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Transition Reports (1977) - Health, Education and Welfare (2)
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Transition Reports (1977) - Health, Education and Welfare (2)
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The original documents are located in Box 37, folder "Transition Reports (1977) - Health,
Education and Welfare (2)" of the John Marsh Files at the Gerald R. Ford Presidential
Library.
Copyright Notice
The copyright law of the United States (Title 17, United States Code) governs the making of
photocopies or other reproductions of copyrighted material. Gerald R. Ford donated to the United
States of America his copyrights in all of his unpublished writings in National Archives collections.
Works prepared by U.S. Government employees as part of their official duties are in the public
domain. The copyrights to materials written by other individuals or organizations are presumed to
remain with them. If you think any of the information displayed in the PDF is subject to a valid
copyright claim, please contact the Gerald R. Ford Presidential Library.
Digitized from Box 37 of The John Marsh Files at the Gerald R. Ford Presidential Library
PUBLIC HEALTH SERVICE
PHS TRANSITION PAPERS
The following papers briefly highlight significant
policy issues which will surface during early 1977.
In addition, a copy of the Forward Plan for Health
1978-82 is attached. This document is produced
annually by the Assistant Secretary as a part of the
planning process. It contains an analysis and
discussion of the major health issues facing the
Nation.
ISSUE: National Influenza Immunization Program (NIIP)
BACKGROUND: A number of issues remain to be addressed in the implementation
of the NIIP. They include:
Short Term
Low Participation by Citizens in Black and Other Ethnic Minority Communities
There is a continuing concern over reports of low citizen participation,
especially among Blacks in large urban areas and other ethnic minority
communities. This citizen dissonance may be due, in part to (a) low
traditional turnout in poverty areas, (b) media focus on controversial
aspects of NIIP, (c) media exploitation of unfounded vaccine-related
deaths, (d) absence to date of swine-like or other flu outbreaks, (e)
general mistrust of programs having big-government connotations, and
(f) lack of readily available material and information on which to base
an affirmative decision.
Steps Being Considered to Resolve This Issue
Immediate development and distribution of mass media information
with special focus on ethnic minority communities. A more
aggressive stepped-up approach at the National level will also
be made to take advantage of the support that Black and other
ethnic minority leaders are willing to give in support of the
immunization program. In addition, efforts are being made to
stimulate State and local health departments as well as voluntary
agencies to conduct intensive public education and public awareness
activities to counter fears of illness and death due to the vaccine
that has been generated through the media.
Vaccine for Healthy Children
On November 15, 1976, following completion of field trials and data
analysis, the Public Health Service announced its policy on inoculation
of normal, healthy children between ages 3 and 18. While a safe and
effective vaccine exists, from a practical standpoint, the manufacturers
can not supply sufficient quantities of the kind of monovalent swine
flu vaccine (split-virus) required by healthy children. Three of four
manufacturers have formally indicated that they cannot produce
additional flu vaccine this year. A potentially serious short-fall,
therefore, exists since currently there is enough vaccine for four
million children--one-tenth the number of children in that age group.
Steps Being Considered to Resolve This Issue
Since attempts to stimulate further split-virus vaccine production
do not appear to be imminently fruitful, efforts are being aimed
at distributing the available split-virus vaccine to inne? city
11/18/76
neighborhood health clinics and other urban sites for children
whose living conditions may make them more susceptible to
influenza infection and serious complications because of
crowded conditions and inadequate existing medical services.
Non-Official Americans Overseas
A policy and plan for the immunization of 1,250,000 American citizens
working and residing overseas in a non-governmental capacity has not
been approved. In late September an interdepartmental consensus
proposal was drafted and forwarded to the White House for consideration
and decision. In early November, it was referred back to the Department
level for resolution by the Secretaries of HEW, Defense, and State.
Steps Being Considered to Resolve This Issue
Submission of the interdepartmental consensus proposal to the
Secretaries of HEW, Defense, and State which recommends that
American corporations and voluntary agencies located in host
countries be permitted to utilize normal Customs Clearance
procedures to import swine flu vaccine.
Program Evaluation
There are five major areas of evaluation of NIIP:
1. Surveillance
2. Assessment of vaccine delivery and distribution
3. Epidemiological evaluation of vaccine efficacy
4. Program costs
5. Special issues as to information dissemination, public attitudes,
and characteristics of participants and non-participants
Steps Being Considered to Resolve This Issue
Augment current CDC activities of program evaluation.
Long Term
Implications for Future Immunization Programs
Efforts to clearly document various aspects of NIIP are needed so as
to prevent a repetition of problems. Additionally, P.L. 93-380 calls
for a study of personal liability and calls for provisions that the
Secretary provide the Congress with reports on litigation and settlement
by August 1977 and semi-annually thereafter.
Steps Being Considered to Resolve This Issue
Data are being compiled for quarterly reports to Congress on the
administration of the swine flu program including vaccine supply,
the number of persons inoculated, amount of funds expended by
States, and the epidemiology of influenza in the United States,
Data are being compiled to meet the requirements of a report to
Congress on the conduct and settlement of litigation activities
specifying the number, value, nature and status of all claims
made. Finally, a study of the scope and extent of liability in
immunization programs is being examined from the standpoint of
alternative approaches to providing protection against such
liability.
ISSUE: Immunization Policy
BACKGROUND: The now well-established role of the Federal Government in
national immunization efforts includes direct support of routine vaccination
programs in State and local health departments through project grants.
In this regard, support takes the form of providing vaccines used routinely
in childhood immunization and purchased under Federal contract and of
supporting staff to coordinate and promote relevant vaccination programs.
Indirect Federal responsibilities involve surveillance of vaccine-preventable
diseases, of vaccine use, and of adverse reactions to vaccination.
In recent years the rate of immunization has been waning. This is particularly
so in some urban and rural areas where the traditionally underserved and
hard-to-reach groups show evidence of rates of immunization in preschool
and childhood groups which are far below what is generally accepted to
preclude outbreaks. The reasons for the decline in rates of immunization
in childhood are not fully known. Thought to be contributing are the
growing lack of personal motivation as program successes have removed the
threat of infectious diseases and the mounting concern over the almost
negligible but acknowledged inherent risk of serious adverse reactions
from some of the commonly used vaccines. This latter issue has been
recently dramatized by litigation of liability for paralysis associated
with oral polio vaccine and for central nervous system reactions to live
measles vaccine. The National Influenze Immunization Program against
swine influenza has further dramatized the liability issues associated
with communitywide use of vaccines and has begun to establish the use of
individualized disclosure documents and consent-obtaining procedures in
public immunization programs.
Future immunization policy should take cognizance of the Federal responsi-
bility to assure uniform and high levels of protection against the infectious
diseases for which effective immunizing agents are available. It should
address more completely the waning public motivation for vaccination,
particularly in the traditionally hard-to-reach populations. The policy
should acknowledge the inherent risk of vaccines in regular use in preven-
tive medical practice and provide solutions to problems of vaccine-associated
disability for those injured as a result of taking federally-licensed and
recommended vaccines which provide both personal and community protection.
POSSIBLE ACTION/DISCUSSION: Recently a National Conference on Immunization
Policy was held and a set of recommendations with respect to this issue
are now being developed. New legislation and resources may be required
to implement these policy recommendations.
11/18/76
ISSUE: Implementation of new legislation on health information, health
promotion, and the prevention of illness.
BACKGROUND: Legislation was enacted on June 23, 1976 (the "National
Consumer Health Information and Health Promotion Act of 1976," P.L. 94-317,
which specifies additional legislative authorities for the Department in
the areas of health information, the prevention of illness, and health
promotion. In addition to the ongoing activities of Departmental agencies
which are related to the dissemination of health information, and preven-
tion and health promotion, the Congress called for expanded coordination,
including the development of national goals and strategies for health
information and health promotion, prevention health services, and
education in the appropriate use of health care. The $4 million supple-
mental budget request will be used to support additional work, including
grants and contracts, by all six Agencies of the Public Health Service,
the Regional Offices, the Office of Education, other DHEW Agencies, as well
as joint efforts with USDA, EPA and other Federal Agencies, and with the
private sector. The principal objective of these activities will not be
the transmission of units of information per se, but transmission of
information that reflects the state of our knowledge in a culturally
appropriate way to help people change their individual and social behavior
in order to improve their health. The primary focus for the expenditure
of funds early in the implementation of this authority will be: research
and evaluation, including state-of-the-art assessments of health education
and health promotion activities, and the identification, through existing
research programs, of the environmental, social and behavioral factors
which affect health and which may be amenable to prevention or health
promotion activities.
POTENTIAL DECISIONS OR ISSUES: A number of policy issues will have to be
resolved as the PHS implements this new authority.
11/18/76
ISSUE: Strengthening the Nation's ability to deliver health care to
children and mothers.
BACKGROUND: It has been estimated that between four and ten million
children in the United States are not enrolled in a health care system
in either private or public sectors. * As many as half a million women
receive totally inadequate prenatal and postnatal health care. For
reasons of poverty, ineligibility for health programs which use means
tests to determine eligibility, and residence in underserved areas,
children and mothers often receive inadequate health care or care on an
emergency basis only. Though progress has been made in the past decade
in reaching children previously underserved, poor and minority children
continue to have fewer physician visits than middle class children and to
suffer disproportionately from ill health. Each year millions of children
suffer needlessly from the effects of preventable or correctable illnesses
and birth defects as a result of inadequate child and maternal health care.
A PHS initiative is being proposed to assure all children and mothers
continuous and comprehensive health care. Those now outside the system
will be identified and the system expanded to provide for their care.
Within this objective the following goals have been identified:
1. Create capacity and participation at State and local levels
assuring access to comprehensive health care for children
and mothers,
2. Develop necessary data base to achieve the above goal, and
3. Assure development of adequate resources to provide more
effective and efficient health care for children and mothers.
POSSIBLE DECISIONS/ACTIONS: A proposal with options is now in the final
stages of development. Recommendations including legislative and cost
implications will be available shortly.
11/18/76
*Estimates vary from Brookings figure of 4 million children to OCHA's
figure of 10 million, based on analyses of provider availability and
practice constraints.
ISSUE: Adolescent Pregnancy and Childbearing
BACKGROUND: In the United States in 1974 there were about 10 million
women age 15-19. An estimated 4.3 million of these women were sexually
active and about 4 million were at risk of unintended pregnancy. An
additional 400 to 600 thousand women age 13 and 14 were also at risk
of unintended pregnancy. In 1974 there were 247,000 births to adoles-
cents age 17 and under. There were 30,000 births to women under 15
years old.
In the age group 15-19 an estimated one million unintended pregnancies
occurred 2/3 of which were concieved out of wedlock. Only 27% of
sexually active teenage females reported always using some form of
contraception; over one-half reported they did not use contraception
the last time they had intercourse; and 9 out of 10 young teenagers
who requested family planning clinic services reported having had
intercourse without contraceptive protection for a year or more prior
to their enrollment in the family planning program.
Early childbearing severely limits opportunities available to young
women since young mothers lack skills, tend to drop out of school, and
have a greater risk of being dependent on welfare.
Maternal deaths are higher for women under age 19, they have more low
weight babies, and death rates in the first year for babies born to the
group are higher. Marriages of women in this age group tend to be less
stable and they on the average have more children.
The reasons why some of these women do not use contraception include
ignorance of their use and inaccessability of suitable and acceptable
services.
Federal action to alleviate this problem is now underway including
the following:
1. Expanding and strengthening subsidized family planning
services for teenagers including specialized services
organized especially for teenagers. Teenagers desire
pregnancy testing services, responsive appointment
schedules, convenient hours, convenient locations, and
simple admission procedures. For continued clinic use
they cite as important staff attitude, clinicians
attitude and clinic efficiency. Clinic services should
include outreach for teenagers, education and counselling
at clinic sessions and responsive follow-up.
11/18/76
2. Expanding one network of preventive family planning
programs directed toward teenagers and school health
services and free clinics. These programs should include
realistic sex education that offers teenagers honest
and pertinent information about fertility regulation
and where they can obtain the service.
3. Providing adequate pregnancy counselling and equal
access to adequate prenatal, obstetrical and pediatric
care for those who desire to carry their pregnancies
to term as well as access to legal abortion for those
who wish to terminate their pregnancies.
4. Expanding of biomedical research to discover new, safe
and effective techniques of fertility regulation better
suited for use by young men and women.
POSSIBLE ACTIONS/DECISIONS: Need to develop a Department-wide
coordinated program to provide additional support for the activities
required to reduce adolescent pregnancies.
ISSUE: Abortion
BACKGROUND: Section 209 of P.L. 94-439 - the HEW-Labor Appropriation
Act for 1977 stated that none of the funds contained in this Act shall
be used to perform abortions except when the life of the mother would
be endangered if the fetus were carried to term.
On October 1, 1976, Judge John Dooling of the U.S. District Court for
the Eastern District of New York issued a temporary restraining order
forbidding the Secretary of DHEW to refuse "to pay federal matching
funds (at the proportionate levels they were being paid before the
Hyde amendment was enacted on September 30, 1976) for abortions pro-
vided to women eligible for Medicaid."
Judge John F. Dooling further issued a preliminary injunction on
October 22 and ordered DHEW to continue making federal reimbursements
for abortion services nationwide, pending the final outcome of the
litigation. He also instructed DHEW to inform its regional offices
of his order, with instructions that they notify State Medicaid agencies
which, in turn, are to notify abortion providers. The notice, specified
by the court, reads as follows:
The Department of Health, Education, and Welfare will provide
reimbursement for all abortions provided to Medicaid-eligible
women by certified Medicaid providers on the same basis as the
Department pays reimbursement for pregnancy and childbirth-re-
lated services.
This notice was sent to DHEW Regional Directors and appropriate officials
of the Bureau of Medical Services and the Bureau of Community Health
Services on November 3, 1976.
In his October 22 order, Judge Dooling had allowed Rep. Henry J. Hyde
(R-I11.), Sens, James L. Buckley (C/R-N.Y.) and Jesse A. Helms (R-N.C.)
to act as "intervenors" (not as members of Congress but as private
citizens) and in the case on the side of the government and, in that
capacity, they had applied to the Supreme Court for a stay, which, in
effect, would have invalidated Judge Dooling's order. DHEW and the
Solicitor General, on the other hand, while continuing to argue in
support of the Hyde amendment, opposed a stay. In a memorandum to the
Supreme Court, the Solicitor General, Robert H. Bork, noted that the
intervenors "fail to suggest any irreparable injury that they will
suffer from the denial of a stay, and we can find none. He added:
Although the Secretary of DHEW has estimated that, during the
current fiscal year, an obligation of between $22 and $27 million
may therefore be incurred by the Federal Government, in contra-
vention of the clear commend of Congress, we do not believe that
this possible monetary loss, although significant, constitutes
an irreparable injury sufficient to warrant issuance of a stay
pending appeal, especially since this loss may be offset at
least partially by the saving of monies that would otherwise have
been expended for childbirth and post-natal care if women were
to carry unwanted pregnancies to term. On November 8, the U. S.
Supreme Court refused to stay the Federal District Court Order.
In the meantime, DHEW had asked Judge Dooling to modify his October 22
order so that, if and when higher courts overruled his judgement, the
department would be able to recoup Medicaid payments made to providers
of abortion services in the interim period.
Judge Dooling did not modify his ruling and stated that even if DHEW
were eventually to win the case, "the payments (made in the interim) will
not have been illegal. They will be payments lawfully made under court
order for lawful services acutally rendered.'
POSSIBLE ACTIONS/DECISION: The issue awaits court action, and lead
responsibility within the Department is with the Office of the General
Counsel.
ISSUE: The National Institutes of Health Guidelines on Recombinant
Deoxyribonucleic Acid (DNA) Research.
BACKGROUND: After extensive scientific and public review, the National
Institutes of Health, on June 23, released guidelines that established
strict conditions for recombinant DNA research. The guidelines were
published in the Federal Register on July 7 for public comment. Further,
the NIH undertook to prepare and filed a draft environmental impact
statement in the Federal Register on September 9 for public comment,
The NIH, in August, also published a volume containing the transcript of
an NIH public hearing held on the proposed guidelines as well as the
correspondence received by the Director, NIH on this matter and relevant
meetings held prior to the release of the guidelines in June.
Further, in a letter to President Ford this summer, Senators Kennedy and
Javits recommended executive action to extend the scope of the NIH guidelines
to the rest of the public and private sectors. In response, President Ford
recommended the creation of an interagency committee to review these and
other important policy matters pertaining to this research. The Senate Health
Subcommittee, under the chairmanship of Senator Kennedy, conducted oversight
hearings on September 22 that focused on the need to extend the NIH guide-
lines to the public and private sectors with a mechanism to ensure compliance.
Dr. Donald Frederickson, Director, NIH, testified for the Administration and
agreed that an interagency committee would review these matters and come
forth with appropriate recommendations. A memorandum was sent by the President
on September 22 to all government department and agency heads requesting their
cooperation in the formation of an interagency committee. Following that
memorandum, Secretary of Health, Education, and Welfare, David Mathews sent
a letter to agency heads requesting that they nominate representatives to
serve on this committee. The committee held its first meeting on November 4.
At Secretary Mathews' request, Dr. Donald Frederickson is serving as chairman.
The mandate of the interagency committee is to review the nature and scope
of Federal and private sector activities relating to recombinant DNA research,
and to determine the applicability of the NIH guidelines to govern this
research in the public and private sectors. Further, the committee will
recommend whether legislative or executive action is necessary to ensure
compliance to standards. Contacts have been made and are being pursued to
determine the scope of this activity and the application of NIH guidelines
to private industry.
POSSIBLE ACTIONS/DECISIONS: The interagency committee will review the nature
and scope of Federal and private sector activities relating to recombinant
DNA research and will determine the applicability of NIH guidelines to govern
research in the public and private sectors. Within the next three to four
months, the committee is expected to have recommendations for the President
regarding legislative or executive actions necessary to ensure compliance
with the standards set for this research.
ISSUE: The Complex Regulation of Federal Research
BACKGROUND: The National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research was mandated by Title II of
P.L. 93-348 to make recommendations to the Secretary of HEW on a variety
of issues related to the Protection of Human Subjects. In the statute
particular emphasis was directed at formulating means for protecting those
with diminuition in their capacity to provide informed consent, specifically,
prisoners, children, and the institutionalized mentally infirm. In addition,
the statute required that the Commission address the propriety of
psychosurgery, fetal research and develop methods for protecting subjects
of research when the regulations developed by DHEW were inapplicable (i.e.,
when no Departmental funds were involved). The law requires the Secretary
to publish Commission recommendations in the Federal Register, evaluate
public comments, and then publish regulations which incorporate the
recommendations of the Commission (or explain why the recommendations are
not incorporated in the regulations).
The Commission has submitted to the Secretary recommendations with respect
to fetal research and these have now been published as rulemaking in the
Federal Register. Among the requirements for full implementation of these
regulations, is the establishment of an Ethical Advisory Board. This Board
has not yet been created; steps within the Department leading to the
establishment of the Board are underway.
The Commission has also submitted recommendations with respect to prison
research and the Department is currently drafting regulations with regard
to this subject group.
The National Commission is also required to report on the maintenance of
confidentiality with respect to research designs, hypotheses, and protocols
contained in research grant applications and contract proposals, the opening
or closing to the public of Initial Review Groups and Councils when reviewing
such applications or proposals, and the release to the public of preliminary
research data.
The other elements of the Commission's charge are rapidly approaching com-
pletion and should be presented to the Secretary before April 1977. However,
the recent Congress extended the life of the Commission by one year, from
April 30, 1977, to April 30, 1978. No additional responsibilities were
placed upon the Commission and it is not clear what the Congress expects
the Commission to accomplish during this extension period. During the
closing days of the 94th Congress, the Senate passed and the House sent
to Committee, a statute to make the Commission a permanent body and elevate
it to a Presidential Commission.
Each of these sets of recommendations will eventually be reduced to
regulation form. Each will have a significant effect on the way that
the PHS pursues its statutory research mission. Taken altogether, these
regulations will have a profound effect on the function, the cost, and
the nature of research conducted, supported, or regulated by the Secretary
of HEW.
The regulations generated by the National Commission for the Protection
of Human Subjects are not the only regulatory activity which is modifying
and transforming the procedures according to which research is carried
out in this country.
The Food and Drug Administration has already issued regulations governing
investigational drugs and has issued sweeping proposed rulemaking concerning
investigational medical devices. It is proposing to issue regulations
concerning good laboratory practices and the testing of vaccines. Each of
these sets of regulations will have significant impact on the conduct of
research in this country.
Other agencies have also issued regulations which, directly or indirectly,
exert influence on the way that research is carried out in the U.S.
The Environmental Protection Agency has sweeping authority to regulate
research that may affect the environment. Already it has required the
National Institutes of Health to issue an environmental impact statement
regarding recombinant DNA research, and such statements may be required
for other types of research in the future. It is likely that legislation
similar to the Clean Air Act will be passed with further possible research
impacts.
The Department of Agriculture promulgates regulations governing the care
and transportation of animals, including animals utilized for research
purposes. The Department of Transportation has published regulations
governing the transportation of hazardous substances, including radioactive
and etiological agents. The list of regulations which direct, constrain,
restrict, or prohibit the conduct of research is growing. (See also, for
example, Toxic Substances and Recombinant DNA Research.)
POSSIBLE ACTION/DECISIONS: It is imperative that a comprehensive evaluation
of the increasingly complex impact of such regulations on research conducted,
supported, or regulated by the Secretary of HEW, as well as research conducted
or supported by other Federal agencies, be made, in order that Congressional
mandates for performing research not be inadvertently impeded by mandates
for other programs.
ISSUE: The implementation of the Health Professions Educational Assistance
Act of 1976 (P.L. 94-484).
BACKGROUND: P.L. 94-484, enacted October 12, 1976, affects the entire spectrum
of health manpower education and training. It authorizes modification and con-
tinuation of current manpower programs in fiscal year 1977 and new and modified
programs in fiscal year 1978. It carries a total authorization level in excess
of $2 billion.
The Public Health Service must simultaneously (1) operate a grant cycle for
41 separate health manpower programs, (2) implement, including the pro-
mulgation of 30 sets of regulations, 25 major programs, and (3) recentralize
personnel and functions from 10 HEW Regional Offices.
The timing for implementing these factors of the law is critical, since they
impinge on the planning and budgeting of every medical and dental school in
the country, assistance to over 20,000 needy students, and the securing of
medical manpower to serve in rural and urban health manpower shortage areas
throughout the country.
POSSIBLE DECISIONS/ACTION: A number of policy issues must be resolved as the
PHS implements this legislation.
11/18/76
ISSUE: Federal Role in the Credentialing of Health Manpower
BACKGROUND: In 1971, pursuant to a Congressional mandate, DHEW
prepared the Report on Licensure and Related Health Personnel
Credentialing that addressed recommendations to States and pro-
fessional organizations concerning health manpower licensure and
certification. The 1971 Licensure Report also called for DHEW to
support a number of studies to determine the most appropriate
alternatives for credentialing health manpower. In 1975, PHS
established the Subcommittee on Health Manpower Credentialing under
the aegis of the Health Manpower Coordinating Committee to review
these studies and make additional recommendation if needed.
After intensive review of DHEW research efforts, as well as those
conducted by States and professional organizations, the Subcommittee
prepared a draft report, A Proposal for Credentialing Health Manpower,
which contained seven far-reaching recommendations for improving
health manpower licensure and certification. However, before formal
PHS or Departmental action was taken on the report, it was submitted
to State agencies and professional organizations for comment. The
report was widely distributed during the summer with a deadline for
comments by October 31, 1976. Approximately 500 responses have been
received and analyzed by the Subcommittee.
The report is presently being revised to address the major issues
raised by the respondents. This revision should be completed during
December 1976.
Major recommendations in the draft report pertain to the development of
a national (non-Federal) certification council to enhance health manpower
certification, development of uniform standards for licensure and certi-
fication, and possible linkage of uniform licensure and certification
standards to Federal reimbursement for health care. In addition, other
recommendations call for improvement of present State licensure pro-
cedures, more research related to proficiency examinations, and more
attention focused on continued competency matters.
POSSIBLE ACTIONS/DECISIONS: The report is being revised based on public
comment and decisions will be required as to its acceptance. The report
will become the general blue-print for future DHEW credentialing activi-
ties over the next several years.
It should be noted that the draft report has engendered considerable
interest and controversy among State agencies, professional organizations.
and health personnel. Therefore, the decisions on the report will have
a significant impact on the professional community.
11/18/76
ISSUE: Graduate Medical Education National Advisory Committee
BACKGROUND: There is general public and professional agreement that
there is an imbalance of physicians among the various medical and surgical
specialties. The current output of graduate medical education training
programs neither reflects a cohesive physician manpower strategy nor is
it derived from any agreed upon national goals for specialty manpower
requirements. To address these problems, the Secretary has established
the Graduate Medical Education National Advisory Committee using existing
authority under Section 222 of the Public Health Service Act as amended,
42 USC 217a. The purpose of GMENAC is to analyze the distribution among
specialties of physicians and residents and to evaluate alternative
approaches to ensure an appropriate balance. Also of special importance
to the Committee will be health care financing and reimbursement issues
which heavily affect the support of, and scope of, graduate medical
education and factors which must be given careful consideration in the
design of national health insurance options.
Rational, dependable goals and policies for specialty physician manpower
production will require a substantial improvement in manpower data,
analytic methodologies, and understanding of the dynamics and content of
specialty practice. Because of this, GMENAC's accomplishments and cont-
ributions must be seen as both short and long range. During its initial
2 year phase, it is anticipated that the Committee will provide the
following: a description of the current supply of physicians by specialty,
nationally and with regional variations; a description of physician
specialty requirements using various assumptions; a characterization
of the current graduate medical education pipeline; a first approximation
of a more appropriate specialty education production mix; the identification
of research issues that must be addressed to improve our understanding
and ability to refine graduate medical education goals in the future; and
provide recommendations for action to the Secretary based upon its findings.
It should also be noted that Congress accepted GMENAC, in concept, and
rejected a more direct regulatory approach to solving the problem of
specialty maldistribution. For this reason, the work of GMENAC is much
more critical in providing the setting of additional congressional
legislation in this area.
POSSIBLE ACTION/DECISION: GMENAC will be providing a major report to the
Secretary embodying its findings and recommendations 18 months after it
convenes. Additionally, a status report will be provided no later than
December 15 in each year of the Committee's existence. At present, the
appointment of members to the Committee is pending.
ISSUE: Promulgation of Occupational Health and Safety Standards
PROBLEM: Today, five years after enactment of the Occupational Safety
and Health Act of 1970 (OSHAct), there are still annually 2-3 million
injuries and over 100,000 deaths from occupational diseases and injuries--
resulting in an annual societal cost of $20 billion from workmens'
compensation payments, property damage losses, and third party product
liability law suit damages. The OSHAct relies strongly on safety and
health standards as a central focus for achieving the goal of a safe and
healthful workplace. Although NIOSH in the Public Health Service, has
recommended more than 50 occupational health standards (criteria documents),
including several for occupational carcinogens, OSHA in the Department
of Labor has promulgated only one health standard through the normal
rulemaking process.
BACKGROUND: Under the OSHAct, NIOSH has the responsibility to develop
recommendations for occupational health and safety standards. Since its
passage, NIOSH's primary focus has been on occupational health through
the development of criteria documents which thoroughly review and evaluate
available scientific information and present a complete occupational health
standard, including a permissible level of exposure, medical monitoring,
training of employees, safe work practices and requirements for monitoring
of workplace air. It is recognized that a major drawback in this effort
has been information as to technical feasibility to meet a proposed
standard. Consequently, NIOSH has initiated efforts to assess available
information in this area.
In addition to this effort, NIOSH in cooperation with OSHA, initiated a
Standards Completion Program in March 1974 to supplement some 400
occupational health standards which had been put into law soon after
passage of the OSHAct and had been developed earlier by occupational
health professional societies on a consensus basis. These standards consist
only of an allowable workplace environmental limit of exposure and do not
include information on monitoring, informing employees of the nature of
the hazard, medical examinations and safe work procedures. NIOSH has
completed its agreed upon share of the Standards Completion Program.
However, OSHA has fallen behind in its role and has yet to promulgate any
of these supplemental standards. Part of this delay is due to OSHA now
unilaterally revising some of the initially agreed to concepts and procedures
of the Standards Completion Program.
RECOMMENDED COURSE OF ACTION: OSHA should be directed and encouraged to
move in a more expedious manner to promulgate standards. OSHA could
employ innovative approaches, such as comprehensive standards for processes
or industries and grouping a number of rulemaking efforts, e.g., a broad
standard for carcinogens and one rulemaking effort for the Standards
Completion Program. Also the process for determining economic feasibility
and inflationary impact should be reevaluated and streamlined with more
emphasis placed on the economic benefits of preventing occupational
illnessess and injuries. When this is done, NIOSH support can be integrated
into a joint effort to achieve well defined goals. This course of action
should also receive the support of both labor and management, who in the
past have been faced with some uncertainty as to OSHA's regulation schedule
and intentions.
ISSUE: Assuring coherence in formulating environmental health policy.
BACKGROUND: Recent environmental crises resulting from kepone and PCB
contamination, and the continuing uncertainties about the efficacy of the
catalytic converter highlight the fact that we do not yet have a coherent
National environmental health strategy. Such a strategy should outline
the necessary regulatory, research, and surveillance goals of the Nation
in environmental health, and it should clearly define each Federal Agency's
role in achieving those goals.
One major objective is to establish within DHEW a systematic process for
policy formulation regarding the health aspects of the environment and for
coordinating our involvement with other Federal Agencies, such as EPA and
DOL, which have primary regulatory responsibilities in this area. This may
require new organizational and decision mechanisms to assure scientific
guidance to other Federal Agencies, and to offer leadership and technical
assistance needed by State and local agencies to resolve environmental health
problems.
As a first step toward this end, a subcommittee on environmental health of
the PHS Policy Board has been formed. In addition, NIH, CDC, and FDA have
been requested to complete by January 1977 an internal review of their
environmental research, regulatory, and surveillance activities to facili-
tate a later reassessment of all PHS responsibilities in environmental
health.
POSSIBLE ACTIONS/DECISIONS: The recent passage of the Toxic Substances
Control Act reemphasizes the necessity for DHEW to develop a national
environmental health strategy and the need to establish a more formal mech-
anism for fulfilling its responsibility in environmental health.
ISSUE: Improvements needed in efforts to help the mentally disabled
return to and remain in communities? (deinstitutionalization)
BACKGROUND: As a result of its study on "deinstitutionalization" the
GAO this past summer issued a draft of the report identified above. The
draft report is currently being reviewed by the various agencies involved
to develop comments to GAO on the document. At the completion of this
process, GAO is expected to issue a final report (estimated to be finished
early 1977).
The draft report identified that "many mentally disabled (i.e. both
mentally retarded and mentally ill) persons have been released from insti-
tutions before sufficient community facilities and services were available
and without adequate planning and follow-up. Many persons remain in,
continue to enter, or reenter institutions unnecessarily. GAO indicated
that many of the problems were due to "1) Federal programs which provide
financial incentives that inhibit the appropriate placement of the mentally
disabled and 2) the lack of leadership and action by many Federal agencies
whose programs do, could, or should impact in community placement. 11 In
addition GAO identified as problems lack of coordination between Federal
agencies, and within agencies and between the State and local governments
and service systems (CMHCs and state institutions).
The draft report had recommendations to Congress; OMB; HEW (including PHS,
Medicare, Medicaid, SSI, Vocational Rehabilitation); HUD and Labor.
ANTICIPATED ACTIONS: When the final report is issued each of the affected
agencies can anticipate having to document what actions they are or have
taken to address the GAO recommendations, or if no action is taken to
justify such a move. In addition, because of the coordination problem
identified the executive branch should anticipate having to deal with
questions and concerns in this area.
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ISSUE: PHS Uniform Charging Policy for Recipients of Services at
Grant Supported Health Service Delivery Projects
BACKGROUND: The need for a definitive or uniform policy arose in
FY 76 during a review of various program regulations and guidelines.
It revealed widely divergent guidances to grantees on charging
individuals for services. For three programs, Community Health
Centers, Community Mental Health Centers and Migrant Health Centers,
legislation passed in July of 1975 (P.L. 94-63) requires projects to:
-- establish fee schedules based upon the costs of operation;
-- establish discount schedules consistent with a patients'
ability to pay; and,
-- secure payment from patient according to those schedules.
It seems desirable that in developing a policy to implement these
provisions of P.L. 94-63, that we should not limit to these three
programs the consideration of how one determines a person's ability
to pay. We should develop a policy that will be equally applicable
in all of our grant-supported health services delivery programs.
Some of the programs considered for conclusion under this policy are:
-- Alcohol Treatment Projects
--- Community Health Centers
-- Community Mental Health Centers
-- Drug Abuse Projects
-- Family Planning Projects
--- Hemophilia Treatment Projects
-- Home Health Projects
-- Maternal and Child Health Projects
-- Migrant Health Projects
-- National Health Service Corp Sites
POTENTIAL DECISIONS/ACTIONS: PHS is in the process of formulating a
basic policy. By December or early January we would expect to have
before the Secretary a Regulations Development (RDP) which will detail
our intended course of action in seeking public input on the proposed
policy. It is anticipated that the proposed PHS charging policy will
lead to similar policy considerations in other Departmental program
supporting the delivery of services to individuals.
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ISSUE: What should be the Federal role in the medical malpractice
insurance problem?
BACKGROUND: The subject area became a "crisis" in the Winter of
1974-75 when medical malpractice insurance became difficult to obtain
in many areas. The availability problem has now largely abated, but
the costs of malpractice insurance continue to rise at an average
national rate of about 20% per year. Other factors, such as high
legal costs, and low percentage of premium dollar reaching the
injured persons, persist. The Department's policy has been that
when government intervention is required, it should occur at the
State level, since it is the States who traditionally have regulated
the insurance industry and licensed hospitals and physicians. For
its part, however, the Federal government has been instrumental in
encouraging cooperation between the important groups--insurance
commissioners, physicians, hospital administrators, law groups, and
insurance representatives. In addition, the Federal government
through HEW has been building a better base of information in which
decisions by both the public and the private sectors can be based.
This work has included acting as an information clearinghouse and
conducting a number of research projects on priority question areas.
Although there remain numerous narrow questions on medical malpractice
warranting research, the major questions identified initially have
either been answered or are currently being addressed. However, as
a result of this work, it has become apparent to a number of researchers
in the area of malpractice that an initiative outside the tort
liability system should be tried. Probably the easiest to try, and
then only in a limited way, is the "designated compensable events
compensation plan. With this plan, certain outcomes of medical care
are determined to be usually avoidable, and when they occur, to be
compensable without the necessity to show fault. This will eliminate
the need to prove malpractice in some, but not all situations. The
validity of the concept, and the cost, need to be studied, and if
proven feasible, a pilot study should be initiated.
POSSIBLE ACTIONS/ISSUES: In order to further define the Federal role,
HEW plans to sponsor the initial feasibility work on a pilot for a
designated compensable event compensation plan. It is expected that
the majority of funding, should the pilot be feasible, will come from
sources outside the Federal Government.
It is expected that the costs of malpractice insurance will continue
to rise, with some slowing as a result of changes in the tort system.
In addition, periodically, small problem areas will arise. Thus,
there will be pressure for Federal intervention.
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ISSUE: BIO-RESEARCH MONITORING
Under the Federal Food, Drug, and Cosmetic Act, manufacturers carry the
burden of demonstrating that their products meet the safety standards of
the law. FDA does relatively little toxicology testing of its own and no
clinical testing. Instead, we set requirements for teratogenic, carcinogenic,
and mutogenic testing, and then review the data submitted by manufacturers
to determine whether they meet these requirements. Animal studies of human
drugs are of particular importance to determine whether new products can be
safely tested in humans to assess their potential therapeutic effect.
Because of the importance of animal toxicology data to decisions regarding
the safety of drugs, food additives, chemical residues, and environmental
contaminants, it is essential that these studies be conducted according to
specifically sound protocols and with detailed attention to their quality
control.
There have been several recent instances of improper withholding or submission
of false animal data in support of new drug applications. Defects in the
design, conduct, and reporting to FDA of animal toxicology studies by a major
pharmaceutical manufacturer were uncovered. Serious flaws in research design
and performance have also been discovered at independent laboratories.
Inspections have indicated that in some cases significant animal toxicity
data were not available to FDA for evaluation prior to approval of extensive
testing in humans.
Because of the significance of the above findings, and because any program
designed to address the total problem would be a new Agency-wide program,
the FDA Policy Board established an Agency-wide steering committee, chaired
by the Associate Commissioner for Compliance, to coordinate the implementation
of the program. Five task forces were established: Toxicology Laboratory
Task Group, Institutional Review Committee Task Group, Investigator/Sponsor
Task Group, Food Additives Task Group, and Administrative Task Group. These
task groups were set up to develop specific plans for the major part of the
program, including inventories, formal agreements with other agencies,
standards, enforcement strategies, etc.
In June FDA was allocated a budget supplement of 200 positions and $1.2 million
for the transitional quarter to develop plans for a Bio-Research Monitoring
Program. For full implementation, 606 positions were included in the fiscal
year 1977 budget.
Proposed Good Laboratory Practices (GLP) regulations, published in the
Federal Register on November 19, set standards for all aspects of animal
and other laboratory studies, from facilities and equipment to personnel and
record-keeping. Non-compliance with the regulations could result in rejection
of data submitted to FDA in support of new drug or food additive application,
withdrawal of approval of a marketed drug or food additive, or disqualification
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of the laboratory in question. The proposed regulations would affect at
least 550 U.S. laboratories as well as foreign laboratories conducting
studies to be submitted to FDA.
During the next three months, FDA investigators will inspect approximately
40 laboratories to evaluate current practices in light of the proposed
regulations as well as to get a broader view of the quality of current
research.
POSSIBLE ACTION/DECISION
Early in 1977 FDA will hold a public hearing to promote an effective exchange
of views concerning the scientific soundness and practicability of the
proposed regulations. Final regulations will be issued after consideration
of written comments and those received at the hearing.
ISSUE: Sterilization Services in HEW programs (Titles XIX and XX of the
Social Security Act and various programs of the Public Health Service).
BACKGROUND: Surgical sterilization is considered a legitimate family
planning method for those who have completed their families and for those
for whom future childbearing carries a severe health risk. As with any
other surgical procedure, age of legal consent for sterilization varies
among states and jurisdictions of the U.S.
On June 14, 1973, two sisters, aged 12 and 14, were sterilized in a
Montgomery, Alabama, family planning project supported by the Office of
Economic Opportunity, with actual payment for the procedures made by
Medicaid. The sterilizations occasioned a series of civil suits (Relf V.
U.S.A., C.A. 74-244, a tort, claiming one million dollars in damages,
National Welfare Rights Organization V. Weinberger (now Mathews) et al.,
C.A. 74-243 and Relf et al., V. Mathews et al., C.A. 1557-73).
Since July, 1973, the Department has issued a number of directives on
its own and in response to Court Order. There are currently two such
directives in effect: a moratorium (August 3, 1973) on federal financial
assistance for sterilizations of persons under the age of 21 or legally
incapable of giving consent; regulations (April 18, 1974) governing the
consent procedures to be followed for sterilizations of persons 21 and
older who are themselves legally able to give consent.
Between February, 1974, and October, 1975, in NWRO V. Mathews, the
Department argued in Federal District Court, that it be permitted to set
its own standards for family planning program services. The Department
proposed that the age of consent be lowered to 18 for sterilization
procedures (unless states imposed stricter age standards) and that steri-
lizations, with added safeguards, be permitted for certain persons legally
incapable of giving consent, but capable of understanding the nature and
consequences of surgical sterilizations. On October 22, 1975, the Court
ruled against the Department on the matter of standards, but denied,
without prejudice, plaintiff's motion that the Court intervene in enforcing
the April 18, 1974, regulations.
POSSIBLE DECISIONS/ACTIONS: Both the Department and plaintiff (NWRO)
appealed the October, 1975, decision of the U.S. District Court judge.
Oral argument on the appeal is set for November 18, 1976.
Dates for further hearings in the tort (Relf V. U.S.A.) are not yet set.
The immediately available alternatives are:
1. The Department will continue its appeal of the October, 1975, U.S.
District Court order, thereby arguing that it has a right to set administrative
procedures for insuring the rights of persons who would be sterilized with
federal funds.
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2. The Department will drop its appeal, thereby allowing the October,
1975 order to stand, and continuing in force the moratorium on federal
financial participation of sterilizations of persons under age 21 or other-
wise legally incapable of consenting, and the regulations of April 18, 1974.
ISSUE: The Need for Improved Mechanisms for Technology Transfer and
Technology Assessment at the Health Research/Health Care Interface.
BACKGROUND: By long tradition within the research community, the main mode
for dissemnination of research results is through publication in the open
science literature, with some dependence also on conferences and workshops.
This modus operandi adequately serves the needs of science. However, there
has been increasing criticism in Congress and elsewhere that these research
results are not getting into health care practice systematically or with
even distribution, and that sometimes introduction is premature or unduly
delayed. High points of effectiveness in this information interchange are
(1) the teaching hospitals associated with main medical schools and (2)
the major disease research centers, where there are also strong clinical
care components. But the dominant picture is of wide variation in the
availability of quality health care across the country.
It is quite clear that dissemination processes and mechanisms on both sides
of the health research/health care interface are inadequate, and require
improvement. It is also true that clear-cut mission and role assignments
for these functions have not been made among the number of Federal agencies
with health responsibilities.
With the above as perspective, the NIH has been exploring means to correct
weaknesses on the research side of the interface. Specifically, the NIH
has been trying to devise acceptable and effective mechanisms for further
processing of research information within the research community, with this
objective: to assure that clinically relevant information flowing from
research is (1) identified promptly; (2) validated adequately for efficacy
and safety; (3) assessed where appropriate for ethical or cost impact
issues; and (4) recommended in easily accessed form for pick up by the
health care system. (Where it is possible to achieve a reasonable consensus
on optimal modes of diagnosis, treatment, or prevention, these will be a
part of the transfer package.)
POSSIBLE ACTIONS/DECISIONS: Many controversial issues--including basic
feasibilities--will have to be worked out within the research community.
When these are settled, there will remain policy issues of added resource
requirements, inter-digitation with processes on the health care side of
the interface, and adjustments in agency missions and roles.
ISSUE
The pay and benefits for clinicians and researchers are substantially below
that of comparable non-Federal positions and need to be raised so that top
quality personnel can be recruited and retained.
BACKGROUND DISCUSSION
The Public Health Service (PHS) is an integral part of a large medical and
research community which consists of hospitals, universities and medical
schools, as well as private practitioners. Movement of staff between various
institutions within this community is essential to the maintenance of creativity
in each of its components.
In recent years the movement of experienced senior level staff between PHS
and other medical and research institutions has increasingly become .a one-way
flow -- out of PHS. Now, when a key staff member accepts a better offer in a
university or a hospital, it is always difficult and frequently impossible to
attract outside candidates with comparable experience and stature. The major
factor contributing to this trend is the difference between the salaries and
benefits provided by non-Federal institutions and those available under the
Civil Service system. Some median salary figures from the Association of
American Medical Colleges Annual Salary Survey for Fiscal Year 1975-76 illustrate
this point. During a period when the top salary for Civil Service employees
was $37,800, half of the full-time professors of clinical sciences received
at least $45,000 in salary and half of the full-time clinical science department
chairmen received at least $57,000 in salary. Individuals who were in the top
20 percent of the range for clinical science faculty -- the group from which
PHS is generally trying to recruit for research positions -- made at least
$55,000 as full professors and $68,000 as department chairmen during this same
1975-76 period. Since benefits in academic institutions are generally superior
to those in Civil Service, a total income comparison would show an even greater
advantage for our competitiors.
Salary competition is not new to PHS but the problems we are facing as a result
of it are much more critical than in the past. It is no longer just a question
of individual, highly specialized positions that are difficult to fill. The
cummulative effect of not providing adequate salaries over the last several
years has dangerously eroded our capacity to retain staff who earlier committed
themselves to a career with PHS and it has so significantly increased the economic
sacrifice of those we try to attract that a substantial number are unwilling to
even talk about the possibility of working for PHS.
ACTION RECOMMENDED
The Department should continue to urge the Commission on Executive Legislative
and Judicial Salaries to substantially raise executive salaries and the ceiling
on senior level Civil Service salaries.
ISSUE
Implementation of the Department's Three-Year Position Classification Review
Program will require downgradings. Downgradings may have an adverse impact on
program operations. This impact should be minimized.
BACKGROUND DISCUSSION
The Three-Year Review Program has as its objective, accurate classification of
all Department positions. The Public Health Service (PHS) supports this objective
and has developed a plan for implementing the findings of the review. We are now
working on the three-year review. Already problems are appearing. The major
problem has to do with the use of reduction-in-force (RIF) procedures. When a
position is identified as inaccurately described and overgraded, RIF procedures
are required to place the incumbent. Civil Service rules require that all
positions involved in a RIF be accurately classified. Since our review is a
three-year review, it will be three years before we can be sure that all positions
that could be involved in a RIF are accurately classified. This leaves us with
two alternatives. One, do the RIF and attempt to assure that all positions
involved are accurately classified. Two, hold all RIF action until all reviews
are completed. While we are following the first alternative, since we see no
legal basis for delaying required action for three years, we expect appeals and
court actions, some of which we may well lose. We also expect that considerable
employee energy will go into resisting downgrading actions; energy that would
otherwise go into programmatic activities. RIF's would also result in employees
being placed in positions for which they are minimally qualified and delaying
action for three years would not solve any problems. The threat of downgrading
can only sap employee energy and encourage turnover. Turnover resulting from
these circumstances usually means losing the better workers because they are
the ones most attractive to other employers. The combined effects of employees
resisting RIF action and increased turnover will diminish productivity.
ACTION RECOMMENDED
That the Department press vigorously for legislation that would guarantee grade
and pay retention for employees found assigned to misclassified positions during
the three-year review. Such retention would continue until the employee leaves
the position voluntarily, in which case normal pay setting rules would be
applied, or the position is abolished, in which case RIF procedures would be
applied.
ISSUE: Reimbursement of Physician Extender Services
BACKGROUND: "Physician extender" (PE) is a term used to describe physician
assistants and nurse practitioners who are trained to perform routine tasks
that are normally performed only by physicians.
Under present Medicare law, PE services can be reimbursed only if the services
are rendered under the direct (on the premises) supervision of a physician and
if the service rendered is one normally delegated to auxiliary personnel. In-
asmuch as PEs often practice in remote site locations without direct supervision
and are trained to perform tasks usually performed by a physician, many of
their services are not now reimbursed under Part B of Medicare.
This reimbursement policy is in contrast with Departmental support for PE
training. Through FY 1976, DHEW allocated approximately $75 million for PE
training programs. Some 8700 PEs have graduated from these programs, and a
substantial number are still in training.
Recognizing the dichotomy in Departmental support for PE training but denial of
reimbursement under Part B of Medicare, the Congress mandated a study of PE re-
imbursement under P.L. 93-603 enacted in 1972. This study is being conducted
by SSA, but has encountered a number of organizational and administrative prob-
lems so that results of the study will not be available until 1978. Meanwhile,
as number of PEs increases and concern about geographic maldistribution of
health manpower continues, there is growing pressure on the Department to sup-
port a legislative proposal to reimburse for the full range of services under
Part B of Medicare. (Medicaid regulations permit reimbursement for PE services
that are rendered in accordance with State law.)
Several bills to permit PE reimbursement under Medicare were introduced during
the last session of Congress, and new legislation will be introduced in 1977.
Inasmuch as the Department will be asked to testify or comment on such legis-
lation, there is a need to formulate a clear Department position on this issue.
POSSIBLE ACTIONS/DECISIONS: A number of major options are now under considera-
tion in the Department.
1. Do not support proposals to expand Medicare coverage for PE services and
try to expedite the SSA study.
2. Support reimbursement for PE services under Medicare on a limited scale--
e.g., in PHS-supported projects or in practices located in underserved
areas--until completion of the SSA study.
3. Support a legislative proposal that would extend Medicare coverage
to include the full range of services rendered by physician extenders.
(The employing physician or institution would bill for these services.)
4. Support a legislative proposal that would permit independent billing by
PEs for selected services under Medicare and Medicaid.
5. Establish a new class of provider "clinics," which, among other things,
would increase availability of support to PE.
A major proposal is under development.
ISSUE: Redirection of mental health manpower clinical training programs.
BACKGROUND: From their inception in 1948, NIMH clinical manpower training
programs have been developed and funded separately from other PHS health
manpower training programs. Such support has substantially increased the
nation's supply of psychiatrists, psychologists, social workers, and
psychiatric nurses. Since 1972, however mental health manpower clinical
training programs have been proposed for phase out by the Administration.
Although the Congress has restored such program funds each year, it has
been at progressively lower levels of funding.
During this same period, the Department formulated a general health manpower
strategy which emphasizes the development of primary care practitioners as
a means of solving shortage and maldistribution problems. In October of
this year, the Congress also endorsed such a strategy for solving resource
problems in passing P.L. 94-484, the new health manpower law which emphasizes
primary care training. The development of the latter legislation, along
with the Department's new manpower strategy brought about reconsideration
by ADAMHA of the direction of its training programs. This reconsideration
was given added incentive in this year's House Appropriations Committee
hearings, when Members asked that ADAMHA keep the Congress informed of any
efforts to redirect mental health manpower training funds.
ADAMHA PROPOSAL: Through a major redirection initiative, ADAMHA proposes
a phase out of long term support for current psychiatric and other mental
health manpower clinical training programs as existing commitments expire.
In exchange, it provides for a phase in of a three-tiered program empha-
sizing primary care, research and development, and state manpower development.
1. Primary Care. Through time-limited grants, programs will be
developed which integrate mental health education into the
curricullum of primary care providers, including physicians,
nurses, and physician assistants.
2. Research and Development. Through short term grants, mechanisms
will be developed providing innovative approaches to mental health
training as well as models which effectively and efficiently
address mental health manpower maldistribution and other manpower
problems.
3. State Manpower Development. This program would distribute funds
to states for assistance and support to build capacity for mental
health manpower planning, resource development, and utilization.
States would be required to submit an annual plan and to work in
cooperation with community mental health service providers and
educational institutions.
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POSSIBLE DECISIONS/ACTIONS:
This proposal has been accepted in principle and will need to be
incorporated into the upcoming session with the Secretary.
ISSUE: Revision of FDA Drug Legislation
BACKGROUND: FDA is developing specifications and justification for a
comprehensive rewrite of drug laws to provide a manufacturer license, a
product license, and a public standard (drug monograph) for the drug
entity. It will cover all drugs -- prescription, over-the-counter,
antibiotic, and insulin. The old drug/new drug considerations would be
eliminated.
Drugs Under Investigation. Revised procedures are needed to enable
FDA and its advisors to become involved early in drug development
and review data in the early phases of drug investigation.
Plant Licenses (Manufacturers, Repackers, or Other Product
Manipulators for Active or Inactive Ingredients). Under the proposed
rewrite, each manufacturer would be issued a license for each
facility on the basis of compliance with good manufacturing practices.
Provisions would be included for amendment, revocation, suspension,
and reinstatement of licenses.
Product Licenses. Each existing product would be granted a product
license according to requirements set forth by FDA,
Miscellaneous Provisions.
1. Extend FDA authority to all drugs and drug handlers.
2. Authorize FDA to restrict distribution and dispensing of
certain drugs.
3. Expand records and reports authority and provide subpoena
authority.
4. Provide for drug embargo, civil fine, and expanded
adminstrative authority.
5. Establish clear U.S. policy on drug exports.
POSSIBLE ACTIONS/DECISIONS: A consideration of this major legislative
package will be required by mid-1977.
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ISSUE: Selection of a site for the main laboratory building of the National
Institute for Occupational Safety and Health (NIOSH).
BACKGROUND: The NIOSH main laboratory operations involving research, technical
assistance, and training have been located in several leased or Federally-owned
structures in Cincinnati, Ohio, for a number of years. The structures are
inadequate for research purposes and with substantial increases in personnel
over the past several years, they are deficient in size.
About nine cities, aware of the facility need, wrote to the then-Secretary
asking that their location be considered as the permanent site for NIOSH
activities and offering to build and lease to the Government an appropriate
structure. A site study team was formed to visit the locations, evaluate
their potentials and provide the Secretary with a recommendation. The study
was accomplished and, Houston, Texas and Cincinnati, Ohio, were recommended
as the best of the nine sites. On April 26, 1973, the Secretary announced
that Cincinnati had been selected.
The House Appropriations Subcommittee report of June 19, 1975, on the fiscal
year 1976 budget was critical of the study and the selection of Cincinnati;
it asked that a second study be initiated considering all potential sites
rather than just those requesting consideration. The 1976 budget also
contained about $1.1 million for the design of a Federally-constructed facility
rather than a lease structure. Design work has been initiated and is about
30 percent complete. A second group was formed and evaluated all possible
sites meeting program criteria previously established. No site visits were
made because of time constraints imposed by Congress for reporting back to it.
The group concluded that there were no compelling reasons to change the
previous selection of Cincinnati and Secretary Mathews affirmed the earlier
decision. Congressional criticism of site criteria, method of evaluation,
and the speed with which the second report was concluded continued during
hearings on the fiscal year 1977 budget.
The House-Senate conferees report of August 3, 1976, on the 1977 budget in
referring to the NIOSH facility states, in part,
"
the Conferees agree
that the Secretary of HEW shall study site selection and report his results
to the Congress prior to December 31, 1976. It has been decided to utilize
an outside contractor to conduct the third study; the firm will be guided by
a set of criteria incorporating program requirements and certain ancilliary
needs that Congress believes appropriate to the evaluation. Contracting
procedures will preclude meeting the December 31 date and the letter trans-
mitting the draft criteria for the review of the Chairmen of the House and
Senate Appropriations Subcommittees carries this notation.
It is not likely that the site survey report will be completed before
March 1977. The report conclusions are not predictable; it could recommend
Cincinnati or one of 20 to 25 other locations. It is also possible that
several cities could be ranked as equally desirable.
ACTION REQUIRED: During March 1977, or shortly thereafter, a decision must
be made on the permanent location of the main research facility for the
National Institute for Occupational Safety and Health.
ISSUE: Transfer of St. Elizabeths Hospital to the District of Columbia
and upgrading of the facility to meet JCAH standards.
BACKGROUND: The fiscal year 1977 budget proposed an appropriation
authorization of $75 million for construction and/or renovation of
mental health facilities at Saint Elizabeths Hospital taking into con-
sideration the mental health facilities needs and resources of the
District of Columbia. This authorization of $75 million (subsequent
OMB concurrence of $100 million) was to be included in legislation, in
the last Congressional session, supported by the D.C. and the Executive
Branch to: 1) establish a future transfer date of the Hospital to
administrative control of the District; 2) gradually reduce Federal
support for operation of the Hospital after transfer; and 3) mutually
arrive at critical decisions with respect to delineated responsibilities
of the two governmental jurisdictions.
In September 1975, the Joint Commission on Accreditation of Hospitals
conducted its most recent survey and, in November, notified the Hospital
of the disaccreditation of its psychiatric facilities (the medical and
surgical program received another one year accreditation). The major
defects identified related to fire and safety items and staff shortages
in specific program areas.
Both the 1974 and 1975 surveys identified needs in the area of internal
management- principally with respect to patients' records. The Hospital
is addressing this problem, and will not require additional resources.
Several other actions are currently underway to correct the facility
problems:
In 1975, a total of $1,260,000 was reprogrammed from other facility
projects, to initiate the early stages of work upon the recommendations
set forth in the 1974 survey.
In 1976, a total of $10,400,000 was appropriated for planning (conduct
of a total engineering, architectural study of a physical plant, Report
on the Master Plan, required by Congressional Appropriations Committees,
to be submitted early January 1977), and move ahead with work necessary
to comply with recommendations of the JCAH related to patient safety,
patient privacy, improving facilities related to patient services, etc.
The supplemental appropriations request of $75,000,000 will permit
proceeding with construction and renovation to relieve overcrowding of
the Hospital and commence a phased plan of replacing obsolete buildings
to comply with standards of JCAH, Life Safety Code, etc. This will
further meet the commitment of President and Congress (funds are included
in the concurrent resolution for FY 77) to regain accreditation and restore
the Hospital to an accredited facility.
11
ACTION REQUIRED:
On-going collaboration with D.C. with respect to planning
for transfer to D.C.;
Planning and preparation with D.C. for placement of some
1,300 patients in community settings to comply with Court
Order in Dixon V. Weinberger;
Activities related to improve operations and management;
Further refinement of draft legislation for introduction at
the earliest opportunity, in the next Congressional session,
transferring the Hospital to the District, thereby establishing
a single administrative authority for the District's Mental
Health Delivery System.
ISSUE: The appropriate course of action to be taken with respect to the
Public Health Service hospital system.
BACKGROUND: The Public Health Service hospital system was established in
1798 to provide medical care to merchant seamen. Over the years, other
classifications of beneficiaries have been served by these facilities.
At its peak, the system had hospitals located at all major ports on each
coast, along the Gulf of Mexico, and on the major rivers of the inland
waterways. Because of the decline in inland waterway traffic and certain
coastal ports, utilization at certain hospitals declined to a point where
their continued operation was no longer justified. After publication of
the Hoover Commission Report in 1955 that recommended one Federal hospital
system, repeated attempts have been made to close or transfer to community
control all of the PHS hospitals. To date, all such attempts have failed
because of strong congressional opposition although about a half dozen
underutilized facilities have been closed one or two at a time. At present,
there are eight General Medical and Surgical (GMS) hospitals in operation
at Boston, Massachusetts; Staten Island, New York; Baltimore, Maryland;
Norfolk, Virginia; New Orleans, Louisiana; Galveston, Texas; San Francisco,
California; and Seattle, Washington. The National Leprosarium at Carville,
Louisiana has not been included in hospital closure efforts and the need
for care and research of Hansen's Disease which are unique to this facility
has not been challenged.
In addition to providing care to American seamen, these hospitals also
provide care to active duty personnel of the Coast Guard, National Oceanic
and Atmospheric Administration, and the Public Health Service. Health care
is provided on a reimbursable basis to other groups when permitted by physical
and staff resources; included in these groups are beneficiaries of other
Federal agencies, e.g., members of the Armed Forces and their dependents,
foreign seamen and community residents. The hospitals also have major
responsibilities in medical education and training, community health services,
biomedical research, and responses to natural and man-made disasters.
Funding for needed maintenance and repairs during the past 21 years has been
minimal and sporadic, most often occurring to meet exigent situations.
Design funds authorized by the Congress in 1965 and 1966 for the modernization
of the system were only partially expended; a significant portion was
reprogrammed for other purposes and the remainder unobligated until 1974.
The failure to expend either all repair and improvement funds or moderni-
zation design money was due to the application of one of two rationales.
The first of these concluded it was not justifiable to spend money on
hospital facilities scheduled for closing or transfer from Federal owner-
ship. The second rationale, applied in the 1960's, reasoned that with
modernization planning under way, funds used for repairs and improvements
in the interim would be lost when modernization work was initiated.
11/18/76
After a number of the previously mentioned efforts to discontinue operation
of the PHS hospitals, Congress in 1973 enacted Section 81.8 of P.L. 93-155,
which requires that the Secretary take such action as necessary to assure
that services continue to be provided by the hospitals in like manner as
such services were provided on January 1, 1973. Alternatively, the
Secretary may propose legislation to the Congress to close hospitals
provided the proposal is accompanied by the written approval of affected
State and local health planning agencies. Within the last year, approvals
of the planning agencies were solicited in anticipation of submitting
legislation to close or transfer to community control the eight PHS hospitals.
However, none of the requested approvals were received and the hospital
system continues to operate at the January 1973 level.
The Federal Government can no longer risk the continued operation of these
facilities in their current states of disrepair. Twenty-one years of
neglect in maintaining the physical plants has led to their serious
deterioration. Congress has recognized the situation and requested a
Master Plan for modernization and renovation of the PHS hospital and clinic
system by October 30, 1976.
ACTION REQUIRED: Because the condition of the PHS hospitals presents a
potential threat to the safety and welfare of patients and staff, an early
decision is required to either close these hospitals or designate them as
research and demonstration centers in the delivery of health care services
and embark on an immediate program to repair and improve them.
ISSUE: Financing of Home Health Services.
BACKGROUND: The Department is concerned about the high cost of medical care
and the attendant problems in the health care delivery system. The role of
home health care as a means of health care delivery that may have the potential
for moderating costs is receiving considerable attention. There are numerous
issues involved in delivering and financing home health services which are
involved in this discussion including barriers to eligibility and range of
services available for home health care as well as the perception that Federal
regulations deter the rational development, expansion and coordination.
Partly in response to public reaction to 1975 proposed changes in the Title
XIX program (Medicaid) regarding home health services, a series of public
hearings were held between September 20 and October 1, 1976. A report,
Home Health Care: Report On The Regional Public Hearings, on the proceedings
was published October 29, 1976. This report highlights the major themes of
those presenting testimony which are listed below:
1. Home health care is socially desirable and beneficial.
2. Coverage of services should be expanded both in scope and
in range of individuals. That is more services such as
homemaker, occupational therapy, transportation be added
and that all age groups be included.
3. More information is needed on cost and methods of financing.
4. Administration of various programs must be better coordinated.
5. Mechanisms of planning, showing need for providers and assuring
quality, need to be strengthened and enforced.
6. Fraud and abuse must be controlled and prevented.
7. Artificial barriers imposed by Federal requirements should
be removed.
8. A more coherent Federal policy regarding home health care
should be developed.
While the comments identified the problems as perceived by the witnesses at
the hearings, there was little consensus on solutions. The effect of pro-
posed changes on the Federal Funding programs; Titles XVIII (Medicare),
XIX (Medicaid), and XX (Social Services) of the Social Security Act, as well as
Titles III and VII of the Older Americans Act was not explored. It summarized
the information presented at the hearings and can serve as a basic discussion
document in efforts aimed at resolving the problems.
POSSIBLE DECISIONS/ACTIONS: A Department-wide Home Health Care Working
Group was just designated to develop a paper which will set forth the
options that the Department must address in achieving a policy position.
Of particular concern will be possible expansion of benefits, optional
financing mechanisms, the pros and cons of further demonstrations, need
for quality assurance mechanisms and training, and cost of various
options. The options paper will be ready in early 1977.
ISSUE: Invitation to Polish Minister of Health to Visit the United
States
BACKGROUND: The Minister of Health and Social Welfare of the Polish
People's Republic, Dr. Marian Sliwinski, is anticipating an invitation
from the Department to visit the United States sometime early in 1977.
Since 1962, this Department has been involved actively in collaboration
with health institutions in Poland which fall within the purview of the
Ministry of Health and Social Welfare (MOH/SW). During this period,
there have been several high level visits on both sides, most recently
including a visit by Minister Sliwinski to the United States (March 1973);
a reciprocal visit by Secretary Weinberger (August 1973); and a visit
by Dr. Theodore Cooper to Poland (July 16-20, 1976). Even before
Dr. Cooper's last visit, we were aware that Minister Sliwinski would
have appreciated an invitation to visit the United States this fall. Due
to numerous commitments surrounding the Bicentenial Celebration and the
elections, the Poles were informally advised that an invitation could
not be extended until after 1977. During Dr. Cooper's visit to Poland
this summer, he reiterated our wish to have Minister Sliwinski visit the
United States as soon as possible after the new administration was in
place.
U.S.-Poland health activities are overseen by a binational "Joint
Committee. The next sessions of this Joint Committee will take place
in the United States in March 1977. During recent discussions with
Polish authorities surrounding the agenda for this meeting, it was
suggested by them that this would be an ideal time, from their perspective,
for Minister Sliwinski's visit, although he himself would not take an
active role in the meeting.
POSSIBLE ACTIONS/DECISIONS: We would advise the new Secretary of HEW
to issue an invitation to Dr. Sliwinski to visit the United States in
March 1977.
.-Polish health cooperation has been among the most mutually
advantageous bilateral relations in which this Department is engaged.
Althouth they would suffer no irrepairable damage if an invitation
could not be immediately forthcoming, we would agree with the Poles
that this would be an excellent time to have him visit the United States.
11/18/76
ISSUE: U.S.-Japan Health and Rehabilitation Agreement
BACKGROUND: U.S.-Japan Cooperation in the field of health began in
1965 as a consequence of discussions between then-President Lyndon B.
Johnson and Prime Minister Sato. The two leaders agreed that it would
be desirable to further scientific knowledge of Asiatic tropical diseases
through collaborative research which would draw upon the technical
expertise of both nations. The U.S.-Japan Cooperative Medical Science
Program was established in October, 1965, to meet this need.
Over the next eight years, cooperation in many scientific and technical
areas grew, and in 1973 the two nations agreed to review the extent of
cooperation under the auspices of a Binational Review Panel on Science
and Technology. Their final Report, published in November, 1974,
recognized the strong existing cooperation in the health field under
the U.S.-Japan Cooperative Medical Science Program and more recently
established programs in Cancer Research, Vision Research, and Food
and Drug Control. In its Recommendations, however, the Panel stated
that strong interests existed on both sides to expand the basis of
cooperation into additional areas and recommend that steps be taken
to establish a mechanism for this purpose.
As a consequence of this Report and informal discussions between the
U.S. and Japanese officials, the Department of Health, Education, and
Welfare and the Department of State met in September, 1976, to discuss
the future basis for health cooperation with Japan. At that meeting,
it was agreed that a Government-to-Government level Agreement was
indicated. It was also proposed by the Department of State that such
an Agreement might be appropriately signed by the President or the
Secretary of State in order to establish the cooperative program on a
highly visible basis. (This trend toward having high level officials
sign health agreements began with the signing of the U.S.-Egypt Health
Agreement by Secretary Kissinger and Minister Fahmi in October, 1975,
and reflects the growing use of bilateral health activities in achieving
politically visible aims.)
POSSIBLE ACTIONS/DECISIONS: A U.S.-Japan Health and Rehabilitation
Agreement has been developed in the field of health. We anticipate
that the Agreement will be ready for signature in late Spring, 1977,
and will be signed by either the President or the Secretary of State.
11/18/76
EDUCATION DIVISION
EDUCATION DIVISION ISSUES
A. General Federal Policy
1. There should be an analysis of when it is appropriate for
the Federal government to deliver services directly, when
Federal assistance should be administered and delivered
through intermediaries (e.g., SEAs), and when income
transfers might be employed.
2. In elementary and secondary education a decision needs to
be made almost immediately on what the basic strategy
of the new Administration will be -- categorial programs,
general aid, consolidation (block grants), school finance
equalization, or some combination. Under the Congressional
Budget Act, an Administration bill covering most elementary
and secondary education programs must be submitted to
Congress by May 15, 1977. Programs affected include:
A. Library Services and Construction Act currently on a
one year extention, having expired in FY 1976.
B. Handicapped discretionary programs
C. P.L. 93-380 programs, including Title I (disadvantaged),
Indian Education, SAFA, Bilingual, and the Title IV
consolidated programs and others.
- 2 -
3. The Department has yet to receive a decision from OMB
concerning its final FY 1978 recommendations for the
education budget to be submitted by the President in January.
Problem areas include:
A. The overall level of Federal aid to education
B. The need to reconsider the OE request sent in September
in view of Education Amendments of 1976 passed in
October. The new law extends financial aid eligibility
to new groups of students, adds several new programs
and contains a "trigger" mechanism which could force
Congressional Appropriation Committees to provide
additional funding for several authorized programs.
C. Restrictions in Salary and Expense accounts, based on
the assumption that no significant increase in
programmatic or administrative responsibilities will
be required of OE.
4. A coordinated policy to foster the linkage of educational
and economic development in financially poor communities
might be developed focusing primarily on inner city and
isolated rural areas.
5. At present there are no unified Federal policies for dealing
with early childhood, with the elderly, etc. Thinking has
been more toward fragmented categories such as daycare,
adolescent education or high school reform. The fragmen-
tation and lack of coordination often leads to conflicting
approaches and confusion in the field. Coordination between
-3 --
educational, health, jobs and income maintenance
strategies should be considered. Specifically regarding
education, attention should be given to issues such as:
A. Assessment of hypotheses of "reverse causality" in
social policy such as income maintenance leading to
increased educational achievement and attainment.
B. The relationships between health, family planning,
and parenting education in the schools, income
maintenance strategies such as AFDC, and the cost
and utility of Federal and state health insurance plans.
C. The relationshps between entry jobs, future educational
opportunity, and long-term careers.
6. Creative consideration should be given to the respective
roles that incentives, sanctions, and technical assistance
should play in encouraging quality performance by grantees
in education programs. Present sanctions are generally in-
effective, incentive strategies are rarely used, and technical
assistance could be greatly improved.
7. Serious consideration should be given to the many proposals
for regulatory reform in Federal-State, Federal-local and
Federal-University relationships. Yet care must be exercised
to insure that actions taken to reduce paper requirements do
not at the same time constrain the ability of the Federal
government to provide funds for those intended -- e.g., the
poor, the handicapped, etc.
B. Programmatic Issues
Title I
1. There is a difference of opinion at the Federal level
on how much discretion LEAs should have in designing
Title I programs. At present, they have wide discretion
to implement academic or non-academic programs according
to their own assessments of student needs. Some people
favor Federal requirements to gear Title I programs more
directly on the basic skills.
2. Should Title I continue to use a "double barreled" eligibility
and targeting system (poverty criteria to the school level,
then educational disadvantagement within the school to select
individual children) or should the program be directed to
low-achieving children regardless of income? The implied
philosophical change is substantial. Allocations may
also be drastically affected. (NIE is conducting a study of
this issue mandated by Congress.)
3. Title I is currently serving less than one-half of the
currently eligible population. The issue here is whether
full or increased funding will be supported. Alternatively,
could an incentive mechanism for State funding of similar
programs be developed.
Indian Education
1. The funding of the various Indian education programs needs
careful review to assure that funding levels are appro-
priate and predictable.
2. There needs to be a clarification between the Federal and
State roles in Indian Education. What responsibilities
does the Federal government have to Indians as Indians?
What responsibilities do the States have to Indians as
citizens?
3. The Federal government needs to assure that the Indian
community has authority and responsibility over their
educational system.
4. The organizational placement of Indian education programs
within the Federal government should be carefully considered.
Student Assistance Strategy
1. Most of the current student assistance programs are distributed
on the basis of economic disadvantagement. In recent months
there has been much pressure from groups and Congressmen
representing students from middle-income families to expand
the eligibility for Federal student aid programs to those
in this income category. Without large increases in the
budgets of these programs, the impact of expanding eligibility
would be to reduce the average award for very low-income
students and theregy, possibly, reducing the effectiveness
of the student aid strategy in addressing the goals of
equalizing access and opportunity. This general policy
issue must be addressed in the near future.
Desegregation
1. What should the role of the Federal government be in
desegregation?
2. A Federal policy on metropolitan desegregation might be
considered. Working alliance with other governmental
agencies particularly HUD, Justice, and the Civil Rights
Commission, should be developed for this approach.
3. The provision of early support to desegregating communities
with the goal of minimizing the conflict and trauma often
associated with desegregation should be considered.
Adult Basic Education
1. About one out of every five adults in the United States
do not have the ability to perform tasks which are daily
requirements for most adults. The Adult Education Act,
which addresses this national problem, is currently
authorized at $210 million and funded at $71.5 million.
The authorization expires at the end of FY 78. Both
budget and legislative strategy decisions must be made
in the next several months, eg., should a substantially
larger appropriation be requested for FY 78 and should
the general framework of the program be modified when
developing replacement legislation?
Guaranteed Student Loan Program
1. The Guaranteed Student Loan program is a basic and very
important component of the federal student assistance
strategy (along with the Basic Grant, the College Work
Study, and the State Student Incentive Grant Programs)
For the overall strategy to be effective, a strong GSLP
is imperative. In recent years, large number of lenders
have stopped participating in the program for several
reasons, among the most important being the low rate
of return on investment relative to other alternatives.
The problem of high default rates also is associated
with the program. A Student Assistance Study Group is
currently reviewing all OE student assistance programs
and will present a report to the Secretary in six months.
Following completion of this report, several Departmental
decisions must be made regarding program structure,
participation requirements, etc.
School Assistance in Federally-Affected Areas (SAFA)
1. The impact aid or SAFA program was designed to meet needs
which may not be relevant in today's society. This pro-
gram needs to be investigated with an eye toward reform
which will distribute SAFA monies in a more equitable manner.
Handicapped Education
1. There are various issues concerning the definitions of
handicapping conditions. The definitions will affect
the questions of who should be served and what types of
services they should receive.
2. Within the national goal of providing an appropriate free
public education to every handicapped child, there is the
budget or cost-sharing question of what proportions should
be paid by the Federal government, State, and local levels
of government.
Dissemination
1. While some efforts are now underway which make the results
of research and development available to the education
community, significant additional efforts need to be mounted
to expand the use of properly validated and productive
educational approaches.
C. Education Research and Analysis Issues
1. Analysis and coordination of Federal and other governments
attempts to increase Basic Skills should be quickly
accomplished. This should include thinking about such
Federal programs as Title I, Handicapped, Bilingual, and
Right to Read.
2. Too little consideration has been given to the issue of
what children should be learning in schools beyond the
basics. By 1990 it seems clear that issues of energy,
the world wide population boom, and food will be dominant
problems in the world and will influence the US directly.
Moreover changing views of the family, demographic trends
in the US including the declining or stabilizing birth
rate, the position of women in the society, etc., will
greatly influence the nature and structure of American
society. Little has been done to consider long range
implication of these areas as they impact on the schools.
3. Children and adults watch television somewhere near
3 hours a day on the average - there is at present no
serious attempt to understand the educational consequences
of this.
4. Little is known about the overall impact of postsecondary
student grant and student loan programs. Consideration
should be given to the possibility of a social experiment
varying critical policy variables in the allocation of
grants and loans. Special attention would be given to
assessing impacts on equal opportunity and on private
V. public institutions.
5. Informed Federal education policy requires the following
knowledge about what is actually happening in the schools:
a) Apparently between 1970 and 1973 there was a dramatic
reshaping of the high schools toward far greater course
offerings, flexibility in choice of offerings, etc.
There may now be a move back toward structure. What
is the nature and impact of these changes?
b) We know that increased time in instruction leads to
increased learning yet we do not know how much time
our students spend in instruction during the school
day. Some tentative evidence suggests that actual
time in instruction is only on the order to 60% of
the school day. What are the implications, if true?
c) Data in some cities indicate that very large number
of students on the rolls do not actually attend schools.
Is this true? Why? Is there some way of redressing
this?
d) We do not have good data on the "back to basics"
movement: the use of different forms of curriculum,
the use and influence of testing in these schools,
the relationship between parents and the schools, etc.
Descriptive data need to be developed.
6. As a result of recent legislation, a Federal policy must
be developed around life-long learning. Is the emphasis
over the next couple of years to be systematic planning
and exploration of the nature and need for Federal inter-
vention or a strategy for an uncoordinated and uninformed
grants program?
7. How can the Federal government help reintroduce the issue
of standards and quality into education? In the past
there existed in peoples minds the identity of "high
quality" schools such as Dunbar and New Trier. Do such
schools presently exist? What is their location,
characteristics, nature, etc? Has the present trend
toward "minimal competency" requirements for graduation
pulled the nation further away from any notion of
"excellence?"
8. For the past ten years the Federal government has promoted
the use of large scale evaluations for assessing the outcomes
of educational programs. Yet too often these evaluations
have been of little use to the Congress, the executive
branch, or the implementers of the programs. Serious
thought must be given to the role, utility, and nature
of evaluations utilized by the Federal government.
D. Management
1. During the past several years the Authorization Committees
of Congress have increasingly directed different components
of the Education Division to undertake specific categories
in addition to normal program development, management
evaluation activities. For example, the Assistant Secretary
for Education, the Commissioner of Education and the
Administrator of NCES have been directed to carry out
specific studies and surveys in areas such as lifelong
learning, compensatory education, and safe schools. The
Appropriations Committees have tended to not provide the
funds and/or positions required to carry out the mandated
activities but have suggested the work be conducted within
present resource allocations. This difference between
the authorization and appropriations committees has resulted
in severe management problems in the Education Division
(especially OE and NCES) because people must be diverted
from other important activities to comply with the specific
Congressional mandates.
MEMORANDUM
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
OFFICE OF EDUCATION
TO
:
The Secretary
DATE:
NOV 19 1976
Through: OS/ES
ASE
FROM
:
Edward Commissioner of agrime
SUBJECT: Major Issues
Per your request I am transmitting a list of the major issues,
priorities and significant activities, affecting the Office of
Education for consideration by the Transition Team. I have
arranged these issues by Bureau/Office within the Office of
Education. Issue papers expanding on each item identified are
presently being refined in the Office of Education.
They include:
Office of Indian Education
The position of Deputy Commissioner for Indian Education has been
vacant since July, 1976.
The Fiscal Year 1977 appropriation for Indian Education has been
decreased from the Fiscal Year 1976 appropriation, adversely
affecting the meeting of the critical needs of American Indians.
There is a need to implement the Morton V. Mancari Supreme
Court ruling of June 17, 1974, which calls for the implementation
of the "Indian preference" laws by the Office of Education in
filling all vacancies in the Office of Indian Education,
including initial hirings, promotions, lateral transfers and
reassignments.
There is a severe and critical need for more professional
educators, teachers and administrators among Indian and Alaskan
natives and to initiate a massive effort in training and develop-
ment of Indian professional educators.
There is a need for a definition of special educational needs
of Indian children.
There is a need for coordinating all USOE programs providing
educational support to Indians.
There is a need to emphasize adult education for Indian people.
There is a need to upgrade all local Indian communities to
impact the education of their children.
The current legislation for the Office of Indian Education
is due to expire July 1978. There is a need to extend the
Indian Education Act and to provide a set of recommended
legislative changes for Congressional review.
Due to the proposed legislation affecting the merger of the
Bureau of Indian Affairs' Division of Education and the Office
of Indian Education, it is recommended that a management analysis
be initiated.
Office of Planning
The overall level of funding for Fiscal Year 1978 has to be
made.
The decision needs to be made on amendments to the 1977 budget
requests concerning implementation of the 1976 Education
Amendments as they affect existing programs. The Amendments
will add funding requirements for existing programs.
Decisions are pending concerning funding for new programs
authorized by the Education Amendments of 1976.
Several major pieces of legislation expire in Fiscal Year 1976;
decisions need to be made concerning legislative changes and
reauthorizations.
The form in which we present the legislation and budget proposals
for Block Grants needs to be determined.
In Fiscal Year 1976 the first Developing Institutions are scheduled
for termination of Federal aid with the possible result of financial
injury to their livelihood.
Decisions concerning additional funding for these institutions
under the AIDP Program need to be made.
Bureau of Postsecondary Education
There is increasing pressure to expand Federal student assistance
programs which have been targeted at the most needy to include
students from middle income families.
Proper procedures for recognizing and dealing with fraud and
abuse in the student assistance programs need to be developed.
The impact of inflation and the costs of implementing and
administering Federally-mandated social programs will increase
the pressure for institutional support.
The interface between State and Federal programs needs to be
examined so as to promote better coordination and more closely
establish a true partnership relationship.
Federal support of graduate education should be examined with a
view toward increasing participation of minorities and assuring
the quality of programs.
Further progress in the area of civil rights and affirmative
action may be achieved only by closely monitoring the problem
of reverse discrimination and the enforcement of Title IX.
Demographics indicate a change in the postsecondary population
to smaller numbers of the traditional college-age segment and
larger numbers in older-age groups. The needs of this new
student population must be assessed and their requirements
reflected through appropriate educational offerings.
Bureau of Elementary and Secondary Education
Dissemination of Promising Educational Practices
o
Should the Federal Government more adequately support this
Federal responsibility for education which during the past two
years has made a substantial start and which when viewed as a
vehicle for the transfer of productive educational programs as
a rule that can be best performed by the Federal Government.
Educational Services to Indochinese Refugee Children
The issue here is whether the Federal Government will continue
support of Indochinese Refugee Children or will now turn the
responsibility for their educational support over to the local
school districts.
Parenting
o Should the Federal Government add increased support to systematically
equipping both adults and adolescents to become better parents and
to more directly augment education which takes place in the
classrooms.
Continued Support for Strengthening State Departments of Education
o
Shall the Federal Government continue support of State Departments
of Education in an effort to further strengthen the State juris-
dictions so that their active participation in the educational
effort will continue to increase and improve.
School Assistance in Federally Affected Areas
o
Shall the Administration continue to alleviate the stringent budget
circumstances which describe the fiscal plight of local school
districts through this legislative vehicle what shall be the
direction for reform and/or modification. Also, what steps shall
be taken to reduce the present backlog of needed repair and
remodeling of school facilities (present backlog--$434 million;
projected backlog by 1978 about $700 million).
Reform of American High Schools
O What measures should be developed at the Federal level to respond
to the trend among the States to require measured demonstration
of competency in the basic skills and how can we turn active
concern toward the problem of reciprocity among the States.
Categorical Grants VS. Consolidated Grants
O
Should the Administration pursue the course for the consolidation
of programs which presently operate under various legislative
authorities and adequately enunciate educational needs as seen
from the Federal prospective.
Bureau of Elementary and Secondary Education
School Finance
What will be the Federal Government's direction to achieve an
equitable distribution of educational resources so that no child
is penalized for lack of resources; providing a relief on the
property tax as a source of educational revenue and increasing
to appropriate levels of the Federal share of the total cost of
education.
Fundamental Goals in Education
How will the Administration respond to the growing widespread
opinion that increased emphasis should be laid upon the develop-
ment of basic skills (this term is not yet completely defined).
School Desegregation
Should the Administration assume a neutral posture or with its
influence capitalize upon both past experience and systematic
studies to reduce the trauma and conflict which frequently
accompany desegregation school activities, also what is the
Administration's posture on Metropolitan school desegregation.
Education for the Disadvantaged
Shall the Federal Government increase its support of this effort
so that a greater proportion of eligible children can be adequately
served (slightly less than one-half of the eligible population).
Early Childhood Education
Shall steps be taken to synchronize Early Childhood activities
so that they become an integral part of the educational program
and can more effectively act as positive change agents in public
school curriculum, resulting ultimately in substantial increased
programs for the education of children prior to the present entry
age of six years.
Bureau of Occupational and Adult Education
Federal Education and training efforts fragmented among many
Federal Agencies.
Sex Bias and Sex Role Stereotyping in Vocational Education
and Employment.
The low level of educational competency of 23.3 million adults.
The expiration of the Adult Education Act and need for new
comprehensive legislation for adults.
The stance that should be taken by the Assistant Secretary
for Education in the required January 1, 1978 report to Congress
on Adult Education.
The role of USOE in implementing the Vocational Education Amendments
of 1976 concerning improved State planning, accountability, sex
role stereotyping and evaluation.
The level of Fiscal Year 1978 budget request for Vocational
Education bilingual training.
The high rate of youth unemployment and the related dirth of
vocational education opportunities, especially in large urban
centers.
Introduction of efforts to convert to Metric System is construed
as an effort which must start at ground zero.
A significant number of people believe that Metric Conversion
is the concern of technical and scientific persons only.
It is difficult to impact the general, non-school, adult
population. An alternative approach involves developing
innovative strategies to motivate the adult learner to seek
out instruction through continuing education courses, special
programs, and specifically designed workshops at low cost to
the Government.
Bureau of Education for the Handicapped
What implications do the current diversity of State fiscal support
systems for special education have for the Federal/State relationship
in assuring the provision of a free appropriate public education
to all handicapped children as mandated under P.L. 94-142?
What are the needs for training of teachers and support personnel
to implement P.L. 94-142? How will these needs be satisfied?
What should be done to improve or extend vocational and other
secondary education to the handicapped? What should be done to
improve job opportunities for the handicapped?
What are the ways to teach severely and profoundly handicapped
individuals more effectively and by doing so to be more successful
in maintaining these individuals in their natural environment?
How can efforts providing programs for very early detection, infant
intervention, and parent training, increase the benefits of
education for the handicapped?
Should educational services for preschool handicapped children
(0-5 years) be expanded beyond current levels of services?
Bureau of Occupational and Adult Education
Minimal allocation of program funds can be construed by a lack of
commitment on the part of our government to a National Metric
Conversion process. Until there is legislation mandating the use
of the metric system, with adequate funds allocated to education in
the use of the metric system, the general public will continue to
believe that the govennment is not fully committed to metric
conversion.
Does the current and projected "general surplus" of educational
personnel obviate the need for Federal support for special
educational personnel development needs?
Any serious effort to improve American education through supplemental
Federal assistance must re-assess the relative potential of personnel
development over the other types of inputs which the Federal Government
currently funds.
The delivery of vocational guidance and counseling services needs
to be expanded so that a full range of services and information
would be accessible to all individuals.
Education and Training Needs of the Displaced Homemaker
The Vocational Education Amendments of 1976 include an emphasis
on displaced homemakers and unskilled heads of households.
As males and females increasingly combine the roles of homemaker
and wage earner, the need exists for programs to prepare youths
and adults for homemaking, parenting and as consumers.
There is a national need for Consumers' Education.
If the Consumer Education Program were divorced from the Special
Projects where funds are limited to what is available under the
"formula" arrangement, it could more adequately meet the mandates
of the legislation in supporting continuations beyond one year,
thus permitting more effective development, refinement, dissemination,
evaluation and assessment.
While there are many evidences of need for a National Consumers'
Education Resource Center, or a system of regional center, it is
imperative that already established efforts to establish such
systems for dissemination and training be utilized fully.
There is a need for coordination of Vocational Education and
Comprehensive Employment and Training Act (CETA) Programs.
The future relevance of the Community School movement to all
Education Programs.