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CMS alerts physicians of payment reductions for PQRS noncompliance
Doctors who did not adequately meet Physician Quality Reporting System (PQRS) requirements in 2016 will soon be receiving notification letters alerting them that their Medicare Part B physician fee schedule payments will be reduced by 2%.
Officials from the Centers for Medicare & Medicaid Services said in a statement that “the majority” of eligible professionals “successfully reported to PQRS and avoided the downward payment adjustment,” but did not state how many doctors are expected to receive letters.
The CMS noted that there are no hardship exemptions to avoid the payment reduction for 2018.
Doctors who did not adequately meet Physician Quality Reporting System (PQRS) requirements in 2016 will soon be receiving notification letters alerting them that their Medicare Part B physician fee schedule payments will be reduced by 2%.
Officials from the Centers for Medicare & Medicaid Services said in a statement that “the majority” of eligible professionals “successfully reported to PQRS and avoided the downward payment adjustment,” but did not state how many doctors are expected to receive letters.
The CMS noted that there are no hardship exemptions to avoid the payment reduction for 2018.
Doctors who did not adequately meet Physician Quality Reporting System (PQRS) requirements in 2016 will soon be receiving notification letters alerting them that their Medicare Part B physician fee schedule payments will be reduced by 2%.
Officials from the Centers for Medicare & Medicaid Services said in a statement that “the majority” of eligible professionals “successfully reported to PQRS and avoided the downward payment adjustment,” but did not state how many doctors are expected to receive letters.
The CMS noted that there are no hardship exemptions to avoid the payment reduction for 2018.
Calcitonin-to-CEA ratio predicts medullary thyroid cancer survival
BOSTON – The ratio of serum calcitonin to the serum level of carcinoembryonic antigen in patients with medullary thyroid cancer can predict which patients have a better chance for survival following thyroidectomy, based on retrospective findings from 164 presurgical patients at one U.S. center.
A lower serum calcitonin–to–serum carcinoembryonic antigen (CEA) ratio following thyroidectomy is a second marker of good postsurgical survival, Tania Jaber, MD, said at the World Congress on Thyroid Cancer.
“Patients want to know whether surgery will cure them, and we have had no prognostic markers to predict this. Depending on the ratio, we can now tell patients whether or not they have a good chance of cure,” said Dr. Jaber, an endocrinological oncologist at MD Anderson in Houston. “Surgery remains the standard of care, so the ratio does not affect the decision of whether to undergo surgery, but it helps patients know what to expect” after surgery, she said in an interview.
“If their ratio is favorable it can be reassuring, and if their ratio is unfavorable it helps set expectations. We are also studying whether the ratio can be a marker for the need for systemic therapy following surgery. Right now, our prognostic tools for medullary thyroid cancer are very limited, so any additional information we can give patients based on their calcitonin-to-CEA ratio is very valuable.”
Her study included 164 patients treated at MD Anderson who had their serum drawn before thyroidectomy, and 187 patients with specimens taken 3-9 months after surgery. Median patient follow-up after surgery was 5 years. Calcitonin levels were measured as pg/mL and CEA levels as ng/mL; despite this difference in unit size the researchers calculated the ratios by a direct numerical comparison that ignored the units.
Among the preoperative patients and specifically among those with a low serum CEA level of less than 25 ng/ML a calcitonin-to-CEA ratio of less than 43 had the best survival rate, Dr. Jaber reported. Among preoperative patients with a CEA level of 25 ng/mL or greater a ratio of less than 18 flagged patients with the best survival rate following thyroidectomy.
Among postoperative patients the ratios that linked with better survival also depended on the CEA level. In patients with a low postoperative CEA a ratio of less than 149 linked with better survival. In patients with a high CEA level a ratio of less than 12 linked with better postoperative survival.
[email protected]
On Twitter @mitchelzoler
BOSTON – The ratio of serum calcitonin to the serum level of carcinoembryonic antigen in patients with medullary thyroid cancer can predict which patients have a better chance for survival following thyroidectomy, based on retrospective findings from 164 presurgical patients at one U.S. center.
A lower serum calcitonin–to–serum carcinoembryonic antigen (CEA) ratio following thyroidectomy is a second marker of good postsurgical survival, Tania Jaber, MD, said at the World Congress on Thyroid Cancer.
“Patients want to know whether surgery will cure them, and we have had no prognostic markers to predict this. Depending on the ratio, we can now tell patients whether or not they have a good chance of cure,” said Dr. Jaber, an endocrinological oncologist at MD Anderson in Houston. “Surgery remains the standard of care, so the ratio does not affect the decision of whether to undergo surgery, but it helps patients know what to expect” after surgery, she said in an interview.
“If their ratio is favorable it can be reassuring, and if their ratio is unfavorable it helps set expectations. We are also studying whether the ratio can be a marker for the need for systemic therapy following surgery. Right now, our prognostic tools for medullary thyroid cancer are very limited, so any additional information we can give patients based on their calcitonin-to-CEA ratio is very valuable.”
Her study included 164 patients treated at MD Anderson who had their serum drawn before thyroidectomy, and 187 patients with specimens taken 3-9 months after surgery. Median patient follow-up after surgery was 5 years. Calcitonin levels were measured as pg/mL and CEA levels as ng/mL; despite this difference in unit size the researchers calculated the ratios by a direct numerical comparison that ignored the units.
Among the preoperative patients and specifically among those with a low serum CEA level of less than 25 ng/ML a calcitonin-to-CEA ratio of less than 43 had the best survival rate, Dr. Jaber reported. Among preoperative patients with a CEA level of 25 ng/mL or greater a ratio of less than 18 flagged patients with the best survival rate following thyroidectomy.
Among postoperative patients the ratios that linked with better survival also depended on the CEA level. In patients with a low postoperative CEA a ratio of less than 149 linked with better survival. In patients with a high CEA level a ratio of less than 12 linked with better postoperative survival.
[email protected]
On Twitter @mitchelzoler
BOSTON – The ratio of serum calcitonin to the serum level of carcinoembryonic antigen in patients with medullary thyroid cancer can predict which patients have a better chance for survival following thyroidectomy, based on retrospective findings from 164 presurgical patients at one U.S. center.
A lower serum calcitonin–to–serum carcinoembryonic antigen (CEA) ratio following thyroidectomy is a second marker of good postsurgical survival, Tania Jaber, MD, said at the World Congress on Thyroid Cancer.
“Patients want to know whether surgery will cure them, and we have had no prognostic markers to predict this. Depending on the ratio, we can now tell patients whether or not they have a good chance of cure,” said Dr. Jaber, an endocrinological oncologist at MD Anderson in Houston. “Surgery remains the standard of care, so the ratio does not affect the decision of whether to undergo surgery, but it helps patients know what to expect” after surgery, she said in an interview.
“If their ratio is favorable it can be reassuring, and if their ratio is unfavorable it helps set expectations. We are also studying whether the ratio can be a marker for the need for systemic therapy following surgery. Right now, our prognostic tools for medullary thyroid cancer are very limited, so any additional information we can give patients based on their calcitonin-to-CEA ratio is very valuable.”
Her study included 164 patients treated at MD Anderson who had their serum drawn before thyroidectomy, and 187 patients with specimens taken 3-9 months after surgery. Median patient follow-up after surgery was 5 years. Calcitonin levels were measured as pg/mL and CEA levels as ng/mL; despite this difference in unit size the researchers calculated the ratios by a direct numerical comparison that ignored the units.
Among the preoperative patients and specifically among those with a low serum CEA level of less than 25 ng/ML a calcitonin-to-CEA ratio of less than 43 had the best survival rate, Dr. Jaber reported. Among preoperative patients with a CEA level of 25 ng/mL or greater a ratio of less than 18 flagged patients with the best survival rate following thyroidectomy.
Among postoperative patients the ratios that linked with better survival also depended on the CEA level. In patients with a low postoperative CEA a ratio of less than 149 linked with better survival. In patients with a high CEA level a ratio of less than 12 linked with better postoperative survival.
[email protected]
On Twitter @mitchelzoler
AT WCTC 2017
Key clinical point:
Major finding: Presurgery, a calcitonin-to-CEA ratio below 18 was linked with superior survival in patients whose CEA was at least 25 ng/Ml.
Data source: A single-center, retrospective study with 164 patients assessed before thyroidectomy and 187 assessed after surgery.
Disclosures: Dr. Jaber had no disclosures.
GERD postop relapse rates highest in women, older adults
Healthy men younger than 45 years have the lowest risk of relapse after reflux surgery compared with other demographic subgroups, according to data from a population-based study of 2,655 adults in Sweden. The findings were published online in JAMA.
“Cohort studies have shown a high risk of recurrent symptoms of GERD after surgery, which may have contributed to the decline in the use of antireflux surgery,” but long-term reflux recurrence rates and potential risk factors have not been well studied, wrote John Maret-Ouda, MD, and colleagues at the Karolinska Institutet in Stockholm, Sweden.
Overall, 18% of the patients suffered a reflux relapse; 84% of these were prescribed long-term medication, and 16% underwent additional surgery.
The highest relapse rates occurred among women, older patients, and those with comorbid conditions. Reflux occurred in 22% of women vs. 14% of men (hazard ratio 1.57), and the hazard ratio was 1.41 for patients aged 61 years and older compared with those aged 45 years and younger. Patients with one or more comorbidities were approximately one-third more likely to have a recurrence of reflux, compared with those who had no comorbidities (hazard ratio 1.36).
Approximately 4% of patients reported complications; the most common complication was infection (1.1%), followed by bleeding (0.9%), and esophageal perforation (0.9%).
The recurrence rate of 18% is low compared with other studies, the researchers noted. Possible reasons for the difference include the population-based design of the current study, which meant that no patients were lost to follow-up, as well as the recent time period, “in which laparoscopic antireflux surgery has become more centralized to expert centers where selection of patients might be stricter and the quality of surgery might be higher,” they wrote.
The study findings were limited by several factors including clinical variations on coding, lack of data on certain confounding variables including body mass index and smoking, and a lack of control GERD patients who did not undergo antireflux surgery, the researchers said. The results suggest that the benefits of laparoscopic antireflux surgery may be diminished by the potential for recurrent GERD, they added.
The Swedish Research Council funded the study. The researchers had no financial conflicts to disclose.
“The operation can be performed with a relatively low rate of morbidity and a very low mortality rate,” Stuart J. Spechler, MD, wrote in an editorial. “Although findings regarding GERD symptom relief and patient satisfaction based on medication usage data should be interpreted with caution, the observation that more than 80% of patients did not restart antireflux medications after laparoscopic antireflux surgery suggests that the operation provided long-lasting relief of GERD symptoms for most patients,” he said. Although surgery is not a permanent cure for all patients with GERD, “the ever-increasing number of proposed [proton pump inhibitor] risks has caused the greatest concern among clinicians and their patients,” said Dr. Spechler. “Whether the greater than 80% possibility of long-term freedom from PPIs and their associated risks warrants the 4% risk of acute surgical complications and the 17.7% risk of GERD recurrence is a decision that individual patients should make after a detailed discussion of these risks and benefits with their physicians,” he said. However, the study findings suggest “that laparoscopic antireflux surgery might be an especially appealing option for young and otherwise healthy men, who seem to have the lowest rate of GERD recurrence after antireflux surgery and who otherwise would likely require decades of PPI treatment without the operation,” he wrote (JAMA 2017;318:913-5).
Dr. Spechler is affiliated with Baylor University in Dallas. He disclosed serving as a consultant for Ironwood Pharmaceuticals and Takeda Pharmaceuticals, and funding support from the National Institutes of Health.
“The operation can be performed with a relatively low rate of morbidity and a very low mortality rate,” Stuart J. Spechler, MD, wrote in an editorial. “Although findings regarding GERD symptom relief and patient satisfaction based on medication usage data should be interpreted with caution, the observation that more than 80% of patients did not restart antireflux medications after laparoscopic antireflux surgery suggests that the operation provided long-lasting relief of GERD symptoms for most patients,” he said. Although surgery is not a permanent cure for all patients with GERD, “the ever-increasing number of proposed [proton pump inhibitor] risks has caused the greatest concern among clinicians and their patients,” said Dr. Spechler. “Whether the greater than 80% possibility of long-term freedom from PPIs and their associated risks warrants the 4% risk of acute surgical complications and the 17.7% risk of GERD recurrence is a decision that individual patients should make after a detailed discussion of these risks and benefits with their physicians,” he said. However, the study findings suggest “that laparoscopic antireflux surgery might be an especially appealing option for young and otherwise healthy men, who seem to have the lowest rate of GERD recurrence after antireflux surgery and who otherwise would likely require decades of PPI treatment without the operation,” he wrote (JAMA 2017;318:913-5).
Dr. Spechler is affiliated with Baylor University in Dallas. He disclosed serving as a consultant for Ironwood Pharmaceuticals and Takeda Pharmaceuticals, and funding support from the National Institutes of Health.
“The operation can be performed with a relatively low rate of morbidity and a very low mortality rate,” Stuart J. Spechler, MD, wrote in an editorial. “Although findings regarding GERD symptom relief and patient satisfaction based on medication usage data should be interpreted with caution, the observation that more than 80% of patients did not restart antireflux medications after laparoscopic antireflux surgery suggests that the operation provided long-lasting relief of GERD symptoms for most patients,” he said. Although surgery is not a permanent cure for all patients with GERD, “the ever-increasing number of proposed [proton pump inhibitor] risks has caused the greatest concern among clinicians and their patients,” said Dr. Spechler. “Whether the greater than 80% possibility of long-term freedom from PPIs and their associated risks warrants the 4% risk of acute surgical complications and the 17.7% risk of GERD recurrence is a decision that individual patients should make after a detailed discussion of these risks and benefits with their physicians,” he said. However, the study findings suggest “that laparoscopic antireflux surgery might be an especially appealing option for young and otherwise healthy men, who seem to have the lowest rate of GERD recurrence after antireflux surgery and who otherwise would likely require decades of PPI treatment without the operation,” he wrote (JAMA 2017;318:913-5).
Dr. Spechler is affiliated with Baylor University in Dallas. He disclosed serving as a consultant for Ironwood Pharmaceuticals and Takeda Pharmaceuticals, and funding support from the National Institutes of Health.
Healthy men younger than 45 years have the lowest risk of relapse after reflux surgery compared with other demographic subgroups, according to data from a population-based study of 2,655 adults in Sweden. The findings were published online in JAMA.
“Cohort studies have shown a high risk of recurrent symptoms of GERD after surgery, which may have contributed to the decline in the use of antireflux surgery,” but long-term reflux recurrence rates and potential risk factors have not been well studied, wrote John Maret-Ouda, MD, and colleagues at the Karolinska Institutet in Stockholm, Sweden.
Overall, 18% of the patients suffered a reflux relapse; 84% of these were prescribed long-term medication, and 16% underwent additional surgery.
The highest relapse rates occurred among women, older patients, and those with comorbid conditions. Reflux occurred in 22% of women vs. 14% of men (hazard ratio 1.57), and the hazard ratio was 1.41 for patients aged 61 years and older compared with those aged 45 years and younger. Patients with one or more comorbidities were approximately one-third more likely to have a recurrence of reflux, compared with those who had no comorbidities (hazard ratio 1.36).
Approximately 4% of patients reported complications; the most common complication was infection (1.1%), followed by bleeding (0.9%), and esophageal perforation (0.9%).
The recurrence rate of 18% is low compared with other studies, the researchers noted. Possible reasons for the difference include the population-based design of the current study, which meant that no patients were lost to follow-up, as well as the recent time period, “in which laparoscopic antireflux surgery has become more centralized to expert centers where selection of patients might be stricter and the quality of surgery might be higher,” they wrote.
The study findings were limited by several factors including clinical variations on coding, lack of data on certain confounding variables including body mass index and smoking, and a lack of control GERD patients who did not undergo antireflux surgery, the researchers said. The results suggest that the benefits of laparoscopic antireflux surgery may be diminished by the potential for recurrent GERD, they added.
The Swedish Research Council funded the study. The researchers had no financial conflicts to disclose.
Healthy men younger than 45 years have the lowest risk of relapse after reflux surgery compared with other demographic subgroups, according to data from a population-based study of 2,655 adults in Sweden. The findings were published online in JAMA.
“Cohort studies have shown a high risk of recurrent symptoms of GERD after surgery, which may have contributed to the decline in the use of antireflux surgery,” but long-term reflux recurrence rates and potential risk factors have not been well studied, wrote John Maret-Ouda, MD, and colleagues at the Karolinska Institutet in Stockholm, Sweden.
Overall, 18% of the patients suffered a reflux relapse; 84% of these were prescribed long-term medication, and 16% underwent additional surgery.
The highest relapse rates occurred among women, older patients, and those with comorbid conditions. Reflux occurred in 22% of women vs. 14% of men (hazard ratio 1.57), and the hazard ratio was 1.41 for patients aged 61 years and older compared with those aged 45 years and younger. Patients with one or more comorbidities were approximately one-third more likely to have a recurrence of reflux, compared with those who had no comorbidities (hazard ratio 1.36).
Approximately 4% of patients reported complications; the most common complication was infection (1.1%), followed by bleeding (0.9%), and esophageal perforation (0.9%).
The recurrence rate of 18% is low compared with other studies, the researchers noted. Possible reasons for the difference include the population-based design of the current study, which meant that no patients were lost to follow-up, as well as the recent time period, “in which laparoscopic antireflux surgery has become more centralized to expert centers where selection of patients might be stricter and the quality of surgery might be higher,” they wrote.
The study findings were limited by several factors including clinical variations on coding, lack of data on certain confounding variables including body mass index and smoking, and a lack of control GERD patients who did not undergo antireflux surgery, the researchers said. The results suggest that the benefits of laparoscopic antireflux surgery may be diminished by the potential for recurrent GERD, they added.
The Swedish Research Council funded the study. The researchers had no financial conflicts to disclose.
FROM JAMA
Key clinical point: Young men were less likely than were other demographic groups to experience recurrence of gastroesophageal reflux after surgery.
Major finding: Overall, 18% of 2,655 adults who underwent reflux surgery experienced recurrent reflux requiring long-term medication or additional surgery.
Data source: A population-based, retrospective cohort study of reflux surgery patients in Sweden.
Disclosures: The Swedish Research Council supported the study.
DACA program in limbo after White House attitude changes
The fate of the Deferred Action for Childhood Arrivals (DACA) program remains uncertain after an unexpected change of tune by President Donald J. Trump to support of protecting young undocumented immigrants from deportation.
Earlier this month, President Trump announced he would phase out the Obama administration’s DACA program, a policy that protected immigrants who came to the United States as children from deportation and authorized them to work in the United States. In a Sept. 5 statement, President Trump said winding down the DACA program was in the nation’s best interest, and that there can be no principled immigration reform if the executive branch is able to “rewrite or nullify federal laws at will.” The Trump administration allowed Congress 6 months to pass legislation that would replace DACA or preserve some of its provisions before the program terminated in March 2018.
In a series of tweets on Sept. 14, President Trump expressed support for those currently protected under DACA, stating an agreement to address the program was in the works.
“Does anybody really want to throw out good, educated, and accomplished young people who have jobs, some serving in the military?” President Trump tweeted. “They have been in our country for many years through no fault of their own – brought in by parents at young age. Plus BIG border security. ... No deal was made last night on DACA. Massive border security would have to be agreed to in exchange for consent. Would be subject to vote.”
“As Congress debates the best ways to address illegal immigration through strong border security and interior enforcement, DACA should be part of those discussions,” Sen. McConnell said in a statement. “We look forward to receiving the Trump administration’s legislative proposal as we continue our work on these issues.”
DACA demise could strand medical students
The DACA program was created by the Obama administration in 2012 as a way of protecting young, undocumented immigrants from deportation after Congress repeatedly blocked legislation that would develop such a safe haven. The policy allowed about 800,000 young adults brought to the United States illegally as children to work legally in the United States and remain in the country without fear of deportation.
If the Trump administration moves forward with termination, the program’s end will affect the growing number of medical students with DACA status and likely jeopardize the funding invested in their training. Sixty-two medical schools accept applications from DACA applicants, according to the Association of American Medical Colleges. For the 2016-2017 school year, 113 students with DACA status applied to U.S. medical schools, and there were 65 medical students enrolled who had DACA status. AAMC does not collect data on medical students with DACA status; the National Resident Matching Program, likewise, does not collect data on residents with DACA status.
“It’s a tragic decision,” Dr. Kuczewski said of the President’s Sept. 5 announcement to end DACA. “It once again puts a cloud over these young people who DACA has given the first real opportunity to come out of the shadows, be educated, and serve the community. Now they’re returned back to the situation of uncertainty.”
If DACA ends, current DACA medical students may not be able to finish their training, and those close to completion may not be able to use their degrees in the workforce, Dr. Kuczewski said. Since they are not citizens, DACA students do not qualify for federal student loans, so medical schools must find ways to help DACA students finance their education. A major Catholic health system provides student loan packages for several DACA students at Loyola’s Stritch School of Medicine, Dr. Kuczewski said. However, such loan programs require DACA status. Without DACA or another path to citizenship, medical students in the middle of training will not be able to obtain financial aid to finish their training, he said. The work authorization that DACA provided will also be eliminated.
Dr. Kuczewski said his university plans to advocate strongly for Congress to pass legislation to protect DACA youth, such as the Development, Relief, and Education for Alien Minors (DREAM) Act. The legislation, which dates back to 2001 with a renewed bill in 2017, would shield young immigrants from deportation and offer a path to citizenship.
“We are going to advocate strongly because we believe this is common sense,” he said. “You don’t just throw away the talents of these young people and the investments they’ve made in their education and the investments we’ve made in them. DACA has given many people the chance to see these young people as students, as employees, as colleagues, and we hope that helps people to mobilize.”
Medical groups push for DREAM Act passage
Dozens of physician and medical associations are also pushing Congress to pass the DREAM Act. On Sept. 14, more than 50 medical and health care groups, including the American Medical Association, the American Academy of Family Physicians, the American College of Physicians, the American Academy of Dermatology Association, and the American Academy of Pediatrics sent a letter to congressional leaders urging them to pass the bill.
“On behalf of the undersigned health professions organizations, we urge you to ensure that all members of the health care workforce with Deferred Action for Childhood Arrivals (DACA) status are able to continue their employment, education, training, and research, with passage of a permanent legislative remedy, such as the bipartisan, bicameral Dream Act of 2017,” the letter stated. “By providing a legal pathway to permanent residency for undocumented Americans brought to the U.S. as children, Congress can help our country produce a diverse and culturally responsive health care workforce to meet the needs of underserved populations, improve cultural awareness, and promote health equity.”
The Immigration Reform Law Institute praised President Trump’s Sept. 5 decision to rescind the DACA program, calling the policy an affront to Congress and a violation of the U.S. Constitution.
“Contrary to former President Obama’s claims, not only is DACA not authorized by federal statute, but prior to the unlawful program, deferred action has only ever been applied to small numbers of illegal aliens on a case-by-case basis,” Dale Wilcox, executive director, said in a statement. “Applying it to approximately 15% of the illegal alien population was never a proper exercise of the president’s discretion under the Constitution and is inconsistent with the president’s duty to take care that the laws be faithfully executed. By rescinding DACA, President Trump has put an end to the previous administration’s flagrant violation of our immigration laws and its abuse of hard-working American taxpayers.”
[email protected]
On Twitter @legal_med
The fate of the Deferred Action for Childhood Arrivals (DACA) program remains uncertain after an unexpected change of tune by President Donald J. Trump to support of protecting young undocumented immigrants from deportation.
Earlier this month, President Trump announced he would phase out the Obama administration’s DACA program, a policy that protected immigrants who came to the United States as children from deportation and authorized them to work in the United States. In a Sept. 5 statement, President Trump said winding down the DACA program was in the nation’s best interest, and that there can be no principled immigration reform if the executive branch is able to “rewrite or nullify federal laws at will.” The Trump administration allowed Congress 6 months to pass legislation that would replace DACA or preserve some of its provisions before the program terminated in March 2018.
In a series of tweets on Sept. 14, President Trump expressed support for those currently protected under DACA, stating an agreement to address the program was in the works.
“Does anybody really want to throw out good, educated, and accomplished young people who have jobs, some serving in the military?” President Trump tweeted. “They have been in our country for many years through no fault of their own – brought in by parents at young age. Plus BIG border security. ... No deal was made last night on DACA. Massive border security would have to be agreed to in exchange for consent. Would be subject to vote.”
“As Congress debates the best ways to address illegal immigration through strong border security and interior enforcement, DACA should be part of those discussions,” Sen. McConnell said in a statement. “We look forward to receiving the Trump administration’s legislative proposal as we continue our work on these issues.”
DACA demise could strand medical students
The DACA program was created by the Obama administration in 2012 as a way of protecting young, undocumented immigrants from deportation after Congress repeatedly blocked legislation that would develop such a safe haven. The policy allowed about 800,000 young adults brought to the United States illegally as children to work legally in the United States and remain in the country without fear of deportation.
If the Trump administration moves forward with termination, the program’s end will affect the growing number of medical students with DACA status and likely jeopardize the funding invested in their training. Sixty-two medical schools accept applications from DACA applicants, according to the Association of American Medical Colleges. For the 2016-2017 school year, 113 students with DACA status applied to U.S. medical schools, and there were 65 medical students enrolled who had DACA status. AAMC does not collect data on medical students with DACA status; the National Resident Matching Program, likewise, does not collect data on residents with DACA status.
“It’s a tragic decision,” Dr. Kuczewski said of the President’s Sept. 5 announcement to end DACA. “It once again puts a cloud over these young people who DACA has given the first real opportunity to come out of the shadows, be educated, and serve the community. Now they’re returned back to the situation of uncertainty.”
If DACA ends, current DACA medical students may not be able to finish their training, and those close to completion may not be able to use their degrees in the workforce, Dr. Kuczewski said. Since they are not citizens, DACA students do not qualify for federal student loans, so medical schools must find ways to help DACA students finance their education. A major Catholic health system provides student loan packages for several DACA students at Loyola’s Stritch School of Medicine, Dr. Kuczewski said. However, such loan programs require DACA status. Without DACA or another path to citizenship, medical students in the middle of training will not be able to obtain financial aid to finish their training, he said. The work authorization that DACA provided will also be eliminated.
Dr. Kuczewski said his university plans to advocate strongly for Congress to pass legislation to protect DACA youth, such as the Development, Relief, and Education for Alien Minors (DREAM) Act. The legislation, which dates back to 2001 with a renewed bill in 2017, would shield young immigrants from deportation and offer a path to citizenship.
“We are going to advocate strongly because we believe this is common sense,” he said. “You don’t just throw away the talents of these young people and the investments they’ve made in their education and the investments we’ve made in them. DACA has given many people the chance to see these young people as students, as employees, as colleagues, and we hope that helps people to mobilize.”
Medical groups push for DREAM Act passage
Dozens of physician and medical associations are also pushing Congress to pass the DREAM Act. On Sept. 14, more than 50 medical and health care groups, including the American Medical Association, the American Academy of Family Physicians, the American College of Physicians, the American Academy of Dermatology Association, and the American Academy of Pediatrics sent a letter to congressional leaders urging them to pass the bill.
“On behalf of the undersigned health professions organizations, we urge you to ensure that all members of the health care workforce with Deferred Action for Childhood Arrivals (DACA) status are able to continue their employment, education, training, and research, with passage of a permanent legislative remedy, such as the bipartisan, bicameral Dream Act of 2017,” the letter stated. “By providing a legal pathway to permanent residency for undocumented Americans brought to the U.S. as children, Congress can help our country produce a diverse and culturally responsive health care workforce to meet the needs of underserved populations, improve cultural awareness, and promote health equity.”
The Immigration Reform Law Institute praised President Trump’s Sept. 5 decision to rescind the DACA program, calling the policy an affront to Congress and a violation of the U.S. Constitution.
“Contrary to former President Obama’s claims, not only is DACA not authorized by federal statute, but prior to the unlawful program, deferred action has only ever been applied to small numbers of illegal aliens on a case-by-case basis,” Dale Wilcox, executive director, said in a statement. “Applying it to approximately 15% of the illegal alien population was never a proper exercise of the president’s discretion under the Constitution and is inconsistent with the president’s duty to take care that the laws be faithfully executed. By rescinding DACA, President Trump has put an end to the previous administration’s flagrant violation of our immigration laws and its abuse of hard-working American taxpayers.”
[email protected]
On Twitter @legal_med
The fate of the Deferred Action for Childhood Arrivals (DACA) program remains uncertain after an unexpected change of tune by President Donald J. Trump to support of protecting young undocumented immigrants from deportation.
Earlier this month, President Trump announced he would phase out the Obama administration’s DACA program, a policy that protected immigrants who came to the United States as children from deportation and authorized them to work in the United States. In a Sept. 5 statement, President Trump said winding down the DACA program was in the nation’s best interest, and that there can be no principled immigration reform if the executive branch is able to “rewrite or nullify federal laws at will.” The Trump administration allowed Congress 6 months to pass legislation that would replace DACA or preserve some of its provisions before the program terminated in March 2018.
In a series of tweets on Sept. 14, President Trump expressed support for those currently protected under DACA, stating an agreement to address the program was in the works.
“Does anybody really want to throw out good, educated, and accomplished young people who have jobs, some serving in the military?” President Trump tweeted. “They have been in our country for many years through no fault of their own – brought in by parents at young age. Plus BIG border security. ... No deal was made last night on DACA. Massive border security would have to be agreed to in exchange for consent. Would be subject to vote.”
“As Congress debates the best ways to address illegal immigration through strong border security and interior enforcement, DACA should be part of those discussions,” Sen. McConnell said in a statement. “We look forward to receiving the Trump administration’s legislative proposal as we continue our work on these issues.”
DACA demise could strand medical students
The DACA program was created by the Obama administration in 2012 as a way of protecting young, undocumented immigrants from deportation after Congress repeatedly blocked legislation that would develop such a safe haven. The policy allowed about 800,000 young adults brought to the United States illegally as children to work legally in the United States and remain in the country without fear of deportation.
If the Trump administration moves forward with termination, the program’s end will affect the growing number of medical students with DACA status and likely jeopardize the funding invested in their training. Sixty-two medical schools accept applications from DACA applicants, according to the Association of American Medical Colleges. For the 2016-2017 school year, 113 students with DACA status applied to U.S. medical schools, and there were 65 medical students enrolled who had DACA status. AAMC does not collect data on medical students with DACA status; the National Resident Matching Program, likewise, does not collect data on residents with DACA status.
“It’s a tragic decision,” Dr. Kuczewski said of the President’s Sept. 5 announcement to end DACA. “It once again puts a cloud over these young people who DACA has given the first real opportunity to come out of the shadows, be educated, and serve the community. Now they’re returned back to the situation of uncertainty.”
If DACA ends, current DACA medical students may not be able to finish their training, and those close to completion may not be able to use their degrees in the workforce, Dr. Kuczewski said. Since they are not citizens, DACA students do not qualify for federal student loans, so medical schools must find ways to help DACA students finance their education. A major Catholic health system provides student loan packages for several DACA students at Loyola’s Stritch School of Medicine, Dr. Kuczewski said. However, such loan programs require DACA status. Without DACA or another path to citizenship, medical students in the middle of training will not be able to obtain financial aid to finish their training, he said. The work authorization that DACA provided will also be eliminated.
Dr. Kuczewski said his university plans to advocate strongly for Congress to pass legislation to protect DACA youth, such as the Development, Relief, and Education for Alien Minors (DREAM) Act. The legislation, which dates back to 2001 with a renewed bill in 2017, would shield young immigrants from deportation and offer a path to citizenship.
“We are going to advocate strongly because we believe this is common sense,” he said. “You don’t just throw away the talents of these young people and the investments they’ve made in their education and the investments we’ve made in them. DACA has given many people the chance to see these young people as students, as employees, as colleagues, and we hope that helps people to mobilize.”
Medical groups push for DREAM Act passage
Dozens of physician and medical associations are also pushing Congress to pass the DREAM Act. On Sept. 14, more than 50 medical and health care groups, including the American Medical Association, the American Academy of Family Physicians, the American College of Physicians, the American Academy of Dermatology Association, and the American Academy of Pediatrics sent a letter to congressional leaders urging them to pass the bill.
“On behalf of the undersigned health professions organizations, we urge you to ensure that all members of the health care workforce with Deferred Action for Childhood Arrivals (DACA) status are able to continue their employment, education, training, and research, with passage of a permanent legislative remedy, such as the bipartisan, bicameral Dream Act of 2017,” the letter stated. “By providing a legal pathway to permanent residency for undocumented Americans brought to the U.S. as children, Congress can help our country produce a diverse and culturally responsive health care workforce to meet the needs of underserved populations, improve cultural awareness, and promote health equity.”
The Immigration Reform Law Institute praised President Trump’s Sept. 5 decision to rescind the DACA program, calling the policy an affront to Congress and a violation of the U.S. Constitution.
“Contrary to former President Obama’s claims, not only is DACA not authorized by federal statute, but prior to the unlawful program, deferred action has only ever been applied to small numbers of illegal aliens on a case-by-case basis,” Dale Wilcox, executive director, said in a statement. “Applying it to approximately 15% of the illegal alien population was never a proper exercise of the president’s discretion under the Constitution and is inconsistent with the president’s duty to take care that the laws be faithfully executed. By rescinding DACA, President Trump has put an end to the previous administration’s flagrant violation of our immigration laws and its abuse of hard-working American taxpayers.”
[email protected]
On Twitter @legal_med
Hepatitis C falls as barrier to heart transplantation
DALLAS – The heart transplant team at Vanderbilt University has successfully placed hearts from deceased, hepatitis C virus–positive patients into recipients, and then eradicated the subsequent infection that appeared in most recipients using a standard regimen.
So far, five of nine heart transplant recipients who developed a posttransplant hepatitis C virus (HCV) infection had the infection eradicated using one of the highly effective HCV drug regimens, and an additional three patients from the series are nearing their 12th week without detectable virus following treatment that marks a sustained response, Kelly H. Schlendorf, MD, said at the annual scientific meeting of the Heart Failure Society of America. The ninth patient died after developing a pulmonary embolism during the 7th week on antiviral therapy.
The recipients have been patients in a marginal clinical state and facing a long projected wait on the heart-recipient queue of the United Network for Organ Sharing (UNOS), Dr. Schlendorf said in an interview.
These have been “patients with a morbidity and mortality risk from waiting that can be mitigated by expanding the donor pool.” She gave an example of a patient with a left ventricular assist device that required replacement by either a second device or transplant, “so getting the transplant quickly was a good thing,” said Dr. Schlendorf, a cardiologist at Vanderbilt in Nashville.
Based on her analysis of UNOS data, “upwards of 100” and perhaps as many as 300 additional donor hearts could be available annually for U.S. transplants if the organs weren’t excluded because of HCV infection.
The Vanderbilt team has so far approached 15 patients in their program wait-listed for hearts about the possibility of accepting an HCV-positive organ, and all 15 have given their consent, she said. “We spend a lot of time talking with patients and their caregivers about the risks and benefits and possible complications.”
The 13 recipients, starting in September 2016, included 12 patients who were HCV naive and 1 patient with a history of HCV exposure. All 13 received the program’s standard three-drug regimen for immunosuppression.
During close surveillance, 9 of the 13 developed an infection. Patients with genotype 1 HCV received 12 weeks of treatment with ledipasvir plus sofosbuvir. Those infected with genotype 3 received 12-24 weeks of treatment with sofosbuvir plus velpatasvir. Treatment with these direct-acting antivirals meant that patients had to adjust the time when they took their proton-pump inhibitors, and they needed to stop treatment with diltiazem and statins while on the antivirals.
“In the era of direct-acting antivirals, HCV-positive donors may provide a safe and effective way to expand the donor pool and reduce wait-list times,” Dr. Schlendorf said. She noted that in recent years an increased number of potential organ donors have been HCV positive. She also cautioned that so far follow-up has been relatively brief, with no patient yet followed as long as 1 year after transplant.
The direct-acting HCV antivirals are expensive, and some payers established clinical criteria that patients must meet to qualify for coverage of these regimens. “We have not encountered difficulties getting insurers to pay,” Dr. Schlendorf said. Despite the antivirals’ cost there are significant cost savings from fewer days in the ICU waiting for heart transplantation and a reduced need for mechanical support as a bridge to transplant, she noted.
[email protected]
On Twitter @mitchelzoler
DALLAS – The heart transplant team at Vanderbilt University has successfully placed hearts from deceased, hepatitis C virus–positive patients into recipients, and then eradicated the subsequent infection that appeared in most recipients using a standard regimen.
So far, five of nine heart transplant recipients who developed a posttransplant hepatitis C virus (HCV) infection had the infection eradicated using one of the highly effective HCV drug regimens, and an additional three patients from the series are nearing their 12th week without detectable virus following treatment that marks a sustained response, Kelly H. Schlendorf, MD, said at the annual scientific meeting of the Heart Failure Society of America. The ninth patient died after developing a pulmonary embolism during the 7th week on antiviral therapy.
The recipients have been patients in a marginal clinical state and facing a long projected wait on the heart-recipient queue of the United Network for Organ Sharing (UNOS), Dr. Schlendorf said in an interview.
These have been “patients with a morbidity and mortality risk from waiting that can be mitigated by expanding the donor pool.” She gave an example of a patient with a left ventricular assist device that required replacement by either a second device or transplant, “so getting the transplant quickly was a good thing,” said Dr. Schlendorf, a cardiologist at Vanderbilt in Nashville.
Based on her analysis of UNOS data, “upwards of 100” and perhaps as many as 300 additional donor hearts could be available annually for U.S. transplants if the organs weren’t excluded because of HCV infection.
The Vanderbilt team has so far approached 15 patients in their program wait-listed for hearts about the possibility of accepting an HCV-positive organ, and all 15 have given their consent, she said. “We spend a lot of time talking with patients and their caregivers about the risks and benefits and possible complications.”
The 13 recipients, starting in September 2016, included 12 patients who were HCV naive and 1 patient with a history of HCV exposure. All 13 received the program’s standard three-drug regimen for immunosuppression.
During close surveillance, 9 of the 13 developed an infection. Patients with genotype 1 HCV received 12 weeks of treatment with ledipasvir plus sofosbuvir. Those infected with genotype 3 received 12-24 weeks of treatment with sofosbuvir plus velpatasvir. Treatment with these direct-acting antivirals meant that patients had to adjust the time when they took their proton-pump inhibitors, and they needed to stop treatment with diltiazem and statins while on the antivirals.
“In the era of direct-acting antivirals, HCV-positive donors may provide a safe and effective way to expand the donor pool and reduce wait-list times,” Dr. Schlendorf said. She noted that in recent years an increased number of potential organ donors have been HCV positive. She also cautioned that so far follow-up has been relatively brief, with no patient yet followed as long as 1 year after transplant.
The direct-acting HCV antivirals are expensive, and some payers established clinical criteria that patients must meet to qualify for coverage of these regimens. “We have not encountered difficulties getting insurers to pay,” Dr. Schlendorf said. Despite the antivirals’ cost there are significant cost savings from fewer days in the ICU waiting for heart transplantation and a reduced need for mechanical support as a bridge to transplant, she noted.
[email protected]
On Twitter @mitchelzoler
DALLAS – The heart transplant team at Vanderbilt University has successfully placed hearts from deceased, hepatitis C virus–positive patients into recipients, and then eradicated the subsequent infection that appeared in most recipients using a standard regimen.
So far, five of nine heart transplant recipients who developed a posttransplant hepatitis C virus (HCV) infection had the infection eradicated using one of the highly effective HCV drug regimens, and an additional three patients from the series are nearing their 12th week without detectable virus following treatment that marks a sustained response, Kelly H. Schlendorf, MD, said at the annual scientific meeting of the Heart Failure Society of America. The ninth patient died after developing a pulmonary embolism during the 7th week on antiviral therapy.
The recipients have been patients in a marginal clinical state and facing a long projected wait on the heart-recipient queue of the United Network for Organ Sharing (UNOS), Dr. Schlendorf said in an interview.
These have been “patients with a morbidity and mortality risk from waiting that can be mitigated by expanding the donor pool.” She gave an example of a patient with a left ventricular assist device that required replacement by either a second device or transplant, “so getting the transplant quickly was a good thing,” said Dr. Schlendorf, a cardiologist at Vanderbilt in Nashville.
Based on her analysis of UNOS data, “upwards of 100” and perhaps as many as 300 additional donor hearts could be available annually for U.S. transplants if the organs weren’t excluded because of HCV infection.
The Vanderbilt team has so far approached 15 patients in their program wait-listed for hearts about the possibility of accepting an HCV-positive organ, and all 15 have given their consent, she said. “We spend a lot of time talking with patients and their caregivers about the risks and benefits and possible complications.”
The 13 recipients, starting in September 2016, included 12 patients who were HCV naive and 1 patient with a history of HCV exposure. All 13 received the program’s standard three-drug regimen for immunosuppression.
During close surveillance, 9 of the 13 developed an infection. Patients with genotype 1 HCV received 12 weeks of treatment with ledipasvir plus sofosbuvir. Those infected with genotype 3 received 12-24 weeks of treatment with sofosbuvir plus velpatasvir. Treatment with these direct-acting antivirals meant that patients had to adjust the time when they took their proton-pump inhibitors, and they needed to stop treatment with diltiazem and statins while on the antivirals.
“In the era of direct-acting antivirals, HCV-positive donors may provide a safe and effective way to expand the donor pool and reduce wait-list times,” Dr. Schlendorf said. She noted that in recent years an increased number of potential organ donors have been HCV positive. She also cautioned that so far follow-up has been relatively brief, with no patient yet followed as long as 1 year after transplant.
The direct-acting HCV antivirals are expensive, and some payers established clinical criteria that patients must meet to qualify for coverage of these regimens. “We have not encountered difficulties getting insurers to pay,” Dr. Schlendorf said. Despite the antivirals’ cost there are significant cost savings from fewer days in the ICU waiting for heart transplantation and a reduced need for mechanical support as a bridge to transplant, she noted.
[email protected]
On Twitter @mitchelzoler
AT THE HFSA ANNUAL SCIENTIFIC MEETING
Key clinical point:
Major finding: Eight of nine patients who developed HCV infection had it eradicated by a direct-acting antiviral regimen.
Data source: A series of 13 patients treated at one U.S. center.
Disclosures: Dr. Schlendorf had no disclosures.
Mitotic rate not tied to SLN biopsy results in thin melanomas
SAN FRANCISCO –
The finding supports the 2017 revision in the American Joint Committee on Cancer guideline, which dropped mitotic rate from its criteria for upstaging thin melanomas.
An earlier version of the guideline, published in 2010, had called for upgrading thin (less than 1 mm), nonulcerated melanomas with a mitotic rate (MR) of at least 1/mm2 to T1B, which could then trigger an SLN biopsy.
SLN biopsy is controversial in thin melanomas, because there is no evidence that it has a survival benefit in these populations, though it is useful as a prognostic measure. However, the procedure carries a risk of complications.
“This makes judicious selection of patients for the procedures even more important,” Heidi Wat, MD, of the division of dermatology at the University of Alberta, Edmonton, said during her presentation of the research at the annual meeting of the Pacific Dermatologic Association.
The researchers set out to determine the predictive value of mitotic rate (the number of cells undergoing cell division) on SLN status, particularly when stratified by tumor thickness. They analyzed 990 SLN biopsy procedures performed in Alberta from January 2007 through December 2013, which were pulled from the Cancer Surgery Alberta tumor database and provincial pathology records. The mean age of the patients was 57 years (range, 15-93 years), and 55% were male; 171 records involved thin melanomas.
Overall, 25.4% of SLN biopsies came back positive, including 8.8% of thin melanomas. Among all cases, there was a statistically significant association between a mitotic rate of 1 or higher and a positive SLN biopsy.
However, when the researchers stratified the results by thickness, they found a statistically significant association only between mitotic rate and SLN biopsy positivity in thicker tumors (1-2 mm, P = .01).
Further analysis of factors including age, ulceration, and tumor location showed that MR and thickness measures were not independent, and the potential for MR to predict SLN biopsy positivity declined at lower thickness values.
“Performing sentinel lymph node biopsy in thin melanomas upstaged purely because of the finding of a single mitotic (event) has questionable clinical value,” said Dr. Wat.
The 2010 AJCC guidelines called for upgrading thin tumors with an MR of 1 or higher, or ulceration, to T1b. The new AJCC guidelines restrict the definition of T1b to tumors 0.8-1.0 mm in size with or without ulceration, or tumors 0.8 mm or smaller with ulceration.
“The results really confirm the latest recommendations,” said Nina Botto, MD, of the department of dermatology at the University of California, San Francisco, who chaired the session in which the research was presented.
SLN status remains a useful prognostic indicator, Dr. Wat said, and MR may still be useful for intermediate and thick melanomas.
Dr. Wat and Dr. Botto reported no relevant financial disclosures.
SAN FRANCISCO –
The finding supports the 2017 revision in the American Joint Committee on Cancer guideline, which dropped mitotic rate from its criteria for upstaging thin melanomas.
An earlier version of the guideline, published in 2010, had called for upgrading thin (less than 1 mm), nonulcerated melanomas with a mitotic rate (MR) of at least 1/mm2 to T1B, which could then trigger an SLN biopsy.
SLN biopsy is controversial in thin melanomas, because there is no evidence that it has a survival benefit in these populations, though it is useful as a prognostic measure. However, the procedure carries a risk of complications.
“This makes judicious selection of patients for the procedures even more important,” Heidi Wat, MD, of the division of dermatology at the University of Alberta, Edmonton, said during her presentation of the research at the annual meeting of the Pacific Dermatologic Association.
The researchers set out to determine the predictive value of mitotic rate (the number of cells undergoing cell division) on SLN status, particularly when stratified by tumor thickness. They analyzed 990 SLN biopsy procedures performed in Alberta from January 2007 through December 2013, which were pulled from the Cancer Surgery Alberta tumor database and provincial pathology records. The mean age of the patients was 57 years (range, 15-93 years), and 55% were male; 171 records involved thin melanomas.
Overall, 25.4% of SLN biopsies came back positive, including 8.8% of thin melanomas. Among all cases, there was a statistically significant association between a mitotic rate of 1 or higher and a positive SLN biopsy.
However, when the researchers stratified the results by thickness, they found a statistically significant association only between mitotic rate and SLN biopsy positivity in thicker tumors (1-2 mm, P = .01).
Further analysis of factors including age, ulceration, and tumor location showed that MR and thickness measures were not independent, and the potential for MR to predict SLN biopsy positivity declined at lower thickness values.
“Performing sentinel lymph node biopsy in thin melanomas upstaged purely because of the finding of a single mitotic (event) has questionable clinical value,” said Dr. Wat.
The 2010 AJCC guidelines called for upgrading thin tumors with an MR of 1 or higher, or ulceration, to T1b. The new AJCC guidelines restrict the definition of T1b to tumors 0.8-1.0 mm in size with or without ulceration, or tumors 0.8 mm or smaller with ulceration.
“The results really confirm the latest recommendations,” said Nina Botto, MD, of the department of dermatology at the University of California, San Francisco, who chaired the session in which the research was presented.
SLN status remains a useful prognostic indicator, Dr. Wat said, and MR may still be useful for intermediate and thick melanomas.
Dr. Wat and Dr. Botto reported no relevant financial disclosures.
SAN FRANCISCO –
The finding supports the 2017 revision in the American Joint Committee on Cancer guideline, which dropped mitotic rate from its criteria for upstaging thin melanomas.
An earlier version of the guideline, published in 2010, had called for upgrading thin (less than 1 mm), nonulcerated melanomas with a mitotic rate (MR) of at least 1/mm2 to T1B, which could then trigger an SLN biopsy.
SLN biopsy is controversial in thin melanomas, because there is no evidence that it has a survival benefit in these populations, though it is useful as a prognostic measure. However, the procedure carries a risk of complications.
“This makes judicious selection of patients for the procedures even more important,” Heidi Wat, MD, of the division of dermatology at the University of Alberta, Edmonton, said during her presentation of the research at the annual meeting of the Pacific Dermatologic Association.
The researchers set out to determine the predictive value of mitotic rate (the number of cells undergoing cell division) on SLN status, particularly when stratified by tumor thickness. They analyzed 990 SLN biopsy procedures performed in Alberta from January 2007 through December 2013, which were pulled from the Cancer Surgery Alberta tumor database and provincial pathology records. The mean age of the patients was 57 years (range, 15-93 years), and 55% were male; 171 records involved thin melanomas.
Overall, 25.4% of SLN biopsies came back positive, including 8.8% of thin melanomas. Among all cases, there was a statistically significant association between a mitotic rate of 1 or higher and a positive SLN biopsy.
However, when the researchers stratified the results by thickness, they found a statistically significant association only between mitotic rate and SLN biopsy positivity in thicker tumors (1-2 mm, P = .01).
Further analysis of factors including age, ulceration, and tumor location showed that MR and thickness measures were not independent, and the potential for MR to predict SLN biopsy positivity declined at lower thickness values.
“Performing sentinel lymph node biopsy in thin melanomas upstaged purely because of the finding of a single mitotic (event) has questionable clinical value,” said Dr. Wat.
The 2010 AJCC guidelines called for upgrading thin tumors with an MR of 1 or higher, or ulceration, to T1b. The new AJCC guidelines restrict the definition of T1b to tumors 0.8-1.0 mm in size with or without ulceration, or tumors 0.8 mm or smaller with ulceration.
“The results really confirm the latest recommendations,” said Nina Botto, MD, of the department of dermatology at the University of California, San Francisco, who chaired the session in which the research was presented.
SLN status remains a useful prognostic indicator, Dr. Wat said, and MR may still be useful for intermediate and thick melanomas.
Dr. Wat and Dr. Botto reported no relevant financial disclosures.
AT PDA 2017
Key clinical point: The results support the latest guidelines, which exclude mitotic rate in the criteria for upstaging thin melanomas.
Major finding: There was no association between mitotic rate and positive sentinel lymph node biopsy results.
Data source: A retrospective analysis of 990 patient records in Alberta, Canada.
Disclosures: Dr. Wat and Dr. Botto reported no relevant financial disclosures.
Doctors testify on health insurance stabilization
WASHINGTON – Physicians testifying before the Senate Health, Education, Labor & Pensions Committee offered recommendations that are generally in line with the narrow, focused legislation to stabilize the individual health insurance markets that Chairman Lamar Alexander (R-Tenn.) is hoping to introduce early in the week of Sept. 17.
Two key provisions of Chairman Alexander’s plan are extending the cost-sharing reduction (CSR) payments to insurers through the end of 2018 and providing additional flexibility to the process that allows states to come up with alternatives to the Affordable Care Act mandates.
Manny Sethi, MD, president of Healthy Tennessee, said he favored repealing and replacing the ACA but offered suggestions to fit the current legislative landscape.
“We must take three steps immediately,” Dr. Sethi, an orthopedic trauma surgeon, testified. “First, in order to stabilize the insurance markets, we must continue the cost-sharing reduction program. Premiums are rapidly rising as insurers fear they will be left bearing the cost. These soaring costs are forcing young members out, saturating the market with higher-need and higher-cost patients and further escalating prices in a troublesome cycle.
“Second, we must quickly create risk pools for those individuals with serious chronic conditions, allowing more affordable coverage options for young, healthy citizens,” Dr. Sethi continued. “Third, I believe a one-size-fits-all plan from Washington, D.C., doesn’t meet the needs of Tennesseans. Open the door for innovation, and allow more flexibility for states to create their own insurance products. For example, a catastrophic plan should be available regardless of age or income status, which is currently not the case.”
Opening the catastrophic plans to all would help bring people into the individual market, even if they don’t have access to any government subsidies, he said.
“Meeting with patients ... I do believe that creating a catastrophic plan open to all ages, all incomes, I think would bring younger folks, and people in general, into the insurance market because I think that’s the problem,” Dr. Sethi said. “You don’t want to pay more for your insurance than you do for your home mortgage. When you do that, something’s wrong.”
Susan Turney, MD, CEO of Marshfield (Wisc.) Clinic Health System, offered similar suggestions. She called for fully funding CSR payments for 2018 and beyond and also recommended creating a reinsurance program, establishing continuous coverage rules that encourage people to get and maintain coverage, enhancing risk adjustment for payments to carriers, and reinstating federal funding for outreach that was recently cut by the Trump administration.
But she also stressed a longer-term goal of how care is delivered, especially in rural areas.
“As we look at this short-term fix to a relatively small group of insured, we have to start thinking differently about how we provide care. The care delivery model needs to be above the payment system, and, once we figure out how to take care of our communities, we can then look differently at the way we support the practices who provide those services,” Dr. Turney said. “Most people don’t ask to get sick. We need to take care of them, and we need to figure out the best way to do that.”
Physicians’ organizations including the American Academy of Family Physicians, American Academy of Pediatrics, American College of Physicians, American Congress of Obstetricians and Gynecologists, American Osteopathic Association, and American Psychiatric Association, submitted a joint statement to the committee that advocated ensuring CSR funding through at least 2019, continuing reinsurance programs, continuing community outreach programs, and expanding public choice through a public option in all exchanges markets.
Chairman Alexander stressed that, in order for this narrowly focused bill to have a chance at passing, it will require a little compromise from both sides of the aisle.
“To get a result, Republicans will have to agree to something – additional funding through the Affordable Care Act – that some are reluctant to support,” he said. “And Democrats will have to agree to something – more flexibility for states – that some may be reluctant to support. I simply won’t be able to persuade the Republican majority in the Senate, the Republican majority in the House, and the Republican president to extend the cost-sharing payments without giving states meaningful flexibility.”
He stressed that the flexibility he is looking for in the 1332 waiver program will not alter consumer protections that are in place, including the ban on charging more for preexisting conditions, guaranteed issue, no annual or lifetime caps on benefits, and allowing those under 26 years of age to remain on their parent’s policy.
“Our goal is to see if we can come to a consensus by early next week so we can hand [Senate Majority Leader Mitch] McConnell and [Senate Minority Leader Chuck] Schumer an agreement that Congress can pass by the end of the month that would help limit premium increases for 18 million Americans next year and begin to lower premiums after that, and to prevent insurers from leaving the markets where those 18 million Americans buy insurance.”
WASHINGTON – Physicians testifying before the Senate Health, Education, Labor & Pensions Committee offered recommendations that are generally in line with the narrow, focused legislation to stabilize the individual health insurance markets that Chairman Lamar Alexander (R-Tenn.) is hoping to introduce early in the week of Sept. 17.
Two key provisions of Chairman Alexander’s plan are extending the cost-sharing reduction (CSR) payments to insurers through the end of 2018 and providing additional flexibility to the process that allows states to come up with alternatives to the Affordable Care Act mandates.
Manny Sethi, MD, president of Healthy Tennessee, said he favored repealing and replacing the ACA but offered suggestions to fit the current legislative landscape.
“We must take three steps immediately,” Dr. Sethi, an orthopedic trauma surgeon, testified. “First, in order to stabilize the insurance markets, we must continue the cost-sharing reduction program. Premiums are rapidly rising as insurers fear they will be left bearing the cost. These soaring costs are forcing young members out, saturating the market with higher-need and higher-cost patients and further escalating prices in a troublesome cycle.
“Second, we must quickly create risk pools for those individuals with serious chronic conditions, allowing more affordable coverage options for young, healthy citizens,” Dr. Sethi continued. “Third, I believe a one-size-fits-all plan from Washington, D.C., doesn’t meet the needs of Tennesseans. Open the door for innovation, and allow more flexibility for states to create their own insurance products. For example, a catastrophic plan should be available regardless of age or income status, which is currently not the case.”
Opening the catastrophic plans to all would help bring people into the individual market, even if they don’t have access to any government subsidies, he said.
“Meeting with patients ... I do believe that creating a catastrophic plan open to all ages, all incomes, I think would bring younger folks, and people in general, into the insurance market because I think that’s the problem,” Dr. Sethi said. “You don’t want to pay more for your insurance than you do for your home mortgage. When you do that, something’s wrong.”
Susan Turney, MD, CEO of Marshfield (Wisc.) Clinic Health System, offered similar suggestions. She called for fully funding CSR payments for 2018 and beyond and also recommended creating a reinsurance program, establishing continuous coverage rules that encourage people to get and maintain coverage, enhancing risk adjustment for payments to carriers, and reinstating federal funding for outreach that was recently cut by the Trump administration.
But she also stressed a longer-term goal of how care is delivered, especially in rural areas.
“As we look at this short-term fix to a relatively small group of insured, we have to start thinking differently about how we provide care. The care delivery model needs to be above the payment system, and, once we figure out how to take care of our communities, we can then look differently at the way we support the practices who provide those services,” Dr. Turney said. “Most people don’t ask to get sick. We need to take care of them, and we need to figure out the best way to do that.”
Physicians’ organizations including the American Academy of Family Physicians, American Academy of Pediatrics, American College of Physicians, American Congress of Obstetricians and Gynecologists, American Osteopathic Association, and American Psychiatric Association, submitted a joint statement to the committee that advocated ensuring CSR funding through at least 2019, continuing reinsurance programs, continuing community outreach programs, and expanding public choice through a public option in all exchanges markets.
Chairman Alexander stressed that, in order for this narrowly focused bill to have a chance at passing, it will require a little compromise from both sides of the aisle.
“To get a result, Republicans will have to agree to something – additional funding through the Affordable Care Act – that some are reluctant to support,” he said. “And Democrats will have to agree to something – more flexibility for states – that some may be reluctant to support. I simply won’t be able to persuade the Republican majority in the Senate, the Republican majority in the House, and the Republican president to extend the cost-sharing payments without giving states meaningful flexibility.”
He stressed that the flexibility he is looking for in the 1332 waiver program will not alter consumer protections that are in place, including the ban on charging more for preexisting conditions, guaranteed issue, no annual or lifetime caps on benefits, and allowing those under 26 years of age to remain on their parent’s policy.
“Our goal is to see if we can come to a consensus by early next week so we can hand [Senate Majority Leader Mitch] McConnell and [Senate Minority Leader Chuck] Schumer an agreement that Congress can pass by the end of the month that would help limit premium increases for 18 million Americans next year and begin to lower premiums after that, and to prevent insurers from leaving the markets where those 18 million Americans buy insurance.”
WASHINGTON – Physicians testifying before the Senate Health, Education, Labor & Pensions Committee offered recommendations that are generally in line with the narrow, focused legislation to stabilize the individual health insurance markets that Chairman Lamar Alexander (R-Tenn.) is hoping to introduce early in the week of Sept. 17.
Two key provisions of Chairman Alexander’s plan are extending the cost-sharing reduction (CSR) payments to insurers through the end of 2018 and providing additional flexibility to the process that allows states to come up with alternatives to the Affordable Care Act mandates.
Manny Sethi, MD, president of Healthy Tennessee, said he favored repealing and replacing the ACA but offered suggestions to fit the current legislative landscape.
“We must take three steps immediately,” Dr. Sethi, an orthopedic trauma surgeon, testified. “First, in order to stabilize the insurance markets, we must continue the cost-sharing reduction program. Premiums are rapidly rising as insurers fear they will be left bearing the cost. These soaring costs are forcing young members out, saturating the market with higher-need and higher-cost patients and further escalating prices in a troublesome cycle.
“Second, we must quickly create risk pools for those individuals with serious chronic conditions, allowing more affordable coverage options for young, healthy citizens,” Dr. Sethi continued. “Third, I believe a one-size-fits-all plan from Washington, D.C., doesn’t meet the needs of Tennesseans. Open the door for innovation, and allow more flexibility for states to create their own insurance products. For example, a catastrophic plan should be available regardless of age or income status, which is currently not the case.”
Opening the catastrophic plans to all would help bring people into the individual market, even if they don’t have access to any government subsidies, he said.
“Meeting with patients ... I do believe that creating a catastrophic plan open to all ages, all incomes, I think would bring younger folks, and people in general, into the insurance market because I think that’s the problem,” Dr. Sethi said. “You don’t want to pay more for your insurance than you do for your home mortgage. When you do that, something’s wrong.”
Susan Turney, MD, CEO of Marshfield (Wisc.) Clinic Health System, offered similar suggestions. She called for fully funding CSR payments for 2018 and beyond and also recommended creating a reinsurance program, establishing continuous coverage rules that encourage people to get and maintain coverage, enhancing risk adjustment for payments to carriers, and reinstating federal funding for outreach that was recently cut by the Trump administration.
But she also stressed a longer-term goal of how care is delivered, especially in rural areas.
“As we look at this short-term fix to a relatively small group of insured, we have to start thinking differently about how we provide care. The care delivery model needs to be above the payment system, and, once we figure out how to take care of our communities, we can then look differently at the way we support the practices who provide those services,” Dr. Turney said. “Most people don’t ask to get sick. We need to take care of them, and we need to figure out the best way to do that.”
Physicians’ organizations including the American Academy of Family Physicians, American Academy of Pediatrics, American College of Physicians, American Congress of Obstetricians and Gynecologists, American Osteopathic Association, and American Psychiatric Association, submitted a joint statement to the committee that advocated ensuring CSR funding through at least 2019, continuing reinsurance programs, continuing community outreach programs, and expanding public choice through a public option in all exchanges markets.
Chairman Alexander stressed that, in order for this narrowly focused bill to have a chance at passing, it will require a little compromise from both sides of the aisle.
“To get a result, Republicans will have to agree to something – additional funding through the Affordable Care Act – that some are reluctant to support,” he said. “And Democrats will have to agree to something – more flexibility for states – that some may be reluctant to support. I simply won’t be able to persuade the Republican majority in the Senate, the Republican majority in the House, and the Republican president to extend the cost-sharing payments without giving states meaningful flexibility.”
He stressed that the flexibility he is looking for in the 1332 waiver program will not alter consumer protections that are in place, including the ban on charging more for preexisting conditions, guaranteed issue, no annual or lifetime caps on benefits, and allowing those under 26 years of age to remain on their parent’s policy.
“Our goal is to see if we can come to a consensus by early next week so we can hand [Senate Majority Leader Mitch] McConnell and [Senate Minority Leader Chuck] Schumer an agreement that Congress can pass by the end of the month that would help limit premium increases for 18 million Americans next year and begin to lower premiums after that, and to prevent insurers from leaving the markets where those 18 million Americans buy insurance.”
AT A SENATE HELP COMMITTEE HEARING
FDA moves to guard against abuse of ‘orphan drug’ program
The Food and Drug Administration is changing the way it approves orphan drugs after revelations that drugmakers may be abusing a law intended to help patients with rare diseases.
In a blog post Sept. 12, FDA Commissioner Scott Gottlieb, MD, said he wants to ensure financial incentives are granted “in a way that’s consistent with the manner Congress intended” when the Orphan Drug Act was passed in 1983. That legislation gave drugmakers a package of incentives, including tax credits, user-fee waivers and 7 years of market exclusivity if they developed medicines for rare diseases.
A Kaiser Health News investigation published in January 2017 found many drugs that now have orphan status aren’t entirely new. Of about 450 drugs that have won orphan approval since 1983, more than 70 were drugs first approved by the FDA for mass-market use. Those include rosuvastatin (Crestor), aripiprazole (Abilify), and adalimumab (Humira), the world’s best-selling drug.
Dr. Gottlieb announced plans to close a loophole that allows manufacturers to skip pediatric testing requirements when developing a common-disease drug for orphan use in children. He also signaled that bigger changes are being considered, announcing a public meeting to explore issues raised by scientific advances, such as the increase in precision medicine and biologics.
“We need to make sure our policies take notice of all of these new challenges and opportunities,” he wrote. Dr. Gottlieb, through his agency, declined multiple requests for interviews.
Over the years, drugmakers have fueled a boom in orphan drugs, which often carry six-figure price tags. Nearly half of the new drugs approved by the FDA are now for rare diseases – even though many of them also treat and are marketed for common diseases.
Dr. Gottlieb became commissioner in May, a few months after three key Republican senators called for a federal investigation into potential abuses of the Orphan Drug Act, and the Government Accountability Office agreed to investigate.
The GAO has yet to begin its investigation, saying it doesn’t expect to start work until late this year, when staff is available. Regardless, in late June, Dr. Gottlieb announced what would be the first in a series of updates that shift the way the FDA handles orphan drugs.
Those include:
- Eliminating a backlog in drug applications for orphan designation or status. Getting a designation is a critical first step if a company wants to win orphan incentives once the drug is approved for treatment use. And, much like the rise in approvals, the requests by companies to get drugs designated with orphan status has also skyrocketed. Dr. Gottlieb said in June that he wanted to get rid of the backlog; his blog post noted the effort was complete. About half of the 200 applications from drugmakers won orphan status.
- Mandating that drugmakers prove their medicine is clinically superior before getting the market exclusivity that comes with orphan drug status. The agency had lost a lawsuit in which a company said it was owed the exclusivity period regardless of whether its medicine was better. And two more lawsuits had been filed by Eagle Pharmaceuticals and United Therapeutics. The FDA Reauthorization Act, which passed in August, made it law that a drug has to be clinically superior to get the incentives.
- Closing the loophole for pediatric orphan drugs by requiring all drugs approved for common adult diseases, like inflammatory bowel disease, undergo pediatric testing when getting approval as a pediatric orphan drug. Pediatric testing is not required for orphan drugs, and last month Congress mandated that orphan drugs for cancer be tested for children. Still, the American Academy of Pediatrics celebrated the proposed change but warned it was only a first step. Bridgette Jones, MD, chair of American Academy of Pediatrics Committee on Drugs, said Sept. 12 that orphan drugs are “still mostly exempt from pediatric study requirements … children deserve access to safe, effective medications.”
Martin Makary, MD, who wrote a critical 2015 paper on orphan approvals, said the changes at the agency indicate that Dr. Gottlieb seems “concerned about all the right things. The government does a lot of lip service in general. This is not lip service.”
The restructuring has been swift in some ways.
Sandra Heibel, PhD, a senior consultant at Haffner Associates, a firm that helps companies submit orphan drug applications, noted that the approval process for designations definitely sped up over the summer, and “we are absolutely getting responses from the FDA back in 90 days. That has come through.”
Other changes to the agency, though, will evolve slowly. For example, the orphan drug office has begun reaching across the FDA’s divisions for help in reviewing drugs. In May, the FDA’s orphan reviews began to work with the office of pediatric therapeutics to review pediatric applications – ideally increasing the expertise applied when considering a company’s request for orphan drug use in children.
In an interview, FDA confirmed that Dr. Gottlieb’s orphan modernization plan is part of a larger effort to increase competition and decrease drug prices. One focus is on targeted drugs – especially those that affect rare diseases or diseases for which there is no effective therapy, the agency said.
“Such drugs present some of the biggest opportunities in medicine to treat and cure debilitating and very costly diseases,” the agency stated.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
The Food and Drug Administration is changing the way it approves orphan drugs after revelations that drugmakers may be abusing a law intended to help patients with rare diseases.
In a blog post Sept. 12, FDA Commissioner Scott Gottlieb, MD, said he wants to ensure financial incentives are granted “in a way that’s consistent with the manner Congress intended” when the Orphan Drug Act was passed in 1983. That legislation gave drugmakers a package of incentives, including tax credits, user-fee waivers and 7 years of market exclusivity if they developed medicines for rare diseases.
A Kaiser Health News investigation published in January 2017 found many drugs that now have orphan status aren’t entirely new. Of about 450 drugs that have won orphan approval since 1983, more than 70 were drugs first approved by the FDA for mass-market use. Those include rosuvastatin (Crestor), aripiprazole (Abilify), and adalimumab (Humira), the world’s best-selling drug.
Dr. Gottlieb announced plans to close a loophole that allows manufacturers to skip pediatric testing requirements when developing a common-disease drug for orphan use in children. He also signaled that bigger changes are being considered, announcing a public meeting to explore issues raised by scientific advances, such as the increase in precision medicine and biologics.
“We need to make sure our policies take notice of all of these new challenges and opportunities,” he wrote. Dr. Gottlieb, through his agency, declined multiple requests for interviews.
Over the years, drugmakers have fueled a boom in orphan drugs, which often carry six-figure price tags. Nearly half of the new drugs approved by the FDA are now for rare diseases – even though many of them also treat and are marketed for common diseases.
Dr. Gottlieb became commissioner in May, a few months after three key Republican senators called for a federal investigation into potential abuses of the Orphan Drug Act, and the Government Accountability Office agreed to investigate.
The GAO has yet to begin its investigation, saying it doesn’t expect to start work until late this year, when staff is available. Regardless, in late June, Dr. Gottlieb announced what would be the first in a series of updates that shift the way the FDA handles orphan drugs.
Those include:
- Eliminating a backlog in drug applications for orphan designation or status. Getting a designation is a critical first step if a company wants to win orphan incentives once the drug is approved for treatment use. And, much like the rise in approvals, the requests by companies to get drugs designated with orphan status has also skyrocketed. Dr. Gottlieb said in June that he wanted to get rid of the backlog; his blog post noted the effort was complete. About half of the 200 applications from drugmakers won orphan status.
- Mandating that drugmakers prove their medicine is clinically superior before getting the market exclusivity that comes with orphan drug status. The agency had lost a lawsuit in which a company said it was owed the exclusivity period regardless of whether its medicine was better. And two more lawsuits had been filed by Eagle Pharmaceuticals and United Therapeutics. The FDA Reauthorization Act, which passed in August, made it law that a drug has to be clinically superior to get the incentives.
- Closing the loophole for pediatric orphan drugs by requiring all drugs approved for common adult diseases, like inflammatory bowel disease, undergo pediatric testing when getting approval as a pediatric orphan drug. Pediatric testing is not required for orphan drugs, and last month Congress mandated that orphan drugs for cancer be tested for children. Still, the American Academy of Pediatrics celebrated the proposed change but warned it was only a first step. Bridgette Jones, MD, chair of American Academy of Pediatrics Committee on Drugs, said Sept. 12 that orphan drugs are “still mostly exempt from pediatric study requirements … children deserve access to safe, effective medications.”
Martin Makary, MD, who wrote a critical 2015 paper on orphan approvals, said the changes at the agency indicate that Dr. Gottlieb seems “concerned about all the right things. The government does a lot of lip service in general. This is not lip service.”
The restructuring has been swift in some ways.
Sandra Heibel, PhD, a senior consultant at Haffner Associates, a firm that helps companies submit orphan drug applications, noted that the approval process for designations definitely sped up over the summer, and “we are absolutely getting responses from the FDA back in 90 days. That has come through.”
Other changes to the agency, though, will evolve slowly. For example, the orphan drug office has begun reaching across the FDA’s divisions for help in reviewing drugs. In May, the FDA’s orphan reviews began to work with the office of pediatric therapeutics to review pediatric applications – ideally increasing the expertise applied when considering a company’s request for orphan drug use in children.
In an interview, FDA confirmed that Dr. Gottlieb’s orphan modernization plan is part of a larger effort to increase competition and decrease drug prices. One focus is on targeted drugs – especially those that affect rare diseases or diseases for which there is no effective therapy, the agency said.
“Such drugs present some of the biggest opportunities in medicine to treat and cure debilitating and very costly diseases,” the agency stated.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
The Food and Drug Administration is changing the way it approves orphan drugs after revelations that drugmakers may be abusing a law intended to help patients with rare diseases.
In a blog post Sept. 12, FDA Commissioner Scott Gottlieb, MD, said he wants to ensure financial incentives are granted “in a way that’s consistent with the manner Congress intended” when the Orphan Drug Act was passed in 1983. That legislation gave drugmakers a package of incentives, including tax credits, user-fee waivers and 7 years of market exclusivity if they developed medicines for rare diseases.
A Kaiser Health News investigation published in January 2017 found many drugs that now have orphan status aren’t entirely new. Of about 450 drugs that have won orphan approval since 1983, more than 70 were drugs first approved by the FDA for mass-market use. Those include rosuvastatin (Crestor), aripiprazole (Abilify), and adalimumab (Humira), the world’s best-selling drug.
Dr. Gottlieb announced plans to close a loophole that allows manufacturers to skip pediatric testing requirements when developing a common-disease drug for orphan use in children. He also signaled that bigger changes are being considered, announcing a public meeting to explore issues raised by scientific advances, such as the increase in precision medicine and biologics.
“We need to make sure our policies take notice of all of these new challenges and opportunities,” he wrote. Dr. Gottlieb, through his agency, declined multiple requests for interviews.
Over the years, drugmakers have fueled a boom in orphan drugs, which often carry six-figure price tags. Nearly half of the new drugs approved by the FDA are now for rare diseases – even though many of them also treat and are marketed for common diseases.
Dr. Gottlieb became commissioner in May, a few months after three key Republican senators called for a federal investigation into potential abuses of the Orphan Drug Act, and the Government Accountability Office agreed to investigate.
The GAO has yet to begin its investigation, saying it doesn’t expect to start work until late this year, when staff is available. Regardless, in late June, Dr. Gottlieb announced what would be the first in a series of updates that shift the way the FDA handles orphan drugs.
Those include:
- Eliminating a backlog in drug applications for orphan designation or status. Getting a designation is a critical first step if a company wants to win orphan incentives once the drug is approved for treatment use. And, much like the rise in approvals, the requests by companies to get drugs designated with orphan status has also skyrocketed. Dr. Gottlieb said in June that he wanted to get rid of the backlog; his blog post noted the effort was complete. About half of the 200 applications from drugmakers won orphan status.
- Mandating that drugmakers prove their medicine is clinically superior before getting the market exclusivity that comes with orphan drug status. The agency had lost a lawsuit in which a company said it was owed the exclusivity period regardless of whether its medicine was better. And two more lawsuits had been filed by Eagle Pharmaceuticals and United Therapeutics. The FDA Reauthorization Act, which passed in August, made it law that a drug has to be clinically superior to get the incentives.
- Closing the loophole for pediatric orphan drugs by requiring all drugs approved for common adult diseases, like inflammatory bowel disease, undergo pediatric testing when getting approval as a pediatric orphan drug. Pediatric testing is not required for orphan drugs, and last month Congress mandated that orphan drugs for cancer be tested for children. Still, the American Academy of Pediatrics celebrated the proposed change but warned it was only a first step. Bridgette Jones, MD, chair of American Academy of Pediatrics Committee on Drugs, said Sept. 12 that orphan drugs are “still mostly exempt from pediatric study requirements … children deserve access to safe, effective medications.”
Martin Makary, MD, who wrote a critical 2015 paper on orphan approvals, said the changes at the agency indicate that Dr. Gottlieb seems “concerned about all the right things. The government does a lot of lip service in general. This is not lip service.”
The restructuring has been swift in some ways.
Sandra Heibel, PhD, a senior consultant at Haffner Associates, a firm that helps companies submit orphan drug applications, noted that the approval process for designations definitely sped up over the summer, and “we are absolutely getting responses from the FDA back in 90 days. That has come through.”
Other changes to the agency, though, will evolve slowly. For example, the orphan drug office has begun reaching across the FDA’s divisions for help in reviewing drugs. In May, the FDA’s orphan reviews began to work with the office of pediatric therapeutics to review pediatric applications – ideally increasing the expertise applied when considering a company’s request for orphan drug use in children.
In an interview, FDA confirmed that Dr. Gottlieb’s orphan modernization plan is part of a larger effort to increase competition and decrease drug prices. One focus is on targeted drugs – especially those that affect rare diseases or diseases for which there is no effective therapy, the agency said.
“Such drugs present some of the biggest opportunities in medicine to treat and cure debilitating and very costly diseases,” the agency stated.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Surgeons strongly influenced chances of contralateral prophylactic mastectomy
Surgeons, not clinical factors, accounted for 20% of variation in rates of contralateral prophylactic mastectomy (CPM), according to the results of a large survey study.
Only 4% of patients elected CPM when their surgeons were among those who least favored it overall and most preferred breast-conserving treatment, according to Steven J. Katz, MD, MPH, of the University of Michigan, Ann Arbor, and his associates. But 34% of patients chose CPM when their surgeons least favored BCT and were most willing to perform CPM, the researchers found. “Attending surgeons exert strong influence on the likelihood of receipt of CPM after diagnosis of breast cancer,” highlighting “the need to help surgeons address this growing clinical conundrum in the examination room,” they wrote (JAMA Surg. 2017 Sep 13. doi: 10.1001/jamasurg.2017.3415).
Rates of CPM have risen markedly in the United States although it has not been shown to confer a survival advantage for average-risk women. To examine how surgeons themselves affected rates of CPM, the investigators sent surveys to 7,810 women treated for stage 0 to II breast cancer from 2013 to 2015 and included in the Surveillance, Epidemiology, and End Results (SEER) registries of Georgia and Los Angeles County. (Among the 7,810 women, 507 were ineligible.) The researchers also surveyed 488 attending surgeons of these patients.
Response rates were high – 70% among patients (5,080 of 7,303) and 77% (377 of 488) among surgeons, the investigators reported. The average age of the patients was 62 years; 28% had an elevated risk of second primary cancer, and 16% underwent CPM. Patients whose surgeons’ rates of CPM exceeded the mean by at least one standard deviation had nearly threefold greater odds of undergoing CPM themselves (odds ratio, 2.8; 95% confidence interval, 2.1-3.4) regardless of age, date of diagnosis, BRCA mutation status, or risk of second primary cancer.
“One quarter of the surgeon influence was explained by attending attitudes about initial recommendations for surgery and responses to patient requests for CPM,” the researchers wrote. Additional predictors of CPM included elevated risk of second primary breast cancer, BRCA mutation, and younger age.
“We observed a range of reasons why a surgeon would be willing to perform CPM if asked: give peace of mind, yield better cosmetic outcomes, avoid conflict with patient, reduce need for surveillance, improve long-term quality of life, reduce recurrence of invasive disease, avoid losing patient to another surgeon, or improve survival (in order of endorsement),” the researchers wrote. “Our findings reinforce the need to address better ways to communicate with patients with regard to their beliefs about the benefits of more extensive surgery and their reactions to the management plan including surgeon training and deployment of decision aids.”
The National Cancer Institute provided funding. The researchers reported having no conflicts of interest.
Patients who are provided education tools regarding the decision between [breast conserving therapy] and mastectomy are more likely to opt for BCT. However, this discussion is arduous and time consuming. We offer decision-making autonomy to patients, but, in creating that autonomy, we have resigned to overtreatment, motivated by the desire to avoid creating conflict in our relationship with the patient.
How do we overcome this hurdle? Consensus statements reinforce that contralateral prophylactic mastectomy should be discouraged in average-risk patients, but it is time to move beyond consensus statements and create communication tools that guide the surgeon and patient through a stepwise informed discussion. We are participating in a multi-institutional randomized trial to develop such an aid, and we believe this will effect real change in the way surgeons counsel patients. The goal is to standardize the methods and information patients receive to ensure that their decisions are based on facts, not fear.
Julie A. Margenthaler, MD, and Amy E. Cyr, MD, are in the department of surgery, Washington University, St. Louis. They reported no conflicts of interest. These comments are from their editorial (JAMA Surg. 2017 Sep 13. doi: 10.1001/jamasurg.2017.3435).
Patients who are provided education tools regarding the decision between [breast conserving therapy] and mastectomy are more likely to opt for BCT. However, this discussion is arduous and time consuming. We offer decision-making autonomy to patients, but, in creating that autonomy, we have resigned to overtreatment, motivated by the desire to avoid creating conflict in our relationship with the patient.
How do we overcome this hurdle? Consensus statements reinforce that contralateral prophylactic mastectomy should be discouraged in average-risk patients, but it is time to move beyond consensus statements and create communication tools that guide the surgeon and patient through a stepwise informed discussion. We are participating in a multi-institutional randomized trial to develop such an aid, and we believe this will effect real change in the way surgeons counsel patients. The goal is to standardize the methods and information patients receive to ensure that their decisions are based on facts, not fear.
Julie A. Margenthaler, MD, and Amy E. Cyr, MD, are in the department of surgery, Washington University, St. Louis. They reported no conflicts of interest. These comments are from their editorial (JAMA Surg. 2017 Sep 13. doi: 10.1001/jamasurg.2017.3435).
Patients who are provided education tools regarding the decision between [breast conserving therapy] and mastectomy are more likely to opt for BCT. However, this discussion is arduous and time consuming. We offer decision-making autonomy to patients, but, in creating that autonomy, we have resigned to overtreatment, motivated by the desire to avoid creating conflict in our relationship with the patient.
How do we overcome this hurdle? Consensus statements reinforce that contralateral prophylactic mastectomy should be discouraged in average-risk patients, but it is time to move beyond consensus statements and create communication tools that guide the surgeon and patient through a stepwise informed discussion. We are participating in a multi-institutional randomized trial to develop such an aid, and we believe this will effect real change in the way surgeons counsel patients. The goal is to standardize the methods and information patients receive to ensure that their decisions are based on facts, not fear.
Julie A. Margenthaler, MD, and Amy E. Cyr, MD, are in the department of surgery, Washington University, St. Louis. They reported no conflicts of interest. These comments are from their editorial (JAMA Surg. 2017 Sep 13. doi: 10.1001/jamasurg.2017.3435).
Surgeons, not clinical factors, accounted for 20% of variation in rates of contralateral prophylactic mastectomy (CPM), according to the results of a large survey study.
Only 4% of patients elected CPM when their surgeons were among those who least favored it overall and most preferred breast-conserving treatment, according to Steven J. Katz, MD, MPH, of the University of Michigan, Ann Arbor, and his associates. But 34% of patients chose CPM when their surgeons least favored BCT and were most willing to perform CPM, the researchers found. “Attending surgeons exert strong influence on the likelihood of receipt of CPM after diagnosis of breast cancer,” highlighting “the need to help surgeons address this growing clinical conundrum in the examination room,” they wrote (JAMA Surg. 2017 Sep 13. doi: 10.1001/jamasurg.2017.3415).
Rates of CPM have risen markedly in the United States although it has not been shown to confer a survival advantage for average-risk women. To examine how surgeons themselves affected rates of CPM, the investigators sent surveys to 7,810 women treated for stage 0 to II breast cancer from 2013 to 2015 and included in the Surveillance, Epidemiology, and End Results (SEER) registries of Georgia and Los Angeles County. (Among the 7,810 women, 507 were ineligible.) The researchers also surveyed 488 attending surgeons of these patients.
Response rates were high – 70% among patients (5,080 of 7,303) and 77% (377 of 488) among surgeons, the investigators reported. The average age of the patients was 62 years; 28% had an elevated risk of second primary cancer, and 16% underwent CPM. Patients whose surgeons’ rates of CPM exceeded the mean by at least one standard deviation had nearly threefold greater odds of undergoing CPM themselves (odds ratio, 2.8; 95% confidence interval, 2.1-3.4) regardless of age, date of diagnosis, BRCA mutation status, or risk of second primary cancer.
“One quarter of the surgeon influence was explained by attending attitudes about initial recommendations for surgery and responses to patient requests for CPM,” the researchers wrote. Additional predictors of CPM included elevated risk of second primary breast cancer, BRCA mutation, and younger age.
“We observed a range of reasons why a surgeon would be willing to perform CPM if asked: give peace of mind, yield better cosmetic outcomes, avoid conflict with patient, reduce need for surveillance, improve long-term quality of life, reduce recurrence of invasive disease, avoid losing patient to another surgeon, or improve survival (in order of endorsement),” the researchers wrote. “Our findings reinforce the need to address better ways to communicate with patients with regard to their beliefs about the benefits of more extensive surgery and their reactions to the management plan including surgeon training and deployment of decision aids.”
The National Cancer Institute provided funding. The researchers reported having no conflicts of interest.
Surgeons, not clinical factors, accounted for 20% of variation in rates of contralateral prophylactic mastectomy (CPM), according to the results of a large survey study.
Only 4% of patients elected CPM when their surgeons were among those who least favored it overall and most preferred breast-conserving treatment, according to Steven J. Katz, MD, MPH, of the University of Michigan, Ann Arbor, and his associates. But 34% of patients chose CPM when their surgeons least favored BCT and were most willing to perform CPM, the researchers found. “Attending surgeons exert strong influence on the likelihood of receipt of CPM after diagnosis of breast cancer,” highlighting “the need to help surgeons address this growing clinical conundrum in the examination room,” they wrote (JAMA Surg. 2017 Sep 13. doi: 10.1001/jamasurg.2017.3415).
Rates of CPM have risen markedly in the United States although it has not been shown to confer a survival advantage for average-risk women. To examine how surgeons themselves affected rates of CPM, the investigators sent surveys to 7,810 women treated for stage 0 to II breast cancer from 2013 to 2015 and included in the Surveillance, Epidemiology, and End Results (SEER) registries of Georgia and Los Angeles County. (Among the 7,810 women, 507 were ineligible.) The researchers also surveyed 488 attending surgeons of these patients.
Response rates were high – 70% among patients (5,080 of 7,303) and 77% (377 of 488) among surgeons, the investigators reported. The average age of the patients was 62 years; 28% had an elevated risk of second primary cancer, and 16% underwent CPM. Patients whose surgeons’ rates of CPM exceeded the mean by at least one standard deviation had nearly threefold greater odds of undergoing CPM themselves (odds ratio, 2.8; 95% confidence interval, 2.1-3.4) regardless of age, date of diagnosis, BRCA mutation status, or risk of second primary cancer.
“One quarter of the surgeon influence was explained by attending attitudes about initial recommendations for surgery and responses to patient requests for CPM,” the researchers wrote. Additional predictors of CPM included elevated risk of second primary breast cancer, BRCA mutation, and younger age.
“We observed a range of reasons why a surgeon would be willing to perform CPM if asked: give peace of mind, yield better cosmetic outcomes, avoid conflict with patient, reduce need for surveillance, improve long-term quality of life, reduce recurrence of invasive disease, avoid losing patient to another surgeon, or improve survival (in order of endorsement),” the researchers wrote. “Our findings reinforce the need to address better ways to communicate with patients with regard to their beliefs about the benefits of more extensive surgery and their reactions to the management plan including surgeon training and deployment of decision aids.”
The National Cancer Institute provided funding. The researchers reported having no conflicts of interest.
FROM JAMA SURGERY
Key clinical point: Attending surgeons explained 20% of variation in rates of contralateral prophylactic mastectomy.
Major finding: Only 4% of patients elected CPM when their surgeons were among those who least favored it and most preferred breast-conserving treatment (BCT). However, 34% of patients chose CPM when their surgeons least favored initial BCT and were most willing to perform CPM.
Data source: Surveys of 5,080 patients with stage 0-II breast cancer and 339 attending surgeons.
Disclosures: The National Cancer Institute provided funding. The researchers reported having no conflicts of interest.
Uninsured rate falls to record low of 8.8%
Three years after the Affordable Care Act’s coverage expansion took effect, the number of Americans without health insurance fell to 28.1 million in 2016, down from 29 million in 2015, according to a federal report released Sept. 12.
The latest numbers from the U.S. Census Bureau showed the nation’s uninsured rate dropped to 8.8%. It had been 9.1% in 2015.
Both the overall number of uninsured and the percentage are record lows.
The latest figures from the Census Bureau effectively close the book on President Barack Obama’s record on lowering the number of uninsured. He made that a linchpin of his 2008 campaign, and his administration’s effort to overhaul the nation’s health system through the ACA focused on expanding coverage.
When Mr. Obama took office in 2009, during the worst economic recession since the Great Depression, more than 50 million Americans were uninsured, or nearly 17% of the population.
The number of uninsured has fallen from 42 million in 2013 – before the ACA in 2014 allowed states to expand Medicaid, the federal-state program that provides coverage to low-income people, and provided federal subsidies to help lower- and middle-income Americans buy coverage on the insurance marketplaces. The decline also reflected the improving economy, which has put more Americans in jobs that offer health coverage.
The dramatic drop in the uninsured over the past few years played a major role in the congressional debate over the summer about whether to replace the 2010 health law. Advocates pleaded with the Republican-controlled Congress not to take steps to reverse the gains in coverage.
The Census Bureau numbers are considered the gold standard for tracking who has insurance because the survey samples are so large.
The uninsured rate has fallen in all 50 states and the District of Columbia since 2013, although the rate has been lower among the 31 states that expanded Medicaid as part of the health law. The lowest uninsured rate last year was 2.5% in Massachusetts, and the highest was 16.6% in Texas, the Census Bureau reported. States that expanded Medicaid had an average uninsured rate of 6.5%, compared with an 11.7% average among states that did not expand.
More than half of Americans – 55.7% – get health insurance through their jobs. But government coverage is becoming more common. Medicaid now covers more than 19% of the population and Medicare, nearly 17%.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Three years after the Affordable Care Act’s coverage expansion took effect, the number of Americans without health insurance fell to 28.1 million in 2016, down from 29 million in 2015, according to a federal report released Sept. 12.
The latest numbers from the U.S. Census Bureau showed the nation’s uninsured rate dropped to 8.8%. It had been 9.1% in 2015.
Both the overall number of uninsured and the percentage are record lows.
The latest figures from the Census Bureau effectively close the book on President Barack Obama’s record on lowering the number of uninsured. He made that a linchpin of his 2008 campaign, and his administration’s effort to overhaul the nation’s health system through the ACA focused on expanding coverage.
When Mr. Obama took office in 2009, during the worst economic recession since the Great Depression, more than 50 million Americans were uninsured, or nearly 17% of the population.
The number of uninsured has fallen from 42 million in 2013 – before the ACA in 2014 allowed states to expand Medicaid, the federal-state program that provides coverage to low-income people, and provided federal subsidies to help lower- and middle-income Americans buy coverage on the insurance marketplaces. The decline also reflected the improving economy, which has put more Americans in jobs that offer health coverage.
The dramatic drop in the uninsured over the past few years played a major role in the congressional debate over the summer about whether to replace the 2010 health law. Advocates pleaded with the Republican-controlled Congress not to take steps to reverse the gains in coverage.
The Census Bureau numbers are considered the gold standard for tracking who has insurance because the survey samples are so large.
The uninsured rate has fallen in all 50 states and the District of Columbia since 2013, although the rate has been lower among the 31 states that expanded Medicaid as part of the health law. The lowest uninsured rate last year was 2.5% in Massachusetts, and the highest was 16.6% in Texas, the Census Bureau reported. States that expanded Medicaid had an average uninsured rate of 6.5%, compared with an 11.7% average among states that did not expand.
More than half of Americans – 55.7% – get health insurance through their jobs. But government coverage is becoming more common. Medicaid now covers more than 19% of the population and Medicare, nearly 17%.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Three years after the Affordable Care Act’s coverage expansion took effect, the number of Americans without health insurance fell to 28.1 million in 2016, down from 29 million in 2015, according to a federal report released Sept. 12.
The latest numbers from the U.S. Census Bureau showed the nation’s uninsured rate dropped to 8.8%. It had been 9.1% in 2015.
Both the overall number of uninsured and the percentage are record lows.
The latest figures from the Census Bureau effectively close the book on President Barack Obama’s record on lowering the number of uninsured. He made that a linchpin of his 2008 campaign, and his administration’s effort to overhaul the nation’s health system through the ACA focused on expanding coverage.
When Mr. Obama took office in 2009, during the worst economic recession since the Great Depression, more than 50 million Americans were uninsured, or nearly 17% of the population.
The number of uninsured has fallen from 42 million in 2013 – before the ACA in 2014 allowed states to expand Medicaid, the federal-state program that provides coverage to low-income people, and provided federal subsidies to help lower- and middle-income Americans buy coverage on the insurance marketplaces. The decline also reflected the improving economy, which has put more Americans in jobs that offer health coverage.
The dramatic drop in the uninsured over the past few years played a major role in the congressional debate over the summer about whether to replace the 2010 health law. Advocates pleaded with the Republican-controlled Congress not to take steps to reverse the gains in coverage.
The Census Bureau numbers are considered the gold standard for tracking who has insurance because the survey samples are so large.
The uninsured rate has fallen in all 50 states and the District of Columbia since 2013, although the rate has been lower among the 31 states that expanded Medicaid as part of the health law. The lowest uninsured rate last year was 2.5% in Massachusetts, and the highest was 16.6% in Texas, the Census Bureau reported. States that expanded Medicaid had an average uninsured rate of 6.5%, compared with an 11.7% average among states that did not expand.
More than half of Americans – 55.7% – get health insurance through their jobs. But government coverage is becoming more common. Medicaid now covers more than 19% of the population and Medicare, nearly 17%.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.