User login
A Severe Sitchuation
This 49-year-old man was first diagnosed with Darier disease at age 8. It has been contained, for the most part, by topical medications and acitretin. But the itching on his legs is especially severe, making it difficult for him to leave them alone.
EXAMINATION
Both legs have heavy scaling and lichenification from the lateral aspects of the knees down to the ankles. There is modest erythema but no suppurative signs. Other areas of scaling are seen on his chest and back, but these are less coarse and rough than the leg rash.
What is the diagnosis?
DISCUSSION
Lichen simplex chronicus (LSC) is the term given to this phenomenon. LSC is always secondary to a primary trigger, which can be dry skin, eczema, psoriasis, or even a bug bite. Excessive scratching induces more itching, and before the patient realizes it, he has jumped aboard the itch-scratch-itch train—a vicious cycle that can be hard to break.
The skin reacts to all this attention by thickening and becoming rough; on a microscopic level, the nerves become more sensitive. The urge to scratch becomes so irresistible that some patients fantasize about giving in.
The first goal of treating LSC is to stop the itching by helping the patient avoid contact with the site. High-potency topical steroids can be effective for this, especially if used under occlusion, which not only potentiates the steroid but also provides a barrier to protect the area from the patient’s fingernails (or hairbrush). Once the condition improves, steroids can be slowly withdrawn.
A biopsy, if it had been necessary, would have shown hypertrophic epidermis and acanthotic changes.
TAKE-HOME LEARNING POINTS
• Lichen simplex chronicus (LSC) is secondary to an inciting condition such as eczema, xerosis, psoriasis, or Darier disease.
• The manifestation of the itch-scratch-itch cycle leads to thickening and lichenification of the skin. The itch of LSC is so compelling that scratching is hard to resist.
• Despite treatment and patient education, recurrences are quite common.
This 49-year-old man was first diagnosed with Darier disease at age 8. It has been contained, for the most part, by topical medications and acitretin. But the itching on his legs is especially severe, making it difficult for him to leave them alone.
EXAMINATION
Both legs have heavy scaling and lichenification from the lateral aspects of the knees down to the ankles. There is modest erythema but no suppurative signs. Other areas of scaling are seen on his chest and back, but these are less coarse and rough than the leg rash.
What is the diagnosis?
DISCUSSION
Lichen simplex chronicus (LSC) is the term given to this phenomenon. LSC is always secondary to a primary trigger, which can be dry skin, eczema, psoriasis, or even a bug bite. Excessive scratching induces more itching, and before the patient realizes it, he has jumped aboard the itch-scratch-itch train—a vicious cycle that can be hard to break.
The skin reacts to all this attention by thickening and becoming rough; on a microscopic level, the nerves become more sensitive. The urge to scratch becomes so irresistible that some patients fantasize about giving in.
The first goal of treating LSC is to stop the itching by helping the patient avoid contact with the site. High-potency topical steroids can be effective for this, especially if used under occlusion, which not only potentiates the steroid but also provides a barrier to protect the area from the patient’s fingernails (or hairbrush). Once the condition improves, steroids can be slowly withdrawn.
A biopsy, if it had been necessary, would have shown hypertrophic epidermis and acanthotic changes.
TAKE-HOME LEARNING POINTS
• Lichen simplex chronicus (LSC) is secondary to an inciting condition such as eczema, xerosis, psoriasis, or Darier disease.
• The manifestation of the itch-scratch-itch cycle leads to thickening and lichenification of the skin. The itch of LSC is so compelling that scratching is hard to resist.
• Despite treatment and patient education, recurrences are quite common.
This 49-year-old man was first diagnosed with Darier disease at age 8. It has been contained, for the most part, by topical medications and acitretin. But the itching on his legs is especially severe, making it difficult for him to leave them alone.
EXAMINATION
Both legs have heavy scaling and lichenification from the lateral aspects of the knees down to the ankles. There is modest erythema but no suppurative signs. Other areas of scaling are seen on his chest and back, but these are less coarse and rough than the leg rash.
What is the diagnosis?
DISCUSSION
Lichen simplex chronicus (LSC) is the term given to this phenomenon. LSC is always secondary to a primary trigger, which can be dry skin, eczema, psoriasis, or even a bug bite. Excessive scratching induces more itching, and before the patient realizes it, he has jumped aboard the itch-scratch-itch train—a vicious cycle that can be hard to break.
The skin reacts to all this attention by thickening and becoming rough; on a microscopic level, the nerves become more sensitive. The urge to scratch becomes so irresistible that some patients fantasize about giving in.
The first goal of treating LSC is to stop the itching by helping the patient avoid contact with the site. High-potency topical steroids can be effective for this, especially if used under occlusion, which not only potentiates the steroid but also provides a barrier to protect the area from the patient’s fingernails (or hairbrush). Once the condition improves, steroids can be slowly withdrawn.
A biopsy, if it had been necessary, would have shown hypertrophic epidermis and acanthotic changes.
TAKE-HOME LEARNING POINTS
• Lichen simplex chronicus (LSC) is secondary to an inciting condition such as eczema, xerosis, psoriasis, or Darier disease.
• The manifestation of the itch-scratch-itch cycle leads to thickening and lichenification of the skin. The itch of LSC is so compelling that scratching is hard to resist.
• Despite treatment and patient education, recurrences are quite common.
The Paradox of Pain Management
Pain was introduced as the “fifth vital sign” in the 1990s, ranking it as important a measure as blood pressure, heart and respiratory rate, and temperature.1 The American Pain Society promoted this notion to increase awareness of pain treatment among health care professionals. Emphasizing its importance, the Veterans Health Administration in 1999 launched the “Pain as the 5th Vital Sign” initiative, which mandated a pain intensity rating at all clinical encounters.2
Interestingly, the Joint Commission standards never stated that pain needed to be treated as a vital sign. But many organizations started to require documentation of routine pain screening for all patients. Health care providers were instructed to inquire about pain and to treat it as an essential element of health history.
These changes were quite controversial. The additional measure, while important, competed with other priority screening needs, including diabetes, cancer, and hypertension. There was—and continues to be—quite the debate on whether pain actually can be measured and what impact that information has on the quality of care.
I do not intend to enter that debate here. Instead, I want to discuss what continues to be a conundrum for me: the paradox of pain management.
For many patients, especially those in acute or emergency care settings, the presenting complaint is pain. I would submit that for many the expectation is for pain to be immediately and permanently relieved. But is this a realistic goal?
I recall a lecture on pain management I attended years ago; at that time, the approach involved early identification and prompt, aggressive treatment. When asked “How much medication and for how long?” the lecturer used diabetes as a treatment model, stating, “You would increase insulin until the blood glucose was controlled—don’t be afraid to increase pain medication until the pain is controlled.” In the early days of pain management, that was the accepted norm. The possibility that a “zero” on the pain scale was unattainable for some patients was not considered.
Yet seemingly overnight, once pain was decreed a vital sign, health care providers were mandated to measure it and faced with the responsibility to treat it. This resulted in a vague 0-1
Faced with growing concern for undertreated pain in the US, however, many of us strove to achieve a balance of sufficient yet appropriate treatment. We struggled to determine how to relieve the pain our patients experienced without creating other problems, such as undesirable side effects, misuse, or addiction. That predicament, paired with the ever-increasing direct-to-consumer advertisements about pain relief and the insistence by (some, not all) patients that nonnarcotic pain medication is ineffective, bred the crisis of opioid overuse and addiction we now face.
But just as I chose not to debate the impact of pain measurement on quality of care, I also choose not to debate the existence of the opioid crisis. What I want to emphasize is that all policy changes have consequences. I reach out to you, my colleagues, for innovative ideas to strike the delicate balance of appropriate use of narcotics. How do we address the needs of patients whose pain is more than just an inconvenience and for whom daily use of a narcotic allows them to function—while also avoiding the pitfalls that we are now regularly warned about?
I have no doubt that each of us knows at least one person—a patient, a family member, a neighbor—for whom pain is a daily occurrence. But we must put that in perspective; not all pain is a barrier to physical and emotional functioning. Data suggest that a “33% to 50% decrease in pain intensity is meaningful from a patient’s perspective and represents a reasonable standard of intervention efficacy.”3 For those who deal with chronic pain, even a slight improvement is progress.
So, while the American Medical Association and the American Pain Society bicker about whether pain is the “fifth vital sign,” we must find a better means to resolve the discord in our society.4 Banning all opioid use is not the answer, but neither is considering narcotics the default treatment for pain.
We must remind our patients, our policymakers, and ourselves that identifying and assessing pain is not equated with writing an opioid or narcotic prescription. Nor will removing those medications from our formulary mitigate the crisis. We need to communicate a clear, consistent message that pain is real, that some pain is a fact of life, and that we will help our patients.
However, it is incumbent upon us to adopt a systematic yet personalized plan of care that is effective, cost conscious, culturally and developmentally appropriate, and safe—and that plan may or may not include prescribing narcotics. We have much work ahead of us in order to minimize the potential for misuse of these medications without impeding patients’ access to necessary health care.
Please share your thoughts on this conundrum by writing to [email protected].
1. Veterans Health Administration. Pain as the 5th vital sign toolkit. www.va.gov/PAINMAN AGEMENT/docs/Pain_As_the_5th_Vital_Sign_Toolkit.pdf. Accessed October 5, 2016.
2. Mularski RA, White-Chu F, Overbay D, et al. Measuring pain as the 5th vital sign does not improve quality of pain management. J Gen Intern Med . 2006;21(6):607-612.
3. Gordon DB, Dahl JL, Miaskowski C, et al. American Pain Society recommendations for improving the quality of acute and cancer pain management. Arch Intern Med . 2005; 165(14):1574-1580.
4. Anson P. AMA drops pain as a vital sign . Pain News Network. June 16, 2016. www.painnewsnetwork.org/stories/2016/6/16/ama-drops-pain-as-vital-sign. Accessed October 5, 2016.
Marie-Eileen Onieal, PhD, CPNP, FAANP
Marie-Eileen Onieal, PhD, CPNP, FAANP
Marie-Eileen Onieal, PhD, CPNP, FAANP
Pain was introduced as the “fifth vital sign” in the 1990s, ranking it as important a measure as blood pressure, heart and respiratory rate, and temperature.1 The American Pain Society promoted this notion to increase awareness of pain treatment among health care professionals. Emphasizing its importance, the Veterans Health Administration in 1999 launched the “Pain as the 5th Vital Sign” initiative, which mandated a pain intensity rating at all clinical encounters.2
Interestingly, the Joint Commission standards never stated that pain needed to be treated as a vital sign. But many organizations started to require documentation of routine pain screening for all patients. Health care providers were instructed to inquire about pain and to treat it as an essential element of health history.
These changes were quite controversial. The additional measure, while important, competed with other priority screening needs, including diabetes, cancer, and hypertension. There was—and continues to be—quite the debate on whether pain actually can be measured and what impact that information has on the quality of care.
I do not intend to enter that debate here. Instead, I want to discuss what continues to be a conundrum for me: the paradox of pain management.
For many patients, especially those in acute or emergency care settings, the presenting complaint is pain. I would submit that for many the expectation is for pain to be immediately and permanently relieved. But is this a realistic goal?
I recall a lecture on pain management I attended years ago; at that time, the approach involved early identification and prompt, aggressive treatment. When asked “How much medication and for how long?” the lecturer used diabetes as a treatment model, stating, “You would increase insulin until the blood glucose was controlled—don’t be afraid to increase pain medication until the pain is controlled.” In the early days of pain management, that was the accepted norm. The possibility that a “zero” on the pain scale was unattainable for some patients was not considered.
Yet seemingly overnight, once pain was decreed a vital sign, health care providers were mandated to measure it and faced with the responsibility to treat it. This resulted in a vague 0-1
Faced with growing concern for undertreated pain in the US, however, many of us strove to achieve a balance of sufficient yet appropriate treatment. We struggled to determine how to relieve the pain our patients experienced without creating other problems, such as undesirable side effects, misuse, or addiction. That predicament, paired with the ever-increasing direct-to-consumer advertisements about pain relief and the insistence by (some, not all) patients that nonnarcotic pain medication is ineffective, bred the crisis of opioid overuse and addiction we now face.
But just as I chose not to debate the impact of pain measurement on quality of care, I also choose not to debate the existence of the opioid crisis. What I want to emphasize is that all policy changes have consequences. I reach out to you, my colleagues, for innovative ideas to strike the delicate balance of appropriate use of narcotics. How do we address the needs of patients whose pain is more than just an inconvenience and for whom daily use of a narcotic allows them to function—while also avoiding the pitfalls that we are now regularly warned about?
I have no doubt that each of us knows at least one person—a patient, a family member, a neighbor—for whom pain is a daily occurrence. But we must put that in perspective; not all pain is a barrier to physical and emotional functioning. Data suggest that a “33% to 50% decrease in pain intensity is meaningful from a patient’s perspective and represents a reasonable standard of intervention efficacy.”3 For those who deal with chronic pain, even a slight improvement is progress.
So, while the American Medical Association and the American Pain Society bicker about whether pain is the “fifth vital sign,” we must find a better means to resolve the discord in our society.4 Banning all opioid use is not the answer, but neither is considering narcotics the default treatment for pain.
We must remind our patients, our policymakers, and ourselves that identifying and assessing pain is not equated with writing an opioid or narcotic prescription. Nor will removing those medications from our formulary mitigate the crisis. We need to communicate a clear, consistent message that pain is real, that some pain is a fact of life, and that we will help our patients.
However, it is incumbent upon us to adopt a systematic yet personalized plan of care that is effective, cost conscious, culturally and developmentally appropriate, and safe—and that plan may or may not include prescribing narcotics. We have much work ahead of us in order to minimize the potential for misuse of these medications without impeding patients’ access to necessary health care.
Please share your thoughts on this conundrum by writing to [email protected].
Pain was introduced as the “fifth vital sign” in the 1990s, ranking it as important a measure as blood pressure, heart and respiratory rate, and temperature.1 The American Pain Society promoted this notion to increase awareness of pain treatment among health care professionals. Emphasizing its importance, the Veterans Health Administration in 1999 launched the “Pain as the 5th Vital Sign” initiative, which mandated a pain intensity rating at all clinical encounters.2
Interestingly, the Joint Commission standards never stated that pain needed to be treated as a vital sign. But many organizations started to require documentation of routine pain screening for all patients. Health care providers were instructed to inquire about pain and to treat it as an essential element of health history.
These changes were quite controversial. The additional measure, while important, competed with other priority screening needs, including diabetes, cancer, and hypertension. There was—and continues to be—quite the debate on whether pain actually can be measured and what impact that information has on the quality of care.
I do not intend to enter that debate here. Instead, I want to discuss what continues to be a conundrum for me: the paradox of pain management.
For many patients, especially those in acute or emergency care settings, the presenting complaint is pain. I would submit that for many the expectation is for pain to be immediately and permanently relieved. But is this a realistic goal?
I recall a lecture on pain management I attended years ago; at that time, the approach involved early identification and prompt, aggressive treatment. When asked “How much medication and for how long?” the lecturer used diabetes as a treatment model, stating, “You would increase insulin until the blood glucose was controlled—don’t be afraid to increase pain medication until the pain is controlled.” In the early days of pain management, that was the accepted norm. The possibility that a “zero” on the pain scale was unattainable for some patients was not considered.
Yet seemingly overnight, once pain was decreed a vital sign, health care providers were mandated to measure it and faced with the responsibility to treat it. This resulted in a vague 0-1
Faced with growing concern for undertreated pain in the US, however, many of us strove to achieve a balance of sufficient yet appropriate treatment. We struggled to determine how to relieve the pain our patients experienced without creating other problems, such as undesirable side effects, misuse, or addiction. That predicament, paired with the ever-increasing direct-to-consumer advertisements about pain relief and the insistence by (some, not all) patients that nonnarcotic pain medication is ineffective, bred the crisis of opioid overuse and addiction we now face.
But just as I chose not to debate the impact of pain measurement on quality of care, I also choose not to debate the existence of the opioid crisis. What I want to emphasize is that all policy changes have consequences. I reach out to you, my colleagues, for innovative ideas to strike the delicate balance of appropriate use of narcotics. How do we address the needs of patients whose pain is more than just an inconvenience and for whom daily use of a narcotic allows them to function—while also avoiding the pitfalls that we are now regularly warned about?
I have no doubt that each of us knows at least one person—a patient, a family member, a neighbor—for whom pain is a daily occurrence. But we must put that in perspective; not all pain is a barrier to physical and emotional functioning. Data suggest that a “33% to 50% decrease in pain intensity is meaningful from a patient’s perspective and represents a reasonable standard of intervention efficacy.”3 For those who deal with chronic pain, even a slight improvement is progress.
So, while the American Medical Association and the American Pain Society bicker about whether pain is the “fifth vital sign,” we must find a better means to resolve the discord in our society.4 Banning all opioid use is not the answer, but neither is considering narcotics the default treatment for pain.
We must remind our patients, our policymakers, and ourselves that identifying and assessing pain is not equated with writing an opioid or narcotic prescription. Nor will removing those medications from our formulary mitigate the crisis. We need to communicate a clear, consistent message that pain is real, that some pain is a fact of life, and that we will help our patients.
However, it is incumbent upon us to adopt a systematic yet personalized plan of care that is effective, cost conscious, culturally and developmentally appropriate, and safe—and that plan may or may not include prescribing narcotics. We have much work ahead of us in order to minimize the potential for misuse of these medications without impeding patients’ access to necessary health care.
Please share your thoughts on this conundrum by writing to [email protected].
1. Veterans Health Administration. Pain as the 5th vital sign toolkit. www.va.gov/PAINMAN AGEMENT/docs/Pain_As_the_5th_Vital_Sign_Toolkit.pdf. Accessed October 5, 2016.
2. Mularski RA, White-Chu F, Overbay D, et al. Measuring pain as the 5th vital sign does not improve quality of pain management. J Gen Intern Med . 2006;21(6):607-612.
3. Gordon DB, Dahl JL, Miaskowski C, et al. American Pain Society recommendations for improving the quality of acute and cancer pain management. Arch Intern Med . 2005; 165(14):1574-1580.
4. Anson P. AMA drops pain as a vital sign . Pain News Network. June 16, 2016. www.painnewsnetwork.org/stories/2016/6/16/ama-drops-pain-as-vital-sign. Accessed October 5, 2016.
1. Veterans Health Administration. Pain as the 5th vital sign toolkit. www.va.gov/PAINMAN AGEMENT/docs/Pain_As_the_5th_Vital_Sign_Toolkit.pdf. Accessed October 5, 2016.
2. Mularski RA, White-Chu F, Overbay D, et al. Measuring pain as the 5th vital sign does not improve quality of pain management. J Gen Intern Med . 2006;21(6):607-612.
3. Gordon DB, Dahl JL, Miaskowski C, et al. American Pain Society recommendations for improving the quality of acute and cancer pain management. Arch Intern Med . 2005; 165(14):1574-1580.
4. Anson P. AMA drops pain as a vital sign . Pain News Network. June 16, 2016. www.painnewsnetwork.org/stories/2016/6/16/ama-drops-pain-as-vital-sign. Accessed October 5, 2016.
7 tips for successful value-based care contracts
During a recent webinar presented by the American Bar Association, legal experts provided guidance on how doctors can successfully draft pay-for-performance contracts and prevent disputes with payers.
1. Clearly define terms
Contract terms and definitions should be clearly outlined and understood by both parties before value-based agreements are signed, said Melissa J. Hulke, a director in the Berkeley Research Group, LLC health analytics practice.
“Contract terms become central to resolving differences, so it’s important the contract is well defined, especially when moving away from fee for service,” she said. “These are more complex arrangements.”
Another area that needs thorough definition surrounds referral volume. Contracts can include the phrases, “predominately refer” or “primarily refer,” without defining the meaning of “predominately” or “primarily,” Ms. Hulke said.
“If that’s not defined in the contract, it’s hard to establish a benchmark to not only project the provider’s performance under the arrangement and how much revenue they can expect to receive, but it’s hard to know if you’re meeting that benchmark, as well,” she said. “I strongly encourage that if [a term states] “primarily, predominately, [or] mostly refer,” that you have a specific percentage benchmark included. That will help to avoid any disagreement later on.”
2. Review payment calculations
Ensure that payment formulas are examined and agreed upon.
“I think that should be baked into the contracts of today because they are so complex and there is so much money at stake,” she said. “Walk through that compensation exhibit, walk through the examples of what’s supposed to happen.
If not in agreement with calculations, talk to the payer’s financial personnel about how the numbers were reached and try to resolve any differences.
3. Monitor results
Actively monitor projected-to-actual financial performance under the contract. If performance is not being monitored and results are not being tested, it’s impossible to tell whether the contract is succeeding or failing, Ms. Hulke said.
It’s a good idea to monitor projected-to-actual financial performance monthly or at least quarterly, she advised.
“Tracking budget to actual performance and investigating successes and failures are important if the contracts are material to the provider’s business,” Ms. Hulke said.
4. Institute time frames for government methodologies
Be specific about when contracts are linked to Medicare reimbursement methodologies.
If commercial payers are tying payment rates to government programs, which often occurs, contracts should include whether the reimbursement is based on Medicare rates and methodologies as of a particular date and time, according to Ms. Hulke. For instance, the contract could specify that rates are tied to Medicare methodologies at the time the contract was executed. Alternatively, contracts could allow the physician payment rate to fluctuate depending on changes the government makes to Medicare rates and methodologies during the span of the contract.
“If this is not defined, when Medicare makes a change, the parties may have differing opinions on the appropriate rate of reimbursement that’s being paid,” she said.
5. Structure around state and federal laws
Conduct a regulatory analysis before inking any value based payment arrangement/transaction, and structure and document around potential legal constraints, Ms. Hanna said.
Know the laws in your state, she advised. Some states have requirements for provider incentive programs, while others may have rules for provider organizations or intermediaries that assume certain financial risk. When working with federal health care payers, review the Stark Law and Anti-Kickback regulations and ensure that if triggered by the arrangement, the venture falls within an exception of the statutes. Other legal considerations when drafting contracts include:
• HIPAA and state privacy laws.
• Antitrust laws.
• Telemedicine and telehealth laws.
• Medicare Advantage benefit guidelines for programs designed for specific Medicare Advantage populations.
• Scope of practice laws applicable to mid-level medical providers.
6. Design a dispute-resolution strategy
Include a thorough dispute-resolution strategy within the contract. The strategies help facilitate an orderly process for resolving disputes cost effectively, Ms. Hanna said. She suggested that policies start with an informal dispute-resolution process that sends unresolved matters to senior executives at each organization.
“This allows business leaders – and not the lawyers – to find a business solution to a thorny and potentially costly problem before each party gets entrenched in its own position and own sense of having been wronged,” she said in an interview. “The business solution may or may not rely on contract language but may be tailored to keep the relationship moving forward. However, if the informal process proves unsuccessful, then the process gets punted to the legal system – whether in a court proceeding or arbitration.”
7. Have an exit strategy
Include an exit strategy that ensures an end to the arrangement goes as smoothly and fairly as possible. The strategy will depend on the nature and structure of the payer-provider alignment and the value-based payment arrangement, Ms. Hanna said in an interview.
For example, in a true, corporate joint venture, the exit strategy may include buyout rights of the newly formed entity. In this case, it’s important to consider and negotiate the price of the buyout and what circumstances that will trigger the buyout. Termination rights should also be included in an exit strategy, Ms. Hanna said. One option is to allow termination “without case,” by either party.
“Clients often do not like this approach because the intention of the parties going in is to build a strong, long-term relationship where provider and payer benefit,” she said. “A ‘without cause’ termination rights gives the parties a safety valve if circumstances change or the relationship is just not successful.”
An alternative is to allow the relationship time to mature and grow before either party can exercise a without cause termination. A related approach is to develop triggering events that would give one or both parties the right to terminate the agreement, without the other party “having committed a bad act,” Ms. Hanna said in the interview.
“For instance, if the relationship does not meet certain financial or other benchmarks within an agreed-upon time frame, this may be a sufficient reason to terminate the relationship, abandon, or renegotiate the value-based purchasing payment formula or, perhaps, end an exclusive or other preferential relationship,” she said.
[email protected]
On Twitter @legal_med
During a recent webinar presented by the American Bar Association, legal experts provided guidance on how doctors can successfully draft pay-for-performance contracts and prevent disputes with payers.
1. Clearly define terms
Contract terms and definitions should be clearly outlined and understood by both parties before value-based agreements are signed, said Melissa J. Hulke, a director in the Berkeley Research Group, LLC health analytics practice.
“Contract terms become central to resolving differences, so it’s important the contract is well defined, especially when moving away from fee for service,” she said. “These are more complex arrangements.”
Another area that needs thorough definition surrounds referral volume. Contracts can include the phrases, “predominately refer” or “primarily refer,” without defining the meaning of “predominately” or “primarily,” Ms. Hulke said.
“If that’s not defined in the contract, it’s hard to establish a benchmark to not only project the provider’s performance under the arrangement and how much revenue they can expect to receive, but it’s hard to know if you’re meeting that benchmark, as well,” she said. “I strongly encourage that if [a term states] “primarily, predominately, [or] mostly refer,” that you have a specific percentage benchmark included. That will help to avoid any disagreement later on.”
2. Review payment calculations
Ensure that payment formulas are examined and agreed upon.
“I think that should be baked into the contracts of today because they are so complex and there is so much money at stake,” she said. “Walk through that compensation exhibit, walk through the examples of what’s supposed to happen.
If not in agreement with calculations, talk to the payer’s financial personnel about how the numbers were reached and try to resolve any differences.
3. Monitor results
Actively monitor projected-to-actual financial performance under the contract. If performance is not being monitored and results are not being tested, it’s impossible to tell whether the contract is succeeding or failing, Ms. Hulke said.
It’s a good idea to monitor projected-to-actual financial performance monthly or at least quarterly, she advised.
“Tracking budget to actual performance and investigating successes and failures are important if the contracts are material to the provider’s business,” Ms. Hulke said.
4. Institute time frames for government methodologies
Be specific about when contracts are linked to Medicare reimbursement methodologies.
If commercial payers are tying payment rates to government programs, which often occurs, contracts should include whether the reimbursement is based on Medicare rates and methodologies as of a particular date and time, according to Ms. Hulke. For instance, the contract could specify that rates are tied to Medicare methodologies at the time the contract was executed. Alternatively, contracts could allow the physician payment rate to fluctuate depending on changes the government makes to Medicare rates and methodologies during the span of the contract.
“If this is not defined, when Medicare makes a change, the parties may have differing opinions on the appropriate rate of reimbursement that’s being paid,” she said.
5. Structure around state and federal laws
Conduct a regulatory analysis before inking any value based payment arrangement/transaction, and structure and document around potential legal constraints, Ms. Hanna said.
Know the laws in your state, she advised. Some states have requirements for provider incentive programs, while others may have rules for provider organizations or intermediaries that assume certain financial risk. When working with federal health care payers, review the Stark Law and Anti-Kickback regulations and ensure that if triggered by the arrangement, the venture falls within an exception of the statutes. Other legal considerations when drafting contracts include:
• HIPAA and state privacy laws.
• Antitrust laws.
• Telemedicine and telehealth laws.
• Medicare Advantage benefit guidelines for programs designed for specific Medicare Advantage populations.
• Scope of practice laws applicable to mid-level medical providers.
6. Design a dispute-resolution strategy
Include a thorough dispute-resolution strategy within the contract. The strategies help facilitate an orderly process for resolving disputes cost effectively, Ms. Hanna said. She suggested that policies start with an informal dispute-resolution process that sends unresolved matters to senior executives at each organization.
“This allows business leaders – and not the lawyers – to find a business solution to a thorny and potentially costly problem before each party gets entrenched in its own position and own sense of having been wronged,” she said in an interview. “The business solution may or may not rely on contract language but may be tailored to keep the relationship moving forward. However, if the informal process proves unsuccessful, then the process gets punted to the legal system – whether in a court proceeding or arbitration.”
7. Have an exit strategy
Include an exit strategy that ensures an end to the arrangement goes as smoothly and fairly as possible. The strategy will depend on the nature and structure of the payer-provider alignment and the value-based payment arrangement, Ms. Hanna said in an interview.
For example, in a true, corporate joint venture, the exit strategy may include buyout rights of the newly formed entity. In this case, it’s important to consider and negotiate the price of the buyout and what circumstances that will trigger the buyout. Termination rights should also be included in an exit strategy, Ms. Hanna said. One option is to allow termination “without case,” by either party.
“Clients often do not like this approach because the intention of the parties going in is to build a strong, long-term relationship where provider and payer benefit,” she said. “A ‘without cause’ termination rights gives the parties a safety valve if circumstances change or the relationship is just not successful.”
An alternative is to allow the relationship time to mature and grow before either party can exercise a without cause termination. A related approach is to develop triggering events that would give one or both parties the right to terminate the agreement, without the other party “having committed a bad act,” Ms. Hanna said in the interview.
“For instance, if the relationship does not meet certain financial or other benchmarks within an agreed-upon time frame, this may be a sufficient reason to terminate the relationship, abandon, or renegotiate the value-based purchasing payment formula or, perhaps, end an exclusive or other preferential relationship,” she said.
[email protected]
On Twitter @legal_med
During a recent webinar presented by the American Bar Association, legal experts provided guidance on how doctors can successfully draft pay-for-performance contracts and prevent disputes with payers.
1. Clearly define terms
Contract terms and definitions should be clearly outlined and understood by both parties before value-based agreements are signed, said Melissa J. Hulke, a director in the Berkeley Research Group, LLC health analytics practice.
“Contract terms become central to resolving differences, so it’s important the contract is well defined, especially when moving away from fee for service,” she said. “These are more complex arrangements.”
Another area that needs thorough definition surrounds referral volume. Contracts can include the phrases, “predominately refer” or “primarily refer,” without defining the meaning of “predominately” or “primarily,” Ms. Hulke said.
“If that’s not defined in the contract, it’s hard to establish a benchmark to not only project the provider’s performance under the arrangement and how much revenue they can expect to receive, but it’s hard to know if you’re meeting that benchmark, as well,” she said. “I strongly encourage that if [a term states] “primarily, predominately, [or] mostly refer,” that you have a specific percentage benchmark included. That will help to avoid any disagreement later on.”
2. Review payment calculations
Ensure that payment formulas are examined and agreed upon.
“I think that should be baked into the contracts of today because they are so complex and there is so much money at stake,” she said. “Walk through that compensation exhibit, walk through the examples of what’s supposed to happen.
If not in agreement with calculations, talk to the payer’s financial personnel about how the numbers were reached and try to resolve any differences.
3. Monitor results
Actively monitor projected-to-actual financial performance under the contract. If performance is not being monitored and results are not being tested, it’s impossible to tell whether the contract is succeeding or failing, Ms. Hulke said.
It’s a good idea to monitor projected-to-actual financial performance monthly or at least quarterly, she advised.
“Tracking budget to actual performance and investigating successes and failures are important if the contracts are material to the provider’s business,” Ms. Hulke said.
4. Institute time frames for government methodologies
Be specific about when contracts are linked to Medicare reimbursement methodologies.
If commercial payers are tying payment rates to government programs, which often occurs, contracts should include whether the reimbursement is based on Medicare rates and methodologies as of a particular date and time, according to Ms. Hulke. For instance, the contract could specify that rates are tied to Medicare methodologies at the time the contract was executed. Alternatively, contracts could allow the physician payment rate to fluctuate depending on changes the government makes to Medicare rates and methodologies during the span of the contract.
“If this is not defined, when Medicare makes a change, the parties may have differing opinions on the appropriate rate of reimbursement that’s being paid,” she said.
5. Structure around state and federal laws
Conduct a regulatory analysis before inking any value based payment arrangement/transaction, and structure and document around potential legal constraints, Ms. Hanna said.
Know the laws in your state, she advised. Some states have requirements for provider incentive programs, while others may have rules for provider organizations or intermediaries that assume certain financial risk. When working with federal health care payers, review the Stark Law and Anti-Kickback regulations and ensure that if triggered by the arrangement, the venture falls within an exception of the statutes. Other legal considerations when drafting contracts include:
• HIPAA and state privacy laws.
• Antitrust laws.
• Telemedicine and telehealth laws.
• Medicare Advantage benefit guidelines for programs designed for specific Medicare Advantage populations.
• Scope of practice laws applicable to mid-level medical providers.
6. Design a dispute-resolution strategy
Include a thorough dispute-resolution strategy within the contract. The strategies help facilitate an orderly process for resolving disputes cost effectively, Ms. Hanna said. She suggested that policies start with an informal dispute-resolution process that sends unresolved matters to senior executives at each organization.
“This allows business leaders – and not the lawyers – to find a business solution to a thorny and potentially costly problem before each party gets entrenched in its own position and own sense of having been wronged,” she said in an interview. “The business solution may or may not rely on contract language but may be tailored to keep the relationship moving forward. However, if the informal process proves unsuccessful, then the process gets punted to the legal system – whether in a court proceeding or arbitration.”
7. Have an exit strategy
Include an exit strategy that ensures an end to the arrangement goes as smoothly and fairly as possible. The strategy will depend on the nature and structure of the payer-provider alignment and the value-based payment arrangement, Ms. Hanna said in an interview.
For example, in a true, corporate joint venture, the exit strategy may include buyout rights of the newly formed entity. In this case, it’s important to consider and negotiate the price of the buyout and what circumstances that will trigger the buyout. Termination rights should also be included in an exit strategy, Ms. Hanna said. One option is to allow termination “without case,” by either party.
“Clients often do not like this approach because the intention of the parties going in is to build a strong, long-term relationship where provider and payer benefit,” she said. “A ‘without cause’ termination rights gives the parties a safety valve if circumstances change or the relationship is just not successful.”
An alternative is to allow the relationship time to mature and grow before either party can exercise a without cause termination. A related approach is to develop triggering events that would give one or both parties the right to terminate the agreement, without the other party “having committed a bad act,” Ms. Hanna said in the interview.
“For instance, if the relationship does not meet certain financial or other benchmarks within an agreed-upon time frame, this may be a sufficient reason to terminate the relationship, abandon, or renegotiate the value-based purchasing payment formula or, perhaps, end an exclusive or other preferential relationship,” she said.
[email protected]
On Twitter @legal_med
‘Committed’ is culmination of journey examining involuntary care
After 3 years of work, Anne Hanson and I are delighted that our book, “Committed: The Battle over Involuntary Psychiatric Care” was officially released Nov. 1! Our publisher, Johns Hopkins University Press, asked me to write a post for its blog to start the launch and with permission, Clinical Psychiatry News has let me begin the story of our research here as well.
So how did I find myself sitting in courtrooms and riding alongside a police officer? Let me tell you a little about the process of writing this book, because it was a quite the adventure for me. The title implies that this is another book by psychiatrists for psychiatrists, but for me, the days I spent working on this manuscript were days off from psychiatry. Those mornings I woke up a psychiatrist and felt like I walked into a phone booth (maybe it was just my shower) and emerged as a journalist.
To read more, please visit the Johns Hopkins University blog here.
After 3 years of work, Anne Hanson and I are delighted that our book, “Committed: The Battle over Involuntary Psychiatric Care” was officially released Nov. 1! Our publisher, Johns Hopkins University Press, asked me to write a post for its blog to start the launch and with permission, Clinical Psychiatry News has let me begin the story of our research here as well.
So how did I find myself sitting in courtrooms and riding alongside a police officer? Let me tell you a little about the process of writing this book, because it was a quite the adventure for me. The title implies that this is another book by psychiatrists for psychiatrists, but for me, the days I spent working on this manuscript were days off from psychiatry. Those mornings I woke up a psychiatrist and felt like I walked into a phone booth (maybe it was just my shower) and emerged as a journalist.
To read more, please visit the Johns Hopkins University blog here.
After 3 years of work, Anne Hanson and I are delighted that our book, “Committed: The Battle over Involuntary Psychiatric Care” was officially released Nov. 1! Our publisher, Johns Hopkins University Press, asked me to write a post for its blog to start the launch and with permission, Clinical Psychiatry News has let me begin the story of our research here as well.
So how did I find myself sitting in courtrooms and riding alongside a police officer? Let me tell you a little about the process of writing this book, because it was a quite the adventure for me. The title implies that this is another book by psychiatrists for psychiatrists, but for me, the days I spent working on this manuscript were days off from psychiatry. Those mornings I woke up a psychiatrist and felt like I walked into a phone booth (maybe it was just my shower) and emerged as a journalist.
To read more, please visit the Johns Hopkins University blog here.
Two factors associated with vocal cord dysfunction in study
LOS ANGELES – Female sex and the absence of wheezing were the only factors significantly associated with vocal cord dysfunction in patients with high pretest probability of disease, a retrospective analysis showed.
The findings differ from those of the Pittsburgh Vocal Cord Index, which identified symptoms of throat tightness, dysphonia, absence of wheezing, and the presence of odors as key features predictive of vocal cord dysfunction (VCD). “This proves the point that VCD is an elusive diagnosis,” lead study author Phalgoon Shah, MD, said, in an interview, at the annual meeting of the American College of Chest Physicians.
The researchers found that a history of depression or anxiety, throat tightness, dysphonia, odor symptom trigger, lack of response to bronchodilator or truncation, and flattening of the inspiratory volume curve did not predict VCD.
The patients were active duty military personnel and veterans who were referred to the pulmonary function lab at Tripler Army Medical Center, Honolulu, for suspected VCD between 2010 and 2014. The researchers identified patients by laryngoscopy procedure code and collected numerous variables, including demographic information, past medical history, pulmonary function test data, and clinical variables such as ED visits for dyspnea.
Dr. Shah of the division of pulmonary and critical care at Tripler said that direct laryngoscopic visualization is used to diagnose VCD in military personnel because the diagnosis is grounds for dismissal, but in other practice settings, the technique is not readily available, even though it is considered the gold standard. “You might still have a very high clinical suspicion of VCD in spite of a negative laryngoscopy, and you send these patients to speech therapy and they get better,” he said. “By logic, you can assume that these patients had VCD, you just didn’t catch it right in the lab. For the first time, we are saying that exercise laryngoscopy is not the gold standard.”
He emphasized that more research is required to develop a validated scoring system to predict a diagnosis of VCD and to distinguish it from asthma. He reported having no financial disclosures.
LOS ANGELES – Female sex and the absence of wheezing were the only factors significantly associated with vocal cord dysfunction in patients with high pretest probability of disease, a retrospective analysis showed.
The findings differ from those of the Pittsburgh Vocal Cord Index, which identified symptoms of throat tightness, dysphonia, absence of wheezing, and the presence of odors as key features predictive of vocal cord dysfunction (VCD). “This proves the point that VCD is an elusive diagnosis,” lead study author Phalgoon Shah, MD, said, in an interview, at the annual meeting of the American College of Chest Physicians.
The researchers found that a history of depression or anxiety, throat tightness, dysphonia, odor symptom trigger, lack of response to bronchodilator or truncation, and flattening of the inspiratory volume curve did not predict VCD.
The patients were active duty military personnel and veterans who were referred to the pulmonary function lab at Tripler Army Medical Center, Honolulu, for suspected VCD between 2010 and 2014. The researchers identified patients by laryngoscopy procedure code and collected numerous variables, including demographic information, past medical history, pulmonary function test data, and clinical variables such as ED visits for dyspnea.
Dr. Shah of the division of pulmonary and critical care at Tripler said that direct laryngoscopic visualization is used to diagnose VCD in military personnel because the diagnosis is grounds for dismissal, but in other practice settings, the technique is not readily available, even though it is considered the gold standard. “You might still have a very high clinical suspicion of VCD in spite of a negative laryngoscopy, and you send these patients to speech therapy and they get better,” he said. “By logic, you can assume that these patients had VCD, you just didn’t catch it right in the lab. For the first time, we are saying that exercise laryngoscopy is not the gold standard.”
He emphasized that more research is required to develop a validated scoring system to predict a diagnosis of VCD and to distinguish it from asthma. He reported having no financial disclosures.
LOS ANGELES – Female sex and the absence of wheezing were the only factors significantly associated with vocal cord dysfunction in patients with high pretest probability of disease, a retrospective analysis showed.
The findings differ from those of the Pittsburgh Vocal Cord Index, which identified symptoms of throat tightness, dysphonia, absence of wheezing, and the presence of odors as key features predictive of vocal cord dysfunction (VCD). “This proves the point that VCD is an elusive diagnosis,” lead study author Phalgoon Shah, MD, said, in an interview, at the annual meeting of the American College of Chest Physicians.
The researchers found that a history of depression or anxiety, throat tightness, dysphonia, odor symptom trigger, lack of response to bronchodilator or truncation, and flattening of the inspiratory volume curve did not predict VCD.
The patients were active duty military personnel and veterans who were referred to the pulmonary function lab at Tripler Army Medical Center, Honolulu, for suspected VCD between 2010 and 2014. The researchers identified patients by laryngoscopy procedure code and collected numerous variables, including demographic information, past medical history, pulmonary function test data, and clinical variables such as ED visits for dyspnea.
Dr. Shah of the division of pulmonary and critical care at Tripler said that direct laryngoscopic visualization is used to diagnose VCD in military personnel because the diagnosis is grounds for dismissal, but in other practice settings, the technique is not readily available, even though it is considered the gold standard. “You might still have a very high clinical suspicion of VCD in spite of a negative laryngoscopy, and you send these patients to speech therapy and they get better,” he said. “By logic, you can assume that these patients had VCD, you just didn’t catch it right in the lab. For the first time, we are saying that exercise laryngoscopy is not the gold standard.”
He emphasized that more research is required to develop a validated scoring system to predict a diagnosis of VCD and to distinguish it from asthma. He reported having no financial disclosures.
AT CHEST 2016
Key clinical point:
Major finding: The only variables significantly associated with VCD were female sex (P = .006) and the absence of wheezing (P = .037).
Data source: A retrospective analysis of 244 patients referred to a pulmonary function lab for suspected VCD.
Disclosures: Dr. Shah reported having no financial disclosures.
Prenatal triple ART arrests HIV transmission
A triple-drug antiretroviral therapy given to HIV-infected pregnant women significantly reduced transmission of the disease to their newborns, but with greater risk of adverse outcomes for mothers and infants, a study showed.
The findings were based on data from three treatment regimens in approximately 3,500 women and infant sets. The three treatments were zidovudine plus intrapartum single-dose nevirapine with 6-14 days of tenofovir and emtricitabine post partum (zidovudine alone); zidovudine, lamivudine, and lopinavir–ritonavir (zidovudine-based antiretroviral therapy [ART]); or tenofovir, emtricitabine, and lopinavir–ritonavir (tenofovir-based ART). All infants received nevirapine once daily, and infants of mothers coinfected with hepatitis B also received hepatitis B vaccination.
The Promoting Maternal and Infant Survival Everywhere (PROMISE) trial included patients at 14 sites in seven countries (India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe). The current study presented findings from women with a CD4 count of at least 350 cells per cubic millimeter who were randomized at 14 weeks’ gestation to one of the three treatment regimens.
Maternal adverse events (grade 2 or higher) were significantly more common in the zidovudine-based ART group than in the zidovudine-only group (21.1% vs. 17.3%), as was the rate of grade 2 or higher abnormal blood chemical values (5.8% vs. 1.3%).
In addition, rates of abnormal blood chemical values grade 2 or higher were significantly more common in women treated with tenofovir-based ART than with zidovudine alone (2.9% vs. 0.8%).
Low birth weight (less than 2,500 g) was significantly more likely for infants of mothers in the zidovudine-based ART group, compared with the zidovudine-only group (23.0% vs. 12.0%) and in the tenofovir-based ART group, compared with the zidovudine-only group (16.9% vs. 8.9%). Preterm delivery and early infant death rates were significantly more likely in the tenofovir-based ART group than in the zidovudine-based ART group. Overall, the rate of HIV-free survival was highest among infants whose mothers received zidovudine-based ART, the investigators reported.
The findings were limited by several factors, and the safest and most effective regimens have yet to be determined, the researchers said. “Our findings emphasize the need for continued research to assess ART in pregnancy to ensure safer pregnancies for HIV-infected women and healthier outcomes for their uninfected infants,” they wrote.
A study coauthor reported receiving grant support from Gilead Sciences and ViiV Healthcare, and consulting fees from Janssen, paid directly to her institution. None of the other researchers, disclosed any financial conflicts.
A triple-drug antiretroviral therapy given to HIV-infected pregnant women significantly reduced transmission of the disease to their newborns, but with greater risk of adverse outcomes for mothers and infants, a study showed.
The findings were based on data from three treatment regimens in approximately 3,500 women and infant sets. The three treatments were zidovudine plus intrapartum single-dose nevirapine with 6-14 days of tenofovir and emtricitabine post partum (zidovudine alone); zidovudine, lamivudine, and lopinavir–ritonavir (zidovudine-based antiretroviral therapy [ART]); or tenofovir, emtricitabine, and lopinavir–ritonavir (tenofovir-based ART). All infants received nevirapine once daily, and infants of mothers coinfected with hepatitis B also received hepatitis B vaccination.
The Promoting Maternal and Infant Survival Everywhere (PROMISE) trial included patients at 14 sites in seven countries (India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe). The current study presented findings from women with a CD4 count of at least 350 cells per cubic millimeter who were randomized at 14 weeks’ gestation to one of the three treatment regimens.
Maternal adverse events (grade 2 or higher) were significantly more common in the zidovudine-based ART group than in the zidovudine-only group (21.1% vs. 17.3%), as was the rate of grade 2 or higher abnormal blood chemical values (5.8% vs. 1.3%).
In addition, rates of abnormal blood chemical values grade 2 or higher were significantly more common in women treated with tenofovir-based ART than with zidovudine alone (2.9% vs. 0.8%).
Low birth weight (less than 2,500 g) was significantly more likely for infants of mothers in the zidovudine-based ART group, compared with the zidovudine-only group (23.0% vs. 12.0%) and in the tenofovir-based ART group, compared with the zidovudine-only group (16.9% vs. 8.9%). Preterm delivery and early infant death rates were significantly more likely in the tenofovir-based ART group than in the zidovudine-based ART group. Overall, the rate of HIV-free survival was highest among infants whose mothers received zidovudine-based ART, the investigators reported.
The findings were limited by several factors, and the safest and most effective regimens have yet to be determined, the researchers said. “Our findings emphasize the need for continued research to assess ART in pregnancy to ensure safer pregnancies for HIV-infected women and healthier outcomes for their uninfected infants,” they wrote.
A study coauthor reported receiving grant support from Gilead Sciences and ViiV Healthcare, and consulting fees from Janssen, paid directly to her institution. None of the other researchers, disclosed any financial conflicts.
A triple-drug antiretroviral therapy given to HIV-infected pregnant women significantly reduced transmission of the disease to their newborns, but with greater risk of adverse outcomes for mothers and infants, a study showed.
The findings were based on data from three treatment regimens in approximately 3,500 women and infant sets. The three treatments were zidovudine plus intrapartum single-dose nevirapine with 6-14 days of tenofovir and emtricitabine post partum (zidovudine alone); zidovudine, lamivudine, and lopinavir–ritonavir (zidovudine-based antiretroviral therapy [ART]); or tenofovir, emtricitabine, and lopinavir–ritonavir (tenofovir-based ART). All infants received nevirapine once daily, and infants of mothers coinfected with hepatitis B also received hepatitis B vaccination.
The Promoting Maternal and Infant Survival Everywhere (PROMISE) trial included patients at 14 sites in seven countries (India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe). The current study presented findings from women with a CD4 count of at least 350 cells per cubic millimeter who were randomized at 14 weeks’ gestation to one of the three treatment regimens.
Maternal adverse events (grade 2 or higher) were significantly more common in the zidovudine-based ART group than in the zidovudine-only group (21.1% vs. 17.3%), as was the rate of grade 2 or higher abnormal blood chemical values (5.8% vs. 1.3%).
In addition, rates of abnormal blood chemical values grade 2 or higher were significantly more common in women treated with tenofovir-based ART than with zidovudine alone (2.9% vs. 0.8%).
Low birth weight (less than 2,500 g) was significantly more likely for infants of mothers in the zidovudine-based ART group, compared with the zidovudine-only group (23.0% vs. 12.0%) and in the tenofovir-based ART group, compared with the zidovudine-only group (16.9% vs. 8.9%). Preterm delivery and early infant death rates were significantly more likely in the tenofovir-based ART group than in the zidovudine-based ART group. Overall, the rate of HIV-free survival was highest among infants whose mothers received zidovudine-based ART, the investigators reported.
The findings were limited by several factors, and the safest and most effective regimens have yet to be determined, the researchers said. “Our findings emphasize the need for continued research to assess ART in pregnancy to ensure safer pregnancies for HIV-infected women and healthier outcomes for their uninfected infants,” they wrote.
A study coauthor reported receiving grant support from Gilead Sciences and ViiV Healthcare, and consulting fees from Janssen, paid directly to her institution. None of the other researchers, disclosed any financial conflicts.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Prenatal ART significantly lowered rates of early HIV transmission from HIV-infected pregnant women to their newborns, compared with zidovudine alone.
Major finding: The transmission rate for HIV was significantly lower in patients who underwent ART, compared with zidovudine alone (0.5% vs. 1.8%).
Data source: A randomized trial including 3,529 HIV-positive pregnant women at at least 14 weeks’ gestation.
Disclosures: A study coauthor reported receiving grant support from Gilead Sciences and ViiV Healthcare, and consulting fees from Janssen, paid directly to her institution. None of the other researchers disclosed any financial conflicts.
Nivolumab + ipilimumab induced fulminant, fatal myocarditis
Two patients taking the immune checkpoint inhibitors nivolumab and ipilimumab for metastatic melanoma developed fulminant, fatal myocarditis, investigators reported in the New England Journal of Medicine.
Even though this adverse effect is rare, “clinicians should be vigilant for immune-mediated myocarditis, particularly because of its early onset, nonspecific symptomatology, and fulminant progression,” said Douglas B. Johnson, MD, of Vanderbilt University Medical Center, Nashville, and his associates.
The first case involved a 65-year-old woman with no cardiac risk factors who was admitted to the hospital with chest pain, dyspnea, and fatigue 12 days after she received her first dose of the combination therapy. She was found to have myocarditis and myositis with rhabdomylysis. Despite treatment with high-dose glucocorticoids, she developed intraventricular conduction delay within 24 hours, followed by complete heart block. She died from multisystem organ failure and refractory ventricular tachycardia.
The second case involved a 63-year-old man with no cardiac risk factors who was admitted with fatigue and myalgias 15 days after he received his first dose of the combination therapy. He showed profound ST-segment depression, an intraventricular conduction delay, myocarditis, and myositis. He also was treated with high-dose glucocorticoids but developed complete heart block and died from cardiac arrest.
Both patients had “strikingly elevated troponin levels and refractory conduction-system abnormalities with preserved cardiac function,” the investigators noted. Postmortem assessments showed intense lymphocytic infiltrates only in striated cardiac and skeletal muscle and in metastases; adjacent smooth muscle and other tissues were unaffected. Pathology results “were reminiscent of those observed in patients with acute allograft rejection after cardiac transplantation,” Dr. Johnson and his associates said (N Engl J Med. 2016 Nov 3. doi: 10.1056/NEJMoa1609214).
To assess the frequency of myocarditis and myositis in patients receiving immune checkpoint inhibitors for many different cancers, the investigators searched Bristol-Myers Squibb safety databases. They found 18 drug-related cases of severe myocarditis among 20,594 patients, for a frequency of 0.09%. Patients who received combined nivolumab and ipilimumab had more frequent and more severe myocarditis than those who took either agent alone.
“There are no known data regarding what monitoring strategy may be of value; in our practice, we are performing baseline ECG and weekly testing of troponin levels during weeks 1-3 for patients receiving combination immunotherapy,” the researchers noted.
This work was supported by the Bready Family Foundation, the National Cancer Institute, Vanderbilt-Ingram Cancer Center Ambassadors, the Breast Cancer Specialized Program of Research Excellence, the National Comprehensive Cancer Network, the National Institutes of Health, the Howard Hughes Medical Institute, and Gilead Life Sciences. Dr. Johnson reported receiving personal fees from Genoptix and Bristol-Myers Squibb, and his associates reported ties to numerous industry sources.
Two patients taking the immune checkpoint inhibitors nivolumab and ipilimumab for metastatic melanoma developed fulminant, fatal myocarditis, investigators reported in the New England Journal of Medicine.
Even though this adverse effect is rare, “clinicians should be vigilant for immune-mediated myocarditis, particularly because of its early onset, nonspecific symptomatology, and fulminant progression,” said Douglas B. Johnson, MD, of Vanderbilt University Medical Center, Nashville, and his associates.
The first case involved a 65-year-old woman with no cardiac risk factors who was admitted to the hospital with chest pain, dyspnea, and fatigue 12 days after she received her first dose of the combination therapy. She was found to have myocarditis and myositis with rhabdomylysis. Despite treatment with high-dose glucocorticoids, she developed intraventricular conduction delay within 24 hours, followed by complete heart block. She died from multisystem organ failure and refractory ventricular tachycardia.
The second case involved a 63-year-old man with no cardiac risk factors who was admitted with fatigue and myalgias 15 days after he received his first dose of the combination therapy. He showed profound ST-segment depression, an intraventricular conduction delay, myocarditis, and myositis. He also was treated with high-dose glucocorticoids but developed complete heart block and died from cardiac arrest.
Both patients had “strikingly elevated troponin levels and refractory conduction-system abnormalities with preserved cardiac function,” the investigators noted. Postmortem assessments showed intense lymphocytic infiltrates only in striated cardiac and skeletal muscle and in metastases; adjacent smooth muscle and other tissues were unaffected. Pathology results “were reminiscent of those observed in patients with acute allograft rejection after cardiac transplantation,” Dr. Johnson and his associates said (N Engl J Med. 2016 Nov 3. doi: 10.1056/NEJMoa1609214).
To assess the frequency of myocarditis and myositis in patients receiving immune checkpoint inhibitors for many different cancers, the investigators searched Bristol-Myers Squibb safety databases. They found 18 drug-related cases of severe myocarditis among 20,594 patients, for a frequency of 0.09%. Patients who received combined nivolumab and ipilimumab had more frequent and more severe myocarditis than those who took either agent alone.
“There are no known data regarding what monitoring strategy may be of value; in our practice, we are performing baseline ECG and weekly testing of troponin levels during weeks 1-3 for patients receiving combination immunotherapy,” the researchers noted.
This work was supported by the Bready Family Foundation, the National Cancer Institute, Vanderbilt-Ingram Cancer Center Ambassadors, the Breast Cancer Specialized Program of Research Excellence, the National Comprehensive Cancer Network, the National Institutes of Health, the Howard Hughes Medical Institute, and Gilead Life Sciences. Dr. Johnson reported receiving personal fees from Genoptix and Bristol-Myers Squibb, and his associates reported ties to numerous industry sources.
Two patients taking the immune checkpoint inhibitors nivolumab and ipilimumab for metastatic melanoma developed fulminant, fatal myocarditis, investigators reported in the New England Journal of Medicine.
Even though this adverse effect is rare, “clinicians should be vigilant for immune-mediated myocarditis, particularly because of its early onset, nonspecific symptomatology, and fulminant progression,” said Douglas B. Johnson, MD, of Vanderbilt University Medical Center, Nashville, and his associates.
The first case involved a 65-year-old woman with no cardiac risk factors who was admitted to the hospital with chest pain, dyspnea, and fatigue 12 days after she received her first dose of the combination therapy. She was found to have myocarditis and myositis with rhabdomylysis. Despite treatment with high-dose glucocorticoids, she developed intraventricular conduction delay within 24 hours, followed by complete heart block. She died from multisystem organ failure and refractory ventricular tachycardia.
The second case involved a 63-year-old man with no cardiac risk factors who was admitted with fatigue and myalgias 15 days after he received his first dose of the combination therapy. He showed profound ST-segment depression, an intraventricular conduction delay, myocarditis, and myositis. He also was treated with high-dose glucocorticoids but developed complete heart block and died from cardiac arrest.
Both patients had “strikingly elevated troponin levels and refractory conduction-system abnormalities with preserved cardiac function,” the investigators noted. Postmortem assessments showed intense lymphocytic infiltrates only in striated cardiac and skeletal muscle and in metastases; adjacent smooth muscle and other tissues were unaffected. Pathology results “were reminiscent of those observed in patients with acute allograft rejection after cardiac transplantation,” Dr. Johnson and his associates said (N Engl J Med. 2016 Nov 3. doi: 10.1056/NEJMoa1609214).
To assess the frequency of myocarditis and myositis in patients receiving immune checkpoint inhibitors for many different cancers, the investigators searched Bristol-Myers Squibb safety databases. They found 18 drug-related cases of severe myocarditis among 20,594 patients, for a frequency of 0.09%. Patients who received combined nivolumab and ipilimumab had more frequent and more severe myocarditis than those who took either agent alone.
“There are no known data regarding what monitoring strategy may be of value; in our practice, we are performing baseline ECG and weekly testing of troponin levels during weeks 1-3 for patients receiving combination immunotherapy,” the researchers noted.
This work was supported by the Bready Family Foundation, the National Cancer Institute, Vanderbilt-Ingram Cancer Center Ambassadors, the Breast Cancer Specialized Program of Research Excellence, the National Comprehensive Cancer Network, the National Institutes of Health, the Howard Hughes Medical Institute, and Gilead Life Sciences. Dr. Johnson reported receiving personal fees from Genoptix and Bristol-Myers Squibb, and his associates reported ties to numerous industry sources.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Two patients taking the immune checkpoint inhibitors nivolumab and ipilimumab for metastatic melanoma developed fulminant, fatal myocarditis.
Major finding: A search of Bristol-Myers Squibb safety databases found 18 drug-related cases of severe myocarditis among 20,594 patients, for a frequency of 0.09%.
Data source: Two case reports of a rare adverse effect of treatment with immune checkpoint inhibitors.
Disclosures: This work was supported by the Bready Family Foundation, the National Cancer Institute, Vanderbilt-Ingram Cancer Center Ambassadors, the Breast Cancer Specialized Program of Research Excellence, the National Comprehensive Cancer Network, the National Institutes of Health, the Howard Hughes Medical Institute, and Gilead Life Sciences. Dr. Johnson reported receiving personal fees from Genoptix and Bristol-Myers Squibb, and his associates reported ties to numerous industry sources.
Discussing screen time with parents
The American Academy of Pediatrics released a new set of recommendations for the appropriate amount of screen time for children and adolescents in October 2016.
Among other changes, the AAP now recommends no screen time (except for video chatting) for infants and children up to 18 months old. For 18- to 24-month-olds, the AAP discourages screen time, recommending that parents introduce only selected “high-quality” programming and cowatch with their children. Likewise, for children up to 5 years old, the AAP urges parents to limit all screen time to 1 hour/day, half of its previous recommendation, and again recommends that parents cowatch with their children and use only reliable providers of quality content, such as the Public Broadcasting Service (PBS). For older children, the AAP does not set specific time limits, but recommends that parents collaborate with the children on a media plan that limits screen time so that it does not interfere with other important activities, including homework, social time, exercise, and sleep.
There also is evidence that teenagers who spend substantial time engaged passively in social media (seeing what others are doing or saying via Facebook or Instagram) report higher levels of depression and anxiety, whereas those who use social media as a platform to stay connected (via two-way communication) report lower levels of these symptoms. While many young people use social sites as a forum to find peer support, share concerns, or develop their own “voice,” some young people might be vulnerable to exploitation, cyberbullying, or even online solicitation. The key here may be for parents, who have a sense of their child’s strengths and vulnerabilities, to be aware of where their children are spending their virtual time and to check in about the kinds of connections they have there. Of course, screen time can be equally seductive for parents. And when a parent is spending time reading texts or checking for Facebook updates, they are missing opportunities to be engaged with their children, helping them with homework or simply noticing that they seem stressed, or catching an opportunity to talk with them.
The pediatrician has the opportunity to educate parents about the potential risks that unchecked screen time can pose to their children’s healthy development. But it is critical that you approach these conversations with specificity and compassion. Customize the conversation to the age and personality of the child and family. A computer in the bedroom may make sense for an academically oriented 9th grader in a demanding school who is generally well-balanced in activities and friendships. A bedroom computer may be a poor choice for an isolated 9th grader almost addicted to video games with few friends or activities.
Simply reciting recommendations may heighten a parent’s feelings of isolation and shame, and not lead to meaningful change. Instead, start by asking about the details: Where are the screens in the home? Bedrooms? Who has a computer, tablet, or smartphone? How are these screens used in the context of the child’s overall psychosocial functioning? Depending on the circumstance, a smaller change, such as “no phones while doing homework,” can make a big difference. Simple, clear rules can be easier to explain and enforce, and protect parents from the perils of daily negotiations of screen terms with their children or teenagers. Perhaps they can have a “phone zone” where phones get parked and charged once kids get home from school. Perhaps there are limits on TV or video games on school nights (for the student performing below potential, rather than the driven student who would benefit from down time). Perhaps for preteens, computer-based homework can be done only on the desktop computer that is kept in a family study, rather than a laptop in a bedroom where kids are more likely to become distracted and surf the net. Pediatricians can help families think through the right approach to screen time that may range from restriction to shared use exploring shared interests to jointly watching a favorite TV show or sporting event.
You can help parents consider how they will talk about all this, acknowledging what is fun and rewarding about TV shows, social media, and the Internet alongside the problems of excessive use. Ask parents if it is hard for them to put down their own phones or tablets. They can acknowledge this explicitly with their children when establishing new media use rules. It is powerful for children, especially teenagers, to hear their parents acknowledge that “phones, tablets, and computers are powerful tools, but we all need to improve our skills at being in control of our use of them.” You might suggest that parents try this exercise: list all of the activities they wish they had time for in every day, and how much time they would spend in them. Then they should guess how much time they spend in screen-based entertainment. If they wish to protect time for screen-based entertainment, they can actively choose to do so. If you are able to help parents better understand the risks of excessive screen time and facilitate desired and appropriate use of media, you will have added to the quality of the family’s life.
The AAP has resources to help pediatricians partner with parents to create a Family Media Use Plan (www.healthychildren.org/MediaUsePlan).
Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
The American Academy of Pediatrics released a new set of recommendations for the appropriate amount of screen time for children and adolescents in October 2016.
Among other changes, the AAP now recommends no screen time (except for video chatting) for infants and children up to 18 months old. For 18- to 24-month-olds, the AAP discourages screen time, recommending that parents introduce only selected “high-quality” programming and cowatch with their children. Likewise, for children up to 5 years old, the AAP urges parents to limit all screen time to 1 hour/day, half of its previous recommendation, and again recommends that parents cowatch with their children and use only reliable providers of quality content, such as the Public Broadcasting Service (PBS). For older children, the AAP does not set specific time limits, but recommends that parents collaborate with the children on a media plan that limits screen time so that it does not interfere with other important activities, including homework, social time, exercise, and sleep.
There also is evidence that teenagers who spend substantial time engaged passively in social media (seeing what others are doing or saying via Facebook or Instagram) report higher levels of depression and anxiety, whereas those who use social media as a platform to stay connected (via two-way communication) report lower levels of these symptoms. While many young people use social sites as a forum to find peer support, share concerns, or develop their own “voice,” some young people might be vulnerable to exploitation, cyberbullying, or even online solicitation. The key here may be for parents, who have a sense of their child’s strengths and vulnerabilities, to be aware of where their children are spending their virtual time and to check in about the kinds of connections they have there. Of course, screen time can be equally seductive for parents. And when a parent is spending time reading texts or checking for Facebook updates, they are missing opportunities to be engaged with their children, helping them with homework or simply noticing that they seem stressed, or catching an opportunity to talk with them.
The pediatrician has the opportunity to educate parents about the potential risks that unchecked screen time can pose to their children’s healthy development. But it is critical that you approach these conversations with specificity and compassion. Customize the conversation to the age and personality of the child and family. A computer in the bedroom may make sense for an academically oriented 9th grader in a demanding school who is generally well-balanced in activities and friendships. A bedroom computer may be a poor choice for an isolated 9th grader almost addicted to video games with few friends or activities.
Simply reciting recommendations may heighten a parent’s feelings of isolation and shame, and not lead to meaningful change. Instead, start by asking about the details: Where are the screens in the home? Bedrooms? Who has a computer, tablet, or smartphone? How are these screens used in the context of the child’s overall psychosocial functioning? Depending on the circumstance, a smaller change, such as “no phones while doing homework,” can make a big difference. Simple, clear rules can be easier to explain and enforce, and protect parents from the perils of daily negotiations of screen terms with their children or teenagers. Perhaps they can have a “phone zone” where phones get parked and charged once kids get home from school. Perhaps there are limits on TV or video games on school nights (for the student performing below potential, rather than the driven student who would benefit from down time). Perhaps for preteens, computer-based homework can be done only on the desktop computer that is kept in a family study, rather than a laptop in a bedroom where kids are more likely to become distracted and surf the net. Pediatricians can help families think through the right approach to screen time that may range from restriction to shared use exploring shared interests to jointly watching a favorite TV show or sporting event.
You can help parents consider how they will talk about all this, acknowledging what is fun and rewarding about TV shows, social media, and the Internet alongside the problems of excessive use. Ask parents if it is hard for them to put down their own phones or tablets. They can acknowledge this explicitly with their children when establishing new media use rules. It is powerful for children, especially teenagers, to hear their parents acknowledge that “phones, tablets, and computers are powerful tools, but we all need to improve our skills at being in control of our use of them.” You might suggest that parents try this exercise: list all of the activities they wish they had time for in every day, and how much time they would spend in them. Then they should guess how much time they spend in screen-based entertainment. If they wish to protect time for screen-based entertainment, they can actively choose to do so. If you are able to help parents better understand the risks of excessive screen time and facilitate desired and appropriate use of media, you will have added to the quality of the family’s life.
The AAP has resources to help pediatricians partner with parents to create a Family Media Use Plan (www.healthychildren.org/MediaUsePlan).
Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
The American Academy of Pediatrics released a new set of recommendations for the appropriate amount of screen time for children and adolescents in October 2016.
Among other changes, the AAP now recommends no screen time (except for video chatting) for infants and children up to 18 months old. For 18- to 24-month-olds, the AAP discourages screen time, recommending that parents introduce only selected “high-quality” programming and cowatch with their children. Likewise, for children up to 5 years old, the AAP urges parents to limit all screen time to 1 hour/day, half of its previous recommendation, and again recommends that parents cowatch with their children and use only reliable providers of quality content, such as the Public Broadcasting Service (PBS). For older children, the AAP does not set specific time limits, but recommends that parents collaborate with the children on a media plan that limits screen time so that it does not interfere with other important activities, including homework, social time, exercise, and sleep.
There also is evidence that teenagers who spend substantial time engaged passively in social media (seeing what others are doing or saying via Facebook or Instagram) report higher levels of depression and anxiety, whereas those who use social media as a platform to stay connected (via two-way communication) report lower levels of these symptoms. While many young people use social sites as a forum to find peer support, share concerns, or develop their own “voice,” some young people might be vulnerable to exploitation, cyberbullying, or even online solicitation. The key here may be for parents, who have a sense of their child’s strengths and vulnerabilities, to be aware of where their children are spending their virtual time and to check in about the kinds of connections they have there. Of course, screen time can be equally seductive for parents. And when a parent is spending time reading texts or checking for Facebook updates, they are missing opportunities to be engaged with their children, helping them with homework or simply noticing that they seem stressed, or catching an opportunity to talk with them.
The pediatrician has the opportunity to educate parents about the potential risks that unchecked screen time can pose to their children’s healthy development. But it is critical that you approach these conversations with specificity and compassion. Customize the conversation to the age and personality of the child and family. A computer in the bedroom may make sense for an academically oriented 9th grader in a demanding school who is generally well-balanced in activities and friendships. A bedroom computer may be a poor choice for an isolated 9th grader almost addicted to video games with few friends or activities.
Simply reciting recommendations may heighten a parent’s feelings of isolation and shame, and not lead to meaningful change. Instead, start by asking about the details: Where are the screens in the home? Bedrooms? Who has a computer, tablet, or smartphone? How are these screens used in the context of the child’s overall psychosocial functioning? Depending on the circumstance, a smaller change, such as “no phones while doing homework,” can make a big difference. Simple, clear rules can be easier to explain and enforce, and protect parents from the perils of daily negotiations of screen terms with their children or teenagers. Perhaps they can have a “phone zone” where phones get parked and charged once kids get home from school. Perhaps there are limits on TV or video games on school nights (for the student performing below potential, rather than the driven student who would benefit from down time). Perhaps for preteens, computer-based homework can be done only on the desktop computer that is kept in a family study, rather than a laptop in a bedroom where kids are more likely to become distracted and surf the net. Pediatricians can help families think through the right approach to screen time that may range from restriction to shared use exploring shared interests to jointly watching a favorite TV show or sporting event.
You can help parents consider how they will talk about all this, acknowledging what is fun and rewarding about TV shows, social media, and the Internet alongside the problems of excessive use. Ask parents if it is hard for them to put down their own phones or tablets. They can acknowledge this explicitly with their children when establishing new media use rules. It is powerful for children, especially teenagers, to hear their parents acknowledge that “phones, tablets, and computers are powerful tools, but we all need to improve our skills at being in control of our use of them.” You might suggest that parents try this exercise: list all of the activities they wish they had time for in every day, and how much time they would spend in them. Then they should guess how much time they spend in screen-based entertainment. If they wish to protect time for screen-based entertainment, they can actively choose to do so. If you are able to help parents better understand the risks of excessive screen time and facilitate desired and appropriate use of media, you will have added to the quality of the family’s life.
The AAP has resources to help pediatricians partner with parents to create a Family Media Use Plan (www.healthychildren.org/MediaUsePlan).
Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
Cosmetic Corner: Dermatologists Weigh in on OTC Rosacea Treatments
To improve patient care and outcomes, leading dermatologists offered their recommendations on OTC rosacea treatments. Consideration must be given to:
- Eucerin Redness Relief
Beiersdorf Inc
Recommended by Gary Goldenberg, MD, New York, New York
- Rosaliac CC Cream
La Roche-Posay Laboratoire Dermatologique
“This product provides hydration and an even tint to correct and reduce the erythema of rosacea. It is made with both titanium dioxide and organic UV filters to give broad-spectrum coverage with SPF 30.”—Cherise Mizrahi-Levi, DO, New York, New York
- Vanicream
Pharmaceutical Specialties, Inc.
“I like Vanicream products since they are mild and hypoallergenic.”—Gary Goldenberg, MD, New York, New York
Cutis invites readers to send us their recommendations. Cleansing devices, skin-lightening agents, and self-tanners will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.
Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.
To improve patient care and outcomes, leading dermatologists offered their recommendations on OTC rosacea treatments. Consideration must be given to:
- Eucerin Redness Relief
Beiersdorf Inc
Recommended by Gary Goldenberg, MD, New York, New York
- Rosaliac CC Cream
La Roche-Posay Laboratoire Dermatologique
“This product provides hydration and an even tint to correct and reduce the erythema of rosacea. It is made with both titanium dioxide and organic UV filters to give broad-spectrum coverage with SPF 30.”—Cherise Mizrahi-Levi, DO, New York, New York
- Vanicream
Pharmaceutical Specialties, Inc.
“I like Vanicream products since they are mild and hypoallergenic.”—Gary Goldenberg, MD, New York, New York
Cutis invites readers to send us their recommendations. Cleansing devices, skin-lightening agents, and self-tanners will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.
Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.
To improve patient care and outcomes, leading dermatologists offered their recommendations on OTC rosacea treatments. Consideration must be given to:
- Eucerin Redness Relief
Beiersdorf Inc
Recommended by Gary Goldenberg, MD, New York, New York
- Rosaliac CC Cream
La Roche-Posay Laboratoire Dermatologique
“This product provides hydration and an even tint to correct and reduce the erythema of rosacea. It is made with both titanium dioxide and organic UV filters to give broad-spectrum coverage with SPF 30.”—Cherise Mizrahi-Levi, DO, New York, New York
- Vanicream
Pharmaceutical Specialties, Inc.
“I like Vanicream products since they are mild and hypoallergenic.”—Gary Goldenberg, MD, New York, New York
Cutis invites readers to send us their recommendations. Cleansing devices, skin-lightening agents, and self-tanners will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.
Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.
Discharging Nodule on the Jaw
The Diagnosis: Dental Sinus Secondary to Osteonecrosis of the Jaw
Cone beam computed tomography revealed an area of lucency measuring 40×20 mm in the body of the right mandible (Figure). The patient subsequently underwent curettage of the wound with sequestrectomy of the involved area.
Osteonecrosis of the jaw is a form of avascular necrosis. It is an uncommon but potentially serious side effect of bisphosphonate use.1 Bisphosphonates commonly are used as first-line therapy for osteoporosis, with proven efficacy to reduce fracture risk by exerting an antiresorptive effect on bones.2 Bisphosphonate-related osteonecrosis of the jaw (BRONJ) is defined by the American Association of Oral and Maxillofacial Surgeons as the presence of exposed necrotic bone in the maxillofacial region that has persisted for more than 8 weeks, with current or prior treatment with a bisphosphonate and absence of prior radiation therapy to the jaw.3 Bisphosphonate-related osteonecrosis of the jaw can be associated with infections, pathologic fractures, extraoral fistulae, or osteolysis extending to the inferior border.
Our patient had a dental sinus that resulted from the underlying BRONJ. The jawbones, unlike the long bones, are in a special environment in that both acute and chronic infections occur often within the bone, and surgical procedures as well as masticatory trauma expose the bone to a bacteria-laden environment.4 Infection around the root apex of a tooth results in a dental abscess and a sinus tract can develop from the abscess, draining either intraorally or extraorally.5 Facial sinus tracts can be either odontogenic or nonodontogenic, and sometimes the lesions of dental origin may be confused with dermatological lesions.
Bisphosphonates inhibit osteoclasts, which are responsible for bone resorption. Antiangiogenetic effects also have been reported in bisphosphonates, resulting in devitalized bone.6 The potent and prolonged inhibition of bone remodeling likely plays an important role in BRONJ. The more frequently occurring microdamage inflicted on the lower jawbone with mastication also may represent a contributory factor.7
Bisphosphonate-related osteonecrosis of the jaw more often is associated with the use of high-dose intravenous (IV) bisphosphonate in cancer-related hypercalcemia and less so with oral bisphosphonates, which are generally used to treat osteoporosis.3 In a Swedish study conducted from 2003 to 2010, 55 cases of BRONJ were documented in a population of 1.2 million individuals. The prevalence of BRONJ in patients on oral bisphosphonates and IV bisphosphonates was estimated to be 0.024% and 2.8%, respectively.8
Bisphosphonates are widely used worldwide as the main treatment of osteoporosis. The association between osteonecrosis of the jaw and oral bisphosphonates is contentious among the osteoporosis population, as most studies focus on IV bisphosphonate use in cancer patients.9 Bisphosphonate-related osteonecrosis of the jaw adversely affects the patient's quality of life, producing notable morbidity in afflicted patients. Thus, a complete dental assessment and treatment is recommended before the initiation of bisphosphonate treatment. The risk for developing BRONJ associated with oral bisphosphonates increases when the duration of therapy exceeds 3 years.3 It has been reported that antifracture efficacy would persist for 1 to 2 years following discontinuation of alendronate or risedronate that had been taken for 3 to 5 years, but patients with low bone mineral density at the femoral neck (T-score below -2.5) after 3 to 5 years of treatment of bisphosphonates are at the highest risk for vertebral fractures and therefore appear to benefit most from continuation of therapy.10 For dental procedures, the American Association of Oral and Maxillofacial Surgeons suggests that if systemic conditions persist, the clinician might consider discontinuation of oral bisphosphonates for a 3-month period before and after elective invasive dental surgery to lower the risk for BRONJ.3 When possible, invasive dentoalveolar procedures such as extractions should be avoided; conservative endodontic treatment is preferable.
Bisphosphonate-related osteonecrosis of the jaw is a devastating condition that is difficult to treat and manage, thus the focus should be on prevention through dental clearance prior to starting bisphosphonates. It also is crucial to have a high index of suspicion for BRONJ in patients presenting with orofacial lesions so that they can be treated expediently.
- Edwards BJ, Gounder M, McKoy JM, et al. Pharmacovigilance and reporting oversight in US FDA fast-track process: bisphosphonates and osteonecrosis of the jaw. Lancet Oncol. 2008;9:1166-1172.
- McClung M, Harris ST, Miller PD, et al. Bisphosphonate therapy for osteoporosis: benefits, risks, and drug holiday. Am J Med. 2013;126:13-20.
- Ruggiero SL, Dodson TB, Assael LA, et al; American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on bisphosphonate-related osteonecrosis of the jaws--2009 update. J Oral Maxillofac Surg. 2009;67(5 suppl):2-12.
- Mawardi H, Treister N, Richardson P, et al. Sinus tracts--an early sign of bisphosphonate-associated osteonecrosis of the jaws? J Oral Maxillofac Surg. 2009;67:593-601.
- Sammut S, Malden N, Lopes V. Facial cutaneous sinuses of dental origin--a diagnostic challenge. Br Dent J. 2013;215:555-558.
- Wood J, Bonjean K, Ruetz S, et al. Novel antiangiogenic effects of the bisphosphonate compound zoledronic acid. J Pharmacol Exp Ther. 2002;302:1055-1061.
- Hoefert S, Schmitz I, Tannapfel A, et al. Importance of microcracks in etiology of bisphosphonate-related osteonecrosis of the jaw: a possible pathogenetic model of symptomatic and non-symptomatic osteonecrosis of the jaw based on scanning electron microscopy findings. Clin Oral Investig. 2010;14:271-284.
- Hallmer F, Bjørnland T, Nicklasson A, et al. Osteonecrosis of the jaw in patients treated with oral and intravenous bisphosphonates: experience in Sweden. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014;118:202-208.
- Lin TC, Yang CY, Kao Yang YH, et al. Incidence and risk of osteonecrosis of the jaw among the Taiwan osteoporosis population [published online February 11, 2014]. Osteoporos Int. 2014;25:1503-1511.
- Watts NB, Diab DL. Long-term use of bisphosphonates in osteoporosis. J Clin Endocrinol Metab. 2010;95:1555-1565.
The Diagnosis: Dental Sinus Secondary to Osteonecrosis of the Jaw
Cone beam computed tomography revealed an area of lucency measuring 40×20 mm in the body of the right mandible (Figure). The patient subsequently underwent curettage of the wound with sequestrectomy of the involved area.
Osteonecrosis of the jaw is a form of avascular necrosis. It is an uncommon but potentially serious side effect of bisphosphonate use.1 Bisphosphonates commonly are used as first-line therapy for osteoporosis, with proven efficacy to reduce fracture risk by exerting an antiresorptive effect on bones.2 Bisphosphonate-related osteonecrosis of the jaw (BRONJ) is defined by the American Association of Oral and Maxillofacial Surgeons as the presence of exposed necrotic bone in the maxillofacial region that has persisted for more than 8 weeks, with current or prior treatment with a bisphosphonate and absence of prior radiation therapy to the jaw.3 Bisphosphonate-related osteonecrosis of the jaw can be associated with infections, pathologic fractures, extraoral fistulae, or osteolysis extending to the inferior border.
Our patient had a dental sinus that resulted from the underlying BRONJ. The jawbones, unlike the long bones, are in a special environment in that both acute and chronic infections occur often within the bone, and surgical procedures as well as masticatory trauma expose the bone to a bacteria-laden environment.4 Infection around the root apex of a tooth results in a dental abscess and a sinus tract can develop from the abscess, draining either intraorally or extraorally.5 Facial sinus tracts can be either odontogenic or nonodontogenic, and sometimes the lesions of dental origin may be confused with dermatological lesions.
Bisphosphonates inhibit osteoclasts, which are responsible for bone resorption. Antiangiogenetic effects also have been reported in bisphosphonates, resulting in devitalized bone.6 The potent and prolonged inhibition of bone remodeling likely plays an important role in BRONJ. The more frequently occurring microdamage inflicted on the lower jawbone with mastication also may represent a contributory factor.7
Bisphosphonate-related osteonecrosis of the jaw more often is associated with the use of high-dose intravenous (IV) bisphosphonate in cancer-related hypercalcemia and less so with oral bisphosphonates, which are generally used to treat osteoporosis.3 In a Swedish study conducted from 2003 to 2010, 55 cases of BRONJ were documented in a population of 1.2 million individuals. The prevalence of BRONJ in patients on oral bisphosphonates and IV bisphosphonates was estimated to be 0.024% and 2.8%, respectively.8
Bisphosphonates are widely used worldwide as the main treatment of osteoporosis. The association between osteonecrosis of the jaw and oral bisphosphonates is contentious among the osteoporosis population, as most studies focus on IV bisphosphonate use in cancer patients.9 Bisphosphonate-related osteonecrosis of the jaw adversely affects the patient's quality of life, producing notable morbidity in afflicted patients. Thus, a complete dental assessment and treatment is recommended before the initiation of bisphosphonate treatment. The risk for developing BRONJ associated with oral bisphosphonates increases when the duration of therapy exceeds 3 years.3 It has been reported that antifracture efficacy would persist for 1 to 2 years following discontinuation of alendronate or risedronate that had been taken for 3 to 5 years, but patients with low bone mineral density at the femoral neck (T-score below -2.5) after 3 to 5 years of treatment of bisphosphonates are at the highest risk for vertebral fractures and therefore appear to benefit most from continuation of therapy.10 For dental procedures, the American Association of Oral and Maxillofacial Surgeons suggests that if systemic conditions persist, the clinician might consider discontinuation of oral bisphosphonates for a 3-month period before and after elective invasive dental surgery to lower the risk for BRONJ.3 When possible, invasive dentoalveolar procedures such as extractions should be avoided; conservative endodontic treatment is preferable.
Bisphosphonate-related osteonecrosis of the jaw is a devastating condition that is difficult to treat and manage, thus the focus should be on prevention through dental clearance prior to starting bisphosphonates. It also is crucial to have a high index of suspicion for BRONJ in patients presenting with orofacial lesions so that they can be treated expediently.
The Diagnosis: Dental Sinus Secondary to Osteonecrosis of the Jaw
Cone beam computed tomography revealed an area of lucency measuring 40×20 mm in the body of the right mandible (Figure). The patient subsequently underwent curettage of the wound with sequestrectomy of the involved area.
Osteonecrosis of the jaw is a form of avascular necrosis. It is an uncommon but potentially serious side effect of bisphosphonate use.1 Bisphosphonates commonly are used as first-line therapy for osteoporosis, with proven efficacy to reduce fracture risk by exerting an antiresorptive effect on bones.2 Bisphosphonate-related osteonecrosis of the jaw (BRONJ) is defined by the American Association of Oral and Maxillofacial Surgeons as the presence of exposed necrotic bone in the maxillofacial region that has persisted for more than 8 weeks, with current or prior treatment with a bisphosphonate and absence of prior radiation therapy to the jaw.3 Bisphosphonate-related osteonecrosis of the jaw can be associated with infections, pathologic fractures, extraoral fistulae, or osteolysis extending to the inferior border.
Our patient had a dental sinus that resulted from the underlying BRONJ. The jawbones, unlike the long bones, are in a special environment in that both acute and chronic infections occur often within the bone, and surgical procedures as well as masticatory trauma expose the bone to a bacteria-laden environment.4 Infection around the root apex of a tooth results in a dental abscess and a sinus tract can develop from the abscess, draining either intraorally or extraorally.5 Facial sinus tracts can be either odontogenic or nonodontogenic, and sometimes the lesions of dental origin may be confused with dermatological lesions.
Bisphosphonates inhibit osteoclasts, which are responsible for bone resorption. Antiangiogenetic effects also have been reported in bisphosphonates, resulting in devitalized bone.6 The potent and prolonged inhibition of bone remodeling likely plays an important role in BRONJ. The more frequently occurring microdamage inflicted on the lower jawbone with mastication also may represent a contributory factor.7
Bisphosphonate-related osteonecrosis of the jaw more often is associated with the use of high-dose intravenous (IV) bisphosphonate in cancer-related hypercalcemia and less so with oral bisphosphonates, which are generally used to treat osteoporosis.3 In a Swedish study conducted from 2003 to 2010, 55 cases of BRONJ were documented in a population of 1.2 million individuals. The prevalence of BRONJ in patients on oral bisphosphonates and IV bisphosphonates was estimated to be 0.024% and 2.8%, respectively.8
Bisphosphonates are widely used worldwide as the main treatment of osteoporosis. The association between osteonecrosis of the jaw and oral bisphosphonates is contentious among the osteoporosis population, as most studies focus on IV bisphosphonate use in cancer patients.9 Bisphosphonate-related osteonecrosis of the jaw adversely affects the patient's quality of life, producing notable morbidity in afflicted patients. Thus, a complete dental assessment and treatment is recommended before the initiation of bisphosphonate treatment. The risk for developing BRONJ associated with oral bisphosphonates increases when the duration of therapy exceeds 3 years.3 It has been reported that antifracture efficacy would persist for 1 to 2 years following discontinuation of alendronate or risedronate that had been taken for 3 to 5 years, but patients with low bone mineral density at the femoral neck (T-score below -2.5) after 3 to 5 years of treatment of bisphosphonates are at the highest risk for vertebral fractures and therefore appear to benefit most from continuation of therapy.10 For dental procedures, the American Association of Oral and Maxillofacial Surgeons suggests that if systemic conditions persist, the clinician might consider discontinuation of oral bisphosphonates for a 3-month period before and after elective invasive dental surgery to lower the risk for BRONJ.3 When possible, invasive dentoalveolar procedures such as extractions should be avoided; conservative endodontic treatment is preferable.
Bisphosphonate-related osteonecrosis of the jaw is a devastating condition that is difficult to treat and manage, thus the focus should be on prevention through dental clearance prior to starting bisphosphonates. It also is crucial to have a high index of suspicion for BRONJ in patients presenting with orofacial lesions so that they can be treated expediently.
- Edwards BJ, Gounder M, McKoy JM, et al. Pharmacovigilance and reporting oversight in US FDA fast-track process: bisphosphonates and osteonecrosis of the jaw. Lancet Oncol. 2008;9:1166-1172.
- McClung M, Harris ST, Miller PD, et al. Bisphosphonate therapy for osteoporosis: benefits, risks, and drug holiday. Am J Med. 2013;126:13-20.
- Ruggiero SL, Dodson TB, Assael LA, et al; American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on bisphosphonate-related osteonecrosis of the jaws--2009 update. J Oral Maxillofac Surg. 2009;67(5 suppl):2-12.
- Mawardi H, Treister N, Richardson P, et al. Sinus tracts--an early sign of bisphosphonate-associated osteonecrosis of the jaws? J Oral Maxillofac Surg. 2009;67:593-601.
- Sammut S, Malden N, Lopes V. Facial cutaneous sinuses of dental origin--a diagnostic challenge. Br Dent J. 2013;215:555-558.
- Wood J, Bonjean K, Ruetz S, et al. Novel antiangiogenic effects of the bisphosphonate compound zoledronic acid. J Pharmacol Exp Ther. 2002;302:1055-1061.
- Hoefert S, Schmitz I, Tannapfel A, et al. Importance of microcracks in etiology of bisphosphonate-related osteonecrosis of the jaw: a possible pathogenetic model of symptomatic and non-symptomatic osteonecrosis of the jaw based on scanning electron microscopy findings. Clin Oral Investig. 2010;14:271-284.
- Hallmer F, Bjørnland T, Nicklasson A, et al. Osteonecrosis of the jaw in patients treated with oral and intravenous bisphosphonates: experience in Sweden. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014;118:202-208.
- Lin TC, Yang CY, Kao Yang YH, et al. Incidence and risk of osteonecrosis of the jaw among the Taiwan osteoporosis population [published online February 11, 2014]. Osteoporos Int. 2014;25:1503-1511.
- Watts NB, Diab DL. Long-term use of bisphosphonates in osteoporosis. J Clin Endocrinol Metab. 2010;95:1555-1565.
- Edwards BJ, Gounder M, McKoy JM, et al. Pharmacovigilance and reporting oversight in US FDA fast-track process: bisphosphonates and osteonecrosis of the jaw. Lancet Oncol. 2008;9:1166-1172.
- McClung M, Harris ST, Miller PD, et al. Bisphosphonate therapy for osteoporosis: benefits, risks, and drug holiday. Am J Med. 2013;126:13-20.
- Ruggiero SL, Dodson TB, Assael LA, et al; American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on bisphosphonate-related osteonecrosis of the jaws--2009 update. J Oral Maxillofac Surg. 2009;67(5 suppl):2-12.
- Mawardi H, Treister N, Richardson P, et al. Sinus tracts--an early sign of bisphosphonate-associated osteonecrosis of the jaws? J Oral Maxillofac Surg. 2009;67:593-601.
- Sammut S, Malden N, Lopes V. Facial cutaneous sinuses of dental origin--a diagnostic challenge. Br Dent J. 2013;215:555-558.
- Wood J, Bonjean K, Ruetz S, et al. Novel antiangiogenic effects of the bisphosphonate compound zoledronic acid. J Pharmacol Exp Ther. 2002;302:1055-1061.
- Hoefert S, Schmitz I, Tannapfel A, et al. Importance of microcracks in etiology of bisphosphonate-related osteonecrosis of the jaw: a possible pathogenetic model of symptomatic and non-symptomatic osteonecrosis of the jaw based on scanning electron microscopy findings. Clin Oral Investig. 2010;14:271-284.
- Hallmer F, Bjørnland T, Nicklasson A, et al. Osteonecrosis of the jaw in patients treated with oral and intravenous bisphosphonates: experience in Sweden. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014;118:202-208.
- Lin TC, Yang CY, Kao Yang YH, et al. Incidence and risk of osteonecrosis of the jaw among the Taiwan osteoporosis population [published online February 11, 2014]. Osteoporos Int. 2014;25:1503-1511.
- Watts NB, Diab DL. Long-term use of bisphosphonates in osteoporosis. J Clin Endocrinol Metab. 2010;95:1555-1565.
An 83-year-old woman presented with a painless, discharging, swollen nodule on the right side of the jaw of 6 months' duration. She had a history of osteoporosis diagnosed 3 years prior for which she was taking alendronate and cholecalciferol. Bone mineral density test scores were -3.93 (spine) and -2.81 (hip)(reference range, -2 and above). She also had hypertension that was treated with amlodipine. On examination there was fetor oris and a discharging sinus with purulent discharge at the jaw. The lower jaw was edentulous. A 5-mm area of red beefy granulation tissue was attached to underlying bone. An exposed sequestrum was seen intraorally with a 3-cm opening at the mandible. There also was submandibular lymphadenopathy.