STATEMENT OF THE AMERICAN OPTOMETRIC ASSOCIATION

The American Optometric Association supports the concept of peer review as one of many instruments available to assure the overall quality of health care in this nation. The concept of standards review has progressed from the idea of cost containment of federally supported health programs like Title XVIII and XIX dealing with in-patient care. This method of review can also assure quality care in additional areas and with additional provider groups. For example, such review can include the services, on an out-patient basis, which the optometrist provides under Title XVIII.

However, we are still talking about a review that is structural and process oriented. That is, the review considers the facilities and manpower used and the processes involved. The Association feels strongly the need to progress to "outcome review."

In an effort to move on to this type of review, one of the current projects of the American Optometric Association will be of great help. Current Optometric Information and Technology (COIT) is being compiled into reference-book form. This reference will detail every vision condition involved in optometric care, with symptoms, typical remedy, criteria for diagnosis, treatment or referral, rate of occurrence, and typical patient problems.

As development of the Professional Standards Review Organizations now stands, medical practitioners will comprise the entire membership of the statewide PSRO, with all final responsibility for review. The American Optometric Association strongly recommends that the advisory groups be given greater authority in influencing the final review decisions. Also the Association recommends that there be more positions with voting power for the various independent health professionals, i.e., dentists, optometrists, podiatrists, etc., on the statewide advisory councils.

In addition, regardless of the number of PSRO's in any state, AOA recommends mandating the creation of a state advisory council and area wide advisory councils. All these advisory groups should carry more authority than presently assigned. This would allow expert evaluations into final decision-making. Again, at all levels, more positions on these advisory groups should be created, in order to allow participation of a wide range of health professionals.

In the administration of the national PSRO program, the Association strongly urges that the health sector of the Department of Health, Education and Welfare retain this responsibility. This is the most logical and workable arrangement. The Association wishes to recommend for your consideration the creation of the advisory group to the national PSRO council. Again, with this national advisory group, more positions should be created, so that primary health care providers, those dealing directly with patient health, may be involved in the decision-making process.

This coordination with advisory groups can prevent potential difficulties as the review process widens and includes out-patient services provided by varied health professionals. Such coordination will eliminate hassling between the medically-dominated PSRO and the advisory Councils of other health groups. Each independent health care professional should be called upon to evaluate his own specialty. Optometrists must review the care provided by optometrists. By virtue of education, training and practice, they are the only health care practitioners capable of fully reviewing such situations.

In the case of optometry, practitioners have been educated and trained at one of the 12 schools and colleges of optometry in the nation. In addition to course

work, during the fourth year of professional study the student spends at least half of his time gaining clinical experience, under professional supervision. After 2-3 years of undergraduate training and 4 years of optometric education, the graduate is ready for the state optometric examination and licensing procedure. The question becomes, how can any profession not familiar with all these procedures and education, establish criteria for evaluation of optometric situations and assume final review for that profession? Evaluation implies that the evaluator will rely on judgments based on his own background and experience. A medical practitioner will surely look into his experiences, which are more oriented toward surgery and eye disease. The optometrist, in concern with the vision performance of the eyes, deals with binocular vision and coordination, vision development, visual perception and development and eye health.

The state optometric groups have already been at work in the area of establishing review organizations. Massachusetts, Michigan, California, Kansas, New York and New York City are some of the areas developing optometric review systems. In addition, AOA has developed a manual on peer review to aid the state groups in this endeavor.

The American Optometric Association, with its membership of 18,000 throughout the nation, is committed to the principle and practice of quality optometric care to all Americans. The profession of optometry is willing and ready to participate fully in a program of true peer review and a Professional Standards Review Organization system which is equitable to all of the health professions. TESTIMONY BY ALICE GOSFIELD, STAFF ATTORNEY FOR THE HEALTH LAW PROJECT, UNIVERSITY OF PENNSYLVANIA LAW SCHOOL

Under a grant from the U.S. Department of Health, Education, and Welfare, the Health Law Project is in the process of preparing a detailed and technical analysis of the PSRO program, based on the statute, the regulations and other examples of PSRO policy implementation. Our focus in this work, as in the other studies we are developing, is the user-patient perspective. The following comments reflect our concern that the patient's perspective be considered of paramount importance in the development of the PSRO program. The five areas we have chosen to address are broad areas which represent some of the problems PSRO decision-makers must face now, lest the program be immutably molded into one which works to the patient's detriment.

1. ACCOUNTABILITY

The statute as written embodies no general legal requirements that the program interact with the public it will serve. As a result, the development of "Support Centers" was possible. There is no legal authority in the statute for these entities, and as the comments below demonstrate, they may seriously undermine the local orientation of the program. No attempt was made to include consumers or their representatives in the negotiations which lead to the development of "Support Centers". This public program which will allocate public monies must not be developed in isolation from public scrutiny. Without affirmative, legal requirements of PSRO inter-action with consumers and the public generally, any systemic accountability will depend on the good will of particular individuals. The development of Support Centers, and their potentially bad effect, is ample evidence of the incontrovertible need for public in-put into this new system.

2 INFORMATION

The PSRO statute gives the Secretary wide discretion in providing information about the program to the people who will be affected by it. (§ 1166; 42 U.S.C. § 1320c-15). There has been no affirmative attempt to circulate information about implementation of the program generally. Once PSROS are operational, their data development potential is enormous. The information obtained in PSRO operations must, of course, be subject to meaningful strictures for confidentiality;

but the basic information about the health care systems of this nation which will be developed must be made public.

PSROS may have the potential for upgrading the quality of care by forcing accountability of physicians to each other. But whether strict review results in improvement of the quality of care will not be known unless PSROS themselves are accountable to the public. PSROS need to make available a range of information for example, how their review system is working; the evaluation criteria being used; quality performance of the hospital and nursing homes being reviewed. Unless information about PSROS and their findings is made available, an unaccountable system for determining allocation of public monies will have been created.

3 NON-PHYSICIAN ROLE

Although the law is clear that none but physicians may participate in final PSRO determinations, there are important roles for non-physicians which must be recognized. In the development of norms, criteria and standards, there will be areas in which there is no immediate consensus among all physicians. (Tonsillectomies and Mastectomies are two examples.) In those situations where there is no direct, scientific or technical data which mandates a specific choice, norms and their applications will be determined by non-medical factors-costs or social needs, for example. Physicians do not have a monopoly on the ability to make non-medical decisions. The consumer and other non-physicians, must be given the opportunity to affect non-medical decisions by participating in norms development, and advising in their application—in Support Centers, Statewide Councils and local PSROS.

Little attention has been devoted to non-technical aspects of quality care such as informed consent or other psycho-social factors of care. It is in these matters which are professionally recognized elements of good medical care that consumers can make a valuable contribution and are, perhaps, better able to evaluate care. There must be an affirmative effort made to include consumers in these ways in the program.

4 PSRO DESIGNATIONS

The following comments demonstrate and support the need for small, locally oriented PSROS, from the consumer perspective.

a. Legislative Intent

Section 1152 of the Social Security Act (42 U.S.C. § 1320c-1) provides the statutory authority for designation of PSROS. There are seven specific criteria for designation. Originally the Act (P.L. 92-603, § 249F of H.R. 1) did not specify the geographical boundaries for PSROs. The Senate Finance Committee Report on the Social Security Amendments of 1972 (Report No. 92-1230, 92d Cong., 2d Sess.) is, however, quite explicit on the issue of local emphasis. "Priority in designation as a PSRO would be given to organizations established at local levels... Local sponsorship and operation should help engender confidence in the familiarity of the review group with norms of medical practice in the areas as well as in their knowledge of available health care resources and facilities." (Emphasis added) (Senate Finance Committee Report (1972) at 259). The Report distinguishes clearly between state and local entities. (See Report (1972) at pp. 258, 259 and 268.) In the Report, statewide designations are to be restricted to "smaller or more sparsely populated States." (at 258).

The dispute over statewide as opposed to local PSROS has been fomented primarily by state medical societies. (See American Medical News, January 7, 1974, October 22, 1973, May 14, 1973 and March 5, 1974, for example.) In none of the reports does it appear a local or county medical society has sought domination of the PSRO in its area by its state society counterpart.

The following additional comments present other reasons for which statewide organizations should be discouraged in all but small sparsely populated, medically underserved areas.

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b. Consumer Accountability

Generally speaking, the PSRO program does not provide for affirmative action by PSROS to seek consumer in-put or response on most issues including granting contracts, developing profiles of medical care, imposition of sanctions and development of norms, among others. Because of this basic lack of consumer accountability in the foundation of the program, it is imperative that PSROs be structured in such a way that consumers can gain access to them. The consumers who will be affected by this program are poor and old people who will not have the resources to involve themselves in the activities of a statewide organization whose center of activity may be geographically and financially inaccessible to them. The general public, as well, will have additional burdens placed on them, should they seek to exercise their right to influence and comment on the activities of a program that will dispose of their tax dollars. PSROs will determine issues which are inherently local-the effectiveness of a particular hospital's review system, the payment of a particular persons bill, for example. Consumer activity around PSROs would be severely curtailed by statewide designations and efforts to focus power at the state level perhaps should be seen as a further attempt to minimize consumer impact on the program.

c. Consumer Rights

PSROS will conduct primary determinations and hearings on review of determinations with which beneficiaries are dissatisfied. (§ 1159 of the Social Security Act, 42 U.S.C. § 1320c-8) The mechanics of review-mustering an argument, gaining access to information necessary to a case, marshalling support from providers or practitioners, effective presentation of the case-are complicated and difficult. To conduct the review process on a centralized statewide basis rather than locally will be detrimental to consumer rights which have been guaranteed by the statute. It would place an unjust burden on Medicaid and Medicare beneficiaries forcing them to travel long distances at great difficulty and inconvenience to present their cases effectively. Making the process inaccessible by virtue of those state designations, will thwart attempts by consumers to avail themselves of their rights.

Medicaid recipients, have in the past enjoyed a fair hearing process which is highly localized (through County Assistance Offices or other similar entities). Although the rights of these recipients may already have been unconstitutionally impaired through jurisdictional amount restrictions on review and preemption of jurisdiction by federal courts (§ 1159 (b) and (c); 42 U.S.C. § 1320c-8 (b) and (c)), the further restrictions of their access to the hearing process by centralizing that activity in a statewide entity, would unduly discriminate against those who can least afford an adverse determination they may be precluded from effectively challenging.

The statute provides for no effective means of enforcing rotation requirements on physicians, although a principal assumption of the value of PSROS lies in the educational effect it can have if all physicians participate. Although rotation of participation is strongly expressed as a necessity and goal of the program (§ 1155(d); 42 U.S.C. § 1320c-4(d); see also, Sen. Fin. Committee Report (1972) at 259 and 262), the system is essentially voluntary. To centralize activities in a statewide PSRO would enhance the possibility of domination by an established group of physicians both politically and functionally, because of the additional burden it would impose on local physicians who might otherwise choose to participate in review activities. Mere remuneration for time spent in review will not be sufficient incentive to participate in the program. A statewide focus may alienate a few physicians active in state medical society activities, but more seriously, may actually discourage the participation of local physicians not interested in state society activities, who will not choose to take the time to go to a centralized location to render services which they may not be anxious to offer in the first instance.

The example of the interaction of centralized fiscal intermediaries and the Social Security Administration (SSA) illustrates enforcement difficulties presented by statewide designations which could hinder public accountability and accountability to the government. When SSA contracted with the Blue Cross Association (BCA) as the fiscal intermediary under the Medicare program, Blue

Cross subcontracted with local Blue Cross Plans. Until a new contract provision was added in 1970, SSA was required to channel all communications through the Chicago organization. Even after revision in the SSA-BCA prime contract to permit direct communication, no regulation or instruction could be prescribed by the Secretary without prior consultation with the BCA. (See, Hospital Insurance Benefits for the Aged, Agreement with Intermediary Pursuant to § 1816 of the Social Security Act (1970) Article VII, § B)

Although the analogy is not direct, it demonstrates the pitfalls in monitoring, enforcement and administration of a program where the actual day-to-day activities are conducted on a local level, but primary authority and administration is in a centralized structure. Even if statewide PSROs were designated in some of the larger states that seek such approval, by necessity day-to-day review will be conducted by various sub-groups. Enforcement and monitoring of local activities might have to be conducted through the statewide PSRO (otherwise there is no raison d'etre for them), and the insulation can, as was the case with fiscal intermediaries, destroy the accountability and effectiveness of the entire program. c. General Comments

The basic issue in the area designation dispute involves a balancing test. We believe that statewide designations in other than the small, sparsely populated states, can seriously undermine the beneficial effects of this program and will result in a structure directly inimical to consumer interests and rights. By the same token, an organization that is too localized (institutional utilization review committees may be an example) can defeat the program as well because of cronyism factors-a hesitancy on the part of physicians to review strictly and sometimes levy sanctions on their friends.' The balance lies somewhere between the two.

If the professional associations which testified in the hearings on the Social Security Amendments of 1972 were correct in their assertions that peer review should be conducted by peers,' it would seem that the better mode for review would be a more localized organization. In some of the states which are seeking single state designations, the differences between urban and rural areas are so great that the difference becomes one of kind. The type of medicine practiced in the disparate areas is not equivalent and review by a single group, would not, for that reason, be performed by peers.

If PSROS will result in better quality medical care through an educational process that will involve substantial numbers of physicians actively participating day-to-day review on a rotating basis, a statewide designation will attenuate the process because of the number of physicians that will have to rotate through a single entity. Service by those physicians will be occasional and sporadic as attempts are made to include everyone. Unless rotation and widespread participation are sought, the program will be defeated by domination by a small group of physicians traditionally involved in state society affairs. Where a local organization serving a smaller area containing a smaller group of physicians is the focus of activity, more physicians can rotate through more often over a shorter period of time thereby enhancing the educational effects of the program. 5 Hearings and Review

Unlike the other areas already discussed which address the regulatory process, the statute itself may unconditionally condition the previously wellestablished hearing rights of Medicaid recipients. (§ 1159; 42 U.S.C. § 1320c-8) The Medicaid hearing process has been locally administered with judicial review available in state courts. These poor patients have never been subject to "amount in controversy" limitations, like those imposed by the PSRO statute. The very fact of their eligibility for the program is eloquent testimony to their inability to absorb adverse determinations on services costing up to $1,000 or

1 See Derbyshire, Medical Licensure and Discipline in the United States, John Hopkins Press, 1969 at 77 demonstrating reluctance of physicians to discipline each other.

2 See hearings of the Senate Finance Committee on H.R. 1 (92d Cong.) Social Security Amendments of 1971, and, for example, testimony of American Dental Association at 2415, American Nurses Association at 2421, American Podiatry Association at 3305, College of American Pathologists at 2885, and the Coalition of Independent Health Professionals at 3363.