[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]
CAN IMPROVED COMPLIANCE WITH THE REGULATORY FLEXIBILITY ACT RESUSCITATE
SMALL HEALTH CARE PROVIDERS?
=======================================================================
HEARING
before the
COMMITTEE ON SMALL BUSINESS
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
__________
WASHINGTON, DC, APRIL 10, 2002
__________
Serial No. 107-53
__________
Printed for the use of the Committee on Small Business
U.S. GOVERNMENT PRINTING OFFICE
79-640 WASHINGTON : 2002
________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512�091800
Fax: (202) 512�092250 Mail: Stop SSOP, Washington, DC 20402�090001
COMMITTEE ON SMALL BUSINESS
DONALD MANZULLO, Illinois, Chairman
LARRY COMBEST, Texas NYDIA M. VELAZQUEZ, New York
JOEL HEFLEY, Colorado JUANITA MILLENDER-McDONALD,
ROSCOE G. BARTLETT, Maryland California
FRANK A. LoBIONDO, New Jersey DANNY K. DAVIS, Illinois
SUE W. KELLY, New York BILL PASCRELL, Jr., New Jersey
STEVE CHABOT, Ohio DONNA M. CHRISTENSEN, Virgin
PATRICK J. TOOMEY, Pennsylvania Islands
JIM DeMINT, South Carolina ROBERT A. BRADY, Pennsylvania
JOHN R. THUNE, South Dakota TOM UDALL, New Mexico
MICHAEL PENCE, Indiana STEPHANIE TUBBS JONES, Ohio
MIKE FERGUSON, New Jersey CHARLES A. GONZALEZ, Texas
DARRELL E. ISSA, California DAVID D. PHELPS, Illinois
SAM GRAVES, Missouri GRACE F. NAPOLITANO, California
EDWARD L. SCHROCK, Virginia BRIAN BAIRD, Washington
FELIX J. GRUCCI, Jr., New York MARK UDALL, Colorado
TODD W. AKIN, Missouri JAMES R. LANGEVIN, Rhode Island
SHELLEY MOORE CAPITO, West Virginia MIKE ROSS, Arkansas
BILL SHUSTER, Pennsylvania BRAD CARSON, Oklahoma
ANIBAL ACEVEDO-VILA, Puerto Rico
Doug Thomas, Staff Director
Phil Eskeland, Deputy Staff Director
Michael Day, Minority Staff Director
C O N T E N T S
----------
Page
Hearing held on April 10, 2002................................... 1
Witnesses
Sullivan, Hon. Thomas, Chief Counsel for Advocacy, U.S. Small
Business Administration........................................ 7
Nielsen, David, M.D., Representing American Academy of
Otolaryngology................................................. 8
Jones, Warren, M.D., Representing American Academy of Family
Physicians..................................................... 12
Evans, Zachary, President, National Association of Portable X-Ray
Providers...................................................... 14
Harroun, Mary, President, Merry Walker Corporation............... 16
Appendix
Opening statements:
Manzullo, Hon. Donald........................................ 32
Christensen, Hon. Donna Christian............................ 35
Ross, Hon. Mike.............................................. 39
Prepared statements:
Sullivan, Hon. Thomas........................................ 40
Nielsen, David............................................... 47
Jones, Warren................................................ 52
Evans, Zachary............................................... 60
Harroun, Mary................................................ 215
Additional Information:
Submission from Congresswoman Christian-Christensen.......... 267
CAN IMPROVED COMPLIANCE WITH THE REGULATORY FLEXIBILITY ACT RESUSCITATE
SMALL HEALTHCARE PROVIDERS?
----------
WEDNESDAY, APRIL 10, 2002
House of Representatives,
Committee on Small Business,
Washington, DC.
The Committee met, pursuant to call, at 10:06 a.m. in room
2360, Rayburn House Office Building, Hon. Donald Manzullo
presiding.
Chairman Manzullo. The Committee will come to order. First
of all, I want to thank the witnesses for showing up. I want
the record to indicate that two weeks ago our office received a
letter that Administrator Scully would be appearing at this
hearing. And I want that letter to be made part of the record.
Subsequent to that time, Mr. Scully has expressed a desire
that he wanted to be on the panel by himself. And the Chairman
of Small Business Committee sets the rules, not the witnesses.
And one of the reasons that we like to put people from the
Administration on panels with the people that are affected by
Administration directives is the fact that the purpose of this
Committee is to solve problems. We are problem-solvers.
Mrs. Velazquez and I have had over 40 hearings. And in all
of those hearings we have been in total agreement on every
issue that was brought up at the hearings at the full Committee
level. And the reason for that is the fact that we are here to
represent small businesses, how they are affected by rules and
regulations.
We unfortunately had to issue an subpoena last night to Mr.
Scully. The subpoena was duly served. Mr. Scully appeared in
this Committee room approximately 15 minutes ago he advised our
staff that notwithstanding the Congressional subpoena, that he
was not going to appear today at this hearing.
We, of course, will take every precaution necessary and
every measure necessary, because we represent small
businesspeople. And he did not like the fact that he had to
appear at a table with lobbyists, end of quote. And we said it
is important that you appear at the table with people who are
affected by regulation. Tom Sullivan is part of the
Administration; it does not bother him to be here.
So it is very disheartening that the person who is in
charge of making all the rules and regulations for the delivery
of health care services, for Medicare and Medicaid,
purposefully, willfully, intentionally is ignoring a subpoena
of the Chairman of the Small Business Committee of the United
States House of Representatives.
This is extremely, extremely serious. But notwithstanding
that, we are going to have the hearing. And I am going to
encourage the members of the Committee to address their
questions to the empty chair.
Mr. Scully put his testimony on the table. His testimony
will not be admitted into the record. The testimony of all the
other witnesses will be admitted into the record, the full and
complete written testimony. In addition to that, I am going to
leave the record open for a couple of weeks. Anybody who wants
to submit testimony to be part of this record can do so. Keep
your comments to under two typewritten pages, and get those to
Mr. Pineles, who is seated next to me.
The purpose of this hearing is to complement what President
Bush said on March 19, 2002. He is a Member of the
Administration. He should be; he is a great President.
But he stated that `every agency is required to analyze the
impact of new regulations on small businesses before issuing
them. This is important law.
The problem is that it has often been ignored. The law is
on the books. The regulators do not care that the law is on the
books. From this day forward they will care that the law is on
the books. We want to enforce the law.' End of quote. That is
what President Bush said on March 19 of 2002.
I concur with the President, the law must be enforced. This
Committee will play its part in ensuring that the regulators
comply with the law because it is important to small
businesses.
This is the first hearing to ensure that the regulators
will care that the law is on the books. The Health Care
Financing Administration, or HCFA as I will continue to refer
to it, not by the new name--you know, you do not change the
nature of a substance by giving it a new name. It is still the
old name. Unfortunately, the old habits continue. I am not
going to refer to it as the CMS, because they have not deserved
the dignity of being given a new name unless they come up with
a new product.
Today's hearing focuses on HCFA's compliance with the
Regulatory Flexibility Act, or RFA. In particular, the
Committee will be examining HCFA's analysis, or more to the
point the lack of analysis, in implementing the physician fee
schedule.
HCFA's failure to comply with RFA in developing the
physician fee schedule is emblematic of an endemic problem at
HCFA. The regulators do not care that RFA is on the books. From
this day forward, HCFA will care that the RFA is on the books.
And I may issue a subpoena every day to Mr. Scully to have him
come here, and just for the purpose of showing up and asking
questions, so he will learn that he is an unelected official.
The purpose of this Committee, one of the purposes is
oversight. We oversee, they show up; they do not determine the
rules. The Committee is not interested in excuses or crabbed
interpretation by lawyers at HCFA to avoid compliance with RFA.
The Committee expects that HCFA, if it wants to demonstrate
that it is a new agency, will comply with the RFA. HCFA should
evaluate the cost of the regulations on small health care
providers, and examine alternatives that are less burdensome to
our health care providers.
I would now yield to our ranking Minority Member for an
opening statement.
Ms. Velazquez. Thank you, Mr. Chairman. Today's hearing is
the fourth in a series of hearings we have convened to examine
the Center for Medicare and Medicaid Services, and its heavy
impact on small businesses.
We are here to hold accountable this very aloof federal
agency for ignoring the law that requires it to reach out and
involve small businesses in drafting the regulations that
affect them the most.
The Regulatory Flexibility Act has been in effect for more
than 20 years. Yet federal agencies still feel free to ignore
its mandate. Well, I want to ask the chief representative of
CMS what he does not understand about following the law.
Doctors and dentists in private practice are the
quintessential small businesses. In fact, two-thirds of all
doctors' offices employ fewer than 25 workers. Most dentists
are solo practitioners with no more than four employees. This
means that the great bulk of our medical serviceproviders lack
the resources they need to absorb administrative burdens and costs put
upon them by federal paperwork and regulation requirements.
With Medicare the burdens are extreme. The senior health
insurance compensation system has more than 10,000 pages of
rules, policies, and regulations. The effect of this complexity
should be obvious.
A recent survey indicated one-third of doctors spend one
hour on Medicare paperwork for every one to four hours of
patient care. For dentists, this burden can be outright
debilitating.
And the end result is what should really concern us. These
health care providers get fed up with the hassle and decreasing
compensation, so they stop taking new Medicare patients.
Making matters worse is the operation of the Centers for
Medicare and Medicaid Services. This agency has been
particularly delinquent in reaching out to small business
during the development of regulations. This is one of the
requirements of Reg Flex that the agency has chosen to ignore.
Regulations can be fair, balanced, and provide the
necessary protection to our health, welfare, and environment.
CMS must work to determine the impact its regulations have on
small businesses, explore the regulatory options for reducing
that impact, and allow itself to be held accountable for the
final choice on a regulatory approach.
Mr. Chairman, I just would like to add that the action and
behavior of Mr. Scully today are just incredible.a And the lack
of respect to this Committee, and to you, and to all the
members of this Committee. I do not understand why he cannot
come and answer questions. Why is it that they are so hostile
to small businesses?
So I am ready, I am willing, I am prepared to work with
you. And if we need to hold him in contempt, we will do so.
Thank you, Mr. Chairman.
Chairman Manzullo. We are going to change the rules a
little bit. I am going to allow two more opening statements. I
have invited Dr. Weldon to come and be on the panel today. I am
going to have him give an opening statement. And then Dr.
Christian-Christensen will also give an opening statement.
Mr. Pascrell. I have a question.
Chairman Manzullo. Yes, go ahead, Bill.
Mr. Pascrell. Mr. Chairman, not as an opening statement,
but a statement. We have an emergency situation in this
country. In the last two months a disproportionate number of
physicians have ceased being Medicare providers. This is a
dangerous situation. And for this Administrator not to be here
at the bequest, at the request of this Committee is an absolute
travesty. And I want you to know personally that I look at it
as a travesty. And I want you, as our Chairman, to do something
about it.
Chairman Manzullo. We will do that. Thank you. Dr. Weldon.
Dr. Weldon. Thank you, Mr. Chairman. And I am honored to be
able to join with one of my other physician colleagues in the
House to speak on this issue. And I would imagine she may say
the same thing that I am going to say.
I practiced medicine for 15 years prior to being elected to
the House of Representatives, and I still see patients about
once a month at the VA clinic. And I made significant use of
portable x-ray services in five nursing homes where I took care
of my own patients in those nursing homes.
In the typical scenario where I would use it, I would be
seeing patients in my office, and I would get a phone call from
one of the nursing homes. And I would get on the phone with a
nurse, and the nurse would tell me that my patient had a fever
and a cough, or had fallen and hurt their wrist or their arm or
their knee. And I was really faced with a simple dilemma in
that situation.
And the simple dilemma was, do I put this patient in an
ambulance and transfer them to my office, and try to evaluate
them in my office? And then put them back in an ambulance and
send them back to the nursing home, at a substantial cost? Or
do I send them by ambulance to the emergency room, at
substantially higher costs? Or do I call one of the portable x-
ray providers if I needed a film?
And I found the portable x-ray service to be extremely
helpful. They would typically be there in less than an hour,
which was often quicker than they could get the x-ray in the
emergency room, amazingly. And they would have it developed,
and then they would have a radiologist calling me with the
results of the x-ray, mind you at no additional charge, which
is something that I could only get with extreme difficulty out
of the hospital.
Often the information was extremely valuable. It was no
fracture, and we could begin a course of anti-inflammatory
agents, splinting, Ace bandages. The results on the chest x-ray
would be no evidence of pneumonia. Even if there was evidence
of a pneumonia, if the patient was not in any distress I could
begin an antibiotic regimen at the nursing home.
The long and the short of it is I felt like these portable
nursing services, or portable x-ray services were saving
Medicare, in my particular experience, thousands and thousands
of dollars a year on unnecessary transportation costs,
unnecessary visits to the emergency room. They were extremely
helpful to the patient. I mean, it is incredibly traumatic.
My colleague from the U.S. Virgin Islands knows this. Take
one of these elderly people and load them into an ambulance,
transport them, it is extremely traumatic to them. And I found
it to be nothing short of a cost-saver, hands down.
And frankly, for those people here from CMS, I understand
Mr. Scully refused----
Chairman Manzullo. Excuse me, is anybody here from CMS?
Dr. Weldon. Nobody is here from CMS, not a single person.
Chairman Manzullo. Anybody here? Not one person here from
CMS.
Dr. Weldon. Well, this is disgraceful. Mr. Chairman----
Chairman Manzullo. Just a second. Let the record, let the
record show that we have approximately 70 people in the hearing
room today, and that not one person here in this hearing room
is from CMS, HCFA. [Laughter.]
Could you conclude so we could----
Dr. Weldon. Yes, I am sorry. I could go on and on about
this, but you know, to me this is just----
Chairman Manzullo. Well, let me make it easier for you. You
can ask questions later on.
Dr. Weldon. I will ask questions later on.
Chairman Manzullo. Thank you.
Dr. Weldon. Thank you, Mr. Chairman.
Chairman Manzullo. All right. Dr. Christian-Christensen,
Congresswoman Christian-Christensen?
Ms. Christian-Christensen. Thank you. Mr. Chairman, I would
like to submit my statement for the record.
Chairman Manzullo. All the statements will be received for
the record, with the exception of Mr. Scully's statement.
Ms. Christian-Christensen. Thank you. At the outset I just
want to express myextreme disappointment in what is happening
here this morning. To me it says a lot about the willingness of HCFA to
really reform and to be responsive to the needs of our providers.
As we were walking down the hall today and talking about
the hearing that we were about to have, which I want to take
this opportunity to also thank you and your ranking Member for
holding, for attempting to hold a hearing and hold CMS, or
HCFA, more accountable. Because certainly we have had a lot of
complaints and needs that have to be addressed on behalf of our
small business.
But as we were walking down here this morning, we were
talking about the hearing and what we hoped to accomplish from
this meeting. And it was not to be a confrontational meeting,
it was to be a problem-solving meeting, with everyone at the
table, as we have sought to do with other agencies. And so this
is extremely, extremely disappointing. And it makes me wonder
about how well the listening sessions are going. Because if the
Administrator is not willing to be here and listen and dialogue
with us, then I am not sure what is happening out here.
But as my other colleague said, you know, this is a real
crisis in health care that we are facing. Many of us are
committed to increasing access for all Americans to quality
health care. And what is happening in this case is exactly the
opposite. Our seniors, our disabled, our poor, those who are
most in need are not being able to access health care. And the
providers are going out of business. They are opting out now.
But this is a serious crisis that has to be addressed.
I have another shot at this on Friday. I think I am going
to make sure that the press is there. The Congressional Black
Caucus Brain Trust is having a hearing, along with the other
minority caucuses, on how well the Department is addressing the
disparities in health care. CMS is our last panel. The Chief
Operating Officer is supposed to be there. I am going to make
sure the press is there, because at that hearing we will also
be having community-based organizations who will be joining us
on the panel. I want to see what is going to happen.
I would also like to suggest that, as we do in every other
instance, when we are having difficulty with someone on one
level we go to the boss. And I would like to suggest that we
call the Secretary in and have him come in, along with Mr.
Scully, and begin to address some of these issues for us.
So with that, I am going to not say any more.
[Ms. Christian-Christensen's statement may be found in
appendix.]
Chairman Manzullo. Appreciate that very much.
Ms. Christian-Christensen. And I look forward, I welcome
our witnesses. I want to especially welcome my President, the
President of the American Academy of Family Physicians, Dr.
Jones, who was willing to join us, and all of our panelists
here this morning.
Thank you.
Chairman Manzullo. Thank you. Congresswoman Napolitano, did
you have a couple words in the opening statement?
Ms. Napolitano. Let's go on with it.
Chairman Manzullo. Okay. Thank you very much. The first
witness will be Mr. Tom Scully. Do you have his bio here? Could
you start the clock, please? Okay.
Could you please state your name for the record?
[No response.]
Chairman Manzullo. Let the record indicate that the seat
reserved for Mr. Scully that has the Honorable Thomas Scully in
front of it is vacant.
Let the record further indicate that this witness is under
subpoena by the United States Congress. If anybody in here is
from HCFA and you do not want to raise your hand, we will give
you the opportunity to get on the phone and get Mr. Scully from
down the hall or outside, where he may have secreted himself.
And he is welcome to join this panel at any time within the
next half-hour.
Could you stop the clock, then? Thank you for your
comments, Mr. Scully.
The first real witness is a man who has done a tremendous
job as the Head of the Office of Advocacy. He is also a member
of the Administration that enjoys appearing on panels with the
people that are affected by administrative rules and
regulations.
The purpose of this Committee is to solve problems, not to
divide Administration and people affected by the Administration
into separate camps or separate panels. That is why we like to
have one panel, so we can have a good cross-discussion going
on.
And Mr. Sullivan, I look forward to your testimony. Thank
you for your tremendous leadership that you have provided as
the Head of the Office of Advocacy. Please.
STATEMENT OF THOMAS SULLIVAN, CHIEF COUNSEL FOR ADVOCACY,
UNITED STATES SMALL BUSINESS ADMINISTRATION
Mr. Sullivan. Good morning, and thank you for the
opportunity to appear before the Committee this morning to
address the adequacy of CMS's compliance with the Regulatory
Flexibility Act.
Before proceeding, let me state that consistent with the
Office of Advocacy's statutory independence, this statement was
not circulated through the Executive Branch for comment.
Because of this, these views do not necessarily reflect the
position of SBA or the Administration.
I thank the Chairman for accepting my complete written
statement into the record. And I will now summarize just the
key points to keep within the five-minute time limit.
It is our goal at the Office of Advocacy that CMS more
fully consider the consequences of their regulatory actions on
small employers prior to finalizing their rules. That is, after
all, the primary tenet of the Reg Flex Act.
Recently the President singled out the Reg Flex Act in his
small business plan. In a speech three weeks ago yesterday here
in Washington, President Bush said, `I want to make sure people
understand that we are going to do everything we can to clean
up the regulatory burdens on small businesses.'
The President then talked specifically about the Reg Flex
Act, saying, `Already it is under current law. Every agency is
required to analyze the impact of new regulations on small
businesses before issuing them.'
The President did not stop there. The Chairman read this
part of the President's speech in his opening statement. The
President said, `From this day forward, they, the regulators,
will care that the law is on the books.' I was right there when
the President said that, and no one in the Reagan Center
clapped louder.
Generally speaking, Advocacy believes that CMS should do a
better job of following that law. Two recent rulemakings served
to highlight Advocacy's ongoing concern with CMS's lack of
compliance with the Reg Flex Act.
In July, 1999, CMS's predecessor, HCFA, issued an interim
final rule entitled `Medicare and Medicaid Programs, Conditions
of Patients' Rights.' The rule contained standards for the use
of patient restraints in hospitals. After reviewing the rule,
Advocacy concluded that the one-hour restriction on the use of
restraints was particularly burdensome on rural hospitals,
primarily because it called for the treating physician to make
a face-to-face assessment of the patientwithin one hour of
initiating restraint or seclusion.
Interestingly, the rule became the subject of a lawsuit
filed in the United States District Court of D.C. In September,
2000, the Court upheld the rule. But because HCFA failed to
comply with the Reg Flex Act, the Court remanded the rule back
to the agency for the completion of a regulatory flexibility
analysis.
The Court's decision reads, `The Secretary' the named
Defendant was Donna Shalala, `did not obtain data or analyze
available data on the impact of the final rule on small
entities. Nor did she properly assess the impact the final rule
would have on small entities.'
The Office of Advocacy continues to insist that CMS
complete the regulatory analysis, as ordered by the Court. This
analysis still has not been done.
Why do the analysis after the fact? Because if CMS can
produce regulatory analyses of the rule's impacts on small
health care entities for the one-hour rule, they can, and
hopefully will, do it for others.
The second rule making is the portable x-ray rule. On three
occasions since 1998, the Office of Advocacy has filed comments
with CMS concerning the agency's determination of payment
policies as they apply to the portable x-ray and EKG industry.
We believed that pursuant to the Reg Flex Act, CMS should
have analyzed the impact on this industry separately. Only then
would the agency have been in a position to decide whether to
certify no impact under the Reg Flex Act, or whether to perform
further analysis.
I know that the portable x-ray rule will be discussed more
by other witnesses on this panel. So I will conclude my
statement by saying that Advocacy is working to implement the
President's commitment towards a full agency compliance with
the Reg Flex Act.
We applaud the President's renewed emphasis toward
Government accountability to the small employer community. My
office has found that early consultation with small business
works. And we are willing to work with CMS to ensure legitimate
small business input.
It is my hope and my desire that the Office of Advocacy and
CMS will develop a working relationship that will result in
better communication and better compliance with the Regulatory
Flexibility Act.
Chairman Manzullo. Thank you very much. Before we go to the
next witness, do you know when the last communique was to, from
your office to CMS was, on the portable x-rays?
Mr. Sullivan. I am told by my counsel that the last letter
to CMS was on December 28, Mr. Chairman.
Chairman Manzullo. Okay, thank you.
[Mr. Sullivan's statement may be found in appendix.]
Chairman Manzullo. Our next witness is, is Dr. David R.
Nielsen, M.D., who is a member of the American Academy of
Otolaryngologists, ENTs. And he has written in their journal, I
am not going to try to mention the name of that again----
[Laughter.]
Chairman Manzullo [continuing]. A very well-esteemed and
well-respected surgeon. We look forward to your testimony, Dr.
Nielsen.
STATEMENT OF DAVID R. NIELSEN, M.D., THE AMERICAN ACADEMY OF
OTOLARYNGOLOGY--HEAD AND NECK SURGERY
Dr. Nielsen. Thank you, Mr. Chairman, and members of the
Committee. I want to thank each of you for the opportunity to
testify today. And I concur with the spirit which you
expressed, Mr. Chairman, about the purpose of this meeting.
I am not a lobbyist. I am not an administrator. I am a
private-practicing physician, and we felt that would be more
useful to the Committee, and more useful to CMS, to have that
kind of input, rather than simply lobbying activities.
My name is David Nielsen. I am a practicing
otolaryngologist. I have no Federal Government contracts. I
currently work at the Mayo Clinic in Scottsdale, Arizona, but
prior to that I was a solo private practitioner for 13 years.
So I can assure the members of the Committee that I can speak
personally about the concerns that we have about the burdens
that are placed on small businesses and private practitioners
in medicine.
We have a common frustration with the barrage of burdensome
Medicare regulations and guidelines, and the constant struggle
that we face to remain compliant. Rather than talk about all of
the issues that I have in my written testimony, let me get
right to the meat of what it is that we want to share with you
today.
The RFA requires that each federal agency perform and make
available to the public an initial and a final regulatory
flexibility analysis of any rule that will have a significant
economic impact on small businesses, including physician
practices. It also states that in this analysis, the Agency
must describe any significant alternative proposals that could
achieve the rule's objectives at a lower cost to small
entities, and explain why each alternative was rejected in
favor of the final rule. This has not been done.
Against a backdrop of dramatically increasing practice
costs and falling reimbursement rates, federal regulations
often have a particularly dramatic and significant effect on
physicians. We are subject to a wide array of federal
regulations, which includes, but is not limited to, the Health
Insurance Portability and Accountability Act regulations on
medical privacy and electronic transactions; Medicare and
Medicaid fraud and abuse regulations, including the Starek
Physician Self-Referral Laws, the Federal Anti-Kickback
Statute, and the False Claims Act; the limited English
proficiency guidance, and the associated need to provide
interpreter services for the deaf, which is required under the
Americans with Disabilities Act; and evaluation and management
documentation guidelines.
These are simply a few of the regulations that we struggle
with.
Let me give you some specific examples. As
otolaryngologists who deal with speech and hearing and
communication problems on a daily basis, I can assure the
Committee members that there is no one more interested in good
communications with our patients.
However, the limited English proficiency guidance issued by
the Department of Health and Human Services requires physicians
who receive payment from Medicaid to provide, at their own
expense, trained and competent interpretation and translation
services for all of their limited-English-proficient patients.
As an example, an otolaryngologist who practices in the
state of Kansas would pay $70 per hour, often with a two-hour
minimum, including transportation costs, for an interpreter.
But Medicaid would only reimburse the otolaryngologist between
$12 and $28 for that visit. That reimbursement not only does
not cover practice costs, but can create hundreds of dollars of
out-of-pocket expenses for a physician who wishes to treat
Medicaid patients. And hence, people are dropping out of
coverage, because it would not be unusual for someone who lived
in an area where there was a large multi-lingual population to
have more expenses for interpretive services than revenue in
the course of the practice day.
We acknowledge that the goals of this departmental issuance
are laudable, but forcing small businesses to bear the burden
of paying for an ever-growing crop of unfunded
regulatorymandates threatens the financial liability of physician
practices, and may ultimately threaten patient access to care.
This is not about physician costs, and it is not about
physician income. It is about access to care, which is being
severely curtailed.
In the context of the Medicare physician fee schedule, CMS
could potentially take into account the high costs of
compliance through the Medicare economic index, which is a
component of the physician fee schedule update formula.
Although CMS references this and has included the physician
practice expense in the MEI, federal health care regulatory
compliance costs are not explicitly taken into account, because
the measures are based on price data which come from across the
country, from the economy as a whole.
Despite the RFA's requirements and CMS's own admission that
physicians are small businesses and qualify for coverage, CMS
did not engage in a full regulatory flexibility analysis in the
final rulemaking and publishing of the 2002 Medicare Physician
Fee Schedule. They do reference the rule.
Moreover, CMS has an obligation to respond to all the
comments which were submitted to the proposed rule, pursuant to
the Administrative Procedure Act. CMS's failure to perform an
analysis of the costs of regulatory compliance under the RFA,
or to acknowledge the comments which were submitted, undermines
the integrity of the regulatory process.
In summary--I am going to run out of time here, but let me
just summarize--we intended to do what you suggested, Mr.
Chairman, which is to provide solutions. We really want to find
a way to solve these problems. And we recommend the following.
Number one. We urge that all House Members encourage their
Senate colleagues to pass the Medicare Regulatory and
Contracting Reform Act, H.R. 3391. And we want to specifically
thank Representatives Toomey and Berkley, who are responsible
for proposing the initial H.R. 868, from which I believe this
came. And we are grateful for their interest and support of the
legislation.
Second, we recommend that Congress direct CMS and all other
agencies to comply fully with the RFA in order to better
protect small business entities, like physician practices, from
the onerous and costly regulations which we now face.
Third, we recommend that Congress expand the RFA to cover
subregulatory issuances to help ensure that small businesses
are not unnecessarily burdened. Right now we suffer from such
issuances as program memoranda, contractor letters, guidance
documents and coverage decisions, which are not technically
regulations, and therefore they fall beneath the radar screen
of the RFA. These create a significant regulatory burden to
small businesses.
And finally, we hope to remove the requirement that small
business physicians be forced to arrange for, provide, and pay
out of pocket for services for which they cannot be reimbursed.
I would be happy to take any questions later on. And thank
you, Mr. Chairman.
[Dr. Nielsen's statement may be found in appendix.]
Chairman Manzullo. Thank you very much. Congresswoman
Christian-Christensen, would you like to introduce the next
witness?
Ms. Christian-Christensen. Thank you. As a family
physician, it is my pleasure to introduce Dr. Warren A. Jones,
a family physician and retired Navy Captain who is President of
the American Academy of Family Physicians. He was elected in
2000.
He previously served on the Board. And the American Academy
of Family Physicians represents more than 93,500 family
physicians and family practice residents and medical students
nationwide. He is a Fellow of the Academy.
He is also Professor of Family Medicine at the University
of Mississippi Medical Center, and Assistant Professor of
Family Medicine at Howard University School of Medicine, and
Deputy Director of the Mississippi Area Health Education
Centers.
He recently retired from his position as Medical Director
of Tri-Care Military Health Program, the military's health
insurance program. So he brings practice experience, as well as
management of a health insurance program, to his testimony
today.
He previously served as Director of Medical and Clinical
Services for the Pacific Region of Tri-Care. He has received
numerous military honors, including the Defense Superior
Service Medal and the Navy Commendation Medal for Superior
Performance. And he has received the Meritorious Service Medal
three times.
It is a pleasure for me to welcome you, Dr. Jones, to our
Committee.
Chairman Manzullo. I think we need a man like him to be in
charge of HCFA, don't you, Congresswoman? Would you second that
nomination?
Before we get into your testimony, Dr. Jones, Dr. Nielsen,
where did you come from to be here today?
Dr. Nielsen. I work at the Mayo Clinic in Scottsdale,
Arizona, and I will be the new incoming Executive Vice
President of the American Academy of Otolaryngology Head and
Neck Surgery.
Chairman Manzullo. And so you traveled all the way from
Scottsdale to be here today?
Dr. Nielsen. Yes, sir.
Chairman Manzullo. And then, Dr. Jones, same question?
Dr. Jones. I traveled from the Jackson, Mississippi area,
sir.
Chairman Manzullo. To be here today. And Mr. Evans, same
question?
Mr. Evans. Mr. Chairman, I traveled from Kansas City,
Missouri.
Chairman Manzullo. Okay. And Mary.
Ms. Harroun. I traveled from Richmond, Illinois.
Chairman Manzullo. Okay. And let the record indicate that
these witnesses have traveled here at their expense. They had
been advised in advance that Mr. Scully would be here. Perhaps
we should get all your expenses and send him a bill, and have
him pay it personally. But I do not know how that would go
over. He just had to come from across the street.
Dr. Jones, we look forward to your testimony. And could you
pull the mike closer?
STATEMENT OF WARREN A. JONES, M.D., THE AMERICAN ACADEMY OF
FAMILY PHYSICIANS
Dr. Jones. Yes, sir, Mr. Chairman. And I would just like to
say before my time begins that if you submitted him a bill for
our expenses, we would only get paid 40 cents on the dollar.
Mr. Chairman, Ranking Member Velazquez, Representative
Christian-Christensen, my good friend and respected colleague,
members of the Committee. We thank you for this wonderful
opportunity to be here today to comment on the small medical
practices and the impact on these practices across the country,
especially those of family physicians and other primary care
docs who work in our communities to take care of our patients,
and to meet their needs.
We particularly appreciate your interest in the CMS
implementation of the Medicare physician fee update as it
relates to the Regulatory Flexibility Act. We would suggest
that the best solution to the problems created by the flawed
formula that determines this update is enactment of the
recommendations of the Medicare Payment Advisory Commission.
You have already heard about the Academy and who we are.
And I would just like to share with you that, in case you may
not know, there are three Members of Congress who are members
of our organization, including a member of this Committee. And
we thank you for all of the leadership you provide in helping
to make sure we meet the needs of our patients across America.
I guess some of you may wonder why I am here. But it is
important to point out that most of the members of the American
Academy of Family Physicians can be characterized in their
practices as small businesses. Moreover, recent studies show
that the presence of a family physician in a rural community is
a substantial economic stimulus.
The study by the Santa Fe Health Policy Research for the
Oklahoma State University Health Sciences Center found that, on
average, each family physician will generate, both direct by
and secondarily, an estimated 50 full-time jobs. And these jobs
will generate over $1.1 million income annually for each of
these communities. It is definitely a small business worth
protecting.
Mr. Chairman and members of the Committee, physicians and
other health care practitioners have experienced a sharp 5.4
percent across-the-board reduction in Medicare payments as of
January 1. Although it is called a physician fee update, these
cuts apply to all services in the more than one million health
professionals, including therapists, advanced health
professionals, nurse practitioners, chiropractors, and
optometrists. And many of these provide services in their own
individual offices and serve as small businesses.
The Medicare Payment Advisory Commission has called for the
elimination of the current update formula, and warned that cuts
of the magnitude expected under this formula could raise
concerns about the adequacy of payments and beneficiary access
across our nation. And that is one of the things I wanted to
talk to you about.
I wanted to tell you a couple of stories, if I might. I
want to tell you a story about a young family physician, Dr.
Casey, who dreamed of being a family physician and entered
medical school late in life. And her goal was to go back to her
town in Kentucky, a small town, Pikeville, and take care of her
neighbors.
Well, while in medical school she had her second child, and
then her third child, and came out with about $145,000 in debt.
But she still went back to the small town, and she delivered
care.
But what she is finding now, after three years in practice,
she found that she could barely meet her bills. But then she
found that the income from Medicare patients decreased so
dramatically that, at six years in practice, she is having to
go into her savings to keep her practice afloat. With her own
savings, she is subsidizing her practice.
She now says that unless the Medicare fee schedule is
fixed, she can only stay in practice two more years. She has
limited taking any new Medicare patients. This is emblematic of
what has occurred.
And as you heard from the introduction, I now live in
Mississippi. And one of my tasks will be to help to increase
the number of health care providers in the Mississippi Delta
and other areas in our state. But I can tell you that the
current reimbursement schedule is a major disincentive to young
people to choose health care, and to deliver care to the
population that is most in need. It is going to be difficult
for me to accomplish that task, and difficult for you to see
that your communities are served.
I will show you this. And I apologize for not having a copy
for each of you right now. But this is a map that shows the
United States and what is recognized as health service shortage
areas. To give you an idea of the magnitude of family
physicians as small businesses, this currently shows in red the
areas that are considered small business, excuse me,
underserved areas.
But if these family physicians in practice now are unable
to remain in practice, and they end up leaving their
communities, the areas in red will now become health shortage
areas.
Chairman Manzullo. Doctor, could you show both of those
pictures to the people that are in the back? Matthew, would you
hold that up so the people who are visiting today can take a
look at each of those?
And again, the first map is?
Dr. Jones. The first map is the state of primary health
care underserved areas in the United States. And this is
including family physicians and all other primary care
provides. And if these small practices of family doctors would
go out of business, these red areas would represent the
underserved areas.
In reality, these small practices deliver care where
Americans live.
What we ask you to do today, sir, is to continue what you
are doing. Hold these hearings, hold CMS accountable, and be as
responsive as possible to the need to make sure that we get the
kind of appropriate reimbursement, not to make money, but to
make sure we keep our offices open.
When we have to lay off nurses and we have to lay off staff
in order to be able to take care of our patients, we limit
access. Seventeen percent of family physicians responded on the
survey last year that they have limited Medicare access; they
are not accepting any new Medicare patients. If we were to do
that survey today, following the 5.4-percent decrease, I am
sure it would be up to 25 percent.
And with the continued negative growth rate that is
projected under the current formula, we will get to a point
where we will have a 17-percent decrease in reimbursement. And
no small business can remain in effect and in practice with a
negative growth rate like that.
Thank you for the opportunity to be here, and I look
forward to entertaining any questions.
[Dr. Jones's statement may be found in appendix.]
Chairman Manzullo. Thank you, Doctor. The exhibits will be
made part of the record. I would like to work with you, and
perhaps your association, afterwards to get enough color
pictures of that to send to every Member of Congress with a
dear colleague. I am sure Mrs. Velazquez would join with me in
showing the critical area we are in with so many doctors that
will be fleeing the practice.
Thank you for your testimony.
Our next witness is Zach Evans, who is with the National
Association of Portable X-Ray Providers. He currently serves as
the Chairman of the Board for the National Association of
Portable X-Ray Providers; is a provider himself. We look
forward to your testimony, Mr. Evans.
STATEMENT OF MR. ZACHARY EVANS, PRESIDENT, NATIONAL ASSOCIATION
OF PORTABLE X-RAY PROVIDERS
Mr. Evans. Thank you, Chairman, Ranking Member Velazquez,
and distinguished Committee members. I also want to recognize
Congressman Weldon. I believe that the proceedings here today
will be of great interest to him.
Mr. Chairman, I appear before you today under a cloud of
fear: fear of reprisal from CMS for speaking to this Committee,
fear of being punished by a federal agency that has targeted my
industry for daring to tell the truth.
Just five weeks ago our association testified before this
Committee regarding CMS' illegal rulemaking against our
industry. The day before the hearing, while John Cavalier, the
President of our association, was here in Washington to meet
with this Committee, his small business wassubjected to an
unannounced audit by CMS.
In light of the clear intent of CMS to intimidate
volunteers who serve on the Board of Directors of the NAPXP, I
wish to thank the Committee for offering to protect my identity
in this hearing. In spite of risks entailed in speaking out, I
feel strongly as a citizen and small business owner that the
only way to combat this abuse is to bring full light to this
matter. And that cannot be done from behind a screen, even if
the screen is there to protect me.
That an honest small businessman would need, might need
such protection from his own government is unconscionable. When
Members of Congress contact CMS regarding the data necessary to
reach informed decisions regarding our industry, they are told,
as you were told, Mr. Chairman, that it cannot be produced. In
fact, it can and has.
This data demonstrates a policy failure that has been
devastating to the health care delivery in rural America. After
Congressman Phil Crane received this stunning information, CMS
realized what it had produced, and attempted to retract it.
Now, in response to your request, Mr. Chairman, CMS claims
that the same data produced last year is impossible to compile.
How can CMS steadfastly hold that their policies are correct,
when they also claim that they are unable to compile basic
usage data?
As we raise awareness of our situation, CMS targets us with
a fraud alert. The February 7 fraud alert was followed by a
March 20 CMS request for comments on improving the health and
safety standards survey process, specifically for portable x-
ray services.
Obviously, looking for irregularities within our industry
has become a very high priority for CMS in the wake of our
discussions with this Committee and others.
While CMS aggressively seeks to uncover supposed fraud
within the industry, they refuse to assist us in educating
small business providers of our services, so that they might
better serve the public and avoid improper activities. We have
repeatedly requested either CMS speakers or responses to
technical questions to assist us in complying with CMS
regulations. Routinely, we are unable to get a speaker or
answers to our questions.
Obviously, preventing improper billing or fraud by
interacting with us is not a priority, while catching someone
at it is.
Mr. Chairman, our role in health care delivery is
relatively simple. We provide x-rays, EKGs, and other
diagnostic services at the patient's bedside. We do so at a
substantial savings to Medicare, over the alternative of
transporting the patient to the hospital.
CMS would have you believe that doctors carry EKG devices
with them to nursing homes, family members of patients
transport their loved ones to other facilities, or nursing
homes purchase the equipment and provide the trained staff to
provide these services themselves.
We are fortunate to have two Members of Congress here who
are also physicians today with us, Dr. Weldon and Dr.
Christiansen. I ask these professionals, are the claims of CMS
credible? Do they stand up to your personal experiences in the
medical profession?
CMS offers no data to support these assumptions. In spite
of the clear statutory requirements contained in the RFA,
SBREFA, the APA, and the Social Security Act, CMS refuses to
consider the impact upon our industry of their rulemaking,
consult with us during the rulemaking process, or in any way
evaluate industry costs prior to setting our reimbursement
rates.
In his letter to you, Mr. Chairman, Mr. Scully states that
the PEAC Committee is the appropriate body to review our
industry costs, and the process is more efficient. We applied
for a seat on that Committee and were denied.
Mr. Chairman, counsels for both the Legislative and
Executive Branches are of the opinion that CMS is engaged in
illegal rulemaking pertaining to this industry. While CMS has
no effort or expense in seeking to uncover fraud within our
industry, they refuse to obey federal rulemaking statute.
We know that small business providers will be prosecuted if
they get caught in expanding, in the expanding CMS fraud net. I
ask you, who will prosecute CMS? How can we be subject to
penalties for improper billing, when the rulemaking that
establishes the billing is illegal? When a federal agency
refuses to obey the law, and then uses its might to punish the
small businesses that dare to complain, where do they go for
justice?
In closing, Mr. Chairman, I want to thank this Committee
again. I would also like to especially thank the two
physicians. Congresswoman Christiansen and your staff have been
most helpful. I appreciate the time that Dr. Weldon has given.
As I know, he does not sit on this Committee. And I would
formally request that this matter be investigated by the
Committee on Government Reform, and specifically the
Subcommittee which Congressman Weldon chairs, Civil Service and
Agency Organization, as he deems appropriate.
Thank you for your time. And I will be available for
questions.
[Mr. Evans's statement may be found in appendix.]
Chairman Manzullo. Thank you very much. Could you, if you
would not mind, take the seat here on the end next to your
props? And Matthew, could you put Mr. Scully's sign down there
at the end, and replace the signs? It will be a little bit
easier for you to testify with your props there.
Mr. Evans. Do I have to sit beside him? [Laughter.]
Chairman Manzullo. Okay. The next witness is a constituent
of mine from Richmond, Illinois. Mary is the President and CEO,
and probably chief manufacturer, of Merry Walker Corporation.
And we look forward to your testimony, Mary.
STATEMENT OF MARY HARROUN, PRESIDENT, MERRY WALKER CORPORATION
Ms. Harroun. Thank you very much, Mr. Chairman.
Chairman Manzullo. Could you pull the mike a little bit
closer to you?
Ms. Harroun. And members of this distinguished Committee.
Back in 1990, I invented the Merry Walker after having
spent 20 years in the nursing home industry watching my
residents melt away under the guise of restraints and sitting
in wheelchairs. Twelve years ago I invented a product known as
the Merry Walker, which is a registered trademark, and is
honored by being protected with two U.S. patents.
When I was in the nursing home business, industry, as a
geriatric psychologist and licensed nursing home administrator,
I looked around at my residents and I said, you all walked
once, why aren't you walking any more? And they were sitting in
wheelchairs at that time, with Posey belts. And now today,
because of CMS, they are now still in wheelchairs, under the
guise of chair alarms, which forbids them from standing because
this horrible, screeching, loud, buzzing noise occurs behind
them every time they go to stand up.
Physical therapists have said it takes three weeks for an
elderly person sitting in a wheelchair to never, ever walk
again. That is intolerable.
My issue with CMS is the minimum data set, which is done on
all 1.8 million residents in nursing homes, hospitals, and VA
facilities. That is done upon entrance; it is maintained every
three months. There are 500 questions that are posed to fill
out this assessment, of which thenCMS somewhere here in this
area has a large database.
There are 500 questions. There are 17,000 nursing homes.
And there are 1.8 million people suffering because of the MDS.
My issue started last summer. Actually, Merry Walker, we
had some discussion back in 1994 as to whether it was a
restraint. I discussed it with Lois Steinford, who was Chief of
the Nursing Home Survey Process for HCFA. She has since
retired. But she stated that Merry Walker is an enabler, and a
piece of adaptive equipment very worthy of praise, and it does
the job of getting elderly ambulatory, and keeping them
ambulatory.
I did not pursue it any further. When the MDS was brought
out in 1995, I got a copy of it on my desk, I read through the
format of the assessment and saw no problems. It was not
interfering with my product. I did not agree with it, but never
mind.
Last summer I was at the Alzheimer Educational Conference
in Chicago, and Mary Lucero, a geriatric psychologist, as I am
also, of geriatric resources, gave a full-hour seminar on the
benefits of the Merry Walker ambulation device. Many of her
attendees of that seminar ended up coming up to my booth
afterwards saying, `We can't use the Merry Walker.' I am going,
`What? Why can't you use it?'
Ended up calling the North Carolina Public Health
Department. And in my fax machine I received page 3158 of the
MDS Users' Guide. I did not even know this was available,
because I am not in that aspect of the field any more.
I read from this lovely publication, under `Devices and
Restraints. Intent to record the frequency over the last seven
days which a resident was restrained by any of the devices
listed below at any time during the day or night.' And we have
a definition of a restraint, which is a mechanical device,
equipment attached to or adjacent to the resident's body that
the resident cannot easily remove, and that restricts freedom
of movement or normal access to one's body.
We have full bedrails. We have other types of bedrails. We
have trunk restraint and we have limb restraint. Then we get
down to the fated clause of chair prevents rising. And I will
read.
`Any type of chair with a locked lapboard or a chair that
places a resident in a recumbent position that restricts
rising, or a chair that is soft and low to the floor (that is,
bean bag chair); includes lap cushions (that is, lap buddy,
Merry Walkers).'
I obviously contested that immediately with CMS, and have
had no result. We have received statements that I feel are
untrue, citing regulations that do not exist. So I am here to
appeal to you to intercede on behalf of the 1.8 million people,
to allow them the possibility of getting out of wheelchairs,
and saving Medicare billions of dollars against decubitus
ulcers and unnecessary fractures.
Thank you.
Chairman Manzullo. As part of your testimony, could you
demonstrate how that latch works, and how it has been
denominated as a restraint?
Ms. Harroun. Anybody who normally walks with the assistance
of one person is the candidate to use Merry Walker. Most of the
people in wheelchairs are able to get up and walk in the Merry
Walker.
This cross-bar, which seems to have CMS in a problem, I
have to have this closed securely, because I have to hold onto
it. And they are able to walk, walk, walk. When they get tired,
they simply sit down.
Chairman Manzullo. Explain the significance of the legal
definition of restraint on the nursing homes, and why those
machines are not in nursing homes. You can resume your chair
and speak into the mike.
Ms. Harroun. The objection that CMS has to the Merry Walker
is the front latch mechanism. And they are claiming that
cognitively-impaired people are unable to open that front gate.
Anybody with an Alzheimer-type dementia is totally impaired
from doing anything in the abstract. They cannot open a
doorknob, they cannot use the commode by themselves, they can
hardly feed themselves, because those things are in the
abstract.
Because the latch mechanism on the Merry Walker happens to
be in the abstract is basically there for their safety. Merry
Walker needs to be deemed an adaptive device, and that is what
they are not doing.
[Ms. Harroun's statement may be found in appendix.]
Chairman Manzullo. Thank you. Dr. Christian-Christensen?
Ms. Christian-Christensen. Thank you. I would like to
first, submit some documents for the record. One of them is a
letter that Congresswoman Nydia Velazquez and I wrote to
Administrator Scully on the issue of the x-ray audit that took
place on the day that they were testifying here. It was, this
came out of the blue. It was something that they thought had
been resolved, or at least was put on hold. And while the
testifying was taking place, they were being audited.
In addition to that, they were meeting here that week, and
they asked for some, for CMS to send some, a representative to
explain some of the regulations to their membership. And they
refused to go. So I wanted to submit that for the record.
And also some documentation from some of my own
constituents on the problems that they have been having, and on
which we want to meet with CMS.
Chairman Manzullo. The documents will be received and be
made part of the record without objection.
Ms. Christian-Christensen. I want to commend Ms. Harroun,
is it?
Ms. Harroun. Yes.
Ms. Christian-Christensen. On the wheelchair. In fact, if I
could just tell a quick story about a person that, I had a
constituent who was in the VA hospital who was in a wheelchair.
And we were able, with working with the American Legion, to get
that person home, into an area where he could have assisted
living. The wheelchair failed to come.
We were called and worked to get this wheelchair to come,
get to the Virgin Islands from the VA in Puerto Rico. I thought
it had been resolved. I was in a little restaurant one day, and
this old man came in to me, walking. And he introduced himself.
It was the same person. The wheelchair never came.
Ms. Harroun. Good. Good.
Ms. Christian-Christensen. He was walking with a cane. So
this is a really great invention, I guess I would call it. I
hope we can work to get it approved.
I wanted to ask Mr. Sullivan a couple of questions. Your
last statement said it is your hope and desire that the Office
of Advocacy and CMS will develop a working relationship that
will result in better communication and action on the issues
that are of concern to the Committee.
I mean, how do we make that happen? This is not the first
time that you have been here. We have gone through this over,
you know, several times. How do we make that happen?
Mr. Sullivan. Congresswoman, we keep trying. We keep trying
over and over again, to the extent that we need to write more
letters that clarify their reluctance to comply with the
Regulatory Flexibility Act. We will do that. To the extent that
we work with OMB in a signed memorandum of understanding that
clarifies exactly how agencies are supposed to comply withthe
Reg Flex Act, we will do that.
Ms. Christian-Christensen. Did you and OMB make any headway
after your last meeting here?
Mr. Sullivan. Yes, we have, Congresswoman. We have actually
signed a memorandum of understanding to share information that
leads to a decision-making by OMB when it comes to rules.
So to the extent that we document non-compliance with the
Regulatory Flexibility Act, we then make available that
analysis, and a response or lack of response to that analysis
to Dr. John Graham, when they make a decision on whether or not
a regulation should move forward.
So the simple answer to your question is, we keep trying.
And we try with the help of this Committee, and any other help
that we can, to convince CMS that it is to their benefit to
adequately consider the impact on small business.
Ms. Christian-Christensen. Are there any suits pending
right now? I cannot remember from the last hearing. Are there
any suits against CMS to which you have filed an amicus?
Mr. Sullivan. As to whether or not we have filed an amicus
brief on pending suits, the answer is no. But there is still
outstanding the court decision that orders CMS to do the
regulatory analysis that is in my written statement. We will
continue to try and work with this Committee to make sure that
CMS does that regulatory analysis and complies with the court
decision.
Ms. Christian-Christensen. Does anyone else want to add
anything to how do we make them comply? Because it is getting
very frustrating, Mr. Chairman.
Dr. Nielsen. Mr. Chairman and Congresswoman Christian-
Christensen, it was our intent, as we came here today, to be
here testifying in the spirit which you mentioned at the
beginning, Mr. Chairman. Our intent was that our testimony not
be an attempt to accuse, or to malign, or to embarrass anyone;
but rather, an opportunity for us to sit around the table,
express the reality of what we face, and work toward some
common conclusions and results.
In fairness to Mr. Scully and to his administration, much
of what we are complaining about, or much of what we see as a
problem, was inherited by him and by his administration. And we
have had assurances from Secretary Thompson and from Mr. Scully
that they intend to sit down with us and work with us on this.
And so my contribution would be that we continue to try to
do that. If this is not the right venue, let's find another
one. But we stand ready to meet whenever and wherever to openly
discuss the reality of these situations, and find solutions for
them. We did not intend in any way for this to be a
confrontational situation.
Mr. Evans. Thank you for letting us have this moment. I
agree with the gentleman that spoke before me, that HCFA did
inherit some of these problems. But I will tell you that the
new CMS has effectively closed their ears. They do not, they do
not want any conversation.
Before, they at least talked to us. They listened to us.
And they may say yes occasionally, once in a blue moon; but
they at least said no, and we knew where we stood.
It is out of control. It is completely out of control.
Ms. Christian-Christensen. Mr. Chairman, I know my time is
up right now, but I get the sense that perhaps Mr. Scully,
Secretary Thompson did not understand the complexity of the
nature of HCFA and what they were going to have to deal with.
You know, I really think it is out of control.
Chairman Manzullo. Dr. Weldon.
Dr. Weldon. Thank you, Mr. Chairman. And I want to again
thank you for providing me with the opportunity to join with
your Committee and your colleagues on this very important
hearing.
Mr. Evans, if you could just answer a few questions for me.
I understand there have been several audits of your industry
throughout the country. Representing your industry today, can
you comment on the outcome of those audits in terms of the
numbers or percentages of portable x-ray companies that have
been found to be over billing, or double-billing, or engaging
in any kind of fraud in the Medicare program?
Mr. Evans. Sure. To give you statistics of the whole
industry is a pretty tough thing to do, because obviously not
all portable x-ray providers belong to our association. I can
tell you that within our industry, we have done anything and
everything to try to make sure that we are compliant. We have
had conversations with CMS on how to be more compliant, how to
avoid fraud.
I think that what is happening is that we do not order the
x-rays, Doctor. We do not know who to bill, unless the skilled
nursing facility, or SNF as they are called, tells us who to
bill. The rules are so confusing that a lot of the time the
finger gets pointed back at us.
I will tell you that I was personally audited recently,
within the last few years. I came through, you know, clean as a
whistle. In fact, they said there was a $29 problem, so to
speak, and we came back and showed them that there, in fact,
was not a $29 problem. There was not an issue there. But as far
as statistics, I cannot tell you exactly.
Dr. Weldon. So you do not keep track of the number of
audits for your members, and----
Mr. Evans. No. We have----
Dr. Weldon. The reason I ask you the question is, Medicare,
CMS has really not provided us any data to support the claim
that would justify a fraud alert for your business. And so I
was wondering if you had any information as to how much fraud
is out there.
Mr. Evans. I think that every, I think that every industry,
be it, and I do not care what industry it is, I think that
every industry has some dirt.
I can tell you that the President of our association was
just recently audited, as I said in my testimony. His came back
clean. And his was a federal audit, not a state audit.
Dr. Weldon. Now, I wanted to get into that a little bit
with you. You implied in the opening comments that his audit
was some kind of a reprisal from CMS?
Mr. Evans. It sure appears that way to me. I have got to
tell you, in my testimony my fear is, as far as I am concerned,
well-founded. I have instructed my staff that if CMS walks in,
or the state walks in, that I am out of town and they will have
to come back. That they do not have all the records there to be
able to go through it.
I am very fearful that they are going to come in and audit
me. I am very fearful, not only for myself, but for the members
who we represent.
Dr. Weldon. How are you typically reimbursed? If you get a
call from a nursing home to go do an x-ray or EKG, do you bill
through Part A or Part B? Either one?
Mr. Evans. The skilled nursing facility has to instruct us.
There is no way for us to go in and know whether this is a Part
A patient, in other words a patient that has spent three days
or more in the hospital and has been released back into that
facility, and is still under the Part A care; or if it is a
Part B patient, and the Part B patient is there under, has not
been in the hospital and is there for just normal care.
We have no control over that. And I think that that is one
of the reasons why this is so hard to track. That is one of the
reasons why we have looked for exclusion from PPS.
It is my understanding that CMS has said we want to treat
everybody the same within a group. We are not treated the same.
We are in the physician's fee schedule, and we are the only
people within the physician's fee schedule that are not
excluded from PPS.
Dr. Weldon. Dr. Jones, as I understand it, CMS is scheduled
to put through another 5-percent reduction for reimbursement,
and then possibly another reduction after that.
Is that what you were alluding to when you showed those two
maps? If these things progress onward, more and more providers
in your association would have to just start refusing to see
Medicare patients? It just would not be profitable at all for
them to see these people? Is that the concern you are raising?
Dr. Jones. Thank you very much for the opportunity to
answer that question, Congressman Weldon.
The formula is so flawed that Mr. Scully was quoted
himself, on the 2nd of February of '02 in The Milwaukee
Journal, as saying that the formula is, quote-unquote, screwed
up and exceedingly harsh. And if he is saying that as the head
of the Agency, it shows that it really needs to be addressed.
The problem is that it is scheduled for 5.4 percent this
year, 5.7 percent next year. And it is the formula that is tied
to the GDP, and not tied to the expense of the office for
seeing patients, as you know.
So the problem is, what we see occurring is that this
negative rate of reimbursement, this negative growth will make
it such a disincentive for our best and brightest to look at
coming into health care and for those who are currently
practicing, to continue to see the Medicare population, which
is our most needy population, those that are elderly and those
that are infirm.
And we just cannot afford to have that happen. We need to
have this formula fixed. The regulators are saying it is beyond
regulatory control. And if it is, then we need to now look at
getting some help from Congress.
Dr. Weldon. It is in the statute in the '97 budget
agreement, Congress has to fix it. Thank you, Mr. Chairman.
Mr. Evans. Congressman Weldon, Mr. Chairman, may I make
another statement?
I would just like to say that the 5.7-percent decrease that
Dr. Jones spoke about translated to our industry as a roughly
12-percent decrease in revenue. If this other 5.4 percent goes
into effect, we are gone. In fact, we have, we have providers
in California that are already going by the wayside.
Added on this with the situation with the prospective
payment system, and us being under that system, in October the
skilled nursing facilities are taking a 17-percent cut in their
revenues. They are paying us for Part A patients; they will no
longer be able to afford to pay us.
While the situation with physicians is a critical
situation, and I agree with it, we are about gone.
Chairman Manzullo. Thank you. Go ahead, Dr. Nielsen.
Dr. Nielsen. Mr. Chairman and Congressman Weldon, the
extent of this goes far beyond that. It has not been too many
weeks since the announcement of the expected decreases over the
next five years were announced. And I do not remember the exact
numbers, but it was approximately 5.5 percent two or three
years in a row, and 2.8 at the end. And when you add those up,
you are talking about a 20-point-something-percent reduction.
And in a small business private practice, where overhead may be
50 percent, that is a 40-percent cut in pay.
It is not about physician pay, but physicians who have to
pay out of pocket to treat patients will stop treating them.
And although this is a map of primary care, we have regions of
the country where specialists such as our head and neck
surgeons, who have to provide very comprehensive care for head/
neck surgery cases with long global periods and extensive
follow-up, are unable to afford to do it. They simply stop
providing the care.
And as a lot of insurance companies adopt Medicare fee
schedules and global periods, it extends way beyond Medicare.
Then it becomes your entire insured population. That cost
shifts all of the specialty and tertiary care to regional
medical centers and academic institutions, who can no longer
bear the burden. And pretty soon we are going to start losing
teaching institutions.
So the ramifications of this go far beyond primary care,
and far beyond the kind of mapping that you see here that Dr.
Jones presented.
Chairman Manzullo. Thank you. Ms. Napolitano.
Ms. Napolitano. Thank you, Mr. Chairman. I think we can
probably spend weeks really getting complaints, if you will, on
HCFA. And I come back from the state level, where we went
through this ad nauseam.
The issue then, Mr. Chairman, is, will you set up a meeting
with Secretary Thompson, and maybe get to the bottom of how can
we work together? Not being punitive, not being aggressively
charging anybody with dereliction of duty or whatever. But get
to the point now. We are facing a critical state.
Chairman Manzullo. We have remedies to take care of people
who obstruct truth from coming forth, and that is the purpose
of this Congressional hearing. We will pursue those avenues
vigorously.
I think it would be a good idea for us to send a letter to
Secretary Thompson, who is a marvelous man, and explain to him
that somebody under his watch is not doing his job.
Ms. Napolitano. Or explain why he is not doing his job to
the satisfaction of this Committee.
But I think it goes beyond. I can tell you that some of my
providers have been, especially home health care providers,
nursing home providers, and some of my dentists are complaining
to me about their not being able to treat patients. They are
cutting down repeatedly because of, the statement has been
because of the lack of reimbursement, and they have to keep
their door open.
So you cannot blame them. And we are not really helping the
people who need it the most, that will not have the access to
this assistance. And whatever can be done, we are with you, Mr.
Chairman. And I think the rest of the Committee understands the
severity of the issue. It is not going to get better, and we
need to act expediently as possible.
Thank you.
Chairman Manzullo. Thank you. Let me put this into the
record. The number of times that I can think of off the top of
my head where we have had members of the Administration along
with small businesspeople.
We had somebody from the VA along with a constituent of
mine complaining about when the VA went into the laundry
business. And that particular match, the VA came in, the
shortest statement I have ever heard. They said as soon as we
got your letter, take our word, as of June 30 last, the VA is
out of the laundry business. We saved about 200 jobs in my
district alone.
We have a match with somebody from the National Parks
Service, and a camp owner from Denali in Alaska. And as a
result of that, Denali National Park decided not to go into the
hotel business. We saved about eight small businesses that had
campgrounds outside.
We had a match with Mr. Barreto, who has been nothing but
fabulous with the SBA, is doing a great job, and Dr. Graham
from OMB. It was a pretty tense meeting. But it brought the
parties together, along with the owner of Albany Travel, over
the size standards. As a result of thathearing bringing the
people together, new size standards were promulgated almost
immediately. Albany got their $600,000 loan and were able to stay in
business.
Again, Hector Barreto came in with people from the industry
with regard to the subsidy rate. And our policy here is
whenever anybody testifies from the Administration, if there is
somebody with the witness that knows the answer better than
they do, that individual just scoots up to the table, identify
them self for the record, and answers the question.
Dr. Blanchard testified, it was about three weeks ago,
extremely productive hearing, all going to the resolution of
that issue.
We had a match with somebody from the Federal Prison
Industries, with the lady from Ohio, dealing with electronic
harnesses. And as a result of that, Federal Prison Industries
went out of the business of making electronic harnesses and she
got her contract.
We had a match with the Defense Logistic Agency when two
Major Generals were here, and a lady from Phoenix, Arizona. As
a result of that hearing, the importation of most of those
black berets stopped. We got a $50 million set-aside for small
businesses and helped save her business in Phoenix, Arizona.
We had a match with the National Park Service and the folks
at West Yellowstone, Yellowstone, Montana. As a result of that
valuable testimony, it went into the record on the impact on
small businesses.
We had a match when I held a field hearing in Santa Fe, New
Mexico, with the people who run the Los Alamos Lab, along with
members of the six Pueblos, the Indian tribes, and others who
were seeking contracts. As a result of that, one person who was
complaining was put in charge of overseeing all contracts at
Los Alamos, with an initial start of $50 million being set
aside for small business involved in construction.
That is how we do business in this Committee. And I think
for Mr. Scully to wield his arrogance, to think that he cannot
sit down with these nice people. I mean, to me it just defies
logic that a person can remain a part of the Administration and
come here, and stiff a Congressional Committee, ignore a
Congressional subpoena, when our only purpose here is to save
the jobs of small businesspeople.
And it has always been within this spirit that we have
worked on this issue. And I would say if Mr. Scully is
somehow--he is missing an opportunity, I think, to redeem
himself and the organization. Now what you have here is an
antagonistic group of people.
I really think that Mr. Scully should resign. He should
resign his office immediately. Anybody who does not take the
time to meet with people, to take the input from the people
most affected, is doing a disservice to the seniors of this
country, and to the poor who rely upon Medicare services. And
the sooner he does that, the better. I mean, we need to get on
with the tremendous problems that are affecting this
Government.
It was in the last Administration where the Doctor
Hulsebus, it was three brothers, from Rockford, Illinois were
savagely and brutally attacked by HCFA that said they owed
$250,000 in chiropractic overpayments as a result of
extrapolation. We took on HCFA at that time, and brought them
out to Rockford, had a meeting and found out that they did not
even know what an x-ray was. They had no idea. How can you say
that an adjustment by a chiropractor was not medically
necessary when you did not look at the x-rays? As a result of
that, that entire fine was lifted. It got down to eventually
$1500. HCFA insisted on appealing the remaining $1500 on that,
and they were persuaded not to do that, and to drop the appeal.
This is an agency that has, my understanding, 4,500
employees. I do not know what they do. They contract with 81
different companies, including Wisconsin Physician Service that
does my area. They are some of the worst people, who know
absolutely nothing about medical care. They have 81 different
sets of regulations, 81 different sets of standards. Totally
confusing the medical industry. Demoralizing people who spent
years in college for the purpose of healing. And many of those
are here in this room today.
I just think when I look upon the tremendous amount of
sacrifice, and the witnesses here, and the time that you have
put in for the practice of healing. You came here today to heal
some of the wounds that have arisen because of the
intransigence of the Health Care Financing Administration.
They are not here today. Perhaps at the next hearing we
will have a new Administrator.
Mr. Davis, did you have any questions?
Mr. Davis. Yes, sir.
Thank you very much, Mr. Chairman. Let me apologize for not
hearing the testimony, but I think I got a good drift of what
has been taking place. Plus I think the fact that I have been
associated with health care now for about 30 years, and have
spent about 15 of those as a health planner, and represent a
district that has 24 hospitals in it, four medical schools, and
the biggest medical center complex in the country, as well as
about 35 or 40 nursing homes and about 25 or 30 community
health centers, I spend a great deal of my time listening to
the woes of people who have interacted with HCFA. And also
having some understanding of why HCFA was created in the first
place, to try and handle, or get a handle on, what was called
the spiraling runaway health care costs.
I kind of understand a little bit of what has taken place.
And I agree with you, it is one of the most complex of all
agencies probably within the Federal Government. And I guess
the one question--and I have heard these arguments and
discussions many, many times, as I am sure most of us have, and
all of us probably have--what would your recommendations be to
us in terms of what it is that you think we really can do, and
need to do, to try to get a, a balance on this problem? That
would be my question to the panel.
Ms. Harroun. I am Mary Harroun, Congressman Davis. I live
in your general area. I am a Chicago person.
I have before me a very ragged-tagged book of nursing home
regulations. They are there. They were passed in 1990. If HCFA,
CMS, would just mandate that their surveyors follow these
regulations, providing the highest quality of care possible to
our residents in long-term care. They are written. They do not
follow them.
Mr. Davis. Follow the rules.
Dr. Nielsen. Congressman Davis, one of the things that I
recommended was passage of the Medicare Regulatory and
Contracting Reform Act. And one of the most important
provisions of that Act is a provision that engages us in
compliance education.
Physicians want to be in compliance. Nobody wants to be
audited, nobody wants to have their reputation ruined, or their
office sacked, or their records reviewed. And we want
education.
So to the degree that we have to deal with this extremely
complex issue, as you mentioned, and we are going to have
difficult regulations whose executive summaries run into the
hundreds of pages, help us to educate ourselves so that we can
comply. And let's reduce those burdens that are unnecessary.
We are being asked to bear the burdens financially for, for
a provision of services that we think are good, but we do not
have the resources to cover. If we are going to make those
services necessary, then we have to provide the resources to
cover them.
I come from a family of 10 children. And if one of us
misbehaved, it was not my father'spattern to spank all of us
just so that he made sure he got the right one in there somewhere. And
that is the way physicians feel. If there is a problem, don't spank all
of us. Let's find the problem, and let's weed it out.
Dr. Jones. And with all due respect, I am number nine of
12, and we all got spanked whether we needed it or not.
[Laughter.]
But Mr. Davis, I appreciate the opportunity to offer you
two suggestions, as a Committee.
I would like to ask your support for the legislation that
was introduced by Representative Nancy Johnson, preserving
patient access Preserving Patient Access to Physicians Act,
H.R. 3882.
The good thing about that is it would affect the MedPAC
recommendations and remove reimbursements for expenditures away
from the GDP. To me, that is the reasonable way to do it.
Some people say it costs too much. My question is, can we
afford not to do it? It is the right thing to do.
And it is interesting to me that CMS found a way to
increase the reimbursement for Medicare Plus Choice. It seems
as though they wanted to ensure that there was money there to
make sure that everyone had an HMO, but not put money into
physician reimbursement to make sure that everyone had a
physician. There is a disconnect here for me. Your support in
helping to make sure this happens, and getting Medicare to do
all they can, getting CMS to do all they can from the
regulatory component would help us tremendously.
Mr. Evans. Congressman Davis, thank you for asking the
question. My name is Zach Evans, and I am with the portable x-
ray providers.
Our industry is 85 percent, 85 to 90 percent dependent on
Medicare. We cannot turn Medicare patients away and look for
other sources of payment.
Like I said before, we are, if we do not get a bill passed,
and it is a bill which Congressman Phil Crane and Chairman
Manzullo have sponsored. It is H.R. 3094, which will help fix
our industry.
Is it a total fix? No, sir, it is not. Do I think that,
that the things that we have mentioned here, all of us have
mentioned here today, will help? I think they will. But I think
it is going to take more than that in the long run. I think it
is going to take an honest effort by Mr. Scully and his
organization to respect this Committee and respect the small
businesses that are out there. Because I do not see any respect
today.
If that had been me, and I ignored a subpoena, I would be
in the pokey right now.
Ms. Harroun. That is right.
Mr. Evans. Thank you.
Mr. Davis. Well, I thank you all very much. And Mr.
Chairman, it seems to me--yes?
Mr. Sullivan. Mr. Congressman, I actually would like to
answer how Congress can help come to a solution, in addition to
having these hearings which are intended to be productive.
As far as the Office of Advocacy is concerned, we do need
your help to help convince CMS that compliance with the Reg
Flex Act is more than simply running a bunch of numbers. When
CMS complies with the Reg Flex Act, and they consider their
consequence on small business, they will learn what Dr. Weldon
has already learned, and what he brought before this Committee.
That is that if you consider the impact on transportation
costs, and you consider what portable x-ray providers do, you
actually save the Medicare system money.
Mr. Davis. Well, I thank all of you for your answers. And
Mr. Chairman, it seems to me that you do a pretty good job of
spanking. [Laughter.]
Chairman Manzullo. Dr. Christensen.
Ms. Christian-Christensen. I am sorry that I did not get to
this before, but this was something that was shared with us at
one of our roundtables. And it shows you what happened to
Medicare payments, which is down all the way at the bottom of
this. And this is what, where practice costs are.
In actuality, what happens is that there is at least a $20
billion shortfall in the payments over just the last, since
1997. A shortfall of $20 billion over the last five years. The
costs are going up, and the discrepancy is just really large.
And one of the problems with this is, and correct me if I
am wrong, but whatever Medicare does, all of the other
insurance companies follow.
Mr. Evans. Very correct.
Ms. Christian-Christensen. So what we are seeing here is
the beginning of a process of getting rid of small business
health care providers. Because the other insurance companies
are going to follow. There is just going to be no way for them
to stay in business.
I know it sounds bad to hear that providers are not going
to serve Medicare patients, but they just cannot. And it is
going to get worse, because this is just the beginning.
Mr. Chairman, I feel like there is a war going on against
small health care practitioners. I felt it before I came here,
I feel it even more now. The references made by Dr. Jones about
the HMOs versus the practitioner, but I feel like they are
trying to get rid of all of us and let the big corporations,
you know, continue to make the money. You know we cannot let
that happen.
Chairman Manzullo. I have a final question that is
technical, Mary, so I am going to read it, if you do not mind.
`It seems clear that in a wheelchair muscles degenerate.
But with the assistance of the Merry Walker, those same muscles
are used and preserved.
`In the Sunday Washington Post, Mr. Scully announced that
HCFA would begin rating nursing homes. The data to be used to
rate nursing homes will come from the MDS, that is the minimum
data set.'
This was originally a question for Mr. Scully, but since he
is not here, I will ask you. I guess you are in his chair. Here
is the question.
Since the Merry Walker is deemed to be a restraint and
nursing homes are discouraged from using restraints, and are
sometimes penalized for doing so, do you believe a nursing home
would receive a poorer rating for using the Merry Walker than a
nursing home that places residents in wheelchairs?
Ms. Harroun. Yes, Mr. Chairman. In my research of this MDS
wrongful tort suit describing the Merry Walker as a chair that
prevents rising, I----
Chairman Manzullo. They actually took your trademark name--
--
Ms. Harroun. That is correct.
Chairman Manzullo [continuing]. And took out the
capitalization----
Ms. Harroun. That is correct.
Chairman Manzullo [continuing]. And used it as a generic
name in their manual.
Ms. Harroun. That is correct.
Chairman Manzullo. Anybody else would have been sued for
doing that.
Ms. Harroun. Yes. And there is no way I can sue them. We
have already pursued that. Because they made no money. You can
only do a trademark lawsuit when there is money to be made.
Chairman Manzullo. I just hope, I just hope people realize
the significance of what they did to you. It is the same as if
somebody took the name Xerox----
Ms. Harroun. And put it with small letters, and `do not use
it,' basically.
Chairman Manzullo. And they used your device, with Merry
Walker spelled the same way, they did not put the trademark on
it, or service mark, in small letters, and used it as an
example of what they do not like.
Ms. Harroun. Right.
Chairman Manzullo. Okay.
Ms. Napolitano. Mr. Chairman, isn't that defamation of a
product?
Chairman Manzullo. I do not know what it is. I think it is
defamation of Congress that these guys do not show up.
Ms. Harroun. Yes, exactly. The thing is, they have now come
across, in their latest writings, which they--when I wrote to
them the 1st of August, we have got two answers here coming
forth. I will answer your question in a second.
Chairman Manzullo. Go ahead.
Ms. Harroun. I did write Tom Scully, Jeane Nitsch, Fred
Gladden, and Steve Pelovitz. I copied them all on the same
letter, showing them Merry Walker was a registered trademark,
it was a patented product. And it is certainly not a chair that
prevents rising. I mean, I went into that in detail.
They wrote back on the internet, on a question/answer on
the internet stating that Merry Walker is not--they used the
trademark. Do you want me to read that?
Chairman Manzullo. That is all right, you can just----
Ms. Harroun. All right, I will just say it. They said that
Merry Walker, although it is not a chair that prevents
standing, it is still a chair that restricts freedom of
movement. That is, residents' access to steps--this is nursing
home regulations--to the commode, to transferring to another
chair, or into their bed. There are no regs on steps in nursing
homes.
Chairman Manzullo. Because there are no steps.
Ms. Harroun. We have things called elevators in nursing
homes. Yes, what a unique idea. And there is no such thing as
transferring to a chair regulations, or to a commode, or to
bed. That is why they are in the nursing home.
Chairman Manzullo. So they made a reference to regulations
that do not exist.
Ms. Harroun. That do not exist, that is correct. And it was
not my say-so. I did have a witness of an expert on these
rules. And there are none.
Now, in answer to your question, I did contact all the MDS
minimum data set coordinators of all the large nursing home
chains. Marriott, Manor Care, all of them. There are like 20 of
them. Got hold of all the MDS coordinators and asked them how
they are able or not able to use the Merry Walker because of
what the MDS has written.
None of them can use the Merry Walker. None of the large
corporations handling the majority of our nursing home
residents are allowed to use the Merry Walker because of the
MDS.
Chairman Manzullo. So because HCFA will not correct the
miscategorization, a nursing home that allows seniors to
deteriorate will fare better under Mr. Scully's rating than a
nursing home that attempts to keep seniors active and healthy.
Ms. Harroun. That is right. So Merry Walker will never be
used in nursing homes under this new policy, because they will
be cited and they will get negative ratings.
Chairman Manzullo. Mary, a final question. How many of
these have you manufactured and put into the market?
Ms. Harroun. There is about 100 a month over the last 12
years.
Chairman Manzullo. So that is, what, about 15,000? Would
that be correct?
Ms. Harroun. About. And there is 1.8 million people that
could use them.
Chairman Manzullo. Have you ever had a liability suit
against you for this machine?
Ms. Harroun. I have never. And I never even had a viable
FDA med watch, in 12 years.
Chairman Manzullo. Okay. This has been a very interesting
hearing.
Let me say this. Mr. Scully's not showing up here, in my
opinion, my wholehearted opinion, this is not indicative of the
President's office. We have worked with numerous agencies. In
fact, I was in China the first week of January as the Chairman
of the American/Chinese Parliamentary Exchange.
And we sat down with Undersecretaries of Commerce, and
state and national security councils, USTR's office. I mean,
there was more than a briefing. It was, it was for the purpose
of making sure that when I went there, we would present the
same message. And I met with the President of China, an
extraordinary hour-and-25-minute meeting.
But everything that we did, and the reason I bring that up,
it was totally in concert with everything that we want to do
with the Department of State, the National Security Council,
the Department of Commerce and the USTR's office. It was done
purposely, to make sure that they were not only notified of
what they were doing, but they helped us set the agenda.
Because I believe that the branches should work together.
And that is why I am very disappointed that we have this,
this total disconnect that is going on. This Committee does not
have the reputation for doing anything other than trying to
solve, solve problems.
We will deal with Mr. Scully appropriately, swiftly,
according to the rules. And I just want to thank you for coming
long distances, paying your own way. Very impressive witnesses.
I thank God that there are people like you that are out there,
that are carrying the torch, especially to the two M.D.s that
studied long and hard and continue to stay in the profession,
even though it becomes more and more discouraging.
This Committee is adjourned--I am sorry, Mr. Davis?
Mr. Davis. Yes. Before you adjourn, I just want to commend
you. I mean, very seriously. I mean, of course this Committee
does not necessarily have jurisdiction over HCFA, and this is a
serious--I mean, this is a gut-wrenching complex. I mean, it
really is.
I mean, I see people come in my office and virtually cry. I
have had nursing home operators and home health agencies;
people who I am wondering if I am going to be able to keep them
from cracking up before they leave.
I just want to commend you for this hearing, and for the
depth of analysis of a problem and of an issue that we have
been able to explore today. And, and pledge, also, support for
your continuing effort as you attempt to deal with HCFA and the
Administration, to try and help us move towards some resolution
of a big problem facing an awful lot of people throughout the
country.
So I commend you for that.
Chairman Manzullo. Thank you, Congressman Davis. This
Committee is adjourned.
[Whereupon, at 11:49 a.m., the Committee was adjourned.]
[GRAPHIC] [TIFF OMITTED] T9640A.001
[GRAPHIC] [TIFF OMITTED] T9640A.002
[GRAPHIC] [TIFF OMITTED] T9640A.003
[GRAPHIC] [TIFF OMITTED] T9640A.004
[GRAPHIC] [TIFF OMITTED] T9640A.005
[GRAPHIC] [TIFF OMITTED] T9640A.006
[GRAPHIC] [TIFF OMITTED] T9640A.007
[GRAPHIC] [TIFF OMITTED] T9640A.008
[GRAPHIC] [TIFF OMITTED] T9640A.009
[GRAPHIC] [TIFF OMITTED] T9640A.010
[GRAPHIC] [TIFF OMITTED] T9640A.011
[GRAPHIC] [TIFF OMITTED] T9640A.012
[GRAPHIC] [TIFF OMITTED] T9640A.013
[GRAPHIC] [TIFF OMITTED] T9640A.014
[GRAPHIC] [TIFF OMITTED] T9640A.015
[GRAPHIC] [TIFF OMITTED] T9640A.016
[GRAPHIC] [TIFF OMITTED] T9640A.017
[GRAPHIC] [TIFF OMITTED] T9640A.018
[GRAPHIC] [TIFF OMITTED] T9640A.019
[GRAPHIC] [TIFF OMITTED] T9640A.020
[GRAPHIC] [TIFF OMITTED] T9640A.021
[GRAPHIC] [TIFF OMITTED] T9640A.022
[GRAPHIC] [TIFF OMITTED] T9640A.023
[GRAPHIC] [TIFF OMITTED] T9640A.024
[GRAPHIC] [TIFF OMITTED] T9640A.025
[GRAPHIC] [TIFF OMITTED] T9640A.026
[GRAPHIC] [TIFF OMITTED] T9640A.027
[GRAPHIC] [TIFF OMITTED] T9640A.028
[GRAPHIC] [TIFF OMITTED] T9640A.029
[GRAPHIC] [TIFF OMITTED] T9640A.030
[GRAPHIC] [TIFF OMITTED] T9640A.031
[GRAPHIC] [TIFF OMITTED] T9640A.032
[GRAPHIC] [TIFF OMITTED] T9640A.033
[GRAPHIC] [TIFF OMITTED] T9640A.034
[GRAPHIC] [TIFF OMITTED] T9640A.035
[GRAPHIC] [TIFF OMITTED] T9640A.036
[GRAPHIC] [TIFF OMITTED] T9640A.037
[GRAPHIC] [TIFF OMITTED] T9640A.038
[GRAPHIC] [TIFF OMITTED] T9640A.039
[GRAPHIC] [TIFF OMITTED] T9640A.040
[GRAPHIC] [TIFF OMITTED] T9640A.041
[GRAPHIC] [TIFF OMITTED] T9640A.042
[GRAPHIC] [TIFF OMITTED] T9640A.043
[GRAPHIC] [TIFF OMITTED] T9640A.044
[GRAPHIC] [TIFF OMITTED] T9640A.045
[GRAPHIC] [TIFF OMITTED] T9640A.046
[GRAPHIC] [TIFF OMITTED] T9640A.047
[GRAPHIC] [TIFF OMITTED] T9640A.048
[GRAPHIC] [TIFF OMITTED] T9640A.049
[GRAPHIC] [TIFF OMITTED] T9640A.050
[GRAPHIC] [TIFF OMITTED] T9640A.051
[GRAPHIC] [TIFF OMITTED] T9640A.052
[GRAPHIC] [TIFF OMITTED] T9640A.053
[GRAPHIC] [TIFF OMITTED] T9640A.054
[GRAPHIC] [TIFF OMITTED] T9640A.055
[GRAPHIC] [TIFF OMITTED] T9640A.056
[GRAPHIC] [TIFF OMITTED] T9640A.057
[GRAPHIC] [TIFF OMITTED] T9640A.058
[GRAPHIC] [TIFF OMITTED] T9640A.059
[GRAPHIC] [TIFF OMITTED] T9640A.060
[GRAPHIC] [TIFF OMITTED] T9640A.061
[GRAPHIC] [TIFF OMITTED] T9640A.062
[GRAPHIC] [TIFF OMITTED] T9640A.063
[GRAPHIC] [TIFF OMITTED] T9640A.064
[GRAPHIC] [TIFF OMITTED] T9640A.065
[GRAPHIC] [TIFF OMITTED] T9640A.066
[GRAPHIC] [TIFF OMITTED] T9640A.067
[GRAPHIC] [TIFF OMITTED] T9640A.068
[GRAPHIC] [TIFF OMITTED] T9640A.069
[GRAPHIC] [TIFF OMITTED] T9640A.070
[GRAPHIC] [TIFF OMITTED] T9640A.071
[GRAPHIC] [TIFF OMITTED] T9640A.072
[GRAPHIC] [TIFF OMITTED] T9640A.073
[GRAPHIC] [TIFF OMITTED] T9640A.074
[GRAPHIC] [TIFF OMITTED] T9640A.075
[GRAPHIC] [TIFF OMITTED] T9640A.076
[GRAPHIC] [TIFF OMITTED] T9640A.077
[GRAPHIC] [TIFF OMITTED] T9640A.078
[GRAPHIC] [TIFF OMITTED] T9640A.079
[GRAPHIC] [TIFF OMITTED] T9640A.080
[GRAPHIC] [TIFF OMITTED] T9640A.081
[GRAPHIC] [TIFF OMITTED] T9640A.082
[GRAPHIC] [TIFF OMITTED] T9640A.083
[GRAPHIC] [TIFF OMITTED] T9640A.084
[GRAPHIC] [TIFF OMITTED] T9640A.085
[GRAPHIC] [TIFF OMITTED] T9640A.086
[GRAPHIC] [TIFF OMITTED] T9640A.087
[GRAPHIC] [TIFF OMITTED] T9640A.088
[GRAPHIC] [TIFF OMITTED] T9640A.089
[GRAPHIC] [TIFF OMITTED] T9640A.090
[GRAPHIC] [TIFF OMITTED] T9640A.091
[GRAPHIC] [TIFF OMITTED] T9640A.092
[GRAPHIC] [TIFF OMITTED] T9640A.093
[GRAPHIC] [TIFF OMITTED] T9640A.094
[GRAPHIC] [TIFF OMITTED] T9640A.095
[GRAPHIC] [TIFF OMITTED] T9640A.096
[GRAPHIC] [TIFF OMITTED] T9640A.097
[GRAPHIC] [TIFF OMITTED] T9640A.098
[GRAPHIC] [TIFF OMITTED] T9640A.099
[GRAPHIC] [TIFF OMITTED] T9640A.100
[GRAPHIC] [TIFF OMITTED] T9640A.101
[GRAPHIC] [TIFF OMITTED] T9640A.102
[GRAPHIC] [TIFF OMITTED] T9640A.103
[GRAPHIC] [TIFF OMITTED] T9640A.104
[GRAPHIC] [TIFF OMITTED] T9640A.105
[GRAPHIC] [TIFF OMITTED] T9640A.106
[GRAPHIC] [TIFF OMITTED] T9640A.107
[GRAPHIC] [TIFF OMITTED] T9640A.108
[GRAPHIC] [TIFF OMITTED] T9640A.109
[GRAPHIC] [TIFF OMITTED] T9640A.110
[GRAPHIC] [TIFF OMITTED] T9640A.111
[GRAPHIC] [TIFF OMITTED] T9640A.112
[GRAPHIC] [TIFF OMITTED] T9640A.113
[GRAPHIC] [TIFF OMITTED] T9640A.114
[GRAPHIC] [TIFF OMITTED] T9640A.115
[GRAPHIC] [TIFF OMITTED] T9640A.116
[GRAPHIC] [TIFF OMITTED] T9640A.117
[GRAPHIC] [TIFF OMITTED] T9640A.118
[GRAPHIC] [TIFF OMITTED] T9640A.119
[GRAPHIC] [TIFF OMITTED] T9640A.120
[GRAPHIC] [TIFF OMITTED] T9640A.121
[GRAPHIC] [TIFF OMITTED] T9640A.122
[GRAPHIC] [TIFF OMITTED] T9640A.123
[GRAPHIC] [TIFF OMITTED] T9640A.124
[GRAPHIC] [TIFF OMITTED] T9640A.125
[GRAPHIC] [TIFF OMITTED] T9640A.126
[GRAPHIC] [TIFF OMITTED] T9640A.127
[GRAPHIC] [TIFF OMITTED] T9640A.128
[GRAPHIC] [TIFF OMITTED] T9640A.129
[GRAPHIC] [TIFF OMITTED] T9640A.130
[GRAPHIC] [TIFF OMITTED] T9640A.131
[GRAPHIC] [TIFF OMITTED] T9640A.132
[GRAPHIC] [TIFF OMITTED] T9640A.133
[GRAPHIC] [TIFF OMITTED] T9640A.134
[GRAPHIC] [TIFF OMITTED] T9640A.135
[GRAPHIC] [TIFF OMITTED] T9640A.136
[GRAPHIC] [TIFF OMITTED] T9640A.137
[GRAPHIC] [TIFF OMITTED] T9640A.138
[GRAPHIC] [TIFF OMITTED] T9640A.139
[GRAPHIC] [TIFF OMITTED] T9640A.140
[GRAPHIC] [TIFF OMITTED] T9640A.141
[GRAPHIC] [TIFF OMITTED] T9640A.142
[GRAPHIC] [TIFF OMITTED] T9640A.143
[GRAPHIC] [TIFF OMITTED] T9640A.144
[GRAPHIC] [TIFF OMITTED] T9640A.145
[GRAPHIC] [TIFF OMITTED] T9640A.146
[GRAPHIC] [TIFF OMITTED] T9640A.147
[GRAPHIC] [TIFF OMITTED] T9640A.148
[GRAPHIC] [TIFF OMITTED] T9640A.149
[GRAPHIC] [TIFF OMITTED] T9640A.150
[GRAPHIC] [TIFF OMITTED] T9640A.151
[GRAPHIC] [TIFF OMITTED] T9640A.152
[GRAPHIC] [TIFF OMITTED] T9640A.153
[GRAPHIC] [TIFF OMITTED] T9640A.154
[GRAPHIC] [TIFF OMITTED] T9640A.155
[GRAPHIC] [TIFF OMITTED] T9640A.156
[GRAPHIC] [TIFF OMITTED] T9640A.157
[GRAPHIC] [TIFF OMITTED] T9640A.158
[GRAPHIC] [TIFF OMITTED] T9640A.159
[GRAPHIC] [TIFF OMITTED] T9640A.160
[GRAPHIC] [TIFF OMITTED] T9640A.161
[GRAPHIC] [TIFF OMITTED] T9640A.162
[GRAPHIC] [TIFF OMITTED] T9640A.163
[GRAPHIC] [TIFF OMITTED] T9640A.164
[GRAPHIC] [TIFF OMITTED] T9640A.165
[GRAPHIC] [TIFF OMITTED] T9640A.166
[GRAPHIC] [TIFF OMITTED] T9640A.167
[GRAPHIC] [TIFF OMITTED] T9640A.168
[GRAPHIC] [TIFF OMITTED] T9640A.169
[GRAPHIC] [TIFF OMITTED] T9640A.170
[GRAPHIC] [TIFF OMITTED] T9640A.171
[GRAPHIC] [TIFF OMITTED] T9640A.172
[GRAPHIC] [TIFF OMITTED] T9640A.173
[GRAPHIC] [TIFF OMITTED] T9640A.174
[GRAPHIC] [TIFF OMITTED] T9640A.175
[GRAPHIC] [TIFF OMITTED] T9640A.176
[GRAPHIC] [TIFF OMITTED] T9640A.177
[GRAPHIC] [TIFF OMITTED] T9640A.178
[GRAPHIC] [TIFF OMITTED] T9640A.179
[GRAPHIC] [TIFF OMITTED] T9640A.180
[GRAPHIC] [TIFF OMITTED] T9640A.181
[GRAPHIC] [TIFF OMITTED] T9640A.182
[GRAPHIC] [TIFF OMITTED] T9640A.183
[GRAPHIC] [TIFF OMITTED] T9640A.184
[GRAPHIC] [TIFF OMITTED] T9640A.185
[GRAPHIC] [TIFF OMITTED] T9640A.186
[GRAPHIC] [TIFF OMITTED] T9640A.187
[GRAPHIC] [TIFF OMITTED] T9640A.188
[GRAPHIC] [TIFF OMITTED] T9640A.189
[GRAPHIC] [TIFF OMITTED] T9640A.190
[GRAPHIC] [TIFF OMITTED] T9640A.191
[GRAPHIC] [TIFF OMITTED] T9640A.192
[GRAPHIC] [TIFF OMITTED] T9640A.193
[GRAPHIC] [TIFF OMITTED] T9640A.194
[GRAPHIC] [TIFF OMITTED] T9640A.195
[GRAPHIC] [TIFF OMITTED] T9640A.196
[GRAPHIC] [TIFF OMITTED] T9640A.197
[GRAPHIC] [TIFF OMITTED] T9640A.198
[GRAPHIC] [TIFF OMITTED] T9640A.199
[GRAPHIC] [TIFF OMITTED] T9640A.200
[GRAPHIC] [TIFF OMITTED] T9640A.201
[GRAPHIC] [TIFF OMITTED] T9640A.202
[GRAPHIC] [TIFF OMITTED] T9640A.203
[GRAPHIC] [TIFF OMITTED] T9640A.204
[GRAPHIC] [TIFF OMITTED] T9640A.205
[GRAPHIC] [TIFF OMITTED] T9640A.206
[GRAPHIC] [TIFF OMITTED] T9640A.207
[GRAPHIC] [TIFF OMITTED] T9640A.208
[GRAPHIC] [TIFF OMITTED] T9640A.209
[GRAPHIC] [TIFF OMITTED] T9640A.210
[GRAPHIC] [TIFF OMITTED] T9640A.211
[GRAPHIC] [TIFF OMITTED] T9640A.212
[GRAPHIC] [TIFF OMITTED] T9640A.213
[GRAPHIC] [TIFF OMITTED] T9640A.214
[GRAPHIC] [TIFF OMITTED] T9640A.215
[GRAPHIC] [TIFF OMITTED] T9640A.216
[GRAPHIC] [TIFF OMITTED] T9640A.217
[GRAPHIC] [TIFF OMITTED] T9640A.218
[GRAPHIC] [TIFF OMITTED] T9640A.219
[GRAPHIC] [TIFF OMITTED] T9640A.220
[GRAPHIC] [TIFF OMITTED] T9640A.221
[GRAPHIC] [TIFF OMITTED] T9640A.222
[GRAPHIC] [TIFF OMITTED] T9640A.223
[GRAPHIC] [TIFF OMITTED] T9640A.224
[GRAPHIC] [TIFF OMITTED] T9640A.225
[GRAPHIC] [TIFF OMITTED] T9640A.226
[GRAPHIC] [TIFF OMITTED] T9640A.227
[GRAPHIC] [TIFF OMITTED] T9640A.228
[GRAPHIC] [TIFF OMITTED] T9640A.229
[GRAPHIC] [TIFF OMITTED] T9640A.230
[GRAPHIC] [TIFF OMITTED] T9640A.231
[GRAPHIC] [TIFF OMITTED] T9640A.232
[GRAPHIC] [TIFF OMITTED] T9640A.233
[GRAPHIC] [TIFF OMITTED] T9640A.234
[GRAPHIC] [TIFF OMITTED] T9640A.235
[GRAPHIC] [TIFF OMITTED] T9640A.236