throughout the course of this debate that employers provide health care 
benefits as a voluntary form of compensation for their employees. We 
must be wary of legislation that will increase costs and liability for 
employers in a way that may reduce the quality and scope of benefit 
packages for employees.
  Our bill, the Patients' Bill of Rights Plus, would make health 
insurance deductible for the self-employed and increase the 
availability of medical savings accounts. I believe that each of these 
provisions would give greater power to the individual and make private 
insurance more affordable for families and individuals. Large 
corporations can claim a 100 percent deduction for health care and 
small business should be treated the same.
  Medical savings accounts, otherwise known as MSAs, combine a high 
deductible and low cost catastrophic policy with tax free savings that 
can be used for routine medical expenses. We should increase the 
availability to all families who desire MSAs. These efforts will prove 
particularly helpful to those individuals working for small business, 
and those in transition from one job to another since MSAs are fully 
portable.
  I want to stress that our legislation will not mandate these accounts 
for everyone, but will simply establish the accounts as an option to 
those who feel they will be best served by MSAs. I believe that medical 
savings accounts are particularly important for uninsured, lower income 
Americans. Allowing consumers to pay for medical expenses through these 
affordable tax-deductible plans, tailored to their needs, is a viable 
free-market approach to decreasing the number of uninsured in America. 
This is a question of providing greater choice for health care 
consumers.
  The Patients' Bill of Rights Plus Act would also permit the carryover 
of unused benefits from flexible spending accounts, again increasing 
the number of options available to the consumers of health care.
  In keeping with presenting more options to the consumer, The 
Patients' Bill of Rights Plus Act includes language that would require 
all group health plans to provide a wide range of comparative 
information about the health coverage they provide. This information 
would include descriptions of health insurance coverage and the 
networks who provide care so that consumers covered by self insured and 
fully insured group health plans can make the best decisions based on 
their needs and preferences.
  One of the most contentious issues in health care has been the issue 
of malpractice liability, grievance procedures and the mechanism for 
the appeal of decisions made by managed care companies. My colleagues 
across the aisle are interested in taking the grievance procedure into 
a court of law, allowing a patient greater access to litigation as a 
means of challenging a managed care organization's decision.
  Lawsuits and the increased threat of litigation will demand that more 
money to be funneled into non-medical administration and away from what 
patients really want--quality health care. Furthermore, making the 
courts a de facto arbiter of health care decisions seems to me to be 
less efficient and less effective in dealing with the interests of the 
patient. The Kennedy bill is an enormous gift for the trial lawyers in 
America who stand to profit by high cost, long-term cases. Patients, 
not lawyers, will fare far better under the Patients' Bill of Rights 
Plus.
  I am also concerned that expanding medical malpractice liability will 
lead to more defensive medical decisions regardless of the merit of a 
particular treatment. High liability exposure and cost has driven 
countless physicians from their profession for years, particularly in 
high-need rural areas.
  This is not a provision we can afford in rural areas of western 
States like Colorado that are already under-served.
  Rather than take health care out of the doctor's office and into the 
courts, the Patients' Bill of Rights Plus Act establishes strict time 
frames for internal and external appeals for the 124 million Americans 
who receive care from self insured and fully insured group plans. 
Routine requests would need to be completed within 30 days, or 72 hours 
in specific cases when a delay would be detrimental to the patient. 
Rather than use the courts in cases of health care appeals our 
legislation would establish a system of independent, internal and 
external review by physicians with appropriate expertise. We are 
talking about doctors with years of experience and medical training 
making health care decisions, not legal arguments.
  I believe that such a system will be more responsive and more 
tailored to the needs of every individual patient--and it will do so 
without creating unnecessary bureaucracy. It is also important to note 
that these internal and external appeals will cost patients and 
employers considerably less than the alternative proposal that is heavy 
on lawsuits, lawyers and litigation.
  Another area of concern that I believe needs to be incorporated in 
any sensible managed care reform legislation is the inclusion of 
protections for patients from genetic discrimination. The Patients' 
Bill of Rights Plus Act would prohibit all group health plans and 
insurers from denying coverage or adjusting premiums based on 
predictive genetic information. The protected genetic information 
includes an

[[Page S8366]]

individual's genetic tests, genetic tests of family members, or 
information about the medical history of family members.
  No one should live in fear of being without health care based on 
genetic traits that may not develop into a health problem.
  Mr. President, I believe these provisions will empower the 
individual, not the lawyers or bureaucracies. I am committed to the 
notion that each individual American consumer of health care is in the 
best position to chose where his or her health care dollar is best 
spent.
  An administrative issue involved in this debate that I am very 
concerned with is the effort to attempt to force all health plans--not 
just HMOs--to report the medical outcomes of their subscribers and the 
physicians who treat them. This makes sense for a managed care plan 
such as an HMO, but it would be virtually impossible for a PPO or 
indemnity plan to monitor and classify this data without becoming 
involved in individual medical cases.
  I believe that if we require all health plans to collect and report 
data like this we will be requiring all plans to be organized like an 
HMO. This would significantly reduce the number of choices consumers 
and employers currently enjoy in selecting their health care.
  The Congressional Budget Office recently determined that if S. 6, the 
Kennedy version of the Patients' Bill of Rights, were to pass that this 
country would see private health insurance premiums increase 6.1 
percent above inflation. What appears to be a minor increase to health 
care premiums would have disastrous and immediate consequences around 
the country, adding 1.9 million Americans to the ranks of the 
uninsured. In my home state that translates to 32,384 people. In 
Colorado the average household would lose $203 in wages and 2,989 jobs 
would be lost by 2003 for this ``minor'' increase.
  We are talking about people in Colorado losing their jobs and their 
health care coverage because Washington wants to do what the State of 
Colorado has been working on for the last thirty years.
  The Congressional Budget Office determined that our bill, the 
Patients' Bill of Rights Plus Act, would increase costs by less than 1 
percent. While I urge my colleagues to be wary of any potential 
increase in costs for the American people, I also believe that the 
Patients' Bill of Rights Plus, and not the current Kennedy bill, 
directly addresses health care quality issues and increases choice for 
consumers with a minimal cost.
  Mr. AKAKA. Mr. President, I rise today to speak on a very important 
piece of legislation--legislation that is vital to the future of health 
care in this country, the Patients' Bill of Rights. Democrats have 
fought long and hard to debate this bill on the floor of the Senate and 
I am thankful for the opportunity to speak in support of the underlying 
measure.
  Today more than 160 million Americans, over 75 percent of the insured 
population, obtain health coverage through some form of managed care. 
Managed care arrangements can and do provide affordable, quality health 
care to large numbers of people. Yet reports of financial consideration 
taking precedence over patients health needs deserve our attention. We 
hear stories and read news articles about people who have paid for 
health insurance or received employer-sponsored insurance, became ill, 
only to discover that their insurance does not provide coverage. Recent 
surveys indicate that Americans are increasingly worried about their 
health care coverage. 115 million Americans report having a bad 
experience with a health insurance company or knowing someone who has. 
This undermining of confidence in our health care system must be 
addressed. We must act to restore the peace of mind of families in 
knowing that their health insurance will be there when they need it 
most. We can accomplish this by establishing real consumer protections, 
restoring the doctors decision-making authority, and ensuring that 
patients get the care they need.
  Some of the important issues that we are debating include the scope 
of coverage, definition of who determines ``medically necessity,'' 
protecting the doctor/patient relationship, access to care, and 
accountability.
  True managed care reform cannot come from a narrow bill that covers 
only a certain segment of the population. Today much of the regulation 
of managed care plans comes form the states. However, federal laws such 
as the Employee Retirement Income Security Act of 1974 (ERISA) and the 
Health Insurance Portability and Accountability Act, combined with the 
various state regulations, form a patchwork of regulation for managed 
care plans. Some in this chamber believe that the protections we are 
considering should only apply to ERISA-covered plans and not to the 113 
million Americans who have private insurance that is regulated by the 
states. They argue that these issues should be left to the states to 
address. Democrats believe that everyone deserves equal protection, 
regardless of where they may live or work. The Patients' Bill of Rights 
would not interfere with patient protection laws passed by the states, 
it would simply extend these patient protection rights to all 
Americans.
  As managed care has grown, so has the pressure on doctors and other 
health care providers to control costs. Complaints receiving widespread 
attention include denials of necessary care, lack of accountability, 
limited choice of providers, inadequate access to care, and deficient 
information disclosure for consumers to make informed plan decisions. 
Mr. President, a strong Patients' Bill of Rights should address the 
shortcomings of managed care. S. 6 takes a comprehensive approach in 
dealing with these issues, which is why I am a cosponsor of the 
measure.
  The dominance of managed care has undermined the doctor-patient 
relationship. Often tools are used to restrain doctors from 
communicating freely with patients or providing them with incentives to 
limit care. We need to ensure that insurers cannot arbitrarily 
interfere in the medical decision making. The Patients' Bill of Rights 
includes a number of provisions to prevent arbitrary interference by 
insurers. Our bill establishes an independent definition of medical 
necessity, prohibits gag clauses on physicians and other restrictions 
on medical communications, and protects providers from retaliation if 
they advocate for their patients.
  The issue of who decides what is medically necessary is probably the 
most fundamental issue of this debate. We must empower patients so they 
receive appropriate medical treatment, not necessarily the cheapest 
treatment, not necessarily the treatment that an insurance company 
determines is appropriate, but the best treatment. Currently, many 
doctors are finding insurance plans second-guessing and overriding 
their medical decisions. Democrats believe that the ``medical 
necessity'' of patient care should be determined by physicians, 
consistent with generally accepted standards of medical practice. 
Doctors are trained to diagnose and make treatment decisions based on 
the best professional medical practice. We need to keep the medical 
decisions in the hands of doctors and not insurance company 
bureaucrats.
  Families in managed care plans often face numerous obstacles when 
seeking access to doctors and health care services. Some of these 
barriers include restrictions on access to emergency room services, 
specialists, needed drugs, and clinical trials. S. 6 would ensure 
access to the closest emergency room, without requiring prior 
authorization. It would provide access to qualified specialists, 
including providers outside of the network if the managed care 
company's choices are inadequate, and direct access to obstetricians 
and gynecologists for women and pediatricians for children. S. 6 would 
also ensure access to drugs not included in a managed care plan's 
covered list when medically indicated and provide access to quality 
clinical trials.
  Finally, the underlying bill allows consumers to hold managed care 
companies accountable for medical negligence. Currently, insurers make 
decisions with almost no accountability. Patients deserve the right to 
a timely internal appeal and an unbiased external review process when 
they disagree with a decision made by the insurer. Patients also 
deserve recourse when the misconduct of managed care plans results in 
serious injury or death. However, under ERISA plans, patients have no 
right to obtain remedy under state

[[Page S8367]]

law. These patients are limited to the narrow federal remedy under 
ERISA, which covers only the cost of the procedure the plan failed to 
pay for. S. 6 would ensure that managed care companies can be held 
accountable for their actions. It does not establish a right to sue, 
but prevents federal law from blocking what the states deem to be 
appropriate remedies. A strong legal liability provision will 
discourage insurers from improper treatment denials or delays and 
result in better health care.
  Mr. President, only a comprehensive bill will guarantee patient 
protection with access to quality, affordable health care. We should 
not miss this important opportunity to enact meaningful legislation 
that is federally enforceable and will improve care and restore 
confidence in our health care system.

                          ____________________