COSTS OF IVF 

It is only 20 years ago that Louise Brown was born in England, and it was in that same month that I started my reproductive endocrinology fellowship. Very few reproductive endocrinologists (REs) existed at that time and even fewer could appreciate what impact the assisted reproductive technologies (ART) would have on our specialty. Today, almost all reproductive endocrinologists participate in one way or another with the assisted reproductive technologies. Indeed, the success of most reproductive endocrinologists both professionally and economically is closely tied to their ART program. This manuscript will review the attributes of a good ART program, how patients can find a good ART program, a brief description of outcomes management, and finally, a discussion of value, the most important concept reproductive endocrinologists need to embrace to be successful in the year 2000 and beyond.

Most reproductive endocrinologists would consider the following attributes to be important for a good ART program.

1. High Quality Laboratory

First, the ART laboratory must be of high quality. In the final analysis, this means that the laboratory can obtain maximum fertilization, maturation, implantation, development, and live birth rates. This, however, is dependent on a large number of factors, including physical facilities, equipment, and supplies. Physical plant requirements include adequate space, clean air, security systems, and proximity to operating rooms for GIFT. Most important, a sufficient number of well-trained and experienced laboratory personnel need to be available. They also need to be able to communicate clearly with each other, with the medical team, and with the patient. A good laboratory also needs to have systems and protocols in place for all aspects of their operation, and need to have these organized in procedures manuals which are easily available and understood by all who work in the laboratory.

The Society for Assisted Reproductive Technology (SART) has developed detailed manuals and inspection lists, and an on-site inspection and certification system with the College of American Pathologists (CAP) and the American Society for Reproductive Medicine. Over one-third of American programs have been certified and an additional one-third have applied for certification. SART has recently required that all programs be certified or have applied for certification with a recognized certifying body. While such certification cannot guarantee laboratory quality, it does promote standards and practices which should improve laboratory quality overall.

2) High Quality Clinical Care

Second, good ART programs must have high quality clinical care. This requires physicians who not only have had sufficient training and experience to provide state-of-the-art ART care, but also are capable of providing non-ART care, such as controlled ovarian hyperstimulation, intrauterine insemination, surgical procedures such as hysteroscopy and laparoscopy, and treatment for the male. It is important to have the best possible ambience that includes adequate facilities, congenial surroundings, an efficient and pleasant staff, and an ability to avoid stress-promoting situations. This requires the ability to see the man and woman separately or together and to provide adequate time for consultation, and to have special areas for infertility patients away from obstetrical patients. The whole team should be involved in the support effort, but it is the physicians’ responsibility to set the tone.

1. Comprehensive Services

   Third, ART programs should provide comprehensive services. These include laboratory services such as intracytoplasmic sperm injection (ICSI), embryo hatching, cryopreservation, and blastocyst culture. Clinical services which should be available include GIFT, donor oocytes, donor sperm, and gestational carrier. Easy access to endocrinology, andrology, and genetics laboratories should be available. The provision of comprehensive services includes the concept of teamwork among the physicians, nurses, embryologists, mental health professionals, business staff, health plans, attorneys, and agencies providing care.

2. Patient Choice

   Fourth, good IVF programs must provide the necessary consultation services and choices of options so that patients can choose from among the different options available to them to deal with their infertility. This includes discussion of the advantages and disadvantages of no treatment, standard treatment such as controlled ovarian hyperstimulation and operative procedures, use of donor gametes, gestational carriers, adoption, and childfree living. The relative benefit or utility of these different options, including an understanding of what is involved with the different choices and the chance of them occurring over what time interval, need to be reviewed. The financial, physical, and emotional costs must be discussed and made specific for the patient’s financial and insurance situation, age, physical condition, and psychological status. Complications which especially need to be discussed include the risks of ovarian hyperstimulation, multiple births, problems of prematurity, congenital anomalies, multifetal reduction, and the relationship between the number of embryos replaced, pregnancy rates, and multiple pregnancy rates. The best choice is the one the patient makes for herself after she has been fully informed and consented regarding the possible options. Good ART programs ensure that the patients choose their treatment based on an optimal understanding of their situation, and do not choose for the patient. Referrals for second opinions to other reproductive endocrinologists or health care professionals are freely offered. In addition, they provide patients with consent forms which meet the legal requirements and are detailed and comprehensive enough to ensure that the patient can choose wisely. Furthermore, the consent forms need to be signed, witnessed and dated at the appropriate times.

3. Excellent Documentation

   Fifth, good IVF programs have excellent documentation of their clinical and laboratory care. This may sound trivial, but it is not. Accurate and detailed documentation is frequently overlooked by clinical and laboratory personnel. This increases the risk of error and seriously compromises the ability to understand prior care, to benchmark outcomes or to do clinical research. Careful documentation can be enhanced by standardized protocols and forms, as well as by information systems, but the most essential ingredient is a commitment by the clinical and laboratory staff.

4. Research

   Sixth, good IVF programs usually do some clinical and/or laboratory research. Research is important not only because it can create new knowledge, but those participating in research learn much more about specific aspects of their program and become better clinicians and embryologists in the process.

5. Professional Management

   Seventh, good IVF programs provide skilled professionals to manage their business. This includes providing advice to patients to maximize insurance reimbursement and to help patients understand the financial implications of their care. If additional financial services are provided, such as financing or "money back" plans, these good programs ensure that their patients are well educated about them before agreeing to them. The ASRM and SART have not found these programs to be unethical per se, but have heard about questionable practices in the implementation of these programs.

6. Cost-Effective Care

   Eighth, good ART programs are aware of and practice cost-effective medicine. This requires that programs only provide services that are clinically appropriate and charge reasonable amounts for their services. It also means that programs constantly strive to reduce their costs and provide better services for their patients.

7. Psychological Support

   Ninth, good ART programs recognize that infertile patients require emotional support as they pursue infertility care. Infertility is a life crisis for many patients, and represents a loss of self-esteem, loss of security, and loss of self as a woman/man, wife/husband, and mother/father. The infertile patient’s overall quality of life is often adversely affected with work schedules, vacations, sex life, and ability to socialize with friends and all being negatively impacted. Serious stresses are put on the marital relationship. It is important that ART programs recognize this aspect of infertility and help patients deal with it. Interventions include giving the patient an accurate prognosis, discussing ways to increase control for the patient, reviewing stress-relieving activities, identifying alternative forms of affection and sexual communication, and facilitating access to information and emotional support, such as that provided by RESOLVE, and also on the Internet. Physicians need to counsel couples about problems associated with success, including the dramatic changes in lifestyle which occur with parenting, and the need not to have unrealistic expectations for themselves or their child. Sometimes the physician just needs to be "there" to listen, to comfort, and "to take on sadness from time to time", become frustrated and tired, but not lose patience.¹

8. Ethical Care

The tenth attribute of a good ART program is that it practices medicine ethically. ART procedures today are at the center of several of the major ethical dilemmas facing our society. These include the use of ART in couples for whom there are religious proscriptions, abortion, multifetal reduction, lifesaving medical treatment of seriously ill babies, appropriate age for parenting, donor sperm, donor oocytes, splitting of donor oocytes, gestational carriers, surrogates, single parenting, sexual orientation’s role in parenting, insurance funding of infertility, limitation of services under managed care, sex selection, preimplantation genetic diagnosis, chorionic villus sampling, amniocentesis, genetic therapy, twinning, embryo research, cloning, and others. Clearly, there are almost no "correct" or "right" answers to most of these issues. Some of what seemed "wrong" ten years ago is accepted today (e.g. IVF), some of what was accepted five years ago is seriously questioned today (e.g. intergenerational oocyte donors), and some of what is questioned today may become commonplace in the future (e.g. preimplantation genetic diagnosis). It is important for reproductive endocrinologists to familiarize themselves with the role ethics play in the development and application of the assisted reproductive technologies if they are to counsel their patients wisely.

HOW TO FIND A GOOD ART PROGRAM

1. Availability, Affability and Ability

   Not so long ago most patients found their doctors either by a referral from another physician or by a referral from a patient. Patients and physicians felt they knew who the "good" doctors were, even though there are few, if any, objective measurements to determine what a "good" doctor is. However, the old maxim that the three As of a successful practice were availability, affability, and ability is still true since the absence of these attributes generally result in lower quality care. The reason practices which focused on the three As were successful is that they were providing what patients wanted, that is, delivering value.

   Quality service is the most important requirement for any good practice. This involves, first of all, being available. This is not as simple as it once seemed. Availability now means having sufficient staff to answer telephones so that patients are not left for long periods of time on hold, or do not have to speak to an answering machine every time they call. It may also involve the judicious use of answering machines both for receiving incoming messages and for leaving messages with patients. In reproductive endocrinology availability frequently means the ability to provide seven day a week, 52 weeks per year service. While it is possible to program some aspects of reproductive endocrinology care, much of it remains tied to patients’ biological rhythms. It is therefore important that patients be able to obtain office visits on short notice, frequently the same day or the next day, at times which are convenient to them, and be seen on time and for as much time as they need. Clearly all of these requirements create many more demands on the reproductive endocrinology office than on the vast majority of other medical offices. The utilization of flexible schedules, as well as ancillary health care personnel such as nurse practitioners, can be instrumental in ensuring that such access to the practice is available most of the time.

   The second major component of quality service is affability. It is axiomatic that the receptionist is frequently one of the lowest paid office personnel, and yet one of the most important in presenting a positive image of the practice both in person and on the telephone. It is essential to have individuals working in these positions who are capable of a very high level of interpersonal skills. This is especially true in a reproductive endocrinology practice where anxieties, frustrations, disappointments, and depressions occur frequently. Strong interpersonal skills with a personal commitment from each staff member at all levels to excellence in caring for patients is necessary. Such care and attention need to be provided consistently, even to patients who may have very difficult clinical situations and/or who can place major time and psychological demands on a practice.

   Ability is the third A important for a good practice. This requires a well-trained, experienced, and highly motivated reproductive endocrinologist who is consistently undertaking continuing medical education through reading, meetings, and the acquisition of new skills. The performance of research generally increases the reproductive endocrinologists' knowledge and appreciation of the complexity of clinical care. Teaching can also be helpful in maintaining current state-of-the-art knowledge and skills. Most high quality reproductive endocrinology practices do undertake both research and teaching responsibilities.

   In addition to these basics there are some additional specific methods of ensuring that patients can find a good ART program and that physicians can attract patients in a managed care environment.

2. Specific Ways to Attract Patients in a Managed Care Environment

   It is important for physicians to be in a plan if they are going to attract patients who are in that plan. This sounds simplistic, yet there are far too many plans to be associated with each and every one. In addition, many plans have extremely poor or non-existent coverage for infertility services, and enrollment in such plans would have very limited chance of generating any referrals. Therefore, it is necessary to determine which plans have the type of patients and the type of coverage which would make it appropriate to join the plan.

   Once a physician is in a plan it is important to ensure that this fact is made known to patients and other physicians. The practice needs to ensure that the physician is listed in all of the literature distributed by the plan. It is not unreasonable to ask that these lists be updated at least every three months and potentially that a separate letter be mailed to physicians in the plan and patients informing them of the doctor's membership. It is our experience that many of these plans are very disorganized, and it is not unusual to join a plan and yet be left off the lists of physicians who are members. If the practice publishes a newsletter, then announcements in the newsletter should be made regarding plan membership. In addition, plans in which the practice participates should be listed in the office so that patients will be aware of their different options.

   Once a physician is in a plan it is important to personally understand the details of the plan and also to train staff in the details of each plan and its different benefits. This will enable the staff to assist patients who have these plans. This will be very much appreciated by the patients who will not have more financial anxiety added on to the frustration of usually limited benefits. In order to attract patients it is also important to be geographically available through having multiple offices or arrangements for patients to have services provided at alternative sites for their convenience. In many locations this is not a necessary requirement, but in some large urban areas it can be a very real distraction for patients who live in one area and commute to another to work.

   It is important for the reproductive endocrinologist to understand what types of patients are in different plans, and whether or not the patients who are in those plans are the ones they want to attract to their practice. Demographics of areas as well as plan demographics can help to ascertain which managed care plans will be attractive for any given practice.

3. Specific Ways to Attract Physicians to Refer in a Managed Care Environment

   The first step in obtaining referrals from physicians is, of course, to provide high quality, reputable care. This is achieved through one's daily work in seeing patients who have been referred for consultation and responding promptly to the referring physician in the appropriate manner, as well as through providing quality care which results in good outcomes. It is important to return patients to their referring physician. The quality of a practice can be enhanced among colleagues through research and publication, lecturing at Grand Rounds and other professional meetings, as well as teaching. Such high profile exposure in the community is important in maintaining a strong reputation for the practice which enables other physicians to refer patients to you with confidence. Physicians who function primarily on a referral basis need to do things on time, do what they say they will do, finish what they start, and say please and thank you to those who are referring patients.

   Once a reproductive endocrinologist has joined a plan it is important to inform other physicians who may refer patients. This can be achieved through inclusion in the membership books, letters from the plan, newsletters from the reproductive endocrinologist practice, or individual letters to physicians who have referred in the past. Once the referring physician is aware of the reproductive endocrinologist's membership it is important for the reproductive endocrinologist to understand the rules of the managed care plan with respect to referral and reimbursement so as to minimize misunderstanding or conflict between the referring physician and the subspecialist, as well as to minimize difficulties with the patient.

   Many reproductive endocrinology practices are rapidly evolving with newer treatment modalities and innovative techniques. It is important to keep other referring physicians in the community aware of these developments both through lecturing, newsletters, and face-to-face meetings with the physician or with the physician's staff. It is also important to include the referring physician in any operations or procedures if this is possible and if it is desired by the referring physician.

4. Specific Ways to Attract Employers and Unions

   The first and most important step is for the reproductive endocrinologist to find out which employers or unions in the area have plans which may cover reproductive endocrinology services and also to determine which of the current patients belong to those plans. In this way the reproductive endocrinologist could determine whether or not involvement in plans with certain employers or unions appears desirable. If it is desirable, and the physician joins the plan, it will be important again to contact both employers and also unions to inform them of the membership so that these groups can inform their employees and/or union members. The reproductive endocrinologist can also offer to provide educational materials and/or lectures or informational sessions to employees or union members. This service provides added value and a sense of caring which is very positive for practice building. More recently large companies may be prepared to refer directly to large practice groups. We could probably expect to see more of this direct negotiation interaction in the future. Reproductive endocrinologists should keep themselves abreast of developments in this area so that they could contact employers or other large groups and consider directly negotiating.

5. Specific Ways to Attract Plans

   Reproductive endocrinologists who wish to join certain plans should contact them and arrange a meeting to review with the managed care plan the value which can be added to the plan through the inclusion of the reproductive endocrinologist practice. This will include the need to demonstrate the need for the services, the high quality of the services as shown by outcome assessment with respect to tests performed, follow-up visits, length of hospital stay, pregnancy rates, as well as the uniqueness of the practice, and that services could be provided by the reproductive endocrinologist which are not provided by others. It is also imperative that the reproductive endocrinologist demonstrate the cost-effectiveness of their practice. This requires data on outcomes, costs, and financial and treatment data. As noted above, the reproductive endocrinologist should be able to participate in the development of protocols and/or treatment guidelines which would be of value to managed care plans. Reproductive endocrinologists can also provide consulting services to the plans either on an individual patient basis or a more generic basis in integrating infertility care into the overall health care of the patient. Frequently the reproductive endocrinologist can also provide 24-hour coverage for services where other generalist obstetrician-gynecologists cannot. This is particularly true for such services as intrauterine insemination and other procedures which frequently need to be performed on weekends. The reproductive endocrinologist can differentiate himself from the competition in this manner.

   From a business perspective it is important to be able to demonstrate a strong financial position, good business record keeping, good systems for billings, collections and accounts receivable, and strong fiscal business control over the reproductive endocrinology practice. It can be helpful for the reproductive endocrinologist to itemize their computer system capabilities to demonstrate these in an objective fashion to the managed care plans. It is also obviously important to have adequate liability insurance so that the managed care plans do not see themselves assuming a larger liability than they ordinarily would.

6. Specific Ways to Attract Consumers

   Consumers can be attracted through the general approaches indicated at the beginning of this section, namely availability, affability, and ability. It is important to emphasize to consumers that this availability is present, to demonstrate through action the affability, and through outcomes the ability. Most consumers cannot differentiate high quality from low quality medical care per se. However, almost all patients have a perception of what good, caring care is compared with indifferent health care. Indeed, most consumers will be comparing their experience in the doctor's office not with another physician, but with companies such as Nordstrom's which consistently provide a very high level of service. Consumers can find ART programs through consumer organizations such as RESOLVE or the Endometriosis Association, if the reproductive endocrinologist is on the referral list. Consumers can also be attracted through advertising on television, radio, and in the print media. Such advertising should be careful to adhere to Federal Trade Commission (FTC) and SART guidelines. Unfortunately, such advertising is very expensive and must be done very carefully or else it can appear unprofessional, self-serving, and be potentially misleading and even break regulatory requirements. This is especially true of advertising success rates, or "money back guarantees" or "cures" for specific problems. Therefore, marketing in the media must be pursued cautiously. Informational sessions open to the public can gain exposure and also provide a useful service for the community. Research and publications also will occasionally bring recognition from the public, although not nearly as frequently as from one's colleagues. Recently, unfortunately, we have seen examples of what many REs felt was exaggeration of research results by the media based on promotional material from ART programs. SART will be following such developments closely. In the last couple of years some programs have marketed on the World Wide Web. Such an approach can be expensive if a sophisticated home page is developed, and the true return in terms of patients is yet to be determined. However, it is clear that computers and the Internet will continue to play an increasing role in the dissemination of information in our lives, and assessment of its applicability to each practice is important. This has been demonstrated in the past year with the popularity of the SART report for 1996 which was placed on the Internet by the Centers for Disease Control (CDC). Additionally, teaching presentations at local organizations, such as Rotary or Lions Clubs, and participation in community events can increase one's visibility in the community and can increase referrals.

7. Attracting Consumers Through Networks

Some reproductive endocrinologists may find it worthwhile to join networks which are being set up to attract patients. It is important, however, to understand the patient demographics of the networks and the financial ramifications of joining in with a large group of other physicians. Currently, networks have limited ability to deliver patients, although this may well change in the future.

OUTCOMES MANAGEMENT

What is "outcomes management"? I believe outcomes management is essentially the practice of medicine, but also that the practice of medicine is changing so that we must think of outcomes in a different way. Outcomes include the sum total of the change in quality of life for the patient, including both the positive changes and the negative changes over the entire spectrum of daily living for the patient. Outcomes management requires evaluation of all of the possible outcomes, the value of each outcome, the probability of each outcome occurring and the costs, including financial, time, physical, and emotional costs. In the past, physicians focused on clinical outcomes defined strictly from a medical perspective, often ignoring financial and other costs. Today, this is no longer acceptable. However, outcomes management is much more than this. Outcomes must be assessed not just from the physician’s perspective, but also for the patient, her family, the potential baby, her employer, and society at large. It is no longer enough, as a profession, to think just of the patient, although individually it is our responsibility as physicians to do what we think is best for each patient. We must learn to work within parameters set by others who are exercising responsibilities given to them by society at large (e.g. professional regulations, laws, HMO guidelines, FDA guidelines). If we do not agree with these regulations and laws, it is our responsibility, as a profession, to try to change them.

Perhaps the biggest problem with outcomes is simply the difficulty in measuring them. An excellent example of this is the SART Registry report. Despite the best efforts of clinicians, biologists, statisticians, computer programmers, and the CDC, the report is not perfect and is criticized by some who would like not to measure outcomes. But we must measure and report our ART outcomes because clinic-specific reporting is mandated by the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA).² In order to optimize this situation, SART’s Registry Committee and Executive Council have had several meetings with the Centers for Disease Control and Prevention to identify variables and outcomes to be collected, and definitions of these variables and outcomes. Much progress has been made but some issues remain which make optimal use of the outcomes reports problematic. SART has surveyed all its members to ask their opinion about collecting and reporting outcomes as well as prospective reporting of cycle starts which is necessary to help differentiate among programs which have very different cycle cancellation rates. Some of the outstanding issues with reporting outcomes are:

1. The definition of success is now live birth per ovarian stimulation. All cancelled cycles need to be included in the denominator. Some REs are opposed to this, but the FCSRCA requires this.
2. Some argue that pregnancies achieved from cryopreserved-thawed oocytes in subsequent cycles should be included in the fresh cycle success rate. No satisfactory way to do this has been identified.
3. Results vary from program to program each year and within programs from year to year based on variation alone.³
4. Patient populations vary greatly from program to program. Some of these differences, such as age, are known to affect pregnancy rates while the impact of others, such as type of prior treatment, are not yet known. Data to identify variables which predict outcomes are now being collected, but much is still to be learned before program-to-program comparisons can be considered valid.
5. Patient selection varies greatly among programs. For example, some programs encourage more patients to use donor oocytes than other programs; this affects the reported success rates.
6. The delay in reporting means that by the time clinic-specific results are reported, many programs have changed personnel and/or protocols, and/or begun utilizing new technology (e.g. intracytoplasmic sperm injection).
7. Different programs use different protocols with some encouraging many patients to undergo standard infertility treatment before pursuing ART, while other programs recommend ART immediately to almost all of their patients.
8. Some programs have focused their advertising on categories of patients in which they have the best results, or may choose to cryopreserve embryos more frequently than other programs.
9. Some programs replace larger numbers of embryos, thereby obtaining higher pregnancy rates, but also higher multiple birth rates, which is not a desired outcome but to which less attention has been given in the past.
10. Individual patient values and preferences vary in different areas of the country. For example, the acceptability of multifetal reduction (MFR) varies greatly, thereby influencing patients’ decisions regarding the use of ovarian stimulation drugs, IVF, and/or blastocyst culture, the number of embryos to be replaced, as well as other treatments.

There are other difficulties with outcomes measurements besides measuring them. How do we account for unwanted outcomes such as spontaneous abortion, multiple birth, congenital anomalies, or other long-term disabilities? These unwanted outcomes affect the babies directly and some have a significant prolonged negative impact. Other unwanted outcomes occur which, as REs, we rarely measure. These include maternal morbidity and mortality, the personal, family, work, and social costs of high multiple birth families, and the financial costs of multiple pregnancies, birth, and their sequelae. We also, of course, have no measure of the cost of failure for those who attempt IVF without success. How do we measure against the potential use of donor oocytes, gestational carrier, surrogacy, adoption, or childfree living?

What is clear, however, is that society is increasingly critical of ART treatments that result in high order multiple births. The cost of these is incredibly high. It can be shown that it is more cost effective to avoid these outcomes. This can be achieved in a number of ways:

1. Use treatments which are more cost effective on patients not needing ART. These treatments almost always also have lower multiple pregnancy rates as well. (Table 1 and Table 2.)
2. Use lower doses of stimulation drugs.
3. Cancel non-IVF stimulation cycles which have more than five or six mature follicles.⁴
4. Replace fewer embryos/oocytes in ART cycles, following SART guidelines.
5. Use blastocyst development as a means to reduce even further the number of blastocysts transferred.
6. Discuss multifetal reduction with all patients. Limit the number of embryos transferred to three in patients for whom multifetal reduction is not acceptable.
7. Ensure that patients with multiple pregnancies have excellent high-risk obstetrical and antenatal care.

It can be shown that even if only the obstetrical and neonatal financial costs are considered, it is more cost effective to perform additional ART cycles with lower multiples than to have a higher pregnancy rate with higher multiple birth rate. (Table 3, 4, 5, and 6.)

These costs show that better financial outcomes are achieved by having lower pregnancy rates and the associated lower multiple birth rates. These costs also do not include the very high costs of educating and caring for children born with developmental problems or other iatrogenic illnesses, nor the personal and family cost to the parents and children in high multiple birth families.

In summary, outcomes management is a complex and evolving field, even in ART which, on the surface, would seem to have easily measured outcomes. While many criticisms of current data collection can be made, it is clear that even poor data are better than no data, and that our data are constantly improving. We have reached the point where we can now benchmark and begin improving outcomes. As REs, we all need to be conscious of outcomes which occur outside of our immediate and intended goal, yet which have profound consequences for our patients, their families, and society.

THE CONCEPT OF VALUE

Value has become a commonly used term in health care in the past few years. Why is this so? What is value and is it the same thing to all people? In the past, physicians really had only to deliver value to their patients, but now others are involved, such as health plans and employers. How do physicians create value for these constituencies?

There is no commonly accepted definition of value among purchasers. Some would consider the following equation:

Value = Quality

Cost

However, especially in health care, many feel that value is not increased if quality is decreased. A more specific description might be: "Value in health care is the highest quality care purchased at the most competitive price, where quality is defined as meeting the needs of customers, demonstrated through performance measures (and the process by which performance results are generated) and satisfaction".⁵ The key features that differentiate health care purchases from others are difficulties in measuring quality and factoring in the "art" of medicine and professionalism. It is also true that the actual "cost" of medical services is often different and/or unknown relative to the fees charged or the amounts actually paid. Therefore, value in medicine is difficult to measure.

Why has value become so important in the delivery of health care? Until the past decade, as health care costs increased, employers simply paid the price. However, the new global economy has resulted in the inability of companies to increase prices for their products. Rather, the price of many products has decreased as companies have found more efficient ways, often through consolidation, technology, and better information, to create the same or higher quality products with a lower price. Much of this improvement has occurred through the development of rigorous systems for benchmarking processes and improving them, i.e. continuous quality improvement (CQI). While American industry has led the world in this transformation, health care has lagged far behind. Furthermore, when employers have attempted to find out why this is so, or tried to implement CQI systems, they have found little data on outcomes, best practices or quality, and very little interest from insurers or physicians in measuring them.

In medicine, we usually associate lower cost with lower quality, while in business lower cost and higher quality frequently go hand in hand. This occurs because higher quality results in fewer mistakes, more efficiency, more volume, all of which lower cost. Higher quality is achieved by implementing processes and systems which measure quality (as perceived by the patient and payor), benchmarking best practices, and continuously improving outcomes. The large HMOs were only temporarily successful in limiting the increases in health care costs because they did not engage the patient or physician in process improvement. Therefore, we currently have a gridlock, with unhappy patients because of limitations on care, unhappy physicians because of reductions in income and loss of professional freedom, and unhappy payors because costs are rising again. The current system is not creating much value for any of the constituencies affected.

What is the solution to this gridlock? First, it is important to understand that different constituencies in health care have different needs. A saying which capsulizes this is: "If you would sell what Jean Smith buys, you must see through Jean Smith’s eyes". In order to create value for others, we must know what their needs are.

Patients need access to quality care at affordable prices. Employers need healthy employees, predictable and manageable health care costs, and measurable outcomes. Physicians need access to facilities to practice medicine, adequate volume of patients, freedom to practice medicine, and adequate compensation for their services. How can such a situation be brought about?

First, patients need to take responsibility for much more of their own health by developing healthy life-styles which emphasize prevention of disease. The government, employers, and physicians all have major roles in educating patients in this regard. Patients must also recognize the need to accept some personal responsibility for paying for some of their health care services when they are not involving critical or life threatening care.

Second, employers need to work with the health care industry to develop long-term solutions to health care problems, not just short-term cost-cutting measures. This involves helping the health care industry develop integrated continuous quality improvement systems, paying for research and prevention programs, and rewarding providers who provide more value to patients and payors with more patient volume.

Third, physicians need to become involved in transforming the cottage industry of medicine into an information-based, integrated industry focused on measuring outcomes, benchmarking best practices, and continuously improving quality while maintaining or decreasing costs.

If these changes take place, we will be able to transform the current gridlocked system into a health care environment of a truly effective, organized delivery system with fully engaged physicians and fully educated patients competing on the basis of quality, efficiency, and customer service, i.e. quality.⁵

For this to occur, physicians need to take a leadership role in creating new health care systems. Today, physicians have an incredible opportunity to determine the future scope and design of health care in the next century. We can create real value for society by working with payors and patients to develop new systems which reduce health care costs and provide high-quality care and universal access. It will not be easy, and will require lateral thinking or "out of the box" thinking, something physicians have not traditionally been good at. It also requires the ability to respect and work with business people and consumers — those for whom we need to create value. It also requires that we take some risk as we abandon old ways and try new. The most important overriding requirement is that we assume ownership of and accountability for the problems in health care, for the sake of our patients and our profession if not for ourselves, and become determined to do something about it. I believe reproductive endocrinologists can help lead the way in restructuring the current health care system into one which creates more value for patients, payors, physicians, and society. Doing so will ensure outstanding care for our patients and a promising future for our specialty.

Table 1

RELATIVE COST AND FECUNDITY PER CYCLE

Treatment	Cost	Relative Cost	Fecundity	Relative Fecundity	Cost Per Pregnancy
Observation	$50	1.0	3%	1.0	$1,667
Clomiphene +IUI	$500	10.0	7%	2.3	$7,142
Gonadotropin + IUI	$2500	50.0	15%	5.0	$16,667
IVF/GIFT	$9,000	180.0	30%	10.0	$30,000
Surgery (1 year) Min/Mild/Mod	$8,000	160.0	Min/Mild/Mod 5%	1.67	$17,391
Surgery (1 year) Severe/Ext.	$10,000	200.0	Sev/Ext 3%	1.0	$32,258

From Adamson. ASRM Practice Committee 1997

 

Table 2

APPROXIMATED RELATIVE COSTS OF COURSES OF TREATMENT

Treatment	Cost	Duration (Mos.)	Total Cost	Approximated ECPR	Cost per Pregnancy
Observation	$50	12	$600	31%	$1,935
CC + IUI	$500	3	$1,500	20%	$7,500
hMG + IUI	$2,500	3	$7,500	39%	$19,230
IVF / GIFT	$9,000	3	$27,000	66%	$40,909
Surgery Min/Mild/Mod	$8,000	12	$8,000	46%	$17,391
Surgery Sev/Ext	$10,000	12	$10,000	31%	$32,258

From Adamson, ASRM Practice Committee 1997

Table 3

PROPORTION OF MULTIPLE BIRTHS CORRELATED WITH LIVE BIRTH RATE

 

	Total Live Birth Rate	Singleton	Twin	Triplet	Quadruplet
Scenario A	30%	59%	33%	7%	1%
Scenario B	50%	40%	45%	12%	3%

 

Table 4

NUMBER OF MULTIPLE BIRTHS CORRELATED WITH LIVE BIRTH RATE

	Number of Patient Cycles	Number of Live Births
		Singleton	Twin	Triplet	Quadruplet
Scenario A Cycle 1 Cycle 2	100 70	17.6 12.4	10.0 7.0	2.1 1.4	0.3 0.2
Total	170	30.0	17.0	3.5	0.5
Scenario B	100	20.0	22.5	6.0	1.5

Table 5

COSTS OF PERINATAL CARE PER BABY AND PER PREGNANCY

	Singleton	Twin	Triplet	Quadruplet
Per Baby	$10,000	$20,000	$40,000	$80,000
Per Pregnancy	$10,000	$40,000	$120,000	$320,000

Table 6

COSTS OF PERINATAL CARE

	Number of IVF Cycles	Number of Live Births
		Singleton	Twin	Triplet	Quadruplet	Total Cost
Scenario A	$1,360,000	$300,000	$680,000	$420,000	$160,000	$2,920,000
Scenario B	$800,000	$200,000	$900,000	$720,000	$480,000	$3,100,000

Assume one cycle of ART costs $8,000

REFERENCES

1. Bradney, N. A piece of my mind, but not alone. JAMA 1986;255:41.
2. Federal Register, Vol. 62, No. 165, Tuesday, August 26, 1997.
3. Chapko KM, Weaver MR, Chapko MS, Pasta DJ, Adamson GD. Stability of in vitro fertilization embryo transfer success rates from 1989, 1990, and 1991 Clinic-Specific Outcome Assessments. Fertil Steril 1995; 65:757-63.
4. Marrs, Richard. Abstract, Pacific Coast OB/GYN Society, 1998.
5. Galvin, RS. What Do Employers Mean by "Value"? Integrated He
6. althcare Report. September 1998 and October 1998.

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