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HHS spends $32 million to enroll children in Medicaid, CHIP
The federal government is parceling out nearly $32 million to state health agencies, community health centers, school-based organizations, and nonprofit groups to help identify and enroll children who are eligible for Medicaid and the Children’s Health Insurance Program.
The 41 grants, which were spread out among groups in 22 states, range from $190,000 to $1 million.
This is the third time that the Department of Health and Human Services has awarded grants with the aim of boosting enrollment and retention efforts for children in these two programs. In this latest round, money was awarded to states with the largest numbers of children who are eligible for the public health programs but are not yet enrolled. The grant funding comes from the Affordable Care Act.
The grants focus mainly on enrollment and retention efforts in schools, outreach to groups of children who are less likely to have health coverage, improving application assistance in local communities, training community officials to help families understand the new application and enrollment system, and streamlining enrollment for children who are participating in other government programs, such as nutritional assistance.
The federal government is parceling out nearly $32 million to state health agencies, community health centers, school-based organizations, and nonprofit groups to help identify and enroll children who are eligible for Medicaid and the Children’s Health Insurance Program.
The 41 grants, which were spread out among groups in 22 states, range from $190,000 to $1 million.
This is the third time that the Department of Health and Human Services has awarded grants with the aim of boosting enrollment and retention efforts for children in these two programs. In this latest round, money was awarded to states with the largest numbers of children who are eligible for the public health programs but are not yet enrolled. The grant funding comes from the Affordable Care Act.
The grants focus mainly on enrollment and retention efforts in schools, outreach to groups of children who are less likely to have health coverage, improving application assistance in local communities, training community officials to help families understand the new application and enrollment system, and streamlining enrollment for children who are participating in other government programs, such as nutritional assistance.
The federal government is parceling out nearly $32 million to state health agencies, community health centers, school-based organizations, and nonprofit groups to help identify and enroll children who are eligible for Medicaid and the Children’s Health Insurance Program.
The 41 grants, which were spread out among groups in 22 states, range from $190,000 to $1 million.
This is the third time that the Department of Health and Human Services has awarded grants with the aim of boosting enrollment and retention efforts for children in these two programs. In this latest round, money was awarded to states with the largest numbers of children who are eligible for the public health programs but are not yet enrolled. The grant funding comes from the Affordable Care Act.
The grants focus mainly on enrollment and retention efforts in schools, outreach to groups of children who are less likely to have health coverage, improving application assistance in local communities, training community officials to help families understand the new application and enrollment system, and streamlining enrollment for children who are participating in other government programs, such as nutritional assistance.
Patient satisfaction rises in importance for hospitalists
Ask any expert on patient satisfaction why hospitalists should care about this issue and they all say the same thing: It’s the right thing to do.
But increasingly, it’s also the smart thing to do from a financial perspective. Most of the financial levers involved are aimed at hospitals, but they tend to trickle down to physicians.
Hospital value-based purchasing is one of the biggest drivers. Under the new program, which began in October 2012, hospitals have a small percentage of their total Medicare charges set aside into a pool used for awarding value-based incentives. Medicare officials measure the hospitals’ performance on a set of process of care measures and on patient satisfaction to determine the amount of the incentive. Depending on their performance, hospitals may earn more or less than what Medicare originally withheld for the incentive pool.
The government began the program by withholding 1% of total Medicare charges, increasing every year until reaching 2% in October 2016.
The program puts a hefty emphasis on patient satisfaction with 30% of the total score coming from performance on patient satisfaction. Medicare officials are using eight dimensions of the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores as the basis for grading performance on patient experience.
Even 1% can be a lot of money depending on the size and patient mix of the institution, said Dr. Peter H. Short, a former pediatric hospitalist and chief medical officer at Northeast Hospital Corp., a 258-bed community hospital network in Beverly, Mass., and a member of Lahey Health.
For instance, a hospital with $300 million in annual operating revenue could have about $150 million coming in from Medicare. That means that $1.5 million is at risk through the hospital value-based purchasing program, which puts a heavy emphasis on patient satisfaction.
"That’s nothing to sneeze at," Dr. Short said. "You don’t want to lose that."
And Medicare isn’t the only payer that is attaching dollars to patient satisfaction. More and more private insurers are including patient satisfaction scores as part of their pay for performance programs for hospitals, Dr. Short said.
All of this means that patient satisfaction is on the radar screen for hospital executives. And they in turn are leaning on hospitalists to make gains in HCAHPS scores.
In 2012, 71% of adult hospitalists with a performance incentive reported that they had measures related to patient satisfaction in the incentive, up from 54% in 2008, according to data collected by the Society of Hospital Medicine (SHM).
"Hospital executives are saying, we’re paying a couple million dollars for this hospitalist program, we want them to be the solution to patient experience. Let’s incentivize that," said Dr. Winthrop F. Whitcomb, medical director of health care quality at Baystate Medical Center in Springfield, Mass., and a past president of SHM.
Training for better satisfaction
In some institutions, hospitalists are actively training to do a better job at patient satisfaction. At Baystate Medical Center, simulations for good doctor-patient interactions are performed just as surgical ones are.
This spring, hospitalists there viewed a training video where they learned tactics for putting patients at ease and earning their trust. The strategies included everything from sitting down and making eye contact to providing patients with a business card with the physician’s photo. After that, hospitalists went into the simulation lab to sit down with former patients and act out common situations.
Dr. Whitcomb, who went through the training himself, said physicians introduced themselves, went through the details of a case, and in some cases explained test results. At the end of the simulation, the hospitalists got feedback on their performance.
The new training has been a hit with hospitalists and could be expanded to other physicians next, Dr. Whitcomb said.
At Northeast Hospital Corp., a 4-day workshop was recently conducted for hospitalists, nurses, case managers, and pharmacists at their Beverly, Mass., hospital. Actors were brought in to portray patients and family members, and the provider teams had a chance to simulate conversations with families.
A survey of providers after the workshop found that most providers thought they did a good job at the outset, but that they learned something to help them do a better job next time, Dr. Short said.
The next step will be to measure the hospital’s HCAHPS scores over the next few months to look for improvement, Dr. Short said.
It takes a team
But large-scale training and simulation efforts take resources and that requires buy-in from the hospital leadership, experts said.
Take the chair example. One of the common tactics for improving patient satisfaction is to sit down when in the patient’s room. Studies show that sitting down makes the patient feel like you’ve given them more time than if you were standing, even when the encounter is actually shorter. It also allows the physician and patient to be at the same eye level.
But what if there isn’t a chair in the room? Or the chair is filled with linens? That’s exactly what happened several years ago at Baystate Medical Center when they first tried to implement a set of behaviors aimed at improving patient satisfaction. To move forward, the physicians had to work with housekeeping to get a free, open chair in every room, Dr. Whitcomb said.
To be effective, patient satisfaction efforts have to include not just physicians and nurses but environmental services, transport, clinical associates, administrative associates, and the hospital board, Dr. Short said.
"You can’t do it alone. You shouldn’t do it alone. You won’t be able to do it alone," he said.
Dr. Short recommended starting with the hospital board because if they buy in, everyone else has to follow. And he said hospitalists shouldn’t be afraid to ask for the resources they need to get this done. Maybe the money goes to compensation incentives or to investments in improved technology in the department. Either way, if it’s important to the hospital leadership, they should provide some extra funding.
"Make it a partnership and not a one way," he said.
Another key element for success is measurement. And HCAHPS scores alone are probably not going to be adequate to advance improvements, said Dr. Richard Slataper, medical director of the hospital medicine service at Our Lady of the Lake Regional Medical Center in Baton Rouge, La. While HCAHPS scores are good for aggregate hospitalwide data, it’s difficult to impossible to relate the scores to specific physicians, he said.
At Our Lady of the Lake, they got around this issue by creating their own simple patient feedback form. The short questionnaire is mailed out to patients after discharge and includes the names of the physicians involved in that patient’s care. Dr. Slataper said they use the homegrown survey to judge if their patient satisfaction initiatives have been successful. Sharing the results is also a good motivator for the providers, he said.
They share all of the positive feedback from the surveys at a staff meeting and then review negative feedback during one-on-one meetings.
If developing your own survey is too complex, Dr. Whitcomb said most of the big vendors have or are developing surveys that can be used to gauge individual physician performance more accurately than HCAHPS.
Hurdles remain
Despite all the talk about patient satisfaction and the increasingly aligned financial incentives, physicians and hospitals are still struggling to make improvements. One problem is that hospitalists practice all over the hospital – from the observation unit to the ICU – and it can be difficult to take the tactics available and practice them consistently, said Dr. Steven B. Deitelzweig, vice president of medical affairs and chair of hospital medicine at Ochsner Health System in New Orleans.
Co-location, where physicians work consistently with the same team of providers, could help alleviate part of the problem, Dr. Deitelzweig said. Another possible solution is increased coaching and mentoring among hospitalists, he said. As a result of the high volume of patient handoffs, hospitalists have a greater opportunity to see each other at work. That’s also an opportunity to share effective tactics when it comes to patient satisfaction, he said.
A tougher hurdle may be that patient satisfaction is being added to a long list of requirements for hospitalists from core measures to hospital-acquired infections to improved documentation.
"They are kind of inundated, and I think some hospitalists are a little bewildered," Dr. Whitcomb said.
His best advice to hospitalists is to remember to "keep the patient at the center" and patient satisfaction will follow.
Dos and don’ts for improving patient satisfaction
Wondering how to get started on improving patient satisfaction? Dr. Peter Short of Northeast Hospital Corporation in Beverly, Mass., suggests that hospitalists get started by choosing three tactics, implementing them, and then measuring their impact. Once those items are hard-wired in the program, move on to other strategies for connecting with patients, he said.
Here are Dr. Short’s dos and don’ts for improving the patient experience.
• Knock on the patient’s door before going in. By doing that you are asking the patient’s permission to come in and showing them respect.
• Introduce yourself and hand out a brochure explaining the hospitalist program. A lot of patients still don’t know what a hospitalist program is and that it’s the hospitalist’s job to communicate with their primary care physician.
• Offer patients and their family members a business card with a photo.
• Connect on a personal level by talking about something other than the patient’s medical care. Ask about the food. How is the TV? It only takes a second to ask.
• Use props to your advantage. Whiteboards in the room are a great place to put the physician’s name and facts about the plan of care. But if the whiteboard isn’t filled out or up-to-date, it can be worse than having no board at all. So make sure it is updated and that all the hospitalists have a steady supply of markers.
• Get a chair and sit down. If you remain standing during the visit, it looks like you want to be somewhere else. Always make sure your patients feel that you have as much time as they need, even if you don’t.
• Never pass a call light. This takes a lot of collaboration by all the providers on the floor. But when hospital staff members pass their room when the call light is on, it makes them feel abandoned.
• Never tell a patient that you are so busy or that you have so many patients. "They don’t want to hear it. What they want to hear is that they are either the most important patient to you or they want to feel like they are the only patient you have to take care of," Dr. Short said. Telling patients about your busy schedule is the surest way to see your scores plummet.
On Twitter @MaryEllenNY
Ask any expert on patient satisfaction why hospitalists should care about this issue and they all say the same thing: It’s the right thing to do.
But increasingly, it’s also the smart thing to do from a financial perspective. Most of the financial levers involved are aimed at hospitals, but they tend to trickle down to physicians.
Hospital value-based purchasing is one of the biggest drivers. Under the new program, which began in October 2012, hospitals have a small percentage of their total Medicare charges set aside into a pool used for awarding value-based incentives. Medicare officials measure the hospitals’ performance on a set of process of care measures and on patient satisfaction to determine the amount of the incentive. Depending on their performance, hospitals may earn more or less than what Medicare originally withheld for the incentive pool.
The government began the program by withholding 1% of total Medicare charges, increasing every year until reaching 2% in October 2016.
The program puts a hefty emphasis on patient satisfaction with 30% of the total score coming from performance on patient satisfaction. Medicare officials are using eight dimensions of the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores as the basis for grading performance on patient experience.
Even 1% can be a lot of money depending on the size and patient mix of the institution, said Dr. Peter H. Short, a former pediatric hospitalist and chief medical officer at Northeast Hospital Corp., a 258-bed community hospital network in Beverly, Mass., and a member of Lahey Health.
For instance, a hospital with $300 million in annual operating revenue could have about $150 million coming in from Medicare. That means that $1.5 million is at risk through the hospital value-based purchasing program, which puts a heavy emphasis on patient satisfaction.
"That’s nothing to sneeze at," Dr. Short said. "You don’t want to lose that."
And Medicare isn’t the only payer that is attaching dollars to patient satisfaction. More and more private insurers are including patient satisfaction scores as part of their pay for performance programs for hospitals, Dr. Short said.
All of this means that patient satisfaction is on the radar screen for hospital executives. And they in turn are leaning on hospitalists to make gains in HCAHPS scores.
In 2012, 71% of adult hospitalists with a performance incentive reported that they had measures related to patient satisfaction in the incentive, up from 54% in 2008, according to data collected by the Society of Hospital Medicine (SHM).
"Hospital executives are saying, we’re paying a couple million dollars for this hospitalist program, we want them to be the solution to patient experience. Let’s incentivize that," said Dr. Winthrop F. Whitcomb, medical director of health care quality at Baystate Medical Center in Springfield, Mass., and a past president of SHM.
Training for better satisfaction
In some institutions, hospitalists are actively training to do a better job at patient satisfaction. At Baystate Medical Center, simulations for good doctor-patient interactions are performed just as surgical ones are.
This spring, hospitalists there viewed a training video where they learned tactics for putting patients at ease and earning their trust. The strategies included everything from sitting down and making eye contact to providing patients with a business card with the physician’s photo. After that, hospitalists went into the simulation lab to sit down with former patients and act out common situations.
Dr. Whitcomb, who went through the training himself, said physicians introduced themselves, went through the details of a case, and in some cases explained test results. At the end of the simulation, the hospitalists got feedback on their performance.
The new training has been a hit with hospitalists and could be expanded to other physicians next, Dr. Whitcomb said.
At Northeast Hospital Corp., a 4-day workshop was recently conducted for hospitalists, nurses, case managers, and pharmacists at their Beverly, Mass., hospital. Actors were brought in to portray patients and family members, and the provider teams had a chance to simulate conversations with families.
A survey of providers after the workshop found that most providers thought they did a good job at the outset, but that they learned something to help them do a better job next time, Dr. Short said.
The next step will be to measure the hospital’s HCAHPS scores over the next few months to look for improvement, Dr. Short said.
It takes a team
But large-scale training and simulation efforts take resources and that requires buy-in from the hospital leadership, experts said.
Take the chair example. One of the common tactics for improving patient satisfaction is to sit down when in the patient’s room. Studies show that sitting down makes the patient feel like you’ve given them more time than if you were standing, even when the encounter is actually shorter. It also allows the physician and patient to be at the same eye level.
But what if there isn’t a chair in the room? Or the chair is filled with linens? That’s exactly what happened several years ago at Baystate Medical Center when they first tried to implement a set of behaviors aimed at improving patient satisfaction. To move forward, the physicians had to work with housekeeping to get a free, open chair in every room, Dr. Whitcomb said.
To be effective, patient satisfaction efforts have to include not just physicians and nurses but environmental services, transport, clinical associates, administrative associates, and the hospital board, Dr. Short said.
"You can’t do it alone. You shouldn’t do it alone. You won’t be able to do it alone," he said.
Dr. Short recommended starting with the hospital board because if they buy in, everyone else has to follow. And he said hospitalists shouldn’t be afraid to ask for the resources they need to get this done. Maybe the money goes to compensation incentives or to investments in improved technology in the department. Either way, if it’s important to the hospital leadership, they should provide some extra funding.
"Make it a partnership and not a one way," he said.
Another key element for success is measurement. And HCAHPS scores alone are probably not going to be adequate to advance improvements, said Dr. Richard Slataper, medical director of the hospital medicine service at Our Lady of the Lake Regional Medical Center in Baton Rouge, La. While HCAHPS scores are good for aggregate hospitalwide data, it’s difficult to impossible to relate the scores to specific physicians, he said.
At Our Lady of the Lake, they got around this issue by creating their own simple patient feedback form. The short questionnaire is mailed out to patients after discharge and includes the names of the physicians involved in that patient’s care. Dr. Slataper said they use the homegrown survey to judge if their patient satisfaction initiatives have been successful. Sharing the results is also a good motivator for the providers, he said.
They share all of the positive feedback from the surveys at a staff meeting and then review negative feedback during one-on-one meetings.
If developing your own survey is too complex, Dr. Whitcomb said most of the big vendors have or are developing surveys that can be used to gauge individual physician performance more accurately than HCAHPS.
Hurdles remain
Despite all the talk about patient satisfaction and the increasingly aligned financial incentives, physicians and hospitals are still struggling to make improvements. One problem is that hospitalists practice all over the hospital – from the observation unit to the ICU – and it can be difficult to take the tactics available and practice them consistently, said Dr. Steven B. Deitelzweig, vice president of medical affairs and chair of hospital medicine at Ochsner Health System in New Orleans.
Co-location, where physicians work consistently with the same team of providers, could help alleviate part of the problem, Dr. Deitelzweig said. Another possible solution is increased coaching and mentoring among hospitalists, he said. As a result of the high volume of patient handoffs, hospitalists have a greater opportunity to see each other at work. That’s also an opportunity to share effective tactics when it comes to patient satisfaction, he said.
A tougher hurdle may be that patient satisfaction is being added to a long list of requirements for hospitalists from core measures to hospital-acquired infections to improved documentation.
"They are kind of inundated, and I think some hospitalists are a little bewildered," Dr. Whitcomb said.
His best advice to hospitalists is to remember to "keep the patient at the center" and patient satisfaction will follow.
Dos and don’ts for improving patient satisfaction
Wondering how to get started on improving patient satisfaction? Dr. Peter Short of Northeast Hospital Corporation in Beverly, Mass., suggests that hospitalists get started by choosing three tactics, implementing them, and then measuring their impact. Once those items are hard-wired in the program, move on to other strategies for connecting with patients, he said.
Here are Dr. Short’s dos and don’ts for improving the patient experience.
• Knock on the patient’s door before going in. By doing that you are asking the patient’s permission to come in and showing them respect.
• Introduce yourself and hand out a brochure explaining the hospitalist program. A lot of patients still don’t know what a hospitalist program is and that it’s the hospitalist’s job to communicate with their primary care physician.
• Offer patients and their family members a business card with a photo.
• Connect on a personal level by talking about something other than the patient’s medical care. Ask about the food. How is the TV? It only takes a second to ask.
• Use props to your advantage. Whiteboards in the room are a great place to put the physician’s name and facts about the plan of care. But if the whiteboard isn’t filled out or up-to-date, it can be worse than having no board at all. So make sure it is updated and that all the hospitalists have a steady supply of markers.
• Get a chair and sit down. If you remain standing during the visit, it looks like you want to be somewhere else. Always make sure your patients feel that you have as much time as they need, even if you don’t.
• Never pass a call light. This takes a lot of collaboration by all the providers on the floor. But when hospital staff members pass their room when the call light is on, it makes them feel abandoned.
• Never tell a patient that you are so busy or that you have so many patients. "They don’t want to hear it. What they want to hear is that they are either the most important patient to you or they want to feel like they are the only patient you have to take care of," Dr. Short said. Telling patients about your busy schedule is the surest way to see your scores plummet.
On Twitter @MaryEllenNY
Ask any expert on patient satisfaction why hospitalists should care about this issue and they all say the same thing: It’s the right thing to do.
But increasingly, it’s also the smart thing to do from a financial perspective. Most of the financial levers involved are aimed at hospitals, but they tend to trickle down to physicians.
Hospital value-based purchasing is one of the biggest drivers. Under the new program, which began in October 2012, hospitals have a small percentage of their total Medicare charges set aside into a pool used for awarding value-based incentives. Medicare officials measure the hospitals’ performance on a set of process of care measures and on patient satisfaction to determine the amount of the incentive. Depending on their performance, hospitals may earn more or less than what Medicare originally withheld for the incentive pool.
The government began the program by withholding 1% of total Medicare charges, increasing every year until reaching 2% in October 2016.
The program puts a hefty emphasis on patient satisfaction with 30% of the total score coming from performance on patient satisfaction. Medicare officials are using eight dimensions of the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores as the basis for grading performance on patient experience.
Even 1% can be a lot of money depending on the size and patient mix of the institution, said Dr. Peter H. Short, a former pediatric hospitalist and chief medical officer at Northeast Hospital Corp., a 258-bed community hospital network in Beverly, Mass., and a member of Lahey Health.
For instance, a hospital with $300 million in annual operating revenue could have about $150 million coming in from Medicare. That means that $1.5 million is at risk through the hospital value-based purchasing program, which puts a heavy emphasis on patient satisfaction.
"That’s nothing to sneeze at," Dr. Short said. "You don’t want to lose that."
And Medicare isn’t the only payer that is attaching dollars to patient satisfaction. More and more private insurers are including patient satisfaction scores as part of their pay for performance programs for hospitals, Dr. Short said.
All of this means that patient satisfaction is on the radar screen for hospital executives. And they in turn are leaning on hospitalists to make gains in HCAHPS scores.
In 2012, 71% of adult hospitalists with a performance incentive reported that they had measures related to patient satisfaction in the incentive, up from 54% in 2008, according to data collected by the Society of Hospital Medicine (SHM).
"Hospital executives are saying, we’re paying a couple million dollars for this hospitalist program, we want them to be the solution to patient experience. Let’s incentivize that," said Dr. Winthrop F. Whitcomb, medical director of health care quality at Baystate Medical Center in Springfield, Mass., and a past president of SHM.
Training for better satisfaction
In some institutions, hospitalists are actively training to do a better job at patient satisfaction. At Baystate Medical Center, simulations for good doctor-patient interactions are performed just as surgical ones are.
This spring, hospitalists there viewed a training video where they learned tactics for putting patients at ease and earning their trust. The strategies included everything from sitting down and making eye contact to providing patients with a business card with the physician’s photo. After that, hospitalists went into the simulation lab to sit down with former patients and act out common situations.
Dr. Whitcomb, who went through the training himself, said physicians introduced themselves, went through the details of a case, and in some cases explained test results. At the end of the simulation, the hospitalists got feedback on their performance.
The new training has been a hit with hospitalists and could be expanded to other physicians next, Dr. Whitcomb said.
At Northeast Hospital Corp., a 4-day workshop was recently conducted for hospitalists, nurses, case managers, and pharmacists at their Beverly, Mass., hospital. Actors were brought in to portray patients and family members, and the provider teams had a chance to simulate conversations with families.
A survey of providers after the workshop found that most providers thought they did a good job at the outset, but that they learned something to help them do a better job next time, Dr. Short said.
The next step will be to measure the hospital’s HCAHPS scores over the next few months to look for improvement, Dr. Short said.
It takes a team
But large-scale training and simulation efforts take resources and that requires buy-in from the hospital leadership, experts said.
Take the chair example. One of the common tactics for improving patient satisfaction is to sit down when in the patient’s room. Studies show that sitting down makes the patient feel like you’ve given them more time than if you were standing, even when the encounter is actually shorter. It also allows the physician and patient to be at the same eye level.
But what if there isn’t a chair in the room? Or the chair is filled with linens? That’s exactly what happened several years ago at Baystate Medical Center when they first tried to implement a set of behaviors aimed at improving patient satisfaction. To move forward, the physicians had to work with housekeeping to get a free, open chair in every room, Dr. Whitcomb said.
To be effective, patient satisfaction efforts have to include not just physicians and nurses but environmental services, transport, clinical associates, administrative associates, and the hospital board, Dr. Short said.
"You can’t do it alone. You shouldn’t do it alone. You won’t be able to do it alone," he said.
Dr. Short recommended starting with the hospital board because if they buy in, everyone else has to follow. And he said hospitalists shouldn’t be afraid to ask for the resources they need to get this done. Maybe the money goes to compensation incentives or to investments in improved technology in the department. Either way, if it’s important to the hospital leadership, they should provide some extra funding.
"Make it a partnership and not a one way," he said.
Another key element for success is measurement. And HCAHPS scores alone are probably not going to be adequate to advance improvements, said Dr. Richard Slataper, medical director of the hospital medicine service at Our Lady of the Lake Regional Medical Center in Baton Rouge, La. While HCAHPS scores are good for aggregate hospitalwide data, it’s difficult to impossible to relate the scores to specific physicians, he said.
At Our Lady of the Lake, they got around this issue by creating their own simple patient feedback form. The short questionnaire is mailed out to patients after discharge and includes the names of the physicians involved in that patient’s care. Dr. Slataper said they use the homegrown survey to judge if their patient satisfaction initiatives have been successful. Sharing the results is also a good motivator for the providers, he said.
They share all of the positive feedback from the surveys at a staff meeting and then review negative feedback during one-on-one meetings.
If developing your own survey is too complex, Dr. Whitcomb said most of the big vendors have or are developing surveys that can be used to gauge individual physician performance more accurately than HCAHPS.
Hurdles remain
Despite all the talk about patient satisfaction and the increasingly aligned financial incentives, physicians and hospitals are still struggling to make improvements. One problem is that hospitalists practice all over the hospital – from the observation unit to the ICU – and it can be difficult to take the tactics available and practice them consistently, said Dr. Steven B. Deitelzweig, vice president of medical affairs and chair of hospital medicine at Ochsner Health System in New Orleans.
Co-location, where physicians work consistently with the same team of providers, could help alleviate part of the problem, Dr. Deitelzweig said. Another possible solution is increased coaching and mentoring among hospitalists, he said. As a result of the high volume of patient handoffs, hospitalists have a greater opportunity to see each other at work. That’s also an opportunity to share effective tactics when it comes to patient satisfaction, he said.
A tougher hurdle may be that patient satisfaction is being added to a long list of requirements for hospitalists from core measures to hospital-acquired infections to improved documentation.
"They are kind of inundated, and I think some hospitalists are a little bewildered," Dr. Whitcomb said.
His best advice to hospitalists is to remember to "keep the patient at the center" and patient satisfaction will follow.
Dos and don’ts for improving patient satisfaction
Wondering how to get started on improving patient satisfaction? Dr. Peter Short of Northeast Hospital Corporation in Beverly, Mass., suggests that hospitalists get started by choosing three tactics, implementing them, and then measuring their impact. Once those items are hard-wired in the program, move on to other strategies for connecting with patients, he said.
Here are Dr. Short’s dos and don’ts for improving the patient experience.
• Knock on the patient’s door before going in. By doing that you are asking the patient’s permission to come in and showing them respect.
• Introduce yourself and hand out a brochure explaining the hospitalist program. A lot of patients still don’t know what a hospitalist program is and that it’s the hospitalist’s job to communicate with their primary care physician.
• Offer patients and their family members a business card with a photo.
• Connect on a personal level by talking about something other than the patient’s medical care. Ask about the food. How is the TV? It only takes a second to ask.
• Use props to your advantage. Whiteboards in the room are a great place to put the physician’s name and facts about the plan of care. But if the whiteboard isn’t filled out or up-to-date, it can be worse than having no board at all. So make sure it is updated and that all the hospitalists have a steady supply of markers.
• Get a chair and sit down. If you remain standing during the visit, it looks like you want to be somewhere else. Always make sure your patients feel that you have as much time as they need, even if you don’t.
• Never pass a call light. This takes a lot of collaboration by all the providers on the floor. But when hospital staff members pass their room when the call light is on, it makes them feel abandoned.
• Never tell a patient that you are so busy or that you have so many patients. "They don’t want to hear it. What they want to hear is that they are either the most important patient to you or they want to feel like they are the only patient you have to take care of," Dr. Short said. Telling patients about your busy schedule is the surest way to see your scores plummet.
On Twitter @MaryEllenNY
Supreme Court: Human genes cannot be patented
Private companies do not have the right to patent human genes, the U.S. Supreme Court has ruled.
In a unanimous decision issued on June 13, the high court ruled that a naturally occurring DNA segment is a "product of nature" and is not eligible for a patent simply because it has been isolated. But the court also ruled that synthetically created DNA known as complementary DNA (cDNA) can be granted a patent.
In Association for Molecular Pathology et al. v. Myriad Genetics, the high court considered the validity of patents held by Utah-based Myriad Genetics for the BRCA1 and BRCA2 genes, which are associated with an increased risk of breast and ovarian cancer.
Scientists at Myriad Genetics uncovered the location and sequence of the BRCA1 and BRCA2 genes in the mid-1990s. Since then, they have held the exclusive rights to the diagnostic testing for the mutations. But critics say the monopoly on testing held by Myriad is bad for patients because the test is expensive and they have no alternative confirmatory test.
"It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes," Justice Clarence Thomas wrote in the court’s opinion. "Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13."
The justices concluded that simply isolating genes and the information they encode from the surrounding genetic material is insufficient for a patent. However, cDNA are not naturally occurring so tests using that technology can be patented.
The American Medical Association, which filed an amicus brief in support of invalidating the Myriad patents, praised the Court’s decision.
"Removing the patents on the building blocks of life ensures that scientific discovery and medical care based on insights into human DNA will remain freely accessible and widely disseminated, not hidden behind a vast thicket of exclusive rights," Dr. Jeremy A. Lazarus, AMA president, said in a statement.
The American Civil Liberties Union, which joined the suit against Myriad, said the decision brings down a major barrier to patient care and medical innovation. "Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued," Sandra Park, senior staff attorney with the ACLU Women’s Rights Project, said in a statement.
The Supreme Court’s decision comes too late to have much of a practical impact on BRCA1 and BRCA2 testing, since Myriad’s 20-year exclusivity on the patents in dispute all expire by 2015.
On Twitter @MaryEllenNY
Private companies do not have the right to patent human genes, the U.S. Supreme Court has ruled.
In a unanimous decision issued on June 13, the high court ruled that a naturally occurring DNA segment is a "product of nature" and is not eligible for a patent simply because it has been isolated. But the court also ruled that synthetically created DNA known as complementary DNA (cDNA) can be granted a patent.
In Association for Molecular Pathology et al. v. Myriad Genetics, the high court considered the validity of patents held by Utah-based Myriad Genetics for the BRCA1 and BRCA2 genes, which are associated with an increased risk of breast and ovarian cancer.
Scientists at Myriad Genetics uncovered the location and sequence of the BRCA1 and BRCA2 genes in the mid-1990s. Since then, they have held the exclusive rights to the diagnostic testing for the mutations. But critics say the monopoly on testing held by Myriad is bad for patients because the test is expensive and they have no alternative confirmatory test.
"It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes," Justice Clarence Thomas wrote in the court’s opinion. "Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13."
The justices concluded that simply isolating genes and the information they encode from the surrounding genetic material is insufficient for a patent. However, cDNA are not naturally occurring so tests using that technology can be patented.
The American Medical Association, which filed an amicus brief in support of invalidating the Myriad patents, praised the Court’s decision.
"Removing the patents on the building blocks of life ensures that scientific discovery and medical care based on insights into human DNA will remain freely accessible and widely disseminated, not hidden behind a vast thicket of exclusive rights," Dr. Jeremy A. Lazarus, AMA president, said in a statement.
The American Civil Liberties Union, which joined the suit against Myriad, said the decision brings down a major barrier to patient care and medical innovation. "Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued," Sandra Park, senior staff attorney with the ACLU Women’s Rights Project, said in a statement.
The Supreme Court’s decision comes too late to have much of a practical impact on BRCA1 and BRCA2 testing, since Myriad’s 20-year exclusivity on the patents in dispute all expire by 2015.
On Twitter @MaryEllenNY
Private companies do not have the right to patent human genes, the U.S. Supreme Court has ruled.
In a unanimous decision issued on June 13, the high court ruled that a naturally occurring DNA segment is a "product of nature" and is not eligible for a patent simply because it has been isolated. But the court also ruled that synthetically created DNA known as complementary DNA (cDNA) can be granted a patent.
In Association for Molecular Pathology et al. v. Myriad Genetics, the high court considered the validity of patents held by Utah-based Myriad Genetics for the BRCA1 and BRCA2 genes, which are associated with an increased risk of breast and ovarian cancer.
Scientists at Myriad Genetics uncovered the location and sequence of the BRCA1 and BRCA2 genes in the mid-1990s. Since then, they have held the exclusive rights to the diagnostic testing for the mutations. But critics say the monopoly on testing held by Myriad is bad for patients because the test is expensive and they have no alternative confirmatory test.
"It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes," Justice Clarence Thomas wrote in the court’s opinion. "Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13."
The justices concluded that simply isolating genes and the information they encode from the surrounding genetic material is insufficient for a patent. However, cDNA are not naturally occurring so tests using that technology can be patented.
The American Medical Association, which filed an amicus brief in support of invalidating the Myriad patents, praised the Court’s decision.
"Removing the patents on the building blocks of life ensures that scientific discovery and medical care based on insights into human DNA will remain freely accessible and widely disseminated, not hidden behind a vast thicket of exclusive rights," Dr. Jeremy A. Lazarus, AMA president, said in a statement.
The American Civil Liberties Union, which joined the suit against Myriad, said the decision brings down a major barrier to patient care and medical innovation. "Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued," Sandra Park, senior staff attorney with the ACLU Women’s Rights Project, said in a statement.
The Supreme Court’s decision comes too late to have much of a practical impact on BRCA1 and BRCA2 testing, since Myriad’s 20-year exclusivity on the patents in dispute all expire by 2015.
On Twitter @MaryEllenNY
Medicare to double the penalty on 30-day readmissions
The penalties are going up in Medicare’s hospital readmission reduction program. Starting on Oct. 1, hospitals could face up to a 2% cut in Medicare payments if their 30-day readmission rates for acute myocardial infarction, heart failure, and pneumonia are too high. The program started on Oct. 1, 2012, with a 1% cap on penalties.
The penalty increase was outlined in Medicare’s proposed fiscal year 2014 inpatient prospective payment system rule released April 26.
The proposal also outlines the government’s plans to expand the readmission reduction program to include two new readmission measures. Starting on Oct. 1, 2014, the program would also include readmissions associated with an acute exacerbation of chronic obstructive pulmonary disease, as well as readmissions for elective total hip or knee arthroplasty.
The inclusion of COPD for fiscal year 2015 was expected since that condition was specifically highlighted by Congress in the Affordable Care Act (ACA), which created the readmission reduction program. However, lawmakers had also recommended adding coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI), and other vascular conditions, which are not included in the Centers for Medicare and Medicaid Services (CMS) proposal.
The reasons for the switch were largely due to cost and volume, according to the proposal rule.
In 2005, annual hospital charges totaled $3.95 billion for primary total hip arthroplasty and $7.42 billion for total knee arthroplasty. When combined, the two procedures represent the largest procedures cost in the Medicare budget. At the same time, inpatient admissions for PCI and other vascular conditions have been declining, according to Medicare officials, as more of those services are being shifted to hospital outpatient departments.
The fiscal 2014 payment proposal also includes a revised methodology for calculating hospital readmission rates in an effort to do a better job of accounting for certain planned readmissions.
The change is a mixed bag for hospitals, according to the Premier healthcare alliance. While the revised methodology will likely result in a more accurate payment calculation, it fails to take into consideration socioeconomic and community factors.
"Hospitals that serve high percentages of lower-income patients will be disproportionately penalized for circumstances outside their control," Blair Childs, senior vice president of public affairs at Premier, said in a statement. "This places additional financial burdens on already stressed local health care systems in these communities."
The Medicare program is also moving forward with the Hospital-Acquired Condition Reduction Program, also created by the ACA.
The new program, which begins on Oct. 1, 2014, levies a 1% penalty on hospitals that rank in the lowest-performing quartile for eight hospital-acquired conditions. The proposed rule includes the quality measures, scoring methodology, and correction process that are planned for the program.
During the first year, officials plan to use quality measures that are calculated using claims data or are part of the Inpatient Quality Reporting program. The eight measures are divided into two domains. Hospitals will receive a score for each measure, which will then be used to calculate a domain score. The two domains will be weighted equally to get a total score under the program, according to CMS.
The measures in the first domain are pressure ulcer rate; volume of foreign object left in the body; iatrogenic pneumothorax rate; postoperative physiologic and metabolic derangement rate; postoperative pulmonary embolism or deep vein thrombosis rate; and accidental puncture and laceration rate. CMS is also considering the use of a composite patient safety indicator measure set as an alternative to the first domain.
The second domain includes two health care–associated infection measures: central line–associated bloodstream infection and catheter-associated urinary tract infection.
CMS plans to account for risk factors such as age, gender, and comorbidities when calculating the measure rates.
There are no surprises in the conditions chosen for the new program, said Erik Johnson, senior vice president at Avalere Health. However, the fact that CMS officials chose to include eight measures at the start of the program indicates how serious they are about hospital-acquired conditions, he said.
Mr. Johnson predicted that hospitals will take these quality programs seriously as well. Through the combination of the hospital-acquired condition program, the readmission reduction program, value-based purchasing, and a few other programs, hospitals now have at least 7% of their Medicare payments at risk based on performance on quality measures, he said.
"It’s already starting to move behaviors," Mr. Johnson said. "Hospitals are by and large making a good-faith effort to get better at all of those things. But there are going to be winners and losers, and the losers may end up losing big on a lot of this stuff."
The agency is scheduled to release its final rule by Aug. 1.
| Dr. Frank Pomposelli |
It’s a slippery slope at best. Take for example the mandated push towards electronic medical records (EMR). Will they improve safety and outcomes? Perhaps. Will they reduce costs? I doubt it. EMRs are costly to implement (up to a billion dollars for one very large system that I am familiar with) and reduce efficiency for physicians. The vast array of commercially available and home grown products cannot communicate with one another and HIPPA regulations make it impossible for information to be easily shared between two different health care systems caring for the same patient. The current initiatives by CMS outlined above are another example of using payment reduction mandates (AKA cost containment) in an attempt to improve outcomes.
I doubt any physician or surgeon would dispute the desire or need to reduce readmissions and the rate of hospital acquired conditions like pressure decubiti, venous thrombo-embolism, line infections etc. However, I wonder whether reducing reimbursement, even though it’s the only method available, is either fair or effective. We already spend an enormous amount of time and resources on disposition planning from the moment a patient enters the hospital until the day they leave and work feverishly to get patients out of the hospital as quickly as possible once their treatment is complete. Occasionally, the care team even finds themselves in the uncomfortable situation of nearly pushing someone they have treated out the door. It stands to reason that the pressure to reduce length of stay will result in a somewhat higher rate of readmission-a trade off that recognizes that we are not perfect and neither are our patients. In my experience, the poor and disenfranchised are especially at risk for readmission. Undoubtedly those hospitals that care for a disproportionate number of poor will be unfairly penalized. Is it reasonable to pressure hospitals simultaneously on length of stay and readmissions? I think not. Moreover, is it reasonable to pick a high volume, high reimbursement program like joint replacement just because it’s a big ticket item? Smaller programs may actually represent areas where there is more room for improvement.
My ire is less aroused with regard to hospital acquired conditions. We can and must do a better job in preventing avoidable complications to our patients. Many but not all hospital acquired morbidities result from deficiencies in the system of care that all hospitals, regardless of the demographic they serve can and must correct. Again, hospitals serving the poor may be unfairly targeted since many have less in house resources than larger wealthier systems serving a more affluent patient population. Moreover, fairness and accuracy requires risk adjusted metrics- something that policy makers don’t always recognize without input from us.
After 26 years in clinical practice, many of which have been spent working with my hospital to correct or improve these problems, I’ve come to realize that in a system as complex as a hospital, achieving success in these areas is difficult and requires not only commitment and hard work but also resources. If resources are going to be continuously cut while expecting us to reduce in hospital complications, keep down length stay and reduce the rate of admissions, I suspect all we’ll wind up with is further reductions in compensation with little or no benefit to patients. The skeptics among us undoubtedly feel that is the true motivation behind these initiatives. I hope they are wrong.
Dr. Frank Pomposelli is chair of surgery, St. Elizabeth’s Medical Center, Boston, and associate medical editor of VASCULAR SPECIALIST.
| Dr. Frank Pomposelli |
It’s a slippery slope at best. Take for example the mandated push towards electronic medical records (EMR). Will they improve safety and outcomes? Perhaps. Will they reduce costs? I doubt it. EMRs are costly to implement (up to a billion dollars for one very large system that I am familiar with) and reduce efficiency for physicians. The vast array of commercially available and home grown products cannot communicate with one another and HIPPA regulations make it impossible for information to be easily shared between two different health care systems caring for the same patient. The current initiatives by CMS outlined above are another example of using payment reduction mandates (AKA cost containment) in an attempt to improve outcomes.
I doubt any physician or surgeon would dispute the desire or need to reduce readmissions and the rate of hospital acquired conditions like pressure decubiti, venous thrombo-embolism, line infections etc. However, I wonder whether reducing reimbursement, even though it’s the only method available, is either fair or effective. We already spend an enormous amount of time and resources on disposition planning from the moment a patient enters the hospital until the day they leave and work feverishly to get patients out of the hospital as quickly as possible once their treatment is complete. Occasionally, the care team even finds themselves in the uncomfortable situation of nearly pushing someone they have treated out the door. It stands to reason that the pressure to reduce length of stay will result in a somewhat higher rate of readmission-a trade off that recognizes that we are not perfect and neither are our patients. In my experience, the poor and disenfranchised are especially at risk for readmission. Undoubtedly those hospitals that care for a disproportionate number of poor will be unfairly penalized. Is it reasonable to pressure hospitals simultaneously on length of stay and readmissions? I think not. Moreover, is it reasonable to pick a high volume, high reimbursement program like joint replacement just because it’s a big ticket item? Smaller programs may actually represent areas where there is more room for improvement.
My ire is less aroused with regard to hospital acquired conditions. We can and must do a better job in preventing avoidable complications to our patients. Many but not all hospital acquired morbidities result from deficiencies in the system of care that all hospitals, regardless of the demographic they serve can and must correct. Again, hospitals serving the poor may be unfairly targeted since many have less in house resources than larger wealthier systems serving a more affluent patient population. Moreover, fairness and accuracy requires risk adjusted metrics- something that policy makers don’t always recognize without input from us.
After 26 years in clinical practice, many of which have been spent working with my hospital to correct or improve these problems, I’ve come to realize that in a system as complex as a hospital, achieving success in these areas is difficult and requires not only commitment and hard work but also resources. If resources are going to be continuously cut while expecting us to reduce in hospital complications, keep down length stay and reduce the rate of admissions, I suspect all we’ll wind up with is further reductions in compensation with little or no benefit to patients. The skeptics among us undoubtedly feel that is the true motivation behind these initiatives. I hope they are wrong.
Dr. Frank Pomposelli is chair of surgery, St. Elizabeth’s Medical Center, Boston, and associate medical editor of VASCULAR SPECIALIST.
| Dr. Frank Pomposelli |
It’s a slippery slope at best. Take for example the mandated push towards electronic medical records (EMR). Will they improve safety and outcomes? Perhaps. Will they reduce costs? I doubt it. EMRs are costly to implement (up to a billion dollars for one very large system that I am familiar with) and reduce efficiency for physicians. The vast array of commercially available and home grown products cannot communicate with one another and HIPPA regulations make it impossible for information to be easily shared between two different health care systems caring for the same patient. The current initiatives by CMS outlined above are another example of using payment reduction mandates (AKA cost containment) in an attempt to improve outcomes.
I doubt any physician or surgeon would dispute the desire or need to reduce readmissions and the rate of hospital acquired conditions like pressure decubiti, venous thrombo-embolism, line infections etc. However, I wonder whether reducing reimbursement, even though it’s the only method available, is either fair or effective. We already spend an enormous amount of time and resources on disposition planning from the moment a patient enters the hospital until the day they leave and work feverishly to get patients out of the hospital as quickly as possible once their treatment is complete. Occasionally, the care team even finds themselves in the uncomfortable situation of nearly pushing someone they have treated out the door. It stands to reason that the pressure to reduce length of stay will result in a somewhat higher rate of readmission-a trade off that recognizes that we are not perfect and neither are our patients. In my experience, the poor and disenfranchised are especially at risk for readmission. Undoubtedly those hospitals that care for a disproportionate number of poor will be unfairly penalized. Is it reasonable to pressure hospitals simultaneously on length of stay and readmissions? I think not. Moreover, is it reasonable to pick a high volume, high reimbursement program like joint replacement just because it’s a big ticket item? Smaller programs may actually represent areas where there is more room for improvement.
My ire is less aroused with regard to hospital acquired conditions. We can and must do a better job in preventing avoidable complications to our patients. Many but not all hospital acquired morbidities result from deficiencies in the system of care that all hospitals, regardless of the demographic they serve can and must correct. Again, hospitals serving the poor may be unfairly targeted since many have less in house resources than larger wealthier systems serving a more affluent patient population. Moreover, fairness and accuracy requires risk adjusted metrics- something that policy makers don’t always recognize without input from us.
After 26 years in clinical practice, many of which have been spent working with my hospital to correct or improve these problems, I’ve come to realize that in a system as complex as a hospital, achieving success in these areas is difficult and requires not only commitment and hard work but also resources. If resources are going to be continuously cut while expecting us to reduce in hospital complications, keep down length stay and reduce the rate of admissions, I suspect all we’ll wind up with is further reductions in compensation with little or no benefit to patients. The skeptics among us undoubtedly feel that is the true motivation behind these initiatives. I hope they are wrong.
Dr. Frank Pomposelli is chair of surgery, St. Elizabeth’s Medical Center, Boston, and associate medical editor of VASCULAR SPECIALIST.
The penalties are going up in Medicare’s hospital readmission reduction program. Starting on Oct. 1, hospitals could face up to a 2% cut in Medicare payments if their 30-day readmission rates for acute myocardial infarction, heart failure, and pneumonia are too high. The program started on Oct. 1, 2012, with a 1% cap on penalties.
The penalty increase was outlined in Medicare’s proposed fiscal year 2014 inpatient prospective payment system rule released April 26.
The proposal also outlines the government’s plans to expand the readmission reduction program to include two new readmission measures. Starting on Oct. 1, 2014, the program would also include readmissions associated with an acute exacerbation of chronic obstructive pulmonary disease, as well as readmissions for elective total hip or knee arthroplasty.
The inclusion of COPD for fiscal year 2015 was expected since that condition was specifically highlighted by Congress in the Affordable Care Act (ACA), which created the readmission reduction program. However, lawmakers had also recommended adding coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI), and other vascular conditions, which are not included in the Centers for Medicare and Medicaid Services (CMS) proposal.
The reasons for the switch were largely due to cost and volume, according to the proposal rule.
In 2005, annual hospital charges totaled $3.95 billion for primary total hip arthroplasty and $7.42 billion for total knee arthroplasty. When combined, the two procedures represent the largest procedures cost in the Medicare budget. At the same time, inpatient admissions for PCI and other vascular conditions have been declining, according to Medicare officials, as more of those services are being shifted to hospital outpatient departments.
The fiscal 2014 payment proposal also includes a revised methodology for calculating hospital readmission rates in an effort to do a better job of accounting for certain planned readmissions.
The change is a mixed bag for hospitals, according to the Premier healthcare alliance. While the revised methodology will likely result in a more accurate payment calculation, it fails to take into consideration socioeconomic and community factors.
"Hospitals that serve high percentages of lower-income patients will be disproportionately penalized for circumstances outside their control," Blair Childs, senior vice president of public affairs at Premier, said in a statement. "This places additional financial burdens on already stressed local health care systems in these communities."
The Medicare program is also moving forward with the Hospital-Acquired Condition Reduction Program, also created by the ACA.
The new program, which begins on Oct. 1, 2014, levies a 1% penalty on hospitals that rank in the lowest-performing quartile for eight hospital-acquired conditions. The proposed rule includes the quality measures, scoring methodology, and correction process that are planned for the program.
During the first year, officials plan to use quality measures that are calculated using claims data or are part of the Inpatient Quality Reporting program. The eight measures are divided into two domains. Hospitals will receive a score for each measure, which will then be used to calculate a domain score. The two domains will be weighted equally to get a total score under the program, according to CMS.
The measures in the first domain are pressure ulcer rate; volume of foreign object left in the body; iatrogenic pneumothorax rate; postoperative physiologic and metabolic derangement rate; postoperative pulmonary embolism or deep vein thrombosis rate; and accidental puncture and laceration rate. CMS is also considering the use of a composite patient safety indicator measure set as an alternative to the first domain.
The second domain includes two health care–associated infection measures: central line–associated bloodstream infection and catheter-associated urinary tract infection.
CMS plans to account for risk factors such as age, gender, and comorbidities when calculating the measure rates.
There are no surprises in the conditions chosen for the new program, said Erik Johnson, senior vice president at Avalere Health. However, the fact that CMS officials chose to include eight measures at the start of the program indicates how serious they are about hospital-acquired conditions, he said.
Mr. Johnson predicted that hospitals will take these quality programs seriously as well. Through the combination of the hospital-acquired condition program, the readmission reduction program, value-based purchasing, and a few other programs, hospitals now have at least 7% of their Medicare payments at risk based on performance on quality measures, he said.
"It’s already starting to move behaviors," Mr. Johnson said. "Hospitals are by and large making a good-faith effort to get better at all of those things. But there are going to be winners and losers, and the losers may end up losing big on a lot of this stuff."
The agency is scheduled to release its final rule by Aug. 1.
The penalties are going up in Medicare’s hospital readmission reduction program. Starting on Oct. 1, hospitals could face up to a 2% cut in Medicare payments if their 30-day readmission rates for acute myocardial infarction, heart failure, and pneumonia are too high. The program started on Oct. 1, 2012, with a 1% cap on penalties.
The penalty increase was outlined in Medicare’s proposed fiscal year 2014 inpatient prospective payment system rule released April 26.
The proposal also outlines the government’s plans to expand the readmission reduction program to include two new readmission measures. Starting on Oct. 1, 2014, the program would also include readmissions associated with an acute exacerbation of chronic obstructive pulmonary disease, as well as readmissions for elective total hip or knee arthroplasty.
The inclusion of COPD for fiscal year 2015 was expected since that condition was specifically highlighted by Congress in the Affordable Care Act (ACA), which created the readmission reduction program. However, lawmakers had also recommended adding coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI), and other vascular conditions, which are not included in the Centers for Medicare and Medicaid Services (CMS) proposal.
The reasons for the switch were largely due to cost and volume, according to the proposal rule.
In 2005, annual hospital charges totaled $3.95 billion for primary total hip arthroplasty and $7.42 billion for total knee arthroplasty. When combined, the two procedures represent the largest procedures cost in the Medicare budget. At the same time, inpatient admissions for PCI and other vascular conditions have been declining, according to Medicare officials, as more of those services are being shifted to hospital outpatient departments.
The fiscal 2014 payment proposal also includes a revised methodology for calculating hospital readmission rates in an effort to do a better job of accounting for certain planned readmissions.
The change is a mixed bag for hospitals, according to the Premier healthcare alliance. While the revised methodology will likely result in a more accurate payment calculation, it fails to take into consideration socioeconomic and community factors.
"Hospitals that serve high percentages of lower-income patients will be disproportionately penalized for circumstances outside their control," Blair Childs, senior vice president of public affairs at Premier, said in a statement. "This places additional financial burdens on already stressed local health care systems in these communities."
The Medicare program is also moving forward with the Hospital-Acquired Condition Reduction Program, also created by the ACA.
The new program, which begins on Oct. 1, 2014, levies a 1% penalty on hospitals that rank in the lowest-performing quartile for eight hospital-acquired conditions. The proposed rule includes the quality measures, scoring methodology, and correction process that are planned for the program.
During the first year, officials plan to use quality measures that are calculated using claims data or are part of the Inpatient Quality Reporting program. The eight measures are divided into two domains. Hospitals will receive a score for each measure, which will then be used to calculate a domain score. The two domains will be weighted equally to get a total score under the program, according to CMS.
The measures in the first domain are pressure ulcer rate; volume of foreign object left in the body; iatrogenic pneumothorax rate; postoperative physiologic and metabolic derangement rate; postoperative pulmonary embolism or deep vein thrombosis rate; and accidental puncture and laceration rate. CMS is also considering the use of a composite patient safety indicator measure set as an alternative to the first domain.
The second domain includes two health care–associated infection measures: central line–associated bloodstream infection and catheter-associated urinary tract infection.
CMS plans to account for risk factors such as age, gender, and comorbidities when calculating the measure rates.
There are no surprises in the conditions chosen for the new program, said Erik Johnson, senior vice president at Avalere Health. However, the fact that CMS officials chose to include eight measures at the start of the program indicates how serious they are about hospital-acquired conditions, he said.
Mr. Johnson predicted that hospitals will take these quality programs seriously as well. Through the combination of the hospital-acquired condition program, the readmission reduction program, value-based purchasing, and a few other programs, hospitals now have at least 7% of their Medicare payments at risk based on performance on quality measures, he said.
"It’s already starting to move behaviors," Mr. Johnson said. "Hospitals are by and large making a good-faith effort to get better at all of those things. But there are going to be winners and losers, and the losers may end up losing big on a lot of this stuff."
The agency is scheduled to release its final rule by Aug. 1.
FDA approves Plan B One-Step OTC for all ages
The Food and Drug Administration approved the emergency contraceptive Plan B One-Step for over-the-counter sale for women and girls of all ages, ending years of litigation over the drug’s status.
On June 20, the FDA complied with an order from the U.S. District Court in New York and approved the one-pill levonorgestrel product with no point-of-sale restrictions. The drug was originally approved without a prescription for women aged 17 and older in 2009. Earlier this year, the agency granted nonprescription sale for women aged 15 and older. This latest approval will make the drug available to all women of childbearing age.
While reproductive rights advocates praised the Obama administration’s decision not to continue fighting greater access to emergency contraception in the courts, they urged the FDA to approve lower-cost generic options for over-the-counter sale.
On Twitter @MaryEllenNY
The Food and Drug Administration approved the emergency contraceptive Plan B One-Step for over-the-counter sale for women and girls of all ages, ending years of litigation over the drug’s status.
On June 20, the FDA complied with an order from the U.S. District Court in New York and approved the one-pill levonorgestrel product with no point-of-sale restrictions. The drug was originally approved without a prescription for women aged 17 and older in 2009. Earlier this year, the agency granted nonprescription sale for women aged 15 and older. This latest approval will make the drug available to all women of childbearing age.
While reproductive rights advocates praised the Obama administration’s decision not to continue fighting greater access to emergency contraception in the courts, they urged the FDA to approve lower-cost generic options for over-the-counter sale.
On Twitter @MaryEllenNY
The Food and Drug Administration approved the emergency contraceptive Plan B One-Step for over-the-counter sale for women and girls of all ages, ending years of litigation over the drug’s status.
On June 20, the FDA complied with an order from the U.S. District Court in New York and approved the one-pill levonorgestrel product with no point-of-sale restrictions. The drug was originally approved without a prescription for women aged 17 and older in 2009. Earlier this year, the agency granted nonprescription sale for women aged 15 and older. This latest approval will make the drug available to all women of childbearing age.
While reproductive rights advocates praised the Obama administration’s decision not to continue fighting greater access to emergency contraception in the courts, they urged the FDA to approve lower-cost generic options for over-the-counter sale.
On Twitter @MaryEllenNY
NHLBI gets out of the guideline business
The National Heart, Lung, and Blood Institute won’t be issuing stand-alone cardiovascular clinical guidelines anymore.
Officials at NHLBI, part of the National Institutes of Health, announced June 19 that they would instead focus on putting out the systematic evidence reviews that other organizations rely on when formulating their clinical guidelines. And in some cases, they will team up with those organizations to issue guidelines.
The switch, which puts NHLBI in line with the rest of NIH, is not expected to delay the release of two highly anticipated clinical guidelines: JNC-8 and ATP-4, according to institute officials. They said those guidelines will be completed in collaboration with other groups and that they should be published within a matter of months. NHLBI will also release evidence reviews on these topics.
The NHLBI decision to move away from issuing its own stand-alone guidelines was due in large part to the changing landscape for guideline development.
In an article published in both Circulation and the Journal of the American College of Cardiology, NHLBI leaders said the number of available guidelines has "exploded," and that guideline developers are now faced with a series of questions about how to ensure that the many guidelines aren’t contradictory and which groups are best to lead guidelines development (Circulation 2019 June 19 [doi: 10.1161/circulationaha.113.004587]).
As a result, NHLBI will focus primarily on convening expert panels to generate systematic evidence reviews and working with partner organizations with frontline clinical experience.
"In this new collaborative partnership model, we want to engage professional societies that are directly involved in frontline clinical practice because they are capable and well suited to drive the effort of guideline development and implementation into evidenced-based clinical practice that enhances the public health," said Dr. Gary H. Gibbons, NHLBI director.
NHLBI plans to follow the best practice standards outlined by the Institute of Medicine in 2011 for generating systematic evidence reviews.
Dr. Doug Campos Outcalt, clinical sciences analyst for the American Academy of Family Physicians, said that if NHLBI is able to produce evidence reviews that meet the criteria for quality set out by the Institute of Medicine, it will be a valuable contribution. However, he emphasized the importance of coordinating with the Agency for Healthcare Research and Quality to avoid duplication of evidence reports and make information available on a wider variety of topics.
The move was praised by the American College of Cardiology. Dr. Pamela Douglas, ACC past president and professor of cardiology at Duke University, Durham, N.C., said that guideline development has grown more different for all organizations involved as the amount of evidence increased and the process has become a science all its own. With the NIH focus on evidence review and the guideline process falling mainly to clinical groups like the ACC, it lets each set of organizations "play to their strengths and it creates a more rigorous evidence synthesis," Dr. Douglas said.
On Twitter @MaryEllenNY
The National Heart, Lung, and Blood Institute won’t be issuing stand-alone cardiovascular clinical guidelines anymore.
Officials at NHLBI, part of the National Institutes of Health, announced June 19 that they would instead focus on putting out the systematic evidence reviews that other organizations rely on when formulating their clinical guidelines. And in some cases, they will team up with those organizations to issue guidelines.
The switch, which puts NHLBI in line with the rest of NIH, is not expected to delay the release of two highly anticipated clinical guidelines: JNC-8 and ATP-4, according to institute officials. They said those guidelines will be completed in collaboration with other groups and that they should be published within a matter of months. NHLBI will also release evidence reviews on these topics.
The NHLBI decision to move away from issuing its own stand-alone guidelines was due in large part to the changing landscape for guideline development.
In an article published in both Circulation and the Journal of the American College of Cardiology, NHLBI leaders said the number of available guidelines has "exploded," and that guideline developers are now faced with a series of questions about how to ensure that the many guidelines aren’t contradictory and which groups are best to lead guidelines development (Circulation 2019 June 19 [doi: 10.1161/circulationaha.113.004587]).
As a result, NHLBI will focus primarily on convening expert panels to generate systematic evidence reviews and working with partner organizations with frontline clinical experience.
"In this new collaborative partnership model, we want to engage professional societies that are directly involved in frontline clinical practice because they are capable and well suited to drive the effort of guideline development and implementation into evidenced-based clinical practice that enhances the public health," said Dr. Gary H. Gibbons, NHLBI director.
NHLBI plans to follow the best practice standards outlined by the Institute of Medicine in 2011 for generating systematic evidence reviews.
Dr. Doug Campos Outcalt, clinical sciences analyst for the American Academy of Family Physicians, said that if NHLBI is able to produce evidence reviews that meet the criteria for quality set out by the Institute of Medicine, it will be a valuable contribution. However, he emphasized the importance of coordinating with the Agency for Healthcare Research and Quality to avoid duplication of evidence reports and make information available on a wider variety of topics.
The move was praised by the American College of Cardiology. Dr. Pamela Douglas, ACC past president and professor of cardiology at Duke University, Durham, N.C., said that guideline development has grown more different for all organizations involved as the amount of evidence increased and the process has become a science all its own. With the NIH focus on evidence review and the guideline process falling mainly to clinical groups like the ACC, it lets each set of organizations "play to their strengths and it creates a more rigorous evidence synthesis," Dr. Douglas said.
On Twitter @MaryEllenNY
The National Heart, Lung, and Blood Institute won’t be issuing stand-alone cardiovascular clinical guidelines anymore.
Officials at NHLBI, part of the National Institutes of Health, announced June 19 that they would instead focus on putting out the systematic evidence reviews that other organizations rely on when formulating their clinical guidelines. And in some cases, they will team up with those organizations to issue guidelines.
The switch, which puts NHLBI in line with the rest of NIH, is not expected to delay the release of two highly anticipated clinical guidelines: JNC-8 and ATP-4, according to institute officials. They said those guidelines will be completed in collaboration with other groups and that they should be published within a matter of months. NHLBI will also release evidence reviews on these topics.
The NHLBI decision to move away from issuing its own stand-alone guidelines was due in large part to the changing landscape for guideline development.
In an article published in both Circulation and the Journal of the American College of Cardiology, NHLBI leaders said the number of available guidelines has "exploded," and that guideline developers are now faced with a series of questions about how to ensure that the many guidelines aren’t contradictory and which groups are best to lead guidelines development (Circulation 2019 June 19 [doi: 10.1161/circulationaha.113.004587]).
As a result, NHLBI will focus primarily on convening expert panels to generate systematic evidence reviews and working with partner organizations with frontline clinical experience.
"In this new collaborative partnership model, we want to engage professional societies that are directly involved in frontline clinical practice because they are capable and well suited to drive the effort of guideline development and implementation into evidenced-based clinical practice that enhances the public health," said Dr. Gary H. Gibbons, NHLBI director.
NHLBI plans to follow the best practice standards outlined by the Institute of Medicine in 2011 for generating systematic evidence reviews.
Dr. Doug Campos Outcalt, clinical sciences analyst for the American Academy of Family Physicians, said that if NHLBI is able to produce evidence reviews that meet the criteria for quality set out by the Institute of Medicine, it will be a valuable contribution. However, he emphasized the importance of coordinating with the Agency for Healthcare Research and Quality to avoid duplication of evidence reports and make information available on a wider variety of topics.
The move was praised by the American College of Cardiology. Dr. Pamela Douglas, ACC past president and professor of cardiology at Duke University, Durham, N.C., said that guideline development has grown more different for all organizations involved as the amount of evidence increased and the process has become a science all its own. With the NIH focus on evidence review and the guideline process falling mainly to clinical groups like the ACC, it lets each set of organizations "play to their strengths and it creates a more rigorous evidence synthesis," Dr. Douglas said.
On Twitter @MaryEllenNY
ACOG to lawmakers: Stop meddling
Ob.gyn. leaders from across the country have issued a strongly worded policy statement telling lawmakers to stop interfering in the physician-patient relationship and calling on doctors to speak out against legislative overreaching.
On June 7, the executive board of the American College of Obstetricians and Gynecologists and the American Congress of Obstetricians and Gynecologists said that laws that require physicians to give or withhold specific information when counseling patients or that mandates the tests, procedures, and treatments that physicians can offer are "ill advised."
"Absent a substantial public health justification, government should not interfere with individual patient-physician encounters," the executive board wrote.
ACOG offered some examples in which they said state legislators have intruded into medical practice with laws that:
• Require medically unnecessary ultrasounds before an abortion and force a patient to view the ultrasound image.
• Prohibit physicians from speaking to patients about firearms and gun safety.
• Mandate an outdated treatment protocol for medical abortion.
• Prescribe what must be communicated to patients about breast density and cancer risk.
While many of the laws in questions affect women’s health, this is an issue that affects all patients and all physicians, said Dr. Jeanne A. Conry, president of the American Congress of Obstetricians and Gynecologists.
For instance, in Pennsylvania, physicians are restricted in what they can tell patients about their chemical exposure from the natural gas extraction practice called fracking. Under the law, physicians can access information about the proprietary chemicals used, but are barred from sharing the information with patients. "Help me understand that one," Dr. Conry said.
The trend toward greater legislating of medical practice has resulted in "disbelief and frustration" among physicians, Dr. Conry said. "It’s an insult to the intelligence of our patients, and it’s an insult to the intelligence of the provider."
The ACOG statement isn’t the first time that organized medicine has rebelled against these types of laws. In October 2012, leaders at ACOG, the American College of Physicians, the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Surgeons wrote a joint editorial opposing the intrusion of lawmakers into medical encounters (N. Engl. J. Med. 2012;367:1157-9).
But since that editorial was published, little has changed. It actually seems to be getting worse, Dr. Conry said.
So ACOG is also issuing a call to action to its members. Dr. Conry said ob.gyns. need to talk to lawmakers and patients to reverse this trend.
"Physicians have to view themselves as the leaders that they are," she said. "I think we use the ostrich approach. We put our heads in the sand all too often."
On Twitter @MaryEllenNY
Ob.gyn. leaders from across the country have issued a strongly worded policy statement telling lawmakers to stop interfering in the physician-patient relationship and calling on doctors to speak out against legislative overreaching.
On June 7, the executive board of the American College of Obstetricians and Gynecologists and the American Congress of Obstetricians and Gynecologists said that laws that require physicians to give or withhold specific information when counseling patients or that mandates the tests, procedures, and treatments that physicians can offer are "ill advised."
"Absent a substantial public health justification, government should not interfere with individual patient-physician encounters," the executive board wrote.
ACOG offered some examples in which they said state legislators have intruded into medical practice with laws that:
• Require medically unnecessary ultrasounds before an abortion and force a patient to view the ultrasound image.
• Prohibit physicians from speaking to patients about firearms and gun safety.
• Mandate an outdated treatment protocol for medical abortion.
• Prescribe what must be communicated to patients about breast density and cancer risk.
While many of the laws in questions affect women’s health, this is an issue that affects all patients and all physicians, said Dr. Jeanne A. Conry, president of the American Congress of Obstetricians and Gynecologists.
For instance, in Pennsylvania, physicians are restricted in what they can tell patients about their chemical exposure from the natural gas extraction practice called fracking. Under the law, physicians can access information about the proprietary chemicals used, but are barred from sharing the information with patients. "Help me understand that one," Dr. Conry said.
The trend toward greater legislating of medical practice has resulted in "disbelief and frustration" among physicians, Dr. Conry said. "It’s an insult to the intelligence of our patients, and it’s an insult to the intelligence of the provider."
The ACOG statement isn’t the first time that organized medicine has rebelled against these types of laws. In October 2012, leaders at ACOG, the American College of Physicians, the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Surgeons wrote a joint editorial opposing the intrusion of lawmakers into medical encounters (N. Engl. J. Med. 2012;367:1157-9).
But since that editorial was published, little has changed. It actually seems to be getting worse, Dr. Conry said.
So ACOG is also issuing a call to action to its members. Dr. Conry said ob.gyns. need to talk to lawmakers and patients to reverse this trend.
"Physicians have to view themselves as the leaders that they are," she said. "I think we use the ostrich approach. We put our heads in the sand all too often."
On Twitter @MaryEllenNY
Ob.gyn. leaders from across the country have issued a strongly worded policy statement telling lawmakers to stop interfering in the physician-patient relationship and calling on doctors to speak out against legislative overreaching.
On June 7, the executive board of the American College of Obstetricians and Gynecologists and the American Congress of Obstetricians and Gynecologists said that laws that require physicians to give or withhold specific information when counseling patients or that mandates the tests, procedures, and treatments that physicians can offer are "ill advised."
"Absent a substantial public health justification, government should not interfere with individual patient-physician encounters," the executive board wrote.
ACOG offered some examples in which they said state legislators have intruded into medical practice with laws that:
• Require medically unnecessary ultrasounds before an abortion and force a patient to view the ultrasound image.
• Prohibit physicians from speaking to patients about firearms and gun safety.
• Mandate an outdated treatment protocol for medical abortion.
• Prescribe what must be communicated to patients about breast density and cancer risk.
While many of the laws in questions affect women’s health, this is an issue that affects all patients and all physicians, said Dr. Jeanne A. Conry, president of the American Congress of Obstetricians and Gynecologists.
For instance, in Pennsylvania, physicians are restricted in what they can tell patients about their chemical exposure from the natural gas extraction practice called fracking. Under the law, physicians can access information about the proprietary chemicals used, but are barred from sharing the information with patients. "Help me understand that one," Dr. Conry said.
The trend toward greater legislating of medical practice has resulted in "disbelief and frustration" among physicians, Dr. Conry said. "It’s an insult to the intelligence of our patients, and it’s an insult to the intelligence of the provider."
The ACOG statement isn’t the first time that organized medicine has rebelled against these types of laws. In October 2012, leaders at ACOG, the American College of Physicians, the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Surgeons wrote a joint editorial opposing the intrusion of lawmakers into medical encounters (N. Engl. J. Med. 2012;367:1157-9).
But since that editorial was published, little has changed. It actually seems to be getting worse, Dr. Conry said.
So ACOG is also issuing a call to action to its members. Dr. Conry said ob.gyns. need to talk to lawmakers and patients to reverse this trend.
"Physicians have to view themselves as the leaders that they are," she said. "I think we use the ostrich approach. We put our heads in the sand all too often."
On Twitter @MaryEllenNY
Supreme Court allows FTC to challenge 'pay for delay' settlements
The Federal Trade Commission has the right to challenge so-called "pay-for-delay" agreements that allow brand-name drug companies to pay their generic competitors to keep products off the market, the Supreme Court ruled June 17.
The high court declared that the FTC could move forward with its antitrust lawsuit against Actavis, Solvay Pharmaceuticals, and others for participating in a legal settlement that delayed the introduction of generic products competing with AndroGel (testosterone gel) 1.62%.
In the case of AndroGel, three generic companies were seeking to invalidate the patent held by Solvay Pharmaceuticals, which in turn sued the generic manufacturers. The companies all settled their cases and reached similar agreements. For instance, Actavis agreed not to bring its generic product to market until August 2015, 65 months before Solvay’s patent expired. The generic drugmaker also agreed to promote AndroGel to physicians. In exchange, Solvay agreed to pay the company between $19 million and $30 million annually for 9 years. The companies said the payments were for a variety of services but the FTC disputes that, saying the real aim was to keep the generic products off the market.
In the 5-3 ruling, the justices held that these "reverse payment settlements" in which the generic company being sued for patent infringement receives the payments, can "sometimes violate the antitrust laws" and allowed the FTC to pursue its case (Federal Trade Commission v. Actavis, Inc., et al.). This overturns a lower court ruling that there was no antitrust violation because the agreement didn’t keep the generic off the market for longer than the length of the brand name drug’s original patent exclusivity period.
The court stopped short of the FTC’s request to declare that all reverse payment settlements are "presumptively unlawful." The courts will have to decide on a case-by-case basis whether the agreement violates antitrust laws, according to the ruling.
The FTC called the decision a victory for consumers that could lead to greater competition and lower drug prices.
"The court has made it clear that pay-for-delay agreements between brand and generic drug companies are subject to antitrust scrutiny, and it has rejected the attempt by branded and generic companies to effectively immunize these agreements from the antitrust laws," Edith Ramirez, the FTC chairwoman, said in a statement. "With this finding, the court has taken a big step toward addressing a problem that has cost Americans $3.5 billion a year in higher drug prices."
The agency plans to move ahead with the Actavis litigation.
Officials at Actavis praised the high court’s decision not to declare reverse payment settlements presumptively unlawful, but said the ruling will place additional and unnecessary administrative burdens on the drug industry.
"Patent settlements have saved and continue to save consumers billions of dollars, and ensure more timely introduction of generic competition," Paul Bisaro, president and CEO of Actavis, said in a statement. "We plan to continue to defend the propriety of such settlements against any further legislative or judicial challenges."
The Federal Trade Commission has the right to challenge so-called "pay-for-delay" agreements that allow brand-name drug companies to pay their generic competitors to keep products off the market, the Supreme Court ruled June 17.
The high court declared that the FTC could move forward with its antitrust lawsuit against Actavis, Solvay Pharmaceuticals, and others for participating in a legal settlement that delayed the introduction of generic products competing with AndroGel (testosterone gel) 1.62%.
In the case of AndroGel, three generic companies were seeking to invalidate the patent held by Solvay Pharmaceuticals, which in turn sued the generic manufacturers. The companies all settled their cases and reached similar agreements. For instance, Actavis agreed not to bring its generic product to market until August 2015, 65 months before Solvay’s patent expired. The generic drugmaker also agreed to promote AndroGel to physicians. In exchange, Solvay agreed to pay the company between $19 million and $30 million annually for 9 years. The companies said the payments were for a variety of services but the FTC disputes that, saying the real aim was to keep the generic products off the market.
In the 5-3 ruling, the justices held that these "reverse payment settlements" in which the generic company being sued for patent infringement receives the payments, can "sometimes violate the antitrust laws" and allowed the FTC to pursue its case (Federal Trade Commission v. Actavis, Inc., et al.). This overturns a lower court ruling that there was no antitrust violation because the agreement didn’t keep the generic off the market for longer than the length of the brand name drug’s original patent exclusivity period.
The court stopped short of the FTC’s request to declare that all reverse payment settlements are "presumptively unlawful." The courts will have to decide on a case-by-case basis whether the agreement violates antitrust laws, according to the ruling.
The FTC called the decision a victory for consumers that could lead to greater competition and lower drug prices.
"The court has made it clear that pay-for-delay agreements between brand and generic drug companies are subject to antitrust scrutiny, and it has rejected the attempt by branded and generic companies to effectively immunize these agreements from the antitrust laws," Edith Ramirez, the FTC chairwoman, said in a statement. "With this finding, the court has taken a big step toward addressing a problem that has cost Americans $3.5 billion a year in higher drug prices."
The agency plans to move ahead with the Actavis litigation.
Officials at Actavis praised the high court’s decision not to declare reverse payment settlements presumptively unlawful, but said the ruling will place additional and unnecessary administrative burdens on the drug industry.
"Patent settlements have saved and continue to save consumers billions of dollars, and ensure more timely introduction of generic competition," Paul Bisaro, president and CEO of Actavis, said in a statement. "We plan to continue to defend the propriety of such settlements against any further legislative or judicial challenges."
The Federal Trade Commission has the right to challenge so-called "pay-for-delay" agreements that allow brand-name drug companies to pay their generic competitors to keep products off the market, the Supreme Court ruled June 17.
The high court declared that the FTC could move forward with its antitrust lawsuit against Actavis, Solvay Pharmaceuticals, and others for participating in a legal settlement that delayed the introduction of generic products competing with AndroGel (testosterone gel) 1.62%.
In the case of AndroGel, three generic companies were seeking to invalidate the patent held by Solvay Pharmaceuticals, which in turn sued the generic manufacturers. The companies all settled their cases and reached similar agreements. For instance, Actavis agreed not to bring its generic product to market until August 2015, 65 months before Solvay’s patent expired. The generic drugmaker also agreed to promote AndroGel to physicians. In exchange, Solvay agreed to pay the company between $19 million and $30 million annually for 9 years. The companies said the payments were for a variety of services but the FTC disputes that, saying the real aim was to keep the generic products off the market.
In the 5-3 ruling, the justices held that these "reverse payment settlements" in which the generic company being sued for patent infringement receives the payments, can "sometimes violate the antitrust laws" and allowed the FTC to pursue its case (Federal Trade Commission v. Actavis, Inc., et al.). This overturns a lower court ruling that there was no antitrust violation because the agreement didn’t keep the generic off the market for longer than the length of the brand name drug’s original patent exclusivity period.
The court stopped short of the FTC’s request to declare that all reverse payment settlements are "presumptively unlawful." The courts will have to decide on a case-by-case basis whether the agreement violates antitrust laws, according to the ruling.
The FTC called the decision a victory for consumers that could lead to greater competition and lower drug prices.
"The court has made it clear that pay-for-delay agreements between brand and generic drug companies are subject to antitrust scrutiny, and it has rejected the attempt by branded and generic companies to effectively immunize these agreements from the antitrust laws," Edith Ramirez, the FTC chairwoman, said in a statement. "With this finding, the court has taken a big step toward addressing a problem that has cost Americans $3.5 billion a year in higher drug prices."
The agency plans to move ahead with the Actavis litigation.
Officials at Actavis praised the high court’s decision not to declare reverse payment settlements presumptively unlawful, but said the ruling will place additional and unnecessary administrative burdens on the drug industry.
"Patent settlements have saved and continue to save consumers billions of dollars, and ensure more timely introduction of generic competition," Paul Bisaro, president and CEO of Actavis, said in a statement. "We plan to continue to defend the propriety of such settlements against any further legislative or judicial challenges."
Fighting to end malnutrition in the hospital
Dr. Melissa Parkhurst, a hospitalist at the University of Kansas Hospital in Kansas City, is on a mission. She wants to get hospitalists around the country to pay more attention to patient malnutrition and to begin taking a systematic approach to recognizing and treating it.
An estimated one in three patients enters the hospital malnourished, and some only get worse during their inpatient stay, according to the Alliance to Advance Patient Nutrition. "Hospital malnutrition is a serious yet underappreciated problem," Dr. Parkhurst said. "It can delay recovery and increase a patient’s length of stay."
Dr. Parkhurst, who has been the medical director for the multidisciplinary Nutrition Support Service at the University of Kansas Hospital since 2002, is also part of a new organization focused on addressing nutrition and malnutrition in the hospital setting. She serves as the Society of Hospital Medicine’s representative to the Alliance to Advance Patient Nutrition. The organization, which formed in May, has released an online toolkit for health care providers. The Alliance is also introducing a nutrition care model designed to foster greater collaboration among clinicians and drive early nutrition screening, intervention, and discharge processes in hospitals.
In an interview with Hospitalist News, Dr. Parkhurst explained the hospitalist’s role in curbing patient malnutrition.
Question: Who is at risk? Should all patients be screened?
Dr. Parkhurst: In 1996, the Joint Commission required hospitals to have a program in place to provide nutrition screening within 24 hours of patient admissions. But they didn’t dictate how to perform the screen.
The screening can’t be simply a visual assessment of the patient. That’s not adequate. There are several simple, validated screening tools that health care providers can use. The Malnutrition Screening Tool, or MST, for example, is made up of just two simple questions that any health care provider can ask: Have you lost weight recently without trying? Have you been eating poorly because of a decreased appetite?
Obviously, many patients with both acute and chronic illnesses could screen positive, and then we need to perform a full assessment. But in particular, geriatric patients are often nutritionally fragile.
Question: What is the hospitalist’s role in this process?
Dr. Parkhurst: Hospitalists should always be aware of the nutritional status of their patient. They should know basic screening questions that they can incorporate into their history taking. They also need to know where to find the nutrition screening and assessments that are done on their patients in the hospital.
It is good to get to know the hospital’s dietitians and make them aware that you are reviewing their recommendations and that you would like their professional input on your patient. There’s also data gathering involved, such as calorie and protein count, keeping track of whether or not your patient is actually consuming the food and supplements that you ordered, and knowing if they are tolerating the tube feed that you ordered. Finally, hospitalists should be incorporating nutrition into daily rounds and notes and in conversations with patients and their families.
Question: You’re part of the Nutrition Support Service at your hospital. How does it work?
Dr. Parkhurst: Nutrition support teams can look very different from hospital to hospital. The main focus for our nutrition team at the University of Kansas is to provide safe and high-quality nutrition care to our parenteral nutrition patients. We also have a large presence in our intensive care units and take on the care of patients who have complex transitions from parenteral to enteral nutrition care.
Nutrition support teams are best when they are multidisciplinary. Our team has registered dietitians, myself as medical director, pharmacists, and a nurse. We have developed everything from parenteral nutrition hyperglycemia management protocols to proper flushing and declogging of feeding tubes to the placement of small bowel feeding tubes. These are system and quality improvement projects that we’ve been able to work on over the years because we are multidisciplinary. I personally oversee the daily parenteral nutrition care of the patients on the adult side, but our group gets together for patient care rounds and discussions twice a week.
Question: Should every hospital have a multidisciplinary nutrition support team?
Dr. Parkhurst:Our hospital works well with a nutrition support team because we have a very complex patient population. Multidisciplinary nutrition support teams like ours often exist at the larger academic centers. What’s most important for hospitals overall is to have multidisciplinary champions. It doesn’t necessarily need to be a formal team, but instead a champion physician, champion nurse, and champion dietitian to work together.
Often the dietitians at the hospital will know where the patient needs are, but what they need most are partners and a voice to the rest of the hospital. For example, at the University of Kansas Hospital, one of the important steps we took as a team was to get ordering privileges for our registered dietitians. This way they could order calorie counts, supplements, and multivitamins and move along the plan of care instead of leaving notes and waiting for orders to be implemented.
Question: What can be done to better treat patient malnutrition in the hospital?
Dr. Parkhurst: The Alliance to Advance Patient Nutrition is at its core a call to action. We’re trying to get the attention of physicians, dietitians, nurses, pharmacists, and hospital administrators. What we’re advocating for are more systemized nutrition care practices and more interdisciplinary collaboration.
There are three basic things that need to happen in order to drive real change in a hospital setting:
First, we need to make sure that all of our patients are getting screened for risk when they are admitted using a simple, validated screening tool.
Second, there needs to be a system in place so that when there’s a positive screen it prompts a timely, full nutrition assessment by a dietitian. And then that information and recommendations need to be effectively communicated back to the patient’s health care team so that there can be immediate interventions as indicated. Ongoing monitoring also needs to be part of that systemized approach.
Third, we need to integrate the nutrition care plan into the discharge plan. We need to ensure that the goals and improvements we make in the hospital don’t get lost in the transition of care.
Take us to your leader. Nominate a hospitalist whose work inspires you. E-mail suggestions to [email protected].
Dr. Melissa Parkhurst, a hospitalist at the University of Kansas Hospital in Kansas City, is on a mission. She wants to get hospitalists around the country to pay more attention to patient malnutrition and to begin taking a systematic approach to recognizing and treating it.
An estimated one in three patients enters the hospital malnourished, and some only get worse during their inpatient stay, according to the Alliance to Advance Patient Nutrition. "Hospital malnutrition is a serious yet underappreciated problem," Dr. Parkhurst said. "It can delay recovery and increase a patient’s length of stay."
Dr. Parkhurst, who has been the medical director for the multidisciplinary Nutrition Support Service at the University of Kansas Hospital since 2002, is also part of a new organization focused on addressing nutrition and malnutrition in the hospital setting. She serves as the Society of Hospital Medicine’s representative to the Alliance to Advance Patient Nutrition. The organization, which formed in May, has released an online toolkit for health care providers. The Alliance is also introducing a nutrition care model designed to foster greater collaboration among clinicians and drive early nutrition screening, intervention, and discharge processes in hospitals.
In an interview with Hospitalist News, Dr. Parkhurst explained the hospitalist’s role in curbing patient malnutrition.
Question: Who is at risk? Should all patients be screened?
Dr. Parkhurst: In 1996, the Joint Commission required hospitals to have a program in place to provide nutrition screening within 24 hours of patient admissions. But they didn’t dictate how to perform the screen.
The screening can’t be simply a visual assessment of the patient. That’s not adequate. There are several simple, validated screening tools that health care providers can use. The Malnutrition Screening Tool, or MST, for example, is made up of just two simple questions that any health care provider can ask: Have you lost weight recently without trying? Have you been eating poorly because of a decreased appetite?
Obviously, many patients with both acute and chronic illnesses could screen positive, and then we need to perform a full assessment. But in particular, geriatric patients are often nutritionally fragile.
Question: What is the hospitalist’s role in this process?
Dr. Parkhurst: Hospitalists should always be aware of the nutritional status of their patient. They should know basic screening questions that they can incorporate into their history taking. They also need to know where to find the nutrition screening and assessments that are done on their patients in the hospital.
It is good to get to know the hospital’s dietitians and make them aware that you are reviewing their recommendations and that you would like their professional input on your patient. There’s also data gathering involved, such as calorie and protein count, keeping track of whether or not your patient is actually consuming the food and supplements that you ordered, and knowing if they are tolerating the tube feed that you ordered. Finally, hospitalists should be incorporating nutrition into daily rounds and notes and in conversations with patients and their families.
Question: You’re part of the Nutrition Support Service at your hospital. How does it work?
Dr. Parkhurst: Nutrition support teams can look very different from hospital to hospital. The main focus for our nutrition team at the University of Kansas is to provide safe and high-quality nutrition care to our parenteral nutrition patients. We also have a large presence in our intensive care units and take on the care of patients who have complex transitions from parenteral to enteral nutrition care.
Nutrition support teams are best when they are multidisciplinary. Our team has registered dietitians, myself as medical director, pharmacists, and a nurse. We have developed everything from parenteral nutrition hyperglycemia management protocols to proper flushing and declogging of feeding tubes to the placement of small bowel feeding tubes. These are system and quality improvement projects that we’ve been able to work on over the years because we are multidisciplinary. I personally oversee the daily parenteral nutrition care of the patients on the adult side, but our group gets together for patient care rounds and discussions twice a week.
Question: Should every hospital have a multidisciplinary nutrition support team?
Dr. Parkhurst:Our hospital works well with a nutrition support team because we have a very complex patient population. Multidisciplinary nutrition support teams like ours often exist at the larger academic centers. What’s most important for hospitals overall is to have multidisciplinary champions. It doesn’t necessarily need to be a formal team, but instead a champion physician, champion nurse, and champion dietitian to work together.
Often the dietitians at the hospital will know where the patient needs are, but what they need most are partners and a voice to the rest of the hospital. For example, at the University of Kansas Hospital, one of the important steps we took as a team was to get ordering privileges for our registered dietitians. This way they could order calorie counts, supplements, and multivitamins and move along the plan of care instead of leaving notes and waiting for orders to be implemented.
Question: What can be done to better treat patient malnutrition in the hospital?
Dr. Parkhurst: The Alliance to Advance Patient Nutrition is at its core a call to action. We’re trying to get the attention of physicians, dietitians, nurses, pharmacists, and hospital administrators. What we’re advocating for are more systemized nutrition care practices and more interdisciplinary collaboration.
There are three basic things that need to happen in order to drive real change in a hospital setting:
First, we need to make sure that all of our patients are getting screened for risk when they are admitted using a simple, validated screening tool.
Second, there needs to be a system in place so that when there’s a positive screen it prompts a timely, full nutrition assessment by a dietitian. And then that information and recommendations need to be effectively communicated back to the patient’s health care team so that there can be immediate interventions as indicated. Ongoing monitoring also needs to be part of that systemized approach.
Third, we need to integrate the nutrition care plan into the discharge plan. We need to ensure that the goals and improvements we make in the hospital don’t get lost in the transition of care.
Take us to your leader. Nominate a hospitalist whose work inspires you. E-mail suggestions to [email protected].
Dr. Melissa Parkhurst, a hospitalist at the University of Kansas Hospital in Kansas City, is on a mission. She wants to get hospitalists around the country to pay more attention to patient malnutrition and to begin taking a systematic approach to recognizing and treating it.
An estimated one in three patients enters the hospital malnourished, and some only get worse during their inpatient stay, according to the Alliance to Advance Patient Nutrition. "Hospital malnutrition is a serious yet underappreciated problem," Dr. Parkhurst said. "It can delay recovery and increase a patient’s length of stay."
Dr. Parkhurst, who has been the medical director for the multidisciplinary Nutrition Support Service at the University of Kansas Hospital since 2002, is also part of a new organization focused on addressing nutrition and malnutrition in the hospital setting. She serves as the Society of Hospital Medicine’s representative to the Alliance to Advance Patient Nutrition. The organization, which formed in May, has released an online toolkit for health care providers. The Alliance is also introducing a nutrition care model designed to foster greater collaboration among clinicians and drive early nutrition screening, intervention, and discharge processes in hospitals.
In an interview with Hospitalist News, Dr. Parkhurst explained the hospitalist’s role in curbing patient malnutrition.
Question: Who is at risk? Should all patients be screened?
Dr. Parkhurst: In 1996, the Joint Commission required hospitals to have a program in place to provide nutrition screening within 24 hours of patient admissions. But they didn’t dictate how to perform the screen.
The screening can’t be simply a visual assessment of the patient. That’s not adequate. There are several simple, validated screening tools that health care providers can use. The Malnutrition Screening Tool, or MST, for example, is made up of just two simple questions that any health care provider can ask: Have you lost weight recently without trying? Have you been eating poorly because of a decreased appetite?
Obviously, many patients with both acute and chronic illnesses could screen positive, and then we need to perform a full assessment. But in particular, geriatric patients are often nutritionally fragile.
Question: What is the hospitalist’s role in this process?
Dr. Parkhurst: Hospitalists should always be aware of the nutritional status of their patient. They should know basic screening questions that they can incorporate into their history taking. They also need to know where to find the nutrition screening and assessments that are done on their patients in the hospital.
It is good to get to know the hospital’s dietitians and make them aware that you are reviewing their recommendations and that you would like their professional input on your patient. There’s also data gathering involved, such as calorie and protein count, keeping track of whether or not your patient is actually consuming the food and supplements that you ordered, and knowing if they are tolerating the tube feed that you ordered. Finally, hospitalists should be incorporating nutrition into daily rounds and notes and in conversations with patients and their families.
Question: You’re part of the Nutrition Support Service at your hospital. How does it work?
Dr. Parkhurst: Nutrition support teams can look very different from hospital to hospital. The main focus for our nutrition team at the University of Kansas is to provide safe and high-quality nutrition care to our parenteral nutrition patients. We also have a large presence in our intensive care units and take on the care of patients who have complex transitions from parenteral to enteral nutrition care.
Nutrition support teams are best when they are multidisciplinary. Our team has registered dietitians, myself as medical director, pharmacists, and a nurse. We have developed everything from parenteral nutrition hyperglycemia management protocols to proper flushing and declogging of feeding tubes to the placement of small bowel feeding tubes. These are system and quality improvement projects that we’ve been able to work on over the years because we are multidisciplinary. I personally oversee the daily parenteral nutrition care of the patients on the adult side, but our group gets together for patient care rounds and discussions twice a week.
Question: Should every hospital have a multidisciplinary nutrition support team?
Dr. Parkhurst:Our hospital works well with a nutrition support team because we have a very complex patient population. Multidisciplinary nutrition support teams like ours often exist at the larger academic centers. What’s most important for hospitals overall is to have multidisciplinary champions. It doesn’t necessarily need to be a formal team, but instead a champion physician, champion nurse, and champion dietitian to work together.
Often the dietitians at the hospital will know where the patient needs are, but what they need most are partners and a voice to the rest of the hospital. For example, at the University of Kansas Hospital, one of the important steps we took as a team was to get ordering privileges for our registered dietitians. This way they could order calorie counts, supplements, and multivitamins and move along the plan of care instead of leaving notes and waiting for orders to be implemented.
Question: What can be done to better treat patient malnutrition in the hospital?
Dr. Parkhurst: The Alliance to Advance Patient Nutrition is at its core a call to action. We’re trying to get the attention of physicians, dietitians, nurses, pharmacists, and hospital administrators. What we’re advocating for are more systemized nutrition care practices and more interdisciplinary collaboration.
There are three basic things that need to happen in order to drive real change in a hospital setting:
First, we need to make sure that all of our patients are getting screened for risk when they are admitted using a simple, validated screening tool.
Second, there needs to be a system in place so that when there’s a positive screen it prompts a timely, full nutrition assessment by a dietitian. And then that information and recommendations need to be effectively communicated back to the patient’s health care team so that there can be immediate interventions as indicated. Ongoing monitoring also needs to be part of that systemized approach.
Third, we need to integrate the nutrition care plan into the discharge plan. We need to ensure that the goals and improvements we make in the hospital don’t get lost in the transition of care.
Take us to your leader. Nominate a hospitalist whose work inspires you. E-mail suggestions to [email protected].
Supreme Court: Human genes cannot be patented
Private companies do not have the right to patent human genes, the U.S. Supreme Court has ruled.
In a unanimous decision issued on June 13, the high court ruled that a naturally occurring DNA segment is a "product of nature" and is not eligible for a patent simply because it has been isolated. But the court also ruled that synthetically created DNA known as complementary DNA (cDNA) can be granted a patent.
In Association for Molecular Pathology et al. v. Myriad Genetics, the high court considered the validity of patents held by Utah-based Myriad Genetics for the BRCA1 and BRCA2 genes, which are associated with an increased risk of breast and ovarian cancer.
Scientists at Myriad Genetics uncovered the location and sequence of the BRCA1 and BRCA2 genes in the mid-1990s. Since then, they have held the exclusive rights to the diagnostic testing for the mutations. But critics say the monopoly on testing held by Myriad is bad for patients because the test is expensive and they have no alternative confirmatory test.
"It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes," Justice Clarence Thomas wrote in the court’s opinion. "Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13."
The justices concluded that simply isolating genes and the information they encode from the surrounding genetic material is insufficient for a patent. However, cDNA are not naturally occurring so tests using that technology can be patented.
The American Medical Association, which filed an amicus brief in support of invalidating the Myriad patents, praised the Court’s decision.
“Removing the patents on the building blocks of life ensures that scientific discovery and medical care based on insights into human DNA will remain freely accessible and widely disseminated, not hidden behind a vast thicket of exclusive rights,” Dr. Jeremy A. Lazarus, AMA president, said in a statement.
The American Civil Liberties Union, which joined the suit against Myriad, said the decision brings down a major barrier to patient care and medical innovation. "Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued," Sandra Park, senior staff attorney with the ACLU Women’s Rights Project, said in a statement.
The Supreme Court’s decision comes too late to have much of a practical impact on BRCA1 and BRCA2 testing, since Myriad’s 20-year exclusivity on the patents in dispute all expire by 2015.
On Twitter @MaryEllenNY
Private companies do not have the right to patent human genes, the U.S. Supreme Court has ruled.
In a unanimous decision issued on June 13, the high court ruled that a naturally occurring DNA segment is a "product of nature" and is not eligible for a patent simply because it has been isolated. But the court also ruled that synthetically created DNA known as complementary DNA (cDNA) can be granted a patent.
In Association for Molecular Pathology et al. v. Myriad Genetics, the high court considered the validity of patents held by Utah-based Myriad Genetics for the BRCA1 and BRCA2 genes, which are associated with an increased risk of breast and ovarian cancer.
Scientists at Myriad Genetics uncovered the location and sequence of the BRCA1 and BRCA2 genes in the mid-1990s. Since then, they have held the exclusive rights to the diagnostic testing for the mutations. But critics say the monopoly on testing held by Myriad is bad for patients because the test is expensive and they have no alternative confirmatory test.
"It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes," Justice Clarence Thomas wrote in the court’s opinion. "Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13."
The justices concluded that simply isolating genes and the information they encode from the surrounding genetic material is insufficient for a patent. However, cDNA are not naturally occurring so tests using that technology can be patented.
The American Medical Association, which filed an amicus brief in support of invalidating the Myriad patents, praised the Court’s decision.
“Removing the patents on the building blocks of life ensures that scientific discovery and medical care based on insights into human DNA will remain freely accessible and widely disseminated, not hidden behind a vast thicket of exclusive rights,” Dr. Jeremy A. Lazarus, AMA president, said in a statement.
The American Civil Liberties Union, which joined the suit against Myriad, said the decision brings down a major barrier to patient care and medical innovation. "Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued," Sandra Park, senior staff attorney with the ACLU Women’s Rights Project, said in a statement.
The Supreme Court’s decision comes too late to have much of a practical impact on BRCA1 and BRCA2 testing, since Myriad’s 20-year exclusivity on the patents in dispute all expire by 2015.
On Twitter @MaryEllenNY
Private companies do not have the right to patent human genes, the U.S. Supreme Court has ruled.
In a unanimous decision issued on June 13, the high court ruled that a naturally occurring DNA segment is a "product of nature" and is not eligible for a patent simply because it has been isolated. But the court also ruled that synthetically created DNA known as complementary DNA (cDNA) can be granted a patent.
In Association for Molecular Pathology et al. v. Myriad Genetics, the high court considered the validity of patents held by Utah-based Myriad Genetics for the BRCA1 and BRCA2 genes, which are associated with an increased risk of breast and ovarian cancer.
Scientists at Myriad Genetics uncovered the location and sequence of the BRCA1 and BRCA2 genes in the mid-1990s. Since then, they have held the exclusive rights to the diagnostic testing for the mutations. But critics say the monopoly on testing held by Myriad is bad for patients because the test is expensive and they have no alternative confirmatory test.
"It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes," Justice Clarence Thomas wrote in the court’s opinion. "Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13."
The justices concluded that simply isolating genes and the information they encode from the surrounding genetic material is insufficient for a patent. However, cDNA are not naturally occurring so tests using that technology can be patented.
The American Medical Association, which filed an amicus brief in support of invalidating the Myriad patents, praised the Court’s decision.
“Removing the patents on the building blocks of life ensures that scientific discovery and medical care based on insights into human DNA will remain freely accessible and widely disseminated, not hidden behind a vast thicket of exclusive rights,” Dr. Jeremy A. Lazarus, AMA president, said in a statement.
The American Civil Liberties Union, which joined the suit against Myriad, said the decision brings down a major barrier to patient care and medical innovation. "Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued," Sandra Park, senior staff attorney with the ACLU Women’s Rights Project, said in a statement.
The Supreme Court’s decision comes too late to have much of a practical impact on BRCA1 and BRCA2 testing, since Myriad’s 20-year exclusivity on the patents in dispute all expire by 2015.
On Twitter @MaryEllenNY