DENVER – The malignancy risk of thyroid nodules can be assessed with reassuring accuracy using ultrasound and the guidelines developed by the American Thyroid Association.

Ultrasound assessment is the first step of the evaluation of any patient with one or more thyroid nodules. “Maybe it shouldn’t be, but, for now, it is,” noted David L. Steward, MD, at the annual meeting of the American Thyroid Association.

The ATA guidelines categorize thyroid nodules on the basis of their ultrasound patterns, with the high risk of malignancy being in nodules that are taller than they are wide and /or have microcalcifications, irregular margins, hypoechoic areas, extrathyroidal extension, interrupted rim calcification with soft tissue extrusion, and suspicious lymph nodes. Between 70% and 90% of thyroids with such patterns will contain malignancy, according to the ATA guidelines. Lesions with an intermediate risk of malignancy have such sonographic findings as hypoechoic solid tissue and regular margins; between 10% and 20% of these are malignant. The third category in the ATA’s guidelines are those that are of low suspicion, with hyperechoic solid tissue, isoechoic solid tissue, partially cystic with eccentric solid area, and regular margins; 5%-10% of these are malignant. Thyroid nodules with a very-low risk of malignancy (less than 3%) are spongiform or partially cystic with no suspicious findings. Finally, benign nodules, of which less than 1% contain malignancy, are cysts, he said.

“We found that the size of the nodule on ultrasound that underwent fine needle aspiration was inversely correlated with malignancy risk: The lower risk nodules were larger,” he said.

Using the ATA’s system, 9 (4%) of the nodules were high risk, 64 (31%) were intermediate risk, 79 (38%) were low risk, 54 (26%) were very-low risk, and none were benign. Five of the nodules were not included in the results presented.

There was good correlation between the Bethesda and ATA classification systems. Of the lesions that were malignant or suspicious for malignancy in the Bethesda system, 77% were very-high risk for malignancy on ultrasound according to the ATA. Of the lesions that were atypia of undetermined significance (AUS)/follicular lesion of undetermined significance (FLUS), 22% were very high risk according to the ATA. Neither of the systems classified as malignant any of the lesions as follicular/Hurthle cell cancer, benign, or nondiagnostic.

The AUS/FLUS nodules “tend to be all over the map,” he noted. Looking at just the AUS/FLUS nodules, malignancy was found on pathology in 100% classified by the ATA system as being high risk; in 21% of those called intermediate risk; in 17% of those called low risk; and in 12% of the very-low risk group.

The study was funded by the University of Cincinnati. Dr. Steward said his only disclosure is that he was a member of the ATA committee that wrote the guidelines under evaluation in this study.

skubetin@frontlinemedcom.com

DENVER – The malignancy risk of thyroid nodules can be assessed with reassuring accuracy using ultrasound and the guidelines developed by the American Thyroid Association.

Ultrasound assessment is the first step of the evaluation of any patient with one or more thyroid nodules. “Maybe it shouldn’t be, but, for now, it is,” noted David L. Steward, MD, at the annual meeting of the American Thyroid Association.

The ATA guidelines categorize thyroid nodules on the basis of their ultrasound patterns, with the high risk of malignancy being in nodules that are taller than they are wide and /or have microcalcifications, irregular margins, hypoechoic areas, extrathyroidal extension, interrupted rim calcification with soft tissue extrusion, and suspicious lymph nodes. Between 70% and 90% of thyroids with such patterns will contain malignancy, according to the ATA guidelines. Lesions with an intermediate risk of malignancy have such sonographic findings as hypoechoic solid tissue and regular margins; between 10% and 20% of these are malignant. The third category in the ATA’s guidelines are those that are of low suspicion, with hyperechoic solid tissue, isoechoic solid tissue, partially cystic with eccentric solid area, and regular margins; 5%-10% of these are malignant. Thyroid nodules with a very-low risk of malignancy (less than 3%) are spongiform or partially cystic with no suspicious findings. Finally, benign nodules, of which less than 1% contain malignancy, are cysts, he said.

“We found that the size of the nodule on ultrasound that underwent fine needle aspiration was inversely correlated with malignancy risk: The lower risk nodules were larger,” he said.

Using the ATA’s system, 9 (4%) of the nodules were high risk, 64 (31%) were intermediate risk, 79 (38%) were low risk, 54 (26%) were very-low risk, and none were benign. Five of the nodules were not included in the results presented.

There was good correlation between the Bethesda and ATA classification systems. Of the lesions that were malignant or suspicious for malignancy in the Bethesda system, 77% were very-high risk for malignancy on ultrasound according to the ATA. Of the lesions that were atypia of undetermined significance (AUS)/follicular lesion of undetermined significance (FLUS), 22% were very high risk according to the ATA. Neither of the systems classified as malignant any of the lesions as follicular/Hurthle cell cancer, benign, or nondiagnostic.

The AUS/FLUS nodules “tend to be all over the map,” he noted. Looking at just the AUS/FLUS nodules, malignancy was found on pathology in 100% classified by the ATA system as being high risk; in 21% of those called intermediate risk; in 17% of those called low risk; and in 12% of the very-low risk group.

The study was funded by the University of Cincinnati. Dr. Steward said his only disclosure is that he was a member of the ATA committee that wrote the guidelines under evaluation in this study.

skubetin@frontlinemedcom.com

DENVER – The malignancy risk of thyroid nodules can be assessed with reassuring accuracy using ultrasound and the guidelines developed by the American Thyroid Association.

Ultrasound assessment is the first step of the evaluation of any patient with one or more thyroid nodules. “Maybe it shouldn’t be, but, for now, it is,” noted David L. Steward, MD, at the annual meeting of the American Thyroid Association.

The ATA guidelines categorize thyroid nodules on the basis of their ultrasound patterns, with the high risk of malignancy being in nodules that are taller than they are wide and /or have microcalcifications, irregular margins, hypoechoic areas, extrathyroidal extension, interrupted rim calcification with soft tissue extrusion, and suspicious lymph nodes. Between 70% and 90% of thyroids with such patterns will contain malignancy, according to the ATA guidelines. Lesions with an intermediate risk of malignancy have such sonographic findings as hypoechoic solid tissue and regular margins; between 10% and 20% of these are malignant. The third category in the ATA’s guidelines are those that are of low suspicion, with hyperechoic solid tissue, isoechoic solid tissue, partially cystic with eccentric solid area, and regular margins; 5%-10% of these are malignant. Thyroid nodules with a very-low risk of malignancy (less than 3%) are spongiform or partially cystic with no suspicious findings. Finally, benign nodules, of which less than 1% contain malignancy, are cysts, he said.

“We found that the size of the nodule on ultrasound that underwent fine needle aspiration was inversely correlated with malignancy risk: The lower risk nodules were larger,” he said.

Using the ATA’s system, 9 (4%) of the nodules were high risk, 64 (31%) were intermediate risk, 79 (38%) were low risk, 54 (26%) were very-low risk, and none were benign. Five of the nodules were not included in the results presented.

There was good correlation between the Bethesda and ATA classification systems. Of the lesions that were malignant or suspicious for malignancy in the Bethesda system, 77% were very-high risk for malignancy on ultrasound according to the ATA. Of the lesions that were atypia of undetermined significance (AUS)/follicular lesion of undetermined significance (FLUS), 22% were very high risk according to the ATA. Neither of the systems classified as malignant any of the lesions as follicular/Hurthle cell cancer, benign, or nondiagnostic.

The AUS/FLUS nodules “tend to be all over the map,” he noted. Looking at just the AUS/FLUS nodules, malignancy was found on pathology in 100% classified by the ATA system as being high risk; in 21% of those called intermediate risk; in 17% of those called low risk; and in 12% of the very-low risk group.

The study was funded by the University of Cincinnati. Dr. Steward said his only disclosure is that he was a member of the ATA committee that wrote the guidelines under evaluation in this study.

skubetin@frontlinemedcom.com

BOSTON – For women with cervical or endometrial cancers, postoperative pelvic irradiation with intensity-modulated radiation therapy (IMRT) is associated with a reduction in acute gastrointestinal or genitourinary side effects, better physical functioning, and better quality of life than standard four-field pelvic radiation therapy, investigators contend.

Five weeks after the start of radiation therapy, women treated with pelvic IMRT in a phase III multicenter randomized trial had significantly better bowel and urinary function scores on the Expanded Prostate Index Composite (EPIC) scale, a patient reported–outcomes instrument, said co-principal investigator Ann H. Klopp, MD, from the University of Texas MD Anderson Cancer in Houston.

EPIC findings

For the primary endpoint of change in the composite of EPIC bowel function and bother score from baseline, patients in both arms had declines in scores, signaling increased symptoms, but the decline was significantly greater among patients treated with four-field radiation (mean 23.6 point decline) vs. IMRT (mean 18.6 point decline, P = .048). Viewed separately, bowel function but not bowel bother scores were significantly lower in the standard radiation group. By 4 to 6 weeks after therapy, however, scores in both groups had recovered to baseline levels, Dr. Klopp noted.

Similarly, bowel-related scores on the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events measure (PRO-CTCAE), a secondary endpoint, were significantly worse among patients who underwent standard radiation for the domains of diarrhea, fecal frequency, and fecal interference. There were no significant differences between the groups in abdominal pain measures, however.

For the secondary endpoint of EPIC urinary scores, IMRT was also associated with lower toxicities, with a mean urinary summary score decline of 5.6 points, compared with a 10.4-point drop among patients treated with standard four-field radiation (P = .03)

Finally, patients on IMRT had a smaller comparative decline in the physical wellbeing scale of the Functional Assessment of Cancer Therapy cervical cancer scale (P = .03).

The results support what many radiation oncologists believe but have not been able to prove until now, commented Geraldine Jacobson, MD, MPH, professor and chair of radiation oncology at West Virginia University, Morgantown.

BOSTON – For women with cervical or endometrial cancers, postoperative pelvic irradiation with intensity-modulated radiation therapy (IMRT) is associated with a reduction in acute gastrointestinal or genitourinary side effects, better physical functioning, and better quality of life than standard four-field pelvic radiation therapy, investigators contend.

Five weeks after the start of radiation therapy, women treated with pelvic IMRT in a phase III multicenter randomized trial had significantly better bowel and urinary function scores on the Expanded Prostate Index Composite (EPIC) scale, a patient reported–outcomes instrument, said co-principal investigator Ann H. Klopp, MD, from the University of Texas MD Anderson Cancer in Houston.

EPIC findings

For the primary endpoint of change in the composite of EPIC bowel function and bother score from baseline, patients in both arms had declines in scores, signaling increased symptoms, but the decline was significantly greater among patients treated with four-field radiation (mean 23.6 point decline) vs. IMRT (mean 18.6 point decline, P = .048). Viewed separately, bowel function but not bowel bother scores were significantly lower in the standard radiation group. By 4 to 6 weeks after therapy, however, scores in both groups had recovered to baseline levels, Dr. Klopp noted.

Similarly, bowel-related scores on the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events measure (PRO-CTCAE), a secondary endpoint, were significantly worse among patients who underwent standard radiation for the domains of diarrhea, fecal frequency, and fecal interference. There were no significant differences between the groups in abdominal pain measures, however.

For the secondary endpoint of EPIC urinary scores, IMRT was also associated with lower toxicities, with a mean urinary summary score decline of 5.6 points, compared with a 10.4-point drop among patients treated with standard four-field radiation (P = .03)

Finally, patients on IMRT had a smaller comparative decline in the physical wellbeing scale of the Functional Assessment of Cancer Therapy cervical cancer scale (P = .03).

The results support what many radiation oncologists believe but have not been able to prove until now, commented Geraldine Jacobson, MD, MPH, professor and chair of radiation oncology at West Virginia University, Morgantown.

BOSTON – For women with cervical or endometrial cancers, postoperative pelvic irradiation with intensity-modulated radiation therapy (IMRT) is associated with a reduction in acute gastrointestinal or genitourinary side effects, better physical functioning, and better quality of life than standard four-field pelvic radiation therapy, investigators contend.

Five weeks after the start of radiation therapy, women treated with pelvic IMRT in a phase III multicenter randomized trial had significantly better bowel and urinary function scores on the Expanded Prostate Index Composite (EPIC) scale, a patient reported–outcomes instrument, said co-principal investigator Ann H. Klopp, MD, from the University of Texas MD Anderson Cancer in Houston.

EPIC findings

For the primary endpoint of change in the composite of EPIC bowel function and bother score from baseline, patients in both arms had declines in scores, signaling increased symptoms, but the decline was significantly greater among patients treated with four-field radiation (mean 23.6 point decline) vs. IMRT (mean 18.6 point decline, P = .048). Viewed separately, bowel function but not bowel bother scores were significantly lower in the standard radiation group. By 4 to 6 weeks after therapy, however, scores in both groups had recovered to baseline levels, Dr. Klopp noted.

Similarly, bowel-related scores on the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events measure (PRO-CTCAE), a secondary endpoint, were significantly worse among patients who underwent standard radiation for the domains of diarrhea, fecal frequency, and fecal interference. There were no significant differences between the groups in abdominal pain measures, however.

For the secondary endpoint of EPIC urinary scores, IMRT was also associated with lower toxicities, with a mean urinary summary score decline of 5.6 points, compared with a 10.4-point drop among patients treated with standard four-field radiation (P = .03)

Finally, patients on IMRT had a smaller comparative decline in the physical wellbeing scale of the Functional Assessment of Cancer Therapy cervical cancer scale (P = .03).

The results support what many radiation oncologists believe but have not been able to prove until now, commented Geraldine Jacobson, MD, MPH, professor and chair of radiation oncology at West Virginia University, Morgantown.

BOSTON – Robot-assisted radical hysterectomy is just as safe, or perhaps safer, than open surgery, according to a new study that examined perioperative and postoperative outcomes with long-term follow-ups for both types of procedures.

“Robotic surgery has been expanding for the last 20 years, but still the recurrence rate with cancer patients is missing data because very few studies are published; they don’t have long-term oncologic outcomes, and if [the technology] works properly we have to put it into the literature,” M. Bilal Sert, MD, of Oslo University, said at the annual Minimally Invasive Surgery Week.

Dr. Sert and his coinvestigators identified 215 women who underwent either open or robot-assisted radical hysterectomy between November 2005 and December 2012. All of the procedures were elective and the robot-assisted operations were performed using the da Vinci robotic surgical platform. After excluding neoadjuvant cases, which totaled 19, the researchers looked at data on 196 patients (122 open radical hysterectomy cases and 74 robot-assisted radical hysterectomy cases).

On average, operating time for open radical hysterectomy was 171 minutes, versus 263 minutes for robot-assisted radical hysterectomy. However, the robotic surgery arm had lower mean estimated blood loss than the open surgery cohort: 80 milliliters versus 468 milliliters, respectively (P = .003). Follow-up time frames were shorter in the robotic surgery cohort by 6 months: 46 months reported for robotic surgery, compared with a 52-month average experienced by those in the open surgery cohort.

Both groups experienced recurrences, including 12 patients in the open surgery cohort (9.8%) and 9 patients in the robotic surgery cohort (12.1%) (P = .3), indicating a statistically insignificant difference. Similarly, rates of perioperative complications were 8% for open surgery and 11% for robotic surgery (P = .3), which was not significantly different.

However, rates of postoperative complications were 36% for open surgery and 12% for robotic surgery (P = .001), which was statistically significant.

“Based on our data, I can say that [robot-assisted radical hysterectomy] is safe, and in fact I prefer to use the robot,” Dr. Sert said at the meeting, which was held by the Society of Laparoendoscopic Surgeons. “Of course, robot-assisted surgery will not automatically make you a better surgeon, but on more complicated radical hysterectomy patients, it will help make the surgeon more precise.”

No funding source was disclosed for this study. Dr. Sert reported having no relevant financial disclosures.

dchitnis@frontlinemedcom.com

BOSTON – Robot-assisted radical hysterectomy is just as safe, or perhaps safer, than open surgery, according to a new study that examined perioperative and postoperative outcomes with long-term follow-ups for both types of procedures.

“Robotic surgery has been expanding for the last 20 years, but still the recurrence rate with cancer patients is missing data because very few studies are published; they don’t have long-term oncologic outcomes, and if [the technology] works properly we have to put it into the literature,” M. Bilal Sert, MD, of Oslo University, said at the annual Minimally Invasive Surgery Week.

Dr. Sert and his coinvestigators identified 215 women who underwent either open or robot-assisted radical hysterectomy between November 2005 and December 2012. All of the procedures were elective and the robot-assisted operations were performed using the da Vinci robotic surgical platform. After excluding neoadjuvant cases, which totaled 19, the researchers looked at data on 196 patients (122 open radical hysterectomy cases and 74 robot-assisted radical hysterectomy cases).

On average, operating time for open radical hysterectomy was 171 minutes, versus 263 minutes for robot-assisted radical hysterectomy. However, the robotic surgery arm had lower mean estimated blood loss than the open surgery cohort: 80 milliliters versus 468 milliliters, respectively (P = .003). Follow-up time frames were shorter in the robotic surgery cohort by 6 months: 46 months reported for robotic surgery, compared with a 52-month average experienced by those in the open surgery cohort.

Both groups experienced recurrences, including 12 patients in the open surgery cohort (9.8%) and 9 patients in the robotic surgery cohort (12.1%) (P = .3), indicating a statistically insignificant difference. Similarly, rates of perioperative complications were 8% for open surgery and 11% for robotic surgery (P = .3), which was not significantly different.

However, rates of postoperative complications were 36% for open surgery and 12% for robotic surgery (P = .001), which was statistically significant.

“Based on our data, I can say that [robot-assisted radical hysterectomy] is safe, and in fact I prefer to use the robot,” Dr. Sert said at the meeting, which was held by the Society of Laparoendoscopic Surgeons. “Of course, robot-assisted surgery will not automatically make you a better surgeon, but on more complicated radical hysterectomy patients, it will help make the surgeon more precise.”

No funding source was disclosed for this study. Dr. Sert reported having no relevant financial disclosures.

dchitnis@frontlinemedcom.com

BOSTON – Robot-assisted radical hysterectomy is just as safe, or perhaps safer, than open surgery, according to a new study that examined perioperative and postoperative outcomes with long-term follow-ups for both types of procedures.

“Robotic surgery has been expanding for the last 20 years, but still the recurrence rate with cancer patients is missing data because very few studies are published; they don’t have long-term oncologic outcomes, and if [the technology] works properly we have to put it into the literature,” M. Bilal Sert, MD, of Oslo University, said at the annual Minimally Invasive Surgery Week.

Dr. Sert and his coinvestigators identified 215 women who underwent either open or robot-assisted radical hysterectomy between November 2005 and December 2012. All of the procedures were elective and the robot-assisted operations were performed using the da Vinci robotic surgical platform. After excluding neoadjuvant cases, which totaled 19, the researchers looked at data on 196 patients (122 open radical hysterectomy cases and 74 robot-assisted radical hysterectomy cases).

On average, operating time for open radical hysterectomy was 171 minutes, versus 263 minutes for robot-assisted radical hysterectomy. However, the robotic surgery arm had lower mean estimated blood loss than the open surgery cohort: 80 milliliters versus 468 milliliters, respectively (P = .003). Follow-up time frames were shorter in the robotic surgery cohort by 6 months: 46 months reported for robotic surgery, compared with a 52-month average experienced by those in the open surgery cohort.

Both groups experienced recurrences, including 12 patients in the open surgery cohort (9.8%) and 9 patients in the robotic surgery cohort (12.1%) (P = .3), indicating a statistically insignificant difference. Similarly, rates of perioperative complications were 8% for open surgery and 11% for robotic surgery (P = .3), which was not significantly different.

However, rates of postoperative complications were 36% for open surgery and 12% for robotic surgery (P = .001), which was statistically significant.

“Based on our data, I can say that [robot-assisted radical hysterectomy] is safe, and in fact I prefer to use the robot,” Dr. Sert said at the meeting, which was held by the Society of Laparoendoscopic Surgeons. “Of course, robot-assisted surgery will not automatically make you a better surgeon, but on more complicated radical hysterectomy patients, it will help make the surgeon more precise.”

No funding source was disclosed for this study. Dr. Sert reported having no relevant financial disclosures.

dchitnis@frontlinemedcom.com

Just as Charlie Brown looks forward to the coming of the Great Pumpkin each Halloween, those of us who dance in the minefields of payment policy await the publication of the Proposed Rule, more formally known as the “Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017.”^1,2 You could read the entire tome—a mere 316 pages (excluding the hundreds of pages of granular supplement data discussed in the last few columns)—or simply read what I have outlined as the good, the bad, and the ugly for the Proposed Rule for 2017.

The Good

In 2017, dermatology will increase its share of the pie by 1% to $3.505 billion of a total $89.467 billion expected to be expended for physician services.¹ The effect on individual providers will vary by geographic location and practice mix. Half is from the 0.5% increase that has come to all physicians across the board as mandated by the Medicare Access and CHIP Reauthorization Act (MACRA).³

Current Procedural Terminology (CPT) codes for reflectance confocal microscopy (96931–96936) will have Centers for Medicare & Medicaid Services valuations beginning in 2017, and individuals performing this service should be able to report it and be paid for their efforts.¹ The values are below the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC) recommendations.

The Bad

Payment rates for 2017 will be based on a conversion factor of 35.7751,¹ a drop from the 2016 conversion factor of 35.8043. Cuts will be made for some specialties. Gastroenterology, nephrology, neurosurgery, radiology, urology, and radiation therapy centers will take a 1% hit; ophthalmology, pathology, and vascular surgery will take 2% cuts; and interventional radiology will lose 7%.¹ A special case within dermatology and pathology is a 15% cut to the technical component of slide preparation for CPT code 88305⁴ due to a redefinition of the valuation of eosin stains.² While the accuracy and precision of the value of these practice expense inputs can be debated, the government by definition makes the rules and involved specialties had an opportunity to appeal this change through the comment process that ended on September 6, 2016. The government can take comments into account, but substantial changes usually are not made from the Proposed Rule to the Final Rule, which usually arrives around the beginning of November; however, in an election year, the Final Rule can be a few weeks late.

The Ugly

The government will increase its unfunded mandates with the creation of new Medicare G codes (global services codes) that will allow the government to track the provision of postoperative care for all 010 and 090 global service periods (Table 1). The codes look mostly at time and do not clearly take into account the severity or complexity of the conditions being cared for and will be reported on claim forms as an unfunded mandate with more confusion and cost.¹ Because not all claim-paying intermediaries are likely to have these G codes smoothly set up in their systems, there will still be a cost to filing the claim. Unless changes occur in the Final Rule, which is unlikely, there will be no payment for the time and effort of submitting these claims. The goal of the US Government is to hone in on postoperative services and parse them down so they can cut payments wherever possible beginning in 2019.¹ Everyone wants to save money, from the consumer⁵ to the payer, and the ultimate payer is playing hardball. Additional validation efforts likely will lower physician fee-for-service payments further.

The US Government also is taking a shot at what they call “misvalued services” that have not had recent refinement within the RUC process.¹ The work list for 2017 includes a number of 000 global period codes where additional evaluation and management services are reported using modifier -25, which implies a substantial, separately identifiable cognitive service performed by the same physician on the day of a procedure above and beyond other services provided or beyond the usual preservice and postservice care associated with the procedure that was performed. Although codes such as biopsies (11100 and 11101) and premalignant destructions (17000–17004) have an adjustment built in and dermatologists who provide services on the same day are actually penalized for the multiple built-in reductions that are already additive, the government is concerned that 19% of the 000 global services were billed more than 50% of the time with an evaluation and management code with modifier -25. Eighty-three codes met the criteria for which the government believes it may be overpaying¹; the codes of interest to dermatology are shown in Table 2.¹

Final Thoughts

I end this column with an appeal to the dermatologists of America. Go to the American Academy of Dermatology Association Political Action Committee website (https://skinpac.org/), the home page for the only political action committee that represents the dermatology specialty, and consider making a donation. Emergency medicine physicians created the “Giving a Shift” campaign, which is a donation to their national political action committee of one shift’s earnings, and most of us could easily donate a half day’s income, as the only way to potentially change the increasingly onerous burdens on practitioners is through political action. As we say at RUC meetings, you can eat lunch or be lunch. The choice is yours.

Just as Charlie Brown looks forward to the coming of the Great Pumpkin each Halloween, those of us who dance in the minefields of payment policy await the publication of the Proposed Rule, more formally known as the “Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017.”^1,2 You could read the entire tome—a mere 316 pages (excluding the hundreds of pages of granular supplement data discussed in the last few columns)—or simply read what I have outlined as the good, the bad, and the ugly for the Proposed Rule for 2017.

The Good

In 2017, dermatology will increase its share of the pie by 1% to $3.505 billion of a total $89.467 billion expected to be expended for physician services.¹ The effect on individual providers will vary by geographic location and practice mix. Half is from the 0.5% increase that has come to all physicians across the board as mandated by the Medicare Access and CHIP Reauthorization Act (MACRA).³

Current Procedural Terminology (CPT) codes for reflectance confocal microscopy (96931–96936) will have Centers for Medicare & Medicaid Services valuations beginning in 2017, and individuals performing this service should be able to report it and be paid for their efforts.¹ The values are below the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC) recommendations.

The Bad

Payment rates for 2017 will be based on a conversion factor of 35.7751,¹ a drop from the 2016 conversion factor of 35.8043. Cuts will be made for some specialties. Gastroenterology, nephrology, neurosurgery, radiology, urology, and radiation therapy centers will take a 1% hit; ophthalmology, pathology, and vascular surgery will take 2% cuts; and interventional radiology will lose 7%.¹ A special case within dermatology and pathology is a 15% cut to the technical component of slide preparation for CPT code 88305⁴ due to a redefinition of the valuation of eosin stains.² While the accuracy and precision of the value of these practice expense inputs can be debated, the government by definition makes the rules and involved specialties had an opportunity to appeal this change through the comment process that ended on September 6, 2016. The government can take comments into account, but substantial changes usually are not made from the Proposed Rule to the Final Rule, which usually arrives around the beginning of November; however, in an election year, the Final Rule can be a few weeks late.

The Ugly

The government will increase its unfunded mandates with the creation of new Medicare G codes (global services codes) that will allow the government to track the provision of postoperative care for all 010 and 090 global service periods (Table 1). The codes look mostly at time and do not clearly take into account the severity or complexity of the conditions being cared for and will be reported on claim forms as an unfunded mandate with more confusion and cost.¹ Because not all claim-paying intermediaries are likely to have these G codes smoothly set up in their systems, there will still be a cost to filing the claim. Unless changes occur in the Final Rule, which is unlikely, there will be no payment for the time and effort of submitting these claims. The goal of the US Government is to hone in on postoperative services and parse them down so they can cut payments wherever possible beginning in 2019.¹ Everyone wants to save money, from the consumer⁵ to the payer, and the ultimate payer is playing hardball. Additional validation efforts likely will lower physician fee-for-service payments further.

The US Government also is taking a shot at what they call “misvalued services” that have not had recent refinement within the RUC process.¹ The work list for 2017 includes a number of 000 global period codes where additional evaluation and management services are reported using modifier -25, which implies a substantial, separately identifiable cognitive service performed by the same physician on the day of a procedure above and beyond other services provided or beyond the usual preservice and postservice care associated with the procedure that was performed. Although codes such as biopsies (11100 and 11101) and premalignant destructions (17000–17004) have an adjustment built in and dermatologists who provide services on the same day are actually penalized for the multiple built-in reductions that are already additive, the government is concerned that 19% of the 000 global services were billed more than 50% of the time with an evaluation and management code with modifier -25. Eighty-three codes met the criteria for which the government believes it may be overpaying¹; the codes of interest to dermatology are shown in Table 2.¹

Final Thoughts

I end this column with an appeal to the dermatologists of America. Go to the American Academy of Dermatology Association Political Action Committee website (https://skinpac.org/), the home page for the only political action committee that represents the dermatology specialty, and consider making a donation. Emergency medicine physicians created the “Giving a Shift” campaign, which is a donation to their national political action committee of one shift’s earnings, and most of us could easily donate a half day’s income, as the only way to potentially change the increasingly onerous burdens on practitioners is through political action. As we say at RUC meetings, you can eat lunch or be lunch. The choice is yours.

Just as Charlie Brown looks forward to the coming of the Great Pumpkin each Halloween, those of us who dance in the minefields of payment policy await the publication of the Proposed Rule, more formally known as the “Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017.”^1,2 You could read the entire tome—a mere 316 pages (excluding the hundreds of pages of granular supplement data discussed in the last few columns)—or simply read what I have outlined as the good, the bad, and the ugly for the Proposed Rule for 2017.

The Good

In 2017, dermatology will increase its share of the pie by 1% to $3.505 billion of a total $89.467 billion expected to be expended for physician services.¹ The effect on individual providers will vary by geographic location and practice mix. Half is from the 0.5% increase that has come to all physicians across the board as mandated by the Medicare Access and CHIP Reauthorization Act (MACRA).³

Current Procedural Terminology (CPT) codes for reflectance confocal microscopy (96931–96936) will have Centers for Medicare & Medicaid Services valuations beginning in 2017, and individuals performing this service should be able to report it and be paid for their efforts.¹ The values are below the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC) recommendations.

The Bad

Payment rates for 2017 will be based on a conversion factor of 35.7751,¹ a drop from the 2016 conversion factor of 35.8043. Cuts will be made for some specialties. Gastroenterology, nephrology, neurosurgery, radiology, urology, and radiation therapy centers will take a 1% hit; ophthalmology, pathology, and vascular surgery will take 2% cuts; and interventional radiology will lose 7%.¹ A special case within dermatology and pathology is a 15% cut to the technical component of slide preparation for CPT code 88305⁴ due to a redefinition of the valuation of eosin stains.² While the accuracy and precision of the value of these practice expense inputs can be debated, the government by definition makes the rules and involved specialties had an opportunity to appeal this change through the comment process that ended on September 6, 2016. The government can take comments into account, but substantial changes usually are not made from the Proposed Rule to the Final Rule, which usually arrives around the beginning of November; however, in an election year, the Final Rule can be a few weeks late.

The Ugly

The government will increase its unfunded mandates with the creation of new Medicare G codes (global services codes) that will allow the government to track the provision of postoperative care for all 010 and 090 global service periods (Table 1). The codes look mostly at time and do not clearly take into account the severity or complexity of the conditions being cared for and will be reported on claim forms as an unfunded mandate with more confusion and cost.¹ Because not all claim-paying intermediaries are likely to have these G codes smoothly set up in their systems, there will still be a cost to filing the claim. Unless changes occur in the Final Rule, which is unlikely, there will be no payment for the time and effort of submitting these claims. The goal of the US Government is to hone in on postoperative services and parse them down so they can cut payments wherever possible beginning in 2019.¹ Everyone wants to save money, from the consumer⁵ to the payer, and the ultimate payer is playing hardball. Additional validation efforts likely will lower physician fee-for-service payments further.

The US Government also is taking a shot at what they call “misvalued services” that have not had recent refinement within the RUC process.¹ The work list for 2017 includes a number of 000 global period codes where additional evaluation and management services are reported using modifier -25, which implies a substantial, separately identifiable cognitive service performed by the same physician on the day of a procedure above and beyond other services provided or beyond the usual preservice and postservice care associated with the procedure that was performed. Although codes such as biopsies (11100 and 11101) and premalignant destructions (17000–17004) have an adjustment built in and dermatologists who provide services on the same day are actually penalized for the multiple built-in reductions that are already additive, the government is concerned that 19% of the 000 global services were billed more than 50% of the time with an evaluation and management code with modifier -25. Eighty-three codes met the criteria for which the government believes it may be overpaying¹; the codes of interest to dermatology are shown in Table 2.¹

Final Thoughts

I end this column with an appeal to the dermatologists of America. Go to the American Academy of Dermatology Association Political Action Committee website (https://skinpac.org/), the home page for the only political action committee that represents the dermatology specialty, and consider making a donation. Emergency medicine physicians created the “Giving a Shift” campaign, which is a donation to their national political action committee of one shift’s earnings, and most of us could easily donate a half day’s income, as the only way to potentially change the increasingly onerous burdens on practitioners is through political action. As we say at RUC meetings, you can eat lunch or be lunch. The choice is yours.

BOSTON – For men with newly diagnosed low- or intermediate-risk prostate cancer, stereotactic body radiotherapy (SBRT) in the right hands can be safe, with low radiation-associated toxicities and with cancer control rates that compare favorably with those produced with external-beam radiotherapy (EBRT), investigators in a multicenter study report.

At 5-year follow-up, there were no grade 4 toxicities, no treatment-related deaths, and just five grade 3 adverse events that occurred in 4 out of 309 patients treated with SBRT, said Robert Meier, MD, at the annual meeting of the American Society for Radiation Oncology.

op@frontlinemedcom.com

BOSTON – For men with newly diagnosed low- or intermediate-risk prostate cancer, stereotactic body radiotherapy (SBRT) in the right hands can be safe, with low radiation-associated toxicities and with cancer control rates that compare favorably with those produced with external-beam radiotherapy (EBRT), investigators in a multicenter study report.

At 5-year follow-up, there were no grade 4 toxicities, no treatment-related deaths, and just five grade 3 adverse events that occurred in 4 out of 309 patients treated with SBRT, said Robert Meier, MD, at the annual meeting of the American Society for Radiation Oncology.

op@frontlinemedcom.com

BOSTON – For men with newly diagnosed low- or intermediate-risk prostate cancer, stereotactic body radiotherapy (SBRT) in the right hands can be safe, with low radiation-associated toxicities and with cancer control rates that compare favorably with those produced with external-beam radiotherapy (EBRT), investigators in a multicenter study report.

At 5-year follow-up, there were no grade 4 toxicities, no treatment-related deaths, and just five grade 3 adverse events that occurred in 4 out of 309 patients treated with SBRT, said Robert Meier, MD, at the annual meeting of the American Society for Radiation Oncology.

op@frontlinemedcom.com

MUNICH – A “bionic pancreas” that delivers glucagon as well as insulin fared well against conventional insulin pump therapy, significantly reducing mean glucose levels and minimizing time spent in hypoglycemia.

The iLet bionic pancreas is being developed by Beta Bionics in conjunction with Eli Lilly and with support from the National Institutes of Health. Beta Bionics bills itself as a public benefit corporation – “a for-profit entity also dedicated to social responsibility and a public benefit mission,” according to an article published by Boston University.

Michele G. Sullivan/Frontline Medical News

msullivan@frontlinemedcom.com

MUNICH – A “bionic pancreas” that delivers glucagon as well as insulin fared well against conventional insulin pump therapy, significantly reducing mean glucose levels and minimizing time spent in hypoglycemia.

The iLet bionic pancreas is being developed by Beta Bionics in conjunction with Eli Lilly and with support from the National Institutes of Health. Beta Bionics bills itself as a public benefit corporation – “a for-profit entity also dedicated to social responsibility and a public benefit mission,” according to an article published by Boston University.

Michele G. Sullivan/Frontline Medical News

msullivan@frontlinemedcom.com

MUNICH – A “bionic pancreas” that delivers glucagon as well as insulin fared well against conventional insulin pump therapy, significantly reducing mean glucose levels and minimizing time spent in hypoglycemia.

The iLet bionic pancreas is being developed by Beta Bionics in conjunction with Eli Lilly and with support from the National Institutes of Health. Beta Bionics bills itself as a public benefit corporation – “a for-profit entity also dedicated to social responsibility and a public benefit mission,” according to an article published by Boston University.

Michele G. Sullivan/Frontline Medical News

msullivan@frontlinemedcom.com

Elimination of the public health threat posed by the hepatitis C virus (HCV) might seem impossible to achieve by 2030, but researchers in Italy say it can be done.

Important elements of success will include the use of oral direct-acting antivirals (DAAs) and a global commitment to prevention.

Earlier this year, the World Health Organization announced plans to wipe out HCV worldwide by 2030 using the time between now and 2021 to reduce the number of annual new

Copyright s-c-s/Thinkstock

With clinical trials consistently demonstrating HCV cure rates in excess of 85%, these short-duration oral treatment courses that are optimally tolerated with no absolute contraindications “offer hope,” especially in combination with best practices in primary prevention, wrote Dr. Lanini and his colleagues.

DAAs – combination therapy of nucleotide analogue inhibitors NS5B and NS5A – are viable treatments across all hepatitis C virus genotypes and are indicated for patients regardless of their potential stage of liver disease, or whether they have failed prior treatments.

Access to these therapies, however, remains at issue.

“We have effective treatments in the form of DAAs but, currently, these are neither affordable nor accessible in many low- and middle-income countries,” study coauthor and scientific director at the Institute, Giuseppe Ippolito, MD, said in a statement. “Global pressure will be required to encourage generic competition to reduce the cost of medicines and diagnostics. This could include direct price negotiations with the pharmaceutical companies responsible for DAA manufacture, differential pricing, [or] voluntary licenses.”

Avoiding the spread of infection will be another key to overcoming HCV, particularly in several African nations such as Nigeria and Egypt, and other lower- and middle-income countries like India, where prevention measures such as screening donated blood for viral contamination are sparse. Worldwide, there is a need for better implementation of protocols to avoid unsafe injections, according to the study authors.

There is also a need for global cooperation and sharing of best practices among nations of all income levels to reduce HCV transmission across high-risk populations such as intravenous drug users and prisoners. Because mother-to-infant transmission prevention measures are essentially ineffective, Dr. Lanini and his colleagues said perinatal prevention of HCV infection should be emphasized. Tattoo and other cosmetic procedures including circumcision are also of concern, the authors wrote, particularly in Western Africa.

Controlling an infectious disease is one thing, but eradicating it takes an entirely different level of commitment, according to Dr. Lanini and his colleagues. There must be an effective intervention that disrupts transmission, such as the DAAs and accurate screening and diagnosis. The infection also must occur only in humans. Additionally, there needs to be a widely held belief among leaders at all levels of government that stopping infection is a relevant public concern; prevention and intervention strategies must meet economic constraints; and epidemiologic support – including access to screening and treatment and tracking of infectious cases – must be in place across all regions, the authors wrote.

Given that these criteria are met, a road map for success largely already exists, according to Dr. Ippolito. “[We] can learn from the innovative HIV service delivery approaches that have already been used successfully in marginalized and vulnerable populations across the world,” he said in the statement.
 

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

Elimination of the public health threat posed by the hepatitis C virus (HCV) might seem impossible to achieve by 2030, but researchers in Italy say it can be done.

Important elements of success will include the use of oral direct-acting antivirals (DAAs) and a global commitment to prevention.

Earlier this year, the World Health Organization announced plans to wipe out HCV worldwide by 2030 using the time between now and 2021 to reduce the number of annual new

Copyright s-c-s/Thinkstock

With clinical trials consistently demonstrating HCV cure rates in excess of 85%, these short-duration oral treatment courses that are optimally tolerated with no absolute contraindications “offer hope,” especially in combination with best practices in primary prevention, wrote Dr. Lanini and his colleagues.

DAAs – combination therapy of nucleotide analogue inhibitors NS5B and NS5A – are viable treatments across all hepatitis C virus genotypes and are indicated for patients regardless of their potential stage of liver disease, or whether they have failed prior treatments.

Access to these therapies, however, remains at issue.

“We have effective treatments in the form of DAAs but, currently, these are neither affordable nor accessible in many low- and middle-income countries,” study coauthor and scientific director at the Institute, Giuseppe Ippolito, MD, said in a statement. “Global pressure will be required to encourage generic competition to reduce the cost of medicines and diagnostics. This could include direct price negotiations with the pharmaceutical companies responsible for DAA manufacture, differential pricing, [or] voluntary licenses.”

Avoiding the spread of infection will be another key to overcoming HCV, particularly in several African nations such as Nigeria and Egypt, and other lower- and middle-income countries like India, where prevention measures such as screening donated blood for viral contamination are sparse. Worldwide, there is a need for better implementation of protocols to avoid unsafe injections, according to the study authors.

There is also a need for global cooperation and sharing of best practices among nations of all income levels to reduce HCV transmission across high-risk populations such as intravenous drug users and prisoners. Because mother-to-infant transmission prevention measures are essentially ineffective, Dr. Lanini and his colleagues said perinatal prevention of HCV infection should be emphasized. Tattoo and other cosmetic procedures including circumcision are also of concern, the authors wrote, particularly in Western Africa.

Controlling an infectious disease is one thing, but eradicating it takes an entirely different level of commitment, according to Dr. Lanini and his colleagues. There must be an effective intervention that disrupts transmission, such as the DAAs and accurate screening and diagnosis. The infection also must occur only in humans. Additionally, there needs to be a widely held belief among leaders at all levels of government that stopping infection is a relevant public concern; prevention and intervention strategies must meet economic constraints; and epidemiologic support – including access to screening and treatment and tracking of infectious cases – must be in place across all regions, the authors wrote.

Given that these criteria are met, a road map for success largely already exists, according to Dr. Ippolito. “[We] can learn from the innovative HIV service delivery approaches that have already been used successfully in marginalized and vulnerable populations across the world,” he said in the statement.
 

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

Elimination of the public health threat posed by the hepatitis C virus (HCV) might seem impossible to achieve by 2030, but researchers in Italy say it can be done.

Important elements of success will include the use of oral direct-acting antivirals (DAAs) and a global commitment to prevention.

Earlier this year, the World Health Organization announced plans to wipe out HCV worldwide by 2030 using the time between now and 2021 to reduce the number of annual new

Copyright s-c-s/Thinkstock

With clinical trials consistently demonstrating HCV cure rates in excess of 85%, these short-duration oral treatment courses that are optimally tolerated with no absolute contraindications “offer hope,” especially in combination with best practices in primary prevention, wrote Dr. Lanini and his colleagues.

DAAs – combination therapy of nucleotide analogue inhibitors NS5B and NS5A – are viable treatments across all hepatitis C virus genotypes and are indicated for patients regardless of their potential stage of liver disease, or whether they have failed prior treatments.

Access to these therapies, however, remains at issue.

“We have effective treatments in the form of DAAs but, currently, these are neither affordable nor accessible in many low- and middle-income countries,” study coauthor and scientific director at the Institute, Giuseppe Ippolito, MD, said in a statement. “Global pressure will be required to encourage generic competition to reduce the cost of medicines and diagnostics. This could include direct price negotiations with the pharmaceutical companies responsible for DAA manufacture, differential pricing, [or] voluntary licenses.”

Avoiding the spread of infection will be another key to overcoming HCV, particularly in several African nations such as Nigeria and Egypt, and other lower- and middle-income countries like India, where prevention measures such as screening donated blood for viral contamination are sparse. Worldwide, there is a need for better implementation of protocols to avoid unsafe injections, according to the study authors.

There is also a need for global cooperation and sharing of best practices among nations of all income levels to reduce HCV transmission across high-risk populations such as intravenous drug users and prisoners. Because mother-to-infant transmission prevention measures are essentially ineffective, Dr. Lanini and his colleagues said perinatal prevention of HCV infection should be emphasized. Tattoo and other cosmetic procedures including circumcision are also of concern, the authors wrote, particularly in Western Africa.

Controlling an infectious disease is one thing, but eradicating it takes an entirely different level of commitment, according to Dr. Lanini and his colleagues. There must be an effective intervention that disrupts transmission, such as the DAAs and accurate screening and diagnosis. The infection also must occur only in humans. Additionally, there needs to be a widely held belief among leaders at all levels of government that stopping infection is a relevant public concern; prevention and intervention strategies must meet economic constraints; and epidemiologic support – including access to screening and treatment and tracking of infectious cases – must be in place across all regions, the authors wrote.

Given that these criteria are met, a road map for success largely already exists, according to Dr. Ippolito. “[We] can learn from the innovative HIV service delivery approaches that have already been used successfully in marginalized and vulnerable populations across the world,” he said in the statement.
 

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

Recent research suggests the novel antimalarial agent KAF156 is effective without visible safety concerns in adults with uncomplicated Plasmodium vivax or P. falciparum malaria, according to a study published in the New England Journal of Medicine.

From March to August 2013, 21 adults with acute uncomplicated malaria (11 with P. vivax malaria and 10 with P. falciparum malaria) were enrolled in multiple-dose cohorts (400 mg of KAF156 given once daily for 3 days). A third cohort of patients was treated with a single 800-mg dose of KAF156 in order to assess the cure rate at 28 days and the potential for a single-dose cure.

CDC/Neva Gleason

llaubach@frontlinemedcom.com

Recent research suggests the novel antimalarial agent KAF156 is effective without visible safety concerns in adults with uncomplicated Plasmodium vivax or P. falciparum malaria, according to a study published in the New England Journal of Medicine.

From March to August 2013, 21 adults with acute uncomplicated malaria (11 with P. vivax malaria and 10 with P. falciparum malaria) were enrolled in multiple-dose cohorts (400 mg of KAF156 given once daily for 3 days). A third cohort of patients was treated with a single 800-mg dose of KAF156 in order to assess the cure rate at 28 days and the potential for a single-dose cure.

CDC/Neva Gleason

llaubach@frontlinemedcom.com

Recent research suggests the novel antimalarial agent KAF156 is effective without visible safety concerns in adults with uncomplicated Plasmodium vivax or P. falciparum malaria, according to a study published in the New England Journal of Medicine.

From March to August 2013, 21 adults with acute uncomplicated malaria (11 with P. vivax malaria and 10 with P. falciparum malaria) were enrolled in multiple-dose cohorts (400 mg of KAF156 given once daily for 3 days). A third cohort of patients was treated with a single 800-mg dose of KAF156 in order to assess the cure rate at 28 days and the potential for a single-dose cure.

CDC/Neva Gleason

llaubach@frontlinemedcom.com

Resective surgery for epilepsy is cost-effective in the medium term, according to a study published online ahead of print September 5 in Epilepsia. A prospective cohort of adult patients with surgically remediable and medically intractable partial epilepsy was followed for more than five years in 15 French centers. During the second year of follow-up, the proportion of patients who had been completely seizure-free for the previous 12 months was 69.0% among participants who underwent surgery and 12.3% in the medical group. The respective rates of seizure freedom were 76.8% and 21% during the fifth year. Direct costs became significantly lower in the surgical group during the third year after surgery as a result of decreased antiepileptic drug use. Surgery became cost-effective between nine and 10 years after surgery.  
 
The NIH Toolbox Cognitive Battery can assess important dimensions of cognition in persons with intellectual disabilities, and several tests may be useful for tracking response to interventions, according to a study published September 6 in the Journal of Neurodevelopmental Disorders. In separate pilot studies of patients with fragile X syndrome, Down syndrome, and idiopathic intellectual disabilities, researchers used the web-based NIH Toolbox Cognitive Battery to measure processing speed, executive function, episodic memory, word and letter reading, receptive vocabulary, and working memory. The test's feasibility was good to excellent for people above mental age 4 for all tests except list sorting. Test-retest stability was good to excellent. More extensive psychometric studies are needed to determine the battery's true utility as a set of outcome measures, said the researchers.  
 
Graded aerobic treadmill testing is a safe, tolerable, and clinically valuable tool that can assist in the evaluation and management of pediatric sports-related concussion, according to a study published online ahead of print September 13 in the Journal of Neurosurgery: Pediatrics. Researchers conducted a retrospective chart review of 106 pediatric patients with sports-related concussion who were referred to a multidisciplinary pediatric concussion program and underwent graded aerobic treadmill testing between October 9, 2014, and February 11, 2016. Treadmill testing confirmed physiologic recovery in 96.9% of 65 patients tested, allowing successful return to play in 93.8% of patients. Of the 41 patients with physiologic post-concussion disorder who had complete follow-up and were treated with tailored submaximal exercise, 90.2% were classified as clinically improved and 80.5% successfully returned to sporting activities.  
 
Exposure to MRI during the first trimester of pregnancy, compared with nonexposure, is not associated with increased risk of harm to the fetus or in early childhood, according to a study published September 6 in JAMA. Gadolinium MRI, however, was associated with an increased risk of rheumatologic, inflammatory, or infiltrative skin conditions, and stillbirth or neonatal death. The study included 1,424,105 deliveries. Researchers compared first-trimester MRI exposure to no MRI exposure. The adjusted relative risk of stillbirth, congenital anomalies, neoplasm, or vision or hearing loss for first-trimester MRI was not significantly higher, compared with no MRI exposure. Comparing gadolinium MRI with no MRI, the adjusted hazard ratio of any rheumatologic, inflammatory, or infiltrative skin condition for first-trimester MRI was 1.36, for an adjusted risk difference of 45.3 per 1,000 person-years.  
 
In women in the United Kingdom, higher BMI is associated with increased risk of ischemic stroke, but decreased risk of hemorrhagic stroke, according to a study published online ahead of print September 7 in Neurology. Researchers recruited 1.3 million previously stroke-free women from the UK between 1996 and 2001 and followed them by record linkage for hospital admissions and deaths. Increased BMI was associated with an increased risk of ischemic stroke, but a decreased risk of hemorrhagic stroke. The BMI-associated trends for ischemic and hemorrhagic stroke were significantly different, but were not significantly different for intracerebral hemorrhage and subarachnoid hemorrhage. Published data from prospective studies showed consistently greater BMI-associated relative risks for ischemic stroke than hemorrhagic stroke, with most evidence before this study coming from Asian populations.
 
Data confirm the relevance of complement biomarkers in mild cognitive impairment (MCI) and Alzheimer's disease, according to a study published September 6 in the Journal of Alzheimer's Disease. Results also indicate the value of multiparameter models for disease prediction and stratification. Researchers studied 292 people to measure five complement proteins and four activation products in plasma from donors with MCI, those with Alzheimer's disease, and healthy controls. Only clusterin differed significantly between control and Alzheimer's disease plasma. Overall, a model combining clusterin with relevant covariables was highly predictive of disease. Clusterin, factor I, and terminal complement complex were significantly different between individuals with MCI who had converted to dementia one year later compared with nonconverters. A model combining these three analytes with informative covariables was highly predictive of conversion.
 
Prenatal exposure to levetiracetam or topiramate may not impair a child's thinking skills, according to a study published online ahead of print August 31 in Neurology. For this cross-sectional observational study, researchers followed women enrolled in the UK Epilepsy and Pregnancy Register. The women received monotherapy levetiracetam, topiramate, or valproate, or took no therapy. Physicians conducted assessor-blinded neuropsychologic assessments of the women's children between ages 5 and 9. In the adjusted analyses, prenatal exposure to levetiracetam and topiramate were not found to be associated with reductions in children's cognitive abilities, and adverse outcomes were not associated with increasing dose. Increasing the dose of valproate was associated with poorer full-scale IQ, verbal abilities, nonverbal abilities, and expressive language ability. The evidence base for newer antiepileptic drugs is limited, said the authors.  
 
At six months, decompressive craniectomy in patients with traumatic brain injury (TBI) and refractory intracranial hypertension results in lower mortality and higher rates of vegetative state and severe disability, compared with medical care, according to a study published online ahead of print September 7 in the New England Journal of Medicine. Researchers randomly assigned 408 patients, ages 10 to 65, with TBI and refractory elevated intracranial pressure to undergo decompressive craniectomy or receive ongoing medical care. At six months, approximately 27% of patients who received a craniectomy had died, compared with 49% of patients who received medical management. Patients who survived after a craniectomy were more likely to be dependent on others for care. At 12 months, mortality was 30% among surgical patients and 52% among medical patients.
 
Contralaterally controlled functional electrical stimulation (CCFES) improves hand dexterity after stroke more than cyclic neuromuscular electrical stimulation (cNMES) does, according to a study published online ahead of print September 8 in Stroke. Researchers enrolled 80 patients with stroke and chronic moderate to severe upper extremity hemiparesis in the study. Participants were randomized to receive 10 sessions per week of CCFES- or cNMES-assisted hand-opening exercise at home, along with 20 sessions of functional task practice in the laboratory for 12 weeks. At six months post treatment, the CCFES group had an improvement of 4.6 on the Box and Block Test, compared with an improvement of 1.8 for the cNMES group. Fugl-Meyer performance and Arm Motor Abilities Test performance did not differ between groups, however.  
 
Antipsychotic use is associated with higher risk of pneumonia, regardless of the choice of drug, according to a study published online ahead of print June 11 in Chest. Researchers investigated whether incident antipsychotic use or specific antipsychotics are related to higher risk of hospitalization or death due to pneumonia in the MEDALZ cohort. The cohort includes all persons who received a clinically verified diagnosis of Alzheimer's disease in Finland from 2005 to 2011. A matched comparison cohort without Alzheimer's disease was used to compare the magnitude of risk. Antipsychotic use was associated with higher risk of pneumonia in the Alzheimer's disease cohort and with somewhat higher risk in the comparison cohort. No major differences were observed between the most commonly used antipsychotics.
 
The FDA has allowed the marketing of two Trevo clot-retrieval devices as an initial therapy to reduce paralysis, speech difficulties, and other disabilities following ischemic stroke. The agency evaluated data from a clinical trial comparing 96 randomly selected patients treated with the Trevo device and t-PA and medical management  with 249 patients who received only t-PA and medical management. Twenty-nine percent of patients treated with the Trevo device were functionally independent at three months after stroke, compared with 19% of patients who were not treated with the Trevo device. These devices should be used within six hours of symptom onset and only following treatment with a clot-dissolving drug, which needs to be given within three hours of symptom onset, said the FDA. Concentric Medical, headquartered in Mountain View, California, markets Trevo.  
 
Class I evidence suggests that for boys with Duchenne muscular dystrophy, daily use of deflazacort or prednisone is effective in preserving muscle strength over a 12-week period, according to a study published online ahead of print August 26 in Neurology. This phase III, double-blind, randomized, placebo-controlled, multicenter study evaluated the muscle strength of 196 boys ages 5 to 15 with Duchenne muscular dystrophy during a 52-week period. Participants received deflazacort, prednisone, or placebo for 12 weeks. At week 13, patients continued active treatment or switched from placebo to active treatment. All treatment groups demonstrated significant improvement in muscle strength, compared with placebo, at 12 weeks. Participants taking prednisone had significantly more weight gain than other participants at 12 weeks and at 52 weeks.  
 
The FDA has granted tentative approval to Supernus Pharmaceuticals's Supplemental New Drug Application (sNDA) requesting a label expansion for Trokendi XR (topiramate) to include prophylaxis of migraine headache in adults. The approval of the sNDA is tentative because the FDA has determined that the drug meets all of the required quality, safety, and efficacy standards for approval, but is subject to the pediatric exclusivity, which expires on March 28, 2017. Final approval may not be made effective until this exclusivity period has expired. The FDA also has granted final approval to expand the label for Trokendi XR for monotherapy treatment of partial onset seizures to include adults and pediatric patients age six and older, rather than age 10 and older. Supernus Pharmaceuticals is headquartered in Rockville, Maryland.

—Kimberly Williams

Resective surgery for epilepsy is cost-effective in the medium term, according to a study published online ahead of print September 5 in Epilepsia. A prospective cohort of adult patients with surgically remediable and medically intractable partial epilepsy was followed for more than five years in 15 French centers. During the second year of follow-up, the proportion of patients who had been completely seizure-free for the previous 12 months was 69.0% among participants who underwent surgery and 12.3% in the medical group. The respective rates of seizure freedom were 76.8% and 21% during the fifth year. Direct costs became significantly lower in the surgical group during the third year after surgery as a result of decreased antiepileptic drug use. Surgery became cost-effective between nine and 10 years after surgery.  
 
The NIH Toolbox Cognitive Battery can assess important dimensions of cognition in persons with intellectual disabilities, and several tests may be useful for tracking response to interventions, according to a study published September 6 in the Journal of Neurodevelopmental Disorders. In separate pilot studies of patients with fragile X syndrome, Down syndrome, and idiopathic intellectual disabilities, researchers used the web-based NIH Toolbox Cognitive Battery to measure processing speed, executive function, episodic memory, word and letter reading, receptive vocabulary, and working memory. The test's feasibility was good to excellent for people above mental age 4 for all tests except list sorting. Test-retest stability was good to excellent. More extensive psychometric studies are needed to determine the battery's true utility as a set of outcome measures, said the researchers.  
 
Graded aerobic treadmill testing is a safe, tolerable, and clinically valuable tool that can assist in the evaluation and management of pediatric sports-related concussion, according to a study published online ahead of print September 13 in the Journal of Neurosurgery: Pediatrics. Researchers conducted a retrospective chart review of 106 pediatric patients with sports-related concussion who were referred to a multidisciplinary pediatric concussion program and underwent graded aerobic treadmill testing between October 9, 2014, and February 11, 2016. Treadmill testing confirmed physiologic recovery in 96.9% of 65 patients tested, allowing successful return to play in 93.8% of patients. Of the 41 patients with physiologic post-concussion disorder who had complete follow-up and were treated with tailored submaximal exercise, 90.2% were classified as clinically improved and 80.5% successfully returned to sporting activities.  
 
Exposure to MRI during the first trimester of pregnancy, compared with nonexposure, is not associated with increased risk of harm to the fetus or in early childhood, according to a study published September 6 in JAMA. Gadolinium MRI, however, was associated with an increased risk of rheumatologic, inflammatory, or infiltrative skin conditions, and stillbirth or neonatal death. The study included 1,424,105 deliveries. Researchers compared first-trimester MRI exposure to no MRI exposure. The adjusted relative risk of stillbirth, congenital anomalies, neoplasm, or vision or hearing loss for first-trimester MRI was not significantly higher, compared with no MRI exposure. Comparing gadolinium MRI with no MRI, the adjusted hazard ratio of any rheumatologic, inflammatory, or infiltrative skin condition for first-trimester MRI was 1.36, for an adjusted risk difference of 45.3 per 1,000 person-years.  
 
In women in the United Kingdom, higher BMI is associated with increased risk of ischemic stroke, but decreased risk of hemorrhagic stroke, according to a study published online ahead of print September 7 in Neurology. Researchers recruited 1.3 million previously stroke-free women from the UK between 1996 and 2001 and followed them by record linkage for hospital admissions and deaths. Increased BMI was associated with an increased risk of ischemic stroke, but a decreased risk of hemorrhagic stroke. The BMI-associated trends for ischemic and hemorrhagic stroke were significantly different, but were not significantly different for intracerebral hemorrhage and subarachnoid hemorrhage. Published data from prospective studies showed consistently greater BMI-associated relative risks for ischemic stroke than hemorrhagic stroke, with most evidence before this study coming from Asian populations.
 
Data confirm the relevance of complement biomarkers in mild cognitive impairment (MCI) and Alzheimer's disease, according to a study published September 6 in the Journal of Alzheimer's Disease. Results also indicate the value of multiparameter models for disease prediction and stratification. Researchers studied 292 people to measure five complement proteins and four activation products in plasma from donors with MCI, those with Alzheimer's disease, and healthy controls. Only clusterin differed significantly between control and Alzheimer's disease plasma. Overall, a model combining clusterin with relevant covariables was highly predictive of disease. Clusterin, factor I, and terminal complement complex were significantly different between individuals with MCI who had converted to dementia one year later compared with nonconverters. A model combining these three analytes with informative covariables was highly predictive of conversion.
 
Prenatal exposure to levetiracetam or topiramate may not impair a child's thinking skills, according to a study published online ahead of print August 31 in Neurology. For this cross-sectional observational study, researchers followed women enrolled in the UK Epilepsy and Pregnancy Register. The women received monotherapy levetiracetam, topiramate, or valproate, or took no therapy. Physicians conducted assessor-blinded neuropsychologic assessments of the women's children between ages 5 and 9. In the adjusted analyses, prenatal exposure to levetiracetam and topiramate were not found to be associated with reductions in children's cognitive abilities, and adverse outcomes were not associated with increasing dose. Increasing the dose of valproate was associated with poorer full-scale IQ, verbal abilities, nonverbal abilities, and expressive language ability. The evidence base for newer antiepileptic drugs is limited, said the authors.  
 
At six months, decompressive craniectomy in patients with traumatic brain injury (TBI) and refractory intracranial hypertension results in lower mortality and higher rates of vegetative state and severe disability, compared with medical care, according to a study published online ahead of print September 7 in the New England Journal of Medicine. Researchers randomly assigned 408 patients, ages 10 to 65, with TBI and refractory elevated intracranial pressure to undergo decompressive craniectomy or receive ongoing medical care. At six months, approximately 27% of patients who received a craniectomy had died, compared with 49% of patients who received medical management. Patients who survived after a craniectomy were more likely to be dependent on others for care. At 12 months, mortality was 30% among surgical patients and 52% among medical patients.
 
Contralaterally controlled functional electrical stimulation (CCFES) improves hand dexterity after stroke more than cyclic neuromuscular electrical stimulation (cNMES) does, according to a study published online ahead of print September 8 in Stroke. Researchers enrolled 80 patients with stroke and chronic moderate to severe upper extremity hemiparesis in the study. Participants were randomized to receive 10 sessions per week of CCFES- or cNMES-assisted hand-opening exercise at home, along with 20 sessions of functional task practice in the laboratory for 12 weeks. At six months post treatment, the CCFES group had an improvement of 4.6 on the Box and Block Test, compared with an improvement of 1.8 for the cNMES group. Fugl-Meyer performance and Arm Motor Abilities Test performance did not differ between groups, however.  
 
Antipsychotic use is associated with higher risk of pneumonia, regardless of the choice of drug, according to a study published online ahead of print June 11 in Chest. Researchers investigated whether incident antipsychotic use or specific antipsychotics are related to higher risk of hospitalization or death due to pneumonia in the MEDALZ cohort. The cohort includes all persons who received a clinically verified diagnosis of Alzheimer's disease in Finland from 2005 to 2011. A matched comparison cohort without Alzheimer's disease was used to compare the magnitude of risk. Antipsychotic use was associated with higher risk of pneumonia in the Alzheimer's disease cohort and with somewhat higher risk in the comparison cohort. No major differences were observed between the most commonly used antipsychotics.
 
The FDA has allowed the marketing of two Trevo clot-retrieval devices as an initial therapy to reduce paralysis, speech difficulties, and other disabilities following ischemic stroke. The agency evaluated data from a clinical trial comparing 96 randomly selected patients treated with the Trevo device and t-PA and medical management  with 249 patients who received only t-PA and medical management. Twenty-nine percent of patients treated with the Trevo device were functionally independent at three months after stroke, compared with 19% of patients who were not treated with the Trevo device. These devices should be used within six hours of symptom onset and only following treatment with a clot-dissolving drug, which needs to be given within three hours of symptom onset, said the FDA. Concentric Medical, headquartered in Mountain View, California, markets Trevo.  
 
Class I evidence suggests that for boys with Duchenne muscular dystrophy, daily use of deflazacort or prednisone is effective in preserving muscle strength over a 12-week period, according to a study published online ahead of print August 26 in Neurology. This phase III, double-blind, randomized, placebo-controlled, multicenter study evaluated the muscle strength of 196 boys ages 5 to 15 with Duchenne muscular dystrophy during a 52-week period. Participants received deflazacort, prednisone, or placebo for 12 weeks. At week 13, patients continued active treatment or switched from placebo to active treatment. All treatment groups demonstrated significant improvement in muscle strength, compared with placebo, at 12 weeks. Participants taking prednisone had significantly more weight gain than other participants at 12 weeks and at 52 weeks.  
 
The FDA has granted tentative approval to Supernus Pharmaceuticals's Supplemental New Drug Application (sNDA) requesting a label expansion for Trokendi XR (topiramate) to include prophylaxis of migraine headache in adults. The approval of the sNDA is tentative because the FDA has determined that the drug meets all of the required quality, safety, and efficacy standards for approval, but is subject to the pediatric exclusivity, which expires on March 28, 2017. Final approval may not be made effective until this exclusivity period has expired. The FDA also has granted final approval to expand the label for Trokendi XR for monotherapy treatment of partial onset seizures to include adults and pediatric patients age six and older, rather than age 10 and older. Supernus Pharmaceuticals is headquartered in Rockville, Maryland.

—Kimberly Williams

Resective surgery for epilepsy is cost-effective in the medium term, according to a study published online ahead of print September 5 in Epilepsia. A prospective cohort of adult patients with surgically remediable and medically intractable partial epilepsy was followed for more than five years in 15 French centers. During the second year of follow-up, the proportion of patients who had been completely seizure-free for the previous 12 months was 69.0% among participants who underwent surgery and 12.3% in the medical group. The respective rates of seizure freedom were 76.8% and 21% during the fifth year. Direct costs became significantly lower in the surgical group during the third year after surgery as a result of decreased antiepileptic drug use. Surgery became cost-effective between nine and 10 years after surgery.  
 
The NIH Toolbox Cognitive Battery can assess important dimensions of cognition in persons with intellectual disabilities, and several tests may be useful for tracking response to interventions, according to a study published September 6 in the Journal of Neurodevelopmental Disorders. In separate pilot studies of patients with fragile X syndrome, Down syndrome, and idiopathic intellectual disabilities, researchers used the web-based NIH Toolbox Cognitive Battery to measure processing speed, executive function, episodic memory, word and letter reading, receptive vocabulary, and working memory. The test's feasibility was good to excellent for people above mental age 4 for all tests except list sorting. Test-retest stability was good to excellent. More extensive psychometric studies are needed to determine the battery's true utility as a set of outcome measures, said the researchers.  
 
Graded aerobic treadmill testing is a safe, tolerable, and clinically valuable tool that can assist in the evaluation and management of pediatric sports-related concussion, according to a study published online ahead of print September 13 in the Journal of Neurosurgery: Pediatrics. Researchers conducted a retrospective chart review of 106 pediatric patients with sports-related concussion who were referred to a multidisciplinary pediatric concussion program and underwent graded aerobic treadmill testing between October 9, 2014, and February 11, 2016. Treadmill testing confirmed physiologic recovery in 96.9% of 65 patients tested, allowing successful return to play in 93.8% of patients. Of the 41 patients with physiologic post-concussion disorder who had complete follow-up and were treated with tailored submaximal exercise, 90.2% were classified as clinically improved and 80.5% successfully returned to sporting activities.  
 
Exposure to MRI during the first trimester of pregnancy, compared with nonexposure, is not associated with increased risk of harm to the fetus or in early childhood, according to a study published September 6 in JAMA. Gadolinium MRI, however, was associated with an increased risk of rheumatologic, inflammatory, or infiltrative skin conditions, and stillbirth or neonatal death. The study included 1,424,105 deliveries. Researchers compared first-trimester MRI exposure to no MRI exposure. The adjusted relative risk of stillbirth, congenital anomalies, neoplasm, or vision or hearing loss for first-trimester MRI was not significantly higher, compared with no MRI exposure. Comparing gadolinium MRI with no MRI, the adjusted hazard ratio of any rheumatologic, inflammatory, or infiltrative skin condition for first-trimester MRI was 1.36, for an adjusted risk difference of 45.3 per 1,000 person-years.  
 
In women in the United Kingdom, higher BMI is associated with increased risk of ischemic stroke, but decreased risk of hemorrhagic stroke, according to a study published online ahead of print September 7 in Neurology. Researchers recruited 1.3 million previously stroke-free women from the UK between 1996 and 2001 and followed them by record linkage for hospital admissions and deaths. Increased BMI was associated with an increased risk of ischemic stroke, but a decreased risk of hemorrhagic stroke. The BMI-associated trends for ischemic and hemorrhagic stroke were significantly different, but were not significantly different for intracerebral hemorrhage and subarachnoid hemorrhage. Published data from prospective studies showed consistently greater BMI-associated relative risks for ischemic stroke than hemorrhagic stroke, with most evidence before this study coming from Asian populations.
 
Data confirm the relevance of complement biomarkers in mild cognitive impairment (MCI) and Alzheimer's disease, according to a study published September 6 in the Journal of Alzheimer's Disease. Results also indicate the value of multiparameter models for disease prediction and stratification. Researchers studied 292 people to measure five complement proteins and four activation products in plasma from donors with MCI, those with Alzheimer's disease, and healthy controls. Only clusterin differed significantly between control and Alzheimer's disease plasma. Overall, a model combining clusterin with relevant covariables was highly predictive of disease. Clusterin, factor I, and terminal complement complex were significantly different between individuals with MCI who had converted to dementia one year later compared with nonconverters. A model combining these three analytes with informative covariables was highly predictive of conversion.
 
Prenatal exposure to levetiracetam or topiramate may not impair a child's thinking skills, according to a study published online ahead of print August 31 in Neurology. For this cross-sectional observational study, researchers followed women enrolled in the UK Epilepsy and Pregnancy Register. The women received monotherapy levetiracetam, topiramate, or valproate, or took no therapy. Physicians conducted assessor-blinded neuropsychologic assessments of the women's children between ages 5 and 9. In the adjusted analyses, prenatal exposure to levetiracetam and topiramate were not found to be associated with reductions in children's cognitive abilities, and adverse outcomes were not associated with increasing dose. Increasing the dose of valproate was associated with poorer full-scale IQ, verbal abilities, nonverbal abilities, and expressive language ability. The evidence base for newer antiepileptic drugs is limited, said the authors.  
 
At six months, decompressive craniectomy in patients with traumatic brain injury (TBI) and refractory intracranial hypertension results in lower mortality and higher rates of vegetative state and severe disability, compared with medical care, according to a study published online ahead of print September 7 in the New England Journal of Medicine. Researchers randomly assigned 408 patients, ages 10 to 65, with TBI and refractory elevated intracranial pressure to undergo decompressive craniectomy or receive ongoing medical care. At six months, approximately 27% of patients who received a craniectomy had died, compared with 49% of patients who received medical management. Patients who survived after a craniectomy were more likely to be dependent on others for care. At 12 months, mortality was 30% among surgical patients and 52% among medical patients.
 
Contralaterally controlled functional electrical stimulation (CCFES) improves hand dexterity after stroke more than cyclic neuromuscular electrical stimulation (cNMES) does, according to a study published online ahead of print September 8 in Stroke. Researchers enrolled 80 patients with stroke and chronic moderate to severe upper extremity hemiparesis in the study. Participants were randomized to receive 10 sessions per week of CCFES- or cNMES-assisted hand-opening exercise at home, along with 20 sessions of functional task practice in the laboratory for 12 weeks. At six months post treatment, the CCFES group had an improvement of 4.6 on the Box and Block Test, compared with an improvement of 1.8 for the cNMES group. Fugl-Meyer performance and Arm Motor Abilities Test performance did not differ between groups, however.  
 
Antipsychotic use is associated with higher risk of pneumonia, regardless of the choice of drug, according to a study published online ahead of print June 11 in Chest. Researchers investigated whether incident antipsychotic use or specific antipsychotics are related to higher risk of hospitalization or death due to pneumonia in the MEDALZ cohort. The cohort includes all persons who received a clinically verified diagnosis of Alzheimer's disease in Finland from 2005 to 2011. A matched comparison cohort without Alzheimer's disease was used to compare the magnitude of risk. Antipsychotic use was associated with higher risk of pneumonia in the Alzheimer's disease cohort and with somewhat higher risk in the comparison cohort. No major differences were observed between the most commonly used antipsychotics.
 
The FDA has allowed the marketing of two Trevo clot-retrieval devices as an initial therapy to reduce paralysis, speech difficulties, and other disabilities following ischemic stroke. The agency evaluated data from a clinical trial comparing 96 randomly selected patients treated with the Trevo device and t-PA and medical management  with 249 patients who received only t-PA and medical management. Twenty-nine percent of patients treated with the Trevo device were functionally independent at three months after stroke, compared with 19% of patients who were not treated with the Trevo device. These devices should be used within six hours of symptom onset and only following treatment with a clot-dissolving drug, which needs to be given within three hours of symptom onset, said the FDA. Concentric Medical, headquartered in Mountain View, California, markets Trevo.  
 
Class I evidence suggests that for boys with Duchenne muscular dystrophy, daily use of deflazacort or prednisone is effective in preserving muscle strength over a 12-week period, according to a study published online ahead of print August 26 in Neurology. This phase III, double-blind, randomized, placebo-controlled, multicenter study evaluated the muscle strength of 196 boys ages 5 to 15 with Duchenne muscular dystrophy during a 52-week period. Participants received deflazacort, prednisone, or placebo for 12 weeks. At week 13, patients continued active treatment or switched from placebo to active treatment. All treatment groups demonstrated significant improvement in muscle strength, compared with placebo, at 12 weeks. Participants taking prednisone had significantly more weight gain than other participants at 12 weeks and at 52 weeks.  
 
The FDA has granted tentative approval to Supernus Pharmaceuticals's Supplemental New Drug Application (sNDA) requesting a label expansion for Trokendi XR (topiramate) to include prophylaxis of migraine headache in adults. The approval of the sNDA is tentative because the FDA has determined that the drug meets all of the required quality, safety, and efficacy standards for approval, but is subject to the pediatric exclusivity, which expires on March 28, 2017. Final approval may not be made effective until this exclusivity period has expired. The FDA also has granted final approval to expand the label for Trokendi XR for monotherapy treatment of partial onset seizures to include adults and pediatric patients age six and older, rather than age 10 and older. Supernus Pharmaceuticals is headquartered in Rockville, Maryland.

—Kimberly Williams

Carmex Comfort Care

Carma Labs Inc introduces Carmex Comfort Care lip balm, a natural lip care product formulated with colloidal oatmeal and cold-pressed fruit oil to deliver soothing, long-lasting moisture and hydration. Colloidal oatmeal also possesses antioxidant and anti-inflammatory properties that benefit sensitive drug skin, especially on the lips. For more information, visit www.mycarmex.com.

Erelzi

Sandoz Inc, a Novartis Division, announces US Food and Drug Administration approval of Erelzi (etanercept-szzs) for all indications included in the reference product label: rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis. Erelzi is the second approved biosimilar from Sandoz. For more information, visit www.erelzi.com.

Loprox Cream

Medimetriks Pharmaceuticals, Inc, announces the launch of Loprox (ciclopirox) Cream 0.77% and the Loprox Cream Kit. Loprox Cream is a broad-spectrum therapy that treats 5 different skin infections from 6 different pathogens. It is indicated for the topical treatment of tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis due to Candia albicans; and tinea (pityriasis) versicolor due to Malassezia furfur. Loprox Cream works quickly, usually within the first week (2 weeks for tinea versicolor), providing patients needed relief of pruritus and other symptoms. The Loprox Cream Kit includes Loprox Cream and Rehyla Hair + Body Cleanser for patient convenience. The cleanser hydrates and conditions and is gentle for daily use on the scalp and body. For more information, visit www.medimetriks.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@frontlinemedcom.com.

Carmex Comfort Care

Carma Labs Inc introduces Carmex Comfort Care lip balm, a natural lip care product formulated with colloidal oatmeal and cold-pressed fruit oil to deliver soothing, long-lasting moisture and hydration. Colloidal oatmeal also possesses antioxidant and anti-inflammatory properties that benefit sensitive drug skin, especially on the lips. For more information, visit www.mycarmex.com.

Erelzi

Sandoz Inc, a Novartis Division, announces US Food and Drug Administration approval of Erelzi (etanercept-szzs) for all indications included in the reference product label: rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis. Erelzi is the second approved biosimilar from Sandoz. For more information, visit www.erelzi.com.

Loprox Cream

Medimetriks Pharmaceuticals, Inc, announces the launch of Loprox (ciclopirox) Cream 0.77% and the Loprox Cream Kit. Loprox Cream is a broad-spectrum therapy that treats 5 different skin infections from 6 different pathogens. It is indicated for the topical treatment of tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis due to Candia albicans; and tinea (pityriasis) versicolor due to Malassezia furfur. Loprox Cream works quickly, usually within the first week (2 weeks for tinea versicolor), providing patients needed relief of pruritus and other symptoms. The Loprox Cream Kit includes Loprox Cream and Rehyla Hair + Body Cleanser for patient convenience. The cleanser hydrates and conditions and is gentle for daily use on the scalp and body. For more information, visit www.medimetriks.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@frontlinemedcom.com.

Carmex Comfort Care

Carma Labs Inc introduces Carmex Comfort Care lip balm, a natural lip care product formulated with colloidal oatmeal and cold-pressed fruit oil to deliver soothing, long-lasting moisture and hydration. Colloidal oatmeal also possesses antioxidant and anti-inflammatory properties that benefit sensitive drug skin, especially on the lips. For more information, visit www.mycarmex.com.

Erelzi

Sandoz Inc, a Novartis Division, announces US Food and Drug Administration approval of Erelzi (etanercept-szzs) for all indications included in the reference product label: rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis. Erelzi is the second approved biosimilar from Sandoz. For more information, visit www.erelzi.com.

Loprox Cream

Medimetriks Pharmaceuticals, Inc, announces the launch of Loprox (ciclopirox) Cream 0.77% and the Loprox Cream Kit. Loprox Cream is a broad-spectrum therapy that treats 5 different skin infections from 6 different pathogens. It is indicated for the topical treatment of tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis due to Candia albicans; and tinea (pityriasis) versicolor due to Malassezia furfur. Loprox Cream works quickly, usually within the first week (2 weeks for tinea versicolor), providing patients needed relief of pruritus and other symptoms. The Loprox Cream Kit includes Loprox Cream and Rehyla Hair + Body Cleanser for patient convenience. The cleanser hydrates and conditions and is gentle for daily use on the scalp and body. For more information, visit www.medimetriks.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@frontlinemedcom.com.