Ibrutinib (Imbruvica)

Photo courtesy of Janssen

The US Food and Drug Administration (FDA) has approved the BTK inhibitor ibrutinib (Imbruvica) as a first-line treatment for patients with chronic lymphocytic leukemia (CLL).

This means ibrutinib is now FDA-approved to treat CLL patients regardless of their treatment history, including patients with 17p deletion.

Ibrutinib is also FDA-approved to treat Waldenström’s macroglobulinemia, and the drug was granted accelerated approval to treat patients with mantle cell lymphoma who have received at least 1 prior therapy.

Ibrutinib is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc. For more details on the drug, see the full prescribing information, available at imbruvica.com.

RESONATE-2 trial

The latest FDA approval for ibrutinib is based on results from the phase 3 RESONATE-2 trial (PCYC-1115), which were presented at the 2015 ASH Annual Meeting and simultaneously published in NEJM.

RESONATE-2 enrolled 269 treatment-naïve patients with CLL or small lymphocytic lymphoma who were 65 or older.

Patients were randomized to receive ibrutinib (n=136) at 420 mg once a day until progression or unacceptable toxicity, or chlorambucil (n=133) on days 1 and 15 of each 28-day cycle for up to 12 cycles. The starting dose for chlorambucil in cycle 1 was 0.5 mg/kg and was increased based on tolerability in cycle 2 by increments of 0.1 mg/kg to a maximum of 0.8 mg/kg.

The primary endpoint of the study was progression-free survival (PFS), as assessed by an independent review committee (IRC) according to the International Workshop on Chronic Lymphocytic Leukemia (iWCLL) 2008 criteria, with modification for treatment-related lymphocytosis.

Key secondary endpoints included overall response rate (based on the same iWCLL criteria), overall survival (OS), and safety.

Ibrutinib significantly prolonged PFS, as determined by the IRC, reducing the risk of progression or death by 84% compared to chlorambucil. The hazard ratio was 0.16 (P<0.001). The median PFS was not reached in the ibrutinib arm but was 18.9 months for the chlorambucil arm.

Ibrutinib significantly prolonged OS as well, although the median OS was not reached in either treatment arm. The OS rate at 24 months was 98% with ibrutinib and 85% with chlorambucil. The relative risk of death with ibrutinib was 84% lower than that with chlorambucil. The hazard ratio was 0.16 (P=0.001).

Ibrutinib was associated with a significantly higher IRC-assessed overall response rate compared to chlorambucil—82% and 35%, respectively (P<0.0001). Five patients (4%) in the ibrutinib arm achieved a complete response, as did 2 patients (2%) in the chlorambucil arm.

The median duration of treatment was 17.4 months in the ibrutinib arm and 7.1 months in the chlorambucil arm.

The most common adverse events of any grade—in the ibrutinib and chlorambucil arms, respectively—were diarrhea (42% and 17%), fatigue (30% and 38%), cough (22% and 15%), nausea (22% and 39%), peripheral edema (19% and 9%), dry eye (17% and 5%), arthralgia (16% and 7%), neutropenia (16% and 23%), and vomiting (13% and 20%).

Adverse events of grade 3 or higher—in the ibrutinib and chlorambucil arms, respectively—were neutropenia (10% and 18%), anemia (6% and 8%), hypertension (4% and 0%), pneumonia (4% and 2%), diarrhea (4% and 0%), maculopapular rash (3% and 2%), decreased platelet count (3% and 1%), abdominal pain (3% and 1%), hyponatremia (3% and 0%), thrombocytopenia (2% and 6%), febrile neutropenia (2% and 2%), upper respiratory tract infection (2% and 2%), pleural effusion (2% and 1%), cellulitis (2% and 0%), fatigue (1% and 5%), syncope (1% and 2%), and hemolytic anemia (0% and 2%).

Ibrutinib (Imbruvica)

Photo courtesy of Janssen

The US Food and Drug Administration (FDA) has approved the BTK inhibitor ibrutinib (Imbruvica) as a first-line treatment for patients with chronic lymphocytic leukemia (CLL).

This means ibrutinib is now FDA-approved to treat CLL patients regardless of their treatment history, including patients with 17p deletion.

Ibrutinib is also FDA-approved to treat Waldenström’s macroglobulinemia, and the drug was granted accelerated approval to treat patients with mantle cell lymphoma who have received at least 1 prior therapy.

Ibrutinib is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc. For more details on the drug, see the full prescribing information, available at imbruvica.com.

RESONATE-2 trial

The latest FDA approval for ibrutinib is based on results from the phase 3 RESONATE-2 trial (PCYC-1115), which were presented at the 2015 ASH Annual Meeting and simultaneously published in NEJM.

RESONATE-2 enrolled 269 treatment-naïve patients with CLL or small lymphocytic lymphoma who were 65 or older.

Patients were randomized to receive ibrutinib (n=136) at 420 mg once a day until progression or unacceptable toxicity, or chlorambucil (n=133) on days 1 and 15 of each 28-day cycle for up to 12 cycles. The starting dose for chlorambucil in cycle 1 was 0.5 mg/kg and was increased based on tolerability in cycle 2 by increments of 0.1 mg/kg to a maximum of 0.8 mg/kg.

The primary endpoint of the study was progression-free survival (PFS), as assessed by an independent review committee (IRC) according to the International Workshop on Chronic Lymphocytic Leukemia (iWCLL) 2008 criteria, with modification for treatment-related lymphocytosis.

Key secondary endpoints included overall response rate (based on the same iWCLL criteria), overall survival (OS), and safety.

Ibrutinib significantly prolonged PFS, as determined by the IRC, reducing the risk of progression or death by 84% compared to chlorambucil. The hazard ratio was 0.16 (P<0.001). The median PFS was not reached in the ibrutinib arm but was 18.9 months for the chlorambucil arm.

Ibrutinib significantly prolonged OS as well, although the median OS was not reached in either treatment arm. The OS rate at 24 months was 98% with ibrutinib and 85% with chlorambucil. The relative risk of death with ibrutinib was 84% lower than that with chlorambucil. The hazard ratio was 0.16 (P=0.001).

Ibrutinib was associated with a significantly higher IRC-assessed overall response rate compared to chlorambucil—82% and 35%, respectively (P<0.0001). Five patients (4%) in the ibrutinib arm achieved a complete response, as did 2 patients (2%) in the chlorambucil arm.

The median duration of treatment was 17.4 months in the ibrutinib arm and 7.1 months in the chlorambucil arm.

The most common adverse events of any grade—in the ibrutinib and chlorambucil arms, respectively—were diarrhea (42% and 17%), fatigue (30% and 38%), cough (22% and 15%), nausea (22% and 39%), peripheral edema (19% and 9%), dry eye (17% and 5%), arthralgia (16% and 7%), neutropenia (16% and 23%), and vomiting (13% and 20%).

Adverse events of grade 3 or higher—in the ibrutinib and chlorambucil arms, respectively—were neutropenia (10% and 18%), anemia (6% and 8%), hypertension (4% and 0%), pneumonia (4% and 2%), diarrhea (4% and 0%), maculopapular rash (3% and 2%), decreased platelet count (3% and 1%), abdominal pain (3% and 1%), hyponatremia (3% and 0%), thrombocytopenia (2% and 6%), febrile neutropenia (2% and 2%), upper respiratory tract infection (2% and 2%), pleural effusion (2% and 1%), cellulitis (2% and 0%), fatigue (1% and 5%), syncope (1% and 2%), and hemolytic anemia (0% and 2%).

Ibrutinib (Imbruvica)

Photo courtesy of Janssen

The US Food and Drug Administration (FDA) has approved the BTK inhibitor ibrutinib (Imbruvica) as a first-line treatment for patients with chronic lymphocytic leukemia (CLL).

This means ibrutinib is now FDA-approved to treat CLL patients regardless of their treatment history, including patients with 17p deletion.

Ibrutinib is also FDA-approved to treat Waldenström’s macroglobulinemia, and the drug was granted accelerated approval to treat patients with mantle cell lymphoma who have received at least 1 prior therapy.

Ibrutinib is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc. For more details on the drug, see the full prescribing information, available at imbruvica.com.

RESONATE-2 trial

The latest FDA approval for ibrutinib is based on results from the phase 3 RESONATE-2 trial (PCYC-1115), which were presented at the 2015 ASH Annual Meeting and simultaneously published in NEJM.

RESONATE-2 enrolled 269 treatment-naïve patients with CLL or small lymphocytic lymphoma who were 65 or older.

Patients were randomized to receive ibrutinib (n=136) at 420 mg once a day until progression or unacceptable toxicity, or chlorambucil (n=133) on days 1 and 15 of each 28-day cycle for up to 12 cycles. The starting dose for chlorambucil in cycle 1 was 0.5 mg/kg and was increased based on tolerability in cycle 2 by increments of 0.1 mg/kg to a maximum of 0.8 mg/kg.

The primary endpoint of the study was progression-free survival (PFS), as assessed by an independent review committee (IRC) according to the International Workshop on Chronic Lymphocytic Leukemia (iWCLL) 2008 criteria, with modification for treatment-related lymphocytosis.

Key secondary endpoints included overall response rate (based on the same iWCLL criteria), overall survival (OS), and safety.

Ibrutinib significantly prolonged PFS, as determined by the IRC, reducing the risk of progression or death by 84% compared to chlorambucil. The hazard ratio was 0.16 (P<0.001). The median PFS was not reached in the ibrutinib arm but was 18.9 months for the chlorambucil arm.

Ibrutinib significantly prolonged OS as well, although the median OS was not reached in either treatment arm. The OS rate at 24 months was 98% with ibrutinib and 85% with chlorambucil. The relative risk of death with ibrutinib was 84% lower than that with chlorambucil. The hazard ratio was 0.16 (P=0.001).

Ibrutinib was associated with a significantly higher IRC-assessed overall response rate compared to chlorambucil—82% and 35%, respectively (P<0.0001). Five patients (4%) in the ibrutinib arm achieved a complete response, as did 2 patients (2%) in the chlorambucil arm.

The median duration of treatment was 17.4 months in the ibrutinib arm and 7.1 months in the chlorambucil arm.

The most common adverse events of any grade—in the ibrutinib and chlorambucil arms, respectively—were diarrhea (42% and 17%), fatigue (30% and 38%), cough (22% and 15%), nausea (22% and 39%), peripheral edema (19% and 9%), dry eye (17% and 5%), arthralgia (16% and 7%), neutropenia (16% and 23%), and vomiting (13% and 20%).

Adverse events of grade 3 or higher—in the ibrutinib and chlorambucil arms, respectively—were neutropenia (10% and 18%), anemia (6% and 8%), hypertension (4% and 0%), pneumonia (4% and 2%), diarrhea (4% and 0%), maculopapular rash (3% and 2%), decreased platelet count (3% and 1%), abdominal pain (3% and 1%), hyponatremia (3% and 0%), thrombocytopenia (2% and 6%), febrile neutropenia (2% and 2%), upper respiratory tract infection (2% and 2%), pleural effusion (2% and 1%), cellulitis (2% and 0%), fatigue (1% and 5%), syncope (1% and 2%), and hemolytic anemia (0% and 2%).

The Centers for Medicare & Medicaid Services (CMS) recently announced the approval of a dedicated specialty billing code for hospitalists that will soon be ready for official use. This is a monumental step for hospital medicine, which continues to be the fastest growing medical specialty in the U.S., with more than 48,000 practitioners identifying as hospitalists.

The Hospitalist recently discussed the implications of this decision with Ron Greeno, MD, MHM, chief strategy officer for IPC Healthcare and chair of SHM’s Public Policy Committee (PPC), and Josh Boswell, director of government relations at SHM, to answer questions raised by SHM members.

Question: What are the benefits to hospitalists using the code?

Dr. Greeno: As we transition from fee-for-service to quality-based payment models, using this code will become critical to ensure hospitalists are reimbursed and evaluated fairly. Under the current code structure, hospitalists are missing opportunities to be rewarded and may be penalized unnecessarily because they are required to identify with internal medicine, family medicine, or another specialty that most closely resembles their daily practice. What current measures do not account for is that hospitalists’ patients are inherently more complex than those seen by practitioners in these other—most often outpatient—specialties. We as hospitalists face unique challenges and work with patients from all demographics, often with severe illnesses, making it nearly impossible to rely on benchmarks used for these other specialties.

There are a few prime examples of this that illustrate the need for the new code. Under the current system, some quality-based patient satisfaction measures under MACRA, on which hospitalists are being evaluated, pertain to the outpatient setting, including waiting room quality and office staff–irrelevant measurements for hospitalists. Hospitalists are also often incorrectly penalized under meaningful use due to complications brought on by observation status and its classification as an outpatient stay. This can cause both quality and cost measures to be extremely flawed and can misrepresent the performance and cost of hospitalists and hospital medicine groups. In the current billing structure, there is no way to accurately identify hospitalists and enable a definite fix to these problems.

To get what we want (fair measurement using relevant metrics), we must be able to identify as a separate group, and fortunately, now we can. There will be benefits we don’t even know about yet. We have to wait and see how healthcare policy continues to evolve and change moving forward. What we do know is that having this code will help us shape MACRA and future healthcare policy so that it works better for hospitalists as the specialty continues to grow in scope and impact.

Q: When will the new code go into effect?

Boswell: While there is not a set date at this time, CMS has reported that it can take up to a year, mostly due to technical changes that need to be made within their own systems. The code has already been officially approved; we just need to wait a bit longer to actually use it.

Q: What happens to hospitalists if they do not use the code?

Dr. Greeno: Some hospitalists might be nervous about the change after having billed a certain way for so long. While there is no absolute requirement for hospitalists to use the new code, the bottom line is that if hospitalists do not adopt the new code, they risk not receiving fair evaluations. Using this code should provide hospitalists with greater insight into their own performance—the data will be much more accurate and meaningful. This will allow hospitalists to hone in on areas needing improvement and provide them with more confidence that they are being compared using accurate benchmarks.

I want to stress that hospitalists, or in some cases their hospital medicine groups, will need to physically change their specialty affiliation when the code becomes effective. Otherwise, they risk not reaping the benefits associated with the new code and will continue to be evaluated using less-than-optimal benchmarks. The ball is in their court to make the change when the code is available, and SHM will serve as a resource to help ensure they know what to do and when.

Q: Where can someone go to find the code? Will it be available on the CMS website?

Boswell: When the code does become available for use, it will be communicated through various channels at SHM and also through the Medicare Learning Network, the site that houses education, information, and resources for healthcare professionals. It will also likely be distributed through additional Medicare circulars and newsletters.

As more details from CMS become available, we will have more specific information to share with members, including information on our website, webinars with billing and coding experts, email communication, and more. Continue to watch your email and social media channels for the latest updates and information.

 Q: What role did SHM play in bringing this code to fruition?

Boswell: We can say with confidence that this effort was driven entirely by SHM. To start, a formal application needs to be filed in order for a code to even be considered. After determining that the benefits associated with this code far outweighed the costs and then receiving the support of our board of directors, SHM’s staff and PPC members collaborated to draft a brief and made the argument for the addition of a hospitalist billing code based on the individual elements CMS requires for consideration.

Due to the fact hospital medicine doesn’t have a board certification, while solid, our argument was far from a slam dunk. After submitting the application, SHM continuously followed up with and pressured CMS through various channels and utilized our grassroots network of hospitalists on the Hill to put this code on legislators’ radars—the result was pressure getting applied from interested members of Congress as well. If it weren’t for the persistent advocacy efforts of SHM and its members over the past several years, this code would not have even been considered, let alone approved.

This is a significant development—to our knowledge, this is the first medical specialty to be granted a code without also having a board certification. We’re thrilled that what we have been advocating for on behalf of our members is now a reality!

For the latest information on the new hospitalist billing code and other important healthcare policy updates, continue to check for SHM emails and follow SHM’s social media channels, including @SHMLive and @SHMAdvocacy on Twitter.

Sign up for the network to get the latest news in healthcare policy and discover opportunities to advocate for yourself and fellow hospitalists. TH

Brett Radler is SHM’s communications coordinator.

The Centers for Medicare & Medicaid Services (CMS) recently announced the approval of a dedicated specialty billing code for hospitalists that will soon be ready for official use. This is a monumental step for hospital medicine, which continues to be the fastest growing medical specialty in the U.S., with more than 48,000 practitioners identifying as hospitalists.

The Hospitalist recently discussed the implications of this decision with Ron Greeno, MD, MHM, chief strategy officer for IPC Healthcare and chair of SHM’s Public Policy Committee (PPC), and Josh Boswell, director of government relations at SHM, to answer questions raised by SHM members.

Question: What are the benefits to hospitalists using the code?

Dr. Greeno: As we transition from fee-for-service to quality-based payment models, using this code will become critical to ensure hospitalists are reimbursed and evaluated fairly. Under the current code structure, hospitalists are missing opportunities to be rewarded and may be penalized unnecessarily because they are required to identify with internal medicine, family medicine, or another specialty that most closely resembles their daily practice. What current measures do not account for is that hospitalists’ patients are inherently more complex than those seen by practitioners in these other—most often outpatient—specialties. We as hospitalists face unique challenges and work with patients from all demographics, often with severe illnesses, making it nearly impossible to rely on benchmarks used for these other specialties.

There are a few prime examples of this that illustrate the need for the new code. Under the current system, some quality-based patient satisfaction measures under MACRA, on which hospitalists are being evaluated, pertain to the outpatient setting, including waiting room quality and office staff–irrelevant measurements for hospitalists. Hospitalists are also often incorrectly penalized under meaningful use due to complications brought on by observation status and its classification as an outpatient stay. This can cause both quality and cost measures to be extremely flawed and can misrepresent the performance and cost of hospitalists and hospital medicine groups. In the current billing structure, there is no way to accurately identify hospitalists and enable a definite fix to these problems.

To get what we want (fair measurement using relevant metrics), we must be able to identify as a separate group, and fortunately, now we can. There will be benefits we don’t even know about yet. We have to wait and see how healthcare policy continues to evolve and change moving forward. What we do know is that having this code will help us shape MACRA and future healthcare policy so that it works better for hospitalists as the specialty continues to grow in scope and impact.

Q: When will the new code go into effect?

Boswell: While there is not a set date at this time, CMS has reported that it can take up to a year, mostly due to technical changes that need to be made within their own systems. The code has already been officially approved; we just need to wait a bit longer to actually use it.

Q: What happens to hospitalists if they do not use the code?

Dr. Greeno: Some hospitalists might be nervous about the change after having billed a certain way for so long. While there is no absolute requirement for hospitalists to use the new code, the bottom line is that if hospitalists do not adopt the new code, they risk not receiving fair evaluations. Using this code should provide hospitalists with greater insight into their own performance—the data will be much more accurate and meaningful. This will allow hospitalists to hone in on areas needing improvement and provide them with more confidence that they are being compared using accurate benchmarks.

I want to stress that hospitalists, or in some cases their hospital medicine groups, will need to physically change their specialty affiliation when the code becomes effective. Otherwise, they risk not reaping the benefits associated with the new code and will continue to be evaluated using less-than-optimal benchmarks. The ball is in their court to make the change when the code is available, and SHM will serve as a resource to help ensure they know what to do and when.

Q: Where can someone go to find the code? Will it be available on the CMS website?

Boswell: When the code does become available for use, it will be communicated through various channels at SHM and also through the Medicare Learning Network, the site that houses education, information, and resources for healthcare professionals. It will also likely be distributed through additional Medicare circulars and newsletters.

As more details from CMS become available, we will have more specific information to share with members, including information on our website, webinars with billing and coding experts, email communication, and more. Continue to watch your email and social media channels for the latest updates and information.

 Q: What role did SHM play in bringing this code to fruition?

Boswell: We can say with confidence that this effort was driven entirely by SHM. To start, a formal application needs to be filed in order for a code to even be considered. After determining that the benefits associated with this code far outweighed the costs and then receiving the support of our board of directors, SHM’s staff and PPC members collaborated to draft a brief and made the argument for the addition of a hospitalist billing code based on the individual elements CMS requires for consideration.

Due to the fact hospital medicine doesn’t have a board certification, while solid, our argument was far from a slam dunk. After submitting the application, SHM continuously followed up with and pressured CMS through various channels and utilized our grassroots network of hospitalists on the Hill to put this code on legislators’ radars—the result was pressure getting applied from interested members of Congress as well. If it weren’t for the persistent advocacy efforts of SHM and its members over the past several years, this code would not have even been considered, let alone approved.

This is a significant development—to our knowledge, this is the first medical specialty to be granted a code without also having a board certification. We’re thrilled that what we have been advocating for on behalf of our members is now a reality!

For the latest information on the new hospitalist billing code and other important healthcare policy updates, continue to check for SHM emails and follow SHM’s social media channels, including @SHMLive and @SHMAdvocacy on Twitter.

Sign up for the network to get the latest news in healthcare policy and discover opportunities to advocate for yourself and fellow hospitalists. TH

Brett Radler is SHM’s communications coordinator.

The Centers for Medicare & Medicaid Services (CMS) recently announced the approval of a dedicated specialty billing code for hospitalists that will soon be ready for official use. This is a monumental step for hospital medicine, which continues to be the fastest growing medical specialty in the U.S., with more than 48,000 practitioners identifying as hospitalists.

The Hospitalist recently discussed the implications of this decision with Ron Greeno, MD, MHM, chief strategy officer for IPC Healthcare and chair of SHM’s Public Policy Committee (PPC), and Josh Boswell, director of government relations at SHM, to answer questions raised by SHM members.

Question: What are the benefits to hospitalists using the code?

Dr. Greeno: As we transition from fee-for-service to quality-based payment models, using this code will become critical to ensure hospitalists are reimbursed and evaluated fairly. Under the current code structure, hospitalists are missing opportunities to be rewarded and may be penalized unnecessarily because they are required to identify with internal medicine, family medicine, or another specialty that most closely resembles their daily practice. What current measures do not account for is that hospitalists’ patients are inherently more complex than those seen by practitioners in these other—most often outpatient—specialties. We as hospitalists face unique challenges and work with patients from all demographics, often with severe illnesses, making it nearly impossible to rely on benchmarks used for these other specialties.

There are a few prime examples of this that illustrate the need for the new code. Under the current system, some quality-based patient satisfaction measures under MACRA, on which hospitalists are being evaluated, pertain to the outpatient setting, including waiting room quality and office staff–irrelevant measurements for hospitalists. Hospitalists are also often incorrectly penalized under meaningful use due to complications brought on by observation status and its classification as an outpatient stay. This can cause both quality and cost measures to be extremely flawed and can misrepresent the performance and cost of hospitalists and hospital medicine groups. In the current billing structure, there is no way to accurately identify hospitalists and enable a definite fix to these problems.

To get what we want (fair measurement using relevant metrics), we must be able to identify as a separate group, and fortunately, now we can. There will be benefits we don’t even know about yet. We have to wait and see how healthcare policy continues to evolve and change moving forward. What we do know is that having this code will help us shape MACRA and future healthcare policy so that it works better for hospitalists as the specialty continues to grow in scope and impact.

Q: When will the new code go into effect?

Boswell: While there is not a set date at this time, CMS has reported that it can take up to a year, mostly due to technical changes that need to be made within their own systems. The code has already been officially approved; we just need to wait a bit longer to actually use it.

Q: What happens to hospitalists if they do not use the code?

Dr. Greeno: Some hospitalists might be nervous about the change after having billed a certain way for so long. While there is no absolute requirement for hospitalists to use the new code, the bottom line is that if hospitalists do not adopt the new code, they risk not receiving fair evaluations. Using this code should provide hospitalists with greater insight into their own performance—the data will be much more accurate and meaningful. This will allow hospitalists to hone in on areas needing improvement and provide them with more confidence that they are being compared using accurate benchmarks.

I want to stress that hospitalists, or in some cases their hospital medicine groups, will need to physically change their specialty affiliation when the code becomes effective. Otherwise, they risk not reaping the benefits associated with the new code and will continue to be evaluated using less-than-optimal benchmarks. The ball is in their court to make the change when the code is available, and SHM will serve as a resource to help ensure they know what to do and when.

Q: Where can someone go to find the code? Will it be available on the CMS website?

Boswell: When the code does become available for use, it will be communicated through various channels at SHM and also through the Medicare Learning Network, the site that houses education, information, and resources for healthcare professionals. It will also likely be distributed through additional Medicare circulars and newsletters.

As more details from CMS become available, we will have more specific information to share with members, including information on our website, webinars with billing and coding experts, email communication, and more. Continue to watch your email and social media channels for the latest updates and information.

 Q: What role did SHM play in bringing this code to fruition?

Boswell: We can say with confidence that this effort was driven entirely by SHM. To start, a formal application needs to be filed in order for a code to even be considered. After determining that the benefits associated with this code far outweighed the costs and then receiving the support of our board of directors, SHM’s staff and PPC members collaborated to draft a brief and made the argument for the addition of a hospitalist billing code based on the individual elements CMS requires for consideration.

Due to the fact hospital medicine doesn’t have a board certification, while solid, our argument was far from a slam dunk. After submitting the application, SHM continuously followed up with and pressured CMS through various channels and utilized our grassroots network of hospitalists on the Hill to put this code on legislators’ radars—the result was pressure getting applied from interested members of Congress as well. If it weren’t for the persistent advocacy efforts of SHM and its members over the past several years, this code would not have even been considered, let alone approved.

This is a significant development—to our knowledge, this is the first medical specialty to be granted a code without also having a board certification. We’re thrilled that what we have been advocating for on behalf of our members is now a reality!

For the latest information on the new hospitalist billing code and other important healthcare policy updates, continue to check for SHM emails and follow SHM’s social media channels, including @SHMLive and @SHMAdvocacy on Twitter.

Sign up for the network to get the latest news in healthcare policy and discover opportunities to advocate for yourself and fellow hospitalists. TH

Brett Radler is SHM’s communications coordinator.

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee unanimously approved recommendations regarding the trivalent and quadrivalent influenza vaccines to be distributed during the 2016-2017 flu season.

The 14-member committee voted that the components of the trivalent influenza vaccine for the upcoming flu season should include an A/California/7/2009 (H1N1) pdm09-like virus; an A/Hong Kong/4801/2014 (H3N2)-like virus; and a B/Brisbane/60/2008-like virus of the B/Victoria lineage.

©pressdigital/iStock

Additionally, the quadrivalent influenza vaccine should include a B/Phuket/3073/2013-like virus of the B/Yamagata lineage as “the second influenza B strain in the vaccine.”

All four components correspond with the recommendations of the World Health Organization, which announced its proposed components for influenza vaccines in the Northern Hemisphere on Feb. 25.

“I’m comfortable trying to follow the footprint of the virus we’ve seen today, quite elegantly put out in front of us,” said committee member Dr. Sarah Long, professor of pediatrics at Drexel University in Philadelphia, adding that she was “very pleased with what happened in the last year” regarding the predictions of dominant virus strains and the effectiveness of the eventual vaccine.

The proposed vaccine for next season differs from the one distributed during the 2015-16 flu season. While both vaccines contain the identical California strain of influenza A and the Phuket strain of influenza B, the 2015-2016 vaccine included an A/Switzerland/9715293/2013 (H3N2)-like virus in its trivalent form, and a B/Brisbane/60/2008-like virus of the B/Victoria lineage in its quadrivalent form.

“Timely vaccine supply requires close collaboration and communication between multiple stakeholders to ensure sufficient provision of [a] well-matched vaccine,” said Matthew Downham, Ph.D., associate director of biopharmaceutical development, AstraZeneca. Timely strain selection will ensure “vaccine availability and usage” for the most widespread and effective coverage.

While the FDA is not obligated to follow the recommendations of the Vaccines and Related Biological Products Advisory Committee, it generally does.

None of the committee members reported any relevant financial disclosures, nor were there any waivers for conflicts of interest.

[email protected]

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee unanimously approved recommendations regarding the trivalent and quadrivalent influenza vaccines to be distributed during the 2016-2017 flu season.

The 14-member committee voted that the components of the trivalent influenza vaccine for the upcoming flu season should include an A/California/7/2009 (H1N1) pdm09-like virus; an A/Hong Kong/4801/2014 (H3N2)-like virus; and a B/Brisbane/60/2008-like virus of the B/Victoria lineage.

©pressdigital/iStock

Additionally, the quadrivalent influenza vaccine should include a B/Phuket/3073/2013-like virus of the B/Yamagata lineage as “the second influenza B strain in the vaccine.”

All four components correspond with the recommendations of the World Health Organization, which announced its proposed components for influenza vaccines in the Northern Hemisphere on Feb. 25.

“I’m comfortable trying to follow the footprint of the virus we’ve seen today, quite elegantly put out in front of us,” said committee member Dr. Sarah Long, professor of pediatrics at Drexel University in Philadelphia, adding that she was “very pleased with what happened in the last year” regarding the predictions of dominant virus strains and the effectiveness of the eventual vaccine.

The proposed vaccine for next season differs from the one distributed during the 2015-16 flu season. While both vaccines contain the identical California strain of influenza A and the Phuket strain of influenza B, the 2015-2016 vaccine included an A/Switzerland/9715293/2013 (H3N2)-like virus in its trivalent form, and a B/Brisbane/60/2008-like virus of the B/Victoria lineage in its quadrivalent form.

“Timely vaccine supply requires close collaboration and communication between multiple stakeholders to ensure sufficient provision of [a] well-matched vaccine,” said Matthew Downham, Ph.D., associate director of biopharmaceutical development, AstraZeneca. Timely strain selection will ensure “vaccine availability and usage” for the most widespread and effective coverage.

While the FDA is not obligated to follow the recommendations of the Vaccines and Related Biological Products Advisory Committee, it generally does.

None of the committee members reported any relevant financial disclosures, nor were there any waivers for conflicts of interest.

[email protected]

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee unanimously approved recommendations regarding the trivalent and quadrivalent influenza vaccines to be distributed during the 2016-2017 flu season.

The 14-member committee voted that the components of the trivalent influenza vaccine for the upcoming flu season should include an A/California/7/2009 (H1N1) pdm09-like virus; an A/Hong Kong/4801/2014 (H3N2)-like virus; and a B/Brisbane/60/2008-like virus of the B/Victoria lineage.

©pressdigital/iStock

Additionally, the quadrivalent influenza vaccine should include a B/Phuket/3073/2013-like virus of the B/Yamagata lineage as “the second influenza B strain in the vaccine.”

All four components correspond with the recommendations of the World Health Organization, which announced its proposed components for influenza vaccines in the Northern Hemisphere on Feb. 25.

“I’m comfortable trying to follow the footprint of the virus we’ve seen today, quite elegantly put out in front of us,” said committee member Dr. Sarah Long, professor of pediatrics at Drexel University in Philadelphia, adding that she was “very pleased with what happened in the last year” regarding the predictions of dominant virus strains and the effectiveness of the eventual vaccine.

The proposed vaccine for next season differs from the one distributed during the 2015-16 flu season. While both vaccines contain the identical California strain of influenza A and the Phuket strain of influenza B, the 2015-2016 vaccine included an A/Switzerland/9715293/2013 (H3N2)-like virus in its trivalent form, and a B/Brisbane/60/2008-like virus of the B/Victoria lineage in its quadrivalent form.

“Timely vaccine supply requires close collaboration and communication between multiple stakeholders to ensure sufficient provision of [a] well-matched vaccine,” said Matthew Downham, Ph.D., associate director of biopharmaceutical development, AstraZeneca. Timely strain selection will ensure “vaccine availability and usage” for the most widespread and effective coverage.

While the FDA is not obligated to follow the recommendations of the Vaccines and Related Biological Products Advisory Committee, it generally does.

None of the committee members reported any relevant financial disclosures, nor were there any waivers for conflicts of interest.

[email protected]

The Rheumatoid Arthritis Support Network (RASN) has the goal of providing up-to-date information and resources for rheumatoid arthritis patients so that they know their options and fully understand their diagnosis.

The RASN provides information on what causes RA, its symptoms, treatment options, positive lifestyles changes that people with RA can make, and resources, such as finding a rheumatologist, support groups, up-to-date literature, blogs about RA, and apps for pain management.

For more information, visit the RASN website (www.rheumatoidarthritis.org), send an email ([email protected]), or call 800-405-4043.

The Rheumatoid Arthritis Support Network (RASN) has the goal of providing up-to-date information and resources for rheumatoid arthritis patients so that they know their options and fully understand their diagnosis.

The RASN provides information on what causes RA, its symptoms, treatment options, positive lifestyles changes that people with RA can make, and resources, such as finding a rheumatologist, support groups, up-to-date literature, blogs about RA, and apps for pain management.

For more information, visit the RASN website (www.rheumatoidarthritis.org), send an email ([email protected]), or call 800-405-4043.

The Rheumatoid Arthritis Support Network (RASN) has the goal of providing up-to-date information and resources for rheumatoid arthritis patients so that they know their options and fully understand their diagnosis.

The RASN provides information on what causes RA, its symptoms, treatment options, positive lifestyles changes that people with RA can make, and resources, such as finding a rheumatologist, support groups, up-to-date literature, blogs about RA, and apps for pain management.

For more information, visit the RASN website (www.rheumatoidarthritis.org), send an email ([email protected]), or call 800-405-4043.

PHILADELPHIA – Are there things you wish you’d learned as a gastroenterology fellow? How to build a reputation as a good speaker, how to grow a successful clinical practice, and even how to choose the best retirement fund options for your personal goals are the kinds of tips and insights you’ll find in The New Gastroenterologist.

The newest publication from the American Gastroenterological Association, The New Gastroenterologist offers practical clinical information, lifestyle features, interviews with leaders in the field, and details on where to find research funding.

“Our goal is to provide unique content that speaks to all the needs that young gastroenterologists have, and to have it all in one place,” says The New Gastroenterologist Editor-in-Chief Dr. Bryson Katona.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Are there things you wish you’d learned as a gastroenterology fellow? How to build a reputation as a good speaker, how to grow a successful clinical practice, and even how to choose the best retirement fund options for your personal goals are the kinds of tips and insights you’ll find in The New Gastroenterologist.

The newest publication from the American Gastroenterological Association, The New Gastroenterologist offers practical clinical information, lifestyle features, interviews with leaders in the field, and details on where to find research funding.

“Our goal is to provide unique content that speaks to all the needs that young gastroenterologists have, and to have it all in one place,” says The New Gastroenterologist Editor-in-Chief Dr. Bryson Katona.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Are there things you wish you’d learned as a gastroenterology fellow? How to build a reputation as a good speaker, how to grow a successful clinical practice, and even how to choose the best retirement fund options for your personal goals are the kinds of tips and insights you’ll find in The New Gastroenterologist.

The newest publication from the American Gastroenterological Association, The New Gastroenterologist offers practical clinical information, lifestyle features, interviews with leaders in the field, and details on where to find research funding.

“Our goal is to provide unique content that speaks to all the needs that young gastroenterologists have, and to have it all in one place,” says The New Gastroenterologist Editor-in-Chief Dr. Bryson Katona.

[email protected]

On Twitter @whitneymcknight

Two new drugs have arrived to challenge our prescription pad or electronic record, depending on which you use. Empagliflozin (Jardiance), a drug used to modify glucose metabolism in type 2 diabetes in patients with preexisting cardiovascular disease, demonstrated a decrease in cardiovascular mortality. The other drug, Entresto, appears to provide an added benefit in heart failure therapy and was compared with a standard ACE inhibitor.

The results of EMPA-REG OUTCOME, reported at the European Association for the Study of Diabetes meeting in Stockholm, showed empagliflozin to be the first drug to decrease the mortality and morbidity of cardiovascular disease in diabetes. It is one of a group of new sodium-glucose cotransporter 2 (SGLT-2) blockers being tested in type 2 diabetes with established cardiovascular disease. Patients were randomized to placebo or empagliflozin while receiving standard medical and cardiovascular medications. After 3 years of follow-up, patients receiving the drug experienced a lower cardiovascular mortality rate, compared with placebo patients (3.7% vs. 5.9%, a 38% reduction) in addition to a decrease in hospitalization for heart failure and death from any cause. No effect was observed on the incidence of myocardial infarction or stroke. In addition, the drug also lowered blood glucose and blood pressure and led to some significant weight loss. The drug also was shown to decrease vascular resistance and albuminuria (N Engl J Med. 2015. 373:2117-2).

Furthermore, an analysis of EMPA-REG OUTCOME presented in November at the American Society of Nephrology meeting in San Diego, showed a profound benefit on the new onset and progression of chronic renal disease in diabetes patients. The importance of these results needs emphasis. Up until recently, the Food and Drug Administration has given a pass to diabetes drugs in regard to cardiovascular endpoints; approval has been based on their primary effect on lowering blood glucose. Some drugs in the past, such as rosiglitazone, actually have shown an increase in mortality in some diabetes patients. At long last, FDA approval for diabetes drugs hinges on acceptable outcomes in cardiovascular endpoints. The addition of a drug that can actually affect cardiovascular mortality and morbidity, the major risk factor of diabetes, provides an important addition to therapy.

The other drug that provides a choice of drugs for the treatment of heart failure is Entresto, a combination of sacubitril, a neprilysin inhibitor, and the angiotensin receptor inhibitor valsartan, approved in July 2015. In PARADIGM-HF, the compound was compared to enalapril in the treatment of patients with class II, III, and IV heart failure who were also receiving beta-blockers. Entresto-treated patients reported a 21.8% incidence of the primary outcome measure, cardiovascular death and hospitalization for heart failure, compared with the enalapril alone incidence of 26.5% (P less than .001) (N Engl J Med. 2014;371:993-1004). Investigators initially excluded 11.4% of the recruited patients from the study who could not tolerate Entresto or enalapril therapy. The drugs were well tolerated without any adverse reactions during therapy. Entresto was more effective than enalapril in regards to the occurrence of heart failure and death from any cause over a 27-month average follow-up.

The observations in this study emphasize how much the mortality of heart failure has decreased over the last decade. Cardiovascular deaths have decreased to roughly 7% per year and rehospitalization occurs in about 8% in the first year. Both drugs provide an important incremental benefit in heart failure patients.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Two new drugs have arrived to challenge our prescription pad or electronic record, depending on which you use. Empagliflozin (Jardiance), a drug used to modify glucose metabolism in type 2 diabetes in patients with preexisting cardiovascular disease, demonstrated a decrease in cardiovascular mortality. The other drug, Entresto, appears to provide an added benefit in heart failure therapy and was compared with a standard ACE inhibitor.

The results of EMPA-REG OUTCOME, reported at the European Association for the Study of Diabetes meeting in Stockholm, showed empagliflozin to be the first drug to decrease the mortality and morbidity of cardiovascular disease in diabetes. It is one of a group of new sodium-glucose cotransporter 2 (SGLT-2) blockers being tested in type 2 diabetes with established cardiovascular disease. Patients were randomized to placebo or empagliflozin while receiving standard medical and cardiovascular medications. After 3 years of follow-up, patients receiving the drug experienced a lower cardiovascular mortality rate, compared with placebo patients (3.7% vs. 5.9%, a 38% reduction) in addition to a decrease in hospitalization for heart failure and death from any cause. No effect was observed on the incidence of myocardial infarction or stroke. In addition, the drug also lowered blood glucose and blood pressure and led to some significant weight loss. The drug also was shown to decrease vascular resistance and albuminuria (N Engl J Med. 2015. 373:2117-2).

Furthermore, an analysis of EMPA-REG OUTCOME presented in November at the American Society of Nephrology meeting in San Diego, showed a profound benefit on the new onset and progression of chronic renal disease in diabetes patients. The importance of these results needs emphasis. Up until recently, the Food and Drug Administration has given a pass to diabetes drugs in regard to cardiovascular endpoints; approval has been based on their primary effect on lowering blood glucose. Some drugs in the past, such as rosiglitazone, actually have shown an increase in mortality in some diabetes patients. At long last, FDA approval for diabetes drugs hinges on acceptable outcomes in cardiovascular endpoints. The addition of a drug that can actually affect cardiovascular mortality and morbidity, the major risk factor of diabetes, provides an important addition to therapy.

The other drug that provides a choice of drugs for the treatment of heart failure is Entresto, a combination of sacubitril, a neprilysin inhibitor, and the angiotensin receptor inhibitor valsartan, approved in July 2015. In PARADIGM-HF, the compound was compared to enalapril in the treatment of patients with class II, III, and IV heart failure who were also receiving beta-blockers. Entresto-treated patients reported a 21.8% incidence of the primary outcome measure, cardiovascular death and hospitalization for heart failure, compared with the enalapril alone incidence of 26.5% (P less than .001) (N Engl J Med. 2014;371:993-1004). Investigators initially excluded 11.4% of the recruited patients from the study who could not tolerate Entresto or enalapril therapy. The drugs were well tolerated without any adverse reactions during therapy. Entresto was more effective than enalapril in regards to the occurrence of heart failure and death from any cause over a 27-month average follow-up.

The observations in this study emphasize how much the mortality of heart failure has decreased over the last decade. Cardiovascular deaths have decreased to roughly 7% per year and rehospitalization occurs in about 8% in the first year. Both drugs provide an important incremental benefit in heart failure patients.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Two new drugs have arrived to challenge our prescription pad or electronic record, depending on which you use. Empagliflozin (Jardiance), a drug used to modify glucose metabolism in type 2 diabetes in patients with preexisting cardiovascular disease, demonstrated a decrease in cardiovascular mortality. The other drug, Entresto, appears to provide an added benefit in heart failure therapy and was compared with a standard ACE inhibitor.

The results of EMPA-REG OUTCOME, reported at the European Association for the Study of Diabetes meeting in Stockholm, showed empagliflozin to be the first drug to decrease the mortality and morbidity of cardiovascular disease in diabetes. It is one of a group of new sodium-glucose cotransporter 2 (SGLT-2) blockers being tested in type 2 diabetes with established cardiovascular disease. Patients were randomized to placebo or empagliflozin while receiving standard medical and cardiovascular medications. After 3 years of follow-up, patients receiving the drug experienced a lower cardiovascular mortality rate, compared with placebo patients (3.7% vs. 5.9%, a 38% reduction) in addition to a decrease in hospitalization for heart failure and death from any cause. No effect was observed on the incidence of myocardial infarction or stroke. In addition, the drug also lowered blood glucose and blood pressure and led to some significant weight loss. The drug also was shown to decrease vascular resistance and albuminuria (N Engl J Med. 2015. 373:2117-2).

Furthermore, an analysis of EMPA-REG OUTCOME presented in November at the American Society of Nephrology meeting in San Diego, showed a profound benefit on the new onset and progression of chronic renal disease in diabetes patients. The importance of these results needs emphasis. Up until recently, the Food and Drug Administration has given a pass to diabetes drugs in regard to cardiovascular endpoints; approval has been based on their primary effect on lowering blood glucose. Some drugs in the past, such as rosiglitazone, actually have shown an increase in mortality in some diabetes patients. At long last, FDA approval for diabetes drugs hinges on acceptable outcomes in cardiovascular endpoints. The addition of a drug that can actually affect cardiovascular mortality and morbidity, the major risk factor of diabetes, provides an important addition to therapy.

The other drug that provides a choice of drugs for the treatment of heart failure is Entresto, a combination of sacubitril, a neprilysin inhibitor, and the angiotensin receptor inhibitor valsartan, approved in July 2015. In PARADIGM-HF, the compound was compared to enalapril in the treatment of patients with class II, III, and IV heart failure who were also receiving beta-blockers. Entresto-treated patients reported a 21.8% incidence of the primary outcome measure, cardiovascular death and hospitalization for heart failure, compared with the enalapril alone incidence of 26.5% (P less than .001) (N Engl J Med. 2014;371:993-1004). Investigators initially excluded 11.4% of the recruited patients from the study who could not tolerate Entresto or enalapril therapy. The drugs were well tolerated without any adverse reactions during therapy. Entresto was more effective than enalapril in regards to the occurrence of heart failure and death from any cause over a 27-month average follow-up.

The observations in this study emphasize how much the mortality of heart failure has decreased over the last decade. Cardiovascular deaths have decreased to roughly 7% per year and rehospitalization occurs in about 8% in the first year. Both drugs provide an important incremental benefit in heart failure patients.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Preterm premature rupture of membranes (PPROM) refers to rupture of membranes prior to the onset of labor before 37 weeks’ gestation. It accounts for one-third of all preterm births.¹ Pregnancy complications associated with PPROM include intrauterine infection (chorioamnionitis), preterm labor, and placental abruption. Should such complications develop, immediate delivery is indicated. When to recommend elective delivery in the absence of complications, however, remains controversial.

The American College of Obstetricians and Gynecologists (ACOG) currently recommends elective delivery at or after 34 weeks’ gestation,² because the prevailing evidence suggests that the risk of pregnancy-related complications (especially ascending infection) exceeds the risks of iatrogenic prematurity at this gestational age. However, ACOG acknowledges that this recommendation is based on “limited and inconsistent scientific evidence.”² To address deficiencies in the literature, investigators designed the PPROMT (preterm prelabor rupture of the membranes close to term) trial to study women with ruptured membranes before the onset of labor between 34 and 37 weeks’ gestation.

PPROMT study designMorris and colleagues present results of their multicenter, international, randomized controlled trial (RCT) of expectant management versus planned delivery in pregnancies complicated by PPROM at 34 0/7 through 36 6/7 weeks’ gestation carried out in 65 centers across 11 countries. A total of 1,839 women not requiring urgent delivery were randomly assigned to either immediate delivery (n = 924) or expectant management (n = 915).

No difference was noted in the primary outcome of neonatal sepsis between the immediate birth (n = 23 [2%]) and expectant management groups (n = 29 [3%]; relative risk [RR], 0.8; 95% confidence interval [CI], 0.5–1.3). This also was true in the subgroup of women who were colonized with group B streptococcus (RR, 0.9; 95% CI, 0.2–4.5).

There also was no difference in the secondary outcome measure, a composite metric including sepsis, ventilation for 24 or more hours, or death (73 [8%] in the immediate delivery group vs 61 [7%] in the expectant management group; RR, 1.2; 95% CI, 0.9–1.6). However, infants born to women randomly assigned to immediate delivery, versus expectant management, had a significantly higher rate of respiratory distress syndrome (RR, 1.6; 95% CI, 1.1–2.3) and mechanical ventilation (RR, 1.4; 95% CI, 1.0–1.8). In addition, the immediate-delivery infants had a longer median stay in the special care nursery/neonatal intensive care unit (4.0 days, interquartile range [IQR], 0.0–10.0 vs 2.0 days, IQR, 0.0–7.0) and total hospital stay (6.0 days, IQR, 3.0–10.0 vs 4.0 days, IQR, 3.0–8.0). As expected, women in the expectant management group had a significantly longer hospital stay than women in the immediate delivery group, because 75% (688/912) were managed as inpatients. Interestingly, women in the immediate delivery group had a higher cesarean delivery rate than those in the expectant management group (239 [26%] vs 169 [19%], respectively; RR, 1.4; 95% CI, 1.2–1.7), although no explanation was offered.

Strengths and limitationsMajor strengths of this study include the large sample size and superior study design. It is by far the largest RCT to address this question. Because this was a pragmatic RCT, certain practices (such as the choice of latency antibiotic regimen) varied across centers, although randomization would be expected to minimize the effect of such variables on study outcome.

A major limitation is that participant recruitment occurred over a period of more than 10 years, during which time antenatal and neonatal intensive care unit practices likely would have changed.

What this evidence means for practiceFew clinical studies have the potential to significantly change obstetric management. This report by Morris and colleagues is one such study. It was well designed, well executed, and powered to look at the most clinically relevant outcome, namely, neonatal sepsis. While these study results do call into question the current American College of Obstetricians and Gynecologists recommendations to electively deliver patients with PPROM at or after 34 weeks’ gestation, additional discussion is needed at the national level before these recommendations can be changed.
—Denis A. Vaughan, MBBCh, BAO, MRCPI, and Errol R. Norwitz, MD, PhD

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Preterm premature rupture of membranes (PPROM) refers to rupture of membranes prior to the onset of labor before 37 weeks’ gestation. It accounts for one-third of all preterm births.¹ Pregnancy complications associated with PPROM include intrauterine infection (chorioamnionitis), preterm labor, and placental abruption. Should such complications develop, immediate delivery is indicated. When to recommend elective delivery in the absence of complications, however, remains controversial.

The American College of Obstetricians and Gynecologists (ACOG) currently recommends elective delivery at or after 34 weeks’ gestation,² because the prevailing evidence suggests that the risk of pregnancy-related complications (especially ascending infection) exceeds the risks of iatrogenic prematurity at this gestational age. However, ACOG acknowledges that this recommendation is based on “limited and inconsistent scientific evidence.”² To address deficiencies in the literature, investigators designed the PPROMT (preterm prelabor rupture of the membranes close to term) trial to study women with ruptured membranes before the onset of labor between 34 and 37 weeks’ gestation.

PPROMT study designMorris and colleagues present results of their multicenter, international, randomized controlled trial (RCT) of expectant management versus planned delivery in pregnancies complicated by PPROM at 34 0/7 through 36 6/7 weeks’ gestation carried out in 65 centers across 11 countries. A total of 1,839 women not requiring urgent delivery were randomly assigned to either immediate delivery (n = 924) or expectant management (n = 915).

No difference was noted in the primary outcome of neonatal sepsis between the immediate birth (n = 23 [2%]) and expectant management groups (n = 29 [3%]; relative risk [RR], 0.8; 95% confidence interval [CI], 0.5–1.3). This also was true in the subgroup of women who were colonized with group B streptococcus (RR, 0.9; 95% CI, 0.2–4.5).

There also was no difference in the secondary outcome measure, a composite metric including sepsis, ventilation for 24 or more hours, or death (73 [8%] in the immediate delivery group vs 61 [7%] in the expectant management group; RR, 1.2; 95% CI, 0.9–1.6). However, infants born to women randomly assigned to immediate delivery, versus expectant management, had a significantly higher rate of respiratory distress syndrome (RR, 1.6; 95% CI, 1.1–2.3) and mechanical ventilation (RR, 1.4; 95% CI, 1.0–1.8). In addition, the immediate-delivery infants had a longer median stay in the special care nursery/neonatal intensive care unit (4.0 days, interquartile range [IQR], 0.0–10.0 vs 2.0 days, IQR, 0.0–7.0) and total hospital stay (6.0 days, IQR, 3.0–10.0 vs 4.0 days, IQR, 3.0–8.0). As expected, women in the expectant management group had a significantly longer hospital stay than women in the immediate delivery group, because 75% (688/912) were managed as inpatients. Interestingly, women in the immediate delivery group had a higher cesarean delivery rate than those in the expectant management group (239 [26%] vs 169 [19%], respectively; RR, 1.4; 95% CI, 1.2–1.7), although no explanation was offered.

Strengths and limitationsMajor strengths of this study include the large sample size and superior study design. It is by far the largest RCT to address this question. Because this was a pragmatic RCT, certain practices (such as the choice of latency antibiotic regimen) varied across centers, although randomization would be expected to minimize the effect of such variables on study outcome.

A major limitation is that participant recruitment occurred over a period of more than 10 years, during which time antenatal and neonatal intensive care unit practices likely would have changed.

What this evidence means for practiceFew clinical studies have the potential to significantly change obstetric management. This report by Morris and colleagues is one such study. It was well designed, well executed, and powered to look at the most clinically relevant outcome, namely, neonatal sepsis. While these study results do call into question the current American College of Obstetricians and Gynecologists recommendations to electively deliver patients with PPROM at or after 34 weeks’ gestation, additional discussion is needed at the national level before these recommendations can be changed.
—Denis A. Vaughan, MBBCh, BAO, MRCPI, and Errol R. Norwitz, MD, PhD

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Preterm premature rupture of membranes (PPROM) refers to rupture of membranes prior to the onset of labor before 37 weeks’ gestation. It accounts for one-third of all preterm births.¹ Pregnancy complications associated with PPROM include intrauterine infection (chorioamnionitis), preterm labor, and placental abruption. Should such complications develop, immediate delivery is indicated. When to recommend elective delivery in the absence of complications, however, remains controversial.

The American College of Obstetricians and Gynecologists (ACOG) currently recommends elective delivery at or after 34 weeks’ gestation,² because the prevailing evidence suggests that the risk of pregnancy-related complications (especially ascending infection) exceeds the risks of iatrogenic prematurity at this gestational age. However, ACOG acknowledges that this recommendation is based on “limited and inconsistent scientific evidence.”² To address deficiencies in the literature, investigators designed the PPROMT (preterm prelabor rupture of the membranes close to term) trial to study women with ruptured membranes before the onset of labor between 34 and 37 weeks’ gestation.

PPROMT study designMorris and colleagues present results of their multicenter, international, randomized controlled trial (RCT) of expectant management versus planned delivery in pregnancies complicated by PPROM at 34 0/7 through 36 6/7 weeks’ gestation carried out in 65 centers across 11 countries. A total of 1,839 women not requiring urgent delivery were randomly assigned to either immediate delivery (n = 924) or expectant management (n = 915).

No difference was noted in the primary outcome of neonatal sepsis between the immediate birth (n = 23 [2%]) and expectant management groups (n = 29 [3%]; relative risk [RR], 0.8; 95% confidence interval [CI], 0.5–1.3). This also was true in the subgroup of women who were colonized with group B streptococcus (RR, 0.9; 95% CI, 0.2–4.5).

There also was no difference in the secondary outcome measure, a composite metric including sepsis, ventilation for 24 or more hours, or death (73 [8%] in the immediate delivery group vs 61 [7%] in the expectant management group; RR, 1.2; 95% CI, 0.9–1.6). However, infants born to women randomly assigned to immediate delivery, versus expectant management, had a significantly higher rate of respiratory distress syndrome (RR, 1.6; 95% CI, 1.1–2.3) and mechanical ventilation (RR, 1.4; 95% CI, 1.0–1.8). In addition, the immediate-delivery infants had a longer median stay in the special care nursery/neonatal intensive care unit (4.0 days, interquartile range [IQR], 0.0–10.0 vs 2.0 days, IQR, 0.0–7.0) and total hospital stay (6.0 days, IQR, 3.0–10.0 vs 4.0 days, IQR, 3.0–8.0). As expected, women in the expectant management group had a significantly longer hospital stay than women in the immediate delivery group, because 75% (688/912) were managed as inpatients. Interestingly, women in the immediate delivery group had a higher cesarean delivery rate than those in the expectant management group (239 [26%] vs 169 [19%], respectively; RR, 1.4; 95% CI, 1.2–1.7), although no explanation was offered.

Strengths and limitationsMajor strengths of this study include the large sample size and superior study design. It is by far the largest RCT to address this question. Because this was a pragmatic RCT, certain practices (such as the choice of latency antibiotic regimen) varied across centers, although randomization would be expected to minimize the effect of such variables on study outcome.

A major limitation is that participant recruitment occurred over a period of more than 10 years, during which time antenatal and neonatal intensive care unit practices likely would have changed.

What this evidence means for practiceFew clinical studies have the potential to significantly change obstetric management. This report by Morris and colleagues is one such study. It was well designed, well executed, and powered to look at the most clinically relevant outcome, namely, neonatal sepsis. While these study results do call into question the current American College of Obstetricians and Gynecologists recommendations to electively deliver patients with PPROM at or after 34 weeks’ gestation, additional discussion is needed at the national level before these recommendations can be changed.
—Denis A. Vaughan, MBBCh, BAO, MRCPI, and Errol R. Norwitz, MD, PhD

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

AUSTIN, TEX. – With ongoing changes in health delivery and ever-increasing government scrutiny over care, physicians face a number of pressing legal risks this year.

At an American Health Lawyers Association meeting, Birmingham, Ala., health law attorney William W. Horton shared the top legal dangers for doctors in 2016.

From False Claims Act investigations and whistle-blower claims to liability connected to value-based care, clinicians have a lot to consider, said Mr. Horton, who is chair of the American Bar Association Health Law Section.

In a video interview, Mr. Horton also discussed how to reduce liability and limit government inquiries.

[email protected]

On Twitter @legal_med

AUSTIN, TEX. – With ongoing changes in health delivery and ever-increasing government scrutiny over care, physicians face a number of pressing legal risks this year.

At an American Health Lawyers Association meeting, Birmingham, Ala., health law attorney William W. Horton shared the top legal dangers for doctors in 2016.

From False Claims Act investigations and whistle-blower claims to liability connected to value-based care, clinicians have a lot to consider, said Mr. Horton, who is chair of the American Bar Association Health Law Section.

In a video interview, Mr. Horton also discussed how to reduce liability and limit government inquiries.

[email protected]

On Twitter @legal_med

AUSTIN, TEX. – With ongoing changes in health delivery and ever-increasing government scrutiny over care, physicians face a number of pressing legal risks this year.

At an American Health Lawyers Association meeting, Birmingham, Ala., health law attorney William W. Horton shared the top legal dangers for doctors in 2016.

From False Claims Act investigations and whistle-blower claims to liability connected to value-based care, clinicians have a lot to consider, said Mr. Horton, who is chair of the American Bar Association Health Law Section.

In a video interview, Mr. Horton also discussed how to reduce liability and limit government inquiries.

[email protected]

On Twitter @legal_med

In the early 1970’s, the three letters that a pediatric house officer hated to see on a slip returning from the lab were Q.N.S. Quality Not Sufficient meant that the minutes, which seemed like hours, you had invested torturing some poor sick child to obtain just a few cc’s of blood had been wasted. It also meant returning to the patient’s crib or bedside to explain to the child and her parents that the torture you had promised was over for the day was in fact not over.

Tourniquets were fished out of lapel buttonholes, and the search for a decent vein had to begin all over again. If the child was chubby or bloated with retained fluid, those veins were invisible. If the child had been ill for weeks – particularly if the patient had been on chemotherapy – all of the good veins had been blown or had clotted days ago.

Many of the patients were saintly and eerily cooperative despite your fumbling attempts at venipuncture, but most were not. Some parents were so supportive of your efforts that you wanted to hug them when the ordeal was over (and you did). A few parents amped up the tension at the bedside so much that you wanted to ask them to leave (but you didn’t). If a parent was understandably incapable of effectively restraining the child, you needed to find an experienced nurse to help. A few of the best nurses were so good that the house officer merely needed to hold the needle still, and the child was repositioned in just the right orientation so that the puncture occurred miraculously.

There were some last ditch efforts at phlebotomy that were so ghastly that you had to ask the parents to leave. I don’t know if the infamous internal jugular stick is still used, but it wasn’t pretty. And it was almost as frightening for the physician holding the needle as it was for the patient. Even in the big teaching hospitals, dedicated phlebotomists hadn’t been invented yet. A few nurses had earned reputations as good vein finders, but for the most part it was on-the-job training for the house officers.

It was not until 1973 that Dr. John Broviac’s central line catheters became available in some hospitals and 1979 until Dr. Robert Hickman’s version appeared. It took a few more years before techniques were perfected for safely drawing specimens from these lines that had been originally intended for infusion. But for me and my cohort of house officers and our unfortunate patients, it was years too late. I am sure that caring for hospitalized pediatric cancer patients today continues to be dominated by challenges. But for those of us tasked with drawing blood from patients without the benefit of central line catheters, it was gut wrenching.

Those battles for a few cc’s of blood left their scars. I have seldom ordered any blood test without asking myself whether there wasn’t a bloodless way of assessing the patient’s condition. Or couldn’t we just do the test on a drop or two of blood? Of course, as I as finishing my training, more tests were downsized so that they could be done “micro.” But as you know, getting enough blood from a heel stick or finger prick isn’t always as easy as it sounds. If the child is shocky or cold, a good blood flow is hard to obtain. Warming helps but squeezing doesn’t because tissue juices can dilute the sample, and the trauma of squeezing can contaminate the sample.

A study published in the American Journal of Clinical Pathology raises the question of how accurately even a single drop of blood reflects what is going on in the patient’s total blood pool (“Drop by drop variation in the cellular components of fingerprick blood: Implications for point-of-care diagnostic development” [Am J Clin Pathol. 2015 Dec;144(6):885-94]). Two bioengineers from Rice University discovered that six successive drops of blood from a single finger prick varied by a significant amount when analyzed for a variety of cellular components. For example, the drop-to-drop variability for hemoglobin was five times that of a sample collected by venipuncture.

You and I may dream of the day when just a drop will do it and we can put our needles away for good. Unfortunately, for now, the answer is that a single drop of blood is a Q.N.S.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.”

In the early 1970’s, the three letters that a pediatric house officer hated to see on a slip returning from the lab were Q.N.S. Quality Not Sufficient meant that the minutes, which seemed like hours, you had invested torturing some poor sick child to obtain just a few cc’s of blood had been wasted. It also meant returning to the patient’s crib or bedside to explain to the child and her parents that the torture you had promised was over for the day was in fact not over.

Tourniquets were fished out of lapel buttonholes, and the search for a decent vein had to begin all over again. If the child was chubby or bloated with retained fluid, those veins were invisible. If the child had been ill for weeks – particularly if the patient had been on chemotherapy – all of the good veins had been blown or had clotted days ago.

Many of the patients were saintly and eerily cooperative despite your fumbling attempts at venipuncture, but most were not. Some parents were so supportive of your efforts that you wanted to hug them when the ordeal was over (and you did). A few parents amped up the tension at the bedside so much that you wanted to ask them to leave (but you didn’t). If a parent was understandably incapable of effectively restraining the child, you needed to find an experienced nurse to help. A few of the best nurses were so good that the house officer merely needed to hold the needle still, and the child was repositioned in just the right orientation so that the puncture occurred miraculously.

There were some last ditch efforts at phlebotomy that were so ghastly that you had to ask the parents to leave. I don’t know if the infamous internal jugular stick is still used, but it wasn’t pretty. And it was almost as frightening for the physician holding the needle as it was for the patient. Even in the big teaching hospitals, dedicated phlebotomists hadn’t been invented yet. A few nurses had earned reputations as good vein finders, but for the most part it was on-the-job training for the house officers.

It was not until 1973 that Dr. John Broviac’s central line catheters became available in some hospitals and 1979 until Dr. Robert Hickman’s version appeared. It took a few more years before techniques were perfected for safely drawing specimens from these lines that had been originally intended for infusion. But for me and my cohort of house officers and our unfortunate patients, it was years too late. I am sure that caring for hospitalized pediatric cancer patients today continues to be dominated by challenges. But for those of us tasked with drawing blood from patients without the benefit of central line catheters, it was gut wrenching.

Those battles for a few cc’s of blood left their scars. I have seldom ordered any blood test without asking myself whether there wasn’t a bloodless way of assessing the patient’s condition. Or couldn’t we just do the test on a drop or two of blood? Of course, as I as finishing my training, more tests were downsized so that they could be done “micro.” But as you know, getting enough blood from a heel stick or finger prick isn’t always as easy as it sounds. If the child is shocky or cold, a good blood flow is hard to obtain. Warming helps but squeezing doesn’t because tissue juices can dilute the sample, and the trauma of squeezing can contaminate the sample.

A study published in the American Journal of Clinical Pathology raises the question of how accurately even a single drop of blood reflects what is going on in the patient’s total blood pool (“Drop by drop variation in the cellular components of fingerprick blood: Implications for point-of-care diagnostic development” [Am J Clin Pathol. 2015 Dec;144(6):885-94]). Two bioengineers from Rice University discovered that six successive drops of blood from a single finger prick varied by a significant amount when analyzed for a variety of cellular components. For example, the drop-to-drop variability for hemoglobin was five times that of a sample collected by venipuncture.

You and I may dream of the day when just a drop will do it and we can put our needles away for good. Unfortunately, for now, the answer is that a single drop of blood is a Q.N.S.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.”

In the early 1970’s, the three letters that a pediatric house officer hated to see on a slip returning from the lab were Q.N.S. Quality Not Sufficient meant that the minutes, which seemed like hours, you had invested torturing some poor sick child to obtain just a few cc’s of blood had been wasted. It also meant returning to the patient’s crib or bedside to explain to the child and her parents that the torture you had promised was over for the day was in fact not over.

Tourniquets were fished out of lapel buttonholes, and the search for a decent vein had to begin all over again. If the child was chubby or bloated with retained fluid, those veins were invisible. If the child had been ill for weeks – particularly if the patient had been on chemotherapy – all of the good veins had been blown or had clotted days ago.

Many of the patients were saintly and eerily cooperative despite your fumbling attempts at venipuncture, but most were not. Some parents were so supportive of your efforts that you wanted to hug them when the ordeal was over (and you did). A few parents amped up the tension at the bedside so much that you wanted to ask them to leave (but you didn’t). If a parent was understandably incapable of effectively restraining the child, you needed to find an experienced nurse to help. A few of the best nurses were so good that the house officer merely needed to hold the needle still, and the child was repositioned in just the right orientation so that the puncture occurred miraculously.

There were some last ditch efforts at phlebotomy that were so ghastly that you had to ask the parents to leave. I don’t know if the infamous internal jugular stick is still used, but it wasn’t pretty. And it was almost as frightening for the physician holding the needle as it was for the patient. Even in the big teaching hospitals, dedicated phlebotomists hadn’t been invented yet. A few nurses had earned reputations as good vein finders, but for the most part it was on-the-job training for the house officers.

It was not until 1973 that Dr. John Broviac’s central line catheters became available in some hospitals and 1979 until Dr. Robert Hickman’s version appeared. It took a few more years before techniques were perfected for safely drawing specimens from these lines that had been originally intended for infusion. But for me and my cohort of house officers and our unfortunate patients, it was years too late. I am sure that caring for hospitalized pediatric cancer patients today continues to be dominated by challenges. But for those of us tasked with drawing blood from patients without the benefit of central line catheters, it was gut wrenching.

Those battles for a few cc’s of blood left their scars. I have seldom ordered any blood test without asking myself whether there wasn’t a bloodless way of assessing the patient’s condition. Or couldn’t we just do the test on a drop or two of blood? Of course, as I as finishing my training, more tests were downsized so that they could be done “micro.” But as you know, getting enough blood from a heel stick or finger prick isn’t always as easy as it sounds. If the child is shocky or cold, a good blood flow is hard to obtain. Warming helps but squeezing doesn’t because tissue juices can dilute the sample, and the trauma of squeezing can contaminate the sample.

A study published in the American Journal of Clinical Pathology raises the question of how accurately even a single drop of blood reflects what is going on in the patient’s total blood pool (“Drop by drop variation in the cellular components of fingerprick blood: Implications for point-of-care diagnostic development” [Am J Clin Pathol. 2015 Dec;144(6):885-94]). Two bioengineers from Rice University discovered that six successive drops of blood from a single finger prick varied by a significant amount when analyzed for a variety of cellular components. For example, the drop-to-drop variability for hemoglobin was five times that of a sample collected by venipuncture.

You and I may dream of the day when just a drop will do it and we can put our needles away for good. Unfortunately, for now, the answer is that a single drop of blood is a Q.N.S.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.”

May 14-18, 2016
Baltimore, MD

President & Annual Meeting Chair
Joseph S. Coselli

Annual Meeting Co-Chairs
Charles D. Fraser
David R. Jones

View Preliminary Program, Speakers, Presentations and Full Abstracts

The 96th Annual Meeting is a five-day program of state-of-the-art presentations by renowned experts. Attendees will enhance their knowledge and skills in a wide-range of subjects including general and specialized cardiac surgery, emerging technologies, congenital heart disease, critical care and aortic/endovascular surgery.

Don’t miss this year’s exciting program including:

Saturday Skills Courses featuring Combined Luncheon Speaker: Denton A. Cooley, followed by Hands-On Sessions

Sunday Postgraduate Symposia with Legends Luncheons featuring Joel D. Cooper and John L. Ochsner

New: Survival Guide for the Cardiothoracic Surgical Team course following by a Hands-On Session (Available to Residents, Fellows and Health Care Professionals Only)

Presidential Address: Competition: Perspiration to Inspiration “Aut viam inveniam aut faciam”, Joseph S. Coselli, Baylor College of Medicine

Basic Science Lecture: Stopping Incurable Cancers through Eliminating their Anti-Oxidative Defenses, James D. Watson, a Nobel Prize-winning biophysicist and researcher who is credited with co-discovering the double-helix structure of DNA.

Honored Guest Lecture: Brian Kelly, Notre Dame Head Football Coach and a veteran of 23 seasons as a collegiate head coach. Brian Kelly brings a championship tradition to his fifth year as the 29th head football coach at the University of Notre Dame.

Emerging Technologies & Techniques For: Adult Cardiac and General Thoracic

VAD/ECMO SessionMasters of Surgery: Video Sessions

AATS Learning Center: Featuring cutting-edge case videos of novel procedures and surgical techniques.

May 14-18, 2016
Baltimore, MD

President & Annual Meeting Chair
Joseph S. Coselli

Annual Meeting Co-Chairs
Charles D. Fraser
David R. Jones

View Preliminary Program, Speakers, Presentations and Full Abstracts

The 96th Annual Meeting is a five-day program of state-of-the-art presentations by renowned experts. Attendees will enhance their knowledge and skills in a wide-range of subjects including general and specialized cardiac surgery, emerging technologies, congenital heart disease, critical care and aortic/endovascular surgery.

Don’t miss this year’s exciting program including:

Saturday Skills Courses featuring Combined Luncheon Speaker: Denton A. Cooley, followed by Hands-On Sessions

Sunday Postgraduate Symposia with Legends Luncheons featuring Joel D. Cooper and John L. Ochsner

New: Survival Guide for the Cardiothoracic Surgical Team course following by a Hands-On Session (Available to Residents, Fellows and Health Care Professionals Only)

Presidential Address: Competition: Perspiration to Inspiration “Aut viam inveniam aut faciam”, Joseph S. Coselli, Baylor College of Medicine

Basic Science Lecture: Stopping Incurable Cancers through Eliminating their Anti-Oxidative Defenses, James D. Watson, a Nobel Prize-winning biophysicist and researcher who is credited with co-discovering the double-helix structure of DNA.

Honored Guest Lecture: Brian Kelly, Notre Dame Head Football Coach and a veteran of 23 seasons as a collegiate head coach. Brian Kelly brings a championship tradition to his fifth year as the 29th head football coach at the University of Notre Dame.

Emerging Technologies & Techniques For: Adult Cardiac and General Thoracic

VAD/ECMO SessionMasters of Surgery: Video Sessions

AATS Learning Center: Featuring cutting-edge case videos of novel procedures and surgical techniques.

May 14-18, 2016
Baltimore, MD

President & Annual Meeting Chair
Joseph S. Coselli

Annual Meeting Co-Chairs
Charles D. Fraser
David R. Jones

View Preliminary Program, Speakers, Presentations and Full Abstracts

The 96th Annual Meeting is a five-day program of state-of-the-art presentations by renowned experts. Attendees will enhance their knowledge and skills in a wide-range of subjects including general and specialized cardiac surgery, emerging technologies, congenital heart disease, critical care and aortic/endovascular surgery.

Don’t miss this year’s exciting program including:

Saturday Skills Courses featuring Combined Luncheon Speaker: Denton A. Cooley, followed by Hands-On Sessions

Sunday Postgraduate Symposia with Legends Luncheons featuring Joel D. Cooper and John L. Ochsner

New: Survival Guide for the Cardiothoracic Surgical Team course following by a Hands-On Session (Available to Residents, Fellows and Health Care Professionals Only)

Presidential Address: Competition: Perspiration to Inspiration “Aut viam inveniam aut faciam”, Joseph S. Coselli, Baylor College of Medicine

Basic Science Lecture: Stopping Incurable Cancers through Eliminating their Anti-Oxidative Defenses, James D. Watson, a Nobel Prize-winning biophysicist and researcher who is credited with co-discovering the double-helix structure of DNA.

Honored Guest Lecture: Brian Kelly, Notre Dame Head Football Coach and a veteran of 23 seasons as a collegiate head coach. Brian Kelly brings a championship tradition to his fifth year as the 29th head football coach at the University of Notre Dame.

Emerging Technologies & Techniques For: Adult Cardiac and General Thoracic

VAD/ECMO SessionMasters of Surgery: Video Sessions

AATS Learning Center: Featuring cutting-edge case videos of novel procedures and surgical techniques.