The physician’s medical office is first and foremost a storehouse of private, and often intimate, information about patients. The Health Insurance Portability and Accountability Act of 1996 (HIPAA)⁷ is generally considered to be the enabling statute that protects the privacy of patient information. For most physicians and patients, HIPAA is little more than a lengthy series of forms, which patients rarely read, do not fully understand, and have to fill out almost every time they visit the physician’s office. Most physicians, patients, and health policy experts also believe that HIPAA’s “privacy rule”
protects medical confidentiality and likely assume that the confidential information contained in the medical record is protected from access by HIPAA. This may have been the legislative intent of the bill, but the reality of HIPAA is that its protection of confidential medical information is considerably less than both patients and physicians think it is. HIPAA is also a disclosure act that provides unanticipated and unwelcome access to patient information by a plethora of health carerelated institutions and individuals.⁸ Physicians in the office, as well as their patients, need to be aware of this: “Effective in April 2003, the federal government gave six hundred thousand ‘covered entities’—such as health care plans, clearing houses, and health maintenance organizations—regulatory permission to use or disclose protected information for treatment, payment, and health care operations (known as TPO) without patient consent.”⁸ The HIPAA rules also permit physicians, nurses, and other health care professionals to disclose protected patient information for treatment purposes without patient authorization. For example, the privacy rule includes a proviso, which allows breach of confidentiality of patient records when the health or safety of third parties is threatened.⁹

Although a discussion of the complexities of HIPAA is well beyond the scope of this chapter, there are several take-home messages which all physicians practicing office gynecology need to communicate to their staff. First, the record-keeping requirements and forms mandated by HIPAA must be complied with to the letter, regardless of how senseless or inefficient the entire paperwork process might appear. Second, all office staff who deal with patient records and insurance matters should be knowledgeable about HIPAA basics so that they can accurately—and in an uncomplicated manner— answer questions patients may have about who might access their medical information and under what circumstances such information might be released even if they do not consent.

The degrees of separation among the widely differing institutions HIPAA regulations apply to are surprisingly narrower than both patients and physicians might think. For example, HIPAA could easily allow an insurer to give data to a bank it owns in order to deny a physician’s patient a loan. The structure of HIPAA allows the creation of paths of information without audit trails which, along with the relative lack of U.S. Department of Health and Human Services (HHS) enforcement and penalties (at the time of this writing, violations of HIPAA have no apparent negative consequences), arguably creates situations, which increase the probability that information might be misused. Despite this, all relevant physician office forms should clearly and legibly indicate that the physician, his or her office personnel, and practice cannot be held responsible for what insurance carriers do with the private patient information they, by law, have access to.

There is little evidence to suggest that the move to electronic medical records will make the risks of unwanted disclosure of private patient information any better. Despite numerous calls from some members of the legal profession that the push for electronic medical records is moving forward without adequate provision for the protection of patient information in electronic health records,¹⁰ legislation with adequate consent provisions or protections is still inadequate at best.

For those physicians and/or medical groups conducting or participating in active clinical trials, HIPAA has had a distinctly negative impact on the conduct of human subjects health research.¹¹ A perusal of any of the subspecialty journals over the past decade will demonstrate a marked decrease in the number of well-done, retrospective surgical studies, which are valuable in guiding clinicians in difficult management decisions. The American Congress of Obstetricians and Gynecologists (hereafter ACOG) has recognized these unanticipated negative effects of HIPAA and recently published a guidance document, HIPAA in Practice, Research Under the HIPAA Privacy Rule, which outlines how HIPAA privacy rules will affect office gynecology practitioners and practices whether they are actively involved in clinical investigations or not. The American Medical Association also has a user-friendly and highly informative webpage, which addresses frequently asked questions about the HIPAA privacy rules.¹²

Physician conduct in the office should be professional at all times. Some of the simpler ways to avoid liability in the office gynecology setting are self-evident: accurate and timely record keeping, preservation of patient confidentiality (particularly if office phone conversations can be overheard by other patients), compliance with HIPAA disclosure requirements, having an educated staff who treats patients with respect and courtesy regardless of whether they are interacting with them on the phone or in person, and professional conduct by all health practitioners in the office. Implicit in the latter is avoidance of inappropriate verbal remarks or physical contact with patients; ACOG has highlighted the importance of this in its August 2007 Committee Opinion on Sexual Misconduct: “Sexual contact or a romantic relationship between a physician and a current patient is always unethical, and sexual contact or a romantic relationship between a physician and a former patient also may be unethical.”¹³ One corollary of this code of conduct is that examinations of patients should be performed only with the necessary amount of physical contact required to obtain a diagnosis and effect treatment, and accompanied by appropriate explanation as well as by a chaperone. Similarly, those clinicians who have medical students or resident house staff working
with them in the office must be sure that the same caveats apply to the interactions of these individuals with patients. Just as patient informed consent is required ahead of time for medical students examination of patients under anesthesia,¹⁴ similar conduct is required for contact between students and patients and/or house staff and patients in the office.

ACOG maintains an extensive array of educational materials on their website that member physicians can access. Maintenance of annual board recertification is strongly recommended (at some institutions it is a requirement) for those physicians who were not “grandfathered” in before 1985, and voluntary recertification for those whom annual recertification is not a requirement has been encouraged for years. It is important that physicians in active clinical practice of office gynecology keep up with the relevant peer-review medical literature in the specialty as well as current recommendations for clinical practice by ACOG.

Physician certification and recertification has become increasingly important in the patient safety/quality of care movement.¹⁵ Maintenance of board certification may be a requirement for obtaining a state medical license, obtaining hospital privileges, or being added to a list of providers for insurance companies or a health maintenance organization. The promotion of board certification has been advanced as one of the integral components of a “systems” solution to the problem of medical errors by physicians.¹⁶ Lack of board certification, ignorance of what the recommended (and published) standard of care is for medical professional societies such as ACOG, and failure to keep up on the current medical literature are all items which may create difficulties when physicians are involved in malpractice litigation, both during deposition by plaintiffs’ counsel as well as during trial.

At the present time, board certification is regulated by the medical profession itself through medical specialty boards. Most medical professional organizations publish medical journals, which frequently contain statements about recommended clinical guidelines. These guidelines, which purport to assist with patient management decisions based on the best available evidence, are not binding on physicians nor necessarily considered the gold standard of care by juries in a medical malpractice trial. However, physicians need to be aware of them, and if their practice differs significantly from commonly accepted guidelines, they should be prepared to provide some evidentiary basis to support their decision-making process(es) should the need arise.

The recently publicized data demonstrating significant individual variations in clinical practice, as well as differences in patient use of medical-surgical services throughout the United States, and the increasing emphasis on cost control and patient safety have created pressure for more uniformity in physician practices. This has created a situation where medical professional practice guidelines may become politicized¹⁷ and where individual state legislatures, as well as the federal government, may be tempted to insert themselves more frequently into the physician-patient relationship by legislating standards of care independent of what the medical profession views as the best practice(s) supported by the best evidence.¹⁸ This transformation of clinical practice guidelines into legislative mandates has thus far been confined mostly to narrow areas, such as abortion and dealing with communicable diseases. Further intrusion by the government into what physicians cannot do, or must do, will inevitably enter dangerous territory¹⁹ when the law specifies how additional types of medical care must be delivered. This will be true even at the office practice level where a “cookie-cutter” algorithmic approach may not take into adequate account individual patient circumstances which might suggest or dictate a clinical management approach at odds with that felt to be the “best practice” by the government.

The bottom line for physicians in this certain-to-be evolving area is that physicians must be aware of what the medical jurisprudence requirements are in the state or states they practice in. Physicians and medical staff must also be aware of what conduct is required in certain clinical situations, such as reporting requirements for communicable diseases or when faced with a patient who may have been a victim of domestic violence.

Because the practice of medicine has become more of a business and industry-sponsored clinical trials have moved from the confines of large academic medical centers into the general medical community, physicianinvestigator ties to the medical device and pharmaceutical industries have deepened. In addition, some physicians have become more entrepreneurial in their business and medical endeavors. Both of these developments have raised the specter of potential conflicts of interest between the physician’s primary fiduciary duty to his or her patient and the demands or pressures for clinical testing and reimbursement for innovative therapies or devices the physician or physicians’ medical group may have a financial interest in.

ACOG and numerous other professional societies have published clear guidelines on commercial enterprises in medical practice.²⁰ These guidelines attempt to delineate the scope of business/industry activities which are/are not permissible. The list of such activities is long and the language is problematic at the very least. For example, “[t]he following activities are considered unethical… sale or promotion of nonprescription
medicine, sale or promotion of presumptively therapeutic agents that are generally not accepted as part of standard medical practice.”²⁰ Under a plain-language reading of these ACOG guidelines, it would appear that recommending a dietary supplement to a patient for treatment of menopausal symptoms is unethical behavior because such herbal remedies or treatments are not U.S. Food and Drug Administration (FDA)-approved, have not undergone rigorous clinical testing, and are generally not considered to be part of the “standard” practice of medicine. Similarly, it would appear that medical practices that advocate, perform, and bill for “alternative” but not universally accepted forms of treatment or therapy (e.g., acupuncture for treatment of a variety of benign conditions) are also engaging in unethical behavior.

It is not clear what the legal ramifications of ACOG’s Committee Opinion are, or what potential liability issues it raises for physicians; from a legal point of view, the ACOG Committee Opinions are not binding and may be viewed as either simply just a general recommendation or advice. These gray areas notwithstanding, some of the recommendations—such as a prohibition against the sale or promotion of any product in whose sale the physician has a significant financial interest in²⁰—would appear to be self-evident and not controversial.

What is clear from the current medical and legal literature is that patients have now rightfully come to expect that treating physicians and physician-investigators be transparent about their vested financial interests in any medical or surgical therapies/devices they are recommending. This holds true in the traditional practice as well as the clinical research setting.²¹ Requiring the routine disclosure of such information does not appear to have an adverse effect on patient willingness to go forward with the recommended drug therapy or medical device, but lack of transparency does seems to create problems, particularly in retrospect when untoward events occur.²²

There is no law or rule as to the precise limits of information physicians with potential financial conflicts of interest must reveal. At present, no one expects physicians to delineate their investment portfolio or what drug or medical device companies they own stock in, and no current or proposed state or federal legislation yet requires this, but a significant financial interest in an innovative new medical device or type of surgical equipment, or ownership interest in a company manufacturing medical products being tested or promoted in the office clearly qualifies for disclosure to patients.

The realm of “innovative” medical practice lies between standard or traditional office medical practice that focuses the physician’s attention exclusively on the well-being of the individual patient, and the structured clinical trial in which an office patient is enrolled in an organized investigation of a particular treatment that is designed to produce generalized knowledge rather than provide direct benefit to a specific patient. What constitutes innovative medical practice, however, is not precisely defined in either the medical or legal literature and thus occupies a legal and regulatory “gray area” between standard therapy and organized clinical research. As such, it also represents a real but ill-defined area of potentially increased medical liability exposure for physicians.²³

Innovative therapy can be surgical or medical in nature, and although it is often thought of as an activity which goes on in the operating room, it could easily apply to alternative medical therapies which physicians employ in the office, or to “experimental” or non-FDA-approved medical therapy for a gravely ill patient.

Standard medical practice is generally governed by medical profession guidelines and individual state medical boards, and clinical investigations or trials are generally reviewed and monitored by local/hospital institutional review boards (IRBs) with oversight provided (depending on funding) by the FDA and the Office of Human Research Protections (OHRP) of the HHS.²⁴ Despite both state and federal involvement in the areas of clinical investigations or trials, the issue of patient access to unapproved medical therapy has been heavily litigated. Efforts by patients and their advocates to establish a constitutional “right” to unapproved but potentially life-saving medical therapy have been firmly rejected by federal Appellate courts²⁵ as well as the U.S. Supreme Court.²⁶

There is no formal oversight of innovative medical or surgical practice in the office setting and no consensus in the medical literature on the precise boundaries between innovative therapy and outright experimentation. One of the few studies²⁷ examined, senior, predominately male surgeons’ attitudes toward innovative surgery and how it should be regulated and had several interesting findings: (a) “planned experimental surgery” was more likely to be classified as surgical research, whereas “introducing small novelty modifications during a standard operation” was most often considered routine clinical practice²⁷; (b) the intent of the surgeon was the dispositive factor; that is, spontaneity would signify routine care, whereas premeditation was the hallmark of clinical research; and (c) the greater the degree of variation from the standard of care the more likely the intervention would be considered both experimental and research.

Of course, one reason why such practice is a gray area is because such intervention may be intended to both benefit the individual patient and to generate generalizable knowledge applicable to similarly situated patients. More importantly, the aforementioned
study demonstrated that almost two-thirds of the participating surgeons were unfamiliar with federal oversight of clinical research through OHRP despite their acknowledgment that specific informed consent is required for planned innovative activity. One firm conclusion which may be drawn from the study is that more oversight of innovative medical and surgical therapy practice is needed because many of the innovative practices, which go on in the operating room as well as in physicians’ offices, are below the regulatory radar screen.

Informed consent must always be obtained from a patient before standard medical therapy is undertaken. Although consent is implied in a general physical examination or evaluation and patient’s need not sign consent forms before a physical examination, specific informed consent is generally required before invasive office procedures such as colposcopy or endometrial biopsy. Similarly, patients may sign specific informed consent forms for planned inpatient or outpatient surgical procedures in the office or hospital setting, and if participating in a clinical trial (e.g., drug study), there are invariably extensive materials which must be read by and reviewed with the patient prior to their agreeing to participate.

The take-home point from the medical and legal literature appears to be that planned deviations from standard office medical or surgical practice require informed consent specific to those planned interventions so that patients can be appraised of their treatment options as well as the unique potential risks (and benefits) innovative therapy holds. ACOG has also advocated this approach²⁸ and cautions physicians to (a) employ innovative procedures only when they have achieved sufficient training to be skillful and (b) to avoid adopting innovative procedures and practices on the basis of advertising and promotion by industry.

Physicians engaging in innovative or nonstandard medical or surgical practice in the office must understand that from a liability point of view, they are on their own: the “learned intermediary” doctrine²⁹ provides a fairly robust shield for manufacturers in this context, and the overwhelming bulk of medical-legal liability is going to fall on the treating physician(s) should untoward events arise. The learned intermediary doctrine provides that manufacturers of prescription drugs and medical devices discharge their duty of care to patients by providing warnings to the prescribing physicians. The justification for this doctrine is grounded in the fact that consumers cannot buy prescription drugs or devices directly; they must consult with and receive the approval of a physician. By providing adequate warnings to a prescribing physician, who in turn provides appropriate patient-specific warnings, the manufacturer discharges its warning responsibilities. The prescribing physician acts as a “learned intermediary” between manufacturer and consumer and has the primary responsibility of warning patients of the hazards of prescribed pharmaceutical products or devices.

Once a patient and his or her physician have voluntarily entered into a treatment or care relationship,³⁰ the relationship may be terminated by mutual consent for any one of a number of legitimate reasons; for example, the physician and patient cannot agree on treatment goals, or personality conflicts make the situation uncomfortable or too difficult.³⁰ A patient may unilaterally terminate a physician-patient relationship for any reason.³⁰ However, physicians do not have the same flexibility and are duty-bound to continue to treat a patient once treatment has begun except under carefully defined circumstances.³⁰ Both federal and state law place limits on required physician conduct,³⁰ although both allow termination of patient treatment for reasons of conscience under certain circumstances. When a physician does unilaterally terminate a treatment relationship with a patient for reasons of conscience, it is usually for religious reasons, although a matter of conscience need not be religious in nature.

Specific care sought by patients, which is more likely to create conflict with a physician’s personal beliefs, is common in the office gynecology setting. These include the provision of contraception (particularly emergency contraception) and performing or counseling regarding abortion or abortion-related services.³¹ Physicians are generally permitted to refuse to provide emergency contraception to patients, counsel regarding abortionrelated services, or to perform abortions if it conflicts with their religious or personal moral beliefs. Largely, as a result of the abortion wars of the past two decades, more than 45 states have “conscience clauses” on their books, which attempt to “balance a physician’s conscientious objection to performing an abortion with the profession’s obligation to afford all patients nondiscriminatory access to services.”³²

Physician refusals to provide reproductive medicine-related services in the office for moral reasons are common enough to be recognized and protected by laws in several states; for example, Texas.³³ Both the American Medical Association³⁴ and the American Congress of Obstetricians and Gynecologists (ACOG)³⁵ support the concept of physician conscience claims as a reason to refuse provision of certain medical services, and both organizations have stated that physician refusal to treat in such circumstances is both legal and ethical. Additional support for physician conscience claims can be found in recent surveys, which have looked at the issue of religion, conscience, and controversial clinical practices. The few clinical studies of this activity have generally found that the majority of physicians (63%) believe that it
is ethically permissible to explain their moral objections to patients. Just as important is the finding that an even higher percentage (86%) also believed that physicians are obligated to present all therapeutic options as well as provide alternate providers who might help the patient,³⁶ an action which is not required under current federal and most state laws.

Physician refusal to provide certain medical services or counseling thus rests on firm medical ethical grounds. There is further statutory protection offered to such conduct under individual state conscience clause legislation, and the First Amendment to the Bill of Rights of the U.S. Constitution,³⁷ which protects actions guided by sincerely healed religious beliefs. There are limits to such protection, however. A physician’s or physician group’s constitutional right to free exercise of religion does not exempt them from providing services when such refusal interferes with their obeying state laws which prohibit discrimination based on sexual orientation. Although there is little medical case law in this area, the recent California Supreme Court case of Guadalupe T. Benitez v North Coast Women’s Care Medical Group, et al.³⁸ determined that a physician does not have a constitutional right to refuse to perform intrauterine insemination (or other medical services) for religious reasons on an established patient merely because they were unmarried and gay when there are state laws specifically prohibiting discrimination in the provision of medical services against individuals simply because of their sexual orientation. Although discrimination against an individual based on sex or gender is not protected conduct, the Court did not resolve whether a physician could refuse to provide artificial insemination for a patient simply because they were not married; it would appear that marriage is not a “protected” class from physician denial of medical care, at least until there is litigation establishing this.

Clinicians also need to be aware that conscience clauses may also operate against them. The central role of pharmacists in providing birth control and emergency contraception, and the ready availability of conscience clauses for pharmacy professionals, have created a situation where clinicians practicing office gynecology may find themselves writing prescriptions for patients, either for routine birth control or emergency contraception, which patients cannot fill because local pharmacies either refuse to carry such medications or because pharmacists refuse to fill them.³⁹ Admittedly, this is less of a problem for emergency contraception because FDA approved some emergency contraceptives for over-thecounter status for women age 17 years or older, but the situation is still potentially a problem for patients and providers.

Pharmacists may refuse to fill a legitimate patient prescription for birth control pills or emergency contraception on conscience grounds. During the past 10 years, this practice has spread to many states but pharmacists’ conscience claims for refusing to fill a prescription for contraceptives remains highly controversial.⁴⁰ At present, there does not appear to be a quick fix for this potential conflict between the conscience of a physician or pharmacist and a legitimate medical need for a patient, particularly for physicians practicing office gynecology in rural settings with few choices among pharmacists and patient populations with limited financial resources who may not be able to afford to order such medications via the Internet. One proposed solution suggests either a required physician notice or referral policy by pharmacists,⁴¹ but it is not unreasonable to expect that many pharmacists who refuse to dispense emergency contraception for conscience reasons may also refuse to refer patients to a pharmacist who will. Telemedicine may offer a potential solution for some patients who have Internet access if they have a willing pharmacist and can access a more distant physician willing to provide contraceptives or abortion drugs.⁴²

One of the most common medical malpractice lawsuits currently being brought against obstetrician-gynecologists is the failure to diagnose breast cancer in premenopausal women. A recent controversy about breast cancer screening was prompted by the publication of the HHS U.S. Preventive Services Task Force’s (hereafter USPSTF) revision on screening for breast cancer, particularly for premenopausal women. In 2009, a panel of scientists selected by HHS to serve on the USPSTF made three specific breast cancer screening recommendations:

The first recommendation was made despite the fact that breast cancer is one of the leading causes of death for women in their 40s, and there is an abundance of data demonstrating that routine mammographic screening of women significantly reduces the breast cancer death rate in this age group. In fact, this recommendation represented an about-face from established practice of beginning routine annual screening of premenopausal women for breast cancer starting at age 40 years (in the absence of strong family history which might warrant annual screening starting at an even younger age).

Sharp criticism of the new federal government regulations was not just restricted to the public or politicians eager to demonstrate their commitments to women’s health; the new mammography screening recommendations did not sit well with the breast cancer community⁴⁴ or numerous specialty medical societies.⁴⁵ Opponents to the new recommendations cited, among many things, the importance of cancer screening in highly touted preventive medicine programs, and limiting government involvement in medical decision making.⁴⁶ Breast cancer experts⁴⁷ were also quick to point out the shortcomings of the new recommendations. The American Society of Breast Surgeons correctly noted that the new recommendations “effectively turn back the clock to premammography days by making the diagnosis of breast cancer occur only when the tumor is large enough to be felt on a physical exam.”⁴⁸ The ACOG rejected the new mammography screening recommendations, particularly for the 40 to 49 years age group, noting: “Our experts … reviewed all the same data reviewed by USPSTF, but also additional data that the USPSTF did not consider. When recommendations are based on judgments about the balance of risks and benefits, reasonable experts can look at the same data and reach different conclusions.”⁴⁹ After several months of media scrutiny, about the only people defending the new mammography screening recommendations were the original members of the committee and some economists,⁵⁰ although even the latter pointed out that the interface between mathematics and psychology would make it difficult for patients and health providers to accept a “rational” health care economic analysis of the issue. Even the Secretary of HHS was forced to issue a statement acknowledging that the new recommendations were confusing and problematic.⁵¹

ACOG’s disagreement with the USPSTF is no small matter and has enormous implications for clinicians practicing gynecology in the office, because these individuals, along with internists and family practitioners, bear the bulk of the burden of responsibility for screening women for occult breast carcinoma. Fortunately for the medical profession, it appears that the new recommendations have found a suspicious public audience⁵² and a medical profession which is going to stay to the course and adhere to established mammography screening standards.⁵³

It is important for physicians who practice office gynecology to be acutely aware of the serious limitations of the new breast cancer screening recommendations and understand their significance on multiple levels. For one, the recommendations are simply that— recommendations. As such, they are neither “binding” on practitioners nor do they represent a “standard of care” in either the legal sense or as advocated by medical professional societies which rejected them out of hand. The new recommendations are no substitute for evidence-based medicine or seasoned clinical judgment. There is no separate accounting for family risk factors in the new screening calculus. Furthermore, the new recommendations will do little to improve the liability of ob-gyns for failure to diagnose breast cancer in young women and will likely make an already bad situation worse by increasing pressure on practitioners to pursue otherwise trivial physical exam findings in younger women or mammography findings in older women who have not been screened for now greater lengths of time.

The impetus behind the new breast cancer screening recommendations is a tradeoff between economic and diagnostic opportunity; that is, the willingness to forego a predictable reduction in the number of new cases of invasive cancer in a particular age group in order to decrease the number of biopsies and surgeries for masses or abnormalities which do not turn out to be invasive cancer. Part of the problem with the new USPSTF recommendations is the view the Task Force has of the falsepositive result; that is, a finding on mammogram which might be suspicious and which results in surgical evaluation (fine needle aspiration under radiologic guidance or surgical excision) which then turns out not to be a cancer. Although it is not positive in the sense that it is cancer, it is not negative in the sense that “nothing” is found. Although the USPSTF clearly believes that a false positive is a real problem, patients may find biopsy or removal of a suspicious lesion that turns out to be benign reassuring rather than problematic⁵⁴ and many if not most patients and medical specialists appear to be willing to put up with the possibility of needle biopsy or surgical intervention and additional imaging if it means that their cancer may be diagnosed at a more curable point.⁵⁵

The solution to this problem should not be to change mammography screening but rather to acknowledge (a) that the only way to definitively rule in or rule out cancer is by obtaining tissue, and this means some sort of surgical intervention; and (b) that some of what propels clinicians to investigate abnormalities is a medical malpractice environment which holds physician liable when they fail to investigate abnormalities on physical examination or mammography.

There has already been significant push back by the academic medical community⁵⁶ against the USPSTF’s recommendations. Clinicians practicing office gynecology should continue to adhere to older National Institutes of Health (NIH)- and ACOG-recommended guidelines. Doing so will negate any increased medical malpractice liability exposure they would incur by adopting the USPSTF’s new guidelines for breast cancer screening, and keep patients and their physicians on the same side in efforts to achieve the earliest possible diagnosis of breast cancer while both parties await new refinements in screening technology.

The establishment of routine cervical cytology screening has had a dramatic effect on the incidence of invasive cervical cancer in the United States over the past
30 years, as evidenced by a decline in the number of new cases of invasive cervical cancer by half. No other malignancy, in either men or women, has had such a dramatic reduction in incidence as a result of a cancer screening program, and the current U.S. approach to screening for cervical cancer is an unqualified public health success. It is important to note, however, that because many of the new cases of invasive cervical cancer in the United States occur in either medically underserved areas or in older patient populations in which individuals may be screened rarely or never, it would appear that the continual manipulation of screening criteria for a population of women who are already being adequately screened is unlikely to significantly further lower the incidence of cervical cancer regardless of the changes made. The number of new cases of invasive cervical cancer in the United States has remained relatively constant for almost a decade regardless of all of the touted advances in superior cervical cytologic analysis and a virtual blizzard of literature on the value of screening for high-risk human papillomavirus (HPV) subtypes.

In December 2009, ACOG revised its recommendations for Pap smear screening for cervical dysplasia. The most dramatic change in the ACOG guidelines from prior years was to initiate cervical cancer screening at 21 years of age, regardless of age at onset of sexual activity. The rationales offered for the change in Pap screening policy were two-fold: (a) screening prior to age 21 years often leads to unnecessary treatment/follow-up treatment and emotional anxiety for young women who are actually at very low risk for developing invasive cervical cancer, so the new recommendations are an effort to achieve better balance in benefit versus harm; and (b) screening prior to 21 years of age often leads to unnecessary and harmful treatment for cervical disease, which has little chance of progression to invasive cancer and a spontaneous regression rate of anywhere from 50 to 90%.⁵⁷