Micrograph showing CLL

Image by Mary Ann Thompson

Adding an anti-CD37 molecule to treatment with bendamustine can improve outcomes in patients with relapsed/refractory chronic lymphocytic leukemia (CLL), according to research published in the British Journal of Haematology.

In a phase 2 trial, researchers found that combining the anti-CD37 molecule otlertuzumab with bendamustine significantly improved overall response rates (ORRs) and progression-free survival (PFS) when compared to bendamustine alone.

“We’re very encouraged by the phase 2 data, which demonstrated a significant increase in median progression-free survival, from approximately 10 to 16 months in patients receiving combination otlertuzumab/bendamustine therapy,” said Marvin L. White, president and chief executive officer of Aptevo Therapeutics Inc, the company developing otlertuzumab.

“These data, coupled with additional results from ongoing studies of otlertuzumab used in combination with current CLL therapies, should help position otlertuzumab for a potential partnership to advance into phase 3 clinical development.”

The phase 2 trial was sponsored by Emergent Product Development Seattle LLC. Aptevo Therapeutics is a spin-off of Emergent Biosolutions.

About otlertuzumab

Otlertuzumab (formerly TRU-016) is a humanized, monospecific ADAPTIR™ molecule that targets CD37.

Aptevo Therapeutics says the company is applying its ADAPTIR technology to develop immuno-oncology candidates that focus on redirected T-cell cytotoxicity. ADAPTIR technology can be used to generate immunotherapeutics with unique mechanisms of action, including targeted cytokine delivery, targeting 2 cell surface receptors, or neutralization of multiple soluble proteins.

According to Aptevo, otlertuzumab mediates death of CD37-expressing cells through various mechanisms, including direct cell death, antibody-dependent cell-mediated cytotoxicity, and phagocytosis. Otlertuzumab is being investigated as part of combination therapies for the treatment of CLL.

Study design

This phase 2 study enrolled 65 patients with relapsed/refractory CLL—32 who received a combination of otlertuzumab and bendamustine and 33 who received bendamustine alone.

Patients in the combination arm received otlertuzumab at 20 mg/kg weekly by intravenous infusion for two 28-day cycles, then every 14 days for four 28-day cycles.

Patients in both arms received intravenous bendamustine at 70 mg/m² on days 1 and 2 of each cycle for up to six 28-day cycles. Dosing was adjusted according to neutrophil and platelet counts.

The study’s primary endpoint was ORR (per IWCLL criteria), and secondary endpoints included PFS and safety.

Patient characteristics

The researchers said the treatment arms were generally well balanced. However, patients in the combination arm were older, had more prior treatment regimens, a longer time from diagnosis, and more bulky disease. More patients in the control arm were Rai stage III or IV.

Two patients in the combination arm and 5 in the control arm had 17p deletion. Four patients in the combination arm and 6 in the control arm had TP53 mutations.

There were 5 patients in the combination arm and 3 in the control arm who were refractory to their prior treatment.

In both arms, patients received a median of 6 cycles of study treatment. Bendamustine exposure was similar between the arms—a median of 143 days. The median treatment duration for otlertuzumab was 156 days.

Seven patients (22%) in the combination arm and 12 (36%) in the control arm discontinued treatment early.

In the combination arm, 3 patients discontinued due to adverse events (AEs), 3 due to disease progression, and 1 patient withdrew to have a stem cell transplant.

In the control arm, 7 patients discontinued due to AEs, 3 due to progression, 1 withdrew for an unspecified reason, and 1 patient died of acute heart failure.

Response and survival

The ORR was 69% in the combination arm and 39% in the control arm (P=0.025).

In the combination arm, 3 patients (9%) had a complete response (CR), 1 patient had a CR with incomplete marrow recovery, and 19 (59%) had a partial response.

In the control arm, 1 patient (3%) had a CR and 12 (36%) had a partial response.

The median PFS was 15.9 months in the combination arm and 10.2 months in the control arm (P=0.0192).

The median overall survival was not reached in either arm. After 2 years of follow-up, there were no deaths in the combination arm and 3 deaths in the control arm.

Safety

Ninety-one percent of patients in the combination arm and 100% of those in the control arm experienced an AE. Serious AEs occurred in 31% and 45%, respectively.

Severe neutropenia was more frequent in the combination arm than the control arm (56% vs 39%), as was severe thrombocytopenia (19% vs 15%).

However, there were fewer grade 3/4 infections in the combination arm than the control arm (13% vs 27%). And 2 patients in the control arm had febrile neutropenia, but there were no cases in the combination arm.

“These latest data show the combination of otlertuzumab and bendamustine is well tolerated and significantly increases the response rate and PFS in patients with relapsed or refractory CLL,” said Scott Stromatt, MD, study director and chief medical officer for Aptevo.

“Consequently, we are now exploring the utility of otlertuzumab in combination with additional CLL therapies to evaluate clinical benefit in distinct CLL patient subgroups.”

Micrograph showing CLL

Image by Mary Ann Thompson

Adding an anti-CD37 molecule to treatment with bendamustine can improve outcomes in patients with relapsed/refractory chronic lymphocytic leukemia (CLL), according to research published in the British Journal of Haematology.

In a phase 2 trial, researchers found that combining the anti-CD37 molecule otlertuzumab with bendamustine significantly improved overall response rates (ORRs) and progression-free survival (PFS) when compared to bendamustine alone.

“We’re very encouraged by the phase 2 data, which demonstrated a significant increase in median progression-free survival, from approximately 10 to 16 months in patients receiving combination otlertuzumab/bendamustine therapy,” said Marvin L. White, president and chief executive officer of Aptevo Therapeutics Inc, the company developing otlertuzumab.

“These data, coupled with additional results from ongoing studies of otlertuzumab used in combination with current CLL therapies, should help position otlertuzumab for a potential partnership to advance into phase 3 clinical development.”

The phase 2 trial was sponsored by Emergent Product Development Seattle LLC. Aptevo Therapeutics is a spin-off of Emergent Biosolutions.

About otlertuzumab

Otlertuzumab (formerly TRU-016) is a humanized, monospecific ADAPTIR™ molecule that targets CD37.

Aptevo Therapeutics says the company is applying its ADAPTIR technology to develop immuno-oncology candidates that focus on redirected T-cell cytotoxicity. ADAPTIR technology can be used to generate immunotherapeutics with unique mechanisms of action, including targeted cytokine delivery, targeting 2 cell surface receptors, or neutralization of multiple soluble proteins.

According to Aptevo, otlertuzumab mediates death of CD37-expressing cells through various mechanisms, including direct cell death, antibody-dependent cell-mediated cytotoxicity, and phagocytosis. Otlertuzumab is being investigated as part of combination therapies for the treatment of CLL.

Study design

This phase 2 study enrolled 65 patients with relapsed/refractory CLL—32 who received a combination of otlertuzumab and bendamustine and 33 who received bendamustine alone.

Patients in the combination arm received otlertuzumab at 20 mg/kg weekly by intravenous infusion for two 28-day cycles, then every 14 days for four 28-day cycles.

Patients in both arms received intravenous bendamustine at 70 mg/m² on days 1 and 2 of each cycle for up to six 28-day cycles. Dosing was adjusted according to neutrophil and platelet counts.

The study’s primary endpoint was ORR (per IWCLL criteria), and secondary endpoints included PFS and safety.

Patient characteristics

The researchers said the treatment arms were generally well balanced. However, patients in the combination arm were older, had more prior treatment regimens, a longer time from diagnosis, and more bulky disease. More patients in the control arm were Rai stage III or IV.

Two patients in the combination arm and 5 in the control arm had 17p deletion. Four patients in the combination arm and 6 in the control arm had TP53 mutations.

There were 5 patients in the combination arm and 3 in the control arm who were refractory to their prior treatment.

In both arms, patients received a median of 6 cycles of study treatment. Bendamustine exposure was similar between the arms—a median of 143 days. The median treatment duration for otlertuzumab was 156 days.

Seven patients (22%) in the combination arm and 12 (36%) in the control arm discontinued treatment early.

In the combination arm, 3 patients discontinued due to adverse events (AEs), 3 due to disease progression, and 1 patient withdrew to have a stem cell transplant.

In the control arm, 7 patients discontinued due to AEs, 3 due to progression, 1 withdrew for an unspecified reason, and 1 patient died of acute heart failure.

Response and survival

The ORR was 69% in the combination arm and 39% in the control arm (P=0.025).

In the combination arm, 3 patients (9%) had a complete response (CR), 1 patient had a CR with incomplete marrow recovery, and 19 (59%) had a partial response.

In the control arm, 1 patient (3%) had a CR and 12 (36%) had a partial response.

The median PFS was 15.9 months in the combination arm and 10.2 months in the control arm (P=0.0192).

The median overall survival was not reached in either arm. After 2 years of follow-up, there were no deaths in the combination arm and 3 deaths in the control arm.

Safety

Ninety-one percent of patients in the combination arm and 100% of those in the control arm experienced an AE. Serious AEs occurred in 31% and 45%, respectively.

Severe neutropenia was more frequent in the combination arm than the control arm (56% vs 39%), as was severe thrombocytopenia (19% vs 15%).

However, there were fewer grade 3/4 infections in the combination arm than the control arm (13% vs 27%). And 2 patients in the control arm had febrile neutropenia, but there were no cases in the combination arm.

“These latest data show the combination of otlertuzumab and bendamustine is well tolerated and significantly increases the response rate and PFS in patients with relapsed or refractory CLL,” said Scott Stromatt, MD, study director and chief medical officer for Aptevo.

“Consequently, we are now exploring the utility of otlertuzumab in combination with additional CLL therapies to evaluate clinical benefit in distinct CLL patient subgroups.”

Micrograph showing CLL

Image by Mary Ann Thompson

Adding an anti-CD37 molecule to treatment with bendamustine can improve outcomes in patients with relapsed/refractory chronic lymphocytic leukemia (CLL), according to research published in the British Journal of Haematology.

In a phase 2 trial, researchers found that combining the anti-CD37 molecule otlertuzumab with bendamustine significantly improved overall response rates (ORRs) and progression-free survival (PFS) when compared to bendamustine alone.

“We’re very encouraged by the phase 2 data, which demonstrated a significant increase in median progression-free survival, from approximately 10 to 16 months in patients receiving combination otlertuzumab/bendamustine therapy,” said Marvin L. White, president and chief executive officer of Aptevo Therapeutics Inc, the company developing otlertuzumab.

“These data, coupled with additional results from ongoing studies of otlertuzumab used in combination with current CLL therapies, should help position otlertuzumab for a potential partnership to advance into phase 3 clinical development.”

The phase 2 trial was sponsored by Emergent Product Development Seattle LLC. Aptevo Therapeutics is a spin-off of Emergent Biosolutions.

About otlertuzumab

Otlertuzumab (formerly TRU-016) is a humanized, monospecific ADAPTIR™ molecule that targets CD37.

Aptevo Therapeutics says the company is applying its ADAPTIR technology to develop immuno-oncology candidates that focus on redirected T-cell cytotoxicity. ADAPTIR technology can be used to generate immunotherapeutics with unique mechanisms of action, including targeted cytokine delivery, targeting 2 cell surface receptors, or neutralization of multiple soluble proteins.

According to Aptevo, otlertuzumab mediates death of CD37-expressing cells through various mechanisms, including direct cell death, antibody-dependent cell-mediated cytotoxicity, and phagocytosis. Otlertuzumab is being investigated as part of combination therapies for the treatment of CLL.

Study design

This phase 2 study enrolled 65 patients with relapsed/refractory CLL—32 who received a combination of otlertuzumab and bendamustine and 33 who received bendamustine alone.

Patients in the combination arm received otlertuzumab at 20 mg/kg weekly by intravenous infusion for two 28-day cycles, then every 14 days for four 28-day cycles.

Patients in both arms received intravenous bendamustine at 70 mg/m² on days 1 and 2 of each cycle for up to six 28-day cycles. Dosing was adjusted according to neutrophil and platelet counts.

The study’s primary endpoint was ORR (per IWCLL criteria), and secondary endpoints included PFS and safety.

Patient characteristics

The researchers said the treatment arms were generally well balanced. However, patients in the combination arm were older, had more prior treatment regimens, a longer time from diagnosis, and more bulky disease. More patients in the control arm were Rai stage III or IV.

Two patients in the combination arm and 5 in the control arm had 17p deletion. Four patients in the combination arm and 6 in the control arm had TP53 mutations.

There were 5 patients in the combination arm and 3 in the control arm who were refractory to their prior treatment.

In both arms, patients received a median of 6 cycles of study treatment. Bendamustine exposure was similar between the arms—a median of 143 days. The median treatment duration for otlertuzumab was 156 days.

Seven patients (22%) in the combination arm and 12 (36%) in the control arm discontinued treatment early.

In the combination arm, 3 patients discontinued due to adverse events (AEs), 3 due to disease progression, and 1 patient withdrew to have a stem cell transplant.

In the control arm, 7 patients discontinued due to AEs, 3 due to progression, 1 withdrew for an unspecified reason, and 1 patient died of acute heart failure.

Response and survival

The ORR was 69% in the combination arm and 39% in the control arm (P=0.025).

In the combination arm, 3 patients (9%) had a complete response (CR), 1 patient had a CR with incomplete marrow recovery, and 19 (59%) had a partial response.

In the control arm, 1 patient (3%) had a CR and 12 (36%) had a partial response.

The median PFS was 15.9 months in the combination arm and 10.2 months in the control arm (P=0.0192).

The median overall survival was not reached in either arm. After 2 years of follow-up, there were no deaths in the combination arm and 3 deaths in the control arm.

Safety

Ninety-one percent of patients in the combination arm and 100% of those in the control arm experienced an AE. Serious AEs occurred in 31% and 45%, respectively.

Severe neutropenia was more frequent in the combination arm than the control arm (56% vs 39%), as was severe thrombocytopenia (19% vs 15%).

However, there were fewer grade 3/4 infections in the combination arm than the control arm (13% vs 27%). And 2 patients in the control arm had febrile neutropenia, but there were no cases in the combination arm.

“These latest data show the combination of otlertuzumab and bendamustine is well tolerated and significantly increases the response rate and PFS in patients with relapsed or refractory CLL,” said Scott Stromatt, MD, study director and chief medical officer for Aptevo.

“Consequently, we are now exploring the utility of otlertuzumab in combination with additional CLL therapies to evaluate clinical benefit in distinct CLL patient subgroups.”

Monoclonal antibodies

Photo by Linda Bartlett

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the rituximab biosimilar Truxima receive marketing authorization for the treatment of several conditions.

The CHMP said studies have shown that Truxima is comparable to the reference product, Mabthera, which was authorized for use in the European Union in 1998.

The active substance in both products is the anti-CD20 monoclonal antibody rituximab.

Truxima is being developed by Celltrion Healthcare Hungary Kft.

The CHMP’s recommendation for Truxima will be reviewed by the European Commission, which normally issues its decision on a product within 67 days of the time the CHMP adopts its opinion.

If the European Commission grants marketing authorization for Truxima, it will be available as a 500 mg concentrate for solution for infusion.

The CHMP has recommended marketing authorization for Truxima in the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and granulomatosis with polyangiitis and microscopic polyangiitis.

The full indications are as follows.

Non-Hodgkin lymphoma 

Truxima is indicated for use in combination with chemotherapy to treat previously untreated patients with stage III-IV follicular lymphoma.

Truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.

Truxima monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.

Truxima is indicated for use in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) for the treatment of patients with CD20-positive diffuse large B-cell lymphoma.

Chronic lymphocytic leukemia

Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia.

The CHMP noted that only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies, including Truxima, or patients refractory to previous Truxima plus chemotherapy.

Rheumatoid arthritis

Truxima in combination with methotrexate is indicated for the treatment of adults with severe active rheumatoid arthritis who have had an inadequate response or cannot tolerate other disease-modifying anti-rheumatic drugs, including one or more tumor necrosis factor inhibitor therapies.

The CHMP noted that Truxima has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.

Granulomatosis with polyangiitis and microscopic polyangiitis

Truxima in combination with glucocorticoids is indicated for the induction of remission in adults with severe, active granulomatosis with polyangiitis and microscopic polyangiitis.

The CHMP proposed that Truxima be administered under the close supervision of an experienced healthcare professional and in an environment where full resuscitation facilities are immediately available.

Monoclonal antibodies

Photo by Linda Bartlett

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the rituximab biosimilar Truxima receive marketing authorization for the treatment of several conditions.

The CHMP said studies have shown that Truxima is comparable to the reference product, Mabthera, which was authorized for use in the European Union in 1998.

The active substance in both products is the anti-CD20 monoclonal antibody rituximab.

Truxima is being developed by Celltrion Healthcare Hungary Kft.

The CHMP’s recommendation for Truxima will be reviewed by the European Commission, which normally issues its decision on a product within 67 days of the time the CHMP adopts its opinion.

If the European Commission grants marketing authorization for Truxima, it will be available as a 500 mg concentrate for solution for infusion.

The CHMP has recommended marketing authorization for Truxima in the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and granulomatosis with polyangiitis and microscopic polyangiitis.

The full indications are as follows.

Non-Hodgkin lymphoma 

Truxima is indicated for use in combination with chemotherapy to treat previously untreated patients with stage III-IV follicular lymphoma.

Truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.

Truxima monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.

Truxima is indicated for use in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) for the treatment of patients with CD20-positive diffuse large B-cell lymphoma.

Chronic lymphocytic leukemia

Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia.

The CHMP noted that only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies, including Truxima, or patients refractory to previous Truxima plus chemotherapy.

Rheumatoid arthritis

Truxima in combination with methotrexate is indicated for the treatment of adults with severe active rheumatoid arthritis who have had an inadequate response or cannot tolerate other disease-modifying anti-rheumatic drugs, including one or more tumor necrosis factor inhibitor therapies.

The CHMP noted that Truxima has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.

Granulomatosis with polyangiitis and microscopic polyangiitis

Truxima in combination with glucocorticoids is indicated for the induction of remission in adults with severe, active granulomatosis with polyangiitis and microscopic polyangiitis.

The CHMP proposed that Truxima be administered under the close supervision of an experienced healthcare professional and in an environment where full resuscitation facilities are immediately available.

Monoclonal antibodies

Photo by Linda Bartlett

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the rituximab biosimilar Truxima receive marketing authorization for the treatment of several conditions.

The CHMP said studies have shown that Truxima is comparable to the reference product, Mabthera, which was authorized for use in the European Union in 1998.

The active substance in both products is the anti-CD20 monoclonal antibody rituximab.

Truxima is being developed by Celltrion Healthcare Hungary Kft.

The CHMP’s recommendation for Truxima will be reviewed by the European Commission, which normally issues its decision on a product within 67 days of the time the CHMP adopts its opinion.

If the European Commission grants marketing authorization for Truxima, it will be available as a 500 mg concentrate for solution for infusion.

The CHMP has recommended marketing authorization for Truxima in the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and granulomatosis with polyangiitis and microscopic polyangiitis.

The full indications are as follows.

Non-Hodgkin lymphoma 

Truxima is indicated for use in combination with chemotherapy to treat previously untreated patients with stage III-IV follicular lymphoma.

Truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.

Truxima monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.

Truxima is indicated for use in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) for the treatment of patients with CD20-positive diffuse large B-cell lymphoma.

Chronic lymphocytic leukemia

Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia.

The CHMP noted that only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies, including Truxima, or patients refractory to previous Truxima plus chemotherapy.

Rheumatoid arthritis

Truxima in combination with methotrexate is indicated for the treatment of adults with severe active rheumatoid arthritis who have had an inadequate response or cannot tolerate other disease-modifying anti-rheumatic drugs, including one or more tumor necrosis factor inhibitor therapies.

The CHMP noted that Truxima has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.

Granulomatosis with polyangiitis and microscopic polyangiitis

Truxima in combination with glucocorticoids is indicated for the induction of remission in adults with severe, active granulomatosis with polyangiitis and microscopic polyangiitis.

The CHMP proposed that Truxima be administered under the close supervision of an experienced healthcare professional and in an environment where full resuscitation facilities are immediately available.

Micrograph showing

mycosis fungoides

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that chlormethine gel (Ledaga®) be approved for use in adults with mycosis fungoides (MF).

Ledaga is a hybrid medicine of Caryolysine, which has been approved for use in the European Union since 1946.

Ledaga contains the same active substance as Caryolysine but is a gel intended for cutaneous use.

The active substance of Ledaga is chlormethine, a bifunctional alkylating agent that inhibits rapidly proliferating cells.

Hybrid drug applications rely, in part, on the results of preclinical tests and clinical trials for a reference product and, in part, on new data.

The CHMP said studies have demonstrated the satisfactory quality of Ledaga. Since Ledaga is administered as a topical agent and results in no systemic exposure, a bioequivalence study versus the reference product, Caryolysine, was not required.

The CHMP’s recommendation for Ledaga will be reviewed by the European Commission, which is expected to issue a final decision by the end of February 2017.

If approved, Ledaga will be available as a 160 μg/g gel.

Actelion Pharmaceuticals Ltd, the company developing Ledaga, has agreed to a list of recommendations from the CHMP (post-authorization measures) with regard to the release of Ledaga in Europe.

Subject to the agreed recommendations and achieving market access in different countries, a potential first launch of Ledaga could occur at the end of 2017, at the earliest.

Phase 2 study

The CHMP’s positive opinion of Ledaga is based on results of a multicenter, randomized, observer-blinded, active-controlled study of patients with stage I and IIA MF. Results from this phase 2 study were published in JAMA Dermatology.

The study enrolled 260 patients who were randomized 1:1 to receive topical treatment with Ledaga or compounded control—chlormethine HCl 0.02% compounded in Aquaphor® ointment—once daily for up to 12 months.

A response was defined as at least a 50% improvement in the baseline Composite Assessment of Index Lesion Severity score.

In the intent-to-treat population, 59% (76/130) of patients who received Ledaga achieved a clinical response, compared to 48% (62/130) of patients treated with the compounded control. The rate of complete response was 14% (n=18) and 12% (n=15), respectively.

Patients who were treated for at least 6 months were included in the efficacy-evaluable population. In this population, 77% (69/90) of patients who received Ledaga achieved a clinical response, compared to 59% (56/95) of patients treated with the compounded control. The rate of complete response was 19% (n=17) and 15% (n=14), respectively.

Reductions in mean lesion severity were seen as early as 4 weeks into the study, with further reductions observed with continuing therapy. The time to first confirmed response favored Ledaga.

The most frequent adverse reactions reported with Ledaga were skin-related—dermatitis (55%; eg, skin irritation, erythema, rash, urticaria, skin-burning sensation, pain of the skin), pruritus (20%), skin infections (12%), skin ulceration and blistering (6%), and skin hyperpigmentation (6%).

No systemic absorption of chlormethine was detected with treatment.

Micrograph showing

mycosis fungoides

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that chlormethine gel (Ledaga®) be approved for use in adults with mycosis fungoides (MF).

Ledaga is a hybrid medicine of Caryolysine, which has been approved for use in the European Union since 1946.

Ledaga contains the same active substance as Caryolysine but is a gel intended for cutaneous use.

The active substance of Ledaga is chlormethine, a bifunctional alkylating agent that inhibits rapidly proliferating cells.

Hybrid drug applications rely, in part, on the results of preclinical tests and clinical trials for a reference product and, in part, on new data.

The CHMP said studies have demonstrated the satisfactory quality of Ledaga. Since Ledaga is administered as a topical agent and results in no systemic exposure, a bioequivalence study versus the reference product, Caryolysine, was not required.

The CHMP’s recommendation for Ledaga will be reviewed by the European Commission, which is expected to issue a final decision by the end of February 2017.

If approved, Ledaga will be available as a 160 μg/g gel.

Actelion Pharmaceuticals Ltd, the company developing Ledaga, has agreed to a list of recommendations from the CHMP (post-authorization measures) with regard to the release of Ledaga in Europe.

Subject to the agreed recommendations and achieving market access in different countries, a potential first launch of Ledaga could occur at the end of 2017, at the earliest.

Phase 2 study

The CHMP’s positive opinion of Ledaga is based on results of a multicenter, randomized, observer-blinded, active-controlled study of patients with stage I and IIA MF. Results from this phase 2 study were published in JAMA Dermatology.

The study enrolled 260 patients who were randomized 1:1 to receive topical treatment with Ledaga or compounded control—chlormethine HCl 0.02% compounded in Aquaphor® ointment—once daily for up to 12 months.

A response was defined as at least a 50% improvement in the baseline Composite Assessment of Index Lesion Severity score.

In the intent-to-treat population, 59% (76/130) of patients who received Ledaga achieved a clinical response, compared to 48% (62/130) of patients treated with the compounded control. The rate of complete response was 14% (n=18) and 12% (n=15), respectively.

Patients who were treated for at least 6 months were included in the efficacy-evaluable population. In this population, 77% (69/90) of patients who received Ledaga achieved a clinical response, compared to 59% (56/95) of patients treated with the compounded control. The rate of complete response was 19% (n=17) and 15% (n=14), respectively.

Reductions in mean lesion severity were seen as early as 4 weeks into the study, with further reductions observed with continuing therapy. The time to first confirmed response favored Ledaga.

The most frequent adverse reactions reported with Ledaga were skin-related—dermatitis (55%; eg, skin irritation, erythema, rash, urticaria, skin-burning sensation, pain of the skin), pruritus (20%), skin infections (12%), skin ulceration and blistering (6%), and skin hyperpigmentation (6%).

No systemic absorption of chlormethine was detected with treatment.

Micrograph showing

mycosis fungoides

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that chlormethine gel (Ledaga®) be approved for use in adults with mycosis fungoides (MF).

Ledaga is a hybrid medicine of Caryolysine, which has been approved for use in the European Union since 1946.

Ledaga contains the same active substance as Caryolysine but is a gel intended for cutaneous use.

The active substance of Ledaga is chlormethine, a bifunctional alkylating agent that inhibits rapidly proliferating cells.

Hybrid drug applications rely, in part, on the results of preclinical tests and clinical trials for a reference product and, in part, on new data.

The CHMP said studies have demonstrated the satisfactory quality of Ledaga. Since Ledaga is administered as a topical agent and results in no systemic exposure, a bioequivalence study versus the reference product, Caryolysine, was not required.

The CHMP’s recommendation for Ledaga will be reviewed by the European Commission, which is expected to issue a final decision by the end of February 2017.

If approved, Ledaga will be available as a 160 μg/g gel.

Actelion Pharmaceuticals Ltd, the company developing Ledaga, has agreed to a list of recommendations from the CHMP (post-authorization measures) with regard to the release of Ledaga in Europe.

Subject to the agreed recommendations and achieving market access in different countries, a potential first launch of Ledaga could occur at the end of 2017, at the earliest.

Phase 2 study

The CHMP’s positive opinion of Ledaga is based on results of a multicenter, randomized, observer-blinded, active-controlled study of patients with stage I and IIA MF. Results from this phase 2 study were published in JAMA Dermatology.

The study enrolled 260 patients who were randomized 1:1 to receive topical treatment with Ledaga or compounded control—chlormethine HCl 0.02% compounded in Aquaphor® ointment—once daily for up to 12 months.

A response was defined as at least a 50% improvement in the baseline Composite Assessment of Index Lesion Severity score.

In the intent-to-treat population, 59% (76/130) of patients who received Ledaga achieved a clinical response, compared to 48% (62/130) of patients treated with the compounded control. The rate of complete response was 14% (n=18) and 12% (n=15), respectively.

Patients who were treated for at least 6 months were included in the efficacy-evaluable population. In this population, 77% (69/90) of patients who received Ledaga achieved a clinical response, compared to 59% (56/95) of patients treated with the compounded control. The rate of complete response was 19% (n=17) and 15% (n=14), respectively.

Reductions in mean lesion severity were seen as early as 4 weeks into the study, with further reductions observed with continuing therapy. The time to first confirmed response favored Ledaga.

The most frequent adverse reactions reported with Ledaga were skin-related—dermatitis (55%; eg, skin irritation, erythema, rash, urticaria, skin-burning sensation, pain of the skin), pruritus (20%), skin infections (12%), skin ulceration and blistering (6%), and skin hyperpigmentation (6%).

No systemic absorption of chlormethine was detected with treatment.

In this issue of ACS Surgery News, you will see articles highlighting the program of the ACS Clinical Congress that took place in Washington, D.C., in mid-October.

This year’s theme, “The Best Surgical Education, All in One Place,” could not be more apt to represent the ACS Clinical Congress. And yet, the Clinical Congress is much, much more than an educational exercise for those who are able to attend. No matter what your age, whether it was your first time attending or, like me, your 41st, there is something at this meeting for everyone. Although the focus is on education, and the meeting does have a dizzying array of educational options, it is also an opportunity to see old friends and make new ones, connect with people with whom you share problems, work with colleagues to devise strategies to solve challenges, put faces with names you’ve only read about, participate in service and governance of our profession, and be inspired by the thoughtful leaders of our profession.

As the years pass by

I remember vividly my earliest ACS Clinical Congress, as a surgical resident at University of California, San Francisco, in October, 1975. It was 3 months into my research year and therefore I was able to attend the congress, which was in San Francisco that year. As one of the few women physicians in attendance at that meeting, I was in strange territory. I watched the opening ceremony with surgical leaders standing on stage, and I thought how homogeneous the group appeared: undeniably brilliant and accomplished, but all white-haired, white, and male. Fast-forward 41 years, and the surgical leaders who appeared on that stage at this year’s meeting were every bit as brilliant and accomplished, but the leaders are now younger and more diverse than in years past. The diversity in the college was evident as I walked the halls of the convention center where Fellows, residents, and guest physicians paused in their rushed transit from Hall D to Ballroom C to converse with an old or new friend.

The program itself has also become far more varied over the years. There is a continued emphasis on basic and clinical research in the scientific forum and scientific sessions. Postgraduate courses still impart new knowledge and skills, and state-of-the-art clinical practice is still taught in panel sessions. But the program now includes numerous nonclinical topics that are of crucial importance to present and future surgeons, such as ethics, end-of-life care, practice management, burnout, deciphering CMS regulations, and global health and humanitarian surgical outreach, to mention only a few. The named lectures continue to feature outstanding speakers who are often inspiring, and even sometimes provocative, and they are well worth attending. I would not want to have missed Past-President Carlos Pellegrini’s profoundly thoughtful John J. Conley Ethics and Philosophy Lecture on “TRUST: The Keystone of the Patient Physician Relationship,” for example.

Even the topics at the scientific forum have expanded over the years. In addition to the traditional basic science and clinical topics, five separate sessions this year on surgical education and on quality, safety, and outcomes attest to the increasing significance of these areas, unheard of when I was a resident. The important topics of ethics, geriatric surgery and palliative care, and global surgery/humanitarian outreach have gained sufficient interest that they now warrant their own sessions. There is something on the program to satisfy everyone’s interests. The forum presentations also provide us aging surgeons a chance to see the impressive contributions that our surgical progeny are making to the future of our profession. That, in itself, is encouraging and comforting.

Serving the profession

Many surgeons attend the congress in part to participate in committees of the ACS or other surgical organizations that meet during the congress to conserve time away from their “real jobs” as surgeons. These meetings offer attendees a chance to “give back” as well as to develop leadership in their profession. Participation in these committees can lead eventually to service on the Board of Governors or Regents, which offer opportunities to help shape the future of our organization and profession.

Profound positive changes in our profession have occurred through the leadership of the college. And some of these initiatives are reflected in the standing committees such as the Women in Surgery Committee, the Committee on Diversity Issues, and the Committee on Health Care Disparities, to name only three. Long-standing groups such as the Committee on Trauma (COT) have evolved greatly through the years and have raised the quality of trauma care and education in trauma across the United States and also globally.
 

Social and networking opportunities

The educational opportunities are unparalleled at the Clinical Congress, but the opportunities to connect with fellow surgeons is a close second. The chance to meet old friends from residency, recruit new partners for one’s practice, or be introduced to someone whom you have only known through postings on the ACS Communities are all invaluable aspects of the week. An email or telephone conversation is no substitute for these enriching face-to-face activities. And there is no substitute for this unique opportunity to create and extend your network of friends, colleagues, and allies. The Clinical Congress is often the beginning of relationships and professional connections that can last a lifetime.

Perhaps my enjoyment of the ACS Clinical Congress stems in part from how familiar it is after all these years and the comfort of being a member of this amazing organization. But my enthusiasm also comes from seeing how increasingly important and relevant the college has become to all of us – student, resident, Fellow, or guest. For surgeons, there is no substitute for the American College of Surgeons and there is indeed something for everyone at the Clinical Congress.
 

Dr. Deveney is professor of surgery and vice chair of education in the department of surgery, Oregon Health & Science University, Portland. She is the Coeditor of ACS Surgery News.

In this issue of ACS Surgery News, you will see articles highlighting the program of the ACS Clinical Congress that took place in Washington, D.C., in mid-October.

This year’s theme, “The Best Surgical Education, All in One Place,” could not be more apt to represent the ACS Clinical Congress. And yet, the Clinical Congress is much, much more than an educational exercise for those who are able to attend. No matter what your age, whether it was your first time attending or, like me, your 41st, there is something at this meeting for everyone. Although the focus is on education, and the meeting does have a dizzying array of educational options, it is also an opportunity to see old friends and make new ones, connect with people with whom you share problems, work with colleagues to devise strategies to solve challenges, put faces with names you’ve only read about, participate in service and governance of our profession, and be inspired by the thoughtful leaders of our profession.

As the years pass by

I remember vividly my earliest ACS Clinical Congress, as a surgical resident at University of California, San Francisco, in October, 1975. It was 3 months into my research year and therefore I was able to attend the congress, which was in San Francisco that year. As one of the few women physicians in attendance at that meeting, I was in strange territory. I watched the opening ceremony with surgical leaders standing on stage, and I thought how homogeneous the group appeared: undeniably brilliant and accomplished, but all white-haired, white, and male. Fast-forward 41 years, and the surgical leaders who appeared on that stage at this year’s meeting were every bit as brilliant and accomplished, but the leaders are now younger and more diverse than in years past. The diversity in the college was evident as I walked the halls of the convention center where Fellows, residents, and guest physicians paused in their rushed transit from Hall D to Ballroom C to converse with an old or new friend.

The program itself has also become far more varied over the years. There is a continued emphasis on basic and clinical research in the scientific forum and scientific sessions. Postgraduate courses still impart new knowledge and skills, and state-of-the-art clinical practice is still taught in panel sessions. But the program now includes numerous nonclinical topics that are of crucial importance to present and future surgeons, such as ethics, end-of-life care, practice management, burnout, deciphering CMS regulations, and global health and humanitarian surgical outreach, to mention only a few. The named lectures continue to feature outstanding speakers who are often inspiring, and even sometimes provocative, and they are well worth attending. I would not want to have missed Past-President Carlos Pellegrini’s profoundly thoughtful John J. Conley Ethics and Philosophy Lecture on “TRUST: The Keystone of the Patient Physician Relationship,” for example.

Even the topics at the scientific forum have expanded over the years. In addition to the traditional basic science and clinical topics, five separate sessions this year on surgical education and on quality, safety, and outcomes attest to the increasing significance of these areas, unheard of when I was a resident. The important topics of ethics, geriatric surgery and palliative care, and global surgery/humanitarian outreach have gained sufficient interest that they now warrant their own sessions. There is something on the program to satisfy everyone’s interests. The forum presentations also provide us aging surgeons a chance to see the impressive contributions that our surgical progeny are making to the future of our profession. That, in itself, is encouraging and comforting.

Serving the profession

Many surgeons attend the congress in part to participate in committees of the ACS or other surgical organizations that meet during the congress to conserve time away from their “real jobs” as surgeons. These meetings offer attendees a chance to “give back” as well as to develop leadership in their profession. Participation in these committees can lead eventually to service on the Board of Governors or Regents, which offer opportunities to help shape the future of our organization and profession.

Profound positive changes in our profession have occurred through the leadership of the college. And some of these initiatives are reflected in the standing committees such as the Women in Surgery Committee, the Committee on Diversity Issues, and the Committee on Health Care Disparities, to name only three. Long-standing groups such as the Committee on Trauma (COT) have evolved greatly through the years and have raised the quality of trauma care and education in trauma across the United States and also globally.
 

Social and networking opportunities

The educational opportunities are unparalleled at the Clinical Congress, but the opportunities to connect with fellow surgeons is a close second. The chance to meet old friends from residency, recruit new partners for one’s practice, or be introduced to someone whom you have only known through postings on the ACS Communities are all invaluable aspects of the week. An email or telephone conversation is no substitute for these enriching face-to-face activities. And there is no substitute for this unique opportunity to create and extend your network of friends, colleagues, and allies. The Clinical Congress is often the beginning of relationships and professional connections that can last a lifetime.

Perhaps my enjoyment of the ACS Clinical Congress stems in part from how familiar it is after all these years and the comfort of being a member of this amazing organization. But my enthusiasm also comes from seeing how increasingly important and relevant the college has become to all of us – student, resident, Fellow, or guest. For surgeons, there is no substitute for the American College of Surgeons and there is indeed something for everyone at the Clinical Congress.
 

Dr. Deveney is professor of surgery and vice chair of education in the department of surgery, Oregon Health & Science University, Portland. She is the Coeditor of ACS Surgery News.

In this issue of ACS Surgery News, you will see articles highlighting the program of the ACS Clinical Congress that took place in Washington, D.C., in mid-October.

This year’s theme, “The Best Surgical Education, All in One Place,” could not be more apt to represent the ACS Clinical Congress. And yet, the Clinical Congress is much, much more than an educational exercise for those who are able to attend. No matter what your age, whether it was your first time attending or, like me, your 41st, there is something at this meeting for everyone. Although the focus is on education, and the meeting does have a dizzying array of educational options, it is also an opportunity to see old friends and make new ones, connect with people with whom you share problems, work with colleagues to devise strategies to solve challenges, put faces with names you’ve only read about, participate in service and governance of our profession, and be inspired by the thoughtful leaders of our profession.

As the years pass by

I remember vividly my earliest ACS Clinical Congress, as a surgical resident at University of California, San Francisco, in October, 1975. It was 3 months into my research year and therefore I was able to attend the congress, which was in San Francisco that year. As one of the few women physicians in attendance at that meeting, I was in strange territory. I watched the opening ceremony with surgical leaders standing on stage, and I thought how homogeneous the group appeared: undeniably brilliant and accomplished, but all white-haired, white, and male. Fast-forward 41 years, and the surgical leaders who appeared on that stage at this year’s meeting were every bit as brilliant and accomplished, but the leaders are now younger and more diverse than in years past. The diversity in the college was evident as I walked the halls of the convention center where Fellows, residents, and guest physicians paused in their rushed transit from Hall D to Ballroom C to converse with an old or new friend.

The program itself has also become far more varied over the years. There is a continued emphasis on basic and clinical research in the scientific forum and scientific sessions. Postgraduate courses still impart new knowledge and skills, and state-of-the-art clinical practice is still taught in panel sessions. But the program now includes numerous nonclinical topics that are of crucial importance to present and future surgeons, such as ethics, end-of-life care, practice management, burnout, deciphering CMS regulations, and global health and humanitarian surgical outreach, to mention only a few. The named lectures continue to feature outstanding speakers who are often inspiring, and even sometimes provocative, and they are well worth attending. I would not want to have missed Past-President Carlos Pellegrini’s profoundly thoughtful John J. Conley Ethics and Philosophy Lecture on “TRUST: The Keystone of the Patient Physician Relationship,” for example.

Even the topics at the scientific forum have expanded over the years. In addition to the traditional basic science and clinical topics, five separate sessions this year on surgical education and on quality, safety, and outcomes attest to the increasing significance of these areas, unheard of when I was a resident. The important topics of ethics, geriatric surgery and palliative care, and global surgery/humanitarian outreach have gained sufficient interest that they now warrant their own sessions. There is something on the program to satisfy everyone’s interests. The forum presentations also provide us aging surgeons a chance to see the impressive contributions that our surgical progeny are making to the future of our profession. That, in itself, is encouraging and comforting.

Serving the profession

Many surgeons attend the congress in part to participate in committees of the ACS or other surgical organizations that meet during the congress to conserve time away from their “real jobs” as surgeons. These meetings offer attendees a chance to “give back” as well as to develop leadership in their profession. Participation in these committees can lead eventually to service on the Board of Governors or Regents, which offer opportunities to help shape the future of our organization and profession.

Profound positive changes in our profession have occurred through the leadership of the college. And some of these initiatives are reflected in the standing committees such as the Women in Surgery Committee, the Committee on Diversity Issues, and the Committee on Health Care Disparities, to name only three. Long-standing groups such as the Committee on Trauma (COT) have evolved greatly through the years and have raised the quality of trauma care and education in trauma across the United States and also globally.
 

Social and networking opportunities

The educational opportunities are unparalleled at the Clinical Congress, but the opportunities to connect with fellow surgeons is a close second. The chance to meet old friends from residency, recruit new partners for one’s practice, or be introduced to someone whom you have only known through postings on the ACS Communities are all invaluable aspects of the week. An email or telephone conversation is no substitute for these enriching face-to-face activities. And there is no substitute for this unique opportunity to create and extend your network of friends, colleagues, and allies. The Clinical Congress is often the beginning of relationships and professional connections that can last a lifetime.

Perhaps my enjoyment of the ACS Clinical Congress stems in part from how familiar it is after all these years and the comfort of being a member of this amazing organization. But my enthusiasm also comes from seeing how increasingly important and relevant the college has become to all of us – student, resident, Fellow, or guest. For surgeons, there is no substitute for the American College of Surgeons and there is indeed something for everyone at the Clinical Congress.
 

Dr. Deveney is professor of surgery and vice chair of education in the department of surgery, Oregon Health & Science University, Portland. She is the Coeditor of ACS Surgery News.

As was summarized last month, Centers for Medicare and Medicaid Services (CMS) released the final rule pertaining to the Medicare Access and CHIP Reauthorization Act (MACRA) on October 14, 2016. In the ensuing weeks, Division of Advocacy and Health Policy staff had the opportunity to read and further analyze the rule. In general, the initial favorable impression held up under more careful scrutiny. Based on the provisions in the final rule, we continue to make adjustments and modifications to the resources available to Fellows to assist them to prepare for 2017 on the website found at www.facs.org/qpp. By the time this column is printed/released, I anticipate that the video series found on the website will have been updated and expanded upon.

Because change is unsettling, one of the most frequent topics of conversation and question concerning MACRA is the new reporting requirement known as Improvement Activities. Previously, in the proposed rule, this component was known as the Clinical Practice Improvement Activities. In the final rule, the nomenclature was shortened to Improvement Activities.

Dr. Bailey is a pediatric surgeon, and Medical Director, Advocacy, for the Division of Advocacy and Health Policy in the ACS offices in Washington, D.C.

As was summarized last month, Centers for Medicare and Medicaid Services (CMS) released the final rule pertaining to the Medicare Access and CHIP Reauthorization Act (MACRA) on October 14, 2016. In the ensuing weeks, Division of Advocacy and Health Policy staff had the opportunity to read and further analyze the rule. In general, the initial favorable impression held up under more careful scrutiny. Based on the provisions in the final rule, we continue to make adjustments and modifications to the resources available to Fellows to assist them to prepare for 2017 on the website found at www.facs.org/qpp. By the time this column is printed/released, I anticipate that the video series found on the website will have been updated and expanded upon.

Because change is unsettling, one of the most frequent topics of conversation and question concerning MACRA is the new reporting requirement known as Improvement Activities. Previously, in the proposed rule, this component was known as the Clinical Practice Improvement Activities. In the final rule, the nomenclature was shortened to Improvement Activities.

Dr. Bailey is a pediatric surgeon, and Medical Director, Advocacy, for the Division of Advocacy and Health Policy in the ACS offices in Washington, D.C.

As was summarized last month, Centers for Medicare and Medicaid Services (CMS) released the final rule pertaining to the Medicare Access and CHIP Reauthorization Act (MACRA) on October 14, 2016. In the ensuing weeks, Division of Advocacy and Health Policy staff had the opportunity to read and further analyze the rule. In general, the initial favorable impression held up under more careful scrutiny. Based on the provisions in the final rule, we continue to make adjustments and modifications to the resources available to Fellows to assist them to prepare for 2017 on the website found at www.facs.org/qpp. By the time this column is printed/released, I anticipate that the video series found on the website will have been updated and expanded upon.

Because change is unsettling, one of the most frequent topics of conversation and question concerning MACRA is the new reporting requirement known as Improvement Activities. Previously, in the proposed rule, this component was known as the Clinical Practice Improvement Activities. In the final rule, the nomenclature was shortened to Improvement Activities.

Dr. Bailey is a pediatric surgeon, and Medical Director, Advocacy, for the Division of Advocacy and Health Policy in the ACS offices in Washington, D.C.

Barbara Lee Bass, MD, FACS, the John F. and Carolyn Bookout Distinguished Endowed Chair and chair, department of surgery, Houston Methodist Hospital, TX, was elected President-Elect of the American College of Surgeons (ACS) at the October 19 Annual Business Meeting of the Members. Dr. Bass is executive director, Houston Methodist Institute for Technology, Innovation and Education (MITIE), a state-of-the-art education and research facility developed to safely train practicing health care professionals in new technologies and procedures. She is professor of surgery at Weill Cornell Medical College, New York, NY, and senior member of the Houston Methodist Hospital Research Institute. A Fellow of the College since 1988, former ACS Regent, and former ACS Governor, Dr. Bass is the recipient of the 2013 ACS Distinguished Service Award—the College’s highest honor.

The First Vice-President-Elect is Charles D. Mabry, MD, FACS, a general surgeon from Pine Bluff, AR, and associate professor of surgery and practice management advisor to the chair, department of surgery, University of Arkansas for Medical Sciences, Little Rock. He is medical director of quality, Jefferson Regional Medical Center, Pine Bluff, and serves on the Arkansas Governor’s Trauma Advisory Committee, chairing the Committee’s Quality Improvement Subcommittee. He is Chairman of the Board for the Arkansas Preferred Provider Organization. Dr. Mabry has served on the ACS Young Surgeons Committee, as an ACS representative on the American Medical Association Relative Value Update Committee, as a member of the General Surgery Coding and Reimbursement Committee, and as an ACS Regent.

The Second Vice-President-Elect is Basil A. Pruitt, Jr., MD, FACS, FCCM, MCCM, the Dr. Ferdinand P. Herff Chair in Surgery, clinical professor of surgery, department of surgery, trauma division, University of Texas Health Science Center, San Antonio, and professor of surgery at USUHS. Dr. Pruitt is an esteemed leader in four broad areas: burn, trauma, injury, and critical care surgery; biomedical research and scholarship; organizational leadership and development; and mentorship. He is a former ACS Governor, Scudder Orator, and Excelsior Surgical Society/Edward D. Churchill Lecturer.
 

Barbara Lee Bass, MD, FACS, the John F. and Carolyn Bookout Distinguished Endowed Chair and chair, department of surgery, Houston Methodist Hospital, TX, was elected President-Elect of the American College of Surgeons (ACS) at the October 19 Annual Business Meeting of the Members. Dr. Bass is executive director, Houston Methodist Institute for Technology, Innovation and Education (MITIE), a state-of-the-art education and research facility developed to safely train practicing health care professionals in new technologies and procedures. She is professor of surgery at Weill Cornell Medical College, New York, NY, and senior member of the Houston Methodist Hospital Research Institute. A Fellow of the College since 1988, former ACS Regent, and former ACS Governor, Dr. Bass is the recipient of the 2013 ACS Distinguished Service Award—the College’s highest honor.

The First Vice-President-Elect is Charles D. Mabry, MD, FACS, a general surgeon from Pine Bluff, AR, and associate professor of surgery and practice management advisor to the chair, department of surgery, University of Arkansas for Medical Sciences, Little Rock. He is medical director of quality, Jefferson Regional Medical Center, Pine Bluff, and serves on the Arkansas Governor’s Trauma Advisory Committee, chairing the Committee’s Quality Improvement Subcommittee. He is Chairman of the Board for the Arkansas Preferred Provider Organization. Dr. Mabry has served on the ACS Young Surgeons Committee, as an ACS representative on the American Medical Association Relative Value Update Committee, as a member of the General Surgery Coding and Reimbursement Committee, and as an ACS Regent.

The Second Vice-President-Elect is Basil A. Pruitt, Jr., MD, FACS, FCCM, MCCM, the Dr. Ferdinand P. Herff Chair in Surgery, clinical professor of surgery, department of surgery, trauma division, University of Texas Health Science Center, San Antonio, and professor of surgery at USUHS. Dr. Pruitt is an esteemed leader in four broad areas: burn, trauma, injury, and critical care surgery; biomedical research and scholarship; organizational leadership and development; and mentorship. He is a former ACS Governor, Scudder Orator, and Excelsior Surgical Society/Edward D. Churchill Lecturer.
 

Barbara Lee Bass, MD, FACS, the John F. and Carolyn Bookout Distinguished Endowed Chair and chair, department of surgery, Houston Methodist Hospital, TX, was elected President-Elect of the American College of Surgeons (ACS) at the October 19 Annual Business Meeting of the Members. Dr. Bass is executive director, Houston Methodist Institute for Technology, Innovation and Education (MITIE), a state-of-the-art education and research facility developed to safely train practicing health care professionals in new technologies and procedures. She is professor of surgery at Weill Cornell Medical College, New York, NY, and senior member of the Houston Methodist Hospital Research Institute. A Fellow of the College since 1988, former ACS Regent, and former ACS Governor, Dr. Bass is the recipient of the 2013 ACS Distinguished Service Award—the College’s highest honor.

The First Vice-President-Elect is Charles D. Mabry, MD, FACS, a general surgeon from Pine Bluff, AR, and associate professor of surgery and practice management advisor to the chair, department of surgery, University of Arkansas for Medical Sciences, Little Rock. He is medical director of quality, Jefferson Regional Medical Center, Pine Bluff, and serves on the Arkansas Governor’s Trauma Advisory Committee, chairing the Committee’s Quality Improvement Subcommittee. He is Chairman of the Board for the Arkansas Preferred Provider Organization. Dr. Mabry has served on the ACS Young Surgeons Committee, as an ACS representative on the American Medical Association Relative Value Update Committee, as a member of the General Surgery Coding and Reimbursement Committee, and as an ACS Regent.

The Second Vice-President-Elect is Basil A. Pruitt, Jr., MD, FACS, FCCM, MCCM, the Dr. Ferdinand P. Herff Chair in Surgery, clinical professor of surgery, department of surgery, trauma division, University of Texas Health Science Center, San Antonio, and professor of surgery at USUHS. Dr. Pruitt is an esteemed leader in four broad areas: burn, trauma, injury, and critical care surgery; biomedical research and scholarship; organizational leadership and development; and mentorship. He is a former ACS Governor, Scudder Orator, and Excelsior Surgical Society/Edward D. Churchill Lecturer.
 

Two new members of the American College of Surgeons (ACS) Board of Regents (B/R) were elected at the October 19 Annual Business Meeting of Members: Anthony Atala, MD, FACS, and Fabrizio Michelassi, MD, FACS. Dr. Atala is director, Wake Forest Institute for Regenerative Medicine, and W. Boyce Professor and Chair, department of urology, Wake Forest University, Winston Salem, NC. Dr. Michelassi is the Lewis Atterbury Stimson Professor and Chair, Weill Cornell Medical Center, and surgeon-in-chief, New York-Presbyterian/Weill Cornell Medical Center, NY, and Immediate Past-Chair of the Board of Governors (B/G).

The 2016-2017 Chair of the B/R is Michael J. Zinner, MD, FACS, an ACS Regent since 2010 and founding chief executive officer and executive medical director, Miami Cancer Institute, Baptist Health South Florida, Coral Gables. The Vice-Chair is Leigh A. Neumayer, MD, MS, FACS, a Regent since 2009 and professor and chair, department of surgery, University of Arizona, and Margaret and Fenton Maynard Endowed Chair in Breast Cancer Research, University of Arizona College of Medicine, Tucson.

Replacing Dr. Michelassi as Chair of the B/G Executive Committee is Diana L. Farmer, MD, FACS, a pediatric surgeon, Pearl Stamps Stewart Professor of Surgery, and chair, department of surgery, University of California Davis Health System, Sacramento. Steven C. Stain, MD, FACS, a general surgeon and Henry and Sally Schaffer Chair and Professor, department of surgery, Albany Medical Center, NY, has been elected Vice-Chair; and Susan K. Mosier, MD, MBA, FACS, an ophthalmologist, Secretary, Kansas Department of Health and Environment, and State Health Officer for Kansas, Topeka, has been elected Secretary.

In addition, S. Rob Todd, MD, FACS, FCCM, was elected to serve an initial one-year term on the Executive Committee of the B/G. Dr. Todd is professor and chief, section of acute care surgery, department of surgery, and program director, surgical critical care residency, Baylor College of Medicine; and chief, general surgery, and director, Ginni and Richard Mithoff Trauma Center, Ben Taub Hospital, Houston, TX. Elected to an initial two-year term on the B/G Executive Committee was Nicole S. Gibran, MD, FACS, David and Nancy Auth-Washington Research Foundation Endowed Chair for Restorative Burn Surgery, professor, department of surgery, director, UW Medicine Regional Burn Center at Harborview Medical Center, and adjunct professor, department of medicine, division of dermatology, University of Washington, Seattle.
 

Two new members of the American College of Surgeons (ACS) Board of Regents (B/R) were elected at the October 19 Annual Business Meeting of Members: Anthony Atala, MD, FACS, and Fabrizio Michelassi, MD, FACS. Dr. Atala is director, Wake Forest Institute for Regenerative Medicine, and W. Boyce Professor and Chair, department of urology, Wake Forest University, Winston Salem, NC. Dr. Michelassi is the Lewis Atterbury Stimson Professor and Chair, Weill Cornell Medical Center, and surgeon-in-chief, New York-Presbyterian/Weill Cornell Medical Center, NY, and Immediate Past-Chair of the Board of Governors (B/G).

The 2016-2017 Chair of the B/R is Michael J. Zinner, MD, FACS, an ACS Regent since 2010 and founding chief executive officer and executive medical director, Miami Cancer Institute, Baptist Health South Florida, Coral Gables. The Vice-Chair is Leigh A. Neumayer, MD, MS, FACS, a Regent since 2009 and professor and chair, department of surgery, University of Arizona, and Margaret and Fenton Maynard Endowed Chair in Breast Cancer Research, University of Arizona College of Medicine, Tucson.

Replacing Dr. Michelassi as Chair of the B/G Executive Committee is Diana L. Farmer, MD, FACS, a pediatric surgeon, Pearl Stamps Stewart Professor of Surgery, and chair, department of surgery, University of California Davis Health System, Sacramento. Steven C. Stain, MD, FACS, a general surgeon and Henry and Sally Schaffer Chair and Professor, department of surgery, Albany Medical Center, NY, has been elected Vice-Chair; and Susan K. Mosier, MD, MBA, FACS, an ophthalmologist, Secretary, Kansas Department of Health and Environment, and State Health Officer for Kansas, Topeka, has been elected Secretary.

In addition, S. Rob Todd, MD, FACS, FCCM, was elected to serve an initial one-year term on the Executive Committee of the B/G. Dr. Todd is professor and chief, section of acute care surgery, department of surgery, and program director, surgical critical care residency, Baylor College of Medicine; and chief, general surgery, and director, Ginni and Richard Mithoff Trauma Center, Ben Taub Hospital, Houston, TX. Elected to an initial two-year term on the B/G Executive Committee was Nicole S. Gibran, MD, FACS, David and Nancy Auth-Washington Research Foundation Endowed Chair for Restorative Burn Surgery, professor, department of surgery, director, UW Medicine Regional Burn Center at Harborview Medical Center, and adjunct professor, department of medicine, division of dermatology, University of Washington, Seattle.
 

Two new members of the American College of Surgeons (ACS) Board of Regents (B/R) were elected at the October 19 Annual Business Meeting of Members: Anthony Atala, MD, FACS, and Fabrizio Michelassi, MD, FACS. Dr. Atala is director, Wake Forest Institute for Regenerative Medicine, and W. Boyce Professor and Chair, department of urology, Wake Forest University, Winston Salem, NC. Dr. Michelassi is the Lewis Atterbury Stimson Professor and Chair, Weill Cornell Medical Center, and surgeon-in-chief, New York-Presbyterian/Weill Cornell Medical Center, NY, and Immediate Past-Chair of the Board of Governors (B/G).

The 2016-2017 Chair of the B/R is Michael J. Zinner, MD, FACS, an ACS Regent since 2010 and founding chief executive officer and executive medical director, Miami Cancer Institute, Baptist Health South Florida, Coral Gables. The Vice-Chair is Leigh A. Neumayer, MD, MS, FACS, a Regent since 2009 and professor and chair, department of surgery, University of Arizona, and Margaret and Fenton Maynard Endowed Chair in Breast Cancer Research, University of Arizona College of Medicine, Tucson.

Replacing Dr. Michelassi as Chair of the B/G Executive Committee is Diana L. Farmer, MD, FACS, a pediatric surgeon, Pearl Stamps Stewart Professor of Surgery, and chair, department of surgery, University of California Davis Health System, Sacramento. Steven C. Stain, MD, FACS, a general surgeon and Henry and Sally Schaffer Chair and Professor, department of surgery, Albany Medical Center, NY, has been elected Vice-Chair; and Susan K. Mosier, MD, MBA, FACS, an ophthalmologist, Secretary, Kansas Department of Health and Environment, and State Health Officer for Kansas, Topeka, has been elected Secretary.

In addition, S. Rob Todd, MD, FACS, FCCM, was elected to serve an initial one-year term on the Executive Committee of the B/G. Dr. Todd is professor and chief, section of acute care surgery, department of surgery, and program director, surgical critical care residency, Baylor College of Medicine; and chief, general surgery, and director, Ginni and Richard Mithoff Trauma Center, Ben Taub Hospital, Houston, TX. Elected to an initial two-year term on the B/G Executive Committee was Nicole S. Gibran, MD, FACS, David and Nancy Auth-Washington Research Foundation Endowed Chair for Restorative Burn Surgery, professor, department of surgery, director, UW Medicine Regional Burn Center at Harborview Medical Center, and adjunct professor, department of medicine, division of dermatology, University of Washington, Seattle.
 

Rheumatology saw nearly 97% of its positions filled during the 2016 Specialty Match Day.

The specialty had 217 open slots and ended the Dec. 7 match day with only 7 positions unfilled. There were 312 applicants that selected rheumatology as their primary specialty, with 206 applicants being matched. Six were matched to different specialties and 100 who selected rheumatology as their primary specialty did not get matched to any program.

However, those seven unfilled slots will likely get matched.

Overall, Dr. Bass, who is the program director of the rheumatology fellowship program at the Hospital for Special Surgery, New York, said the numbers reflect strong interest in rheumatology.

“In 2012, there were 240 applicants to rheumatology, and this year there were 312,” she said. “It’s been a linear trend. ... The number of programs has actually gone up but it has not kept pace with demand. In 2012, 63 applicants didn’t match at any program, and this year, the number was 100.”

Dr. Bass said that this speaks to the attractiveness of rheumatology as a field and that there will be a need to create more fellowship slots.

To that end, the Rheumatology Research Foundation, the grant-giving philanthropic arm of ACR that funds research grants and fellowship training awards, is examining that very issue.

“I am leading a working group to try to figure out how to configure this award so that we try to direct them to fellowship programs that can expand or even [create] new fellowship programs,” Dr. Bass said. “The ACR and RRF will continue to fund fellowship programs because many programs have to scramble to fund the salary to support trainees and in particular to try to direct resources that will actually end up creating a new rheumatology fellow where one would not have existed before.”

The group is also looking at ways to encourage programs that have internal funding to increase their capacity if they are able to do so, she added.

Rheumatology was among a number of specialties that were able to fill at least 90% of their open slots, Other areas included allergy/immunology, cardiovascular disease, gastroenterology, hematology and oncology, pulmonary disease and pulmonary/critical care.

On the flip side, nephrology, infectious disease, and geriatric medicine had more positions available than there were applicants who prefer those specialties.

“The results this year mirror prior-year results, with slight improvement in a few specialties but no significant changes,” Mona Singer, president and CEO of the National Resident Match Program, said.

Overall, across all specialties, there were 4,731 slots, with 4,139 positions filled, accounting for about 75% of the 5,512 enrolled applicants.

[email protected]

Rheumatology saw nearly 97% of its positions filled during the 2016 Specialty Match Day.

The specialty had 217 open slots and ended the Dec. 7 match day with only 7 positions unfilled. There were 312 applicants that selected rheumatology as their primary specialty, with 206 applicants being matched. Six were matched to different specialties and 100 who selected rheumatology as their primary specialty did not get matched to any program.

However, those seven unfilled slots will likely get matched.

Overall, Dr. Bass, who is the program director of the rheumatology fellowship program at the Hospital for Special Surgery, New York, said the numbers reflect strong interest in rheumatology.

“In 2012, there were 240 applicants to rheumatology, and this year there were 312,” she said. “It’s been a linear trend. ... The number of programs has actually gone up but it has not kept pace with demand. In 2012, 63 applicants didn’t match at any program, and this year, the number was 100.”

Dr. Bass said that this speaks to the attractiveness of rheumatology as a field and that there will be a need to create more fellowship slots.

To that end, the Rheumatology Research Foundation, the grant-giving philanthropic arm of ACR that funds research grants and fellowship training awards, is examining that very issue.

“I am leading a working group to try to figure out how to configure this award so that we try to direct them to fellowship programs that can expand or even [create] new fellowship programs,” Dr. Bass said. “The ACR and RRF will continue to fund fellowship programs because many programs have to scramble to fund the salary to support trainees and in particular to try to direct resources that will actually end up creating a new rheumatology fellow where one would not have existed before.”

The group is also looking at ways to encourage programs that have internal funding to increase their capacity if they are able to do so, she added.

Rheumatology was among a number of specialties that were able to fill at least 90% of their open slots, Other areas included allergy/immunology, cardiovascular disease, gastroenterology, hematology and oncology, pulmonary disease and pulmonary/critical care.

On the flip side, nephrology, infectious disease, and geriatric medicine had more positions available than there were applicants who prefer those specialties.

“The results this year mirror prior-year results, with slight improvement in a few specialties but no significant changes,” Mona Singer, president and CEO of the National Resident Match Program, said.

Overall, across all specialties, there were 4,731 slots, with 4,139 positions filled, accounting for about 75% of the 5,512 enrolled applicants.

[email protected]

Rheumatology saw nearly 97% of its positions filled during the 2016 Specialty Match Day.

The specialty had 217 open slots and ended the Dec. 7 match day with only 7 positions unfilled. There were 312 applicants that selected rheumatology as their primary specialty, with 206 applicants being matched. Six were matched to different specialties and 100 who selected rheumatology as their primary specialty did not get matched to any program.

However, those seven unfilled slots will likely get matched.

Overall, Dr. Bass, who is the program director of the rheumatology fellowship program at the Hospital for Special Surgery, New York, said the numbers reflect strong interest in rheumatology.

“In 2012, there were 240 applicants to rheumatology, and this year there were 312,” she said. “It’s been a linear trend. ... The number of programs has actually gone up but it has not kept pace with demand. In 2012, 63 applicants didn’t match at any program, and this year, the number was 100.”

Dr. Bass said that this speaks to the attractiveness of rheumatology as a field and that there will be a need to create more fellowship slots.

To that end, the Rheumatology Research Foundation, the grant-giving philanthropic arm of ACR that funds research grants and fellowship training awards, is examining that very issue.

“I am leading a working group to try to figure out how to configure this award so that we try to direct them to fellowship programs that can expand or even [create] new fellowship programs,” Dr. Bass said. “The ACR and RRF will continue to fund fellowship programs because many programs have to scramble to fund the salary to support trainees and in particular to try to direct resources that will actually end up creating a new rheumatology fellow where one would not have existed before.”

The group is also looking at ways to encourage programs that have internal funding to increase their capacity if they are able to do so, she added.

Rheumatology was among a number of specialties that were able to fill at least 90% of their open slots, Other areas included allergy/immunology, cardiovascular disease, gastroenterology, hematology and oncology, pulmonary disease and pulmonary/critical care.

On the flip side, nephrology, infectious disease, and geriatric medicine had more positions available than there were applicants who prefer those specialties.

“The results this year mirror prior-year results, with slight improvement in a few specialties but no significant changes,” Mona Singer, president and CEO of the National Resident Match Program, said.

Overall, across all specialties, there were 4,731 slots, with 4,139 positions filled, accounting for about 75% of the 5,512 enrolled applicants.

[email protected]

WASHINGTON – Now that implementation of the Medicare Access and CHIP Reauthorization Act is on rheumatologists’ doorsteps, figuring out what is required in 2017 is imperative to avoid future penalties and maximize the chance of earning a bonus.

Recent announcements from the Centers for Medicare & Medicaid Services (CMS) on performance thresholds and how to meet them in 2017 give rheumatologists a great shot at not getting penalized when payment adjustments begin in 2019.

Targets for 2017 and adjustments beyond 2017

Each year in November, CMS will announce the base performance threshold goal that physicians will need to reach in the following year in order to avoid negative Medicare payment adjustments 2 years later.

Each year’s threshold will be based on the data collected from the prior year. For the year starting Jan. 1, 2017, in order to avoid a 4% cut in their Medicare Part B base rate payment in 2019, rheumatologists will need to meet a base performance threshold score of just 3 out of 100.

“Basically, if you participate in a program in any way whatsoever, you can hit this target,” Dr. Harvey said.

In 2017, getting a score of 70 or more out of 100 puts rheumatologists into a high performance category that makes them eligible for a piece of the $500 million pool of positive payment adjustments that will be available in each of the first 6 years of MIPS.

Providers who score less than 3 out of 100 will get the maximum penalty – a 4% cut in their 2019 Medicare payment rate. Further, in 2017, only 90 days of reporting is required to qualify for positive adjustments in 2019.

The base performance threshold will certainly go up for 2018 to “probably 30, 40, 50; something like that,” Dr. Harvey said.

Knowing the threshold in advance should help rheumatologists to predict by the middle of each year whether they are going to make it, but how much of any increase (or decrease) in payment adjustment they will have 2 years hence will be very difficult to know, he said, because each year the adjustment must be budget neutral and is dependent on how many physicians are above and below the threshold.

The MIPS score is based on four categories that total up to 100 points:

Quality (60% of 2017 score)

The quality category is determined by six measures that are worth 10 points each. All of the quality domains from PQRS are gone, and out of those six measures providers must have one cross-cutting measure and one outcome measure, or just one high-priority measure. Since rheumatology does not yet have any designated outcome measures, rheumatologists will need to report other designated measures. For each of these six required measures, a provider would earn 3 points for reaching the benchmark, and then the score could be increased to 4-10 points per measure based on a decile system that determines the provider’s performance against others who have met the benchmark for that measure.

Of the 13 quality metrics that are in the rheumatology quality measure set, 7 are not specific to rheumatology (advanced directive documentation, body mass index screening and follow-up, taking a comprehensive medication list, tobacco screening in adolescents, tobacco screening in adults, hypertension screening and follow-up, and sending consult note to referring doctor), whereas 6 are (TB screening within 6 months of starting a biologic, yearly TB screening on biologics, measuring rheumatoid arthritis [RA] disease activity, measuring RA functional assessment, documenting RA prognosis, and RA steroid management).

The quality category will account for 50% of the MIPS score in 2018.

Resource use (0% of 2017 score)

“The fact that the resource use part of the equation has been set to 0% for the 2017 performance year is a really good thing for rheumatologists because we use some of the most expensive drugs around,” Dr. Harvey said. “Part of the reason that CMS did this is that they are having trouble accounting for the fact that they have easy access to Part B cost data – infusion cost data – but they don’t have very good access to Part D self-injectable drug cost data.”

“We are going to make it a key advocacy point that they appropriately take into account cost in future years,” he added.

While the resource use category of MIPS contributes nothing to the 2017 MIPS score, it will increase to 10% in 2018 and by 2021 it’s anticipated to be 30% of the MIPS score, while the quality category is anticipated to drop to 30%.

Clinical practice improvement activities (15% of 2017 score)

This part includes more than 90 proposed activities to count toward the category’s score, including patient engagement activities, care coordination, extended office hours, and participation in a qualified clinical data registry (QCDR), such as the ACR’s RISE Registry, which is already a certified QCDR. A total of 40 points in this category gives full credit for the 15 percentage point value given to it for 2017.

All of the proposed activities for 2017 are weighted as medium (10 points) or high weight (20 points). For example, 40 points could be earned by meeting two medium-weight measures and one high-weight measure.

The clinical practice improvement activities category will stay at 15% of the MIPS score in 2018.

Advancing care information (25% of 2017 score)

“This is another one that gets complicated, but there’s one key take-home message: This is way easier than Meaningful Use has ever been,” Dr. Harvey said. There are 100 points needed in the advancing care information category in order to get the full 25 percentage points that it accounts for in the 2017 MIPS score.

For reporting on five required measures (electronic health record [EHR] security analysis, e-prescribing, patient access to an EHR, and being able to send and accept summary of care documents), a provider will earn 50 points.

Another 90 performance points are available for reporting certain information, and this is based on a decile system just like the quality category in which a rheumatologist’s performance is measured against other rheumatologists who have met the benchmark for each particular measure. These optional measures include providing patient-specific educational information; patients being able to view, download, and transmit their own medical records; secure messaging; acceptance of patient-generated health data; medication reconciliation; and submitting data to a state immunization registry.

Another 15 bonus points are available for additional public health reporting and reporting to CMS using a certified EHR or QCDR.

All these measures together give providers the potential to earn 155 points toward the 100-point threshold.

“If you’re already doing Meaningful Use, chances are you’re going to do really well in this area,” he said.

The advancing care information category will stay at 25% of the MIPS score in 2018.

Problems with current APMs

Under MACRA, participation in an APM means that the physician is exempt from MIPS and will receive a 5% lump sum bonus per year in 2019-2024, a higher annual increase in fee-for-service revenues, and the general benefits of participating in an APM. However, few rheumatologists will qualify for the APM pathway, and there are no rheumatology-specific APMs in existence.

Creating rheumatology-focused APMs

MACRA designated the development of the Physician-Focused Payment Model Technical Advisory Committee, of which Mr. Miller is a member, to solicit and review physician-focused payment models and make recommendations to CMS about which ones to implement.

Physician-focused payment models got their start through pioneering work by physicians who obtained data from insurers to find ways to reach out proactively to patients to address problems before patients are hospitalized. Through these efforts, they have reduced cost and increased patient satisfaction while also increasing payment to physicians by supporting “medical home” services, according to Dr. Miller.

These efforts to create APMs that support high-quality, physician-directed care begin by identifying avoidable spending that varies from specialty to specialty and from condition to condition. Then they address barriers in the current fee-for-service system – such as no payment for many high-value services and insufficient revenue to cover costs when using fewer or low-cost services – by providing flexible, adequate payment while requiring physicians to take responsibility for the things they said could be avoidable when paid in that way. However, this responsibility must be focused on what a particular physician can influence, Mr. Miller noted.

Rheumatologists could be helped by these physician-focused payment models because they receive less than 10% of the total Medicare health care spending per patient whose care was directed by a rheumatologist. In that case, finding ways to drop total spending per patient by 5% could at the same time give rheumatologists a 25% increase in payment while also saving Medicare 3% overall, he said.

Rheumatologists are best set up to take condition-based payments that are geared to keep patients out of the hospital, rather than the hospital episode–based payments that have dominated APMs in existence so far. Central to this condition-based model is getting the right diagnosis at the start, so payment for getting the correct diagnosis would be critical.

APMs designed for rheumatologists could take into account the diseases often seen by a rheumatologist, such as RA, and then identify opportunities to improve care and reduce costs while identifying barriers in the current payment system for achieving those goals, Mr. Miller said. These opportunities and barriers would vary from condition to condition. In some cases, particularly for low-frequency conditions, there may not need to be a new payment model established and it could be done through fee-for-service.

Ideally, these condition-based payment models for specialists such as rheumatologists would exist within the “medical neighborhood” of primary care physicians who could refer to them when necessary. Specialists would be accountable for the aspects of care that they can control, such as avoiding unnecessary tests and procedures and avoiding infections and complications.

“That’s building the ACO from the bottom up, rather than what Medicare is trying to do, which is to create it from the top down,” Mr. Miller said.

Mr. Miller noted that it will be important for specialties such as rheumatology to define the cost data it needs in order to develop condition-based payment models.

Dr. Harvey had no relevant disclosures. Mr. Miller has no financial relationships with any commercial interests.

[email protected]

WASHINGTON – Now that implementation of the Medicare Access and CHIP Reauthorization Act is on rheumatologists’ doorsteps, figuring out what is required in 2017 is imperative to avoid future penalties and maximize the chance of earning a bonus.

Recent announcements from the Centers for Medicare & Medicaid Services (CMS) on performance thresholds and how to meet them in 2017 give rheumatologists a great shot at not getting penalized when payment adjustments begin in 2019.

Targets for 2017 and adjustments beyond 2017

Each year in November, CMS will announce the base performance threshold goal that physicians will need to reach in the following year in order to avoid negative Medicare payment adjustments 2 years later.

Each year’s threshold will be based on the data collected from the prior year. For the year starting Jan. 1, 2017, in order to avoid a 4% cut in their Medicare Part B base rate payment in 2019, rheumatologists will need to meet a base performance threshold score of just 3 out of 100.

“Basically, if you participate in a program in any way whatsoever, you can hit this target,” Dr. Harvey said.

In 2017, getting a score of 70 or more out of 100 puts rheumatologists into a high performance category that makes them eligible for a piece of the $500 million pool of positive payment adjustments that will be available in each of the first 6 years of MIPS.

Providers who score less than 3 out of 100 will get the maximum penalty – a 4% cut in their 2019 Medicare payment rate. Further, in 2017, only 90 days of reporting is required to qualify for positive adjustments in 2019.

The base performance threshold will certainly go up for 2018 to “probably 30, 40, 50; something like that,” Dr. Harvey said.

Knowing the threshold in advance should help rheumatologists to predict by the middle of each year whether they are going to make it, but how much of any increase (or decrease) in payment adjustment they will have 2 years hence will be very difficult to know, he said, because each year the adjustment must be budget neutral and is dependent on how many physicians are above and below the threshold.

The MIPS score is based on four categories that total up to 100 points:

Quality (60% of 2017 score)

The quality category is determined by six measures that are worth 10 points each. All of the quality domains from PQRS are gone, and out of those six measures providers must have one cross-cutting measure and one outcome measure, or just one high-priority measure. Since rheumatology does not yet have any designated outcome measures, rheumatologists will need to report other designated measures. For each of these six required measures, a provider would earn 3 points for reaching the benchmark, and then the score could be increased to 4-10 points per measure based on a decile system that determines the provider’s performance against others who have met the benchmark for that measure.

Of the 13 quality metrics that are in the rheumatology quality measure set, 7 are not specific to rheumatology (advanced directive documentation, body mass index screening and follow-up, taking a comprehensive medication list, tobacco screening in adolescents, tobacco screening in adults, hypertension screening and follow-up, and sending consult note to referring doctor), whereas 6 are (TB screening within 6 months of starting a biologic, yearly TB screening on biologics, measuring rheumatoid arthritis [RA] disease activity, measuring RA functional assessment, documenting RA prognosis, and RA steroid management).

The quality category will account for 50% of the MIPS score in 2018.

Resource use (0% of 2017 score)

“The fact that the resource use part of the equation has been set to 0% for the 2017 performance year is a really good thing for rheumatologists because we use some of the most expensive drugs around,” Dr. Harvey said. “Part of the reason that CMS did this is that they are having trouble accounting for the fact that they have easy access to Part B cost data – infusion cost data – but they don’t have very good access to Part D self-injectable drug cost data.”

“We are going to make it a key advocacy point that they appropriately take into account cost in future years,” he added.

While the resource use category of MIPS contributes nothing to the 2017 MIPS score, it will increase to 10% in 2018 and by 2021 it’s anticipated to be 30% of the MIPS score, while the quality category is anticipated to drop to 30%.

Clinical practice improvement activities (15% of 2017 score)

This part includes more than 90 proposed activities to count toward the category’s score, including patient engagement activities, care coordination, extended office hours, and participation in a qualified clinical data registry (QCDR), such as the ACR’s RISE Registry, which is already a certified QCDR. A total of 40 points in this category gives full credit for the 15 percentage point value given to it for 2017.

All of the proposed activities for 2017 are weighted as medium (10 points) or high weight (20 points). For example, 40 points could be earned by meeting two medium-weight measures and one high-weight measure.

The clinical practice improvement activities category will stay at 15% of the MIPS score in 2018.

Advancing care information (25% of 2017 score)

“This is another one that gets complicated, but there’s one key take-home message: This is way easier than Meaningful Use has ever been,” Dr. Harvey said. There are 100 points needed in the advancing care information category in order to get the full 25 percentage points that it accounts for in the 2017 MIPS score.

For reporting on five required measures (electronic health record [EHR] security analysis, e-prescribing, patient access to an EHR, and being able to send and accept summary of care documents), a provider will earn 50 points.

Another 90 performance points are available for reporting certain information, and this is based on a decile system just like the quality category in which a rheumatologist’s performance is measured against other rheumatologists who have met the benchmark for each particular measure. These optional measures include providing patient-specific educational information; patients being able to view, download, and transmit their own medical records; secure messaging; acceptance of patient-generated health data; medication reconciliation; and submitting data to a state immunization registry.

Another 15 bonus points are available for additional public health reporting and reporting to CMS using a certified EHR or QCDR.

All these measures together give providers the potential to earn 155 points toward the 100-point threshold.

“If you’re already doing Meaningful Use, chances are you’re going to do really well in this area,” he said.

The advancing care information category will stay at 25% of the MIPS score in 2018.

Problems with current APMs

Under MACRA, participation in an APM means that the physician is exempt from MIPS and will receive a 5% lump sum bonus per year in 2019-2024, a higher annual increase in fee-for-service revenues, and the general benefits of participating in an APM. However, few rheumatologists will qualify for the APM pathway, and there are no rheumatology-specific APMs in existence.

Creating rheumatology-focused APMs

MACRA designated the development of the Physician-Focused Payment Model Technical Advisory Committee, of which Mr. Miller is a member, to solicit and review physician-focused payment models and make recommendations to CMS about which ones to implement.

Physician-focused payment models got their start through pioneering work by physicians who obtained data from insurers to find ways to reach out proactively to patients to address problems before patients are hospitalized. Through these efforts, they have reduced cost and increased patient satisfaction while also increasing payment to physicians by supporting “medical home” services, according to Dr. Miller.

These efforts to create APMs that support high-quality, physician-directed care begin by identifying avoidable spending that varies from specialty to specialty and from condition to condition. Then they address barriers in the current fee-for-service system – such as no payment for many high-value services and insufficient revenue to cover costs when using fewer or low-cost services – by providing flexible, adequate payment while requiring physicians to take responsibility for the things they said could be avoidable when paid in that way. However, this responsibility must be focused on what a particular physician can influence, Mr. Miller noted.

Rheumatologists could be helped by these physician-focused payment models because they receive less than 10% of the total Medicare health care spending per patient whose care was directed by a rheumatologist. In that case, finding ways to drop total spending per patient by 5% could at the same time give rheumatologists a 25% increase in payment while also saving Medicare 3% overall, he said.

Rheumatologists are best set up to take condition-based payments that are geared to keep patients out of the hospital, rather than the hospital episode–based payments that have dominated APMs in existence so far. Central to this condition-based model is getting the right diagnosis at the start, so payment for getting the correct diagnosis would be critical.

APMs designed for rheumatologists could take into account the diseases often seen by a rheumatologist, such as RA, and then identify opportunities to improve care and reduce costs while identifying barriers in the current payment system for achieving those goals, Mr. Miller said. These opportunities and barriers would vary from condition to condition. In some cases, particularly for low-frequency conditions, there may not need to be a new payment model established and it could be done through fee-for-service.

Ideally, these condition-based payment models for specialists such as rheumatologists would exist within the “medical neighborhood” of primary care physicians who could refer to them when necessary. Specialists would be accountable for the aspects of care that they can control, such as avoiding unnecessary tests and procedures and avoiding infections and complications.

“That’s building the ACO from the bottom up, rather than what Medicare is trying to do, which is to create it from the top down,” Mr. Miller said.

Mr. Miller noted that it will be important for specialties such as rheumatology to define the cost data it needs in order to develop condition-based payment models.

Dr. Harvey had no relevant disclosures. Mr. Miller has no financial relationships with any commercial interests.

[email protected]

WASHINGTON – Now that implementation of the Medicare Access and CHIP Reauthorization Act is on rheumatologists’ doorsteps, figuring out what is required in 2017 is imperative to avoid future penalties and maximize the chance of earning a bonus.

Recent announcements from the Centers for Medicare & Medicaid Services (CMS) on performance thresholds and how to meet them in 2017 give rheumatologists a great shot at not getting penalized when payment adjustments begin in 2019.

Targets for 2017 and adjustments beyond 2017

Each year in November, CMS will announce the base performance threshold goal that physicians will need to reach in the following year in order to avoid negative Medicare payment adjustments 2 years later.

Each year’s threshold will be based on the data collected from the prior year. For the year starting Jan. 1, 2017, in order to avoid a 4% cut in their Medicare Part B base rate payment in 2019, rheumatologists will need to meet a base performance threshold score of just 3 out of 100.

“Basically, if you participate in a program in any way whatsoever, you can hit this target,” Dr. Harvey said.

In 2017, getting a score of 70 or more out of 100 puts rheumatologists into a high performance category that makes them eligible for a piece of the $500 million pool of positive payment adjustments that will be available in each of the first 6 years of MIPS.

Providers who score less than 3 out of 100 will get the maximum penalty – a 4% cut in their 2019 Medicare payment rate. Further, in 2017, only 90 days of reporting is required to qualify for positive adjustments in 2019.

The base performance threshold will certainly go up for 2018 to “probably 30, 40, 50; something like that,” Dr. Harvey said.

Knowing the threshold in advance should help rheumatologists to predict by the middle of each year whether they are going to make it, but how much of any increase (or decrease) in payment adjustment they will have 2 years hence will be very difficult to know, he said, because each year the adjustment must be budget neutral and is dependent on how many physicians are above and below the threshold.

The MIPS score is based on four categories that total up to 100 points:

Quality (60% of 2017 score)

The quality category is determined by six measures that are worth 10 points each. All of the quality domains from PQRS are gone, and out of those six measures providers must have one cross-cutting measure and one outcome measure, or just one high-priority measure. Since rheumatology does not yet have any designated outcome measures, rheumatologists will need to report other designated measures. For each of these six required measures, a provider would earn 3 points for reaching the benchmark, and then the score could be increased to 4-10 points per measure based on a decile system that determines the provider’s performance against others who have met the benchmark for that measure.

Of the 13 quality metrics that are in the rheumatology quality measure set, 7 are not specific to rheumatology (advanced directive documentation, body mass index screening and follow-up, taking a comprehensive medication list, tobacco screening in adolescents, tobacco screening in adults, hypertension screening and follow-up, and sending consult note to referring doctor), whereas 6 are (TB screening within 6 months of starting a biologic, yearly TB screening on biologics, measuring rheumatoid arthritis [RA] disease activity, measuring RA functional assessment, documenting RA prognosis, and RA steroid management).

The quality category will account for 50% of the MIPS score in 2018.

Resource use (0% of 2017 score)

“The fact that the resource use part of the equation has been set to 0% for the 2017 performance year is a really good thing for rheumatologists because we use some of the most expensive drugs around,” Dr. Harvey said. “Part of the reason that CMS did this is that they are having trouble accounting for the fact that they have easy access to Part B cost data – infusion cost data – but they don’t have very good access to Part D self-injectable drug cost data.”

“We are going to make it a key advocacy point that they appropriately take into account cost in future years,” he added.

While the resource use category of MIPS contributes nothing to the 2017 MIPS score, it will increase to 10% in 2018 and by 2021 it’s anticipated to be 30% of the MIPS score, while the quality category is anticipated to drop to 30%.

Clinical practice improvement activities (15% of 2017 score)

This part includes more than 90 proposed activities to count toward the category’s score, including patient engagement activities, care coordination, extended office hours, and participation in a qualified clinical data registry (QCDR), such as the ACR’s RISE Registry, which is already a certified QCDR. A total of 40 points in this category gives full credit for the 15 percentage point value given to it for 2017.

All of the proposed activities for 2017 are weighted as medium (10 points) or high weight (20 points). For example, 40 points could be earned by meeting two medium-weight measures and one high-weight measure.

The clinical practice improvement activities category will stay at 15% of the MIPS score in 2018.

Advancing care information (25% of 2017 score)

“This is another one that gets complicated, but there’s one key take-home message: This is way easier than Meaningful Use has ever been,” Dr. Harvey said. There are 100 points needed in the advancing care information category in order to get the full 25 percentage points that it accounts for in the 2017 MIPS score.

For reporting on five required measures (electronic health record [EHR] security analysis, e-prescribing, patient access to an EHR, and being able to send and accept summary of care documents), a provider will earn 50 points.

Another 90 performance points are available for reporting certain information, and this is based on a decile system just like the quality category in which a rheumatologist’s performance is measured against other rheumatologists who have met the benchmark for each particular measure. These optional measures include providing patient-specific educational information; patients being able to view, download, and transmit their own medical records; secure messaging; acceptance of patient-generated health data; medication reconciliation; and submitting data to a state immunization registry.

Another 15 bonus points are available for additional public health reporting and reporting to CMS using a certified EHR or QCDR.

All these measures together give providers the potential to earn 155 points toward the 100-point threshold.

“If you’re already doing Meaningful Use, chances are you’re going to do really well in this area,” he said.

The advancing care information category will stay at 25% of the MIPS score in 2018.

Problems with current APMs

Under MACRA, participation in an APM means that the physician is exempt from MIPS and will receive a 5% lump sum bonus per year in 2019-2024, a higher annual increase in fee-for-service revenues, and the general benefits of participating in an APM. However, few rheumatologists will qualify for the APM pathway, and there are no rheumatology-specific APMs in existence.

Creating rheumatology-focused APMs

MACRA designated the development of the Physician-Focused Payment Model Technical Advisory Committee, of which Mr. Miller is a member, to solicit and review physician-focused payment models and make recommendations to CMS about which ones to implement.

Physician-focused payment models got their start through pioneering work by physicians who obtained data from insurers to find ways to reach out proactively to patients to address problems before patients are hospitalized. Through these efforts, they have reduced cost and increased patient satisfaction while also increasing payment to physicians by supporting “medical home” services, according to Dr. Miller.

These efforts to create APMs that support high-quality, physician-directed care begin by identifying avoidable spending that varies from specialty to specialty and from condition to condition. Then they address barriers in the current fee-for-service system – such as no payment for many high-value services and insufficient revenue to cover costs when using fewer or low-cost services – by providing flexible, adequate payment while requiring physicians to take responsibility for the things they said could be avoidable when paid in that way. However, this responsibility must be focused on what a particular physician can influence, Mr. Miller noted.

Rheumatologists could be helped by these physician-focused payment models because they receive less than 10% of the total Medicare health care spending per patient whose care was directed by a rheumatologist. In that case, finding ways to drop total spending per patient by 5% could at the same time give rheumatologists a 25% increase in payment while also saving Medicare 3% overall, he said.

Rheumatologists are best set up to take condition-based payments that are geared to keep patients out of the hospital, rather than the hospital episode–based payments that have dominated APMs in existence so far. Central to this condition-based model is getting the right diagnosis at the start, so payment for getting the correct diagnosis would be critical.

APMs designed for rheumatologists could take into account the diseases often seen by a rheumatologist, such as RA, and then identify opportunities to improve care and reduce costs while identifying barriers in the current payment system for achieving those goals, Mr. Miller said. These opportunities and barriers would vary from condition to condition. In some cases, particularly for low-frequency conditions, there may not need to be a new payment model established and it could be done through fee-for-service.

Ideally, these condition-based payment models for specialists such as rheumatologists would exist within the “medical neighborhood” of primary care physicians who could refer to them when necessary. Specialists would be accountable for the aspects of care that they can control, such as avoiding unnecessary tests and procedures and avoiding infections and complications.

“That’s building the ACO from the bottom up, rather than what Medicare is trying to do, which is to create it from the top down,” Mr. Miller said.

Mr. Miller noted that it will be important for specialties such as rheumatology to define the cost data it needs in order to develop condition-based payment models.

Dr. Harvey had no relevant disclosures. Mr. Miller has no financial relationships with any commercial interests.

[email protected]