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Emerging trends and practical issues: a roundtable discussion among obstetrician/gynecologists in private practice.

KEY POINTS AND RECOMMENDATIONS

* Patients experience a high level of comfort and satisfaction when procedures are done in the familiar surroundings of their physicians' offices instead of a hospital or ambulatory surgery center.

* Very few changes in personnel, office setup, or equipment are needed to successfully incorporate in-office procedures into an established physician's office.

* Practice profitability is likely to be enhanced by adding in-office procedures because of higher reimbursement and improved time management.

* Hysteroscopic sterilization, diagnostic hysteroscopy, and some endometrial ablation techniques are ideally suited to be performed in most physicians' offices.

Clinicians face challenges in their efforts to provide new services that improve patient outcomes and satisfaction. They also strive to create more efficient business models and generate new revenue streams. Some strategies include:

* Adopting office-based procedures that effectively utilize existing equipment and personnel

* Adding procedures amenable to the office setting

* Evaluating potential costs/benefits of equipment needed to perform new procedures

* Branching out to provide nontraditional services, such as cosmetic procedures In this panel discussion, 3 obstetrician/gynecologists in single-specialty, private practice groups describe how they have maintained excellent patient outcomes, extended the offerings within their practices, and enhanced revenues.

Dr Soll: The majority of ob/gyns today practice, as I do, in single-specialty group practices. A 2003 ACOG survey noted that this percentage is increasing, from 40.3% in 1991 to 45.2% in 2003. (1) Our group is probably typical. It includes 7 physicians and 2 nurse practitioners. We offer full-spectrum service, including standard gynecologic procedures, such as loop electrosurgical excision procedure (LEEP) and colposcopy. Occasionally, we perform dilation and curettage (D&C) for miscarriage. We also insert intrauterine devices. We have recently added hysteroscopic procedures, specifically, endometrial ablations and permanent sterilization. We are fortunate because our offices are situated 2 blocks from the hospital with which we are affiliated, which makes performing ambulatory in-hospital procedures relatively convenient for us and for our patients. About 2 years ago, we added cosmetic procedures.

Dr Tidwell: We have a single-specialty, stand-alone practice with 5 physicians and 5 certified nurse midwives. We, too, perform basic procedures. We have added dual energy X-ray absorptiometry (DEXA) bone mineral density testing and operative hysteroscopy, including removal of uterine polyps and permanent sterilization. Additionally, we have added cryoablation and uterine balloon therapy for abnormal uterine bleeding. Our biggest addition was a spa that offered cosmetic laser and other procedures.

Dr Snyder: Our setting includes 3 physicians and 1 nurse practitioner. We have offerings similar to the other participants: We introduced hysteroscopy in February 2003 in order to provide hysteroscopic sterilization (Essure [R]) for our patients. As we saw its utility, we performed diagnostic hysteroscopy more frequently. Simple diagnostic hysteroscopy is underused by ob/gyns. Reports in the medical literature have suggested that increased use of this technique could prevent more invasive and less useful procedures. Although nearly all urologists evaluate bladder pathology using office cystoscopy, fewer than 20% of gynecologists assess intrauterine pathology by hysteroscopy. Reasons for this may include a perception that few patients would benefit from the procedure, equipment costs, reimbursement issues, and lack of comfort with performing the procedure. (2) We added endometrial cryoablation in early 2006.

Diagnostic procedures

Dr Snyder: Diagnostic procedures--specifically DEXA and ultrasonography--provide patient convenience and also enhance revenue for the practice. Patients appreciate having these tests performed in a familiar setting by staff members they know, and it's more convenient for us. We also have immediate access to films and reports.

Although reimbursement for DEXA is at risk, it remains cost effective for us to offer this service. We partner with a large primary care practice in our building: Those clinicians refer their patients to us for scanning and reimburse us on a "per click" basis, so that we, in effect, receive a rental fee on our equipment and personnel. Certainly, volume has been important for this to become an attractive source of revenue. We perform about 8 DEXA scans each week.

Dr Tidwell: We perform approximately 7 to 10 DEXA procedures a week. You raise an important point: If we didn't perform these procedures, our patients would have to visit other providers, who would receive that revenue. These offerings--and their revenue models--differ from procedures such as endometrial ablations, for which the provider will receive revenue (although perhaps in differing amounts) regardless of whether the intervention is performed in the office or in the hospital.

Dr Soll: We offer ultrasonography and DEXA in our office. Ultrasonography is extremely important for us and our patients, not only for the revenue but because of instant access to the information. Ultrasonography has additional importance: it produces an independent revenue stream, but it also has an essential component of some endometrial ablation technologies.

Other modalities, in addition to office hysteroscopy, provide assistance in diagnostic evaluation of patients. We also provide saline infusion ultrasonography to evaluate uterine and endometrial abnormalities. Patients like the rapid availability of ultrasonography in both gynecologic and obstetric applications. The use of DEXA scans also has been a helpful adjunct to our practice. I believe that making this test available to the patient helps patient compliance with interventions that may be recommended, based on test results.

Cosmetic procedures

Dr Soll: We have also added nontraditional procedures for skin treatments and hair removal. These additions have not been as successful as we initially predicted. Unfortunately, we, as gynecologists, have not been able to market effectively outside of our practice to give more women in our community an opportunity to utilize these services. We also did not anticipate the rapid growth of laser centers in our geographic area. If obstetrician/gynecologists are considering the addition of these services, I believe it would be beneficial to have a physician in the practice who champions this activity or else recruit an aesthetician to drive the service.

Dr Snyder: We don't offer these procedures but, like many practitioners, we are evaluating whether they fit in with our practice; they are not a part of our core competencies, but getting the additional training is something I am considering. It is, as you note, difficult to evaluate the potential impact of such procedures on a practice.

Dr Tidwell: We added these procedures, creating an adjacent 1000-square-foot office space with a separate entrance and spa environment.

We felt that our skill sets did not differ significantly from those of plastic surgeons for these noninvasive procedures, since training for the newest laser technologies was not available for any residency program when most of us finished our training.

Still, in 16 months of operation, we've seen profits only in the past 4 months. Our high overhead, in part, stems from our decision to purchase several very high-quality lasers. We felt this was essential to ensure good outcomes for our patients, with whom we have ongoing, long-term relationships. When we tell a patient that we can remove sun damage, wrinkles, or unwanted hair, we must back up our claims and produce the best results possible.

We have faced challenges in hiring people with expertise in these fields and in determining who in the office will be responsible for this new line of business. Fortunately, one of our physicians retired and manages this part of the business as a sideline. He performs the Botox [R] and laser treatments. When he retires completely, the active physicians in our practice certainly won't have time to add these services to their workload.

These additions have also been challenging for our office managers as we ask them to take on new responsibilities in these areas.

Selection of in-office gynecologic procedures

Dr Soll: Gynecologists as a specialty perform more surgical procedures today--in the hospital and office settings--than in years past. In 1994, 88.69% of ob/gyns reported that they performed surgical procedures annually versus 95.54% in 2003.1

We have to ask: How profitable are these procedures in the hospital setting? Gynecologic surgery is reimbursed at a lower relative value unit (RVU) than are many other surgeries: One study reported that the RVU per case ranged from a high of 41.26 for neurosurgery to 15.54 for gynecologic surgeries. Relative hospital margin units per operating room hour ranged from a high of 1435.18 per case for transplant surgery to 25.81 for gynecologic procedures. (3)

If the physician is competent in the procedures offered in the hospital, including hysteroscopic tubals or ablations, then these procedures can be performed safely in the office. There, the physician will receive the facility fee in addition to the professional component. This is an advantage for all 3 parties: the patient, the physician, and the insurer.

Reimbursement is only one part of the picture: One must be aware that it is more efficient to perform procedures in the office. In the hospital, you have to redo the history and physical, follow hospital guidelines, produce discharge summaries, allow for travel time, etc.

Dr Tidwell: Time management is important. Today, for example, I performed an ablation procedure in the middle of my afternoon appointments. If I had scheduled it in the hospital, it would have been less efficient.

Dr Soll: Selection of an in-office versus an in-hospital procedure is also about convenience for the patient. For a hospital procedure, the patient has to arrive much earlier and remain in the hospital longer. For in-office procedures, the patient is usually on the way home within an hour of the procedure's completion.

Dr Snyder: Pain management also is a critical issue in our process of selecting appropriate procedures: One that is truly appropriate for the office requires a minimal need for pain management. Some procedures that are marketed as "in office" are actually procedures that can be performed in an office setting but are more appropriate for a hospital environment.

Office-based gynecologic procedures: what works

Hysteroscopic sterilization

Dr Soll: Many office procedures stem from technical developments, such as improvements in optics and continuous flow hysteroscopes. Office-based hysteroscopy is very rewarding for the patient and physician alike. Hysteroscopy in the office under appropriate sterile techniques and local anesthetics can give direct feedback to a patient. As a physician, I can evaluate problems such as abnormal bleeding while the patient is awake and let her know--that day--what her problem may be. Still, many clinicians seem to perform hysteroscopy only as a result of their interest in performing hysteroscopic sterilization, a procedure very well suited to the office setting because it does not require incisions or access to the peritoneal cavity. It can be done under local anesthesia.

Clinicians who are uncomfortable about performing in-office procedures often begin with hysteroscopic sterilization and then quickly incorporate other procedures into their service offerings.

A helpful introduction to office procedures is to perform a given procedure in the ambulatory surgery center under local anesthesia. This helps give the provider the confidence that the procedure is safe and tolerable for the patient.

Dr Snyder: As I mentioned earlier, I started performing hysteroscopic sterilization in the office setting in February 2003. It received FDA approval in November of the prior year. I investigated it because it appeared to be a very appropriate procedure for the office setting. I thought it would be a popular procedure and wanted to add it as soon as possible so that I could "stay ahead of the curve" in terms of my offerings to patients. In order to perform this procedure, we purchased hysteroscopic equipment. Previously, I hadn't thought of hysteroscopy as an office-based procedure.

When we considered bringing hysteroscopy into the office, we evaluated our endometrial biopsy volume; we determined that in-office hysteroscopy would be an appropriate adjunct to biopsy in about a third of patients undergoing endometrial biopsy.

The addition of hysteroscopic sterilization is particularly important, given the limitations of tubal ligation. (4) All methods (bipolar, unipolar, Falope ring, clips, interval and postpartum salpingectomy) have shown a significant probability of failure, complications, or a need for unintended major surgery. (5) However, the safety of hysteroscopic sterilization is well established. (6-8)

Dr Tidwell: Hysteroscopic sterilization has changed the way we manage our patients. Since we introduced it in our practice 2 years ago, I have not performed any laparoscopic tubal sterilizations.

Dr Snyder: I have done very few postpartum tubals since we began using hysteroscopic sterilization; it's very difficult to advocate tubal procedures in which the patient experiences considerable discomfort and the risks associated with what is, in fact, a minilaparotomy. Patients also like the fact that this form of contraception does not contain hormones.

The procedure can be performed with only a paracervical block. I have never had a patient ask me to stop a hysteroscopic sterilization procedure or endometrial ablation because of pain.

I always tell the patient, "Our contract is that if I do anything that is more uncomfortable than what you wish to tolerate, I will abandon the procedure. You have control over that." It's important that patients feel empowered and they can put the brakes on a procedure it they so desire, or if their discomfort level exceeds their tolerance.

Despite the advantages of the hysteroscopic sterilization, I haven't stopped performing tubal ligations. We have a significant Medicaid population; the state will only reimburse us for the traditional tubal sterilization procedures. Unfortunately, Indiana Medicaid reimbursement for hysteroscopic sterilization is the same whether the procedure is performed in the office or hospital setting and does not cover the cost of the device at this time (to either the hospital or doctor's office). I have been in contact with the state to try to get this changed to improve access to care for that population of patients. Many state Medicaid programs pay quite well for Essure in the office, and the landscape is changing, so doctors need to know their state's position on this. For our privately insured or self-pay patients, however, we perform hysteroscopic sterilization. Dr Soll: I have also had some patients request an in-office hysteroscopic tubal 6 weeks after a cesarean section. If a patient is unsure as to whether they want permanent birth control, waiting 6 weeks or longer is a viable option. Hysteroscopic sterilization has given us another option for safe and effective birth control. Patients don't have to be pressured to make a decision to have permanent birth control out of fear of another major surgery.

Also, some patients have been concerned about the possibility of "posttubal ligation syndrome." This phenomenon is debated and cannot be predicted. Dr Tidwell: We try to individualize treatment for each patient. Most patients want a tubal ligation at the time of their cesarean section; however, a subset of patients who receive a cesarean section also request a hysteroscopic sterilization. They may make this decision either because they are unsure of whether they want a tubal at that time or because the effects of tubal ligation on subsequent menstrual patterns are inconclusive. (4,9)

Endometrial ablation

Dr Snyder: Endometrial ablation represents another viable in-office procedure. All global endometrial ablation techniques are safe and effective. Quite likely, our decisions regarding which technologies we will use depend on our skill level and our comfort with in-office procedures.

Cryoablation

Dr Tidwell: Cryoablation is easily performed in the office. Unlike some other procedures, it does not require manipulation of devices or careful pain management. For these reasons, it is not necessary to "practice" in the OR with the patient under conscious sedation. Safety and efficacy are well established. (10,11) Cryoablation is generally approved for in-office use under current procedural terminology (CPT) code 58356, with an approved Medicare payment of $2,602.

Dr Snyder: This procedure is very comfortable for the patient. I've been performing it in parous women without even the need for a paracervical block. The probe requires minimal cervical dilation and no distension, further lessening the likelihood of pain. In an evaluation of 110 patients treated without intravenous sedation, only 4% reported discomfort during the procedure. (12)

Dr Tidwell: We've performed cryoablation for 2 years with very positive results and have performed hysteroscopic sterilization after cryoablation. I've never had a problem seeing the ostia.

Pain management is minimal; the freezing produces an analgesic effect. I administer nonsteroidal agents and ketorolac (Toradol [R]) plus diazepam (Valium [R]), if needed, and a paracervical block. I use 1% lidocaine without epinephrine. I inject 2 ml at the 12 o'clock position and 5 ml at the 4 o'clock and 8 o'clock positions. I don't use B&O (belladonna/ opium) suppositories.

The procedure has 2 practical disadvantages: it ties up the ultrasonography unit for 40 minutes, which means the unit can't produce additional revenue. And, while I like the procedure, it is not FDA-approved for concomitant use after hysteroscopic sterilization. Because I've placed many such devices, I felt that I should incorporate the uterine balloon technology in case there are safety issues with endometrial ablation following hysteroscopic sterilization.

Uterine balloon technology

Dr Soll: I use uterine balloon technology; it has the longest duration of approved use and the longest follow-up of any available technologies, and it has demonstrated safety and efficacy. (13-17)

In 2005, Medicare created a global payment for endometrial ablation procedures performed in the physician's office: CPT 58553 (hysteroscopy, surgical; with endometrial ablation [any method]) has a 2005 National Medicare Average Payment of $2,390.95. Also, CPT 58353 (endometrial ablation, thermal, without hysteroscopic guidance) has a 2005 National Medicare Average Payment of $1,501.88. Still, some private companies may not reimburse global payment for the single-use silicone balloon catheter and other expenses related to an in-office procedure. (18)

I usually give a patient 48 hours of nonsteroidal anti-inflammatory drugs (NSAIDs) and add an anxiolytic and a narcotic on the morning of the procedure. I ask patients to continue taking medications for the remainder of the day to stay ahead of the pain. After approximately 8 to 10 hours, the postoperative pain management markedly improves.

Dr Snyder: I've done some in-office ablations with the balloon and typically the procedure goes very well, but I do receive calls complaining about pain after the patient gets home, particularly if a patient does not fill her narcotic prescription and prophylactically address potential pain. I have used ketorolac tromethamine 60 mg IM 30 minutes prior to the patient entering the procedure room. It is essential to counsel the patient so that she knows that she has to "stay ahead of the pain curve" after the balloon procedure by using ibuprofen (600 mg q 6 hours) and/or prescribed oral narcotics on a regular schedule the first day.

Dr Tidwell: I have performed several uterine balloon procedures in the office and realized that those patients need more pain medications than do patients who receive cryoablations. In fact, I have recommended that patients who choose the uterine balloon procedure add one B&O suppository 1 hour prior to the procedure.

Dr Soll: Postoperative pain has also presented problems for my patients. Some clinicians do well with a protocol that includes ibuprofen and mefenamic acid, although my patient population tends to have problems with these agents.

Radiofrequency technology

Dr Soll: Even if we have technologies with which we are comfortable, we always have the option of trying something new. I also offer NovaSure [R] ablation as an in-office procedure. It uses radio frequency bipolar energy to produce its effects. Like the other available endometrial ablation systems, it's been shown to be safe and effective. (19,20)

Studies also have shown a high level of satisfaction--90% in one study--among patients treated with the NovaSure system. (21,22)

This procedure is particularly interesting because of its rapid action, which is especially important from a pain-management perspective. In the procedure today, my patient hardly flinched. I called her 4 hours later, and she experienced no postprocedure pain from cramping.

Dr Snyder: After performing many radio frequency ablations under anesthesia, I tried this procedure a few times in the hospital under conditions similar to my office, while contemplating which modality to purchase for the office. I would recommend that radio-frequency ablation first be performed under general anesthesia until the physician is comfortable with the procedure, after which it could be performed in the operating room under conditions that "mimic" an in-office setting. If the procedure is performed successfully under those conditions, it can then be considered for the office.

In some cases, it may be best to perform the procedure only in the hospital with the patient under sedation or anesthesia, especially if they do not tolerate a pelvic exam or endometrial biopsy well, or if their anatomy is not straightforward. The device must be manipulated, so more technical skill is required in using this device compared with some others.

I have not performed radio frequency ablation in the office because we purchased the cryoablation system, and that is all we use for ablation procedures.

Other and future procedures

Dr Snyder: The development of in-office procedures represents a continually evolving field, with many new possibilities. Right now, I am interested in bringing the TVT SECUR [TM] for urinary incontinence into the office setting. I've performed this procedure successfully using local anesthesia at the hospital. There are no exit wounds, which makes it potentially attractive. However, the procedure does require a sterile field, and suction must be available; this procedure therefore poses significant challenges in the office setting--beyond pain control--which I am convinced is adequate with a local anesthetic alone. There is also some question regarding reimbursement, since, at this time, there is no site of service differential as there is with hysteroscopic sterilization and ablation; the cost of the device will not be recovered under the current global reimbursement fee.

Adding procedures: equipment needs

Dr Soll: Clinicians need to be aware that adding in-office procedures often requires the purchase of high-quality equipment. Lower- or medium-quality equipment may meet some needs; for example, I use an older hysteroscopic, single-chip, black-and-white camera, which serves my purpose. Conversely, the ultrasonography units required, for example, to visualize the uterus prior to endometrial ablation must perform at a very high level. Technology with regard to ultrasonography equipment has really improved.

Dr Tidwell: For a clinician who is contemplating adding new procedures, one option is to lease equipment for a specific period of time. Although the cost of the rental will affect your profit, this approach allows clinicians to evaluate their comfort levels with procedures and determine if the patient volume will be sufficient to make purchases cost effective. We leased equipment for about 6 months when we introduced the Essure and HerOption [R] procedures. It may also be cost-effective to purchase refurbished factory-cerified equipment from a trusted supplier.

Space requirements

Dr Snyder: Space planning is also important. We use our ultrasonography suite for cryoablations. Our comfort lies with having the ultrasonography technician with us to view the uterus.

We use our procedures room (where we have always done LEEPs and colposcopies) for our hysteroscopies and hysteroscopic sterilizations. This eliminates some of the scheduling problems, since room turnover and setup is considerable, compared with how we use our standard exam rooms.

Dr Soll: It is important to understand that when a room is blocked off for procedures, it is unavailable for the entire time for setup, procedure, and cleanup. While a procedure may take only 40 minutes, the room may be effectively in use for an hour and a half.

Staff training for in-office procedures

Dr Snyder: Once we bring procedures into the office, all office staff members must understand the basics of the procedures. Patients may ask questions of the receptionist, the office manager, etc, so everyone needs to be able to speak positively about procedures and add to the patient's level of comfort.

Dr Tidwell: The procedure really begins when the patient walks into the office. If, for example, a patient is scheduled for a hysteroscopic sterilization, the entire office staff should be able to describe the procedure and answer basic questions from patients.

These procedures are very service-oriented and the staff needs to accommodate the patients: After all, the patient has made a choice to have the procedure in the office versus the hospital. So our staff understands the importance of making the experience comfortable and making the patient feel special.

Assisting with in-office procedures

Dr Tidwell: These procedures require different skill sets from office personnel, particularly from the individuals who assist with the procedure. The patient is awake, so everything has to go smoothly during the setup and the procedure. The assistant also has to help the patient during the procedure, talking to her and enhancing her comfort level. In my practice, we have 1 assistant, a well-trained registered nurse who works with all of the physicians in our practice, whether procedures are scheduled for the office or hospital. A second assistant is available as a backup.

Dr Snyder: For my in-office procedures, 1 medical assistant assists me. I trained her on the procedures and, as the other physicians in our practice adopted the procedures, she taught their assistants.

Before introducing a new procedure, we go through several practice "dry runs." Unlike Dr Tidwell, whose assistant is accustomed to working in hospital-based procedures, my assistant had to be trained on the use of equipment, so it helps that these are not complicated setups in general. It's also important to develop a routine to handle equipment and sterile supplies. For instance, with the Essure procedure, my assistant will open just one device package and then put on sterile gloves prior to handling the insert and passing it to me. She then repeats the procedure with the second insert when it is needed. I use extra gloves, but I only need 1 helper.

Dr Soll: I have to have 2 assistants. My certified surgical technician (CST) is in charge of equipment sterilization and sterile technique. She also works with me in surgery at the hospital, so we work very well together. Her participation also improves efficiencies.

Pain-management protocols

Dr Snyder: For pre-op medication, my protocols are as follows: For Essure, I have the patient take 800 mg ibuprofen orally 60 to 90 minutes prior to the scheduled start time. I offer--but I don't recommend or encourage--alprazolam (Xanax [R]) 0.5 mg po 60 to 90 minutes prior. If a patient has a stenotic cervix, I have them take misoprostol (Cytotec [R]) 400 mcg the night before to soften the cervix.

For cryoablation, I give ketorolac tromethamine 60 mg IM 30 minutes prior to the scheduled start time.

My paracervical block of choice is 1% lidocaine with epinephrine, and I use a "dental syringe" for repeated aspiration with a 27-gauge needle and 2" needle extender. I never use more than 20 cc in total, and I warn the patient she may feel her heart race with the adrenaline, so that she's not alarmed by these reactions. The patient is also instructed to tell me immediately if she has a metallic taste or ringing in her ears (these are warning signs of toxicity). I place a small amount in the anterior cervix in advance of the tenaculum placement, then deliver 4 to 5 cc each deeply at approximately the 3, 9, 5, and 7 o'clock positions.

Dr Tidwell: For in-office procedures that require pain management, we recommend the following: For hysteroscopic sterilization, 48 hours prior to the procedure, we recommend ibuprofen 600 mg every 8 hours, diazepam 5 mg to 10 mg 1 hour before the procedure. For cryoablation, we recommend the above, plus 30 mg ketorolac IM 1 hour before the procedure. We use the paracervical block previously described.

What should we be prepared for in terms of vasovagal reaction, as this can occur even from a paracervical block?

Dr Soll: Our protocol for both hysteroscopic sterilization and ablations is to give NSAIDs for 48 hours prior to the procedures. Ketorolac is given 30 minutes prior to the procedure. Diazepam, 5 mg to 10 mg, is offered and given based on patient request. Hydrocodone and phenergan are also offered after a procedure. Hysteroscopic sterilization requires very little postoperative pain medication, whereas ablations require more medication.

My local anesthetic paracervical block comprises 20 cc of 1% lidocaine with 1:200,000 epinephrine. I will add mepivacaine (Polocaine [R]), approximately 10 cc, if patients are still uncomfortable. Lidocaine decreases the bleeding associated with the injection. I find it helpful to leave the room after the paracervical block to give the block a chance to set up. I use a 21-gauge, 1-1/2" needle with a 6" needle extender. This gives more control over the injection.

Dr Snyder: I recommend having either atropine or glycopyrrolate, which may have fewer CNS side effects than does atropine. Most patients, however, display mild symptoms, such as dizziness, lightheadedness, and tinnitus and will require only standard supportive care, such as a cool cloth placed on her forehead, and you will need to stop the stimulus until the symptoms improve. However, adverse reactions to local anesthetic agents can include unconsciousness, seizure, arrhythmia, cardiac depression, or asystole if an intravascular local anesthetic is inadvertently given; impeccable technique and avoidance of the more cardiotoxic drugs such as bupivacaine (Marcaine [R]) is recommended, especially for the novice.

For a vasovagal reaction that does not break with supportive care alone, I tape a vial of glycopyrrolate (0.2 mg/mL) to the inside of the cabinet, with a syringe and needle right there in case I need it; 1 cc can then be given IM and repeated in 3 to 5 minutes if needed.

I have an automated BP cuff and oximeter available in case the patient doesn't feel well, and I want to be sure that she's maintaining her vital signs.

For either ablation or hysteroscopic sterilization, an open-sided Graves speculum, tenaculum, sponge forceps, gauze, and Hegar dilators up to 5 mm are useful.

For hysteroscopic fluid management, an under-bottom drape with a pouch is needed, while a 3000cc warm bag of saline delivered via gravity from an IV pole through urology tubing (as opposed to IV tubing) is recommended for distending the uterus. You can scavenge a "disposable" pressure cuff from the hospital for the bag of saline and reuse it as needed to help distend the cavity. I've been using our "disposable" cuff for 4 years!

Dr Soll: We're mentioned that office hysteroscopy is generally considered a clean procedure. After placing a sterile speculum, I prep the vagina and cervix with povidone-iodine (Betadine [R]). I then drape the perineum with sterile towels. The hysteroscope is soaked in Cidex OPA Solution and inserted into the cervix and uterus in a clean, sterile fashion. My assistant is important to me because she keeps the instruments and the Essure catheter tip sterile. We sometimes change gloves many times during the procedure.

Dr Snyder: For both procedures, I prep the upper vagina and cervix with Techni-Care [R] (chloroxylenol USP 3%). I then change to sterile gloves after the prep for Essure and HerOption, and we are careful not to contaminate the devices that will come into contact with the patient. I like using a sterile camera drape, but I don't put drapes or towels around the perineum. These are very clean, but not truly sterile environments. I don't wear a mask or hat.

Reimbursement issues

Dr Snyder: Unfortunately, reimbursement systems differ for various technologies. Cryoablation offers a well-developed system in which the global fee (CPT 58356) is loaded into the payer's computer and has a site-of-service differential, which is desirable when doing procedures in the office. Be sure that site-of-service code 11 (physician's office) is used on the standard 1500 form to obtain the higher reimbursement. I don't have to send in an explanation for what I did or a copy of the procedure note, or bill separately for the device.

Dr Tidwell: Essure, too, has a global fee, total CPT code 58565, and also has a site-of-service differential, so you will get paid more in the office than if it was done in the hospital.

Dr Soll: I find that, because of the lack of payment differentials, it is not cost-effective to do some procedures in the office.

Dr Tidwell. We find a considerable variety among payers. Two will pay for in-office procedures, but the third--and of course it's the biggest--will only reimburse for ThermaChoice [R] in the hospital. We are trying to convince them that it's cheaper in the office.

Dr Soll: Additionally, there is a state-by-state differential office procedure. Tennessee is quite liberal, basing decisions on whether or not the patient is conscious. Providers should understand the processes in their own states before adding procedures.

Dr Snyder: Because many in-office procedures are new or recently adapted to the office, the cost of disposables may not be recovered from some third-party payers without an in-office site-of-service differential being available. It's important to know this; it's essential to determine from the insurance companies what the expected out-of-pocket costs for the patient will be. From these, clinicians should develop a protocol to ensure that the patient is aware of those costs and that payment is arranged in advance or at time of service.

Fortunately, my most prominent payer asks the patient to provide only an office co-pay for Essure or HerOption, which is financially much better for the patient than having an in-hospital procedure done, for which a large surgical deductible has to be met prior to the insurance kicking in.

Dr Soll: When we started looking at office-based procedures, we sent the appropriate codes for the procedures to our top 5 payers to find out what the reimbursement would be. It was reassuring to know--before we got started--that we had reimbursement in place.

Conclusions

Office-based procedures represent an expanding field with new opportunities for ob/gyns, who must combine medical skills with business acumen and practice management. While this represents a new development for the specialty, it is likely that more procedures will migrate to the office setting, providing increased challenges and opportunities.

References

(1.) American College of Obstetricians and Gynecologists. ACOG 2003 economic survey results: profile of ob-gyn practice. Available at:www.acog.org/from_home/departments/practice/ ProfileofOb-gynPractice19912003.pdf. Accessed May 11, 2007.

(2.) Isaacson K. Office hysteroscopy: a valuable but under-utilized technique. Curr Opin Obstet Gynecol. 2002;14:381-385.

(3.) Resnick AS, Corrigan D, Mullen JL. Surgical contribution to hospital bottom line: not all are created equal. Ann Surg. 2005;242:530-539.

(4.) Peterson HB, Xia Z, Hughes JM, et al. The risk of pregnancy after tubal sterilization: findings from the US Collaborative Review of Sterilization. Am J Obstet Gynecol. 1996;174:1161-1170.

(5.) Jamieson DJ, Hillis SD, Duerr A, et al. Complications of interval laparoscopic tubal sterilization: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol. 2000;96:997-1002.

(6.) Valle RF, Cargnan CS, Wright TC for the STOP Prehysterectomy Investigation Group. Tissue response to the STOP microcoil transcervical permanent contraceptive device: results from a prehysterectomy study. Fertil Steril. 2001;76:974-980.

(7.) Kerin JF, Cooper JM, Price T, et al. Hysteroscopic sterilization using a micro-insert device: results of a multicenter phase II study. Hum Reprod. 2003;18:1223-1230.

(8.) Kerin JF, Carignan CS, Cher D. The safety and effectiveness of a new hysteroscopic method for permanent birth control: results of the first Essure pbc clinical study. Aust NZ J Obstet Gynaecol. 2001;41:364-370.

(9.) Harlow BL, Missmer SA, Cramer DW, et al. Does tubal sterilization influence the subsequent risk of menorrhagia or dysmenorrhea? Fertil Steril. 2002;77:754-760.

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David Soll, MD

Donald P. Snyder, MD

Craig Tidwell, MD

* Performing hysteroscopic sterilization

Visibility is improved if the procedure is performed in the early phase of the patient's menstrual cycle. A pregnancy test is performed prior to the procedure. Diagnostic hysteroscopy evaluates the presence of any polyps, fibroids, or other abnormalities that should be removed.

Pretreatment with an anti-inflammatory agent reduces tubal spasm, a possible side effect.

To begin the procedure, the cervix may be dilated to accommodate the diameter of the hysteroscope, which is then introduced through the cervix, and a clear view of both tubal ostia is obtained. The catheter is delivered under hysteroscopic guidance through the operative channel into the proximal portion of the fallopian tube. After the catheter is placed, a micro-insert is deployed into the fallopian tube by manipulating the buttons on the handle of the device. Once the micro-insert is deployed, its outer coil, made from a nickel-titanium alloy, expands to the diameter of the uterotubal junction. The delivery catheter is then removed. This process is repeated for the opposite tube. The micro-insert components promote tissue ingrowth so that, within 12 weeks, total tubal occlusion occurs with localized tissue effects. At 3 months, hysterosalpingography verifies proper placement of the micro-inserts and complete tubal occlusion.

* Performing cryoablation

The patient should be instructed not to void prior to the procedure to improve visualization by ultrasound. The ultrasound image should line up with the cryoprobe; an anteverted or retroverted uterus may need to be straightened with gentle traction on the tenaculum.

Prior to performing the procedure, the size of the cavity can be demonstrated using sounding, hysteroscopy, or saline sonohysterogram.

The device features a cryoprobe and disposable sheath covering. The probe's tip is cooled to temperatures of-80[degrees]C to -100[degrees]C, using a nonflammable, nontoxic, noncorrosive, and environmentally safe gas mixture administered under relatively low pressure.

The low temperatures cause intracellular ice formation and cell death.

Penetration of 9 mm to 12 mm into endometrial tissue destroys the endometrium's blood vessel supply. For safety, treatment duration is limited to a 10-minute cycle.

* Performing thermal balloon endometrial ablation

After hysteroscopy or a saline sonohysterogram confirms appropriate cavity size, a 5-mm catheter is inserted through the cervical canal to the level of the uterine fundus. No additional manipulation or positioning is needed. The balloon is inflated to a pressure of 160 to 180 mm Hg, as small amounts of sterile D5W solution are added gradually. Pressure is allowed to stabilize for 30 to 45 seconds prior to activating the device. Throughout the procedure, uterine pressure, temperature, and treatment time are monitored. When the uterus is distended, an initial warming cycle begins, and pressure is maintained, although it may vary slightly as the uterus relaxes. The fluid temperature is heated to 87 [degrees] C (plus or minus 5 degrees) for 8 minutes. The procedure is discontinued automatically if pressure drops rapidly or reaches 210 mm Hg, or if temperature varies outside of specific parameters. Tissue damage reaches a depth of 1 mm to 3.5 mm from the tubal ostia.

* Performing radio frequency ablation The uterus is evaluated by a saline infusion sonogram or diagnostic hysteroscopy to rule out the presence of large polyps, congenital abnormalities, or submucous fibroids (the type, size, and number will help to determine if this procedure or other procedure is appropriate). The uterine cavity length can be evaluated. The system first insufflates the uterine cavity with carbon dioxide and evaluates the uterine cavity, confirms correct probe placement and the presence of a tight seal, and determines the power level required for that specific uterus.

The bipolar electrode array, consisting of a gold-plated, porous fabric, housed in a 7.2-mm diameter sheath, is inserted into the uterine cavity. The array expands to conform to the size of the uterus. A quick burst of radio frequency (RF) bipolar energy vaporizes endometrial tissue. While the total procedure takes an average of 4 minutes, the active treatment phase requires about 90 seconds. Simultaneously, a moisture transport vacuum system applies suction to enhance contact of the endometrium with the array, compensating for irregular surfaces. This process also removes steam and moisture from the tissue, enhancing controlled levels of vaporization. Debris is evacuated to allow further penetration of the uterine cavity wall. Thus, the device may be used at any point in the menstrual cycle.

Disclosures. Dr Snyder reports that he is a consultant and shareholder in Conceptus. Dr Soil reports that he is a consultant to Conceptus and Ethicon and is on the speakers' bureau for GlaxoSmithKline. Dr Tidwell reports that he is on the speakers' bureau for Conceptus and American Medical Systems.
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Title Annotation:IN-OFFICE PROCEDURES
Author:Soll, David; Snyder, Donald P.; Tidwell, Craig
Publication:OBG Management
Article Type:Discussion
Geographic Code:1USA
Date:Jun 1, 2007
Words:7035
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