Thoracic Surgery News (Archived)

Progression free survival was significantly better in unresectable stage 3 non–small cell lung cancer when patients were treated with durvalumab in combination with other immunotherapies, instead of durvalumab alone, following chemoradiotherapy.

Both combinations – durvalumab plus either the anti-CD73 monoclonal antibody oleclumab or the anti-NKG2A mAb monalizumab – also numerically improved objective response rate. “Safety profiles were consistent across arms and no new safety signals were identified,” said Alexandre Martinez-Marti, MD, the lead investigator on the phase 2 trial, dubbed COAST, which he presented (abstract LBA42) at the 2021 European Society for Medical Oncology Congress on Sept. 17.

“These data support further evaluations of these combinations,” said Dr. Martinez-Marti, also a thoracic medical oncologist at the Vall d’Hebron Institute of Oncology in Barcelona.

Durvalumab is already established as a standard of care option for patients with unresectable stage 3 NSCLC who don’t progress after concurrent chemoradiation. There’s been preliminary data suggesting the benefits might be greater with oleclumab or monalizumab, so the study team looked into the issue.

They randomized 66 patients with unresectable stage 3 NSCLC and no progression after chemoradiotherapy to durvalumab 1,500 mg IV every 4 weeks; 59 others to durvalumab at the same dosage plus oleclumab 3,000 mg IV every 2 weeks for the first two cycles then every 4 weeks, and 61 were randomized to durvalumab plus monalizumab 750 mg IV every 2 weeks.

Patients were treated for up to 12 months, and they started treatment no later than 42 days after completing chemoradiation.

Over a median follow-up of 11.5 months, median progression-free survival (PFS) was 6.3 months in the durvalumab arm, but 15.1 months with the monalizumab combination (PFS hazard ratio versus durvalumab alone, 0.65; 95% CI, 0.49-0.85), and not reached in the oleclumab arm (PFS HR, 0.44; 95% CI, 0.26-0.75).

There were only a few complete responders across the study groups. Partial responses rates were 22.4% of the durvalumab alone arm, 36.7% in the oleclumab group, and 32.3% in the monalizumab arm.

The investigator assessed objective response rate was 25.4% with durvalumab alone, 38.3% in the oleclumab group, and 37.1% with the monalizumab combination. Curves started to separate from durvalumab monotherapy at around 2-4 months.

“Overall, the safety profiles of the two combinations were generally similar to the safety profile of durvalumab alone,” Dr. Martinez-Marti said. The rate of grade 3 or higher treatment-emergent events incidence was 39.4% with durvalumab, 40.7% the oleclumab combination, and 27.9% with monalizumab.

The most common grade 3/4 events were pneumonia (5.9%) and decreased lymphocyte count (3.2%); both were less common with the monalizumab combination.

Combined rates of pneumonitis and radiation pneumonitis of any grade were 21.2% with durvalumab, 28.8% in the oleclumab group, and 21.3% with monalizumab.

The groups were generally well balanced at baseline. The majority of subjects were men, White, and former smokers. Most subjects had stage 3A or 3B disease.

The work was funded by AstraZeneca. The investigators disclosed numerous ties to the company, including Dr. Martinez-Marti, who reported personal fees, travel expenses, and other connections.

This article was updated 9/24/21.

aotto@mdedge.com

Progression free survival was significantly better in unresectable stage 3 non–small cell lung cancer when patients were treated with durvalumab in combination with other immunotherapies, instead of durvalumab alone, following chemoradiotherapy.

Both combinations – durvalumab plus either the anti-CD73 monoclonal antibody oleclumab or the anti-NKG2A mAb monalizumab – also numerically improved objective response rate. “Safety profiles were consistent across arms and no new safety signals were identified,” said Alexandre Martinez-Marti, MD, the lead investigator on the phase 2 trial, dubbed COAST, which he presented (abstract LBA42) at the 2021 European Society for Medical Oncology Congress on Sept. 17.

“These data support further evaluations of these combinations,” said Dr. Martinez-Marti, also a thoracic medical oncologist at the Vall d’Hebron Institute of Oncology in Barcelona.

Durvalumab is already established as a standard of care option for patients with unresectable stage 3 NSCLC who don’t progress after concurrent chemoradiation. There’s been preliminary data suggesting the benefits might be greater with oleclumab or monalizumab, so the study team looked into the issue.

They randomized 66 patients with unresectable stage 3 NSCLC and no progression after chemoradiotherapy to durvalumab 1,500 mg IV every 4 weeks; 59 others to durvalumab at the same dosage plus oleclumab 3,000 mg IV every 2 weeks for the first two cycles then every 4 weeks, and 61 were randomized to durvalumab plus monalizumab 750 mg IV every 2 weeks.

Patients were treated for up to 12 months, and they started treatment no later than 42 days after completing chemoradiation.

Over a median follow-up of 11.5 months, median progression-free survival (PFS) was 6.3 months in the durvalumab arm, but 15.1 months with the monalizumab combination (PFS hazard ratio versus durvalumab alone, 0.65; 95% CI, 0.49-0.85), and not reached in the oleclumab arm (PFS HR, 0.44; 95% CI, 0.26-0.75).

There were only a few complete responders across the study groups. Partial responses rates were 22.4% of the durvalumab alone arm, 36.7% in the oleclumab group, and 32.3% in the monalizumab arm.

The investigator assessed objective response rate was 25.4% with durvalumab alone, 38.3% in the oleclumab group, and 37.1% with the monalizumab combination. Curves started to separate from durvalumab monotherapy at around 2-4 months.

“Overall, the safety profiles of the two combinations were generally similar to the safety profile of durvalumab alone,” Dr. Martinez-Marti said. The rate of grade 3 or higher treatment-emergent events incidence was 39.4% with durvalumab, 40.7% the oleclumab combination, and 27.9% with monalizumab.

The most common grade 3/4 events were pneumonia (5.9%) and decreased lymphocyte count (3.2%); both were less common with the monalizumab combination.

Combined rates of pneumonitis and radiation pneumonitis of any grade were 21.2% with durvalumab, 28.8% in the oleclumab group, and 21.3% with monalizumab.

The groups were generally well balanced at baseline. The majority of subjects were men, White, and former smokers. Most subjects had stage 3A or 3B disease.

The work was funded by AstraZeneca. The investigators disclosed numerous ties to the company, including Dr. Martinez-Marti, who reported personal fees, travel expenses, and other connections.

This article was updated 9/24/21.

aotto@mdedge.com

Progression free survival was significantly better in unresectable stage 3 non–small cell lung cancer when patients were treated with durvalumab in combination with other immunotherapies, instead of durvalumab alone, following chemoradiotherapy.

Both combinations – durvalumab plus either the anti-CD73 monoclonal antibody oleclumab or the anti-NKG2A mAb monalizumab – also numerically improved objective response rate. “Safety profiles were consistent across arms and no new safety signals were identified,” said Alexandre Martinez-Marti, MD, the lead investigator on the phase 2 trial, dubbed COAST, which he presented (abstract LBA42) at the 2021 European Society for Medical Oncology Congress on Sept. 17.

“These data support further evaluations of these combinations,” said Dr. Martinez-Marti, also a thoracic medical oncologist at the Vall d’Hebron Institute of Oncology in Barcelona.

Durvalumab is already established as a standard of care option for patients with unresectable stage 3 NSCLC who don’t progress after concurrent chemoradiation. There’s been preliminary data suggesting the benefits might be greater with oleclumab or monalizumab, so the study team looked into the issue.

They randomized 66 patients with unresectable stage 3 NSCLC and no progression after chemoradiotherapy to durvalumab 1,500 mg IV every 4 weeks; 59 others to durvalumab at the same dosage plus oleclumab 3,000 mg IV every 2 weeks for the first two cycles then every 4 weeks, and 61 were randomized to durvalumab plus monalizumab 750 mg IV every 2 weeks.

Patients were treated for up to 12 months, and they started treatment no later than 42 days after completing chemoradiation.

Over a median follow-up of 11.5 months, median progression-free survival (PFS) was 6.3 months in the durvalumab arm, but 15.1 months with the monalizumab combination (PFS hazard ratio versus durvalumab alone, 0.65; 95% CI, 0.49-0.85), and not reached in the oleclumab arm (PFS HR, 0.44; 95% CI, 0.26-0.75).

There were only a few complete responders across the study groups. Partial responses rates were 22.4% of the durvalumab alone arm, 36.7% in the oleclumab group, and 32.3% in the monalizumab arm.

The investigator assessed objective response rate was 25.4% with durvalumab alone, 38.3% in the oleclumab group, and 37.1% with the monalizumab combination. Curves started to separate from durvalumab monotherapy at around 2-4 months.

“Overall, the safety profiles of the two combinations were generally similar to the safety profile of durvalumab alone,” Dr. Martinez-Marti said. The rate of grade 3 or higher treatment-emergent events incidence was 39.4% with durvalumab, 40.7% the oleclumab combination, and 27.9% with monalizumab.

The most common grade 3/4 events were pneumonia (5.9%) and decreased lymphocyte count (3.2%); both were less common with the monalizumab combination.

Combined rates of pneumonitis and radiation pneumonitis of any grade were 21.2% with durvalumab, 28.8% in the oleclumab group, and 21.3% with monalizumab.

The groups were generally well balanced at baseline. The majority of subjects were men, White, and former smokers. Most subjects had stage 3A or 3B disease.

The work was funded by AstraZeneca. The investigators disclosed numerous ties to the company, including Dr. Martinez-Marti, who reported personal fees, travel expenses, and other connections.

This article was updated 9/24/21.

aotto@mdedge.com

While postoperative conformal radiotherapy (PORT) reduces the risk of mediastinal relapse in completely resected non–small cell lung cancer with mediastinal nodal metastases (N2), it does not have a significant impact on disease-free and overall survival, according to a report (abstract 1170O) recently presented at the 2021 European Society for Medical Oncology Congress on Sept. 17.

The report was an update on the LungART international clinical trial, which, at the 2020 ESMO meeting, was shown not to improve disease-free survival over the course of 3 years. The update showed that, in addition to the lack of disease-free survival benefit, there was also no difference in metastases, and patients randomized to PORT had higher rates of death and grade 3/4 cardiopulmonary toxicity. The investigators returned this year to expand on another finding from the trial, a 51% reduction in the risk of mediastinal relapse with postoperative radiotherapy. The new analysis suggests there might still be a role for PORT in select patients, perhaps those with heavy nodal involvement, said lead investigator and presenter Cecile Le Pechoux, MD, radiation oncologist at the Gustave Roussy cancer treatment center in Villejuif, France.

For now, “personalized prescription of PORT should be based on prognostic factors of relapse and joint assessment of toxicity and efficacy,” she said.

Study discussant Pilar Garrido, MD, PhD, head of thoracic tumors Ramon y Cajal University Hospital, Madrid, agreed that there might still be a benefit for people with multiple N2 nodal station involvement, but at present, she said, “for me PORT cannot be the standard of care ... given the toxicity and mortality among PORT patients in LungART.”

The trial randomized 501 patients with non–small cell lung cancer with mediastinal involvement to either PORT at 54 Gy over 5.5 weeks or no further treatment following complete resection. Neoadjuvant or adjuvant chemotherapy were allowed.

The 3-year mediastinal relapse-free survival was 72.26% in the control arm but 86.06% with PORT (hazard ratio, 0.45; 95% confidence interval, 0.3-0.69).

“There is a significant difference” when it comes to mediastinal relapse, and “patients who have PORT do better. If we look at the location of mediastinal relapse, most [patients] relapse within the initially involved node. This is important information,” Dr. Le Pechoux said.

For left-sided tumors, the most frequent sites of mediastinal relapse were thoracic lymph node stations 7, 4L, and 4R. For right sided tumors, the most frequent stations were 4R, 2R and 7.

Prognostic factors for disease-free survival included quality of resection, extent of mediastinal involvement, and lymph node ratio (involved/explored). Nodal involvement was a significant prognostic factor for overall survival, but PORT was not (HR, 0.98; 95% CI, 0.7-1.4).

Mediastinal involvement with more than two node stations and less than an RO, or microscopically margin-negative resection, increased the risk of relapse.

The work was funded by the French National Cancer Institute, French Health Ministry, Institute Gustave Roussy, and Cancer Research UK. Dr. Pechoux and Dr. Garido disclosed ties to AstraZeneca, Roche, Amgen, and other companies.

This article was updated 9/24/21.

aotto@mdedge.com

While postoperative conformal radiotherapy (PORT) reduces the risk of mediastinal relapse in completely resected non–small cell lung cancer with mediastinal nodal metastases (N2), it does not have a significant impact on disease-free and overall survival, according to a report (abstract 1170O) recently presented at the 2021 European Society for Medical Oncology Congress on Sept. 17.

The report was an update on the LungART international clinical trial, which, at the 2020 ESMO meeting, was shown not to improve disease-free survival over the course of 3 years. The update showed that, in addition to the lack of disease-free survival benefit, there was also no difference in metastases, and patients randomized to PORT had higher rates of death and grade 3/4 cardiopulmonary toxicity. The investigators returned this year to expand on another finding from the trial, a 51% reduction in the risk of mediastinal relapse with postoperative radiotherapy. The new analysis suggests there might still be a role for PORT in select patients, perhaps those with heavy nodal involvement, said lead investigator and presenter Cecile Le Pechoux, MD, radiation oncologist at the Gustave Roussy cancer treatment center in Villejuif, France.

For now, “personalized prescription of PORT should be based on prognostic factors of relapse and joint assessment of toxicity and efficacy,” she said.

Study discussant Pilar Garrido, MD, PhD, head of thoracic tumors Ramon y Cajal University Hospital, Madrid, agreed that there might still be a benefit for people with multiple N2 nodal station involvement, but at present, she said, “for me PORT cannot be the standard of care ... given the toxicity and mortality among PORT patients in LungART.”

The trial randomized 501 patients with non–small cell lung cancer with mediastinal involvement to either PORT at 54 Gy over 5.5 weeks or no further treatment following complete resection. Neoadjuvant or adjuvant chemotherapy were allowed.

The 3-year mediastinal relapse-free survival was 72.26% in the control arm but 86.06% with PORT (hazard ratio, 0.45; 95% confidence interval, 0.3-0.69).

“There is a significant difference” when it comes to mediastinal relapse, and “patients who have PORT do better. If we look at the location of mediastinal relapse, most [patients] relapse within the initially involved node. This is important information,” Dr. Le Pechoux said.

For left-sided tumors, the most frequent sites of mediastinal relapse were thoracic lymph node stations 7, 4L, and 4R. For right sided tumors, the most frequent stations were 4R, 2R and 7.

Prognostic factors for disease-free survival included quality of resection, extent of mediastinal involvement, and lymph node ratio (involved/explored). Nodal involvement was a significant prognostic factor for overall survival, but PORT was not (HR, 0.98; 95% CI, 0.7-1.4).

Mediastinal involvement with more than two node stations and less than an RO, or microscopically margin-negative resection, increased the risk of relapse.

The work was funded by the French National Cancer Institute, French Health Ministry, Institute Gustave Roussy, and Cancer Research UK. Dr. Pechoux and Dr. Garido disclosed ties to AstraZeneca, Roche, Amgen, and other companies.

This article was updated 9/24/21.

aotto@mdedge.com

While postoperative conformal radiotherapy (PORT) reduces the risk of mediastinal relapse in completely resected non–small cell lung cancer with mediastinal nodal metastases (N2), it does not have a significant impact on disease-free and overall survival, according to a report (abstract 1170O) recently presented at the 2021 European Society for Medical Oncology Congress on Sept. 17.

The report was an update on the LungART international clinical trial, which, at the 2020 ESMO meeting, was shown not to improve disease-free survival over the course of 3 years. The update showed that, in addition to the lack of disease-free survival benefit, there was also no difference in metastases, and patients randomized to PORT had higher rates of death and grade 3/4 cardiopulmonary toxicity. The investigators returned this year to expand on another finding from the trial, a 51% reduction in the risk of mediastinal relapse with postoperative radiotherapy. The new analysis suggests there might still be a role for PORT in select patients, perhaps those with heavy nodal involvement, said lead investigator and presenter Cecile Le Pechoux, MD, radiation oncologist at the Gustave Roussy cancer treatment center in Villejuif, France.

For now, “personalized prescription of PORT should be based on prognostic factors of relapse and joint assessment of toxicity and efficacy,” she said.

Study discussant Pilar Garrido, MD, PhD, head of thoracic tumors Ramon y Cajal University Hospital, Madrid, agreed that there might still be a benefit for people with multiple N2 nodal station involvement, but at present, she said, “for me PORT cannot be the standard of care ... given the toxicity and mortality among PORT patients in LungART.”

The trial randomized 501 patients with non–small cell lung cancer with mediastinal involvement to either PORT at 54 Gy over 5.5 weeks or no further treatment following complete resection. Neoadjuvant or adjuvant chemotherapy were allowed.

The 3-year mediastinal relapse-free survival was 72.26% in the control arm but 86.06% with PORT (hazard ratio, 0.45; 95% confidence interval, 0.3-0.69).

“There is a significant difference” when it comes to mediastinal relapse, and “patients who have PORT do better. If we look at the location of mediastinal relapse, most [patients] relapse within the initially involved node. This is important information,” Dr. Le Pechoux said.

For left-sided tumors, the most frequent sites of mediastinal relapse were thoracic lymph node stations 7, 4L, and 4R. For right sided tumors, the most frequent stations were 4R, 2R and 7.

Prognostic factors for disease-free survival included quality of resection, extent of mediastinal involvement, and lymph node ratio (involved/explored). Nodal involvement was a significant prognostic factor for overall survival, but PORT was not (HR, 0.98; 95% CI, 0.7-1.4).

Mediastinal involvement with more than two node stations and less than an RO, or microscopically margin-negative resection, increased the risk of relapse.

The work was funded by the French National Cancer Institute, French Health Ministry, Institute Gustave Roussy, and Cancer Research UK. Dr. Pechoux and Dr. Garido disclosed ties to AstraZeneca, Roche, Amgen, and other companies.

This article was updated 9/24/21.

aotto@mdedge.com

A proposed Trump administration plan for paying for drugs under Medicare Part B has raised red flags for doctors.

money_pills_web.jpg

The Centers for Medicare & Medicaid Services announced Oct. 25 that it will test paying for Part B drugs by more closely aligning those payments with international rates.

The so-called International Price Index (IPI) model “would test whether increasing competition for private-sector vendors to negotiate drug prices, and aligning Medicare payments for drugs with prices that are paid in foreign countries, improves beneficiary access and quality of care while reducing expenditures,” according to a government fact sheet.

Under the test, private vendors would “procure drugs, distribute them to physicians and hospitals, and take on the responsibility of billing Medicare. Vendors would aggregate purchasing, seek volume-based discounts, and compete for providers’ business, thereby creating competition where none exists today.”

Health care professionals and hospitals in certain geographic areas would receive their Part B drugs under this program, while the rest of the country would continue under the current buy-and-bill system. Eventually, over the 5-year phase-in period, half of the geographic regions would fall under this IPI model.

CMS officials note that the IPI model “would maintain beneficiaries’ choice of provider and treatments and would have meaningful beneficiary protections such as enhanced monitoring and Medicare Beneficiary Ombudsman supports.”

Initially, only single-source drugs and biologics with available international pricing data would be provided under the IPI model, which could be expanded over time to include drugs available via multiple sources.

Currently, Medicare typically pays average sales price (ASP) plus a 6% add-on for drugs under Part B. Under IPI, if the international price is determined to be lower than the ASP, the CMS would reimburse based on a target price derived from an international price index, with the hope that manufacturers would match the international price. The target price would be phased in over a 5-year period.

The plan also calls for an add-on price similar to the current buy-and-bill system; however, the CMS aims to bring the add-on back to 6% rather than the actual 4.3% under the budget sequestration.

Other add-ons are also under consideration, such as paying a fixed amount per encounter or per month as well as a unique payment based on drug class, physician specialty, or physician practice.

Early takes on the proposal were met with skepticism.

The Community Oncology Alliance (COA) said in a statement that it is “concerned that the IPI will either repeat past reform mistakes [such as the Competitive Acquisition Program] or introduce the same cancer treatment access challenges experienced by cancer patients today with pharmacy benefit managers and other middlemen under Medicare Part D.”

“What the administration is proposing is incredibly complex and extremely difficult to comprehend how it would be implemented in the real-world of medical practice,” said Ted Okon, executive director of the COA. “It is also disturbing that the administration is trying to end-run the Congress by forcing a mandatory CMS Innovation Center demonstration that will effectively change Medicare reimbursement, as the sequester cut to Part B drug reimbursement has already done.”

The American College of Rheumatology was more measured in its reaction, noting that any change in policy needs to be thoughtful in its process to ensure that patient care is not adversely affected.

“Efforts to address high costs can sometimes create significant access issues for patients while penalizing doctors for providing quality care,” ACR officials said in a statement. “These proposals include those restructuring reimbursement for Medicare Part B drugs through either flat fee payments or a competitive acquisition program, or allowing utilization management such as step therapy or ‘fail first’ protocols in the Medicare Part B program. It is imperative that policy makers stay focused on the players who control drug prices and not penalize Medicare patients who depend on timely access to needed therapies.”

The American Medical Association raised some concerns as well.

“The administration’s proposal for an International Pricing Index Model for Part B drugs raises a number of questions, and we need to have a greater understanding of the potential impact of the proposal on patients, physicians, and the health care system,” AMA President Barbara McAneny, MD, said in a statement. “We look forward to working constructively with the Administration as it seeks feedback.”

The advanced notice of proposed rulemaking was posted to the Federal Register website on Oct. 25 and is scheduled to be formally published in the publication on Oct. 30. Comments are due Dec. 24. The CMS plans to issue the proposed rule related to this model in the spring of 2019.

gtwachtman@mdedge.com

A proposed Trump administration plan for paying for drugs under Medicare Part B has raised red flags for doctors.

money_pills_web.jpg

The Centers for Medicare & Medicaid Services announced Oct. 25 that it will test paying for Part B drugs by more closely aligning those payments with international rates.

The so-called International Price Index (IPI) model “would test whether increasing competition for private-sector vendors to negotiate drug prices, and aligning Medicare payments for drugs with prices that are paid in foreign countries, improves beneficiary access and quality of care while reducing expenditures,” according to a government fact sheet.

Under the test, private vendors would “procure drugs, distribute them to physicians and hospitals, and take on the responsibility of billing Medicare. Vendors would aggregate purchasing, seek volume-based discounts, and compete for providers’ business, thereby creating competition where none exists today.”

Health care professionals and hospitals in certain geographic areas would receive their Part B drugs under this program, while the rest of the country would continue under the current buy-and-bill system. Eventually, over the 5-year phase-in period, half of the geographic regions would fall under this IPI model.

CMS officials note that the IPI model “would maintain beneficiaries’ choice of provider and treatments and would have meaningful beneficiary protections such as enhanced monitoring and Medicare Beneficiary Ombudsman supports.”

Initially, only single-source drugs and biologics with available international pricing data would be provided under the IPI model, which could be expanded over time to include drugs available via multiple sources.

Currently, Medicare typically pays average sales price (ASP) plus a 6% add-on for drugs under Part B. Under IPI, if the international price is determined to be lower than the ASP, the CMS would reimburse based on a target price derived from an international price index, with the hope that manufacturers would match the international price. The target price would be phased in over a 5-year period.

The plan also calls for an add-on price similar to the current buy-and-bill system; however, the CMS aims to bring the add-on back to 6% rather than the actual 4.3% under the budget sequestration.

Other add-ons are also under consideration, such as paying a fixed amount per encounter or per month as well as a unique payment based on drug class, physician specialty, or physician practice.

Early takes on the proposal were met with skepticism.

The Community Oncology Alliance (COA) said in a statement that it is “concerned that the IPI will either repeat past reform mistakes [such as the Competitive Acquisition Program] or introduce the same cancer treatment access challenges experienced by cancer patients today with pharmacy benefit managers and other middlemen under Medicare Part D.”

“What the administration is proposing is incredibly complex and extremely difficult to comprehend how it would be implemented in the real-world of medical practice,” said Ted Okon, executive director of the COA. “It is also disturbing that the administration is trying to end-run the Congress by forcing a mandatory CMS Innovation Center demonstration that will effectively change Medicare reimbursement, as the sequester cut to Part B drug reimbursement has already done.”

The American College of Rheumatology was more measured in its reaction, noting that any change in policy needs to be thoughtful in its process to ensure that patient care is not adversely affected.

“Efforts to address high costs can sometimes create significant access issues for patients while penalizing doctors for providing quality care,” ACR officials said in a statement. “These proposals include those restructuring reimbursement for Medicare Part B drugs through either flat fee payments or a competitive acquisition program, or allowing utilization management such as step therapy or ‘fail first’ protocols in the Medicare Part B program. It is imperative that policy makers stay focused on the players who control drug prices and not penalize Medicare patients who depend on timely access to needed therapies.”

The American Medical Association raised some concerns as well.

“The administration’s proposal for an International Pricing Index Model for Part B drugs raises a number of questions, and we need to have a greater understanding of the potential impact of the proposal on patients, physicians, and the health care system,” AMA President Barbara McAneny, MD, said in a statement. “We look forward to working constructively with the Administration as it seeks feedback.”

The advanced notice of proposed rulemaking was posted to the Federal Register website on Oct. 25 and is scheduled to be formally published in the publication on Oct. 30. Comments are due Dec. 24. The CMS plans to issue the proposed rule related to this model in the spring of 2019.

gtwachtman@mdedge.com

A proposed Trump administration plan for paying for drugs under Medicare Part B has raised red flags for doctors.

money_pills_web.jpg

The Centers for Medicare & Medicaid Services announced Oct. 25 that it will test paying for Part B drugs by more closely aligning those payments with international rates.

The so-called International Price Index (IPI) model “would test whether increasing competition for private-sector vendors to negotiate drug prices, and aligning Medicare payments for drugs with prices that are paid in foreign countries, improves beneficiary access and quality of care while reducing expenditures,” according to a government fact sheet.

Under the test, private vendors would “procure drugs, distribute them to physicians and hospitals, and take on the responsibility of billing Medicare. Vendors would aggregate purchasing, seek volume-based discounts, and compete for providers’ business, thereby creating competition where none exists today.”

Health care professionals and hospitals in certain geographic areas would receive their Part B drugs under this program, while the rest of the country would continue under the current buy-and-bill system. Eventually, over the 5-year phase-in period, half of the geographic regions would fall under this IPI model.

CMS officials note that the IPI model “would maintain beneficiaries’ choice of provider and treatments and would have meaningful beneficiary protections such as enhanced monitoring and Medicare Beneficiary Ombudsman supports.”

Initially, only single-source drugs and biologics with available international pricing data would be provided under the IPI model, which could be expanded over time to include drugs available via multiple sources.

Currently, Medicare typically pays average sales price (ASP) plus a 6% add-on for drugs under Part B. Under IPI, if the international price is determined to be lower than the ASP, the CMS would reimburse based on a target price derived from an international price index, with the hope that manufacturers would match the international price. The target price would be phased in over a 5-year period.

The plan also calls for an add-on price similar to the current buy-and-bill system; however, the CMS aims to bring the add-on back to 6% rather than the actual 4.3% under the budget sequestration.

Other add-ons are also under consideration, such as paying a fixed amount per encounter or per month as well as a unique payment based on drug class, physician specialty, or physician practice.

Early takes on the proposal were met with skepticism.

The Community Oncology Alliance (COA) said in a statement that it is “concerned that the IPI will either repeat past reform mistakes [such as the Competitive Acquisition Program] or introduce the same cancer treatment access challenges experienced by cancer patients today with pharmacy benefit managers and other middlemen under Medicare Part D.”

“What the administration is proposing is incredibly complex and extremely difficult to comprehend how it would be implemented in the real-world of medical practice,” said Ted Okon, executive director of the COA. “It is also disturbing that the administration is trying to end-run the Congress by forcing a mandatory CMS Innovation Center demonstration that will effectively change Medicare reimbursement, as the sequester cut to Part B drug reimbursement has already done.”

The American College of Rheumatology was more measured in its reaction, noting that any change in policy needs to be thoughtful in its process to ensure that patient care is not adversely affected.

“Efforts to address high costs can sometimes create significant access issues for patients while penalizing doctors for providing quality care,” ACR officials said in a statement. “These proposals include those restructuring reimbursement for Medicare Part B drugs through either flat fee payments or a competitive acquisition program, or allowing utilization management such as step therapy or ‘fail first’ protocols in the Medicare Part B program. It is imperative that policy makers stay focused on the players who control drug prices and not penalize Medicare patients who depend on timely access to needed therapies.”

The American Medical Association raised some concerns as well.

“The administration’s proposal for an International Pricing Index Model for Part B drugs raises a number of questions, and we need to have a greater understanding of the potential impact of the proposal on patients, physicians, and the health care system,” AMA President Barbara McAneny, MD, said in a statement. “We look forward to working constructively with the Administration as it seeks feedback.”

The advanced notice of proposed rulemaking was posted to the Federal Register website on Oct. 25 and is scheduled to be formally published in the publication on Oct. 30. Comments are due Dec. 24. The CMS plans to issue the proposed rule related to this model in the spring of 2019.

gtwachtman@mdedge.com

Medicaid enrollment fell by 0.6% in 2018 – its first drop since 2007 – because of the strong economy and increased efforts in some states to verify eligibility, a new report finds.

But costs continue to go up. Total Medicaid spending rose 4.2% in 2018, same as a year ago, as a result of rising costs for drugs, long-term care, and mental health services, according to the study released Oct. 25 by the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

States expect total Medicaid spending growth to accelerate modestly to 5.3% in 2019 as enrollment increases by about 1%, according to the annual survey of state Medicaid directors.

About 73 million people were enrolled in Medicaid in August, according to a federal report released Wednesday.

Medicaid, the state-federal health insurance program for low-income Americans, has seen its rolls soar in the past decade – initially as a result of massive job losses during the Great Recession and in recent years when dozens of states expanded eligibility using federal financing provided by the Affordable Care Act. Thirty-three states expanded their programs to cover people with incomes under 138% of the federal poverty level, or an income of about $16,750 for an individual in 2018.

Medicaid spending and enrollment typically rise during economic downturns as more people lose jobs and health benefits. When the economy is humming, Medicaid enrollment flattens as more people get back to work and can get coverage at work or can afford to buy it on their own. The national unemployment rate was 3.7% in September, the lowest since 1969.

The falling unemployment rate is the main reason for the drop in Medicaid enrollment, but some states have reduced their rolls by requiring adults and families to verify their eligibility. Arkansas, for example, has cut thousands of people after instituting new steps to confirm eligibility.

The brightening economic outlook for states has led many to increase benefits to enrollees and payment rates for health providers.

“A total of 19 states expanded or enhanced covered benefits in fiscal 2018 and 24 states plan to add or enhance benefits for the current fiscal year, which for most states started in July,” the Kaiser report said. “The most common benefit enhancements reported were for mental health and substance abuse services. A handful of states reported expansions related to dental services, telehealth, physical or occupational therapies and home visiting services for pregnant women.”

A dozen states increased pay to dentists and 18 states added to primary care doctors’ reimbursements for fiscal year 2019.

Medicaid covers about 20% of U.S. residents and accounts for nearly one-sixth of health care expenditures. Nearly half of enrollees are children.

Overall, the federal government pays about 62% of Medicaid costs with state’s picking up the rest. Poorer states get a higher federal match rate.

Seventeen Republican-controlled states have not expanded Medicaid. For individuals accepted into the program as part of the ACA expansion, the federal government paid the full cost of coverage from 2014 through 2016. It will pay no less than 90% thereafter.

In 2018, the states’ share of spending rose 4.9%. This was the first full year that states were responsible for part of the cost of the expansion. States expect their spending will grow about 3.5% in 2019.

Robin Rudowitz, one of the authors of the study and associate director of the Kaiser Commission on Medicaid and the Uninsured, said the survey found many states were using Medicaid to address the opioid crisis by expanding benefits for substance disorders and also by implementing tougher restrictions on prescriptions.

“Almost every governor wants to do something, and Medicaid is generally a large part of it,” she said.

While the Trump administration’s approval of work requirements for some adults on Medicaid has generated controversy over the past year, the report shows that states are making many other changes to the program, such as increasing benefits and changing how it pays providers to get better value.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Medicaid enrollment fell by 0.6% in 2018 – its first drop since 2007 – because of the strong economy and increased efforts in some states to verify eligibility, a new report finds.

But costs continue to go up. Total Medicaid spending rose 4.2% in 2018, same as a year ago, as a result of rising costs for drugs, long-term care, and mental health services, according to the study released Oct. 25 by the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

States expect total Medicaid spending growth to accelerate modestly to 5.3% in 2019 as enrollment increases by about 1%, according to the annual survey of state Medicaid directors.

About 73 million people were enrolled in Medicaid in August, according to a federal report released Wednesday.

Medicaid, the state-federal health insurance program for low-income Americans, has seen its rolls soar in the past decade – initially as a result of massive job losses during the Great Recession and in recent years when dozens of states expanded eligibility using federal financing provided by the Affordable Care Act. Thirty-three states expanded their programs to cover people with incomes under 138% of the federal poverty level, or an income of about $16,750 for an individual in 2018.

Medicaid spending and enrollment typically rise during economic downturns as more people lose jobs and health benefits. When the economy is humming, Medicaid enrollment flattens as more people get back to work and can get coverage at work or can afford to buy it on their own. The national unemployment rate was 3.7% in September, the lowest since 1969.

The falling unemployment rate is the main reason for the drop in Medicaid enrollment, but some states have reduced their rolls by requiring adults and families to verify their eligibility. Arkansas, for example, has cut thousands of people after instituting new steps to confirm eligibility.

The brightening economic outlook for states has led many to increase benefits to enrollees and payment rates for health providers.

“A total of 19 states expanded or enhanced covered benefits in fiscal 2018 and 24 states plan to add or enhance benefits for the current fiscal year, which for most states started in July,” the Kaiser report said. “The most common benefit enhancements reported were for mental health and substance abuse services. A handful of states reported expansions related to dental services, telehealth, physical or occupational therapies and home visiting services for pregnant women.”

A dozen states increased pay to dentists and 18 states added to primary care doctors’ reimbursements for fiscal year 2019.

Medicaid covers about 20% of U.S. residents and accounts for nearly one-sixth of health care expenditures. Nearly half of enrollees are children.

Overall, the federal government pays about 62% of Medicaid costs with state’s picking up the rest. Poorer states get a higher federal match rate.

Seventeen Republican-controlled states have not expanded Medicaid. For individuals accepted into the program as part of the ACA expansion, the federal government paid the full cost of coverage from 2014 through 2016. It will pay no less than 90% thereafter.

In 2018, the states’ share of spending rose 4.9%. This was the first full year that states were responsible for part of the cost of the expansion. States expect their spending will grow about 3.5% in 2019.

Robin Rudowitz, one of the authors of the study and associate director of the Kaiser Commission on Medicaid and the Uninsured, said the survey found many states were using Medicaid to address the opioid crisis by expanding benefits for substance disorders and also by implementing tougher restrictions on prescriptions.

“Almost every governor wants to do something, and Medicaid is generally a large part of it,” she said.

While the Trump administration’s approval of work requirements for some adults on Medicaid has generated controversy over the past year, the report shows that states are making many other changes to the program, such as increasing benefits and changing how it pays providers to get better value.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Medicaid enrollment fell by 0.6% in 2018 – its first drop since 2007 – because of the strong economy and increased efforts in some states to verify eligibility, a new report finds.

But costs continue to go up. Total Medicaid spending rose 4.2% in 2018, same as a year ago, as a result of rising costs for drugs, long-term care, and mental health services, according to the study released Oct. 25 by the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

States expect total Medicaid spending growth to accelerate modestly to 5.3% in 2019 as enrollment increases by about 1%, according to the annual survey of state Medicaid directors.

About 73 million people were enrolled in Medicaid in August, according to a federal report released Wednesday.

Medicaid, the state-federal health insurance program for low-income Americans, has seen its rolls soar in the past decade – initially as a result of massive job losses during the Great Recession and in recent years when dozens of states expanded eligibility using federal financing provided by the Affordable Care Act. Thirty-three states expanded their programs to cover people with incomes under 138% of the federal poverty level, or an income of about $16,750 for an individual in 2018.

Medicaid spending and enrollment typically rise during economic downturns as more people lose jobs and health benefits. When the economy is humming, Medicaid enrollment flattens as more people get back to work and can get coverage at work or can afford to buy it on their own. The national unemployment rate was 3.7% in September, the lowest since 1969.

The falling unemployment rate is the main reason for the drop in Medicaid enrollment, but some states have reduced their rolls by requiring adults and families to verify their eligibility. Arkansas, for example, has cut thousands of people after instituting new steps to confirm eligibility.

The brightening economic outlook for states has led many to increase benefits to enrollees and payment rates for health providers.

“A total of 19 states expanded or enhanced covered benefits in fiscal 2018 and 24 states plan to add or enhance benefits for the current fiscal year, which for most states started in July,” the Kaiser report said. “The most common benefit enhancements reported were for mental health and substance abuse services. A handful of states reported expansions related to dental services, telehealth, physical or occupational therapies and home visiting services for pregnant women.”

A dozen states increased pay to dentists and 18 states added to primary care doctors’ reimbursements for fiscal year 2019.

Medicaid covers about 20% of U.S. residents and accounts for nearly one-sixth of health care expenditures. Nearly half of enrollees are children.

Overall, the federal government pays about 62% of Medicaid costs with state’s picking up the rest. Poorer states get a higher federal match rate.

Seventeen Republican-controlled states have not expanded Medicaid. For individuals accepted into the program as part of the ACA expansion, the federal government paid the full cost of coverage from 2014 through 2016. It will pay no less than 90% thereafter.

In 2018, the states’ share of spending rose 4.9%. This was the first full year that states were responsible for part of the cost of the expansion. States expect their spending will grow about 3.5% in 2019.

Robin Rudowitz, one of the authors of the study and associate director of the Kaiser Commission on Medicaid and the Uninsured, said the survey found many states were using Medicaid to address the opioid crisis by expanding benefits for substance disorders and also by implementing tougher restrictions on prescriptions.

“Almost every governor wants to do something, and Medicaid is generally a large part of it,” she said.

While the Trump administration’s approval of work requirements for some adults on Medicaid has generated controversy over the past year, the report shows that states are making many other changes to the program, such as increasing benefits and changing how it pays providers to get better value.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

MUNICH – Restrictive transfusion strategy during cardiovascular surgery, versus a more traditional liberal approach, did not increase the risk of poor outcomes at 6 months in a large, randomized trial presented at the annual congress of the European Society of Cardiology, and published simultaneously in the New England Journal of Medicine.

The investigators previously reported that 28 day outcomes were non-inferior with the restrictive approach, but they wanted to look into 6 month results to rule out latent problems, such as sequelae from perioperative organ hypoxia.

The new outcomes from the study, dubbed the Transfusion Requirements in Cardiac Surgery (TRICS) III trial, offer some reassurance at a time when cardiac surgeons are shifting towards more restrictive transfusion policies (N Engl J Med. 2018 Aug 26.doi: 10.1056/NEJMoa1808561).

The trial randomized 2,317 patients to red cell transfusions if their hemoglobin concentrations fell below 7.5 g/dL intraoperatively or postoperatively. Another 2,347 were randomized to the liberal approach, with transfusions below 9.5 g/dL in the operating room and ICU, and below 8.5 g/dL outside of the ICU. The arms were well matched, with a mean score of 8 in both groups on the 47-point European System for Cardiac Operative Risk Evaluation I score.

mazer_c_david_toronto_web.jpg

aotto@mdedge.com

SOURCE: Mazer CD et al. N Engl J Med. 2018 Aug 26. doi:10.1056/NEJMoa1808561

MUNICH – Restrictive transfusion strategy during cardiovascular surgery, versus a more traditional liberal approach, did not increase the risk of poor outcomes at 6 months in a large, randomized trial presented at the annual congress of the European Society of Cardiology, and published simultaneously in the New England Journal of Medicine.

The investigators previously reported that 28 day outcomes were non-inferior with the restrictive approach, but they wanted to look into 6 month results to rule out latent problems, such as sequelae from perioperative organ hypoxia.

The new outcomes from the study, dubbed the Transfusion Requirements in Cardiac Surgery (TRICS) III trial, offer some reassurance at a time when cardiac surgeons are shifting towards more restrictive transfusion policies (N Engl J Med. 2018 Aug 26.doi: 10.1056/NEJMoa1808561).

The trial randomized 2,317 patients to red cell transfusions if their hemoglobin concentrations fell below 7.5 g/dL intraoperatively or postoperatively. Another 2,347 were randomized to the liberal approach, with transfusions below 9.5 g/dL in the operating room and ICU, and below 8.5 g/dL outside of the ICU. The arms were well matched, with a mean score of 8 in both groups on the 47-point European System for Cardiac Operative Risk Evaluation I score.

mazer_c_david_toronto_web.jpg

aotto@mdedge.com

SOURCE: Mazer CD et al. N Engl J Med. 2018 Aug 26. doi:10.1056/NEJMoa1808561

MUNICH – Restrictive transfusion strategy during cardiovascular surgery, versus a more traditional liberal approach, did not increase the risk of poor outcomes at 6 months in a large, randomized trial presented at the annual congress of the European Society of Cardiology, and published simultaneously in the New England Journal of Medicine.

The investigators previously reported that 28 day outcomes were non-inferior with the restrictive approach, but they wanted to look into 6 month results to rule out latent problems, such as sequelae from perioperative organ hypoxia.

The new outcomes from the study, dubbed the Transfusion Requirements in Cardiac Surgery (TRICS) III trial, offer some reassurance at a time when cardiac surgeons are shifting towards more restrictive transfusion policies (N Engl J Med. 2018 Aug 26.doi: 10.1056/NEJMoa1808561).

The trial randomized 2,317 patients to red cell transfusions if their hemoglobin concentrations fell below 7.5 g/dL intraoperatively or postoperatively. Another 2,347 were randomized to the liberal approach, with transfusions below 9.5 g/dL in the operating room and ICU, and below 8.5 g/dL outside of the ICU. The arms were well matched, with a mean score of 8 in both groups on the 47-point European System for Cardiac Operative Risk Evaluation I score.

mazer_c_david_toronto_web.jpg

aotto@mdedge.com

SOURCE: Mazer CD et al. N Engl J Med. 2018 Aug 26. doi:10.1056/NEJMoa1808561

DENVER – Percutaneous coronary intervention plus optimal medical therapy in stable coronary artery disease (CAD) patients with at least one coronary lesion having an abnormal fractional flow reserve measurement resulted in superior clinical outcomes, better quality of life, and virtually identical cost, compared with optimal medical management alone over 3 years of follow-up in the FAME 2 trial.

“These results reinforce the point that the greater the burden of ischemia, the greater the benefit of revascularization with PCI [percutaneous coronary intervention],” William F. Fearon, MD, said while presenting the FAME 2 findings at the Transcatheter Cardiovascular Therapeutics annual meeting.

129444_Fearon_William_F_CA_web.jpg

bjancin@frontlinemedcom.com

DENVER – Percutaneous coronary intervention plus optimal medical therapy in stable coronary artery disease (CAD) patients with at least one coronary lesion having an abnormal fractional flow reserve measurement resulted in superior clinical outcomes, better quality of life, and virtually identical cost, compared with optimal medical management alone over 3 years of follow-up in the FAME 2 trial.

“These results reinforce the point that the greater the burden of ischemia, the greater the benefit of revascularization with PCI [percutaneous coronary intervention],” William F. Fearon, MD, said while presenting the FAME 2 findings at the Transcatheter Cardiovascular Therapeutics annual meeting.

129444_Fearon_William_F_CA_web.jpg

bjancin@frontlinemedcom.com

DENVER – Percutaneous coronary intervention plus optimal medical therapy in stable coronary artery disease (CAD) patients with at least one coronary lesion having an abnormal fractional flow reserve measurement resulted in superior clinical outcomes, better quality of life, and virtually identical cost, compared with optimal medical management alone over 3 years of follow-up in the FAME 2 trial.

“These results reinforce the point that the greater the burden of ischemia, the greater the benefit of revascularization with PCI [percutaneous coronary intervention],” William F. Fearon, MD, said while presenting the FAME 2 findings at the Transcatheter Cardiovascular Therapeutics annual meeting.

129444_Fearon_William_F_CA_web.jpg

bjancin@frontlinemedcom.com

State spending on Medicaid in fiscal 2017 was up 6.1% over 2016, and the program’s share of state budgets increased for the fifth year in a row, according to the National Association of State Budget Officers.

Total spending by the states on Medicaid benefits for more than 74 million individuals was an estimated $574 billion in 2017, which represented 29% of all expenditures. That compares with 28.7% in 2016 and 23.6% in 2012 – the last year that Medicaid’s share of state spending decreased, NASBO said in its annual State Expenditure Report.

129379_graphic_web.png

rfranki@frontlinemedcom.com

State spending on Medicaid in fiscal 2017 was up 6.1% over 2016, and the program’s share of state budgets increased for the fifth year in a row, according to the National Association of State Budget Officers.

Total spending by the states on Medicaid benefits for more than 74 million individuals was an estimated $574 billion in 2017, which represented 29% of all expenditures. That compares with 28.7% in 2016 and 23.6% in 2012 – the last year that Medicaid’s share of state spending decreased, NASBO said in its annual State Expenditure Report.

129379_graphic_web.png

rfranki@frontlinemedcom.com

State spending on Medicaid in fiscal 2017 was up 6.1% over 2016, and the program’s share of state budgets increased for the fifth year in a row, according to the National Association of State Budget Officers.

Total spending by the states on Medicaid benefits for more than 74 million individuals was an estimated $574 billion in 2017, which represented 29% of all expenditures. That compares with 28.7% in 2016 and 23.6% in 2012 – the last year that Medicaid’s share of state spending decreased, NASBO said in its annual State Expenditure Report.

129379_graphic_web.png

rfranki@frontlinemedcom.com

A one-time dose of radiation to arrhythmogenic scars eliminated or at least greatly reduced ventricular tachycardia in five patients who had failed to respond to medical management and, in some cases, catheter ablation, according to a report in the New England Journal of Medicine.
 

tachycardia_web.jpg

aotto@frontlinemedcom.com

SOURCE: Cuculich P et al. N Engl J Med. 2017 Dec 13. doi: 10.1056/NEJMoa1613773.

A one-time dose of radiation to arrhythmogenic scars eliminated or at least greatly reduced ventricular tachycardia in five patients who had failed to respond to medical management and, in some cases, catheter ablation, according to a report in the New England Journal of Medicine.
 

tachycardia_web.jpg

aotto@frontlinemedcom.com

SOURCE: Cuculich P et al. N Engl J Med. 2017 Dec 13. doi: 10.1056/NEJMoa1613773.

A one-time dose of radiation to arrhythmogenic scars eliminated or at least greatly reduced ventricular tachycardia in five patients who had failed to respond to medical management and, in some cases, catheter ablation, according to a report in the New England Journal of Medicine.
 

tachycardia_web.jpg

aotto@frontlinemedcom.com

SOURCE: Cuculich P et al. N Engl J Med. 2017 Dec 13. doi: 10.1056/NEJMoa1613773.

The use of methylphenidate by pregnant women is associated with a small increased risk of congenital cardiac malformations in newborns. However, a comparable increased risk is not found with intrauterine exposure to stimulants, according to a population-based cohort study published Dec. 13.

Krista F. Huybrechts, PhD, and her associates analyzed data from more than 1 million pregnancies in the United States. They found that the overall incidence of congenital malformations among the 1,813,894 pregnancies was 35 per 1,000 control infants, compared with 45.9 per 1,000 infants whose mothers used methylphenidate and 45.4 per 1,000 infants whose mothers used amphetamines.

Pregnant_with_pills_web.jpg

The use of methylphenidate by pregnant women is associated with a small increased risk of congenital cardiac malformations in newborns. However, a comparable increased risk is not found with intrauterine exposure to stimulants, according to a population-based cohort study published Dec. 13.

Krista F. Huybrechts, PhD, and her associates analyzed data from more than 1 million pregnancies in the United States. They found that the overall incidence of congenital malformations among the 1,813,894 pregnancies was 35 per 1,000 control infants, compared with 45.9 per 1,000 infants whose mothers used methylphenidate and 45.4 per 1,000 infants whose mothers used amphetamines.

Pregnant_with_pills_web.jpg

The use of methylphenidate by pregnant women is associated with a small increased risk of congenital cardiac malformations in newborns. However, a comparable increased risk is not found with intrauterine exposure to stimulants, according to a population-based cohort study published Dec. 13.

Krista F. Huybrechts, PhD, and her associates analyzed data from more than 1 million pregnancies in the United States. They found that the overall incidence of congenital malformations among the 1,813,894 pregnancies was 35 per 1,000 control infants, compared with 45.9 per 1,000 infants whose mothers used methylphenidate and 45.4 per 1,000 infants whose mothers used amphetamines.

Pregnant_with_pills_web.jpg