On July 30, 1965, Lyndon B. Johnson signed H.R. 6675 into law, establishing Medicare and Medicaid as Title XVIII and Title XIX of the Social Security Act.¹ Shortly after, Medicare’s “extended care benefit” began, offering Medicare beneficiaries skilled nursing facility (SNF) care after a qualifying stay of 3 or more consecutive inpatient midnights.² Fifty years later, the word “inpatient” remains embedded in statute, limiting SNF coverage for Medicare beneficiaries hospitalized as outpatients under observation for part or all of a 3-midnight stay.³

At the individual Medicare beneficiary level, the financial impact of this policy is clear. The Office of Inspector General (OIG) reported a $10,503 beneficiary out-of-pocket cost per uncovered SNF stay following an observation hospitalization in 2012.⁴ But the actual number of Medicare beneficiaries impacted by this coverage gap is unknown. Using 2009 claims data, Feng et al.⁵ estimated that 0.75% of previously community dwelling Medicare beneficiaries are discharged to a SNF following an observation hospitalization, and the OIG reported 617,702 beneficiary hospital stays of 3 or more midnights not meeting the 3-midnight inpatient requirement in 2012, with 4% of these beneficiaries discharging to SNFs.⁴ Yet these studies based on Medicare claims data only capture actual SNF utilization, failing to answer the critical question: How many Medicare beneficiaries need, but forgo, SNF care following a non-qualifying observation hospital stay? In this issue of the Journal of Hospital Medicine, Goldstein et al.⁶ provide insight to that question. Using chart review of physical therapy and case management recommendations for post-acute SNF care, Goldstein et al.⁶ compare actual discharge rate to SNF or acute inpatient rehabilitation following an observation stay when such disposition is recommended. In their two-hospital system, fewer than 20% of previously community-dwelling hospitalist patients followed recommendation for post-acute facility stay after observation hospitalization, and more than 40% cited financial concerns as the reason for declining. Patients recommended for SNF also were more likely to be rehospitalized in the subsequent 30 days after discharge, confirming this as a vulnerable patient population. Given Medicare’s original intent to improve health care access for seniors, the case for change seems clear, and the repercussions of not addressing the plight of patients hospitalized under observation is having negative financial and overall detrimental health impacts.

But there are other compelling reasons why this 50-year-old law needs to be improved. Hospital care today is vastly different than when Medicare became law. Average hospital length of stay for patients 65 years and older was 14.2 days in 1965⁷ compared to 5.2 days today,⁸ clearly a shift in what 3 days of hospital care means. Most importantly, observation stays have become a major part of hospital care. Between 2006 and 2014, per-beneficiary outpatient visits (which include all observation stays) increased 44.2% nationally, while inpatient discharges decreased 19.9%.⁹ In 2012, the Centers for Medicare & Medicaid Services (CMS) received 1.7 million outpatient observation claims and an additional 700,000 inpatient claims that started with observation days.¹⁰ CMS also expected the 2-midnight rule to reduce outpatient observation stays,⁴ but a recent OIG report¹¹ found that outpatient stays increased 8.1% in the first year (FY 2014) under the new rule, and there were still 748,337 long observation stays (those lasting 2 midnights or longer) in 2014, only a small (2.8%) decrease from the prior year. These factors limit Medicare beneficiary post–acute SNF eligibility in ways that could not have been anticipated when the extended care benefit was created to help seniors access needed health care.

Policymakers must consider cost when considering statutory change. Waiver programs in the 1980s suspending the 3-midnight requirement raised concerns over potential increase in both SNF utilization and associated costs.¹² However, more recent data suggest that altering the 3-midnight requirement may not increase post-acute SNF utilization. From 2006 to 2010, Medicare Advantage programs that waived the 3-midnight requirement saw a decrease in hospital length of stay without increased SNF utilization or SNF length of stay, indicating that access to the right level of care at the right time could be cost-saving.¹³ Recent data from the Bundled Payments for Care Improvement (BPCI) program found savings were largely related to decreased SNF utilization when payments were episode-based,¹⁴ a trend that may continue as Medicare moves away from fee-for-service towards bundled payments for more conditions. And although neither example directly tests changing the 3-midnight requirement to include observation midnights, both studies suggest that innovative health care delivery and modification of SNF access did not result in increased SNF utilization or greater post-acute costs. In fact, as Goldstein et al.⁶ showed, patients recommended for post-acute SNF following observation stay were more likely to be rehospitalized within 30 days, an additional cost that could potentially be avoided if these patients had SNF access. We believe that these correlations strongly support rescinding the 3-midnight requirement, or at least amending it to allow nights spend under observation to count as “inpatient” for the purposes of SNF benefit coverage.

That being said, what can be done? In 2015, the Medicare Payment Advisory Commission (MedPAC) recommended changing the 3-night requirement to require just one of 3 midnights to be inpatient to make a qualifying stay.¹⁰ Although an improvement over current law, this proposal would not help the majority of beneficiaries who are exclusively hospitalized under observation status. The “Improving Access to Medicare Coverage Act of 2015”, to be reintroduced in Congress in the coming weeks, would count any midnight spent in the hospital towards the 3-midnight stay requirement, and has bipartisan, bicameral support and cosponsorship.¹⁵ In 2015, through unanimous bipartisan, bicameral support, Congress passed the NOTICE Act (PL 114-42), which requires hospitals to inform Medicare beneficiaries hospitalized under observation.¹⁶ We believe that the data are clear to both sides of the aisle that Congress should now work together using scientifically-supported research to improve the exact observation policies they felt patients should be informed of. Passing the Improving Access to Medicare Coverage Act is the logical next step in this arena.

Medicare was intended to give seniors access to the healthcare they need. Growth in hospital-based observation care begs for modernization of the statutory 3-inpatient midnight rule. Counting all midnights towards the 3-midnight requirement, whether those midnights are outpatient observation or inpatient, is the right first step.

Disclosures

Representative Courtney is the bill sponsor of the Improving Access to Medicare Coverage Act. The authors report no other conflicts.

On July 30, 1965, Lyndon B. Johnson signed H.R. 6675 into law, establishing Medicare and Medicaid as Title XVIII and Title XIX of the Social Security Act.¹ Shortly after, Medicare’s “extended care benefit” began, offering Medicare beneficiaries skilled nursing facility (SNF) care after a qualifying stay of 3 or more consecutive inpatient midnights.² Fifty years later, the word “inpatient” remains embedded in statute, limiting SNF coverage for Medicare beneficiaries hospitalized as outpatients under observation for part or all of a 3-midnight stay.³

At the individual Medicare beneficiary level, the financial impact of this policy is clear. The Office of Inspector General (OIG) reported a $10,503 beneficiary out-of-pocket cost per uncovered SNF stay following an observation hospitalization in 2012.⁴ But the actual number of Medicare beneficiaries impacted by this coverage gap is unknown. Using 2009 claims data, Feng et al.⁵ estimated that 0.75% of previously community dwelling Medicare beneficiaries are discharged to a SNF following an observation hospitalization, and the OIG reported 617,702 beneficiary hospital stays of 3 or more midnights not meeting the 3-midnight inpatient requirement in 2012, with 4% of these beneficiaries discharging to SNFs.⁴ Yet these studies based on Medicare claims data only capture actual SNF utilization, failing to answer the critical question: How many Medicare beneficiaries need, but forgo, SNF care following a non-qualifying observation hospital stay? In this issue of the Journal of Hospital Medicine, Goldstein et al.⁶ provide insight to that question. Using chart review of physical therapy and case management recommendations for post-acute SNF care, Goldstein et al.⁶ compare actual discharge rate to SNF or acute inpatient rehabilitation following an observation stay when such disposition is recommended. In their two-hospital system, fewer than 20% of previously community-dwelling hospitalist patients followed recommendation for post-acute facility stay after observation hospitalization, and more than 40% cited financial concerns as the reason for declining. Patients recommended for SNF also were more likely to be rehospitalized in the subsequent 30 days after discharge, confirming this as a vulnerable patient population. Given Medicare’s original intent to improve health care access for seniors, the case for change seems clear, and the repercussions of not addressing the plight of patients hospitalized under observation is having negative financial and overall detrimental health impacts.

But there are other compelling reasons why this 50-year-old law needs to be improved. Hospital care today is vastly different than when Medicare became law. Average hospital length of stay for patients 65 years and older was 14.2 days in 1965⁷ compared to 5.2 days today,⁸ clearly a shift in what 3 days of hospital care means. Most importantly, observation stays have become a major part of hospital care. Between 2006 and 2014, per-beneficiary outpatient visits (which include all observation stays) increased 44.2% nationally, while inpatient discharges decreased 19.9%.⁹ In 2012, the Centers for Medicare & Medicaid Services (CMS) received 1.7 million outpatient observation claims and an additional 700,000 inpatient claims that started with observation days.¹⁰ CMS also expected the 2-midnight rule to reduce outpatient observation stays,⁴ but a recent OIG report¹¹ found that outpatient stays increased 8.1% in the first year (FY 2014) under the new rule, and there were still 748,337 long observation stays (those lasting 2 midnights or longer) in 2014, only a small (2.8%) decrease from the prior year. These factors limit Medicare beneficiary post–acute SNF eligibility in ways that could not have been anticipated when the extended care benefit was created to help seniors access needed health care.

Policymakers must consider cost when considering statutory change. Waiver programs in the 1980s suspending the 3-midnight requirement raised concerns over potential increase in both SNF utilization and associated costs.¹² However, more recent data suggest that altering the 3-midnight requirement may not increase post-acute SNF utilization. From 2006 to 2010, Medicare Advantage programs that waived the 3-midnight requirement saw a decrease in hospital length of stay without increased SNF utilization or SNF length of stay, indicating that access to the right level of care at the right time could be cost-saving.¹³ Recent data from the Bundled Payments for Care Improvement (BPCI) program found savings were largely related to decreased SNF utilization when payments were episode-based,¹⁴ a trend that may continue as Medicare moves away from fee-for-service towards bundled payments for more conditions. And although neither example directly tests changing the 3-midnight requirement to include observation midnights, both studies suggest that innovative health care delivery and modification of SNF access did not result in increased SNF utilization or greater post-acute costs. In fact, as Goldstein et al.⁶ showed, patients recommended for post-acute SNF following observation stay were more likely to be rehospitalized within 30 days, an additional cost that could potentially be avoided if these patients had SNF access. We believe that these correlations strongly support rescinding the 3-midnight requirement, or at least amending it to allow nights spend under observation to count as “inpatient” for the purposes of SNF benefit coverage.

That being said, what can be done? In 2015, the Medicare Payment Advisory Commission (MedPAC) recommended changing the 3-night requirement to require just one of 3 midnights to be inpatient to make a qualifying stay.¹⁰ Although an improvement over current law, this proposal would not help the majority of beneficiaries who are exclusively hospitalized under observation status. The “Improving Access to Medicare Coverage Act of 2015”, to be reintroduced in Congress in the coming weeks, would count any midnight spent in the hospital towards the 3-midnight stay requirement, and has bipartisan, bicameral support and cosponsorship.¹⁵ In 2015, through unanimous bipartisan, bicameral support, Congress passed the NOTICE Act (PL 114-42), which requires hospitals to inform Medicare beneficiaries hospitalized under observation.¹⁶ We believe that the data are clear to both sides of the aisle that Congress should now work together using scientifically-supported research to improve the exact observation policies they felt patients should be informed of. Passing the Improving Access to Medicare Coverage Act is the logical next step in this arena.

Medicare was intended to give seniors access to the healthcare they need. Growth in hospital-based observation care begs for modernization of the statutory 3-inpatient midnight rule. Counting all midnights towards the 3-midnight requirement, whether those midnights are outpatient observation or inpatient, is the right first step.

Disclosures

Representative Courtney is the bill sponsor of the Improving Access to Medicare Coverage Act. The authors report no other conflicts.

On July 30, 1965, Lyndon B. Johnson signed H.R. 6675 into law, establishing Medicare and Medicaid as Title XVIII and Title XIX of the Social Security Act.¹ Shortly after, Medicare’s “extended care benefit” began, offering Medicare beneficiaries skilled nursing facility (SNF) care after a qualifying stay of 3 or more consecutive inpatient midnights.² Fifty years later, the word “inpatient” remains embedded in statute, limiting SNF coverage for Medicare beneficiaries hospitalized as outpatients under observation for part or all of a 3-midnight stay.³

At the individual Medicare beneficiary level, the financial impact of this policy is clear. The Office of Inspector General (OIG) reported a $10,503 beneficiary out-of-pocket cost per uncovered SNF stay following an observation hospitalization in 2012.⁴ But the actual number of Medicare beneficiaries impacted by this coverage gap is unknown. Using 2009 claims data, Feng et al.⁵ estimated that 0.75% of previously community dwelling Medicare beneficiaries are discharged to a SNF following an observation hospitalization, and the OIG reported 617,702 beneficiary hospital stays of 3 or more midnights not meeting the 3-midnight inpatient requirement in 2012, with 4% of these beneficiaries discharging to SNFs.⁴ Yet these studies based on Medicare claims data only capture actual SNF utilization, failing to answer the critical question: How many Medicare beneficiaries need, but forgo, SNF care following a non-qualifying observation hospital stay? In this issue of the Journal of Hospital Medicine, Goldstein et al.⁶ provide insight to that question. Using chart review of physical therapy and case management recommendations for post-acute SNF care, Goldstein et al.⁶ compare actual discharge rate to SNF or acute inpatient rehabilitation following an observation stay when such disposition is recommended. In their two-hospital system, fewer than 20% of previously community-dwelling hospitalist patients followed recommendation for post-acute facility stay after observation hospitalization, and more than 40% cited financial concerns as the reason for declining. Patients recommended for SNF also were more likely to be rehospitalized in the subsequent 30 days after discharge, confirming this as a vulnerable patient population. Given Medicare’s original intent to improve health care access for seniors, the case for change seems clear, and the repercussions of not addressing the plight of patients hospitalized under observation is having negative financial and overall detrimental health impacts.

But there are other compelling reasons why this 50-year-old law needs to be improved. Hospital care today is vastly different than when Medicare became law. Average hospital length of stay for patients 65 years and older was 14.2 days in 1965⁷ compared to 5.2 days today,⁸ clearly a shift in what 3 days of hospital care means. Most importantly, observation stays have become a major part of hospital care. Between 2006 and 2014, per-beneficiary outpatient visits (which include all observation stays) increased 44.2% nationally, while inpatient discharges decreased 19.9%.⁹ In 2012, the Centers for Medicare & Medicaid Services (CMS) received 1.7 million outpatient observation claims and an additional 700,000 inpatient claims that started with observation days.¹⁰ CMS also expected the 2-midnight rule to reduce outpatient observation stays,⁴ but a recent OIG report¹¹ found that outpatient stays increased 8.1% in the first year (FY 2014) under the new rule, and there were still 748,337 long observation stays (those lasting 2 midnights or longer) in 2014, only a small (2.8%) decrease from the prior year. These factors limit Medicare beneficiary post–acute SNF eligibility in ways that could not have been anticipated when the extended care benefit was created to help seniors access needed health care.

Policymakers must consider cost when considering statutory change. Waiver programs in the 1980s suspending the 3-midnight requirement raised concerns over potential increase in both SNF utilization and associated costs.¹² However, more recent data suggest that altering the 3-midnight requirement may not increase post-acute SNF utilization. From 2006 to 2010, Medicare Advantage programs that waived the 3-midnight requirement saw a decrease in hospital length of stay without increased SNF utilization or SNF length of stay, indicating that access to the right level of care at the right time could be cost-saving.¹³ Recent data from the Bundled Payments for Care Improvement (BPCI) program found savings were largely related to decreased SNF utilization when payments were episode-based,¹⁴ a trend that may continue as Medicare moves away from fee-for-service towards bundled payments for more conditions. And although neither example directly tests changing the 3-midnight requirement to include observation midnights, both studies suggest that innovative health care delivery and modification of SNF access did not result in increased SNF utilization or greater post-acute costs. In fact, as Goldstein et al.⁶ showed, patients recommended for post-acute SNF following observation stay were more likely to be rehospitalized within 30 days, an additional cost that could potentially be avoided if these patients had SNF access. We believe that these correlations strongly support rescinding the 3-midnight requirement, or at least amending it to allow nights spend under observation to count as “inpatient” for the purposes of SNF benefit coverage.

That being said, what can be done? In 2015, the Medicare Payment Advisory Commission (MedPAC) recommended changing the 3-night requirement to require just one of 3 midnights to be inpatient to make a qualifying stay.¹⁰ Although an improvement over current law, this proposal would not help the majority of beneficiaries who are exclusively hospitalized under observation status. The “Improving Access to Medicare Coverage Act of 2015”, to be reintroduced in Congress in the coming weeks, would count any midnight spent in the hospital towards the 3-midnight stay requirement, and has bipartisan, bicameral support and cosponsorship.¹⁵ In 2015, through unanimous bipartisan, bicameral support, Congress passed the NOTICE Act (PL 114-42), which requires hospitals to inform Medicare beneficiaries hospitalized under observation.¹⁶ We believe that the data are clear to both sides of the aisle that Congress should now work together using scientifically-supported research to improve the exact observation policies they felt patients should be informed of. Passing the Improving Access to Medicare Coverage Act is the logical next step in this arena.

Medicare was intended to give seniors access to the healthcare they need. Growth in hospital-based observation care begs for modernization of the statutory 3-inpatient midnight rule. Counting all midnights towards the 3-midnight requirement, whether those midnights are outpatient observation or inpatient, is the right first step.

Disclosures

Representative Courtney is the bill sponsor of the Improving Access to Medicare Coverage Act. The authors report no other conflicts.

In the article by Riddle et al,¹ the authors state that in the example of Cluster A type personality disorder, the elderly male patient’s paranoid disorder should be ignored, rather than confronting the paranoia. We do not need to confront the paranoia, but we need to treat the paranoid disorder. The symptom of paranoia extends beyond the single diagnostic category of delusional disorder and has been noted in many elderly patients with other underlying disorders.² This patient needs early psychiatric consultation and therapy.

They also give recommendations regarding Ms. B for her ever-increasing need of opiates. I find it too naïve for me to offer this patient “…choices, such as walking with her around the unit or listen to the music.” This patient needs pain physician consultations and aggressive interventional pain control.³

In the article by Riddle et al,¹ the authors state that in the example of Cluster A type personality disorder, the elderly male patient’s paranoid disorder should be ignored, rather than confronting the paranoia. We do not need to confront the paranoia, but we need to treat the paranoid disorder. The symptom of paranoia extends beyond the single diagnostic category of delusional disorder and has been noted in many elderly patients with other underlying disorders.² This patient needs early psychiatric consultation and therapy.

They also give recommendations regarding Ms. B for her ever-increasing need of opiates. I find it too naïve for me to offer this patient “…choices, such as walking with her around the unit or listen to the music.” This patient needs pain physician consultations and aggressive interventional pain control.³

In the article by Riddle et al,¹ the authors state that in the example of Cluster A type personality disorder, the elderly male patient’s paranoid disorder should be ignored, rather than confronting the paranoia. We do not need to confront the paranoia, but we need to treat the paranoid disorder. The symptom of paranoia extends beyond the single diagnostic category of delusional disorder and has been noted in many elderly patients with other underlying disorders.² This patient needs early psychiatric consultation and therapy.

They also give recommendations regarding Ms. B for her ever-increasing need of opiates. I find it too naïve for me to offer this patient “…choices, such as walking with her around the unit or listen to the music.” This patient needs pain physician consultations and aggressive interventional pain control.³

Thank you for the opportunity to reply to Dr. Hunasikatti’s comments regarding our article.¹ He brings up some excellent points and we appreciate the opportunity to clarify.

With regards to our example of Cluster A personality, the elderly individual with paranoia, we agree that the differential must include delirium and dementia and an appropriate work-up completed.  The intent of the vignette was to illustrate a functional but eccentric individual with paranoid beliefs.  The paranoia associated with paranoid personality disorder is classically not responsive to medications—nor are patients typically amenable to such treatment—and behavioral interventions remain paramount, minimizing the negative impact of paranoia on the individual’s care.^2,3

Regarding Ms. B, the vignette stated that the pain service was consulted, as Dr. Hunasikatti suggested it should be, but despite aggressive pain control, requests for opiates continued.  We agree that appropriate pain management is critical in management of all patients, and pain can exacerbate behavioral issues when insufficiently treated.  However, individuals who look to external sources of comfort may continue to request pain medications beyond what is clinically prudent and can benefit from learning additional skills to self-soothe and manage the psychological aspects of pain.^4,5

Thank you for the opportunity to reply to Dr. Hunasikatti’s comments regarding our article.¹ He brings up some excellent points and we appreciate the opportunity to clarify.

With regards to our example of Cluster A personality, the elderly individual with paranoia, we agree that the differential must include delirium and dementia and an appropriate work-up completed.  The intent of the vignette was to illustrate a functional but eccentric individual with paranoid beliefs.  The paranoia associated with paranoid personality disorder is classically not responsive to medications—nor are patients typically amenable to such treatment—and behavioral interventions remain paramount, minimizing the negative impact of paranoia on the individual’s care.^2,3

Regarding Ms. B, the vignette stated that the pain service was consulted, as Dr. Hunasikatti suggested it should be, but despite aggressive pain control, requests for opiates continued.  We agree that appropriate pain management is critical in management of all patients, and pain can exacerbate behavioral issues when insufficiently treated.  However, individuals who look to external sources of comfort may continue to request pain medications beyond what is clinically prudent and can benefit from learning additional skills to self-soothe and manage the psychological aspects of pain.^4,5

Thank you for the opportunity to reply to Dr. Hunasikatti’s comments regarding our article.¹ He brings up some excellent points and we appreciate the opportunity to clarify.

With regards to our example of Cluster A personality, the elderly individual with paranoia, we agree that the differential must include delirium and dementia and an appropriate work-up completed.  The intent of the vignette was to illustrate a functional but eccentric individual with paranoid beliefs.  The paranoia associated with paranoid personality disorder is classically not responsive to medications—nor are patients typically amenable to such treatment—and behavioral interventions remain paramount, minimizing the negative impact of paranoia on the individual’s care.^2,3

Regarding Ms. B, the vignette stated that the pain service was consulted, as Dr. Hunasikatti suggested it should be, but despite aggressive pain control, requests for opiates continued.  We agree that appropriate pain management is critical in management of all patients, and pain can exacerbate behavioral issues when insufficiently treated.  However, individuals who look to external sources of comfort may continue to request pain medications beyond what is clinically prudent and can benefit from learning additional skills to self-soothe and manage the psychological aspects of pain.^4,5

Photo courtesy of Celgene

The US Food and Drug Administration (FDA) has approved a new indication for lenalidomide (Revlimid).

The drug is now approved for use as maintenance therapy after autologous hematopoietic stem cell transplant (auto-HSCT) in patients with multiple myeloma (MM).

The expanded indication makes lenalidomide the first treatment to receive FDA approval for maintenance following auto-HSCT.

The drug was previously FDA-approved for use in combination with dexamethasone to treat patients with MM.

Lenalidomide is also FDA-approved to treat patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes associated with deletion 5q, with or without additional cytogenetic abnormalities.

And lenalidomide is FDA-approved to treat patients with mantle cell lymphoma who have relapsed or progressed after 2 prior therapies, one of which included bortezomib.

Lenalidomide is a product of Celgene.

Studies: Lenalidomide maintenance

The latest approval for lenalidomide was based on results of 2 cooperative group-led studies, CALGB 10010410 and IFM 2005-0211.

Results from both studies were published in NEJM in May 2012 (CALGB 100104, IFM 2005-02). The updated data reported here are included in the prescribing information for lenalidomide.

CALGB 100104 was a phase 3, double-blind study of 460 patients with newly diagnosed MM undergoing auto-HSCT. The patients received continuous daily treatment with lenalidomide or placebo until relapse.

IFM 2005-02 was a phase 3, double-blind study of 614 patients newly diagnosed with MM. The patients were randomized to receive a 2-month consolidation regimen after auto-HSCT, which consisted of lenalidomide monotherapy followed by continuous daily treatment with lenalidomide or placebo until relapse.

Survival

In both studies, the primary efficacy endpoint was progression-free survival (PFS). The PFS data for both studies were updated to reflect results as of March 2015.

In the CALGB study, the median PFS was 5.7 years in the lenalidomide arm and 1.9 years in the placebo arm (hazard ratio [HR]=0.38 [95% CI: 0.28-0.50]).

In the IFM study, the median PFS was 3.9 years in the lenalidomide arm and 2 years in the placebo arm (HR=0.53 [95% CI: 0.44-0.64]).

These studies were not powered for an overall survival (OS) endpoint. However, OS was recorded, and the OS data for both studies were updated to reflect results as of February 2016.

The median OS in the CALGB study was 9.3 years in the lenalidomide arm and 7 years in the placebo arm (HR=0.59 [95% CI: 0.44-0.78]).

In the IFM study, the median OS was 8.8 years in the lenalidomide arm and 7.3 years in the placebo arm (HR=0.90 [95% CI: 0.72-1.13]).

Adverse events

The most frequently reported adverse events in ≥20% of patients in the lenalidomide arm across both  studies (CALGB and IFM, respectively) were neutropenia (79%, 61%), thrombocytopenia (72%, 24%), leukopenia (23%, 32%), anemia (21%, 9%), upper respiratory tract infection (27%, 11%), bronchitis (5%, 47%), nasopharyngitis (2%, 35%), cough (10%, 27%), gastroenteritis (0%, 23%), diarrhea (55%, 39%), rash (32%, 8%), fatigue (23%, 11%), asthenia (0%, 30%), muscle spasm (0%, 33%), and pyrexia (8%, 21%).

The most frequently reported grade 3/4 events (more than 20% in the lenalidomide arm) were neutropenia, thrombocytopenia, and leukopenia.

Hematologic second primary malignancies (SPM) occurred in 7.5% of patients receiving lenalidomide maintenance and 3.3% of controls.

The incidence of hematologic plus solid tumor SPM (excluding squamous cell carcinoma and basal cell carcinoma) was 14.9% in the lenalidomide group and 8.8% in the control group, with a median follow-up of 91.5 months.

Non-melanoma skin cancer SPM, including squamous cell carcinoma and basal cell carcinoma, occurred in 3.9% of patients receiving lenalidomide maintenance and 2.6% of controls.

Photo courtesy of Celgene

The US Food and Drug Administration (FDA) has approved a new indication for lenalidomide (Revlimid).

The drug is now approved for use as maintenance therapy after autologous hematopoietic stem cell transplant (auto-HSCT) in patients with multiple myeloma (MM).

The expanded indication makes lenalidomide the first treatment to receive FDA approval for maintenance following auto-HSCT.

The drug was previously FDA-approved for use in combination with dexamethasone to treat patients with MM.

Lenalidomide is also FDA-approved to treat patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes associated with deletion 5q, with or without additional cytogenetic abnormalities.

And lenalidomide is FDA-approved to treat patients with mantle cell lymphoma who have relapsed or progressed after 2 prior therapies, one of which included bortezomib.

Lenalidomide is a product of Celgene.

Studies: Lenalidomide maintenance

The latest approval for lenalidomide was based on results of 2 cooperative group-led studies, CALGB 10010410 and IFM 2005-0211.

Results from both studies were published in NEJM in May 2012 (CALGB 100104, IFM 2005-02). The updated data reported here are included in the prescribing information for lenalidomide.

CALGB 100104 was a phase 3, double-blind study of 460 patients with newly diagnosed MM undergoing auto-HSCT. The patients received continuous daily treatment with lenalidomide or placebo until relapse.

IFM 2005-02 was a phase 3, double-blind study of 614 patients newly diagnosed with MM. The patients were randomized to receive a 2-month consolidation regimen after auto-HSCT, which consisted of lenalidomide monotherapy followed by continuous daily treatment with lenalidomide or placebo until relapse.

Survival

In both studies, the primary efficacy endpoint was progression-free survival (PFS). The PFS data for both studies were updated to reflect results as of March 2015.

In the CALGB study, the median PFS was 5.7 years in the lenalidomide arm and 1.9 years in the placebo arm (hazard ratio [HR]=0.38 [95% CI: 0.28-0.50]).

In the IFM study, the median PFS was 3.9 years in the lenalidomide arm and 2 years in the placebo arm (HR=0.53 [95% CI: 0.44-0.64]).

These studies were not powered for an overall survival (OS) endpoint. However, OS was recorded, and the OS data for both studies were updated to reflect results as of February 2016.

The median OS in the CALGB study was 9.3 years in the lenalidomide arm and 7 years in the placebo arm (HR=0.59 [95% CI: 0.44-0.78]).

In the IFM study, the median OS was 8.8 years in the lenalidomide arm and 7.3 years in the placebo arm (HR=0.90 [95% CI: 0.72-1.13]).

Adverse events

The most frequently reported adverse events in ≥20% of patients in the lenalidomide arm across both  studies (CALGB and IFM, respectively) were neutropenia (79%, 61%), thrombocytopenia (72%, 24%), leukopenia (23%, 32%), anemia (21%, 9%), upper respiratory tract infection (27%, 11%), bronchitis (5%, 47%), nasopharyngitis (2%, 35%), cough (10%, 27%), gastroenteritis (0%, 23%), diarrhea (55%, 39%), rash (32%, 8%), fatigue (23%, 11%), asthenia (0%, 30%), muscle spasm (0%, 33%), and pyrexia (8%, 21%).

The most frequently reported grade 3/4 events (more than 20% in the lenalidomide arm) were neutropenia, thrombocytopenia, and leukopenia.

Hematologic second primary malignancies (SPM) occurred in 7.5% of patients receiving lenalidomide maintenance and 3.3% of controls.

The incidence of hematologic plus solid tumor SPM (excluding squamous cell carcinoma and basal cell carcinoma) was 14.9% in the lenalidomide group and 8.8% in the control group, with a median follow-up of 91.5 months.

Non-melanoma skin cancer SPM, including squamous cell carcinoma and basal cell carcinoma, occurred in 3.9% of patients receiving lenalidomide maintenance and 2.6% of controls.

Photo courtesy of Celgene

The US Food and Drug Administration (FDA) has approved a new indication for lenalidomide (Revlimid).

The drug is now approved for use as maintenance therapy after autologous hematopoietic stem cell transplant (auto-HSCT) in patients with multiple myeloma (MM).

The expanded indication makes lenalidomide the first treatment to receive FDA approval for maintenance following auto-HSCT.

The drug was previously FDA-approved for use in combination with dexamethasone to treat patients with MM.

Lenalidomide is also FDA-approved to treat patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes associated with deletion 5q, with or without additional cytogenetic abnormalities.

And lenalidomide is FDA-approved to treat patients with mantle cell lymphoma who have relapsed or progressed after 2 prior therapies, one of which included bortezomib.

Lenalidomide is a product of Celgene.

Studies: Lenalidomide maintenance

The latest approval for lenalidomide was based on results of 2 cooperative group-led studies, CALGB 10010410 and IFM 2005-0211.

Results from both studies were published in NEJM in May 2012 (CALGB 100104, IFM 2005-02). The updated data reported here are included in the prescribing information for lenalidomide.

CALGB 100104 was a phase 3, double-blind study of 460 patients with newly diagnosed MM undergoing auto-HSCT. The patients received continuous daily treatment with lenalidomide or placebo until relapse.

IFM 2005-02 was a phase 3, double-blind study of 614 patients newly diagnosed with MM. The patients were randomized to receive a 2-month consolidation regimen after auto-HSCT, which consisted of lenalidomide monotherapy followed by continuous daily treatment with lenalidomide or placebo until relapse.

Survival

In both studies, the primary efficacy endpoint was progression-free survival (PFS). The PFS data for both studies were updated to reflect results as of March 2015.

In the CALGB study, the median PFS was 5.7 years in the lenalidomide arm and 1.9 years in the placebo arm (hazard ratio [HR]=0.38 [95% CI: 0.28-0.50]).

In the IFM study, the median PFS was 3.9 years in the lenalidomide arm and 2 years in the placebo arm (HR=0.53 [95% CI: 0.44-0.64]).

These studies were not powered for an overall survival (OS) endpoint. However, OS was recorded, and the OS data for both studies were updated to reflect results as of February 2016.

The median OS in the CALGB study was 9.3 years in the lenalidomide arm and 7 years in the placebo arm (HR=0.59 [95% CI: 0.44-0.78]).

In the IFM study, the median OS was 8.8 years in the lenalidomide arm and 7.3 years in the placebo arm (HR=0.90 [95% CI: 0.72-1.13]).

Adverse events

The most frequently reported adverse events in ≥20% of patients in the lenalidomide arm across both  studies (CALGB and IFM, respectively) were neutropenia (79%, 61%), thrombocytopenia (72%, 24%), leukopenia (23%, 32%), anemia (21%, 9%), upper respiratory tract infection (27%, 11%), bronchitis (5%, 47%), nasopharyngitis (2%, 35%), cough (10%, 27%), gastroenteritis (0%, 23%), diarrhea (55%, 39%), rash (32%, 8%), fatigue (23%, 11%), asthenia (0%, 30%), muscle spasm (0%, 33%), and pyrexia (8%, 21%).

The most frequently reported grade 3/4 events (more than 20% in the lenalidomide arm) were neutropenia, thrombocytopenia, and leukopenia.

Hematologic second primary malignancies (SPM) occurred in 7.5% of patients receiving lenalidomide maintenance and 3.3% of controls.

The incidence of hematologic plus solid tumor SPM (excluding squamous cell carcinoma and basal cell carcinoma) was 14.9% in the lenalidomide group and 8.8% in the control group, with a median follow-up of 91.5 months.

Non-melanoma skin cancer SPM, including squamous cell carcinoma and basal cell carcinoma, occurred in 3.9% of patients receiving lenalidomide maintenance and 2.6% of controls.

Photo by Bill Branson

ORLANDO, FL—Results of a phase 3 trial suggest an inactivated varicella zoster virus (VZV) vaccine known as V212 can reduce the risk of herpes zoster (HZ) in patients who have undergone autologous hematopoietic stem cell transplant (HSCT).

V212 reduced the hazard rate of HZ by an estimated 64% compared to placebo.

The vaccine also reduced the incidence of moderate-to-severe HZ pain and other HZ-related complications, such as hospitalization.

The overall incidence of adverse events (AEs) and the incidence of serious AEs were similar among vaccinated patients and those who received placebo.

Drew J. Winston, MD, of the University of California Los Angeles Medical Center, presented these results as one of the “Best Abstracts” at the 2017 BMT Tandem Meetings (abstract 6). The trial was sponsored by Merck, the company developing V212.

Treatment

This randomized, double-blind trial enrolled 1230 patients age 18 and older who were undergoing HSCT for any indication and had a history of varicella infection and/or were seropositive for VZV antibody.

The patients were randomized to receive:

• A 4-dose regimen of V212 (n=560) from a consistency lot (a lot having a targeted potency as required by regulators in order to demonstrate that the vaccine can be manufactured consistently)
• A 4-dose regimen of V212 (n=106) from a high-antigen lot (a lot having a higher antigen potency added to assess the safety profile of V212)
• Placebo (n=564).

Randomization was stratified by age (< 50 years vs ≥ 50 years) and by intended duration of post-transplant antiviral prophylaxis (≤3 months vs >3 to 6 months).

Dose 1 of V212 or placebo was given within approximately 30 days before HSCT, and doses 2, 3, and 4 were given approximately 30, 60, and 90 days after HSCT.

Patient characteristics

The median patient age was 57 (range, 19-76) for the consistency lot group, 56 (range, 21-75) for the high-antigen lot group, and 56 (range, 19-79) for the placebo group.

Underlying diseases were non-Hodgkin lymphoma (42%, 40%, and 44%, respectively), Hodgkin lymphoma (10%, 9%, and 9%, respectively), multiple myeloma (44%, 47% and 41%, respectively), acute leukemia (2%, 1%, and 2%, respectively), and “other” diseases (2%, 3% and 4%, respectively).

Roughly 30% of patients in each group received anti-viral agents for 3 months or less after HSCT. Twenty percent to 25% received antiviral therapy for more than 3 months to 6 months.

Thirty-seven percent to 40% received antiviral agents for more than 6 months. And 7% to 12% of patients did not receive any antiviral therapy.

HZ incidence

The average follow-up time for HZ surveillance was approximately 2.3 years (median: 2.6 years) post-vaccination.

Confirmed HZ occurred in 42 of the 538 patients who received V212 from a consistency lot and 113 of the 535 patients who received placebo. (Patients receiving V212 from a high-antigen lot were only included in the safety analysis.)

The estimated efficacy of V212 was 63.8% after adjustment for patient age and the duration of antiviral prophylaxis. Vaccine efficacy against HZ was defined as the relative reduction of hazard rate of HZ in vaccine recipients compared with placebo recipients.

The vaccine met the pre-specified criterion for success, as the lower bound of the 95% confidence interval (CI) was greater than 25%. The 95% CI was 48.4% to 74.6% (P<0.0001).

“The study demonstrates that the inactivated varicella vaccine is very effective for preventing herpes zoster after autologous stem cell transplantation,” Dr Winston said.

Pain, PHN, and other complications

V212 also reduced the incidence of moderate-to-severe HZ pain—according to the Zoster Brief Pain Inventory (ZBPI) score—by an estimated 69.5% (95% CI, 0.490-0.818).

Nineteen patients in the V212 consistency lot group had moderate-to-severe pain, as did 61 placebo-treated patients.

V212 conferred an estimated 83.7% (95% CI, 0.446-0.952) reduction in the incidence of post-herpetic neuralgia (PHN). Three patients in the V212 consistency lot group and 18 patients in the placebo group had PHN.

PHN was defined as pain in the area of the HZ rash with a “worst pain in the last 24 hours” score of 3 or greater (on a 0-10 scale) on the ZBPI that persists or appears 90 days or beyond after HZ rash onset following HSCT.

Patients who received V212 also saw an estimated 73.5% (95% CI, 0.498-0.860) reduction in “other” HZ complications. Twelve patients in the V212 consistency group and 44 in the placebo group had such complications.

“Other” complications included hospitalization or prolongation of hospitalization due to HZ, disseminated HZ (including disseminated HZ rash or VZV viremia), visceral HZ, ophthalmic HZ, neurological impairment due to HZ, and the administration of intravenous acyclovir therapy for the treatment of HZ post-HSCT.

Safety

All patients who received at least 1 dose of the vaccine or placebo and had follow-up data were included in the safety analysis. Patients were followed for AEs up to 28 days after the fourth vaccination dose.

AEs occurred in 97% of patients who received the vaccine (consistency and high-antigen groups assessed together) and 96.9% of placebo-treated patients. Vaccine-related AEs occurred in 32.6% and 12.6%, respectively.

“Of course, in this population of autologous stem cell transplant patients, adverse events of any type were very common in almost all patients,” Dr Winston said. “However, vaccine-related adverse events were greater in the vaccine recipients compared to the placebo patients, but this was primarily due to an increased incidence of injection-site adverse events in the vaccine recipients.”

Injection-site reactions occurred in 191 vaccinated patients and 36 placebo-treated patients.

The most common systemic AEs—in vaccinated and placebo-treated patients, respectively—were diarrhea (60.1% and 61.9%), nausea (56.5% and 57.8%), pyrexia (49.8% and 46.9%), mucosal inflammation (39.7% and 41.7%), thrombocytopenia (36.4% and 38.4%), febrile neutropenia (33.9% and 28.3%), vomiting (32.6% and 36.6%), anemia (26.6% and 24.4%), neutropenia (25.1% and 23.5%), decreased appetite (23.1% and 23.8%), fatigue (21.8% and 20.7%), hypokalemia (21.3% and 19.9%), and constipation (16.1% and 18.4%).

The incidence of serious AEs was 32.9% in vaccinated patients and 32.7% in the placebo group. The incidence of serious vaccine-related AEs was 0.8% and 0.9%, respectively.

The most common serious AEs—in vaccinated and placebo-treated patients, respectively—were infection (12.3% and 11.9%), relapsed malignancy (7.8% for both), febrile neutropenia (5.3% and 4.9%), pyrexia (3.2% and 4.0%), gastrointestinal disorders (3.2% and 3.6%), respiratory failure (2.7% and 2.2%), cardiac disorders (1.7% and 1.6%), and mucositis (1.2% and 0.9%).

Death occurred in 6.2% of vaccinated patients and 6.3% of placebo-treated patients. Three percent and 3.1%, respectively, discontinued the study due to AEs.

Photo by Bill Branson

ORLANDO, FL—Results of a phase 3 trial suggest an inactivated varicella zoster virus (VZV) vaccine known as V212 can reduce the risk of herpes zoster (HZ) in patients who have undergone autologous hematopoietic stem cell transplant (HSCT).

V212 reduced the hazard rate of HZ by an estimated 64% compared to placebo.

The vaccine also reduced the incidence of moderate-to-severe HZ pain and other HZ-related complications, such as hospitalization.

The overall incidence of adverse events (AEs) and the incidence of serious AEs were similar among vaccinated patients and those who received placebo.

Drew J. Winston, MD, of the University of California Los Angeles Medical Center, presented these results as one of the “Best Abstracts” at the 2017 BMT Tandem Meetings (abstract 6). The trial was sponsored by Merck, the company developing V212.

Treatment

This randomized, double-blind trial enrolled 1230 patients age 18 and older who were undergoing HSCT for any indication and had a history of varicella infection and/or were seropositive for VZV antibody.

The patients were randomized to receive:

• A 4-dose regimen of V212 (n=560) from a consistency lot (a lot having a targeted potency as required by regulators in order to demonstrate that the vaccine can be manufactured consistently)
• A 4-dose regimen of V212 (n=106) from a high-antigen lot (a lot having a higher antigen potency added to assess the safety profile of V212)
• Placebo (n=564).

Randomization was stratified by age (< 50 years vs ≥ 50 years) and by intended duration of post-transplant antiviral prophylaxis (≤3 months vs >3 to 6 months).

Dose 1 of V212 or placebo was given within approximately 30 days before HSCT, and doses 2, 3, and 4 were given approximately 30, 60, and 90 days after HSCT.

Patient characteristics

The median patient age was 57 (range, 19-76) for the consistency lot group, 56 (range, 21-75) for the high-antigen lot group, and 56 (range, 19-79) for the placebo group.

Underlying diseases were non-Hodgkin lymphoma (42%, 40%, and 44%, respectively), Hodgkin lymphoma (10%, 9%, and 9%, respectively), multiple myeloma (44%, 47% and 41%, respectively), acute leukemia (2%, 1%, and 2%, respectively), and “other” diseases (2%, 3% and 4%, respectively).

Roughly 30% of patients in each group received anti-viral agents for 3 months or less after HSCT. Twenty percent to 25% received antiviral therapy for more than 3 months to 6 months.

Thirty-seven percent to 40% received antiviral agents for more than 6 months. And 7% to 12% of patients did not receive any antiviral therapy.

HZ incidence

The average follow-up time for HZ surveillance was approximately 2.3 years (median: 2.6 years) post-vaccination.

Confirmed HZ occurred in 42 of the 538 patients who received V212 from a consistency lot and 113 of the 535 patients who received placebo. (Patients receiving V212 from a high-antigen lot were only included in the safety analysis.)

The estimated efficacy of V212 was 63.8% after adjustment for patient age and the duration of antiviral prophylaxis. Vaccine efficacy against HZ was defined as the relative reduction of hazard rate of HZ in vaccine recipients compared with placebo recipients.

The vaccine met the pre-specified criterion for success, as the lower bound of the 95% confidence interval (CI) was greater than 25%. The 95% CI was 48.4% to 74.6% (P<0.0001).

“The study demonstrates that the inactivated varicella vaccine is very effective for preventing herpes zoster after autologous stem cell transplantation,” Dr Winston said.

Pain, PHN, and other complications

V212 also reduced the incidence of moderate-to-severe HZ pain—according to the Zoster Brief Pain Inventory (ZBPI) score—by an estimated 69.5% (95% CI, 0.490-0.818).

Nineteen patients in the V212 consistency lot group had moderate-to-severe pain, as did 61 placebo-treated patients.

V212 conferred an estimated 83.7% (95% CI, 0.446-0.952) reduction in the incidence of post-herpetic neuralgia (PHN). Three patients in the V212 consistency lot group and 18 patients in the placebo group had PHN.

PHN was defined as pain in the area of the HZ rash with a “worst pain in the last 24 hours” score of 3 or greater (on a 0-10 scale) on the ZBPI that persists or appears 90 days or beyond after HZ rash onset following HSCT.

Patients who received V212 also saw an estimated 73.5% (95% CI, 0.498-0.860) reduction in “other” HZ complications. Twelve patients in the V212 consistency group and 44 in the placebo group had such complications.

“Other” complications included hospitalization or prolongation of hospitalization due to HZ, disseminated HZ (including disseminated HZ rash or VZV viremia), visceral HZ, ophthalmic HZ, neurological impairment due to HZ, and the administration of intravenous acyclovir therapy for the treatment of HZ post-HSCT.

Safety

All patients who received at least 1 dose of the vaccine or placebo and had follow-up data were included in the safety analysis. Patients were followed for AEs up to 28 days after the fourth vaccination dose.

AEs occurred in 97% of patients who received the vaccine (consistency and high-antigen groups assessed together) and 96.9% of placebo-treated patients. Vaccine-related AEs occurred in 32.6% and 12.6%, respectively.

“Of course, in this population of autologous stem cell transplant patients, adverse events of any type were very common in almost all patients,” Dr Winston said. “However, vaccine-related adverse events were greater in the vaccine recipients compared to the placebo patients, but this was primarily due to an increased incidence of injection-site adverse events in the vaccine recipients.”

Injection-site reactions occurred in 191 vaccinated patients and 36 placebo-treated patients.

The most common systemic AEs—in vaccinated and placebo-treated patients, respectively—were diarrhea (60.1% and 61.9%), nausea (56.5% and 57.8%), pyrexia (49.8% and 46.9%), mucosal inflammation (39.7% and 41.7%), thrombocytopenia (36.4% and 38.4%), febrile neutropenia (33.9% and 28.3%), vomiting (32.6% and 36.6%), anemia (26.6% and 24.4%), neutropenia (25.1% and 23.5%), decreased appetite (23.1% and 23.8%), fatigue (21.8% and 20.7%), hypokalemia (21.3% and 19.9%), and constipation (16.1% and 18.4%).

The incidence of serious AEs was 32.9% in vaccinated patients and 32.7% in the placebo group. The incidence of serious vaccine-related AEs was 0.8% and 0.9%, respectively.

The most common serious AEs—in vaccinated and placebo-treated patients, respectively—were infection (12.3% and 11.9%), relapsed malignancy (7.8% for both), febrile neutropenia (5.3% and 4.9%), pyrexia (3.2% and 4.0%), gastrointestinal disorders (3.2% and 3.6%), respiratory failure (2.7% and 2.2%), cardiac disorders (1.7% and 1.6%), and mucositis (1.2% and 0.9%).

Death occurred in 6.2% of vaccinated patients and 6.3% of placebo-treated patients. Three percent and 3.1%, respectively, discontinued the study due to AEs.

Photo by Bill Branson

ORLANDO, FL—Results of a phase 3 trial suggest an inactivated varicella zoster virus (VZV) vaccine known as V212 can reduce the risk of herpes zoster (HZ) in patients who have undergone autologous hematopoietic stem cell transplant (HSCT).

V212 reduced the hazard rate of HZ by an estimated 64% compared to placebo.

The vaccine also reduced the incidence of moderate-to-severe HZ pain and other HZ-related complications, such as hospitalization.

The overall incidence of adverse events (AEs) and the incidence of serious AEs were similar among vaccinated patients and those who received placebo.

Drew J. Winston, MD, of the University of California Los Angeles Medical Center, presented these results as one of the “Best Abstracts” at the 2017 BMT Tandem Meetings (abstract 6). The trial was sponsored by Merck, the company developing V212.

Treatment

This randomized, double-blind trial enrolled 1230 patients age 18 and older who were undergoing HSCT for any indication and had a history of varicella infection and/or were seropositive for VZV antibody.

The patients were randomized to receive:

• A 4-dose regimen of V212 (n=560) from a consistency lot (a lot having a targeted potency as required by regulators in order to demonstrate that the vaccine can be manufactured consistently)
• A 4-dose regimen of V212 (n=106) from a high-antigen lot (a lot having a higher antigen potency added to assess the safety profile of V212)
• Placebo (n=564).

Randomization was stratified by age (< 50 years vs ≥ 50 years) and by intended duration of post-transplant antiviral prophylaxis (≤3 months vs >3 to 6 months).

Dose 1 of V212 or placebo was given within approximately 30 days before HSCT, and doses 2, 3, and 4 were given approximately 30, 60, and 90 days after HSCT.

Patient characteristics

The median patient age was 57 (range, 19-76) for the consistency lot group, 56 (range, 21-75) for the high-antigen lot group, and 56 (range, 19-79) for the placebo group.

Underlying diseases were non-Hodgkin lymphoma (42%, 40%, and 44%, respectively), Hodgkin lymphoma (10%, 9%, and 9%, respectively), multiple myeloma (44%, 47% and 41%, respectively), acute leukemia (2%, 1%, and 2%, respectively), and “other” diseases (2%, 3% and 4%, respectively).

Roughly 30% of patients in each group received anti-viral agents for 3 months or less after HSCT. Twenty percent to 25% received antiviral therapy for more than 3 months to 6 months.

Thirty-seven percent to 40% received antiviral agents for more than 6 months. And 7% to 12% of patients did not receive any antiviral therapy.

HZ incidence

The average follow-up time for HZ surveillance was approximately 2.3 years (median: 2.6 years) post-vaccination.

Confirmed HZ occurred in 42 of the 538 patients who received V212 from a consistency lot and 113 of the 535 patients who received placebo. (Patients receiving V212 from a high-antigen lot were only included in the safety analysis.)

The estimated efficacy of V212 was 63.8% after adjustment for patient age and the duration of antiviral prophylaxis. Vaccine efficacy against HZ was defined as the relative reduction of hazard rate of HZ in vaccine recipients compared with placebo recipients.

The vaccine met the pre-specified criterion for success, as the lower bound of the 95% confidence interval (CI) was greater than 25%. The 95% CI was 48.4% to 74.6% (P<0.0001).

“The study demonstrates that the inactivated varicella vaccine is very effective for preventing herpes zoster after autologous stem cell transplantation,” Dr Winston said.

Pain, PHN, and other complications

V212 also reduced the incidence of moderate-to-severe HZ pain—according to the Zoster Brief Pain Inventory (ZBPI) score—by an estimated 69.5% (95% CI, 0.490-0.818).

Nineteen patients in the V212 consistency lot group had moderate-to-severe pain, as did 61 placebo-treated patients.

V212 conferred an estimated 83.7% (95% CI, 0.446-0.952) reduction in the incidence of post-herpetic neuralgia (PHN). Three patients in the V212 consistency lot group and 18 patients in the placebo group had PHN.

PHN was defined as pain in the area of the HZ rash with a “worst pain in the last 24 hours” score of 3 or greater (on a 0-10 scale) on the ZBPI that persists or appears 90 days or beyond after HZ rash onset following HSCT.

Patients who received V212 also saw an estimated 73.5% (95% CI, 0.498-0.860) reduction in “other” HZ complications. Twelve patients in the V212 consistency group and 44 in the placebo group had such complications.

“Other” complications included hospitalization or prolongation of hospitalization due to HZ, disseminated HZ (including disseminated HZ rash or VZV viremia), visceral HZ, ophthalmic HZ, neurological impairment due to HZ, and the administration of intravenous acyclovir therapy for the treatment of HZ post-HSCT.

Safety

All patients who received at least 1 dose of the vaccine or placebo and had follow-up data were included in the safety analysis. Patients were followed for AEs up to 28 days after the fourth vaccination dose.

AEs occurred in 97% of patients who received the vaccine (consistency and high-antigen groups assessed together) and 96.9% of placebo-treated patients. Vaccine-related AEs occurred in 32.6% and 12.6%, respectively.

“Of course, in this population of autologous stem cell transplant patients, adverse events of any type were very common in almost all patients,” Dr Winston said. “However, vaccine-related adverse events were greater in the vaccine recipients compared to the placebo patients, but this was primarily due to an increased incidence of injection-site adverse events in the vaccine recipients.”

Injection-site reactions occurred in 191 vaccinated patients and 36 placebo-treated patients.

The most common systemic AEs—in vaccinated and placebo-treated patients, respectively—were diarrhea (60.1% and 61.9%), nausea (56.5% and 57.8%), pyrexia (49.8% and 46.9%), mucosal inflammation (39.7% and 41.7%), thrombocytopenia (36.4% and 38.4%), febrile neutropenia (33.9% and 28.3%), vomiting (32.6% and 36.6%), anemia (26.6% and 24.4%), neutropenia (25.1% and 23.5%), decreased appetite (23.1% and 23.8%), fatigue (21.8% and 20.7%), hypokalemia (21.3% and 19.9%), and constipation (16.1% and 18.4%).

The incidence of serious AEs was 32.9% in vaccinated patients and 32.7% in the placebo group. The incidence of serious vaccine-related AEs was 0.8% and 0.9%, respectively.

The most common serious AEs—in vaccinated and placebo-treated patients, respectively—were infection (12.3% and 11.9%), relapsed malignancy (7.8% for both), febrile neutropenia (5.3% and 4.9%), pyrexia (3.2% and 4.0%), gastrointestinal disorders (3.2% and 3.6%), respiratory failure (2.7% and 2.2%), cardiac disorders (1.7% and 1.6%), and mucositis (1.2% and 0.9%).

Death occurred in 6.2% of vaccinated patients and 6.3% of placebo-treated patients. Three percent and 3.1%, respectively, discontinued the study due to AEs.

Kristyna Wentz-Graff

A newly discovered issue with the Ba/F3 transformation assay could “jeopardize attempts to characterize the signaling mechanisms and drug sensitivities of leukemic oncogenes,” researchers reported in Oncotarget.

The researchers said the assay “remains an invaluable tool” for validating activating mutations in primary leukemias.

However, the assay is prone to a previously unreported flaw, where Ba/F3 cells can acquire additional mutations.

This issue was discovered by Kevin Watanabe-Smith, PhD, of Oregon Health & Science University in Portland.

He identified the problem while studying a growth-activating mutation in a patient with T-cell leukemia. (The results of that research were published in Leukemia in April 2016).

“When I was sequencing the patient’s DNA to make sure the original, known mutation is there, I was finding additional, unexpected mutations in the gene that I didn’t put there,” Dr Watanabe-Smith said. “And I was getting different mutations every time.”

“After we saw this in several cases, we knew it was worth further study,” added Cristina Tognon, PhD, of Oregon Health & Science University.

So the researchers decided to study Ba/F3 cell lines with and without 4 mutations (found in 3 cytokine receptors) that have “known transformative capacity,” including:

• CSF2RB R461C, a germline mutation found in a patient with T-cell acute lymphoblastic leukemia (ALL)
• CSF3R T618I, a mutation found in chronic neutrophilic leukemia (CNL) and atypical chronic myelogenous leukemia (aCML)
• CSF3R W791X, also found in CNL and aCML
• IL7R 243InsPPCL, which was found in a patient with B-cell ALL.

The researchers said they observed acquired mutations in 1 of 3 CSF2RB wild-type cell lines that transformed and all 4 CSF3R wild-type cell lines, which all transformed.

Furthermore, most CSF2RB R461C lines (4/5) and CSF3R W791X lines (3/4) had additional acquired mutations. However, the CSF3R T618I lines and the IL7R 243InsPPCL lines did not contain acquired mutations.

The researchers said acquired mutations were observed only in weakly transforming oncogenes, which were defined as mutations with a weaker ability to transform cells (less than 1 in every 200 cells) or a slower time to outgrowth (5 days or longer to reach a 5-fold increase over the initial cell number).

The team also said their findings indicate that the majority of the acquired mutations likely exist before IL-3 withdrawal but only expand to levels detectable by Sanger sequencing in the absence of IL-3.

“The potential impact [of these acquired mutations] is that a non-functional mutation could appear functional, and a researcher could publish results that would not be reproducible,” Dr Watanabe-Smith said.

To overcome this problem, Dr Watanabe-Smith and his colleagues recommended taking an additional step when using the Ba/F3 assay—sequencing outgrown cell lines. They also said additional research is needed to devise methods that reduce the incidence of acquired mutations in such assays. 

Kristyna Wentz-Graff

A newly discovered issue with the Ba/F3 transformation assay could “jeopardize attempts to characterize the signaling mechanisms and drug sensitivities of leukemic oncogenes,” researchers reported in Oncotarget.

The researchers said the assay “remains an invaluable tool” for validating activating mutations in primary leukemias.

However, the assay is prone to a previously unreported flaw, where Ba/F3 cells can acquire additional mutations.

This issue was discovered by Kevin Watanabe-Smith, PhD, of Oregon Health & Science University in Portland.

He identified the problem while studying a growth-activating mutation in a patient with T-cell leukemia. (The results of that research were published in Leukemia in April 2016).

“When I was sequencing the patient’s DNA to make sure the original, known mutation is there, I was finding additional, unexpected mutations in the gene that I didn’t put there,” Dr Watanabe-Smith said. “And I was getting different mutations every time.”

“After we saw this in several cases, we knew it was worth further study,” added Cristina Tognon, PhD, of Oregon Health & Science University.

So the researchers decided to study Ba/F3 cell lines with and without 4 mutations (found in 3 cytokine receptors) that have “known transformative capacity,” including:

• CSF2RB R461C, a germline mutation found in a patient with T-cell acute lymphoblastic leukemia (ALL)
• CSF3R T618I, a mutation found in chronic neutrophilic leukemia (CNL) and atypical chronic myelogenous leukemia (aCML)
• CSF3R W791X, also found in CNL and aCML
• IL7R 243InsPPCL, which was found in a patient with B-cell ALL.

The researchers said they observed acquired mutations in 1 of 3 CSF2RB wild-type cell lines that transformed and all 4 CSF3R wild-type cell lines, which all transformed.

Furthermore, most CSF2RB R461C lines (4/5) and CSF3R W791X lines (3/4) had additional acquired mutations. However, the CSF3R T618I lines and the IL7R 243InsPPCL lines did not contain acquired mutations.

The researchers said acquired mutations were observed only in weakly transforming oncogenes, which were defined as mutations with a weaker ability to transform cells (less than 1 in every 200 cells) or a slower time to outgrowth (5 days or longer to reach a 5-fold increase over the initial cell number).

The team also said their findings indicate that the majority of the acquired mutations likely exist before IL-3 withdrawal but only expand to levels detectable by Sanger sequencing in the absence of IL-3.

“The potential impact [of these acquired mutations] is that a non-functional mutation could appear functional, and a researcher could publish results that would not be reproducible,” Dr Watanabe-Smith said.

To overcome this problem, Dr Watanabe-Smith and his colleagues recommended taking an additional step when using the Ba/F3 assay—sequencing outgrown cell lines. They also said additional research is needed to devise methods that reduce the incidence of acquired mutations in such assays. 

Kristyna Wentz-Graff

A newly discovered issue with the Ba/F3 transformation assay could “jeopardize attempts to characterize the signaling mechanisms and drug sensitivities of leukemic oncogenes,” researchers reported in Oncotarget.

The researchers said the assay “remains an invaluable tool” for validating activating mutations in primary leukemias.

However, the assay is prone to a previously unreported flaw, where Ba/F3 cells can acquire additional mutations.

This issue was discovered by Kevin Watanabe-Smith, PhD, of Oregon Health & Science University in Portland.

He identified the problem while studying a growth-activating mutation in a patient with T-cell leukemia. (The results of that research were published in Leukemia in April 2016).

“When I was sequencing the patient’s DNA to make sure the original, known mutation is there, I was finding additional, unexpected mutations in the gene that I didn’t put there,” Dr Watanabe-Smith said. “And I was getting different mutations every time.”

“After we saw this in several cases, we knew it was worth further study,” added Cristina Tognon, PhD, of Oregon Health & Science University.

So the researchers decided to study Ba/F3 cell lines with and without 4 mutations (found in 3 cytokine receptors) that have “known transformative capacity,” including:

• CSF2RB R461C, a germline mutation found in a patient with T-cell acute lymphoblastic leukemia (ALL)
• CSF3R T618I, a mutation found in chronic neutrophilic leukemia (CNL) and atypical chronic myelogenous leukemia (aCML)
• CSF3R W791X, also found in CNL and aCML
• IL7R 243InsPPCL, which was found in a patient with B-cell ALL.

The researchers said they observed acquired mutations in 1 of 3 CSF2RB wild-type cell lines that transformed and all 4 CSF3R wild-type cell lines, which all transformed.

Furthermore, most CSF2RB R461C lines (4/5) and CSF3R W791X lines (3/4) had additional acquired mutations. However, the CSF3R T618I lines and the IL7R 243InsPPCL lines did not contain acquired mutations.

The researchers said acquired mutations were observed only in weakly transforming oncogenes, which were defined as mutations with a weaker ability to transform cells (less than 1 in every 200 cells) or a slower time to outgrowth (5 days or longer to reach a 5-fold increase over the initial cell number).

The team also said their findings indicate that the majority of the acquired mutations likely exist before IL-3 withdrawal but only expand to levels detectable by Sanger sequencing in the absence of IL-3.

“The potential impact [of these acquired mutations] is that a non-functional mutation could appear functional, and a researcher could publish results that would not be reproducible,” Dr Watanabe-Smith said.

To overcome this problem, Dr Watanabe-Smith and his colleagues recommended taking an additional step when using the Ba/F3 assay—sequencing outgrown cell lines. They also said additional research is needed to devise methods that reduce the incidence of acquired mutations in such assays. 

Image from CDC/Mae Melvin

An investigational malaria vaccine can protect healthy adults from infection with a malaria strain different from that contained in the vaccine, according to a phase 1 study published in PNAS.

The vaccine, known as the PfSPZ Vaccine, contains weakened Plasmodium falciparum sporozoites that are able to generate a protective immune response against live malaria infection.

Prior research showed that the PfSPZ Vaccine can provide long-term protection against a single malaria strain matched to the vaccine.

The new study has shown that the PfSPZ Vaccine can protect against a different strain of P falciparum as well.

“An effective malaria vaccine will need to protect people living in endemic areas against multiple strains of the mosquito-borne disease,” said Anthony S. Fauci, MD, of the National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland.

“These new findings showing cross-protection with the PfSPZ Vaccine suggest that it may be able to accomplish this goal.”

The PfSPZ Vaccine was developed by Sanaria Inc. The company designed, manufactured, and provided PfSPZ Vaccine and the heterologous challenge mosquitoes for this trial. The NIAID supported the development of the vaccine through several grants.

Study details

The study enrolled 31 healthy, malaria-naive adults ages 19 to 45.

Fifteen subjects were scheduled to receive 3 doses of the PfSPZ Vaccine—9.0 × 10⁵ PfSPZ administered intravenously 3 times at 8-week intervals. The remaining subjects served as controls.

Nineteen weeks after receiving the final dose of the test vaccine, vaccinated subjects and controls were exposed to bites from mosquitoes infected with the same strain of P falciparum parasites (NF54) that were used to manufacture PfSPZ Vaccine.

Nine of the 14 subjects (64%) who received PfSPZ Vaccine demonstrated no evidence of malaria parasites. All 6 of the non-vaccinated subjects who were challenged at the same time had malaria parasites in their blood.

Of the 9 subjects who showed no evidence of malaria, 6 subjects were again exposed to mosquito bites, this time from mosquitoes infected with a different strain of P falciparum (Pf7G8), 33 weeks after the final immunization.

In this group, 5 of the 6 subjects (83%) were protected against malaria infection. None of the 6 control subjects who were challenged were protected.

“Achieving durable protection against a malaria strain different from the vaccine strain, over 8 months after vaccination, is an indication of this vaccine’s potential,” said Robert A. Seder, MD, of NIAID.

“If we can build on these findings with the PfSPZ Vaccine and induce higher efficacy, we may be on our way to a vaccine that could effectively protect people against a variety of malaria parasites where the disease is prevalent.”

The researchers found the PfSPZ Vaccine activated T cells and induced antibody responses in all vaccine recipients. Vaccine-specific T-cell responses were comparable when measured against both malaria challenge strains, providing some insight into how the vaccine was mediating protection.

Ongoing research should determine whether protective efficacy can be improved by changes to the PfSPZ Vaccine dose and number of immunizations.

A phase 2 trial testing 3 different dosages in a 3-dose vaccine regimen is now underway in 5-to 12-month-old infants in Western Kenya to assess safety and efficacy of the vaccine against natural infection.

Image from CDC/Mae Melvin

An investigational malaria vaccine can protect healthy adults from infection with a malaria strain different from that contained in the vaccine, according to a phase 1 study published in PNAS.

The vaccine, known as the PfSPZ Vaccine, contains weakened Plasmodium falciparum sporozoites that are able to generate a protective immune response against live malaria infection.

Prior research showed that the PfSPZ Vaccine can provide long-term protection against a single malaria strain matched to the vaccine.

The new study has shown that the PfSPZ Vaccine can protect against a different strain of P falciparum as well.

“An effective malaria vaccine will need to protect people living in endemic areas against multiple strains of the mosquito-borne disease,” said Anthony S. Fauci, MD, of the National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland.

“These new findings showing cross-protection with the PfSPZ Vaccine suggest that it may be able to accomplish this goal.”

The PfSPZ Vaccine was developed by Sanaria Inc. The company designed, manufactured, and provided PfSPZ Vaccine and the heterologous challenge mosquitoes for this trial. The NIAID supported the development of the vaccine through several grants.

Study details

The study enrolled 31 healthy, malaria-naive adults ages 19 to 45.

Fifteen subjects were scheduled to receive 3 doses of the PfSPZ Vaccine—9.0 × 10⁵ PfSPZ administered intravenously 3 times at 8-week intervals. The remaining subjects served as controls.

Nineteen weeks after receiving the final dose of the test vaccine, vaccinated subjects and controls were exposed to bites from mosquitoes infected with the same strain of P falciparum parasites (NF54) that were used to manufacture PfSPZ Vaccine.

Nine of the 14 subjects (64%) who received PfSPZ Vaccine demonstrated no evidence of malaria parasites. All 6 of the non-vaccinated subjects who were challenged at the same time had malaria parasites in their blood.

Of the 9 subjects who showed no evidence of malaria, 6 subjects were again exposed to mosquito bites, this time from mosquitoes infected with a different strain of P falciparum (Pf7G8), 33 weeks after the final immunization.

In this group, 5 of the 6 subjects (83%) were protected against malaria infection. None of the 6 control subjects who were challenged were protected.

“Achieving durable protection against a malaria strain different from the vaccine strain, over 8 months after vaccination, is an indication of this vaccine’s potential,” said Robert A. Seder, MD, of NIAID.

“If we can build on these findings with the PfSPZ Vaccine and induce higher efficacy, we may be on our way to a vaccine that could effectively protect people against a variety of malaria parasites where the disease is prevalent.”

The researchers found the PfSPZ Vaccine activated T cells and induced antibody responses in all vaccine recipients. Vaccine-specific T-cell responses were comparable when measured against both malaria challenge strains, providing some insight into how the vaccine was mediating protection.

Ongoing research should determine whether protective efficacy can be improved by changes to the PfSPZ Vaccine dose and number of immunizations.

A phase 2 trial testing 3 different dosages in a 3-dose vaccine regimen is now underway in 5-to 12-month-old infants in Western Kenya to assess safety and efficacy of the vaccine against natural infection.

Image from CDC/Mae Melvin

An investigational malaria vaccine can protect healthy adults from infection with a malaria strain different from that contained in the vaccine, according to a phase 1 study published in PNAS.

The vaccine, known as the PfSPZ Vaccine, contains weakened Plasmodium falciparum sporozoites that are able to generate a protective immune response against live malaria infection.

Prior research showed that the PfSPZ Vaccine can provide long-term protection against a single malaria strain matched to the vaccine.

The new study has shown that the PfSPZ Vaccine can protect against a different strain of P falciparum as well.

“An effective malaria vaccine will need to protect people living in endemic areas against multiple strains of the mosquito-borne disease,” said Anthony S. Fauci, MD, of the National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland.

“These new findings showing cross-protection with the PfSPZ Vaccine suggest that it may be able to accomplish this goal.”

The PfSPZ Vaccine was developed by Sanaria Inc. The company designed, manufactured, and provided PfSPZ Vaccine and the heterologous challenge mosquitoes for this trial. The NIAID supported the development of the vaccine through several grants.

Study details

The study enrolled 31 healthy, malaria-naive adults ages 19 to 45.

Fifteen subjects were scheduled to receive 3 doses of the PfSPZ Vaccine—9.0 × 10⁵ PfSPZ administered intravenously 3 times at 8-week intervals. The remaining subjects served as controls.

Nineteen weeks after receiving the final dose of the test vaccine, vaccinated subjects and controls were exposed to bites from mosquitoes infected with the same strain of P falciparum parasites (NF54) that were used to manufacture PfSPZ Vaccine.

Nine of the 14 subjects (64%) who received PfSPZ Vaccine demonstrated no evidence of malaria parasites. All 6 of the non-vaccinated subjects who were challenged at the same time had malaria parasites in their blood.

Of the 9 subjects who showed no evidence of malaria, 6 subjects were again exposed to mosquito bites, this time from mosquitoes infected with a different strain of P falciparum (Pf7G8), 33 weeks after the final immunization.

In this group, 5 of the 6 subjects (83%) were protected against malaria infection. None of the 6 control subjects who were challenged were protected.

“Achieving durable protection against a malaria strain different from the vaccine strain, over 8 months after vaccination, is an indication of this vaccine’s potential,” said Robert A. Seder, MD, of NIAID.

“If we can build on these findings with the PfSPZ Vaccine and induce higher efficacy, we may be on our way to a vaccine that could effectively protect people against a variety of malaria parasites where the disease is prevalent.”

The researchers found the PfSPZ Vaccine activated T cells and induced antibody responses in all vaccine recipients. Vaccine-specific T-cell responses were comparable when measured against both malaria challenge strains, providing some insight into how the vaccine was mediating protection.

Ongoing research should determine whether protective efficacy can be improved by changes to the PfSPZ Vaccine dose and number of immunizations.

A phase 2 trial testing 3 different dosages in a 3-dose vaccine regimen is now underway in 5-to 12-month-old infants in Western Kenya to assess safety and efficacy of the vaccine against natural infection.

Features of the plenary session (P151) at this year’s American Academy of Dermatology annual meeting include the Clarence S. Livingood, MD Memorial Award and Lectureship, on “Telemedicine and the Future of Medicine,” presented by Carrie L. Kovarik, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia.

Dr. Kovarik’s presentation will be followed by the AAD president’s address, by outgoing president Abel Torres, MD, JD, professor and chairman of the department of dermatology at Case Western Reserve University MetroHealth Systems, Cleveland; and professor and chairman of the department of dermatology at Loma Linda University Medical Center, Loma Linda, California.

Christine Léauté-Labrèze, MD, of the Hôpital Pellegrin–Enfants, Centre Hospitalier Universitaire, Bordeaux, France, will then present the Eugene J. Van Scott Award for Innovative Therapy of the Skin and Phillip Frost Leadership Lecture: “Propranolol in Infantile Hemangiomas: A Successful Drug Repurposing.” Dr. Léauté-Labrèze was the lead author of the multicenter, randomized controlled study that evaluated the efficacy and safety of oral propranolol for treating infantile hemangiomas (N Engl J Med. 2015;372:735-46).

Incoming AAD president Henry W. Lim, MD, will follow, with the president-elect’s address. Dr. Lim is the chairman of the department of dermatology and Clarence S. Livingood Chair in Dermatology at Henry Ford Health System in Detroit.

Boris C. Bastian, MD, professor of dermatology and pathology, University of California, San Francisco, will give the Lila and Murray Gruber Memorial Cancer Research Award and Lectureship, on “How Moles Become Cancer.” Dr. Bastian is also the director of the Clinical Cancer Genomics Laboratory at UCSF.

This year, the Marion B. Sulzberger, MD, Memorial Award and Lectureship – titled “Getting to the Heart (and other Comorbidities) of Psoriasis” – will be given by Joel M. Gelfand, MD, professor of dermatology, University of Pennsylvania.

Finally, this year’s guest speaker is the Center for Disease Control and Prevention’s Jordan W. Tappero, MD, whose lecture is titled: “The West African Ebola Epidemic and the Global Health Security Agenda.” Dr. Tappero is director of the Division of Global Health Protection, in the CDC’s Center for Global Health.



The plenary session is scheduled for Sunday March 5, 8 AM to 11:30 AM, in the Chapin Theater at the Orange County Convention Center, Orlando.

[email protected]
 

Features of the plenary session (P151) at this year’s American Academy of Dermatology annual meeting include the Clarence S. Livingood, MD Memorial Award and Lectureship, on “Telemedicine and the Future of Medicine,” presented by Carrie L. Kovarik, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia.

Dr. Kovarik’s presentation will be followed by the AAD president’s address, by outgoing president Abel Torres, MD, JD, professor and chairman of the department of dermatology at Case Western Reserve University MetroHealth Systems, Cleveland; and professor and chairman of the department of dermatology at Loma Linda University Medical Center, Loma Linda, California.

Christine Léauté-Labrèze, MD, of the Hôpital Pellegrin–Enfants, Centre Hospitalier Universitaire, Bordeaux, France, will then present the Eugene J. Van Scott Award for Innovative Therapy of the Skin and Phillip Frost Leadership Lecture: “Propranolol in Infantile Hemangiomas: A Successful Drug Repurposing.” Dr. Léauté-Labrèze was the lead author of the multicenter, randomized controlled study that evaluated the efficacy and safety of oral propranolol for treating infantile hemangiomas (N Engl J Med. 2015;372:735-46).

Incoming AAD president Henry W. Lim, MD, will follow, with the president-elect’s address. Dr. Lim is the chairman of the department of dermatology and Clarence S. Livingood Chair in Dermatology at Henry Ford Health System in Detroit.

Boris C. Bastian, MD, professor of dermatology and pathology, University of California, San Francisco, will give the Lila and Murray Gruber Memorial Cancer Research Award and Lectureship, on “How Moles Become Cancer.” Dr. Bastian is also the director of the Clinical Cancer Genomics Laboratory at UCSF.

This year, the Marion B. Sulzberger, MD, Memorial Award and Lectureship – titled “Getting to the Heart (and other Comorbidities) of Psoriasis” – will be given by Joel M. Gelfand, MD, professor of dermatology, University of Pennsylvania.

Finally, this year’s guest speaker is the Center for Disease Control and Prevention’s Jordan W. Tappero, MD, whose lecture is titled: “The West African Ebola Epidemic and the Global Health Security Agenda.” Dr. Tappero is director of the Division of Global Health Protection, in the CDC’s Center for Global Health.



The plenary session is scheduled for Sunday March 5, 8 AM to 11:30 AM, in the Chapin Theater at the Orange County Convention Center, Orlando.

[email protected]
 

Features of the plenary session (P151) at this year’s American Academy of Dermatology annual meeting include the Clarence S. Livingood, MD Memorial Award and Lectureship, on “Telemedicine and the Future of Medicine,” presented by Carrie L. Kovarik, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia.

Dr. Kovarik’s presentation will be followed by the AAD president’s address, by outgoing president Abel Torres, MD, JD, professor and chairman of the department of dermatology at Case Western Reserve University MetroHealth Systems, Cleveland; and professor and chairman of the department of dermatology at Loma Linda University Medical Center, Loma Linda, California.

Christine Léauté-Labrèze, MD, of the Hôpital Pellegrin–Enfants, Centre Hospitalier Universitaire, Bordeaux, France, will then present the Eugene J. Van Scott Award for Innovative Therapy of the Skin and Phillip Frost Leadership Lecture: “Propranolol in Infantile Hemangiomas: A Successful Drug Repurposing.” Dr. Léauté-Labrèze was the lead author of the multicenter, randomized controlled study that evaluated the efficacy and safety of oral propranolol for treating infantile hemangiomas (N Engl J Med. 2015;372:735-46).

Incoming AAD president Henry W. Lim, MD, will follow, with the president-elect’s address. Dr. Lim is the chairman of the department of dermatology and Clarence S. Livingood Chair in Dermatology at Henry Ford Health System in Detroit.

Boris C. Bastian, MD, professor of dermatology and pathology, University of California, San Francisco, will give the Lila and Murray Gruber Memorial Cancer Research Award and Lectureship, on “How Moles Become Cancer.” Dr. Bastian is also the director of the Clinical Cancer Genomics Laboratory at UCSF.

This year, the Marion B. Sulzberger, MD, Memorial Award and Lectureship – titled “Getting to the Heart (and other Comorbidities) of Psoriasis” – will be given by Joel M. Gelfand, MD, professor of dermatology, University of Pennsylvania.

Finally, this year’s guest speaker is the Center for Disease Control and Prevention’s Jordan W. Tappero, MD, whose lecture is titled: “The West African Ebola Epidemic and the Global Health Security Agenda.” Dr. Tappero is director of the Division of Global Health Protection, in the CDC’s Center for Global Health.



The plenary session is scheduled for Sunday March 5, 8 AM to 11:30 AM, in the Chapin Theater at the Orange County Convention Center, Orlando.

[email protected]
 

According to the VA, 23% of veterans in the U.S., nearly 5.2 million individuals, live in rural areas.¹ The VHA serves more than 3 million rural veterans, and 56% of those enrolled in the VA system are aged ≥ 65 years.¹ Thus, aging veterans in rural areas constitute a substantial group who need support and assistance from the VA. Fortunately, the VA offers numerous benefits for veterans that support aging in place and improve quality of life through the VHA, Veterans Benefits Administration (VBA), and National Cemetery Administration (NCA).

Despite the opportunities, many VA benefits go unclaimed. In some cases, veterans simply do not know these benefits exist.² In a 2010 VA report, only 41% of veterans indicated that they understood their benefits “a lot” or “some.”² However, their understanding of specific benefits tended to be lower. For example, many veterans stated that they had “heard about” burial options at VA cemeteries (41.5%), but few understood specific benefits, such as cash burial allowances (10.6%).²

Many veterans also hold misperceptions about eligibility, which prevents them from applying. For example, some veterans believe that a high income or lack of combat service disqualifies them from receiving VA benefits.³ Some veterans believe that others are more deserving of VA services, and they don’t want to “take a spot someone else needs.”³ Finally, some veterans hold negative attitudes about the VA, making them less likely to claim VA benefits, such as health care.⁴

For rural veterans, accessing benefits can be especially difficult, because most VA facilities that offer assistance are in urban centers.⁵ Though online access to benefit information is improving through programs like My HealtheVet and public facing websites, some older adults do not use computers, and Internet and mobile phone connectivity are often limited in rural communities.⁶ Nearly 43% of rural veterans do not have broadband Internet in their homes.¹ Moreover, the complexity of navigating benefits information via the Internet can be a frustrating and confusing process for older veterans.⁶

Accessing services and benefits in the community is similarly difficult. For more than 30 years, community organizations have noted the frustration that clients experienced with navigating a complex network of community providers who provide long-term services and supports (LTSS).^7,8 In 2003, the Administration on Aging and the Centers for Medicare and Medicaid Services developed the Aging and Disability Resource Center (ADRC) program to promote a “no wrong door” approach for LTSS. Aging and Disability Resource Centers are a single point of entry into a network of community, state, and federal LTSS for older adults and individuals with disabilities.⁸ Options counselors at ADRCs provide information, counseling, and assistance with connecting to a vast network of programs such as Social Security, Medicaid, local transportation, Meals on Wheels, and housing assistance through a single office.

Backround

In 2012, VHA Office of Rural Health Resource (ORH) and Utah ADRC conducted a national survey of ADRC sites about their experiences working with veterans and found that 95% of ADRCs always or usually asked clients about their veteran status. The survey found that veteran clients present to ADRCs with diverse needs, many of which could be addressed through a VA benefit. However, the majority (58%) of ADRC respondents reported that they had never attempted to help a veteran apply for VA benefits (unpublished data, 2012).

Respondents reported a limited understanding of VA benefits, infrequent contact with VA, and frustrations with the VA system. Although familiar with several sources for information about VA benefits (eg, toll-free number, websites, local VA facilities, etc), respondents generally found these sources unhelpful and insufficient for answering their questions. The only positive anecdotal comments that respondents made regarding VA were from those with personal relationships with employees at the VA who could help with veteran needs. Finally, all respondents reported a need for more information about VA benefits and to assist them with helping veteran clients.

Survey Response

In 2013, the ORH and the VA Salt Lake City Geriatric Research Education and Clinical Center (GRECC), under the sponsorship of the VA Office of Geriatrics and Extended Care (GEC), developed a collaborative demonstration with the Utah ADRC to address the needs identified in this survey. Connecting Older Veterans (Especially Rural) to Community or Veteran Eligible Resources (COVER to COVER) is a demonstration project designed to create a new access point for VA benefits for veterans living in rural areas. The pilot had 2 aims: (1) train ADRC options counselors as Veteran Benefits Specialists (VBSs); and (2) build relationships between the ADRCs and VA to facilitate information and referral.

Between 2013 and 2015, the demonstration was housed at the VA Salt Lake City Health Care System GRECC as part of the clinical demonstration portfolio. The GRECC staff provided administrative support and mentorship for the developing partnerships. Subsequently, the demonstration was selected as a Promising Practice for enterprise-wide implementation. Both ORH and GEC coordinated opportunities for broad dissemination.

Program Elements

In Utah, 5 pilot ADRC agencies cover 19 counties, 14 of which are entirely rural. The remaining counties contain populations that are 20% to 49% urbanized (1 county), 50% to 80% urbanized (1 county), and 80% to 100% urbanized (3 counties). More than 95,000 veterans (12,857 in the 14 rural counties) live in the participating counties. The average income for veterans in all participating counties is $36,699 for men and $30,915 for women.⁹ Furthermore, about 53% of veterans in all these counties are aged > 65 years.⁹

For this pilot, each ADRC site assigned an existing options counselor as a dedicated VBS. Each VBS completed 80 to 100 hours of training in VA benefits. To facilitate the amount of training required to become experts, the ORH funded a portion of the salary for each VBS.

An outreach specialist at the VA Salt Lake City Regional Benefit Office, a geriatric social worker at the VA Salt Lake City Health Care System, and an outreach specialist at the Utah Department of Veterans and Military Affairs (UDVMA) were primary trainers for this pilot. Trainers provided 15 training sessions between February 2013 and September 2015, totaling 74 hours. The 5 designated VBSs attended all trainings, but meetings were opened to all ADRC staff and other community organizations; 115 individuals from Utah, Idaho, Nevada, New Mexico, and Wyoming attended at least 1 training. In the first year and a half, trainings ranged from 1.5 to 4.5 hours and provided a general overview of benefits. As the value of these trainings increased among the ADRCs and other community providers, longer seminars were offered, the longest lasting 2 days, which provided in-depth training.

Training topics comprised the following 4 general categories:

• Core—VA structure, military culture
• VHA—health care, enrollment and eligibility, in-home services
• VBA—pension, aid and attendance, disability compensation, nursing home, dependency and indemnity compensation
• NCA burial benefits

In response to participant requests for training on other VA benefits, additional VA staff presented topics such as mental health, homelessness, telehealth, Vet Centers, and My HealtheVet. Information on the Veterans Choice Program was incorporated into later trainings.


In addition to the training provided by COVER to COVER, the 5 ADRC VBSs completed the 25-hour Training Responsibility Involvement and Preparation of Claims (TRIP) online course. This coursework qualified them to take the examination to become certified veterans service officers.

With the information received in training, ADRC VBSs assist veteran clients and their families to learn about and apply for VA benefits. Veterans or family members contact the ADRC with a variety of needs, such as difficulty paying utilities, functional limitations, etc. All ADRC staff screen callers for veteran status and refer willing veterans or family members to the VBS who provides information about LTSS options and screens for eligibility for VA benefits.

Through these training events, VBSs also formed relationships with the VA trainers, resulting in the ability to refer to and coordinate with the VA on cases when needed. The VBSs often work closely with the UDVMA by helping veterans organize needed documents and coordinate with UDVMA staff to complete VA benefit claims. Furthermore, VBSs can help veterans navigate the VA system and advocate for their needs in coordination with the VA trainers.

The VBAs have described numerous positive outcomes from the COVER to COVER program. They universally report improved knowledge and confidence in assisting veteran clients. In many cases, simply identifying clients’ veteran status in the normal ADRC intake protocol has placed them in touch with many veterans without any significant change in their workload. One specialist reported that COVER to COVER has improved the quality of services she can provide to veterans and that connecting veteran clients to VA frees public resources for other clients in need. Finally, they report that the trainings introduced them to key VA contacts and laid the groundwork for developing relationships with new partners. The following case is representative of the types of client experiences VBSs routinely describe.

Case Study

“Larry,” a 94 year-old World War II veteran who had never applied for VA benefits, presented to a rural ADRC for assistance with paying his utility bills. Larry had numerous health issues, including early stage dementia. He relied on his 96-year-old wife, “Sandy,” to assist him with activities of daily living (ADLs) and instrumental activities of living (IADLs). However, Sandy also had health problems that limited her ability to help. The couple wanted to stay in their home but worried they could not do it without help.

An ADRC staff member referred Larry and Sandy to the VBS, who helped the couple enroll in a community LTSS program called Aging Alternatives for in-home services. During this time, Sandy passed away, but the VBS continued to work with Larry and helped him apply for VA disability compensation, enroll in VHA health care, and connect to VA’s Veteran Directed Home and Community Based Services (VDHCBS) program for in-home services.

Larry received a 70% service-connected disability rating and started receiving monthly compensation from the VA. Although Larry wants to stay at home, the rating of 70% service connection allows VA to cover nursing home placement should it be needed. He established a VA primary care physician and uses VDHCBS to purchase in-home services. Since Larry receives in-home services from the VHA, he was discharged from the Aging Alternatives program. This allowed the ADRC to reallocate this resource to another person in need. Larry is still living at home.

Future Directions

This case study highlights the benefits for veterans of COVER to COVER program through its emphasis on productive relationships between VA and community partners. More extensive data collection related to veteran outcomes is ongoing and will be essential for sustaining the program locally and to support broader dissemination to other states. Ideally, expansion to other sites will include temporary pilot funding to offset the time needed to gain the knowledgeand skills to become a VBS and to provide consultation and training to other ADRC staff. Once the pilot funding ends, the ADRC staff would have the necessary knowledge, skills, and relationships to continue providing services to veterans.

Acknowledgments
This project was supported by the VHA Office of Rural Health. The authors thank all ADRC, UDVMA, and VHA staff who participated in the project.

According to the VA, 23% of veterans in the U.S., nearly 5.2 million individuals, live in rural areas.¹ The VHA serves more than 3 million rural veterans, and 56% of those enrolled in the VA system are aged ≥ 65 years.¹ Thus, aging veterans in rural areas constitute a substantial group who need support and assistance from the VA. Fortunately, the VA offers numerous benefits for veterans that support aging in place and improve quality of life through the VHA, Veterans Benefits Administration (VBA), and National Cemetery Administration (NCA).

Despite the opportunities, many VA benefits go unclaimed. In some cases, veterans simply do not know these benefits exist.² In a 2010 VA report, only 41% of veterans indicated that they understood their benefits “a lot” or “some.”² However, their understanding of specific benefits tended to be lower. For example, many veterans stated that they had “heard about” burial options at VA cemeteries (41.5%), but few understood specific benefits, such as cash burial allowances (10.6%).²

Many veterans also hold misperceptions about eligibility, which prevents them from applying. For example, some veterans believe that a high income or lack of combat service disqualifies them from receiving VA benefits.³ Some veterans believe that others are more deserving of VA services, and they don’t want to “take a spot someone else needs.”³ Finally, some veterans hold negative attitudes about the VA, making them less likely to claim VA benefits, such as health care.⁴

For rural veterans, accessing benefits can be especially difficult, because most VA facilities that offer assistance are in urban centers.⁵ Though online access to benefit information is improving through programs like My HealtheVet and public facing websites, some older adults do not use computers, and Internet and mobile phone connectivity are often limited in rural communities.⁶ Nearly 43% of rural veterans do not have broadband Internet in their homes.¹ Moreover, the complexity of navigating benefits information via the Internet can be a frustrating and confusing process for older veterans.⁶

Accessing services and benefits in the community is similarly difficult. For more than 30 years, community organizations have noted the frustration that clients experienced with navigating a complex network of community providers who provide long-term services and supports (LTSS).^7,8 In 2003, the Administration on Aging and the Centers for Medicare and Medicaid Services developed the Aging and Disability Resource Center (ADRC) program to promote a “no wrong door” approach for LTSS. Aging and Disability Resource Centers are a single point of entry into a network of community, state, and federal LTSS for older adults and individuals with disabilities.⁸ Options counselors at ADRCs provide information, counseling, and assistance with connecting to a vast network of programs such as Social Security, Medicaid, local transportation, Meals on Wheels, and housing assistance through a single office.

Backround

In 2012, VHA Office of Rural Health Resource (ORH) and Utah ADRC conducted a national survey of ADRC sites about their experiences working with veterans and found that 95% of ADRCs always or usually asked clients about their veteran status. The survey found that veteran clients present to ADRCs with diverse needs, many of which could be addressed through a VA benefit. However, the majority (58%) of ADRC respondents reported that they had never attempted to help a veteran apply for VA benefits (unpublished data, 2012).

Respondents reported a limited understanding of VA benefits, infrequent contact with VA, and frustrations with the VA system. Although familiar with several sources for information about VA benefits (eg, toll-free number, websites, local VA facilities, etc), respondents generally found these sources unhelpful and insufficient for answering their questions. The only positive anecdotal comments that respondents made regarding VA were from those with personal relationships with employees at the VA who could help with veteran needs. Finally, all respondents reported a need for more information about VA benefits and to assist them with helping veteran clients.

Survey Response

In 2013, the ORH and the VA Salt Lake City Geriatric Research Education and Clinical Center (GRECC), under the sponsorship of the VA Office of Geriatrics and Extended Care (GEC), developed a collaborative demonstration with the Utah ADRC to address the needs identified in this survey. Connecting Older Veterans (Especially Rural) to Community or Veteran Eligible Resources (COVER to COVER) is a demonstration project designed to create a new access point for VA benefits for veterans living in rural areas. The pilot had 2 aims: (1) train ADRC options counselors as Veteran Benefits Specialists (VBSs); and (2) build relationships between the ADRCs and VA to facilitate information and referral.

Between 2013 and 2015, the demonstration was housed at the VA Salt Lake City Health Care System GRECC as part of the clinical demonstration portfolio. The GRECC staff provided administrative support and mentorship for the developing partnerships. Subsequently, the demonstration was selected as a Promising Practice for enterprise-wide implementation. Both ORH and GEC coordinated opportunities for broad dissemination.

Program Elements

In Utah, 5 pilot ADRC agencies cover 19 counties, 14 of which are entirely rural. The remaining counties contain populations that are 20% to 49% urbanized (1 county), 50% to 80% urbanized (1 county), and 80% to 100% urbanized (3 counties). More than 95,000 veterans (12,857 in the 14 rural counties) live in the participating counties. The average income for veterans in all participating counties is $36,699 for men and $30,915 for women.⁹ Furthermore, about 53% of veterans in all these counties are aged > 65 years.⁹

For this pilot, each ADRC site assigned an existing options counselor as a dedicated VBS. Each VBS completed 80 to 100 hours of training in VA benefits. To facilitate the amount of training required to become experts, the ORH funded a portion of the salary for each VBS.

An outreach specialist at the VA Salt Lake City Regional Benefit Office, a geriatric social worker at the VA Salt Lake City Health Care System, and an outreach specialist at the Utah Department of Veterans and Military Affairs (UDVMA) were primary trainers for this pilot. Trainers provided 15 training sessions between February 2013 and September 2015, totaling 74 hours. The 5 designated VBSs attended all trainings, but meetings were opened to all ADRC staff and other community organizations; 115 individuals from Utah, Idaho, Nevada, New Mexico, and Wyoming attended at least 1 training. In the first year and a half, trainings ranged from 1.5 to 4.5 hours and provided a general overview of benefits. As the value of these trainings increased among the ADRCs and other community providers, longer seminars were offered, the longest lasting 2 days, which provided in-depth training.

Training topics comprised the following 4 general categories:

• Core—VA structure, military culture
• VHA—health care, enrollment and eligibility, in-home services
• VBA—pension, aid and attendance, disability compensation, nursing home, dependency and indemnity compensation
• NCA burial benefits

In response to participant requests for training on other VA benefits, additional VA staff presented topics such as mental health, homelessness, telehealth, Vet Centers, and My HealtheVet. Information on the Veterans Choice Program was incorporated into later trainings.


In addition to the training provided by COVER to COVER, the 5 ADRC VBSs completed the 25-hour Training Responsibility Involvement and Preparation of Claims (TRIP) online course. This coursework qualified them to take the examination to become certified veterans service officers.

With the information received in training, ADRC VBSs assist veteran clients and their families to learn about and apply for VA benefits. Veterans or family members contact the ADRC with a variety of needs, such as difficulty paying utilities, functional limitations, etc. All ADRC staff screen callers for veteran status and refer willing veterans or family members to the VBS who provides information about LTSS options and screens for eligibility for VA benefits.

Through these training events, VBSs also formed relationships with the VA trainers, resulting in the ability to refer to and coordinate with the VA on cases when needed. The VBSs often work closely with the UDVMA by helping veterans organize needed documents and coordinate with UDVMA staff to complete VA benefit claims. Furthermore, VBSs can help veterans navigate the VA system and advocate for their needs in coordination with the VA trainers.

The VBAs have described numerous positive outcomes from the COVER to COVER program. They universally report improved knowledge and confidence in assisting veteran clients. In many cases, simply identifying clients’ veteran status in the normal ADRC intake protocol has placed them in touch with many veterans without any significant change in their workload. One specialist reported that COVER to COVER has improved the quality of services she can provide to veterans and that connecting veteran clients to VA frees public resources for other clients in need. Finally, they report that the trainings introduced them to key VA contacts and laid the groundwork for developing relationships with new partners. The following case is representative of the types of client experiences VBSs routinely describe.

Case Study

“Larry,” a 94 year-old World War II veteran who had never applied for VA benefits, presented to a rural ADRC for assistance with paying his utility bills. Larry had numerous health issues, including early stage dementia. He relied on his 96-year-old wife, “Sandy,” to assist him with activities of daily living (ADLs) and instrumental activities of living (IADLs). However, Sandy also had health problems that limited her ability to help. The couple wanted to stay in their home but worried they could not do it without help.

An ADRC staff member referred Larry and Sandy to the VBS, who helped the couple enroll in a community LTSS program called Aging Alternatives for in-home services. During this time, Sandy passed away, but the VBS continued to work with Larry and helped him apply for VA disability compensation, enroll in VHA health care, and connect to VA’s Veteran Directed Home and Community Based Services (VDHCBS) program for in-home services.

Larry received a 70% service-connected disability rating and started receiving monthly compensation from the VA. Although Larry wants to stay at home, the rating of 70% service connection allows VA to cover nursing home placement should it be needed. He established a VA primary care physician and uses VDHCBS to purchase in-home services. Since Larry receives in-home services from the VHA, he was discharged from the Aging Alternatives program. This allowed the ADRC to reallocate this resource to another person in need. Larry is still living at home.

Future Directions

This case study highlights the benefits for veterans of COVER to COVER program through its emphasis on productive relationships between VA and community partners. More extensive data collection related to veteran outcomes is ongoing and will be essential for sustaining the program locally and to support broader dissemination to other states. Ideally, expansion to other sites will include temporary pilot funding to offset the time needed to gain the knowledgeand skills to become a VBS and to provide consultation and training to other ADRC staff. Once the pilot funding ends, the ADRC staff would have the necessary knowledge, skills, and relationships to continue providing services to veterans.

Acknowledgments
This project was supported by the VHA Office of Rural Health. The authors thank all ADRC, UDVMA, and VHA staff who participated in the project.

According to the VA, 23% of veterans in the U.S., nearly 5.2 million individuals, live in rural areas.¹ The VHA serves more than 3 million rural veterans, and 56% of those enrolled in the VA system are aged ≥ 65 years.¹ Thus, aging veterans in rural areas constitute a substantial group who need support and assistance from the VA. Fortunately, the VA offers numerous benefits for veterans that support aging in place and improve quality of life through the VHA, Veterans Benefits Administration (VBA), and National Cemetery Administration (NCA).

Despite the opportunities, many VA benefits go unclaimed. In some cases, veterans simply do not know these benefits exist.² In a 2010 VA report, only 41% of veterans indicated that they understood their benefits “a lot” or “some.”² However, their understanding of specific benefits tended to be lower. For example, many veterans stated that they had “heard about” burial options at VA cemeteries (41.5%), but few understood specific benefits, such as cash burial allowances (10.6%).²

Many veterans also hold misperceptions about eligibility, which prevents them from applying. For example, some veterans believe that a high income or lack of combat service disqualifies them from receiving VA benefits.³ Some veterans believe that others are more deserving of VA services, and they don’t want to “take a spot someone else needs.”³ Finally, some veterans hold negative attitudes about the VA, making them less likely to claim VA benefits, such as health care.⁴

For rural veterans, accessing benefits can be especially difficult, because most VA facilities that offer assistance are in urban centers.⁵ Though online access to benefit information is improving through programs like My HealtheVet and public facing websites, some older adults do not use computers, and Internet and mobile phone connectivity are often limited in rural communities.⁶ Nearly 43% of rural veterans do not have broadband Internet in their homes.¹ Moreover, the complexity of navigating benefits information via the Internet can be a frustrating and confusing process for older veterans.⁶

Accessing services and benefits in the community is similarly difficult. For more than 30 years, community organizations have noted the frustration that clients experienced with navigating a complex network of community providers who provide long-term services and supports (LTSS).^7,8 In 2003, the Administration on Aging and the Centers for Medicare and Medicaid Services developed the Aging and Disability Resource Center (ADRC) program to promote a “no wrong door” approach for LTSS. Aging and Disability Resource Centers are a single point of entry into a network of community, state, and federal LTSS for older adults and individuals with disabilities.⁸ Options counselors at ADRCs provide information, counseling, and assistance with connecting to a vast network of programs such as Social Security, Medicaid, local transportation, Meals on Wheels, and housing assistance through a single office.

Backround

In 2012, VHA Office of Rural Health Resource (ORH) and Utah ADRC conducted a national survey of ADRC sites about their experiences working with veterans and found that 95% of ADRCs always or usually asked clients about their veteran status. The survey found that veteran clients present to ADRCs with diverse needs, many of which could be addressed through a VA benefit. However, the majority (58%) of ADRC respondents reported that they had never attempted to help a veteran apply for VA benefits (unpublished data, 2012).

Respondents reported a limited understanding of VA benefits, infrequent contact with VA, and frustrations with the VA system. Although familiar with several sources for information about VA benefits (eg, toll-free number, websites, local VA facilities, etc), respondents generally found these sources unhelpful and insufficient for answering their questions. The only positive anecdotal comments that respondents made regarding VA were from those with personal relationships with employees at the VA who could help with veteran needs. Finally, all respondents reported a need for more information about VA benefits and to assist them with helping veteran clients.

Survey Response

In 2013, the ORH and the VA Salt Lake City Geriatric Research Education and Clinical Center (GRECC), under the sponsorship of the VA Office of Geriatrics and Extended Care (GEC), developed a collaborative demonstration with the Utah ADRC to address the needs identified in this survey. Connecting Older Veterans (Especially Rural) to Community or Veteran Eligible Resources (COVER to COVER) is a demonstration project designed to create a new access point for VA benefits for veterans living in rural areas. The pilot had 2 aims: (1) train ADRC options counselors as Veteran Benefits Specialists (VBSs); and (2) build relationships between the ADRCs and VA to facilitate information and referral.

Between 2013 and 2015, the demonstration was housed at the VA Salt Lake City Health Care System GRECC as part of the clinical demonstration portfolio. The GRECC staff provided administrative support and mentorship for the developing partnerships. Subsequently, the demonstration was selected as a Promising Practice for enterprise-wide implementation. Both ORH and GEC coordinated opportunities for broad dissemination.

Program Elements

In Utah, 5 pilot ADRC agencies cover 19 counties, 14 of which are entirely rural. The remaining counties contain populations that are 20% to 49% urbanized (1 county), 50% to 80% urbanized (1 county), and 80% to 100% urbanized (3 counties). More than 95,000 veterans (12,857 in the 14 rural counties) live in the participating counties. The average income for veterans in all participating counties is $36,699 for men and $30,915 for women.⁹ Furthermore, about 53% of veterans in all these counties are aged > 65 years.⁹

For this pilot, each ADRC site assigned an existing options counselor as a dedicated VBS. Each VBS completed 80 to 100 hours of training in VA benefits. To facilitate the amount of training required to become experts, the ORH funded a portion of the salary for each VBS.

An outreach specialist at the VA Salt Lake City Regional Benefit Office, a geriatric social worker at the VA Salt Lake City Health Care System, and an outreach specialist at the Utah Department of Veterans and Military Affairs (UDVMA) were primary trainers for this pilot. Trainers provided 15 training sessions between February 2013 and September 2015, totaling 74 hours. The 5 designated VBSs attended all trainings, but meetings were opened to all ADRC staff and other community organizations; 115 individuals from Utah, Idaho, Nevada, New Mexico, and Wyoming attended at least 1 training. In the first year and a half, trainings ranged from 1.5 to 4.5 hours and provided a general overview of benefits. As the value of these trainings increased among the ADRCs and other community providers, longer seminars were offered, the longest lasting 2 days, which provided in-depth training.

Training topics comprised the following 4 general categories:

• Core—VA structure, military culture
• VHA—health care, enrollment and eligibility, in-home services
• VBA—pension, aid and attendance, disability compensation, nursing home, dependency and indemnity compensation
• NCA burial benefits

In response to participant requests for training on other VA benefits, additional VA staff presented topics such as mental health, homelessness, telehealth, Vet Centers, and My HealtheVet. Information on the Veterans Choice Program was incorporated into later trainings.


In addition to the training provided by COVER to COVER, the 5 ADRC VBSs completed the 25-hour Training Responsibility Involvement and Preparation of Claims (TRIP) online course. This coursework qualified them to take the examination to become certified veterans service officers.

With the information received in training, ADRC VBSs assist veteran clients and their families to learn about and apply for VA benefits. Veterans or family members contact the ADRC with a variety of needs, such as difficulty paying utilities, functional limitations, etc. All ADRC staff screen callers for veteran status and refer willing veterans or family members to the VBS who provides information about LTSS options and screens for eligibility for VA benefits.

Through these training events, VBSs also formed relationships with the VA trainers, resulting in the ability to refer to and coordinate with the VA on cases when needed. The VBSs often work closely with the UDVMA by helping veterans organize needed documents and coordinate with UDVMA staff to complete VA benefit claims. Furthermore, VBSs can help veterans navigate the VA system and advocate for their needs in coordination with the VA trainers.

The VBAs have described numerous positive outcomes from the COVER to COVER program. They universally report improved knowledge and confidence in assisting veteran clients. In many cases, simply identifying clients’ veteran status in the normal ADRC intake protocol has placed them in touch with many veterans without any significant change in their workload. One specialist reported that COVER to COVER has improved the quality of services she can provide to veterans and that connecting veteran clients to VA frees public resources for other clients in need. Finally, they report that the trainings introduced them to key VA contacts and laid the groundwork for developing relationships with new partners. The following case is representative of the types of client experiences VBSs routinely describe.

Case Study

“Larry,” a 94 year-old World War II veteran who had never applied for VA benefits, presented to a rural ADRC for assistance with paying his utility bills. Larry had numerous health issues, including early stage dementia. He relied on his 96-year-old wife, “Sandy,” to assist him with activities of daily living (ADLs) and instrumental activities of living (IADLs). However, Sandy also had health problems that limited her ability to help. The couple wanted to stay in their home but worried they could not do it without help.

An ADRC staff member referred Larry and Sandy to the VBS, who helped the couple enroll in a community LTSS program called Aging Alternatives for in-home services. During this time, Sandy passed away, but the VBS continued to work with Larry and helped him apply for VA disability compensation, enroll in VHA health care, and connect to VA’s Veteran Directed Home and Community Based Services (VDHCBS) program for in-home services.

Larry received a 70% service-connected disability rating and started receiving monthly compensation from the VA. Although Larry wants to stay at home, the rating of 70% service connection allows VA to cover nursing home placement should it be needed. He established a VA primary care physician and uses VDHCBS to purchase in-home services. Since Larry receives in-home services from the VHA, he was discharged from the Aging Alternatives program. This allowed the ADRC to reallocate this resource to another person in need. Larry is still living at home.

Future Directions

This case study highlights the benefits for veterans of COVER to COVER program through its emphasis on productive relationships between VA and community partners. More extensive data collection related to veteran outcomes is ongoing and will be essential for sustaining the program locally and to support broader dissemination to other states. Ideally, expansion to other sites will include temporary pilot funding to offset the time needed to gain the knowledgeand skills to become a VBS and to provide consultation and training to other ADRC staff. Once the pilot funding ends, the ADRC staff would have the necessary knowledge, skills, and relationships to continue providing services to veterans.

Acknowledgments
This project was supported by the VHA Office of Rural Health. The authors thank all ADRC, UDVMA, and VHA staff who participated in the project.

Seventh Sense Biosystems

The US Food and Drug Administration (FDA) has granted 510(k) clearance for a push-button blood collection device called TAP.

It provides “virtually painless, simple, and fast” blood collection, according to Seventh Sense Biosystems, Inc., the company marketing the device.

The FDA clearance allows healthcare workers to use TAP only for the collection of capillary blood for hemoglobin A1c testing.

However, Seventh Sense Biosystems said it is working with the FDA to expand the use of TAP to add additional tests, as well as at-home blood collection.

How TAP works

The TAP device is placed on a patient’s upper arm, and blood collection starts with the press of a button. The process typically takes 2 to 3 minutes.

When TAP is placed on the arm, the base of the device generates a seal with the skin to create a vacuum. When the user presses the button, TAP deploys microneedles that puncture the skin above the dermis.

The vacuum draws capillary blood out of the micropunctures and through microfluidic channels into a collection chamber prefilled with lithium heparin.

TAP collects up to 100 μL of blood. To transfer the blood to an analyzer, a precision pipette is placed in an access port at the bottom of the device.

Seventh Sense Biosystems said it will launch TAP over the coming months. For up-to-date information, visit www.7sbio.com. 

Seventh Sense Biosystems

The US Food and Drug Administration (FDA) has granted 510(k) clearance for a push-button blood collection device called TAP.

It provides “virtually painless, simple, and fast” blood collection, according to Seventh Sense Biosystems, Inc., the company marketing the device.

The FDA clearance allows healthcare workers to use TAP only for the collection of capillary blood for hemoglobin A1c testing.

However, Seventh Sense Biosystems said it is working with the FDA to expand the use of TAP to add additional tests, as well as at-home blood collection.

How TAP works

The TAP device is placed on a patient’s upper arm, and blood collection starts with the press of a button. The process typically takes 2 to 3 minutes.

When TAP is placed on the arm, the base of the device generates a seal with the skin to create a vacuum. When the user presses the button, TAP deploys microneedles that puncture the skin above the dermis.

The vacuum draws capillary blood out of the micropunctures and through microfluidic channels into a collection chamber prefilled with lithium heparin.

TAP collects up to 100 μL of blood. To transfer the blood to an analyzer, a precision pipette is placed in an access port at the bottom of the device.

Seventh Sense Biosystems said it will launch TAP over the coming months. For up-to-date information, visit www.7sbio.com. 

Seventh Sense Biosystems

The US Food and Drug Administration (FDA) has granted 510(k) clearance for a push-button blood collection device called TAP.

It provides “virtually painless, simple, and fast” blood collection, according to Seventh Sense Biosystems, Inc., the company marketing the device.

The FDA clearance allows healthcare workers to use TAP only for the collection of capillary blood for hemoglobin A1c testing.

However, Seventh Sense Biosystems said it is working with the FDA to expand the use of TAP to add additional tests, as well as at-home blood collection.

How TAP works

The TAP device is placed on a patient’s upper arm, and blood collection starts with the press of a button. The process typically takes 2 to 3 minutes.

When TAP is placed on the arm, the base of the device generates a seal with the skin to create a vacuum. When the user presses the button, TAP deploys microneedles that puncture the skin above the dermis.

The vacuum draws capillary blood out of the micropunctures and through microfluidic channels into a collection chamber prefilled with lithium heparin.

TAP collects up to 100 μL of blood. To transfer the blood to an analyzer, a precision pipette is placed in an access port at the bottom of the device.

Seventh Sense Biosystems said it will launch TAP over the coming months. For up-to-date information, visit www.7sbio.com.