CONGRESSIONAL RECORD SENATE

S12370 CONGRESSIONAL RECORD — SENATE December 4, 2001

at least January 1, 2003, any changes in This legislation is especially crucial ters of the Association for Marriage

medicaid regulations that modify the to rural seniors who are often forced to and Family Therapy, the California As-

medicaid upper payment limit for non- travel long distances to utilize the sociation of Marriage and Family

State Government-owned or operated services of mental health providers Therapists, and the National Rural

hospitals. currently recognized by the Medicare Health Association.

S. 1749 program. Rural communities have dif- I believe this legislation is critically

At the request of Mr. KENNEDY, the ficulty recruiting and retaining pro- important to the health and well-being

names of the Senator from New Mexico viders, especially mental health pro- of our Nation’s Seniors and I strongly

(Mr. BINGAMAN), the Senator from New viders. In many small towns a mental urge all my colleagues to become a co-

York (Mr. SCHUMER), the Senator from health counselor or a marriage and sponsor.

Nebraska (Mr. HAGEL), and the Senator family therapist is the only mental Mr. President, I ask unanimous con-

from Nevada (Mr. REID) were added as health care provider in the area. Medi- sent that the text of the bill and let-

cosponsors of S. 1749 , a bill to enhance care law, as it exists today, compounds ters of endorsement from supporting

the border security of the United the situation because only psychia- organizations be printed in the

States, and for other purposes. trists, clinical psychologists, clinical RECORD.

S. 1757 social workers and clinical nurse spe- There being no objection, the mate-

At the request of Mr. CRAIG, the cialists are able to bill Medicare for rial was ordered to be printed in the

name of the Senator from Idaho (Mr. their services. RECORD, as follows:

CRAPO) was added as a cosponsor of S. It is time the Medicare program rec- S. 1760

1757, a bill to authorize an additional ognized the qualifications of mental Be it enacted by the Senate and House of Rep-

permanent judgeship in the district of health counselors and marriage and resentatives of the United States of America in

Idaho, and for other purposes. family therapists as well as the critical Congress assembled,

role they play in the mental health SECTION 1. SHORT TITLE.

S.J. RES. 12

care infrastructure. These providers go This Act may be cited as the ‘‘Seniors

At the request of Mr. SMITH of New through rigorous training, similar to Mental Health Access Improvement Act of

Hampshire, the name of the Senator the curriculum of masters level social 2001’’.

from Maine (Ms. SNOWE) was added as a workers, and yet are excluded from the SEC. 2. COVERAGE OF MARRIAGE AND FAMILY

cosponsor of S.J. Res. 12, a joint resolu- Medicare program. THERAPIST SERVICES AND MENTAL

tion granting the consent of Congress Particularly troubling to me is the HEALTH COUNSELOR SERVICES

to the International Emergency Man- UNDER PART B OF THE MEDICARE

fact that seniors have PROGRAM.

agement Assistance Memorandum of disproportionally higher rates of de- (a) COVERAGE OF SERVICES.—

Understanding. pression and suicide than other popu- (1) IN GENERAL.—Section 1861(s)(2) of the

AMENDMENT NO. 2152 lations. Additionally, 75 percent of the Social Security Act (42 U.S.C. 1395x(s)(2)), as

At the request of Mr. DEWINE, the 518 nationally designated Mental amended by sections 102(a) and 105(a) of the

name of the Senator from Hawaii (Mr. Health Professional Shortage Areas are Medicare, Medicaid, and SCHIP Benefits Im-

INOUYE) was added as a cosponsor of provement and Protection Act of 2000 (114

located in rural areas and one-fifth of

amendment No. 2152 intended to be pro- Stat. 2763A–468 and 2763A–471), as enacted

all rural counties have no mental into law by section 1(a)(6) of Public Law 106–

posed to H.R. 3090, a bill to provide tax health services of any kind. Frontier 554, is amended—

incentives for economic recovery. counties have even more drastic num- (A) in subparagraph (U), by striking ‘‘and’’

AMENDMENT NO. 2157 bers as 95 percent do not have a psy- after the semicolon at the end;

At the request of Mr. MCCAIN, the chiatrist, 68 percent do not have a psy- (B) in subparagraph (V)(iii), by inserting

name of the Senator from Vermont chologist and 78 percent do not have a ‘‘and’’ after the semicolon at the end; and

(Mr. JEFFORDS) was added as a cospon- social worker. It is quite obvious we (C) by adding at the end the following new

sor of amendment No. 2157 intended to subparagraph:

have an enormous task ahead of us to

‘‘(W) marriage and family therapist serv-

be proposed to H.R. 3090, a bill to pro- reduce these staggering statistics. Pro- ices (as defined in subsection (ww)(1)) and

vide tax incentives for economic recov- viding mental health counselors and mental health counselor services (as defined

ery. marriage and family therapists the in subsection (ww)(3));’’.

AMENDMENT NO. 2202 ability to bill Medicare for their serv- (2) DEFINITIONS.—Section 1861 of such Act

At the request of Mr. CONRAD, his ices is a key part of the solution. (42 U.S.C. 1395x), as amended by sections

name was added as a cosponsor of Virtually all of my State of Wyoming 102(b) and 105(b) of the Medicare, Medicaid,

amendment No. 2202. is a mental health professional short- and SCHIP Benefits Improvement and Pro-

age area and will greatly benefit from tection Act of 2000 (114 Stat. 2763A–468 and

f 2763A–471), as enacted into law by section

this legislation. Wyoming has 169 psy-

STATEMENTS ON INTRODUCED 1(a)(6) of Public Law 106–554, is amended by

chologists, 121 psychiatrists, and 247 adding at the end the following new sub-

BILLS AND JOINTS RESOLUTIONS social workers for a total of 537 Medi- section:

By Mr. THOMAS (for himself and care eligible mental health providers. ‘‘Marriage and Family Therapist Services;

Mrs. LINCOLN): Enactment of the Seniors Mental Marriage and Family Therapist; Mental

S. 1760. A bill to amend title XVIII of Health Access Improvement Act of 2001 Health Counselor Services; Mental Health

the Social Security Act to provide for will double the number of mental Counselor

the coverage of marriage and family health providers available to seniors in ‘‘(ww)(1) The term ‘marriage and family

therapist services and mental health my State with the addition of 517 men- therapist services’ means services performed

counselor services under part B of the tal health counselors and 55 marriage by a marriage and family therapist (as de-

Medicare Program, and for other pur- and family therapists currently li- fined in paragraph (2)) for the diagnosis and

poses; to the Committee on Finance. censed in the State. treatment of mental illnesses, which the

Mr. THOMAS. Mr. President, I am In crafting this legislation Senator marriage and family therapist is legally au-

thorized to perform under State law (or the

pleased to rise today to introduce the LINCOLN and I worked with numerous

State regulatory mechanism provided by

Seniors Mental Health Access Improve- outside organizations with an interest State law) of the State in which such serv-

ment Act of 2001 with my distinguished in this issue. As a result of this col- ices are performed, as would otherwise be

colleague from Arkansas, Mrs. LIN- laboration, the ‘‘Seniors Mental Health covered if furnished by a physician or as an

COLN. Specifically, the Seniors Mental Access Improvement Act of 2001’’ is incident to a physician’s professional serv-

Health Access Improvement Act of 2001 strongly supported by the American ice, but only if no facility or other provider

permits mental health counselors and Counseling Association, the Wyoming charges or is paid any amounts with respect

marriage and family therapists to bill Counseling Association, the American to the furnishing of such services.

‘‘(2) The term ‘marriage and family thera-

Medicare for their services. This will Mental Health Counselors Association,

pist’ means an individual who—

result in an increased choice of pro- the Arkansas Mental Health Coun- ‘‘(A) possesses a master’s or doctoral de-

viders for seniors and enhance their selors Association, the American Asso- gree which qualifies for licensure or certifi-

ability to access mental health serv- ciation for Marriage and Family Ther- cation as a marriage and family therapist

ices in their communities. apy, the Wyoming and Arkansas Chap- pursuant to State law;









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December 4, 2001 CONGRESSIONAL RECORD — SENATE S12371

‘‘(B) after obtaining such degree has per- SCHIP Benefits Improvement and Protection those of clinical social workers, who have

formed at least 2 years of clinical supervised Act of 2000 (114 Stat. 2763A–472), as enacted been covered under Medicare for over ten

experience in marriage and family therapy; into law by section 1(a)(6) of Public Law 106– years.

and 554, is amended by adding at the end the fol- Thank you for your leadership in intro-

‘‘(C) in the case of an individual per- lowing new clauses: ducing this important legislation. We look

forming services in a State that provides for ‘‘(vii) A marriage and family therapist (as forward to working with you to gain its en-

licensure or certification of marriage and defined in section 1861(ww)(2)). actment, and I urge you and your staff to

family therapists, is licensed or certified as ‘‘(viii) A mental health counselor (as de- call on us if we can be of any assistance.

a marriage and family therapist in such fined in section 1861(ww)(4)).’’. Sincerely,

State. (b) COVERAGE OF CERTAIN MENTAL HEALTH JANE GOODMAN,

‘‘(3) The term ‘mental health counselor SERVICES PROVIDED IN CERTAIN SETTINGS.— President.

services’ means services performed by a men- (1) RURAL HEALTH CLINICS AND FEDERALLY

tal health counselor (as defined in paragraph QUALIFIED HEALTH CENTERS.—Section AMERICAN COUNSELING ASSOCIATION,

(2)) for the diagnosis and treatment of men- 1861(aa)(1)(B) of the Social Security Act (42 Alexandria, VA, November 27, 2001.

tal illnesses which the mental health coun- U.S.C. 1395x(aa)(1)(B)) is amended by insert- Hon. BLANCHE L. LINCOLN,

selor is legally authorized to perform under ing ‘‘, by a marriage and family therapist (as U.S. Senate,

State law (or the State regulatory mecha- defined in subsection (ww)(2)), by a mental Washington, DC.

nism provided by the State law) of the State health counselor (as defined in subsection DEAR SENATOR LINCOLN: I am writing on

in which such services are performed, as (ww)(4)),’’ after ‘‘by a clinical psychologist behalf of the American Counseling Associa-

would otherwise be covered if furnished by a (as defined by the Secretary)’’.

physician or as incident to a physician’s pro- tion, which with over 53,000 members is the

(2) HOSPICE PROGRAMS.—Section nation’s largest non-profit membership orga-

fessional service, but only if no facility or 1861(dd)(2)(B)(i)(III) of such Act (42 U.S.C.

other provider charges or is paid any nization representing state-licensed profes-

1395x(dd)(2)(B)(i)(III)) is amended by insert- sional mental health counselors, to express

amounts with respect to the furnishing of ing ‘‘or a marriage and family therapist (as

such services. our strong support for your legislation, the

defined in subsection (ww)(2))’’ after ‘‘social ‘‘Seniors Mental Health Access Improvement

‘‘(4) The term ‘mental health counselor’

means an individual who— worker’’. Act of 2001’’. We applaud your leadership in

(c) AUTHORIZATION OF MARRIAGE AND FAM- introducing this legislation.

‘‘(A) possesses a master’s or doctor’s de-

ILY THERAPISTS TO DEVELOP DISCHARGE Medicare’s mental health benefit currently

gree in mental health counseling or a related

PLANS FOR POST-HOSPITAL SERVICES.—Sec- excludes two core mental health professions:

field;

tion 1861(ee)(2)(G) of the Social Security Act licensed professional counselors and licensed

‘‘(B) after obtaining such a degree has per-

(42 U.S.C. 1395x(ee)(2)(G)) is amended by in- marriage and family therapists. Statistics

formed at least 2 years of supervised mental

serting ‘‘marriage and family therapist (as such as those included in the attached fact

health counselor practice; and

defined in subsection (ww)(2)),’’ after ‘‘social sheet show that Medicare beneficiaries are

‘‘(C) in the case of an individual per-

worker,’’. not getting the mental health treatment

forming services in a State that provides for

(d) EFFECTIVE DATE.—The amendments

licensure or certification of mental health they need. Lack of access to providers is one

made by this section shall apply with respect

counselors or professional counselors, is li- of the primary factors involved.

to services furnished on or after January 1,

censed or certified as a mental health coun- As with other areas of health care, access-

2002.

selor or professional counselor in such ing mental health services is especially prob-

State.’’. lematic in rural areas. In many underserved

AMERICAN COUNSELING ASSOCIATION,

(3) PROVISION FOR PAYMENT UNDER PART communities, licensed professional coun-

Alexandria, VA, November 27, 2001.

B.—Section 1832(a)(2)(B) of such Act (42 selors are the only mental health specialists

Hon. CRAIG THOMAS,

U.S.C. 1395k(a)(2)(B)) is amended by adding available. We feel strongly that proposals to

U.S. Senate,

at the end the following new clause: improve rural Medicare beneficiaries’ access

Washington, DC.

‘‘(v) marriage and family therapist services DEAR SENATOR THOMAS: I am writing on be- to mental health care must include expand-

and mental health counselor services;’’. half of the American Counseling Association, ing the pool of covered providers. However,

(4) AMOUNT OF PAYMENT.—Section 1833(a)(1) which with over 53,000 members is the na- access to providers is not only a rural issue.

of such Act (42 U.S.C. 1395l(a)(1)), as amended tion’s largest non-profit membership organi- An article cited on the enclosed fact sheet,

by sections 105(c) and 223(c) of the Medicare, zation representing state-licensed profes- recently published by the American Psy-

Medicaid, and SCHIP Benefits Improvement sional mental health counselors, to express chiatric Association, states that ‘‘the supply

and Protection Act of 2000 (114 Stat. 2763A– our strong support for your legislation, the of both specialists and resources cannot

472 and 2763A–489), as enacted into law by ‘‘Seniors Mental Health Access Improvement meet current or future demands’’ for mental

section 1(a)(6) of Public Law 106–554, is Act of 2001’’. We applaud your leadership in health treatment of older Americans.

amended— introducing this legislation. Coverage of licensed professional coun-

(A) by striking ‘‘and (U)’’ and inserting Medicare’s mental health benefit currently selors under Medicare is a common-sense

‘‘(U)’’; and excludes two core mental health professions: step toward ensuring that all beneficiaries

(B) by inserting before the semicolon at licensed professional counselors and licensed get the help they need. There are over 81,000

the end the following: ‘‘, and (V) with respect marriage and family therapists. Statistics professional counselors licensed as master’s

to marriage and family therapist services such as those included in the attached fact level mental health professionals in Arkan-

and mental health counselor services under sheet show that Medicare beneficiaries are sas and 44 other states across the country.

section 1861(s)(2)(W), the amounts paid shall not getting the mental health treatment These providers meet education, training,

be 80 percent of the lesser of the actual they need. Lack of access to providers is one and examination requirements on par with

charge for the services or 75 percent of the of the primary factors involved. those of clinical social workers, who have

amount determined for payment of a psy- As with other areas of health care, access- been covered under Medicare for over ten

chologist under clause (L)’’. ing mental health services is especially prob- years.

(5) EXCLUSION OF MARRIAGE AND FAMILY lematic in rural areas. In many underserved Thank you for your leadership in intro-

THERAPIST SERVICES AND MENTAL HEALTH communities, licensed professional coun- ducing this important legislation. We look

COUNSELOR SERVICES FROM SKILLED NURSING selors are the only mental health specialists forward to working with you to gain its en-

FACILITY PROSPECTIVE PAYMENT SYSTEM.— available. We feel strongly that proposals to actment, and I urge you and your staff to

Section 1888(e) of the Social Security Act (42 improve rural Medicare beneficiaries’ access call on us if we can be of any assistance.

U.S.C. 1395yy(e)) is amended— to mental health care must include expand- Sincerely,

(A) in paragraph (2)(A)(i)(II), by striking ing the pool of covered providers. However, JANE GOODMAN,

‘‘clauses (ii) and (iii)’’ and inserting ‘‘clauses access to providers is not only a rural issue. President.

(ii) through (iv)’’; and An article cited on the enclosed fact sheet,

(B) by adding at the end of paragraph (2)(A) recently published by the American Psy- WYOMING COUNSELING ASSOCIATION,

the following new clause: chiatric Association, states that ‘‘the supply November 27, 2001.

‘‘(iv) EXCLUSION OF CERTAIN MENTAL HEALTH of both specialists and resources cannot Hon. CRAIG THOMAS,

SERVICES.—Services described in this clause meet current or future demands’’ for mental U.S. Senate,

are marriage and family therapist services health treatment of older Americans. Washington, DC

(as defined in section 1861(ww)(1)) and mental Coverage of licensed professional coun- DEAR SENATOR THOMAS: The Wyoming

health counselor services (as defined in sec- selors under Medicare is a common-sense Counseling Association is pleased to convey

tion 1861(ww)(3)).’’. step toward ensuring that all beneficiaries its strong support of your legislation, the

(6) INCLUSION OF MARRIAGE AND FAMILY get the help they need. There are over 81,000 ‘‘Seniors Mental Health Access Improvement

THERAPISTS AND MENTAL HEALTH COUNSELORS professional counselors licensed as master’s Act of 2001’’. We are proud of your leadership

AS PRACTITIONERS FOR ASSIGNMENT OF level mental health professionals in Wyo- on mental health issues, as evidenced by

CLAIMS.—Section 1842(b)(18)(C) of such Act ming and 44 other states across the country. your introduction of this and other legisla-

(42 U.S.C. 1395u(b)(18)(C)), as amended by sec- These providers meet education, training, tion, and your support of S. 543, the ‘‘Mental

tion 105(d) of the Medicare, Medicaid, and and examination requirements on par with Health Equitable Treatment Act of 2001’’.









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S12372 CONGRESSIONAL RECORD — SENATE December 4, 2001

Wyoming’s residents often have only lim- and for your commitment to ensuring great- ARKANSAS MENTAL HEALTH

ited—if any—access to mental health profes- er access for seniors affected by mental ill- COUNSELORS ASSOCIATION,

sionals. There simply aren’t enough pro- ness. If I can be of assistance to you as you Jonesboro, AR, November 27, 2001.

viders. Given this fact, it makes no sense to work towards the enactment of the Seniors Hon. BLANCHE L. LINCOLN,

continue to exclude licensed professional Mental Health Access Improvement Act, U.S. Senate, Dirksen Senate Office Building,

counselors from Medicare coverage, when please feel free to contact me. Beth Powell, Washington, DC.

similarly-trained providers are covered. In AMHCA’s Director of Public Policy and Pro- DEAR SENATOR LINCOLN: I am writing on

many parts of the state, licensed profes- fessional Issues, is also available to assist behalf of the Arkansas Mental Health Coun-

sional counselors are the only mental health you and your staff. selors Association (ArMHCA) to express our

specialists around. Sincerely, strong support for the Seniors Mental Health

We believe that establishing Medicare cov- MIDGE WILLIAMS, Access Improvement Act and to convey our

erage of licensed professional counselors is a sincere appreciation to you for introducing

President.

cost-effective means of improving the health this legislation. As a Licensed Professional

and well-being of enrollees. The more than Counselor (LPC) and a constituent, I want to

500 professional counselors licensed in Wyo- AMERICAN MENTAL HEALTH express to you the importance of this legisla-

ming should be allowed to help meet their COUNSELORS ASSOCIATION, tion to LPCs in our state and to the nation’s

mental health needs. It should jolt Congress Alexandria, VA, November 28, 2001 39 million Medicare beneficiaries.

into action to know that older Americans Hon. BLANCHE L. LINCOLN, Mental health counselors-called Licensed

are the demographic group in the U.S. most U.S. Senate, Dirksen Senate Office Building, Professional Counselor in Arkansas are men-

at risk of committing suicide. This must be Washington, DC tal health professionals with a master’s or

remedied. doctoral degree in counseling or related dis-

Please let us know if there is anything we DEAR SENATOR LINCOLN: I am writing on

behalf of the American Mental Health Coun- ciplines who provide services along a con-

can do to assist you on mental health issues, tinuum of care. Currently, 45 states and the

and thank you again for your leadership, ini- selors Association (AMHCA) to express our

strong support of the Seniors Mental Health District of Columbia license or certify men-

tiative, and hard work. tal health counselors to independently pro-

Sincerely, Access Improvement Act, legislation to ex-

pand access to mental health providers in vide mental health services, including the di-

KAREN ROBERTSON, agnosis and treatment of mental and emo-

President. the Medicare program. As president of

AMHCA and a Licensed Mental Health Coun- tional disorders. LPCs practice in a variety

DR. DAVID L. BECK, of settings, including hospitals, community

Past-President. selor (LMHC), I commend you and Senator

mental health centers, managed behavioral

LESLEY TRAVERS, Thomas for introducing this important legis-

health care organizations, employee assist-

President-elect. lation.

ance plans, substance abuse treatment cen-

AMHCA is the nation’s largest professional ters, and private practice.

AMERICAN MENTAL HEALTH organization exclusively representing the Medicare currently covers the services of

COUNSELORS ASSOCIATION, mental health counseling profession. Our independently practicing psychiatrists, clin-

Alexandria, VA, November 27, 2001. members practice in a variety of settings, in- ical psychologists, clinical social workers,

Hon. CRAIG THOMAS, cluding hospitals, community mental health and clinical nurse specialists, however; it

U.S. Senate, Hart Senate Office Building, centers, managed behavioral health care or- does not recognize mental health counselors

Washington, DC ganizations, employee assistance plans, sub- or marriage and family therapists as sepa-

DEAR SENATOR THOMAS: I am writing on be- stance abuse treatment centers, and private rately reimbursable mental health providers.

half of the American Mental Health Coun- practice. Currently, there are more than The Seniors Mental Health Access Improve-

selors Association (AMHCA) to express our 80,000 licensed or certified professional coun- ment Act corrects this oversight by includ-

strong support for the Seniors Mental Health selors practicing in the United States, in- ing mental Health counselors and marriage

Access Improvement Act, legislation to ex- cluding many in rural areas where access to and family therapist among the list of pro-

pand access to mental health providers in mental health care is often scarce. The Ar- viders who deliver mental health services to

the Medicare program. As president of kansas Mental Health Counselors Associa- Medicare beneficiaries, provided they are le-

AMHCA and a Licensed Mental Health Coun- tion (ArMHCA), a state chapter of AMHCA, gally authorized to perform the services

selor (LMHC), I commend you and Senator represents the interests of mental health under state law. Enactment of this provision

Lincoln for introducing this important legis-

counselors practicing in your state. would increase access to and the availability

lation.

AMHCA is the nation’s largest professional As you know, Medicare covers the services of mental health services to Medicare bene-

organization exclusively representing the of independently practicing psychiatrists, ficiaries, particularly for those seniors who

mental health counseling profession. Our clinical psychologists, clinical social work- reside in rural and underserved area. The in-

members practice in a variety of settings, in- ers, and clinical nurse specialists, but does clusion of mental health counselors and mar-

cluding hospitals, community mental health not recognize mental health counselors or riage and family therapists in the program

centers, managed behavioral health care or- marriage and family therapists as separately would also afford beneficiaries a choice

ganizations, employee assistance plans, sub- reimbursable mental health providers. Spe- among qualified providers.

stance abuse treatment centers, and private Again, thank you for the leadership you

cifically, the Seniors Mental Health Access

practice. Currently, there are more than have shown in introducing this important

Improvement Act would correct this in-

80,000 licensed or certified professional coun- legislation. If I can be of assistance to you as

equity by including mental health coun-

selors practicing in the United States, in- your work towards enactment of the Seniors

selors and marriage and family therapists

cluding many in rural areas where access to Mental Health Improvement Access Act

among the list of providers who can deliver

mental health care is often scarce. please feel free to contact me. Beth Powell,

mental health services to Medicare bene-

As you know, Medicare covers the services AMHCA’s Director of Public and Profes-

ficiaries, provided they are legally author-

of independently practicing psychiatrists, sional Issues, is also available to assist you

ized to deliver such care under state law. En-

clinical psychologists, clinical social work- and your staff.

actment of this provision would increase ac-

ers, and clinical nurse specialists, but does Sincerely,

cess to and the availability of mental health

not recognize mental health counselors or DEE KERNODLE

services to Medicare beneficiaries, particu-

marriage and family therapists as separately President.

larly for those seniors who reside in rural

reimbursable mental health providers. Spe- and underserved areas. The inclusion of men-

cifically, the Seniors Mental Health Access AMERICAN ASSOCIATION FOR

tal health counselors and marriage and fam-

Improvement Act would correct this in- MARRIAGE AND FAMILY THERAPY,

ily therapists as Medicare providers would

equity by including mental health coun- Washington, DC, December 3, 2001.

also afford beneficiaries greater choice

selors and marriage and family therapists Hon. CRAIG THOMAS,

among qualified providers.

among the list of providers who can deliver Hart Senate Office Building,

mental health services to Medicare bene- Again, thank you for the leadership you Washington, DC.

ficiaries, provided they are legally author- have shown in introducing this legislation DEAR SENATOR THOMAS: The American As-

ized to deliver such care under state law. En- and for your commitment to ensuring great- sociation for Marriage and Family Therapy

actment of this provision would increase ac- er access for seniors affected by mental ill- is writing on behalf of the 46,000 marriage

cess to and the availability of mental health ness. If I can be of assistance to you as you and family therapists throughout the United

services to Medicare beneficiaries, particu- work towards the enactment of the Seniors States to commend you for sponsoring the

larly for those seniors who reside in rural Mental Health Access Improvement Act, Seniors Mental Health Access Improvement

and underserved areas. The inclusion of men- please feel free to contact me. Beth Powell, Act of 2001. This crucial legislation to ex-

tal health counselors and marriage and fam- AMHCA’s Director of Public Policy and Pro- pand the mental health benefits for our el-

ily therapists as Medicare providers would fessional Issues, is also available to assist derly will go a long way towards improving

also afford beneficiaries greater choice you and your staff. Medicare beneficiaries’ access to critical

among qualified providers. Sincerely, mental health services provided by Marriage

Again, thank you for the leadership you MIDGE WILLIAMS, and Family Therapist (MFTs) and Mental

have shown in introducing this legislation President. Health Counselors (MHCs) across the nation.









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December 4, 2001 CONGRESSIONAL RECORD — SENATE S12373

As you know, mental illness is a major that Medicare beneficiaries in need of men- ARKANSAS ASSOCIATION FOR

problem for many Americans, and particu- tal health services will have the same free- MARRIAGE AND FAMILY THERAPY,

larly for the elderly. Research demonstrates dom to choose a mental health professional December 1, 2001.

that depression is disproportionately high available in their community as the non- Hon. BLANCHE LAMBERT LINCOLN,

among older persons, as is the incidence of Medicare population. The Archives of Gen- Dirksen Senate Office Building,

suicide. The Surgeon General’s Report on eral Psychiatry projects that the number of Washington, DC.

Mental Health has indicated that there are people over 65 years with psychiatric dis- DEAR SENATOR LINCOLN: I was part of a co-

effective treatments for these and other orders will increase from about 4 million in alition of four mental health organizations

mental illnesses. The Seniors Mental Health 1970 to 15 million in 2030. It also indicates that wrote to you last week on behalf of the

Access Improvement Act of 2001 helps make that the current health care system is unpre- Seniors Mental Health Improvement Act of

these treatments accessible to elderly citi- pared to meet the upcoming crisis in geri- 2001. However, I wanted to address that again

zens. By expanding the pool of qualified pro- atric mental health. Providing access to li- with you specifically from the Arkansas As-

viders, the bill also achieves the important censed MFTs and MHCs will help ensure that sociation for Marriage and Family Therapy.

objective of increasing access to mental there are an adequate number of providers This is such an important piece of legislation

health services for elderly in rural areas, available to meet the needs of the growing on behalf of our aging population.

where there is a recognized shortage of pro- elderly population. This important legislation will go a long

fessionals.

Passage of the Seniors Mental Health Ac- Your leadership and support to address the way towards improving Medicare bene-

cess Improvement Act of 2001 will ensure mental health needs of our seniors is greatly ficiaries’ access to critical mental health

that Medicare beneficiaries in need of men- appreciated. It is about time the Medicare services in our state. As you know, more

tal health services will have the same free- program is structured to respond to the de- than 90 percent of Arkansas has been des-

dom to choose a mental health professional mands of the elderly population it serves. ignated by the federal government as a men-

available in their community as the non- AAMFT hopes the Seniors Mental Health tal health professional shortage area. By au-

Medicare population. The Archives of Gen- Improvement Act of 2001 will become law. thorizing Medicare coverage for both Mar-

eral Psychiatry projects that the number of We look forward to working with you to riage and Family Therapists (MFTs) and Li-

people over 65 years with psychiatric dis- meet this objective. Thank you again for censed Professional Counselors (LPCs) or

orders will increase from about 4 million in your commitment to improving the lives of Mental Health counselors (MHCs) you are

1970 to 15 million in 2030. It also indicates the elderly. more than doubling the number of mental

that the current health care system is unpre- Sincerely, health professionals available to provide

pared to meet the upcoming crisis in geri- DAVID M. BERGMAN, services to the Medicare population in these

atric mental health. Providing access to li- Director of under-served regions.

censed MFTs and MHCs will help ensure that Legal and Government Affairs. Your legislation will also ensure that Ar-

there are an adequate number of providers kansas Medicare beneficiaries in need of

available to meet the needs of the growing mental health services will have the same

elderly population. WYOMING ASSOCIATION FOR freedom to choose the mental health profes-

Your leadership and support to address the MARRIAGE AND FAMILY THERAPY, sional available in their community as the

mental health needs of our seniors is greatly Jackson, WY, November 30, 2001. non-Medicare population. As you are aware,

appreciated. It is about time the Medicare Hon. CRAIG THOMAS, our state has already authorized MFTs to

program is structured to respond to the de- Hart Senate Office Building, provide a wide range of mental health serv-

mands of the elderly population it serves. Washington, DC. ices covered by the Medicare program. Un-

AAMFT hopes the Seniors Mental Health DEAR SENATOR THOMAS: On behalf of the fortunately, because Medicare does not cur-

Improvement Act of 2001 will become law. Wyoming Association for Marriage and Fam- rently recognize MFTs, Medicare bene-

We look forward to working with you to ily Therapy, I want to thank you for agree- ficiaries must often travel hundreds of miles

meet this objective. Thank you again for ing to sponsor the Seniors Mental Health Im- to be seen by a mental health professional

your commitment to improving the lives of provement Act of 2001. that is recognized by Medicare. In my prac-

the elderly. tice, I am aware of long waits for seniors to

This important legislation will go a long

Sincerely, see providers due to the few and the overload

way toward improving Medicare bene-

DAVID M. BERGMAN, of those providers. This, despite the fact that

Director of ficiaries’ access to critical mental health

services in our state. As you know, more there may be a Marriage and Family Thera-

Legal and Government Affairs. pist in their community that the state has

than 90 percent of Wyoming has been des-

ignated by the federal government as a men- already deemed qualified to provide the cov-

AMERICAN ASSOCIATION FOR ered services.

MARRIAGE AND FAMILY THERAPY, tal health professional shortage area. By au-

thorizing Medicare coverage for both Mar- Your support for improved access to men-

Washington, DC, December 3, 2001. tal health services is greatly appreciated. We

Hon. BLANCHE LAMBERT LINCOLN, riage and Family Therapists (MFTs) and

Mental Health Counselors (MHCs), you are look forward to working with you on this

Dirksen Senate Office Building, important legislation.

Washington, DC. more than doubling the number of mental

health professionals available to provide Sincerely,

DEAR SENATOR LINCOLN: The American As- DELL TYSON,

sociation for Marriage and Family Therapy services to the Medicare population in these

underserved areas. President.

is writing on behalf of the 46,000 marriage

and family therapists throughout the United Your legislation will also ensure that Wyo- NATIONAL RURAL HEALTH ASSOCIATION,

States to commend you for sponsoring the ming beneficiaries in need of mental health Kansas City, MO, December 3, 2001.

Seniors Mental Health Access Improvement services will have the same freedom to Hon. CRAIG THOMAS,

Act of 2001. This crucial legislation to ex- choose the mental health professional avail- U.S. Senate, Hart Senate Office Building,

pand the mental health benefits for our el- able in their community as the non-Medicare Washington, DC.

derly will go a long way towards improving population. As you are aware, our state has DEAR SENATOR THOMAS: On behalf of the

Medicare beneficiaries’ access to critical already authorized MFTs to provide a wide National Rural Health Association, I would

mental health services provided by Marriage range of mental health services covered by like to convey our strong support for the

and Family Therapist (MFTs) and Mental the Medicare program. Unfortunately, be- Seniors Mental Health Access Improvement

health Counselors (MHCs) across the nation. cause Medicare does not currently recognize

As you know, mental illness is a major Act of 2001.

MFTs, Medicare beneficiaries must often While a lack of primary care services in

problem for many Americans, and particu- travel hundreds of miles to be seen by a men-

larly for the elderly. Research demonstrates rural and frontier areas has long been ac-

tal health professional who is recognized by knowledged, the scarcity of rural mental

that depression is disproportionately high the Medicare program. This, despite the fact

among older persons, as is the incidence of health services has only recently received in-

that there may be a Marriage and Family creased attention. At the end of 1997, 76% of

suicide. The Surgeon General’s Report on Therapist in their community that the state

Mental Health has indicated that there are designated mental health professional short-

has already deemed qualified to provide the age areas were located in non-metropolitan

effective treatments for these and other covered services.

mental illnesses. The Seniors Mental Health areas with a total population of over 30 mil-

Access Improvement Act of 2001 helps make Your support for improved access to men- lion Americans. Currently there is an in-

these treatments accessible to elderly citi- tal health services is greatly appreciated. We creased need for intervention by mental

zens. By expanding the pool of qualified pro- look forward to working with you on this health care professionals to help people cope

viders, the bill also achieves the important important legislation. I would also person- with the aftermath of the September 11 ter-

objective of increasing access to mental ally like to send my best wishes to you and rorist attacks as well as the ongoing war on

health services for elderly in rural areas, Susan and hope that all is well in Wash- terrorism. Because there is less access to

where there is a recognized shortage of pro- ington. mental health care in rural America, rural

fessionals. Sincerely, residents will have a subsequent lack of pro-

Passage of the Seniors Mental Health Ac- CINDY KNIGHT fessional guidance in dealing with the recent

cess Improvement Act of 2001 will ensure President. trauma experienced by our country.









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S12374 CONGRESSIONAL RECORD — SENATE December 4, 2001

The Seniors Mental Health Access Im- ingness to cosponsor legislation that would Mrs. LINCOLN. Mr. President, I am

provement Act of 2001 would help provide in- dramatically improve access to mental pleased to join my colleague Senator

creased access to mental health car services health services for Medicare beneficiaries. THOMAS today in introducing the Sen-

in rural and frontier areas by allowing Li- By adding licensed marriage and family

therapists and licensed professional coun-

iors Mental Health Access Improve-

censed Professional Counselors and Marriage

and Family Therapists to bill Medicare for selors, it will open many opportunities with- ment Act of 2001.

their services and be paid 80 percent of the in Medicare for patients to locate and re- This bill would expand Medicare cov-

lesser of the actual charge for the services or ceive therapy from appropriately trained and erage to licensed professional coun-

75 percent of the amount determined for pay- qualified professionals. selors and licensed marriage and fam-

ment of a psychologist. On behalf of the 24,500 members of the Cali- ily therapists. One result of this ex-

The membership of the NRHA appreciates fornia Association of Marriage and Family panded coverage will be to increase

your bringing attention to the critical issue Therapists, we support your willingness to seniors’ access to mental health serv-

of access to mental health care in rural areas co-sponsor this legislation. Under California

law, licensed marriage and family therapists

ices, especially in rural and under-

as well as your ongoing leadership on rural served areas.

health issues. The NRHA stands ready to are legally authorized to provide mental

health services and are reimbursed by most Licensed professional counselors and

work with you on enactment of the Seniors

Mental Health Access Improvement Act of all third party payers for the diagnosis and marriage and family therapists are cur-

2001, which would help to increase the avail- treatment of mental disorders. However, be- rently excluded from Medicare cov-

ability of mental health care in rural and cause Medicare does not recognize this par- erage even though they meet the same

frontier areas. ticular discipline, California licensed mar- education, training, and examination

Sincerely, riage and family therapists are precluded requirements that clinical social work-

CHARLOTTE HARDT, from providing these services and Medicare ers do. The only difference is that clin-

President. beneficiaries are precluded from utilizing

marriage and family therapists to provide

ical social workers have been covered

mental health counseling and treatment. under Medicare for over a decade.

NATIONAL RURAL HEALTH ASSOCIATION, Why do we need this legislation? The

Marriage and family therapists are consid-

Kansas City, MO, December 3, 2001. mental health needs of older Ameri-

ered one of the five ‘‘core mental health pro-

Hon. BLANCHE LINCOLN,

U.S. Senate, Hart Senate Office Building,

fessions’’ recognized by the federal govern- cans are not being met. Although the

ment. Unfortunately, however, we are the rate of suicide among older Americans

Washington, DC.

only core mental health profession not rec- is higher than for any other age group,

DEAR SENATOR LINCOLN: On behalf of the

ognized by Medicare. less than three percent of older Ameri-

National Rural Health Association, I would

We appreciate and thank you for you will-

like to convey our strong support for the

ingness to take on the challenge of spon-

cans report seeing mental health pro-

Seniors Mental Health Access Improvement fessionals for treatment. And going to

soring legislation to make LMFTs and LPCs

Act of 2001. their primary care physician is simply

eligible for reimbursement by Medicare.

While a lack of primary care services in not enough. Research shows that most

Sincerely,

rural and frontier areas has long been ac-

MARY RIEMERSMA, primary care providers receive inad-

knowledged, the scarcity of rural mental

Executive Director. equate mental health training, particu-

health services has only recently received in-

creased attention. At the end of 1997, 76% of larly in geriatrics.

CALIFORNIA ASSOCIATION OF Lack of access to mental health pro-

designated mental health professional short- MARRIAGE AND FAMILY THERAPISTS,

age areas were located in non-metropolitan viders is one of the primary reasons

San Diego, CA, November 19, 2001.

areas with a total population of over 30 mil- Re Medicare Legislation to Recognize Mar-

why older Americans don’t get the

lion Americans. Currently there is an in- riage and Family Therapists and Profes- mental health treatment they need.

creased need for intervention by mental sional Counselors. Not surprisingly, this problem is exac-

health care professionals to help people cope Hon. BLANCHE LINCOLN, erbated in rural and underserved areas.

with the aftermath of the September 11 ter- U.S. Senate, Licensed professional counselors are

rorist attacks as well as the ongoing war on Washington, DC. often the only mental health special-

terrorism. Because there is less access to

mental health care in rural America, rural

DEAR SENATOR LINCOLN: We are writing to ists available in rural and underserved

residents will have a subsequent lack of pro-

you in recognition and support of your will- communities. This is true in my home

ingness to cosponsor legislation that would State of Arkansas, where 91 percent of

fessional guidance in dealing with the recent

dramatically improve access to mental Arkansans reside in a mental health

trauma experienced by our country.

health services for Medicare beneficiaries. professional shortage area.

The Seniors Mental Health Access Im-

By adding licensed marriage and family

provement Act of 2001 would help provide in- Since there are more licensed profes-

therapists and licensed professional coun-

creased access to mental health car services sional counselors practicing in my

selors, it will open many opportunities with-

in rural and frontier areas by allowing Li- State than any other mental health

in Medicare for patients to locate and re-

censed Professional Counselors and Marriage professional, this legislation will sig-

ceive therapy from appropriately trained and

and Family Therapists to bill Medicare for

their services and be paid 80 percent of the

qualified professionals. nificantly increase the number of

On behalf of the 24,500 members of the Cali- Medicare—eligible mental health pro-

lesser of the actual charge for the services or

fornia Association of Marriage and Family viders in Arkansas. Licensed profes-

75 percent of the amount determined for pay-

Therapists, we support your willingness to sional counselors are already serving

ment of a psychologist.

co-sponsor this legislation. Under California

The membership of the NRHA appreciates

law, licensed marriage and family therapists

patients who have private insurance or

your bringing attention to the critical issue Medicaid. It is time for Medicare pa-

are legally authorized to provide mental

of access to mental health care in rural areas tients to also have access to these pro-

health services and are reimbursed by most

as well as your ongoing leadership on rural fessionals.

all third party payers for the diagnosis and

health issues. The NRHA stands ready to The bill we are introducing today is

treatment of mental disorders. However, be-

work with you on enactment of the Seniors

Mental Health Access Improvement Act of

cause Medicare does not recognize this par- an important first step in expanding

ticular discipline, California licensed mar- access to good mental health. By in-

2001, which would help to increase the avail-

riage and family therapists are precluded cluding licensed professional coun-

ability of mental health care in rural and

from providing these services and Medicare

frontier areas. selors and licensed marriage and fam-

beneficiaries are precluded from utilizing

Sincerely,

marriage and family therapists to provide ily therapists among the list of pro-

CHARLOTTE HARDT, viders who deliver mental health serv-

mental health counseling and treatment.

President. Marriage and family therapists are consid- ices to Medicare beneficiaries, we will

ered one of the five ‘‘core mental health pro- help ensure that all seniors, no matter

CALIFORNIA ASSOCIATION OF fessions’’ recognized by the federal govern-

MARRIAGE AND FAMILY THERAPISTS,

where they live, have the opportunity

ment. Unfortunately, however, we are the to receive mental health treatment.

San Diego, CA, November 19, 2001. only core mental health profession not rec-

Re Medicare Legislation to Recognize Mar- ognized by Medicare.

riage and Family Therapists and Profes- By Mr. DORGAN (for himself, Mr.

We appreciate and thank you for you will-

sional Counselors. CAMPBELL, and Mr. BINGAMAN):

ingness to take on the challenge of spon-

Hon. CRAIG THOMAS, S. 1761. A bill to amend title XVII of

soring legislation to make LMFTs and LPCs

U.S. Senate, eligible for reimbursement by Medicare. the Social Security Act to provide for

Washington, DC. Sincerely, coverage of cholesterol and blood lipid

DEAR SENATOR THOMAS: We are writing to MARY RIEMERSMA, screening under the Medicare Program;

you in recognition and support of your will- Executive Director. to the Committee on Finance.







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December 4, 2001 CONGRESSIONAL RECORD — SENATE S12375

Mr. DORGAN. Mr. President, today I It is only right that the Congress do To me, homeland security also means

am introducing the Medicare Choles- what it can to help implement the giving all of our Nation’s law enforce-

terol Screening Coverage Act of 2001, guidelines of the National Heart, Lung ment officers the tools and training

along with my colleagues Mr. CAMP- and Blood Institute, and it is only they need to do their jobs. And that

BELL and Mr. BINGAMAN. This bipar- right that we provide these benefits for means recognizing that law enforce-

tisan legislation, which also has been all Medicare recipients. I urge my Sen- ment in rural America has its own

introduced in the House of Representa- ate colleagues to join me in cospon- unique set of challenges: rural law en-

tives, would add blood cholesterol soring this piece of legislation. I ask forcement officers patrol larger areas,

screening as a covered benefit for Medi- unanimous consent that the text of the and operate under tighter budgets with

care beneficiaries. bill be printed in the RECORD. smaller staffs, than most of their urban

The most recent guidelines from the There being no objection, the bill was and suburban counterparts.

National Heart, Lung and Blood Insti- ordered to be printed in the RECORD, as In States like South Dakota, often,

tute recommends that all Americans follows: just a handful of people are responsible

over the age of 20 be screened for high S. 1761 for patrolling an entire county. Law

cholesterol. Yet current Medicare pol- Be it enacted by the Senate and House of Rep- enforcement officers respond to a lot of

icy only covers cholesterol testing for resentatives of the United States of America in calls alone, and often have to commu-

patients who already have heart dis- Congress assembled, nicate with each other by cell phone.

ease, stroke or other disorders associ- SECTION 1. SHORT TITLE. Backup can be several hours away. Yet

ated with elevated cholesterol levels. This Act may be cited as the ‘‘Medicare we expect the same quality of service,

Thus, enactment of this bill will help Cholesterol Screening Coverage Act of 2001’’. and we demand lower crime rates.

save lives of the approximately one- SEC. 2. MEDICARE COVERAGE OF CHOLESTEROL I believe Washington can and must

AND BLOOD LIPID SCREENING. do a better job of helping rural law en-

third of Medicare recipients not al-

(a) IN GENERAL.—Section 1861 of the Social forcement do their work. That is why I

ready covered for cholesterol testing.

Security Act (42 U.S.C. 1395x) is amended—

High cholesterol is a major risk fac- (1) in subsection (s)(2)—

am proud to join my colleague and

tor for heart disease and stroke, the (A) by striking ‘‘and’’ at the end of sub- friend, Senator TIM JOHNSON, in intro-

Nation’s number 1 and number 3 killers paragraph (U); ducing the Rural Safety Act of 2001.

of both men and women. Cardio- (B) by adding ‘‘and’’ at the end of subpara- While TIM and I are the ones intro-

vascular disease kills nearly a million graph (V); and ducing this bill, we want to thank all

people each year in this country, more (C) by adding at the end the following new of the South Dakota sheriffs with

than the next seven leading causes of subparagraph: whom we’ve spoken whose ideas and

death combined. In particular, Ameri- ‘‘(W) cholesterol and other blood lipid experiences are incorporated within it.

screening tests (as defined in subsection For my part, I’d like to recognize:

cans over the age of 65 have the highest (ww)(1));’’; and

rate of coronary heart disease, CHD, in (2) by adding at the end the following new

Sheriff Mike Milstead of Minnehaha

the Nation and about 80 percent of the subsection: County, Sheriff Mark Milbrandt of

deaths from CHD occur in this age ‘‘Cholesterol and Other Blood Lipid Brown County, Sheriff Leidholt of

group. It is not surprising that cardio- Screening Test Hughes County, Chief Al Aden of

vascular diseases account for one-third ‘‘(ww)(1) The term ‘cholesterol and other Pierre, Chief Duane Heeney of

of all Medicare’s spending for hos- blood lipid screening test’ means diagnostic Yankton, Chief Ken Schwab of my

pitalizations. testing of cholesterol and other lipid levels hometown, Aberdeen, Chief Doug

Obviously, in order to slow the onset of the blood for the purpose of early detec- Feltman of Mitchell; and Chief Craig

of CHD, it is first necessary to identify tion of abnormal cholesterol and other lipid Tieszen of Rapid City.

those with elevated cholesterol, which levels. One theme I’ve heard repeated on

is why passage of this bill is so critical. ‘‘(2) The Secretary shall establish stand- visit after visit is this: Washington

ards, in consultation with appropriate orga- needs to do a better job working with

The importance of identifying those at

nizations, regarding the frequency and type

risk for CHD is illustrated by the re- of cholesterol and other blood lipid screening

State and local law enforcement agen-

sults of just released research from Ox- tests for individuals who do not otherwise cies. To me, that means building on

ford University. This study showed qualify for coverage for cholesterol and what we know works, and developing

that in elderly people, lowering of cho- other blood lipid testing based on established new initiatives that respond to the spe-

lesterol was associated with a one- clinical diagnoses.’’. cial law enforcement challenges of

third reduction in heart attack and (b) FREQUENCY.—Section 1862(a)(1) of such small towns and rural communities. To

stroke and a substantially reduced Act (42 U.S.C. 1395y(a)(1)) is amended— that end, this bill does six things:

(1) by striking ‘‘and’’ at the end of subpara- First, it builds on our success with the

need for surgery to repair or open graph (H);

clogged arteries. (2) by striking the semicolon at the end of

COPS program. COPS has enabled

Clearly, this bill can save lives. Yet subparagraph (I) and inserting ‘‘; and’’; and South Dakota communities to hire

despite the importance of identifying (3) by adding at the end the following new more than 300 law enforcement officers.

this major, changeable risk factor for subparagraph: Across the country, it’s added more

cardiovascular disease, screening for ‘‘(J) in the case of a cholesterol and other than 100,000 new officers to the ‘‘thin

cholesterol is not covered by Medicare. blood lipid screening test (as defined in sec- blue line.’’ Under this proposal, rural

I have felt for a long while that our tion 1861(ww)(1)), which is performed more communities that hire officers through

health care system, and Medicare in frequently than is covered under section the COPS program will be eligible for

1861(ww)(2).’’.

particular, needs to place a greater em- (c) EFFECTIVE DATE.—The amendments federal funding to keep those offices on

phasis on preventative health care. Im- made by this section shall apply to tests fur- for a fourth year.

plementation of the measures in this nished on or after January 1, 2003. Second, because rural law enforce-

bill can potentially decrease the inci- ment officers have to cover such large

dence of cardiovascular disease result- By Mr. DASCHLE (for himself areas, rural law enforcement agencies

ing in reduced illness, debilitation and and Mr. JOHNSON): arguably have a greater need for ad-

death. Early detection of illness is S. 1763. A bill to promote rural safety vanced communications equipment

often an important factor in successful and improve rural law enforcement; to than many urban and suburban depart-

treatment and has been effective in re- the Committee on Finance. ments, but have fewer resources to pur-

ducing long-term health care costs. Mr. DASCHLE. Mr. President, in the chase them. Recently, I received a let-

Previously, Congress in its wisdom, weeks since September 11, we’ve heard ter from Sgt. Marty Goetsch in the

has acted to provide for other screen- a lot about homeland security. Right Lawrence County Sheriff’s Office in

ing tests including bone mass measure- now, we’re working to make our Na- Deadwood, SD. He told me that his of-

ment, and screenings for glaucoma and tion’s infrastructure more secure, our fice, and its staff of 11, are ‘‘very much

for colorectal, prostate and breast can- food and water supply safer, and to im- behind in the available technology.’’

cer. Now we must take another step in prove our government’s ability to re- This bill provides funds to help rural

the right direction by extending Medi- spond to chemical and biological weap- communities obtain things like mobile

care coverage for cholesterol screening. ons attacks. data computers and dash-mounted







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S12376 CONGRESSIONAL RECORD — SENATE December 4, 2001

video cameras. It will also provide ad- Mr. LIEBERMAN. Mr. President, ture and do so for business reasons that

ditional funds for training to use new America has a major flaw in its de- make sense for their investors on the

technologies. fenses against bioterrorism. Recent bottom line.

Third, this bill will establish a Rural hearings I chaired in the Government Enactment of these incentives is nec-

Policing Institute as a way to help Affairs Committee on bioterrorism essary as most biotech companies have

rural law enforcement officers upgrade demonstrated that America has not no approved products or revenue from

their skills and tactics. made a national commitment to re- product sales to fund research. They

Fourth, it will expand and improve search and development of treatments rely on investors and equity capital

the 9-1-1 emergency assistance systems and cures for those who might be ex- markets to fund the research. They

in rural areas. Many of us take for posed to or infected by a biological must necessarily focus on research

granted that in an emergency, we can agent or chemical toxin. Correcting that will lead to product sales and rev-

call 9-1-1, and help will be there. In this critical gap is the purpose of legis- enue and, thus, to an end to their de-

rural and remote areas, the nearest lation I am introducing today. pendence on investor capital. There is

help may be miles away. We need to Obviously, our first priority must be no established or predictable market

make sure that people in rural areas to attempt to prevent the use of these for countermeasures. Investors are jus-

can rely on a modern, integrated sys- agents and toxins by terrorists, quick- tifiably reluctant to fund this research,

tem of communication between law en- ly assess when an attack has occurred, which will present challenges similar

forcement, and fire and other safety of- take appropriate public health steps to in complexity to AIDS. Investors need

ficials. The Rural Safety Act will pro- contain the exposure, stop the spread assurances that research on counter-

vide the resources to finish the job and of contagion, and then detoxify the measures has the potential to provide a

develop a seamless 9-1-1 system all site. These are all critical functions, rate of return commensurate with the

across America. but in the end we must recognize that risk, complexity and cost of the re-

Fifth, the bill will help communities some individuals may be exposed or in- search, a rate of return comparable to

create ‘‘restorative justice’’ for first- fected. Then the critical issue is wheth- that which may arise from a treatment

time, non-violent juvenile offenders. er we can treat and cure them and pre- for cancer, MS, Cystic Fibrosis and

These programs offer victims the op- vent death and disability. other major diseases.

portunity to confront youthful offend- We need a diversified portfolio of It is in our national interest to enlist

ers and require that these offenders medicines. In cases where we have these companies in the development of

make meaningful restitution to their ample advance warning of an attack countermeasures as biotech companies

victims. In many cases, that will meet and specific information about the tend to be innovative and nimble and

our societal goals more effectively and agent or toxin, we may be able to vac- intently focused on the intractable dis-

more efficiently that costly incarcer- cinate the vulnerable population in ad- eases for which no effective medical

ation. vance. In other cases, even if we have a treatments are available.

Sixth, it will enable us to stop the The incentives I have proposed are

vaccine, we might well prefer to use

spread of ‘‘meth’’ now, before it be-

medicines that would quickly stop the innovative and some may be controver-

comes a crisis. A study released last

progression of the disease or the toxic sial. I invite everyone who has an in-

year by the Center on Addiction and

effects. We also need a powerful capac- terest and a stake in this research to

Substance Abuse at Columbia Univer-

ity quickly to develop new counter- enter into a dialogue about the issue

sity shows that eighth graders living in

measures where we face a new agent or and about the nature and terms of the

rural communities are 104 percent

toxin. appropriate incentives. I have at-

more likely to have used amphet-

Unfortunately, we are woefully short tempted to anticipate the many com-

amines, including methamphetamine.

of vaccines and medicines to treat indi- plicated technical and policy issues

We need to stop the use of all of these

viduals who are exposed or infected. We that this legislation raises. The key

drugs, but in rural America, meth is

have antibiotics that seem to work for focus of our debate should be how, not

particularly addictive, and devastat-

most of those infected in the current whether, we address this critical gap in

ingly destructive. This proposal will in-

anthrax attack, but these have not pre- our public health infrastructure and

crease prevention and treatment of

meth use, and cleanup of meth labs vented five deaths. We have no effec- the role that the private sector should

that have been discovered and shut tive vaccines or medicines for most play. Millions of Americans will be at

down. other biological agents and chemical risk if we fail to enact legislation to

Seventh and finally, our plan will toxins we might confront. In some meet this need.

offer gun owners tax credits to pur- cases we have vaccines to prevent, but My proposal is complimentary to leg-

chase gun safes. It will also provide law no medicines to treat, an agent. We islation on bioterrorism preparedness

enforcement agencies with resources to have limited capacity to speed the de- sponsored by Senators FRIST and KEN-

buy and install gun safes or gun stor- velopment of vaccines and medicines to NEDY. Their bill, the Bioweapons Pre-

age racks for officers’ homes. I don’t prevent or treat novel agents and tox- paredness Act of 2001, S. 1715, focuses

believe Washington should restrict the ins not currently known to us. on many needed improvements in our

right of law-abiding citizens to own We have provided, and should con- public health infrastructure. It builds

guns. But if gun owners want help in tinue to provide, direct Federal funding on their proposal in the 106th Congress,

preventing accidental gun tragedies, I for research and development of new S. 2731, and H.R. 4961, sponsored by

believe Washington can, and should, medicines, however, this funding is un- Congressman RICHARD BURR.

help. likely to be sufficient. Even with Among the provisions in these bills

When we talk about homeland secu- ample Federal funding, many private are initiatives on improving bioter-

rity, I believe we need to think about companies will be reluctant to enter rorism preparedness capacities, im-

the law enforcement needs of those into agreements with government proving communication about bioter-

who live in America’s rural areas. That agencies to conduct this research. rorism, protection of children, protec-

is what this bill does, and that is why Other companies would be willing to tion of food safety, and global pathogen

I encourage all of my colleagues to sup- conduct the research with their own surveillance and response. The Senate

port it. capital and at their own risk but are Appropriations Committee reported

not able to secure the funding from in- legislation to appropriate the funds for

By Mr. LIEBERMAN: vestors. the purposes authorized in the Frist-

S. 1764. A bill to provide incentives to The legislation I introduce today Kennedy proposal and that was incor-

increase research by commercial, for- would provide incentives for private porated in the stimulus package pend-

profit entities to develop vaccines, biotechnology companies to form cap- ing in the Senate before the Thanks-

microbicides, diagnostic technologies, ital to develop countermeasures, medi- giving recess.

and other drugs to prevent and treat cines, to prevent, treat and cure vic- Title IV of their bill includes provi-

illnesses associated with a biological or tims of bioterror attacks. This will en- sions to expand research on biological

chemical weapons attack; to the Com- able this industry to become a vital agents and toxins, as well as new treat-

mittee on Finance. part of the national defense infrastruc- ments and vaccines for such agents and







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December 4, 2001 CONGRESSIONAL RECORD — SENATE S12377

toxins. Since the effectiveness of vac- of Congressional staffers and postal to either of them. Furthermore, two

cines, drugs, and therapeutics for many workers awaiting their Cipro. Think signatories of the BWC, Iran and Iraq,

biological agents and toxins often may what it would be like if we could only are among the seven governments that

not ethically be tested in humans, the say, ‘‘We have nothing to treat you and the Secretary of State has designated

bill ensures that the Food and Drug hope you don’t contract the disease.’’ as state sponsors of international ter-

Administration, FDA, will finalize by a Think of the public panic that we rorism, and we know for a fact that

date certain its rule regarding the ap- might see. they have both pursued clandestine bi-

proval of new countermeasures on the I am grateful that this product exists ological weapons programs. The BWC,

basis of animal data. Priority counter- and proud of the fact that the Bayer unlike the CWC, has no teeth, it does

measures will also be given enhanced Company is based in Connecticut. The not include any provisions for

consideration for expedited review by last thing we should be doing is criti- verification or enforcement. Since we

the FDA. They rely on the authority, cizing this company for their research clearly cannot assume that any coun-

through an existing Executive Order, success. The company has dispensed try that signs on to the Convention

to ensure indemnification of sponsors millions of dollars worth of Cipro free does so in good faith, the Convention’s

who supply vaccines to the Govern- of charge. Criticizing it for the price protective value is limited.

ment. And the bill provides a limited that it charges tells other research On November 1 of this year, the

antitrust exemption to allow potential companies that the more valuable their President announced his intent to

sponsors to discuss and agree upon how products are in protecting the public strengthen the BWC as part of his com-

to develop, manufacture, and produce health, the more likely they are to be prehensive strategy for combating ter-

new countermeasures, including vac- criticized and bullied. rorism. A BWC review conference, held

cines, and drugs. Federal Trade Com- It is fortuitous that Cipro seems to every 5 years to consider ways of im-

mission and the Department of Justice be effective against anthrax. The prod- proving the Convention’s effectiveness,

approval of such agreements is re- uct was not developed with this use in will convene in Geneva beginning No-

quired to ensure such agreements are mind. My point with this legislation is vember 19. In anticipation of that

not anti-competitive. we cannot rely on good fortune and meeting, the President has urged that

My legislation builds on these provi- chance in the development of counter- all parties to the Convention enact

sions by providing incentives to enable measures. We need to make sure that strict national criminal legislation to

the biotechnology industry acting on these countermeasures will be devel- crack down on prohibited biological

its own initiative to fund and conduct oped. We need more companies like weapons activities, and he has called

research on countermeasures. It in- Bayer, we need them focused specifi- for an effective United Nations proce-

cludes tax, procurement, intellectual cally on developing medicines to deal dure for investigating suspicious out-

property and liability incentives. Ac- with the new bioterror threat, and we breaks of disease or allegations of bio-

cordingly, my proposal raises issues need to tell them that there are good logical weapons use.

falling within the jurisdiction of the business reasons for this focus. These steps are welcomed, but they

HELP, Finance, and Judiciary Com- We also are fortunate to have an

are small. Even sweeping reforms, like

mittees. FDA-licensed vaccine, made by

creating a more stringent verification

The Frist-Kennedy bill and my bill BioPort Corporation, that is rec-

and enforcement regime, would not

are complimentary. We do need to con- ommended by our country’s medical

guarantee our safety. The robust

form the two bills to one another on experts at the DOD and CDC for pre-an-

verification and enforcement mecha-

some issues: the bills have different thrax exposure vaccination of individ-

nisms in the CWC, for instance, have

definitions of the term ‘‘counter- uals in the military and some individ-

proven to be imperfect, and scientists

measure,’’ my bill gives the Director of uals in certain laboratory and other oc-

agree that it is much easier to conceal

Homeland Defense authority over the cupational settings where there is a

the production of biological agents

countermeasure list whereas the Sec- high risk of exposure to anthrax. This

than chemical weapons.

retary of Health and Human Services vaccine is also recommended for use

with Cipro after exposure to anthrax to The inescapable fact, therefore, is

would have authority under Frist/Ken-

give optimal and long-lasting protec- that we cannot count on international

nedy, and my bill establishes a ‘‘pur-

tion. That vaccine is not now available regimes to prevent those who wish us

chase fund’’ and Frist-Kennedy is a

for use. We must do everything nec- ill from acquiring biological and chem-

‘‘stockpile.’’ The best, most com-

essary to make this and other vaccines ical weapons. We must be prepared for

prehensive approach would be to meld

available in adequate quantities to pro- the reality that these weapons could

the two bills together.

The bottom line is that we need both tect against future attacks. But the fall into the hands of terrorists, and

bills, one focusing on public health and point of this legislation is that we need could be used against Americans on

one focusing on medical research. many more Cipro-like and antrax vac- American soil. And we must be pre-

Without medical research, public cine-like products. That we have these pared to treat the victims of such an

health workers will not have the single products is the good news; that we have attack if it were ever to occur.

most important tool to use in an at- so few others is the problem. On November 26, the Centers for Dis-

tack, medicine to prevent death and One unfortunate truth in this debate ease Control issued its interim working

disability and medicine that will help is that we cannot rely upon inter- draft plan for responding to an out-

us avoid public panic. national legal norms and treaties alone break of smallpox. The plan does not

We are fortunate that we have broad- to protect our citizens from the threat call for mass vaccination in advance of

spectrum antibiotics including Cipro to of biological or chemical attack. a smallpox outbreak because the risk

treat the type of anthrax to which so The United States ratified the Bio- of side effects from the vaccine out-

many have been exposed. This treat- logical and Toxin Weapons Convention, weighs the risks of someone actually

ment seems to be effective before the BWC, on January 22, 1975. That Conven- being exposed to the smallpox virus. At

anthrax symptoms become manifest, tion now counts 144 nations as parties. the heart of the plan is a strategy

and effective to treat cutaneous an- Twenty-two years later, on April 24, sometimes called ‘‘search and contain-

thrax, and we have been able to effec- 1997, the United States Senate joined 74 ment.’’

tively treat some individuals who have other countries when it ratified the This strategy involves identifying in-

inhalation anthrax. I am thankful that Chemical Weapons Convention, CWC. fected individual or individuals with

this drug exists to treat those who While these Conventions serve impor- confirmed smallpox, identifying and lo-

have been exposed, including my own tant purposes, they do not in any way cating those people who come in con-

Senate staff. Our offices are imme- guarantee our safety in a world with tact with that person, and vaccinating

diately above those of Senator rogue states and terrorist organiza- those people in outward rings of con-

DASCHLE. tions. tact. The goal is to produce a buffer of

We have seen how reassuring it is The effectiveness of both Conven- immune individuals and was shown to

that we have an effective treatment for tions is constrained by the fact that prevent smallpox and to ultimately

this biological agent. We see long lines many countries have failed to sign on eradicate the outbreak. Priorities







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S12378 CONGRESSIONAL RECORD — SENATE December 4, 2001

would be set on who is vaccinated, per- or limit the transmission of the disease to all those who might have been ex-

haps focusing on the outward rings be- to others.’’ Federal law on this subject posed may be exceedingly difficult.

fore those at the center of the out- is very strong and the Administration And once infection has occurred, we

break. The plan assumes that the can always rely on the President’s Con- have no effective treatment options.

smallpox vaccination is effective for stitution authority as Commander in In the last century 500 million people

persons who have been exposed to the Chief. have died of smallpox, more than have

disease as long as the disease has not Let us try to imagine, however, what from any other infectious diseases, as

taken hold. it would be like if a quarantine is im- compared to 320 million deaths in all

In practice it may be necessary to set posed. Let us assume that there is not the wars of the twentieth century.

a wide perimeter for these areas be- enough smallpox vaccine available for Smallpox was one of the diseases that

cause smallpox is highly contagious be- use in a large outbreak, that the pri- nearly wiped out the entire Native

fore it might be diagnosed. There may ority is to vaccinate those in the out- American population in this hemi-

be many areas subject to search and ward rings of the containment area sphere. The last naturally acquired

containment because people in our so- first, that the available vaccines can- case of smallpox occurred in Somalia

ciety travel frequently and widely. Ter- not be quickly deployed inside the in 1977 and the last case from labora-

rorists might trigger attacks in a wide quarantined area, that it is not pos- tory exposure was in 1978.

range of locations to multiply the con- sible to quickly trace and identify all Smallpox is a nasty pathogen, car-

fusion and panic. The most common of the individuals who might have been ried in microscopic airborne droplets

form of smallpox has a 30-percent mor- exposed, and/or that public health inhaled by its victims. The first signs

tality rate, but terrorists might be able workers themselves might be infected. are headache, fever, nausea and back-

to obtain supplies of ‘‘flat-type’’ small- We know that there is no medicine to ache, sometimes convulsions and delir-

pox with a mortality rate of 96 percent treat those who do become infected. We ium. Soon, the skin turns scarlet.

and hemorrhagic-type smallpox, which know the mortality rates. It is not When the fever lets up, the telltale

is almost always fatal. For these rea- hard to imagine how much force might rash appears, flat red spots that turn

sons, the CDC plan accepts the possi- be necessary to enforce the quarantine. into pimples, then big yellow pustules,

bility that whole cities or other geo- It would be quite unacceptable to per- then scabs. Smallpox also affects the

graphic areas could be cordoned off, mit individuals to leave the quar- throat and eyes, and inflames the

letting no one in or out, a quarantine antined area no matter how much heart, lungs, liver, intestines and other

enforced by police or troops. panic had taken hold. internal organs. Death often came from

The plan focuses on enforcement au- Think about how different this sce- internal bleeding, or from the organs

thority through police or National nario would be if we had medicines simply being overwhelmed by the

Guard, isolation and quarantine, man- that could effectively treat and cure virus. Survivors were left covered with

datory medical examinations, and ra- those who become infected by small- pockmarks, if they were lucky. The un-

tioning of medicines. It includes a dis- pox. We still might implement the CDC lucky ones were left blind, their eyes

cussion of ‘‘population-wide quarantine plan but a major element of the strat- permanently clouded over. Nearly one

measures which restrict activities or egy would be to persuade people to in four victims died. The infection rate

limit movement of individuals [includ- visit their local clinic or hospital to be is estimated to be 25–40 percent for

ing] suspension of large public gath- dispensed their supply of medicine. We those who are unvaccinated and a sin-

erings, closing of public places, restric- could trust that there would be a very gle case can cause 20 or more addi-

tion on travel [air, rail, water, motor high degree of voluntary compliance. tional infections.

vehicle, and pedestrian], and/or ‘cordon This would give us more time, give us During the 16th Century, 3.5 million

sanitaire’ [literally a ‘sanitary cord’ or options if the containment is not suc- Aztecs, more than half the population,

line around a quarantined area guarded cessful, give us options to treat those died of smallpox during a 2-year span

to prevent spread of disease by restrict- in the containment area who are in- after the Spanish army brought the

ing passage into or out of the area].’’ fected, and enable us to quell the pub- disease to Mexico. Two centuries later,

The CDC recommends that States up- lic panic. the virus ravaged George Washington’s

date their laws to provide authority for Because we have no medicine to treat troops at Valley Forge. And it cut a

‘‘enforcing quarantine measures’’ and those infected by smallpox, we have to deadly path through the Crow, Dakota,

it recommends that States in ‘‘pre- be prepared to implement a plan like Sioux, Blackfoot, Apache, Comanche

event planning’’ identify ‘‘personnel the one CDC has proposed. Theirs is the and other American Indian tribes, help-

who can enforce these isolation and only option because our options are so ing to clear the way for white settlers

quarantine measures, if necessary.’’ limited. We need to expand our range to lay claim to the western plains. The

Guide C, Isolation and Quarantine, of options. epidemics began to subside with one of

page 17. We should not be lulled by the appar- medicine’s most famous discoveries:

On October 23, 2001, the CDC pub- ent successes with Cipro and the the finding by British physician Ed-

lished a ‘‘Model State Emergency strains of anthrax we have seen in the ward Jenner in 1796 that English milk-

Health Powers Act.’’ It was prepared by recent attacks. We have not been able maids who were exposed to cowpox, a

the Center for Law and the Public’s to prevent death in some of the pa- mild second cousin to smallpox that af-

Health at Georgetown and Johns Hop- tients with late-stage inhalation an- flicts cattle, seemed to be protected

kins Universities, in conjunction with thrax and Robert Stevens, Thomas against the more deadly disease.

the National Governors Association, Morris Jr., Joseph Curseen, Kathy Jenner’s work led to the development

National Conference of State Legisla- Nguyen, and Ottilie Lundgren have of the first vaccine in Western medi-

tures, Association of State and Terri- died. This legislation is named in honor cine. While later vaccines used either a

torial Health Officials, National Asso- of them. What we needed for them, and killed or inactivated form of the virus

ciation of City and County Health Offi- did not have, is a drug or vaccine that they were intended to combat, the

cers, and National Association of At- would treat late stage inhalation an- smallpox vaccine worked in a different

torneys General. A copy of the model thrax. way. It relied on a separate, albeit re-

law is printed at As I have said, we need an effective lated virus: first cowpox and the

www.publichealthlaw.net. The law treatment for those who become in- vaccinia, a virus of mysterious origins

would provide powers to enforce the fected with smallpox. We have a vac- that is believed to be a cowpox deriva-

‘‘compulsory physical separation, in- cine that effectively prevents smallpox tive. The last American was vaccinated

cluding the restriction of movement or infection, and administering this vac- back in the 1970s and half of the U.S.

confinement, of individuals and/or cine within four days of first exposure population has never been vaccinated.

groups believed to have been exposed to has been shown to offer some protec- It is not known how long these vac-

or known to have been infected with a tions against acquiring infection and cines provide protection, but it is esti-

contagious disease from individuals significant protection against a fatal mated that the term is 3–5 years.

who are believed not to have been ex- outcome. The problem is that admin- In an elaborate smallpox biowarfare

posed or infected, in order to prevent istering the vaccine in this time frame scenario enacted in February 1999 by







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December 4, 2001 CONGRESSIONAL RECORD — SENATE S12379

the Johns Hopkins Center for Civilian days minimum, 4–14 days maximum.’’ lewisite, nitrogenadn sulfur mustards,

Biodefense Studies, it was projected The instructions listed the symptoms and phosgene oxime; heavy metals, ar-

that within 2 months 15,000 people had of ricin as vomiting, stomach cramps, senic, lead, and mercury; and volatile

died, epidemics were out of control in extreme thirst, bloody diarrhoea, toxins, benzene, chloroform,

fourteen countries, all supplies of throat irritation, respiratory collapse trihalomethanes; pulmonary agents,

smallpox vaccine were depleted, the and death. Phosgene, chlorine, vinly chloride; and

global economy was on the verge of No specific treatment or vaccine for incapacitating agents, BZ.

collapse, and military control and ricin toxin exists. Ricin is produced The naturally occurring forms of

quarantines were in place. Within easily and inexpensively, highly toxic, these agents and toxins are enough to

twelve months it was projected that and stable in aerosolized form. A large cause concern, but we also know that

eighty million people worldwide had amount of ricin is necessary to infect during the 1980s and 1990s the Soviet

died. whole populations, the amount of ricin Union conducted bioweapons research

A single case of smallpox today necessary to cover a 100-km 2 area and at 47 laboratories and testing sites, em-

would become a global public health cause 50 percent lethality, assuming ployed nearly 50,000 scientists in the

threat and it has been estimated that a aerosol toxicity of 3 mcg/kg and opti- work, and that they developed geneti-

single smallpox bioterror attack on a mum dispersal conditions, is approxi- cally modified versions of some of

single American city would necessitate mately 4 metric tons, whereas only 1 these agents and toxins. The goal was

the vaccination of 30–40 million people. kg of Bacillus anthracis is required. to develop an agent or toxin that was

The U.S. Government is now in the But it can be used to terrorize a large particularly virulent or not vulnerable

process of purchasing substantial population with great effect because it to available antibiotics.

stocks of the smallpox vaccine. We is so lethal. The United States has publicly stat-

then face a very difficult decision on Use of ricin as a terror weapon is not ed that five countries are developing

deploying the vaccine. We know that theoretical. In 1991 in Minnesota, 4 biological weapons in violation of the

some individuals will have an adverse members of the Patriots Council, an Biological Weapons convention, North

reaction to this vaccine. No one in the extremist group that held Korea, Iraq, Iran, Syria, and Libya, and

United States has been vaccinated antigovernment and antitax ideals and stated that additional countries not

against smallpox in 25 years. Those advocated the overthrow of the U.S. yet named, possibly including Russia,

that were vaccinated back then may Government, were arrested for plotting China, Israel, Sudan and Egypt, are

not be protected against the disease to kill a U.S. marshal with ricin. The also doing so as well.

today. If we had an effective treatment ricin was produced in a home labora- What is so insidious about biological

for those who might become infected tory. They planned to mix the ricin weapons is that in many cases the

by smallpox, we would face much less with the solvent dimethyl sulfoxide, symptoms resulting from a biological

pressure regarding deploying the vac- DMSO, and then smear it on the door weapons attack would likely take time

cine. If we face a smallpox epidemic handles of the marshal’s vehicle. The to develop, so an act of bioterrorism

from a bioterrorism attack, we will plan was discovered, and the 4 men may go undetected for days or weeks.

have no Cipro to reassure the public were convicted. In 1995, a man entered Affected individuals would seek med-

and we will be facing a highly con- Canada from Alaska on his way to ical attention not from special emer-

tagious disease and epidemic. To be North Carolina. Canadian custom offi- gency response teams but in a variety

blunt, it will make the current anthrax cials stopped the man and found him in of civilian settings at scattered loca-

attack look benign by comparison. possession of several guns, $98,000, and tions. This means we will need medi-

Smallpox is not the only threat. We a container of white powder, which was cines that can treat a late stage of the

have seen other epidemics in this cen- identified as ricin. In 1997, a man shot disease, long after the infection has

tury. The 1918 influenza epidemic pro- his stepson in the face. Investigators taken hold.

We must recognize that the distinc-

vides a sobering admonition about the discovered a makeshift laboratory in

tive characteristic of biological weap-

need for research to develop medicines. his basement and found agents such as

ons is that they are living micro-orga-

In 2 years, a fifth of the world’s popu- ricin and nicotine sulfate. And, ricin

nisms and are thus the only weapons

lation was infected. In the United was used by the Bulgarian secret police

that can continue to proliferate with-

States the 1918 epidemic killed more when they killed Georgi Markov by

out further assistance once released in

than 650,000 people in a short period of stabbing him with a poison umbrella as

a suitable environment.

time and left 20 million seriously ill, he crossed Waterloo Bridge in 1978. The lethality of these agents and tox-

one-fourth of the entire population. Going beyond smallpox, influenza,

ins, and the panic they can cause, is

The average lifespan in the U.S. was and ricin, we do not have an effective quite frightening. The capacity for ter-

depressed by ten years. In just 1 year, vaccine or treatment for dozens of ror is nearly beyond comprehension. I

the epidemic killed 21 million human other deadly and disabling agents and do not believe it is necessary to de-

beings worldwide—well over twice the toxins. Here is a partial list of some of scribe the facts here. My point is sim-

number of combat deaths in the whole the other biological agents and chem- ple: we need more than military intel-

of World War I. The flu was exception- ical toxins for which we have no effec- ligence, surveillance, and public health

ally virulent to begin with and it then tive treatments: clostridium botu- capacity. We also need effective medi-

underwent several sudden and dramatic linum toxin, botulism; francisella cines. We also need more powerful re-

mutations in its structure. Such tularensis, tularaemia; Ebola hemor- search tools that will enable us to

mutations can turn flu into a killer be- rhagic fever, Marbug hemorrhagic quickly develop treatments for agents

cause its victims’ immune systems fever, Lassa fever, Julin, Argentine and toxins not on this or any other list.

have no antibodies to fight off the al- hemorrhagic fever; Coxiella burnetti, Q We need to do whatever it takes to be

tered virus. Fatal pneumonia can rap- fever; brucella species, brucellosis; able to reassure the American people

idly develop. burkholderia mallei, glanders; Ven- that hospitals and doctors have power-

Another deadly toxin, ricin toxin, ezuelan encephalomyelitis, eastern and ful medicines to treat them if they are

was of interest to the al-Qaeda ter- western equine encephalomyelitis, ep- exposed to biological agents or toxins,

rorist network. At an al-Qaeda silon toxin of clostridium perfringens, that we can contain an outbreak of an

safehouse in Saraq Panza, Kabul re- staphylococcus entretoxin B, sal- infectious agent, and that there is lit-

porters found instructions for making monella species, shigella dysenteriae, tle to fear. To achieve this objective,

ricin. The instructions make chilling escherichia coli O157:H7, vibrio we need to rely on the entrepreneur-

reading. ‘‘A certain amount, equal to a cholerae, cryptosporidium parvum, ship of the biotechnology industry.

strong dose, will be able to kill an nipah virus, hantaviruses, tickborne There is already some direct funding

adult, and a dose equal to seven seeds hemorrhagic fever viruses, tickborne of research by the Defense Advanced

will kill a child,’’ one page reads. An- encephalitis virus, yellow fever, nerve Research Projects Agency, DARPA, the

other page says: ‘‘Gloves and face mask agents, tabun, sarin, soman, GF, and National Institutes of Health, NIH, and

are essential for the preparation of VX; blood agents, hydrogen cyanide the Centers for Disease Control, CDC.

ricin. Period of death varies from 3–5 and cyanogens chloride; blister agents, This research should go forward.







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S12380 CONGRESSIONAL RECORD — SENATE December 4, 2001

DARPA, for instance, has been de- Some companies are willing to enter 350 of these companies have managed

scribed as the Pentagon’s ‘‘venture into a research relationships funded by to go public. The industry employs

capital fund,’’ its mission to provide DARPA and other agencies to develop 124,000, Ernest & Young data, people.

seed money for novel research projects countermeasures. Relationships be- The top five companies spent an aver-

that offer the potential for revolu- tween the Government and private in- age of $89,000 per employee on research,

tionary findings. Last year, DARPA’s dustry can be very productive, but they making it the most research-intensive

Unconventional Pathogen Counter- can also involve complex issues reflect- industry in the world. The industry has

measures program awarded contracts ing the different cultures of govern- 350 products in human clinical trials

totalling $50 million to universities, ment and industry. Some companies, targeting more than 200 diseases.

foundations, pharmaceutical and bio- including some of the most entrepre- Losses for the industry were $5.8 billion

technology companies seeking new neurial, might prefer to take their own in 2001, $5.6 billion in 2000, $4.4 billion

ways to fight biological agents and tox- initiative to conduct this research. Re- in 1999, $4.1 billion in 1998, $4.5 billion

ins. lationships with government entities in 1997, $4.6 billion in 1996, and similar

The Unconventional Pathogen Coun- involve risks, issues, and bureaucracy amounts before that. In 2000 fully 38

termeasures program now funds 43 sep- that are not present in relationships percent of the public biotech compa-

arate research efforts on anti- among biotechnology companies and nies had less than 2 years of funding for

bacterials, anti-toxins, anti-virals, de- between them and non-governmental their research. Only one-quarter of the

contamination, external protection partners. biotech companies in the United States

from pathogens, immunization and The Defense Departments Joint Vac- are publicly traded and they tend to be

multi-purpose vaccines and treat- cine Acquisition Program, JVAP, illus- the best funded.

ments. A common thread among many trates the problems with a government There is a broad range of research

of these undertakings is the goal of de- led and managed program. A report in that could be undertaken under this

veloping drugs that provide broad-spec- December 2000 by a panel of inde- legislation. Vaccines could be devel-

trum protection against several dif- pendent experts found that the current oped to prevent infection or treat an

ferent pathogens. This year, with a program ‘‘is insufficient and will fail’’ infection from a bioterror attack.

budget of $63 million, the program has and recommended it adopt an approach Broad-spectrum antibiotics are needed.

received over 100 research proposals in more on the model of a private sector Also, promising research has been un-

the last two months alone. effort. It needs to adopt ‘‘industry dertaken on antitoxins that could neu-

Some of this DARPA research is di- practices,’’ ‘‘capture industry inter- tralize the toxins that are released, for

rected at developing revolutionary, est,’’ ‘‘implement an organizational example, by anthrax. With anthrax it

broad-spectrum, medical counter- alignment that mirrors the vaccine in- is the toxins, not the bacteria itself,

measures against significantly patho- dustry’s short chain of command and that cause death. An antitoxin could

genic microorganisms and/or their decision making,’’ ‘‘adopt an industry- act like a decoy, attaching itself to

pathogenic products. The goal is to de- sites on cells where active anthrax

based management philosophy,’’ and

velop countermeasures that are toxin binds and then combining with

‘‘develop a sound investment strat-

versatile enough to eliminate biologi- normal active forms of the toxin and

egy.’’ It bemoaned the ‘‘extremely lim-

cal threats, whether from natural inactivating them. An antitoxin could

ited’’ input from industry in the JVAP

sources or modified through bio- block the production of the toxin.

program. We can rely on the innovativeness of

engineering or other manipulation. The It is clear from this experience that

countermeasures would need the poten- the biotech industry, working in col-

we should not rely exclusively on gov-

tial to provide protection both within laboration with academic medical cen-

ernment funding of countermeasures

the body and at the most common por- ters, to explore a broad range of inno-

research. We should take advantage of

vative approaches. This mobilizes the

tals of entry, e.g., inhalation, inges- the entrepreneurial fervor, and the entire biotechnology industry as a

tion, transcutaneous. The strategies independence, of our biotechnology in- vital component of our national de-

might include defeating the pathogen’s dustry entrepreneurs. It is not likely fense against bioterror weapons.

ability to enter the body, traverse the that the Government will be willing or The legislation takes a comprehen-

bloodstream or lymphatics, and enter able to provide sufficient funding for sive approach to the challenges the bio-

target tissues; identifying novel patho- the development of the counter- technology industry faces in forming

gen vulnerabilities based on funda- measures we need. Some of the most capital to conduct research on counter-

mental, critical molecular mechanisms innovative approaches to vaccines and measures. It includes capital formation

of survival or pathogenesis, e.g., Type medicines might not be funded with tax incentives, guaranteed purchase

III secretion, cellular energetics, the limited funds available to the Gov- funds, patent protections, and liability

virulence modulation; constructing ernment. We need to provide incentives protections. I believe we will have to

unique, robust vehicles for the delivery that will encourage every biotech com- include each of these types of incen-

of countermeasures into or within the pany to review its research priorities tives to ensure that we mobilize the

body; and modulating the advan- and technology portfolio for its rel- biotechnology industry for this urgent

tageous and/or deleterious aspects of evance and potential for counter- national defense research.

the immune response to significantly measure research. Some of this re- I am aware that all three of the tax

pathogenic microorganisms and/or the search is early stage, basic research incentives I have proposed, and both of

pathogenic products in the body that is being developed and considered the two patent incentives I have pro-

While DAPRA’s work is specifically only for its value in treating an en- posed, may be controversial. In my

aimed at protecting our military per- tirely different disease. We need to kin- view, we can debate tax or patent pol-

sonnel, the National Institutes of dle the imagination of biotechnology icy as long as you want, but let’s not

Health also spent $49.7 million in the companies and their tens of thousands lose track of the issue here, develop-

last fiscal year to find new therapies of scientists regarding counter- ment of countermeasures to treat peo-

for those who contract smallpox and on measures research. ple infected or exposed to lethal and

systems for detecting the disease. In My proposal would supplement direct disabling bioterror weapons.

recent years, NIH’s research programs Federal government funding of re- We know that incentives can spur re-

have sought to create more rapid and search with incentives that make it search. In 1983 we enacted the Orphan

accurate diagnostics, develop vaccines possible for private companies to form Drug Act to provide incentives for

for those at risk of exposure to biologi- the capital to conduct this research on companies to develop treatments for

cal agents, and improve treatment for their own initiative, utilizing their rare diseases with small potential mar-

those infected. Moreover, in the last own capital, and at their own risk, all kets deemed to be unprofitable by the

fiscal year, the Centers for Disease for good business reasons going to their industry. In the decade before this leg-

Control has allocated $18 million to bottom line. islation was enacted, fewer than 10

continue research on an anthrax vac- The U.S. biotechnology industry, ap- drugs for orphan diseases were devel-

cine and $22.4 million on smallpox re- proximately 1,300 companies, spent oped and these were mostly chance dis-

search. $13.8 billion on research last year. Only coveries. Since the Act became law, 218







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December 4, 2001 CONGRESSIONAL RECORD — SENATE S12381

orphan drugs have been approved and The legislation contemplates that a search and development tax credits and

800 more are in the pipeline. The Act company might well register and seek depreciation deductions for the com-

provides 7 years of market exclusivity certification with respect to more than pany may be passed by the corporation

and a tax credit covering some re- one research project and become eligi- through to its partners to be used to

search costs. The effectiveness of the ble for the tax, purchase, patent, and offset their individual tax liability.

incentives we have enacted for orphan liability incentives for each. There is These deductions and credits are then

disease research show us how much we no policy rationale for limiting a com- lost to the corporation.

can accomplish when we set a national pany to one registration and one cer- The company is eligible to issue a

priority for certain types of research. tification. special class of stock for the entity to

The incentives I have proposed differ This process is similar to the current conduct the research. The investors

from those set by the Orphan Drug Act. registration process for research on or- would be entitled to a zero capital

We need to maintain the effectiveness phan, rare, diseases. In that case, com- gains tax rate on any gains realized on

of the Orphan Drug Act and not under- panies that are certified by the FDA the stock held for at least 3 years. This

mine it by adding many other disease become eligible for both tax and mar- is a modification of the current Sec-

research targets. In addition, the tax ket exclusivity incentives. This process tion 1202 where only 50 percent of the

credits for research for orphan drug re- gives the Government complete control gains are not taxed. This provision is

search have no value for most bio- on the number of registrations and cer- adapted from legislation I have intro-

technology companies because few of tifications. This gives the Government duced, S. 1134, and introduced in the

them have tax liability with respect to control over the cost and impact of the House by Representatives DUNN and

which to claim the credit. This ex- legislation on private sector research. MATSUI, H.R. 2383. A similar bill has

plains why I have not proposed to uti- The legislation includes three tax in- been introduced by Senator COLLINS, S.

lize tax credits to spur counter- centives to enable biotechnology com- 455.

The company is eligible to receive re-

measures research. It is also clear that panies to form capital to fund research

funds for Net Operating Losses, NOLs,

the market for countermeasures is and development of countermeasures.

to fund the research. Under current

even more speculative than the market Companies must irrevocably elect only

law, net operating losses can only be

for orphan drugs and we need to enact one of the incentives with regard to the used to offset a company’s tax liabil-

a broader and deeper package of incen- research. These tax incentives are ity. If a company has no profits and

tives. available only to biotechnology compa- therefore no tax liability, it cannot use

The Government determines which nies with less than $750,000,000 in paid- its net operating losses. It can carry

research is covered by the legislation. in capital. them forward, but the losses have no

The legislation confers on the Director The paid-in capital of a corporation current value. This option would allow

of the Office of Homeland Security, in is quite distinct from the market cap- the company to receive a refund of its

consultation with the Secretary of De- italization of the firm. The paid-in cap- NOLs at a rate of 75 percent of their

fense and Secretary of Health and ital is the aggregate amount paid by value. Once the company becomes prof-

Human Services, authority to set the investors into the corporation when itable, and incurs tax liability, it must

list of agents and toxins with respect this stock was issued, the price at issue repay all of the refunds it has received.

to which the legislation applies. The multiplied by the number of shares The provision in my legislation is

Director determines which agents and sold. The market capitalization is the adapted from bills introduced by Sen-

toxins present a threat and on whether value of this stock in the stock market ator TORRICELLI, S. 1049, and Congress-

the countermeasures are more likely to as it is traded among investors. I have man ROBERT MATSUI, H.R. 2153.

be developed with the application of focused on the paid-in capital as this is A company that elects to utilize one

the incentives of the legislation. The the amount of capital actually avail- of these incentives is not eligible to re-

Director may determine that an agent able to the corporation to fund its re- ceive benefits of the Orphan Drug Tax

or toxin does not present a threat or search. Credit. Companies that can utilize tax

that countermeasures are not more The legislation includes three dif- credits, companies with taxable income

likely to be developed with the incen- ferent tax incentives to give companies and tax liability, might find the Or-

tives. The legislation includes an illus- flexibility in forming capital to fund phan Credit more valuable. The legisla-

trative list of agents and toxins that the research. Each of the options tion includes an amendment to the Or-

might be selected by the Director. The comes with advantages and limitations phan Credit to correct a defect in the

decisions of the Director are final and that may make it appropriate or inap- current credit. The amendment has

cannot be subject to judicial review. propriate for a given company or re- been introduced in the Senate as S.

Once the list of agents and toxins is search project. We do not now know 1341 by Senators HATCH, KENNEDY and

set, companies may register with the fully how investors and capital mar- JEFFORDS. The amendment simply

Food and Drug Administration their kets will respond to the different op- states that the Credit is available

intent to undertake research and devel- tions, but we assume that companies starting the day an application for or-

opment of a countermeasure to prevent will consult with the investor commu- phan drug status is filed, not the date

or treat the agent or toxin. This reg- nity about which option will work best the FDA finally acts on it. The amend-

istration is required only for compa- for a given research project. Capital ment was one of many initiatives

nies that seek to be eligible for the tax, markets are diverse and investors have championed by Lisa J. Raines, who

purchase, patent, and liability provi- different needs and expectations. Over died on September 11 in the plane that

sions of the legislation. The registra- time these markets and investor expec- hit the Pentagon, and the amendment

tion does not apply to non-profit enti- tations evolve. If companies register is named in her honor. As we go for-

ties or to companies that do not seek for more than one research project, ward in the legislative process, I hope

such eligibility. The registration re- they may well utilize different tax in- we will have an opportunity to speak

quirement gives the FDA vital infor- centives for the different projects. in more detail about the service of Ms.

mation about the research effort and Companies are permitted to under- Raines on behalf of medical research,

the personnel involved with the re- take a series of discrete and separate particularly on rare diseases.

search. research projects and make this elec- My legislation does not include an

The Director of the Office of Home- tion with respect to each project. They enhanced tax credit for this research.

land Security then may certify that may only utilize one of the options Very few biotechnology companies can

the company is eligible for the tax, with respect to each of these research utilize a tax credit as they have no tax-

purchase, patent, and liability incen- projects. able revenue and tax liability with re-

tives in the legislation. Eligibility for The company is eligible to establish spect to which to claim a credit. In-

the purchase fund, patent and liability an R&D Limited Partnership to con- stead, they can carry the credit for-

incentives is contingent on successful duct the research. The partnership ward and utilize it when they do have

development of a countermeasure ac- passes through all business deductions tax liability. But that may be many

cording to the standards set in the leg- and credits to the partners. For exam- years from now. That is why I have fo-

islation. ple, under this arrangement, the re- cused on other incentives to assist the







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S12382 CONGRESSIONAL RECORD — SENATE December 4, 2001

biotechnology industry to form capital companies for one simple reason: they the PTO in the patent system. The

to fund this countermeasures research. need to know that if they successfully term of a patent used to be fixed at 17

The guaranteed purchase fund, and develop a medical product another years from the date the patent was

the patent bonus and liability provi- company cannot expropriate it. It’s a granted by the PTO. It made no dif-

sions described below provide an addi- simple matter of incentives. ference how long it took for the PTO to

tional incentive for investors to fund The patent system has its basis in process the patent application and

the research. Without capital from in- the U.S. Constitution where the Fed- sometimes the processing took years,

vestors these biotechnology companies eral Government is given the mandate even decades. Under this system, there

do not have the capacity, irrespective to ‘‘promote the Progress of Science were cases where the patent would

of their interest, to conduct the re- and the Useful Arts by securing for a issue before final action at the FDA,

search. limited time to Authors and Inventors but there were other cases where the

The market for countermeasures is the exclusive right to their respective FDA acted to approve a product before

speculative and small. This means that Writings and Discoveries.’’ In exchange the patent was issued. Erosion was an

if a company successfully develops a for full disclosure of the terms of their issue, but it did not occur in many

countermeasure, it may not receive inventions, inventors are granted the cases.

sufficient revenue on sales to justify right to exclude others from making, Since 1995 the term of a patent has

the risk and expense of the research. using, or selling their inventions for a been set at 20 years from the date of

This is why the legislation establishes limited period of time. This quid pro application for the patent. This means

a countermeasures purchase fund that quo provides investors with the incen- that the processing time by the PTO of

will define the market for the products tive to invent. In the absence of the the application all came while the

with some specificity before the re- patent law, discoverable inventions term of the patent is running. This

search begins. would be freely available to anyone gives companies a profound incentive

The fund managers will set standards who wanted to use them and inventors to rush the patent through the PTO.

for which countermeasures it will pur- would not be able to capture the value Under the old system, companies had

chase and define the financial terms of of their inventions or secure a return the opposite incentive. With patents

the purchase commitment. This will on their investments.

being issued earlier by the PTO, the

enable companies to evaluate the mar- The patent system strikes a balance.

Companies receive limited protection issue of erosion of patent term due to

ket potential of its research before it delays at the FDA is becoming more

launches into the project. The speci- of their inventions if they are willing

to publish the terms of their invention serious and more common.

fications will need to be set with suffi- The provision in my legislation sim-

cient specificity so that the company, for all to see. At the end of the term of

the patent, anyone can practice the in- ply states that in the case of bioter-

and its investors, can evaluate the rorism countermeasures, no erosion in

market and with enough flexibility so vention without any threat of an in-

fringement action. During the term of the term of the patent will occur. The

that it does not inhibit the innovative- term of the patent at the date of FDA

ness of the researchers. This approach the patent, competitors can learn from

the published description of the inven- approval will be the same as the term

is akin to setting a performance stand- of the patent when it was issued by the

ard for a new military aircraft. tion and may well find a new and dis-

tinct patentable invention. PTO. There is no extension of the pat-

The legislation provides that the pur-

The legislation provides two types of ent, simply protections against ero-

chase fund is not obligated to purchase

intellectual property protection. One sion. Under the new 20-year term, pat-

more than one product per class. This

simply provides that the term of the ents might be more or less than 17

seeks to avoid a situation where the

patent on the countermeasure will be years depending on the processing time

Government must purchase more than

the term of the patent granted by the at the PTO, and all this legislation

one product when it only intends to use

one. But it might make more sense, as Patent and Trademark Office without says is that whatever term is set by the

an incentive, for the Government to any erosion due to delays in approval PTO will govern irrespective of the

commit to purchasing more than one of the product by the Food and Drug delays at the FDA. This option is avail-

product so that many more than one Administration. The second provides able to any company that successfully

company conducts the research. A win- that a company that successfully de- develops a countermeasure eligible to

ner-take-all system may well intimi- velops a countermeasure will receive a be purchased by the fund.

bonus of 2 years on the term of any The second option, the bonus patent

date some companies and we may end

patent held by that company. Compa- term, is only available to small bio-

up without a countermeasure to be

purchased. It is also possible that we nies must elect one of these two pro- technology companies. It provides that

will find that we need more than one tections and only small biotechnology a company that successfully develops a

countermeasure because different prod- companies may elect the second pro- countermeasure is entitled to a 2-year

ucts are useful for different patients. tection. Large, profitable pharma- extension of any patent in its portfolio.

We may also find that the first product ceutical companies may elect only the This does not apply to any patent of

developed is not the most effective. first of the two options. another company bought or transferred

Given the urgency of the research, we The first protection against erosion in to the countermeasure research

would like to have the problem of see- of the term of the patent is an issue company.

ing more than one effective counter- that is partially addressed in current I am well aware that this bonus pat-

measure developed. How we reconcile law, the Hatch-Waxman Patent Term ent term provision will be controver-

these competing considerations is a Restoration Act. That act provides par- sial with some. A company would tend

key issue we need to resolve. tial protection against erosion of the to utilize this option if it owned the

My legislation provides that the term, length of a patent when there are patent on a product that still had, or

countermeasure must be approved by delays at the FDA in approving a prod- might have, market value at the end of

the FDA. The standards that the FDA uct. The erosion occurs when the PTO the term of the patent. Because this

should apply in reviewing these types issues a patent before the product is option is only available to small bio-

of products is an issue have been dis- approved by the FDA. In these cases, technology companies, most of whom

cussed in some detail and we need to the term of the patent is running but have no product on the market, in

fashion the most effective provision on the company cannot market the prod- most cases they would be speculating

this subject. We need to recognize that uct. The Hatch-Waxman Act provides about the value of a product at the end

the requirement for FDA approval some protections against erosion of the of its patent. The company might

might, in some cases, not be needed, term of the patent, but the protections apply this provision to a patent that

appropriate or possible. are incomplete. As a result, many com- otherwise would be eroded due to FDA

The purchase commitment for coun- panies end up with a patent with a re- delays or it might apply it to a patent

termeasures is available to any com- duced term, sometimes substantially that was not eroded. The result might

pany irrespective of its paid-in capital. reduced. be a patent term that is no longer than

Intellectual property protection of The issue of patent term erosion has the patent term issued by the PTO. It

research is essential to biotechnology become more serious due to changes at all depends on which companies elect







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December 4, 2001 CONGRESSIONAL RECORD — SENATE S12383

this option and which patent they se- basis. So, it doesn’t provide protection them ineffective. It is even possible

lect. In some cases, the effect of this based on the product being developed, that a scientist could develop an orga-

provision might be to delay the entry only if that product is being developed nism that develops resistance to anti-

onto the market of lower priced under a specific government contract. biotics at an accelerated rate.

generics. This would tend to shift some Therefore, it’s negotiated case by case This means we need to develop tech-

of the cost of the incentive to develop by HHS and a company. Your proposal nology, research tools, that will enable

a countermeasure to insurance compa- provides assurance to companies, espe- us to quickly develop a tailor-made,

nies and patients with an unrelated cially small and medium sized compa- specific countermeasure to a pre-

disease. nies, that they will be protected. This viously unknown organism or agent.

My rationale for including the patent will allow them to go forward with These research tools will enable us to

bonus in the legislation is simple: I their development plans. Their lawyers develop a tailor-made vaccine or drug

want this legislation to say emphati- may be leery of trying to negotiate to deploy as a countermeasure against

cally that we mean business, we are se- their own deal with HHS. So, the EO a new threat. The legislation author-

rious, and we want biotechnology com- may be effective for a large company izes companies to register and receive

panies to reconfigure their research when it negotiates making additional a certification making them eligible

portfolios to focus in part on develop- smallpox vaccine, but it provides little for the tax incentives in the bill for

ment of countermeasures. The other assurance to a small company that this research.

provisions in the legislation are power- wants to start development. Also, the Perhaps the greatest strength of our

ful, but they may not be sufficient. administration says the EO will be biomedical research establishment in

This proposal protects companies used to protect companies, however, the United States is the synergy be-

willing to take the risks of producing the next administration could inter- tween our superb basic research insti-

anti-terrorism products for the Amer- pret it differently. That’s why a statu- tutions and private companies. The

ican public from potential losses in- tory provision will provide greater as- Bayh-Dole Act and Stevenson-Wydler

curred from lawsuits alleging adverse surance to companies. Act form the legal framework for mu-

reactions to these products. It also pre- The legislation focuses intently on tually beneficially partnerships be-

serves the right for plaintiffs to seek development of vaccines and medi- tween academia and industry. My leg-

recourse for alleged adverse reactions cines, but it is possible that we will islation strengthens this synergy and

in Federal District Court, with proce- face biological agents and chemical these relationships with two provi-

dural and monetary limitations. agents we’ve never seen before. As I’ve sions, one to upgrades in the basic re-

Under the plan, the Secretary of HHS mentioned, the Soviet Union bioterror search infrastructure available to con-

is authorized, and in the case of con- research focused in part on use of ge- duct research on countermeasures and

tractors with HHS, is required, to in- netic modification technology to de- the other to increase cooperation be-

demnify and defend persons engaged in velop agents and toxins that currently- tween the National Institutes of Health

research, development and other ac- available antibiotics can not treat. and private companies.

tivities related to biological defense Australian researchers accidentally Research on countermeasures neces-

products through execution of ‘‘indem- created a modified mousepox virus, sitates the use of special facilities

nification and defense agreements.’’ An which does not affect humans, but it where biological agents can be handled

exclusive means of resolving civil cases was 100 percent lethal to the mice. safely without exposing researchers

that fall within the scope of the indem- Their research focused on trying to and the public to danger. Very few aca-

nification and defense agreements is make a mouse contraceptive vaccine demic institutions or private compa-

provided with litigation rights for in- for pest control. The surprise was that nies can justify or capitalize the con-

jured parties. Non-economic damages it totally suppressed the ‘‘cell-medi- struction of these special facilities.

are limited to $250,000 per plaintiff and ated response,’’ the arm of the immune The Federal Government can facilitate

no punitive or exemplary damages may system that combats viral infection. research and development of counter-

be awarded. To make matters worse, the engineered measures by financing the construction

Some have tried to apply the existing virus also appears unnaturally resist- of these facilities for use on a fee-for-

Vaccine Injury Compensation Program, ant to attempts to vaccinate the mice. service basis. The legislation author-

VICP, to this national effort. That is A vaccine that would normally protect izes appropriations for grants to non-

inappropriate because that program mouse strains that are susceptible to profit and for-profit institutions to

will be extremely difficult to use, both the virus only worked in half the mice construct, maintain, and manage up to

administratively and scientifically. exposed to the killer version. If bio- ten Biosafety Level 3–4 facilities, or

For example, it would take several terrorists created a human version of their equivalent, in different regions of

years to develop the appropriate the virus, vaccination programs would the country for use in research to de-

‘‘table’’ that identifies a compensable be of limited use. This highlights the velop countermeasures. BSL 3–4 facili-

injury. Companies will be liable during drawback of working on vaccines ties are ones used for research on indig-

this process. Note that when VICP was against bioweapons rather than treat- enous, exotic or dangerous agents with

created, there had been studies of what ments. potential for aerosol transmission of

adverse reactions to mandated child- With the advances in gene sequenc- disease that may have serious or lethal

hood vaccines had occurred and the ing, genomics, we will know the exact consequences or where the agents pose

table was based largely on this experi- genetic structure of a biological agent. high risk of life-threatening disease,

ence. Even so, it has taken years of ef- This information in the wrong hands aerosol-transmitted lab infections, or

fort, ultimately resulting in wholesale could easily be manipulated to design related agents with unknown risk of

revisions to the table by regulation, to and possibly grow a lethal new bac- transmission. The Director of the Of-

get the current table in place. For anti- terial and viral strains not found in na- fice and NIH shall issue regulations re-

bioterrorism products currently being ture. A scientist might be able to mix garding the qualifications of the re-

developed, it will simply be impossible and match traits from different micro- searchers who may utilize the facili-

to construct a meaningful Vaccine In- organisms, called recombinant tech- ties. Companies that have registered

jury Table, there will be no experience nology, to take a gene that makes a with and been certified by the Director,

with the product. deadly toxin from one strain of bac- to develop countermeasures under Sec-

The Frist-Kennedy bill relies on the teria and introduce it into other bac- tion 5(d) of the legislation, shall be

President’s Executive Order regarding terial strains. Dangerous pathogens or given priority in the use of the facili-

liability protections, so there is a basis infectious agents could be made more ties.

for an agreement regarding this issue deadly, and relatively benign agents The legislation also reauthorizes a

as applied to bioterrorism counter- could be designed as major public very successful NIH-industry partner-

measures. The provisions that I have health problems. Bacteria that cause ship program launched in FY 2000 in

proposed are superior to those in the diseases such as anthrax could be al- Public Law 106–113. The funding is for

Executive Order because the order pro- tered in such a way that would make partnership challenge grants to pro-

vides protection only on a contract current vaccines or antibiotics against mote joint ventures between NIH and







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S12384 CONGRESSIONAL RECORD — SENATE December 4, 2001

its grantees and for-profit bio- This same issue arises with the Or- The incentives are needed because most

technology, pharmaceutical and med- phan Drug Act, which provides both biotech companies have no approved prod-

ical device industries with regard to tax and FDA approval incentives for ucts or revenue from product sales to fund

research. They rely on investors and equity

the development of countermeasures, companies that develop medicines to capital markets to fund the research. These

as defined in Section 3 of the bill, and treat rare diseases. In some cases these companies must focus on research that will

research tools, as defined in Section treatments can also be used for larger lead to product sales and revenue and end

4(d)(3) of the bill. Such grants shall be disease populations. There are few who their dependence on investor capital. When

awarded on a one-for-one matching object to this situation. We have come they are able to form the capital to fund re-

basis. So far the matching grants have to the judgment that the urgency of search, biotech companies tend to be innova-

focused on development of medicines to this research is worth the possible ad- tive and nimble and focused on the intrac-

treat malaria, tuberculosis, emerging table diseases for which no effective medical

ditional benefits that might accrue to

treatments are available.

and resistant infections, and thera- a company. There is no established or predictable mar-

peutics for emerging threats. My pro- In the context of research to develop ket for countermeasures. Investors are jus-

posal should be matched by reauthor- countermeasures, I do not consider it a tifiably reluctant to fund this research,

ization of the challenge grant program problem that a company might find a which will present technical challenges simi-

for these deadly diseases. broader commercial market for a coun- lar in complexity to development of effective

My legislation is carefully calibrated termeasure. Indeed, it may well be the treatments for AIDS. Investors need assur-

to provide incentives only where they ances that research on countermeasures has

combination of the incentives in this

are needed. This accounts for the the potential to provide a rate of return

legislation and these broader markets commensurate with the risk, complexity and

choices in the legislation about which that drives the successful development cost of the research, a rate of return com-

provisions are available to small bio- of a countermeasure. If our intense parable to that which may arise from a

technology companies and large phar- focus on developing countermeasures, treatment for cancer, MS, Cystic Fibrosis

maceutical companies. and research tools, provides benefits and other major diseases or from other in-

Most biotechnology companies rely for mankind going well beyond terror vestments.

on infusions of investor capital to fund The legislation provides tax incentives to

weapons, we should rejoice. If this re-

research, so the capital formation tax enable biotech companies to form capital to

search helps us to develop an effective conduct the research. It then provides a

incentives only apply to them. Large vaccine or treatment for AIDS, we

pharmaceutical companies have ample guaranteed and pre-determined market for

should give the company the Nobel the countermeasures and special intellectual

revenues from product sales, and access Prize for Medicine. If we do not develop property protections to serve as a substitute

to debt capital, so they do not need a vaccine or treatment for AIDS, we for a market. Finally, it establishes liability

these incentives for capital formation. may see 100 million people die of AIDS. protections for the countermeasures that are

The guaranteed purchase fund applies developed.

We also have 400 million people in-

to any company that successfully de- Specifics of the legislation are as follows:

fected with malaria and more than a one, Office of Homeland Security sets re-

velops a countermeasure. There is no

million annual deaths. Millions of chil- search priorities in advance. Biotech compa-

reason to make any distinction be-

dren die of diarrhea, cholera and other nies that seek to be eligible for the incen-

tween small and large companies. They

deadly and disabling diseases. Counter- tives in the legislation must register with

all need to know the terms and dimen-

measures research may deepen our un- the Food and Drug Administration and be

sions of the potential market for the certified as eligible for the incentives; two,

derstanding of the immune system and

products they seek to develop. With once a company is certified as eligible for

countermeasures the market may well speed development of treatments for

cancer and autoimmune diseases. That the incentives, it becomes eligible for the

be uncertain or small, necessitating tax, purchasing, patent, and liability provi-

the creation of the purchase fund. is not the central purpose of this legis- sions. A company is eligible for certification

The patent protection provisions are lation, but it is an additional rationale for the tax and patent provisions if it seeks

also well calibrated. Both small and for it. to develop a research tool that will make it

large companies face the patent term The issue raised by my legislation is possible to quickly develop a counter-

erosion problem due to delays at the very simple: do we want the Federal measure to a previously unknown agent or

FDA. There is no reason why compa- Government to fund and supervise toxin, or an agent or toxin not targeted for

much of the research to develop coun- research; three, Capital Formation for Coun-

nies that successfully develop a coun- termeasures Research: The legislation pro-

termeasure should end up with a pat- termeasures or should we also provide

vides that a company seeking to fund re-

ent with an eroded term. incentives that make it possible for the

search is eligible to elect from among three

With regard to the patent bonus pro- private sector, at its own expense, and tax incentives. The three alternatives are as

vision, this is included to supplement at its own risk, to undertake this re- follows: a. The company is eligible to estab-

the capital formation tax incentives search for good business reasons. The lish an R&D Limited Partnership to conduct

for small biotechnology companies. It Frist-Kennedy legislation focuses effec- the research. The partnership passes through

provides a dramatic statement to in- tively on direct Federal funding and all business deductions and credits to the

coordination issues, but it does not in- partners; b. The company is eligible to issue

vestors that this research makes good

clude sufficient incentives for the pri- a special class of stock for the entity to con-

business sense. As capital formation is duct the research. The investors would be en-

not a challenge for a large pharma- vate sector to undertake this research

titled to a zero capital gains tax rate on any

ceutical company, this patent bonus on its own initiative. Their proposal gains realized on the stock; and, c. The com-

provision is not available to them. and mine are perfectly complimentary. pany is eligible to receive refunds for Net

Finally, with regard to the liability We need to enact both to ensure that Operating Losses, NOLs, to fund the re-

provisions, there is no reason to make we are prepared for bioterror attacks. search.

any distinction between small and I ask unanimous consent that an out- These tax incentives are available only to

large companies. line of my legislation appear at this biotechnology companies with less than

The legislation makes choices. It sets point in the RECORD. $750,000 in paid-in capital.

A company must elect only one of these in-

the priorities. It provides a dose of in- There being no objection, the outline

centives and, if it elects one of these incen-

centives and seeks a response in the was ordered to be printed in the tives, it is then not eligible to receive bene-

private sector. We are attempting here RECORD, as follows fits under the Orphan Drug Act. The legisla-

to do something that has not been done BIOLOGICAL AND CHEMICAL WEAPONS tion includes amendments to the Orphan

before. This is uncharted territory. COUNTERMEASURES RESEARCH ACT OF 2001 Drug Act championed by Senators HATCH,

And it’s also an urgent mission. The premise of the legislation is that there KENNEDY and JEFFORDS, S. 1341. The amend-

There may be cases where a counter- will be limits on direct Federal funding of re- ments make the Credit available from the

measure developed to treat a biological search and development of countermeasures, date of the application for Orphan Drug sta-

toxin or chemical agent will have ap- vaccines, drugs, and other medicines, to pre- tus, not the date the application is approved

vent or treat infections from biological and as provided under current law; four, Counter-

plications beyond this use. A broad- chemical agents and toxins. The legislation measure Purchase Fund: The legislation pro-

spectrum antibiotic capable of treating proposes incentives that will enable bio- vides that a company that successfully de-

many different biological agents may technology companies to take the initiative, velops a countermeasure, through FDA ap-

well have the capacity to treat natu- for good business reasons, to conduct re- proval, is eligible to sell the product to the

rally occurring diseases. search to develop these countermeasures. Federal Government at a pre-established









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December 4, 2001 CONGRESSIONAL RECORD — SENATE S12385

price and in a pre-determined amount. The Jr. to be Assistant Secretary of the War Crimes Issues, Department of

company is given notice of the terms of the Army for Acquisition, Logistics, and State, Washington, DC.

sale before it commences the research. Sales Technology and, following the open Panel II: George J. Terwilliger III,

to this fund may be made by any company session, to meet in executive session to Partner, White and Case, former Dep-

irrespective of its paid-in capital; five, Intel-

lectual Property Incentives: The legislation

consider certain pending nominations. uty Attorney General, Washington, DC;

provides that a company that successfully

The PRESIDING OFFICER. Without Professor Laurence H. Tribe, Harvard

develops a countermeasure is eligible to objection, it is so ordered. Law School, Cambridge, MA; Major

elect one of two patent incentives. The two COMMITTEE ON ENVIRONMENT AND PUBLIC General Michael J. Nardotti, Jr., Part-

alternatives are as follows: a. The company WORKS ner, Patton Boggs LLP, former Army

is eligible to receive a patent for its inven- Ms. STABENOW. Mr. President, I ask Judge Advocate General, Washington,

tion with a term as long as the term of the unanimous consent that the Com- DC; Professor Cass R. Sunstein, Uni-

patent when it was issued by the Patent and mittee on Environment and Public versity of Chicago Law School, Chi-

Trademark Office, without any erosion due Works be authorized to meet on Tues-

to delays in the FDA approval process. This cago, IL; and Timothy Lynch, Esq., Di-

day, December 4, 2001, at 9:30 a.m. to rector, Project on Criminal Justice,

alternative is available to any company that

conduct a hearing on the remediation Cato Institute, Washington, DC.

successfully develops a countermeasure irre-

spective of its paid-in capital; b. The com-

process of biologically contaminated The PRESIDING OFFICER. Without

pany is eligible to extend the term of any buildings. Specifically, the Committee objection, it is so ordered.

patent owned by the company for two years. is interested in the challenges of, and

COMMITTEE ON THE JUDICIARY

The patent may not be one that is acquired technologies available for, remediating

by the company from a third party. This is buildings contaminated by biological Ms. STABENOW. Mr. President, I ask

included as a capital formation incentive for contaminants. The hearing will be held unanimous consent that the Com-

small biotechnology companies with less in the Rm. SD–406. mittee on the Judiciary be authorized

than $750,000 in paid-in capital. The PRESIDING OFFICER. Without to meet to conduct a hearing on ‘‘De-

Six, Liability Protections: The legislation objection, it is so ordered. partment of Justice Oversight: Pre-

provides for protections against liability for COMMITTEE ON FOREIGN RELATIONS serving Our Freedoms While Defending

the company that successfully develops a Against Terrorism,’’ Tuesday, Decem-

countermeasure. This option is available to Ms. STABENOW. Mr. President, I ask

unanimous consent that the Com- ber 4, 2001, at 2 p.m. in Dirksen Room

any company that successfully develops a

countermeasure irrespective of its paid-in mittee on Foreign Relations be author- 226.

capital; and seven, Strengthening of Bio- ized to meet during the session of the

Witness List

medical Research Infrastructure: Authorizes Senate on Tuesday, December 4, 2001,

appropriations for grants to construct spe- at 2:15 p.m. to hold a nomination hear- Panel I: Viet D. Dinh, Assistant At-

cialized biosafety containment facilities ing. torney General, Office of Legal Policy,

where biological agents can be handled safe- U.S. Department of Justice.

ly without exposing researchers and the pub- Agenda

Panel II: Ali Al-Maqtari, New Haven,

lic to danger. Also reauthorizes a successful Nominees: Adolfo Franco, of Vir- CT; Michael J. Boyle, Esq., Law Offices

NIH-industry partnership challenge grants ginia, to be an Assistant Administrator of Michael J. Boyle, North Haven CT;

to promote joint ventures between NIH and (Latin America and the Caribbean) of

its grantees and for-profit biotechnology, Steven Emerson, The Investigative

the United States Agency for Inter- Project, Washington, DC; Gerald H.

pharmaceutical and medical device indus-

tries with regard to the development of

national Development; Frederick Goldstein, Esq., Goldstein, Goldstein &

countermeasures and research tools. Schieck, of Virginia, to be Deputy Ad- Hilley, San Antonio, TX; Nadine

ministrator of the United States Agen- Strossen, President, American Civil

f

cy for International Development; and Liberties Union, Professor, New York

SUBMITTED RESOLUTIONS Roger Winter, of Maryland, to be an Law School, New York, NY; and Vic-

Assistant Administrator (Democracy, toria Toensing, Esq., DiGenova &

Conflict, and Humanitarian Assistance)

SENATE RESOLUTION 186—TO AU- Toensing, Washington, DC.

of the United States Agency for Inter-

THORIZE REPRESENTATION OF The PRESIDING OFFICER. Without

national Development.

SENATOR LOTT IN THE CASE OF The PRESIDING OFFICER. Without objection, it is so ordered.

LEE V. LOTT objection, it is so ordered. f

Mr. DASCHLE submitted the fol- COMMITTEE ON FOREIGN RELATIONS

PRIVILEGE OF THE FLOOR

lowing resolution; which was consid- Ms. STABENOW. Mr. President, I ask

unanimous consent that the Com- Mr. REID. Mr. President, John Stew-

ered and agreed to:

mittee on Foreign Relations be author- art and Scott Donelly are interns in

S. RES. 186

ized to meet during the session of the the office of the Finance Committee

Whereas, in the case of Lee v. Lott, Case chairman, Senator BAUCUS. I ask unan-

No. 01–CV–792, pending in the United States

Senate on Tuesday, December 4, 2001,

at 4:30 p.m. to hold a nomination hear- imous consent that the privilege of the

District Court for the Southern District of

Mississippi, the plaintiff has named Senator ing. floor be granted to them today during

Trent Lott as the sole defendant; and the pendency of the Railroad Retire-

Agenda

Whereas, pursuant to sections 703(a) and ment Act.

704(a)(1) of the Ethics in Government Act of Nominees: William R. Brownfield, of The PRESIDING OFFICER. Without

1978, 2 U.S.C. §§ 288b(a) and 288c(a)(1), the Texas, to be Ambassador to the Repub- objection, it is so ordered.

Senate may direct its counsel to defend lic of Chile; and Charles S. Shapiro, of

f

Members of the Senate in civil actions relat- Georgia, to be Ambassador to the

ing to their official responsibilities: Now, Bolivarian Republic of Venezuela. UNANIMOUS CONSENT

therefore, be it The PRESIDING OFFICER. Without AGREEMENT—H.R. 10

Resolved, That the Senate Legal Counsel is objection, it is so ordered.

authorized to represent Senator Lott in the Mr. REID. Mr. President, I ask unan-

COMMITTEE ON THE JUDICIARY

case of Lee v. Lott. imous consent that at 9:30 a.m. tomor-

Ms. STABENOW. Mr. President, I ask

f row Senator NICKLES be recognized to

unanimous consent that the Com-

raise a point of order against the pend-

AUTHORITY FOR COMMITTEES TO mittee on the Judiciary be authorized

to meet to conduct a hearing on ‘‘De- ing substitute with Senator BAUCUS

MEET

partment of Justice Oversight: Pre- then immediately to be recognized to

COMMITTEE ON ARMED SERVICES

serving Our Freedoms While Defending make a motion to waive. Further, I ask

Ms. STABENOW. Mr. President, I ask Against Terrorism,’’ Tuesday, Decem- unanimous consent that there then be

unanimous consent that the Com- ber 4, 2001, at 10 a.m. in Dirksen Room 30 minutes equally divided between

mittee on Armed Services be author- 226. Senators BAUCUS and NICKLES or their

ized to meet during the session of the designees. I also ask unanimous con-

Senate on Tuesday, December 4, 2001, Tentative Witness List sent that following the debate time the

at 9:30 a.m., in open session to consider Panel I: The Honorable Pierre-Rich- Senate proceed to a vote on the motion

the nomination of Claude M. Bolton, ard Prosper, Ambassador-at-Large for to waive, and if the motion to waive is







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