Two recent studies—one conducted by researchers from Yale University in New Haven and one conducted by researchers from VA Puget Sound Health Care System in Seattle—suggest it is possible to help patients get better sleep, both in the intensive care unit (ICU) and after ICU discharge. However, protocol and policy changes—as well as education—are needed.

To read the full article, go to Federal Practitioner: http://www.fedprac.com/articles/the-latest/article/insomnia-in-the-icu-and-after/7823e1c993201366966884fa1863b588/ocregister.html.

Two recent studies—one conducted by researchers from Yale University in New Haven and one conducted by researchers from VA Puget Sound Health Care System in Seattle—suggest it is possible to help patients get better sleep, both in the intensive care unit (ICU) and after ICU discharge. However, protocol and policy changes—as well as education—are needed.

To read the full article, go to Federal Practitioner: http://www.fedprac.com/articles/the-latest/article/insomnia-in-the-icu-and-after/7823e1c993201366966884fa1863b588/ocregister.html.

Two recent studies—one conducted by researchers from Yale University in New Haven and one conducted by researchers from VA Puget Sound Health Care System in Seattle—suggest it is possible to help patients get better sleep, both in the intensive care unit (ICU) and after ICU discharge. However, protocol and policy changes—as well as education—are needed.

To read the full article, go to Federal Practitioner: http://www.fedprac.com/articles/the-latest/article/insomnia-in-the-icu-and-after/7823e1c993201366966884fa1863b588/ocregister.html.

New antiviral medications for hepatitis C are effective, but the cost of a full course of treatment can reach $100,000. In “How to pay for costly hepatitis C drugs,” which is available at http://www.everydayhealth.com/news/how-pay-costly-hepatitis-c-drugs/, Madeline Vann, MPH, details strategies that patients can use to obtain these medications, including negotiating directly with an insurance company, checking if the manufacturer offers a patient assistance program, and contacting the Patient Access Network Foundation.

New antiviral medications for hepatitis C are effective, but the cost of a full course of treatment can reach $100,000. In “How to pay for costly hepatitis C drugs,” which is available at http://www.everydayhealth.com/news/how-pay-costly-hepatitis-c-drugs/, Madeline Vann, MPH, details strategies that patients can use to obtain these medications, including negotiating directly with an insurance company, checking if the manufacturer offers a patient assistance program, and contacting the Patient Access Network Foundation.

New antiviral medications for hepatitis C are effective, but the cost of a full course of treatment can reach $100,000. In “How to pay for costly hepatitis C drugs,” which is available at http://www.everydayhealth.com/news/how-pay-costly-hepatitis-c-drugs/, Madeline Vann, MPH, details strategies that patients can use to obtain these medications, including negotiating directly with an insurance company, checking if the manufacturer offers a patient assistance program, and contacting the Patient Access Network Foundation.

NASHVILLE, TENN. – Bisphosphonates help prevent fractures in some children with osteogenesis imperfecta, but they don't do the same for adults with the condition, according to a review from Johns Hopkins University and the Kennedy Krieger Institute.

Even so, bisphosphonates are used widely for adult osteogenesis imperfecta (OI) “because people have nothing else to hang their hat on, and the average physician doesn’t understand that osteogenesis imperfecta is not the same as age-related osteoporosis,” said senior investigator Dr. Jay R. Shapiro, director of Kennedy Krieger’s osteogenesis imperfecta program in Baltimore.

“We see adults with OI all the time who have been on bisphosphonates for 10 years, 12 years. It’s not doing anything for them, and sooner or later they come to realize that.” Meanwhile, “I think people are getting a little bit of a queasy feeling about not fully understanding the effectiveness and side effects of long-term treatment with bisphosphonates,” said Dr. Shapiro, also professor in the department of physical medicine and rehabilitation at Johns Hopkins University, Baltimore.

Adults with OI “also don’t respond to Forteo [teriparatide]. I do not recommend treatment with bisphosphonates or Forteo in” adults, he said at the annual meeting of the American Association of Clinical Endocrinologists.

Dr. Shapiro shared his thoughts during an interview regarding his latest study, an analysis of five children with OI under 18 years of age who responded to pamidronate (Aredia) and 11 who did not, meaning that they had two or more fractures per year while on the drug.

His team also compared fracture outcomes in 34 adults with OI treated with oral or intravenous bisphosphonates with 12 untreated adults. The adults were, on average, 52 years old.

The goal was to see if common bone markers predicted who would respond to bisphosphonates, but they did not. Vitamin D, phosphorus, alkaline phosphatase, C-telopeptide, and other measures were the same in children regardless of their response to pamidronate, and the same in adults with OI whether or not they were on bisphosphonates.

“We have not yet defined what the difference is between responders and nonresponders. If you take a crack at the simple things, they don’t help,” Dr. Shapiro said.

Children who responded had a mean of 4.8 fractures over an average of 42.6 months of treatment. Nonresponders had a mean of 15.6 fractures over an average of 72.7 months of treatment.

“For a period of time, you can expect about two-thirds of kids to respond. I would look to see a decrease in fracture rates within 2 years of treatment. If they haven’t decreased their fracture rate [by then], I would be very cautious about continuing,” he said, adding that the optimal duration of treatment in children is unknown.

In adults, the team found no difference in fracture rates at 5 and 10 years. Treated adults had an average of 1.71 fractures over 10 years, versus 1.23 in untreated adults (P = 0.109).

The numbers in the study were too small for meaningful subgroup analysis by OI type.

The findings parallel recent meta-analyses; some have found that bisphosphonates help OI children, but none has found benefits for adults (J. Bone. Miner. Res. 2015;30:929-33). “To date, there is no evidence indicating that bisphosphonates have a positive effect on fracture rates in adults,” Dr. Shapiro said.

Bone turnover declines after puberty, which may explain why the drugs lose their effectiveness after age 18 or so. “What happens in OI anyway is that, after puberty, the fracture rates normally go way down,” Dr. Shapiro said.

Dr. Shapiro said that he had no relevant disclosures, and that there was no outside funding for the work.

[email protected]

NASHVILLE, TENN. – Bisphosphonates help prevent fractures in some children with osteogenesis imperfecta, but they don't do the same for adults with the condition, according to a review from Johns Hopkins University and the Kennedy Krieger Institute.

Even so, bisphosphonates are used widely for adult osteogenesis imperfecta (OI) “because people have nothing else to hang their hat on, and the average physician doesn’t understand that osteogenesis imperfecta is not the same as age-related osteoporosis,” said senior investigator Dr. Jay R. Shapiro, director of Kennedy Krieger’s osteogenesis imperfecta program in Baltimore.

“We see adults with OI all the time who have been on bisphosphonates for 10 years, 12 years. It’s not doing anything for them, and sooner or later they come to realize that.” Meanwhile, “I think people are getting a little bit of a queasy feeling about not fully understanding the effectiveness and side effects of long-term treatment with bisphosphonates,” said Dr. Shapiro, also professor in the department of physical medicine and rehabilitation at Johns Hopkins University, Baltimore.

Adults with OI “also don’t respond to Forteo [teriparatide]. I do not recommend treatment with bisphosphonates or Forteo in” adults, he said at the annual meeting of the American Association of Clinical Endocrinologists.

Dr. Shapiro shared his thoughts during an interview regarding his latest study, an analysis of five children with OI under 18 years of age who responded to pamidronate (Aredia) and 11 who did not, meaning that they had two or more fractures per year while on the drug.

His team also compared fracture outcomes in 34 adults with OI treated with oral or intravenous bisphosphonates with 12 untreated adults. The adults were, on average, 52 years old.

The goal was to see if common bone markers predicted who would respond to bisphosphonates, but they did not. Vitamin D, phosphorus, alkaline phosphatase, C-telopeptide, and other measures were the same in children regardless of their response to pamidronate, and the same in adults with OI whether or not they were on bisphosphonates.

“We have not yet defined what the difference is between responders and nonresponders. If you take a crack at the simple things, they don’t help,” Dr. Shapiro said.

Children who responded had a mean of 4.8 fractures over an average of 42.6 months of treatment. Nonresponders had a mean of 15.6 fractures over an average of 72.7 months of treatment.

“For a period of time, you can expect about two-thirds of kids to respond. I would look to see a decrease in fracture rates within 2 years of treatment. If they haven’t decreased their fracture rate [by then], I would be very cautious about continuing,” he said, adding that the optimal duration of treatment in children is unknown.

In adults, the team found no difference in fracture rates at 5 and 10 years. Treated adults had an average of 1.71 fractures over 10 years, versus 1.23 in untreated adults (P = 0.109).

The numbers in the study were too small for meaningful subgroup analysis by OI type.

The findings parallel recent meta-analyses; some have found that bisphosphonates help OI children, but none has found benefits for adults (J. Bone. Miner. Res. 2015;30:929-33). “To date, there is no evidence indicating that bisphosphonates have a positive effect on fracture rates in adults,” Dr. Shapiro said.

Bone turnover declines after puberty, which may explain why the drugs lose their effectiveness after age 18 or so. “What happens in OI anyway is that, after puberty, the fracture rates normally go way down,” Dr. Shapiro said.

Dr. Shapiro said that he had no relevant disclosures, and that there was no outside funding for the work.

[email protected]

NASHVILLE, TENN. – Bisphosphonates help prevent fractures in some children with osteogenesis imperfecta, but they don't do the same for adults with the condition, according to a review from Johns Hopkins University and the Kennedy Krieger Institute.

Even so, bisphosphonates are used widely for adult osteogenesis imperfecta (OI) “because people have nothing else to hang their hat on, and the average physician doesn’t understand that osteogenesis imperfecta is not the same as age-related osteoporosis,” said senior investigator Dr. Jay R. Shapiro, director of Kennedy Krieger’s osteogenesis imperfecta program in Baltimore.

“We see adults with OI all the time who have been on bisphosphonates for 10 years, 12 years. It’s not doing anything for them, and sooner or later they come to realize that.” Meanwhile, “I think people are getting a little bit of a queasy feeling about not fully understanding the effectiveness and side effects of long-term treatment with bisphosphonates,” said Dr. Shapiro, also professor in the department of physical medicine and rehabilitation at Johns Hopkins University, Baltimore.

Adults with OI “also don’t respond to Forteo [teriparatide]. I do not recommend treatment with bisphosphonates or Forteo in” adults, he said at the annual meeting of the American Association of Clinical Endocrinologists.

Dr. Shapiro shared his thoughts during an interview regarding his latest study, an analysis of five children with OI under 18 years of age who responded to pamidronate (Aredia) and 11 who did not, meaning that they had two or more fractures per year while on the drug.

His team also compared fracture outcomes in 34 adults with OI treated with oral or intravenous bisphosphonates with 12 untreated adults. The adults were, on average, 52 years old.

The goal was to see if common bone markers predicted who would respond to bisphosphonates, but they did not. Vitamin D, phosphorus, alkaline phosphatase, C-telopeptide, and other measures were the same in children regardless of their response to pamidronate, and the same in adults with OI whether or not they were on bisphosphonates.

“We have not yet defined what the difference is between responders and nonresponders. If you take a crack at the simple things, they don’t help,” Dr. Shapiro said.

Children who responded had a mean of 4.8 fractures over an average of 42.6 months of treatment. Nonresponders had a mean of 15.6 fractures over an average of 72.7 months of treatment.

“For a period of time, you can expect about two-thirds of kids to respond. I would look to see a decrease in fracture rates within 2 years of treatment. If they haven’t decreased their fracture rate [by then], I would be very cautious about continuing,” he said, adding that the optimal duration of treatment in children is unknown.

In adults, the team found no difference in fracture rates at 5 and 10 years. Treated adults had an average of 1.71 fractures over 10 years, versus 1.23 in untreated adults (P = 0.109).

The numbers in the study were too small for meaningful subgroup analysis by OI type.

The findings parallel recent meta-analyses; some have found that bisphosphonates help OI children, but none has found benefits for adults (J. Bone. Miner. Res. 2015;30:929-33). “To date, there is no evidence indicating that bisphosphonates have a positive effect on fracture rates in adults,” Dr. Shapiro said.

Bone turnover declines after puberty, which may explain why the drugs lose their effectiveness after age 18 or so. “What happens in OI anyway is that, after puberty, the fracture rates normally go way down,” Dr. Shapiro said.

Dr. Shapiro said that he had no relevant disclosures, and that there was no outside funding for the work.

[email protected]

Case: Patient becomes a liability when nonadherant to prescribed tests
MC, a 42-year-old woman (G1P1001), presents for an office visit. As the medical assistant hands you the chart, she says, “Good luck with this one. She yelled at me because you were 20 minutes behind schedule. She didn’t like sitting in the waiting room.” You greet the patient, obtain her medical history, proceed with a physical examination, and outline a management plan. You recall from the chart that you operated on her 8 months ago and there was a complication/maloccurrence in which postoperative bleeding necessitated return to the operating room (OR) for a laparotomy to control bleeding. The patient has not brought this up since being discharged from the hospital. 

During the current office visit, the esprit de corps in the consultation room is a bit uncomfortable, and you sense the patient is not happy. You leave the examination room and discuss the management plan with the nurse, who then returns to the patient to review the plan. The patient is unhappy with the battery of tests you have ordered but tells the nurse that she will comply.

One week later the nurse follows up with the patient by phone because she has not obtained the requested lab tests. The nurse reports to you, “She read me the riot act: ‘Why do I need all these tests? They are expensive.’ The patient indicated that she has no understanding as to why the tests were ordered in the first place.” After a discussion with you, the nurse calls the patient back in an effort to clarify her understanding of the need for the tests. The patient hangs up on her in the middle of the conversation.

The office manager tracks you down to discuss this patient. “Enough is enough,” she exclaims. “This patient is harassing the staff. She told the nurse what tests she herself believes are best and that those are the only ones she will comply with.” Your office manager states that this patient is “a liability.”

What are your choices at this point? You have thought about picking up the phone and calling her. You have considered ending her relationship with your practice. You ask yourself again, what is the best approach?

Patients have the legal right to “dismiss” or change health care providers at any time and for almost any reason without notice. But that right is not reciprocal—clinicians have a legal duty not to abandon a patient and an ethical duty to promote continuity of patient care. A clinician may dismiss a patient from his or her practice (other than for a discriminatory reason that violates ethical or legal limitations), but it must be done in the proper way.

We examine the legal, practical, and ethical issues in dismissing a patient, and how to do it without unnecessary risk. In addition, we will look at a new issue that sometimes arises in these circumstances—managed care limitations.
 

Legal and medical issues
Why would you end a clinician−patient relationship?
There are a number of reasons for dismissing a patient, including^1,2:

The legal details vary from state to state, but fortunately there is sufficient similarity that best practices can be determined. The law starts with the proposition that ordinarily professionals may choose their patients or clients. There are limits, however, in state and federal law. A clinician may not discriminate based, for example, on ethnicity, religion, gender, or sexual orientation. In addition, the Americans with Disabilities Act limits the basis for not providing care to a patient.³

Limiting factors when dismissing a patient
Once a patient has been accepted and a professional relationship has begun, the clinician has a duty of continued care and must act reasonably to end the relationship in a way that protects the patient’s well-being. 

Other recognized limitations to the ending of a treatment relationship exist. These are:

Abandonment
The legal and ethical issues are essentially related to “abandonment”—dismissing a patient improperly. Technically, abandonment is a form of negligence (the clinician does not act reasonably to protect the patient’s interests). The Oklahoma Supreme Court put it clearly: “When further medical and/or surgical attention is needed, a physician may terminate the doctor−patient relationship only after giving reasonable notice and affording an ample opportunity for the patient to secure other medical attention from other physicians” (emphasis added).^4–6

How to end a patient relationship
Always send a letter
Two elements must be taken into account when dismissing a patient:

Together, these elements mean that the intention of ending the clinician−patient relationship and the importance of finding an alternative care provider must be clearly communicated to the patient. That communication needs to be in writing—both to get the patient’s attention and as clear proof of what was said.

Some experts suggest that the best process is to have a face-to-face meeting with the patient followed by a letter. A goal of such a meeting is to make the parting as amicable as possible. It may seem more professional for a clinician to communicate such an important matter in person. The risk is that it may become a confrontation that exacerbates the situation because one or both parties may have some built-up emotion. It, therefore, depends on the circumstances as to whether such a meeting is desirable. Even if there is an oral conversation, it must be followed up with a letter to the patient.

A reasonable time frame to give the patient to find another clinician is commonly a maximum of 30 days of follow-up and emergency care. A set period of time may be a legitimate starting point but it needs to be adjusted in lieu of special circumstances, such as the availability of other similar specialists in the vicinity who are taking new patients or managed care complications. A specific time period should be indicated, along with an agreement to provide care during that time period in “emergency” or “urgent” circumstances. Of course, ongoing care also should be continued for a reasonable time (30 days is often reasonable, as mentioned). It may be best to also discuss any specific ongoing issues that should be attended to (such as the recommended tests in our opening case). 

There is disagreement among experts as to whether a general statement of the reasons for ending the care relationship should be included in the letter. The argument for doing so is that, without a stated reason, the patient may call to ask why. The other side of the argument is that it adds an element of accusation; the patient undoubtedly knows what the problem is. Not writing down the reasons seems the better part of valor, especially if there has been an oral conversation.^7,8

The box above provides an example of a letter to a patient (but not a model). Experts agree that the letter should be sent by certified mail with return receipt. Should the patient reject the letter, a regular delivery letter should be sent with full documentation kept in the file of the time and place it was mailed.

Managed care considerations
A consideration of increasing importance is managed care. Before taking any action, ensure that the managed care contract(s) (including federal or state government programs) have provisions concerning patient dismissals. These may be as simple as notifying the organization as to any time limits for care or of the process of dismissal. 

Make sure your staff knows
Your scheduling staff needs to know with clarity the rules for scheduling (or not scheduling) this patient in the future. As a general matter, the better course of action is to allow an appointment if the patient reports that it is an emergency, whether the staff believes it is or not. In such cases it may be good to document to the patient that the emergency care does not constitute reestablishing a regular clinician−patient relationship.

Document everything
The patient’s record, at a minimum, should contain a copy of the letter sent to the patient and a log of any conversations with her about ending the relationship. Keep your own notes concerning the disruption or problems with the patient over time. 

Are there risks of a malpractice lawsuit?
The abandonment claim is, of course, one possibility for a malpractice lawsuit. That is why documentation and careful communication are so important. This is one area in which having legal advice when developing a letter template should be part of the ongoing relationship with a health law attorney. 

There is another malpractice risk illustrated in our hypothetical case. The physician “operated on her 8 months ago and there was a complication/maloccurrence in which postoperative bleeding necessitated return to the OR and laparotomy to control bleeding.”  Malpractice claims (as opposed to actual malpractice occurrences) most often arise because of bad communication with patients or when patients feel ignored. The clinician is thus between a rock and a hard place. On one hand, by ending this relationship, the clinician could well precipitate a claim based primarily on the earlier “maloccurrence.” On the other hand, continuing to treat a patient who is resisting care and creating problems with the staff has its own difficulties. It may be time for the health care professional to discuss the matter with an attorney.

Although not present in this hypothetical case, ending a patient relationship because of nonpayment of professional fees is also a touchy situation. It can be one of the other precipitating events for malpractice claims, and calls for special care.

Tread with care
Having to dismiss a patient is almost always a difficult process. The decision neither can be made lightly nor implemented sloppily. Because it is difficult, it calls on professionals to be particularly careful to not cut essential corners.⁹ 

Case: Resolved
You ask the nurse to note the details of her follow-up phone conversation with the patient in the chart. You then call MC to explain the importance of the tests. She says she is unavailable to talk right now, so you ask her to come in for an appointment, free of charge. The patient makes an appointment but does not show.

You send a letter by certified mail describing the medical necessity for the tests and that her lack of adherence and refusal to come to the office have compelled you to end your clinician−patient relationship. You write that she should immediately identify another health care professional and suggest that she contact her managed care organization for assistance. You note that, should there be a medical emergency or urgent care needed in the next 30 days, you will provide that care. You enclose a release of medical records form in the letter.

In the patient’s record you note the details of the phone conversation and ask the office manager to add that the patient was a no show for her appointment. You include a copy of the certified letter and proof of mailing in the chart.

Two weeks later, the office manager reports that she is sending the patient’s records to another physician upon receipt of the release of medical records form from the patient.

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

Case: Patient becomes a liability when nonadherant to prescribed tests
MC, a 42-year-old woman (G1P1001), presents for an office visit. As the medical assistant hands you the chart, she says, “Good luck with this one. She yelled at me because you were 20 minutes behind schedule. She didn’t like sitting in the waiting room.” You greet the patient, obtain her medical history, proceed with a physical examination, and outline a management plan. You recall from the chart that you operated on her 8 months ago and there was a complication/maloccurrence in which postoperative bleeding necessitated return to the operating room (OR) for a laparotomy to control bleeding. The patient has not brought this up since being discharged from the hospital. 

During the current office visit, the esprit de corps in the consultation room is a bit uncomfortable, and you sense the patient is not happy. You leave the examination room and discuss the management plan with the nurse, who then returns to the patient to review the plan. The patient is unhappy with the battery of tests you have ordered but tells the nurse that she will comply.

One week later the nurse follows up with the patient by phone because she has not obtained the requested lab tests. The nurse reports to you, “She read me the riot act: ‘Why do I need all these tests? They are expensive.’ The patient indicated that she has no understanding as to why the tests were ordered in the first place.” After a discussion with you, the nurse calls the patient back in an effort to clarify her understanding of the need for the tests. The patient hangs up on her in the middle of the conversation.

The office manager tracks you down to discuss this patient. “Enough is enough,” she exclaims. “This patient is harassing the staff. She told the nurse what tests she herself believes are best and that those are the only ones she will comply with.” Your office manager states that this patient is “a liability.”

What are your choices at this point? You have thought about picking up the phone and calling her. You have considered ending her relationship with your practice. You ask yourself again, what is the best approach?

Patients have the legal right to “dismiss” or change health care providers at any time and for almost any reason without notice. But that right is not reciprocal—clinicians have a legal duty not to abandon a patient and an ethical duty to promote continuity of patient care. A clinician may dismiss a patient from his or her practice (other than for a discriminatory reason that violates ethical or legal limitations), but it must be done in the proper way.

We examine the legal, practical, and ethical issues in dismissing a patient, and how to do it without unnecessary risk. In addition, we will look at a new issue that sometimes arises in these circumstances—managed care limitations.
 

Legal and medical issues
Why would you end a clinician−patient relationship?
There are a number of reasons for dismissing a patient, including^1,2:

The legal details vary from state to state, but fortunately there is sufficient similarity that best practices can be determined. The law starts with the proposition that ordinarily professionals may choose their patients or clients. There are limits, however, in state and federal law. A clinician may not discriminate based, for example, on ethnicity, religion, gender, or sexual orientation. In addition, the Americans with Disabilities Act limits the basis for not providing care to a patient.³

Limiting factors when dismissing a patient
Once a patient has been accepted and a professional relationship has begun, the clinician has a duty of continued care and must act reasonably to end the relationship in a way that protects the patient’s well-being. 

Other recognized limitations to the ending of a treatment relationship exist. These are:

Abandonment
The legal and ethical issues are essentially related to “abandonment”—dismissing a patient improperly. Technically, abandonment is a form of negligence (the clinician does not act reasonably to protect the patient’s interests). The Oklahoma Supreme Court put it clearly: “When further medical and/or surgical attention is needed, a physician may terminate the doctor−patient relationship only after giving reasonable notice and affording an ample opportunity for the patient to secure other medical attention from other physicians” (emphasis added).^4–6

How to end a patient relationship
Always send a letter
Two elements must be taken into account when dismissing a patient:

Together, these elements mean that the intention of ending the clinician−patient relationship and the importance of finding an alternative care provider must be clearly communicated to the patient. That communication needs to be in writing—both to get the patient’s attention and as clear proof of what was said.

Some experts suggest that the best process is to have a face-to-face meeting with the patient followed by a letter. A goal of such a meeting is to make the parting as amicable as possible. It may seem more professional for a clinician to communicate such an important matter in person. The risk is that it may become a confrontation that exacerbates the situation because one or both parties may have some built-up emotion. It, therefore, depends on the circumstances as to whether such a meeting is desirable. Even if there is an oral conversation, it must be followed up with a letter to the patient.

A reasonable time frame to give the patient to find another clinician is commonly a maximum of 30 days of follow-up and emergency care. A set period of time may be a legitimate starting point but it needs to be adjusted in lieu of special circumstances, such as the availability of other similar specialists in the vicinity who are taking new patients or managed care complications. A specific time period should be indicated, along with an agreement to provide care during that time period in “emergency” or “urgent” circumstances. Of course, ongoing care also should be continued for a reasonable time (30 days is often reasonable, as mentioned). It may be best to also discuss any specific ongoing issues that should be attended to (such as the recommended tests in our opening case). 

There is disagreement among experts as to whether a general statement of the reasons for ending the care relationship should be included in the letter. The argument for doing so is that, without a stated reason, the patient may call to ask why. The other side of the argument is that it adds an element of accusation; the patient undoubtedly knows what the problem is. Not writing down the reasons seems the better part of valor, especially if there has been an oral conversation.^7,8

The box above provides an example of a letter to a patient (but not a model). Experts agree that the letter should be sent by certified mail with return receipt. Should the patient reject the letter, a regular delivery letter should be sent with full documentation kept in the file of the time and place it was mailed.

Managed care considerations
A consideration of increasing importance is managed care. Before taking any action, ensure that the managed care contract(s) (including federal or state government programs) have provisions concerning patient dismissals. These may be as simple as notifying the organization as to any time limits for care or of the process of dismissal. 

Make sure your staff knows
Your scheduling staff needs to know with clarity the rules for scheduling (or not scheduling) this patient in the future. As a general matter, the better course of action is to allow an appointment if the patient reports that it is an emergency, whether the staff believes it is or not. In such cases it may be good to document to the patient that the emergency care does not constitute reestablishing a regular clinician−patient relationship.

Document everything
The patient’s record, at a minimum, should contain a copy of the letter sent to the patient and a log of any conversations with her about ending the relationship. Keep your own notes concerning the disruption or problems with the patient over time. 

Are there risks of a malpractice lawsuit?
The abandonment claim is, of course, one possibility for a malpractice lawsuit. That is why documentation and careful communication are so important. This is one area in which having legal advice when developing a letter template should be part of the ongoing relationship with a health law attorney. 

There is another malpractice risk illustrated in our hypothetical case. The physician “operated on her 8 months ago and there was a complication/maloccurrence in which postoperative bleeding necessitated return to the OR and laparotomy to control bleeding.”  Malpractice claims (as opposed to actual malpractice occurrences) most often arise because of bad communication with patients or when patients feel ignored. The clinician is thus between a rock and a hard place. On one hand, by ending this relationship, the clinician could well precipitate a claim based primarily on the earlier “maloccurrence.” On the other hand, continuing to treat a patient who is resisting care and creating problems with the staff has its own difficulties. It may be time for the health care professional to discuss the matter with an attorney.

Although not present in this hypothetical case, ending a patient relationship because of nonpayment of professional fees is also a touchy situation. It can be one of the other precipitating events for malpractice claims, and calls for special care.

Tread with care
Having to dismiss a patient is almost always a difficult process. The decision neither can be made lightly nor implemented sloppily. Because it is difficult, it calls on professionals to be particularly careful to not cut essential corners.⁹ 

Case: Resolved
You ask the nurse to note the details of her follow-up phone conversation with the patient in the chart. You then call MC to explain the importance of the tests. She says she is unavailable to talk right now, so you ask her to come in for an appointment, free of charge. The patient makes an appointment but does not show.

You send a letter by certified mail describing the medical necessity for the tests and that her lack of adherence and refusal to come to the office have compelled you to end your clinician−patient relationship. You write that she should immediately identify another health care professional and suggest that she contact her managed care organization for assistance. You note that, should there be a medical emergency or urgent care needed in the next 30 days, you will provide that care. You enclose a release of medical records form in the letter.

In the patient’s record you note the details of the phone conversation and ask the office manager to add that the patient was a no show for her appointment. You include a copy of the certified letter and proof of mailing in the chart.

Two weeks later, the office manager reports that she is sending the patient’s records to another physician upon receipt of the release of medical records form from the patient.

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

Case: Patient becomes a liability when nonadherant to prescribed tests
MC, a 42-year-old woman (G1P1001), presents for an office visit. As the medical assistant hands you the chart, she says, “Good luck with this one. She yelled at me because you were 20 minutes behind schedule. She didn’t like sitting in the waiting room.” You greet the patient, obtain her medical history, proceed with a physical examination, and outline a management plan. You recall from the chart that you operated on her 8 months ago and there was a complication/maloccurrence in which postoperative bleeding necessitated return to the operating room (OR) for a laparotomy to control bleeding. The patient has not brought this up since being discharged from the hospital. 

During the current office visit, the esprit de corps in the consultation room is a bit uncomfortable, and you sense the patient is not happy. You leave the examination room and discuss the management plan with the nurse, who then returns to the patient to review the plan. The patient is unhappy with the battery of tests you have ordered but tells the nurse that she will comply.

One week later the nurse follows up with the patient by phone because she has not obtained the requested lab tests. The nurse reports to you, “She read me the riot act: ‘Why do I need all these tests? They are expensive.’ The patient indicated that she has no understanding as to why the tests were ordered in the first place.” After a discussion with you, the nurse calls the patient back in an effort to clarify her understanding of the need for the tests. The patient hangs up on her in the middle of the conversation.

The office manager tracks you down to discuss this patient. “Enough is enough,” she exclaims. “This patient is harassing the staff. She told the nurse what tests she herself believes are best and that those are the only ones she will comply with.” Your office manager states that this patient is “a liability.”

What are your choices at this point? You have thought about picking up the phone and calling her. You have considered ending her relationship with your practice. You ask yourself again, what is the best approach?

Patients have the legal right to “dismiss” or change health care providers at any time and for almost any reason without notice. But that right is not reciprocal—clinicians have a legal duty not to abandon a patient and an ethical duty to promote continuity of patient care. A clinician may dismiss a patient from his or her practice (other than for a discriminatory reason that violates ethical or legal limitations), but it must be done in the proper way.

We examine the legal, practical, and ethical issues in dismissing a patient, and how to do it without unnecessary risk. In addition, we will look at a new issue that sometimes arises in these circumstances—managed care limitations.
 

Legal and medical issues
Why would you end a clinician−patient relationship?
There are a number of reasons for dismissing a patient, including^1,2:

The legal details vary from state to state, but fortunately there is sufficient similarity that best practices can be determined. The law starts with the proposition that ordinarily professionals may choose their patients or clients. There are limits, however, in state and federal law. A clinician may not discriminate based, for example, on ethnicity, religion, gender, or sexual orientation. In addition, the Americans with Disabilities Act limits the basis for not providing care to a patient.³

Limiting factors when dismissing a patient
Once a patient has been accepted and a professional relationship has begun, the clinician has a duty of continued care and must act reasonably to end the relationship in a way that protects the patient’s well-being. 

Other recognized limitations to the ending of a treatment relationship exist. These are:

Abandonment
The legal and ethical issues are essentially related to “abandonment”—dismissing a patient improperly. Technically, abandonment is a form of negligence (the clinician does not act reasonably to protect the patient’s interests). The Oklahoma Supreme Court put it clearly: “When further medical and/or surgical attention is needed, a physician may terminate the doctor−patient relationship only after giving reasonable notice and affording an ample opportunity for the patient to secure other medical attention from other physicians” (emphasis added).^4–6

How to end a patient relationship
Always send a letter
Two elements must be taken into account when dismissing a patient:

Together, these elements mean that the intention of ending the clinician−patient relationship and the importance of finding an alternative care provider must be clearly communicated to the patient. That communication needs to be in writing—both to get the patient’s attention and as clear proof of what was said.

Some experts suggest that the best process is to have a face-to-face meeting with the patient followed by a letter. A goal of such a meeting is to make the parting as amicable as possible. It may seem more professional for a clinician to communicate such an important matter in person. The risk is that it may become a confrontation that exacerbates the situation because one or both parties may have some built-up emotion. It, therefore, depends on the circumstances as to whether such a meeting is desirable. Even if there is an oral conversation, it must be followed up with a letter to the patient.

A reasonable time frame to give the patient to find another clinician is commonly a maximum of 30 days of follow-up and emergency care. A set period of time may be a legitimate starting point but it needs to be adjusted in lieu of special circumstances, such as the availability of other similar specialists in the vicinity who are taking new patients or managed care complications. A specific time period should be indicated, along with an agreement to provide care during that time period in “emergency” or “urgent” circumstances. Of course, ongoing care also should be continued for a reasonable time (30 days is often reasonable, as mentioned). It may be best to also discuss any specific ongoing issues that should be attended to (such as the recommended tests in our opening case). 

There is disagreement among experts as to whether a general statement of the reasons for ending the care relationship should be included in the letter. The argument for doing so is that, without a stated reason, the patient may call to ask why. The other side of the argument is that it adds an element of accusation; the patient undoubtedly knows what the problem is. Not writing down the reasons seems the better part of valor, especially if there has been an oral conversation.^7,8

The box above provides an example of a letter to a patient (but not a model). Experts agree that the letter should be sent by certified mail with return receipt. Should the patient reject the letter, a regular delivery letter should be sent with full documentation kept in the file of the time and place it was mailed.

Managed care considerations
A consideration of increasing importance is managed care. Before taking any action, ensure that the managed care contract(s) (including federal or state government programs) have provisions concerning patient dismissals. These may be as simple as notifying the organization as to any time limits for care or of the process of dismissal. 

Make sure your staff knows
Your scheduling staff needs to know with clarity the rules for scheduling (or not scheduling) this patient in the future. As a general matter, the better course of action is to allow an appointment if the patient reports that it is an emergency, whether the staff believes it is or not. In such cases it may be good to document to the patient that the emergency care does not constitute reestablishing a regular clinician−patient relationship.

Document everything
The patient’s record, at a minimum, should contain a copy of the letter sent to the patient and a log of any conversations with her about ending the relationship. Keep your own notes concerning the disruption or problems with the patient over time. 

Are there risks of a malpractice lawsuit?
The abandonment claim is, of course, one possibility for a malpractice lawsuit. That is why documentation and careful communication are so important. This is one area in which having legal advice when developing a letter template should be part of the ongoing relationship with a health law attorney. 

There is another malpractice risk illustrated in our hypothetical case. The physician “operated on her 8 months ago and there was a complication/maloccurrence in which postoperative bleeding necessitated return to the OR and laparotomy to control bleeding.”  Malpractice claims (as opposed to actual malpractice occurrences) most often arise because of bad communication with patients or when patients feel ignored. The clinician is thus between a rock and a hard place. On one hand, by ending this relationship, the clinician could well precipitate a claim based primarily on the earlier “maloccurrence.” On the other hand, continuing to treat a patient who is resisting care and creating problems with the staff has its own difficulties. It may be time for the health care professional to discuss the matter with an attorney.

Although not present in this hypothetical case, ending a patient relationship because of nonpayment of professional fees is also a touchy situation. It can be one of the other precipitating events for malpractice claims, and calls for special care.

Tread with care
Having to dismiss a patient is almost always a difficult process. The decision neither can be made lightly nor implemented sloppily. Because it is difficult, it calls on professionals to be particularly careful to not cut essential corners.⁹ 

Case: Resolved
You ask the nurse to note the details of her follow-up phone conversation with the patient in the chart. You then call MC to explain the importance of the tests. She says she is unavailable to talk right now, so you ask her to come in for an appointment, free of charge. The patient makes an appointment but does not show.

You send a letter by certified mail describing the medical necessity for the tests and that her lack of adherence and refusal to come to the office have compelled you to end your clinician−patient relationship. You write that she should immediately identify another health care professional and suggest that she contact her managed care organization for assistance. You note that, should there be a medical emergency or urgent care needed in the next 30 days, you will provide that care. You enclose a release of medical records form in the letter.

In the patient’s record you note the details of the phone conversation and ask the office manager to add that the patient was a no show for her appointment. You include a copy of the certified letter and proof of mailing in the chart.

Two weeks later, the office manager reports that she is sending the patient’s records to another physician upon receipt of the release of medical records form from the patient.

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

Congratulations, OBG Management readers! After years of hard work and collective advocacy on your part, the US Congress finally passed, and President Barack Obama quickly signed into law, a permanent repeal of the Medicare Sustainable Growth Rate (SGR) physician payment system. Yes, celebrations are in order.

The US House of Representatives passed the bill, HR 2, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), sponsored by American College of Obstetricians and Gynecologists (ACOG) Fellow and US Rep. ­Michael ­Burgess (R-TX), on March 26, with 382 Republicans and Democrats voting “Yes.” The Senate followed, on April 14, and agreed with the House to repeal, forever, the Medicare SGR, passing the Burgess bill without amendment, on a bipartisan vote of 92–8. With only hours to go before the scheduled 21.2% cut took effect, the President signed the bill, now Public Law (PL) 114-10, on April 16. The President noted that he was “proud to sign the bill into law.” ACOG is proud to have been such an important part of this landmark moment.

SGR: the perennial nemesis of physicians
The SGR has wreaked havoc on medicine and patient care for 15 years or more. Approximately 30,000 ObGyns participate in Medicare, and many private health insurers use Medicare payment policies, as does TriCare, the nation’s health care coverage for military members and their families. The SGR’s effect was felt widely across medicine, making it nearly impossible for physician practices to invest in health information technology and other patient safety advances, or even to plan for the next year or continue accepting Medicare patients.

When it was introduced last year, HR 2 was supported by more than 600 national and state medical societies and specialty organizations, plus patient and provider organizations, policy think tanks, and advocacy groups across the political spectrum.

ACOG Fellows petitioned their members of Congress with incredible passion, perseverance, and commitment to put an end to the SGR wrecking ball. Hundreds flew into Washington, DC, sent thousands of emails, made phone calls, wrote letters, and personally lobbied at home and in the halls of Congress.

Special kudos, too, to our champions in Congress, and there are many, led by ACOG Fellows and US Reps. Dr. Burgess and Phil Roe, MD (R-TN). Burgess wrote the House bill and, together with Roe, pushed nonstop to get this bill over the finish line. It wouldn’t have happened without them.

ACOG worked tirelessly on its own and in coalition with the American Medical Association, surgical groups, and many other partners. We were able to win important provisions in the statute that we anticipate will greatly help ObGyns successfully transition to this new payment system.

PL114-10 replaces the SGR with a new payment system intended to promote care coordination and quality improvement and lead to better health for our nation’s seniors. Congress developed this new payment plan with the physician community, rather than imposing it on us. That’s why throughout the statute, we see repeated requirements that the Secretary of Health and Human Services must develop quality measures, alternative payment models, and a host of key aspects with input from and in consultation with physicians and the relevant medical specialties, ensuring that physicians retain their preeminent roles in these areas. Funding is provided for quality measure development at $15 million per year from 2015 to 2019.

This law will likely change physician practices more than the ACA ever will, and Congress agreed that physicians should be integral to its development to ensure that they can continue to thrive and provide high-quality care and access for their patients.

Let’s take a closer look at the new Medicare payment system—especially what it will mean for your practice.

What the new law does
Important provisions

MACRA stabilizes the Medicare payment system by permanently repealing the SGR and scheduling payments into the future:

Two payment system options reward continuous quality improvement
Option 1: MIPS. MACRA consolidates and expands pay-for-performance incentives within the old SGR fee-for-service system, creating the new MIPS. Under MIPS, the Physician Quality Reporting System (PQRS), electronic health record (EHR) meaningful use incentive program, and physician value-based modifiers (VBMs) become a single program. In 2019, a physician’s individual score on these measures will be used to adjust his or her Medicare payments, and the penalties previously associated with these programs come to an end.

MACRA creates 4 categories of measures that are weighted to calculate an individual physician’s MIPS score:

Physicians will only be assessed on the categories, measures, and activities that apply to them. A physician’s composite score (0–100) will be compared with a performance threshold that reflects all physicians. Those who score above the threshold will receive increased payments; those who score below the threshold will receive reduced payments. Physicians will know these thresholds in advance and will know the score they must reach to avoid penalties and win higher reimbursements in each performance period.

As physicians as a whole improve their performance, the threshold will move with them. So each year, physicians will have the incentive to keep improving their quality, resource use, clinical improvement, and EHR use. A physician’s payment adjustment in one year will not affect his or her payment adjustment in the next year.

The range of potential payment adjustments based on MIPS performance measures increases each year through 2022. Providers who have high scores are rewarded with a 4% increase in 2019. By 2022, the reward is 9%. The program is budget-neutral, so total positive adjustments across all providers will equal total negative adjustments across all providers to poor performers. Separate funds are set aside to reward the highest performers, who will earn bonuses of up to 10% of their fee-for-service payment rate from 2019 through 2024, as well as to help low performers improve and qualify for increased payments from 2016 through 2020.

Help for physicians includes:

Option 2: APMs. Physicians can earn higher fees by opting out of MIPS fee for service and participating in APMs. The law defines qualifying APMs as those that require participating providers to take on “more than nominal” financial risk, report quality measures, and use certified EHR technology.

APMs will cover multiple services, show that they can limit the growth of spending, and use performance-based methods of compensation. These and other provisions will likely continue the trend away from physicians practicing in solo or small-group fee-for-service practices into risk-based multispecialty settings that are subject to increased management and oversight.

From 2019 to 2024, qualified APM physicians will receive a 5% annual lump sum bonus based on their prior year’s physician fee-schedule payments plus shared savings from participation. This bonus is based on patient volume, not just revenue, to make it easier for ObGyns to qualify. To make the bonus widely available, the Secretary of Health and Human Services must test APMs designed for specific specialties and physicians in small practices. As in MIPS, top APM performers will also receive an additional bonus.

To qualify, physicians must meet increasing thresholds for the percentage of their revenue that they receive through APMs. Those who are below but near the required level of APM revenue can be exempted from MIPS adjustments.

Who pays the bill?
Medicare beneficiaries pay more
The new law increases the percentage of Medicare Parts B and D premiums that high-income beneficiaries must pay beginning in 2018:

This change will affect about 2% of Medicare beneficiaries; half of all Medicare beneficiaries currently have annual incomes below $26,000.¹

Medigap “first-dollar coverage” will end
Many Medigap plans on the market today provide “first-dollar coverage” for beneficiaries, which means that the plans pay the deductibles and copayments so that the beneficiaries have no out-of-pocket costs. Beginning in 2020, Medigap plans will only be available to cover costs above the Medicare Part B deductible, currently $147 per year, for new Medigap enrollees. Many lawmakers thought it was important for Medicare beneficiaries to have “skin in the game.”

The law cuts payments for some providers
To partially offset the cost of repealing the SGR, MACRA cuts Medicare payments to hospitals and postacute providers. It:

The law extends many programs
These programs are vital to support the future ObGyn workforce and access to health care. Among these programs are:

Next steps
It’s very important that ObGyns and other physicians use these early years to understand and get ready for the new payment systems. ACOG is developing educational material for our members, and will work closely with our colleague medical organizations and the Department of Health and Human Services to develop key aspects of the law and ensure that it is properly implemented to work for physicians and patients.

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

Congratulations, OBG Management readers! After years of hard work and collective advocacy on your part, the US Congress finally passed, and President Barack Obama quickly signed into law, a permanent repeal of the Medicare Sustainable Growth Rate (SGR) physician payment system. Yes, celebrations are in order.

The US House of Representatives passed the bill, HR 2, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), sponsored by American College of Obstetricians and Gynecologists (ACOG) Fellow and US Rep. ­Michael ­Burgess (R-TX), on March 26, with 382 Republicans and Democrats voting “Yes.” The Senate followed, on April 14, and agreed with the House to repeal, forever, the Medicare SGR, passing the Burgess bill without amendment, on a bipartisan vote of 92–8. With only hours to go before the scheduled 21.2% cut took effect, the President signed the bill, now Public Law (PL) 114-10, on April 16. The President noted that he was “proud to sign the bill into law.” ACOG is proud to have been such an important part of this landmark moment.

SGR: the perennial nemesis of physicians
The SGR has wreaked havoc on medicine and patient care for 15 years or more. Approximately 30,000 ObGyns participate in Medicare, and many private health insurers use Medicare payment policies, as does TriCare, the nation’s health care coverage for military members and their families. The SGR’s effect was felt widely across medicine, making it nearly impossible for physician practices to invest in health information technology and other patient safety advances, or even to plan for the next year or continue accepting Medicare patients.

When it was introduced last year, HR 2 was supported by more than 600 national and state medical societies and specialty organizations, plus patient and provider organizations, policy think tanks, and advocacy groups across the political spectrum.

ACOG Fellows petitioned their members of Congress with incredible passion, perseverance, and commitment to put an end to the SGR wrecking ball. Hundreds flew into Washington, DC, sent thousands of emails, made phone calls, wrote letters, and personally lobbied at home and in the halls of Congress.

Special kudos, too, to our champions in Congress, and there are many, led by ACOG Fellows and US Reps. Dr. Burgess and Phil Roe, MD (R-TN). Burgess wrote the House bill and, together with Roe, pushed nonstop to get this bill over the finish line. It wouldn’t have happened without them.

ACOG worked tirelessly on its own and in coalition with the American Medical Association, surgical groups, and many other partners. We were able to win important provisions in the statute that we anticipate will greatly help ObGyns successfully transition to this new payment system.

PL114-10 replaces the SGR with a new payment system intended to promote care coordination and quality improvement and lead to better health for our nation’s seniors. Congress developed this new payment plan with the physician community, rather than imposing it on us. That’s why throughout the statute, we see repeated requirements that the Secretary of Health and Human Services must develop quality measures, alternative payment models, and a host of key aspects with input from and in consultation with physicians and the relevant medical specialties, ensuring that physicians retain their preeminent roles in these areas. Funding is provided for quality measure development at $15 million per year from 2015 to 2019.

This law will likely change physician practices more than the ACA ever will, and Congress agreed that physicians should be integral to its development to ensure that they can continue to thrive and provide high-quality care and access for their patients.

Let’s take a closer look at the new Medicare payment system—especially what it will mean for your practice.

What the new law does
Important provisions

MACRA stabilizes the Medicare payment system by permanently repealing the SGR and scheduling payments into the future:

Two payment system options reward continuous quality improvement
Option 1: MIPS. MACRA consolidates and expands pay-for-performance incentives within the old SGR fee-for-service system, creating the new MIPS. Under MIPS, the Physician Quality Reporting System (PQRS), electronic health record (EHR) meaningful use incentive program, and physician value-based modifiers (VBMs) become a single program. In 2019, a physician’s individual score on these measures will be used to adjust his or her Medicare payments, and the penalties previously associated with these programs come to an end.

MACRA creates 4 categories of measures that are weighted to calculate an individual physician’s MIPS score:

Physicians will only be assessed on the categories, measures, and activities that apply to them. A physician’s composite score (0–100) will be compared with a performance threshold that reflects all physicians. Those who score above the threshold will receive increased payments; those who score below the threshold will receive reduced payments. Physicians will know these thresholds in advance and will know the score they must reach to avoid penalties and win higher reimbursements in each performance period.

As physicians as a whole improve their performance, the threshold will move with them. So each year, physicians will have the incentive to keep improving their quality, resource use, clinical improvement, and EHR use. A physician’s payment adjustment in one year will not affect his or her payment adjustment in the next year.

The range of potential payment adjustments based on MIPS performance measures increases each year through 2022. Providers who have high scores are rewarded with a 4% increase in 2019. By 2022, the reward is 9%. The program is budget-neutral, so total positive adjustments across all providers will equal total negative adjustments across all providers to poor performers. Separate funds are set aside to reward the highest performers, who will earn bonuses of up to 10% of their fee-for-service payment rate from 2019 through 2024, as well as to help low performers improve and qualify for increased payments from 2016 through 2020.

Help for physicians includes:

Option 2: APMs. Physicians can earn higher fees by opting out of MIPS fee for service and participating in APMs. The law defines qualifying APMs as those that require participating providers to take on “more than nominal” financial risk, report quality measures, and use certified EHR technology.

APMs will cover multiple services, show that they can limit the growth of spending, and use performance-based methods of compensation. These and other provisions will likely continue the trend away from physicians practicing in solo or small-group fee-for-service practices into risk-based multispecialty settings that are subject to increased management and oversight.

From 2019 to 2024, qualified APM physicians will receive a 5% annual lump sum bonus based on their prior year’s physician fee-schedule payments plus shared savings from participation. This bonus is based on patient volume, not just revenue, to make it easier for ObGyns to qualify. To make the bonus widely available, the Secretary of Health and Human Services must test APMs designed for specific specialties and physicians in small practices. As in MIPS, top APM performers will also receive an additional bonus.

To qualify, physicians must meet increasing thresholds for the percentage of their revenue that they receive through APMs. Those who are below but near the required level of APM revenue can be exempted from MIPS adjustments.

Who pays the bill?
Medicare beneficiaries pay more
The new law increases the percentage of Medicare Parts B and D premiums that high-income beneficiaries must pay beginning in 2018:

This change will affect about 2% of Medicare beneficiaries; half of all Medicare beneficiaries currently have annual incomes below $26,000.¹

Medigap “first-dollar coverage” will end
Many Medigap plans on the market today provide “first-dollar coverage” for beneficiaries, which means that the plans pay the deductibles and copayments so that the beneficiaries have no out-of-pocket costs. Beginning in 2020, Medigap plans will only be available to cover costs above the Medicare Part B deductible, currently $147 per year, for new Medigap enrollees. Many lawmakers thought it was important for Medicare beneficiaries to have “skin in the game.”

The law cuts payments for some providers
To partially offset the cost of repealing the SGR, MACRA cuts Medicare payments to hospitals and postacute providers. It:

The law extends many programs
These programs are vital to support the future ObGyn workforce and access to health care. Among these programs are:

Next steps
It’s very important that ObGyns and other physicians use these early years to understand and get ready for the new payment systems. ACOG is developing educational material for our members, and will work closely with our colleague medical organizations and the Department of Health and Human Services to develop key aspects of the law and ensure that it is properly implemented to work for physicians and patients.

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

Congratulations, OBG Management readers! After years of hard work and collective advocacy on your part, the US Congress finally passed, and President Barack Obama quickly signed into law, a permanent repeal of the Medicare Sustainable Growth Rate (SGR) physician payment system. Yes, celebrations are in order.

The US House of Representatives passed the bill, HR 2, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), sponsored by American College of Obstetricians and Gynecologists (ACOG) Fellow and US Rep. ­Michael ­Burgess (R-TX), on March 26, with 382 Republicans and Democrats voting “Yes.” The Senate followed, on April 14, and agreed with the House to repeal, forever, the Medicare SGR, passing the Burgess bill without amendment, on a bipartisan vote of 92–8. With only hours to go before the scheduled 21.2% cut took effect, the President signed the bill, now Public Law (PL) 114-10, on April 16. The President noted that he was “proud to sign the bill into law.” ACOG is proud to have been such an important part of this landmark moment.

SGR: the perennial nemesis of physicians
The SGR has wreaked havoc on medicine and patient care for 15 years or more. Approximately 30,000 ObGyns participate in Medicare, and many private health insurers use Medicare payment policies, as does TriCare, the nation’s health care coverage for military members and their families. The SGR’s effect was felt widely across medicine, making it nearly impossible for physician practices to invest in health information technology and other patient safety advances, or even to plan for the next year or continue accepting Medicare patients.

When it was introduced last year, HR 2 was supported by more than 600 national and state medical societies and specialty organizations, plus patient and provider organizations, policy think tanks, and advocacy groups across the political spectrum.

ACOG Fellows petitioned their members of Congress with incredible passion, perseverance, and commitment to put an end to the SGR wrecking ball. Hundreds flew into Washington, DC, sent thousands of emails, made phone calls, wrote letters, and personally lobbied at home and in the halls of Congress.

Special kudos, too, to our champions in Congress, and there are many, led by ACOG Fellows and US Reps. Dr. Burgess and Phil Roe, MD (R-TN). Burgess wrote the House bill and, together with Roe, pushed nonstop to get this bill over the finish line. It wouldn’t have happened without them.

ACOG worked tirelessly on its own and in coalition with the American Medical Association, surgical groups, and many other partners. We were able to win important provisions in the statute that we anticipate will greatly help ObGyns successfully transition to this new payment system.

PL114-10 replaces the SGR with a new payment system intended to promote care coordination and quality improvement and lead to better health for our nation’s seniors. Congress developed this new payment plan with the physician community, rather than imposing it on us. That’s why throughout the statute, we see repeated requirements that the Secretary of Health and Human Services must develop quality measures, alternative payment models, and a host of key aspects with input from and in consultation with physicians and the relevant medical specialties, ensuring that physicians retain their preeminent roles in these areas. Funding is provided for quality measure development at $15 million per year from 2015 to 2019.

This law will likely change physician practices more than the ACA ever will, and Congress agreed that physicians should be integral to its development to ensure that they can continue to thrive and provide high-quality care and access for their patients.

Let’s take a closer look at the new Medicare payment system—especially what it will mean for your practice.

What the new law does
Important provisions

MACRA stabilizes the Medicare payment system by permanently repealing the SGR and scheduling payments into the future:

Two payment system options reward continuous quality improvement
Option 1: MIPS. MACRA consolidates and expands pay-for-performance incentives within the old SGR fee-for-service system, creating the new MIPS. Under MIPS, the Physician Quality Reporting System (PQRS), electronic health record (EHR) meaningful use incentive program, and physician value-based modifiers (VBMs) become a single program. In 2019, a physician’s individual score on these measures will be used to adjust his or her Medicare payments, and the penalties previously associated with these programs come to an end.

MACRA creates 4 categories of measures that are weighted to calculate an individual physician’s MIPS score:

Physicians will only be assessed on the categories, measures, and activities that apply to them. A physician’s composite score (0–100) will be compared with a performance threshold that reflects all physicians. Those who score above the threshold will receive increased payments; those who score below the threshold will receive reduced payments. Physicians will know these thresholds in advance and will know the score they must reach to avoid penalties and win higher reimbursements in each performance period.

As physicians as a whole improve their performance, the threshold will move with them. So each year, physicians will have the incentive to keep improving their quality, resource use, clinical improvement, and EHR use. A physician’s payment adjustment in one year will not affect his or her payment adjustment in the next year.

The range of potential payment adjustments based on MIPS performance measures increases each year through 2022. Providers who have high scores are rewarded with a 4% increase in 2019. By 2022, the reward is 9%. The program is budget-neutral, so total positive adjustments across all providers will equal total negative adjustments across all providers to poor performers. Separate funds are set aside to reward the highest performers, who will earn bonuses of up to 10% of their fee-for-service payment rate from 2019 through 2024, as well as to help low performers improve and qualify for increased payments from 2016 through 2020.

Help for physicians includes:

Option 2: APMs. Physicians can earn higher fees by opting out of MIPS fee for service and participating in APMs. The law defines qualifying APMs as those that require participating providers to take on “more than nominal” financial risk, report quality measures, and use certified EHR technology.

APMs will cover multiple services, show that they can limit the growth of spending, and use performance-based methods of compensation. These and other provisions will likely continue the trend away from physicians practicing in solo or small-group fee-for-service practices into risk-based multispecialty settings that are subject to increased management and oversight.

From 2019 to 2024, qualified APM physicians will receive a 5% annual lump sum bonus based on their prior year’s physician fee-schedule payments plus shared savings from participation. This bonus is based on patient volume, not just revenue, to make it easier for ObGyns to qualify. To make the bonus widely available, the Secretary of Health and Human Services must test APMs designed for specific specialties and physicians in small practices. As in MIPS, top APM performers will also receive an additional bonus.

To qualify, physicians must meet increasing thresholds for the percentage of their revenue that they receive through APMs. Those who are below but near the required level of APM revenue can be exempted from MIPS adjustments.

Who pays the bill?
Medicare beneficiaries pay more
The new law increases the percentage of Medicare Parts B and D premiums that high-income beneficiaries must pay beginning in 2018:

This change will affect about 2% of Medicare beneficiaries; half of all Medicare beneficiaries currently have annual incomes below $26,000.¹

Medigap “first-dollar coverage” will end
Many Medigap plans on the market today provide “first-dollar coverage” for beneficiaries, which means that the plans pay the deductibles and copayments so that the beneficiaries have no out-of-pocket costs. Beginning in 2020, Medigap plans will only be available to cover costs above the Medicare Part B deductible, currently $147 per year, for new Medigap enrollees. Many lawmakers thought it was important for Medicare beneficiaries to have “skin in the game.”

The law cuts payments for some providers
To partially offset the cost of repealing the SGR, MACRA cuts Medicare payments to hospitals and postacute providers. It:

The law extends many programs
These programs are vital to support the future ObGyn workforce and access to health care. Among these programs are:

Next steps
It’s very important that ObGyns and other physicians use these early years to understand and get ready for the new payment systems. ACOG is developing educational material for our members, and will work closely with our colleague medical organizations and the Department of Health and Human Services to develop key aspects of the law and ensure that it is properly implemented to work for physicians and patients.

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Warfarin tablets

Anticoagulant bridge therapy may be harmful for patients with a low to moderate risk of venous thromboembolism (VTE), according to research published in JAMA Internal Medicine.

The study included more than 1000 patients with VTE who had to stop receiving warfarin prior to a procedure.

Investigators compared outcomes in patients who received bridge therapy—a short-acting anticoagulant during the periprocedural period—and patients who did not.

Nathan Clark, PharmD, of Kaiser Permanente Colorado in Aurora, and his colleagues conducted this research.

They examined the electronic medical records of 1178 patients with VTE who underwent 1812 invasive diagnostic or surgical procedures between January 2006 and March 2012 that required the interruption of warfarin.

The investigators divided patients into 3 groups based on their annual risk of VTE recurrence without anticoagulant therapy. Seventy-nine percent of patients were categorized as low-risk, 17.9% as moderate-risk, and 3.1% as high-risk.

The team then divided patients according to the use of bridge therapy. Of the 1812 procedures, 555 included bridge therapy, and 1257 did not.

Patients in the bridged group had a significantly higher incidence of clinically relevant bleeding at 30 days than patients in the non-bridged group—2.7% and 0.2%, respectively (P=0.01).

When the investigators assessed patients according to VTE risk, they found the increased incidence of bleeding in the bridged group was significant among low-risk patients (2.0% vs 0.1%, P<0.001) and moderate-risk patients (4.6% vs 0%, P=0.004) but not high-risk patients (5.6% vs 4.8%, P=0.90).

On the other hand, there was no significant difference in VTE recurrence between the bridged and non-bridged groups—for all risk categories (0 vs 3 cases, P=0.56), low-risk patients (0 vs 2, P=0.37), moderate-risk patients (0 vs 1, P=0.48), or high-risk patients (0 vs 0, P>0.99)

The investigators said further research is needed to identify patient and procedure-related characteristics associated with the highest risk for perioperative VTE recurrence where targeted bridge therapy may be beneficial.

Warfarin tablets

Anticoagulant bridge therapy may be harmful for patients with a low to moderate risk of venous thromboembolism (VTE), according to research published in JAMA Internal Medicine.

The study included more than 1000 patients with VTE who had to stop receiving warfarin prior to a procedure.

Investigators compared outcomes in patients who received bridge therapy—a short-acting anticoagulant during the periprocedural period—and patients who did not.

Nathan Clark, PharmD, of Kaiser Permanente Colorado in Aurora, and his colleagues conducted this research.

They examined the electronic medical records of 1178 patients with VTE who underwent 1812 invasive diagnostic or surgical procedures between January 2006 and March 2012 that required the interruption of warfarin.

The investigators divided patients into 3 groups based on their annual risk of VTE recurrence without anticoagulant therapy. Seventy-nine percent of patients were categorized as low-risk, 17.9% as moderate-risk, and 3.1% as high-risk.

The team then divided patients according to the use of bridge therapy. Of the 1812 procedures, 555 included bridge therapy, and 1257 did not.

Patients in the bridged group had a significantly higher incidence of clinically relevant bleeding at 30 days than patients in the non-bridged group—2.7% and 0.2%, respectively (P=0.01).

When the investigators assessed patients according to VTE risk, they found the increased incidence of bleeding in the bridged group was significant among low-risk patients (2.0% vs 0.1%, P<0.001) and moderate-risk patients (4.6% vs 0%, P=0.004) but not high-risk patients (5.6% vs 4.8%, P=0.90).

On the other hand, there was no significant difference in VTE recurrence between the bridged and non-bridged groups—for all risk categories (0 vs 3 cases, P=0.56), low-risk patients (0 vs 2, P=0.37), moderate-risk patients (0 vs 1, P=0.48), or high-risk patients (0 vs 0, P>0.99)

The investigators said further research is needed to identify patient and procedure-related characteristics associated with the highest risk for perioperative VTE recurrence where targeted bridge therapy may be beneficial.

Warfarin tablets

Anticoagulant bridge therapy may be harmful for patients with a low to moderate risk of venous thromboembolism (VTE), according to research published in JAMA Internal Medicine.

The study included more than 1000 patients with VTE who had to stop receiving warfarin prior to a procedure.

Investigators compared outcomes in patients who received bridge therapy—a short-acting anticoagulant during the periprocedural period—and patients who did not.

Nathan Clark, PharmD, of Kaiser Permanente Colorado in Aurora, and his colleagues conducted this research.

They examined the electronic medical records of 1178 patients with VTE who underwent 1812 invasive diagnostic or surgical procedures between January 2006 and March 2012 that required the interruption of warfarin.

The investigators divided patients into 3 groups based on their annual risk of VTE recurrence without anticoagulant therapy. Seventy-nine percent of patients were categorized as low-risk, 17.9% as moderate-risk, and 3.1% as high-risk.

The team then divided patients according to the use of bridge therapy. Of the 1812 procedures, 555 included bridge therapy, and 1257 did not.

Patients in the bridged group had a significantly higher incidence of clinically relevant bleeding at 30 days than patients in the non-bridged group—2.7% and 0.2%, respectively (P=0.01).

When the investigators assessed patients according to VTE risk, they found the increased incidence of bleeding in the bridged group was significant among low-risk patients (2.0% vs 0.1%, P<0.001) and moderate-risk patients (4.6% vs 0%, P=0.004) but not high-risk patients (5.6% vs 4.8%, P=0.90).

On the other hand, there was no significant difference in VTE recurrence between the bridged and non-bridged groups—for all risk categories (0 vs 3 cases, P=0.56), low-risk patients (0 vs 2, P=0.37), moderate-risk patients (0 vs 1, P=0.48), or high-risk patients (0 vs 0, P>0.99)

The investigators said further research is needed to identify patient and procedure-related characteristics associated with the highest risk for perioperative VTE recurrence where targeted bridge therapy may be beneficial.

Preparation for HSCT

Photo by Chad McNeeley

Research has shown that caring for cancer patients after hematopoietic stem cell transplant (HSCT) can have negative psychological effects on the caregiver, but results of a new study suggest a psychosocial intervention could change that.

The trial showed that counseling sessions focused on stress management could significantly reduce stress, anxiety, depression, and mood disturbance among these caregivers.

“The first 100 days after a stem cell transplant is a critical period for patients, in which caregivers are called upon to deliver around-the-clock care, providing support for patients’ everyday needs and also patients’ emotional health, but who takes care of the caregivers?” asked Mark Laudenslager, PhD, of the University of Colorado Denver.

To address this problem, Dr Laudenslager and his colleagues studied 148 caregivers of patients who underwent allogeneic HSCT. The team described this research in Bone Marrow Transplantation.

The caregivers were randomized to a group that was offered a psychosocial intervention (n=74) and a group that received standard treatment, in which mental health support services were available but not required (n=74).

In the experimental group, caregivers attended 8 sessions on stress management. These one-on-one sessions focused on understanding stress and its physical consequences, changing roles as caregivers, cognitive behavioral stress management, pacing respiration, and identifying social support. The researchers call this intervention PsychoEducation, Paced Respiration and Relaxation (PEPRR).

After a patient underwent HSCT, Dr Laudenslager and his colleagues used several questionnaires to follow the trajectory of caregiver distress over time. The questionnaires were used to measure stress, depression, anxiety, mood disturbance, sleep quality, and other mental health outcomes.

There was no significant difference in stress or other mental health measures between the 2 treatment groups at baseline.

However, at 3 months after transplant, caregivers in the PEPRR group saw some significant improvements over caregivers in the standard treatment group.

The PEPRR group had less stress according to the Perceived Stress Scale (P=0.039), less depression according to the Center for Epidemiologic Studies Depression test (P=0.016), less anxiety according to the State-Trait Anxiety Inventory-State questionnaire (P=0.0009), and less mood disturbance according to the Profile of Mood States-Total Mood Disturbance test (P=0.039).

Overall caregiver distress (composite scores from the questionnaires) was significantly lower in the PEPRR group than the standard treatment group (P=0.019).

However, there was no significant difference in caregiver well-being (composite scores) or scores on the Caregiver Reaction Assessment, Pittsburgh Sleep Quality Index, Short Form 36 Health Survey, or Impact of Events scale.

Still, the other improvements caregivers experienced suggest PEPRR is a promising intervention, Dr Laudenslager said.

He and his colleagues are now recruiting subjects for a follow-up study (NCT02037568) focused on evaluating quality of life in allogeneic HSCT recipients whose caregivers participate in programs similar to the PEPRR intervention.

Preparation for HSCT

Photo by Chad McNeeley

Research has shown that caring for cancer patients after hematopoietic stem cell transplant (HSCT) can have negative psychological effects on the caregiver, but results of a new study suggest a psychosocial intervention could change that.

The trial showed that counseling sessions focused on stress management could significantly reduce stress, anxiety, depression, and mood disturbance among these caregivers.

“The first 100 days after a stem cell transplant is a critical period for patients, in which caregivers are called upon to deliver around-the-clock care, providing support for patients’ everyday needs and also patients’ emotional health, but who takes care of the caregivers?” asked Mark Laudenslager, PhD, of the University of Colorado Denver.

To address this problem, Dr Laudenslager and his colleagues studied 148 caregivers of patients who underwent allogeneic HSCT. The team described this research in Bone Marrow Transplantation.

The caregivers were randomized to a group that was offered a psychosocial intervention (n=74) and a group that received standard treatment, in which mental health support services were available but not required (n=74).

In the experimental group, caregivers attended 8 sessions on stress management. These one-on-one sessions focused on understanding stress and its physical consequences, changing roles as caregivers, cognitive behavioral stress management, pacing respiration, and identifying social support. The researchers call this intervention PsychoEducation, Paced Respiration and Relaxation (PEPRR).

After a patient underwent HSCT, Dr Laudenslager and his colleagues used several questionnaires to follow the trajectory of caregiver distress over time. The questionnaires were used to measure stress, depression, anxiety, mood disturbance, sleep quality, and other mental health outcomes.

There was no significant difference in stress or other mental health measures between the 2 treatment groups at baseline.

However, at 3 months after transplant, caregivers in the PEPRR group saw some significant improvements over caregivers in the standard treatment group.

The PEPRR group had less stress according to the Perceived Stress Scale (P=0.039), less depression according to the Center for Epidemiologic Studies Depression test (P=0.016), less anxiety according to the State-Trait Anxiety Inventory-State questionnaire (P=0.0009), and less mood disturbance according to the Profile of Mood States-Total Mood Disturbance test (P=0.039).

Overall caregiver distress (composite scores from the questionnaires) was significantly lower in the PEPRR group than the standard treatment group (P=0.019).

However, there was no significant difference in caregiver well-being (composite scores) or scores on the Caregiver Reaction Assessment, Pittsburgh Sleep Quality Index, Short Form 36 Health Survey, or Impact of Events scale.

Still, the other improvements caregivers experienced suggest PEPRR is a promising intervention, Dr Laudenslager said.

He and his colleagues are now recruiting subjects for a follow-up study (NCT02037568) focused on evaluating quality of life in allogeneic HSCT recipients whose caregivers participate in programs similar to the PEPRR intervention.

Preparation for HSCT

Photo by Chad McNeeley

Research has shown that caring for cancer patients after hematopoietic stem cell transplant (HSCT) can have negative psychological effects on the caregiver, but results of a new study suggest a psychosocial intervention could change that.

The trial showed that counseling sessions focused on stress management could significantly reduce stress, anxiety, depression, and mood disturbance among these caregivers.

“The first 100 days after a stem cell transplant is a critical period for patients, in which caregivers are called upon to deliver around-the-clock care, providing support for patients’ everyday needs and also patients’ emotional health, but who takes care of the caregivers?” asked Mark Laudenslager, PhD, of the University of Colorado Denver.

To address this problem, Dr Laudenslager and his colleagues studied 148 caregivers of patients who underwent allogeneic HSCT. The team described this research in Bone Marrow Transplantation.

The caregivers were randomized to a group that was offered a psychosocial intervention (n=74) and a group that received standard treatment, in which mental health support services were available but not required (n=74).

In the experimental group, caregivers attended 8 sessions on stress management. These one-on-one sessions focused on understanding stress and its physical consequences, changing roles as caregivers, cognitive behavioral stress management, pacing respiration, and identifying social support. The researchers call this intervention PsychoEducation, Paced Respiration and Relaxation (PEPRR).

After a patient underwent HSCT, Dr Laudenslager and his colleagues used several questionnaires to follow the trajectory of caregiver distress over time. The questionnaires were used to measure stress, depression, anxiety, mood disturbance, sleep quality, and other mental health outcomes.

There was no significant difference in stress or other mental health measures between the 2 treatment groups at baseline.

However, at 3 months after transplant, caregivers in the PEPRR group saw some significant improvements over caregivers in the standard treatment group.

The PEPRR group had less stress according to the Perceived Stress Scale (P=0.039), less depression according to the Center for Epidemiologic Studies Depression test (P=0.016), less anxiety according to the State-Trait Anxiety Inventory-State questionnaire (P=0.0009), and less mood disturbance according to the Profile of Mood States-Total Mood Disturbance test (P=0.039).

Overall caregiver distress (composite scores from the questionnaires) was significantly lower in the PEPRR group than the standard treatment group (P=0.019).

However, there was no significant difference in caregiver well-being (composite scores) or scores on the Caregiver Reaction Assessment, Pittsburgh Sleep Quality Index, Short Form 36 Health Survey, or Impact of Events scale.

Still, the other improvements caregivers experienced suggest PEPRR is a promising intervention, Dr Laudenslager said.

He and his colleagues are now recruiting subjects for a follow-up study (NCT02037568) focused on evaluating quality of life in allogeneic HSCT recipients whose caregivers participate in programs similar to the PEPRR intervention.

Micrograph showing HL

LONDON—Results of a small, phase 1 trial suggest CD30-directed chimeric antigen receptor (CAR) T-cell therapy is feasible in patients with aggressive Hodgkin lymphoma (HL).

The trial included 7 patients with relapsed or refractory HL.

Five of the patients achieved stable disease or better after infusions of CAR T cells, and the researchers said treatment-related adverse events were manageable.

William (Wei) Cao, PhD, of Cellular Biomedicine Group, presented these results at the 10th Annual World Stem Cells & Regenerative Medicine Congress.

The research was funded by Cellular Biomedicine Group, the company developing the CAR T-cell therapy (known as CBM-C30.1), as well as by grants from the National Natural Science Foundation of China and the National Basic Science and Development Program of China.

The trial included 7 patients with progressive HL. Two patients had stage III disease, and 5 had stage IV. The patients had a median of 16 prior treatments (range, 8-24) and limited prognosis (several months to less than 2-year survival) with currently available therapies.

The patients received escalating doses of autologous T cells transduced with a CD30-directed CAR moiety for 3 to 5 days, following a conditioning regimen. The researchers measured the level of CAR transgenes in peripheral blood and biopsied tumor tissues by quantitative PCR.

Two patients achieved a partial response to CAR T-cell therapy, and 3 attained stable disease. So the therapy resulted in an overall disease control rate of 71.4% (5/7) and an objective response rate of 28.6% (2/7).

Stable disease lasted 2 months in 2 of the patients and more than 3.5 months in the third patient. Partial response lasted more than 2 months in 1 patient and more than 3.5 months in the other.

Dr Cao said adverse events consisted largely of fever and were manageable with medical intervention. One patient experienced 5-day self-limiting arthralgia, myalgia, and dual knee swelling 2 weeks after cell infusion. There were no delayed or severe adverse events.

“We are very encouraged by the efficacy and toxicity profile of our CAR-T CD30 technology,” Dr Cao said, “given that the [patients] were diagnosed with stage III and IV Hodgkin’s lymphoma.”

Micrograph showing HL

LONDON—Results of a small, phase 1 trial suggest CD30-directed chimeric antigen receptor (CAR) T-cell therapy is feasible in patients with aggressive Hodgkin lymphoma (HL).

The trial included 7 patients with relapsed or refractory HL.

Five of the patients achieved stable disease or better after infusions of CAR T cells, and the researchers said treatment-related adverse events were manageable.

William (Wei) Cao, PhD, of Cellular Biomedicine Group, presented these results at the 10th Annual World Stem Cells & Regenerative Medicine Congress.

The research was funded by Cellular Biomedicine Group, the company developing the CAR T-cell therapy (known as CBM-C30.1), as well as by grants from the National Natural Science Foundation of China and the National Basic Science and Development Program of China.

The trial included 7 patients with progressive HL. Two patients had stage III disease, and 5 had stage IV. The patients had a median of 16 prior treatments (range, 8-24) and limited prognosis (several months to less than 2-year survival) with currently available therapies.

The patients received escalating doses of autologous T cells transduced with a CD30-directed CAR moiety for 3 to 5 days, following a conditioning regimen. The researchers measured the level of CAR transgenes in peripheral blood and biopsied tumor tissues by quantitative PCR.

Two patients achieved a partial response to CAR T-cell therapy, and 3 attained stable disease. So the therapy resulted in an overall disease control rate of 71.4% (5/7) and an objective response rate of 28.6% (2/7).

Stable disease lasted 2 months in 2 of the patients and more than 3.5 months in the third patient. Partial response lasted more than 2 months in 1 patient and more than 3.5 months in the other.

Dr Cao said adverse events consisted largely of fever and were manageable with medical intervention. One patient experienced 5-day self-limiting arthralgia, myalgia, and dual knee swelling 2 weeks after cell infusion. There were no delayed or severe adverse events.

“We are very encouraged by the efficacy and toxicity profile of our CAR-T CD30 technology,” Dr Cao said, “given that the [patients] were diagnosed with stage III and IV Hodgkin’s lymphoma.”

Micrograph showing HL

LONDON—Results of a small, phase 1 trial suggest CD30-directed chimeric antigen receptor (CAR) T-cell therapy is feasible in patients with aggressive Hodgkin lymphoma (HL).

The trial included 7 patients with relapsed or refractory HL.

Five of the patients achieved stable disease or better after infusions of CAR T cells, and the researchers said treatment-related adverse events were manageable.

William (Wei) Cao, PhD, of Cellular Biomedicine Group, presented these results at the 10th Annual World Stem Cells & Regenerative Medicine Congress.

The research was funded by Cellular Biomedicine Group, the company developing the CAR T-cell therapy (known as CBM-C30.1), as well as by grants from the National Natural Science Foundation of China and the National Basic Science and Development Program of China.

The trial included 7 patients with progressive HL. Two patients had stage III disease, and 5 had stage IV. The patients had a median of 16 prior treatments (range, 8-24) and limited prognosis (several months to less than 2-year survival) with currently available therapies.

The patients received escalating doses of autologous T cells transduced with a CD30-directed CAR moiety for 3 to 5 days, following a conditioning regimen. The researchers measured the level of CAR transgenes in peripheral blood and biopsied tumor tissues by quantitative PCR.

Two patients achieved a partial response to CAR T-cell therapy, and 3 attained stable disease. So the therapy resulted in an overall disease control rate of 71.4% (5/7) and an objective response rate of 28.6% (2/7).

Stable disease lasted 2 months in 2 of the patients and more than 3.5 months in the third patient. Partial response lasted more than 2 months in 1 patient and more than 3.5 months in the other.

Dr Cao said adverse events consisted largely of fever and were manageable with medical intervention. One patient experienced 5-day self-limiting arthralgia, myalgia, and dual knee swelling 2 weeks after cell infusion. There were no delayed or severe adverse events.

“We are very encouraged by the efficacy and toxicity profile of our CAR-T CD30 technology,” Dr Cao said, “given that the [patients] were diagnosed with stage III and IV Hodgkin’s lymphoma.”

Blood for transfusion

Photo by Elise Amendola

A patient blood management (PBM) program can reduce transfusion use, cut costs, and improve outcomes in cardiac surgery patients, according to a single-center study.

A PBM program instituted at Eastern Maine Medical Center (EMMC) in Bangor substantially decreased the use of blood products, the loss of red blood cells, the length of hospital stays, the incidence of acute kidney injury, and direct costs.

Irwin Gross, MD, of EMMC, and his colleagues reported these results in Transfusion.

The team compared clinical and transfusion data from cardiac surgery patients treated at the center before the PBM program began (July 2006-March 2007) and after (April 2007-September 2012).

EMMC’s PBM initiative involved pre- and post-operative anemia management, a more restrictive transfusion threshold, the use of single-unit transfusions when necessary, and other measures.

The researchers analyzed data on 2662 patients, 387 treated before the PBM program began and 2275 treated after.

As expected, the rate of transfusions decreased after the PBM program began. The rate of red blood cell transfusion decreased from 39.3% to 20.8% (P<0.001), the rate of fresh-frozen plasma transfusion decreased from 18.3% to 6.5% (P<0.001), and the rate of platelet transfusion decreased from 17.8% to 9.8% (P<0.001).

Red blood cell loss decreased from a median of 721 mL to 552 mL (P<0.001), and pre-transfusion hemoglobin decreased from a mean of 7.2 ± 1.4 g/dL to 6.6 ± 1.2 g/dL (P<0.001).

Patients saw a decrease in the incidence of post-operative kidney injury from 7.6% to 5.0% (P=0.039) and a decrease in the median length of hospital stay from 10 days to 8 days (P<0.001).

Total adjusted direct costs decreased after the program began as well, falling from a median of $39,709 to $36,906 (P< 0.001).

There was no significant difference in the rate of hospital mortality or the incidence of cerebral vascular accident before and after the PBM program began.

Blood for transfusion

Photo by Elise Amendola

A patient blood management (PBM) program can reduce transfusion use, cut costs, and improve outcomes in cardiac surgery patients, according to a single-center study.

A PBM program instituted at Eastern Maine Medical Center (EMMC) in Bangor substantially decreased the use of blood products, the loss of red blood cells, the length of hospital stays, the incidence of acute kidney injury, and direct costs.

Irwin Gross, MD, of EMMC, and his colleagues reported these results in Transfusion.

The team compared clinical and transfusion data from cardiac surgery patients treated at the center before the PBM program began (July 2006-March 2007) and after (April 2007-September 2012).

EMMC’s PBM initiative involved pre- and post-operative anemia management, a more restrictive transfusion threshold, the use of single-unit transfusions when necessary, and other measures.

The researchers analyzed data on 2662 patients, 387 treated before the PBM program began and 2275 treated after.

As expected, the rate of transfusions decreased after the PBM program began. The rate of red blood cell transfusion decreased from 39.3% to 20.8% (P<0.001), the rate of fresh-frozen plasma transfusion decreased from 18.3% to 6.5% (P<0.001), and the rate of platelet transfusion decreased from 17.8% to 9.8% (P<0.001).

Red blood cell loss decreased from a median of 721 mL to 552 mL (P<0.001), and pre-transfusion hemoglobin decreased from a mean of 7.2 ± 1.4 g/dL to 6.6 ± 1.2 g/dL (P<0.001).

Patients saw a decrease in the incidence of post-operative kidney injury from 7.6% to 5.0% (P=0.039) and a decrease in the median length of hospital stay from 10 days to 8 days (P<0.001).

Total adjusted direct costs decreased after the program began as well, falling from a median of $39,709 to $36,906 (P< 0.001).

There was no significant difference in the rate of hospital mortality or the incidence of cerebral vascular accident before and after the PBM program began.

Blood for transfusion

Photo by Elise Amendola

A patient blood management (PBM) program can reduce transfusion use, cut costs, and improve outcomes in cardiac surgery patients, according to a single-center study.

A PBM program instituted at Eastern Maine Medical Center (EMMC) in Bangor substantially decreased the use of blood products, the loss of red blood cells, the length of hospital stays, the incidence of acute kidney injury, and direct costs.

Irwin Gross, MD, of EMMC, and his colleagues reported these results in Transfusion.

The team compared clinical and transfusion data from cardiac surgery patients treated at the center before the PBM program began (July 2006-March 2007) and after (April 2007-September 2012).

EMMC’s PBM initiative involved pre- and post-operative anemia management, a more restrictive transfusion threshold, the use of single-unit transfusions when necessary, and other measures.

The researchers analyzed data on 2662 patients, 387 treated before the PBM program began and 2275 treated after.

As expected, the rate of transfusions decreased after the PBM program began. The rate of red blood cell transfusion decreased from 39.3% to 20.8% (P<0.001), the rate of fresh-frozen plasma transfusion decreased from 18.3% to 6.5% (P<0.001), and the rate of platelet transfusion decreased from 17.8% to 9.8% (P<0.001).

Red blood cell loss decreased from a median of 721 mL to 552 mL (P<0.001), and pre-transfusion hemoglobin decreased from a mean of 7.2 ± 1.4 g/dL to 6.6 ± 1.2 g/dL (P<0.001).

Patients saw a decrease in the incidence of post-operative kidney injury from 7.6% to 5.0% (P=0.039) and a decrease in the median length of hospital stay from 10 days to 8 days (P<0.001).

Total adjusted direct costs decreased after the program began as well, falling from a median of $39,709 to $36,906 (P< 0.001).

There was no significant difference in the rate of hospital mortality or the incidence of cerebral vascular accident before and after the PBM program began.

Pedicle subtraction osteotomies (PSOs) have been used in the treatment of multiple spinal conditions involving a fixed sagittal imbalance, such as degenerative scoliosis, idiopathic scoliosis, posttraumatic deformities, iatrogenic flatback syndrome, and ankylosing spondylitis. The procedure was first described by Thomasen¹ for the treatment of ankylosing spondylitis. More recently, multiple centers have reported the expanded use and good success of PSO in the treatment of fixed sagittal imbalance of other etiologies.^2,3 According to Bridwell and colleagues,² lumbar lordosis can be increased 34.1°, and sagittal plumb line can be improved 13.5 cm.

PSO is a complex, extensive surgery most often performed in the revision setting. Multiple authors have described the technique for PSO.^4,5 There are significant technical challenges and many complications, including neurologic deficits, pseudarthrosis of adjacent levels, and wound infections.⁶ Short-term challenges include a large loss of blood, 2.4 L on average, according to Bridwell and colleagues.⁶ Time of closure of the osteotomy gap is a crucial point in the surgery. Blood loss, often large, slows only after the gap is closed and stabilized.

In this article, we describe a technique in which an additional rod or pedicle screw construct is used at the periosteotomy levels to close the osteotomy gap during PSO and simplify subsequent instrumentation. In addition, we report our experience with the procedure.

Materials and Methods

Seventeen consecutive patients (mean age, 58 years; range, 12-81 years) with fixed sagittal imbalance were treated with lumbar PSO. The indication in all cases was flatback syndrome after previous spinal surgery. Mean follow-up was 13 months. Mean number of prior surgeries was 3. Thirteen PSOs were performed at L3, and 4 were performed at L2.

Radiographic data were collected from before surgery, in the immediate postoperative period, and at final follow-up. All the radiographs were standing films. Established radiographic parameters were measured: thoracic kyphosis from T5 to T12, lumbar lordosis from L1 to S1, PSO angle (1 level above to 1 level below osteotomy level), sagittal plumb line (from center of C7 body to posterosuperior aspect of S1 body), and coronal plumb line (from center of C7 body to center of S1 body).²

Good clinical outcomes in the treatment of spinal disorders require careful attention to the alignment of the spine in the sagittal plane.^7,8 When evaluating the preoperative radiographs, we measured and documented pelvic parameters. Figure 1A shows how pelvic incidence was determined. We measured this as the angle between a line drawn from the center of the S1 endplate to the center of the femoral head and the perpendicular off the S1 endplate. Figure 1B shows pelvic tilt as determined by the angle between a line drawn from the center of S1 to the femoral head and a vertical line originating from the center of the femoral head. Figure 1C shows the sacral slope, which we measured as the angle between a line drawn parallel to the endplate of S1 and its intersection with a horizontal line.

Surgical Technique

The overall surgical technique for PSO has been well described.^4,5 Here we describe the “outrigger” modification to osteotomy closure (Figures 2, 3).

Most of our 17 cases were revisions. In these cases, new fixation points are first established. All fixation points that will be needed for the final fusion are placed. If a pedicle above or below the osteotomy level is not suitable for a screw, it can be skipped.

Wide decompression of the involved level is performed from pedicle to pedicle, ensuring that the nerve roots are completely decompressed. The dissection is then continued around the lateral wall of the vertebral body. While the neural elements are protected with gentle retraction, the pedicle and a portion of the posterior aspect of the vertebral body are removed with a combination of a rongeur and reverse-angle curettes. Resection of the vertebral body can be facilitated by attaching a short rod to the pedicle screws on either side of the osteotomy level and using it to provide gentle distraction.

Once sufficient bone has been removed to close the osteotomy, short rods are placed in the pedicle screws in the level above and the level below the osteotomy site. These rods are attached with offset connectors that allow the rods to be placed lateral to the screws. Before the surgical procedure is started, the patient is positioned on 2 sets of posts separated by the break in the table. The break in the table allows flexion to accommodate the preoperative kyphosis and allows hyperextension to help close the osteotomy site. Now, with the osteotomy site ready for closure, the table is gradually positioned in extension along with a combination of posterior pressure and compression between the pedicle screws above and below the osteotomy. Once the osteotomy is adequately compressed, the short rods are tightened, holding the osteotomy in good position. With the osteotomy held by the short rods and table positioning, decompression of the neural elements is confirmed and hemostasis obtained.

Final instrumentation is then performed with long rods that can bypass the osteotomized levels, allowing for simpler contouring. If desired, a cross connector can be placed between the long rod of the fusion construct and the short rod holding the osteotomy. The rest of the fusion procedure is completed in standard fashion with at least 1 subfascial drain.

Results

Our 17 patients’ results are summarized in the Table. Mean sagittal plumb line improved from 17.7 cm (range, 5.9 to 29 cm) before surgery to 4.5 cm (range, –0.2 to 12.9 cm) after surgery, for a mean improvement of 13.2 cm. At final follow-up, mean sagittal plumb line was 5.1 cm (range, –1.4 to 10.2 cm).

Mean lumbar lordosis improved from 10° (range, –14° to 34°) before surgery to 49° (range, 36° to 63°) after surgery, for a mean improvement of 39°. Mean PSO angle improved from 3° (range, –36° to 23°) before surgery to 41° (range, 25° to 65°) after surgery, for a mean improvement of 38°. At final follow-up, mean lumbar lordosis remained at 47° (range, 26° to 64°), and mean PSO angle was 39° (range, 24° to 59°).

Mean thoracic kyphosis improved from 18° (range, –8° to 52°) before surgery to 30° (range, 3° to 58°) after surgery, for a mean improvement of 12°. At final follow-up, mean thoracic kyphosis was 31° (range, 2° to 57°).

Fourteen patients did not have complications during the study period. Of the 3 patients with complications, 1 had an early infection, treated effectively with irrigation and débridement and intravenous antibiotics; 1 had a late deep infection, treated with multiple débridements, hardware removal, and, eventually, suppressive antibiotics; and 1 had cauda equina syndrome (caused by extensive scar tissue on the dura, which buckled with restoration of lordosis leading to cord compression), treated with duraplasty, which resulted in full neurologic recovery.

Discussion

In the present series of patients, the described technique for facilitating PSO for correction of sagittal imbalance was effective, and complications were similar to those previously reported.

The benefit of the outrigger construct is that it allows controlled compression of the osteotomy site and can be left in place at time of final instrumentation, locking in compression and correction. Other techniques involve removing the temporary rod and replacing it with final instrumentation^4,5—an extra step that complicates instrumentation of the additional levels of the fusion construct and possibly adds pedicle screw stress and contributes to loosening when the new rod is reduced to the pedicle screw. The final long rod construct can bypass the osteotomy levels and allow for simpler instrumentation.

 Mean age was 58 years in this series versus 52.4 years in the series reported by Bridwell and colleagues.² Given the higher mean age of our patients, though no objective measures of bone quality were available, this technique is likely applicable to patients with poor bone quality.

The complications we have reported are in line with those reported in previous series, and maintenance of radiographic parameters at final follow-up indicates that this osteotomy technique allows for solid fusion constructs.

The outrigger technique for controlling PSO closure is an effective method that simplifies instrumentation during a complex revision case.

Pedicle subtraction osteotomies (PSOs) have been used in the treatment of multiple spinal conditions involving a fixed sagittal imbalance, such as degenerative scoliosis, idiopathic scoliosis, posttraumatic deformities, iatrogenic flatback syndrome, and ankylosing spondylitis. The procedure was first described by Thomasen¹ for the treatment of ankylosing spondylitis. More recently, multiple centers have reported the expanded use and good success of PSO in the treatment of fixed sagittal imbalance of other etiologies.^2,3 According to Bridwell and colleagues,² lumbar lordosis can be increased 34.1°, and sagittal plumb line can be improved 13.5 cm.

PSO is a complex, extensive surgery most often performed in the revision setting. Multiple authors have described the technique for PSO.^4,5 There are significant technical challenges and many complications, including neurologic deficits, pseudarthrosis of adjacent levels, and wound infections.⁶ Short-term challenges include a large loss of blood, 2.4 L on average, according to Bridwell and colleagues.⁶ Time of closure of the osteotomy gap is a crucial point in the surgery. Blood loss, often large, slows only after the gap is closed and stabilized.

In this article, we describe a technique in which an additional rod or pedicle screw construct is used at the periosteotomy levels to close the osteotomy gap during PSO and simplify subsequent instrumentation. In addition, we report our experience with the procedure.

Materials and Methods

Seventeen consecutive patients (mean age, 58 years; range, 12-81 years) with fixed sagittal imbalance were treated with lumbar PSO. The indication in all cases was flatback syndrome after previous spinal surgery. Mean follow-up was 13 months. Mean number of prior surgeries was 3. Thirteen PSOs were performed at L3, and 4 were performed at L2.

Radiographic data were collected from before surgery, in the immediate postoperative period, and at final follow-up. All the radiographs were standing films. Established radiographic parameters were measured: thoracic kyphosis from T5 to T12, lumbar lordosis from L1 to S1, PSO angle (1 level above to 1 level below osteotomy level), sagittal plumb line (from center of C7 body to posterosuperior aspect of S1 body), and coronal plumb line (from center of C7 body to center of S1 body).²

Good clinical outcomes in the treatment of spinal disorders require careful attention to the alignment of the spine in the sagittal plane.^7,8 When evaluating the preoperative radiographs, we measured and documented pelvic parameters. Figure 1A shows how pelvic incidence was determined. We measured this as the angle between a line drawn from the center of the S1 endplate to the center of the femoral head and the perpendicular off the S1 endplate. Figure 1B shows pelvic tilt as determined by the angle between a line drawn from the center of S1 to the femoral head and a vertical line originating from the center of the femoral head. Figure 1C shows the sacral slope, which we measured as the angle between a line drawn parallel to the endplate of S1 and its intersection with a horizontal line.

Surgical Technique

The overall surgical technique for PSO has been well described.^4,5 Here we describe the “outrigger” modification to osteotomy closure (Figures 2, 3).

Most of our 17 cases were revisions. In these cases, new fixation points are first established. All fixation points that will be needed for the final fusion are placed. If a pedicle above or below the osteotomy level is not suitable for a screw, it can be skipped.

Wide decompression of the involved level is performed from pedicle to pedicle, ensuring that the nerve roots are completely decompressed. The dissection is then continued around the lateral wall of the vertebral body. While the neural elements are protected with gentle retraction, the pedicle and a portion of the posterior aspect of the vertebral body are removed with a combination of a rongeur and reverse-angle curettes. Resection of the vertebral body can be facilitated by attaching a short rod to the pedicle screws on either side of the osteotomy level and using it to provide gentle distraction.

Once sufficient bone has been removed to close the osteotomy, short rods are placed in the pedicle screws in the level above and the level below the osteotomy site. These rods are attached with offset connectors that allow the rods to be placed lateral to the screws. Before the surgical procedure is started, the patient is positioned on 2 sets of posts separated by the break in the table. The break in the table allows flexion to accommodate the preoperative kyphosis and allows hyperextension to help close the osteotomy site. Now, with the osteotomy site ready for closure, the table is gradually positioned in extension along with a combination of posterior pressure and compression between the pedicle screws above and below the osteotomy. Once the osteotomy is adequately compressed, the short rods are tightened, holding the osteotomy in good position. With the osteotomy held by the short rods and table positioning, decompression of the neural elements is confirmed and hemostasis obtained.

Final instrumentation is then performed with long rods that can bypass the osteotomized levels, allowing for simpler contouring. If desired, a cross connector can be placed between the long rod of the fusion construct and the short rod holding the osteotomy. The rest of the fusion procedure is completed in standard fashion with at least 1 subfascial drain.

Results

Our 17 patients’ results are summarized in the Table. Mean sagittal plumb line improved from 17.7 cm (range, 5.9 to 29 cm) before surgery to 4.5 cm (range, –0.2 to 12.9 cm) after surgery, for a mean improvement of 13.2 cm. At final follow-up, mean sagittal plumb line was 5.1 cm (range, –1.4 to 10.2 cm).

Mean lumbar lordosis improved from 10° (range, –14° to 34°) before surgery to 49° (range, 36° to 63°) after surgery, for a mean improvement of 39°. Mean PSO angle improved from 3° (range, –36° to 23°) before surgery to 41° (range, 25° to 65°) after surgery, for a mean improvement of 38°. At final follow-up, mean lumbar lordosis remained at 47° (range, 26° to 64°), and mean PSO angle was 39° (range, 24° to 59°).

Mean thoracic kyphosis improved from 18° (range, –8° to 52°) before surgery to 30° (range, 3° to 58°) after surgery, for a mean improvement of 12°. At final follow-up, mean thoracic kyphosis was 31° (range, 2° to 57°).

Fourteen patients did not have complications during the study period. Of the 3 patients with complications, 1 had an early infection, treated effectively with irrigation and débridement and intravenous antibiotics; 1 had a late deep infection, treated with multiple débridements, hardware removal, and, eventually, suppressive antibiotics; and 1 had cauda equina syndrome (caused by extensive scar tissue on the dura, which buckled with restoration of lordosis leading to cord compression), treated with duraplasty, which resulted in full neurologic recovery.

Discussion

In the present series of patients, the described technique for facilitating PSO for correction of sagittal imbalance was effective, and complications were similar to those previously reported.

The benefit of the outrigger construct is that it allows controlled compression of the osteotomy site and can be left in place at time of final instrumentation, locking in compression and correction. Other techniques involve removing the temporary rod and replacing it with final instrumentation^4,5—an extra step that complicates instrumentation of the additional levels of the fusion construct and possibly adds pedicle screw stress and contributes to loosening when the new rod is reduced to the pedicle screw. The final long rod construct can bypass the osteotomy levels and allow for simpler instrumentation.

 Mean age was 58 years in this series versus 52.4 years in the series reported by Bridwell and colleagues.² Given the higher mean age of our patients, though no objective measures of bone quality were available, this technique is likely applicable to patients with poor bone quality.

The complications we have reported are in line with those reported in previous series, and maintenance of radiographic parameters at final follow-up indicates that this osteotomy technique allows for solid fusion constructs.

The outrigger technique for controlling PSO closure is an effective method that simplifies instrumentation during a complex revision case.

Pedicle subtraction osteotomies (PSOs) have been used in the treatment of multiple spinal conditions involving a fixed sagittal imbalance, such as degenerative scoliosis, idiopathic scoliosis, posttraumatic deformities, iatrogenic flatback syndrome, and ankylosing spondylitis. The procedure was first described by Thomasen¹ for the treatment of ankylosing spondylitis. More recently, multiple centers have reported the expanded use and good success of PSO in the treatment of fixed sagittal imbalance of other etiologies.^2,3 According to Bridwell and colleagues,² lumbar lordosis can be increased 34.1°, and sagittal plumb line can be improved 13.5 cm.

PSO is a complex, extensive surgery most often performed in the revision setting. Multiple authors have described the technique for PSO.^4,5 There are significant technical challenges and many complications, including neurologic deficits, pseudarthrosis of adjacent levels, and wound infections.⁶ Short-term challenges include a large loss of blood, 2.4 L on average, according to Bridwell and colleagues.⁶ Time of closure of the osteotomy gap is a crucial point in the surgery. Blood loss, often large, slows only after the gap is closed and stabilized.

In this article, we describe a technique in which an additional rod or pedicle screw construct is used at the periosteotomy levels to close the osteotomy gap during PSO and simplify subsequent instrumentation. In addition, we report our experience with the procedure.

Materials and Methods

Seventeen consecutive patients (mean age, 58 years; range, 12-81 years) with fixed sagittal imbalance were treated with lumbar PSO. The indication in all cases was flatback syndrome after previous spinal surgery. Mean follow-up was 13 months. Mean number of prior surgeries was 3. Thirteen PSOs were performed at L3, and 4 were performed at L2.

Radiographic data were collected from before surgery, in the immediate postoperative period, and at final follow-up. All the radiographs were standing films. Established radiographic parameters were measured: thoracic kyphosis from T5 to T12, lumbar lordosis from L1 to S1, PSO angle (1 level above to 1 level below osteotomy level), sagittal plumb line (from center of C7 body to posterosuperior aspect of S1 body), and coronal plumb line (from center of C7 body to center of S1 body).²

Good clinical outcomes in the treatment of spinal disorders require careful attention to the alignment of the spine in the sagittal plane.^7,8 When evaluating the preoperative radiographs, we measured and documented pelvic parameters. Figure 1A shows how pelvic incidence was determined. We measured this as the angle between a line drawn from the center of the S1 endplate to the center of the femoral head and the perpendicular off the S1 endplate. Figure 1B shows pelvic tilt as determined by the angle between a line drawn from the center of S1 to the femoral head and a vertical line originating from the center of the femoral head. Figure 1C shows the sacral slope, which we measured as the angle between a line drawn parallel to the endplate of S1 and its intersection with a horizontal line.

Surgical Technique

The overall surgical technique for PSO has been well described.^4,5 Here we describe the “outrigger” modification to osteotomy closure (Figures 2, 3).

Most of our 17 cases were revisions. In these cases, new fixation points are first established. All fixation points that will be needed for the final fusion are placed. If a pedicle above or below the osteotomy level is not suitable for a screw, it can be skipped.

Wide decompression of the involved level is performed from pedicle to pedicle, ensuring that the nerve roots are completely decompressed. The dissection is then continued around the lateral wall of the vertebral body. While the neural elements are protected with gentle retraction, the pedicle and a portion of the posterior aspect of the vertebral body are removed with a combination of a rongeur and reverse-angle curettes. Resection of the vertebral body can be facilitated by attaching a short rod to the pedicle screws on either side of the osteotomy level and using it to provide gentle distraction.

Once sufficient bone has been removed to close the osteotomy, short rods are placed in the pedicle screws in the level above and the level below the osteotomy site. These rods are attached with offset connectors that allow the rods to be placed lateral to the screws. Before the surgical procedure is started, the patient is positioned on 2 sets of posts separated by the break in the table. The break in the table allows flexion to accommodate the preoperative kyphosis and allows hyperextension to help close the osteotomy site. Now, with the osteotomy site ready for closure, the table is gradually positioned in extension along with a combination of posterior pressure and compression between the pedicle screws above and below the osteotomy. Once the osteotomy is adequately compressed, the short rods are tightened, holding the osteotomy in good position. With the osteotomy held by the short rods and table positioning, decompression of the neural elements is confirmed and hemostasis obtained.

Final instrumentation is then performed with long rods that can bypass the osteotomized levels, allowing for simpler contouring. If desired, a cross connector can be placed between the long rod of the fusion construct and the short rod holding the osteotomy. The rest of the fusion procedure is completed in standard fashion with at least 1 subfascial drain.

Results

Our 17 patients’ results are summarized in the Table. Mean sagittal plumb line improved from 17.7 cm (range, 5.9 to 29 cm) before surgery to 4.5 cm (range, –0.2 to 12.9 cm) after surgery, for a mean improvement of 13.2 cm. At final follow-up, mean sagittal plumb line was 5.1 cm (range, –1.4 to 10.2 cm).

Mean lumbar lordosis improved from 10° (range, –14° to 34°) before surgery to 49° (range, 36° to 63°) after surgery, for a mean improvement of 39°. Mean PSO angle improved from 3° (range, –36° to 23°) before surgery to 41° (range, 25° to 65°) after surgery, for a mean improvement of 38°. At final follow-up, mean lumbar lordosis remained at 47° (range, 26° to 64°), and mean PSO angle was 39° (range, 24° to 59°).

Mean thoracic kyphosis improved from 18° (range, –8° to 52°) before surgery to 30° (range, 3° to 58°) after surgery, for a mean improvement of 12°. At final follow-up, mean thoracic kyphosis was 31° (range, 2° to 57°).

Fourteen patients did not have complications during the study period. Of the 3 patients with complications, 1 had an early infection, treated effectively with irrigation and débridement and intravenous antibiotics; 1 had a late deep infection, treated with multiple débridements, hardware removal, and, eventually, suppressive antibiotics; and 1 had cauda equina syndrome (caused by extensive scar tissue on the dura, which buckled with restoration of lordosis leading to cord compression), treated with duraplasty, which resulted in full neurologic recovery.

Discussion

In the present series of patients, the described technique for facilitating PSO for correction of sagittal imbalance was effective, and complications were similar to those previously reported.

The benefit of the outrigger construct is that it allows controlled compression of the osteotomy site and can be left in place at time of final instrumentation, locking in compression and correction. Other techniques involve removing the temporary rod and replacing it with final instrumentation^4,5—an extra step that complicates instrumentation of the additional levels of the fusion construct and possibly adds pedicle screw stress and contributes to loosening when the new rod is reduced to the pedicle screw. The final long rod construct can bypass the osteotomy levels and allow for simpler instrumentation.

 Mean age was 58 years in this series versus 52.4 years in the series reported by Bridwell and colleagues.² Given the higher mean age of our patients, though no objective measures of bone quality were available, this technique is likely applicable to patients with poor bone quality.

The complications we have reported are in line with those reported in previous series, and maintenance of radiographic parameters at final follow-up indicates that this osteotomy technique allows for solid fusion constructs.

The outrigger technique for controlling PSO closure is an effective method that simplifies instrumentation during a complex revision case.