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Administration Accomplishments-Issue Briefs [2]
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The Clinton Administration has reached 21 agreements with Japan since 1993,
covering a range of market sectors: autos and auto parts, medical technology, flat
glass, insurance, financial services, telecommunications, supercomputers, construction,
cellular phones, chemicals, rice, paper, apples, wood, and intellectual property rights.
According to the Council of Economic Advisers, U.S. exports in sectors covered by
these market-opening agreements, have grown over 85% since 1993. That's three
times as fast as other U.S. exports to Japan over the past three years. For example:
-
U.S. auto and auto parts exports to Japan increased over 35% since the
agreement went into effect in August 1995, totaling $3.8 billion in 1995. The
Big Three auto manufacturers and Japanese transplant producers sold over
140,000 U.S.-made vehicles in Japan in 1995, up 40% since 1994.
-
U.S. exports of telecommunications equipment to Japan have grown nearly
50% since November 1994 -- almost two times as fast as telecom equipment
exports to the EU. U.S. telecom exports to Japan reached $1.7 billion in 1995.
-
U.S. exports of medical technology to Japan have grown over 35% since
November 1994, reaching nearly $2 billion.
-
U.S. exports of chemicals to Japan have grown nearly 25% since the Uruguay
Round was concluded, reaching $2.8 billion in 1995.
-
U.S. copper exports to Japan are up over 80% since the conclusion of the
Uruguay Round, reaching $350 million in 1995.
-
Just a few years ago, rice exports to Japan were virtually banned. Since a crop
failure in Japan, however, U.S. rice producers have sold $287 million of rice to
Japan -- more than the previous 25 years combined. In 1995, U.S. exports of
rice to Japan reached $31 million.
U.S. manufacturing firms increased their share of the Japanese market over the past
three years -- up 20% in 1995 over 1992.
Overall agricultural exports surged to $56 billion in 1995, up almost 22% over 1994,
with highs in poultry, pork, wheat, and cotton.
Even with the difficult economic situation in Mexico, U.S. exports to Mexico in 1995
were $46 billion. That's 11% higher than 1993 -- the year before NAFTA was
implemented. And 74 cents of every dollar that Mexicans spend on imported goods
go to buy U.S. goods.
Created Over 1 Million High-Wage American Jobs Through an Unprecedented Export
Boom: Implemented a National Export Strategy that has helped create American jobs by
promoting U.S. goods and services abroad, including providing high-level government
advocacy, financing and risk insurance for our American companies. Reduced tariff and non-
tariff barriers to trade in the markets of our largest and fastest growing trading partners.
The United States is the world's largest exporter. Exports have grown 31% since
President Clinton took office. In 1995 alone, exports were up more than 14%.
Exports accounted for one-third of overall U.S. economic growth since the beginning
of the Clinton Administration.
Over one million high-quality, high-wage jobs have been created as a direct result of
increased exports. 11 million American jobs are supported by exports and since 1993,
roughly one out of every ten American workers depends on exports for their jobs.
Export-related jobs pay on average of 13-16% better than other jobs.
One in five manufacturing jobs is supported by U.S. exports. Almost 300,000
manufacturing jobs have been created just in the past three years. Auto jobs have
increased by 89,000 during the Clinton Administration, after declining during the
previous four years.
Put America First by Restoring U.S. Competitiveness: Put the United States' financial
house in order through sound macroeconomic policies such as a smart and tough
deficit reduction plan and reduced government. Promoted education and training
programs to give the American people the tools they need to prosper in the new global
economy. Strengthened our economy by opening up opportunities to sell American
goods and services in foreign markets.
Put America First by Restoring U.S. Competitiveness: Put the United States' financial
house in order through sound macroeconomic policies such as a smart and tough deficit
reduction plan and reduced government. Promoted education and training programs to give
the American people the tools they need to prosper in the new global economy. Strengthened
our economy by opening up opportunities to sell American goods and services in foreign
markets.
The United States has been ranked Number One on competitiveness for two years in a
row -- up from Number Five in 1992.
The United States is the world's Number One producer of automobiles for the first
time since the 1970's -- overtaking Japan.
U.S. aircraft industry dominates the world market -- supplying 65% Asia's imports.
The United States is once again the world's Number One producer of semiconductors,
surpassing Japan.
THE CHALLENGES AHEAD:
President Clinton will continue to open markets around the world and will continue to
promote American exports by:
Aggressively pushing foreign trading partners to further open their markets to
U.S. goods and services.
Ensuring that our trading partners live up to their obligations by strictly
enforcing our trade agreements, using sanctions and other punitive measures
when necessary.
Continuing to place special emphasis on the fast-growing emerging markets
around the world.
Continuing to help small and medium sized enterprises export.
Continuing to give American workers and businesses the tools they need to
compete and win in the new global economy.
Last Update:
May 8, 1996
DRAFT
VETERANS AFFAIRS
"To honor our veterans gratitude and ceremonies are not enough. We must
protect the benefits you have earned, address fully the dangers imposed by
modern warfare, and preserve what you fought for: the American Dream at
home and our leadership around the world."
President Bill Clinton
March 6, 1995
President Clinton has fought to protect the benefits that veterans have earned in service to this
nation and to address the new needs and challenges created by a changing world. The Clinton
Administration has also worked to make the Department of Veterans Affairs more efficient
and responsive, proposing and implementing changes at VA that will improve services and
save money, many of which have long been advocated by veterans. The Administration has
also aggressively responded to veterans of the Persian Gulf War suffering from unexplained
illnesses, to the challenges created as the military downsized after the Cold War and to the
needs of homeless veterans.
A RECORD OF ACCOMPLISHMENT:
Improved and Restructured VA Health Care System: The Clinton Administration
implemented significant management restructuring of VA medical system, creating
integrated service networks and consolidating duplicative medical and administrative
services, to ensure that scarce resources are focused on patient care. To further
expand resources, the Administration proposed "gainsharing" to allow VA medical
facilities to retain a portion of the money VA collects from third parties. These
changes will allow VA to provide 1.6 million more patient visits in 1996 with fewer
resources.
Protecting Veterans Benefits: The Clinton Administration ensured full cost of living
adjustment on benefits going to disabled veterans and military retirees; fought to fully
fund benefit programs; expanded eligibility for disability compensation for Vietnam
veterans exposed to Agent Orange; opposed Congressional proposals to eliminate
compensation for certain mentally incompetent veterans; and proposed increased
funding for national cemetery system to ensure that veterans and their families are
buried with dignity.
Persian Gulf War Veterans' Illness: President Clinton established the Presidential
Advisory Committee on Gulf War Veterans' Illness aimed at finding the causes of
these illnesses and improving the care available to Persian Gulf veterans. As part of
Gulf War illness effort, the Administration expanded funding for research, medical
care and communication at the Department of Defense, Veterans Affairs, and Health
and Human Services.
Firm Commitment to Veterans in Federal Hiring: Despite overall hiring declines
across the federal government in the last three years, the percentage of jobs going to
veterans has increased. The federal government continues to lead the nation in the
percentage of veterans and disabled veterans in its workforce. The proportion of
veterans in the federal workforce increased from 23.6% in 1992 to 33.3% in 1994.
Training and Assistance: The Clinton Administration helped over 1.5 million
veterans into jobs through the Department of Labor's veterans employment service.
Nearly 500,000 separating service members and their spouses received job search
training under the Department's Transition Assistance Program. The veterans'
unemployment rate has been cut by almost a third during the first three years of the
Clinton Administration (7.2% in January 1993 to 4.9% in January 1996).
Faster Benefits Delivery: The Administration improved processing time and reduced
pending caseload for compensation and pension claims at the Veterans Benefits
Administration. The President's FY 97 budget included funding for 50 positions for
the Board of Veterans' Appeals to improve timeliness in processing appeals. In FY
97, the Veterans Benefits Administration will process original compensation claims 33
days faster than in FY 96, and the pending caseload will be reduced from 378,600 at
the end of FY 95 to 277,000 cases at the end of FY 97 -- a 27% reduction.
Targeted, Supportive Assistance to Homeless Veterans: President Clinton fought
for increased funding to assist communities in developing local, coordinated solutions
to break the cycle of homelessness. The Administration more than doubled VA
funding of homeless programs in three years, to the current level of $76 million. As
part of a new Homeless Providers Grant Program, VA awarded more than $11.8
million to 59 public and private nonprofit groups to develop new programs to assist
homeless veterans. The Administration's Interagency Council on the Homeless
established a Homeless Veterans Task Force to improve services and programs for
homeless veterans across agencies.
THE CHALLENGES AHEAD:
President Clinton will continue to fight to protect the benefits veterans have earned and to
help veterans respond to new needs and challenges:
Work for passage of reinventing government initiatives that will improve
services to veterans, simplify complex eligibility rules, and save money through
streamlining.
Continue restructuring of VA's health care system.
Continue to improve veterans' benefits delivery system to give veterans
increased access and more efficient service.
Continue to work with Presidential Advisory Committee to find causes and care
for Persian Gulf Veterans with undiagnosed illnesses.
Continue unprecedented outreach to veterans and veterans service
organizations.
Last Update:
May 8, 1996
SENIORS
"I think we're obligated to balance this budget to take the debt off our
children and our grandchildren, but we're obligated to do it in a way that
represents -- that reflects our responsibility to our parents and our
grandparents...'
"
President Bill Clinton
September 20, 1995
Today, there are thirty-three million older Americans. By 2030, older Americans will
number seventy million--twenty percent of our population. Older Americans are doing
better today--healthier and wealthier--than ever before. As we move into the twentieth
century, President Clinton is fighting to protect and improve those programs which have
successfully provided older Americans a base of health, economic security and
independence for decades, and to prepare for the challenges ahead.
A RECORD OF ACCOMPLISHMENT:
Fighting Drastic Cuts in Medicare and Medicaid: President Clinton is fighting
Republican proposals for Medicare and Medicaid that would shift a staggering
financial burden to elderly and disabled Medicare beneficiaries, reduce Medicaid
nursing home coverage for elderly and disabled Americans, and result in damaging
structural changes in the Medicare program.
Strengthening and improving Medicare and Medicaid: President Clinton enacted
and continues to fight for proposals that strengthen the Medicare Trust Fund: the
President's 1993 Economic Plan extended the life of the Trust Fund by 3 years, and
his balanced budget guarantees the life of the Trust Fund for a decade. President
Clinton is also strengthening the Medicare program by combating fraud and abuse,
enhancing quality, and supporting an expansion of voluntary managed-care options
to increase choices for beneficiaries -- not as a smokescreen for deep and arbitrary
cuts. In addition, he has proposed providing more preventive services and a respite
care benefit for families of victims of Alzheimer's disease under Medicare.
Long-Term Care: The President opposes Republican proposals to reduce Medicaid
long-term care coverage. He has consistently supported expanding state
administered home and community-based care services, tax clarifications and
consumer standards for private long-term care insurance, and penalty-free
withdrawals from IRAs to pay for long-term care.
Social Security: Recognizing that Social Security has successfully provided a
foundation of economic security to older Americans for decades, President Clinton is
committed to ensuring the long-term integrity of the Trust Fund through a bipartisan
solution that keeps the program dependable for all recipients. The President firmly
opposes proposals to use Social Security benefits to balance the budget or pay for
tax cuts for the wealthy.
Promoting and Strengthening Retirement Savings: President Clinton's pension
initiatives are helping more Americans save for retirement and ensuring that pension
benefits are safeguarded for retirement. The Retirement Savings and Security Act
proposed this year by the President would increase pension portability, enhance
pension protection and expand coverage. The Retirement Protection Act signed by
the President in 1994 strengthened pension plan standards and enhanced enforcement
authority so that workers and retirees can count on receiving the pensions they have
earned.
Strengthening Supportive Services and Opportunity: This year, President Clinton
proposed reauthorization of the Older Americans Act that will renew and strengthen
critical Meals on Wheels, transportation, senior community employment and
ombudsman services. The President is also fighting to support and protect the
Corporation for National Service's Senior Service Programs -- Foster Grandparents,
Senior Companions and the Retired Senior Volunteer Program. These programs
give older Americans the opportunity for continued involvement in their
communities and allow the nation to benefit from the rich resource that our elderly
are.
Bringing Seniors to the Table: President Clinton elevated the Commissioner of
Aging to Assistant Secretary status and called for the fourth White House
Conference on Aging, after the 1991 Conference failed to take place.
Making Our Communities Safer: President Clinton broke six years of
Congressional gridlock by signing the toughest and smartest Crime Bill ever with
bipartisan support and endorsements from every major law enforcement
organization. In addition, the President fought for and signed the Brady Bill which
has prevented over 60,000 convicted felons, fugitives, stalkers and other criminals
from buying handguns. These efforts are contributing to safer communities: in
1995, the number of murders fell 8% --one of the largest declines in more than three
decades--and overall crime fall 6% in our nation's largest cities.
THE CHALLENGES AHEAD:
The President will continue to fight for policies that honor our commitments to older
Americans and allow them to remain independent and active participants in our
communities. The President will continue to work to:
Preserve and strengthen Medicare through: assured financial solvency without
substantial new costs on beneficiaries or damaging structural changes;
expanded choices of high-quality health plans and delivery systems; and new
preventive benefits and strong new protections against fraud and abuse.
Improve access to home and community-based care and to protect nursing
home coverage under Medicaid.
Implement private long-term care insurance standards to protect consumers
against substandard policies and unacceptable insurance practices.
Maintain federal quality standards for nursing homes and protections against
impoverishment for spouses of nursing home residents in the Medicaid
program.
Enhance economic security for older Americans through an improved pension
system and a strong long-term financial basis for Social Security.
June 1996
MEDICAID
"I vetoed the Republican budget plan that was sent to me by Congress
because [it
included] the most massive cuts in Medicare and Medicaid in history, a tax increase on
working people, and deep, deep cuts in education and the environment.
My seven year
balanced budget plan reflects our values and protects our investments in the future
At
stake is far more than just numbers and abstract programs and proposals, and far more than
the normal political debates in Washington. This debate is about people, the lives they lead,
the hopes they have, the desires they have for a better life."
President Clinton
Radio Address
December 9, 1995
Overview. For 30 years, Medicaid has provided a guarantee to meaningful health benefits for
millions of people with disabilities, pregnant women, poor children, and older Americans --
particularly those in need of nursing home care. President Clinton is committed to giving
states flexibility to manage the program more efficiently, while retaining the Medicaid
guarantee and refusing to go backwards on health care coverage for Americans.
Accomplishments.
Flexibility and Coverage Expansions. Section 1115 of the Social Security Act
gives the Secretary of Health and Human Services broad discretion to waive
certain Medicaid requirements in order to set up experimental or demonstration
projects. Through this authority, the Clinton Administration has worked with
states to test new and innovative approaches to benefits and services, eligibility
requirements and processes, payment and service delivery. These waivers are
often aimed at saving money to allow states to extend Medicaid coverage to
additional low-income and uninsured people. Since January 1, 1993,
comprehensive health care reform demonstration waivers have been approved for
12 states and ten have already been implemented.
Improving Quality in Managed Care. The Clinton Administration has also
granted 1915(b) "freedom of choice" waivers that permit states to require
beneficiaries to enroll in managed care plans. States often use these waivers to
establish primary care case management programs and other forms of managed
care. As the number of Medicaid beneficiaries enrolled in managed care has
increased, the Clinton Administration has been working closely with states,
insurers, health care professionals and consumers to assure the quality of care
provided in managed care plans. For example, Medicaid HEDIS (Health Plan
Employer Data Information Set), which was released in February 1996, will help
monitor and improve quality in managed care plans and educate Medicaid
beneficiaries about plan performance.
Simplifying and Streamlining Medicaid. As part of its regulatory reform
efforts, the Department of Health and Human Services has simplified the process
of obtaining Medicaid home and community-based waivers and changed
duplicative nursing home regulation while maintaining strong Federal quality
standards.
Cracking Down on Fraud and Abuse. Last year, the President announced a
two-year partnership of Federal and state agencies to prevent and detect health
care fraud in specific industries. Operation Restore Trust targets five states which
together account for about 40 percent of the nation's Medicare and Medicaid
beneficiaries.
Statistical Backup.
Over 650,000 people have received health care coverage under Medicaid because
of implemented state demonstrations. When all 12 are implemented, 2.2 million
previously uninsured individuals are expected to receive health coverage.
Regulatory reform efforts across the Department of Health and Human Services
will result in an almost 25 percent reduction in total pages of Department
regulations.
Agenda.
The President will not accept the Republican budget proposal to end the Medicaid
guarantee to meaningful health benefits for millions of people with disabilities,
pregnant women, poor children and older Americans -- particularly those in need
of nursing home care.
Instead, he has put forward a balanced budget proposal that maintains the
guarantee while giving states unprecedented flexibility to manage the program.
Key elements of the President's Medicaid proposal are:
Maintains guarantee of coverage.
Constrains Federal spending through a per capita cap that protects
states in times of economic downturns, inflation, or other situations
that cause enrollment to grow.
Gives states flexibility by repealing the Boren Amendment (so that
states can determine payment rates without interference) and allowing
states to implement managed care without waivers.
Maintains federal nursing home quality standards and enforcement.
Retains financial protections for families, including protections against
impoverishment for spouses of nursing home residents.
Contact:
Jennifer Klein or Chris Jennings
Last Update:
March 10, 1996
MEDICARE
" (W)e must have a common commitment to preserve the basic protections of Medicare and
Medicaid. In the past three years, we've saved $15 billion just by fighting health care fraud
and abuse. We have all agreed to save much more. We have all agreed to stabilize the
Medicare Trust Fund. But we must not abandon our fundamental obligations to the people
who need Medicare and Medicaid. America cannot become stronger if they become weaker."
President Clinton
State of the Union Address
January 23, 1996
Overview. For over three decades, Medicare has provided basic health care benefits for
millions of elderly and people with disabilities. A recent study has cited Medicare as one of
the reasons why Americans who turn age 80 are more likely to live longer than any other 80-
year-old in the world. President Clinton is committed to strengthening and modernizing
Medicare by incorporating the positive aspects of innovations in the private sector health care
delivery system, while preserving the nation's commitment to this important program. He has
already presided over an unprecedented increase in the number of beneficiaries choosing
managed care options. He has cracked down on fraud and abuse, and has asked Congress to
give him the authority to do more. And finally, he has offered proposals to constrain growth
in program expenditures and extend the life of the Medicare Trust Fund by at least ten years
from now. The President has illustrated how these goals can be achieved while still providing
new preventive care services and an even greater array of plan choices to the over 37 million
beneficiaries the program now serves. But, unlike other proposals, his new plan options
would compete on cost and quality -- not by "cherry-picking" the healthiest and wealthiest.
Accomplishments.
Cracking Down on Fraud and Abuse. Building on the billions of dollars that the
Clinton Administration has saved by tracking down purveyors of Medicare fraud and
abuse in the last three years, the President announced a new two-year partnership of
Federal and state agencies to further prevent and detect fraud in the parts of the
program that are expanding the most rapidly. "Operation Restore Trust" targets five
states that account for 40 percent of the nation's Medicare and Medicaid beneficiaries.
This new initiative is already paying dividends and it is expected that the investment
will yield a multi-fold return in recoveries, fines, penalties, and savings to the
Medicare Trust Fund.
Expanding Plan Choices for Beneficiaries. Through its ongoing efforts to
collaborate with the managed care industry and provide objective information to
beneficiaries about plan choices under Medicare, the Clinton Administration has
presided over unprecedented growth in voluntary enrollment in Medicare managed
care plans. The recently launched demonstration "Medicare Choices" is just one
example of this commitment to provide more managed care options to beneficiaries,
particularly for beneficiaries in previously underserved rural areas.
Improving Quality. As plan choices are increased, the President has been vigilant to
ensure that quality is preserved and enhanced. The establishment of the Medicare
HEDIS (the Health Plan Employer Data Information Set), the Foundation for
Accountability, and the Medicare Managed Care Quality Improvement Project are just
a few examples of the Clinton Administration's commitment to quality. These
initiatives will help ensure that managed care plans use standardized reporting criteria
to help beneficiaries judge these plans' quality and medical outcome performance.
Simplifying and Streamlining Medicare. Historically, the Medicare program
has been over-regulated and micromanaged. In the last year alone, the President has
directed the Department to (1) alter the focus of regulations to measures of outcomes
of care rather than measures of process, (2) eliminate the so-called "physician
attestation" form, which was required to certify the accuracy of all diagnosis and
procedures before any claim could be submitted, and (3) reduce excessive reporting
requirements and streamline inspections for excessively regulated clinical labs.
Statistical Backup.
In the last three years, anti-fraud and abuse efforts have saved almost $15 billion in
Medicare and Medicaid costs. Under Operation Restore Trust, there have already been
30 convictions, 12 indictments, 10 civil judgements and 36 program exclusions. These
actions resulted in $2.2 million in program savings and $34.9 million in fines,
recoveries, settlements and civil money penalties.
As of February 1996, almost 4 million Medicare beneficiaries were enrolled in
managed care plans. Since 1993, there has been a 67 percent increase in enrollment in
these plans. In fact, in 1995, an average of 68,000 beneficiaries a month voluntarily
enrolled in these plans.
Regulatory reform efforts across the Department of Health and Human Services will
result in an almost 25 percent reduction in total pages of Department regulations.
Ending the "physician attestation" requirement alone will eliminate 11 million forms a
year, saving almost 200,000 hours of physician time and decreasing hospital
administrative costs by about $22,500 per hospital a year.
Agenda.
The President has and will continue to reject Republican budget proposals that provide
for excessive cuts in Medicare, unnecessarily increase out-of-pocket costs (directly
through increased premiums and indirectly through the elimination of balanced billing
protections), and that propose untested plans (such as Medicare Medical Savings
Accounts) that would compete by attracting healthy and wealthy beneficiaries, rather
than by providing high quality, cost-effective services.
Instead, the President has submitted a balanced budget proposal that would reduce
program growth and, in so doing, strengthen the Medicare Trust Fund. His plan
provides more plan choices and more preventive care. Key elements include:
--
Achieves $124 billion in savings over seven years through specific and scored
initiatives without any new beneficiary cuts. This would extend the life of the
Medicare Trust Fund by over a decade from now.
Provides for more choices, including new Medicare Preferred Provider
Organizations (PPOs) and new Provider Sponsored Organizations (PSOs).
Provides for an unprecedented preventive care package that would include no
copayments for mammograms, a new colorectal screening benefit, and a new
diabetes maintenance program.
Provides for a downpayment on long-term care through the establishment of a
new respite benefit for families of Medicare beneficiaries who have
Alzheimer's disease.
Strengthens the hands of Federal fraud and abuse prosecutors with more
penalties and other legal remedies, and increases financial incentives for
Medicare to go after abusers of the system because they can reinvest these
savings to help finance additional investigations.
Contact:
Chris Jennings or Jennifer Klein
Last Update:
March 11, 1996
HEALTH CARE REFORM
"
[1]f our working families are going to succeed in the new economy, they must be able
to buy health insurance policies that they do not lose when they change jobs or when
someone in their family gets sick.
We have to do more to make health care available to
every American. And Congress should start by passing the bipartisan bill sponsored by
Senator Kennedy and Senator Kassebaum that would require insurance companies to stop
dropping people when they switch jobs, and stop denying coverage for preexisting
conditions."
President Clinton
State of the Union Address
January 23, 1996
Overview, Since taking office, the President has fought hard for health care reform. While
we could not reach agreement on legislation in 1994, there is little disagreement that the
problems remain.
Nearly forty million Americans have no health insurance.
84 percent of the uninsured in 1993 were in working families, and more than 55
percent of the uninsured lived in families headed by full-time workers.
As many as 4 million people have been affected by "job lock" -- the inability to
change jobs for fear of losing insurance and every year 18 million people change
insurance when someone in their family changes jobs.
Agenda. The President remains firmly committed to guaranteeing health security to all
Americans. The President believes we should take a step-by-step approach.
That is why he included reforms in his balanced budget proposal that would:
Reform the insurance market -- so that people don't lose health insurance when they
lose their job or change jobs or a family member falls ill, and so that small businesses
can afford to buy health insurance for their workers.
Help workers who lose their jobs keep health insurance by making them eligible
for premium subsidies to pay for private insurance coverage for up to six months.
This proposal would provide coverage for 3.8 million Americans each year.
Level the playing field for the self-employed by gradually increasing the self-
employed tax deduction to 50 percent.
Crack down on fraud and abuse by strengthening the fraud and abuse laws so that
we can better prosecute health care fraud in all government programs and private
plans, guaranteeing funding to investigate and prosecute fraud in Medicare and
Medicaid, increasing penalties so that wrongdoers are punished severely, and better
coordinating state and federal anti-fraud activities.
That is why the President has urged Congress to pass the Kassebaum-Kennedy health
reform bill immediately. It is reasonable, bipartisan and has the support of business and
labor. It will stop insurance companies from denying coverage because someone has a so-
called "pre-existing condition." It will ensure that if you lose a job of change jobs you will
not lose your health insurance. The General Accounting Office estimates that will help as
many as 25 million American workers.
Contact:
Jennifer Klein or Chris Jennings
Last Update:
March 11. 1996
58-28-96 18:26
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THE ENVIRONMENT UNDER PRESIDENT CLINTON: AN OVERVIEW
"We must ask more of ourselves, we must expect more of each
other, and we must face our challenges together Our fifih
challenge: to leave our environment safe and clean for the next
generation People do have a right to know that their air and their
water are safe."
President Clinton
State of the Union Address
January 23, 1996
Overview. During the last generation, we have made great progress in protecting the
environment. We now have cleaner, safer air and water. Lead levels in children's blood have
been cut 70 percent, and toxic emissions from factories have been cut in half. We must
continue to move forward. A third of us still breathe air that endangers our heath, and in too
many communities, the water is not safe to drink. President Clinton is committed to stopping
attempts to roll back the progress made to provide safe food and water for our families while
making the common-sense reforms that provide lasting economic opportunities.
Accomplishments.
Community Right to Know. Issued a "Pollution Disclosure" Executive Order to
require industry to disclose information about toxic releases to their neighbors,
countering GOP attempts to allow polluters to keep people in the dark.
Safe Drinking Water. Required drinking water systems to test for and eliminate
dangerous contaminants, while the GOP Congress moved to block funds to help
communities upgrade treatment and keep harmful pollutants out of drinking water.
Reinventing Environmental Regulation. Cutting paperwork by 25% and
allowing businesses to throw out the EPA rulebook and write their own if they
can do it cleaner and cheaper. Issued an executive order to make health, safety
and environmental programs more fair, efficient and effective.
Clean Air. Issued new rule to reduce by 90% the toxic air pollutants released
from chemical plants by 1997.
Clean Water. Vowed to veto the lobbyist-written GOP bill to roll back the
Clean Water Act that keeps billions of pounds of toxic pollutants and sewage out
of our rivers, lakes and streams. Stopped the bill dead in its tracks.
Meat Safety. Issued new standard to prevent E. coli contamination in meat,
fighting off GOP attempts to block the rule and have fought off misguided
"regulatory reform" legislation that would put food safety at risk.
Statistical Backup.
Cut paperwork requirements by 25%.
Eliminating 16,000 pages of unnecessary regulations.
50 million Americans breath cleaner air.
EB-28-96 18:26
FROM:
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PAGE: 04
Agenda. President Clinton will continue to support policies that protect our health and natural
resources while continuing to make common sense reforms to environmental programs by:
Expanding community right-to-know laws and challenging
communities to use the information to work with business to cut
pollution;
Challenging Congress to drop proposals to force taxpayers to pickup
the tab for environmental cleanup. The President strongly believes
the polluters must pay;
Replacing one-size-fits-all regulations with result focused programs;
Challenging American businesses to take more initiative in
protecting the environment;
Challenging Congress to re-examine and reverse those policies that
would endanger our health and safety by weakening health and
safety programs such as safe drinking water and clean air;
Continuing to work with state and community leaders and
businesses to find better ways to protect our natural resources and
provide economic opportunities.
Contact:
Dan Collins, 197 OEOB, 456-5691
Last Update:
February 21, 1996
FEB-28-96 18:26 FROM:
TO: 67028
PAGE 02
To: DPC
ISSUE BRIEF FORMAT
Due 3/11
STAFF
PLEASE gento
JEN KLEIN
TITLE
in WW as
well
Recent quote
RETURN TO JOA
Overview:
Narrative description of the President's general view of
the issue, the context or challenge of the issue, and his
vision.
Accomplishments:
Listing of the Administration's accomplishments on the
issue with full description of the purpose and expected
results of the legislation/initiative/program
Statistical Backup:
Listing of numerical facts and figures showing the impact
and results of the accomplishments.
Agenda:
Narrative description of additional action the
Administration plans to take on the issue.
Contact: Name, location, phone number
Last Update: xx/xx/xx
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SERVICES
MINAN
DEPARTMENT OF HEALTH & HUMAN SERVICES
WEARTH
Office of the Secretary
8
ANTERIATED
Washington, D.C. 20201
March 8, 1996
NOTE TO:
JENNIFER KLINE
CHRIS JENNINGS
Herc's the package on accomplishments. I'm sending the same one
to both of you and letting you decide how to divide it up.
The core piece of the package contains a summary of major HHS
accomplishments in 1995 (minus the section on welfare/child
support). This is the best overview we have on the shelf of
health related accomplishments. It isn't organized exactly the
way either of you outlined, but it is easy to connect the dots
(e.g., major pieces of AIDS and immunization sections would come
under prevention).
I have supplemented the accomplishments summary with additional
materials which either give 2 fuller description of something
highlighted in the summary, relate to something you asked about
specifically, or represent an additional accomplishment I thought
might be of interest.
If you need to reach me over the weekend you can call me at home
(202) 237-8422. I hope this helps.
Islaudia
Claudia Cooley
Attachments
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p.3 deleted sicce it
covers welfare
HHS FACT SHEET
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
January, 1996
Contact: HHS Press Office
(202)-690-6343
1995 -- A Year of Progress
In 1995, the impact of the Clinton Administration
investments in HHS programs came into sharp focus. Guided by
twin goals of a healthier and more independent citizenry, this
department has made progress across the board -- with increased
coverage and choice in the Medicare and Medicaid programs; higher
rates of infant immunizations and lower levels of preventable
disease; more and better treatment options for individuals
living with AIDS; breakthroughs in breast cancer research; more
children enrolled in Head Start programs; increased child support
collections; and more people working rather than collecting
welfare.
Meanwhile, we continued our drive to improve customer
service, tighten management, cut red tape, and eliminate waste,
fraud and abuse in all our programs. We have made further
progress in reducing drug review times; finalized an innovative
system to safeguard seafood safety; and eliminated an entire
layer of management staff, folding the Office of the Assistant
Secretary for Health into the Office of the Secretary.
Through the above innovations and in countless other ways,
the Clinton Administration has been delivering on its mandate: to
help people help themselves in pursuing more healthy and
independent lives.
Donna E. Shalala
Secretary
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A list of HHS accomplishments in five major areas follows:
HEALTH CARE
State demonstrations flourish, increasing coverage and
choice; efforts to eliminate waste, fraud and abuse are
stepped-up.
More Choice, More Coverage: This Administration has enacted
reforms in Medicare and Medicaid that protect the people we serve
while enhancing the quality of care we deliver.
Medicaid: Since President Clinton took office, the Health
Care Financing Administration has enabled 12 states to develop
comprehensive health care reform demonstration projects through
the Medicaid program. Seven of these waiver demonstrations were
approved in 1995 alone. By comparison, there were no statewide
health care reform projects approved between the years 1988 and
1992. Over 657,000 individuals otherwise not covered under
Medicaid have been enrolled in the program under implemented
state demonstrations approved by this Administration. With
increased flexibility at the federal level, Medicaid
beneficiaries are also moving into managed care at a record pace.
In 1995, 11.6 million beneficiaries were in managed care,
representing a one-year increase of 67 percent. More than 32
percent of all Medicaid beneficiaries have now enrolled in
managed care.
Medicare: Because of the Medicare program, elderly Americans
live longer and fuller lives without the threat of medical costs
throwing them into bankruptcy. The Administration has bolstered
this vital protection with an unprecedented menu of medical
choices. As a result of reforms in the past three years, most
Medicare beneficiaries now have the option to enroll in a
managed-care plan. And seniors are embracing the new options.
Since the beginning of 1993, there has been a greater than 66
percent increase in Medicare beneficiaries choosing managed care.
As of December 1995, more than 3.8 million people, or 10 percent
of Medicare beneficiaries, have voluntarily enrolled in managed
care. As we work together to balance the federal budget, we will
continue to protect and improve the Medicare program.
Study of Managed Care: As the public health programs explore
managed care options, the Department continues to ensure that
such care provides essential protections for beneficiaries. Dr.
Philip R. Lee, Assistant Secretary for Health, and Dr. Bruce
Vladeck, Administrator, Health Care Financing Administration, are
co-chairing an "HHS Managed Care Forum" to focus the Department's
extensive efforts at measuring and analyzing the effects of this
important development in health care delivery.
-more-
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Efforts to Combat Fraud and Abuse: In 1995, the
Administration launched "Operation Restore Trust, M a new effort
to combat health care fraud, waste and abuse in the five states
with the highest Medicare and Medicaid expenditures. In
partnership with the Department of Justice and state governments,
HHS is coordinating an interdisciplinary strategy to stem fraud
in California, Florida, New York, Texas and Florida. These
interdisciplinary teams are focusing on three of the fastest
growing areas of health expenditures -- home health care, nursing
home care and durable medical equipment.
These investments in program integrity are paying dividends. In
the last three years, anti-fraud and abuse efforts have saved
almost $15 billion in Medicare and Medicaid costs. An agreement
with the Los Alamos National Laboratories to use our nation's
most powerful computer systems will keep our anti-fraud efforts
on the cutting edge of technology.
Nursing Home Reform: Roughly 68 percent of nursing home
residents rely on Medicaid and they are among the most vulnerable
of Medicaid beneficiaries. On July 1, 1995, HHS implemented the
last major phase of a longstanding bipartisan agreement to assure
quality care in America's nursing homes. A flexible system is
now in place to enforce uniform quality standards while giving
state and federal officials a choice of remedies, depending on
the seriousness of the situation. The enforcement system shows
the standards are working: only 7 to 10 percent of homes surveyed
are expected to be ultimately sanctioned for violations.
Proposal to Reduce Teen Smoking: In 1995, the Clinton
Administration proposed a coordinated plan to reduce smoking
among children and adolescents by 50 percent. It builds on
previous actions taken by Congress and follows recommendations by
the American Medical Association and the Institute of Medicine.
In part, the proposals reduce easy access by children through
requirements for age verification and face-to-face sale and
reduce appeal to children through bans on outdoor advertising
within 1,000 feet of schools and playgrounds.
-
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IMMUNIZATIONS
In 1995, vaccine-preventable diseases in the United
States fell to an all-time low while immunization rates
reached an all-time - high.
childhood Immunization Initiative: In 1995, the United
States reported the highest levels of immunizations among pre-
school children in history. Approximately 75 percent of two-year
old children were fully immunized -- up from 50 percent or lower
in most communities during the 1989-91 measles outbreak. Public
service announcements and national conferences bolstered the
effort.
Measles: As of December 31, 1995, the U.S. recorded just 288
cases of measles in 1995, compared with 963 cases in all of 1994.
Measles can cause pneumonia, brain inflammation, diarrhea and
even death. States have also reported that cases of other
vaccine-preventable diseases were at or near all-time low levels
in 1995.
Flu shots for the Elderly: A flu shot is prevention that
works, and since 1993, the Clinton Administration has covered flu
shots under the Medicare program. In 1994, more than 10.9
million people received a flu shot through Medicare, up from 9.8
million in 1993. According to methodology from a HCFA study, the
additional 1.1 million beneficiaries receiving the shot
translates into roughly 5,000 avoided hospital admissions and $25
million in savings to beneficiaries and the Medicare program.
Chicken-pox vaccine: The Food and Drug Administration
approved the first vaccine to prevent chicken pox in 1995.
Polio: The World Health Organization reports that it is on
track to reach its goal of worldwide eradication of polio by the
year 2000. Worldwide, reported polio cases fell to 7,524 in 1994
from 10,505 in 1993. Polio has been eliminated in North America
and the Western Hemisphere has been declared officially free of
this devastating illness. Upon worldwide eradication, the U.S.
will be able to save $200 million spent annually for polio
vaccine and its administration.
-more-
5
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AIDS
Patients live longer as treatment options increase; new
prevention campaign launched; President hosts White
House conference.
New treatments: When the Clinton Administration took office,
we had only one anti-viral drug for the treatment of HIV/AIDS.
We now have six such drugs licensed by the Food and Drug
Administration -- including the first of a promising new class of
drugs called protease inhibitors. Saquinovir, the first protease
inhibitor approved by the FDA, was given the green light in a
see
record 97 days after the manufacturer submitted the application.
This is the most potent drug yet to stall the spread of HIV, the
3/1/96
virus that causes AIDS. We have also moved rapidly to stem
for
new
transmission of the HIV virus to babies by promoting voluntary
on,
5.
testing and treatment with zidovudine (AZT) among pregnant women
approva
who are infected.
Prevention: In December, HHS launched a new public service
announcement campaign, titled "Respect Yourself, Protect
Yourself." Featuring young adults speaking candidly to young
adults, the campaign has already more than paid for itself in
free television time.
Funding: This Administration has made AIDS programs a top
investment priority. In his three budgets submitted to Congress,
President Clinton has increased total government funding for AIDS
research, prevention and treatment by 37 percent.
Leadership: In December, President Clinton hosted the first
White House Conference on HIV/AIDS. He also named a Presidential
Advisory Council on HIV and AIDS to provide him and his
Administration with expert outside advice on developing effective
responses to the HIV/AIDS epidemic. This council will provide
recommendations to the Office of National AIDS Policy, which
brings a central focus to the federal government's efforts on the
issue.
-more-
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BREAST CANCER
Research funds rise; new breast cancer genes found;
death rates fall: public service announcement campaign
launched.
Federal Breast Cancer Research Funding Increased: Funding
for breast cancer research and programs at NIH totaled $377
million in 1995, up from just $88 million in 1990.
New Breast Cancer Genes Isolated: Building on the
breakthrough discovery in late 1994 of a breast-cancer
susceptibility gene (BRCA 1), researchers in 1995 identified two
additional genes that are associated with increased risk of the
disease. Genetic links were found to be especially prevalent
among Jewish women of eastern European descent. And in early
1996, two studies indicate that the younger women are when they
get breast cancer, the more likely that the cancer is related to
problems with an identified депе. These findings hold promise
for the development of new research and treatment strategies.
Death Rates Fall: The National Cancer Institute reported in
1995 that death rates from breast cancer decreased an average of
5 percent from 1989 to 1992. The decreases were most pronounced
among younger women and caucasians. These data suggest the value
of early detection and treatment, and the need for further
outreach to older women and minorities.
Record Inspections of Mammography Facilities: To ensure the
safety and effectiveness of the mammograms women receive, the
Food and Drug Administration continues its inspection and
certification of all new and existing mammography facilities.
Since October, 1994, FDA has certified 10,200 such facilities in
the United States -- nearly every facility nationwide.
Early Detection Program for Breast and Cervical Cancer: In
partnership with 35 states and 9 tribal organizations, the
Centers for Disease Control and Prevention offer free or low-cost
mammography screening to women in need. Over 700,000 women have
been screened through the program; which will ultimately be
available in all states and U.S. territories.
outreach -- "Mammogram: It's a picture that can save your
life": On Mother's Day, 1995, First Lady Hillary Rodham Clinton,
the Health Care Financing Administration and the Office on
Women's Health began a campaign to educate women over 65 that
mammograms save lives. The campaign continues this year with
public service announcements by Mrs. Clinton and the President,
whose mother died of breast cancer.
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HHS NEWS
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOR IMMEDIATE RELEASE
contact: FDA Press Office
Thursday, Nov. 9, 1995
(301) 443-3285
REINVENTING REGULATION OF DRUGS MADE FROM BIOTECHNOLOGY
The Food and Drug Administration today is proposing several
measures that will reduce costs for manufacturers of biotechnology
derived pharmaceuticals, increase the agency's efficiency and
continue to protect the public health. The six proposals -- which
constitute FDA's most significant overhaul of biotech regulations to
date -- complement and build on the drug and medical device reforms
announced last spring as part of the Clinton Administration's
National Performance Review.
"Biotechnology holds great promise for American patients.
These reforms will help industry deliver on those promises while
maintaining the Food and Drug Administration's critical role in
protecting the American people," said Vice President Gore.
The Vice President also announced the release of a report by
the National Science and Technology Council, "Biotechnology for the
21st Century: New Horizons," which describes the federal investment
in biotechnology and identifies research priorities and
opportunities for the future.
Two of the most far-reaching FDA modifications apply to well-
characterized, therapeutic biotechnology-derived drugs, a product
category that includes most biotech drugs.
The United States biotech drug industry has estimated that the
proposed changes will cut drug development time by months, reduce
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- 2 -
the required paperwork by thousands of pages, and save the companies
millions of dollars. None of the proposed changes will diminish the
safety and effectiveness of the industry's products.
The proposals include the following changes:
Elimination of establishment license application (ELA) for
well-characterized therapeutic biotech drugs.
Impact: Firms developing and manufacturing these products will be
spared the cost of preparing ELAs, some of which may be lengthy and
elaborate. FDA will save review time.
*
Elimination of FDA's lot-by-lot release for well-
characterized therapeutic biologic drugs that are licensed for
marketing.
Impact: Significant savings of time and resources for the industry.
The agency will monitor companies' compliance with the requirement
that they release only lots that have been tested and found to be
acceptable.
# Consolidation of 21 different approval application forms
into a single, user-friendly format.
Impact: Manufacturers should save time and be able to prepare higher
quality submissions. The agency should be able to expedite the
application review and use the standard format as a basis for
electronic submissions.
*
Elimination of the need for approval of promotional labeling
before launching a new product.
Impact: Industry will no longer need to wait for FDA's approval of
promotional labeling before disseminating it, and FDA will save
resources for other activities.
*
FDA commitment to review and respond within 30 days to
information submitted in response to a clinical hold on a study of
an investigational drug or biologic.
Impact: The measure will prevent unnecessary delays of the clinical
trials because the agency's failure to respond within the time limit
will automatically terminate the hold, and the investigation will be
able to proceed.
*
Revision of the manufacturers' requirements to appoint a
"responsible head" for compliance and official contacts with FDA.
Impact: Firms will be able to divide management responsibility
among appropriate regulatory, medical or manufacturing staff. These
individuals will be able to communicate directly with the agency on
official matters related to their company's biological products.
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The U.S. biotech industry comprises about 1,300 mostly small-
to-medium-size companies, which explore new approaches to the
diagnosis, prevention, treatment and cure of life-threatening and
seriously debilitating diseases.
The industry has developed all of the two dozen biotech drugs
on the U.S. market today, and exports about $1 billion worth of
these products each year. More than 450 biotech drugs are being
tested by U.S. biotech companies in humans for diseases for which
there are no satisfactory therapies, such as cancer, AIDS, and
arthritis.
Recognized as the world's leader in its field, the U.S. biotech
industry employs more than 100,000 skilled workers, and last year
invested $8 billion in research and development.
###
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NOTE: we issue
sepect
fluirat.
toonte as not DRAFT
#38
#
certain yet.
P96-
Food and Drug Administration
FOR IMMEDIATE RELEASE
Sharon snider (301) 443-3285
Date
Home (301) 622-0977
FDA TO TEST THIRD PARTY REVIEW OF MEDICAL DEVICE APPLICATIONS
The Food and Drug Administration today announced a pilot
program to use third parties to review marketing applications for
certain medical devices.
The program will test whether using third parties to help
review some of FDA'S 17,000 medical device applications each year
will hasten the review process and get products to patients sooner.
The pilot program is one of the drug and medical device
reforms resulting from the Clinton Administration's National
Performance Review.
"FDA's highest priority is to get safe and effective medical
devices to patients who need them, as quickly as possible," said
FDA Commissioner David A. Kessler, M.D. "The pilot program will
demonstrate whether the process can be speeded up, without
compromising the public health."
Third party review will be used for low and moderate risk
devices for which FDA does not require clinical data on safety and
effectiveness -- products such as electronic thermometers, surgical
gloves and menstrual pads. FDA receives about 1,500 applications
a year for these types of products. Manufacturers are required to
show in premarket notification (510k) applications that products
-more
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DRAFT
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#38
are comparable in safety and effectiveness to a product already
legally marketed.
High risk devices, such as artificial heart valves,
artificial hips, and implanted pacemakers, will not be included in
the third party review program. FDA will continue a full review of
applications for these devices.
Participation in the pilot program is voluntary. Firms can
choose to have their applications reviewed by a third party or
continue to have them reviewed entirely by FDA.
If third party review is chosen, the manufacturer selects an
FDA-recognized third party reviewer and submits its marketing
application to that party for review. when the review is
completed, the third party reviewer submits the application, the
results of its review, and its recommendation to FDA. The
application will bypass the first phase of FDA's normal review
process and instead go directly to an FDA supervisor for a final
assessment. An agency decision will be made within 30 days --
much quicker than the 90 days normally required for review.
Third party reviewers must be impartial, independent and
recognized by FDA as fully qualified to assess the comparability of
the new product to a legally marketed one. Third party reviewers
will be trained by FDA on how to properly review 510(k)
applications and must meet strict conflict-of-interest criteria.
FDA will monitor the pilot program closely and will make any
necessary changes to protect the public health.
Tine The pilot program will begin (date) and run for two years.
FDA will accept applications for recognition as third party
-more-
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reviewers through (date). An information session for prospective
third party reviewers will be held (date) to clarify the criteria
by which third parties will be evaluated.
Details of the pilot program are published in today's Federal
Register.
###
DRAFT
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Drug Approvals- -
Reduction times, in processing
THE FOOD AND DRUG ADMINISTRATION IN 1996
HEETING AND EXCEEDING THE PRESCRIPTION DRUG USER FEE PERFORMANCE
GOALS
According to the General Accounting Office (GAO), the average
approval time for new drug applications (NDA) submitted to the
Agency in 1987 was 33 months. For NDAS submitted in 1992 the
time had been reduced to 19 months. These improved approval
times have been made possible by shortening the time for
completion of most first reviews to only 12 months. How did we
do it? Congress, the Agency, and the pharmaceutical industry
recognized that additional resources were one key to improving
FDA's review of drugs and biologicals, and Congress enacted the
Prescription Drugs User Fee Act of 1992 (PDUFA). The Agency, in
turn, committed to very aggressive performance standards, with
higher hurdles in each succeeding year until full implementation
in fiscal year 1997. These performance standards were negotiated
with and agreed to by the pharmaceutical and biotech industries.
We. already have achieved one of the major 1997 performance goals.
We achieved it in fiscal year 1994 -- a full three years ahead of
schedule. For the drugs submitted to FDA in fiscal year 1994, we
reviewed and acted upon 96 percent of them on time. In most
cases, that meant first action within 12 months.
1
This improved performance has been validated by GAO. At the
request of this Committee, GAO looked at how FDA was performing
even before PDUFA was enacted. GAO found that review and
approval times for new drugs have been reduced dramatically. In
addition GAO found that by 1994, FDA review and approval times
were faster than those in the United Kingdom -- a country many
critics like to cite as a way of doing things better and faster.
If a major amendment is submitted by the manufacturer late
in the process, an additional three months is granted.
2
IV
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HHS NEWS
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
P96-4
Food and Drug Administration
FOR IMMEDIATE RELEASE
Ivy F. Kupec (301) 443-3285
March 1, 1996
Home (703) 516-0440
FDA APPROVES SECOND PROTEASE INHIBITOR TO TREAT HIV
The Food and Drug Administration today approved the second in a
new class of AIDS drugs called protease inhibitors. Ritonavir, the
new drug, received full approval for use alone or in combination
with nucleoside analogue medications, such as AZT, in people with
advanced HIV disease. Ritonavir also received accelerated approval
for less advanced HIV disease. FDA approved the drug about two
months after receiving its application for its marketing.
"Even as we celebrate this milestone, we must recommit
ourselves to President Clinton's goal of finding a cure,' said HHS
Secretary Donna E. Shalala. "We must also face the new challenge of
providing life prolonging medications to all who need them. "
"The review of ritonavir is the fastest approval of any AIDS
drug so far -- 72 days," said Commissioner of Food and Drugs David
A. Kessler, MD. "This drug provides real hope for patients with
AIDS. Patients will live longer."
FDA based its approval for ritonavir on data showing that the
drug not only improves laboratory markers, such as CD4 counts and
viral load, but that it can reduce disease progression and mortality
in people with advanced HIV disease.
Both protease inhibitors and nucleoside analogues chemically
inhibit HIV development, although at different points in the
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Page 2, P96-4, Ritonavir
replication process. FDA approved the first nucleoside analogue,
AZT, in 1987 and the first protease inhibitor, saquinavir, in
December 1995.
In clinical studies, ritonavir was studied alone and in
combination with nucleoside analogues in HIV-infected people in
various stages of disease. Each of these trials monitored changes
in participants' CD4 cell counts, an indication of immune system
strength and viral load, a measure of the amount of virus that can
be detected in the bloodstream.
The largest of the studies also examined mortality rates in
advanced HIV patients. The cumulative mortality rate among
ritonavir participante was approximately 40 percent of that seen in
the placebo-controlled participants, and ritonavir participants also
experienced a 50 percent greater reduction in disease progression
during the six months of the study.
Another study compared patient groups on ritonavir alone,
ritonavir in combination with AZT, and AZT alone. Those in the
groups taking ritonavir experienced a marked increase in their CD4
cell counts and a significant decrease in their viral load.
A third noncomparative study assigned 32 HIV-infected
individuals to receive a triple combination of ritonavir plus AZT
and ddc. Again, the results showed marked increases in CD4
counts and significant decreases in viral load.
For patients with less advanced HIV disease, none of these
studies included clinical endpoints. Accelerated approval for
ritonavir in this patient population requires that longer-term data
be collected.
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Page 3, P96-4, Ritonavir
Accelerated approval is a regulatory mechanism under which FDA
bases early marketing approval for a product on laboratory markers
such as CD4 cell counts until information about clinical endpoints
such as disease progression or mortality is available.
Adverse events associated with ritonavir treatment
included diarrhea, nausea, vomiting, weakness, tingling, liver
inflammation, elevation of lipid levels and taste disturbance. FDA
has worked with the drug manufacturer to assure that potentially
severe drug interactions with ritonavir are clearly highlighted in
the package label and that patient education materials are made
available to patients.
Abbott Laboratories is marketing ritonavir under the trade name
Norvir.
####
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Reduction In CFR Pages - Health
(note: nothing about. to brag
The June reports projected that:
FDA would eliminate 941 CFR pages; as of 2/29/96, the
actual figure eliminated was 163
FDA would reinvent 1170 pages; as of 2/29/96, the
actual total eliminated was 242
The June reports projected that:
HCFA would eliminate 397 CFR pages; as of 2/29/96, the
actual figure eliminated was 37
HCFA would reinvent 525 CFR pages; as of 2/29/96, the
actual figure reinvented was 178
03/08/96
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Operation Restore 1)eust
(Initiative on Health Care Fraud)
Last year, the President announced a two-year partnership of Federal and State
agencies working together to prevent and detect health care fraud in specific
industries. Operation Restore Trust targets five States which together account for
40 percent of the nation's Medicare and Medicaid beneficiaries. The project uses
the shared resources of the U.S. Department of Health and Human Services as well
as State and local resources to address fraud, waste and abuse in three rapidly
growing sectors of the health care industry: home health agencies, nursing
facilities and durable medical equipment suppliers.
The project is now one year old. Already we have accomplished much. New and
innovative projects are underway to identify fraud, waste and abuse, from the use
of new computer technology and data gathering techniques, to personal contact
with beneficiaries during the course of provider audits, to the use of state
surveyors and long term care ombudsmen in the fight against fraud. We have over
250 active investigations of fraud underway. Since the beginning of ORT, in the
areas targeted, we have obtained 30 convictions, 12 indictments, 10 civil
judgements and 36 exclusions. These actions resulted in $2.2 million in program
savings and $34.9 million in fines, recoveries, settlements and civil money
penalties. In addition, we have undertaken scores of audits of providers to
determine if payments were properly made, and have identified millions of dollars
in potential overpayments.
We expect that at the conclusion of this project we will find that our investment in
the detection and pursuit of fraud, waste and abuse is returned many times over in
recoveries, fines, penalties, and savings to the Medicare trust fund.
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HHS NEWS
u.s. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOR IMMEDIATE RELEASE
Contact: HHS Press Office
Wednesday, Sept. 6, 1995
(202) 690-6343
HHS WILL ABOLISH MORE THAN 1,000 PAGES OF UNNECESSARY REGULATION
HHS Secretary Donna E. Shalala will propose the elimination of
more than 1,000 pages of rules under the jurisdiction of the
Department, furthering efforts to reduce the regulatory burden on
HHS' partners and beneficiaries. The Secretary will also propose
the elimination of an additional 700 pages that would take effect
with congressional approval. Taken together, these proposals
represent close to a 25 percent reduction in the total pages of the
Department's published regulations.
As a down payment on these commitments, the Department has
already eliminated more than 300 pages of regulations under the
authority of the Administration for Children and Families. HHS will
also revise an additional 2,200 pages of regulation. All told, more
than half of HHS' 6900 pages in the Code of Federal Regulations will
be targeted for elimination or revision.
"We're putting outdated regulations out-of-print," Secretary
Shalala said. "This is another step in our continuing drive to
eliminate unnecessary regulations while maintaining the critical
public health standards that Americans expect."
These proposals represent another step in the Department's
efforts to institute real and lasting regulatory reform. Taken
together, these ongoing efforts are intended to reduce regulatory
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burden and promote consensus building with HHS' partners. [Fact
sheets on further reinvention efforts are available.]
FDA will propose to eliminate 941 pages of regulation that it
has determined are obsolete or no longer achieve public health goals
(735 pages require congressional approval). In addition, FDA plans
to revise or modify an additional 1,170 pages of regulation to ease
the burden on regulated industries and consumers without sacrificing
public health protection. HCFA will propose to eliminate 397 pages
and revise an additional 525 pages.
In addition to the results of the page-by-page review released
today, Shalala spotlighted additional examples of cooperation and
coordination with the Department's beneficiaries and partners. In
creating a government that works better and costs less, HHS has:
-- Eliminated reporting requirements when unnecessary.
Example: HCFA will no longer require the "attestation
statements" that physicians had to sign before hospitals
could submit claims for payment by Medicare. These
statements will be officially abolished on October I,
1995. Ending this requirement will eliminate 11 million
forms a year, saving almost 200,000 hours of physician
time and decreasing hospital administrative costs by
approximately $22,500 per hospital annually.
-- Promoted smart regulation that can lead to cost savings.
Example: Before a regulation issued in July by the
National Institute for Occupational Safety and Health
(NIOSH), the only respirator that met criteria for the
prevention of tuberculosis cost the purchaser
approximately $8.00. Working closely with the industry,
NIOSH developed a revised regulation that provides better
protection for workers and increased savings for industry.
The first respirators certified under this revised
regulation range in price from about $1 to $3, according
to the manufacturers' data.
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Proposed grassroots partnerships that give states enhanced
flexibility to direct federal money.
Example: As part of HHS' budget request in May, we
proposed a new basis for relationships with the states:
performance partnerships. The Administration has proposed
consolidating more than 100 separate health programs into
6 new partnership grants and 11 consolidated grants.
These will offer states greater flexibility in setting
priorities and managing their programs.
"Taken together, these regulatory reforms improve services to
our customers, strengthen our partnerships with states and local
governments and make better use of the public's dollars," Shalala
said.
###
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HHS FACT SHEET
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOR IMMEDIATE RELEASE
Contact: HHS Press Office
Wednesday, Sept.6, 1995
(202) 690-6343
FDA Press office
(301) 443-1130
REINVENTING DRUG AND MEDICAL DEVICE REGULATION
Introduction
The high standards of the Food and Drug Administration (FDA)
have given Americans access to drugs and medical devices that are
safe and effective. The Clinton Administration is building on
these high standards with efforts to speed up drug and device
approval through regulatory reforms. Some of these reforms will
directly expedite the review process. Others will reduce
unnecessary regulatory burdens on industry. All will maintain and
protect Americans' confidence in the safety and effectiveness of
the drugs they take and the medical devices they use.
FDA has already reformed drug and medical device regulation by:
-- Pre-Approval: Making guidance available to manufacturers of
drugs and biologics (products made from biological materials) that
markedly reduces the number of changes in manufacturing that must
be pre-approved by FDA if the risk is negligible.
Impact: Industry can modernize facilities and processes
more easily; FDA can shift resources to more critical
review needs.
-- Pilot Facilities: Clarifying that manufacturers of biological
drugs may use pilot and small-scale facilities to demonstrate the
safety and effectiveness of their products.
Impact: Manufacturers will have lower start-up costs and can
more quickly begin production of new drugs.
No Reference List: Eliminating the "reference list" and
clarifying that premarket review of medical devices can be affected
only if good manufacturing practice (GMP) violations are related to
a specific device.
Impact: Industry concerns that GMP for one product can
slow down approval for other devices unrelated to those
problems will be alleviated.
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-- Effectiveness Standard: Clarifying the effectiveness standard
for new drugs.
Impact: Industry will have a better understanding of how
to develop new products, reducing the time it takes to
bring a drug to FDA for review.
FDA plans to further reform drug and device regulation by:
-- Permitting greater flexibility in how distributors' names appear
on biological product containers, package labels and labeling.
Impact: Small start-up companies, many of them
biotechnology firms, may more readily enter into
manufacturing arrangements with larger companies and
bring products to market quicker.
-- Eliminating special requirements for manufacturing insulin and
antibiotic drugs.
Impact: Industry will no longer be burdened with outdated
requirements and FDA can regulate these products the same
way it does other drugs.
-- Excluding drug and biologics manufacturers from requirements for
most environmental assessments.
Impact: Industry will be spared the expense of preparing
assessments that FDA has found unnecessary.
-- Developing a pilot program for the review of low to moderate
risk medical devices by outside organizations.
Impact: This program will help determine if such a system
can speed the review of these devices, maintain the
independence of the review process and save money.
-- Speeding the marketing of medical devices by charging industry
user fees to give FDA more resources for product reviews and
committing FDA to strict performance goals.
Impact: A similar program for prescription drugs has
substantially reduced review times.
-- Expanding the opportunities for the export of unapproved drugs
and medical devices to industrialized countries.
Impact: Industry will have wider markets for its products
and will be encouraged to maintain operations in this
country.
In the coming months, the agency will propose further reforms in
the drug and device area in addition to reforms in the areas of
human food products, animal drugs and medicated animal feeds.
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HHS FACT SHEET
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
January 1996
Contact:
HCFA Press Office
(202) 690-6145
STATE MEDICAID DEMONSTRATIONS
Section 1115 of the Social Security Act provides the Secretary of Health and Human
Services broad discretion to waive certain laws pertaining to Medicaid, in order to
conduct experimental, pilot or demonstration projects. This allows states, and the
federal government, to pursue Medicaid projects which test new and innovative ideas
relating to benefits and services, eligibility requirements and processes, program
payment. and service delivery.
These demonstrations are frequently aimed at serving more low-income and uninsured
people while saving money through new program efficiencies.
HHS is fully committed to assisting states in using this waiver authority to test well
designed and creative approaches to health care. Significant strides have been made to
make the waiver review process more efficient and straightforward, and HHS continues
to seek improvement.
0
Since January 1993, HHS has approved 12 comprehensive health care reform
demonstration projects, and the framework of one additional demonstration.
0
In addition, 14 states have received Medicaid waivers since January 1993, as
part of larger welfare reform projects These complementary Medicaid waivers
enable states to continue providing essential health care services while
encouraging independence from welfare
0
Finally, 24 sub-state Medicaid demonstration projects have been approved
affecting smaller components of state Medicaid programs
In the years 1988-1992, no statewide health care reform projects were approved, four
states received welfare-related Medicaid waivers, and 16 sub-state demonstrations were
granted, Demonstrations are monitored by HHS' Health Care Financing
Administration.
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HHS FACT SHEET
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
February 1996
Contact:
HCFA Press Office
(202) 690-6145
MANAGED CARE IN MEDICARE AND MEDICAID
Overview: Since 1993, the number of Medicare and Medicaid beneficiaries
enrolled in managed care plans has experienced unprecedented growth. As a
result, the Health Care Financing Administration (HCFA). which administers
these two programs, is the largest purchaser of managed care in the country,
accounting for 15.5 million Americans. The Clinton Administration has worked
in close partnership with the states to provide maximum flexibility through the
waiver of Federal rules to expand the availability of managed care plans to
Medicaid beneficiaries. The Administration has also worked to expand choices
for Medicare beneficiaries and to ensure that all beneficiaries enrolled in
managed care receive quality care.
As part of his seven-year balanced hudget proposal, President Clinton would
further expand the availability of managed care to Medicare and Medicaid
beneficiaries by increasing the number of Medicare options available and
providing states with additional flexibility to enroll Medicaid beneficiaries in
such plans without requesting a waiver of federal Medicaid rules.
Medicare
As of Feb. 1, 1996, almost 4 million Medicare beneficiaries were enrolled in managed care plans,
accounting for more than 10 percent of the total Medicare population. That represents a 67
percent increase in managed care enrollment since 1993. In 1995. an average of 68,000 Medicare
beneficiaries voluntarily enrolled in risk-bearing HMOs each month. Medicare beneficiaries can
enroll or disenroll in a managed care plan at any time and for any reason with only 30 days notice.
Managed care plans can serve Medicare beneficiaries through three types of contracts: risk, cost,
and health care prepayment plans (HCPPs). All plans receive a monthly payment from the
Medicare program.
Risk plans are paid a per capita premium set at approximately 95 percent of the projected
average expenses for fee-for-service beneficiaries in a given county. Risk plans assume
full financial risk for all care provided to Medicare beneficiaries. Risk plans must provide
all Medicare-covered services, and most plans offer additional services, such as
prescription drugs and eyeglasses.
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With the exception of emergency and out-of-area urgent care, members of risk plans must
receive all of their care through the plan. However, as of January 1, 1996, risk plans can
provide an out-of-network option that, subject to certain conditions, allows beneficiaries
to go to providers who are not part of the plan. Since Jan. 1, 1993, enrollment in risk
plans has grown 105 percent. Currently, 81.6 percent of Medicare beneficiaries in
managed care are in risk plans. As of Feb. 1, 1996, risk plans made up 194 of the 278
managed care plans participating in Medicare.
Cost plans are paid a pre-determined monthly amount per beneficiary based on a total
estimated budget. Adjustments to that payment are made at the end of the year for any
variations from the budget. Cost plans must provide all Medicare-covered services but do
not provide the additional services that some risk plans offer. Beneficiaries can also obtain
Medicare-covered services outside the plan without limitation. When a beneficiary goes
outside the plan, Medicare pays its traditional share of those costs and the beneficiary pays
Medicare's coinsurance and deductibles.
Health Care Prepayment Plans (HCPPs) are paid in a similar manner as cost plans but
only cover part of the Medicare benefit package. HCPPs do not cover Medicare Part A
services (inpatient hospital care, skilled nursing, hospice, and some home health care) but
some do arrange for services and may file Part A claims for their members.
Nationally, 74 percent of beneficiaries have 8 choice of at least one managed care plan while 56
percent of beneficiaries have a choice of two or more plans. Medicare managed care enrollment
varies greatly depending on geographic location. The majority of beneficiaries enrolled in such
plans live in California, Florida. Oregon, New York, Arizona, and Hawaii.
HCFA recently launched "Medicare Choices," a demonstration project designed to allow
beneficiaries to join a greater variety of managed care plans, including provider sponsored
organizations (PSOs) and preferred provider organizations (PPOs). This project will also
experiment with alternative payment methods such as partial capitation, risk adjustment, and
competitive bidding. Another goal of this project is to increase access to Medicare managed care
organizations in rural communities.
Medicaid
The growth in Medicaid managed care enrollment has been even greater than that experienced in
Medicare. Since Jan. 1, 1993, enrollment in Medicaid managed care plans has increased 140
percent, including a 51 percent increase in 1995 alone. As of June 30, 1995, 11.6 million
Medicaid beneficiaries were enrolled in managed care plans, representing 32 percent of total
beneficiaries.
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Currently, 49 states offer some form of managed care. Since 1993, states have utilized federal
Medicaid waivers to increase enrollment in managed care and to develop other innovative changes
to their Medicaid programs. Several states have used the resulting savings from managed care
enrollment to expand the number of individuals covered by Medicaid and/or the number of
services covered under their programs.
The federal government grants two kinds of Medicaid waivers: Section 1915(b) "freedom of
choice" waivers and Section 1115 demonstrations. Freedom of Choice waivers permit states to
require beneficiaries to enroll in managed care plans. To receive such a waiver, states must prove
that these plans have the capacity to serve Medicaid beneficiaries who will be enrolled in the plan.
States often use Freedom of Choice waivers to establish primary care case management programs
and other forms of managed care. In 1995 alone, HCFA approved 58 Freedom of Choice
waivers.
Section 1115 demonstrations allow states to test new approaches to benefits, services, eligibility,
program payments, and service delivery, often on a statewide basis. These approaches are
frequently aimed at saving money to allow states to extend Medicaid coverage to additional low-
income and uninsured people. Since January 1, 1993, comprehensive health care reform
demonstration waivers have been approved for 12 states and eight have already been
implemented. When all 12 are implemented, 2.2 million previously uninsured individuals are
expected to receive health coverage.
Quality
As the number of beneficiaries enrolled in managed care plans has increased, the Clinton
Administration has been working closely with states, insurers, health care professionals, and
consumers to assure the quality of care provided in that setting. Several initiatives are already
underway. For example:
Medicaid Health Plan Employer Data Information Set (HEDIS) was developed in partnership
with the National Committee for Quality Assurance (NCQA) to provide states, managed care
plans, health care professionals, and consumers with the information and tools they need to assure
high quality in managed care plans serving Medicaid beneficiaries. Medicaid HEDIS is an
adaptation of the commercial sector's HMO performance measurement system used by more than
300 private plans.
Medicaid HEDIS will provide states with information on the performance of their Medicaid
managed care contractors, assist managed care plans in quality improvement efforts, support
efforts to inform Medicaid beneficiaries about managed care plan performance, and promote
standardization of managed care plan reporting across the public and private sectors. Medicaid
HEDIS was released to the states in February 1996.
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Medicare HEDIS is a parallel effort in partnership with the Kaiser Family Foundation to establish
a proven performance measurement system that will minimize reporting burdens on managed care
plans serving Medicare beneficiaries. The new measures will help plans to improve the quality of
their care and support efforts to improve the health status of beneficiaries. Medicare HEDIS is
expected to be implemented in the beginning of 1997.
Foundation for Accountability (FAcct) is a collaboration of private and public health care
purchasers (including HCFA) and consumer groups working to develop outcomes measures that
will allow comparison of the quality of care delivered in managed care settings to that provided in
fee-for-service settings. Information will be released later this year.
Quality Assurance Reform Initiative (QARI) is a collaborative effort of HCFA, states, the
managed care industry, consumer advocates and others to design practical and credible
approaches to monitoring and improving the quality of Medicaid managed care services. In July
1993, QARI issued A Health Care Quality Improvement System for Managed Care, providing
states with a broad range of Federally-recommended guidelines for building and operating quality
assurance and improvement systems. These guidelines were tested in three states in 1993-95 by
the Kaiser Family Foundation and the results were issued in 1995 through the National Academy
for State Health Policy's Quality Improvement Primer for Medicaid Managed Care. In 1995,
QARI published Health Care Quality Improvement Studies in Managed Care, in partnership with
the National Center for Quality Assurance (NCQA).
Medicare Managed Care Quality Improvement Project is being conducted in partnership with
the Delmarva Foundation for Medical Care to develop performance measures as part of the
strategy to overhaul external peer review of HMO contractors and promote quality improvement
in Medicare managed care. Preliminary results are expected in Spring 1996.
HHS Interagency Managed Care Forum is chaired by HCFA Administrator Bruce C. Vladeck
and Assistant Secretary for Health Philip R. Lee. M.D., and is made up of representatives from
operating and staff divisions of the Department of Health and Human Service. The forum meets
regularly to share information concerning ongoing managed care activities and to coordinate
managed care policy on cross-cutting issues before the Department. Managed care quality is a
top priority for this group.
# # #
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HHS FACT SHEET
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOR IMMEDIATE RELEASE
Contact: HHS Press Office
Wednesday, Sept. 6, 1995
(202) 690-6343
HCFA Press Office
(301) 690-6145
REINVENTING HEALTH CARE REGULATION
Introduction
The Health Care Financing Administration (HCFA) serves
nearly 37 million Medicare beneficiaries and, in partnership with
state governments, another 36 million Medicaid beneficiaries.
HCFA ensures program beneficiaries are aware of the services for
which they are eligible and that those services are accessible,
meet quality standards and are delivered in an efficient manner.
HCFA also ensures that health care providers meet approved
standards and program funds are used effectively.
Regulatory Reform Initiatives
The following are the major HCFA initiatives and proposals
in the regulatory reform process. Some result directly from
collaborative efforts and public consultation with industry
groups, beneficiary organizations, state associations and state
agencies. All proposals cut red tape and demonstrate HCFA's
customer-focus and responsiveness to the changing needs of its
customers and partners.
1. Physician Attestation: HCFA is eliminating the physician
form required to certify the accuracy of all diagnosis and
procedures before submission for payment by Medicare. These
statements will be officially abolished on October 1, 1995.
Ending this requirement eliminates 11 million forms a year,
saving almost 200,000 hours of physician time and decreasing
hospital administrative costs by approximately $22,500 per
hospital annually.
2. Physician Acknowledgment: HCFA has replaced the requirement
for physicians to provide hospitals annually with a signed
acknowledgment concerning penalties for misrepresenting certain
information with a one-time signing requirement at the time a
physician is initially granted hospital admitting privileges.
One major medical association said this change will alleviate the
"hassle factor" for physicians and marks an important step toward
restoring mutual trust between the federal government and the
medical industry.
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3. Medicaid Home and Community-Based Services Waivers: HCFA has
simplified the process of obtaining Medicaid home and community-
based waivers. States now may offer a wide variety of home and
community-based services as cost-effective alternatives to more
expensive institutional care. Without this regulatory change,
joint state and federal efforts to expand cost-effective options
would have been frustrated.
4. Modify Annual Resident Review Requirements: Currently, states
must perform annual assessments of Medicaid nursing home
residents with mental illness or mental retardation. This
duplicates the requirement for Medicare- and Medicaid-certified
nursing homes to assess their residents promptly after admission,
after a significant change in condition, and no less often than
annually. Under a legislative proposal, the duplicative
requirement for annual state reviews would be eliminated,
reducing costly duplication and improving health care outcomes
for residents. The assessments conducted by the nursing homes
ensure that residents' continuing needs are properly evaluated
and met.
5. Clinical Laboratory Improvement Amendments: Improve the CLIA
system and reduce regulatory burden by rewarding good laboratory
performance. This will help create incentives for manufacturers
to develop more reliable testing equipment; allow private
organizations under certain criteria to accredit laboratories;
and use proficiency testing as an outcome measure to monitor
laboratory performance. A flexible, targeted survey system to
reduce information requirements and streamlined inspection
process has been initiated.
6. Outcome Performance Measures: Change focus of regulations to
measures of outcomes of care rather than measures of process
requirements. Changes will eliminate unnecessary process
requirements and instead develop outcome-based performance
standards: collect and analyze patient care data needed for
continuous quality improvement; increase consistency of
requirements across providers; and ask the customer to provide
input on what the outcome measures should be.
Changes involve:
Home Health Agency Conditions of Participation
Medicare Hospital Conditions of Participation
ESRD Facility Conditions of Coverage
##
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NIH Science Advances
Prepared for the FY97 OMB Request
September 1995
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The Beacfits of Biomedical Research
The NIH record of performance and the number of truly outstanding scientific opportunities
provides assurance that current and future investment in NIH biomedical and behavioral science
will result in sustain progress in our fight against human disease and disability. In FY 1995,
NIH-Supported researchers realized a number of significant scientific advances. This work can be
divided along three fronts: laboratory research, clinical research, and applied research. A few
examples follow.
Laboratory Research Advances
Scientists have for the first time identified genes involved in hereditary predisposition to
breast cancer. This is a critical step in beginning to understand the biochemical events
that can lead to cancer. Ultimately, this may lead to improved diagnostic tools, drug -
therapies, and preventive measures. The discovery and isolation of breast cancer
susceptibility genes bring US significantly closer to understanding the origins of this
devastating disease. This will also allow scientists to begin to study the effects of
environmental agents that may contribute to many cases of breast cancer. As important,
tests may be developed to identify women who are at increased risk for the disease.
Researchers have also Identified key pieces in the puzzle of melanoms, the most serious
form of skin cancer. Investigators found that about 10 percent of all melenoma cases
arise from inherited mutations in a gene that normally suppresses turnor growth This
finding is an important milestone in identifying persons who are especially prone to this
fast-spreading and often deadly cancer. and in developing vital treatment and preventive
measures.
Investigators have made a key discovery about the role of a protein associated with von
Hippel-Lindau (VHL) disease. This inherited cancer syndrome is characterized by the
development of multiple tumors, including kidney cancer. kidney cysts and non-
malignant tumors in the adrenal glands. Although VHL disease is rare. a non-inherited
form of kidney cancer is much more common Mutations in a tumor suppressor gent
associated with VHL have been identified in families with the disease as well as in
about 90 percent of parients with non-inherited kidney cancer. These findings could
lead to methods for identifying family members at risk for developing tumors
associated with VHL, and to new ways to prevent and treat cancer.
A mouse model for obesity was instrumental in the recent identification and isolation of
a hormone (leptin) that significantly reduced body weight in obeso micc. This intriguing
finding hold promise for new insights into human obesity.
Researchers found that mice with mutations in specific genes involved in the immune
response develop a disease that resembles human inflammatory bowel disease, This
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debilitating disorder that affects 500,000 Americans and is characterized by extreme
intestinal inflammatory reactions that cause chronic tissue injury and destruction.
Scientists succeeded in producing mice that contain a defective human gene known to be
involved in a hereditary form of Low Gehrig's disease (ALS, or amyotrophic lateral
selerosis). The mice develop symptoms similar to those experienced by humans afflicted
with ALS, including limb weakness, impaired gait, limb tremor, paralysis and ultimately,
die.
Lupus erythematosus is a chronic and potentially faral disease that occurs primarily in
women of child bearing age. I1 affects many systems of the body, including the joints
and the kidneys. Investigators discovered that a strain of mice which develop a lupus-like
illness have a defective gene for controlling the process of programmed cell death. When
they replaced the defective gene with a normal one, the mice no longer developed signs
of lupus.
Using an animal model of esteoarthritis, researchers determined that prophylactic oral
administration of the commonly used antibiotic daxycycline reduced the severity of
cartilage damage typical of this disease.
Investigators have created a mouse model for studying a type of lymphoma that arises in
persons with AIDS. The model was used to gauge the potential effectiveness of
immunotherapy with interleukin-2, a natural substance produced ty specialized immune
system cells. This approach is now being tested as an innovative strategy in human
AIDS-related lymphomas.
Researchers are exploring the dynamics of HIV-1 production and destruction in infected
individuals. They are using as'a tool 2 class of drugs that inhibit crucial enzymes
involved in HIV-1 replication These critical studies will be vital for developing
innovative strategies for long-term control of HIV-1 replication.
Recent findings about Kaposi's sarcoms (KS), & normally rare cancer that affects a
significant number of HIV-infected persons, may lead to novel approaches for treatment
and prevention. Scientists analyzing AIDS-KS tumor tissue detected unusual stretches of
DNA in more than 90 percent of the tumors. The DNA was very similar to that of two
known herpesviruses which are associated with lymphomas in primates and humans.
This finding and subsequent epidemiologic studies provide strong support for the idea
that infection with a new herpesvirus plays 8 role in the development of KS. The same
stretches of DNA were also detected in AIDS-related lymphomas of the body cavity.
These findings raise the possibility that AIDS-related malignancies may be prevented or
treated with antiviral drugs.
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Clinical Research Advances
Scientists are gaining key insights into the control of HIV-1 by studying a unique subset
of HIV+ individuals who have survived for more than 10 years with no evidence of
disease. Understanding the mechanisms by which these infected individuals continue to
survive with intact immune systems may lead to novel approaches to the treatment of
HIV+ men and women who experience the normal rapid progression of disease.
A number of recent advances have enhanced our understanding of factors which
predispose individuals to develop cardiovascular, pulmonary and blood diseases across
the life span. For example, results from 8 recent study will help postmenopausal women
and their physicians assess the risks and benefits of hormonal regimens to improve heart
disease risk factors. Researchers found that with the four hormonal regimens
tested-including estrogen and combinations of estrogen and progesterone-post-
menopausal women safely and significantly increased their levels of HDL cholesterol,
which protects against coronary heart disease. In addition, the hormonal regimens
decreased LDL ("bad") cholesterol and fibrinogen (a blood clotting factor predictive of
stroke and heart attack).
For the first time a medication which effectively reduces craving for alcohol has been
identified. Clinical trials of naltrexone-s chemical that neutralizes or impedes the effects
of opiates-showed it to be very effective in reducing both alcohol craving and
consumption. If it is approved by the FDA, naltrexone will be the first medication for the
treatment of alcoholism since antabuse.
Sickle cell disease (SCD) is a painful. debilitating, inherited disorder that primarily
affects blacks, including an estimated 72,000 Americans. Researchers have shown that
treatment with a chemical known as hydroxyured effectively relieves the severe pain of
sickle cell crises, reduces the number of recurring episodes and their associated
complications, and significantly lessens the need for transfusions and hospitalizations.
This important discovery was based on extensive laboratory research on the expression
and regulation of the genes for hemoglobin. the oxygen-carrying molecule in red blood
cells Scientists learned that at birth, the body "switches" from producing fetal
hemoglobin to an adult form. They also determined that adult hemoglobin. but not the
fetal form, is defective in SCD. Researchers studied the biochemical differences between
fetal and adult hemoglobin and focused on ways to switch back on the production of fetal
hemoglobin They discovered an agent that increased fetal hemogiobin levels, but was
toxic in humans. After learning how that chemical worked in cells, they found that
hydroxyurea acted in the same way and was not overly toxic in humans.
Retinitis pigmentosm (RP) is a group of inherited diseases that affects the sight of
100,000 Americans and 1.5 million people worldwide. In RP, cells in the retina
progressively degenerare, resulting in night blindness, loss of peripheral vision. tunnel
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HHS FACT SHEET
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Feb. 9, 1996
Contact: HHS Press Office
(202) -690-6343
Dennis Siebert -- HCFA
(202) -690-5727
REVITALIZING THE NIH CLINICAL CENTER
Overview: In an effort to reduce the costs and improve
the efficiency of government programs, the Vice
President's Reinventing Government II initiative
designated the NIH Clinical Center as an organization
to be critically reviewed and reengineered to improve
its effectiveness and efficiency. An NIH Clinical
Center "Options Team" was created by HHS Secretary
Donna E. Shalala to perform that review, under the
leadership of Helen L. Smits, M.D., Deputy
Administrator of the Health Care Financing
Administration. A report has been presented to the
Secretary, summarizing findings, conclusions and
recommendations.
Background
The Warren Grant Magnuson Clinical Center is the core
clinical research facility at the National Institutes of Health
(NIH) and is the largest center of its kind in the world. A
recent study of NIH described the Clinical Center as "a unique
and invaluable resource for the direct clinical application of
new knowledge derived from basic research." The Clinical Center
provides protocol-specific patient care in support of the
intramural research programs sponsored by most NIH Institutes.
The Clinical Center also serves as a resource for training
clinical investigators.
Clinical Center patients are drawn from a nationwide patient
referral base to participate as research volunteers in NIH-
sponsored protocols. In Fiscal Year 1994, 72,200 inpatient-days
and 73,400 outpatient visits occurred at the Clinical Center.
This represents approximately 50 percent of the research days and
27 percent of the research outpatient visits supported by NIH
throughout the United States. The Clinical Center supports a
portfolio of approximately 1,000 active protocols. The research
mix at the Clinical Center emphasizes Phase I and Phase II
clinical trials and the study of the pathogenesis and natural
history of disease. on occasion, investigators from outside NIH
also use the Clinical Center.
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Issues
The Clinical Center is at a critical point in its history.
The translation of bench research to clinical practice in areas
such as genetic and immunologic therapy will accelerate in the
next decade, placing new demands on the Clinical Center. At the
same time, changes in the delivery of health care have already
decreased the traditional flow of referrals from physicians to
the Center, and patient loads for inpatient and outpatient care
have declined in recent years. Patients are less willing to
accept long hospital stays and to return to the Center for
follow-up procedures. The Clinical Center needs new
relationships with outside physicians, insurers and patients to
facilitate recruitment. New approaches, such as the use of
telemedicine to broaden access of patients to protocols, are
critical to maintaining the viability of the Center.
At present, the Clinical Center lacks a clear structure of
governance to implement necessary changes. Responsibility for
the Center is in the hands of a series of NIH committees and this
structure restricts formal access to the experience of external
experts in hospital and research management.
The Center's budget is also unstable and unwieldy. Funding
must be first appropriated to individual Institutes and then
transferred from an Institute to the Clinical Center. As
currently configured, the procurement and personnel systems
provide no incentives for increased efficiency and do not
encourage increased use of the Center to lower unit costs.
Finally, the physical structure of the Clinical Center needs
improvement. Built in the 1950s, the physical plant is not well
suited to sustain modern practice in either patient care or
research because of deteriorating infrastructure, including air
heating systems and other utilities.
The Options Team
The internal NIH Options Team evaluated Clinical Center
functions in the broadest sense possible, exploring everything
from the Center's structure and strategic direction to the
details of day-to-day management, information systems, and
benchmarking.
Subcommittees of the Options Team visited a variety of
government, academic and private-sector organizations. In
interviews with staff, they learned how other institutions have
dealt with the problems the Clinical Center now faces.
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- 3 -
Outside advisors met with the Options Team in a two-day
retreat held in Annapolis, Maryland, during October 1995. These
same advisors had served as hosts to various team members during
visits to their institutions. The recommendations in the report
reflect information gathered from visits to many institutions and
input from these outside advisors or consultants.
Major Recommendations
The recommendations that follow propose that the Clinical
Center undergo significant change to improve efficiency and to
ensure that the Center flourishes into the next decade. To
remain the national core of clinical research in this information
age, the Clinical Center must change the way it is governed,
funded, and managed.
The Options Team and the external consultants agree that the
following recommendations are the most important for the Clinical
Center to address now:
0
A Board of Governors should be created to oversee the
Clinical Center. The Board's responsibilities should
include annual budgeting and strategic planning as well as
oversight of operations. The majority of this Board and the
chair should be individuals from outside government; the
remainder of the Board should be representatives of NIH
Institutes. Appointments should be made by the Director of
NIH upon the recommendation of Institute directors and the
Director of the Clinical Center.
0
The Clinical Center should have a clearly defined budget of
its own, and this budget should be as stable as the NIH
budget as a whole.
O
The Clinical Center should have a means of retaining
reserves from year to year. The Center should also be
permitted to accept monies from insurance companies for some
services and to solicit donations. The new budgeting
process should include methods to (1) ensure that all
Institutes have continued access to a baseline level of
activity at the Center; (2) permit Institutes that improve
the efficiency of their protocols to increase their overall
activity; and (3) permit outside investigators to use the
Clinical Center.
O
As one of its first official actions, the new governing
Board of the Clinical Center should direct development of a
strategic plan for operations with clear and measurable
objectives. The plan should serve as the keystone by which
managers can allocate and distribute resources. Clinical
Center management should immediately begin to develop the
background information upon which such a plan can be based.
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The Options Team and external consultants recommend that the
Clinical Center be designated a "Reinvention Laboratory," a
Federal demonstration site with reduced regulation, enhanced
local autonomy, and improved federal personnel and
procurement practices. The Options Team did evaluate
several other structural approaches that were not ultimately
right for the Center. These include continuing to operate
the Center as a standard Federal organization; converting it
to one of many federally-sponsored organizational
arrangements; and managing the Center by contract.
The Options Team also recommends that the Center do the
following:
0
Actively seek funding for a new clinical research center
facility that will be more efficient to run and maintain and
that will permit more efficient use of staff.
0
Explore increased contracting out of individual Clinical
Center functions.
O
Invest in integrated information systems that provide real-
time information for managers about costs and human
resources.
0
Adopt an ongoing program of benchmarking, integrated with
the strategic plan adopted by the new Board of Governors.
O
Establish new methods for recruiting patients to protocols.
The body of the report contains additional recommendations,
background information, justification, and methods for
implementation.
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This document was a
copperative effort between
HTTS are the White House
office of AIDS Polley
ilone 14. the face of 1995.
The Clinton Administration and HIV/AIDS
In 1992, when he ran for President of the United States, Bill Clinton said he would
"provide the leadership this country needs for a loud, clear, and consistent war on AIDS." In
his first three years in office, the President has translated that pledge into action, turning around
more than a decade of governmental policies that were regarded as at best apathetic and at worst
hostile to those living with HIV/AIDS. Following are the highlights of the Administration's
HIV/AIDS-related actions taken since January 20, 1993.
AIDS Advisory Council. The President has created a 30-member Presidential Advisory Council
on HIV and AIDS to provide him and his Administration with expert outside advice on the ways
in which the Federal government should respond to the HIV/AIDS epidemic. Specifically, the
Council is charged with making recommendations in the areas of AIDS-related research,
prevention, and care.
AIDS Funding. The President has placed AIDS programs among his investment priorities. In
the three budgets he has submitted to the Congress, the President has increased total government
funding for AIDS research, prevention, and care by 40%, including a 108% increase for the
Ryan White CARE Act programs.
Anti-Discrimnination. The Justice Department and the Equal Employment Opportunity
Commission have vigorously enforced provisions of the Americans with Disabilities Act that
prohibit discrimination against people with HIV/AIDS. The EBOC has received more than 900
charges alleging employment discrimination against people with HIV and AIDS and has resolved
789 charges, obtaining monetary benefits of over $6.1 million. The Health Care Financing
Administration (HCFA) has taken action on nearly 20 complaints of denial of care by health care
facilities or providers to persons with HIV/AIDS and new efforts are being made to address
discrimination in nursing homes.
Blood Safety. The Food and Drug Administration (FDA) held ground-breaking public meetings
on the use of new technologies to reduce the risk of HIV transmission by blood product
transfusion. The Administration has received the Institute of Medicine report examining the
issues surrounding transmission of HIV throughout the blood supply before 1987. The
Department of Health and Human Services has named the Assistant Secretary for Health to be
the Department's blood safety director, with overall responsibility for ensuring the IOM's
recommendations are carried out and the coordination and oversight of the Public Health
Service's blood safety programs.
Consumer Protection. The FDA is working with community organizations to prevent
fraudulent activities aimed at people living with HIV disease. To date, 10 FDA-funded
coalitions throughout the country including representatives from the community, health
professionals, and law enforcement agencies - have been established to educate and protect
people with HIV and AIDS from fraudulent products.
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Data Gathering. The Department of Health and Human Services (HHS) is supporting three
major efforts directed at gathering and analyzing services provided to persons with HIV disease.
The "AIDS Cost and Services Utilization Survey," the "HIV Cost and Services Utilization
Survey," and the "Hospital Cost and Utilization Project," will provide an important data base
on the cost of AIDS care and the use of health care services by people living with HIV.
Dental Care. The AIDS dental reimbursement program was expanded to address the lack of
dental care available to low-income and under-insured individuals living with HIV/AIDS. The
program, which reimburses accredited dental schools and post-doctoral dental training programs
for uncompensated costs incurred in providing oral health care to HIV-positive Individuals,
includes 124 institutions in 35 states.
Disability Eligibility. The Social Security Administration published revised regulations
expanding the list of health manifestations that will be considered in determining eligibility due
to HIV/AIDS for Social Security and Supplemental Security Income disability benefits. The
agency also revised its rules to allow physicians and other health professionals to provide
information to Social Security field offices, which then can make immediate disability findings.
Drug Approval The FDA has approved or provided new labelling indications for fifteen new
products to treat HIV or HIV-related conditions while dramatically reducing the time it takes for
drug review and approval.
Drug Development. HHS created the National Task Force on AIDS Drug Development, an
historic partnership between government, industry, academia, medicine, and AIDS-affected
community organizations to identify and eliminate barriers to the rapid development of drugs for
HIV and HIV-related conditions. The Task Force has issued 45 specific recommendations,
many of which are currently being implemented.
Early Intervention. The Agency for Health Care Policy and Research issued clinical practice
guidelines for health care professionals to assist in the evaluation and management of early HIV
infection. The guidelines stress the importance of prevention of HIV-related opportunistic
infections and the link between prevention and early diagnosis and care. A quick reference
guide for physicians and consumer guides for adults, adolescents, and the parents of children
with HIV infection was also made available. The U.S. Public Health Service provided support
for a new campaign by the National Minority AIDS Council to promote the use of prophylactic
treatment to prevent the occurrence of pneumocystis carinii pneumonia in people with HIV.
Health Benefits. Federal medical assistance programs serve nearly 50% of people living with
AIDS and more than 90% of children with AIDS. Medicaid is the largest single payer of direct
medical services, paying an estimated 25% of the aggregate cost of AIDS-related care. Under
Title II of the Ryan White CARE Act, 18 states operate health insurance continuation programs
that allow low-income people with HIV to continue their private health insurance.
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Home Care. A total of 15 Medicaid State waivers are in place, allowing States to provide
targeted home and community-based services to people with HIV/AIDS. In 1995, those
programs will serve an estimated 21,170 individuals. HHS also is developing prototype waivers
to help other States gain quick approval of future waiver applications.
Housing. In the last two years, the Department of Housing and Urban Development's (HUD)
Housing Opportunities for People with AIDS (HOPWA) program has provided $300 million to
communities with a high incidence of HIV infection to provide housing assistance to people
living with HIV/AIDS. HUD also has established the National Office of HIV/AIDS Housing
to assist low-income people with HIV/AIDS to pay for housing. President Clinton cited the
proposal to cut $30 million from HOPWA as one of the reasons for his veto of the fiscal year
1995 rescissions bill.
International Cooperation. The U.S. is actively cultivating international cooperation in
HIV/AIDS prevention and care through participation in the United Nations' new Joint
Programme on HIV/AIDS. Representatives of the U.S. participated in the Tenth International
HIV/AIDS Conference in Yokohama, Japan, and the World AIDS Summit in Paris and is
participating in regional conferences for Latin America and the Caribbean, Asia, and Africa,
The U.S. Agency for International Development sponsored the Third HIV/AIDS Prevention
Conference in Washington DC, which allowed for an exchange of information among diverse
prevention and care groups from around the world and resulted in an agenda of effective
prevention measures to be pursued worldwide. Through USAID, the U.S. is the largest bilateral
donor in international assistance for prevention HIV/AIDS transmission, providing more than
$120 million annually.
Mental Health. HHS awarded the first Federal grants to develop mental health services for
persons living with HIV/AIDS and their families and partners. Approximately 260,000 mental
health counseling sessions for people with HIV were reported during the last six months of 1994.
Approximately 100,000 individuals with HIV also received mental health services under the
Ryan White CARE Act.
Minority Communities. The Public Health Service convened the National Congress on the
State of HIV in Racial and Ethnic Communities, bringing together individuals and organizations
to develop plans to alter the course of HIV in those communities. The National Institutes of
Health (NIH) added four new sites to its AIDS Clinical Trials Group at institutions that serve
predominantly minority populations.
Perinatal Transmission. An NIH-sponsored clinical trial (ACTG 076) provided strong evidence
that use of AZT by HIV-positive pregnant women dramatically reduced the rate of HIV
transmission from mother to infant. The FDA expeditiously approved changes in labelling
indications for AZT to include treatment of HIV-infected pregnant women. The U.S. Public
Health Service issued guidelines in August 1994 on using AZT during pregnancy to reduce the
risk of perinatal HIV transmission. In July 1995, CDC published PHS recommendations for
routine HIV counseling and voluntary HIV testing for all pregnant women in the U.S.
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Widespread implementation of those recommendations will enable women to seek and receive
the care they need for themselves and to reduce the risk of transmitting HIV to their infants by
as much as two-thirds.
Policy Coordination. To provide a central focus for governmental efforts against HIV/AIDS,
the President created the Office of National AIDS Policy within the White House, to advise him
on AIDS policy issues and coordinate interdepartmental activities. An Interdepartmental Task
Force on HIV/AIDS, chaired by National AIDS Policy Director Patricia Fleming, was created
to assist in that effort.
Prevention. CDC has initiated a comprehensive community planning process for HIV
prevention programs, placing control of such programs in the hands of local community
organizations rather than having them dictated by the Federal government. CDC also Initiated
an unprecedented review of government-funded HIV/AIDS prevention activities conducted by
panels of individuals from outside of the government. In January 1994, the Centers for Disease
Control and Prevention (CDC) launched the Prevention Marketing Initiative aimed at young
adults (ages 18-25) to change behaviors that contribute to the transmission of HIV. The
initiative features production of frank, forward-thinking public service announcements promoting
both abstinence and the consistent and correct use of latex condoms.
Research Organization. The President signed the National Institutes of Health Revitalization
Act of 1993, placing full responsibility for planning, budgeting, and evaluation of the AIDS
research program at NIH in the Office of AIDS Research. Dr. William Paul, an internationally
acclaimed immunologist, was appointed to head that office and has developed the first
contiprehensive plan and budget for AIDS research.
Ryan White CARE Act. In the three budgets be has sent to Congress, the President has
increased funding for the Ryan White CARE Act by 108%, fulfilling the President's promise
to fully fund that program. During the last two years, the number of metropolitan areas eligible
for assistance under Title I of the Ryan White CARE Act has increased from 25 to 49.
Preliminary data Indicate that approximately 360,000 clients were served under Title I of the
Act. Eighty percent of U.S. metropolitan areas report providing new or expanded Ryan White
services to people living with HIV, including HIV/AIDS drug assistance; services for women,
children, and other special needs populations; and expanded rural services. All 54 states and
territories are currently funded under Ryan White Title II, serving an estimated 296,000 clients
with those funds. Title Ш(b), which pays for counseling, testing, and early intervention
services, including treatment, served more than 175,000 clients, including a large number of
women and minorities. Currently, 144 community-based organizations, located in 33 states, the
District of Columbia, and Puerto Rico, are supported with Title III(b) funds. Title IV develops
comprehensive coordinated care systems linked to clinical research in more than 80
communities, meeting the unique needs of children, youth, women, and families.
Reauthorization of the Ryan White CARE Act is a top priority for the Administration in 1995.
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Treatment. The NIH Preclinical AIDS Drug Screening Program has screened 72,000 potential
agents for treatment of HIV disease and approved six compounds for Phase I clinical trials NIH
clinical trials involve more than 45,000 HIV-infected individuals. Several promising HIV
protease inhibitors and potent combination drug regimens are slated to begin Phase III efficacy
trials in the near future. Thousands of other HIV-positive individuals are receiving promising
investigational therapies through clinical trials and various expanded access programs.
Vaccines. The NIH has significantly expanded its basic research efforts to design new
approaches to developing AIDS vaccines. It is now evaluating 14 vaccine candidates to identify
those that might be appropriate for efficacy trials. The Department of Defense is also
developing and testing several candidate HIV vaccines to protect U.S. military personnel.
Veterans. The Department of Veterans Affairs (VA) provides care to nearly 17,000 veterans
with HIV-related diseases. The VA operates four specialized AIDS Clinical Units in New York
City, Miami, West Los Angeles, and San Francisco medical centers. AIDS research is
conducted at 85 medical centers, comprising over 800 individual research projects Specialized
ADDS Research Centers dedicated to conducting HIV research are located in New York City;
Durham, NC; San Diego CA; and Atlanta VA AIDS research is funded by about $6 million
in VA research funds and over $24 million in extramural grants. VA also maintains a national
AIDS data base to track the epidemic within the veterans' population.
Water Safety. The Centers for Disease Control and Prevention and the Environmental
Protection Agency issued guidance for vulnerable populations recommending steps to purify
drinking water to protect against Cryptosporidium, which can be fatal to those with compromised
immune systems. These agencies have also conducted research and outreach about threats of
water-borne diseases to such individuals through funding and hosting several workshops and
training programs.
Women and AIDS. The NIH created a Women's Interagency HIV Study to identify the nature
and rate of HIV disease progression in women. NIH requires that women and members of
minority groups be included in all NIH supported biomedical and behavioral research involving
human subjects. NIH has initiated a major research effort to develop female-controlled barrier
methods, including vaginal compounds, to prevent HIV transmission.
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THE CLINTON ADMINISTRATION RECORD ON
REDUCING TEEN PREGNANCY
A Summary Report
President Clinton has called teen pregnancy one of the nation's most serious social problems, and
reducing its incidence has been a key goal of this administration's policy for young people. All over
the country Americans are beginning to address this and other issues by reasserting responsibility for
themselves, their families and their communities, and they are starting to make a difference -- the
teen pregnancy rate has come down two years in a row.
Although there has been progress, teenage pregnancy remains a profound problem, and we need to
do more. Real solutions lie at the grassroots level, with families, communities and young people
themselves. The federal government can help focus resources in support of work at the local level,
and most important, it can help ensure that our policies support our national values. The Clinton
Administration's policy on teen pregnancy, and on youth generally, have been built on two
fundamental values:
Responsible Rehavior: Personal responsibility has been a central part of the President's
message to young people, as he has urged them not to become parents before they are adults,
have finished school, and are ready to support their children. He has supported policies that
embody this principle, including abstinence-based curricula, welfare reforms that discourage
early parenting and require young mothers to live at home and stay in school, and tough new
child support enforcement provisions that drive home the responsibility of parenthood to
young men.
Opportunities for Youth: Teen pregnancy cannot be addressed in isolation from the wide
range of other problems confronting youth, their families, their communities and their schools.
Much of the Administration's social and economic agenda, ranging from education 10 crime
prevention to empowerment zones, is designed to provide increased opportunities for young
people and to give them something to say 'yes' to. If our youth do not have access 10
education, health services, jobs, or safe places to go after school and on weekends, they will
not have a chance to make the right choices.
This summary report provides some facts about teen pregnancy in the United States and highlights
some of the key components of Administration's teen pregnancy, and youth agenda, including: (1)
Research and Evaluation to learn more about the causes of teen pregnancy, (2) Community
demonstrations to help communities try different approaches 10 learn what works, (3) Policies that
promote responsible behavior among young people, and (4) Policies that provide young people with
greater opportunities.
Recognizing that government cannot solve this problem alone, the President has called for a national
private sector campaign to prevent teen pregnancy, and the administration has been working to
catalyze such an effort. This report is not intended to address the status of private sector initiatives,
nor does it provide a comprehensive description of all federal efforts directed at teens.
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The Facts About Teen Pregnancy
A NATIONAL EPIDEMIC
Every year, about 1 million American teenagers become pregnant -- that's approximately 11%
of women ages 15-19.
From the 1950s through the early 1980s. the rate of births to teens decreased steadily.
However, in 1986, that trend reversed, and over the period 1986-91. the rate grew by 24%.
Recent news has been somewhat positive: From 1991 to 1993, the national rate declined by
4%.
As the teenage population grows, teen births are expected to increase. Even if the teen birth
rate remains constant, the number of births is expected to jump 30% by the year 2010.
TREND TOWARDS OUT-OF-WEDLOCK CHILDBEARING
In 1960, only 15% of teenage mothers were unmarried. As of 1993, 71% were unmarried.
INTERNATIONAL COMPARISONS
The rate of births to teens in the United States is now twice as high as in the United
Kingdom and six times as high as in France, Italy, and Denmark.
ROLE OF ADULT MALES
A recent survey indicates that at least half the babies born to leenage women ages 15-17 are
fathered by adult men ages 20 or older.
COSTS TO THE CHILDREN
Children born to teens are more likely to die in their first year of life, to have lower cognitive
achievement, to repeat a grade in school, to be victims of abuse and neglect, and to become
teen parents themselves.
80% of children bom to unwed teenage mothers who have not completed high school live in
poverty. In contrast. of those children born to 20 year-old married parents who are high
school graduates, only 8% live in poverty.
COSTS TO SOCIETY
In 1990, slightly more than half of all mothers receiving Aid to Families and Dependent
Children (AFDC) first had children as teenagers. And 43% of the long-term welfare
recipients are women who gave birth at or before age 17.
More than three-fourths of all unmarried tecn mothers receive welfare (AFDC) at some point
during the S years following the birth of their child.
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Research and Evaluation:
Learning What Works to Prevent Teen Pregnancy
The Clinton Administration supports comprehensive approaches 10 research and evaluation with an
emphasis on prevention of both first and repeat pregnancies. Working to understand leen
populations and the many forces that influence behavior both in and outside of the home, monitoring
and targeting new data, and evaluating old and new programs to learn more about what approaches
may be most effective in lowering leen pregnancy rates in the United States are priority elements of
our approach to research and evaluation. Following are some examples:
Comprehensive Study: In June of 1995, the Department of Health and Human Services
issued, "Beginning Too Soon: Adolescent Sexual Behavior, Pregnancy, and Parenthood,"
a two volume report containing a comprehensive and exhaustive review of the most recent
research literature on teenage sexual behavior, pregnancy and parenthood and on effectiveness
of teenage pregnancy prevention programs. This report was produced by Child Trends, Inc.
with funding from the Department of Health and Human Services, and is now available on the
Internet at http://aspe.os.dhhs.gov/hsp/cyphome.htm.
State Data: In September 1995, HHS reported state-level teenage pregnancy data for 1991
and 1992. This marks the first time that HHS is able to report state-level teen pregnancy
data. Updating trends on a state-by-state basis regularly provides more information for
making effective policy decisions and enables us to see where we need to target our
resources.
Family Planning and Adolescent Family Life: HHS funds, as part of Family Planning and
Adolescent Family Life programs, research projects and studies that focus on adolescent
sexual behavior. Goals of these studies range from developing strategies to improve services
to sexually active adolescents who are at-risk for contraceptive non-compliance and young
women who visit family planning clinics, to learning more about: precursors and results of
pregnancy and birth among adolescent males, the factors that influence teen attitudes toward
sexual behavior, and the consequences for teen mothers who decide to parent as compared to
those who place their children for adoption.
New Mothers' Study: HHS funds The New Mothers' Study and has expanded its original
scope to provide support for a 5-year follow-up to look at longer term outcomes. including.
employment and welfare dependency. The Study focuses on research and analysis of a study
in Memphis, Tennessee, where a sample of first-time, low-income, pregnant women received
weekly visits from a nurse. Approximately 65% of the research sample were 18 or younger at
enrollment. Early findings indicate that there were significantly fewer repeat pregnancies
within two years following the birth of the child for those women who received home visits.
It was originally started in 1988. and is also supported by other government agencies and
private foundations.
Teenage Parent Demonstration: In order 10 gain further insight into the occurrence of repeat
pregnancies, in 1993, HHS funded a 5-year follow-up evaluation of the Teenage Parent
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Demonstration, initially conducted from 1986 to 1991. This program targeted the high-risk
population of teenage mothers on welfare, providing case management and support services
such as education, training and child care. The follow-up evaluation continues to monitor
these mothers and focuses on the occurrence of repeat pregnancies.
Reaching Into Our Communities And Promoting Partnerships
to Prevent Teen Pregnancy
"I'm trying 10 do things that I believe will help our country meet the challenges
we face today so that young people will have a better future. And it's obvious
10 me that unless young people have good, healthy, constructive lives at the
grass-roots level, the things that I do will not succeed in getting you the future
you deserve." President Clinton; August 9, 1995
The Clinton Administration encourages local governments and communities 10 pilot new and
innovative demonstration efforts to prevent teenage pregnancy, and works with them 10 help
make these programs a reality. The Administration has sponsored a range of approaches
from abstinence-based education to service-oriented community collaborations. If a program
proves effective, one goal of collaboration is to foster sustainability so that it can eventually
operate without government assistance. Following are some examples of programs funded
under the Clinton Administration:
Adolescent Family Life Program: In September of 1995, HHS's Adolescent Family
Life Program awarded 15 grants totaling $4.2 million dollars for comprehensive
demonstration programs aimed at preventing early teenage sexual activity and reducing
teenage pregnancies. These programs feature innovative ways to emphasize
abstinence as the best way to prevent adolescent pregnancy and to encourage the
involvement of parents in these discussions with their children.
Community Coalition Partnership Programs for Prevention of Teen Pregnancy: In
September of 1995, Centers for Disease Control and Prevention launched the new
Community Coalition Partnership Programs for Prevention of Teen Pregnancy by
awarding 13 grants totalling $6.5 million over two years. These grants enable
communities to develop plans for implementing and evaluating community-wide
interventions that are innovative, comprehensive and sustainable. In addition, these
demonstrations include an evaluation component.
Healthy Schools/Healthy Communities: In 1994, the Administration started the new
Healthy Schools/Healthy Communities program -- funding 27 new school-based
health centers in 20 states and the District of Columbia. These centers provide for
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the health services and education needs of children and teenagers at high risk for poor
health, teenage pregnancy, and other problems. A comprehensive evaluation of this
program is currently being conducted.
The Corporation for National Service: Created under the Clinton Administration in
1993, the Corporation for National Service supports over 50 teen pregnancy programs
in 20 states across the country -- working both to prevent teen pregnancy and to
assist teen parents. National service participants provide case management, mentor
pregnant teens, sponsor health fairs, teach parenting skills to teen parents, make
presentations on teen pregnancy prevention to school-age youth, help youth access
health care, provide referrals to health care providers, and develop social supports for
teen parents. National service programs are operated with members of AmeriCorps,
Learn and Serve America, and the National Senior Service Corps, who work
collaboratively with school districts, universities, churches, health departments,
national non-profits, and community-based organizations.
Healthy Start Program: HHS continues to support the Healthy Start Program, which
has demonstration projects underway in 22 communities nationwide to reduce infant
mortality in the highest-risk areas and to improve the health and well-being of
women, infants and their families. Among a broad array of services provided,
thousands of teenagers participate in prevention programs exclusively designed for
them that encourage healthy lifestyles, youth empowerment, sexual responsibility,
conflict resolution, goal setting, and the enhancement of self-esteem. A
comprehensive evaluation is ongoing and results are expected in 1997.
The Home Visiting Services Demonstration: In September 1994, HHS launched this
new grant program that is currently operating in three sites. Under the demonstration,
paraprofessional home visitors provide first-time teenage parents on welfare with
instruction and supportive guidance related to family planning, parenting skills, health
care for themselves and their children, and child support. The visitors also facilitate the
teenagers' participation in the required education and employment-related activities.
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006
Promoting Personal Responsibility
Among Young People
President Clinton has made personal responsibility a central part of his message to young people.
urging young people not to get pregnant or father a child. Estimates indicate that over half the
mothers who receive Aid 10 Families with Dependent Children were teenagers when they had their
first child. To prevent welfare dependency in the first place, leenagers must get the message that
staying in school, postponing sexual activity, and preparing 10 work are the right things 10 do.
By supporting welfare reform that promotes work, demands responsibility, and toughens child
support enforcement activities, President Clinton has sent a message that, "Nobody should get
pregnant or father a child who isn't prepared to raise the child, love the child, and take
responsibility for the child's future."
Welfare Reform: The President supports welfare reform that sends a clear message to minor parents
seeking assistance: to get help. you have to live with a responsible adult, you have to stay in school,
and you have to prepare for work. Congress has endorsed the President's proposal requiring
unmarried teen mothers to live at home and stay in school in order to qualify for assistance.
Congress also supports the Administration's efforts to establish "Second Chance" homes, or adult-
supervised group homes, as alternative living situations to help teen parents break the cycle of
welfare dependency.
Strengthening Child Support Enforcement: In 1995, the Administration collected a record $11 billion
in child support from non-custodial parents, an increase of 40% since 1992. From 1992 to 1995,
paternity establishments have also risen by over 40%, to an estimated 735,000. This increase
includes, for the first time, paternities established as part of the Clinton Administration's in-hospital
paternity establishment program.
President Clinton proposed a comprehensive child support enforcement plan as part of his welfare
reform legislation. The plan would streamline paternity establishment: require new hire reporting;
make child support laws uniform across state lines; computerize state-wide collections to speed up
payments; and require states to revoke drivers' and professional licenses to parents who refuse to pay
child support. Both House and Senate have adopted these provisions--changes that should increase
child support collections by $24 billion over the next 10 years. In addition, in 1995 President Clinton
signed an Executive Order to crack down on Federal employees who owe child support.
State Welfare Reform Demonstrations: The Administration has approved state welfare reform
demonstrations to a record 35 states that include various provisions affecting minor parents. Nineteen
states have authority to implement provisions linking AFDC benefits to the school attendance of
minor parents. Seven states have received waiver authority to require minor parents to live with their
parents or guardians or in an adult-supervised setting. A comprehensive evaluation will be conducted
for each of these demonstrations.
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Teen Pregnancy Prevention As Part Of A
Comprehensive Approach to Youth Policy
The Clinton Administration has worked 10 address the high rate of leen pregnancy by
confronting the complex economic and social factors often behind these high rates. We have
stressed the importance of investing in young people and in the communities where they live
in order 10 offer them positive alternatives to early parenting and sexual behavior. Crittcal
to this effort are Administration initiatives to invest in early childhood and adolescent
development, to provide equal educational opportunities for our children and youth. 10 invest
in distressed urban and rural communities, and 10 create more jobs.
Researchers have documented correlations berween poor academic skills and early
childbearing; high dropout rates, illiteracy, a history of physical and/or sexual abuse, and
poor employment prospects are all risk factors for early childbearing. Research has also
shown that the risk factors for teen pregnancy, violent behavior, delinquency, and drug use
are similar and that comprehensive programs focused on changing behaviors related to
alcohol, drugs and teen pregnancy - such as focusing on raising self-esteem -- have an
impact.
Following are examples of programs and initiatives in this area that the Administration
supports:
LEARNING MORE ABOUT YOUTH AT-RISK
National Adolescent Health Survey: Teens have been a significantly understudied
sector of the population. In 1994, the National Institutes of Health began funding a
new 5-year study known as Add Health, the first comprehensive study of the
determinants of adolescent health. Using a national sample of 7th through 12th
graders, Add Health examines the personal, familial, peer-related and community
related influences on health behavior, taking a more comprehensive look at the
health of our nation's teenagers in order to provide a better understanding of the
complex forces that promote good health for our young people and those factors that
put youth at risk.
Preventing Youth Violence in Public Housing: This year, HUD and CDC have
awarded a $550,000 grant to collect and develop information on youth violence
prevention research. The intent is to disseminate existing information on successful
programs to Indian and Public Housing authorities SO that they can make more
informed choices about prevention programs, which offer alternative services and
activities for youth that can play a major role in preventing teen pregnancy as well.
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Comprehensive Strategy and Guide for Implementation: In December of 1993. the
Department of Justice published a Comprehensive Strategy for Serious. Violent, and
Chronic Juvenile Offenders, following up with a Guide to implementing the
Comprehensive Strategy in June of 1995. Studies on the causes and correlates of
delinquency, which used large random samples of inner-city, high-risk youth in three
sites, provided the research underpinnings for these publications. All three studies
showed that chronic violent delinquent offenders have higher rates of dropping out
of school, gun ownership for protection, gun use, gang membership, teenage
sexual activity, teenage parenthood, and early independence from their family.
Comprehensive Strategy and its Guide for implementation provide an alternative to
increasing reliance on the criminal justice system by calling for the establishment of a
coordinated system of prevention and graduated sanctions programs that provide a
continuum of care for each child.
Review for Practitioners: Family Life, Delinquency, and Crime: A Policymaker's
Guide--Research Summary, was completed in May of 1994 by the Department of
Justice. Its findings indicate that family is one of the most powerful socializing
forces for young people, and can therefore seriously impact children's behavior.
Parenting Initiative: The Department of Justice completed research work in 1993
under a grant to the University of Utah and the Pacific Institute for Research and
Evaluation. This four-year major parenting initiative resulted in a document entitled
Effective Parenting Strategies for Families of High-Risk Youth (December 1993).
which identified a representative group of 25 programs as potentially the most
promising. The research findings underscore the importance of a family-focused
approach to prevention and intervention of youthful problem behavior.
EXPANDING OPPORTUNITIES FOR YOUTH AT-RISK
SafeFutures: In September 1995, the Department of Justice created the SafeFutures
Program, a five-year program which will provide approximately $8 million per year to
six jurisdictions for a comprehensive and coordinated delinquency prevention and
intervention program for at-risk and delinquent youth. Several programmatic
components allow the four cities, one rural jurisdiction and one tribal government, to
address teen pregnancy and receive support for specific counseling and education
services. These include support for family strengthening activities, mentoring, specific
services to at-risk and delinquent females, and general delinquency prevention
activities.
High Risk Youth Demonstration: HHS supports the High Risk Youth Demonstration
program, which funds innovative and effective model programs for preventing
alcohol and drug use among high-risk youth. One component of the program targets
the specific needs of females from 12 to 20 whose use of substances often occurs with
special factors (e.g. sexual abuse and domestic violence) that underlie or contribute to
women's addictive problems. Every component of the program is evaluated.
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School Health Programs: The CDC has established a national framework to support
school health programs that are locally determined and consistent with community
values. Programs in all 50 states and 18 major cities are designed to help young
people avoid those risk behaviors that result in HIV infection, other sexually
transmitted diseases, and unintended pregnancies. CDC's Youth Risk Surveillance
System provides information about the prevalence of behaviors practiced by youth that
put their health at risk, and states, cities, and CDC use this information to more
effectively target and evaluate school health programs.
Youth Development Initiative: Started in 1994 under the Departments of Veterans
Affairs and Housing and Urban Development, the purpose of this initiative is to
address the problem of violence in low-income communities by providing young
people aged 13 to 25, with access to education and employment opportunities and
supportive services. Offering these positive alternatives and services to youth to
reduce violence are shown to be effective for affecting other teen behavior as well,
such as sexual behavior that could lead to teen pregnancy.
Youth Fair Chance: In July 1994, the Department of Labor implemented the Youth
Fair Chance program, funding seventeen sites. Youth Fair Chance is a community-
based program that targets money directly into high poverty areas where youth
problems are greatest. Working in cooperation with local service providers, these
sites use in- and out-of-school components to provide a variety of services that focus
on youth problems, like teen pregnancy, unemployment, drug and gang involvement,
and dropping out of school. Some of the sites utilize AmeriCorps volunteers.
The Community Schools Youth Services and Supervision Grant: Through this new
program established in 1994 under the Crime Bill, HHS provides matching grants to
communities with significant poverty and juvenile delinquency for after-school,
weekend and summer recreation and education programs. The program includes
an evaluation component.
Family Planning: In the face of strong opposition, the President has proposed budget
increases for the federal Family Planning Program each year and successfully
maintained the program. Among other reproductive health and education services, this
program makes family planning information and contraception available to millions of
women who might not otherwise get reproductive health care.
4-H Youth Development Program and Children, Youth and Families at Risk Initiative:
The Department of Agriculture, through the Cooperative Extension System, funds
these important initiatives serving young people. These programs work with
communities to implement effective research-based programs which address a broad
range of issues and needs, including teen pregnancy, child abuse, infant mortality,
community crime and violence, and child care.
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Safe and Drug-Free School Act: Passed in 1994, this act responds to the continuing
crisis of violence and drugs in our schools by supporting comprehensive school-and
community-based drug abuse and violence prevention programs. Local school
districts in high need areas are coordinating violence and drug prevention programs
with comprehensive school health education programs.
Comprehensive Services for Teenage Parents on Welfare: In 1994, HHS funded these
grants, which supported development of programs providing comprehensive services
to meet the personal, physical and social needs of teenage parents, as well as
aiding the cognitive, physical and emotional development of their children. They were
implemented in conjunction with mandatory participation requirements for education
and employment-related activities.
LIFELONG LEARNING: INVESTING IN OUR YOUNG PEOPLE
"We can do all these things -- put our economic house in order, expand world
trade, larget the jobs of the future, guarantee equal opportunity -- but if we're
honest, we'll admit that this strategy still cannot work unless we also give our
people the education, training, and skills they need 10 seize the opportunities of
tomorrow." President Clinton; January 25, 1994
Under the Clinton Administration, the Department of Education has launched a number of
initiatives that address teen pregnancy prevention through improved schooling for
disadvantaged students, coordination of health and social services, and school-to-work
opportunities to increase economic self-sufficiency. Drop-out prevention and drug-free
schools and communities programs address risk factors that are the same or related to those
leading to teen pregnancy.
Specific initiatives started or expanded include: The Goals 2000: Educate America Act,
Improving America's Schools Act, Title I Program; 1994 School-To-Work Opportunities
Act; and Head Start.
EMPOWERING COMMUNITIES TO SOLVE PROBLEMS
The Clinton Administration has worked hard to encourage investment in distressed
communities, to create jobs and to help these communities rebuild themselves by designing
initiatives like the Empowerment Zones and Enterprise Communities and The Community
Development Banking and Financial Institutions Act.
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HEALTH RESOURCES AND SERVICES ADMINISTRATION Items
Bureau of Health Professions
relate highlighted to
Program Data
timeframe of
this Administrative
BENEFITS AND ACCOMPLISHMENTS
Title VII and Title VIII programs have been the key to the growth and
development of primary care medicine and public health training, area health
education centers, health professions workforce, minority/disadvantaged
representation, and nursing education and practice. Despite funding
appropriations which are only 15% in constant dollars of the level twenty years
ago, Title VII and Title VIII programs have made substantive in-roads in meeting
their statutory objectives. Program data analyses, as summarized below, clearly
document the benefits and accomplishments of these programs towards
meeting these goals.
TITLE VII
Training in Family Medicine, General Internal Medicine, General Pediatrics.
Preventive Medicine, Physician Assistants. and General Dentistry
The ratio of primary care physicians to the population has increased by
over 32% since the inception of Title VII programs. For the five years
prior to Title VII programs, there had been more than a 10% decrease
in the ratio of primary care physicians to the population.
Targeted funding has been a primary influence for a nearly 25%
increase In the number of Departments of Family Medicine since 1980.
Targeted funding has resulted in on increase of 40% in the number of
required family medicine clerkships in just the past four years.
Title VII funding provided the means for expanding the number of
family medicine residency training programs by nearly 10% in just the
past four years. The current rate of expansion is the highest in the
past twenty years. Since 1978, Title VII funded family medicine
residency programs have resulted in the training of nearly 9,000
residents.
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Title VII funded 43% of the current General Internal Medicine (GIM)
P.03
residency programs.
Nearly 14,000 general internal medicine residents have been
trained through Title VII funded institutions since the inception of
the program.
Over 88% of the graduates of currently funded programs
practice in primary care, a rate nearly twice that of programs not
receiving Title VII funds.
o
Over 37% of the graduates of the currently funded programs
have established practices in medically underserved communities
in the past two years
Title VII funding has been the primary influence for a 25% increase in
divisions of general pediatrics over the past 10 years.
Title VII funded 28% of current General Pediatrics (GP) residency
programs. Over 33% of the graduates of these programs have
established practices in medically underserved communities in the past
two years.
Title VII funding has been instrumental in establishing Departments of
Family Medicine in 100% of the current colleges of osteopathic
medicine.
Title VII funds have been key to the training of nearly 2,300
osteopathic interns and over 1,200 general practice/family practice
osteopathic residents over the past 15 years.
Title VII provided training support which developed or fostered 90% of
the current physician assistant programs. On average, Title VII has
provided nearly one quarter of the infrastructure support for physician
assistant programs over the past four years.
Title VII funded nearly 80% of the 27,000 physician assistants (PAs)
graduates. Over 50% of the graduates from Title VII supported
programs entered practice in primary care last year,
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programs started practice in rural communities last year. Title VII
funding has served to increase PA practice In rural areas by nearly
40% in the just past four years.
Since grants were first awarded in 1983, Title VII funding has played
an essential role in the development of nearly 100% of the General
Preventive Medicine and Public Health Residency Programs. As B
result, nearly 350 resident physicians have received graduate medical
education in the specialty of preventive medicine.
The Advanced General Dentistry grent program resulted in the creation
of 53 new postgraduate general dentistry programs, or 67% of the
total growth in those programs.
Nearly 80% of the graduates of these programs provided primary
care dentistry in the past year.
Nearly 30% of these graduates provided care In medically
underserved communities over the past 4 years.
Title VII funding incentives have resulted in an increase of almost
100% in the enrollment of disadvantaged dental students in the
past eight years.
Area Health Education Centers
Area Health Education Center programs have coordinated and
supported the training of nearly 1.5 million health professions students
and primary care residents in underserved areas.
Area Health Education Centers provided community-based clinical
training to nearly 10,000 medical school students, or 13% of the
nation's total medical school enrollment, in the past fiscal year.
In just the past year, 32 Area Health Education Center programs
assisted in providing community-based training experiences at 1400
rural and urban areas nationwide for: 2 900 primary care residents;
600 physician assistant students; 1, 100 nurse practitioner students;
and 8,800 other health professions students.
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Over 10% of all National Health Service Corps personnel Utilized
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Health Education Center supported training last year.
Fifty four percent (54%) of graduates from the recently enacted
Interdisciplinary Rural Training Grant program are employed in rural or
frontler areas since the program began three years age.
Title VII funding has established geriatric education centers in 86% of
the 29 states whose aged populations exceed the national average.
Geriatric education centers have provided training to over 226,000
participants in the last 10 years.
Title VII support has developed public health training projects in 40%
of the states in just the past 4 years to address substance abuse,
violence, HIV/AIDS, Infant mortality, genatric health care and other
serious public health issues in underserved communities.
Title VII supports graduate training in public health for over 8,000
students annually. This support targets improvement in the quality
and representativeness of the public health workforce and channels
graduates to positions serving underserved and high-risk populations.
Health Professions Workforce Development
Distance-Based Learning (DBL) projects have been highly successful in
providing training to allied health professionals in remote areas. For
instance, 84% of the University of Nebraska Medical Center's DBL
graduates are employed in underserved communities.
Title VII funding has been instrumental in prompting an increase of
more than 350% in accredited health administration programs over the
past 25 years.
Title VII funded 80%, or over 5,500, of all graduating health
administration students.
During this same time period. minority/disadvantaged
representation in health administration increased nine-fold.
Title VII funding was instrumental in the startup of 70% of the current
podiatric primary care residency training programs.
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National Health Service Corps Scholarship and Loan Repayment and Related
Programs
The National Health Service Corps (NHSC) placed nearly 2,000 health
professionals in underserved rural and urban areas in just the past year
On average, nearly 50% of all NHSC placements have been retained in
underserved areas over the past four years.
National Health Service Corps members provided care to over 3 million
patients, and made nearly 7 million patient visits to residents of
underserved urban and rural areas in just the past year.
Minority/Disadvantaged Health Professions Institutional Assistance
Underrepresented minority enrollment in health professions schools has
increased more than 200% since the implementation of Title VII
funding for minority/disadvantaged programs.
Medical schools participating in the Health Careers Opportunity
Program have accepted underrepresented applicants at a rate over
20% higher than the national average over the past five years.
The first year of implementation of the Health Careers Opportunity
Post-Baccalaureate Program directly resulted in a 15% increase in the
number of underrepresented minority medical school matriculants. As
a result of this program, 90 additional underrepresented minorities
enter medical school each year. a number equal to the first year
enrollment of most medical schools.
Financial Assistance to Minorlty/Disadvantaged Students
Eighty-three percent (83%) of allopathic medical, osteopathic medical,
and dental schools provide Title VII financial assistance to
disadvantaged students. Over 53% of disadvantaged health
professions students from those institutions rely upon disadvantaged
student financial assistance as their primary means of financial support
to gain access to health professions schools.
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Other Student Assistance
Over 96% of all allopathic medical, osteopathic medical, and dental
schools provide primary care and health professions student loans to
students in need. in just the past year, over $60 million in loans were
provided to nearly 11,000 students.
Over 70% of allopathic medical, osteopathic medical, and dental
schools include Health Education Assistance Loans (HEAL) as a key
part of their financial assistance to students. In just the past year,
nearly 12,000 students relied on HEAL loans as their primary means of
financial support for attending school.
TITLE VIII
Nursing Workforce Development
Title VIII funded more than 60% of all current nurse practitioner
programs in the United States.
0
Approximately 50% of the graduates of these programs are
employed in Inner city and rural areas.
Over 75% of working nurse practitioners are in ambulatory care
and outpatient settings providing primary care.
D
Nearly 50% of certified nurse practitioners provide primary care
services to predominantly minority/disadvantaged patients.
Nearly 45% of nurse practitioners care for patient populations in
areas with a high proportion of Medicaid beneficiaries (levels of
25% or more).
Title VIII has provided substantial support to over 83% of the existing
nurse-midwifery programs over the past 20 years.
Over 30% of the graduates of these programs started practice in
underserved areas.
Nearly 100% of the 3,000 currently practicing nurse-midwives
provide primary care services.
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Over BO% of current practicing nurse midwives devote a
significant portion of their service to low-income or uninsured
women.
Title VIII has provided funding for the development and/or expansion of
nearly 20% of all nurse anesthetist educational programs, and
supported over 75% of nurse anesthetist graduates in the past year.
D
Nurse anesthetists provide 65% of the 26 million anesthetics
administered each year.
0
Nurse anesthetists are the sole providers of anesthesia In 85% of
rural area hospitals.
0
Last year, 34% of nurse anesthetists practiced in communities
with populations of less than 50,000.
The Professional Nurse Traineeship Program supported nearly 95% of
the 5,845 full-time graduate nursing students. Over 35% of Title VIII
supported nurse graduates over the past 3 years serve in medically
underserved communities.
Programs receiving support from Title VIII funding for minority and
disadvantaged students have enrollments in which 75% of students
are from minority groups, compared to the 16% national average.
Over the past five years, the number of new nursing graduates from
disadvantaged backgrounds rose over 24% nationally.
Title VIII established and/or expanded over 50% of the currently
operating nurse managed clinics providing care to high risk and
vulnerable populations. These federally funded clinics provided an
estimated 32,000 primary care visits in elementary schools, senior
citizens centers, colleges housing complexes, homeless shelters, and
other areas of need last year.
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DRAFT
CLIA REGULATORY REFORM INITIATIVES
Proposal: Waive routine 2-year survey of users of certain test
systems that demonstrate their accuracy and precision. This will
create incentives for manufacturers to develop more reliable
testing equipment by stimulating demand for accurate and precise
testing systems.
Implementation: A proposed rule was published on November 14,
1995, and the public comments are being considered.
Proposal: Clarify and expand the waiver criteria and streamline
the waiver process so that CLIA regulations can be waived for
more tests.
Implementation: A proposed rule was published on November 13,
1995, and the public comments are being considered. In the
interim, a streamlined review has already been introduced
resulting in waiver of five additional test systems.
Proposal: Reward good performers with fewer inspections as a
positive incentive to improve performance.
Implementation: The Health Care Financing Administration has
began recertifying certain laboratories with past exceptional
performance by allowing them to complete a self-survey
questionnaire. Laboratories can go for 4 years without an on-
site survey if they are excellent performers as compared to the
usual bi-annual inspection schedule.
Proposal: Recognize private accrediting organizations and State
laboratory quality programs as alternative avenues for compliance
with CLIA requirements.
Implementation: Six major private organizations that accredit
laboratories and two state licensure programs have been approved
as alternatives to the regular CLIA program.
Proposal: Use proficiency testing "failures" for education and
as an outcome indicator in laboratory quality.
Implementation: The Health Care Financing Administration is now
directing laboratories which demonstrate potential testing
problems by poor proficiency testing performance to obtain
technical training and education to correct problems in lieu of
imposing sanctions. Sanctions (such as loss of approval to
perform a test) are imposed only in rare situations where a
laboratory fails the same tests repeatedly or refuses to take
corrective action or otherwise poses immediate jeopardy to
patient health and safety.