Prescription medications

Photo courtesy of the CDC

The UK’s National Institute for Health and Care Excellence (NICE) has issued a final guidance recommending the oral anticoagulant edoxaban tosylate (Lixiana) as an option for preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation (NVAF).

The patients must have one or more risk factors for stroke, including congestive heart failure, hypertension, diabetes, prior stroke or transient ischemic attack, and age of 75 years or older.

In the UK, such patients are generally treated with warfarin or the newer oral anticoagulants dabigatran, rivaroxaban, and apixaban.

NICE decided that edoxaban should be added to that list because data suggest the drug is a clinically and cost-effective treatment option for these patients.

Edoxaban should be available on the National Health Service within 3 months of the date NICE’s final guidance was issued, September 23.

NICE’s guidance says the decision about whether to start treatment with edoxaban should be made after an informed discussion between the clinician and the patient about the risks and benefits of edoxaban compared with warfarin, apixaban, dabigatran, and rivaroxaban.

For patients considering switching from warfarin, edoxaban’s potential benefits should be weighed against its potential risks, taking into account the patient’s level of international normalized ratio control.

Clinical effectiveness

NICE’s conclusion that edoxaban is clinically effective was based primarily on results of the ENGAGE AF-TIMI 48 trial. In this trial, researchers compared edoxaban and warfarin as prophylaxis for stroke or systemic embolism in patients with NVAF.

Results suggested edoxaban was at least non-inferior to warfarin with regard to efficacy, and edoxaban was associated with a significantly lower rate of major and fatal bleeding.

A committee advising NICE also reviewed a meta-analysis prepared by Daiichi Sankyo Co., Ltd., the company developing edoxaban.

The goal of the meta-analysis was to compare edoxaban with rivaroxaban, apixaban, and dabigatran. The analysis included 4 trials: ENGAGE AF-TIMI 48, ARISTOTLE (apixaban), RE-LY (dabigatran), and ROCKET-AF (rivaroxaban). All 4 trials had a warfarin comparator arm.

The results of the meta-analysis indicated that, for the composite endpoint of stroke and systemic embolism, efficacy was similar for high-dose edoxaban and the other new oral anticoagulants.

However, edoxaban significantly reduced major bleeding risk by 24% compared to rivaroxaban, 28% compared to dabigatran at 150 mg, and 17% compared to dabigatran at 110 mg. Major bleeding rates were similar for high-dose edoxaban and apixaban.

The committee advising NICE said these results should be interpreted with caution, but edoxaban is unlikely to be different from rivaroxaban, apixaban, and dabigatran in clinical practice.

Cost-effectiveness

Edoxaban costs £58.80 for a 28-tablet pack (60 mg or 30 mg), and the daily cost of treatment is £2.10 (excluding value-added tax). However, costs may vary in different settings because of negotiated procurement discounts.

The committee advising NICE analyzed cost information and concluded that edoxaban is cost-effective compared with warfarin, but there is insufficient evidence to distinguish between the clinical and cost-effectiveness of edoxaban and the other new oral anticoagulants.

Prescription medications

Photo courtesy of the CDC

The UK’s National Institute for Health and Care Excellence (NICE) has issued a final guidance recommending the oral anticoagulant edoxaban tosylate (Lixiana) as an option for preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation (NVAF).

The patients must have one or more risk factors for stroke, including congestive heart failure, hypertension, diabetes, prior stroke or transient ischemic attack, and age of 75 years or older.

In the UK, such patients are generally treated with warfarin or the newer oral anticoagulants dabigatran, rivaroxaban, and apixaban.

NICE decided that edoxaban should be added to that list because data suggest the drug is a clinically and cost-effective treatment option for these patients.

Edoxaban should be available on the National Health Service within 3 months of the date NICE’s final guidance was issued, September 23.

NICE’s guidance says the decision about whether to start treatment with edoxaban should be made after an informed discussion between the clinician and the patient about the risks and benefits of edoxaban compared with warfarin, apixaban, dabigatran, and rivaroxaban.

For patients considering switching from warfarin, edoxaban’s potential benefits should be weighed against its potential risks, taking into account the patient’s level of international normalized ratio control.

Clinical effectiveness

NICE’s conclusion that edoxaban is clinically effective was based primarily on results of the ENGAGE AF-TIMI 48 trial. In this trial, researchers compared edoxaban and warfarin as prophylaxis for stroke or systemic embolism in patients with NVAF.

Results suggested edoxaban was at least non-inferior to warfarin with regard to efficacy, and edoxaban was associated with a significantly lower rate of major and fatal bleeding.

A committee advising NICE also reviewed a meta-analysis prepared by Daiichi Sankyo Co., Ltd., the company developing edoxaban.

The goal of the meta-analysis was to compare edoxaban with rivaroxaban, apixaban, and dabigatran. The analysis included 4 trials: ENGAGE AF-TIMI 48, ARISTOTLE (apixaban), RE-LY (dabigatran), and ROCKET-AF (rivaroxaban). All 4 trials had a warfarin comparator arm.

The results of the meta-analysis indicated that, for the composite endpoint of stroke and systemic embolism, efficacy was similar for high-dose edoxaban and the other new oral anticoagulants.

However, edoxaban significantly reduced major bleeding risk by 24% compared to rivaroxaban, 28% compared to dabigatran at 150 mg, and 17% compared to dabigatran at 110 mg. Major bleeding rates were similar for high-dose edoxaban and apixaban.

The committee advising NICE said these results should be interpreted with caution, but edoxaban is unlikely to be different from rivaroxaban, apixaban, and dabigatran in clinical practice.

Cost-effectiveness

Edoxaban costs £58.80 for a 28-tablet pack (60 mg or 30 mg), and the daily cost of treatment is £2.10 (excluding value-added tax). However, costs may vary in different settings because of negotiated procurement discounts.

The committee advising NICE analyzed cost information and concluded that edoxaban is cost-effective compared with warfarin, but there is insufficient evidence to distinguish between the clinical and cost-effectiveness of edoxaban and the other new oral anticoagulants.

Prescription medications

Photo courtesy of the CDC

The UK’s National Institute for Health and Care Excellence (NICE) has issued a final guidance recommending the oral anticoagulant edoxaban tosylate (Lixiana) as an option for preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation (NVAF).

The patients must have one or more risk factors for stroke, including congestive heart failure, hypertension, diabetes, prior stroke or transient ischemic attack, and age of 75 years or older.

In the UK, such patients are generally treated with warfarin or the newer oral anticoagulants dabigatran, rivaroxaban, and apixaban.

NICE decided that edoxaban should be added to that list because data suggest the drug is a clinically and cost-effective treatment option for these patients.

Edoxaban should be available on the National Health Service within 3 months of the date NICE’s final guidance was issued, September 23.

NICE’s guidance says the decision about whether to start treatment with edoxaban should be made after an informed discussion between the clinician and the patient about the risks and benefits of edoxaban compared with warfarin, apixaban, dabigatran, and rivaroxaban.

For patients considering switching from warfarin, edoxaban’s potential benefits should be weighed against its potential risks, taking into account the patient’s level of international normalized ratio control.

Clinical effectiveness

NICE’s conclusion that edoxaban is clinically effective was based primarily on results of the ENGAGE AF-TIMI 48 trial. In this trial, researchers compared edoxaban and warfarin as prophylaxis for stroke or systemic embolism in patients with NVAF.

Results suggested edoxaban was at least non-inferior to warfarin with regard to efficacy, and edoxaban was associated with a significantly lower rate of major and fatal bleeding.

A committee advising NICE also reviewed a meta-analysis prepared by Daiichi Sankyo Co., Ltd., the company developing edoxaban.

The goal of the meta-analysis was to compare edoxaban with rivaroxaban, apixaban, and dabigatran. The analysis included 4 trials: ENGAGE AF-TIMI 48, ARISTOTLE (apixaban), RE-LY (dabigatran), and ROCKET-AF (rivaroxaban). All 4 trials had a warfarin comparator arm.

The results of the meta-analysis indicated that, for the composite endpoint of stroke and systemic embolism, efficacy was similar for high-dose edoxaban and the other new oral anticoagulants.

However, edoxaban significantly reduced major bleeding risk by 24% compared to rivaroxaban, 28% compared to dabigatran at 150 mg, and 17% compared to dabigatran at 110 mg. Major bleeding rates were similar for high-dose edoxaban and apixaban.

The committee advising NICE said these results should be interpreted with caution, but edoxaban is unlikely to be different from rivaroxaban, apixaban, and dabigatran in clinical practice.

Cost-effectiveness

Edoxaban costs £58.80 for a 28-tablet pack (60 mg or 30 mg), and the daily cost of treatment is £2.10 (excluding value-added tax). However, costs may vary in different settings because of negotiated procurement discounts.

The committee advising NICE analyzed cost information and concluded that edoxaban is cost-effective compared with warfarin, but there is insufficient evidence to distinguish between the clinical and cost-effectiveness of edoxaban and the other new oral anticoagulants.

Young cancer patient

Photo by Bill Branson

Results of a small study reveal the material hardships families experience when a child is undergoing cancer treatment.

Researchers surveyed 99 families of children with cancer.

Six months after the child’s diagnosis, 29% of the families reported having at least one household material hardship, such as food, housing, or energy insecurity.

Twenty percent of the families had reported having such hardships at the time of the child’s diagnosis.

Kira Bona, MD, of Dana-Farber/Boston Children’s Cancer and Blood Disorders Center in Massachusetts, and her colleagues reported results from this survey in Pediatric Blood & Cancer.

The researchers surveyed 99 families of pediatric cancer patients treated at Dana-Farber/Boston Children’s, first within a month of diagnosis and then 6 months later.

At diagnosis, 20% of the families were low-income, which was defined as 200% of the federal poverty level. Six months later, an additional 12% suffered income losses that pushed them into the low-income group.

At 6 months, 25% of the families said they had lost more than 40% of their household income due to treatment-related work disruptions. A total of 56% of adults who supported their families experienced a disruption of their work.

This included 15% of parents who either quit their jobs or were laid off as a result of their child’s illness, as well as 37% of respondents who cut their hours or took a leave of absence. Thirty-four percent of these individuals were paid during their leave.

At 6 months, 29% of families said they had at least one material hardship. Twenty percent reported food insecurity, 17% reported energy insecurity, and 8% reported housing insecurity.*

These findings surprised researchers, who said they expected lower levels of need at their center because it provides psychosocial support for patients and has resource specialists to help families facing financial difficulties.

“What it says is that even at a well-resourced, large referral center, about a third of families are reporting food, housing, or energy insecurity 6 months into treatment,” Dr Bona said. “If anything, the numbers in our study are an underestimate of what might be seen at less well-resourced institutions, which was somewhat surprising to us.”

By focusing on specific material hardships, which can be addressed through governmental or philanthropic support, the researchers hope they have identified variables that are easier for clinicians to ameliorate than overall income.

Dr Bona said subsequent research will examine whether material hardship has the same effect on patient outcomes as low-income status.

“If household material hardship is linked to poorer outcomes in pediatric oncology, just like income is, then we can design interventions to fix food, housing, and energy insecurity,” she said. “It’s not clear what you do about income in a clinical setting.”

*Definitions for household material hardships were as follows.

Food insecurity was measured via the US Household Food Security Survey Module: Six-Item Short Form, which includes questions to asses if respondents:

• sometimes/often do not have enough food to eat
• sometimes/often cannot afford to eat balanced meals
• sometimes/often worry about having enough money to buy food, etc.

Families met the definition for housing insecurity if they reported any of the following:

• crowding (defined as >2 people per bedroom in the home)
• multiple moves (>1 move in the prior year)
• doubling up (having to live with other people, even temporarily, because of financial difficulties in the past 6 months).

Families met the definition for energy insecurity if, in the prior 6 months, they had experienced any of the following:

• received a letter threatening to shut off the gas/electricity/oil to their house because they had not paid the bills
• had the gas/electric/oil company shut off electricity or refused to deliver oil/gas because they had not paid the bills
• had any days that their home was not heated/cooled because they couldn’t pay the bills
• had ever used a cooking stove to heat their home because they couldn’t pay the bills.

Young cancer patient

Photo by Bill Branson

Results of a small study reveal the material hardships families experience when a child is undergoing cancer treatment.

Researchers surveyed 99 families of children with cancer.

Six months after the child’s diagnosis, 29% of the families reported having at least one household material hardship, such as food, housing, or energy insecurity.

Twenty percent of the families had reported having such hardships at the time of the child’s diagnosis.

Kira Bona, MD, of Dana-Farber/Boston Children’s Cancer and Blood Disorders Center in Massachusetts, and her colleagues reported results from this survey in Pediatric Blood & Cancer.

The researchers surveyed 99 families of pediatric cancer patients treated at Dana-Farber/Boston Children’s, first within a month of diagnosis and then 6 months later.

At diagnosis, 20% of the families were low-income, which was defined as 200% of the federal poverty level. Six months later, an additional 12% suffered income losses that pushed them into the low-income group.

At 6 months, 25% of the families said they had lost more than 40% of their household income due to treatment-related work disruptions. A total of 56% of adults who supported their families experienced a disruption of their work.

This included 15% of parents who either quit their jobs or were laid off as a result of their child’s illness, as well as 37% of respondents who cut their hours or took a leave of absence. Thirty-four percent of these individuals were paid during their leave.

At 6 months, 29% of families said they had at least one material hardship. Twenty percent reported food insecurity, 17% reported energy insecurity, and 8% reported housing insecurity.*

These findings surprised researchers, who said they expected lower levels of need at their center because it provides psychosocial support for patients and has resource specialists to help families facing financial difficulties.

“What it says is that even at a well-resourced, large referral center, about a third of families are reporting food, housing, or energy insecurity 6 months into treatment,” Dr Bona said. “If anything, the numbers in our study are an underestimate of what might be seen at less well-resourced institutions, which was somewhat surprising to us.”

By focusing on specific material hardships, which can be addressed through governmental or philanthropic support, the researchers hope they have identified variables that are easier for clinicians to ameliorate than overall income.

Dr Bona said subsequent research will examine whether material hardship has the same effect on patient outcomes as low-income status.

“If household material hardship is linked to poorer outcomes in pediatric oncology, just like income is, then we can design interventions to fix food, housing, and energy insecurity,” she said. “It’s not clear what you do about income in a clinical setting.”

*Definitions for household material hardships were as follows.

Food insecurity was measured via the US Household Food Security Survey Module: Six-Item Short Form, which includes questions to asses if respondents:

• sometimes/often do not have enough food to eat
• sometimes/often cannot afford to eat balanced meals
• sometimes/often worry about having enough money to buy food, etc.

Families met the definition for housing insecurity if they reported any of the following:

• crowding (defined as >2 people per bedroom in the home)
• multiple moves (>1 move in the prior year)
• doubling up (having to live with other people, even temporarily, because of financial difficulties in the past 6 months).

Families met the definition for energy insecurity if, in the prior 6 months, they had experienced any of the following:

• received a letter threatening to shut off the gas/electricity/oil to their house because they had not paid the bills
• had the gas/electric/oil company shut off electricity or refused to deliver oil/gas because they had not paid the bills
• had any days that their home was not heated/cooled because they couldn’t pay the bills
• had ever used a cooking stove to heat their home because they couldn’t pay the bills.

Young cancer patient

Photo by Bill Branson

Results of a small study reveal the material hardships families experience when a child is undergoing cancer treatment.

Researchers surveyed 99 families of children with cancer.

Six months after the child’s diagnosis, 29% of the families reported having at least one household material hardship, such as food, housing, or energy insecurity.

Twenty percent of the families had reported having such hardships at the time of the child’s diagnosis.

Kira Bona, MD, of Dana-Farber/Boston Children’s Cancer and Blood Disorders Center in Massachusetts, and her colleagues reported results from this survey in Pediatric Blood & Cancer.

The researchers surveyed 99 families of pediatric cancer patients treated at Dana-Farber/Boston Children’s, first within a month of diagnosis and then 6 months later.

At diagnosis, 20% of the families were low-income, which was defined as 200% of the federal poverty level. Six months later, an additional 12% suffered income losses that pushed them into the low-income group.

At 6 months, 25% of the families said they had lost more than 40% of their household income due to treatment-related work disruptions. A total of 56% of adults who supported their families experienced a disruption of their work.

This included 15% of parents who either quit their jobs or were laid off as a result of their child’s illness, as well as 37% of respondents who cut their hours or took a leave of absence. Thirty-four percent of these individuals were paid during their leave.

At 6 months, 29% of families said they had at least one material hardship. Twenty percent reported food insecurity, 17% reported energy insecurity, and 8% reported housing insecurity.*

These findings surprised researchers, who said they expected lower levels of need at their center because it provides psychosocial support for patients and has resource specialists to help families facing financial difficulties.

“What it says is that even at a well-resourced, large referral center, about a third of families are reporting food, housing, or energy insecurity 6 months into treatment,” Dr Bona said. “If anything, the numbers in our study are an underestimate of what might be seen at less well-resourced institutions, which was somewhat surprising to us.”

By focusing on specific material hardships, which can be addressed through governmental or philanthropic support, the researchers hope they have identified variables that are easier for clinicians to ameliorate than overall income.

Dr Bona said subsequent research will examine whether material hardship has the same effect on patient outcomes as low-income status.

“If household material hardship is linked to poorer outcomes in pediatric oncology, just like income is, then we can design interventions to fix food, housing, and energy insecurity,” she said. “It’s not clear what you do about income in a clinical setting.”

*Definitions for household material hardships were as follows.

Food insecurity was measured via the US Household Food Security Survey Module: Six-Item Short Form, which includes questions to asses if respondents:

• sometimes/often do not have enough food to eat
• sometimes/often cannot afford to eat balanced meals
• sometimes/often worry about having enough money to buy food, etc.

Families met the definition for housing insecurity if they reported any of the following:

• crowding (defined as >2 people per bedroom in the home)
• multiple moves (>1 move in the prior year)
• doubling up (having to live with other people, even temporarily, because of financial difficulties in the past 6 months).

Families met the definition for energy insecurity if, in the prior 6 months, they had experienced any of the following:

• received a letter threatening to shut off the gas/electricity/oil to their house because they had not paid the bills
• had the gas/electric/oil company shut off electricity or refused to deliver oil/gas because they had not paid the bills
• had any days that their home was not heated/cooled because they couldn’t pay the bills
• had ever used a cooking stove to heat their home because they couldn’t pay the bills.

U.S. Compounding Inc. is issuing a recall on all sterile products distributed between March 14, 2015, and Sept. 9, 2015, according to a safety alert from the Food and Drug Administration.

The product recall applies to all aseptically compounded and packaged USC sterile products distributed to hospitals, patients, providers, and clinics because of FDA concerns over lack of sterility assurance. Because of the risk to any patients using a compromised product, USC is proceeding voluntarily with the recall.

Patients or providers who received sterile compounded products from USC within the recall date and have not expired should stop using the products immediately, quarantine the product until proper disposal is possible, and contact USC as soon as possible to coordinate a plan to return the product.

Patients should also contact their physicians if they have experienced any issues relating to the recalled product, and physicians should contact patients to inform them of the recall and to advise them to stop using the product.

The USC recall does not apply to any nonsterile compounded medication produced or distributed by USC, according to the FDA alert.

Find the full safety alert on the FDA website.

[email protected]

U.S. Compounding Inc. is issuing a recall on all sterile products distributed between March 14, 2015, and Sept. 9, 2015, according to a safety alert from the Food and Drug Administration.

The product recall applies to all aseptically compounded and packaged USC sterile products distributed to hospitals, patients, providers, and clinics because of FDA concerns over lack of sterility assurance. Because of the risk to any patients using a compromised product, USC is proceeding voluntarily with the recall.

Patients or providers who received sterile compounded products from USC within the recall date and have not expired should stop using the products immediately, quarantine the product until proper disposal is possible, and contact USC as soon as possible to coordinate a plan to return the product.

Patients should also contact their physicians if they have experienced any issues relating to the recalled product, and physicians should contact patients to inform them of the recall and to advise them to stop using the product.

The USC recall does not apply to any nonsterile compounded medication produced or distributed by USC, according to the FDA alert.

Find the full safety alert on the FDA website.

[email protected]

U.S. Compounding Inc. is issuing a recall on all sterile products distributed between March 14, 2015, and Sept. 9, 2015, according to a safety alert from the Food and Drug Administration.

The product recall applies to all aseptically compounded and packaged USC sterile products distributed to hospitals, patients, providers, and clinics because of FDA concerns over lack of sterility assurance. Because of the risk to any patients using a compromised product, USC is proceeding voluntarily with the recall.

Patients or providers who received sterile compounded products from USC within the recall date and have not expired should stop using the products immediately, quarantine the product until proper disposal is possible, and contact USC as soon as possible to coordinate a plan to return the product.

Patients should also contact their physicians if they have experienced any issues relating to the recalled product, and physicians should contact patients to inform them of the recall and to advise them to stop using the product.

The USC recall does not apply to any nonsterile compounded medication produced or distributed by USC, according to the FDA alert.

Find the full safety alert on the FDA website.

[email protected]

Gynecologists have used the cystoscope for decades to examine the urethra and bladder, despite urology’s traditional claim that the procedure falls under its purview.

The lines between urology and gynecology have blurred, and cystoscopy has become an even more important and natural part of gynecology’s realm.

During the past 2 decades, gynecologists have become even more involved both in evaluating problems such as overactive bladder symptoms, recurrent urinary tract infection, and bladder/pelvic pain, and in performing pelvic reconstruction procedures.

The American College of Obstetricians and Gynecologists has recommended adoption of cystoscopy by ob.gyns. for diagnostic purposes and some operative indications – most importantly for ruling out cystotomy and intravesical or intraurethral suture or mesh placement, and for verifying ureteral patency. ACOG’s 2007 committee opinion on the role of cystourethroscopy in the generalist obstetrican-gyncecologist practice was reaffirmed in 2015 (Obstet Gynecol. 2007 Jul;110[1]:221-24.).

Yet, to a large extent, cystoscopy has been a good fit in principle, rather than in practice. Training in residency programs has been limited, and traditional cystoscopy can be cumbersome and time consuming. It also is costly, requiring equipment – including a light source and camera – and service contracts that may make it too expensive for many gynecologists to set up and maintain in their offices.

Cystoscopy has therefore often required referral to urologists, resulting in additional appointments, patient inconvenience, and increased costs to the health care system. The learning curve for traditional cystoscopy has been relatively steep, and delays in diagnosis and management as a result of referrals are not uncommon.

Courtesy Emmy Medical

Moreover, cystoscopes were never designed to be safe and comfortable for women. Men and women have different anatomy, yet there always has been a one-size-fits-all device. The flexible cystoscope commonly used by urologists was designed for the unique length and anatomy of the male urethra.

A new catheter-based system specifically for female cystoscopy and simple diagnostic visualization of the female bladder and ureters is now available. The system – called CystoSure (Emmy Medical) – comprises a single-use silicone access catheter (18 French today, 16 French in development) and a reusable 2.7 mm, 70-degree rigid-rod lens optic.

The CystoSure catheter is of shorter length than the traditional catheter is, and it adds a fourth self-sealing port; this fourth port allows it to function both as a three-way urinary catheter and as an access sheath for female cystoscopy. When the scope is not inserted, the port remains sealed. The catheter design allows for multiple passes of the Cystosure scope without additional trauma, infection risk, or discomfort.

Additionally, the distal tip of the catheter is open with a flat pancake-shaped balloon that ensures that the scope is consistently placed and fixed at the trigonal ridge. Since the scope tip cannot advance beyond the lower bladder segment, bladder perforation and trauma risk are negligible.

Comprehensive evaluation of the entire bladder lumen including the trigone and ureters is performed with a simple 360-degree rotation of the scope, with minimal manipulation, compared with the traditional in-and-out technique used to circumferentially view sections of the bladder surface.

Courtesy Emmy Medical

Full evaluation of the bladder and ureters takes less than 1 minute, and the urethra can be visualized, if desired, by decompressing the distal balloon and removing the entire unit.

The new cystoscopy procedure involves no assembly and is safer, simpler and more consistent than traditional cystoscopy – factors that we hope will make it easier to perform more often in the office for evaluation of bladder conditions (with or without simple cystometrogram testing), as well as during laparoscopic surgery, hysterectomy, incontinence/prolapse surgery, and other urologic procedures to ensure that the bladder and ureters are uninjured and to verify bilateral ureteral flow.

From May 2015 through the mid-summer, we completed and reviewed 55 cases of cystoscopy with Cystosure at several Harvard hospitals, including Brigham and Women’s Faulkner Hospital, Boston, the majority of them in the operating room during sling procedures and other laparoscopic surgeries. We achieved complete bladder and ureter visualization in all cases – including a small number of procedures done in the office setting – with no complications and an extremely short learning curve. For most physicians, it was possible to learn how to perform comprehensive cystoscopy with Cystosure in just one case.

Intraoperative cystoscopy

Reported rates of ureteral and bladder injury during gynecologic procedures have varied by study, type of injury, and complexity of surgery.

In an early report on the usefulness of intra-operative cystoscopy, Dr. Sergio Ribeirio and his colleagues reported that the procedure enabled early recognition and treatment of ureteral injuries in four of a series of 118 patients (3.4%) undergoing total laparoscopic hysterectomy with vault suspension (Hum Reprod. 1999 Jul;14[7]:1727-9.)

A review of 236,392 patients who underwent various laparoscopic gynecologic operations during 1994-2000 showed a urinary tract injury rate ranging from 0.02% to 1.7% (Clin Obstet Gynecol. 2002 Jun;45[2]:469- 80.). And, in another review specifically of ureteral injury in laparoscopic pelvic surgery, incidences of injury ranged from less than 1% to 2% (Obstet Gynecol Surv. 2003 Dec;58[12]:794-9.).

Other studies on the use of cystoscopy have reported injury rates up to and above 3%. In most cases, such reports include the incidence of bladder injury, which is less uncommon. Intraoperative bladder perforation occurs in 3%-9% of cases of midurethral retropubic sling procedures, for instance, according to ACOG’s opinion paper.

In a recent chart review of almost 1,000 women who underwent uterosacral colpopexy for pelvic organ prolapse, on the other hand, the intraoperative bladder injury rate was only 1%, and the rate of ureteral kinking/obstruction requiring stitch removal was significantly higher at 4.5% (Am J Obstet Gynecol. 2015;212:603.e1-7.).

Urinary tract injuries can have serious implications in terms of morbidity and litigation. When an injury is detected intraoperatively, the surgeon can repair it immediately and reduce the risk of complications and readmissions. The ureteral kinking detected in the previously mentioned study would not have been diagnosed without routine cystoscopy; nor would most cases of inadvertent suture or mesh placement in the bladder or urethral lumen.

The advisability of performing cystoscopy routinely in all gynecologic surgical procedures has been debated and should be studied further. However, given the advantages of early detection and the new availability of relatively simple and inexpensive cystoscopy, it is now possible – and will likely be beneficial – to move toward more routine use.

Currently, cystoscopy is performed in only a minority of indicated cases. In the 2003 review cited above from Obstetrical & Gynecological Survey, the ureteral injuries that occurred were identified intraoperatively in only 8.6% of the cases. And in an additional systematic literature review of urinary tract injury from gynecologic surgery, only 17 of the 47 studies included in the review employed routine intraoperative cystoscopy (Obstet Gynecol. 2006 Jun;107[6]:1366-72.).

A survey of ob.gyn residents presented at the ACOG meeting in May 2015 similarly showed that for hysterectomy, universal cystoscopy (defined as being performed in more than 90% of cases) was performed in the residents’ training settings for only a fraction of various types of hysterectomies, from vaginal hysterectomy to total laparoscopic hysterectomy.

Yet, in looking toward their future practice, the residents indicated in the survey that they plan to perform universal cystoscopy more frequently. The majority of them – almost 80% – had been involved with a hysterectomy having a bladder or ureter injury, according to the survey.

The Cystosure system facilitates a complete check of ureteral patency and bladder integrity. The system’s three-way catheter can be placed once and used for multiple passes of the cystoscope as well as for intraoperative retrograde fill of the bladder, postoperative drainage, and IV-based hands-free backfill voiding trials prior to discharge. The catheter’s red balloon port accepts the standard 5 cc syringe, and the blue inflow port provides a universal IV/cysto tubing fitting. The yellow drainage port may be attached to a standardized urinary drainage bag.

With Cystosure, a postoperative voiding trial thus becomes simpler and more efficient than it has in the past. Our nurses can clamp the outflow port, attach the IV bag to the inflow port, and briefly turn their attention elsewhere while the bladder fills hands free. The catheter is then removed, and the patient is allowed to void.

In the office

In the office, Cystosure can similarly make the evaluation of conditions like overactive bladder, urinary incontinence, incomplete bladder emptying, and recurrent urinary tract infections much easier and less expensive, enabling more gynecologists to take the lead in diagnosis.

Currently, there are various methods for performing cystometric testing. One technique, sometimes called “poor man’s cystometry,” involves placing a Foley red rubber catheter in the bladder, attaching a large syringe with the plunger removed, filling the bladder by pour technique, and monitoring the patient’s described sensations of bladder fullness and urge to urinate. This basic test can provide useful information about bladder functioning; patients with overactive bladder feel sensation at much smaller volumes than do patients with neurogenic bladder, for instance.

Courtesy Emmy Medical

Yet, while the technique is simple and cheap, it is far from precise and may be misleading. It provides for a fast fill of the bladder in that water enters the bladder as fast as gravity allows. The rapid infusion can sometimes cause an artifact in the patient’s sensation – a significant feeling of pressure or fullness that is premature.

The more-sophisticated technique, multichannel urodynamics, pumps fluid at a slower, controlled rate and provides more accurate information. Yet, it requires expensive equipment, more time, and special expertise. It has not been universally accessible and relevant to the ob.gyn.’s office.

Cystosure bridges the gap between the accurate but costly multichannel urodynamics and the simple but less accurate fast-fill testing method. The nurse can place the Cystosure catheter, attach IV tubing to the inflow port, and then control the drip rate, emulating the pump of the complex urodynamics equipment. When the patient indicates fullness and the overactive bladder/incontinence evaluation is completed, the physician may immediately proceed with simple diagnostic cystoscopy without any further urethral manipulation.

The system can also be coupled to an LED-based battery light source and/or attached to a smartphone/iPad, so that cystoscopy can be performed in any room or at bedside without large bulky equipment and cords. Images and video can be saved and shared from remote locations or used for documentation or teaching.

Dr. Kohli is medical director of Boston Urogyn in Wellesley, Mass., an ob.gyn. staff member at Brigham and Women's Hospital/Newton Wellesley Hospital, and assistant professor of ob.gyn. at Harvard Medical School in Boston. He serves as chief medical officer at Emmy Medical, Holliston, Mass., which manufactures Cystosure.

Gynecologists have used the cystoscope for decades to examine the urethra and bladder, despite urology’s traditional claim that the procedure falls under its purview.

The lines between urology and gynecology have blurred, and cystoscopy has become an even more important and natural part of gynecology’s realm.

During the past 2 decades, gynecologists have become even more involved both in evaluating problems such as overactive bladder symptoms, recurrent urinary tract infection, and bladder/pelvic pain, and in performing pelvic reconstruction procedures.

The American College of Obstetricians and Gynecologists has recommended adoption of cystoscopy by ob.gyns. for diagnostic purposes and some operative indications – most importantly for ruling out cystotomy and intravesical or intraurethral suture or mesh placement, and for verifying ureteral patency. ACOG’s 2007 committee opinion on the role of cystourethroscopy in the generalist obstetrican-gyncecologist practice was reaffirmed in 2015 (Obstet Gynecol. 2007 Jul;110[1]:221-24.).

Yet, to a large extent, cystoscopy has been a good fit in principle, rather than in practice. Training in residency programs has been limited, and traditional cystoscopy can be cumbersome and time consuming. It also is costly, requiring equipment – including a light source and camera – and service contracts that may make it too expensive for many gynecologists to set up and maintain in their offices.

Cystoscopy has therefore often required referral to urologists, resulting in additional appointments, patient inconvenience, and increased costs to the health care system. The learning curve for traditional cystoscopy has been relatively steep, and delays in diagnosis and management as a result of referrals are not uncommon.

Courtesy Emmy Medical

Moreover, cystoscopes were never designed to be safe and comfortable for women. Men and women have different anatomy, yet there always has been a one-size-fits-all device. The flexible cystoscope commonly used by urologists was designed for the unique length and anatomy of the male urethra.

A new catheter-based system specifically for female cystoscopy and simple diagnostic visualization of the female bladder and ureters is now available. The system – called CystoSure (Emmy Medical) – comprises a single-use silicone access catheter (18 French today, 16 French in development) and a reusable 2.7 mm, 70-degree rigid-rod lens optic.

The CystoSure catheter is of shorter length than the traditional catheter is, and it adds a fourth self-sealing port; this fourth port allows it to function both as a three-way urinary catheter and as an access sheath for female cystoscopy. When the scope is not inserted, the port remains sealed. The catheter design allows for multiple passes of the Cystosure scope without additional trauma, infection risk, or discomfort.

Additionally, the distal tip of the catheter is open with a flat pancake-shaped balloon that ensures that the scope is consistently placed and fixed at the trigonal ridge. Since the scope tip cannot advance beyond the lower bladder segment, bladder perforation and trauma risk are negligible.

Comprehensive evaluation of the entire bladder lumen including the trigone and ureters is performed with a simple 360-degree rotation of the scope, with minimal manipulation, compared with the traditional in-and-out technique used to circumferentially view sections of the bladder surface.

Courtesy Emmy Medical

Full evaluation of the bladder and ureters takes less than 1 minute, and the urethra can be visualized, if desired, by decompressing the distal balloon and removing the entire unit.

The new cystoscopy procedure involves no assembly and is safer, simpler and more consistent than traditional cystoscopy – factors that we hope will make it easier to perform more often in the office for evaluation of bladder conditions (with or without simple cystometrogram testing), as well as during laparoscopic surgery, hysterectomy, incontinence/prolapse surgery, and other urologic procedures to ensure that the bladder and ureters are uninjured and to verify bilateral ureteral flow.

From May 2015 through the mid-summer, we completed and reviewed 55 cases of cystoscopy with Cystosure at several Harvard hospitals, including Brigham and Women’s Faulkner Hospital, Boston, the majority of them in the operating room during sling procedures and other laparoscopic surgeries. We achieved complete bladder and ureter visualization in all cases – including a small number of procedures done in the office setting – with no complications and an extremely short learning curve. For most physicians, it was possible to learn how to perform comprehensive cystoscopy with Cystosure in just one case.

Intraoperative cystoscopy

Reported rates of ureteral and bladder injury during gynecologic procedures have varied by study, type of injury, and complexity of surgery.

In an early report on the usefulness of intra-operative cystoscopy, Dr. Sergio Ribeirio and his colleagues reported that the procedure enabled early recognition and treatment of ureteral injuries in four of a series of 118 patients (3.4%) undergoing total laparoscopic hysterectomy with vault suspension (Hum Reprod. 1999 Jul;14[7]:1727-9.)

A review of 236,392 patients who underwent various laparoscopic gynecologic operations during 1994-2000 showed a urinary tract injury rate ranging from 0.02% to 1.7% (Clin Obstet Gynecol. 2002 Jun;45[2]:469- 80.). And, in another review specifically of ureteral injury in laparoscopic pelvic surgery, incidences of injury ranged from less than 1% to 2% (Obstet Gynecol Surv. 2003 Dec;58[12]:794-9.).

Other studies on the use of cystoscopy have reported injury rates up to and above 3%. In most cases, such reports include the incidence of bladder injury, which is less uncommon. Intraoperative bladder perforation occurs in 3%-9% of cases of midurethral retropubic sling procedures, for instance, according to ACOG’s opinion paper.

In a recent chart review of almost 1,000 women who underwent uterosacral colpopexy for pelvic organ prolapse, on the other hand, the intraoperative bladder injury rate was only 1%, and the rate of ureteral kinking/obstruction requiring stitch removal was significantly higher at 4.5% (Am J Obstet Gynecol. 2015;212:603.e1-7.).

Urinary tract injuries can have serious implications in terms of morbidity and litigation. When an injury is detected intraoperatively, the surgeon can repair it immediately and reduce the risk of complications and readmissions. The ureteral kinking detected in the previously mentioned study would not have been diagnosed without routine cystoscopy; nor would most cases of inadvertent suture or mesh placement in the bladder or urethral lumen.

The advisability of performing cystoscopy routinely in all gynecologic surgical procedures has been debated and should be studied further. However, given the advantages of early detection and the new availability of relatively simple and inexpensive cystoscopy, it is now possible – and will likely be beneficial – to move toward more routine use.

Currently, cystoscopy is performed in only a minority of indicated cases. In the 2003 review cited above from Obstetrical & Gynecological Survey, the ureteral injuries that occurred were identified intraoperatively in only 8.6% of the cases. And in an additional systematic literature review of urinary tract injury from gynecologic surgery, only 17 of the 47 studies included in the review employed routine intraoperative cystoscopy (Obstet Gynecol. 2006 Jun;107[6]:1366-72.).

A survey of ob.gyn residents presented at the ACOG meeting in May 2015 similarly showed that for hysterectomy, universal cystoscopy (defined as being performed in more than 90% of cases) was performed in the residents’ training settings for only a fraction of various types of hysterectomies, from vaginal hysterectomy to total laparoscopic hysterectomy.

Yet, in looking toward their future practice, the residents indicated in the survey that they plan to perform universal cystoscopy more frequently. The majority of them – almost 80% – had been involved with a hysterectomy having a bladder or ureter injury, according to the survey.

The Cystosure system facilitates a complete check of ureteral patency and bladder integrity. The system’s three-way catheter can be placed once and used for multiple passes of the cystoscope as well as for intraoperative retrograde fill of the bladder, postoperative drainage, and IV-based hands-free backfill voiding trials prior to discharge. The catheter’s red balloon port accepts the standard 5 cc syringe, and the blue inflow port provides a universal IV/cysto tubing fitting. The yellow drainage port may be attached to a standardized urinary drainage bag.

With Cystosure, a postoperative voiding trial thus becomes simpler and more efficient than it has in the past. Our nurses can clamp the outflow port, attach the IV bag to the inflow port, and briefly turn their attention elsewhere while the bladder fills hands free. The catheter is then removed, and the patient is allowed to void.

In the office

In the office, Cystosure can similarly make the evaluation of conditions like overactive bladder, urinary incontinence, incomplete bladder emptying, and recurrent urinary tract infections much easier and less expensive, enabling more gynecologists to take the lead in diagnosis.

Currently, there are various methods for performing cystometric testing. One technique, sometimes called “poor man’s cystometry,” involves placing a Foley red rubber catheter in the bladder, attaching a large syringe with the plunger removed, filling the bladder by pour technique, and monitoring the patient’s described sensations of bladder fullness and urge to urinate. This basic test can provide useful information about bladder functioning; patients with overactive bladder feel sensation at much smaller volumes than do patients with neurogenic bladder, for instance.

Courtesy Emmy Medical

Yet, while the technique is simple and cheap, it is far from precise and may be misleading. It provides for a fast fill of the bladder in that water enters the bladder as fast as gravity allows. The rapid infusion can sometimes cause an artifact in the patient’s sensation – a significant feeling of pressure or fullness that is premature.

The more-sophisticated technique, multichannel urodynamics, pumps fluid at a slower, controlled rate and provides more accurate information. Yet, it requires expensive equipment, more time, and special expertise. It has not been universally accessible and relevant to the ob.gyn.’s office.

Cystosure bridges the gap between the accurate but costly multichannel urodynamics and the simple but less accurate fast-fill testing method. The nurse can place the Cystosure catheter, attach IV tubing to the inflow port, and then control the drip rate, emulating the pump of the complex urodynamics equipment. When the patient indicates fullness and the overactive bladder/incontinence evaluation is completed, the physician may immediately proceed with simple diagnostic cystoscopy without any further urethral manipulation.

The system can also be coupled to an LED-based battery light source and/or attached to a smartphone/iPad, so that cystoscopy can be performed in any room or at bedside without large bulky equipment and cords. Images and video can be saved and shared from remote locations or used for documentation or teaching.

Dr. Kohli is medical director of Boston Urogyn in Wellesley, Mass., an ob.gyn. staff member at Brigham and Women's Hospital/Newton Wellesley Hospital, and assistant professor of ob.gyn. at Harvard Medical School in Boston. He serves as chief medical officer at Emmy Medical, Holliston, Mass., which manufactures Cystosure.

Gynecologists have used the cystoscope for decades to examine the urethra and bladder, despite urology’s traditional claim that the procedure falls under its purview.

The lines between urology and gynecology have blurred, and cystoscopy has become an even more important and natural part of gynecology’s realm.

During the past 2 decades, gynecologists have become even more involved both in evaluating problems such as overactive bladder symptoms, recurrent urinary tract infection, and bladder/pelvic pain, and in performing pelvic reconstruction procedures.

The American College of Obstetricians and Gynecologists has recommended adoption of cystoscopy by ob.gyns. for diagnostic purposes and some operative indications – most importantly for ruling out cystotomy and intravesical or intraurethral suture or mesh placement, and for verifying ureteral patency. ACOG’s 2007 committee opinion on the role of cystourethroscopy in the generalist obstetrican-gyncecologist practice was reaffirmed in 2015 (Obstet Gynecol. 2007 Jul;110[1]:221-24.).

Yet, to a large extent, cystoscopy has been a good fit in principle, rather than in practice. Training in residency programs has been limited, and traditional cystoscopy can be cumbersome and time consuming. It also is costly, requiring equipment – including a light source and camera – and service contracts that may make it too expensive for many gynecologists to set up and maintain in their offices.

Cystoscopy has therefore often required referral to urologists, resulting in additional appointments, patient inconvenience, and increased costs to the health care system. The learning curve for traditional cystoscopy has been relatively steep, and delays in diagnosis and management as a result of referrals are not uncommon.

Courtesy Emmy Medical

Moreover, cystoscopes were never designed to be safe and comfortable for women. Men and women have different anatomy, yet there always has been a one-size-fits-all device. The flexible cystoscope commonly used by urologists was designed for the unique length and anatomy of the male urethra.

A new catheter-based system specifically for female cystoscopy and simple diagnostic visualization of the female bladder and ureters is now available. The system – called CystoSure (Emmy Medical) – comprises a single-use silicone access catheter (18 French today, 16 French in development) and a reusable 2.7 mm, 70-degree rigid-rod lens optic.

The CystoSure catheter is of shorter length than the traditional catheter is, and it adds a fourth self-sealing port; this fourth port allows it to function both as a three-way urinary catheter and as an access sheath for female cystoscopy. When the scope is not inserted, the port remains sealed. The catheter design allows for multiple passes of the Cystosure scope without additional trauma, infection risk, or discomfort.

Additionally, the distal tip of the catheter is open with a flat pancake-shaped balloon that ensures that the scope is consistently placed and fixed at the trigonal ridge. Since the scope tip cannot advance beyond the lower bladder segment, bladder perforation and trauma risk are negligible.

Comprehensive evaluation of the entire bladder lumen including the trigone and ureters is performed with a simple 360-degree rotation of the scope, with minimal manipulation, compared with the traditional in-and-out technique used to circumferentially view sections of the bladder surface.

Courtesy Emmy Medical

Full evaluation of the bladder and ureters takes less than 1 minute, and the urethra can be visualized, if desired, by decompressing the distal balloon and removing the entire unit.

The new cystoscopy procedure involves no assembly and is safer, simpler and more consistent than traditional cystoscopy – factors that we hope will make it easier to perform more often in the office for evaluation of bladder conditions (with or without simple cystometrogram testing), as well as during laparoscopic surgery, hysterectomy, incontinence/prolapse surgery, and other urologic procedures to ensure that the bladder and ureters are uninjured and to verify bilateral ureteral flow.

From May 2015 through the mid-summer, we completed and reviewed 55 cases of cystoscopy with Cystosure at several Harvard hospitals, including Brigham and Women’s Faulkner Hospital, Boston, the majority of them in the operating room during sling procedures and other laparoscopic surgeries. We achieved complete bladder and ureter visualization in all cases – including a small number of procedures done in the office setting – with no complications and an extremely short learning curve. For most physicians, it was possible to learn how to perform comprehensive cystoscopy with Cystosure in just one case.

Intraoperative cystoscopy

Reported rates of ureteral and bladder injury during gynecologic procedures have varied by study, type of injury, and complexity of surgery.

In an early report on the usefulness of intra-operative cystoscopy, Dr. Sergio Ribeirio and his colleagues reported that the procedure enabled early recognition and treatment of ureteral injuries in four of a series of 118 patients (3.4%) undergoing total laparoscopic hysterectomy with vault suspension (Hum Reprod. 1999 Jul;14[7]:1727-9.)

A review of 236,392 patients who underwent various laparoscopic gynecologic operations during 1994-2000 showed a urinary tract injury rate ranging from 0.02% to 1.7% (Clin Obstet Gynecol. 2002 Jun;45[2]:469- 80.). And, in another review specifically of ureteral injury in laparoscopic pelvic surgery, incidences of injury ranged from less than 1% to 2% (Obstet Gynecol Surv. 2003 Dec;58[12]:794-9.).

Other studies on the use of cystoscopy have reported injury rates up to and above 3%. In most cases, such reports include the incidence of bladder injury, which is less uncommon. Intraoperative bladder perforation occurs in 3%-9% of cases of midurethral retropubic sling procedures, for instance, according to ACOG’s opinion paper.

In a recent chart review of almost 1,000 women who underwent uterosacral colpopexy for pelvic organ prolapse, on the other hand, the intraoperative bladder injury rate was only 1%, and the rate of ureteral kinking/obstruction requiring stitch removal was significantly higher at 4.5% (Am J Obstet Gynecol. 2015;212:603.e1-7.).

Urinary tract injuries can have serious implications in terms of morbidity and litigation. When an injury is detected intraoperatively, the surgeon can repair it immediately and reduce the risk of complications and readmissions. The ureteral kinking detected in the previously mentioned study would not have been diagnosed without routine cystoscopy; nor would most cases of inadvertent suture or mesh placement in the bladder or urethral lumen.

The advisability of performing cystoscopy routinely in all gynecologic surgical procedures has been debated and should be studied further. However, given the advantages of early detection and the new availability of relatively simple and inexpensive cystoscopy, it is now possible – and will likely be beneficial – to move toward more routine use.

Currently, cystoscopy is performed in only a minority of indicated cases. In the 2003 review cited above from Obstetrical & Gynecological Survey, the ureteral injuries that occurred were identified intraoperatively in only 8.6% of the cases. And in an additional systematic literature review of urinary tract injury from gynecologic surgery, only 17 of the 47 studies included in the review employed routine intraoperative cystoscopy (Obstet Gynecol. 2006 Jun;107[6]:1366-72.).

A survey of ob.gyn residents presented at the ACOG meeting in May 2015 similarly showed that for hysterectomy, universal cystoscopy (defined as being performed in more than 90% of cases) was performed in the residents’ training settings for only a fraction of various types of hysterectomies, from vaginal hysterectomy to total laparoscopic hysterectomy.

Yet, in looking toward their future practice, the residents indicated in the survey that they plan to perform universal cystoscopy more frequently. The majority of them – almost 80% – had been involved with a hysterectomy having a bladder or ureter injury, according to the survey.

The Cystosure system facilitates a complete check of ureteral patency and bladder integrity. The system’s three-way catheter can be placed once and used for multiple passes of the cystoscope as well as for intraoperative retrograde fill of the bladder, postoperative drainage, and IV-based hands-free backfill voiding trials prior to discharge. The catheter’s red balloon port accepts the standard 5 cc syringe, and the blue inflow port provides a universal IV/cysto tubing fitting. The yellow drainage port may be attached to a standardized urinary drainage bag.

With Cystosure, a postoperative voiding trial thus becomes simpler and more efficient than it has in the past. Our nurses can clamp the outflow port, attach the IV bag to the inflow port, and briefly turn their attention elsewhere while the bladder fills hands free. The catheter is then removed, and the patient is allowed to void.

In the office

In the office, Cystosure can similarly make the evaluation of conditions like overactive bladder, urinary incontinence, incomplete bladder emptying, and recurrent urinary tract infections much easier and less expensive, enabling more gynecologists to take the lead in diagnosis.

Currently, there are various methods for performing cystometric testing. One technique, sometimes called “poor man’s cystometry,” involves placing a Foley red rubber catheter in the bladder, attaching a large syringe with the plunger removed, filling the bladder by pour technique, and monitoring the patient’s described sensations of bladder fullness and urge to urinate. This basic test can provide useful information about bladder functioning; patients with overactive bladder feel sensation at much smaller volumes than do patients with neurogenic bladder, for instance.

Courtesy Emmy Medical

Yet, while the technique is simple and cheap, it is far from precise and may be misleading. It provides for a fast fill of the bladder in that water enters the bladder as fast as gravity allows. The rapid infusion can sometimes cause an artifact in the patient’s sensation – a significant feeling of pressure or fullness that is premature.

The more-sophisticated technique, multichannel urodynamics, pumps fluid at a slower, controlled rate and provides more accurate information. Yet, it requires expensive equipment, more time, and special expertise. It has not been universally accessible and relevant to the ob.gyn.’s office.

Cystosure bridges the gap between the accurate but costly multichannel urodynamics and the simple but less accurate fast-fill testing method. The nurse can place the Cystosure catheter, attach IV tubing to the inflow port, and then control the drip rate, emulating the pump of the complex urodynamics equipment. When the patient indicates fullness and the overactive bladder/incontinence evaluation is completed, the physician may immediately proceed with simple diagnostic cystoscopy without any further urethral manipulation.

The system can also be coupled to an LED-based battery light source and/or attached to a smartphone/iPad, so that cystoscopy can be performed in any room or at bedside without large bulky equipment and cords. Images and video can be saved and shared from remote locations or used for documentation or teaching.

Dr. Kohli is medical director of Boston Urogyn in Wellesley, Mass., an ob.gyn. staff member at Brigham and Women's Hospital/Newton Wellesley Hospital, and assistant professor of ob.gyn. at Harvard Medical School in Boston. He serves as chief medical officer at Emmy Medical, Holliston, Mass., which manufactures Cystosure.

In 2012, the AAGL issued Guidelines for Intraoperative Cystoscopy in Laparoscopic Hysterectomy (J Minim Invasive Gynecol. 2012 Jul-Aug;19[4]:407-11.). In this AAGL report, a meta-analysis noted 27 published trials comprising 3,643 cases. Laparoscopic hysterectomy was associated with an increased risk of urinary tract injury when compared with abdominal hysterectomy (odds ratio, 2.61; 95% confidence interval, 1.22-5.60), according to the meta-analysis (BMJ. 2005 Jun 25;330[7506]:1478.).

As a result of this meta-analysis, as well as multiple other studies, the AAGL Guidelines Committee noted that “current evidence supports the conclusion that cystoscopic evaluation of the lower urinary tract should be readily available to gynecologic surgeons performing laparoscopic hysterectomy.” The resultant guidelines recommend that “a surgeon with appropriate education, training, and institutional privileges be available without delay to perform the task (cystoscopy).”

Besides the evaluation of the urinary tract for potential injury at hysterectomy, cystoscopy is useful in evaluation of various urogynecologic concerns, potential malignancy, and possible genitourinary fistula.

In this edition of the Master Class in Gynecologic Surgery, I have asked urogynecologist Dr. Neeraj Kohli to discuss the use of cystoscopy in gynecology, as well as to present new instrumentation to aide in the performance of the procedure.

Dr. Kohli is in private practice as medical director of Boston Urogyn in Wellesley, Mass., an ob.gyn. staff member at Brigham Women’s Hospital/Newton Wellesley Hospital, and assistant professor of ob.gyn. at Harvard Medical School in Boston.

Dr. Kohli is a nationally recognized leader in the field of urogynecology and reconstructive pelvic surgery, specializing in the treatment of pelvic prolapse, urinary incontinence, and advanced pelvic surgery. He has authored more than 100 scientific articles, book chapters, research abstracts, clinical presentations and multimedia educational tools.

Dr. Miller is a clinical associate professor at the University of Illinois at Chicago, immediate past president of the International Society for Gynecologic Endoscopy (ISGE), and a past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville, Ill., and Schaumburg, Ill.; director of minimally invasive gynecologic surgery and the director of the AAGL/SRS fellowship in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill; and the medical editor of this column, Master Class. Dr. Miller reported having no financial disclosures relevant to this Master Class.

In 2012, the AAGL issued Guidelines for Intraoperative Cystoscopy in Laparoscopic Hysterectomy (J Minim Invasive Gynecol. 2012 Jul-Aug;19[4]:407-11.). In this AAGL report, a meta-analysis noted 27 published trials comprising 3,643 cases. Laparoscopic hysterectomy was associated with an increased risk of urinary tract injury when compared with abdominal hysterectomy (odds ratio, 2.61; 95% confidence interval, 1.22-5.60), according to the meta-analysis (BMJ. 2005 Jun 25;330[7506]:1478.).

As a result of this meta-analysis, as well as multiple other studies, the AAGL Guidelines Committee noted that “current evidence supports the conclusion that cystoscopic evaluation of the lower urinary tract should be readily available to gynecologic surgeons performing laparoscopic hysterectomy.” The resultant guidelines recommend that “a surgeon with appropriate education, training, and institutional privileges be available without delay to perform the task (cystoscopy).”

Besides the evaluation of the urinary tract for potential injury at hysterectomy, cystoscopy is useful in evaluation of various urogynecologic concerns, potential malignancy, and possible genitourinary fistula.

In this edition of the Master Class in Gynecologic Surgery, I have asked urogynecologist Dr. Neeraj Kohli to discuss the use of cystoscopy in gynecology, as well as to present new instrumentation to aide in the performance of the procedure.

Dr. Kohli is in private practice as medical director of Boston Urogyn in Wellesley, Mass., an ob.gyn. staff member at Brigham Women’s Hospital/Newton Wellesley Hospital, and assistant professor of ob.gyn. at Harvard Medical School in Boston.

Dr. Kohli is a nationally recognized leader in the field of urogynecology and reconstructive pelvic surgery, specializing in the treatment of pelvic prolapse, urinary incontinence, and advanced pelvic surgery. He has authored more than 100 scientific articles, book chapters, research abstracts, clinical presentations and multimedia educational tools.

Dr. Miller is a clinical associate professor at the University of Illinois at Chicago, immediate past president of the International Society for Gynecologic Endoscopy (ISGE), and a past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville, Ill., and Schaumburg, Ill.; director of minimally invasive gynecologic surgery and the director of the AAGL/SRS fellowship in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill; and the medical editor of this column, Master Class. Dr. Miller reported having no financial disclosures relevant to this Master Class.

In 2012, the AAGL issued Guidelines for Intraoperative Cystoscopy in Laparoscopic Hysterectomy (J Minim Invasive Gynecol. 2012 Jul-Aug;19[4]:407-11.). In this AAGL report, a meta-analysis noted 27 published trials comprising 3,643 cases. Laparoscopic hysterectomy was associated with an increased risk of urinary tract injury when compared with abdominal hysterectomy (odds ratio, 2.61; 95% confidence interval, 1.22-5.60), according to the meta-analysis (BMJ. 2005 Jun 25;330[7506]:1478.).

As a result of this meta-analysis, as well as multiple other studies, the AAGL Guidelines Committee noted that “current evidence supports the conclusion that cystoscopic evaluation of the lower urinary tract should be readily available to gynecologic surgeons performing laparoscopic hysterectomy.” The resultant guidelines recommend that “a surgeon with appropriate education, training, and institutional privileges be available without delay to perform the task (cystoscopy).”

Besides the evaluation of the urinary tract for potential injury at hysterectomy, cystoscopy is useful in evaluation of various urogynecologic concerns, potential malignancy, and possible genitourinary fistula.

In this edition of the Master Class in Gynecologic Surgery, I have asked urogynecologist Dr. Neeraj Kohli to discuss the use of cystoscopy in gynecology, as well as to present new instrumentation to aide in the performance of the procedure.

Dr. Kohli is in private practice as medical director of Boston Urogyn in Wellesley, Mass., an ob.gyn. staff member at Brigham Women’s Hospital/Newton Wellesley Hospital, and assistant professor of ob.gyn. at Harvard Medical School in Boston.

Dr. Kohli is a nationally recognized leader in the field of urogynecology and reconstructive pelvic surgery, specializing in the treatment of pelvic prolapse, urinary incontinence, and advanced pelvic surgery. He has authored more than 100 scientific articles, book chapters, research abstracts, clinical presentations and multimedia educational tools.

Dr. Miller is a clinical associate professor at the University of Illinois at Chicago, immediate past president of the International Society for Gynecologic Endoscopy (ISGE), and a past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville, Ill., and Schaumburg, Ill.; director of minimally invasive gynecologic surgery and the director of the AAGL/SRS fellowship in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill; and the medical editor of this column, Master Class. Dr. Miller reported having no financial disclosures relevant to this Master Class.

To view the supplement, click the image to the right

To view the supplement, click the image to the right

To view the supplement, click the image to the right

Adolescent medicine presents a unique challenge. Many pediatricians find themselves extrapolating treatment of childhood issues or modifying adult treatment to address adolescent issues. But the reality is adolescents are not big kids or little adults. They are a unique group that require special considerations and analysis for appropriate treatment.

Macromastia, enlarged breast, is a condition that affects many teenagers. It impacts their self-esteem, limits physical ability, and causes musculoskeletal and dermatologic issues, and yet most pediatricians cannot recall a specific lesson that covered the evaluation and treatment of this condition. Juvenile, or virginal, gigantomastia is a rare condition that consists of a period of rapid breast tissue growth followed by sustained growth in the peripubertal years. Growth can be symmetrical or asymmetrical. Either condition can lead to disfigurement, social anxiety, unwanted attention, and withdrawal. Therefore, acknowledging the condition and intervening are essential.

With obesity on the rise, the issue of macromastia continues to grow. Although macromastia and obesity can occur independently, obesity certainly augments the condition, and more and more physicians are confronted with complaints of neck, back, and shoulder pain. Left untreated, macromastia can cause physical limitation leading to further morbidity. The exact etiology is unknown, but it is presumed to be associated with a hypersensitivity of the mammary estrogen receptors and exposure to exogenous estrogen through food, drugs, or the environment.

Although a patient who has significant discomfort may benefit from physical therapy and strengthening exercises to improve posture, the definitive treatment for macromastia and juvenile gigantomastia is surgical breast reduction, even in adolescence. Medical management with injections of tamoxifen will halt the continued growth, but it will not reduce the size, and therefore will not correct the associated side effects. Weight loss may reduce the general appearance, but it will do little to reduce the actual size of the breast tissue itself.

Because breast development arrests before adulthood, delaying surgical intervention to adulthood is not necessary. In a retrospective study, recurrence took place with juvenile gigantomastia only if intervention was done in early adolescence and did not take place at all with macromastia (Mayo Clin Proc. 2001;76:503-10).

Indications for surgical intervention are chronic shoulder, neck, and back pain; shoulder grooving; skin irritation and skin breakdown underneath the breast; and social stress. It is important that the growth of the breast has ceased for at least a year, and a psychological assessment of the impact of the condition is performed.

Misconceptions associated with breast reduction include that it is for cosmetic purposes only; that macromastia can be reduced by weight loss, and therefore a surgical intervention is not necessary; that lactation is not possible after the procedure; and that insurance will not cover this procedure. As explained previously, there is an identifiable negative impact of macromastia on the musculoskeletal system as well as huge self-esteem and social issues.

Decades ago, breast reduction was seen as a cosmetic surgery. Surprisingly, many insurance companies will now cover the procedure if the morbidity is well documented.

Inability to breastfeed was the initial concern with early surgical intervention. Several studies have evaluated this, and all have come to the same conclusion: Although milk production may be reduced, postsurgical patients can breastfeed without difficulty. Given that lactation is not inhibited and continued stress on the musculoskeletal system causes further harm, early intervention is imperative.

Breast reduction surgery is safe. There is a risk of bleeding, infection, fat necrosis, and loss of sensation, but there is no higher incidence of these adverse effects in adolescents than there is in adults (J Pediatr Adolesc Gynecol. 2013;26[4]:228-33).

Macromastia clearly impacts the emotional, social, and physical well-being of an adolescent, and it likely will not be addressed by the young patient because of embarrassment. Therefore, it is up to the pediatrician to inquire about body image with all routine health exams, and to keep up to date with the latest recommendations to ensure the best outcomes.

Dr. Pearce is a pediatrician in Frankfort, Ill. E-mail her at [email protected].

Adolescent medicine presents a unique challenge. Many pediatricians find themselves extrapolating treatment of childhood issues or modifying adult treatment to address adolescent issues. But the reality is adolescents are not big kids or little adults. They are a unique group that require special considerations and analysis for appropriate treatment.

Macromastia, enlarged breast, is a condition that affects many teenagers. It impacts their self-esteem, limits physical ability, and causes musculoskeletal and dermatologic issues, and yet most pediatricians cannot recall a specific lesson that covered the evaluation and treatment of this condition. Juvenile, or virginal, gigantomastia is a rare condition that consists of a period of rapid breast tissue growth followed by sustained growth in the peripubertal years. Growth can be symmetrical or asymmetrical. Either condition can lead to disfigurement, social anxiety, unwanted attention, and withdrawal. Therefore, acknowledging the condition and intervening are essential.

With obesity on the rise, the issue of macromastia continues to grow. Although macromastia and obesity can occur independently, obesity certainly augments the condition, and more and more physicians are confronted with complaints of neck, back, and shoulder pain. Left untreated, macromastia can cause physical limitation leading to further morbidity. The exact etiology is unknown, but it is presumed to be associated with a hypersensitivity of the mammary estrogen receptors and exposure to exogenous estrogen through food, drugs, or the environment.

Although a patient who has significant discomfort may benefit from physical therapy and strengthening exercises to improve posture, the definitive treatment for macromastia and juvenile gigantomastia is surgical breast reduction, even in adolescence. Medical management with injections of tamoxifen will halt the continued growth, but it will not reduce the size, and therefore will not correct the associated side effects. Weight loss may reduce the general appearance, but it will do little to reduce the actual size of the breast tissue itself.

Because breast development arrests before adulthood, delaying surgical intervention to adulthood is not necessary. In a retrospective study, recurrence took place with juvenile gigantomastia only if intervention was done in early adolescence and did not take place at all with macromastia (Mayo Clin Proc. 2001;76:503-10).

Indications for surgical intervention are chronic shoulder, neck, and back pain; shoulder grooving; skin irritation and skin breakdown underneath the breast; and social stress. It is important that the growth of the breast has ceased for at least a year, and a psychological assessment of the impact of the condition is performed.

Misconceptions associated with breast reduction include that it is for cosmetic purposes only; that macromastia can be reduced by weight loss, and therefore a surgical intervention is not necessary; that lactation is not possible after the procedure; and that insurance will not cover this procedure. As explained previously, there is an identifiable negative impact of macromastia on the musculoskeletal system as well as huge self-esteem and social issues.

Decades ago, breast reduction was seen as a cosmetic surgery. Surprisingly, many insurance companies will now cover the procedure if the morbidity is well documented.

Inability to breastfeed was the initial concern with early surgical intervention. Several studies have evaluated this, and all have come to the same conclusion: Although milk production may be reduced, postsurgical patients can breastfeed without difficulty. Given that lactation is not inhibited and continued stress on the musculoskeletal system causes further harm, early intervention is imperative.

Breast reduction surgery is safe. There is a risk of bleeding, infection, fat necrosis, and loss of sensation, but there is no higher incidence of these adverse effects in adolescents than there is in adults (J Pediatr Adolesc Gynecol. 2013;26[4]:228-33).

Macromastia clearly impacts the emotional, social, and physical well-being of an adolescent, and it likely will not be addressed by the young patient because of embarrassment. Therefore, it is up to the pediatrician to inquire about body image with all routine health exams, and to keep up to date with the latest recommendations to ensure the best outcomes.

Dr. Pearce is a pediatrician in Frankfort, Ill. E-mail her at [email protected].

Adolescent medicine presents a unique challenge. Many pediatricians find themselves extrapolating treatment of childhood issues or modifying adult treatment to address adolescent issues. But the reality is adolescents are not big kids or little adults. They are a unique group that require special considerations and analysis for appropriate treatment.

Macromastia, enlarged breast, is a condition that affects many teenagers. It impacts their self-esteem, limits physical ability, and causes musculoskeletal and dermatologic issues, and yet most pediatricians cannot recall a specific lesson that covered the evaluation and treatment of this condition. Juvenile, or virginal, gigantomastia is a rare condition that consists of a period of rapid breast tissue growth followed by sustained growth in the peripubertal years. Growth can be symmetrical or asymmetrical. Either condition can lead to disfigurement, social anxiety, unwanted attention, and withdrawal. Therefore, acknowledging the condition and intervening are essential.

With obesity on the rise, the issue of macromastia continues to grow. Although macromastia and obesity can occur independently, obesity certainly augments the condition, and more and more physicians are confronted with complaints of neck, back, and shoulder pain. Left untreated, macromastia can cause physical limitation leading to further morbidity. The exact etiology is unknown, but it is presumed to be associated with a hypersensitivity of the mammary estrogen receptors and exposure to exogenous estrogen through food, drugs, or the environment.

Although a patient who has significant discomfort may benefit from physical therapy and strengthening exercises to improve posture, the definitive treatment for macromastia and juvenile gigantomastia is surgical breast reduction, even in adolescence. Medical management with injections of tamoxifen will halt the continued growth, but it will not reduce the size, and therefore will not correct the associated side effects. Weight loss may reduce the general appearance, but it will do little to reduce the actual size of the breast tissue itself.

Because breast development arrests before adulthood, delaying surgical intervention to adulthood is not necessary. In a retrospective study, recurrence took place with juvenile gigantomastia only if intervention was done in early adolescence and did not take place at all with macromastia (Mayo Clin Proc. 2001;76:503-10).

Indications for surgical intervention are chronic shoulder, neck, and back pain; shoulder grooving; skin irritation and skin breakdown underneath the breast; and social stress. It is important that the growth of the breast has ceased for at least a year, and a psychological assessment of the impact of the condition is performed.

Misconceptions associated with breast reduction include that it is for cosmetic purposes only; that macromastia can be reduced by weight loss, and therefore a surgical intervention is not necessary; that lactation is not possible after the procedure; and that insurance will not cover this procedure. As explained previously, there is an identifiable negative impact of macromastia on the musculoskeletal system as well as huge self-esteem and social issues.

Decades ago, breast reduction was seen as a cosmetic surgery. Surprisingly, many insurance companies will now cover the procedure if the morbidity is well documented.

Inability to breastfeed was the initial concern with early surgical intervention. Several studies have evaluated this, and all have come to the same conclusion: Although milk production may be reduced, postsurgical patients can breastfeed without difficulty. Given that lactation is not inhibited and continued stress on the musculoskeletal system causes further harm, early intervention is imperative.

Breast reduction surgery is safe. There is a risk of bleeding, infection, fat necrosis, and loss of sensation, but there is no higher incidence of these adverse effects in adolescents than there is in adults (J Pediatr Adolesc Gynecol. 2013;26[4]:228-33).

Macromastia clearly impacts the emotional, social, and physical well-being of an adolescent, and it likely will not be addressed by the young patient because of embarrassment. Therefore, it is up to the pediatrician to inquire about body image with all routine health exams, and to keep up to date with the latest recommendations to ensure the best outcomes.

Dr. Pearce is a pediatrician in Frankfort, Ill. E-mail her at [email protected].

This month I am writing to encourage Fellows to contact their representatives and senators to ask that they support the Critical Access Hospital Relief Act, H.R. 169 and S. 258.

Approximately 2 years ago, surgeons working at Critical Access Hospitals (CAHs) began to encounter a new barrier to caring for their patients and in some cases have been forced to send patients to other hospitals far from their homes to receive care. The barrier responsible is contained in legislation originally passed in the Balanced Budget Act of 1997, the same legislation responsible for the sustainable growth rate (SGR) and the current caps on Medicare-sponsored graduate medical education positions.

Under current law, for facilities to qualify for Medicare certification and thus participate in the Medicare program itself, CAHs must meet minimum health and safety standards known as conditions of participation. In addition, the Centers for Medicare & Medicaid Services (CMS) imposes certain Medicare conditions of payment that must be met for a CAH to receive Medicare Part A reimbursement.

The CAH 96-hour rule imposes both a condition of participation and a condition of payment on CAHs. As mentioned above, though this provision has been in the law since 1997, it was not until fall of 2013 that the condition of payment began to be enforced. Prior to that time, only the condition of participation, requiring that acute inpatient care not exceed 96 hours per patient on an average basis, had been enforced by the CMS. Despite being written in the same legislation passed in 1997, the condition of payment was virtually unknown until September of 2013 when the CMS released a statement in a document pertaining to a related policy. At that time, it was indicated that the condition of payment in the 96-hour rule would be more strictly enforced. That condition of payment states that CAHs will receive Medicare Part A reimbursement only if the admitting physician certifies, at the time of admission, that the patient can reasonably be expected to be discharged or transferred within 96 hours. This was the first time many CAHs and the surgeons and other physicians working in such facilities had ever heard of the 96-hour rule’s condition of payment certification requirement.

Since the advisory was released, administrators at some CAHs have begun requiring surgeons to sign certifications upon admission stating that the patient being admitted can reasonably be expected to be discharged or transferred within 96 hours of admission. Obviously, this has caused great concern for surgeons and other providers serving populations who receive care in CAHs. Many surgeons practicing in such rural settings routinely perform procedures and provide care for surgical patients in those CAHs with expected stays likely to exceed 4 days. On the other hand, while any individual patient may require inpatient admission exceeding 96 hours, CAHs have generally not had difficulty maintaining the 96-hour average required by the condition of participation.

In response to the CMS notice on enforcement of the 96-hour rule, Representative Adrian Smith (R-Neb.) and Senator Pat Roberts (R-Kan.) introduced the Critical Access Hospital Relief Act (H.R. 169/S. 258). The legislation proposes to simply remove the 96-hour rule condition of payment, leaving in place the currently enforced 96-hour average patient stay required by the condition of participation. As of Aug. 26, 2015, there were 75 cosponsors (58 R and 17 D) in the House of Representatives for H.R. 169 and 30 cosponsors (19 R and 11 D) in the Senate for S. 258.

While it is unlikely this legislation will progress to the floor of either the House or Senate as a “standalone” bill, it is entirely possible that the Critical Access Hospital Relief Act could be included in a larger package of legislation moving in the coming months before Congress recesses for the holidays.

The American College of Surgeons strongly supports this straightforward legislation and we would urge Fellows, especially those who either serve populations receiving care in CAHs or those practicing in states with large numbers of CAHs, to contact their representatives and senators to request that they sign on as cosponsors of H.R. 169 or S. 258 and support the inclusion of the bill in any legislation coming to the floor of either chamber for a vote this year.

Until next month …

Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy, for the Division of Advocacy and Health Policy, in the ACS offices in Washington.

This month I am writing to encourage Fellows to contact their representatives and senators to ask that they support the Critical Access Hospital Relief Act, H.R. 169 and S. 258.

Approximately 2 years ago, surgeons working at Critical Access Hospitals (CAHs) began to encounter a new barrier to caring for their patients and in some cases have been forced to send patients to other hospitals far from their homes to receive care. The barrier responsible is contained in legislation originally passed in the Balanced Budget Act of 1997, the same legislation responsible for the sustainable growth rate (SGR) and the current caps on Medicare-sponsored graduate medical education positions.

Under current law, for facilities to qualify for Medicare certification and thus participate in the Medicare program itself, CAHs must meet minimum health and safety standards known as conditions of participation. In addition, the Centers for Medicare & Medicaid Services (CMS) imposes certain Medicare conditions of payment that must be met for a CAH to receive Medicare Part A reimbursement.

The CAH 96-hour rule imposes both a condition of participation and a condition of payment on CAHs. As mentioned above, though this provision has been in the law since 1997, it was not until fall of 2013 that the condition of payment began to be enforced. Prior to that time, only the condition of participation, requiring that acute inpatient care not exceed 96 hours per patient on an average basis, had been enforced by the CMS. Despite being written in the same legislation passed in 1997, the condition of payment was virtually unknown until September of 2013 when the CMS released a statement in a document pertaining to a related policy. At that time, it was indicated that the condition of payment in the 96-hour rule would be more strictly enforced. That condition of payment states that CAHs will receive Medicare Part A reimbursement only if the admitting physician certifies, at the time of admission, that the patient can reasonably be expected to be discharged or transferred within 96 hours. This was the first time many CAHs and the surgeons and other physicians working in such facilities had ever heard of the 96-hour rule’s condition of payment certification requirement.

Since the advisory was released, administrators at some CAHs have begun requiring surgeons to sign certifications upon admission stating that the patient being admitted can reasonably be expected to be discharged or transferred within 96 hours of admission. Obviously, this has caused great concern for surgeons and other providers serving populations who receive care in CAHs. Many surgeons practicing in such rural settings routinely perform procedures and provide care for surgical patients in those CAHs with expected stays likely to exceed 4 days. On the other hand, while any individual patient may require inpatient admission exceeding 96 hours, CAHs have generally not had difficulty maintaining the 96-hour average required by the condition of participation.

In response to the CMS notice on enforcement of the 96-hour rule, Representative Adrian Smith (R-Neb.) and Senator Pat Roberts (R-Kan.) introduced the Critical Access Hospital Relief Act (H.R. 169/S. 258). The legislation proposes to simply remove the 96-hour rule condition of payment, leaving in place the currently enforced 96-hour average patient stay required by the condition of participation. As of Aug. 26, 2015, there were 75 cosponsors (58 R and 17 D) in the House of Representatives for H.R. 169 and 30 cosponsors (19 R and 11 D) in the Senate for S. 258.

While it is unlikely this legislation will progress to the floor of either the House or Senate as a “standalone” bill, it is entirely possible that the Critical Access Hospital Relief Act could be included in a larger package of legislation moving in the coming months before Congress recesses for the holidays.

The American College of Surgeons strongly supports this straightforward legislation and we would urge Fellows, especially those who either serve populations receiving care in CAHs or those practicing in states with large numbers of CAHs, to contact their representatives and senators to request that they sign on as cosponsors of H.R. 169 or S. 258 and support the inclusion of the bill in any legislation coming to the floor of either chamber for a vote this year.

Until next month …

Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy, for the Division of Advocacy and Health Policy, in the ACS offices in Washington.

This month I am writing to encourage Fellows to contact their representatives and senators to ask that they support the Critical Access Hospital Relief Act, H.R. 169 and S. 258.

Approximately 2 years ago, surgeons working at Critical Access Hospitals (CAHs) began to encounter a new barrier to caring for their patients and in some cases have been forced to send patients to other hospitals far from their homes to receive care. The barrier responsible is contained in legislation originally passed in the Balanced Budget Act of 1997, the same legislation responsible for the sustainable growth rate (SGR) and the current caps on Medicare-sponsored graduate medical education positions.

Under current law, for facilities to qualify for Medicare certification and thus participate in the Medicare program itself, CAHs must meet minimum health and safety standards known as conditions of participation. In addition, the Centers for Medicare & Medicaid Services (CMS) imposes certain Medicare conditions of payment that must be met for a CAH to receive Medicare Part A reimbursement.

The CAH 96-hour rule imposes both a condition of participation and a condition of payment on CAHs. As mentioned above, though this provision has been in the law since 1997, it was not until fall of 2013 that the condition of payment began to be enforced. Prior to that time, only the condition of participation, requiring that acute inpatient care not exceed 96 hours per patient on an average basis, had been enforced by the CMS. Despite being written in the same legislation passed in 1997, the condition of payment was virtually unknown until September of 2013 when the CMS released a statement in a document pertaining to a related policy. At that time, it was indicated that the condition of payment in the 96-hour rule would be more strictly enforced. That condition of payment states that CAHs will receive Medicare Part A reimbursement only if the admitting physician certifies, at the time of admission, that the patient can reasonably be expected to be discharged or transferred within 96 hours. This was the first time many CAHs and the surgeons and other physicians working in such facilities had ever heard of the 96-hour rule’s condition of payment certification requirement.

Since the advisory was released, administrators at some CAHs have begun requiring surgeons to sign certifications upon admission stating that the patient being admitted can reasonably be expected to be discharged or transferred within 96 hours of admission. Obviously, this has caused great concern for surgeons and other providers serving populations who receive care in CAHs. Many surgeons practicing in such rural settings routinely perform procedures and provide care for surgical patients in those CAHs with expected stays likely to exceed 4 days. On the other hand, while any individual patient may require inpatient admission exceeding 96 hours, CAHs have generally not had difficulty maintaining the 96-hour average required by the condition of participation.

In response to the CMS notice on enforcement of the 96-hour rule, Representative Adrian Smith (R-Neb.) and Senator Pat Roberts (R-Kan.) introduced the Critical Access Hospital Relief Act (H.R. 169/S. 258). The legislation proposes to simply remove the 96-hour rule condition of payment, leaving in place the currently enforced 96-hour average patient stay required by the condition of participation. As of Aug. 26, 2015, there were 75 cosponsors (58 R and 17 D) in the House of Representatives for H.R. 169 and 30 cosponsors (19 R and 11 D) in the Senate for S. 258.

While it is unlikely this legislation will progress to the floor of either the House or Senate as a “standalone” bill, it is entirely possible that the Critical Access Hospital Relief Act could be included in a larger package of legislation moving in the coming months before Congress recesses for the holidays.

The American College of Surgeons strongly supports this straightforward legislation and we would urge Fellows, especially those who either serve populations receiving care in CAHs or those practicing in states with large numbers of CAHs, to contact their representatives and senators to request that they sign on as cosponsors of H.R. 169 or S. 258 and support the inclusion of the bill in any legislation coming to the floor of either chamber for a vote this year.

Until next month …

Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy, for the Division of Advocacy and Health Policy, in the ACS offices in Washington.