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issue standards for laboratories without any guidelines from the Congress at all. The danger here is that unrealistic and uncompromising standards may be promulgated which would put an unnecessary and unwarranted burden on even the best qualified laboratory. In order to minimize the possibility of this occurring, we respectfully urge that precise guidelines be incorporated in the bill delimiting the Secretary's authority in this respect. As a legislative precedent, we invite attention to Section 401 of the Federal Food, Drug and Cosmetic Act in which the Congress has established guidelines for the Secretary to follow in prescribing standards for food products. Surely laboratories could be dealt with similarly in this important area.

Our second objection with respect to standards has to do with the fact that the Secretary already has prescribed standards for independent laboratories as authorized under Section 1861(s) (11) of the Social Security Act. We see no reason why a laboratory should be required to meet two sets of Federal standards, particularly when both supervisory activities are to be administered in the same Government department. Nor should standards applicable to services for those 65 years of age and older be materially different from those prescribed for the benefit of the general public under a licensure statute. In our opinion, a laboratory that qualifies under the Medicare Program should prima facie be eligible for license under the provisions of H.R. 6418 and be exempt from fees, inspections and other evidences of licensure qualification and enforcement. Such exemption would be in keeping with the fact that the laboratory had already qualified for a license and additional tests of qualification would constitute harassment.

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SEC. 353 (d) (3). FEES

We also are very much concerned with Section 353 (d)(3) which authorizes the Secretary to require payment of fees for the issuance and renewal of licenses sufficient "to provide, maintain, and equip an adequate service for the purpose ***." The quoted language may seem innocuous at first, but on further inquiry one will find that as a practical matter the Secretary may-and most likely he will-impose fees upon laboratories sufficient to cover the multitude of costs incident to the administration of the licensure program. We are advised the estimated cost of these activities during the first year alone will amount to $1.5 million. It also is estimated by the Department of Health, Education, and Welfare that approximately 1,000 laboratories will be required to secure licenses under the propsed law. On the basis, the average annual cost of a license would amount to $1,500. An aportionment of the cost among the affected laboratories obviously would lessen the amount of fees to be paid by some but, by the same token, it would greatly increase the burden imposed upon the others. If this section of the bill were allowed to stand as written, I can foresee that some laboratories may be required to pay annual fees in excess of $5,000. Despite the title "Clinical Laboratories Improvement Act of 1967", this is strictly a licensure stataute. The licensee is not to be directly benefited under the act as though it had a product to sell requiring testing and approval by the Government, such as in the case of foods, drugs, color additives and pesticides. Unless fees are reasonably related to benefits received for services, they in effect become a tax. If benefits are indeed to be received by the laboratories in the administration of the program, let us wait to see what the benefits are and not, in the meantime, permit taxation in the guise of fees. Congressman Devine, in discussing the subject earlier in the hearings asked this question:

"Since the licensing of the laboratories is in the public welfare, should the Government pay the cost of the activity and the amount of license fee be set by statute as customary?"

To which Under Secretary Cohen replied in part as follows:

"*** I want to stress very strongly that I consider this whole area of laboratory performance an important public health service rather than one in which the consumer should necessarily pay for it."

We thoroughly agree that this would be a public health service and respectfully urge therefore that Section 353 (d) (3) be stricken from the bill.

Other independent laboratories that agree in principle in the above views and suggested amendments to H.R. 6418 are:

Bio-Chemical Procedures, Inc., North Hollywood, California;

King County Research Laboratories, Inc., New York, New York;
Laboratory Procedures, Inc., Culver City, California.

Thank you for giving us this opportunity to state our views.

Mr. ROGERS. The next witness is the Honorable Paul H. Todd, chief executive officer, Planned Parenthood-World Population, accompanied by Dr. Bruce Jessup, California State Health Department. STATEMENT OF PAUL H. TODD, JR., CHIEF EXECUTIVE OFFICER, PLANNED PARENTHOOD-WORLD POPULATION; ACCOMPANIED BY DR. BRUCE JESSUP, BUREAU OF MATERNAL AND CHILD HEALTH, CALIFORNIA STATE DEPARTMENT OF HEALTH

Mr. TODD. Thank you, Mr. Chairman.

Mr. ROGERS. Mr. Todd, it is a pleasure to have you with us today. Mr. TODD. I am delighted to be here, Mr. Chairman, and to see some old friends.

I realize it is very late in your schedule and that you have activities on the House floor. I wonder if I might submit my statement for the record and summarize it.

Mr. ROGERS. That will be helpful to the committee. Your statement will be made a part of the record at the conclusion of your remarks.

Mr. TODD. Might I also submit at this point for the record a resolution adopted by the board of directors of Planned Parenthood-World Population, dated May 6, and a statement by Dr. Edward O'Rourke, commissioner of health of New York City, who asked me to present his statement to you.

Mr. ROGERS. They will be accepted for the record.

Mr. TODD. Thank you, Mr. Chairman.

Let me say that I represent an organization of some 150 affiliates throughout the United States which is currently providing birth control services to some 350,000 women. We provide birth control services to approximately half of the individuals who are supplied by public and private agencies.

Our interest in this legislation is concerned with the provision of such services through the sections in the bill which have to do with comprehensive health programs for the various communities. Our organization feels that if birth control information and services are to be provided for indigent women in the United States, this must be done so through a number of pieces of legislation, including the type of legislation which members of your committee, such as Dr. Carter, have introduced.

We believe that the Carter proposal, essentially the same as the proposal of Mr. Moss and the proposal of Mr. Friedel, would be preferable to having a limited authorization for family planning services in the partnership for health bill, but short of that type of legislation we believe that earmarking of some $20 million in the partnership for health proposal would be required to assist in providing family planning services to those in the United States who now do not have access to them.

We believe that unless such services are provided, neither personal, maternal, child, nor family health in this country can be assisted in a reasonable manner, and that in terms of not only human welfare and human dignity but in terms of budget dollars this program should be one of highest priority.

Let me further say that at this point there are many in the State, Federal, and local governments who have advocated the rapid expansion of such programs. In our opinion, the expansion is proceeding at a very, very reluctant pace. I think Dr. Jessup can testify to this. We have appended to my testimony an estimate of the unfilled need in various selected communities in the United States. I think this will be of particular interest to the members of the committee because it does indicate the numbers of low-income patients not now served in various communities represented by members of this committee.

I think if the members of this committee can interpret the impact of providing services to these individuals in their communities, upon the well-being of their communities, they will see that the proposals we are talking about have considerable merit.

Thank you, Mr. Chairman.

(Mr. Todd's statement and appended material follow :)

STATEMENT OF PAUL H. TODD, JR., CHIEF EXECUTIVE OFFICER, PLANNED PARENTHOOD-WORLD POPULATION

Mr. Chairman, members of the Committee, I am delighted to be with you this morning and to see again the many friends with whom I spent some very happy days. I particularly appreciate the opportunity to present to you some thoughts of Planned Parenthood-World Population on a matter which may seem minorand perhaps non-controversial-compared with such subjects as the railroad dispute which is under the jurisdiction of your Committee. I well identify with your problem of sifting from the many points of view and many needs those which are most appropriate for your time, attention, and action.

Although the subject to which we devote our time and energies as an organization is now only a very small part of governmental concern, and especially support, I believe no subject is more fundamental to family health and wellbeing, and through these, to the well-being of the social fabric of our great nation. As most of you know, the organization I represent is a non-profit national organization which has during the past 50 years provided high quality medical service in the area of family planning to literally millions of American couples. Today our organization is providing family planning services to approximately 315,000 women a year through 450 clinics established in 150 communities throughout the United States.

In spite of massive efforts in the past few years to expand our services in as many places as possible, we cannot-indeed, we should not-be expected to reach all medically indigent families with a service they cannot normally afford. It has become clear to most Americans, as many members of this Congress well known, that Federal, state and local health agencies must increasingly become involved in the provision of family planning services, with special emphasis on providing those services to families living in poverty.

It is because Planned Parenthood-World Population shares with this Congress, this Administration and the vast majority of American people, concern for the extent and the quality of health services available to this nation's impoverished families, that I am here today. Family planning is a health service which has too long been denied to poor families. By making this service available to those who could not afford private medical care, our organization has for many years acted to make health care more comprehensive. We thus associate ourselves with the Public Health Service's concern to develop better and more comprehensive health services.

At the community level, there are five major channels available for delivery of family planning services: local hospitals, health departments, community action organizations, private physicians and voluntary health agencies. Some of these resources exist in almost all communities, but the pattern varies widely from one community to the next, and these different agencies do not all reach the same patients. To deliver family planning services to all impoverished families who need and want them will require coordinated efforts to encourage each of these channels to undertake active programs in this field.

We estimate that there are approximately 5 million medically dependent women in their childbearing years who are not seeking a desired pregnancy and are potential patients for subsidized family planning services. Of these, only about 700,000 are currently being served by all public and private agencies concerned. Thus, 85 percent of those who need these services do not currently have access to them.

To extend family planning to the remaining 85 percent, greatly intensified short- and long-term efforts are required. Far from duplicating services at the local level, a flexible program involving all the relevant Federal agencies is essential in order to accomplish the job. For example, hospital services would be stimulated best through the Children's Bureau Maternity and Infant Care program, and would be geared mainly to helping pregnant and recently delivered mothers. Couples who are newly married and wish to space their children-or who have already had the number of children they want-would best be reached through health department services, assisted by grants from the Public Health Service, and through community action and voluntary agency programs, aided by Office of Economic Opportunity grants, which permit greater flexibility in bringing services close to the population in need. Private physicians are likely to become more involved, in the long run, through the development of the Medical Assistance Program.

Not only are these varied programs not mutually exclusive, but they actually complement each other. Only through a multi-faceted program such as this will local communities receive the level of assistance they need.

I would like to submit for your study a table representing preliminary estimates of the need for family planning services in 25 selected communities and states, many of which the members of this Committee represent. In these 25 areas alone, a minimum of 545,000 families are not currently receiving family planning services, out of an estimated total of 708,000 who need and want them. The financial requirements for these services are estimated at between $11 and $14 million. Most of you will concur with the repeated statements of local officials that these communities do not have surplus budget funds of this magnitude available to finance this new and vital field of health care.

To reach the 4,300,000 medically indigent women throughout the country who are not now being served, we believe it is necessary for Congress to act simultaneously on several pending proposals. If enacted, these proposals would allocate funds to all relevant Federal agencies for expansion of family planning services. These proposals were endorsed by the Board of Directors of Planned Parenthood-World Population last month, and I would like to submit their resolution for the record.

Briefly, these proposed complementary efforts include:

1. Dr. Alan Guttmacher, President of our organization, in testifying before the Ways and Means Committee last March 22, suggested that in view of the minimal increase in authorization requested for the Maternity and Infant Care program which would do no more than offset rising medical costs, the Committee should give serious consideration to earmarking additional funds for family planning services through this program.

2. Representative Scheuer has introduced a bill, now before the Committee on Education and Labor, that would earmark funds for family planning services through the OEO's War on Poverty.

3. Proposals to allocate funds for family planning to be administered by either the Public Health Service or the Children's Bureau, at the discretion of the Secretary, have been introduced in this Committee by Representative Carter (H.R. 355) by Representative Hawkins (H.R. 6858 and H.R. 9743); by Representative Friedel (H.R. 8461); and by Representative Moss (H.R. 9045).

Our experience convinces us that for a limited period of time necessary to launch this new program, funds need to be allocated specifically, because:

Family planning is a relatively new service to most Federal, state and local governmental health agencies;

Family planning is an area unprotected by existing and entrenched professional staffs at all levels of government:

Family planning has a long history of neglect by health agencies; and When many health programs must contend for appropriations from a very limited budget, the changes for expansion of family planning services are extremely remote.

In our opinion this special allocation of family planning funds can be provided by this Committee in one of two ways: The bills introduced by Representatives Friedel, Carter, Hawkins and Moss could be reported out favorably, or the allocation of specific sums for family planning in the Partnership for Health Act could be considered.

Let us look for one moment at H.R. 6418, the Partnership for Health Amendments of 1947. The emphasis of this legislation is on the development of a comprehensive approach to health needs on a state-wide basis. The states are encouraged to take stock and to determine what needs to be done and how to do it most expeditiously, using existing resources and, presumably, developing new ones. By establishing a system of block grants to the states, the legislation, at least formally, does away with the old categorical approach to illness and disease. I say at least formally, for this is more theoretical than real.

In fact, the current bill calls for an increase of only $7.2 million each in state formula grants and in project grants over the present level of funding. We can only guess how much of this increase would be absorbed by the rising cost of health care, but certainly a substantial amount would be diverted in this manner. Under these conditions, it seems most likely that the states will continue, at perhaps a slightly expanded level, the programs of TB and venereal disease control, cancer control, etc., which they are now conducting. And this is probably as it should be, for these programs are needed and should not be terminated. Theoretically again, some reallocation of priorities and perhaps some economies can be realized under a comprehensive state program. It certainly cannot be expected, however, that the funds released in this fashion will be sufficient to finance new endeavors in anything but a minimal manner. We do not feel, therefore, that any sizable extension of family planning services can be realistically be expected through the proposed Partnership for Health bill.

Should the sums authorized for the program be greatly increased as we believe they should be if the legislation is to fulfill its goal, we are still doubtful that funds in sufficient amounts would become available for broad extension of family planing programs. Considerable interest exists at the State and local level. as Dr. Venable of the Association of State and Territorial Health Offices noted in reporting to you the results of the survey undertaken by the Association which indicated that at least 30 states listed family planning among their first ten priorities. But state and local health departments must choose among many unmet health needs, and even several large states such as California, New York or Maryland, where sizable beginnings have already been made in the family planning field, indicated in response to this survey that they did not expect to be able to devote sizable funds to family planning under the Partnership for Health program. Dr. Venable indicated that the State of Georgia would need roughly $1.4 million to reach 70% of its potential case load. You will hear shortly from Dr. Jessup who will report on the level of accomplishment and the level of need in the State of California, and I call your attention to the testimony of Dr. O'Rourke, Health Commissioner for the City of New York, which we would like to submit for the record. The State of Florida has a county-by-county plan and a specially trained staff of professional personnel at all levels ready to do the job-but there are no existing resources. The interest is there, the cost is relatively moderate, but we realize that as long as funds are limited, as they always are, programs which are older and better established, which have carefully cultivated administrative and political support, and which are "glamorous” will fare better in the allocation of funds.

To summarize, Mr. Chairman, family planning services are urgently needed. They are of high benefit to the individual, the family and the community at a relatively low cost. We urge that you and the Committee give consideration to providing financial support to initiate a broad program. The legislation introduced by four members of this Committee, Representatives Friedel. Carter. Hawkins and Moss, would provide the necessary funds. Alternatively, we submit that the authorization for Partnership for Health should be greatly increased if the legislation is to be effective, and that within this increase a sum of $20 million for Fiscal 1968 should be reserved for family planning services.

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