Mr. ROGERS. Would the gentleman yield at that point? Mr. BROYHILL. I will be glad to yield. Mr. ROGERS. Does the present authority also include the cost of acquiring or constructing facilities or equipment which the Secretary determines necessay? Dr. STEWART. Yes, it does. "Mr. ROGERS. There is no additional authority? It is simply an extension of present authority? Dr. STEWART. That is correct. Mr. BROYHILL. Since it is unlimited." Mr. ROGERS. Without any limitation. Thank you. Dr. STEWART. This is authority which we feel we need all the time in order to carry out our effort and particularly as we move into the developmental area. This has been exercised on a few occasions. For example, when one is making a research contract to pilot study a new vaccine, a type of facility may have to be constructed under the contract arrangement to see if you can make the vaccine this way. Two of those have been made and there are five presently under consideration which include costs of construction of the research facility to carry out the specific research contract purpose. Mr. DINGELL. Thank you, Mr. Chairman. The CHAIRMAN. Mr. Dingell. Mr. DINGELL. Thank you, Mr. Chairman. It is a pleasure to welcome my old friend, Mr. Cohen, to the committee, and the distinguished gentlemen with him. Very briefly, this legislation does nothing to provide for new construction of hospitals, does it? Dr. STEWART. That is correct. Mr. DINGELL. There is great need for new construction in terms of Hill-Burton in all areas of the country. Mr. COHEN. There is a tremendous need for modernization of hospitals and new construction and also for nursing homes and other facilities as well. Mr. DINGELL. Can we look forward to new legislation in that area coming forward from the administration shortly? Mr. COHEN. Well, the President's statement in his message indicating that Hill-Burton expires on June 30, 1969, and the importance of all of these factors has indicated that, in that he recommends in his message the appointment of a national commission to study the entire problem with a view to seeing in what way Hill-Burton ought to be modified or extended. Mr. DINGELL. Now, you have in section 5 of the legislation before us a provision dealing with licensing of clinics and facilities of this kind. I happen to think that this is a desirable thing. As you recall, Mr. Secretary, there has been some correspondence between my office and the Department of Health, Education, and Welfare with regard to the utilization of the medicare program for this function. As you will recall, I have questioned the authority of the Department of Health, Education, and Welfare to utilize the medicare device as an instrument for the regulation of these facilities even though I recognize that certain regulation is necessary. I would like to refer you to that section, if I may, now and ask you what standards will be utilized by the Secretary in terms of issuance of licenses? Mr. COHEN. Dr. Sencer will respond to that. Dr. SENCER. There are four major areas in which standards will be set. Undoubtedly you would have to set standards for the qualifications. Mr. DINGELL. I am in thorough agreement but in view of the very short time I have, I would like you to be as particular as you can as to what are the standards in the bill which the Secretary would apply in licensing those agencies. As a matter of fact I can make the bald statement, and I think you will agree, that there are no standards that the Secretary would apply that are fixed by statute. These criteria that he would apply in this matter would be fixed entirely by him, not by the statute, am I correct? Dr. SENCER. I think that the statutory authority would be on pages 11 and 12, Mr. Dingell. Mr. DINGELL. But nowhere in this is there any fixing of the qualifications that an individual concerned under this legislation would be required to meet by law. We are in this sense vesting the broadest kind of authority in the Secretary to do this. Dr. SENCER. That is correct. Mr. DINGELL. What I would like to know is why is it not possible for the Secretary to come up to this committee with some kind of understanding of what he proposes to do and why is it not possible to include some statutory language? You will recall in many instances the Supreme Court has held statutes to be unconstitutional where they have failed to present adequate framework for the administrators to utilize in terms of the regulatory policies that they would carry out. Clearly, Mr. Secretary, I am troubled that there is no such set of statutory standards presented for the Secretary for his administration. Mr. COHEN. First, let me say that I think you are quite correct that the bill does not establish any criteria in any detail. Second, I will be glad to put in the record the kind of factors and criteria that we would use in regulation, for your consideration. (The information requested follows:) STATEMENT OF THE DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE ON RECOMMENDED STANDARDS FOR CLINICAL LABORATORY LICENSURE The following standards would be required of clinical laboratories to qualify for a license: 1. The laboratory must maintain a quality control program which would assure the accuracy of the laboratory's procedures and services. This program would include the use of reference or control sera; calibrating standards, etc. 2. The laboratory must maintain records, equipment and facilities necessary, to the effective operation of a laboratory. This would include records on specimens received and a system for their identification; procedures to minimize the risk of infection and to insure the rapid reporting of results to physicians. 3. The director of the laboratory and other supervisory professional personnel must meet qualification standards to assure the adequate and efficient operation of the laboratory. www Mr. DINGELL. Wouldn't it be well, wouldn't it be really very well, Mr. Secretary, for us to have a clear statement included in the legis lation? Mr. COHEN. I think to the extent that you can develop the elements, it would be proper to define them generally in the legislation and to expand in the committee report the character of them. I would see no objection to that. Mr. DINGELL. I would think this would be very important. For example, under medicare your agency has sought to regulate these kinds of services to require that in a certain period of time they should have a person who would have a degree, some with a bachelor's degree, some with a Ph. D., or be a doctor of medicine. Mr. COHEN. Yes, sir. Mr. DINGELL. There would be different standards applied under that for clinical services available within the doctor's office and those available without. The proposed regulations have sought to have an M.D. or Ph. D. be available on the premises. There was, for example, no grandfather clause available to those who, I am sure, lack that Ph. D. or M.D. yet who I am satisfied in many instances are providing valuable and useful and adequate services in this area. Mr. Secretary, the other question I would like to know is: What have you been doing in terms of carrying forward the discussions that have been going on between my office and the Department of Health, Education, and Welfare with regard to the fairness of these clinical standards which we are establishing here? Mr. COHEN. All I could say is those questions are now under review in the Committee on Ways and Means. We are in executive session and the committee has asked us to review those with them, and we are doing so now. Mr. DINGELL. I think in view of the fact that you do have a clear duplication of regulatory authority within the Department of Health, Education, and Welfare in one instance before Ways and Means and in the other before this committee, it would be very well for us to have a very clear view in the record both of what is going on in Ways and Means in terms of the regulatory authority that you are seeking to exercise and the activities that the Ways and Means is taking, and also as I indicated with regard to the question of what regulation we want and whether it should be statutory and not left to the discretion of the Secretary and not just conferring upon the Secretary the divine right of kings to issue regulations without any regulatory guidelines from the Congress at all. I hope I have not been too hard on you. It is always a pleasure to see you. Mr. COHEN. No, sir. The CHAIRMAN. Mr. Friedel. Mr. FRIEDEL. Mr. Chairman, I have eight questions I would like to have answered, The first one is in four parts. I wish you would furnish for the record the questions and answers: How much is the Public Health Service spending in 1967 for family planning and so forth? Mr. COHEN. We would be glad to answer those, Mr. Friedel. Mr. FRIEDEL. Send me a copy. (The information requested follows:) DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, Hon. HARLEY O. STAGGERS, Chairman, Interstate and Foreign Commerce Committee, DEAR MR. CHAIRMAN: On May 2, when I appeared before the Committee to testify on H.R. 6418, the "Partnership for Health Amendments of 1967", Congressman Friedel raised several questions concerning the Department's family planning program, and asked that we submit answers for inclusion in the record of the hearings. In response to his request, I am enclosing answers to the questions, a current status report of the Department's family planning programs, and a detailed breakdown of expenditures in 1967 and 1968 for family planning activities conducted by HEW. If I can be of any further assistance, please let me know. Sincerely yours, WILBUR J. COHEN, REPLIES TO QUESTIONS PROPOUNDED BY CONGRESSMAN FRIEDEL 1. How much is the PHS spending in 1967 on family planning? How much of those funds are going for training? How much of those funds are going for research? How much of those funds are going for direct services through demonstrations projects? Public Health Services expenditures on family planning 1967- $8, 361, 000 Training Services, information and counseling_ 2,047, 000 199,000 6, 115, 000 2. Of the increase of $7.5 million (for project grants and for formula grants respectively) proposed under H.R. 6418, what new areas do you anticipate will be included, or to what extent does the increase in funding merely reflect higher health costs? The State agencies and applicants for project grants will be submitting plans and applications on the basis of their estimates of health priority areas. We anticipate that the requested increase of $7.5 million for project grants and $7.5 million for formula grants will permit support of programs in areas such as family planning, alcoholism, and rural health which could not be supported under the categorical approach. Although we anticipate that there will be considerable emphasis on family planning, since Federally pre-determined categories of support have been eliminated, we cannot predict which areas of activity will receive support in 1968. The increased authorization requested reflects the need for support of health services and is not predicated on increased costs. 3. How much of the proposed $7.5 million (for formula and project grants respectively) would you expect to be expended on family planning? What would be proportion of investment into (a) services, (b) training, (c) research? Since we will not prescribe the activities which will be supported, we cannot say what the level of requests for support of family planning will be. Requests for support of family planning activity, because of the nature of the grant program, will be principally in the services area. 4. During the hearings on this measure last October, the Surgeon General in response to questioning by members of the Committee estimated that at least $15 million would be needed in fiscal 1968 for family planning and larger amounts in subsequent years. Following the hearings on H.R. 1823.1, Under Secretary of HEW, Wilbur Cohen projected expenditures for family planning in a letter to Senator Joseph Tydings dated October 20, 1966 as follows, "For the purposes of supporting programs under S. 3008 in the field of family planning, our present plans contemplate $20 million in fiscal year 1968, $25 million in fiscal year 1969 and $30 million in fiscal year 1970." What are the expectations of achieving this level of spending in this area for fiscal 1968 in view of the level of funding projected? 80-641-67 The estimate provided by Under Secretary Cohen to Senator Tydings on October 1, 1966, was based upon an estimated appropriation authorization for formula and project grants for 1968 in excess of $270,000,000 as provided in S. 3008. Since this anticipated authorization was ultimately reduced to $125,000,000 by both Houses, it is doubtful that the State and other applicant agencies will request support at the level projected in October 1966. In any event, under P.L. 89-749 categorical support will no longer be provided and, therefore, we cannot predict the impact of the increased authorization in any health services area, including family planning. 5. It is our understanding that in a recent survey, 30 out of 45 State Health Departments listed family planning in the first 10 items of the priority un-met needs. Did the survey indicate how much money would be needed in each State to establish State-wide family planning programs? What proportion could be expected to be available locally? The survey which was conducted by the Association of State and Territorial Health Officers was concerned principally with Federal support of health services. It did indicate that many States intend to emphasize the importance of family planning, but since it did not require specific funding estimates for each priority area or cost figures on State and local funding support, no such figures are available. 6. In the initial starting period of new programs, it has been customary to provide sheltered or special funding to enable these programs to get underway. Will family planning programs which are new and a disadvantage in relation to established older programs, have to depend for funding on whatever is left after existing programs are supported at existing or higher level? Could they be expanded more rapidly and more widely if special funds were to be made available, for a limited, initial starting period? The intention of the "Partnership for Health" legislation is to permit those at the State and local level close to the problem of health services to determine their priority health needs. Accordingly, if family planning projects are identified by the State planning agencies as being among the top health priorities, and if support is requested, such projects can be funded, depending upon the availability of funds in relation to the priority rating. It is likely that categorical support of family planning would result in rapid expansion of projects. However, we believe that special categories in the "Partnership for Health" program by the Federal government would defeat the purpose of the Act, which is to allow State and local determination of health priorities. 7. What new health programs have been initiated or established by the PHS without specific sheltered or categorical funds in the initial period? The initial formula grant program, authorized by the Social Security Act of 1935, provided general health grants to support any part of a State's public health program. Subsequently, specific health problems aroused public and Congressional concern and these problems were isolated for special attack with earmarked grants. These categorical formula grant programs included: cancer control, chronic illness and aged, dental health, heart disease control, home health services, mental health, radiological health, and tuberculosis control. The first categorical project grant programs established in 1947, was for venereal disease, Subsequently, project grants were authorized for cancer, radiological health, tuberculosis, chronic illness and aged, neurology and sensory diseases, and mental retardation. 8. Family Planning is becoming an increasingly important part of our foreign assistance efforts. The PHS is the principal professional health resource of the U.S. Government and is being increasingly called on to offer technical assistance for AID. What provision is now made for a central focus within the PHS for family planning activities for service programs in family planning, for training and for research? Who has primary responsibility for developing and promoting these programs? How many staff members are working in this area? The Public Health Service does provide technical assistance to the Agency for International Development and the Peace Corps. The responsibility for conducting family planning programs, developing new activities, and defending budget requests resides within the Bureaus and Divisions that make up the operating components of the Public Health Service Population Committee, composed of senior professional representatives of the com |