Clinically integrated networks: 5 roadblocks and how to overcome them

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Fri, 01/18/2019 - 16:55

 

CHICAGO – With growing pressure to deliver higher-quality care at reduced costs, more physicians and practices are looking to join a clinically integrated network. But establishing and successfully operating such a network is sometimes easier said than done.

A clinically integrated network is defined as a collection of health providers, such as physicians, hospitals, and post-acute specialists that join together to improve care and reduce costs. Such networks generally share record systems, track data, and rely on evidence-based guidelines to provide high-quality care across participating providers.

If a group meets Federal Trade Commission compliance requirements to be considered a clinically integrated network, the government will provide a safe harbor from antitrust scrutiny. The four components that networks must meet to be considered clinically integrated include: physician leadership and commitment, development and implementation of clinical practice guidelines to improve performance, development of infrastructure and technology, and financial incentives for achieving goals.

An accountable care organization (ACO) that participates in the Medicare Shared Savings Program is deemed “clinically integrated.” The clinical integration network (CIN) is the actual legal entity/network that the physicians join. Unlike physician hospital organizations (PHOs), clinically integrated networks can jointly negotiate contractual fees as long as the primary purpose of the negotiation is to achieve care improvement, according to a summary by the Medical Group Management Association.

Clinically integrated networks can also support ACOs or patient centered medical homes as part of the clinically integrated network by serving as a mechanism for sharing infrastructure and development costs.

“For doctors, participating in a clinically integrated network is an opportunity to work as part of a group, without giving up their independence,” George Mayzell, MD, chief clinical officer for Vizient Southeast, said during a recent American Bar Association meeting. Participation in such a network also may potentially support some of the alternative payment models under the Medicare Access and CHIP Reauthorization Act (MACRA), he said.

From financial challenges to lack of collaboration to data woes, physicians can face unexpected barriers as their clinically integrated network gets off the ground. Below, experts discuss the top five roadblocks to clinically integrated networks and how doctors and hospitals can overcome them.
 

1. Contribution reluctance

Although there is no hard-and-fast level, investments of time, energy, and financial resources by all participating providers are necessary to create and maintain a clinically integrated network, according to the Federal Trade Commission. However, physicians can sometimes be wary of contributing substantially to a new network, said April E. Schweitzer, a Chicago-based health law attorney who specializes in clinical integration networks and accountable care organizations.

Some doctors feel comfortable contributing only nominal amounts or believe that the system should bear the burden of costs, Ms. Schweitzer said at an American Bar Association meeting.

April Schweitzer
“There’s no bright line dollar amount that the government agencies say is enough,” Ms. Schweitzer said at the meeting. “So [networks] really need to demonstrate participation and physician buy-in.”

Consider different contribution options that will satisfy new members. One option is charging initiation fees, which typically run between $250 and $500, Ms. Schweitzer said. Another option is charging annual dues, which can be a similar amount, depending on specialty. If hesitation among members continues, come up with an alternative plan, Ms. Schweitzer said.

“If opposition is strong, you might do away with those [options],” she said. “[Instead], you may say, ‘We’re going to take a portion of the bonus pool before going into any bonus distribution methodology to reimburse what we would’ve used those dues or initiation fees to cover to pay back the [network] and operating costs.”

2. Savings expectations

Network members often have high hopes when it comes to the savings and reimbursement bonuses they expect to see once the network launches. The reality can be disappointing, said Dr. Mayzell.

“Creating savings takes time and a high level of patience/commitment,” Dr. Mayzell said in an interview. “Even when the savings are realized early on, financial awards are often low, and if they’re spread out between all of the primary care physicians and the specialists, they are not very motivating. This must be taken into account.”

It helps to set reasonable expectations early on about reimbursement, Ms. Schweitzer said. The same goes for managing payer contract expectations.

“You want to manage expectations at the outset,” she said during the meeting. “And you really do want to be honest about what the payers in your market are looking for and are expecting.”

3. Balancing leadership

Sophisticated clinically integrated networks require significant infrastructure and IT costs, thus most are funded by a hospital or health system, Ms. Schweitzer said. As a result, the hospital or health system is likely to be the sole corporate member of the legal entity serving as the network. But because success within the network requires physicians to potentially change their practice patterns, it is important to have true physician leadership on the governing board of the clinically integrated network.

 

 

Class voting is one way to balance the need for a physician-led network with appropriate governance of a clinically integrated network, Ms. Schweitzer said in an interview. Class voting allows “physicians to comprise a majority of the governing board of a clinically integrated network [while allowing the corporate member] to retain decision-making power because the physician class gets one vote and the hospital or health system class gets one vote.”

In addition, she advised giving the hospital or health system certain reserved powers to protect the health system’s tax-exempt status. This includes:

  • Ensuring that the CIN serves community and charitable purposes.
  • Protecting and promoting the community benefits served by the corporate member and ensuring that the assets and income of the corporate member and the CIN are used to serve community objectives.
  • Protecting the assets and income of the corporate member and the CIN by ensuring that the CIN complies with all applicable laws and regulatory requirements.

4. EHR interoperability

For a successful network, quality data must be aggregated from all providers. This can prove challenging when independent physicians each have separate electronic health record systems, Dr. Mayzell said.

“You can try to aggregate this data manually, but that is extremely challenging,” he said in an interview. “To aggregate [EHR] level data, you generally need to use additional software and organizations that connect electronically with each of their systems. This is often very expensive and cumbersome, with each system requiring a different interface and often each version of each system requiring a different interface.”

In the beginning stages of the network, survey all participating providers about the most widely used EHR systems to narrow interfacing to a manageable number, Ms. Schweitzer advised.

“This is what a lot of our clients are doing during the steering committee phase,” she said. “That’s when you’re bringing the health system and the doctors together to make decisions about how this entity will run.”

Additionally, consider alternative methods for data downloads, such as flat fees, payer downloads, or manual entries. Incorporate a long-term strategy about how many record systems the network will be using in future years, added Dr. Mayzell.

5. Resistance to data download

When it comes to data, many physicians feel that patient data are “their” data, and they are uneasy about giving access to that data when participating in a clinically integrated network, Ms. Schweitzer said. Patient privacy is also a top concern.

While these are valid concerns, networks need as much data as possible in their data warehouse to show payers that their participating physicians are providing quality care, while reducing cost, she said.

A full data download is beneficial for the network because overinclusion allows for more accurate assessment and better extrapolation in quality improvement, she said. This means each participating physician submits all their patient data, regardless of payer. Remind members that from an IT perspective, data from one doctor are merely grains of sand in a beach of data. Explain to uneasy members that the data are scrubbed of all patient identifiers and that it is the aggregate data that are most valuable to the network.

“If you’re going through one of these processes, I would encourage you to push the lawyers hard because there are answers to these questions about data privacy and you should understand that 99% of the time, the data that are going to be seen, are going to be scrubbed,” she said. “I urge you to ask tough questions if you’re in the room and discussing that particular issue.”

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CHICAGO – With growing pressure to deliver higher-quality care at reduced costs, more physicians and practices are looking to join a clinically integrated network. But establishing and successfully operating such a network is sometimes easier said than done.

A clinically integrated network is defined as a collection of health providers, such as physicians, hospitals, and post-acute specialists that join together to improve care and reduce costs. Such networks generally share record systems, track data, and rely on evidence-based guidelines to provide high-quality care across participating providers.

If a group meets Federal Trade Commission compliance requirements to be considered a clinically integrated network, the government will provide a safe harbor from antitrust scrutiny. The four components that networks must meet to be considered clinically integrated include: physician leadership and commitment, development and implementation of clinical practice guidelines to improve performance, development of infrastructure and technology, and financial incentives for achieving goals.

An accountable care organization (ACO) that participates in the Medicare Shared Savings Program is deemed “clinically integrated.” The clinical integration network (CIN) is the actual legal entity/network that the physicians join. Unlike physician hospital organizations (PHOs), clinically integrated networks can jointly negotiate contractual fees as long as the primary purpose of the negotiation is to achieve care improvement, according to a summary by the Medical Group Management Association.

Clinically integrated networks can also support ACOs or patient centered medical homes as part of the clinically integrated network by serving as a mechanism for sharing infrastructure and development costs.

“For doctors, participating in a clinically integrated network is an opportunity to work as part of a group, without giving up their independence,” George Mayzell, MD, chief clinical officer for Vizient Southeast, said during a recent American Bar Association meeting. Participation in such a network also may potentially support some of the alternative payment models under the Medicare Access and CHIP Reauthorization Act (MACRA), he said.

From financial challenges to lack of collaboration to data woes, physicians can face unexpected barriers as their clinically integrated network gets off the ground. Below, experts discuss the top five roadblocks to clinically integrated networks and how doctors and hospitals can overcome them.
 

1. Contribution reluctance

Although there is no hard-and-fast level, investments of time, energy, and financial resources by all participating providers are necessary to create and maintain a clinically integrated network, according to the Federal Trade Commission. However, physicians can sometimes be wary of contributing substantially to a new network, said April E. Schweitzer, a Chicago-based health law attorney who specializes in clinical integration networks and accountable care organizations.

Some doctors feel comfortable contributing only nominal amounts or believe that the system should bear the burden of costs, Ms. Schweitzer said at an American Bar Association meeting.

April Schweitzer
“There’s no bright line dollar amount that the government agencies say is enough,” Ms. Schweitzer said at the meeting. “So [networks] really need to demonstrate participation and physician buy-in.”

Consider different contribution options that will satisfy new members. One option is charging initiation fees, which typically run between $250 and $500, Ms. Schweitzer said. Another option is charging annual dues, which can be a similar amount, depending on specialty. If hesitation among members continues, come up with an alternative plan, Ms. Schweitzer said.

“If opposition is strong, you might do away with those [options],” she said. “[Instead], you may say, ‘We’re going to take a portion of the bonus pool before going into any bonus distribution methodology to reimburse what we would’ve used those dues or initiation fees to cover to pay back the [network] and operating costs.”

2. Savings expectations

Network members often have high hopes when it comes to the savings and reimbursement bonuses they expect to see once the network launches. The reality can be disappointing, said Dr. Mayzell.

“Creating savings takes time and a high level of patience/commitment,” Dr. Mayzell said in an interview. “Even when the savings are realized early on, financial awards are often low, and if they’re spread out between all of the primary care physicians and the specialists, they are not very motivating. This must be taken into account.”

It helps to set reasonable expectations early on about reimbursement, Ms. Schweitzer said. The same goes for managing payer contract expectations.

“You want to manage expectations at the outset,” she said during the meeting. “And you really do want to be honest about what the payers in your market are looking for and are expecting.”

3. Balancing leadership

Sophisticated clinically integrated networks require significant infrastructure and IT costs, thus most are funded by a hospital or health system, Ms. Schweitzer said. As a result, the hospital or health system is likely to be the sole corporate member of the legal entity serving as the network. But because success within the network requires physicians to potentially change their practice patterns, it is important to have true physician leadership on the governing board of the clinically integrated network.

 

 

Class voting is one way to balance the need for a physician-led network with appropriate governance of a clinically integrated network, Ms. Schweitzer said in an interview. Class voting allows “physicians to comprise a majority of the governing board of a clinically integrated network [while allowing the corporate member] to retain decision-making power because the physician class gets one vote and the hospital or health system class gets one vote.”

In addition, she advised giving the hospital or health system certain reserved powers to protect the health system’s tax-exempt status. This includes:

  • Ensuring that the CIN serves community and charitable purposes.
  • Protecting and promoting the community benefits served by the corporate member and ensuring that the assets and income of the corporate member and the CIN are used to serve community objectives.
  • Protecting the assets and income of the corporate member and the CIN by ensuring that the CIN complies with all applicable laws and regulatory requirements.

4. EHR interoperability

For a successful network, quality data must be aggregated from all providers. This can prove challenging when independent physicians each have separate electronic health record systems, Dr. Mayzell said.

“You can try to aggregate this data manually, but that is extremely challenging,” he said in an interview. “To aggregate [EHR] level data, you generally need to use additional software and organizations that connect electronically with each of their systems. This is often very expensive and cumbersome, with each system requiring a different interface and often each version of each system requiring a different interface.”

In the beginning stages of the network, survey all participating providers about the most widely used EHR systems to narrow interfacing to a manageable number, Ms. Schweitzer advised.

“This is what a lot of our clients are doing during the steering committee phase,” she said. “That’s when you’re bringing the health system and the doctors together to make decisions about how this entity will run.”

Additionally, consider alternative methods for data downloads, such as flat fees, payer downloads, or manual entries. Incorporate a long-term strategy about how many record systems the network will be using in future years, added Dr. Mayzell.

5. Resistance to data download

When it comes to data, many physicians feel that patient data are “their” data, and they are uneasy about giving access to that data when participating in a clinically integrated network, Ms. Schweitzer said. Patient privacy is also a top concern.

While these are valid concerns, networks need as much data as possible in their data warehouse to show payers that their participating physicians are providing quality care, while reducing cost, she said.

A full data download is beneficial for the network because overinclusion allows for more accurate assessment and better extrapolation in quality improvement, she said. This means each participating physician submits all their patient data, regardless of payer. Remind members that from an IT perspective, data from one doctor are merely grains of sand in a beach of data. Explain to uneasy members that the data are scrubbed of all patient identifiers and that it is the aggregate data that are most valuable to the network.

“If you’re going through one of these processes, I would encourage you to push the lawyers hard because there are answers to these questions about data privacy and you should understand that 99% of the time, the data that are going to be seen, are going to be scrubbed,” she said. “I urge you to ask tough questions if you’re in the room and discussing that particular issue.”

 

CHICAGO – With growing pressure to deliver higher-quality care at reduced costs, more physicians and practices are looking to join a clinically integrated network. But establishing and successfully operating such a network is sometimes easier said than done.

A clinically integrated network is defined as a collection of health providers, such as physicians, hospitals, and post-acute specialists that join together to improve care and reduce costs. Such networks generally share record systems, track data, and rely on evidence-based guidelines to provide high-quality care across participating providers.

If a group meets Federal Trade Commission compliance requirements to be considered a clinically integrated network, the government will provide a safe harbor from antitrust scrutiny. The four components that networks must meet to be considered clinically integrated include: physician leadership and commitment, development and implementation of clinical practice guidelines to improve performance, development of infrastructure and technology, and financial incentives for achieving goals.

An accountable care organization (ACO) that participates in the Medicare Shared Savings Program is deemed “clinically integrated.” The clinical integration network (CIN) is the actual legal entity/network that the physicians join. Unlike physician hospital organizations (PHOs), clinically integrated networks can jointly negotiate contractual fees as long as the primary purpose of the negotiation is to achieve care improvement, according to a summary by the Medical Group Management Association.

Clinically integrated networks can also support ACOs or patient centered medical homes as part of the clinically integrated network by serving as a mechanism for sharing infrastructure and development costs.

“For doctors, participating in a clinically integrated network is an opportunity to work as part of a group, without giving up their independence,” George Mayzell, MD, chief clinical officer for Vizient Southeast, said during a recent American Bar Association meeting. Participation in such a network also may potentially support some of the alternative payment models under the Medicare Access and CHIP Reauthorization Act (MACRA), he said.

From financial challenges to lack of collaboration to data woes, physicians can face unexpected barriers as their clinically integrated network gets off the ground. Below, experts discuss the top five roadblocks to clinically integrated networks and how doctors and hospitals can overcome them.
 

1. Contribution reluctance

Although there is no hard-and-fast level, investments of time, energy, and financial resources by all participating providers are necessary to create and maintain a clinically integrated network, according to the Federal Trade Commission. However, physicians can sometimes be wary of contributing substantially to a new network, said April E. Schweitzer, a Chicago-based health law attorney who specializes in clinical integration networks and accountable care organizations.

Some doctors feel comfortable contributing only nominal amounts or believe that the system should bear the burden of costs, Ms. Schweitzer said at an American Bar Association meeting.

April Schweitzer
“There’s no bright line dollar amount that the government agencies say is enough,” Ms. Schweitzer said at the meeting. “So [networks] really need to demonstrate participation and physician buy-in.”

Consider different contribution options that will satisfy new members. One option is charging initiation fees, which typically run between $250 and $500, Ms. Schweitzer said. Another option is charging annual dues, which can be a similar amount, depending on specialty. If hesitation among members continues, come up with an alternative plan, Ms. Schweitzer said.

“If opposition is strong, you might do away with those [options],” she said. “[Instead], you may say, ‘We’re going to take a portion of the bonus pool before going into any bonus distribution methodology to reimburse what we would’ve used those dues or initiation fees to cover to pay back the [network] and operating costs.”

2. Savings expectations

Network members often have high hopes when it comes to the savings and reimbursement bonuses they expect to see once the network launches. The reality can be disappointing, said Dr. Mayzell.

“Creating savings takes time and a high level of patience/commitment,” Dr. Mayzell said in an interview. “Even when the savings are realized early on, financial awards are often low, and if they’re spread out between all of the primary care physicians and the specialists, they are not very motivating. This must be taken into account.”

It helps to set reasonable expectations early on about reimbursement, Ms. Schweitzer said. The same goes for managing payer contract expectations.

“You want to manage expectations at the outset,” she said during the meeting. “And you really do want to be honest about what the payers in your market are looking for and are expecting.”

3. Balancing leadership

Sophisticated clinically integrated networks require significant infrastructure and IT costs, thus most are funded by a hospital or health system, Ms. Schweitzer said. As a result, the hospital or health system is likely to be the sole corporate member of the legal entity serving as the network. But because success within the network requires physicians to potentially change their practice patterns, it is important to have true physician leadership on the governing board of the clinically integrated network.

 

 

Class voting is one way to balance the need for a physician-led network with appropriate governance of a clinically integrated network, Ms. Schweitzer said in an interview. Class voting allows “physicians to comprise a majority of the governing board of a clinically integrated network [while allowing the corporate member] to retain decision-making power because the physician class gets one vote and the hospital or health system class gets one vote.”

In addition, she advised giving the hospital or health system certain reserved powers to protect the health system’s tax-exempt status. This includes:

  • Ensuring that the CIN serves community and charitable purposes.
  • Protecting and promoting the community benefits served by the corporate member and ensuring that the assets and income of the corporate member and the CIN are used to serve community objectives.
  • Protecting the assets and income of the corporate member and the CIN by ensuring that the CIN complies with all applicable laws and regulatory requirements.

4. EHR interoperability

For a successful network, quality data must be aggregated from all providers. This can prove challenging when independent physicians each have separate electronic health record systems, Dr. Mayzell said.

“You can try to aggregate this data manually, but that is extremely challenging,” he said in an interview. “To aggregate [EHR] level data, you generally need to use additional software and organizations that connect electronically with each of their systems. This is often very expensive and cumbersome, with each system requiring a different interface and often each version of each system requiring a different interface.”

In the beginning stages of the network, survey all participating providers about the most widely used EHR systems to narrow interfacing to a manageable number, Ms. Schweitzer advised.

“This is what a lot of our clients are doing during the steering committee phase,” she said. “That’s when you’re bringing the health system and the doctors together to make decisions about how this entity will run.”

Additionally, consider alternative methods for data downloads, such as flat fees, payer downloads, or manual entries. Incorporate a long-term strategy about how many record systems the network will be using in future years, added Dr. Mayzell.

5. Resistance to data download

When it comes to data, many physicians feel that patient data are “their” data, and they are uneasy about giving access to that data when participating in a clinically integrated network, Ms. Schweitzer said. Patient privacy is also a top concern.

While these are valid concerns, networks need as much data as possible in their data warehouse to show payers that their participating physicians are providing quality care, while reducing cost, she said.

A full data download is beneficial for the network because overinclusion allows for more accurate assessment and better extrapolation in quality improvement, she said. This means each participating physician submits all their patient data, regardless of payer. Remind members that from an IT perspective, data from one doctor are merely grains of sand in a beach of data. Explain to uneasy members that the data are scrubbed of all patient identifiers and that it is the aggregate data that are most valuable to the network.

“If you’re going through one of these processes, I would encourage you to push the lawyers hard because there are answers to these questions about data privacy and you should understand that 99% of the time, the data that are going to be seen, are going to be scrubbed,” she said. “I urge you to ask tough questions if you’re in the room and discussing that particular issue.”

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Appeals court strikes down Wisconsin medical malpractice cap

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An appeals court has struck down Wisconsin’s medical malpractice cap for noneconomic damages, ruling that the $750,000 limit is unconstitutional.

In a July opinion, a panel of the First District Court of Appeals wrote that the medical liability cap denies equal protection for the most severely injured patients who are awarded damages exceeding the limit. The decision reinstates a $16.5 million noneconomic damages verdict awarded to a Wisconsin women who lost her limbs after a delayed sepsis diagnosis, according to court documents.

The Wisconsin Medical Society expressed its disappointment at the decision, warning that the ruling could destabilize Wisconsin’s medical liability environment and endanger patients’ access to high-quality, affordable care.

“This decision endangers the long-term solvency of the Injured Patients and Families Compensation Fund and its ability to adequately compensate patients and incentivizes attorneys to file questionable cases in hopes of astronomical jury awards seen in other states without caps,” Noel Deep, MD, president of the Wisconsin Medical Society, said in a statement. “We look forward to further opportunities to explain the importance of the cap to the stability of Wisconsin’s medical liability environment and its benefits for all Wisconsin patients as this case progresses.”

The Wisconsin Association for Justice, an association for the plaintiffs’ bar, praised the cap’s elimination.

“The Court of Appeals, in a concise and well-reasoned opinion, took a brave step toward ensuring that injured patients in Wisconsin can achieve justice by utilizing their constitutional right to a civil jury trial,” Association President Benjamin S. Wagner said in a statement. “The data the court relied upon speaks for itself. The imposition of damage caps against a person like Ascaris Mayo has no rational relationship to controlling medical costs, nor does the verdict impose a financial hardship on the Injured Patients and Families Compensation Fund. To the contrary, the court’s decision ensures that the fund meets its dual statutory obligations to provide excess insurance to medical professionals and provide compensation to injured patients and families.”

The ruling results from a medical malpractice lawsuit filed by patient Ascaris Mayo and her family against Infinity Health Care in Milwaukee, an emergency physician, a physician assistant, ProAssurance Wisconsin Insurance, and the Wisconsin Injured Patients and Families Compensation Fund. The suit claimed that, during a visit to the emergency department at Columbia St. Mary’s Hospital in Milwaukee for abdominal pain and a high fever, health providers failed to diagnosis and treat Ms. Mayo for sepsis. The sepsis led to organ failure, dry gangrene, and, eventually, amputation of her extremities, according to court documents.

A jury awarded Ms. Mayo and her husband $9 million in economic damages and $16.5 million in noneconomic damages. After the verdict, representatives for the Wisconsin Injured Patients and Families Compensation Fund moved to reduce the noneconomic damages award to $750,000 per the state’s cap. The Mayos challenged the reduction, arguing that the cap violated their constitutional rights. A circuit court concluded that the cap was not facially unconstitutional and that it was unconstitutional as applied to the Mayos because it violated the Mayos’ rights to equal protection and due process. Both the Mayos and representatives for the compensation fund appealed.

In their decision, the appeals panel shot down the reasoning used by Wisconsin’s Legislature to enact the noneconomic damages cap, raising doubts that the limit reduces defensive medicine by physicians and prevents a doctor shortage in the state.

“The record before us does not support a finding that the legislative objectives articulated in [the statute] are promoted in any way because the amount of the noneconomic damages cap is $750,000,” the judges wrote. “Data demonstrate that many states with no caps on noneconomic damages actually have higher physician retention rates than Wisconsin. [In addition,] the record before us shows that the ability to accurately measure the financial impact of ‘defensive medicine’ practices has not improved. ... Indeed, data suggest that the existence of noneconomic damages caps may actually increase the risk to patient safety.”

The case is expected to be appealed to the Wisconsin Supreme Court.

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An appeals court has struck down Wisconsin’s medical malpractice cap for noneconomic damages, ruling that the $750,000 limit is unconstitutional.

In a July opinion, a panel of the First District Court of Appeals wrote that the medical liability cap denies equal protection for the most severely injured patients who are awarded damages exceeding the limit. The decision reinstates a $16.5 million noneconomic damages verdict awarded to a Wisconsin women who lost her limbs after a delayed sepsis diagnosis, according to court documents.

The Wisconsin Medical Society expressed its disappointment at the decision, warning that the ruling could destabilize Wisconsin’s medical liability environment and endanger patients’ access to high-quality, affordable care.

“This decision endangers the long-term solvency of the Injured Patients and Families Compensation Fund and its ability to adequately compensate patients and incentivizes attorneys to file questionable cases in hopes of astronomical jury awards seen in other states without caps,” Noel Deep, MD, president of the Wisconsin Medical Society, said in a statement. “We look forward to further opportunities to explain the importance of the cap to the stability of Wisconsin’s medical liability environment and its benefits for all Wisconsin patients as this case progresses.”

The Wisconsin Association for Justice, an association for the plaintiffs’ bar, praised the cap’s elimination.

“The Court of Appeals, in a concise and well-reasoned opinion, took a brave step toward ensuring that injured patients in Wisconsin can achieve justice by utilizing their constitutional right to a civil jury trial,” Association President Benjamin S. Wagner said in a statement. “The data the court relied upon speaks for itself. The imposition of damage caps against a person like Ascaris Mayo has no rational relationship to controlling medical costs, nor does the verdict impose a financial hardship on the Injured Patients and Families Compensation Fund. To the contrary, the court’s decision ensures that the fund meets its dual statutory obligations to provide excess insurance to medical professionals and provide compensation to injured patients and families.”

The ruling results from a medical malpractice lawsuit filed by patient Ascaris Mayo and her family against Infinity Health Care in Milwaukee, an emergency physician, a physician assistant, ProAssurance Wisconsin Insurance, and the Wisconsin Injured Patients and Families Compensation Fund. The suit claimed that, during a visit to the emergency department at Columbia St. Mary’s Hospital in Milwaukee for abdominal pain and a high fever, health providers failed to diagnosis and treat Ms. Mayo for sepsis. The sepsis led to organ failure, dry gangrene, and, eventually, amputation of her extremities, according to court documents.

A jury awarded Ms. Mayo and her husband $9 million in economic damages and $16.5 million in noneconomic damages. After the verdict, representatives for the Wisconsin Injured Patients and Families Compensation Fund moved to reduce the noneconomic damages award to $750,000 per the state’s cap. The Mayos challenged the reduction, arguing that the cap violated their constitutional rights. A circuit court concluded that the cap was not facially unconstitutional and that it was unconstitutional as applied to the Mayos because it violated the Mayos’ rights to equal protection and due process. Both the Mayos and representatives for the compensation fund appealed.

In their decision, the appeals panel shot down the reasoning used by Wisconsin’s Legislature to enact the noneconomic damages cap, raising doubts that the limit reduces defensive medicine by physicians and prevents a doctor shortage in the state.

“The record before us does not support a finding that the legislative objectives articulated in [the statute] are promoted in any way because the amount of the noneconomic damages cap is $750,000,” the judges wrote. “Data demonstrate that many states with no caps on noneconomic damages actually have higher physician retention rates than Wisconsin. [In addition,] the record before us shows that the ability to accurately measure the financial impact of ‘defensive medicine’ practices has not improved. ... Indeed, data suggest that the existence of noneconomic damages caps may actually increase the risk to patient safety.”

The case is expected to be appealed to the Wisconsin Supreme Court.

 

An appeals court has struck down Wisconsin’s medical malpractice cap for noneconomic damages, ruling that the $750,000 limit is unconstitutional.

In a July opinion, a panel of the First District Court of Appeals wrote that the medical liability cap denies equal protection for the most severely injured patients who are awarded damages exceeding the limit. The decision reinstates a $16.5 million noneconomic damages verdict awarded to a Wisconsin women who lost her limbs after a delayed sepsis diagnosis, according to court documents.

The Wisconsin Medical Society expressed its disappointment at the decision, warning that the ruling could destabilize Wisconsin’s medical liability environment and endanger patients’ access to high-quality, affordable care.

“This decision endangers the long-term solvency of the Injured Patients and Families Compensation Fund and its ability to adequately compensate patients and incentivizes attorneys to file questionable cases in hopes of astronomical jury awards seen in other states without caps,” Noel Deep, MD, president of the Wisconsin Medical Society, said in a statement. “We look forward to further opportunities to explain the importance of the cap to the stability of Wisconsin’s medical liability environment and its benefits for all Wisconsin patients as this case progresses.”

The Wisconsin Association for Justice, an association for the plaintiffs’ bar, praised the cap’s elimination.

“The Court of Appeals, in a concise and well-reasoned opinion, took a brave step toward ensuring that injured patients in Wisconsin can achieve justice by utilizing their constitutional right to a civil jury trial,” Association President Benjamin S. Wagner said in a statement. “The data the court relied upon speaks for itself. The imposition of damage caps against a person like Ascaris Mayo has no rational relationship to controlling medical costs, nor does the verdict impose a financial hardship on the Injured Patients and Families Compensation Fund. To the contrary, the court’s decision ensures that the fund meets its dual statutory obligations to provide excess insurance to medical professionals and provide compensation to injured patients and families.”

The ruling results from a medical malpractice lawsuit filed by patient Ascaris Mayo and her family against Infinity Health Care in Milwaukee, an emergency physician, a physician assistant, ProAssurance Wisconsin Insurance, and the Wisconsin Injured Patients and Families Compensation Fund. The suit claimed that, during a visit to the emergency department at Columbia St. Mary’s Hospital in Milwaukee for abdominal pain and a high fever, health providers failed to diagnosis and treat Ms. Mayo for sepsis. The sepsis led to organ failure, dry gangrene, and, eventually, amputation of her extremities, according to court documents.

A jury awarded Ms. Mayo and her husband $9 million in economic damages and $16.5 million in noneconomic damages. After the verdict, representatives for the Wisconsin Injured Patients and Families Compensation Fund moved to reduce the noneconomic damages award to $750,000 per the state’s cap. The Mayos challenged the reduction, arguing that the cap violated their constitutional rights. A circuit court concluded that the cap was not facially unconstitutional and that it was unconstitutional as applied to the Mayos because it violated the Mayos’ rights to equal protection and due process. Both the Mayos and representatives for the compensation fund appealed.

In their decision, the appeals panel shot down the reasoning used by Wisconsin’s Legislature to enact the noneconomic damages cap, raising doubts that the limit reduces defensive medicine by physicians and prevents a doctor shortage in the state.

“The record before us does not support a finding that the legislative objectives articulated in [the statute] are promoted in any way because the amount of the noneconomic damages cap is $750,000,” the judges wrote. “Data demonstrate that many states with no caps on noneconomic damages actually have higher physician retention rates than Wisconsin. [In addition,] the record before us shows that the ability to accurately measure the financial impact of ‘defensive medicine’ practices has not improved. ... Indeed, data suggest that the existence of noneconomic damages caps may actually increase the risk to patient safety.”

The case is expected to be appealed to the Wisconsin Supreme Court.

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DOJ charges 412 in massive health care fraud bust

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Wed, 04/03/2019 - 10:26

 

The U.S. Department of Justice (DOJ) has charged more than 400 health professionals with fraud for allegedly bilking $1.3 billion from the government through false billings to the Medicare, Medicaid, and TRICARE programs.

In all, 412 people, including 56 doctors, were charged across 41 federal districts for their participation in the alleged schemes, a large portion of which involved unnecessarily prescribing and distributing opioids to patients, according to a July 13 announcement by the DOJ. The agency called the enforcement the largest health care fraud action in DOJ history.

Copyright Alex_str/Thinkstock
The defendants allegedly submitted claims to Medicare, Medicaid and TRICARE for treatments that were medically unnecessary and often never provided. In many cases, patient recruiters, beneficiaries, and other coconspirators were allegedly paid cash kickbacks in return for supplying beneficiary information so that the providers could submit fraudulent bills to Medicare.

Defendants were charged in more than 20 states, including Florida, Michigan, Texas, California, Illinois, and Louisiana, where the federal government operates Medicare Fraud Strike Forces.

Southern Florida had the highest number of defendants, with 77 health professionals charged with a combined $141 million in false billings for alleged home health care, mental health services, and pharmacy fraud. In one case, an owner and operator of a Florida addiction treatment center is accused of actively recruiting addicted patients to move to South Florida so that coconspirators could bill for treatment and testing. In return, the coconspirators offered kickbacks to patients in the form of gift cards, free airline travel, trips to casinos and strip clubs, and drugs, according to the DOJ.

Health care fraud is not only a criminal act that costs billions of taxpayer dollars, it is an affront to all Americans who rely on national health care programs, Tom Price, MD, Secretary of Health and Human Services, said in a statement. “The United States is home to the world’s best medical professionals, but their ability to provide affordable, high-quality care to their patients is jeopardized every time a criminal commits health care fraud,” Dr. Price said.

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The U.S. Department of Justice (DOJ) has charged more than 400 health professionals with fraud for allegedly bilking $1.3 billion from the government through false billings to the Medicare, Medicaid, and TRICARE programs.

In all, 412 people, including 56 doctors, were charged across 41 federal districts for their participation in the alleged schemes, a large portion of which involved unnecessarily prescribing and distributing opioids to patients, according to a July 13 announcement by the DOJ. The agency called the enforcement the largest health care fraud action in DOJ history.

Copyright Alex_str/Thinkstock
The defendants allegedly submitted claims to Medicare, Medicaid and TRICARE for treatments that were medically unnecessary and often never provided. In many cases, patient recruiters, beneficiaries, and other coconspirators were allegedly paid cash kickbacks in return for supplying beneficiary information so that the providers could submit fraudulent bills to Medicare.

Defendants were charged in more than 20 states, including Florida, Michigan, Texas, California, Illinois, and Louisiana, where the federal government operates Medicare Fraud Strike Forces.

Southern Florida had the highest number of defendants, with 77 health professionals charged with a combined $141 million in false billings for alleged home health care, mental health services, and pharmacy fraud. In one case, an owner and operator of a Florida addiction treatment center is accused of actively recruiting addicted patients to move to South Florida so that coconspirators could bill for treatment and testing. In return, the coconspirators offered kickbacks to patients in the form of gift cards, free airline travel, trips to casinos and strip clubs, and drugs, according to the DOJ.

Health care fraud is not only a criminal act that costs billions of taxpayer dollars, it is an affront to all Americans who rely on national health care programs, Tom Price, MD, Secretary of Health and Human Services, said in a statement. “The United States is home to the world’s best medical professionals, but their ability to provide affordable, high-quality care to their patients is jeopardized every time a criminal commits health care fraud,” Dr. Price said.

 

The U.S. Department of Justice (DOJ) has charged more than 400 health professionals with fraud for allegedly bilking $1.3 billion from the government through false billings to the Medicare, Medicaid, and TRICARE programs.

In all, 412 people, including 56 doctors, were charged across 41 federal districts for their participation in the alleged schemes, a large portion of which involved unnecessarily prescribing and distributing opioids to patients, according to a July 13 announcement by the DOJ. The agency called the enforcement the largest health care fraud action in DOJ history.

Copyright Alex_str/Thinkstock
The defendants allegedly submitted claims to Medicare, Medicaid and TRICARE for treatments that were medically unnecessary and often never provided. In many cases, patient recruiters, beneficiaries, and other coconspirators were allegedly paid cash kickbacks in return for supplying beneficiary information so that the providers could submit fraudulent bills to Medicare.

Defendants were charged in more than 20 states, including Florida, Michigan, Texas, California, Illinois, and Louisiana, where the federal government operates Medicare Fraud Strike Forces.

Southern Florida had the highest number of defendants, with 77 health professionals charged with a combined $141 million in false billings for alleged home health care, mental health services, and pharmacy fraud. In one case, an owner and operator of a Florida addiction treatment center is accused of actively recruiting addicted patients to move to South Florida so that coconspirators could bill for treatment and testing. In return, the coconspirators offered kickbacks to patients in the form of gift cards, free airline travel, trips to casinos and strip clubs, and drugs, according to the DOJ.

Health care fraud is not only a criminal act that costs billions of taxpayer dollars, it is an affront to all Americans who rely on national health care programs, Tom Price, MD, Secretary of Health and Human Services, said in a statement. “The United States is home to the world’s best medical professionals, but their ability to provide affordable, high-quality care to their patients is jeopardized every time a criminal commits health care fraud,” Dr. Price said.

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How to raise HPV vaccine rates: Work together

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Fri, 01/18/2019 - 16:53

 

Despite widespread availability of the human papillomavirus vaccine over the last 11 years, vaccination rates continue to lag behind national targets and are far behind other vaccines routinely administered in adolescence, such as the meningococcal and tetanus vaccines.

Better collaboration among pediatricians and obstetrician-gynecologists to promote the HPV vaccine may be one answer to turning the tide, said David W. Kimberlin, MD, codirector of the division of pediatric infectious diseases at the University of Alabama at Birmingham and president of the Pediatric Infectious Diseases Society.

Courtesy Steve Wood/University of Alabama, Birmingham
Dr. David Kimberlin coauthored a paper on the importance of collaboration between ob.gyns. and pediatricians to raise HPV vaccination rates.
“Prevention of HPV-related cancers is in the pediatric period, but the disease being prevented [occurs] in women and men who are well into adulthood,” Dr. Kimberlin said in an interview. “We have to work together to raise awareness so that lives can be saved. Every patient encounter is an opportunity to do so, thereby the coordination between ob.gyn. and pediatrics that we are advocating is all the more important.”

As of 2015, just 63% of eligible U.S. girls completed the first dose of the HPV vaccination, 52% completed two doses, and 42% finished the three-dose series, according to a recent “Call to Action” paper in the American Journal of Obstetrics and Gynecology (doi: 10.1016/j.ajog.2017.02.026). Although the HPV vaccine has been recommended for boys since 2011, just half of eligible boys completed the first dose, 39% completed two doses, and 28% finished the full series. By contrast, 86% of adolescents received the tetanus, diphtheria, and acellular pertussis vaccine, and 81% received the first dose of the meningococcal vaccine. The federal government’s Office of Disease Prevention and Health Promotion aims for an 80% HPV vaccination completion rate for girls and boys aged 13-15 years by 2020.

[polldaddy:{"method":"iframe","type":"survey","src":"//newspolls2017.polldaddy.com/s/how-to-raise-hpv-vaccine-rates?iframe=1"}]The CDC now recommends that 11- to 12-year-olds get two doses of the HPV vaccine, rather than three, with the second dose given 6-12 months after the first (MMWR. 2016;65:1405-8).

The common ways in which the HPV vaccine is introduced to parents likely contributes to the low vaccination rates, said Beth Auslander, PhD, a clinical psychologist and associate professor in the department of pediatrics at the University of Texas Medical Branch in Galveston. Some pediatricians may tell parents about school-mandated vaccines first and then as a side note, mention the HPV vaccine.

“The way it’s presented at times is being separate from the other vaccines,” Dr. Auslander said. “Sometimes it sounds optional.”

Parents often are uncertain about the safety and efficacy of the HPV vaccine, she added, and some wrongly assume the vaccine will lead to sexual activity among their children.

Dr. Jennie Yoost
Both ob.gyns. and pediatricians could do a better job of giving stronger recommendations about the HPV vaccine, said Jennie Yoost, MD, a Huntington, W.Va.–based pediatric and adolescent gynecologist and a member of the American Congress of Obstetricians and Gynecologists’ (ACOG) Immunization Expert Work Group. She is also an assistant professor of ob.gyn. at Marshall University in Huntington, W.Va.* 

“Sometimes it can take a little longer to talk about,” Dr. Yoost said in an interview. “A lot of times, parents will bring up questions or concerns about the HPV vaccine. If physicians aren’t comfortable talking about those topics, they may not give the best recommendation. Pediatricians are not dealing with cervical cancer, so they may have a harder time recommending a vaccine based on outcomes they don’t deal with.”

Ob.gyns. are in a unique position to reach out to their pediatric counterparts and discuss strategies for catching more patients eligible for the HPV vaccine, said Sarah Dilley, MD, a gynecologic oncology fellow at the University of Alabama at Birmingham and the lead author of the recent Call to Action paper.

“We offer a unique perspective in that we are treating the conditions that the HPV vaccine is preventing, so we have more of a sense of urgency and an understanding of why that is so important,” Dr. Dilley said in an interview. “Obviously, pediatricians understand this as well, but it’s not something they see every day in their practice. We, as ob.gyns., have the opportunity to talk to our pediatric colleagues about the importance and really how devastating these conditions can be and how important it is to prevent them.”

In the recent paper, Dr. Dilley and her colleagues recommend that ob.gyns. speak to pediatricians and primary care physicians in their community to promote the vaccine and encourage them to view the Centers for Disease Control and Prevention’s You Are the Key presentation. The CDC resources include tips for how to discuss the burden of HPV-related diseases and effective communication with parents, an update on state vaccination rates, and the latest HPV vaccination recommendations.

Dr. Dilley encourages ob.gyns. and pediatricians to find different opportunities and venues to discuss the HPV vaccine. Ask about the pediatrician’s current approach to the vaccine, the doctor’s communication with parents, and how such practices could be improved, she said.

“People like to hear from their colleagues,” Dr. Dilley said. “Hearing from ob.gyns. [about] their experiences could be really helpful, whether it’s doing lunch and learns, formal education, grand rounds, or even more informal talks at the hospital.”

Ob.gyns. and pediatricians also need to better coordinate their messaging so that there is more consistent emphasis during each patient encounter about the need of the HPV vaccination, Dr. Kimberlin said. There needs to be a renewed focus on the vaccine as a cancer vaccination, he said.

“The nuances of HPV and the way that HPV is acquired, namely sexually transmitted, has taken too much of a front row consideration in the conversations that parents sometimes want to have with their child’s health care providers,” Dr. Kimberlin said. “We have to stress this is a cancer vaccine. This is a vaccine that prevents the deaths of thousands of women and men. We simply need to get that message out more forcefully.”

In addition, there’s a need for joint action to debunk myths about the vaccine and work toward eliminating the stigma surrounding it, Dr. Dilley said.

“I talk to a lot parents about the HPV vaccine and there’s so much misinformation online,” she said. “But a lot of patients do look at websites of their ob.gyn. or their pediatrician, [and] if they see something reputable coming from one of those sites, they might listen. We have a lot of patients who are mothers or grandmothers of kids; that’s also an opportunity for us to say, ‘Hey while we’re screening you for cervical cancer, let’s talk about the HPV vaccine.’ That’s a really good opportunity to help our [pediatric] colleagues out.”

 

 

5 steps to increase HPV vaccination

Melissa Kottke, MD, director of the Jane Fonda Center for Adolescent Reproductive Health at Emory University offered her practice steps for increased HPV vaccination rates.

1. Be clear about your recommendation. For example, “I recommend the HPV vaccine. It can help prevent cancer.”

Dr. Melissa Kottke
2. Do not delay. From an immune response and potential HPV exposure standpoint, receiving the vaccine at a younger age is better than receiving it at an older age.

3. Educate the entire clinical team (front desk staff, nursing, medical assistants, etc.) about the HPV vaccine so there is consistent messaging and delivery.

4. Establish streamlined systems. The vaccine recommendation, order, and follow-up should be streamlined and automated, if possible. Systems should also ensure documentation of vaccine receipt.

5. Make time for conversations with patients who are mothers and grandmothers. Recommend the HPV vaccine for males and females aged 9-26 years old. Encourage parents/grandparents to follow-up with the child’s doctor or offer to provide the vaccine in your office.

*This story was updated 8/22/2017.
 

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Despite widespread availability of the human papillomavirus vaccine over the last 11 years, vaccination rates continue to lag behind national targets and are far behind other vaccines routinely administered in adolescence, such as the meningococcal and tetanus vaccines.

Better collaboration among pediatricians and obstetrician-gynecologists to promote the HPV vaccine may be one answer to turning the tide, said David W. Kimberlin, MD, codirector of the division of pediatric infectious diseases at the University of Alabama at Birmingham and president of the Pediatric Infectious Diseases Society.

Courtesy Steve Wood/University of Alabama, Birmingham
Dr. David Kimberlin coauthored a paper on the importance of collaboration between ob.gyns. and pediatricians to raise HPV vaccination rates.
“Prevention of HPV-related cancers is in the pediatric period, but the disease being prevented [occurs] in women and men who are well into adulthood,” Dr. Kimberlin said in an interview. “We have to work together to raise awareness so that lives can be saved. Every patient encounter is an opportunity to do so, thereby the coordination between ob.gyn. and pediatrics that we are advocating is all the more important.”

As of 2015, just 63% of eligible U.S. girls completed the first dose of the HPV vaccination, 52% completed two doses, and 42% finished the three-dose series, according to a recent “Call to Action” paper in the American Journal of Obstetrics and Gynecology (doi: 10.1016/j.ajog.2017.02.026). Although the HPV vaccine has been recommended for boys since 2011, just half of eligible boys completed the first dose, 39% completed two doses, and 28% finished the full series. By contrast, 86% of adolescents received the tetanus, diphtheria, and acellular pertussis vaccine, and 81% received the first dose of the meningococcal vaccine. The federal government’s Office of Disease Prevention and Health Promotion aims for an 80% HPV vaccination completion rate for girls and boys aged 13-15 years by 2020.

[polldaddy:{"method":"iframe","type":"survey","src":"//newspolls2017.polldaddy.com/s/how-to-raise-hpv-vaccine-rates?iframe=1"}]The CDC now recommends that 11- to 12-year-olds get two doses of the HPV vaccine, rather than three, with the second dose given 6-12 months after the first (MMWR. 2016;65:1405-8).

The common ways in which the HPV vaccine is introduced to parents likely contributes to the low vaccination rates, said Beth Auslander, PhD, a clinical psychologist and associate professor in the department of pediatrics at the University of Texas Medical Branch in Galveston. Some pediatricians may tell parents about school-mandated vaccines first and then as a side note, mention the HPV vaccine.

“The way it’s presented at times is being separate from the other vaccines,” Dr. Auslander said. “Sometimes it sounds optional.”

Parents often are uncertain about the safety and efficacy of the HPV vaccine, she added, and some wrongly assume the vaccine will lead to sexual activity among their children.

Dr. Jennie Yoost
Both ob.gyns. and pediatricians could do a better job of giving stronger recommendations about the HPV vaccine, said Jennie Yoost, MD, a Huntington, W.Va.–based pediatric and adolescent gynecologist and a member of the American Congress of Obstetricians and Gynecologists’ (ACOG) Immunization Expert Work Group. She is also an assistant professor of ob.gyn. at Marshall University in Huntington, W.Va.* 

“Sometimes it can take a little longer to talk about,” Dr. Yoost said in an interview. “A lot of times, parents will bring up questions or concerns about the HPV vaccine. If physicians aren’t comfortable talking about those topics, they may not give the best recommendation. Pediatricians are not dealing with cervical cancer, so they may have a harder time recommending a vaccine based on outcomes they don’t deal with.”

Ob.gyns. are in a unique position to reach out to their pediatric counterparts and discuss strategies for catching more patients eligible for the HPV vaccine, said Sarah Dilley, MD, a gynecologic oncology fellow at the University of Alabama at Birmingham and the lead author of the recent Call to Action paper.

“We offer a unique perspective in that we are treating the conditions that the HPV vaccine is preventing, so we have more of a sense of urgency and an understanding of why that is so important,” Dr. Dilley said in an interview. “Obviously, pediatricians understand this as well, but it’s not something they see every day in their practice. We, as ob.gyns., have the opportunity to talk to our pediatric colleagues about the importance and really how devastating these conditions can be and how important it is to prevent them.”

In the recent paper, Dr. Dilley and her colleagues recommend that ob.gyns. speak to pediatricians and primary care physicians in their community to promote the vaccine and encourage them to view the Centers for Disease Control and Prevention’s You Are the Key presentation. The CDC resources include tips for how to discuss the burden of HPV-related diseases and effective communication with parents, an update on state vaccination rates, and the latest HPV vaccination recommendations.

Dr. Dilley encourages ob.gyns. and pediatricians to find different opportunities and venues to discuss the HPV vaccine. Ask about the pediatrician’s current approach to the vaccine, the doctor’s communication with parents, and how such practices could be improved, she said.

“People like to hear from their colleagues,” Dr. Dilley said. “Hearing from ob.gyns. [about] their experiences could be really helpful, whether it’s doing lunch and learns, formal education, grand rounds, or even more informal talks at the hospital.”

Ob.gyns. and pediatricians also need to better coordinate their messaging so that there is more consistent emphasis during each patient encounter about the need of the HPV vaccination, Dr. Kimberlin said. There needs to be a renewed focus on the vaccine as a cancer vaccination, he said.

“The nuances of HPV and the way that HPV is acquired, namely sexually transmitted, has taken too much of a front row consideration in the conversations that parents sometimes want to have with their child’s health care providers,” Dr. Kimberlin said. “We have to stress this is a cancer vaccine. This is a vaccine that prevents the deaths of thousands of women and men. We simply need to get that message out more forcefully.”

In addition, there’s a need for joint action to debunk myths about the vaccine and work toward eliminating the stigma surrounding it, Dr. Dilley said.

“I talk to a lot parents about the HPV vaccine and there’s so much misinformation online,” she said. “But a lot of patients do look at websites of their ob.gyn. or their pediatrician, [and] if they see something reputable coming from one of those sites, they might listen. We have a lot of patients who are mothers or grandmothers of kids; that’s also an opportunity for us to say, ‘Hey while we’re screening you for cervical cancer, let’s talk about the HPV vaccine.’ That’s a really good opportunity to help our [pediatric] colleagues out.”

 

 

5 steps to increase HPV vaccination

Melissa Kottke, MD, director of the Jane Fonda Center for Adolescent Reproductive Health at Emory University offered her practice steps for increased HPV vaccination rates.

1. Be clear about your recommendation. For example, “I recommend the HPV vaccine. It can help prevent cancer.”

Dr. Melissa Kottke
2. Do not delay. From an immune response and potential HPV exposure standpoint, receiving the vaccine at a younger age is better than receiving it at an older age.

3. Educate the entire clinical team (front desk staff, nursing, medical assistants, etc.) about the HPV vaccine so there is consistent messaging and delivery.

4. Establish streamlined systems. The vaccine recommendation, order, and follow-up should be streamlined and automated, if possible. Systems should also ensure documentation of vaccine receipt.

5. Make time for conversations with patients who are mothers and grandmothers. Recommend the HPV vaccine for males and females aged 9-26 years old. Encourage parents/grandparents to follow-up with the child’s doctor or offer to provide the vaccine in your office.

*This story was updated 8/22/2017.
 

 

Despite widespread availability of the human papillomavirus vaccine over the last 11 years, vaccination rates continue to lag behind national targets and are far behind other vaccines routinely administered in adolescence, such as the meningococcal and tetanus vaccines.

Better collaboration among pediatricians and obstetrician-gynecologists to promote the HPV vaccine may be one answer to turning the tide, said David W. Kimberlin, MD, codirector of the division of pediatric infectious diseases at the University of Alabama at Birmingham and president of the Pediatric Infectious Diseases Society.

Courtesy Steve Wood/University of Alabama, Birmingham
Dr. David Kimberlin coauthored a paper on the importance of collaboration between ob.gyns. and pediatricians to raise HPV vaccination rates.
“Prevention of HPV-related cancers is in the pediatric period, but the disease being prevented [occurs] in women and men who are well into adulthood,” Dr. Kimberlin said in an interview. “We have to work together to raise awareness so that lives can be saved. Every patient encounter is an opportunity to do so, thereby the coordination between ob.gyn. and pediatrics that we are advocating is all the more important.”

As of 2015, just 63% of eligible U.S. girls completed the first dose of the HPV vaccination, 52% completed two doses, and 42% finished the three-dose series, according to a recent “Call to Action” paper in the American Journal of Obstetrics and Gynecology (doi: 10.1016/j.ajog.2017.02.026). Although the HPV vaccine has been recommended for boys since 2011, just half of eligible boys completed the first dose, 39% completed two doses, and 28% finished the full series. By contrast, 86% of adolescents received the tetanus, diphtheria, and acellular pertussis vaccine, and 81% received the first dose of the meningococcal vaccine. The federal government’s Office of Disease Prevention and Health Promotion aims for an 80% HPV vaccination completion rate for girls and boys aged 13-15 years by 2020.

[polldaddy:{"method":"iframe","type":"survey","src":"//newspolls2017.polldaddy.com/s/how-to-raise-hpv-vaccine-rates?iframe=1"}]The CDC now recommends that 11- to 12-year-olds get two doses of the HPV vaccine, rather than three, with the second dose given 6-12 months after the first (MMWR. 2016;65:1405-8).

The common ways in which the HPV vaccine is introduced to parents likely contributes to the low vaccination rates, said Beth Auslander, PhD, a clinical psychologist and associate professor in the department of pediatrics at the University of Texas Medical Branch in Galveston. Some pediatricians may tell parents about school-mandated vaccines first and then as a side note, mention the HPV vaccine.

“The way it’s presented at times is being separate from the other vaccines,” Dr. Auslander said. “Sometimes it sounds optional.”

Parents often are uncertain about the safety and efficacy of the HPV vaccine, she added, and some wrongly assume the vaccine will lead to sexual activity among their children.

Dr. Jennie Yoost
Both ob.gyns. and pediatricians could do a better job of giving stronger recommendations about the HPV vaccine, said Jennie Yoost, MD, a Huntington, W.Va.–based pediatric and adolescent gynecologist and a member of the American Congress of Obstetricians and Gynecologists’ (ACOG) Immunization Expert Work Group. She is also an assistant professor of ob.gyn. at Marshall University in Huntington, W.Va.* 

“Sometimes it can take a little longer to talk about,” Dr. Yoost said in an interview. “A lot of times, parents will bring up questions or concerns about the HPV vaccine. If physicians aren’t comfortable talking about those topics, they may not give the best recommendation. Pediatricians are not dealing with cervical cancer, so they may have a harder time recommending a vaccine based on outcomes they don’t deal with.”

Ob.gyns. are in a unique position to reach out to their pediatric counterparts and discuss strategies for catching more patients eligible for the HPV vaccine, said Sarah Dilley, MD, a gynecologic oncology fellow at the University of Alabama at Birmingham and the lead author of the recent Call to Action paper.

“We offer a unique perspective in that we are treating the conditions that the HPV vaccine is preventing, so we have more of a sense of urgency and an understanding of why that is so important,” Dr. Dilley said in an interview. “Obviously, pediatricians understand this as well, but it’s not something they see every day in their practice. We, as ob.gyns., have the opportunity to talk to our pediatric colleagues about the importance and really how devastating these conditions can be and how important it is to prevent them.”

In the recent paper, Dr. Dilley and her colleagues recommend that ob.gyns. speak to pediatricians and primary care physicians in their community to promote the vaccine and encourage them to view the Centers for Disease Control and Prevention’s You Are the Key presentation. The CDC resources include tips for how to discuss the burden of HPV-related diseases and effective communication with parents, an update on state vaccination rates, and the latest HPV vaccination recommendations.

Dr. Dilley encourages ob.gyns. and pediatricians to find different opportunities and venues to discuss the HPV vaccine. Ask about the pediatrician’s current approach to the vaccine, the doctor’s communication with parents, and how such practices could be improved, she said.

“People like to hear from their colleagues,” Dr. Dilley said. “Hearing from ob.gyns. [about] their experiences could be really helpful, whether it’s doing lunch and learns, formal education, grand rounds, or even more informal talks at the hospital.”

Ob.gyns. and pediatricians also need to better coordinate their messaging so that there is more consistent emphasis during each patient encounter about the need of the HPV vaccination, Dr. Kimberlin said. There needs to be a renewed focus on the vaccine as a cancer vaccination, he said.

“The nuances of HPV and the way that HPV is acquired, namely sexually transmitted, has taken too much of a front row consideration in the conversations that parents sometimes want to have with their child’s health care providers,” Dr. Kimberlin said. “We have to stress this is a cancer vaccine. This is a vaccine that prevents the deaths of thousands of women and men. We simply need to get that message out more forcefully.”

In addition, there’s a need for joint action to debunk myths about the vaccine and work toward eliminating the stigma surrounding it, Dr. Dilley said.

“I talk to a lot parents about the HPV vaccine and there’s so much misinformation online,” she said. “But a lot of patients do look at websites of their ob.gyn. or their pediatrician, [and] if they see something reputable coming from one of those sites, they might listen. We have a lot of patients who are mothers or grandmothers of kids; that’s also an opportunity for us to say, ‘Hey while we’re screening you for cervical cancer, let’s talk about the HPV vaccine.’ That’s a really good opportunity to help our [pediatric] colleagues out.”

 

 

5 steps to increase HPV vaccination

Melissa Kottke, MD, director of the Jane Fonda Center for Adolescent Reproductive Health at Emory University offered her practice steps for increased HPV vaccination rates.

1. Be clear about your recommendation. For example, “I recommend the HPV vaccine. It can help prevent cancer.”

Dr. Melissa Kottke
2. Do not delay. From an immune response and potential HPV exposure standpoint, receiving the vaccine at a younger age is better than receiving it at an older age.

3. Educate the entire clinical team (front desk staff, nursing, medical assistants, etc.) about the HPV vaccine so there is consistent messaging and delivery.

4. Establish streamlined systems. The vaccine recommendation, order, and follow-up should be streamlined and automated, if possible. Systems should also ensure documentation of vaccine receipt.

5. Make time for conversations with patients who are mothers and grandmothers. Recommend the HPV vaccine for males and females aged 9-26 years old. Encourage parents/grandparents to follow-up with the child’s doctor or offer to provide the vaccine in your office.

*This story was updated 8/22/2017.
 

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Malpractice reform: House passes bill to cap damages

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Wed, 04/03/2019 - 10:26

 

The House of Representatives has passed a bill that would cap damages in medical malpractice cases and impose a tighter time frame for legal challenges against physicians.

The House passed the Protecting Access to Care Act (H.R. 1215) on June 28 by a 218-210 vote. The bill, modeled after California’s Medical Injury Compensation Reform Act (MICRA), would limit noneconomic damages in medical malpractice cases to $250,000, restrict contingency fees charged by attorneys, and enforce a 3-year statute of limitations for liability lawsuits from the date of alleged injury. The legislation also includes a fair share rule in which defendants are liable only for the damages in direct proportion to their percentage of responsibility.

The American College of Physicians (ACP) praised the House for passing the bill, saying the time is ripe to develop and pass common-sense liability reforms.

“The American College of Physicians applauds the House of Representatives for its passage of a multifaceted approach to medical-liability reform,” Jack Ende, MD, ACP president, said in a statement. “ACP believes that any solution to improve the medical liability system in the U.S. should include a multifaceted approach, because no single program or law by itself is likely to achieve the goals of improving patient safety, ensuring fair compensation to patients, strengthening rather than undermining the patient-physician relationship, and reducing the economic costs associated with the current system.”

The American Association for Justice, a lobbying organization for plaintiffs’ attorneys, sent a letter to the House prior to the bill’s passage urging legislators to oppose the bill. More than 75 organizations signed the letter.

“Even if H.R. 1215 applied only to doctors and hospitals, recent studies clearly establish that its provisions would lead to more deaths and injuries, and increased health care costs due to a ‘broad relaxation of care,’ ” the letter stated. “... The latest statistics show that medical errors, most of which are preventable, are the third leading cause of death in America. This intolerable situation is perhaps all the more shocking because we already know about how to fix much of this problem. Congress should focus on improving patient safety and reducing deaths and injuries, not insulating negligent providers from accountability, harming patients, and saddling taxpayers with the cost.”

The legislation would apply to any patient who receives medical care provided via a federal program, such as Medicare or Medicaid, or via a subsidy or tax benefit, such as coverage purchased under the Affordable Care Act or a replacement. Medical care paid for via employer health plans also would fall under the legislation’s umbrella since insurance premiums receive federal tax exemptions. The bill would not preempt state medical malpractice laws that impose damage caps, whether higher or lower than $250,000, nor would the legislation affect the availability of economic damages, according to bill language.

As part of the H.R. 1215, courts could limit how much attorneys receive from a patient’s ultimate award. Specifically, courts would have the power to restrict payments from a plaintiff’s damage recovery to an attorney who claims a financial stake in the outcome by virtue of a contingent fee.

PIAA, a trade association representing medical liability insurers, said the House passage of the bill is a major victory for tort reform advocates. The bill is the first comprehensive medical liability reform legislation to be passed by either chamber of Congress in more than 5 years, according to PIAA.

Mike Stinson
“We are now one step closer to enacting federal medical liability reforms that will reduce the nonmeritorious litigation that undermines the physician-patient relationship,” Mike Stinson, PIAA vice president of government relations and public policy, said in a statement. “This legislation will truly benefit both patients and healthcare professionals alike.”

H.R. 1215 now moves on to the Senate.

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The House of Representatives has passed a bill that would cap damages in medical malpractice cases and impose a tighter time frame for legal challenges against physicians.

The House passed the Protecting Access to Care Act (H.R. 1215) on June 28 by a 218-210 vote. The bill, modeled after California’s Medical Injury Compensation Reform Act (MICRA), would limit noneconomic damages in medical malpractice cases to $250,000, restrict contingency fees charged by attorneys, and enforce a 3-year statute of limitations for liability lawsuits from the date of alleged injury. The legislation also includes a fair share rule in which defendants are liable only for the damages in direct proportion to their percentage of responsibility.

The American College of Physicians (ACP) praised the House for passing the bill, saying the time is ripe to develop and pass common-sense liability reforms.

“The American College of Physicians applauds the House of Representatives for its passage of a multifaceted approach to medical-liability reform,” Jack Ende, MD, ACP president, said in a statement. “ACP believes that any solution to improve the medical liability system in the U.S. should include a multifaceted approach, because no single program or law by itself is likely to achieve the goals of improving patient safety, ensuring fair compensation to patients, strengthening rather than undermining the patient-physician relationship, and reducing the economic costs associated with the current system.”

The American Association for Justice, a lobbying organization for plaintiffs’ attorneys, sent a letter to the House prior to the bill’s passage urging legislators to oppose the bill. More than 75 organizations signed the letter.

“Even if H.R. 1215 applied only to doctors and hospitals, recent studies clearly establish that its provisions would lead to more deaths and injuries, and increased health care costs due to a ‘broad relaxation of care,’ ” the letter stated. “... The latest statistics show that medical errors, most of which are preventable, are the third leading cause of death in America. This intolerable situation is perhaps all the more shocking because we already know about how to fix much of this problem. Congress should focus on improving patient safety and reducing deaths and injuries, not insulating negligent providers from accountability, harming patients, and saddling taxpayers with the cost.”

The legislation would apply to any patient who receives medical care provided via a federal program, such as Medicare or Medicaid, or via a subsidy or tax benefit, such as coverage purchased under the Affordable Care Act or a replacement. Medical care paid for via employer health plans also would fall under the legislation’s umbrella since insurance premiums receive federal tax exemptions. The bill would not preempt state medical malpractice laws that impose damage caps, whether higher or lower than $250,000, nor would the legislation affect the availability of economic damages, according to bill language.

As part of the H.R. 1215, courts could limit how much attorneys receive from a patient’s ultimate award. Specifically, courts would have the power to restrict payments from a plaintiff’s damage recovery to an attorney who claims a financial stake in the outcome by virtue of a contingent fee.

PIAA, a trade association representing medical liability insurers, said the House passage of the bill is a major victory for tort reform advocates. The bill is the first comprehensive medical liability reform legislation to be passed by either chamber of Congress in more than 5 years, according to PIAA.

Mike Stinson
“We are now one step closer to enacting federal medical liability reforms that will reduce the nonmeritorious litigation that undermines the physician-patient relationship,” Mike Stinson, PIAA vice president of government relations and public policy, said in a statement. “This legislation will truly benefit both patients and healthcare professionals alike.”

H.R. 1215 now moves on to the Senate.

 

The House of Representatives has passed a bill that would cap damages in medical malpractice cases and impose a tighter time frame for legal challenges against physicians.

The House passed the Protecting Access to Care Act (H.R. 1215) on June 28 by a 218-210 vote. The bill, modeled after California’s Medical Injury Compensation Reform Act (MICRA), would limit noneconomic damages in medical malpractice cases to $250,000, restrict contingency fees charged by attorneys, and enforce a 3-year statute of limitations for liability lawsuits from the date of alleged injury. The legislation also includes a fair share rule in which defendants are liable only for the damages in direct proportion to their percentage of responsibility.

The American College of Physicians (ACP) praised the House for passing the bill, saying the time is ripe to develop and pass common-sense liability reforms.

“The American College of Physicians applauds the House of Representatives for its passage of a multifaceted approach to medical-liability reform,” Jack Ende, MD, ACP president, said in a statement. “ACP believes that any solution to improve the medical liability system in the U.S. should include a multifaceted approach, because no single program or law by itself is likely to achieve the goals of improving patient safety, ensuring fair compensation to patients, strengthening rather than undermining the patient-physician relationship, and reducing the economic costs associated with the current system.”

The American Association for Justice, a lobbying organization for plaintiffs’ attorneys, sent a letter to the House prior to the bill’s passage urging legislators to oppose the bill. More than 75 organizations signed the letter.

“Even if H.R. 1215 applied only to doctors and hospitals, recent studies clearly establish that its provisions would lead to more deaths and injuries, and increased health care costs due to a ‘broad relaxation of care,’ ” the letter stated. “... The latest statistics show that medical errors, most of which are preventable, are the third leading cause of death in America. This intolerable situation is perhaps all the more shocking because we already know about how to fix much of this problem. Congress should focus on improving patient safety and reducing deaths and injuries, not insulating negligent providers from accountability, harming patients, and saddling taxpayers with the cost.”

The legislation would apply to any patient who receives medical care provided via a federal program, such as Medicare or Medicaid, or via a subsidy or tax benefit, such as coverage purchased under the Affordable Care Act or a replacement. Medical care paid for via employer health plans also would fall under the legislation’s umbrella since insurance premiums receive federal tax exemptions. The bill would not preempt state medical malpractice laws that impose damage caps, whether higher or lower than $250,000, nor would the legislation affect the availability of economic damages, according to bill language.

As part of the H.R. 1215, courts could limit how much attorneys receive from a patient’s ultimate award. Specifically, courts would have the power to restrict payments from a plaintiff’s damage recovery to an attorney who claims a financial stake in the outcome by virtue of a contingent fee.

PIAA, a trade association representing medical liability insurers, said the House passage of the bill is a major victory for tort reform advocates. The bill is the first comprehensive medical liability reform legislation to be passed by either chamber of Congress in more than 5 years, according to PIAA.

Mike Stinson
“We are now one step closer to enacting federal medical liability reforms that will reduce the nonmeritorious litigation that undermines the physician-patient relationship,” Mike Stinson, PIAA vice president of government relations and public policy, said in a statement. “This legislation will truly benefit both patients and healthcare professionals alike.”

H.R. 1215 now moves on to the Senate.

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Poll: Most voters oppose House and Senate health care bills

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Thu, 03/28/2019 - 14:50

 

Voters in nearly every region of the United States are opposed to the health reform bills that have been proposed in the House and Senate, according to a poll by the American Medical Association.

Surveys conducted in Alaska, Arkansas, Colorado, Nevada, Ohio, Tennessee, and West Virginia showed that voters in each state had an overall low opinion of the House-passed American Health Care Act (AHCA), according to an AMA analysis released June 27.

When asked whether the reform bill was a “good idea” or a “bad idea,” the most common response in each state was “bad idea,” ranging from 40% in Arkansas to 58% in Colorado. The majority of respondents in Alaska, Arkansas, Colorado, Nevada, and Ohio replied that the Senate should not pass the House legislation and the ACA should remain in place.

The plurality of Tennessee voters said the Senate should make major changes to the AHCA and pass it, while voters in West Virginia were split on what should happen to the AHCA.

Voters were not asked their views on the Senate’s Better Care Reconciliation Act (BCRA), but they were asked about specific provisions of the proposal.

When asked if federal funding for Medicaid expansion should be eliminated or reduced – as both the House and Senate propose – the majority of respondents in each state were opposed, ranging from 54% to 63%.

Voters in each state also strongly opposed BCRA provisions that would allow insurers to offer low-cost health plans, referred to as “skinny plans,” that would limit coverage for prescription drugs, mental health care, and other areas. When asked if low-income people should be provided with federal assistance to purchase inexpensive plans that would cover expensive illnesses, but not include preventive health care, a plurality of respondents were opposed, ranging from 43% in Arkansas to 58% in Ohio.

Respondents were supportive of the ACA’s individual mandate. When asked whether the ACA’s individual mandate should be eliminated and replaced with allowing health insurance companies to charge people 30% higher premiums for a year if they have not had continuous coverage, the majority of voters surveyed in all seven states were strongly opposed.

However, most voters were supportive of changing the Medicaid program to a federal grant program. When asked whether the government should change Medicaid from an entitlement program to a federal grant program and allow states to decide how to best use federal dollars to cover their low-income population, most voters agreed, ranging from 45% in Ohio to 52% in West Virginia.

The survey was conducted by phone in Alaska, Arkansas, Colorado, Nevada, Ohio, and Tennessee June 13-20, 2017. Samples were drawn from the voter file proportional to the statewide registered voter population. Quotas were set by specific demographics such as region, age, gender, and ethnicity based on data from the U.S. Census and the voter file to ensure a representative sample. Polling in West Virginia was conducted June 19-22, 2017.

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Voters in nearly every region of the United States are opposed to the health reform bills that have been proposed in the House and Senate, according to a poll by the American Medical Association.

Surveys conducted in Alaska, Arkansas, Colorado, Nevada, Ohio, Tennessee, and West Virginia showed that voters in each state had an overall low opinion of the House-passed American Health Care Act (AHCA), according to an AMA analysis released June 27.

When asked whether the reform bill was a “good idea” or a “bad idea,” the most common response in each state was “bad idea,” ranging from 40% in Arkansas to 58% in Colorado. The majority of respondents in Alaska, Arkansas, Colorado, Nevada, and Ohio replied that the Senate should not pass the House legislation and the ACA should remain in place.

The plurality of Tennessee voters said the Senate should make major changes to the AHCA and pass it, while voters in West Virginia were split on what should happen to the AHCA.

Voters were not asked their views on the Senate’s Better Care Reconciliation Act (BCRA), but they were asked about specific provisions of the proposal.

When asked if federal funding for Medicaid expansion should be eliminated or reduced – as both the House and Senate propose – the majority of respondents in each state were opposed, ranging from 54% to 63%.

Voters in each state also strongly opposed BCRA provisions that would allow insurers to offer low-cost health plans, referred to as “skinny plans,” that would limit coverage for prescription drugs, mental health care, and other areas. When asked if low-income people should be provided with federal assistance to purchase inexpensive plans that would cover expensive illnesses, but not include preventive health care, a plurality of respondents were opposed, ranging from 43% in Arkansas to 58% in Ohio.

Respondents were supportive of the ACA’s individual mandate. When asked whether the ACA’s individual mandate should be eliminated and replaced with allowing health insurance companies to charge people 30% higher premiums for a year if they have not had continuous coverage, the majority of voters surveyed in all seven states were strongly opposed.

However, most voters were supportive of changing the Medicaid program to a federal grant program. When asked whether the government should change Medicaid from an entitlement program to a federal grant program and allow states to decide how to best use federal dollars to cover their low-income population, most voters agreed, ranging from 45% in Ohio to 52% in West Virginia.

The survey was conducted by phone in Alaska, Arkansas, Colorado, Nevada, Ohio, and Tennessee June 13-20, 2017. Samples were drawn from the voter file proportional to the statewide registered voter population. Quotas were set by specific demographics such as region, age, gender, and ethnicity based on data from the U.S. Census and the voter file to ensure a representative sample. Polling in West Virginia was conducted June 19-22, 2017.

 

Voters in nearly every region of the United States are opposed to the health reform bills that have been proposed in the House and Senate, according to a poll by the American Medical Association.

Surveys conducted in Alaska, Arkansas, Colorado, Nevada, Ohio, Tennessee, and West Virginia showed that voters in each state had an overall low opinion of the House-passed American Health Care Act (AHCA), according to an AMA analysis released June 27.

When asked whether the reform bill was a “good idea” or a “bad idea,” the most common response in each state was “bad idea,” ranging from 40% in Arkansas to 58% in Colorado. The majority of respondents in Alaska, Arkansas, Colorado, Nevada, and Ohio replied that the Senate should not pass the House legislation and the ACA should remain in place.

The plurality of Tennessee voters said the Senate should make major changes to the AHCA and pass it, while voters in West Virginia were split on what should happen to the AHCA.

Voters were not asked their views on the Senate’s Better Care Reconciliation Act (BCRA), but they were asked about specific provisions of the proposal.

When asked if federal funding for Medicaid expansion should be eliminated or reduced – as both the House and Senate propose – the majority of respondents in each state were opposed, ranging from 54% to 63%.

Voters in each state also strongly opposed BCRA provisions that would allow insurers to offer low-cost health plans, referred to as “skinny plans,” that would limit coverage for prescription drugs, mental health care, and other areas. When asked if low-income people should be provided with federal assistance to purchase inexpensive plans that would cover expensive illnesses, but not include preventive health care, a plurality of respondents were opposed, ranging from 43% in Arkansas to 58% in Ohio.

Respondents were supportive of the ACA’s individual mandate. When asked whether the ACA’s individual mandate should be eliminated and replaced with allowing health insurance companies to charge people 30% higher premiums for a year if they have not had continuous coverage, the majority of voters surveyed in all seven states were strongly opposed.

However, most voters were supportive of changing the Medicaid program to a federal grant program. When asked whether the government should change Medicaid from an entitlement program to a federal grant program and allow states to decide how to best use federal dollars to cover their low-income population, most voters agreed, ranging from 45% in Ohio to 52% in West Virginia.

The survey was conducted by phone in Alaska, Arkansas, Colorado, Nevada, Ohio, and Tennessee June 13-20, 2017. Samples were drawn from the voter file proportional to the statewide registered voter population. Quotas were set by specific demographics such as region, age, gender, and ethnicity based on data from the U.S. Census and the voter file to ensure a representative sample. Polling in West Virginia was conducted June 19-22, 2017.

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Supreme Court allows partial travel ban to proceed

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Wed, 04/03/2019 - 10:27


The U.S. Supreme Court has allowed a limited version of President Trump’s travel ban to move forward, prohibiting certain foreign nationals from six majority-Muslim countries from entering the country.

 

The justices’ June 26 order means that travelers from the affected countries who do not have a bona fide relationship with U.S. nationals or U.S. entities may not enter the United States. Conversely, it means that foreign physicians who have accepted a job at a U.S. institution or students who have been accepted to a U.S. medical school will be allowed to take those positions.

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The Supreme Court also agreed to hear oral arguments on the case this term.

“In practical terms, this means that [the executive order] may not be enforced against foreign nationals who have a credible claim of a bona fide relationship with a person or entity in the United States,” justices wrote in their order. “All other foreign nationals are subject to the provisions. For individuals, a close familial relationship is required. A foreign national who wishes to enter the United States to live with or visit a family member ... clearly has such a relationship. As for entities, the relationship must be formal, documented, and formed in the ordinary course, rather than for the purpose of evading [the executive order].”

In a dissenting statement, Associate Justice Clarence Thomas wrote that the full ban should have gone into effect. Associate Justice Samuel Alito and Associate Justice Neil Gorsuch joined the dissent.

“I agree with the court’s implicit conclusion that the government has made a strong showing that it is likely to succeed on the merits – that is, that the [lower] judgments will be reversed,”Associate Justice Thomas wrote. “The government has also established that failure to stay the injunctions will cause irreparable harm by interfering with its compelling need to provide for the nation’s security. Finally, weighing the government’s interest in preserving national security against the hardships caused to respondents by temporary denials of entry into the country, the balance of the equities favors the government. I would thus grant the government’s applications for a stay in their entirety.”

President Trump’s revised executive order, signed March 6, bars citizens of Iran, Libya, Somalia, Sudan, Syria, and Yemen from obtaining visas for 90 days and blocks refugees from the affected countries from entering the U.S. for 120 days. The executive measure superseded President Trump’s original Jan. 27 travel ban. The revised order clarified that citizens of the six countries who are legal permanent U.S. residents or who have current visas to enter the country are exempt from the travel prohibition. Federal judges in Hawaii and Maryland ruled that the revised order was discriminatory and blocked the order from taking effect, a decision upheld by the 9th U.S. Circuit Court of Appeals.

Justices will hear oral arguments in the case this fall.

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The U.S. Supreme Court has allowed a limited version of President Trump’s travel ban to move forward, prohibiting certain foreign nationals from six majority-Muslim countries from entering the country.

 

The justices’ June 26 order means that travelers from the affected countries who do not have a bona fide relationship with U.S. nationals or U.S. entities may not enter the United States. Conversely, it means that foreign physicians who have accepted a job at a U.S. institution or students who have been accepted to a U.S. medical school will be allowed to take those positions.

wellesenterprises/Thinkstock
The Supreme Court also agreed to hear oral arguments on the case this term.

“In practical terms, this means that [the executive order] may not be enforced against foreign nationals who have a credible claim of a bona fide relationship with a person or entity in the United States,” justices wrote in their order. “All other foreign nationals are subject to the provisions. For individuals, a close familial relationship is required. A foreign national who wishes to enter the United States to live with or visit a family member ... clearly has such a relationship. As for entities, the relationship must be formal, documented, and formed in the ordinary course, rather than for the purpose of evading [the executive order].”

In a dissenting statement, Associate Justice Clarence Thomas wrote that the full ban should have gone into effect. Associate Justice Samuel Alito and Associate Justice Neil Gorsuch joined the dissent.

“I agree with the court’s implicit conclusion that the government has made a strong showing that it is likely to succeed on the merits – that is, that the [lower] judgments will be reversed,”Associate Justice Thomas wrote. “The government has also established that failure to stay the injunctions will cause irreparable harm by interfering with its compelling need to provide for the nation’s security. Finally, weighing the government’s interest in preserving national security against the hardships caused to respondents by temporary denials of entry into the country, the balance of the equities favors the government. I would thus grant the government’s applications for a stay in their entirety.”

President Trump’s revised executive order, signed March 6, bars citizens of Iran, Libya, Somalia, Sudan, Syria, and Yemen from obtaining visas for 90 days and blocks refugees from the affected countries from entering the U.S. for 120 days. The executive measure superseded President Trump’s original Jan. 27 travel ban. The revised order clarified that citizens of the six countries who are legal permanent U.S. residents or who have current visas to enter the country are exempt from the travel prohibition. Federal judges in Hawaii and Maryland ruled that the revised order was discriminatory and blocked the order from taking effect, a decision upheld by the 9th U.S. Circuit Court of Appeals.

Justices will hear oral arguments in the case this fall.


The U.S. Supreme Court has allowed a limited version of President Trump’s travel ban to move forward, prohibiting certain foreign nationals from six majority-Muslim countries from entering the country.

 

The justices’ June 26 order means that travelers from the affected countries who do not have a bona fide relationship with U.S. nationals or U.S. entities may not enter the United States. Conversely, it means that foreign physicians who have accepted a job at a U.S. institution or students who have been accepted to a U.S. medical school will be allowed to take those positions.

wellesenterprises/Thinkstock
The Supreme Court also agreed to hear oral arguments on the case this term.

“In practical terms, this means that [the executive order] may not be enforced against foreign nationals who have a credible claim of a bona fide relationship with a person or entity in the United States,” justices wrote in their order. “All other foreign nationals are subject to the provisions. For individuals, a close familial relationship is required. A foreign national who wishes to enter the United States to live with or visit a family member ... clearly has such a relationship. As for entities, the relationship must be formal, documented, and formed in the ordinary course, rather than for the purpose of evading [the executive order].”

In a dissenting statement, Associate Justice Clarence Thomas wrote that the full ban should have gone into effect. Associate Justice Samuel Alito and Associate Justice Neil Gorsuch joined the dissent.

“I agree with the court’s implicit conclusion that the government has made a strong showing that it is likely to succeed on the merits – that is, that the [lower] judgments will be reversed,”Associate Justice Thomas wrote. “The government has also established that failure to stay the injunctions will cause irreparable harm by interfering with its compelling need to provide for the nation’s security. Finally, weighing the government’s interest in preserving national security against the hardships caused to respondents by temporary denials of entry into the country, the balance of the equities favors the government. I would thus grant the government’s applications for a stay in their entirety.”

President Trump’s revised executive order, signed March 6, bars citizens of Iran, Libya, Somalia, Sudan, Syria, and Yemen from obtaining visas for 90 days and blocks refugees from the affected countries from entering the U.S. for 120 days. The executive measure superseded President Trump’s original Jan. 27 travel ban. The revised order clarified that citizens of the six countries who are legal permanent U.S. residents or who have current visas to enter the country are exempt from the travel prohibition. Federal judges in Hawaii and Maryland ruled that the revised order was discriminatory and blocked the order from taking effect, a decision upheld by the 9th U.S. Circuit Court of Appeals.

Justices will hear oral arguments in the case this fall.

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Follow five tips to mitigate opioid prescribing risks

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Thu, 03/28/2019 - 14:50

 

CHICAGO – As the epidemic of opioid addiction and overdose deaths continues to surge, state and federal authorities are keeping a close eye on physicians who prescribe controlled substances.

Experts offer the following guidance on how well-meaning doctors can avoid coming under scrutiny for prescribing opioids and successfully manage investigations and audits.

1. Know who’s on the radar: The Drug Enforcement Agency (DEA) compiles a “black list” yearly of physicians and health care providers they plan to target for audits, said Natalia Mazina, a San Francisco–based attorney who specializes in health and pharmacy law. For 2017, the list includes physicians who have prior noncompliance records, providers who specialize in pain management, and those who dispense or administer large quantities of controlled substances.

Natalia Mazina
However, physicians also can be randomly audited without falling under these categories, Ms. Mazina said during an interview at a conference held by the American Bar Association. Last year, for example, the DEA conducted random security audits to ensure security compliance controls were in place at certain practices that prescribed controlled substances.

In addition, family physicians, psychiatrists, and other specialists who come under investigation by a state medical board because of suspected inappropriate prescribing or reporting violations may also come under the purview of federal authorities, Ms. Mazina said.

“If they come on the medical board radar, they may come on the [DEA’s] radar as well,” she said during the interview. “They just have to watch how many prescriptions they write for controlled substances and make sure they are legitimate prescriptions.”

 

2. Maintain proper records: Poor record keeping is a top reason that the DEA investigates health care providers for potential prescribing violations, said Dennis A. Wichern, a DEA agent with the Chicago Field Division. Federal law requires that registered practitioners who store or dispense controlled substances keep records of controlled substances coming in and out of the practice. That includes physicians who hand out samples of controlled substances to patients and also pertains to samples provided to doctors by pharmaceutical companies.

Alicia Gallegos/Frontline Medical News
Dennis A. Wichern, a DEA agent with the Chicago Field Division, speaks at a recent ABA meeting about opioid prescribing risks.
“Think bank, checkbook, and money; if you have controlled substances, you need to keep the same records,” Mr. Wichern said during the meeting. “If you’re dispensing drugs at your office, you have to keep dispensing records. It seems like most providers are unaware of this.”

Records should include whether the inventory was taken at the beginning or close of business, names of controlled substances, each finished form of the substances, the number of dosage units of each finished form in the commercial container, the number of commercial containers of each finished form, and disposition of the controlled substances.

Law requires that physicians take a new inventory of all controlled substances on hand every 2 years. Doctors are not required to keep records of controlled substances that are merely prescribed, unless such substances are prescribed in the course of maintenance or detoxification treatment.

Ms. Mazina notes that there are many software platforms that can assist practices with proper inventory and record keeping for opioids and other drugs.

 

3. Check the state database: Before prescribing opioids, check your state’s prescription drug monitoring program (PDMP) database, advises Ms. Mazina. At least 37 states have operational PDMPs that receive and distribute controlled substance prescription information to authorized users. About 11 states have enacted legislation to establish a PDMP, but some databases are not fully operational.

A state’s PDMP can reveal whether patients may be obtaining multiple controlled substance prescriptions from different doctors or doctor-shopping, Ms. Mazina said. Such due diligence helps inform treatment decisions and can assist a doctor’s case if a medical board or DEA investigation later arises.

“Even if your state law does not require you to check a patient’s history prior to prescribing, you have to check it to protect yourself,” she said. “If you want to avoid controlled substances problems, PDMP is the way to go.”

4. Establish an audit response plan: Have an audit response plan ready to roll should an inquiry arise, experts advise. The policies ensure that only approved information is released to authorities, and that all staff members are on the same page about how to react to audits, Ms. Mazina said.

Plans should clearly state what information can be collected and what data should be kept confidential. Financial information, for example, should be off limits, she said. Government agents are entitled to inventory, dispensary data, and records of receipts.

“Agents very often do the mirror image of the database, and they get too much information,” she said. “You don’t want to [allow] that.”

Train staff members how to respond to government authorities seeking audit information, and explain they have the right to refuse being interviewed, Ms. Mazina said.

“Train your employees on what’s going to happen if the DEA comes in,” she said. “If I don’t have clear policies and procedures, and I’m not trained, I might disclose everything and blame someone. That puts everyone in a [bad] position, because [authorities] will record everything and use it against [the practice].”

 

 

5. Confer with the experts: It doesn’t hurt to consult with other medical professionals, such as emergency physicians or pain management specialists, for practical advice on inventory policies or software suggestions. But when it comes to staying updated on new drug laws and regulations, confer with a health law attorney or compliance officer, Ms. Mazina said. The DEA website also includes useful information about recent laws and rules pertaining to prescription drugs, as does the Centers for Disease Control and Prevention website.

If an investigation or audit emerges, work with an attorney as early as possible. Often, practices wait until too late after an investigation begins to contact legal counsel, Ms. Mazina noted. The earlier an attorney gets involved, the sooner that person can build a strong case for the practice and work toward the best resolution.

“Very often, the physician thinks they are right, and there’s nothing for them to fear,” she said. “There is something for you to fear. There’s a lot at stake.”

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CHICAGO – As the epidemic of opioid addiction and overdose deaths continues to surge, state and federal authorities are keeping a close eye on physicians who prescribe controlled substances.

Experts offer the following guidance on how well-meaning doctors can avoid coming under scrutiny for prescribing opioids and successfully manage investigations and audits.

1. Know who’s on the radar: The Drug Enforcement Agency (DEA) compiles a “black list” yearly of physicians and health care providers they plan to target for audits, said Natalia Mazina, a San Francisco–based attorney who specializes in health and pharmacy law. For 2017, the list includes physicians who have prior noncompliance records, providers who specialize in pain management, and those who dispense or administer large quantities of controlled substances.

Natalia Mazina
However, physicians also can be randomly audited without falling under these categories, Ms. Mazina said during an interview at a conference held by the American Bar Association. Last year, for example, the DEA conducted random security audits to ensure security compliance controls were in place at certain practices that prescribed controlled substances.

In addition, family physicians, psychiatrists, and other specialists who come under investigation by a state medical board because of suspected inappropriate prescribing or reporting violations may also come under the purview of federal authorities, Ms. Mazina said.

“If they come on the medical board radar, they may come on the [DEA’s] radar as well,” she said during the interview. “They just have to watch how many prescriptions they write for controlled substances and make sure they are legitimate prescriptions.”

 

2. Maintain proper records: Poor record keeping is a top reason that the DEA investigates health care providers for potential prescribing violations, said Dennis A. Wichern, a DEA agent with the Chicago Field Division. Federal law requires that registered practitioners who store or dispense controlled substances keep records of controlled substances coming in and out of the practice. That includes physicians who hand out samples of controlled substances to patients and also pertains to samples provided to doctors by pharmaceutical companies.

Alicia Gallegos/Frontline Medical News
Dennis A. Wichern, a DEA agent with the Chicago Field Division, speaks at a recent ABA meeting about opioid prescribing risks.
“Think bank, checkbook, and money; if you have controlled substances, you need to keep the same records,” Mr. Wichern said during the meeting. “If you’re dispensing drugs at your office, you have to keep dispensing records. It seems like most providers are unaware of this.”

Records should include whether the inventory was taken at the beginning or close of business, names of controlled substances, each finished form of the substances, the number of dosage units of each finished form in the commercial container, the number of commercial containers of each finished form, and disposition of the controlled substances.

Law requires that physicians take a new inventory of all controlled substances on hand every 2 years. Doctors are not required to keep records of controlled substances that are merely prescribed, unless such substances are prescribed in the course of maintenance or detoxification treatment.

Ms. Mazina notes that there are many software platforms that can assist practices with proper inventory and record keeping for opioids and other drugs.

 

3. Check the state database: Before prescribing opioids, check your state’s prescription drug monitoring program (PDMP) database, advises Ms. Mazina. At least 37 states have operational PDMPs that receive and distribute controlled substance prescription information to authorized users. About 11 states have enacted legislation to establish a PDMP, but some databases are not fully operational.

A state’s PDMP can reveal whether patients may be obtaining multiple controlled substance prescriptions from different doctors or doctor-shopping, Ms. Mazina said. Such due diligence helps inform treatment decisions and can assist a doctor’s case if a medical board or DEA investigation later arises.

“Even if your state law does not require you to check a patient’s history prior to prescribing, you have to check it to protect yourself,” she said. “If you want to avoid controlled substances problems, PDMP is the way to go.”

4. Establish an audit response plan: Have an audit response plan ready to roll should an inquiry arise, experts advise. The policies ensure that only approved information is released to authorities, and that all staff members are on the same page about how to react to audits, Ms. Mazina said.

Plans should clearly state what information can be collected and what data should be kept confidential. Financial information, for example, should be off limits, she said. Government agents are entitled to inventory, dispensary data, and records of receipts.

“Agents very often do the mirror image of the database, and they get too much information,” she said. “You don’t want to [allow] that.”

Train staff members how to respond to government authorities seeking audit information, and explain they have the right to refuse being interviewed, Ms. Mazina said.

“Train your employees on what’s going to happen if the DEA comes in,” she said. “If I don’t have clear policies and procedures, and I’m not trained, I might disclose everything and blame someone. That puts everyone in a [bad] position, because [authorities] will record everything and use it against [the practice].”

 

 

5. Confer with the experts: It doesn’t hurt to consult with other medical professionals, such as emergency physicians or pain management specialists, for practical advice on inventory policies or software suggestions. But when it comes to staying updated on new drug laws and regulations, confer with a health law attorney or compliance officer, Ms. Mazina said. The DEA website also includes useful information about recent laws and rules pertaining to prescription drugs, as does the Centers for Disease Control and Prevention website.

If an investigation or audit emerges, work with an attorney as early as possible. Often, practices wait until too late after an investigation begins to contact legal counsel, Ms. Mazina noted. The earlier an attorney gets involved, the sooner that person can build a strong case for the practice and work toward the best resolution.

“Very often, the physician thinks they are right, and there’s nothing for them to fear,” she said. “There is something for you to fear. There’s a lot at stake.”

 

CHICAGO – As the epidemic of opioid addiction and overdose deaths continues to surge, state and federal authorities are keeping a close eye on physicians who prescribe controlled substances.

Experts offer the following guidance on how well-meaning doctors can avoid coming under scrutiny for prescribing opioids and successfully manage investigations and audits.

1. Know who’s on the radar: The Drug Enforcement Agency (DEA) compiles a “black list” yearly of physicians and health care providers they plan to target for audits, said Natalia Mazina, a San Francisco–based attorney who specializes in health and pharmacy law. For 2017, the list includes physicians who have prior noncompliance records, providers who specialize in pain management, and those who dispense or administer large quantities of controlled substances.

Natalia Mazina
However, physicians also can be randomly audited without falling under these categories, Ms. Mazina said during an interview at a conference held by the American Bar Association. Last year, for example, the DEA conducted random security audits to ensure security compliance controls were in place at certain practices that prescribed controlled substances.

In addition, family physicians, psychiatrists, and other specialists who come under investigation by a state medical board because of suspected inappropriate prescribing or reporting violations may also come under the purview of federal authorities, Ms. Mazina said.

“If they come on the medical board radar, they may come on the [DEA’s] radar as well,” she said during the interview. “They just have to watch how many prescriptions they write for controlled substances and make sure they are legitimate prescriptions.”

 

2. Maintain proper records: Poor record keeping is a top reason that the DEA investigates health care providers for potential prescribing violations, said Dennis A. Wichern, a DEA agent with the Chicago Field Division. Federal law requires that registered practitioners who store or dispense controlled substances keep records of controlled substances coming in and out of the practice. That includes physicians who hand out samples of controlled substances to patients and also pertains to samples provided to doctors by pharmaceutical companies.

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Dennis A. Wichern, a DEA agent with the Chicago Field Division, speaks at a recent ABA meeting about opioid prescribing risks.
“Think bank, checkbook, and money; if you have controlled substances, you need to keep the same records,” Mr. Wichern said during the meeting. “If you’re dispensing drugs at your office, you have to keep dispensing records. It seems like most providers are unaware of this.”

Records should include whether the inventory was taken at the beginning or close of business, names of controlled substances, each finished form of the substances, the number of dosage units of each finished form in the commercial container, the number of commercial containers of each finished form, and disposition of the controlled substances.

Law requires that physicians take a new inventory of all controlled substances on hand every 2 years. Doctors are not required to keep records of controlled substances that are merely prescribed, unless such substances are prescribed in the course of maintenance or detoxification treatment.

Ms. Mazina notes that there are many software platforms that can assist practices with proper inventory and record keeping for opioids and other drugs.

 

3. Check the state database: Before prescribing opioids, check your state’s prescription drug monitoring program (PDMP) database, advises Ms. Mazina. At least 37 states have operational PDMPs that receive and distribute controlled substance prescription information to authorized users. About 11 states have enacted legislation to establish a PDMP, but some databases are not fully operational.

A state’s PDMP can reveal whether patients may be obtaining multiple controlled substance prescriptions from different doctors or doctor-shopping, Ms. Mazina said. Such due diligence helps inform treatment decisions and can assist a doctor’s case if a medical board or DEA investigation later arises.

“Even if your state law does not require you to check a patient’s history prior to prescribing, you have to check it to protect yourself,” she said. “If you want to avoid controlled substances problems, PDMP is the way to go.”

4. Establish an audit response plan: Have an audit response plan ready to roll should an inquiry arise, experts advise. The policies ensure that only approved information is released to authorities, and that all staff members are on the same page about how to react to audits, Ms. Mazina said.

Plans should clearly state what information can be collected and what data should be kept confidential. Financial information, for example, should be off limits, she said. Government agents are entitled to inventory, dispensary data, and records of receipts.

“Agents very often do the mirror image of the database, and they get too much information,” she said. “You don’t want to [allow] that.”

Train staff members how to respond to government authorities seeking audit information, and explain they have the right to refuse being interviewed, Ms. Mazina said.

“Train your employees on what’s going to happen if the DEA comes in,” she said. “If I don’t have clear policies and procedures, and I’m not trained, I might disclose everything and blame someone. That puts everyone in a [bad] position, because [authorities] will record everything and use it against [the practice].”

 

 

5. Confer with the experts: It doesn’t hurt to consult with other medical professionals, such as emergency physicians or pain management specialists, for practical advice on inventory policies or software suggestions. But when it comes to staying updated on new drug laws and regulations, confer with a health law attorney or compliance officer, Ms. Mazina said. The DEA website also includes useful information about recent laws and rules pertaining to prescription drugs, as does the Centers for Disease Control and Prevention website.

If an investigation or audit emerges, work with an attorney as early as possible. Often, practices wait until too late after an investigation begins to contact legal counsel, Ms. Mazina noted. The earlier an attorney gets involved, the sooner that person can build a strong case for the practice and work toward the best resolution.

“Very often, the physician thinks they are right, and there’s nothing for them to fear,” she said. “There is something for you to fear. There’s a lot at stake.”

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Supreme Court rules to speed biosimilar drugs to market

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The U.S. Supreme Court has ruled that biosimilar companies can take their versions of biological drugs to the market 6 months sooner in a precedential ruling that could mean quicker access to less expensive medications.

The unanimous ruling overturns an appeals court ruling in favor of California-based Amgen that had barred competitor Sandoz from marketing its biosimilar of Neupogen (filgrastim) until 6 months after Food and Drug Administration approval. Justices held that the Biologics Price Competition and Innovation Act of 2009 (BPCIA) allows biosimilar applicants to provide notice of commercial marketing prior to obtaining licensure by the FDA.

Carol Lynch, global head of Biopharmaceuticals at Sandoz, said the ruling helps to eliminate unnecessary barriers so that patients can access more affordable medicine in a more timely manner.

“Biosimilars offer significant value to patients, providers, and payers, increasing the number of treatment options available to patients across many disease areas at a reduced cost to the health care system,” Ms. Lynch said in a statement. “The justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments. We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward.”

Gregory Twachtman/Frontline Medical Media
The U.S. Supreme Court Building


In a statement, an Amgen spokeswoman said the company was “disappointed in the court’s decision on the notice of commercial marketing,” but that it will “continue to seek to enforce our intellectual property against those parties that infringe upon our rights.”

The “patent dance” referred to by Ms. Lynch is the often lengthy process by which companies marketing brand name and biosimilar medications spar and undergo legal proceedings before the biosimilar can enter the market.

In this case, Sandoz filed an application with the FDA in May 2014 seeking approval to market Zarxio (filgrastim-sndz). Amgen, the manufacturer of the reference product, has marketed Neupogen since 1991 and holds patents on methods of manufacturing and using filgrastim. In July 2014, the FDA accepted Sandoz’ application for review. In October 2014, Amgen sued for patent infringement, alleging that Sandoz failed to adhere to the BPCIA by unlawfully providing its notice of commercial marketing before FDA licensure, among other arguments.

The U.S. Court of Appeals for the Federal Circuit in Washington ruled in favor of Amgen, holding that Sandoz must wait for an FDA license before marketing its biosimilar, which meant another 6-month waiting period. The Supreme Court disagreed. Justices based their decision on the plain language of the BPCIA, ruling that the statute allows for applicants to provide marketing notice either before or after receiving FDA approval.

In a statement, the Pharmaceutical Care Management Association said the Supreme Court’s ruling on biosimilars will help create more competition among costly biologic medications, “which is the key to reducing overall prescription drug costs for consumers, employers, government programs, and others.”

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The U.S. Supreme Court has ruled that biosimilar companies can take their versions of biological drugs to the market 6 months sooner in a precedential ruling that could mean quicker access to less expensive medications.

The unanimous ruling overturns an appeals court ruling in favor of California-based Amgen that had barred competitor Sandoz from marketing its biosimilar of Neupogen (filgrastim) until 6 months after Food and Drug Administration approval. Justices held that the Biologics Price Competition and Innovation Act of 2009 (BPCIA) allows biosimilar applicants to provide notice of commercial marketing prior to obtaining licensure by the FDA.

Carol Lynch, global head of Biopharmaceuticals at Sandoz, said the ruling helps to eliminate unnecessary barriers so that patients can access more affordable medicine in a more timely manner.

“Biosimilars offer significant value to patients, providers, and payers, increasing the number of treatment options available to patients across many disease areas at a reduced cost to the health care system,” Ms. Lynch said in a statement. “The justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments. We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward.”

Gregory Twachtman/Frontline Medical Media
The U.S. Supreme Court Building


In a statement, an Amgen spokeswoman said the company was “disappointed in the court’s decision on the notice of commercial marketing,” but that it will “continue to seek to enforce our intellectual property against those parties that infringe upon our rights.”

The “patent dance” referred to by Ms. Lynch is the often lengthy process by which companies marketing brand name and biosimilar medications spar and undergo legal proceedings before the biosimilar can enter the market.

In this case, Sandoz filed an application with the FDA in May 2014 seeking approval to market Zarxio (filgrastim-sndz). Amgen, the manufacturer of the reference product, has marketed Neupogen since 1991 and holds patents on methods of manufacturing and using filgrastim. In July 2014, the FDA accepted Sandoz’ application for review. In October 2014, Amgen sued for patent infringement, alleging that Sandoz failed to adhere to the BPCIA by unlawfully providing its notice of commercial marketing before FDA licensure, among other arguments.

The U.S. Court of Appeals for the Federal Circuit in Washington ruled in favor of Amgen, holding that Sandoz must wait for an FDA license before marketing its biosimilar, which meant another 6-month waiting period. The Supreme Court disagreed. Justices based their decision on the plain language of the BPCIA, ruling that the statute allows for applicants to provide marketing notice either before or after receiving FDA approval.

In a statement, the Pharmaceutical Care Management Association said the Supreme Court’s ruling on biosimilars will help create more competition among costly biologic medications, “which is the key to reducing overall prescription drug costs for consumers, employers, government programs, and others.”

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The U.S. Supreme Court has ruled that biosimilar companies can take their versions of biological drugs to the market 6 months sooner in a precedential ruling that could mean quicker access to less expensive medications.

The unanimous ruling overturns an appeals court ruling in favor of California-based Amgen that had barred competitor Sandoz from marketing its biosimilar of Neupogen (filgrastim) until 6 months after Food and Drug Administration approval. Justices held that the Biologics Price Competition and Innovation Act of 2009 (BPCIA) allows biosimilar applicants to provide notice of commercial marketing prior to obtaining licensure by the FDA.

Carol Lynch, global head of Biopharmaceuticals at Sandoz, said the ruling helps to eliminate unnecessary barriers so that patients can access more affordable medicine in a more timely manner.

“Biosimilars offer significant value to patients, providers, and payers, increasing the number of treatment options available to patients across many disease areas at a reduced cost to the health care system,” Ms. Lynch said in a statement. “The justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments. We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward.”

Gregory Twachtman/Frontline Medical Media
The U.S. Supreme Court Building


In a statement, an Amgen spokeswoman said the company was “disappointed in the court’s decision on the notice of commercial marketing,” but that it will “continue to seek to enforce our intellectual property against those parties that infringe upon our rights.”

The “patent dance” referred to by Ms. Lynch is the often lengthy process by which companies marketing brand name and biosimilar medications spar and undergo legal proceedings before the biosimilar can enter the market.

In this case, Sandoz filed an application with the FDA in May 2014 seeking approval to market Zarxio (filgrastim-sndz). Amgen, the manufacturer of the reference product, has marketed Neupogen since 1991 and holds patents on methods of manufacturing and using filgrastim. In July 2014, the FDA accepted Sandoz’ application for review. In October 2014, Amgen sued for patent infringement, alleging that Sandoz failed to adhere to the BPCIA by unlawfully providing its notice of commercial marketing before FDA licensure, among other arguments.

The U.S. Court of Appeals for the Federal Circuit in Washington ruled in favor of Amgen, holding that Sandoz must wait for an FDA license before marketing its biosimilar, which meant another 6-month waiting period. The Supreme Court disagreed. Justices based their decision on the plain language of the BPCIA, ruling that the statute allows for applicants to provide marketing notice either before or after receiving FDA approval.

In a statement, the Pharmaceutical Care Management Association said the Supreme Court’s ruling on biosimilars will help create more competition among costly biologic medications, “which is the key to reducing overall prescription drug costs for consumers, employers, government programs, and others.”

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Survey: Most doctors would pick single payer over ACA, ACHA

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CHICAGO – If given the option, the majority of physicians would scrap both the Affordable Care Act and the proposed American Health Care Act (AHCA) and opt for a single payer health care system, according to a survey of 1,059 doctors by the Chicago Medical Society (CMS).

When asked their preferred health care structure, 53% of physician said they would prefer a single payer health system, while 26% preferred the Affordable Care Act, and 13% said they would like to see the ACA repealed and replaced with the AHCA. Another 8% of doctors stated they would prefer repeal of the ACA but did not offer a replacement option.

The high percentage of physicians who favored a single payer system was surprising, said A. Jay Chauhan, DO, secretary and chair of public health for the Chicago Medical Society.

“That is a shift from past surveys,” Dr. Chauhan said during an interview at a conference held by the American Bar Association. “It certainly speaks to the frustration that physicians are [feeling] and how difficult it is to practice. I think they’re trying to reach out for other alternatives because the current manner in which we’re practicing doesn’t seem to fulfill our desires to better take care of patients.”

Physicians' views on systems of health care.
When asked whether they felt favorable or unfavorable toward individual reform models, 77% of doctors felt unfavorable toward the AHCA and 23% felt favorable toward the legislation. Of physicians, 67% felt favorable toward a single payer system, and 33% said they felt unfavorable toward such a model. As for the ACA, 63% of doctors felt favorable toward the ACA, while 37% felt unfavorable toward the health care law.

Respondents also choose a single payer system as their top preference when asked which health care system they believed would provide “the best care to the greatest number of people for a given amount of funding.”

A primary takeaway from the survey is that physicians want to see better access to health care for their patients and more affordable insurance coverage, said Katherine M. Tynus, MD, immediate past president of the Chicago Medical Society and president-elect of the Illinois State Medical Society.

“I think what the Affordable Care Act did was raise expectations as far as access to care and people being able to afford their health care,” Dr. Tynus said in an interview at the meeting. “Since that system seems to be failing, the expectation remains. Now, we need to find an alternative solution to achieve that.”

The online survey, released at the Physicians Legal Issues Conference held by the American Bar Association, was conducted between March 2017 and May 2017 and featured questions about health reform. Survey participants were physicians primarily based in the Chicago area or within Illinois and the majority practiced in an urban area. Respondents represented a variety of political affiliations and medical specialties. The majority said they identifying as independent (43%), and the most common specialty was general medicine (19%).

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CHICAGO – If given the option, the majority of physicians would scrap both the Affordable Care Act and the proposed American Health Care Act (AHCA) and opt for a single payer health care system, according to a survey of 1,059 doctors by the Chicago Medical Society (CMS).

When asked their preferred health care structure, 53% of physician said they would prefer a single payer health system, while 26% preferred the Affordable Care Act, and 13% said they would like to see the ACA repealed and replaced with the AHCA. Another 8% of doctors stated they would prefer repeal of the ACA but did not offer a replacement option.

The high percentage of physicians who favored a single payer system was surprising, said A. Jay Chauhan, DO, secretary and chair of public health for the Chicago Medical Society.

“That is a shift from past surveys,” Dr. Chauhan said during an interview at a conference held by the American Bar Association. “It certainly speaks to the frustration that physicians are [feeling] and how difficult it is to practice. I think they’re trying to reach out for other alternatives because the current manner in which we’re practicing doesn’t seem to fulfill our desires to better take care of patients.”

Physicians' views on systems of health care.
When asked whether they felt favorable or unfavorable toward individual reform models, 77% of doctors felt unfavorable toward the AHCA and 23% felt favorable toward the legislation. Of physicians, 67% felt favorable toward a single payer system, and 33% said they felt unfavorable toward such a model. As for the ACA, 63% of doctors felt favorable toward the ACA, while 37% felt unfavorable toward the health care law.

Respondents also choose a single payer system as their top preference when asked which health care system they believed would provide “the best care to the greatest number of people for a given amount of funding.”

A primary takeaway from the survey is that physicians want to see better access to health care for their patients and more affordable insurance coverage, said Katherine M. Tynus, MD, immediate past president of the Chicago Medical Society and president-elect of the Illinois State Medical Society.

“I think what the Affordable Care Act did was raise expectations as far as access to care and people being able to afford their health care,” Dr. Tynus said in an interview at the meeting. “Since that system seems to be failing, the expectation remains. Now, we need to find an alternative solution to achieve that.”

The online survey, released at the Physicians Legal Issues Conference held by the American Bar Association, was conducted between March 2017 and May 2017 and featured questions about health reform. Survey participants were physicians primarily based in the Chicago area or within Illinois and the majority practiced in an urban area. Respondents represented a variety of political affiliations and medical specialties. The majority said they identifying as independent (43%), and the most common specialty was general medicine (19%).

 

CHICAGO – If given the option, the majority of physicians would scrap both the Affordable Care Act and the proposed American Health Care Act (AHCA) and opt for a single payer health care system, according to a survey of 1,059 doctors by the Chicago Medical Society (CMS).

When asked their preferred health care structure, 53% of physician said they would prefer a single payer health system, while 26% preferred the Affordable Care Act, and 13% said they would like to see the ACA repealed and replaced with the AHCA. Another 8% of doctors stated they would prefer repeal of the ACA but did not offer a replacement option.

The high percentage of physicians who favored a single payer system was surprising, said A. Jay Chauhan, DO, secretary and chair of public health for the Chicago Medical Society.

“That is a shift from past surveys,” Dr. Chauhan said during an interview at a conference held by the American Bar Association. “It certainly speaks to the frustration that physicians are [feeling] and how difficult it is to practice. I think they’re trying to reach out for other alternatives because the current manner in which we’re practicing doesn’t seem to fulfill our desires to better take care of patients.”

Physicians' views on systems of health care.
When asked whether they felt favorable or unfavorable toward individual reform models, 77% of doctors felt unfavorable toward the AHCA and 23% felt favorable toward the legislation. Of physicians, 67% felt favorable toward a single payer system, and 33% said they felt unfavorable toward such a model. As for the ACA, 63% of doctors felt favorable toward the ACA, while 37% felt unfavorable toward the health care law.

Respondents also choose a single payer system as their top preference when asked which health care system they believed would provide “the best care to the greatest number of people for a given amount of funding.”

A primary takeaway from the survey is that physicians want to see better access to health care for their patients and more affordable insurance coverage, said Katherine M. Tynus, MD, immediate past president of the Chicago Medical Society and president-elect of the Illinois State Medical Society.

“I think what the Affordable Care Act did was raise expectations as far as access to care and people being able to afford their health care,” Dr. Tynus said in an interview at the meeting. “Since that system seems to be failing, the expectation remains. Now, we need to find an alternative solution to achieve that.”

The online survey, released at the Physicians Legal Issues Conference held by the American Bar Association, was conducted between March 2017 and May 2017 and featured questions about health reform. Survey participants were physicians primarily based in the Chicago area or within Illinois and the majority practiced in an urban area. Respondents represented a variety of political affiliations and medical specialties. The majority said they identifying as independent (43%), and the most common specialty was general medicine (19%).

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