OBG Management

INTRODUCTION

Steven R. Goldstein, MD, CCD, NCMP
Professor, Department of Obstetrics and Gynecology, New York University School of Medicine; Director, Gynecologic Ultrasound; and Co-Director, Bone Densitometry, New York University Medical Center, New York

In this month’s Images in GYN Ultrasound, Drs. Stalnaker and Kaunitz have done an excellent job of discussing the various uterine malformations as well as characterizing their appearance on 3D transvaginal ultrasound.

Unfortunately, many women are still subjected to the cost, inconvenience, and time involvement of magnetic resonance imaging (MRI) in cases of suspected uterine malformations. The exquisite visualization of 3D transvaginal ultrasound, so nicely depicted in this installment of Images in GYN Ultrasound, allow the observer to see the endometrial contours in the same plane as the serosal surface. This view is not available in traditional 2D ultrasound images. Thus, it is akin to doing laparoscopy and hysteroscopy simultaneously in order to arrive at the proper diagnosis. Although not mandatory, when such 3D ultrasound is performed late in the cycle, the thickened endometrium acts as a nice sonic backdrop to better delineate these structures. Alternatively, 3D saline infusion sonohysterography can be performed.

As more and more ultrasound equipment becomes available with 3D capability as a standard feature, clinicians who do perform ultrasonography will find that obtaining this “z-plane” is relatively simple and extremely informative, and can and should be done in cases of suspected uterine malformations in lieu of ordering MRI.

Congenital uterine anomalies: A resource of diagnostic images, Part 1

Michelle L. Stalnaker Ozcan, MD
Assistant Professor and Associate Program Director, Obstetrics and Gynecology Residency, Department of Obstetrics and Gynecology at the University of Florida College of Medicine–Jacksonville

Andrew M. Kaunitz, MD
University of Florida Research Foundation Professor and Associate Chairman, Department of Obstetrics and Gynecology at the University of Florida College of Medicine–Jacksonville. Dr. Kaunitz is a member of the OBG Management Board of Editors.

Uterine malformations make up a diverse group of congenital anomalies that can result from various alterations in the normal development of the Müllerian ducts, including underdevelopment of one or both Müllerian ducts, disorders in Müllerian duct fusion, and alterations in septum reabsorption. How common are such anomalies, how are they classified, and what is the best approach for optimal visualization? Here, we explore these questions and offer an atlas of diagnostic images as an ongoing reference for your practice. Many of the images we offer will be found only online at obgmanagement.com.

How common are congenital uterine anomalies?
The reported prevalence of uterine malformations varies among publications due to heterogeneous population samples, differences in diagnostic techniques, and variations in nomenclature. In general, they are estimated to occur in 0.4% (0.1% to 3.0%) of the population at large, 4% of infertile women, and between 3% and 38% of women with repetitive spontaneous miscarriage.¹

Classical classification
A classification of the Müllerian anomalies was introduced in 1980 and, with few modifications, was adopted by the American Fertility Society (currently, ASRM). The Society identified seven basic groups according to Müllerian development and their relationship to fertility: agenesis and hypoplasias, unicornuate uteri (unilateral hypoplasia), didelphys uteri (complete nonfusion), bicornuate uteri (incomplete fusion), septate uteri (nonreabsorption of septum), arcuate uteri (almost complete reabsorption of septum), and anomalies related to fetal DES exposure.²

Anomalies also can be categorized in terms of progression along the developmental continuum, taking into account that many cases result from partial failure of fusion and reabsorption: agenesis (Types I and II), lack of fusion (Types III and IV), lack of reabsorption(Types V and VI), and lack of posterior development (Type VII) (FIGURE 1).³

FIGURE 1. Classification of müllerian anomalies Developed by the American Fertility Society (ASRM)
Source: The American Fertility Society classifications of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, müllerian anomalies and intrauterine adhesions. Fertil Steril. 1988. 49(6):944-955.

3D ultrasonography offers accurate, cost-efficient diagnosis
Using only 2D imaging, neither an unenhanced sonogram nor a sonohysterogram can provide definitive information regarding the possibility of a uterine anomaly. The fundal contour cannot be evaluated with 2D imaging; likewise, details regarding the configuration of the uterine cavity (or cavities) may not be appreciated with the use of 2D imaging (FIGURE 2).

Figure 2: Normal appearance, but abnormal uteri In sagittal view, a uterus with a congenital anomaly can appear normal. 2D sagittal views of a normal uterus (top), a didelphic uterus (middle), and a sonohysterogram of a septate uterus (bottom).

To fully evaluate the uterine fundal contour and determine the type of ­uterine anomaly, it previously was necessary to obtain magnetic resonance imaging (MRI) or perform laparoscopy. Today, however, 3D coronal ultrasonography (US) can allow for accurate evaluation of fundal contour and diagnosis of uterine anomalies with lower cost and greater patient convenience. Several ­studies have confirmed the high accuracy of 3D US compared with MRI and surgical findings in the diagnosis of uterine anomalies (with 3D US showing 98% to 100% sensitivity and specificity).^4-6

Case: Partial septate uterus Upon 2D sagittal sonography (top), the uterus of a patient undergoing infertility evaluation shows a left lateral fibroid but otherwise appears normal. Transverse 2D view reveals 2 endometrial canals (hands) at the fundus and fibroid (arrows; middle). 3D coronal imaging of the same patient demonstrates partial septate cavity and left lateral fibroid (bottom).

ADDITIONAL IMAGES

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

INTRODUCTION

Steven R. Goldstein, MD, CCD, NCMP
Professor, Department of Obstetrics and Gynecology, New York University School of Medicine; Director, Gynecologic Ultrasound; and Co-Director, Bone Densitometry, New York University Medical Center, New York

In this month’s Images in GYN Ultrasound, Drs. Stalnaker and Kaunitz have done an excellent job of discussing the various uterine malformations as well as characterizing their appearance on 3D transvaginal ultrasound.

Unfortunately, many women are still subjected to the cost, inconvenience, and time involvement of magnetic resonance imaging (MRI) in cases of suspected uterine malformations. The exquisite visualization of 3D transvaginal ultrasound, so nicely depicted in this installment of Images in GYN Ultrasound, allow the observer to see the endometrial contours in the same plane as the serosal surface. This view is not available in traditional 2D ultrasound images. Thus, it is akin to doing laparoscopy and hysteroscopy simultaneously in order to arrive at the proper diagnosis. Although not mandatory, when such 3D ultrasound is performed late in the cycle, the thickened endometrium acts as a nice sonic backdrop to better delineate these structures. Alternatively, 3D saline infusion sonohysterography can be performed.

As more and more ultrasound equipment becomes available with 3D capability as a standard feature, clinicians who do perform ultrasonography will find that obtaining this “z-plane” is relatively simple and extremely informative, and can and should be done in cases of suspected uterine malformations in lieu of ordering MRI.

Congenital uterine anomalies: A resource of diagnostic images, Part 1

Michelle L. Stalnaker Ozcan, MD
Assistant Professor and Associate Program Director, Obstetrics and Gynecology Residency, Department of Obstetrics and Gynecology at the University of Florida College of Medicine–Jacksonville

Andrew M. Kaunitz, MD
University of Florida Research Foundation Professor and Associate Chairman, Department of Obstetrics and Gynecology at the University of Florida College of Medicine–Jacksonville. Dr. Kaunitz is a member of the OBG Management Board of Editors.

Uterine malformations make up a diverse group of congenital anomalies that can result from various alterations in the normal development of the Müllerian ducts, including underdevelopment of one or both Müllerian ducts, disorders in Müllerian duct fusion, and alterations in septum reabsorption. How common are such anomalies, how are they classified, and what is the best approach for optimal visualization? Here, we explore these questions and offer an atlas of diagnostic images as an ongoing reference for your practice. Many of the images we offer will be found only online at obgmanagement.com.

How common are congenital uterine anomalies?
The reported prevalence of uterine malformations varies among publications due to heterogeneous population samples, differences in diagnostic techniques, and variations in nomenclature. In general, they are estimated to occur in 0.4% (0.1% to 3.0%) of the population at large, 4% of infertile women, and between 3% and 38% of women with repetitive spontaneous miscarriage.¹

Classical classification
A classification of the Müllerian anomalies was introduced in 1980 and, with few modifications, was adopted by the American Fertility Society (currently, ASRM). The Society identified seven basic groups according to Müllerian development and their relationship to fertility: agenesis and hypoplasias, unicornuate uteri (unilateral hypoplasia), didelphys uteri (complete nonfusion), bicornuate uteri (incomplete fusion), septate uteri (nonreabsorption of septum), arcuate uteri (almost complete reabsorption of septum), and anomalies related to fetal DES exposure.²

Anomalies also can be categorized in terms of progression along the developmental continuum, taking into account that many cases result from partial failure of fusion and reabsorption: agenesis (Types I and II), lack of fusion (Types III and IV), lack of reabsorption(Types V and VI), and lack of posterior development (Type VII) (FIGURE 1).³

FIGURE 1. Classification of müllerian anomalies Developed by the American Fertility Society (ASRM)
Source: The American Fertility Society classifications of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, müllerian anomalies and intrauterine adhesions. Fertil Steril. 1988. 49(6):944-955.

3D ultrasonography offers accurate, cost-efficient diagnosis
Using only 2D imaging, neither an unenhanced sonogram nor a sonohysterogram can provide definitive information regarding the possibility of a uterine anomaly. The fundal contour cannot be evaluated with 2D imaging; likewise, details regarding the configuration of the uterine cavity (or cavities) may not be appreciated with the use of 2D imaging (FIGURE 2).

Figure 2: Normal appearance, but abnormal uteri In sagittal view, a uterus with a congenital anomaly can appear normal. 2D sagittal views of a normal uterus (top), a didelphic uterus (middle), and a sonohysterogram of a septate uterus (bottom).

To fully evaluate the uterine fundal contour and determine the type of ­uterine anomaly, it previously was necessary to obtain magnetic resonance imaging (MRI) or perform laparoscopy. Today, however, 3D coronal ultrasonography (US) can allow for accurate evaluation of fundal contour and diagnosis of uterine anomalies with lower cost and greater patient convenience. Several ­studies have confirmed the high accuracy of 3D US compared with MRI and surgical findings in the diagnosis of uterine anomalies (with 3D US showing 98% to 100% sensitivity and specificity).^4-6

Case: Partial septate uterus Upon 2D sagittal sonography (top), the uterus of a patient undergoing infertility evaluation shows a left lateral fibroid but otherwise appears normal. Transverse 2D view reveals 2 endometrial canals (hands) at the fundus and fibroid (arrows; middle). 3D coronal imaging of the same patient demonstrates partial septate cavity and left lateral fibroid (bottom).

ADDITIONAL IMAGES

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

INTRODUCTION

Steven R. Goldstein, MD, CCD, NCMP
Professor, Department of Obstetrics and Gynecology, New York University School of Medicine; Director, Gynecologic Ultrasound; and Co-Director, Bone Densitometry, New York University Medical Center, New York

In this month’s Images in GYN Ultrasound, Drs. Stalnaker and Kaunitz have done an excellent job of discussing the various uterine malformations as well as characterizing their appearance on 3D transvaginal ultrasound.

Unfortunately, many women are still subjected to the cost, inconvenience, and time involvement of magnetic resonance imaging (MRI) in cases of suspected uterine malformations. The exquisite visualization of 3D transvaginal ultrasound, so nicely depicted in this installment of Images in GYN Ultrasound, allow the observer to see the endometrial contours in the same plane as the serosal surface. This view is not available in traditional 2D ultrasound images. Thus, it is akin to doing laparoscopy and hysteroscopy simultaneously in order to arrive at the proper diagnosis. Although not mandatory, when such 3D ultrasound is performed late in the cycle, the thickened endometrium acts as a nice sonic backdrop to better delineate these structures. Alternatively, 3D saline infusion sonohysterography can be performed.

As more and more ultrasound equipment becomes available with 3D capability as a standard feature, clinicians who do perform ultrasonography will find that obtaining this “z-plane” is relatively simple and extremely informative, and can and should be done in cases of suspected uterine malformations in lieu of ordering MRI.

Congenital uterine anomalies: A resource of diagnostic images, Part 1

Michelle L. Stalnaker Ozcan, MD
Assistant Professor and Associate Program Director, Obstetrics and Gynecology Residency, Department of Obstetrics and Gynecology at the University of Florida College of Medicine–Jacksonville

Andrew M. Kaunitz, MD
University of Florida Research Foundation Professor and Associate Chairman, Department of Obstetrics and Gynecology at the University of Florida College of Medicine–Jacksonville. Dr. Kaunitz is a member of the OBG Management Board of Editors.

Uterine malformations make up a diverse group of congenital anomalies that can result from various alterations in the normal development of the Müllerian ducts, including underdevelopment of one or both Müllerian ducts, disorders in Müllerian duct fusion, and alterations in septum reabsorption. How common are such anomalies, how are they classified, and what is the best approach for optimal visualization? Here, we explore these questions and offer an atlas of diagnostic images as an ongoing reference for your practice. Many of the images we offer will be found only online at obgmanagement.com.

How common are congenital uterine anomalies?
The reported prevalence of uterine malformations varies among publications due to heterogeneous population samples, differences in diagnostic techniques, and variations in nomenclature. In general, they are estimated to occur in 0.4% (0.1% to 3.0%) of the population at large, 4% of infertile women, and between 3% and 38% of women with repetitive spontaneous miscarriage.¹

Classical classification
A classification of the Müllerian anomalies was introduced in 1980 and, with few modifications, was adopted by the American Fertility Society (currently, ASRM). The Society identified seven basic groups according to Müllerian development and their relationship to fertility: agenesis and hypoplasias, unicornuate uteri (unilateral hypoplasia), didelphys uteri (complete nonfusion), bicornuate uteri (incomplete fusion), septate uteri (nonreabsorption of septum), arcuate uteri (almost complete reabsorption of septum), and anomalies related to fetal DES exposure.²

Anomalies also can be categorized in terms of progression along the developmental continuum, taking into account that many cases result from partial failure of fusion and reabsorption: agenesis (Types I and II), lack of fusion (Types III and IV), lack of reabsorption(Types V and VI), and lack of posterior development (Type VII) (FIGURE 1).³

FIGURE 1. Classification of müllerian anomalies Developed by the American Fertility Society (ASRM)
Source: The American Fertility Society classifications of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, müllerian anomalies and intrauterine adhesions. Fertil Steril. 1988. 49(6):944-955.

3D ultrasonography offers accurate, cost-efficient diagnosis
Using only 2D imaging, neither an unenhanced sonogram nor a sonohysterogram can provide definitive information regarding the possibility of a uterine anomaly. The fundal contour cannot be evaluated with 2D imaging; likewise, details regarding the configuration of the uterine cavity (or cavities) may not be appreciated with the use of 2D imaging (FIGURE 2).

Figure 2: Normal appearance, but abnormal uteri In sagittal view, a uterus with a congenital anomaly can appear normal. 2D sagittal views of a normal uterus (top), a didelphic uterus (middle), and a sonohysterogram of a septate uterus (bottom).

To fully evaluate the uterine fundal contour and determine the type of ­uterine anomaly, it previously was necessary to obtain magnetic resonance imaging (MRI) or perform laparoscopy. Today, however, 3D coronal ultrasonography (US) can allow for accurate evaluation of fundal contour and diagnosis of uterine anomalies with lower cost and greater patient convenience. Several ­studies have confirmed the high accuracy of 3D US compared with MRI and surgical findings in the diagnosis of uterine anomalies (with 3D US showing 98% to 100% sensitivity and specificity).^4-6

Case: Partial septate uterus Upon 2D sagittal sonography (top), the uterus of a patient undergoing infertility evaluation shows a left lateral fibroid but otherwise appears normal. Transverse 2D view reveals 2 endometrial canals (hands) at the fundus and fibroid (arrows; middle). 3D coronal imaging of the same patient demonstrates partial septate cavity and left lateral fibroid (bottom).

ADDITIONAL IMAGES

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The payment structure for physicians is changing. Our government, the American public, purchasers, and employers are unhappy with the fee-for-service system as it currently exists, and are pushing to drive the system into what is called “value-based purchasing.”

But what is value?

One way to define it is quality divided by cost—but how do we measure quality?

At present, insurers are measuring your quality based on some nebulous definition created at United Healthcare or Blue Cross Blue Shield—looking specifically at your “efficiency,” based on the costs attributed to you, as revealed in the codes you and others submit to payers.

Let’s say you perform minimally invasive surgery, and the referring physician ordered a lot of tests before sending the patient to you. Are you aware that all of those costs may be attributed to you in an administrative system?

ACOG is working hard to establish clinical systems rather than administrative ones to determine the true cost of care. We may want to think of obstetrics and gynecology as primary care and take advantage of advanced payment models and the opportunities afforded to accountable care organizations, but the truth is, insurers frequently do not consider us primary care. Although some of us may develop medical homes for women’s health care, we are unlikely to collect a per-patient, per-month income like primary care physicians do. That means that we need to be more assertive in negotiating contracts with insurers.

In this article, I offer recommendations for such negotiations and explain how to determine what you can and cannot accept in terms of payment.

You are the responsible party
Some of us do our own coding and some of us do not. However, if that coding is inaccurate, it is the physician who goes to jail, not the coder. You are personally responsible and liable for the coding submitted under your provider number.

Clearly, we need to do a better job of advocating for ourselves. We need to lobby. Legislators and bureaucrats are less likely to target people who have strong lobbyists working consistently on their behalf.

Accountable care organizations may have some leverage in negotiating lower prices, and some market forces may come into play in large systems. It remains to be seen which models will succeed as new payment structures develop. The overarching question: What can we do today to optimize our payments, given the system that we have? Here are 13 tactics that can enhance your bottom line.

1. Know the rules
To play the game, you must know the rules. You need to know what systems payers are using to determine your reimbursement—and you have to understand those systems as well as, or better than, the payers do. Then you’ll be able to use them to your advantage.

Payers are well aware that we don’t like to focus on this end of practice, that what we really want to do is spend the day practicing medicine. However, we need to learn these details because we’re leaving money on the table every single day.

2. Educate yourself
With the change to the International Classification of Diseases (ICD) scheduled to take effect on October 1, 2015, many of us are worried that payers are going to reject our claims because of our lack of familiarity with ICD-10.

Rest assured. There are crosswalks from ICD-9 to ICD-10. ACOG has published an information sheet for both obstetrics and gynecology that pairs typically used ICD-9 codes with their ICD-10 counterparts. And because it is published by ACOG, payers will find it hard to claim that it’s inaccurate.

ACOG also offers half-day courses on  ICD-10 coding for both physicians and staff.

3. Record your decision-making process
When I audit medical charts, I often discover that this process has been neglected. Instead, the coder has relied on documentation from the electronic health record and a basic description of the treatment plan. But a plan is just that—what someone intends to do. It doesn’t convey the decision-making that underlies it. What was the differential diagnosis? What did you discuss with the patient? These details are critical for appropriate coding of the level of service—whether it’s high, intermediate, or low.

4. Refine your approach to coding
Recognize that the system is currently set up to pay physicians for the services we provide—and that service must be justified by the appropriate diagnosis code. Tougher cases, or high-risk patients, tend to have longer surgeries and hospital stays, and their outcomes often are not as good as those of more typical patients. They may have more complications because they’re obese or have severe diabetes, for example. If so, it is critical that these other conditions—obesity and severe diabetes—be included with the principal diagnosis code so that risk stratification is possible. Otherwise, we will be held to the same standard as someone treating a routine, low-risk case.

Risk stratification is being performed according to algorithms in the payers’ software—and payers are unlikely to share the details with us. However, the only real data payers have to run through these algorithms come from diagnosis coding. Even though you’re not required to code for variables such as obesity and diabetes in order to get paid for what you do, you do need to use those additional codes to make risk stratification possible—so that you don’t get inappropriately placed into a group of low-risk providers when you are treating a higher-risk cohort.

5. Develop an understanding of RVUs
Another variable that changes regularly is relative value units (RVUs) under Medicare rules. ACOG’s Committee on Health Economics and Coding—which enjoys the participation of AAGL, the American Urogynecologic Society (AUGS), the Society of Gynecologic Surgeons (SGS), and the Society of Gynecologic Oncology (SGO), as well as other organizations—tries to maintain the RVUs as up to date and appropriate as possible relative to other services in the fee schedule.

For example, about 10 years ago many urogynecologic procedures were getting bundled together when they were performed at the same time. We had only one or two ICD-9 codes to describe prolapse, with no separate codes to describe whether it affected the anterior, apical, or posterior compartment, even though we performed different procedures in the individual compartments. Payers were mapping all prolapse procedures to the same diagnosis code. So ACOG went to the National Center for Health Statistics, where ICD-9 coding was done—and developed a series of about 10 codes to describe the different areas that prolapse could affect.

That kind of nuanced coding is continuing today. In fact, we have a long list of areas to go forward with now that ICD-10 is scheduled to take effect. A good example involves new Pap smear guidelines, which recommend testing every 3 or 5 years except for patients who have undergone hysterectomy for benign disease. How do you code for a patient who has had a hysterectomy? There was no code for a woman with an absent cervix, so we created a “V-code,” a code classification for factors that influence health status, so that it is possible to explain why a Pap smear was not performed.

As we go forward into a value-based system, specialists like us likely will be negotiating contracts according to RVU-based payments. That’s why it’s important for you to understand the resource-based relative value scale (RBRVS). It has three components: a work component, which makes up about 52% of the total RVUs; a practice expense, which makes up more than 45% of total RVUS; and, finally, a malpractice component, a small percentage. There also is a geographic adjustment and a uniform conversion factor.

When you hear about the sustainable growth rate (SGR) fix, and the fact that we’re going to see a 20% or 24% reduction in payment, that talk is referring to a reduction in the conversion factor. Each component of the RVU is adjusted for geography and then multiplied by the dollar conversion factor to calculate the total RVUs. The work, practice, and malpractice components vary by where the service is provided.

Let’s use placement of Essure inserts as an example. If you perform the procedure in the hospital, then the hospital buys the equipment, including the hysteroscope and light source. The hospital also pays for the room and staff and manages equipment sterilization. If, on the other hand, you perform the procedure in your office, all those responsibilities are yours. If it’s done in your office, you get paid more but it also costs you more.

The Relative Value Update Committee, or RUC, plays a major role in determining RVUs. This committee is composed of 31 clinicians, including nonphysician providers, psychologists, and nurses who deliver services under the Medicare fee schedule. The RUC makes recommendations to the Centers for Medicare and Medicaid Services (CMS), but it is the Secretary of Health and Human Services who determines the final rule on RVUs.

Approximately 75% to 95% of the recommendations of the RUC are accepted by the Secretary and become law. So it’s not the RUC or the American Medical Association (AMA) that determines RVUs; in the long run, it is CMS and the Secretary of Health and Human Services. We are fortunate that, when CMS assigns RVUs we’re not happy with, we have an opportunity to appeal.

Under Medicare, all physician payments are based on the same conversion factor, regardless of specialty. That’s not necessarily true for other payers, who may, essentially, do whatever they wish. These other payers frequently will contract at higher or lower rates, depending on how prevalent a specialist is in the community. Sometimes they use a higher conversion factor for surgical specialists than they use for primary care.

6. Find out which RVUs the payer is using
When you negotiate contracts with payers, and you are in private practice or part of a medical practice, it’s important to know what year’s RVUs the payer is using, as RVUs vary from year to year. For example, if the payer is using the RBRVS from 2002, it is paying you less than you should be getting. So when you look at a contract, you should determine not only whether the payer is anchoring your payment to the RBRVS but also whether it is keeping up with current RVUs as well. What dollar conversion factor is the payer using? What global periods—the same as CMS, or something different?

7. Determine what global period is in play
Some private payers use 6 postoperative weeks as the global period for a surgical procedure, whereas Medicare uses 90 days. You need to know which period is in play so that you don’t leave money on the table if you see the patient within 90 days but more than 6 weeks postoperatively.

Current Procedural Terminology (CPT) has global surgical packages that include a 10-day or 90-day period. But those periods do not include services provided more than 24 hours before the procedure. They don’t include the administration of anesthesia or conscious sedation. And they don’t include management of complications, exacerbations, or recurrences. Nor do they include additional services that might be necessary due to the presence of another disease or injury.

Under Medicare, the rules are different. Medicare preoperative services begin 1 day before surgery. However, any preoperative intervention is included whether it’s performed 1 day or 1 week before surgery. If it’s simply a preoperative physical examination for the patient and you aren’t performing significant evaluation and management, it’s included in the global package, along with all the intraoperative work. In addition, under Medicare, you don’t get paid for the management of complications unless a return to the operating room is required.

8. Learn to use modifiers
As ObGyns, we often see patients for multiple conditions or problem reports, so you need to be aware that if a patient is within a global period and you do not submit a bill with a modifier to indicate special circumstances, the intervention will be bundled into the global and you will not get paid for it. Modifiers are two-digit codes that describe these separate services. They provide critical information to payers so that their computer programs separate these services out for payment.

Major surgical procedures don’t include unrelated procedures that are performed at the same time of surgery. Nor do they include visits that take place during the global period that are unrelated to the original surgery. For example, if a patient presents with a breast lump after you performed a hysterectomy, and you do a work-up, you deserve full payment for that evaluation and management service. If you don’t use a modifier, however, you won’t get that payment.

9. Don’t be passive when payers won’t pay
Let’s say you contract with HMOs or independent practice associations (IPAs), and they’re not compensating you for the extra things you’re doing and are failing to recognize surgical modifiers. What can you do about it?

You need to develop a profile of your typical patient. Because these organizations are individualizing it—they are saying that, in a typical scenario, this is the type of work you do. So these organizations offer a different kind of contract. Nevertheless, you can use your coding to help you determine what a fair payment should be, by going through your billing to determine what you’ve spent.

10. Analyze payer bundling
Medicare put in place a correct coding initiative (CCI) that lists services typically provided by the same person on the same day of service. The aim: to prevent separate payment for these services. These are “bundled” services. The CCI bundles are revised every quarter. They are listed on the ACOG Web site under “practice management.”

On October 1, 2014, the CCI inappropriately bundled pelvic organ prolapse repair procedures into the vaginal hysterectomy codes. ACOG, AUGS, SGS, and AAGL are arguing vehemently as this article is going to press to ensure that these damaging bundles are rescinded.

Private payers can bundle anything, and it may or may not make sense or be fair. One ACOG resource is the book Ob/Gyn Coding Manual: Components of Correct Procedural Coding, which is revised every year. It has a tear-out page for every procedure code and will help you determine whether or not a bundle is appropriate.

You need to know about bundling and dispute resolution. Why? Because it is possible to insert clauses into your contract that give you some rights. Insurers have all the clout and you have nothing unless you fight for it.

You may see clauses such as “the company reserves the right to re-bundle to the primary procedure....” You shouldn’t tolerate that. Rather, you want to say, “the company will use CCI bundled rules” so that you at least know what the rules are.

11. Don’t be afraid to revise a contract
If we have to hold a payer harmless, the payer should hold us harmless as well. If we consult an insurer’s Web site to confirm that a patient is covered, and we take her to surgery because we have evidence she has insurance, the insurer shouldn’t be able to rescind payment 6 months later because the patient didn’t pay for her insurance that month. That’s not fair. The company told you she was covered, and you deserve to get paid for that surgery because you are relying on information from the company itself. So when you sign a contract, you need to ensure that you are being held harmless as well as the insurer.

12. Calculate your own RVUs
Use your claims software for data. Consult the Federal Register or ACOG to determine the total number of RVUs for a given CPT code. Multiply the RVUs by the quantity for each code. Let’s say it’s an evaluation and management visit, code 99213, and you’ve done 50 this month. That’s 50 multiplied by 1.3 RVUs. Add all the codes together, then use your monthly profit and loss statement to determine what your expenses are. Divide your total expenses by the total number of RVUs to determine your practice cost per RVU. You then can decide on a conversion factor you can tolerate, and you can use this information when contracting with IPAs, HMOs, and other insurers.

13. Spend money to make money
There are many coding resources available to you. Coding is well worth what you spend on it because you can get it back in a heartbeat.

This information may not be easy to master, but it’s critically important for your economic survival—to get what’s rightfully yours and get paid fairly for what you do.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The payment structure for physicians is changing. Our government, the American public, purchasers, and employers are unhappy with the fee-for-service system as it currently exists, and are pushing to drive the system into what is called “value-based purchasing.”

But what is value?

One way to define it is quality divided by cost—but how do we measure quality?

At present, insurers are measuring your quality based on some nebulous definition created at United Healthcare or Blue Cross Blue Shield—looking specifically at your “efficiency,” based on the costs attributed to you, as revealed in the codes you and others submit to payers.

Let’s say you perform minimally invasive surgery, and the referring physician ordered a lot of tests before sending the patient to you. Are you aware that all of those costs may be attributed to you in an administrative system?

ACOG is working hard to establish clinical systems rather than administrative ones to determine the true cost of care. We may want to think of obstetrics and gynecology as primary care and take advantage of advanced payment models and the opportunities afforded to accountable care organizations, but the truth is, insurers frequently do not consider us primary care. Although some of us may develop medical homes for women’s health care, we are unlikely to collect a per-patient, per-month income like primary care physicians do. That means that we need to be more assertive in negotiating contracts with insurers.

In this article, I offer recommendations for such negotiations and explain how to determine what you can and cannot accept in terms of payment.

You are the responsible party
Some of us do our own coding and some of us do not. However, if that coding is inaccurate, it is the physician who goes to jail, not the coder. You are personally responsible and liable for the coding submitted under your provider number.

Clearly, we need to do a better job of advocating for ourselves. We need to lobby. Legislators and bureaucrats are less likely to target people who have strong lobbyists working consistently on their behalf.

Accountable care organizations may have some leverage in negotiating lower prices, and some market forces may come into play in large systems. It remains to be seen which models will succeed as new payment structures develop. The overarching question: What can we do today to optimize our payments, given the system that we have? Here are 13 tactics that can enhance your bottom line.

1. Know the rules
To play the game, you must know the rules. You need to know what systems payers are using to determine your reimbursement—and you have to understand those systems as well as, or better than, the payers do. Then you’ll be able to use them to your advantage.

Payers are well aware that we don’t like to focus on this end of practice, that what we really want to do is spend the day practicing medicine. However, we need to learn these details because we’re leaving money on the table every single day.

2. Educate yourself
With the change to the International Classification of Diseases (ICD) scheduled to take effect on October 1, 2015, many of us are worried that payers are going to reject our claims because of our lack of familiarity with ICD-10.

Rest assured. There are crosswalks from ICD-9 to ICD-10. ACOG has published an information sheet for both obstetrics and gynecology that pairs typically used ICD-9 codes with their ICD-10 counterparts. And because it is published by ACOG, payers will find it hard to claim that it’s inaccurate.

ACOG also offers half-day courses on  ICD-10 coding for both physicians and staff.

3. Record your decision-making process
When I audit medical charts, I often discover that this process has been neglected. Instead, the coder has relied on documentation from the electronic health record and a basic description of the treatment plan. But a plan is just that—what someone intends to do. It doesn’t convey the decision-making that underlies it. What was the differential diagnosis? What did you discuss with the patient? These details are critical for appropriate coding of the level of service—whether it’s high, intermediate, or low.

4. Refine your approach to coding
Recognize that the system is currently set up to pay physicians for the services we provide—and that service must be justified by the appropriate diagnosis code. Tougher cases, or high-risk patients, tend to have longer surgeries and hospital stays, and their outcomes often are not as good as those of more typical patients. They may have more complications because they’re obese or have severe diabetes, for example. If so, it is critical that these other conditions—obesity and severe diabetes—be included with the principal diagnosis code so that risk stratification is possible. Otherwise, we will be held to the same standard as someone treating a routine, low-risk case.

Risk stratification is being performed according to algorithms in the payers’ software—and payers are unlikely to share the details with us. However, the only real data payers have to run through these algorithms come from diagnosis coding. Even though you’re not required to code for variables such as obesity and diabetes in order to get paid for what you do, you do need to use those additional codes to make risk stratification possible—so that you don’t get inappropriately placed into a group of low-risk providers when you are treating a higher-risk cohort.

5. Develop an understanding of RVUs
Another variable that changes regularly is relative value units (RVUs) under Medicare rules. ACOG’s Committee on Health Economics and Coding—which enjoys the participation of AAGL, the American Urogynecologic Society (AUGS), the Society of Gynecologic Surgeons (SGS), and the Society of Gynecologic Oncology (SGO), as well as other organizations—tries to maintain the RVUs as up to date and appropriate as possible relative to other services in the fee schedule.

For example, about 10 years ago many urogynecologic procedures were getting bundled together when they were performed at the same time. We had only one or two ICD-9 codes to describe prolapse, with no separate codes to describe whether it affected the anterior, apical, or posterior compartment, even though we performed different procedures in the individual compartments. Payers were mapping all prolapse procedures to the same diagnosis code. So ACOG went to the National Center for Health Statistics, where ICD-9 coding was done—and developed a series of about 10 codes to describe the different areas that prolapse could affect.

That kind of nuanced coding is continuing today. In fact, we have a long list of areas to go forward with now that ICD-10 is scheduled to take effect. A good example involves new Pap smear guidelines, which recommend testing every 3 or 5 years except for patients who have undergone hysterectomy for benign disease. How do you code for a patient who has had a hysterectomy? There was no code for a woman with an absent cervix, so we created a “V-code,” a code classification for factors that influence health status, so that it is possible to explain why a Pap smear was not performed.

As we go forward into a value-based system, specialists like us likely will be negotiating contracts according to RVU-based payments. That’s why it’s important for you to understand the resource-based relative value scale (RBRVS). It has three components: a work component, which makes up about 52% of the total RVUs; a practice expense, which makes up more than 45% of total RVUS; and, finally, a malpractice component, a small percentage. There also is a geographic adjustment and a uniform conversion factor.

When you hear about the sustainable growth rate (SGR) fix, and the fact that we’re going to see a 20% or 24% reduction in payment, that talk is referring to a reduction in the conversion factor. Each component of the RVU is adjusted for geography and then multiplied by the dollar conversion factor to calculate the total RVUs. The work, practice, and malpractice components vary by where the service is provided.

Let’s use placement of Essure inserts as an example. If you perform the procedure in the hospital, then the hospital buys the equipment, including the hysteroscope and light source. The hospital also pays for the room and staff and manages equipment sterilization. If, on the other hand, you perform the procedure in your office, all those responsibilities are yours. If it’s done in your office, you get paid more but it also costs you more.

The Relative Value Update Committee, or RUC, plays a major role in determining RVUs. This committee is composed of 31 clinicians, including nonphysician providers, psychologists, and nurses who deliver services under the Medicare fee schedule. The RUC makes recommendations to the Centers for Medicare and Medicaid Services (CMS), but it is the Secretary of Health and Human Services who determines the final rule on RVUs.

Approximately 75% to 95% of the recommendations of the RUC are accepted by the Secretary and become law. So it’s not the RUC or the American Medical Association (AMA) that determines RVUs; in the long run, it is CMS and the Secretary of Health and Human Services. We are fortunate that, when CMS assigns RVUs we’re not happy with, we have an opportunity to appeal.

Under Medicare, all physician payments are based on the same conversion factor, regardless of specialty. That’s not necessarily true for other payers, who may, essentially, do whatever they wish. These other payers frequently will contract at higher or lower rates, depending on how prevalent a specialist is in the community. Sometimes they use a higher conversion factor for surgical specialists than they use for primary care.

6. Find out which RVUs the payer is using
When you negotiate contracts with payers, and you are in private practice or part of a medical practice, it’s important to know what year’s RVUs the payer is using, as RVUs vary from year to year. For example, if the payer is using the RBRVS from 2002, it is paying you less than you should be getting. So when you look at a contract, you should determine not only whether the payer is anchoring your payment to the RBRVS but also whether it is keeping up with current RVUs as well. What dollar conversion factor is the payer using? What global periods—the same as CMS, or something different?

7. Determine what global period is in play
Some private payers use 6 postoperative weeks as the global period for a surgical procedure, whereas Medicare uses 90 days. You need to know which period is in play so that you don’t leave money on the table if you see the patient within 90 days but more than 6 weeks postoperatively.

Current Procedural Terminology (CPT) has global surgical packages that include a 10-day or 90-day period. But those periods do not include services provided more than 24 hours before the procedure. They don’t include the administration of anesthesia or conscious sedation. And they don’t include management of complications, exacerbations, or recurrences. Nor do they include additional services that might be necessary due to the presence of another disease or injury.

Under Medicare, the rules are different. Medicare preoperative services begin 1 day before surgery. However, any preoperative intervention is included whether it’s performed 1 day or 1 week before surgery. If it’s simply a preoperative physical examination for the patient and you aren’t performing significant evaluation and management, it’s included in the global package, along with all the intraoperative work. In addition, under Medicare, you don’t get paid for the management of complications unless a return to the operating room is required.

8. Learn to use modifiers
As ObGyns, we often see patients for multiple conditions or problem reports, so you need to be aware that if a patient is within a global period and you do not submit a bill with a modifier to indicate special circumstances, the intervention will be bundled into the global and you will not get paid for it. Modifiers are two-digit codes that describe these separate services. They provide critical information to payers so that their computer programs separate these services out for payment.

Major surgical procedures don’t include unrelated procedures that are performed at the same time of surgery. Nor do they include visits that take place during the global period that are unrelated to the original surgery. For example, if a patient presents with a breast lump after you performed a hysterectomy, and you do a work-up, you deserve full payment for that evaluation and management service. If you don’t use a modifier, however, you won’t get that payment.

9. Don’t be passive when payers won’t pay
Let’s say you contract with HMOs or independent practice associations (IPAs), and they’re not compensating you for the extra things you’re doing and are failing to recognize surgical modifiers. What can you do about it?

You need to develop a profile of your typical patient. Because these organizations are individualizing it—they are saying that, in a typical scenario, this is the type of work you do. So these organizations offer a different kind of contract. Nevertheless, you can use your coding to help you determine what a fair payment should be, by going through your billing to determine what you’ve spent.

10. Analyze payer bundling
Medicare put in place a correct coding initiative (CCI) that lists services typically provided by the same person on the same day of service. The aim: to prevent separate payment for these services. These are “bundled” services. The CCI bundles are revised every quarter. They are listed on the ACOG Web site under “practice management.”

On October 1, 2014, the CCI inappropriately bundled pelvic organ prolapse repair procedures into the vaginal hysterectomy codes. ACOG, AUGS, SGS, and AAGL are arguing vehemently as this article is going to press to ensure that these damaging bundles are rescinded.

Private payers can bundle anything, and it may or may not make sense or be fair. One ACOG resource is the book Ob/Gyn Coding Manual: Components of Correct Procedural Coding, which is revised every year. It has a tear-out page for every procedure code and will help you determine whether or not a bundle is appropriate.

You need to know about bundling and dispute resolution. Why? Because it is possible to insert clauses into your contract that give you some rights. Insurers have all the clout and you have nothing unless you fight for it.

You may see clauses such as “the company reserves the right to re-bundle to the primary procedure....” You shouldn’t tolerate that. Rather, you want to say, “the company will use CCI bundled rules” so that you at least know what the rules are.

11. Don’t be afraid to revise a contract
If we have to hold a payer harmless, the payer should hold us harmless as well. If we consult an insurer’s Web site to confirm that a patient is covered, and we take her to surgery because we have evidence she has insurance, the insurer shouldn’t be able to rescind payment 6 months later because the patient didn’t pay for her insurance that month. That’s not fair. The company told you she was covered, and you deserve to get paid for that surgery because you are relying on information from the company itself. So when you sign a contract, you need to ensure that you are being held harmless as well as the insurer.

12. Calculate your own RVUs
Use your claims software for data. Consult the Federal Register or ACOG to determine the total number of RVUs for a given CPT code. Multiply the RVUs by the quantity for each code. Let’s say it’s an evaluation and management visit, code 99213, and you’ve done 50 this month. That’s 50 multiplied by 1.3 RVUs. Add all the codes together, then use your monthly profit and loss statement to determine what your expenses are. Divide your total expenses by the total number of RVUs to determine your practice cost per RVU. You then can decide on a conversion factor you can tolerate, and you can use this information when contracting with IPAs, HMOs, and other insurers.

13. Spend money to make money
There are many coding resources available to you. Coding is well worth what you spend on it because you can get it back in a heartbeat.

This information may not be easy to master, but it’s critically important for your economic survival—to get what’s rightfully yours and get paid fairly for what you do.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The payment structure for physicians is changing. Our government, the American public, purchasers, and employers are unhappy with the fee-for-service system as it currently exists, and are pushing to drive the system into what is called “value-based purchasing.”

But what is value?

One way to define it is quality divided by cost—but how do we measure quality?

At present, insurers are measuring your quality based on some nebulous definition created at United Healthcare or Blue Cross Blue Shield—looking specifically at your “efficiency,” based on the costs attributed to you, as revealed in the codes you and others submit to payers.

Let’s say you perform minimally invasive surgery, and the referring physician ordered a lot of tests before sending the patient to you. Are you aware that all of those costs may be attributed to you in an administrative system?

ACOG is working hard to establish clinical systems rather than administrative ones to determine the true cost of care. We may want to think of obstetrics and gynecology as primary care and take advantage of advanced payment models and the opportunities afforded to accountable care organizations, but the truth is, insurers frequently do not consider us primary care. Although some of us may develop medical homes for women’s health care, we are unlikely to collect a per-patient, per-month income like primary care physicians do. That means that we need to be more assertive in negotiating contracts with insurers.

In this article, I offer recommendations for such negotiations and explain how to determine what you can and cannot accept in terms of payment.

You are the responsible party
Some of us do our own coding and some of us do not. However, if that coding is inaccurate, it is the physician who goes to jail, not the coder. You are personally responsible and liable for the coding submitted under your provider number.

Clearly, we need to do a better job of advocating for ourselves. We need to lobby. Legislators and bureaucrats are less likely to target people who have strong lobbyists working consistently on their behalf.

Accountable care organizations may have some leverage in negotiating lower prices, and some market forces may come into play in large systems. It remains to be seen which models will succeed as new payment structures develop. The overarching question: What can we do today to optimize our payments, given the system that we have? Here are 13 tactics that can enhance your bottom line.

1. Know the rules
To play the game, you must know the rules. You need to know what systems payers are using to determine your reimbursement—and you have to understand those systems as well as, or better than, the payers do. Then you’ll be able to use them to your advantage.

Payers are well aware that we don’t like to focus on this end of practice, that what we really want to do is spend the day practicing medicine. However, we need to learn these details because we’re leaving money on the table every single day.

2. Educate yourself
With the change to the International Classification of Diseases (ICD) scheduled to take effect on October 1, 2015, many of us are worried that payers are going to reject our claims because of our lack of familiarity with ICD-10.

Rest assured. There are crosswalks from ICD-9 to ICD-10. ACOG has published an information sheet for both obstetrics and gynecology that pairs typically used ICD-9 codes with their ICD-10 counterparts. And because it is published by ACOG, payers will find it hard to claim that it’s inaccurate.

ACOG also offers half-day courses on  ICD-10 coding for both physicians and staff.

3. Record your decision-making process
When I audit medical charts, I often discover that this process has been neglected. Instead, the coder has relied on documentation from the electronic health record and a basic description of the treatment plan. But a plan is just that—what someone intends to do. It doesn’t convey the decision-making that underlies it. What was the differential diagnosis? What did you discuss with the patient? These details are critical for appropriate coding of the level of service—whether it’s high, intermediate, or low.

4. Refine your approach to coding
Recognize that the system is currently set up to pay physicians for the services we provide—and that service must be justified by the appropriate diagnosis code. Tougher cases, or high-risk patients, tend to have longer surgeries and hospital stays, and their outcomes often are not as good as those of more typical patients. They may have more complications because they’re obese or have severe diabetes, for example. If so, it is critical that these other conditions—obesity and severe diabetes—be included with the principal diagnosis code so that risk stratification is possible. Otherwise, we will be held to the same standard as someone treating a routine, low-risk case.

Risk stratification is being performed according to algorithms in the payers’ software—and payers are unlikely to share the details with us. However, the only real data payers have to run through these algorithms come from diagnosis coding. Even though you’re not required to code for variables such as obesity and diabetes in order to get paid for what you do, you do need to use those additional codes to make risk stratification possible—so that you don’t get inappropriately placed into a group of low-risk providers when you are treating a higher-risk cohort.

5. Develop an understanding of RVUs
Another variable that changes regularly is relative value units (RVUs) under Medicare rules. ACOG’s Committee on Health Economics and Coding—which enjoys the participation of AAGL, the American Urogynecologic Society (AUGS), the Society of Gynecologic Surgeons (SGS), and the Society of Gynecologic Oncology (SGO), as well as other organizations—tries to maintain the RVUs as up to date and appropriate as possible relative to other services in the fee schedule.

For example, about 10 years ago many urogynecologic procedures were getting bundled together when they were performed at the same time. We had only one or two ICD-9 codes to describe prolapse, with no separate codes to describe whether it affected the anterior, apical, or posterior compartment, even though we performed different procedures in the individual compartments. Payers were mapping all prolapse procedures to the same diagnosis code. So ACOG went to the National Center for Health Statistics, where ICD-9 coding was done—and developed a series of about 10 codes to describe the different areas that prolapse could affect.

That kind of nuanced coding is continuing today. In fact, we have a long list of areas to go forward with now that ICD-10 is scheduled to take effect. A good example involves new Pap smear guidelines, which recommend testing every 3 or 5 years except for patients who have undergone hysterectomy for benign disease. How do you code for a patient who has had a hysterectomy? There was no code for a woman with an absent cervix, so we created a “V-code,” a code classification for factors that influence health status, so that it is possible to explain why a Pap smear was not performed.

As we go forward into a value-based system, specialists like us likely will be negotiating contracts according to RVU-based payments. That’s why it’s important for you to understand the resource-based relative value scale (RBRVS). It has three components: a work component, which makes up about 52% of the total RVUs; a practice expense, which makes up more than 45% of total RVUS; and, finally, a malpractice component, a small percentage. There also is a geographic adjustment and a uniform conversion factor.

When you hear about the sustainable growth rate (SGR) fix, and the fact that we’re going to see a 20% or 24% reduction in payment, that talk is referring to a reduction in the conversion factor. Each component of the RVU is adjusted for geography and then multiplied by the dollar conversion factor to calculate the total RVUs. The work, practice, and malpractice components vary by where the service is provided.

Let’s use placement of Essure inserts as an example. If you perform the procedure in the hospital, then the hospital buys the equipment, including the hysteroscope and light source. The hospital also pays for the room and staff and manages equipment sterilization. If, on the other hand, you perform the procedure in your office, all those responsibilities are yours. If it’s done in your office, you get paid more but it also costs you more.

The Relative Value Update Committee, or RUC, plays a major role in determining RVUs. This committee is composed of 31 clinicians, including nonphysician providers, psychologists, and nurses who deliver services under the Medicare fee schedule. The RUC makes recommendations to the Centers for Medicare and Medicaid Services (CMS), but it is the Secretary of Health and Human Services who determines the final rule on RVUs.

Approximately 75% to 95% of the recommendations of the RUC are accepted by the Secretary and become law. So it’s not the RUC or the American Medical Association (AMA) that determines RVUs; in the long run, it is CMS and the Secretary of Health and Human Services. We are fortunate that, when CMS assigns RVUs we’re not happy with, we have an opportunity to appeal.

Under Medicare, all physician payments are based on the same conversion factor, regardless of specialty. That’s not necessarily true for other payers, who may, essentially, do whatever they wish. These other payers frequently will contract at higher or lower rates, depending on how prevalent a specialist is in the community. Sometimes they use a higher conversion factor for surgical specialists than they use for primary care.

6. Find out which RVUs the payer is using
When you negotiate contracts with payers, and you are in private practice or part of a medical practice, it’s important to know what year’s RVUs the payer is using, as RVUs vary from year to year. For example, if the payer is using the RBRVS from 2002, it is paying you less than you should be getting. So when you look at a contract, you should determine not only whether the payer is anchoring your payment to the RBRVS but also whether it is keeping up with current RVUs as well. What dollar conversion factor is the payer using? What global periods—the same as CMS, or something different?

7. Determine what global period is in play
Some private payers use 6 postoperative weeks as the global period for a surgical procedure, whereas Medicare uses 90 days. You need to know which period is in play so that you don’t leave money on the table if you see the patient within 90 days but more than 6 weeks postoperatively.

Current Procedural Terminology (CPT) has global surgical packages that include a 10-day or 90-day period. But those periods do not include services provided more than 24 hours before the procedure. They don’t include the administration of anesthesia or conscious sedation. And they don’t include management of complications, exacerbations, or recurrences. Nor do they include additional services that might be necessary due to the presence of another disease or injury.

Under Medicare, the rules are different. Medicare preoperative services begin 1 day before surgery. However, any preoperative intervention is included whether it’s performed 1 day or 1 week before surgery. If it’s simply a preoperative physical examination for the patient and you aren’t performing significant evaluation and management, it’s included in the global package, along with all the intraoperative work. In addition, under Medicare, you don’t get paid for the management of complications unless a return to the operating room is required.

8. Learn to use modifiers
As ObGyns, we often see patients for multiple conditions or problem reports, so you need to be aware that if a patient is within a global period and you do not submit a bill with a modifier to indicate special circumstances, the intervention will be bundled into the global and you will not get paid for it. Modifiers are two-digit codes that describe these separate services. They provide critical information to payers so that their computer programs separate these services out for payment.

Major surgical procedures don’t include unrelated procedures that are performed at the same time of surgery. Nor do they include visits that take place during the global period that are unrelated to the original surgery. For example, if a patient presents with a breast lump after you performed a hysterectomy, and you do a work-up, you deserve full payment for that evaluation and management service. If you don’t use a modifier, however, you won’t get that payment.

9. Don’t be passive when payers won’t pay
Let’s say you contract with HMOs or independent practice associations (IPAs), and they’re not compensating you for the extra things you’re doing and are failing to recognize surgical modifiers. What can you do about it?

You need to develop a profile of your typical patient. Because these organizations are individualizing it—they are saying that, in a typical scenario, this is the type of work you do. So these organizations offer a different kind of contract. Nevertheless, you can use your coding to help you determine what a fair payment should be, by going through your billing to determine what you’ve spent.

10. Analyze payer bundling
Medicare put in place a correct coding initiative (CCI) that lists services typically provided by the same person on the same day of service. The aim: to prevent separate payment for these services. These are “bundled” services. The CCI bundles are revised every quarter. They are listed on the ACOG Web site under “practice management.”

On October 1, 2014, the CCI inappropriately bundled pelvic organ prolapse repair procedures into the vaginal hysterectomy codes. ACOG, AUGS, SGS, and AAGL are arguing vehemently as this article is going to press to ensure that these damaging bundles are rescinded.

Private payers can bundle anything, and it may or may not make sense or be fair. One ACOG resource is the book Ob/Gyn Coding Manual: Components of Correct Procedural Coding, which is revised every year. It has a tear-out page for every procedure code and will help you determine whether or not a bundle is appropriate.

You need to know about bundling and dispute resolution. Why? Because it is possible to insert clauses into your contract that give you some rights. Insurers have all the clout and you have nothing unless you fight for it.

You may see clauses such as “the company reserves the right to re-bundle to the primary procedure....” You shouldn’t tolerate that. Rather, you want to say, “the company will use CCI bundled rules” so that you at least know what the rules are.

11. Don’t be afraid to revise a contract
If we have to hold a payer harmless, the payer should hold us harmless as well. If we consult an insurer’s Web site to confirm that a patient is covered, and we take her to surgery because we have evidence she has insurance, the insurer shouldn’t be able to rescind payment 6 months later because the patient didn’t pay for her insurance that month. That’s not fair. The company told you she was covered, and you deserve to get paid for that surgery because you are relying on information from the company itself. So when you sign a contract, you need to ensure that you are being held harmless as well as the insurer.

12. Calculate your own RVUs
Use your claims software for data. Consult the Federal Register or ACOG to determine the total number of RVUs for a given CPT code. Multiply the RVUs by the quantity for each code. Let’s say it’s an evaluation and management visit, code 99213, and you’ve done 50 this month. That’s 50 multiplied by 1.3 RVUs. Add all the codes together, then use your monthly profit and loss statement to determine what your expenses are. Divide your total expenses by the total number of RVUs to determine your practice cost per RVU. You then can decide on a conversion factor you can tolerate, and you can use this information when contracting with IPAs, HMOs, and other insurers.

13. Spend money to make money
There are many coding resources available to you. Coding is well worth what you spend on it because you can get it back in a heartbeat.

This information may not be easy to master, but it’s critically important for your economic survival—to get what’s rightfully yours and get paid fairly for what you do.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The AAGL, formerly the American Association of Gynecologic Laparoscopists, has approved the first-ever set of privileging and credentialing guidelines for robotic surgery.¹

Why has this prestigious minimally invasive surgery organization done that?

Maybe you’ve seen the Internet and TV ads and billboard trucks driving outside of many major medical society meetings recently, advertising “1-800-BAD-Robot.”² You also are probably aware of recent articles in the headlines of national periodicals like the Wall Street Journal claiming that robotic surgery can be harmful.³

And yet, robotic gynecologic surgery has grown at an unprecedented rate since its approval by the US Food and Drug Administration (FDA) in April 2005. Recent data from the Nationwide Inpatient Sample from the Agency for Healthcare Research and Quality indicate that robot-assisted hysterectomies have increased at a dramatic rate.⁴ In a recent study of the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database, investigators found that more than 30% of injuries during robotic surgery are related to operator error or robot failure, but the majority of problems are not associated with the technology.⁵

In this article, I use the aviation industry as an example of a sector that has gotten safety right. By emulating many of its standards, our specialty can make great strides toward patient safety and improved outcomes. I also outline the main points of the new AAGL guidelines and the rationale behind them.¹ See, for example, the summary box on page 46.

A “shining example”
The robot clearly is an enabling technology. With its high-definition 3D vision and scaled motion with wristed instruments, surgeons are more comfortable performing many complex gynecologic procedures that previously would have required open surgery to safely accomplish … but the da Vinci Robot does not make a poor surgeon a great surgeon.

Hospitals now are being sued for allowing surgeons to perform robotic surgery on patients without documenting adequate surgeon training or providing consistent oversight.⁶ This new technology has outpaced the ability of hospital medical staffs to establish practice guidelines and rules to ensure patient safety. 

The aviation industry is a shining example of a highly reliable industry. Each day, thousands of commercial aircraft fly all over the world with amazing safety. Most of the time, the pilot and copilot have never flown together. However, each crew member knows his or her role precisely and clearly understands what is expected. Crew members must meet standards that transcend all airlines and all aircraft.⁷ They all practice communication and undergo standardized training, including simulation, prior to taking off with live passengers on board.

In addition, all pilots must demonstrate their proficiency and competence on a regular basis—by exhibiting actual safe flight performance (over multiple takeoffs and landings) and undergoing check rides with flight examiners and practicing routine and emergency procedures on flight simulators. Airline passengers have come to expect that all pilots are equally proficient and safe. Shouldn’t patients be able to expect the same from their surgeons and hospitals? And yet there is no national or local organization that ensures that all surgeons are equally safe in the operating room. That responsibility is too often left up to the courts.

Three requirements of robotic credentialing
In 2008, the MultiCare Health System in the Pacific Northwest adopted a unique system of robotic credentialing that was based on the aviation model.⁸ This model has three main components, which are identical to the guidelines imposed on pilots: 

Adoption of these tried-and-true safety principles would ensure that hospitals exercise their responsibility to protect patients who undergo robotic surgeries in their systems.

The AAGL’s Robotics Special Interest Group, formed in 2010, is now the largest special interest group in the organization. The group was initially tasked to develop ­evidence-based guidelines for robotic surgery training and credentialing. Using the aviation industry’s model, the group developed a basic template of robotic surgery credentialing and privileging guidelines that can be used anywhere in the world. This proposal is not meant to be a standard-of-care definition; rather, it is intended simply as a starting point.

Initial training

Annual currency

Annual recertification

Initial training involves a long learning curve
There is a long learning curve for surgeons to become competent in robotic surgery. In initial studies of experienced advanced laparoscopic surgeons, investigators found that learning curves could involve 50 cases or more.^9,10 In a recent study of gynecologic oncologists and urogynecologists at the Mayo Clinic, researchers found that it took 91 cases for experienced surgeons to become proficient on the robot.¹¹

ObGyns in the United States are doing fewer hysterectomies than they used to.¹² Many surgeons now perform fewer than 10 hysterectomies per year. These surgeons clearly have worse outcomes than surgeons who operate more frequently.^13–15 Therefore, these new guidelines suggest that hospitals should choose to train only surgeons who have a case volume that will allow them to get through their learning curve in a short time and continue to have enough surgeries to maintain their skills. These guidelines recommend that surgeons who are candidates for robotic surgery training already perform a minimum of 20 major gynecologic operations per year.

It is important to learn to walk before you run. New student pilots start out with single-engine propeller planes before graduating to multi-engine props, jets, and commercial aircraft. Similarly, new medical students start out with easy surgical tasks before training for more complex procedures. This approach seems like common sense, although many surgeons may feel that, after orienting on the robot, they can start doing complex cases right away, as the robot enables them to do better and more precise surgery. Nothing could be further from the truth.

It is very important that new robotic surgeons start with easy, basic cases to completely familiarize themselves with the operation of the robot console before attempting more complex and difficult cases.

There is no absolute number of cases that ensures competency with the robot; the number depends on the surgeon’s case load, surgical prowess, and psychomotor skills. A surgeon should be restricted to simple cases initially, and should have an experienced robot-credentialed surgeon operating with him or her during this initial learning period.

Practice makes perfect
Musicians will tell you that the more often you practice, the more skilled you become. This is true for anyone whose job requires special training. It would be naïve to assume that surgeons can maintain optimal skills for robotic surgery by performing only a few cases each year.

Psychomotor skill degradation has been explored in relation to various surgical skills. The more complex the skill, the more likely that skill set will deteriorate without use. In recent studies, investigators have shown that robotic surgery skills begin to decline significantly after only 2 weeks of inactivity, and that skills continue to degrade without use.^16,17

Based on this information, the currency requirement for surgeons to maintain privileges was set at 20 cases per year—fewer than two cases per month. Although the members of the Robotics Special Interest Group strongly agree that
maintenance of privileges should not be based ­entirely on an arbitrary currency number, as Tracy and colleagues also argue in a recent publication,¹⁸ it is clear that frequent performance of robotic surgery by high-­volume surgeons clearly is more efficient and safer, with lower total operative times and complication rates, than robotic surgery performed by lower-volume surgeons.⁸

Currency is a well-accepted safety standard in aviation, and pilots know the importance of frequent practice and repetition in the cockpit under real-world conditions.

Ensure annual competency
Although a pilot must accomplish a minimum number of flying hours each year to maintain certification, this does not ensure that passengers will be safe. Pilots also must prove their competence by undergoing periodic check rides and demonstrating their skills on flight simulators.

Surgeons also can use these models to verify competency. Proctors who are independently certified by the FDA or another government agency as examiners could observe and evaluate surgeons performing robotic surgery using standardized ­checklists and grading forms. If done locally, care must be taken to assure standardization, as local hospital politics could interfere.

The only other methods currently available to verify surgeon competency are to demonstrate proficiency on simulation and to review outcomes data, looking for outliers in important areas such as complications, robotic console times, total operative times, length of stay, etc.

Simulation offers a standardized, independent method to monitor competency.¹⁹ A passing test score on a robotic simulator exercise could be a way for a surgeon to prove his or her competency. Basic robotic skills such as camera control and clutching, energy use, and sewing and ­needle control can be practiced on a robotic simulator.

Virtual cases such as hysterectomy and myomectomy are not yet available on the simulator, nor are cases involving typical complications. These are being developed, however, and will be available shortly.

Several gynecologic resident and fellowship training programs are using simulation to train novice surgeons, and some community hospitals are using simulation as an annual requirement for all practicing surgeons to demonstrate proficiency, similar to pilots.⁸ Some newer validated training protocols require a surgeon to demonstrate mastery of a particular robotic skill by achieving passing scores at least five times, with at least two consecutive passing scores.^20,21

As simulators evolve, they will continue to be incorporated into training, used for surgeon warm-up before surgery, as refreshers for surgeons after a period of robotic inactivity, and for annual recertification.

A recent medical malpractice case highlights the importance of having guidelines in place to protect patients. In Bremerton, Washington, in 2008,1 a urologist performed his first nonproctored robotic prostatectomy. The challenging and difficult procedure took more than 13 hours; he converted to an open procedure after 7 hours. The patient developed significant postoperative complications and died.1

In the litigation that followed, the surgeon was sued for negligence and for failing to disclose that this was his first solo robot-assisted surgery. The surgeon settled, as did the hospital, which was sued for not supervising the surgeon and failing to ensure that he could use the robot safely. The family also sued Intuitive Surgical, the manufacturer of the da Vinci Robot, for failing to provide adequate training to the surgeon.²

The jury ruled in favor of the manufacturer, stating that the verification of adequate surgeon training was the responsibility of the hospital and specialty medical societies, not the industry.

References

A word to the wise
If hospital departments really want to ensure that they are doing all that they can to make robotic surgeries safe for their patients, they will utilize the recent guidelines approved by AAGL. In order for these guidelines to work, hospital systems need to commit re­sources for medical staff oversight, inclu­ding a robotics peer-review committee with a physician chairman and adequate medical staff support to monitor physicians and manage those who cannot meet these goals.

There clearly will be push-back from surgeons who feel that it is unfair to restrict their ability to perform surgery just because their volumes are low or they can’t master the simulation exercises. However, in the final analysis, would we want the airlines to employ pilots who fly only a couple of times a year or who can’t master the required simulation skills to safely operate a commercial passenger jet?

The important question is, what is our focus? Is it to be “fair” to all surgeons, or is it to provide the best and safest outcomes for our patients? As surgeons, we each need to remember the oath we took when we became physicians to “First, do no harm.” By following these new AAGL robotic surgery ­guidelines, we will reassure our patients that we, as physicians, do take that oath seriously.

INSTANT POLL
For credentialing and privileging of robotic gynecologic surgery, do you agree that the following points are essential components of the process?

1. Surgeons should be selected for training who are most likely to be successful in performing robotic surgeries safely and efficiently.
2. There should be a minimum number of procedures performed on a regular basis to ensure that the surgeon maintains his or her psychomotor (hand-eye coordination) skills.
3. Surgeons, like pilots, should be required to demonstrate their competency in operating the robot on a regular basis.

Answer:
a. Yes, I agree.
b. No, I believe this approach is too restrictive.
c. No, I believe this approach is not restrictive enough.

To vote, please visit obgmanagement.com and look for “Quick Poll” on the right side of the homepage.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The AAGL, formerly the American Association of Gynecologic Laparoscopists, has approved the first-ever set of privileging and credentialing guidelines for robotic surgery.¹

Why has this prestigious minimally invasive surgery organization done that?

Maybe you’ve seen the Internet and TV ads and billboard trucks driving outside of many major medical society meetings recently, advertising “1-800-BAD-Robot.”² You also are probably aware of recent articles in the headlines of national periodicals like the Wall Street Journal claiming that robotic surgery can be harmful.³

And yet, robotic gynecologic surgery has grown at an unprecedented rate since its approval by the US Food and Drug Administration (FDA) in April 2005. Recent data from the Nationwide Inpatient Sample from the Agency for Healthcare Research and Quality indicate that robot-assisted hysterectomies have increased at a dramatic rate.⁴ In a recent study of the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database, investigators found that more than 30% of injuries during robotic surgery are related to operator error or robot failure, but the majority of problems are not associated with the technology.⁵

In this article, I use the aviation industry as an example of a sector that has gotten safety right. By emulating many of its standards, our specialty can make great strides toward patient safety and improved outcomes. I also outline the main points of the new AAGL guidelines and the rationale behind them.¹ See, for example, the summary box on page 46.

A “shining example”
The robot clearly is an enabling technology. With its high-definition 3D vision and scaled motion with wristed instruments, surgeons are more comfortable performing many complex gynecologic procedures that previously would have required open surgery to safely accomplish … but the da Vinci Robot does not make a poor surgeon a great surgeon.

Hospitals now are being sued for allowing surgeons to perform robotic surgery on patients without documenting adequate surgeon training or providing consistent oversight.⁶ This new technology has outpaced the ability of hospital medical staffs to establish practice guidelines and rules to ensure patient safety. 

The aviation industry is a shining example of a highly reliable industry. Each day, thousands of commercial aircraft fly all over the world with amazing safety. Most of the time, the pilot and copilot have never flown together. However, each crew member knows his or her role precisely and clearly understands what is expected. Crew members must meet standards that transcend all airlines and all aircraft.⁷ They all practice communication and undergo standardized training, including simulation, prior to taking off with live passengers on board.

In addition, all pilots must demonstrate their proficiency and competence on a regular basis—by exhibiting actual safe flight performance (over multiple takeoffs and landings) and undergoing check rides with flight examiners and practicing routine and emergency procedures on flight simulators. Airline passengers have come to expect that all pilots are equally proficient and safe. Shouldn’t patients be able to expect the same from their surgeons and hospitals? And yet there is no national or local organization that ensures that all surgeons are equally safe in the operating room. That responsibility is too often left up to the courts.

Three requirements of robotic credentialing
In 2008, the MultiCare Health System in the Pacific Northwest adopted a unique system of robotic credentialing that was based on the aviation model.⁸ This model has three main components, which are identical to the guidelines imposed on pilots: 

Adoption of these tried-and-true safety principles would ensure that hospitals exercise their responsibility to protect patients who undergo robotic surgeries in their systems.

The AAGL’s Robotics Special Interest Group, formed in 2010, is now the largest special interest group in the organization. The group was initially tasked to develop ­evidence-based guidelines for robotic surgery training and credentialing. Using the aviation industry’s model, the group developed a basic template of robotic surgery credentialing and privileging guidelines that can be used anywhere in the world. This proposal is not meant to be a standard-of-care definition; rather, it is intended simply as a starting point.

Initial training

Annual currency

Annual recertification

Initial training involves a long learning curve
There is a long learning curve for surgeons to become competent in robotic surgery. In initial studies of experienced advanced laparoscopic surgeons, investigators found that learning curves could involve 50 cases or more.^9,10 In a recent study of gynecologic oncologists and urogynecologists at the Mayo Clinic, researchers found that it took 91 cases for experienced surgeons to become proficient on the robot.¹¹

ObGyns in the United States are doing fewer hysterectomies than they used to.¹² Many surgeons now perform fewer than 10 hysterectomies per year. These surgeons clearly have worse outcomes than surgeons who operate more frequently.^13–15 Therefore, these new guidelines suggest that hospitals should choose to train only surgeons who have a case volume that will allow them to get through their learning curve in a short time and continue to have enough surgeries to maintain their skills. These guidelines recommend that surgeons who are candidates for robotic surgery training already perform a minimum of 20 major gynecologic operations per year.

It is important to learn to walk before you run. New student pilots start out with single-engine propeller planes before graduating to multi-engine props, jets, and commercial aircraft. Similarly, new medical students start out with easy surgical tasks before training for more complex procedures. This approach seems like common sense, although many surgeons may feel that, after orienting on the robot, they can start doing complex cases right away, as the robot enables them to do better and more precise surgery. Nothing could be further from the truth.

It is very important that new robotic surgeons start with easy, basic cases to completely familiarize themselves with the operation of the robot console before attempting more complex and difficult cases.

There is no absolute number of cases that ensures competency with the robot; the number depends on the surgeon’s case load, surgical prowess, and psychomotor skills. A surgeon should be restricted to simple cases initially, and should have an experienced robot-credentialed surgeon operating with him or her during this initial learning period.

Practice makes perfect
Musicians will tell you that the more often you practice, the more skilled you become. This is true for anyone whose job requires special training. It would be naïve to assume that surgeons can maintain optimal skills for robotic surgery by performing only a few cases each year.

Psychomotor skill degradation has been explored in relation to various surgical skills. The more complex the skill, the more likely that skill set will deteriorate without use. In recent studies, investigators have shown that robotic surgery skills begin to decline significantly after only 2 weeks of inactivity, and that skills continue to degrade without use.^16,17

Based on this information, the currency requirement for surgeons to maintain privileges was set at 20 cases per year—fewer than two cases per month. Although the members of the Robotics Special Interest Group strongly agree that
maintenance of privileges should not be based ­entirely on an arbitrary currency number, as Tracy and colleagues also argue in a recent publication,¹⁸ it is clear that frequent performance of robotic surgery by high-­volume surgeons clearly is more efficient and safer, with lower total operative times and complication rates, than robotic surgery performed by lower-volume surgeons.⁸

Currency is a well-accepted safety standard in aviation, and pilots know the importance of frequent practice and repetition in the cockpit under real-world conditions.

Ensure annual competency
Although a pilot must accomplish a minimum number of flying hours each year to maintain certification, this does not ensure that passengers will be safe. Pilots also must prove their competence by undergoing periodic check rides and demonstrating their skills on flight simulators.

Surgeons also can use these models to verify competency. Proctors who are independently certified by the FDA or another government agency as examiners could observe and evaluate surgeons performing robotic surgery using standardized ­checklists and grading forms. If done locally, care must be taken to assure standardization, as local hospital politics could interfere.

The only other methods currently available to verify surgeon competency are to demonstrate proficiency on simulation and to review outcomes data, looking for outliers in important areas such as complications, robotic console times, total operative times, length of stay, etc.

Simulation offers a standardized, independent method to monitor competency.¹⁹ A passing test score on a robotic simulator exercise could be a way for a surgeon to prove his or her competency. Basic robotic skills such as camera control and clutching, energy use, and sewing and ­needle control can be practiced on a robotic simulator.

Virtual cases such as hysterectomy and myomectomy are not yet available on the simulator, nor are cases involving typical complications. These are being developed, however, and will be available shortly.

Several gynecologic resident and fellowship training programs are using simulation to train novice surgeons, and some community hospitals are using simulation as an annual requirement for all practicing surgeons to demonstrate proficiency, similar to pilots.⁸ Some newer validated training protocols require a surgeon to demonstrate mastery of a particular robotic skill by achieving passing scores at least five times, with at least two consecutive passing scores.^20,21

As simulators evolve, they will continue to be incorporated into training, used for surgeon warm-up before surgery, as refreshers for surgeons after a period of robotic inactivity, and for annual recertification.

A recent medical malpractice case highlights the importance of having guidelines in place to protect patients. In Bremerton, Washington, in 2008,1 a urologist performed his first nonproctored robotic prostatectomy. The challenging and difficult procedure took more than 13 hours; he converted to an open procedure after 7 hours. The patient developed significant postoperative complications and died.1

In the litigation that followed, the surgeon was sued for negligence and for failing to disclose that this was his first solo robot-assisted surgery. The surgeon settled, as did the hospital, which was sued for not supervising the surgeon and failing to ensure that he could use the robot safely. The family also sued Intuitive Surgical, the manufacturer of the da Vinci Robot, for failing to provide adequate training to the surgeon.²

The jury ruled in favor of the manufacturer, stating that the verification of adequate surgeon training was the responsibility of the hospital and specialty medical societies, not the industry.

References

A word to the wise
If hospital departments really want to ensure that they are doing all that they can to make robotic surgeries safe for their patients, they will utilize the recent guidelines approved by AAGL. In order for these guidelines to work, hospital systems need to commit re­sources for medical staff oversight, inclu­ding a robotics peer-review committee with a physician chairman and adequate medical staff support to monitor physicians and manage those who cannot meet these goals.

There clearly will be push-back from surgeons who feel that it is unfair to restrict their ability to perform surgery just because their volumes are low or they can’t master the simulation exercises. However, in the final analysis, would we want the airlines to employ pilots who fly only a couple of times a year or who can’t master the required simulation skills to safely operate a commercial passenger jet?

The important question is, what is our focus? Is it to be “fair” to all surgeons, or is it to provide the best and safest outcomes for our patients? As surgeons, we each need to remember the oath we took when we became physicians to “First, do no harm.” By following these new AAGL robotic surgery ­guidelines, we will reassure our patients that we, as physicians, do take that oath seriously.

INSTANT POLL
For credentialing and privileging of robotic gynecologic surgery, do you agree that the following points are essential components of the process?

1. Surgeons should be selected for training who are most likely to be successful in performing robotic surgeries safely and efficiently.
2. There should be a minimum number of procedures performed on a regular basis to ensure that the surgeon maintains his or her psychomotor (hand-eye coordination) skills.
3. Surgeons, like pilots, should be required to demonstrate their competency in operating the robot on a regular basis.

Answer:
a. Yes, I agree.
b. No, I believe this approach is too restrictive.
c. No, I believe this approach is not restrictive enough.

To vote, please visit obgmanagement.com and look for “Quick Poll” on the right side of the homepage.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The AAGL, formerly the American Association of Gynecologic Laparoscopists, has approved the first-ever set of privileging and credentialing guidelines for robotic surgery.¹

Why has this prestigious minimally invasive surgery organization done that?

Maybe you’ve seen the Internet and TV ads and billboard trucks driving outside of many major medical society meetings recently, advertising “1-800-BAD-Robot.”² You also are probably aware of recent articles in the headlines of national periodicals like the Wall Street Journal claiming that robotic surgery can be harmful.³

And yet, robotic gynecologic surgery has grown at an unprecedented rate since its approval by the US Food and Drug Administration (FDA) in April 2005. Recent data from the Nationwide Inpatient Sample from the Agency for Healthcare Research and Quality indicate that robot-assisted hysterectomies have increased at a dramatic rate.⁴ In a recent study of the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database, investigators found that more than 30% of injuries during robotic surgery are related to operator error or robot failure, but the majority of problems are not associated with the technology.⁵

In this article, I use the aviation industry as an example of a sector that has gotten safety right. By emulating many of its standards, our specialty can make great strides toward patient safety and improved outcomes. I also outline the main points of the new AAGL guidelines and the rationale behind them.¹ See, for example, the summary box on page 46.

A “shining example”
The robot clearly is an enabling technology. With its high-definition 3D vision and scaled motion with wristed instruments, surgeons are more comfortable performing many complex gynecologic procedures that previously would have required open surgery to safely accomplish … but the da Vinci Robot does not make a poor surgeon a great surgeon.

Hospitals now are being sued for allowing surgeons to perform robotic surgery on patients without documenting adequate surgeon training or providing consistent oversight.⁶ This new technology has outpaced the ability of hospital medical staffs to establish practice guidelines and rules to ensure patient safety. 

The aviation industry is a shining example of a highly reliable industry. Each day, thousands of commercial aircraft fly all over the world with amazing safety. Most of the time, the pilot and copilot have never flown together. However, each crew member knows his or her role precisely and clearly understands what is expected. Crew members must meet standards that transcend all airlines and all aircraft.⁷ They all practice communication and undergo standardized training, including simulation, prior to taking off with live passengers on board.

In addition, all pilots must demonstrate their proficiency and competence on a regular basis—by exhibiting actual safe flight performance (over multiple takeoffs and landings) and undergoing check rides with flight examiners and practicing routine and emergency procedures on flight simulators. Airline passengers have come to expect that all pilots are equally proficient and safe. Shouldn’t patients be able to expect the same from their surgeons and hospitals? And yet there is no national or local organization that ensures that all surgeons are equally safe in the operating room. That responsibility is too often left up to the courts.

Three requirements of robotic credentialing
In 2008, the MultiCare Health System in the Pacific Northwest adopted a unique system of robotic credentialing that was based on the aviation model.⁸ This model has three main components, which are identical to the guidelines imposed on pilots: 

Adoption of these tried-and-true safety principles would ensure that hospitals exercise their responsibility to protect patients who undergo robotic surgeries in their systems.

The AAGL’s Robotics Special Interest Group, formed in 2010, is now the largest special interest group in the organization. The group was initially tasked to develop ­evidence-based guidelines for robotic surgery training and credentialing. Using the aviation industry’s model, the group developed a basic template of robotic surgery credentialing and privileging guidelines that can be used anywhere in the world. This proposal is not meant to be a standard-of-care definition; rather, it is intended simply as a starting point.

Initial training

Annual currency

Annual recertification

Initial training involves a long learning curve
There is a long learning curve for surgeons to become competent in robotic surgery. In initial studies of experienced advanced laparoscopic surgeons, investigators found that learning curves could involve 50 cases or more.^9,10 In a recent study of gynecologic oncologists and urogynecologists at the Mayo Clinic, researchers found that it took 91 cases for experienced surgeons to become proficient on the robot.¹¹

ObGyns in the United States are doing fewer hysterectomies than they used to.¹² Many surgeons now perform fewer than 10 hysterectomies per year. These surgeons clearly have worse outcomes than surgeons who operate more frequently.^13–15 Therefore, these new guidelines suggest that hospitals should choose to train only surgeons who have a case volume that will allow them to get through their learning curve in a short time and continue to have enough surgeries to maintain their skills. These guidelines recommend that surgeons who are candidates for robotic surgery training already perform a minimum of 20 major gynecologic operations per year.

It is important to learn to walk before you run. New student pilots start out with single-engine propeller planes before graduating to multi-engine props, jets, and commercial aircraft. Similarly, new medical students start out with easy surgical tasks before training for more complex procedures. This approach seems like common sense, although many surgeons may feel that, after orienting on the robot, they can start doing complex cases right away, as the robot enables them to do better and more precise surgery. Nothing could be further from the truth.

It is very important that new robotic surgeons start with easy, basic cases to completely familiarize themselves with the operation of the robot console before attempting more complex and difficult cases.

There is no absolute number of cases that ensures competency with the robot; the number depends on the surgeon’s case load, surgical prowess, and psychomotor skills. A surgeon should be restricted to simple cases initially, and should have an experienced robot-credentialed surgeon operating with him or her during this initial learning period.

Practice makes perfect
Musicians will tell you that the more often you practice, the more skilled you become. This is true for anyone whose job requires special training. It would be naïve to assume that surgeons can maintain optimal skills for robotic surgery by performing only a few cases each year.

Psychomotor skill degradation has been explored in relation to various surgical skills. The more complex the skill, the more likely that skill set will deteriorate without use. In recent studies, investigators have shown that robotic surgery skills begin to decline significantly after only 2 weeks of inactivity, and that skills continue to degrade without use.^16,17

Based on this information, the currency requirement for surgeons to maintain privileges was set at 20 cases per year—fewer than two cases per month. Although the members of the Robotics Special Interest Group strongly agree that
maintenance of privileges should not be based ­entirely on an arbitrary currency number, as Tracy and colleagues also argue in a recent publication,¹⁸ it is clear that frequent performance of robotic surgery by high-­volume surgeons clearly is more efficient and safer, with lower total operative times and complication rates, than robotic surgery performed by lower-volume surgeons.⁸

Currency is a well-accepted safety standard in aviation, and pilots know the importance of frequent practice and repetition in the cockpit under real-world conditions.

Ensure annual competency
Although a pilot must accomplish a minimum number of flying hours each year to maintain certification, this does not ensure that passengers will be safe. Pilots also must prove their competence by undergoing periodic check rides and demonstrating their skills on flight simulators.

Surgeons also can use these models to verify competency. Proctors who are independently certified by the FDA or another government agency as examiners could observe and evaluate surgeons performing robotic surgery using standardized ­checklists and grading forms. If done locally, care must be taken to assure standardization, as local hospital politics could interfere.

The only other methods currently available to verify surgeon competency are to demonstrate proficiency on simulation and to review outcomes data, looking for outliers in important areas such as complications, robotic console times, total operative times, length of stay, etc.

Simulation offers a standardized, independent method to monitor competency.¹⁹ A passing test score on a robotic simulator exercise could be a way for a surgeon to prove his or her competency. Basic robotic skills such as camera control and clutching, energy use, and sewing and ­needle control can be practiced on a robotic simulator.

Virtual cases such as hysterectomy and myomectomy are not yet available on the simulator, nor are cases involving typical complications. These are being developed, however, and will be available shortly.

Several gynecologic resident and fellowship training programs are using simulation to train novice surgeons, and some community hospitals are using simulation as an annual requirement for all practicing surgeons to demonstrate proficiency, similar to pilots.⁸ Some newer validated training protocols require a surgeon to demonstrate mastery of a particular robotic skill by achieving passing scores at least five times, with at least two consecutive passing scores.^20,21

As simulators evolve, they will continue to be incorporated into training, used for surgeon warm-up before surgery, as refreshers for surgeons after a period of robotic inactivity, and for annual recertification.

A recent medical malpractice case highlights the importance of having guidelines in place to protect patients. In Bremerton, Washington, in 2008,1 a urologist performed his first nonproctored robotic prostatectomy. The challenging and difficult procedure took more than 13 hours; he converted to an open procedure after 7 hours. The patient developed significant postoperative complications and died.1

In the litigation that followed, the surgeon was sued for negligence and for failing to disclose that this was his first solo robot-assisted surgery. The surgeon settled, as did the hospital, which was sued for not supervising the surgeon and failing to ensure that he could use the robot safely. The family also sued Intuitive Surgical, the manufacturer of the da Vinci Robot, for failing to provide adequate training to the surgeon.²

The jury ruled in favor of the manufacturer, stating that the verification of adequate surgeon training was the responsibility of the hospital and specialty medical societies, not the industry.

References

A word to the wise
If hospital departments really want to ensure that they are doing all that they can to make robotic surgeries safe for their patients, they will utilize the recent guidelines approved by AAGL. In order for these guidelines to work, hospital systems need to commit re­sources for medical staff oversight, inclu­ding a robotics peer-review committee with a physician chairman and adequate medical staff support to monitor physicians and manage those who cannot meet these goals.

There clearly will be push-back from surgeons who feel that it is unfair to restrict their ability to perform surgery just because their volumes are low or they can’t master the simulation exercises. However, in the final analysis, would we want the airlines to employ pilots who fly only a couple of times a year or who can’t master the required simulation skills to safely operate a commercial passenger jet?

The important question is, what is our focus? Is it to be “fair” to all surgeons, or is it to provide the best and safest outcomes for our patients? As surgeons, we each need to remember the oath we took when we became physicians to “First, do no harm.” By following these new AAGL robotic surgery ­guidelines, we will reassure our patients that we, as physicians, do take that oath seriously.

INSTANT POLL
For credentialing and privileging of robotic gynecologic surgery, do you agree that the following points are essential components of the process?

1. Surgeons should be selected for training who are most likely to be successful in performing robotic surgeries safely and efficiently.
2. There should be a minimum number of procedures performed on a regular basis to ensure that the surgeon maintains his or her psychomotor (hand-eye coordination) skills.
3. Surgeons, like pilots, should be required to demonstrate their competency in operating the robot on a regular basis.

Answer:
a. Yes, I agree.
b. No, I believe this approach is too restrictive.
c. No, I believe this approach is not restrictive enough.

To vote, please visit obgmanagement.com and look for “Quick Poll” on the right side of the homepage.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

CASE: Preterm labor in an older woman
G.S. is a 41-year-old G1P0 with a several-year history of infertility and a medical history of chronic hypertension. She undergoes in vitro fertilization (IVF) using her own oocytes, with transfer of two embryos. Early ultrasonography (US) confirms a diamniotic/dichorionic twin gestation. She undergoes chorionic villus sampling (CVS) during the first trimester, with normal fetal karyotypes noted.

For her chronic hypertension, the patient is treated with oral labetalol 200 mg twice daily, beginning in the first trimester. Results of a baseline comprehensive metabolic profile and complete blood count, and electrocardiogram are normal. Baseline 24-hour urine study results reveal no significant proteinuria and a normal creatinine clearance.

At 18 weeks’ gestation, US results show normal growth and amniotic fluid volume for each fetus, with no anomalies detected. Because of a gradual increase in the patient’s blood pressure, her labetalol dose is increased to 400 mg orally thrice daily. Her urine protein output remains negative on dipstick, and US every 4 weeks until 28 weeks’ gestation continues to show normal fetal growth and amniotic fluid volume.

At 33 weeks’ gestation, the patient presents with regular uterine activity. Nonstress tests for both fetuses are reactive. She is given a 1-L intravenous (IV) fluid bolus of lactated Ringers solution, as well as subcutaneous terbutaline sulfate every 15 minutes for four doses, without resolution of the uterine contractions. Her pulse has increased to 120 bpm.

How do you manage this patient’s care?

Nine times as many women aged 35 and older gave birth to their first child in 2012 than did women of the same age 40 years ago, according to the most recent data from the National Center for Health Statistics.¹ The rate of first births for women aged 40 to 44 remained ­essentially stable during the 1970s and early 1980s but increased more than fourfold from 1985 through 2012—from 0.5 to 2.3 per 1,000 women.¹ Clearly, more women are delaying childbearing to a later age by personal choice for reasons such as completion of education and career advancement.²

The path to late motherhood is not without thorns, however. Heightened risks associated with increasing maternal age include:

• fetal aneuploidy
• fetal malformation
• gestational diabetes
• chronic and gestational hypertension
• antepartum hemorrhage
• placenta previa
• prelabor rupture of membranes
• preterm labor.^3,4

Women with advanced age at conception also are more likely to have a multifetal gestation because of the need for assisted reproduction and are more likely to require cesarean delivery⁵ as a result of abnormal placentation, fetal malpresentation, an abnormal pattern of labor, or increased use of oxytocin in labor. In addition, they are more likely to experience rupture of the sphincter, postpartum hemorrhage, and thromboembolism.³ Advanced maternal age also is associated with a higher risk of stillbirth throughout gestation, with the peak risk period reported to occur at 37 to 41 weeks.⁶

Maternal age-related risks of autosomal trisomies (especially Down syndrome) are well understood and have been quantified for singleton and twin gestations. TABLE 1 shows the risks at term for singleton and twin gestations for at least one chromosomally abnormal fetus by maternal age (40–46 years) and race.⁷

Preconception considerations
Aging and fertility
These combined result of  aging of the ovary and uterus and an escalating risk of underlying medical comorbidities has a detrimental effect on fertility.⁸ Although assisted reproductive technologies are helpful, they cannot guarantee a live birth or completely compensate for an age-related decline in fertility.⁹

Many IVF programs refuse infertility treatment to women over age 43 or 44 who want to use their own oocytes. The reason: low pregnancy rates. The use of donor oocytes, however, increases the risks of gestational hypertension and preeclampsia. And if assisted reproductive technologies are needed, the risk for multifetal pregnancy increases.

Women of advanced maternal age are likely to have an older spouse or partner. There is no clearly accepted definition of advanced paternal age, but it is most often defined as an age of 40 years or older at the time of conception. Advanced paternal age has been associated with a higher risk for autism spectrum disorder and schizophrenia, as well as mutations in the FGFR2 and FGFR3 genes that result in skeletal dysplasias and craniosynostosis syndromes.¹⁰

Medical conditions are more common
Women of advanced maternal age have an increased rate of such prepregnancy chronic medical complications as diabetes, chronic hypertension, obesity, and renal and cardiac disease. Therefore, it is best to optimize control of these chronic illnesses prior to conception to minimize the risks of miscarriage, fetal anomalies, and gestational hypertension and preeclampsia.

Preeclampsia. Although daily low-dose (60–81 mg) aspirin has been used to reduce the risk of preeclampsia, current recommendations from the American College of Obstetricians and Gynecologists (ACOG) suggest that this therapy be reserved for women with a medical history of early-onset preeclampsia or those who have had preeclampsia in more than one pregnancy.¹¹

Impact of obesity. We recently examined the influence of age and obesity on ­pregnancy outcomes of nulliparous women aged 40 or older at delivery.¹² The study included women aged 20 to 29 years (n = 52,249) and 40 or older (n = 1,231) who delivered singleton infants. Women who reported medical disorders, tobacco use, or conception with assisted reproductive technology were excluded.

In the older age group (≥40 years), obese women had significantly higher rates of cesarean delivery, gestational hypertension, preeclampsia, gestational diabetes, preterm delivery before 37 weeks’ gestation, and preterm delivery before 28 weeks, and their infants had higher rates of admission to the neonatal intensive care unit (NICU), compared with nonobese women (FIGURE).

It would appear, however, that healthy, obese women who delay pregnancy until the age of 40 or later may modify their risk for cesarean delivery, gestational diabetes mellitus, and gestational hypertension and preeclampsia by reducing their body mass index to nonobese levels prior to conception.

In addition to maternal risks for women of advanced maternal age, there are risks to the fetus and neonate, as well as a risk of placental abnormalities. These risks are summarized in TABLE 2.

 Placental

 Fetal/neonatal

Folic acid supplementation can reduce some risks
The potential benefit of folic acid supplementation to reduce the risk of fetal open neural tube defects is well documented. More recent data suggest that folic acid also is associated with a reduction in the risks of congenital heart defects, abdominal wall defects, cleft lip and palate, and spontaneous abortion. ­Supplementation should be initiated at least 3 months prior to conception and continued through the first trimester.

The first trimester
Early pregnancy loss is a risk
Women of advanced maternal age are more likely than younger women to experience early pregnancy loss. This risk is due to higher rates of fetal aneuploidy as well as declining ovarian and uterine function and a higher rate of ectopic pregnancy.

In the First and Second Trimester Evaluation of Risk (FASTER) trial, in which investigators reported pregnancy outcomes by maternal age for 36,056 pregnancies, the rate of spontaneous abortion after 10 weeks of gestation was 0.8% among women younger than 35 years, compared with 2.2% for women aged 40 or older.⁴

The likelihood of multiple gestation increases
The background risk of multiple births is higher in women of advanced maternal age, compared with younger women. This risk increases further with fertility treatment.

Multiple gestations at any age are associated with increased risks for preterm birth and very-low–birthweight infants. Potential maternal risks are listed in TABLE 3.

To reduce the number of multiple gestations with assisted reproduction, consider elective single embryo transfer, especially if the mother has significant underlying medical complications.

Multiple gestations present difficult management issues in older women. Strategies shown to prevent preterm delivery in singleton gestations, including weekly 17-hydroxyprogesterone injections and cervical cerclage, are not effective in multiple gestations. Moreover, many of these therapies—including bed rest—increase the risk of thromboembolic events in multiple gestations, particularly when the mother is of advanced age.

Maternal adaptations in multiple gestations also may be poorly tolerated by older patients, particularly cardiac changes that markedly increase stroke volume, heart rate, cardiac output, and plasma volume.

The range of genetic screening and testing options has broadened
Options include first-trimester CVS, which provides information about the fetal chromosomal complement but not the presence of a fetal open neural tube defect. The procedure-­related rate of fetal loss with CVS is quoted as 1%.

Options for genetic testing in the second trimester include transabdominal amniocentesis. A procedure-related fetal loss rate of 1 in 500 to 1 in 1,600 is quoted for midtrimester amniocentesis.

A relatively new screening option is analysis of cell-free fetal DNA in maternal blood, which can be performed after 10 weeks’ gestation in singleton and multiple gestations. This directed analysis measures the relative proportions of chromosomes. The detection rate for fetal Down syndrome using cell-free fetal DNA is greater than 98%, with a false-positive rate of less than 0.5%. However, this screening is unreliable in triplet gestations.

Other screening options include US and biochemical screening to detect fetal aneuploidy and open neural tube defects during the second trimester. These options should be included in counseling of the patient.

Second and third trimesters
Gestational hypertension and preeclampsia are significant risks
Older pregnant women have an incidence of gestational hypertension and preeclampsia 2 to 4 times as high as that of patients younger than 30 years.¹³ The underlying risk for preeclampsia is further increased if coexisting medical disorders such as diabetes or chronic hypertension are present. Moreover, the risk for preeclampsia increases to 10% to 20% in twin gestations and 25% to 60% in triplet gestations. Le Ray and colleagues reported that, if oocyte donation is used with IVF in women older than age 43, the risk for preeclampsia triples.¹⁴

We previously studied 379 women aged 35 and older who had mild gestational hypertension remote from term, comparing them with their younger adult counterparts in a matched cohort design.¹⁵ Outpatient management produced similar maternal outcomes in both groups, but older women had a statistically insignificant increase in the rate of stillbirth (5 vs 0; P = .063).¹⁵

Gestational diabetes risk doubles
The rates of both diabetes mellitus and gestational diabetes increase with advanced maternal age. Data from the FASTER consortium included an adjusted odds ratio of 2.4 for gestational diabetes in women aged 40 or older, compared with a younger control group.⁴ This increased risk may be a consequence of greater maternal habitus as well as declining insulin sensitivity.

Diabetes increases the risks of macrosomia, cesarean birth, and gestational hypertension. Among women with pregestational diabetes, the risks of congenital heart disease and fetal neural tube defects increase threefold. Because of this increased risk, perinatal screening is indicated for both anomalies in older women.

Pulmonary complications increase
Another risk facing women of advanced maternal age—particularly those carrying a multiple gestation—is pulmonary edema, owing to the increased cardiac output, heart rate, and blood volume, the decreased systemic vascular resistance, and the physiologic anemia of pregnancy. These risks rise further in women who develop preterm labor that requires therapy and in those who develop gestational hypertension and/or preeclampsia. Judicious use of IV fluids, particularly those with lower sodium concentrations, can reduce the risk of pulmonary complications.

Women who develop pulmonary edema have an increased risk of peripartum cardiomyopathy.¹⁶

Preterm delivery is more common
Cleary-Goodman and colleagues noted an increased incidence of preterm delivery in women aged 40 and older, compared with women younger than age 35, but no increase in spontaneous preterm labor.⁴ Advanced maternal age appears to be associated with an increased risk of preterm birth largely as a consequence of underlying complications of fetal growth restriction and maternal disease, including hypertension. Because preterm birth is an important contributor to perinatal morbidity and mortality, steroids should be administered for fetal lung maturity whenever preterm labor is diagnosed before 34 weeks’ gestation.

Risk of placenta previa is 1.1%
Joseph and colleagues found the risk of placenta previa to be 1.1% in women aged 40 and older, compared with 0.3% in women aged 25 to 29 years.¹⁷ This increased risk likely is a consequence not only of maternal age but increased parity and a history of prior uterine surgery. If transabdominal US results are suspicious for placenta previa, transvaginal US is indicated for confirmation. Additional US assessment of the cord insertion site to the placenta also should be performed to rule out vasa previa.

Look for neonatal complications
Ziadeh and colleagues found that, although maternal morbidity was increased in older women, the overall neonatal outcome did not appear to be affected.¹⁸ However, we noted a higher rate of neonatal complications in women aged 40 or older, including higher NICU admission rates and more low-birth–weight infants.¹¹

In addition, Odibo and colleagues found advanced maternal age to be an independent risk factor for intrauterine growth restriction (IUGR).¹⁹ In that study, the odds ratio for IUGR was 3.2 (95% confidence interval [CI], 1.9–5.4) for a maternal age of 40 years or older, compared with a control group. For that reason, they recommend routine screening for IUGR in all pregnant women of advanced age.

Stillbirth risk peaks at 37 to 41 weeks
In a review of more than 5.4 million singleton pregnancies without reported congenital anomalies, Reddy and colleagues found an association between advanced maternal age and stillbirth, with a higher risk of stillbirth at 37 to 41 weeks’ gestation.⁶ This effect of maternal age persisted despite adjusting for medical disease, parity, and race/ethnicity.

Many women older than age 40 have independent medical or fetal indications for antenatal testing. Some experts have suggested antepartum surveillance starting at 37 weeks for women of advanced maternal age; they argue that the risk of stillbirth at this gestational age is similar in frequency to other high-risk conditions for which testing is performed routinely. However, the National Institute of Child Health and Human Development (NICHD) workshop on antepartum fetal monitoring found insufficient evidence that antenatal testing for the sole indication of advanced maternal age reduces stillbirth or improves perinatal outcomes.²⁰

If increased antenatal testing is indicated for a high-risk condition or electively chosen given advanced age, it should include electronic fetal monitoring as well as amniotic fluid volume assessment. Because the risk of fetal loss sharply increased at 40 weeks’ gestation in the study by Reddy and colleagues,⁶ women older than age 40 should be considered for delivery by 40 weeks’ gestation in the presence of good dating criteria.

Some clinicians also would consider delivery by 39 weeks’ gestation with good dating criteria if the Bishop score is favorable.

Risks of labor and delivery
Multiple variables contribute to a higher cesarean delivery rate
The risk of cesarean delivery increases with advancing maternal age.^5,11 This increased risk is a consequence of multiple variables, including the rate of previous cesarean delivery, malpresentation, underlying complications such as preeclampsia and diabetes, and a higher prevalence of dysfunctional labor.²¹ Further, Vaughn and colleagues noted that the cesarean delivery rate increases in direct proportion to age, with a rate of 54.4% in women older than age 40.⁵

As Cohen pointed out in a commentary accompanying a study of dysfunctional labor in women of advancing age, “the notion of a premium baby (ie, that the fetus of a woman with a reduced likelihood of having another pregnancy is somehow more deserving of being spared the rigours of labour than the fetus of a young woman) may play a role” in the high rate of cesarean delivery.^21,22

Postpartum hemorrhage risk may be lower in older women
Advanced maternal age is assumed to be a risk factor for postpartum hemorrhage.²³ The increased risk was thought to be related to the increased incidence of multiple underlying factors, such as cesarean delivery, multiple gestation, and hypertensive disorders of pregnancy.

However, in a retrospective cohort study, Lao and colleagues found that advanced maternal age (≥35 years) served only as a surrogate factor for postpartum hemorrhage due to associated risk factors, obstetric complications, and interventions.²⁴ After multivariate analysis, aging was associated with a decreased rate of postpartum hemorrhage, which declined progressively from ages 25 to 40 years and older, compared with women aged 20 to 24.²⁴

Nevertheless, medical interventions should be readily available at the time of delivery for treatment of uterine atony, especially with multiple gestation and grand multiparity.

Case: Resolved
The patient is admitted to the hospital, where she is given IV magnesium sulfate (6-g load followed by an infusion of 3 g/hr) and betamethasone for fetal lung maturity enhancement. She continues to receive IV fluids as well (125 mL/hr lactated Ringers solution). Uterine activity abates.

IV magnesium sulfate is continued for 36 hours, but urine protein output is not monitored. Her heart rate ranges from 105 to 115 bpm, and blood pressure from 130/80 mm Hg to 138/88 mm Hg. Forty-eight hours after admission, she reports a gradual onset of tightness of the chest and breathlessness. She is agitated, with a pulse of 130 bpm, 30 respirations/min, and room air pulse oximetry of 90%. Rales are noted upon ­auscultation of both lungs. A radiograph of the chest demonstrates bilateral air-space disease consistent with pulmonary edema. IV furosemide and oxygen (by mask) are provided, with some respiratory improvement.

The patient then reports leakage of amniotic fluid, and preterm rupture of membranes is confirmed on examination. Because steroids for fetal lung maturity have been administered, and given improvement in her pulmonary edema and a footling breech presentation for Twin A, cesarean delivery is performed.

The patient’s immediate postoperative course is uncomplicated. On postoperative day 2, however, she develops recurrent pulmonary edema, as confirmed by physical examination and chest radiograph. She also reports headache, and her blood pressure rises to 164/114 mm Hg—findings consistent with postpartum preeclampsia. Magnesium sulfate and antihypertensive therapy are initiated, along with IV furosemide and oxygen, which improves her respiratory status.

An echocardiogram to rule out peripartum dilated cardiomyopathy finds no evidence of a dilated left ventricle, and the calculated left ventricular ejection fraction (55%) is normal.

After diuresis and improvement in her blood pressure, she is discharged home. By the time of her follow-up office visit 7 days later, her blood pressure has normalized on labetalol therapy.

For an overview of evaluation and management of pregnant women aged 40 or older, see TABLE 4.

Preconception

 First trimester

Second trimester

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

CASE: Preterm labor in an older woman
G.S. is a 41-year-old G1P0 with a several-year history of infertility and a medical history of chronic hypertension. She undergoes in vitro fertilization (IVF) using her own oocytes, with transfer of two embryos. Early ultrasonography (US) confirms a diamniotic/dichorionic twin gestation. She undergoes chorionic villus sampling (CVS) during the first trimester, with normal fetal karyotypes noted.

For her chronic hypertension, the patient is treated with oral labetalol 200 mg twice daily, beginning in the first trimester. Results of a baseline comprehensive metabolic profile and complete blood count, and electrocardiogram are normal. Baseline 24-hour urine study results reveal no significant proteinuria and a normal creatinine clearance.

At 18 weeks’ gestation, US results show normal growth and amniotic fluid volume for each fetus, with no anomalies detected. Because of a gradual increase in the patient’s blood pressure, her labetalol dose is increased to 400 mg orally thrice daily. Her urine protein output remains negative on dipstick, and US every 4 weeks until 28 weeks’ gestation continues to show normal fetal growth and amniotic fluid volume.

At 33 weeks’ gestation, the patient presents with regular uterine activity. Nonstress tests for both fetuses are reactive. She is given a 1-L intravenous (IV) fluid bolus of lactated Ringers solution, as well as subcutaneous terbutaline sulfate every 15 minutes for four doses, without resolution of the uterine contractions. Her pulse has increased to 120 bpm.

How do you manage this patient’s care?

Nine times as many women aged 35 and older gave birth to their first child in 2012 than did women of the same age 40 years ago, according to the most recent data from the National Center for Health Statistics.¹ The rate of first births for women aged 40 to 44 remained ­essentially stable during the 1970s and early 1980s but increased more than fourfold from 1985 through 2012—from 0.5 to 2.3 per 1,000 women.¹ Clearly, more women are delaying childbearing to a later age by personal choice for reasons such as completion of education and career advancement.²

The path to late motherhood is not without thorns, however. Heightened risks associated with increasing maternal age include:

• fetal aneuploidy
• fetal malformation
• gestational diabetes
• chronic and gestational hypertension
• antepartum hemorrhage
• placenta previa
• prelabor rupture of membranes
• preterm labor.^3,4

Women with advanced age at conception also are more likely to have a multifetal gestation because of the need for assisted reproduction and are more likely to require cesarean delivery⁵ as a result of abnormal placentation, fetal malpresentation, an abnormal pattern of labor, or increased use of oxytocin in labor. In addition, they are more likely to experience rupture of the sphincter, postpartum hemorrhage, and thromboembolism.³ Advanced maternal age also is associated with a higher risk of stillbirth throughout gestation, with the peak risk period reported to occur at 37 to 41 weeks.⁶

Maternal age-related risks of autosomal trisomies (especially Down syndrome) are well understood and have been quantified for singleton and twin gestations. TABLE 1 shows the risks at term for singleton and twin gestations for at least one chromosomally abnormal fetus by maternal age (40–46 years) and race.⁷

Preconception considerations
Aging and fertility
These combined result of  aging of the ovary and uterus and an escalating risk of underlying medical comorbidities has a detrimental effect on fertility.⁸ Although assisted reproductive technologies are helpful, they cannot guarantee a live birth or completely compensate for an age-related decline in fertility.⁹

Many IVF programs refuse infertility treatment to women over age 43 or 44 who want to use their own oocytes. The reason: low pregnancy rates. The use of donor oocytes, however, increases the risks of gestational hypertension and preeclampsia. And if assisted reproductive technologies are needed, the risk for multifetal pregnancy increases.

Women of advanced maternal age are likely to have an older spouse or partner. There is no clearly accepted definition of advanced paternal age, but it is most often defined as an age of 40 years or older at the time of conception. Advanced paternal age has been associated with a higher risk for autism spectrum disorder and schizophrenia, as well as mutations in the FGFR2 and FGFR3 genes that result in skeletal dysplasias and craniosynostosis syndromes.¹⁰

Medical conditions are more common
Women of advanced maternal age have an increased rate of such prepregnancy chronic medical complications as diabetes, chronic hypertension, obesity, and renal and cardiac disease. Therefore, it is best to optimize control of these chronic illnesses prior to conception to minimize the risks of miscarriage, fetal anomalies, and gestational hypertension and preeclampsia.

Preeclampsia. Although daily low-dose (60–81 mg) aspirin has been used to reduce the risk of preeclampsia, current recommendations from the American College of Obstetricians and Gynecologists (ACOG) suggest that this therapy be reserved for women with a medical history of early-onset preeclampsia or those who have had preeclampsia in more than one pregnancy.¹¹

Impact of obesity. We recently examined the influence of age and obesity on ­pregnancy outcomes of nulliparous women aged 40 or older at delivery.¹² The study included women aged 20 to 29 years (n = 52,249) and 40 or older (n = 1,231) who delivered singleton infants. Women who reported medical disorders, tobacco use, or conception with assisted reproductive technology were excluded.

In the older age group (≥40 years), obese women had significantly higher rates of cesarean delivery, gestational hypertension, preeclampsia, gestational diabetes, preterm delivery before 37 weeks’ gestation, and preterm delivery before 28 weeks, and their infants had higher rates of admission to the neonatal intensive care unit (NICU), compared with nonobese women (FIGURE).

It would appear, however, that healthy, obese women who delay pregnancy until the age of 40 or later may modify their risk for cesarean delivery, gestational diabetes mellitus, and gestational hypertension and preeclampsia by reducing their body mass index to nonobese levels prior to conception.

In addition to maternal risks for women of advanced maternal age, there are risks to the fetus and neonate, as well as a risk of placental abnormalities. These risks are summarized in TABLE 2.

 Placental