NEWPORT BEACH, CALIF. – A combination of propranolol and laser is more effective than propranolol alone for infantile hemangiomas, and rapamycin can improve pulse die laser results for port wine stains.

Meanwhile, lasers hurt, so general anesthesia is in order for children as long as they’re older than 6 months.

Those are just a few of the pearls Dr. Kristen Kelly, a University of California, Irvine, professor of dermatology and surgery, shared at the Summit in Aesthetic Medicine. Dr. Kelly explained the latest developments in an interview at the conference, held by Global Academy for Medical Education.

Global Academy and this news organization are owned the same company.

[email protected]

NEWPORT BEACH, CALIF. – A combination of propranolol and laser is more effective than propranolol alone for infantile hemangiomas, and rapamycin can improve pulse die laser results for port wine stains.

Meanwhile, lasers hurt, so general anesthesia is in order for children as long as they’re older than 6 months.

Those are just a few of the pearls Dr. Kristen Kelly, a University of California, Irvine, professor of dermatology and surgery, shared at the Summit in Aesthetic Medicine. Dr. Kelly explained the latest developments in an interview at the conference, held by Global Academy for Medical Education.

Global Academy and this news organization are owned the same company.

[email protected]

NEWPORT BEACH, CALIF. – A combination of propranolol and laser is more effective than propranolol alone for infantile hemangiomas, and rapamycin can improve pulse die laser results for port wine stains.

Meanwhile, lasers hurt, so general anesthesia is in order for children as long as they’re older than 6 months.

Those are just a few of the pearls Dr. Kristen Kelly, a University of California, Irvine, professor of dermatology and surgery, shared at the Summit in Aesthetic Medicine. Dr. Kelly explained the latest developments in an interview at the conference, held by Global Academy for Medical Education.

Global Academy and this news organization are owned the same company.

[email protected]

Sheep are thought of as nervous animals, a good target for predators. You do not want to be a sheep. Unfortunately, many electronic health record (EHR) programs make you a target for audits and requests for the return of payments for a variety of reasons. Although you likely are aware of the uses of modifier -25, it is the abuses—either intentional or accidental—that can bring an audit your way. The use of modifier -25 was previously reviewed in Cutis.¹ Despite the availability of this excellent review, I have found that there is still great confusion about both the use of modifier -25 and the selection of the correct evaluation and management (E&M) code when used.

When to Bill for E&M

Based on recent discussions with colleagues in the New York area who have been audited, an easy way to bring on a request for medical records is to report an E&M 100% of the time with a procedure. In these instances, every single E&M was performed on the same visit as a dermatologic procedure, most commonly biopsies(Current Procedural Terminology [CPT] code 11100, 11101) and premalignant destructions (CPT code 17000, 17003, 17004), which is in contrast with typical practitioners who perform an E&M approximately 70% of the time (RUC rationale; American Medical Association RBRVS Data Manager; May 12, 2016). One circumstance involved the reporting of E&M services 100% of the time when performed during the same visit as Mohs micrographic surgery (CPT code 17311–17315), a surprising frequency considering that the typical same day use of a code for this procedure with an E&M in the Medicare population is less than 25%.

According to the National Correct Coding Initiative Policy Manual for Medicare Services, procedures with a global period of 90 days are defined as major surgical procedures,² which only include adjacent tissue transfers and grafts for dermatology. If an E&M is performed on the same date of service as one of these procedures to decide whether to perform the procedure, the E&M can be reported separately using modifier -57. Other preoperative E&M services provided on the same date of service as a major surgical procedure are included in the global payment for the procedure and are not reported separately.²

All other procedures dermatologists perform generally are considered minor, which are defined as having a global period of 0 or 10 days. Because the decision to perform a minor procedure is included in the payment for the procedure, E&M services should not be reported separately from the minor procedure. However, “a significant and separately identifiable E&M service unrelated to the decision to perform the minor surgical procedure is separately reportable with modifier 25. The E&M service and minor surgical procedure do not require different diagnoses. If a minor surgical procedure is performed on a new patient, the same rules for reporting E&M services apply.”²

Documentation Guidelines

These guidelines seem straightforward, but as with so much else where the government is involved, the devil is in the details. When making coding decisions, you may consult the documentation guidelines from either 1995³ or 1997,⁴ which are available for download on the Centers for Medicare & Medicaid Services (CMS) website (https://www.cms.gov/outreach-and-education/medicare-learning-network-MLN/MLNedwebguide/emdoc.html). The 1995 guidelines are less empiric and offer more flexibility, while the 1997 guidelines rely on number of “bullets” as examination elements.

1995 Guidelines

According to the 1995 documentation guidelines, the levels of E&M services are based on 4 types of examination that are defined as follows: (1) problem focused, a limited examination of the affected body area or organ system; (2) expanded problem focused, a limited examination of the affected body area or organ system and other symptomatic or related organ system(s); (3) detailed, an extended examination of the affected body area(s) and other symptomatic or related organ system(s); and (4) comprehensive, a general multisystem examination or complete examination of a single organ system.³ Detailed history is the fuzziest part of the coding universe. Some insurers take an approach that you need to examine 2 to 7 organ systems and 4 distinct lesions in 4 body areas, which is discussed in audit tools available from some Medicare intermediaries (Advancing the Business of Healthcare forum; April 10, 2014). As a result, the 12-bullet examination from the 1997 documentation guidelines may be more suitable for a new level 3 or established level 4 visit. For a comprehensive examination, the 1995 criteria allow for a complete examination of a single organ system such as the full-body skin examination with the patient completely undressed, which is medically necessary in our melanoma patients.

For purposes of examination, 9 body areas are recognized in the 1995 guidelines,³ along with more than a dozen organ systems of which the skin is of most interest to dermatologists.

According to the 1995 guidelines,³ the extent of examinations performed and documented is dependent upon clinical judgment and the nature of the presenting problem(s) and range from focused examinations of single body areas to general multisystem or complete single organ system examinations. Specific abnormal and relevant negative findings of the examination of the affected or symptomatic body area(s) or organ system(s) should be documented. Although a notation of normal is sufficient, abnormal without elaboration is insufficient, and abnormal or unexpected findings of the examination of the unaffected or asymptomatic body area(s) or organ system(s) should be described. The medical record for a general multisystem examination should include findings involving approximately 8 or more of the 12 organ systems.

An expanded problem focused examination under the 1995 guidelines could be as simple as “Scar on cancer excision site on left cheek soft and supple. No cervical adenopathy.” There is some confusion regarding detailed examinations, and one consultant went as far as calling the guidelines “vague,”5 while others such as a Medicare intermediary make a quantum leap that if a comprehensive general system examination includes 8 to 12 organ systems, one step below should include 2 to 7 organ systems.6 In essence, the payer makes the rules here.

1997 Guidelines

According to the 1997 documentation guidelines, count bullets that are examination elements, which can be either general or single organ system.⁴ (A table showing the bullets for the examination elements is available from the CMS.⁴) For each type of examination, apply the following: problem focused examination requires 1 to 5 elements identified by a bullet, expanded problem focused examination needs at least 6, detailed examination requires at least 12, and comprehensive examination requires all elements identified by a bullet with documentation of every element in each box with a shaded border and at least 1 element in each box with an unshaded border.⁴ Although you may do more writing when using the 1997 guidelines, you can easily count up bullets and these guidelines are amenable to template examinations on paper and obviously easily coded into EHR software that will do the bullet counting for you.

Unfortunately, this is where a ewe becomes a sheep, ripe for hunting for a number of reasons. First, just because you documented an E&M service does not mean it is medically necessary. Do you really need vital signs for every visit? If you are a meaningful EHR user working on penalty avoidance, you may capture examination data for meaningful use that is not medically necessary but cannot be parsed out by the autocoder in your EHR. As a result, simply do a quick manual audit of your notes to see if you are overcoding, which becomes second nature if you do it often.

The second trap, which brings us back to modifier -25, is when you perform a procedure the same day as your E&M or vice versa. Every procedure we do within the Resource-Based Relative Value Scale contains preservice time, which includes review of materials relevant to the procedure, examination of the area, and all preparation (eg, marking, time out, anesthesia, scrub and drape) before the surgery begins. The detailed vignettes are available to those involved in the Relative Value Scale Update Committee process and to the rest of the world in a subscription product called the RBRVS DataManager Online, which is produced by the American Medical Association. Unfortunately, the American Medical Association is not accepting new subscriptions to this product, as it has decided to outsource most of its coding resources to Optum360, one of the many arms of UnitedHealth Group, and will not have a replacement product until after June 30, 2016.⁷

In essence, if you (and your EHR) are counting bullets and then treating the body area in question, you are double-dipping, as the examination of the area is included in the procedure. So if you are heading toward a CPT 99213-25 with 6 bullets, one of which is on the left arm, and you perform a 0- or 10-day global procedure on that arm, you are down to 5 bullets, which drops your level of examination to problem focused. Remember, you need only 2 of 3—history, examination, and decision making—to be at or above that need for that particular level of reporting. If only one of your history or decision making is at or above the needed level for a 99213, the loss of a single bullet drops you down to a 99212! An audit where a handful of medical records are pulled and a request for money back on the universe of payments the insurer has paid is always unpleasant and you should, if you get a request for same, follow all the rules and timelines outlined by the payer. If you knowingly behaved in a risky fashion, consult a good attorney.

Of course, you may argue that the effort needed for the E&M work for the procedure was above and beyond what is typical for the service, which can be a hard standard to meet. Although the CMS requires a “significant and separately identifiable E&M service” as noted above and a separate diagnosis is not needed, the onus is on you to prove it. It is much easier to have a separate diagnosis that stands on its own, which will probably make an audit less common (unless you do it too often).

Final Thoughts

In summary, document what you do, do what you document, and report what is medically necessary. Keep watch over your EHR to be sure it is not overcoding for you. You do not want to be a ewe!

Sheep are thought of as nervous animals, a good target for predators. You do not want to be a sheep. Unfortunately, many electronic health record (EHR) programs make you a target for audits and requests for the return of payments for a variety of reasons. Although you likely are aware of the uses of modifier -25, it is the abuses—either intentional or accidental—that can bring an audit your way. The use of modifier -25 was previously reviewed in Cutis.¹ Despite the availability of this excellent review, I have found that there is still great confusion about both the use of modifier -25 and the selection of the correct evaluation and management (E&M) code when used.

When to Bill for E&M

Based on recent discussions with colleagues in the New York area who have been audited, an easy way to bring on a request for medical records is to report an E&M 100% of the time with a procedure. In these instances, every single E&M was performed on the same visit as a dermatologic procedure, most commonly biopsies(Current Procedural Terminology [CPT] code 11100, 11101) and premalignant destructions (CPT code 17000, 17003, 17004), which is in contrast with typical practitioners who perform an E&M approximately 70% of the time (RUC rationale; American Medical Association RBRVS Data Manager; May 12, 2016). One circumstance involved the reporting of E&M services 100% of the time when performed during the same visit as Mohs micrographic surgery (CPT code 17311–17315), a surprising frequency considering that the typical same day use of a code for this procedure with an E&M in the Medicare population is less than 25%.

According to the National Correct Coding Initiative Policy Manual for Medicare Services, procedures with a global period of 90 days are defined as major surgical procedures,² which only include adjacent tissue transfers and grafts for dermatology. If an E&M is performed on the same date of service as one of these procedures to decide whether to perform the procedure, the E&M can be reported separately using modifier -57. Other preoperative E&M services provided on the same date of service as a major surgical procedure are included in the global payment for the procedure and are not reported separately.²

All other procedures dermatologists perform generally are considered minor, which are defined as having a global period of 0 or 10 days. Because the decision to perform a minor procedure is included in the payment for the procedure, E&M services should not be reported separately from the minor procedure. However, “a significant and separately identifiable E&M service unrelated to the decision to perform the minor surgical procedure is separately reportable with modifier 25. The E&M service and minor surgical procedure do not require different diagnoses. If a minor surgical procedure is performed on a new patient, the same rules for reporting E&M services apply.”²

Documentation Guidelines

These guidelines seem straightforward, but as with so much else where the government is involved, the devil is in the details. When making coding decisions, you may consult the documentation guidelines from either 1995³ or 1997,⁴ which are available for download on the Centers for Medicare & Medicaid Services (CMS) website (https://www.cms.gov/outreach-and-education/medicare-learning-network-MLN/MLNedwebguide/emdoc.html). The 1995 guidelines are less empiric and offer more flexibility, while the 1997 guidelines rely on number of “bullets” as examination elements.

1995 Guidelines

According to the 1995 documentation guidelines, the levels of E&M services are based on 4 types of examination that are defined as follows: (1) problem focused, a limited examination of the affected body area or organ system; (2) expanded problem focused, a limited examination of the affected body area or organ system and other symptomatic or related organ system(s); (3) detailed, an extended examination of the affected body area(s) and other symptomatic or related organ system(s); and (4) comprehensive, a general multisystem examination or complete examination of a single organ system.³ Detailed history is the fuzziest part of the coding universe. Some insurers take an approach that you need to examine 2 to 7 organ systems and 4 distinct lesions in 4 body areas, which is discussed in audit tools available from some Medicare intermediaries (Advancing the Business of Healthcare forum; April 10, 2014). As a result, the 12-bullet examination from the 1997 documentation guidelines may be more suitable for a new level 3 or established level 4 visit. For a comprehensive examination, the 1995 criteria allow for a complete examination of a single organ system such as the full-body skin examination with the patient completely undressed, which is medically necessary in our melanoma patients.

For purposes of examination, 9 body areas are recognized in the 1995 guidelines,³ along with more than a dozen organ systems of which the skin is of most interest to dermatologists.

According to the 1995 guidelines,³ the extent of examinations performed and documented is dependent upon clinical judgment and the nature of the presenting problem(s) and range from focused examinations of single body areas to general multisystem or complete single organ system examinations. Specific abnormal and relevant negative findings of the examination of the affected or symptomatic body area(s) or organ system(s) should be documented. Although a notation of normal is sufficient, abnormal without elaboration is insufficient, and abnormal or unexpected findings of the examination of the unaffected or asymptomatic body area(s) or organ system(s) should be described. The medical record for a general multisystem examination should include findings involving approximately 8 or more of the 12 organ systems.

An expanded problem focused examination under the 1995 guidelines could be as simple as “Scar on cancer excision site on left cheek soft and supple. No cervical adenopathy.” There is some confusion regarding detailed examinations, and one consultant went as far as calling the guidelines “vague,”5 while others such as a Medicare intermediary make a quantum leap that if a comprehensive general system examination includes 8 to 12 organ systems, one step below should include 2 to 7 organ systems.6 In essence, the payer makes the rules here.

1997 Guidelines

According to the 1997 documentation guidelines, count bullets that are examination elements, which can be either general or single organ system.⁴ (A table showing the bullets for the examination elements is available from the CMS.⁴) For each type of examination, apply the following: problem focused examination requires 1 to 5 elements identified by a bullet, expanded problem focused examination needs at least 6, detailed examination requires at least 12, and comprehensive examination requires all elements identified by a bullet with documentation of every element in each box with a shaded border and at least 1 element in each box with an unshaded border.⁴ Although you may do more writing when using the 1997 guidelines, you can easily count up bullets and these guidelines are amenable to template examinations on paper and obviously easily coded into EHR software that will do the bullet counting for you.

Unfortunately, this is where a ewe becomes a sheep, ripe for hunting for a number of reasons. First, just because you documented an E&M service does not mean it is medically necessary. Do you really need vital signs for every visit? If you are a meaningful EHR user working on penalty avoidance, you may capture examination data for meaningful use that is not medically necessary but cannot be parsed out by the autocoder in your EHR. As a result, simply do a quick manual audit of your notes to see if you are overcoding, which becomes second nature if you do it often.

The second trap, which brings us back to modifier -25, is when you perform a procedure the same day as your E&M or vice versa. Every procedure we do within the Resource-Based Relative Value Scale contains preservice time, which includes review of materials relevant to the procedure, examination of the area, and all preparation (eg, marking, time out, anesthesia, scrub and drape) before the surgery begins. The detailed vignettes are available to those involved in the Relative Value Scale Update Committee process and to the rest of the world in a subscription product called the RBRVS DataManager Online, which is produced by the American Medical Association. Unfortunately, the American Medical Association is not accepting new subscriptions to this product, as it has decided to outsource most of its coding resources to Optum360, one of the many arms of UnitedHealth Group, and will not have a replacement product until after June 30, 2016.⁷

In essence, if you (and your EHR) are counting bullets and then treating the body area in question, you are double-dipping, as the examination of the area is included in the procedure. So if you are heading toward a CPT 99213-25 with 6 bullets, one of which is on the left arm, and you perform a 0- or 10-day global procedure on that arm, you are down to 5 bullets, which drops your level of examination to problem focused. Remember, you need only 2 of 3—history, examination, and decision making—to be at or above that need for that particular level of reporting. If only one of your history or decision making is at or above the needed level for a 99213, the loss of a single bullet drops you down to a 99212! An audit where a handful of medical records are pulled and a request for money back on the universe of payments the insurer has paid is always unpleasant and you should, if you get a request for same, follow all the rules and timelines outlined by the payer. If you knowingly behaved in a risky fashion, consult a good attorney.

Of course, you may argue that the effort needed for the E&M work for the procedure was above and beyond what is typical for the service, which can be a hard standard to meet. Although the CMS requires a “significant and separately identifiable E&M service” as noted above and a separate diagnosis is not needed, the onus is on you to prove it. It is much easier to have a separate diagnosis that stands on its own, which will probably make an audit less common (unless you do it too often).

Final Thoughts

In summary, document what you do, do what you document, and report what is medically necessary. Keep watch over your EHR to be sure it is not overcoding for you. You do not want to be a ewe!

Sheep are thought of as nervous animals, a good target for predators. You do not want to be a sheep. Unfortunately, many electronic health record (EHR) programs make you a target for audits and requests for the return of payments for a variety of reasons. Although you likely are aware of the uses of modifier -25, it is the abuses—either intentional or accidental—that can bring an audit your way. The use of modifier -25 was previously reviewed in Cutis.¹ Despite the availability of this excellent review, I have found that there is still great confusion about both the use of modifier -25 and the selection of the correct evaluation and management (E&M) code when used.

When to Bill for E&M

Based on recent discussions with colleagues in the New York area who have been audited, an easy way to bring on a request for medical records is to report an E&M 100% of the time with a procedure. In these instances, every single E&M was performed on the same visit as a dermatologic procedure, most commonly biopsies(Current Procedural Terminology [CPT] code 11100, 11101) and premalignant destructions (CPT code 17000, 17003, 17004), which is in contrast with typical practitioners who perform an E&M approximately 70% of the time (RUC rationale; American Medical Association RBRVS Data Manager; May 12, 2016). One circumstance involved the reporting of E&M services 100% of the time when performed during the same visit as Mohs micrographic surgery (CPT code 17311–17315), a surprising frequency considering that the typical same day use of a code for this procedure with an E&M in the Medicare population is less than 25%.

According to the National Correct Coding Initiative Policy Manual for Medicare Services, procedures with a global period of 90 days are defined as major surgical procedures,² which only include adjacent tissue transfers and grafts for dermatology. If an E&M is performed on the same date of service as one of these procedures to decide whether to perform the procedure, the E&M can be reported separately using modifier -57. Other preoperative E&M services provided on the same date of service as a major surgical procedure are included in the global payment for the procedure and are not reported separately.²

All other procedures dermatologists perform generally are considered minor, which are defined as having a global period of 0 or 10 days. Because the decision to perform a minor procedure is included in the payment for the procedure, E&M services should not be reported separately from the minor procedure. However, “a significant and separately identifiable E&M service unrelated to the decision to perform the minor surgical procedure is separately reportable with modifier 25. The E&M service and minor surgical procedure do not require different diagnoses. If a minor surgical procedure is performed on a new patient, the same rules for reporting E&M services apply.”²

Documentation Guidelines

These guidelines seem straightforward, but as with so much else where the government is involved, the devil is in the details. When making coding decisions, you may consult the documentation guidelines from either 1995³ or 1997,⁴ which are available for download on the Centers for Medicare & Medicaid Services (CMS) website (https://www.cms.gov/outreach-and-education/medicare-learning-network-MLN/MLNedwebguide/emdoc.html). The 1995 guidelines are less empiric and offer more flexibility, while the 1997 guidelines rely on number of “bullets” as examination elements.

1995 Guidelines

According to the 1995 documentation guidelines, the levels of E&M services are based on 4 types of examination that are defined as follows: (1) problem focused, a limited examination of the affected body area or organ system; (2) expanded problem focused, a limited examination of the affected body area or organ system and other symptomatic or related organ system(s); (3) detailed, an extended examination of the affected body area(s) and other symptomatic or related organ system(s); and (4) comprehensive, a general multisystem examination or complete examination of a single organ system.³ Detailed history is the fuzziest part of the coding universe. Some insurers take an approach that you need to examine 2 to 7 organ systems and 4 distinct lesions in 4 body areas, which is discussed in audit tools available from some Medicare intermediaries (Advancing the Business of Healthcare forum; April 10, 2014). As a result, the 12-bullet examination from the 1997 documentation guidelines may be more suitable for a new level 3 or established level 4 visit. For a comprehensive examination, the 1995 criteria allow for a complete examination of a single organ system such as the full-body skin examination with the patient completely undressed, which is medically necessary in our melanoma patients.

For purposes of examination, 9 body areas are recognized in the 1995 guidelines,³ along with more than a dozen organ systems of which the skin is of most interest to dermatologists.

According to the 1995 guidelines,³ the extent of examinations performed and documented is dependent upon clinical judgment and the nature of the presenting problem(s) and range from focused examinations of single body areas to general multisystem or complete single organ system examinations. Specific abnormal and relevant negative findings of the examination of the affected or symptomatic body area(s) or organ system(s) should be documented. Although a notation of normal is sufficient, abnormal without elaboration is insufficient, and abnormal or unexpected findings of the examination of the unaffected or asymptomatic body area(s) or organ system(s) should be described. The medical record for a general multisystem examination should include findings involving approximately 8 or more of the 12 organ systems.

An expanded problem focused examination under the 1995 guidelines could be as simple as “Scar on cancer excision site on left cheek soft and supple. No cervical adenopathy.” There is some confusion regarding detailed examinations, and one consultant went as far as calling the guidelines “vague,”5 while others such as a Medicare intermediary make a quantum leap that if a comprehensive general system examination includes 8 to 12 organ systems, one step below should include 2 to 7 organ systems.6 In essence, the payer makes the rules here.

1997 Guidelines

According to the 1997 documentation guidelines, count bullets that are examination elements, which can be either general or single organ system.⁴ (A table showing the bullets for the examination elements is available from the CMS.⁴) For each type of examination, apply the following: problem focused examination requires 1 to 5 elements identified by a bullet, expanded problem focused examination needs at least 6, detailed examination requires at least 12, and comprehensive examination requires all elements identified by a bullet with documentation of every element in each box with a shaded border and at least 1 element in each box with an unshaded border.⁴ Although you may do more writing when using the 1997 guidelines, you can easily count up bullets and these guidelines are amenable to template examinations on paper and obviously easily coded into EHR software that will do the bullet counting for you.

Unfortunately, this is where a ewe becomes a sheep, ripe for hunting for a number of reasons. First, just because you documented an E&M service does not mean it is medically necessary. Do you really need vital signs for every visit? If you are a meaningful EHR user working on penalty avoidance, you may capture examination data for meaningful use that is not medically necessary but cannot be parsed out by the autocoder in your EHR. As a result, simply do a quick manual audit of your notes to see if you are overcoding, which becomes second nature if you do it often.

The second trap, which brings us back to modifier -25, is when you perform a procedure the same day as your E&M or vice versa. Every procedure we do within the Resource-Based Relative Value Scale contains preservice time, which includes review of materials relevant to the procedure, examination of the area, and all preparation (eg, marking, time out, anesthesia, scrub and drape) before the surgery begins. The detailed vignettes are available to those involved in the Relative Value Scale Update Committee process and to the rest of the world in a subscription product called the RBRVS DataManager Online, which is produced by the American Medical Association. Unfortunately, the American Medical Association is not accepting new subscriptions to this product, as it has decided to outsource most of its coding resources to Optum360, one of the many arms of UnitedHealth Group, and will not have a replacement product until after June 30, 2016.⁷

In essence, if you (and your EHR) are counting bullets and then treating the body area in question, you are double-dipping, as the examination of the area is included in the procedure. So if you are heading toward a CPT 99213-25 with 6 bullets, one of which is on the left arm, and you perform a 0- or 10-day global procedure on that arm, you are down to 5 bullets, which drops your level of examination to problem focused. Remember, you need only 2 of 3—history, examination, and decision making—to be at or above that need for that particular level of reporting. If only one of your history or decision making is at or above the needed level for a 99213, the loss of a single bullet drops you down to a 99212! An audit where a handful of medical records are pulled and a request for money back on the universe of payments the insurer has paid is always unpleasant and you should, if you get a request for same, follow all the rules and timelines outlined by the payer. If you knowingly behaved in a risky fashion, consult a good attorney.

Of course, you may argue that the effort needed for the E&M work for the procedure was above and beyond what is typical for the service, which can be a hard standard to meet. Although the CMS requires a “significant and separately identifiable E&M service” as noted above and a separate diagnosis is not needed, the onus is on you to prove it. It is much easier to have a separate diagnosis that stands on its own, which will probably make an audit less common (unless you do it too often).

Final Thoughts

In summary, document what you do, do what you document, and report what is medically necessary. Keep watch over your EHR to be sure it is not overcoding for you. You do not want to be a ewe!

SCOTTSDALE, ARIZ. – The Janus kinase (JAK) inhibitor tofacitinib dramatically improved several cases of alopecia areata (AA), although some patients relapsed to worse than baseline after completing treatment in a small open label pilot trial.

“Regrowth was demonstrated in 11 out of 12 patients on tofacitinib. Seven out of 12 patients achieved more than 50% regrowth,” Dr. Shawn Sidharthan reported at the annual meeting of the Society for Investigative Dermatology.

Worldwide, alopecia areata, which is caused by immune-mediated destruction of hair follicles, has a lifetime incidence of about 2% (Clin Cosmet Investig Dermatol. 2015;8:397-403). But there are no Food and Drug Administration–approved treatments for AA. Tofacitinib (Xeljanz), which is approved by the FDA for moderate to severe rheumatoid arthritis in adults, is a JAK1 and JAK3 inhibitor that curbs the interferon-gamma response inflammatory pathway, said Dr. Sidharthan of the department of dermatology and genetics at Columbia University, New York.

Abbassyma/Wikimedia Commons/Public Domain

AA shares the same interferon response pathway, and tofacitinib prevented alopecia in mice and led to hair regrowth in a patient with alopecia universalis, he noted.

The single-arm trial included seven patients with moderate to severe patchy AA and five patients with alopecia totalis or alopecia universalis. Patients were treated for 6 months. They initially received 5 mg tofacitinib orally twice daily, which was increased to 10 mg twice daily to improve response. The investigators evaluated patients based on SALT (Severity of Alopecia Tool) scores and the Alopecia Areata Disease Activity Index (ALADIN), which uses three-dimensional bioinformatics to identify groups of genes linked to alopecia.

Seven of 12 patients experienced at least 50% regrowth, including six patients who only improved on 10 mg tofacitinib twice daily, Dr. Sidharthan said. Three additional patients “had good regrowth, but not 50%,” he reported. Among the two remaining patients, one had full regrowth, but dropped out of the study because of uncontrolled hypertension, and one patient with alopecia universalis had little or no regrowth.

Notably, two patients began shedding hair after stopping tofacitinib during the observation period of the study, and their final SALT scores were worse than baseline, Dr. Sidharthan said.

Laboratory monitoring of the cohort revealed no severe adverse events, but one patient paused treatment because of thrombocytopenia. The patient’s platelet count normalized after 2 weeks off tofacitinib, and remained normal when the dose was gradually increased to 10 mg twice daily. Another patient developed leukocytosis that resolved during the off-treatment observation period. One patient who did not comply with instructions to avoid alcohol had elevated liver function tests and was taken off the study. Two patients experienced self-limiting diarrhea, and one patient developed trace hematuria, Dr. Sidharthan noted.

In the study, ALADIN scores correlated with clinical response, he said.

He and his coinvestigators concluded that the overall results “provide a strong rationale for larger clinical trials using JAK inhibitors in alopecia areata,” he said.

Dr. Sidharthan noted that another oral JAK inhibitor, ruxolitinib (Jakafi), led to nearly full hair regrowth in three patients with alopecia in a Columbia University study (Nat Med. 2014 Sep; 20[9]:1043-9).

The Locks of Love Foundation funded the research. Dr. Sidharthan, a clinical research fellow in dermatology at Columbia, had no disclosures.

SCOTTSDALE, ARIZ. – The Janus kinase (JAK) inhibitor tofacitinib dramatically improved several cases of alopecia areata (AA), although some patients relapsed to worse than baseline after completing treatment in a small open label pilot trial.

“Regrowth was demonstrated in 11 out of 12 patients on tofacitinib. Seven out of 12 patients achieved more than 50% regrowth,” Dr. Shawn Sidharthan reported at the annual meeting of the Society for Investigative Dermatology.

Worldwide, alopecia areata, which is caused by immune-mediated destruction of hair follicles, has a lifetime incidence of about 2% (Clin Cosmet Investig Dermatol. 2015;8:397-403). But there are no Food and Drug Administration–approved treatments for AA. Tofacitinib (Xeljanz), which is approved by the FDA for moderate to severe rheumatoid arthritis in adults, is a JAK1 and JAK3 inhibitor that curbs the interferon-gamma response inflammatory pathway, said Dr. Sidharthan of the department of dermatology and genetics at Columbia University, New York.

Abbassyma/Wikimedia Commons/Public Domain

AA shares the same interferon response pathway, and tofacitinib prevented alopecia in mice and led to hair regrowth in a patient with alopecia universalis, he noted.

The single-arm trial included seven patients with moderate to severe patchy AA and five patients with alopecia totalis or alopecia universalis. Patients were treated for 6 months. They initially received 5 mg tofacitinib orally twice daily, which was increased to 10 mg twice daily to improve response. The investigators evaluated patients based on SALT (Severity of Alopecia Tool) scores and the Alopecia Areata Disease Activity Index (ALADIN), which uses three-dimensional bioinformatics to identify groups of genes linked to alopecia.

Seven of 12 patients experienced at least 50% regrowth, including six patients who only improved on 10 mg tofacitinib twice daily, Dr. Sidharthan said. Three additional patients “had good regrowth, but not 50%,” he reported. Among the two remaining patients, one had full regrowth, but dropped out of the study because of uncontrolled hypertension, and one patient with alopecia universalis had little or no regrowth.

Notably, two patients began shedding hair after stopping tofacitinib during the observation period of the study, and their final SALT scores were worse than baseline, Dr. Sidharthan said.

Laboratory monitoring of the cohort revealed no severe adverse events, but one patient paused treatment because of thrombocytopenia. The patient’s platelet count normalized after 2 weeks off tofacitinib, and remained normal when the dose was gradually increased to 10 mg twice daily. Another patient developed leukocytosis that resolved during the off-treatment observation period. One patient who did not comply with instructions to avoid alcohol had elevated liver function tests and was taken off the study. Two patients experienced self-limiting diarrhea, and one patient developed trace hematuria, Dr. Sidharthan noted.

In the study, ALADIN scores correlated with clinical response, he said.

He and his coinvestigators concluded that the overall results “provide a strong rationale for larger clinical trials using JAK inhibitors in alopecia areata,” he said.

Dr. Sidharthan noted that another oral JAK inhibitor, ruxolitinib (Jakafi), led to nearly full hair regrowth in three patients with alopecia in a Columbia University study (Nat Med. 2014 Sep; 20[9]:1043-9).

The Locks of Love Foundation funded the research. Dr. Sidharthan, a clinical research fellow in dermatology at Columbia, had no disclosures.

SCOTTSDALE, ARIZ. – The Janus kinase (JAK) inhibitor tofacitinib dramatically improved several cases of alopecia areata (AA), although some patients relapsed to worse than baseline after completing treatment in a small open label pilot trial.

“Regrowth was demonstrated in 11 out of 12 patients on tofacitinib. Seven out of 12 patients achieved more than 50% regrowth,” Dr. Shawn Sidharthan reported at the annual meeting of the Society for Investigative Dermatology.

Worldwide, alopecia areata, which is caused by immune-mediated destruction of hair follicles, has a lifetime incidence of about 2% (Clin Cosmet Investig Dermatol. 2015;8:397-403). But there are no Food and Drug Administration–approved treatments for AA. Tofacitinib (Xeljanz), which is approved by the FDA for moderate to severe rheumatoid arthritis in adults, is a JAK1 and JAK3 inhibitor that curbs the interferon-gamma response inflammatory pathway, said Dr. Sidharthan of the department of dermatology and genetics at Columbia University, New York.

Abbassyma/Wikimedia Commons/Public Domain

AA shares the same interferon response pathway, and tofacitinib prevented alopecia in mice and led to hair regrowth in a patient with alopecia universalis, he noted.

The single-arm trial included seven patients with moderate to severe patchy AA and five patients with alopecia totalis or alopecia universalis. Patients were treated for 6 months. They initially received 5 mg tofacitinib orally twice daily, which was increased to 10 mg twice daily to improve response. The investigators evaluated patients based on SALT (Severity of Alopecia Tool) scores and the Alopecia Areata Disease Activity Index (ALADIN), which uses three-dimensional bioinformatics to identify groups of genes linked to alopecia.

Seven of 12 patients experienced at least 50% regrowth, including six patients who only improved on 10 mg tofacitinib twice daily, Dr. Sidharthan said. Three additional patients “had good regrowth, but not 50%,” he reported. Among the two remaining patients, one had full regrowth, but dropped out of the study because of uncontrolled hypertension, and one patient with alopecia universalis had little or no regrowth.

Notably, two patients began shedding hair after stopping tofacitinib during the observation period of the study, and their final SALT scores were worse than baseline, Dr. Sidharthan said.

Laboratory monitoring of the cohort revealed no severe adverse events, but one patient paused treatment because of thrombocytopenia. The patient’s platelet count normalized after 2 weeks off tofacitinib, and remained normal when the dose was gradually increased to 10 mg twice daily. Another patient developed leukocytosis that resolved during the off-treatment observation period. One patient who did not comply with instructions to avoid alcohol had elevated liver function tests and was taken off the study. Two patients experienced self-limiting diarrhea, and one patient developed trace hematuria, Dr. Sidharthan noted.

In the study, ALADIN scores correlated with clinical response, he said.

He and his coinvestigators concluded that the overall results “provide a strong rationale for larger clinical trials using JAK inhibitors in alopecia areata,” he said.

Dr. Sidharthan noted that another oral JAK inhibitor, ruxolitinib (Jakafi), led to nearly full hair regrowth in three patients with alopecia in a Columbia University study (Nat Med. 2014 Sep; 20[9]:1043-9).

The Locks of Love Foundation funded the research. Dr. Sidharthan, a clinical research fellow in dermatology at Columbia, had no disclosures.

Special activities are everywhere today at the Vascular Annual Meeting, including the official welcome and an opening reception, not to mention the opening of the Exhibit Hall.

Activities include:

• The Opening Ceremony, 8 to 8:30 a.m. in Potomac Ballroom A/B.

• The SVS Awards Ceremony, 2:50 to 3 p.m., Potomac Ballroom A/B. Who will receive SVS’ highest honor, the Lifetime Achievement Award? Find out at the ceremony.

• Opening of the Exhibit Hall at 12 p.m. Exhibits will close at 6 p.m.

• The Opening Reception, 5:30 to 6:30 p.m., Exhibit Halls A-C.

• Alumni receptions. Alums from many institutions – Harvard, Yale, UCLA, Montefiore, Cleveland Clinic, Mayo Clinic, Baylor and many others – will catch up with former classmates and other graduates at receptions Thursday evening. The full list can be found in the Mobile App. Only the Baylor reception is off-site; all others are held at the Gaylord National Resort & Convention Center.

Special activities are everywhere today at the Vascular Annual Meeting, including the official welcome and an opening reception, not to mention the opening of the Exhibit Hall.

Activities include:

• The Opening Ceremony, 8 to 8:30 a.m. in Potomac Ballroom A/B.

• The SVS Awards Ceremony, 2:50 to 3 p.m., Potomac Ballroom A/B. Who will receive SVS’ highest honor, the Lifetime Achievement Award? Find out at the ceremony.

• Opening of the Exhibit Hall at 12 p.m. Exhibits will close at 6 p.m.

• The Opening Reception, 5:30 to 6:30 p.m., Exhibit Halls A-C.

• Alumni receptions. Alums from many institutions – Harvard, Yale, UCLA, Montefiore, Cleveland Clinic, Mayo Clinic, Baylor and many others – will catch up with former classmates and other graduates at receptions Thursday evening. The full list can be found in the Mobile App. Only the Baylor reception is off-site; all others are held at the Gaylord National Resort & Convention Center.

Special activities are everywhere today at the Vascular Annual Meeting, including the official welcome and an opening reception, not to mention the opening of the Exhibit Hall.

Activities include:

• The Opening Ceremony, 8 to 8:30 a.m. in Potomac Ballroom A/B.

• The SVS Awards Ceremony, 2:50 to 3 p.m., Potomac Ballroom A/B. Who will receive SVS’ highest honor, the Lifetime Achievement Award? Find out at the ceremony.

• Opening of the Exhibit Hall at 12 p.m. Exhibits will close at 6 p.m.

• The Opening Reception, 5:30 to 6:30 p.m., Exhibit Halls A-C.

• Alumni receptions. Alums from many institutions – Harvard, Yale, UCLA, Montefiore, Cleveland Clinic, Mayo Clinic, Baylor and many others – will catch up with former classmates and other graduates at receptions Thursday evening. The full list can be found in the Mobile App. Only the Baylor reception is off-site; all others are held at the Gaylord National Resort & Convention Center.

Thursday’s lineup includes special lectures and invited speakers, including:

John Homans Lecture, 10 to 10:30 a.m., Potomac Ballroom A/B. Dr. Frank Veith will take “A Look at the Future of Vascular Surgery."

E. Stanley Crawford Critical Issues Forum, Potomac Ballroom A/B, will discuss “In Search of Clarity: SFA-Popliteal Interventions for Claudication.” 

Roy Greenberg Distinguished Lecture, 3 to 3:30 p.m., Potomac Ballroom A/B. Dr. Timothy A. Resch will present a talk on “Aortic Disease – The Quest to Improve Patient Outcomes.”

Thursday’s lineup includes special lectures and invited speakers, including:

John Homans Lecture, 10 to 10:30 a.m., Potomac Ballroom A/B. Dr. Frank Veith will take “A Look at the Future of Vascular Surgery."

E. Stanley Crawford Critical Issues Forum, Potomac Ballroom A/B, will discuss “In Search of Clarity: SFA-Popliteal Interventions for Claudication.” 

Roy Greenberg Distinguished Lecture, 3 to 3:30 p.m., Potomac Ballroom A/B. Dr. Timothy A. Resch will present a talk on “Aortic Disease – The Quest to Improve Patient Outcomes.”

Thursday’s lineup includes special lectures and invited speakers, including:

John Homans Lecture, 10 to 10:30 a.m., Potomac Ballroom A/B. Dr. Frank Veith will take “A Look at the Future of Vascular Surgery."

E. Stanley Crawford Critical Issues Forum, Potomac Ballroom A/B, will discuss “In Search of Clarity: SFA-Popliteal Interventions for Claudication.” 

Roy Greenberg Distinguished Lecture, 3 to 3:30 p.m., Potomac Ballroom A/B. Dr. Timothy A. Resch will present a talk on “Aortic Disease – The Quest to Improve Patient Outcomes.”

Clinical question: Is a delay in completion of hospital discharge summary associated with hospital readmissions?

Background: Inpatient discharge summaries serve as a communication tool to future care providers. Previous studies have shown mixed impact on the timeliness of discharge summaries on hospital readmissions.

Study design: Retrospective cohort study.

Setting: Adult medical patients at Johns Hopkins University Hospital, Baltimore.

Synopsis: Study authors examined the time between hospital discharge and discharge summary completion on 87,994 hospitalizations to assess whether a delay increased the odds of hospital readmission. In those hospitalizations, 14,248 patients (16.2%) were readmitted within 30 days of discharge. There was a statistically significant adjusted odds ratio of 1.09 (P=0.001) for readmission associated with discharge summaries completed more than three days after discharge.

The main advantage of the study is that the investigators reviewed a large number of hospitalizations. The major limitation is that deaths or admissions to other hospitals within 30 days of discharge were not measured.

Bottom line: Completing a discharge summary within three days of discharge may decrease the risk of 30-day readmission.

Citation: Hoyer EH, Odonkor CA, Bhatia SN, Leung C, Deutschendorf A, Brotman DJ. Association between days to complete inpatient discharge summaries with all-payer hospital readmissions in Maryland [published online ahead of print February 23, 2016]. J Hosp Med. doi:10.1002/jhm.2556

Short Take

Effectiveness of Rapid Response Teams

A meta-analysis of 30 eligible studies evaluating the impact of rapid response teams (RRTs) from 2000 to 2016 found that RRTs are effective at reducing both in-hospital cardiac arrest and hospital mortality.

Citation: Solomon RS, Corwin GS, Barclay DC, Quddusi SF, Dannenberg MD. Effectiveness of rapid response teams on rates of in-hospital cardiopulmonary arrest and mortality: a systematic review and meta-analysis [published online ahead of print Febraury 1, 2016]. J Hosp Med. doi:10.1002/jhm.2554.

Clinical question: Is a delay in completion of hospital discharge summary associated with hospital readmissions?

Background: Inpatient discharge summaries serve as a communication tool to future care providers. Previous studies have shown mixed impact on the timeliness of discharge summaries on hospital readmissions.

Study design: Retrospective cohort study.

Setting: Adult medical patients at Johns Hopkins University Hospital, Baltimore.

Synopsis: Study authors examined the time between hospital discharge and discharge summary completion on 87,994 hospitalizations to assess whether a delay increased the odds of hospital readmission. In those hospitalizations, 14,248 patients (16.2%) were readmitted within 30 days of discharge. There was a statistically significant adjusted odds ratio of 1.09 (P=0.001) for readmission associated with discharge summaries completed more than three days after discharge.

The main advantage of the study is that the investigators reviewed a large number of hospitalizations. The major limitation is that deaths or admissions to other hospitals within 30 days of discharge were not measured.

Bottom line: Completing a discharge summary within three days of discharge may decrease the risk of 30-day readmission.

Citation: Hoyer EH, Odonkor CA, Bhatia SN, Leung C, Deutschendorf A, Brotman DJ. Association between days to complete inpatient discharge summaries with all-payer hospital readmissions in Maryland [published online ahead of print February 23, 2016]. J Hosp Med. doi:10.1002/jhm.2556

Short Take

Effectiveness of Rapid Response Teams

A meta-analysis of 30 eligible studies evaluating the impact of rapid response teams (RRTs) from 2000 to 2016 found that RRTs are effective at reducing both in-hospital cardiac arrest and hospital mortality.

Citation: Solomon RS, Corwin GS, Barclay DC, Quddusi SF, Dannenberg MD. Effectiveness of rapid response teams on rates of in-hospital cardiopulmonary arrest and mortality: a systematic review and meta-analysis [published online ahead of print Febraury 1, 2016]. J Hosp Med. doi:10.1002/jhm.2554.

Clinical question: Is a delay in completion of hospital discharge summary associated with hospital readmissions?

Background: Inpatient discharge summaries serve as a communication tool to future care providers. Previous studies have shown mixed impact on the timeliness of discharge summaries on hospital readmissions.

Study design: Retrospective cohort study.

Setting: Adult medical patients at Johns Hopkins University Hospital, Baltimore.

Synopsis: Study authors examined the time between hospital discharge and discharge summary completion on 87,994 hospitalizations to assess whether a delay increased the odds of hospital readmission. In those hospitalizations, 14,248 patients (16.2%) were readmitted within 30 days of discharge. There was a statistically significant adjusted odds ratio of 1.09 (P=0.001) for readmission associated with discharge summaries completed more than three days after discharge.

The main advantage of the study is that the investigators reviewed a large number of hospitalizations. The major limitation is that deaths or admissions to other hospitals within 30 days of discharge were not measured.

Bottom line: Completing a discharge summary within three days of discharge may decrease the risk of 30-day readmission.

Citation: Hoyer EH, Odonkor CA, Bhatia SN, Leung C, Deutschendorf A, Brotman DJ. Association between days to complete inpatient discharge summaries with all-payer hospital readmissions in Maryland [published online ahead of print February 23, 2016]. J Hosp Med. doi:10.1002/jhm.2556

Short Take

Effectiveness of Rapid Response Teams

A meta-analysis of 30 eligible studies evaluating the impact of rapid response teams (RRTs) from 2000 to 2016 found that RRTs are effective at reducing both in-hospital cardiac arrest and hospital mortality.

Citation: Solomon RS, Corwin GS, Barclay DC, Quddusi SF, Dannenberg MD. Effectiveness of rapid response teams on rates of in-hospital cardiopulmonary arrest and mortality: a systematic review and meta-analysis [published online ahead of print Febraury 1, 2016]. J Hosp Med. doi:10.1002/jhm.2554.

Clinical question: Does assigning a single medical team to a nursing unit (regionalizing) improve communication and prevent adverse events?

Background: Many factors impact communication in healthcare delivery. Failures in communication are a known source of adverse events in hospital care. Previous studies of the impact of regionalized care (assigning medical physician teams to nursing units) on communication and outcomes have had mixed results.

Study design: Pre-post intervention cohort analysis.

Setting: Brigham and Women’s Hospital, Boston.

Synopsis: Three medical teams were assigned to 15-bed nursing units with structured multidisciplinary meeting times for one year. Assessments of concordance of care plan and adverse event detection (with a focus on adverse drug events and poor glycemic control) were performed before and after this assignment. Regionalization of care in the study site improved recognition of care team members (0.56 versus 0.86; P<0.001), discussion of care plan (0.73 versus 0.88; P<0.001), and agreement on estimated discharge date (0.56 versus 0.68; P<0.003). However, it did not significantly improve nurse and physician concordance of the plan or reduce the odds of preventable adverse events.

This study may not have captured an impact on more subtle adverse events or other aspects of interprofessional relationships that enhance patient care.

Bottom line: Regionalization effectively promotes communication but may not lead to patient safety improvements.

Citation: Mueller SK, Schnipper JL, Giannelli K, Roy CL, Boxer R. Impact of regionalized care on concordance of plan and preventable adverse events on general medicine services [published online ahead of print February 24, 2016]. J Hosp Med. doi:10.1002/jhm.2566.

Clinical question: Does assigning a single medical team to a nursing unit (regionalizing) improve communication and prevent adverse events?

Background: Many factors impact communication in healthcare delivery. Failures in communication are a known source of adverse events in hospital care. Previous studies of the impact of regionalized care (assigning medical physician teams to nursing units) on communication and outcomes have had mixed results.

Study design: Pre-post intervention cohort analysis.

Setting: Brigham and Women’s Hospital, Boston.

Synopsis: Three medical teams were assigned to 15-bed nursing units with structured multidisciplinary meeting times for one year. Assessments of concordance of care plan and adverse event detection (with a focus on adverse drug events and poor glycemic control) were performed before and after this assignment. Regionalization of care in the study site improved recognition of care team members (0.56 versus 0.86; P<0.001), discussion of care plan (0.73 versus 0.88; P<0.001), and agreement on estimated discharge date (0.56 versus 0.68; P<0.003). However, it did not significantly improve nurse and physician concordance of the plan or reduce the odds of preventable adverse events.

This study may not have captured an impact on more subtle adverse events or other aspects of interprofessional relationships that enhance patient care.

Bottom line: Regionalization effectively promotes communication but may not lead to patient safety improvements.

Citation: Mueller SK, Schnipper JL, Giannelli K, Roy CL, Boxer R. Impact of regionalized care on concordance of plan and preventable adverse events on general medicine services [published online ahead of print February 24, 2016]. J Hosp Med. doi:10.1002/jhm.2566.

Clinical question: Does assigning a single medical team to a nursing unit (regionalizing) improve communication and prevent adverse events?

Background: Many factors impact communication in healthcare delivery. Failures in communication are a known source of adverse events in hospital care. Previous studies of the impact of regionalized care (assigning medical physician teams to nursing units) on communication and outcomes have had mixed results.

Study design: Pre-post intervention cohort analysis.

Setting: Brigham and Women’s Hospital, Boston.

Synopsis: Three medical teams were assigned to 15-bed nursing units with structured multidisciplinary meeting times for one year. Assessments of concordance of care plan and adverse event detection (with a focus on adverse drug events and poor glycemic control) were performed before and after this assignment. Regionalization of care in the study site improved recognition of care team members (0.56 versus 0.86; P<0.001), discussion of care plan (0.73 versus 0.88; P<0.001), and agreement on estimated discharge date (0.56 versus 0.68; P<0.003). However, it did not significantly improve nurse and physician concordance of the plan or reduce the odds of preventable adverse events.

This study may not have captured an impact on more subtle adverse events or other aspects of interprofessional relationships that enhance patient care.

Bottom line: Regionalization effectively promotes communication but may not lead to patient safety improvements.

Citation: Mueller SK, Schnipper JL, Giannelli K, Roy CL, Boxer R. Impact of regionalized care on concordance of plan and preventable adverse events on general medicine services [published online ahead of print February 24, 2016]. J Hosp Med. doi:10.1002/jhm.2566.

ASCO Annual Meeting 2016

© ASCO/Matt Herp

CHICAGO—The first interim analysis of rituximab plus chemotherapy in children and adolescents with high-risk B-cell non-Hodgkin lymphoma (B-NHL) and acute leukemia has yielded results that “will change our clinical practice,” according to Veronique Minard-Colin, MD, PhD, one of the study investigators.

Patients who received rituximab had 13% better event-free survival (EFS) than those who did not. “The new standard of care will be rituximab plus chemotherapy,” she said, for these high-risk patients.

“And it is very unlikely that this outcome will change if the study continues,” she added.

Dr Minard-Colin, of Institut Gustave Roussy in Villejuif, France, presented the interim analysis of the phase 3 Intergroup trial Inter-B-NHL Ritux 2010 at the 2016 ASCO Annual Meeting as abstract 10507.

She explained that when the study was started in 2010, there was a clear need to demonstrate the effectiveness of rituximab in childhood B-NHL.

So the investigators conducted the trial, which took place in 292 sites in 12 countries.

The investigators enrolled 310 patients under the age of 18 years who had mature B-NHL, including Burkitt lymphoma, diffuse large B-cell lymphoma (DLBCL), high-grade B-NHL not otherwise specified, and B-cell acute leukemia (B-AL). The investigators excluded patients with primary mediastinal B-cell lymphoma.

They defined advanced stages as stage III with LDH levels more than twice normal, any stage IV disease, or B-AL.

They randomized patients to receive the French LMB chemotherapy regimen either with or without rituximab—6 doses at 375 mg/m2.

The randomization was stratified based on national group, histology, and therapeutic group. Group B patients were in stage III or IV, with no central nervous system symptoms; group C1 patients were stage IV/B-AL with cerebrospinal fluid (CSF) negative; and group C3 patients were CSF positive.

One hundred fifty-five patients were randomized to receive rituximab, and 155 were randomized to the control arm.

The primary endpoint was improvement in EFS. Secondary endpoints included complete remission (CR) rate, overall survival (OS), safety, immunity status, and long-term risks.

Investigators performed the first interim analysis after 27 events occurred.

Patient characteristics

Patients were a median age of 8.2 years, 45% were stage III with high LDH, and 85% had Burkitt lymphoma.

About half (51%) the patients were in group B, 39% in C1, and 10% in C3.

Toxicity

There were 6 deaths due to toxicity, 3 in each arm.

Dr Minard-Colin indicated that this number reflects the high toxicity of the LMB regimen and is “similar” to the previous rate of toxic deaths observed in the international LMB 96 study.

She added, “Importantly, 5 out of 6 toxic deaths occurred in group C. The only patient who died in group B died of surgical complications after extensive inappropriate surgery at diagnosis.”

Toxicity was similar between the 2 arms except for the high rate of febrile neutropenia after the third course of cytarabine and etoposide in the rituximab arm (50% vs 34%, P=0.012).

Of the 27 events, 20 occurred in the control arm and 7 in the rituximab arm.

The control arm had 17 lymphoma events, while the rituximab arm had 3.

Only 1 patient relapsed in the rituximab arm compared to 12 who relapsed in the control arm.  And no patient died of lymphoma in the rituximab arm, while 2 died of lymphoma in the control arm.

One second malignancy, melanoma, occurred in the rituximab arm.

Dr Minard-Colin noted that all events occurred in the first year after randomization

Efficacy

Event-free survival at 1 year was 94.2% in the rituximab arm and 81.5% in the control arm.

However, the investigators could not definitely conclude superiority for the rituximab arm because the P value was higher than the significance level of 0.0014 required for this first interim analysis. The hazard ratio was 0.33 (90%CI: 0.16-0.69), P = 0.006.

The investigators performed additional analyses and found the probability of getting a positive study at final analysis was very high, from 99% – 100%.

This past November, following the recommendation of the independent monitoring committee, sponsors decided to halt the randomization and continue follow-up of all patients so as to have mature data.

And in March of this year, they reopened the study with single-arm rituximab for 120 additional patients to answer the secondary objectives.

Dr Minard-Colin emphasized that the results are consistent with the recently performed LMBA02 trial in adult Burkitt lymphoma, with a gain of 13% in EFS for the rituximab arm. The 3-year EFS was 62% in the control arm compared with 75% in the rituximab arm (HR 0.59).

So while rituximab in high-risk patients appears to be practice changing, “in the standard- risk patients,” she added, “the use of rituximab is questionable.”

Sponsors of the trial are Gustave Roussy Cancer, Children’s Oncology Group, and Roche.

Data analyses will be conducted annually hereafter.

ASCO Annual Meeting 2016

© ASCO/Matt Herp

CHICAGO—The first interim analysis of rituximab plus chemotherapy in children and adolescents with high-risk B-cell non-Hodgkin lymphoma (B-NHL) and acute leukemia has yielded results that “will change our clinical practice,” according to Veronique Minard-Colin, MD, PhD, one of the study investigators.

Patients who received rituximab had 13% better event-free survival (EFS) than those who did not. “The new standard of care will be rituximab plus chemotherapy,” she said, for these high-risk patients.

“And it is very unlikely that this outcome will change if the study continues,” she added.

Dr Minard-Colin, of Institut Gustave Roussy in Villejuif, France, presented the interim analysis of the phase 3 Intergroup trial Inter-B-NHL Ritux 2010 at the 2016 ASCO Annual Meeting as abstract 10507.

She explained that when the study was started in 2010, there was a clear need to demonstrate the effectiveness of rituximab in childhood B-NHL.

So the investigators conducted the trial, which took place in 292 sites in 12 countries.

The investigators enrolled 310 patients under the age of 18 years who had mature B-NHL, including Burkitt lymphoma, diffuse large B-cell lymphoma (DLBCL), high-grade B-NHL not otherwise specified, and B-cell acute leukemia (B-AL). The investigators excluded patients with primary mediastinal B-cell lymphoma.

They defined advanced stages as stage III with LDH levels more than twice normal, any stage IV disease, or B-AL.

They randomized patients to receive the French LMB chemotherapy regimen either with or without rituximab—6 doses at 375 mg/m2.

The randomization was stratified based on national group, histology, and therapeutic group. Group B patients were in stage III or IV, with no central nervous system symptoms; group C1 patients were stage IV/B-AL with cerebrospinal fluid (CSF) negative; and group C3 patients were CSF positive.

One hundred fifty-five patients were randomized to receive rituximab, and 155 were randomized to the control arm.

The primary endpoint was improvement in EFS. Secondary endpoints included complete remission (CR) rate, overall survival (OS), safety, immunity status, and long-term risks.

Investigators performed the first interim analysis after 27 events occurred.

Patient characteristics

Patients were a median age of 8.2 years, 45% were stage III with high LDH, and 85% had Burkitt lymphoma.

About half (51%) the patients were in group B, 39% in C1, and 10% in C3.

Toxicity

There were 6 deaths due to toxicity, 3 in each arm.

Dr Minard-Colin indicated that this number reflects the high toxicity of the LMB regimen and is “similar” to the previous rate of toxic deaths observed in the international LMB 96 study.

She added, “Importantly, 5 out of 6 toxic deaths occurred in group C. The only patient who died in group B died of surgical complications after extensive inappropriate surgery at diagnosis.”

Toxicity was similar between the 2 arms except for the high rate of febrile neutropenia after the third course of cytarabine and etoposide in the rituximab arm (50% vs 34%, P=0.012).

Of the 27 events, 20 occurred in the control arm and 7 in the rituximab arm.

The control arm had 17 lymphoma events, while the rituximab arm had 3.

Only 1 patient relapsed in the rituximab arm compared to 12 who relapsed in the control arm.  And no patient died of lymphoma in the rituximab arm, while 2 died of lymphoma in the control arm.

One second malignancy, melanoma, occurred in the rituximab arm.

Dr Minard-Colin noted that all events occurred in the first year after randomization

Efficacy

Event-free survival at 1 year was 94.2% in the rituximab arm and 81.5% in the control arm.

However, the investigators could not definitely conclude superiority for the rituximab arm because the P value was higher than the significance level of 0.0014 required for this first interim analysis. The hazard ratio was 0.33 (90%CI: 0.16-0.69), P = 0.006.

The investigators performed additional analyses and found the probability of getting a positive study at final analysis was very high, from 99% – 100%.

This past November, following the recommendation of the independent monitoring committee, sponsors decided to halt the randomization and continue follow-up of all patients so as to have mature data.

And in March of this year, they reopened the study with single-arm rituximab for 120 additional patients to answer the secondary objectives.

Dr Minard-Colin emphasized that the results are consistent with the recently performed LMBA02 trial in adult Burkitt lymphoma, with a gain of 13% in EFS for the rituximab arm. The 3-year EFS was 62% in the control arm compared with 75% in the rituximab arm (HR 0.59).

So while rituximab in high-risk patients appears to be practice changing, “in the standard- risk patients,” she added, “the use of rituximab is questionable.”

Sponsors of the trial are Gustave Roussy Cancer, Children’s Oncology Group, and Roche.

Data analyses will be conducted annually hereafter.

ASCO Annual Meeting 2016

© ASCO/Matt Herp

CHICAGO—The first interim analysis of rituximab plus chemotherapy in children and adolescents with high-risk B-cell non-Hodgkin lymphoma (B-NHL) and acute leukemia has yielded results that “will change our clinical practice,” according to Veronique Minard-Colin, MD, PhD, one of the study investigators.

Patients who received rituximab had 13% better event-free survival (EFS) than those who did not. “The new standard of care will be rituximab plus chemotherapy,” she said, for these high-risk patients.

“And it is very unlikely that this outcome will change if the study continues,” she added.

Dr Minard-Colin, of Institut Gustave Roussy in Villejuif, France, presented the interim analysis of the phase 3 Intergroup trial Inter-B-NHL Ritux 2010 at the 2016 ASCO Annual Meeting as abstract 10507.

She explained that when the study was started in 2010, there was a clear need to demonstrate the effectiveness of rituximab in childhood B-NHL.

So the investigators conducted the trial, which took place in 292 sites in 12 countries.

The investigators enrolled 310 patients under the age of 18 years who had mature B-NHL, including Burkitt lymphoma, diffuse large B-cell lymphoma (DLBCL), high-grade B-NHL not otherwise specified, and B-cell acute leukemia (B-AL). The investigators excluded patients with primary mediastinal B-cell lymphoma.

They defined advanced stages as stage III with LDH levels more than twice normal, any stage IV disease, or B-AL.

They randomized patients to receive the French LMB chemotherapy regimen either with or without rituximab—6 doses at 375 mg/m2.

The randomization was stratified based on national group, histology, and therapeutic group. Group B patients were in stage III or IV, with no central nervous system symptoms; group C1 patients were stage IV/B-AL with cerebrospinal fluid (CSF) negative; and group C3 patients were CSF positive.

One hundred fifty-five patients were randomized to receive rituximab, and 155 were randomized to the control arm.

The primary endpoint was improvement in EFS. Secondary endpoints included complete remission (CR) rate, overall survival (OS), safety, immunity status, and long-term risks.

Investigators performed the first interim analysis after 27 events occurred.

Patient characteristics

Patients were a median age of 8.2 years, 45% were stage III with high LDH, and 85% had Burkitt lymphoma.

About half (51%) the patients were in group B, 39% in C1, and 10% in C3.

Toxicity

There were 6 deaths due to toxicity, 3 in each arm.

Dr Minard-Colin indicated that this number reflects the high toxicity of the LMB regimen and is “similar” to the previous rate of toxic deaths observed in the international LMB 96 study.

She added, “Importantly, 5 out of 6 toxic deaths occurred in group C. The only patient who died in group B died of surgical complications after extensive inappropriate surgery at diagnosis.”

Toxicity was similar between the 2 arms except for the high rate of febrile neutropenia after the third course of cytarabine and etoposide in the rituximab arm (50% vs 34%, P=0.012).

Of the 27 events, 20 occurred in the control arm and 7 in the rituximab arm.

The control arm had 17 lymphoma events, while the rituximab arm had 3.

Only 1 patient relapsed in the rituximab arm compared to 12 who relapsed in the control arm.  And no patient died of lymphoma in the rituximab arm, while 2 died of lymphoma in the control arm.

One second malignancy, melanoma, occurred in the rituximab arm.

Dr Minard-Colin noted that all events occurred in the first year after randomization

Efficacy

Event-free survival at 1 year was 94.2% in the rituximab arm and 81.5% in the control arm.

However, the investigators could not definitely conclude superiority for the rituximab arm because the P value was higher than the significance level of 0.0014 required for this first interim analysis. The hazard ratio was 0.33 (90%CI: 0.16-0.69), P = 0.006.

The investigators performed additional analyses and found the probability of getting a positive study at final analysis was very high, from 99% – 100%.

This past November, following the recommendation of the independent monitoring committee, sponsors decided to halt the randomization and continue follow-up of all patients so as to have mature data.

And in March of this year, they reopened the study with single-arm rituximab for 120 additional patients to answer the secondary objectives.

Dr Minard-Colin emphasized that the results are consistent with the recently performed LMBA02 trial in adult Burkitt lymphoma, with a gain of 13% in EFS for the rituximab arm. The 3-year EFS was 62% in the control arm compared with 75% in the rituximab arm (HR 0.59).

So while rituximab in high-risk patients appears to be practice changing, “in the standard- risk patients,” she added, “the use of rituximab is questionable.”

Sponsors of the trial are Gustave Roussy Cancer, Children’s Oncology Group, and Roche.

Data analyses will be conducted annually hereafter.

Doctor and patient in hospital
Photo courtesy of the CDC

A new study sheds light on whether an increased risk of death in the 30 days to 2 years after contracting sepsis is caused by sepsis itself, or because of pre-existing health conditions the patients had before acquiring the complication.

Using detailed survey data and medical records of more than 30,000 older Americans, the researchers conducted a propensity matched cohort study to investigate the phenomenon of late death after sepsis.

Late death refers to deaths that take place months to years after the acute infection has resolved.

"We know sicker patients are more likely to develop sepsis," lead author Hallie Prescott, MD, of the University of Michigan in Ann Arbor, said. "And that made us wonder: Perhaps those previous health conditions are driving the risk of late death after sepsis?"

So the investigators compared 960 patients aged 65 or older who were admitted to the hospital with sepsis to 3 control groups: 777 adults not currently hospitalized, 788 patients hospitalized with non-sepsis infections, and 504 patients admitted with acute sterile inflammatory conditions.

All patients had participated in the US Health and Retirement Study, a longitudinal survey of 37,000 adults aged over 50 in 23,000 households. The survey is considered broadly representative of the older US population.

The current study included Medicare beneficiaries who had participated in at least one survey between 1998 and 2008.

The main outcome measure was late mortality 31 days to 2 years after sepsis and odds of death at various intervals.

Results

In the sepsis cohort, the mean age was 79, 54% were women, 81% were white, and 12% were nursing home residents.

There were no significant differences among the cohorts in terms of demographics, socioeconomic characteristics, baseline health status, or recent healthcare use.

The sepsis cohort had a 25.4% mortality rate at 30 days, 35.3% at 90 days, 41.3% at 180 days, 48.5% at 1 year, and 56.5% at 2 years.

Over 40% of sepsis patients who survived 30 days after their hospitalization died in the next 2 years. If sepsis patients survived to a year, the adjusted 2-year mortality was 16.0% versus 10.7% for controls not in the hospital.

When investigators compared these mortality rates to matched patients who were not hospitalized, they found that those with sepsis experienced a 22.1% absolute increase in late mortality. This translated into a 2.2-fold relative increase in late mortality.

And when they compared the sepsis patients to patients hospitalized for non-sepsis infections, the investigators determined that sepsis patients experienced a 10.4% absolute increase in late mortality. This translated into a 1.3-fold relative increase in late mortality.

Finally, they compared the sepsis patients to those patients hospitalized for sterile inflammatory conditions and found that the sepsis patients who survived to 31 days experienced a 16.2% absolute increase in late mortality. This translated into 1.6-fold relative increase.

The investigators said this high rate of late mortality could not be explained by the patients’ age, socio-demographics, or their pre-sepsis health status.

"Rather, we found that, compared to the group of adults not in the hospital,” Dr Prescott said, “1 in 5 patients who survived sepsis had a late death that was not explained by their baseline characteristics.”

The investigators said this suggests that late mortality after sepsis could be more amendable to intervention than previously thought.

The investigators published their findings in BMJ.

Doctor and patient in hospital
Photo courtesy of the CDC

A new study sheds light on whether an increased risk of death in the 30 days to 2 years after contracting sepsis is caused by sepsis itself, or because of pre-existing health conditions the patients had before acquiring the complication.

Using detailed survey data and medical records of more than 30,000 older Americans, the researchers conducted a propensity matched cohort study to investigate the phenomenon of late death after sepsis.

Late death refers to deaths that take place months to years after the acute infection has resolved.

"We know sicker patients are more likely to develop sepsis," lead author Hallie Prescott, MD, of the University of Michigan in Ann Arbor, said. "And that made us wonder: Perhaps those previous health conditions are driving the risk of late death after sepsis?"

So the investigators compared 960 patients aged 65 or older who were admitted to the hospital with sepsis to 3 control groups: 777 adults not currently hospitalized, 788 patients hospitalized with non-sepsis infections, and 504 patients admitted with acute sterile inflammatory conditions.

All patients had participated in the US Health and Retirement Study, a longitudinal survey of 37,000 adults aged over 50 in 23,000 households. The survey is considered broadly representative of the older US population.

The current study included Medicare beneficiaries who had participated in at least one survey between 1998 and 2008.

The main outcome measure was late mortality 31 days to 2 years after sepsis and odds of death at various intervals.

Results

In the sepsis cohort, the mean age was 79, 54% were women, 81% were white, and 12% were nursing home residents.

There were no significant differences among the cohorts in terms of demographics, socioeconomic characteristics, baseline health status, or recent healthcare use.

The sepsis cohort had a 25.4% mortality rate at 30 days, 35.3% at 90 days, 41.3% at 180 days, 48.5% at 1 year, and 56.5% at 2 years.

Over 40% of sepsis patients who survived 30 days after their hospitalization died in the next 2 years. If sepsis patients survived to a year, the adjusted 2-year mortality was 16.0% versus 10.7% for controls not in the hospital.

When investigators compared these mortality rates to matched patients who were not hospitalized, they found that those with sepsis experienced a 22.1% absolute increase in late mortality. This translated into a 2.2-fold relative increase in late mortality.

And when they compared the sepsis patients to patients hospitalized for non-sepsis infections, the investigators determined that sepsis patients experienced a 10.4% absolute increase in late mortality. This translated into a 1.3-fold relative increase in late mortality.

Finally, they compared the sepsis patients to those patients hospitalized for sterile inflammatory conditions and found that the sepsis patients who survived to 31 days experienced a 16.2% absolute increase in late mortality. This translated into 1.6-fold relative increase.

The investigators said this high rate of late mortality could not be explained by the patients’ age, socio-demographics, or their pre-sepsis health status.

"Rather, we found that, compared to the group of adults not in the hospital,” Dr Prescott said, “1 in 5 patients who survived sepsis had a late death that was not explained by their baseline characteristics.”

The investigators said this suggests that late mortality after sepsis could be more amendable to intervention than previously thought.

The investigators published their findings in BMJ.

Doctor and patient in hospital
Photo courtesy of the CDC

A new study sheds light on whether an increased risk of death in the 30 days to 2 years after contracting sepsis is caused by sepsis itself, or because of pre-existing health conditions the patients had before acquiring the complication.

Using detailed survey data and medical records of more than 30,000 older Americans, the researchers conducted a propensity matched cohort study to investigate the phenomenon of late death after sepsis.

Late death refers to deaths that take place months to years after the acute infection has resolved.

"We know sicker patients are more likely to develop sepsis," lead author Hallie Prescott, MD, of the University of Michigan in Ann Arbor, said. "And that made us wonder: Perhaps those previous health conditions are driving the risk of late death after sepsis?"

So the investigators compared 960 patients aged 65 or older who were admitted to the hospital with sepsis to 3 control groups: 777 adults not currently hospitalized, 788 patients hospitalized with non-sepsis infections, and 504 patients admitted with acute sterile inflammatory conditions.

All patients had participated in the US Health and Retirement Study, a longitudinal survey of 37,000 adults aged over 50 in 23,000 households. The survey is considered broadly representative of the older US population.

The current study included Medicare beneficiaries who had participated in at least one survey between 1998 and 2008.

The main outcome measure was late mortality 31 days to 2 years after sepsis and odds of death at various intervals.

Results

In the sepsis cohort, the mean age was 79, 54% were women, 81% were white, and 12% were nursing home residents.

There were no significant differences among the cohorts in terms of demographics, socioeconomic characteristics, baseline health status, or recent healthcare use.

The sepsis cohort had a 25.4% mortality rate at 30 days, 35.3% at 90 days, 41.3% at 180 days, 48.5% at 1 year, and 56.5% at 2 years.

Over 40% of sepsis patients who survived 30 days after their hospitalization died in the next 2 years. If sepsis patients survived to a year, the adjusted 2-year mortality was 16.0% versus 10.7% for controls not in the hospital.

When investigators compared these mortality rates to matched patients who were not hospitalized, they found that those with sepsis experienced a 22.1% absolute increase in late mortality. This translated into a 2.2-fold relative increase in late mortality.

And when they compared the sepsis patients to patients hospitalized for non-sepsis infections, the investigators determined that sepsis patients experienced a 10.4% absolute increase in late mortality. This translated into a 1.3-fold relative increase in late mortality.

Finally, they compared the sepsis patients to those patients hospitalized for sterile inflammatory conditions and found that the sepsis patients who survived to 31 days experienced a 16.2% absolute increase in late mortality. This translated into 1.6-fold relative increase.

The investigators said this high rate of late mortality could not be explained by the patients’ age, socio-demographics, or their pre-sepsis health status.

"Rather, we found that, compared to the group of adults not in the hospital,” Dr Prescott said, “1 in 5 patients who survived sepsis had a late death that was not explained by their baseline characteristics.”

The investigators said this suggests that late mortality after sepsis could be more amendable to intervention than previously thought.

The investigators published their findings in BMJ.