Thoracic Surgery News (Archived)

VIENNA – Inherited platelet function disorders are associated with a significant bleeding risk during surgery, a retrospective, multicenter study shows.

“The frequency of excessive bleeding assessed by one of three criteria at surgery is pretty remarkable because we had rates ranging from 13% to about 19% depending on the assessment criteria,” Dr. Paolo Gresele said at the annual congress of the European Hematology Association.

Patrice Wendling/Frontline Medical News

Any excessive bleeding by any criteria took place in about 23% of patients.

Although conventionally considered rare, inherited platelet function disorders (IPFD) are more frequent than previously thought, and recent advances in their diagnosis have expanded the forms and number of reported patients.

Only a handful of case reports or small case series have evaluated the bleeding risk associated with surgery in patients with IPFD. As a result, the exact bleeding risk and most appropriate management options in IPFD are not known, Dr. Gresele of University of Perugia (Italy) said.

He reported on a retrospective study involving patients with IPFD enrolled at 42 centers from 16 countries. The median age of the 205 patients was 35 years, and 56% were women; 89 had Glanzmann thrombasthenia, 46 had primary secretion defect, 14 had combined alpha-delta granule deficiency, 11 had Hermansky-Pudlak syndrome, 9 had gray platelet syndrome, and 36 had other forms of IPFD.

Data were collected from 389 procedures, of which 54.5% were surgeries, 30% were dental procedures, and 15.5% were invasive procedures. The most frequent surgeries were otolaryngologic, abdominal, orthopedic, gynecologic, urologic, and dermatologic.

The frequency of excessive bleeding at surgery was about 19.7% by the Bleeding Academic Research Consortium (BARC) bleeding classification, 17% by subjective evaluation by the surgeon or patient, and 13% based on duration of bleeding at surgery of at least 6 or more hours, Dr. Gresele said.

The World Health Organization (WHO) bleeding scale before surgery was quite predictive of excessive bleeding at surgery, with patients at grade 3 and 4 having an odds ratio for excessive bleeding of 9.22 and 28, respectively, compared with patients at grade 0, he said.

Somewhat unexpectedly, the most serious bleeders based on a BARC of at least 2 or more at surgery were patients with Hermansky-Pudlak syndrome, Glanzmann thrombasthenia, and gray platelet syndrome. Those with primary secretion defect and combined alpha-delta granule deficiency had a relatively low risk of bleeding at surgery, he said.

The procedures associated with more excessive bleeding were urologic surgery, gynecologic surgery, and abdominal surgery.

Preparation for surgery was made in 82% of procedures and included prophylactic platelet transfusions in 38.5%, desmopressin (DDAVP) in about 19%, antifibrinolytic agents in about 12%, factor VIIa in less than 10%, and other interventions such as cryoprecipitate, fibrinogen, fresh frozen plasma, intravenous immunoglobulin, suture, and local hemostatic agent in less than 5%.

Generally all measures had a good ability to prevent excessive bleeding, bringing rates down to about 20% or less, Dr. Gresele said. The two exceptions were no prophylaxis and “other” interventions, where the bleeding rate reached a high of about 45% for the latter. In contrast, bleeding risk was significantly reduced when any prophylaxis (odds ratio, 0.38) or DDAVP (OR, 0.24) were used.

In 87 cases, however, emergency treatment for excessive bleeding was required, he said. Platelet transfusions were the most common treatment, given in roughly half of patients, followed by antifibrinolytic agents. The success rate was about 80% for all measures, except for “other” interventions, which had a success rate of about 65%.

“Treatment of excessive bleeding is made mostly with platelet transfusions or antifibrinolytic agents and is able to stop bleeding in many, but not all cases,” Dr. Gresele concluded.

pwendling@frontlinemedcom.com

On Twitter @pwendl

VIENNA – Inherited platelet function disorders are associated with a significant bleeding risk during surgery, a retrospective, multicenter study shows.

“The frequency of excessive bleeding assessed by one of three criteria at surgery is pretty remarkable because we had rates ranging from 13% to about 19% depending on the assessment criteria,” Dr. Paolo Gresele said at the annual congress of the European Hematology Association.

Patrice Wendling/Frontline Medical News

Any excessive bleeding by any criteria took place in about 23% of patients.

Although conventionally considered rare, inherited platelet function disorders (IPFD) are more frequent than previously thought, and recent advances in their diagnosis have expanded the forms and number of reported patients.

Only a handful of case reports or small case series have evaluated the bleeding risk associated with surgery in patients with IPFD. As a result, the exact bleeding risk and most appropriate management options in IPFD are not known, Dr. Gresele of University of Perugia (Italy) said.

He reported on a retrospective study involving patients with IPFD enrolled at 42 centers from 16 countries. The median age of the 205 patients was 35 years, and 56% were women; 89 had Glanzmann thrombasthenia, 46 had primary secretion defect, 14 had combined alpha-delta granule deficiency, 11 had Hermansky-Pudlak syndrome, 9 had gray platelet syndrome, and 36 had other forms of IPFD.

Data were collected from 389 procedures, of which 54.5% were surgeries, 30% were dental procedures, and 15.5% were invasive procedures. The most frequent surgeries were otolaryngologic, abdominal, orthopedic, gynecologic, urologic, and dermatologic.

The frequency of excessive bleeding at surgery was about 19.7% by the Bleeding Academic Research Consortium (BARC) bleeding classification, 17% by subjective evaluation by the surgeon or patient, and 13% based on duration of bleeding at surgery of at least 6 or more hours, Dr. Gresele said.

The World Health Organization (WHO) bleeding scale before surgery was quite predictive of excessive bleeding at surgery, with patients at grade 3 and 4 having an odds ratio for excessive bleeding of 9.22 and 28, respectively, compared with patients at grade 0, he said.

Somewhat unexpectedly, the most serious bleeders based on a BARC of at least 2 or more at surgery were patients with Hermansky-Pudlak syndrome, Glanzmann thrombasthenia, and gray platelet syndrome. Those with primary secretion defect and combined alpha-delta granule deficiency had a relatively low risk of bleeding at surgery, he said.

The procedures associated with more excessive bleeding were urologic surgery, gynecologic surgery, and abdominal surgery.

Preparation for surgery was made in 82% of procedures and included prophylactic platelet transfusions in 38.5%, desmopressin (DDAVP) in about 19%, antifibrinolytic agents in about 12%, factor VIIa in less than 10%, and other interventions such as cryoprecipitate, fibrinogen, fresh frozen plasma, intravenous immunoglobulin, suture, and local hemostatic agent in less than 5%.

Generally all measures had a good ability to prevent excessive bleeding, bringing rates down to about 20% or less, Dr. Gresele said. The two exceptions were no prophylaxis and “other” interventions, where the bleeding rate reached a high of about 45% for the latter. In contrast, bleeding risk was significantly reduced when any prophylaxis (odds ratio, 0.38) or DDAVP (OR, 0.24) were used.

In 87 cases, however, emergency treatment for excessive bleeding was required, he said. Platelet transfusions were the most common treatment, given in roughly half of patients, followed by antifibrinolytic agents. The success rate was about 80% for all measures, except for “other” interventions, which had a success rate of about 65%.

“Treatment of excessive bleeding is made mostly with platelet transfusions or antifibrinolytic agents and is able to stop bleeding in many, but not all cases,” Dr. Gresele concluded.

pwendling@frontlinemedcom.com

On Twitter @pwendl

VIENNA – Inherited platelet function disorders are associated with a significant bleeding risk during surgery, a retrospective, multicenter study shows.

“The frequency of excessive bleeding assessed by one of three criteria at surgery is pretty remarkable because we had rates ranging from 13% to about 19% depending on the assessment criteria,” Dr. Paolo Gresele said at the annual congress of the European Hematology Association.

Patrice Wendling/Frontline Medical News

Any excessive bleeding by any criteria took place in about 23% of patients.

Although conventionally considered rare, inherited platelet function disorders (IPFD) are more frequent than previously thought, and recent advances in their diagnosis have expanded the forms and number of reported patients.

Only a handful of case reports or small case series have evaluated the bleeding risk associated with surgery in patients with IPFD. As a result, the exact bleeding risk and most appropriate management options in IPFD are not known, Dr. Gresele of University of Perugia (Italy) said.

He reported on a retrospective study involving patients with IPFD enrolled at 42 centers from 16 countries. The median age of the 205 patients was 35 years, and 56% were women; 89 had Glanzmann thrombasthenia, 46 had primary secretion defect, 14 had combined alpha-delta granule deficiency, 11 had Hermansky-Pudlak syndrome, 9 had gray platelet syndrome, and 36 had other forms of IPFD.

Data were collected from 389 procedures, of which 54.5% were surgeries, 30% were dental procedures, and 15.5% were invasive procedures. The most frequent surgeries were otolaryngologic, abdominal, orthopedic, gynecologic, urologic, and dermatologic.

The frequency of excessive bleeding at surgery was about 19.7% by the Bleeding Academic Research Consortium (BARC) bleeding classification, 17% by subjective evaluation by the surgeon or patient, and 13% based on duration of bleeding at surgery of at least 6 or more hours, Dr. Gresele said.

The World Health Organization (WHO) bleeding scale before surgery was quite predictive of excessive bleeding at surgery, with patients at grade 3 and 4 having an odds ratio for excessive bleeding of 9.22 and 28, respectively, compared with patients at grade 0, he said.

Somewhat unexpectedly, the most serious bleeders based on a BARC of at least 2 or more at surgery were patients with Hermansky-Pudlak syndrome, Glanzmann thrombasthenia, and gray platelet syndrome. Those with primary secretion defect and combined alpha-delta granule deficiency had a relatively low risk of bleeding at surgery, he said.

The procedures associated with more excessive bleeding were urologic surgery, gynecologic surgery, and abdominal surgery.

Preparation for surgery was made in 82% of procedures and included prophylactic platelet transfusions in 38.5%, desmopressin (DDAVP) in about 19%, antifibrinolytic agents in about 12%, factor VIIa in less than 10%, and other interventions such as cryoprecipitate, fibrinogen, fresh frozen plasma, intravenous immunoglobulin, suture, and local hemostatic agent in less than 5%.

Generally all measures had a good ability to prevent excessive bleeding, bringing rates down to about 20% or less, Dr. Gresele said. The two exceptions were no prophylaxis and “other” interventions, where the bleeding rate reached a high of about 45% for the latter. In contrast, bleeding risk was significantly reduced when any prophylaxis (odds ratio, 0.38) or DDAVP (OR, 0.24) were used.

In 87 cases, however, emergency treatment for excessive bleeding was required, he said. Platelet transfusions were the most common treatment, given in roughly half of patients, followed by antifibrinolytic agents. The success rate was about 80% for all measures, except for “other” interventions, which had a success rate of about 65%.

“Treatment of excessive bleeding is made mostly with platelet transfusions or antifibrinolytic agents and is able to stop bleeding in many, but not all cases,” Dr. Gresele concluded.

pwendling@frontlinemedcom.com

On Twitter @pwendl

One in four intermediate-sized (8-20 mm) pulmonary nodules were found to be malignant, based on results from a retrospective study of 377 patients seen in 18 community pulmonology practices.

Malignant nodules were more likely to be found in current or former smokers and to be larger than the benign nodules.

Further, despite guideline recommendations for surveillance of pulmonary nodules with less than a 5% pretest probability of malignancy, 44% of 36 patients with low-risk pulmonary nodules underwent at least one invasive procedure.

“To our knowledge, this is the first study that documents the prevalence of cancer (25%) in patients with intermediate-sized nodules referred to community-based pulmonologists,” wrote Dr. Nichole T. Tanner of the Medical University of South Carolina, Charleston, and her coauthors in the study published online (Chest 2015 June 18 [doi:10.1378/chest.15-0630]). “This finding has implications for managing pulmonary nodules in the community; because the risk of cancer is substantial, patients should be managed based on their individualized risk for malignancy.”

Biopsy – either by transthoracic needle aspiration or bronchoscopy – was performed in 33% (125) of patients, of whom 35% were found to have a malignancy and 57% had a specific benign diagnosis; biopsies in 8% were nondiagnostic and those patients were followed for 2 years.

Referrals for surgery were given to 20% (77) of patients; 19 had previously undergone a biopsy, with 11 having a nondiagnostic biopsy and eight having a received a benign result. Of patients who underwent surgery, 65% were diagnosed with a malignancy, and 35% had benign disease. However, the rate of surgical resection was similar regardless of patients’ pretest probability of malignancy.

PET scanning, performed in 37% of patients, was more likely in those who had a biopsy or surgery. The overall accuracy of PET was 74%, and the false-negative rate decreased slightly as the size of the nodule increased.

“Guidelines recommend surgery if the pretest probability of cancer is high (pCA > 65%) because a negative biopsy would not dissuade the clinician from pursuing a definitive diagnosis and a positive biopsy would lead to surgery anyway.”

The researchers pointed out that there are a range of noninvasive options now available to determine the likelihood that a nodule is malignant, such as CT scanning with the use of volumetric software to measure diameter and volume-doubling time of a nodule in between scans.

The study was supported by Integrated Diagnostics. All but one study author declared consulting fees, grant funding, stock options, or employment with Integrated Diagnostics.

One in four intermediate-sized (8-20 mm) pulmonary nodules were found to be malignant, based on results from a retrospective study of 377 patients seen in 18 community pulmonology practices.

Malignant nodules were more likely to be found in current or former smokers and to be larger than the benign nodules.

Further, despite guideline recommendations for surveillance of pulmonary nodules with less than a 5% pretest probability of malignancy, 44% of 36 patients with low-risk pulmonary nodules underwent at least one invasive procedure.

“To our knowledge, this is the first study that documents the prevalence of cancer (25%) in patients with intermediate-sized nodules referred to community-based pulmonologists,” wrote Dr. Nichole T. Tanner of the Medical University of South Carolina, Charleston, and her coauthors in the study published online (Chest 2015 June 18 [doi:10.1378/chest.15-0630]). “This finding has implications for managing pulmonary nodules in the community; because the risk of cancer is substantial, patients should be managed based on their individualized risk for malignancy.”

Biopsy – either by transthoracic needle aspiration or bronchoscopy – was performed in 33% (125) of patients, of whom 35% were found to have a malignancy and 57% had a specific benign diagnosis; biopsies in 8% were nondiagnostic and those patients were followed for 2 years.

Referrals for surgery were given to 20% (77) of patients; 19 had previously undergone a biopsy, with 11 having a nondiagnostic biopsy and eight having a received a benign result. Of patients who underwent surgery, 65% were diagnosed with a malignancy, and 35% had benign disease. However, the rate of surgical resection was similar regardless of patients’ pretest probability of malignancy.

PET scanning, performed in 37% of patients, was more likely in those who had a biopsy or surgery. The overall accuracy of PET was 74%, and the false-negative rate decreased slightly as the size of the nodule increased.

“Guidelines recommend surgery if the pretest probability of cancer is high (pCA > 65%) because a negative biopsy would not dissuade the clinician from pursuing a definitive diagnosis and a positive biopsy would lead to surgery anyway.”

The researchers pointed out that there are a range of noninvasive options now available to determine the likelihood that a nodule is malignant, such as CT scanning with the use of volumetric software to measure diameter and volume-doubling time of a nodule in between scans.

The study was supported by Integrated Diagnostics. All but one study author declared consulting fees, grant funding, stock options, or employment with Integrated Diagnostics.

One in four intermediate-sized (8-20 mm) pulmonary nodules were found to be malignant, based on results from a retrospective study of 377 patients seen in 18 community pulmonology practices.

Malignant nodules were more likely to be found in current or former smokers and to be larger than the benign nodules.

Further, despite guideline recommendations for surveillance of pulmonary nodules with less than a 5% pretest probability of malignancy, 44% of 36 patients with low-risk pulmonary nodules underwent at least one invasive procedure.

“To our knowledge, this is the first study that documents the prevalence of cancer (25%) in patients with intermediate-sized nodules referred to community-based pulmonologists,” wrote Dr. Nichole T. Tanner of the Medical University of South Carolina, Charleston, and her coauthors in the study published online (Chest 2015 June 18 [doi:10.1378/chest.15-0630]). “This finding has implications for managing pulmonary nodules in the community; because the risk of cancer is substantial, patients should be managed based on their individualized risk for malignancy.”

Biopsy – either by transthoracic needle aspiration or bronchoscopy – was performed in 33% (125) of patients, of whom 35% were found to have a malignancy and 57% had a specific benign diagnosis; biopsies in 8% were nondiagnostic and those patients were followed for 2 years.

Referrals for surgery were given to 20% (77) of patients; 19 had previously undergone a biopsy, with 11 having a nondiagnostic biopsy and eight having a received a benign result. Of patients who underwent surgery, 65% were diagnosed with a malignancy, and 35% had benign disease. However, the rate of surgical resection was similar regardless of patients’ pretest probability of malignancy.

PET scanning, performed in 37% of patients, was more likely in those who had a biopsy or surgery. The overall accuracy of PET was 74%, and the false-negative rate decreased slightly as the size of the nodule increased.

“Guidelines recommend surgery if the pretest probability of cancer is high (pCA > 65%) because a negative biopsy would not dissuade the clinician from pursuing a definitive diagnosis and a positive biopsy would lead to surgery anyway.”

The researchers pointed out that there are a range of noninvasive options now available to determine the likelihood that a nodule is malignant, such as CT scanning with the use of volumetric software to measure diameter and volume-doubling time of a nodule in between scans.

The study was supported by Integrated Diagnostics. All but one study author declared consulting fees, grant funding, stock options, or employment with Integrated Diagnostics.

CHICAGO – Too often, physicians sign managed care contracts without negotiating or truly understanding all the terms. The complex clauses – or lack thereof – can come back to bite doctors in the form of delayed payments, sudden policy changes, and termination woes, health law attorney Mark S. Kopson warned at conference held by the American Bar Association.

To avoid these unwelcome surprises, prepare for contract discussions well before the conversation starts, Mr. Kopson advised.

Alicia Gallegos/Frontline Medical News

“Don’t go into any negotiation unless you know two things. The first is what your starting position will be and, equally if not more important, is what is your ultimate line in the sand?” said Mr. Kopson, who practices in Bloomfield Hills, Mich. “If you go in there not knowing those answers, you’re liable to give away the store or not get what you really need.”

One major “gotcha” is an insurer that does not reveal upfront that it is not the actual payer, Mr. Kopson said. Some national companies that enter into contracts with doctors are basically network aggregators that negotiate price discounts but then sell the network to the health insurance marketplace, he explained. Physicians later realize their contract states that the company is not responsible for paying claims and that the doctor does not have a contract directly with the payer.

“This is a really big issue that I’ve been seeing more and more frequently,” Mr. Kopson said at the meeting. “If you don’t have a direct contract with the payer, you have the possibility of not being able to force payment obligations against the responsible party.”

Specify in your contract that the plan must require the payer to pay, he said. That way, if a payer fails to pay, the plan has breached its contract obligation.

Contract terms that involve medical necessity also can lead to frustration if not properly negotiated. In some cases, the fine print states that medical necessity will be determined by the plan’s medical director or otherwise will be ultimately decided by the payer. Instead, include language specifying that a treating physician’s professional opinion will be entitled to great deference if medical necessity comes into question, Mr. Kopson said.

The process surrounding clean claims is often overlooked by physicians during contract negotiations, he added. The “gotcha” occurs when a plan retains full control over how contested claims are handled.

“If you don’t adequately address this in the contract, you wind up with the payer taking multiple bites of the apple,” Mr. Kopson said.

Make sure to clarify parameters for how long insurers have to request additional information about a claim and whether they must pay a portion of the claim that is being contested, he advised. Include a firm time line of when payers must complete their review and address payment after the requested information is provided.

Another critical issue: changes to the contract. In some cases, doctors enter into a contract with a plan and then the plan decides some details aren’t working out and makes changes. The physician later learns that the contract language allowed the plan to make unilateral changes. In other instances, a plan institutes new products and doctors learn that they had only a certain timeframe to opt out.

To avoid these situations, specify during contract negotiations that policies in conflict with the contract are prohibited, that contract changes can only be made bilaterally, and that unless you directly opt-in to new products, you will not participate.

Mr. Kopson encouraged physicians to have a solid exit strategy in their contracts and to ensure terms regarding contract termination are clearly understood. Clearly defined criteria around “cause” for termination are imperative, he said. Additionally, if a plan alleges a termination breach, require it to send a written notice to a specific person/title and ensure that the notice also is provided to counsel.

The bottom line: To avoid trouble later, strongly negotiate at the start of a managed care contract, Mr. Kopson said.

“If you don’t ask, if you don’t negotiate it in there, you’re not going to have that weapon,” he said.

agallegos@frontlinemedcom.com

On Twitter @legal_med

CHICAGO – Too often, physicians sign managed care contracts without negotiating or truly understanding all the terms. The complex clauses – or lack thereof – can come back to bite doctors in the form of delayed payments, sudden policy changes, and termination woes, health law attorney Mark S. Kopson warned at conference held by the American Bar Association.

To avoid these unwelcome surprises, prepare for contract discussions well before the conversation starts, Mr. Kopson advised.

Alicia Gallegos/Frontline Medical News

“Don’t go into any negotiation unless you know two things. The first is what your starting position will be and, equally if not more important, is what is your ultimate line in the sand?” said Mr. Kopson, who practices in Bloomfield Hills, Mich. “If you go in there not knowing those answers, you’re liable to give away the store or not get what you really need.”

One major “gotcha” is an insurer that does not reveal upfront that it is not the actual payer, Mr. Kopson said. Some national companies that enter into contracts with doctors are basically network aggregators that negotiate price discounts but then sell the network to the health insurance marketplace, he explained. Physicians later realize their contract states that the company is not responsible for paying claims and that the doctor does not have a contract directly with the payer.

“This is a really big issue that I’ve been seeing more and more frequently,” Mr. Kopson said at the meeting. “If you don’t have a direct contract with the payer, you have the possibility of not being able to force payment obligations against the responsible party.”

Specify in your contract that the plan must require the payer to pay, he said. That way, if a payer fails to pay, the plan has breached its contract obligation.

Contract terms that involve medical necessity also can lead to frustration if not properly negotiated. In some cases, the fine print states that medical necessity will be determined by the plan’s medical director or otherwise will be ultimately decided by the payer. Instead, include language specifying that a treating physician’s professional opinion will be entitled to great deference if medical necessity comes into question, Mr. Kopson said.

The process surrounding clean claims is often overlooked by physicians during contract negotiations, he added. The “gotcha” occurs when a plan retains full control over how contested claims are handled.

“If you don’t adequately address this in the contract, you wind up with the payer taking multiple bites of the apple,” Mr. Kopson said.

Make sure to clarify parameters for how long insurers have to request additional information about a claim and whether they must pay a portion of the claim that is being contested, he advised. Include a firm time line of when payers must complete their review and address payment after the requested information is provided.

Another critical issue: changes to the contract. In some cases, doctors enter into a contract with a plan and then the plan decides some details aren’t working out and makes changes. The physician later learns that the contract language allowed the plan to make unilateral changes. In other instances, a plan institutes new products and doctors learn that they had only a certain timeframe to opt out.

To avoid these situations, specify during contract negotiations that policies in conflict with the contract are prohibited, that contract changes can only be made bilaterally, and that unless you directly opt-in to new products, you will not participate.

Mr. Kopson encouraged physicians to have a solid exit strategy in their contracts and to ensure terms regarding contract termination are clearly understood. Clearly defined criteria around “cause” for termination are imperative, he said. Additionally, if a plan alleges a termination breach, require it to send a written notice to a specific person/title and ensure that the notice also is provided to counsel.

The bottom line: To avoid trouble later, strongly negotiate at the start of a managed care contract, Mr. Kopson said.

“If you don’t ask, if you don’t negotiate it in there, you’re not going to have that weapon,” he said.

agallegos@frontlinemedcom.com

On Twitter @legal_med

CHICAGO – Too often, physicians sign managed care contracts without negotiating or truly understanding all the terms. The complex clauses – or lack thereof – can come back to bite doctors in the form of delayed payments, sudden policy changes, and termination woes, health law attorney Mark S. Kopson warned at conference held by the American Bar Association.

To avoid these unwelcome surprises, prepare for contract discussions well before the conversation starts, Mr. Kopson advised.

Alicia Gallegos/Frontline Medical News

“Don’t go into any negotiation unless you know two things. The first is what your starting position will be and, equally if not more important, is what is your ultimate line in the sand?” said Mr. Kopson, who practices in Bloomfield Hills, Mich. “If you go in there not knowing those answers, you’re liable to give away the store or not get what you really need.”

One major “gotcha” is an insurer that does not reveal upfront that it is not the actual payer, Mr. Kopson said. Some national companies that enter into contracts with doctors are basically network aggregators that negotiate price discounts but then sell the network to the health insurance marketplace, he explained. Physicians later realize their contract states that the company is not responsible for paying claims and that the doctor does not have a contract directly with the payer.

“This is a really big issue that I’ve been seeing more and more frequently,” Mr. Kopson said at the meeting. “If you don’t have a direct contract with the payer, you have the possibility of not being able to force payment obligations against the responsible party.”

Specify in your contract that the plan must require the payer to pay, he said. That way, if a payer fails to pay, the plan has breached its contract obligation.

Contract terms that involve medical necessity also can lead to frustration if not properly negotiated. In some cases, the fine print states that medical necessity will be determined by the plan’s medical director or otherwise will be ultimately decided by the payer. Instead, include language specifying that a treating physician’s professional opinion will be entitled to great deference if medical necessity comes into question, Mr. Kopson said.

The process surrounding clean claims is often overlooked by physicians during contract negotiations, he added. The “gotcha” occurs when a plan retains full control over how contested claims are handled.

“If you don’t adequately address this in the contract, you wind up with the payer taking multiple bites of the apple,” Mr. Kopson said.

Make sure to clarify parameters for how long insurers have to request additional information about a claim and whether they must pay a portion of the claim that is being contested, he advised. Include a firm time line of when payers must complete their review and address payment after the requested information is provided.

Another critical issue: changes to the contract. In some cases, doctors enter into a contract with a plan and then the plan decides some details aren’t working out and makes changes. The physician later learns that the contract language allowed the plan to make unilateral changes. In other instances, a plan institutes new products and doctors learn that they had only a certain timeframe to opt out.

To avoid these situations, specify during contract negotiations that policies in conflict with the contract are prohibited, that contract changes can only be made bilaterally, and that unless you directly opt-in to new products, you will not participate.

Mr. Kopson encouraged physicians to have a solid exit strategy in their contracts and to ensure terms regarding contract termination are clearly understood. Clearly defined criteria around “cause” for termination are imperative, he said. Additionally, if a plan alleges a termination breach, require it to send a written notice to a specific person/title and ensure that the notice also is provided to counsel.

The bottom line: To avoid trouble later, strongly negotiate at the start of a managed care contract, Mr. Kopson said.

“If you don’t ask, if you don’t negotiate it in there, you’re not going to have that weapon,” he said.

agallegos@frontlinemedcom.com

On Twitter @legal_med

Patients with Barrett’s esophagus, a condition in which cells lining the esophagus are replaced by the type of cells that normally line the intestine, need to be monitored carefully to prevent the development of esophageal cancer, a gastroenterologist expert in the condition said here at Digestive Diseases: New Advances. The condition can occur following exposure to stomach acids and bile from gastroesophageal reflux disease (GERD).

“The reason we worry about Barrett’s is because it’s a major risk factor for developing esophageal adenocarcinoma, and that’s a tumor that has been experiencing an enormous increase in frequency over the past few decades,” said Dr. Stuart Spechler, chief of gastroenterology for the VA North Texas Healthcare System and co-director of the Esophageal Diseases Center at the University of Texas Southwestern Medical Center in Dallas.

The incidence of esophageal adenocarcinoma increased more than sevenfold over 33 years, going from 3.6 per million in 1973 to 25.6 per million in 2006. Barrett’s esophagus affects about 5.6% of U.S. adults, he noted.

Endoscopic screening for Barrett’s esophagus is recommended for patients with multiple risk factors for esophageal cancer, including chronic GERD (having GERD for more than 5 years), hiatal hernia, age of at least 50 years, male gender, white race, and an elevated body mass index, especially if there’s an intra-abdominal body fat distribution, Dr. Spechler said.

Barrett’s esophagus traditionally is treated with proton pump inhibitors because of their ability to decrease gastric acid production and acid reflux and heal reflux esophagitis. “We also recommend that these patients have regular endoscopic surveillance to look for precancerous changes,” most notably dysplasia, he said. If no dysplasia is found, patients should receive a repeat endoscopy every 3-5 years. Patients with high-grade dysplasia should be treated with endoscopic eradication therapy. The risk of developing cancer in patients with high-grade dysplasia is about 6% per year, he said, which is “sufficient to warrant intervention.”

For patients with visible mucosal irregularities, endoscopic mucosal resection can determine how far the neoplasms have spread, Dr. Spechler said.

For those neoplasms confined to the mucosa, like high-grade dysplasia, radiofrequency ablation can be used to burn the abnormal mucosa away. As the esophagus heals, normal cells grow back. The procedure is safe and effective and has been shown to prevent neoplastic progression at 1 year, he said – the most serious complication is esophageal stricture (N. Engl. J. Med. 2009;360:2277-88). Radiofrequency ablation also can be considered in patients with low-grade dysplasia, and even for highly selected patients with nondysplastic Barrett’s esophagus deemed to be at increased risk for progression to high-grade dysplasia or cancer.

“We do worry about Barrett’s esophagus recurring after endoscopic eradication, and there is a rate of recurrence, but this newer treatment seems to be very effective, at least in the short term, for preventing progression to cancer,” he said.

More advanced cancers can be treated by surgery and chemotherapy or radiation therapy.

Overall, “this is a condition that’s increasing in frequency, and we do worry about it, but as long as you are treating patients, screening for Barrett’s esophagus, and following them regularly with surveillance, the prognosis for any individual patient is really excellent,” he said at the meeting, which was held by Global Academy for Medical Education and Rutgers, the State University of New Jersey. Global Academy and this news organization are owned by the same company.

Dr. Spechler has served a consultant for Takeda Pharmaceuticals and is currently a consultant for Interpace Diagnostics.

Patients with Barrett’s esophagus, a condition in which cells lining the esophagus are replaced by the type of cells that normally line the intestine, need to be monitored carefully to prevent the development of esophageal cancer, a gastroenterologist expert in the condition said here at Digestive Diseases: New Advances. The condition can occur following exposure to stomach acids and bile from gastroesophageal reflux disease (GERD).

“The reason we worry about Barrett’s is because it’s a major risk factor for developing esophageal adenocarcinoma, and that’s a tumor that has been experiencing an enormous increase in frequency over the past few decades,” said Dr. Stuart Spechler, chief of gastroenterology for the VA North Texas Healthcare System and co-director of the Esophageal Diseases Center at the University of Texas Southwestern Medical Center in Dallas.

The incidence of esophageal adenocarcinoma increased more than sevenfold over 33 years, going from 3.6 per million in 1973 to 25.6 per million in 2006. Barrett’s esophagus affects about 5.6% of U.S. adults, he noted.

Endoscopic screening for Barrett’s esophagus is recommended for patients with multiple risk factors for esophageal cancer, including chronic GERD (having GERD for more than 5 years), hiatal hernia, age of at least 50 years, male gender, white race, and an elevated body mass index, especially if there’s an intra-abdominal body fat distribution, Dr. Spechler said.

Barrett’s esophagus traditionally is treated with proton pump inhibitors because of their ability to decrease gastric acid production and acid reflux and heal reflux esophagitis. “We also recommend that these patients have regular endoscopic surveillance to look for precancerous changes,” most notably dysplasia, he said. If no dysplasia is found, patients should receive a repeat endoscopy every 3-5 years. Patients with high-grade dysplasia should be treated with endoscopic eradication therapy. The risk of developing cancer in patients with high-grade dysplasia is about 6% per year, he said, which is “sufficient to warrant intervention.”

For patients with visible mucosal irregularities, endoscopic mucosal resection can determine how far the neoplasms have spread, Dr. Spechler said.

For those neoplasms confined to the mucosa, like high-grade dysplasia, radiofrequency ablation can be used to burn the abnormal mucosa away. As the esophagus heals, normal cells grow back. The procedure is safe and effective and has been shown to prevent neoplastic progression at 1 year, he said – the most serious complication is esophageal stricture (N. Engl. J. Med. 2009;360:2277-88). Radiofrequency ablation also can be considered in patients with low-grade dysplasia, and even for highly selected patients with nondysplastic Barrett’s esophagus deemed to be at increased risk for progression to high-grade dysplasia or cancer.

“We do worry about Barrett’s esophagus recurring after endoscopic eradication, and there is a rate of recurrence, but this newer treatment seems to be very effective, at least in the short term, for preventing progression to cancer,” he said.

More advanced cancers can be treated by surgery and chemotherapy or radiation therapy.

Overall, “this is a condition that’s increasing in frequency, and we do worry about it, but as long as you are treating patients, screening for Barrett’s esophagus, and following them regularly with surveillance, the prognosis for any individual patient is really excellent,” he said at the meeting, which was held by Global Academy for Medical Education and Rutgers, the State University of New Jersey. Global Academy and this news organization are owned by the same company.

Dr. Spechler has served a consultant for Takeda Pharmaceuticals and is currently a consultant for Interpace Diagnostics.

Patients with Barrett’s esophagus, a condition in which cells lining the esophagus are replaced by the type of cells that normally line the intestine, need to be monitored carefully to prevent the development of esophageal cancer, a gastroenterologist expert in the condition said here at Digestive Diseases: New Advances. The condition can occur following exposure to stomach acids and bile from gastroesophageal reflux disease (GERD).

“The reason we worry about Barrett’s is because it’s a major risk factor for developing esophageal adenocarcinoma, and that’s a tumor that has been experiencing an enormous increase in frequency over the past few decades,” said Dr. Stuart Spechler, chief of gastroenterology for the VA North Texas Healthcare System and co-director of the Esophageal Diseases Center at the University of Texas Southwestern Medical Center in Dallas.

The incidence of esophageal adenocarcinoma increased more than sevenfold over 33 years, going from 3.6 per million in 1973 to 25.6 per million in 2006. Barrett’s esophagus affects about 5.6% of U.S. adults, he noted.

Endoscopic screening for Barrett’s esophagus is recommended for patients with multiple risk factors for esophageal cancer, including chronic GERD (having GERD for more than 5 years), hiatal hernia, age of at least 50 years, male gender, white race, and an elevated body mass index, especially if there’s an intra-abdominal body fat distribution, Dr. Spechler said.

Barrett’s esophagus traditionally is treated with proton pump inhibitors because of their ability to decrease gastric acid production and acid reflux and heal reflux esophagitis. “We also recommend that these patients have regular endoscopic surveillance to look for precancerous changes,” most notably dysplasia, he said. If no dysplasia is found, patients should receive a repeat endoscopy every 3-5 years. Patients with high-grade dysplasia should be treated with endoscopic eradication therapy. The risk of developing cancer in patients with high-grade dysplasia is about 6% per year, he said, which is “sufficient to warrant intervention.”

For patients with visible mucosal irregularities, endoscopic mucosal resection can determine how far the neoplasms have spread, Dr. Spechler said.

For those neoplasms confined to the mucosa, like high-grade dysplasia, radiofrequency ablation can be used to burn the abnormal mucosa away. As the esophagus heals, normal cells grow back. The procedure is safe and effective and has been shown to prevent neoplastic progression at 1 year, he said – the most serious complication is esophageal stricture (N. Engl. J. Med. 2009;360:2277-88). Radiofrequency ablation also can be considered in patients with low-grade dysplasia, and even for highly selected patients with nondysplastic Barrett’s esophagus deemed to be at increased risk for progression to high-grade dysplasia or cancer.

“We do worry about Barrett’s esophagus recurring after endoscopic eradication, and there is a rate of recurrence, but this newer treatment seems to be very effective, at least in the short term, for preventing progression to cancer,” he said.

More advanced cancers can be treated by surgery and chemotherapy or radiation therapy.

Overall, “this is a condition that’s increasing in frequency, and we do worry about it, but as long as you are treating patients, screening for Barrett’s esophagus, and following them regularly with surveillance, the prognosis for any individual patient is really excellent,” he said at the meeting, which was held by Global Academy for Medical Education and Rutgers, the State University of New Jersey. Global Academy and this news organization are owned by the same company.

Dr. Spechler has served a consultant for Takeda Pharmaceuticals and is currently a consultant for Interpace Diagnostics.

GAITHERSBURG, MD. – The benefit-risk profile of the PCSK9 inhibitor evolocumab, injected subcutaneously once or twice a month, supports its approval for treating hypercholesterolemia in certain high-risk populations, a Food and Drug Administration advisory panel has agreed.

At a meeting on June 10, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 15-0 that evolocumab should be approved for treating patients aged 12 years and older and adults with homozygous familial hypercholesterolemia (HoFH), based on its impact on lowering low-density lipoprotein cholesterol (LDL-C) in patients and what is currently known about its safety profile.

In a separate vote on other populations included in the indication proposed by Amgen, the panel voted 11-4 to recommend approval for treating other types of patients but limited it to patients at higher CVD risk and elevated LDL-C levels, particularly those with heterozygous FH. There also was support for approval for other higher-risk patients, such as those at high risk for CVD and high LDL-C levels and those with high LDL-C levels on maximum statin doses, but there was not support for approval for lower-risk groups, such as those with mixed hyperlipidemia.

Amgen has proposed that evolocumab be approved for patients with HoFH, as well as adults with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia.

With these votes, it is likely that evolocumab will be approved this year since the FDA usually follows the recommendations of its advisory panels. Evolocumab and another PCSK9 inhibitor, alirocumab – which the majority of the panel recommended for approval the day before – will be the first in this new class of lipid-lowering agents to be approved in the United States. The recommended doses for adults with primary hyperlipidemia and mixed dyslipidemia are 140 mg every 2 weeks or 420 mg once a month; 420 mg every 2 or 4 weeks is recommended for those with HoFH.

PCSK9 inhibitors are human monoclonal antibodies that bind to proprotein convertase subtilisin kexin type 9 (PCSK9), a serine protease that is involved in the regulation of LDL receptor (LDL-R). Inactivation of PCSK9 results in an increase of LDL-R available to clear LDL-C, reducing LDL-C levels.

The data presented by Amgen include four 12-week, phase III double-blind randomized studies comparing the two doses of evolocumab to placebo and/or ezetimibe in about 3,100 patients. The four studies involved patients with HoFH, patients at high CV risk on background statin therapy, patients on monotherapy with diet as background therapy, and patients intolerant to statins who were on no or low-dose statin. The primary efficacy endpoint was reduction n LDL-C at 10-12 weeks.

Both dosing regimens resulted in significantly lower LDL-C levels from baseline, compared with placebo and ezetimibe. Treatment with the two doses resulted in “consistent, clinically equivalent” LDL-C reductions in patients with primary hyperlipidemia and those with mixed dyslipidemia, with reductions of 55%-75% compared with placebo and 35%-45% compared with ezetimibe. Effects were maintained over 2 years in an open-label extension study in different subgroups, including gender and region, according to Amgen.

In a phase III study of 49 patients with HoFH treated with 420 mg once a month or placebo, evolocumab was associated with LDL-C reductions of about 31%, compared with placebo. In phase II and III studies of almost 5,000 patients who received evolocumab, the overall incidence of adverse events was similar to the comparators, and adverse events in long-term studies were similar to those seen in the initial studies, according to Amgen. To date, no major safety issues have been associated with evolocumab, including in patients with very low LDL-C levels (below 25 mg/dL or 40 mg/dL), compared with levels of 40 mg/dL or greater, according to the company.

Adverse events of interest include neurocognitive events and glycemic changes, recently reported with statins. The incidence of new-onset diabetes was low and similar between those on evolocumab and comparators, although there was a “small imbalance” in glycemic changes in patients on evolocumab, a risk that cannot be ruled out and will be monitored in ongoing studies, including the CV outcomes study, according to Amgen. In phase II and III studies, over a median exposure of about 3 months, the rate of neurocognitive adverse events was low and there was no association between low and very low LDL-C levels and neurocognitive events. Most adverse events were rash and eczema and were mild to moderate.

Although the panel agreed there was no major safety signal of concern in the studies, which was reassuring, the members said that safety issues should continue to be followed and that whether very low levels of LDL-C may be associated with adverse events remained an open question and needed to be studied on a long-term basis, including in the CV outcomes study. The concern was raised that, if LDL-C levels dropped to low levels, some clinicians might reduce or withdraw the statin.

As with alirocumab, the panel was asked to discuss whether the impact on LDL-C with evolocumab was sufficient to demonstrate an effect on clinical outcomes; historically, the FDA has considered reductions in LDL-C sufficient to establish the effectiveness of a lipid-lowering drug and does not require that benefit be shown in a CV outcomes trial before approval, “provided the reduction is sufficiently robust” and the product does not have any safety issues that raise concerns about the benefit-risk profile, according to the FDA. Although several panelists said that, while the drug targets LDL-C via a mechanism that is fairly close to the statin target, which provided more confidence in using LDL-C as a surrogate for CV benefit, they said this question can only be answered definitely with the CV outcomes trial.

The CV outcomes study, the FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk), has been fully enrolled, with about 27,500 patients, and is expected to be completed no later than 2017, according to Amgen. The study also will provide safety data in more than 5,000 patients with LDL-C levels below 40 mg/dL.

The FDA usually follows the recommendations of its advisory panels. The FDA panelists had no potential conflicts of interest. A decision is expected by Aug. 27. If approved, Amgen plans to market evolocumab as Repatha.

emechcatie@frontlinemedcom.com

GAITHERSBURG, MD. – The benefit-risk profile of the PCSK9 inhibitor evolocumab, injected subcutaneously once or twice a month, supports its approval for treating hypercholesterolemia in certain high-risk populations, a Food and Drug Administration advisory panel has agreed.

At a meeting on June 10, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 15-0 that evolocumab should be approved for treating patients aged 12 years and older and adults with homozygous familial hypercholesterolemia (HoFH), based on its impact on lowering low-density lipoprotein cholesterol (LDL-C) in patients and what is currently known about its safety profile.

In a separate vote on other populations included in the indication proposed by Amgen, the panel voted 11-4 to recommend approval for treating other types of patients but limited it to patients at higher CVD risk and elevated LDL-C levels, particularly those with heterozygous FH. There also was support for approval for other higher-risk patients, such as those at high risk for CVD and high LDL-C levels and those with high LDL-C levels on maximum statin doses, but there was not support for approval for lower-risk groups, such as those with mixed hyperlipidemia.

Amgen has proposed that evolocumab be approved for patients with HoFH, as well as adults with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia.

With these votes, it is likely that evolocumab will be approved this year since the FDA usually follows the recommendations of its advisory panels. Evolocumab and another PCSK9 inhibitor, alirocumab – which the majority of the panel recommended for approval the day before – will be the first in this new class of lipid-lowering agents to be approved in the United States. The recommended doses for adults with primary hyperlipidemia and mixed dyslipidemia are 140 mg every 2 weeks or 420 mg once a month; 420 mg every 2 or 4 weeks is recommended for those with HoFH.

PCSK9 inhibitors are human monoclonal antibodies that bind to proprotein convertase subtilisin kexin type 9 (PCSK9), a serine protease that is involved in the regulation of LDL receptor (LDL-R). Inactivation of PCSK9 results in an increase of LDL-R available to clear LDL-C, reducing LDL-C levels.

The data presented by Amgen include four 12-week, phase III double-blind randomized studies comparing the two doses of evolocumab to placebo and/or ezetimibe in about 3,100 patients. The four studies involved patients with HoFH, patients at high CV risk on background statin therapy, patients on monotherapy with diet as background therapy, and patients intolerant to statins who were on no or low-dose statin. The primary efficacy endpoint was reduction n LDL-C at 10-12 weeks.

Both dosing regimens resulted in significantly lower LDL-C levels from baseline, compared with placebo and ezetimibe. Treatment with the two doses resulted in “consistent, clinically equivalent” LDL-C reductions in patients with primary hyperlipidemia and those with mixed dyslipidemia, with reductions of 55%-75% compared with placebo and 35%-45% compared with ezetimibe. Effects were maintained over 2 years in an open-label extension study in different subgroups, including gender and region, according to Amgen.

In a phase III study of 49 patients with HoFH treated with 420 mg once a month or placebo, evolocumab was associated with LDL-C reductions of about 31%, compared with placebo. In phase II and III studies of almost 5,000 patients who received evolocumab, the overall incidence of adverse events was similar to the comparators, and adverse events in long-term studies were similar to those seen in the initial studies, according to Amgen. To date, no major safety issues have been associated with evolocumab, including in patients with very low LDL-C levels (below 25 mg/dL or 40 mg/dL), compared with levels of 40 mg/dL or greater, according to the company.

Adverse events of interest include neurocognitive events and glycemic changes, recently reported with statins. The incidence of new-onset diabetes was low and similar between those on evolocumab and comparators, although there was a “small imbalance” in glycemic changes in patients on evolocumab, a risk that cannot be ruled out and will be monitored in ongoing studies, including the CV outcomes study, according to Amgen. In phase II and III studies, over a median exposure of about 3 months, the rate of neurocognitive adverse events was low and there was no association between low and very low LDL-C levels and neurocognitive events. Most adverse events were rash and eczema and were mild to moderate.

Although the panel agreed there was no major safety signal of concern in the studies, which was reassuring, the members said that safety issues should continue to be followed and that whether very low levels of LDL-C may be associated with adverse events remained an open question and needed to be studied on a long-term basis, including in the CV outcomes study. The concern was raised that, if LDL-C levels dropped to low levels, some clinicians might reduce or withdraw the statin.

As with alirocumab, the panel was asked to discuss whether the impact on LDL-C with evolocumab was sufficient to demonstrate an effect on clinical outcomes; historically, the FDA has considered reductions in LDL-C sufficient to establish the effectiveness of a lipid-lowering drug and does not require that benefit be shown in a CV outcomes trial before approval, “provided the reduction is sufficiently robust” and the product does not have any safety issues that raise concerns about the benefit-risk profile, according to the FDA. Although several panelists said that, while the drug targets LDL-C via a mechanism that is fairly close to the statin target, which provided more confidence in using LDL-C as a surrogate for CV benefit, they said this question can only be answered definitely with the CV outcomes trial.

The CV outcomes study, the FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk), has been fully enrolled, with about 27,500 patients, and is expected to be completed no later than 2017, according to Amgen. The study also will provide safety data in more than 5,000 patients with LDL-C levels below 40 mg/dL.

The FDA usually follows the recommendations of its advisory panels. The FDA panelists had no potential conflicts of interest. A decision is expected by Aug. 27. If approved, Amgen plans to market evolocumab as Repatha.

emechcatie@frontlinemedcom.com

GAITHERSBURG, MD. – The benefit-risk profile of the PCSK9 inhibitor evolocumab, injected subcutaneously once or twice a month, supports its approval for treating hypercholesterolemia in certain high-risk populations, a Food and Drug Administration advisory panel has agreed.

At a meeting on June 10, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 15-0 that evolocumab should be approved for treating patients aged 12 years and older and adults with homozygous familial hypercholesterolemia (HoFH), based on its impact on lowering low-density lipoprotein cholesterol (LDL-C) in patients and what is currently known about its safety profile.

In a separate vote on other populations included in the indication proposed by Amgen, the panel voted 11-4 to recommend approval for treating other types of patients but limited it to patients at higher CVD risk and elevated LDL-C levels, particularly those with heterozygous FH. There also was support for approval for other higher-risk patients, such as those at high risk for CVD and high LDL-C levels and those with high LDL-C levels on maximum statin doses, but there was not support for approval for lower-risk groups, such as those with mixed hyperlipidemia.

Amgen has proposed that evolocumab be approved for patients with HoFH, as well as adults with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia.

With these votes, it is likely that evolocumab will be approved this year since the FDA usually follows the recommendations of its advisory panels. Evolocumab and another PCSK9 inhibitor, alirocumab – which the majority of the panel recommended for approval the day before – will be the first in this new class of lipid-lowering agents to be approved in the United States. The recommended doses for adults with primary hyperlipidemia and mixed dyslipidemia are 140 mg every 2 weeks or 420 mg once a month; 420 mg every 2 or 4 weeks is recommended for those with HoFH.

PCSK9 inhibitors are human monoclonal antibodies that bind to proprotein convertase subtilisin kexin type 9 (PCSK9), a serine protease that is involved in the regulation of LDL receptor (LDL-R). Inactivation of PCSK9 results in an increase of LDL-R available to clear LDL-C, reducing LDL-C levels.

The data presented by Amgen include four 12-week, phase III double-blind randomized studies comparing the two doses of evolocumab to placebo and/or ezetimibe in about 3,100 patients. The four studies involved patients with HoFH, patients at high CV risk on background statin therapy, patients on monotherapy with diet as background therapy, and patients intolerant to statins who were on no or low-dose statin. The primary efficacy endpoint was reduction n LDL-C at 10-12 weeks.

Both dosing regimens resulted in significantly lower LDL-C levels from baseline, compared with placebo and ezetimibe. Treatment with the two doses resulted in “consistent, clinically equivalent” LDL-C reductions in patients with primary hyperlipidemia and those with mixed dyslipidemia, with reductions of 55%-75% compared with placebo and 35%-45% compared with ezetimibe. Effects were maintained over 2 years in an open-label extension study in different subgroups, including gender and region, according to Amgen.

In a phase III study of 49 patients with HoFH treated with 420 mg once a month or placebo, evolocumab was associated with LDL-C reductions of about 31%, compared with placebo. In phase II and III studies of almost 5,000 patients who received evolocumab, the overall incidence of adverse events was similar to the comparators, and adverse events in long-term studies were similar to those seen in the initial studies, according to Amgen. To date, no major safety issues have been associated with evolocumab, including in patients with very low LDL-C levels (below 25 mg/dL or 40 mg/dL), compared with levels of 40 mg/dL or greater, according to the company.

Adverse events of interest include neurocognitive events and glycemic changes, recently reported with statins. The incidence of new-onset diabetes was low and similar between those on evolocumab and comparators, although there was a “small imbalance” in glycemic changes in patients on evolocumab, a risk that cannot be ruled out and will be monitored in ongoing studies, including the CV outcomes study, according to Amgen. In phase II and III studies, over a median exposure of about 3 months, the rate of neurocognitive adverse events was low and there was no association between low and very low LDL-C levels and neurocognitive events. Most adverse events were rash and eczema and were mild to moderate.

Although the panel agreed there was no major safety signal of concern in the studies, which was reassuring, the members said that safety issues should continue to be followed and that whether very low levels of LDL-C may be associated with adverse events remained an open question and needed to be studied on a long-term basis, including in the CV outcomes study. The concern was raised that, if LDL-C levels dropped to low levels, some clinicians might reduce or withdraw the statin.

As with alirocumab, the panel was asked to discuss whether the impact on LDL-C with evolocumab was sufficient to demonstrate an effect on clinical outcomes; historically, the FDA has considered reductions in LDL-C sufficient to establish the effectiveness of a lipid-lowering drug and does not require that benefit be shown in a CV outcomes trial before approval, “provided the reduction is sufficiently robust” and the product does not have any safety issues that raise concerns about the benefit-risk profile, according to the FDA. Although several panelists said that, while the drug targets LDL-C via a mechanism that is fairly close to the statin target, which provided more confidence in using LDL-C as a surrogate for CV benefit, they said this question can only be answered definitely with the CV outcomes trial.

The CV outcomes study, the FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk), has been fully enrolled, with about 27,500 patients, and is expected to be completed no later than 2017, according to Amgen. The study also will provide safety data in more than 5,000 patients with LDL-C levels below 40 mg/dL.

The FDA usually follows the recommendations of its advisory panels. The FDA panelists had no potential conflicts of interest. A decision is expected by Aug. 27. If approved, Amgen plans to market evolocumab as Repatha.

emechcatie@frontlinemedcom.com

Individuals with chronic ischemic mitral regurgitation who undergo mitral valve replacement show significantly superior exercise performance up to almost 3½ years after the operation when compared with those who have restrictive mitral valve annuloplasty, according to a study in the June issue of the Journal of Cardiovascular Surgery. (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.03.003]).

Doctors at three institutions in France, Italy, and the United Kingdom set out to predict what factors determined long-term functional capacity in patients with chronic ischemic mitral regurgitation (CIMR) who had either mitral valve replacement (MVR) or annuloplasty. They performed a retrospective analysis of 121 patients with significant chronic mitral regurgitation, 62 of whom had restrictive mitral valve annuloplasty and 59 of whom underwent MVR between 2005 and 2011. All the subjects had a resting echocardiography and a 6-minute treadmill test before their procedures and again at an average of 41 months afterwards. The MVR group walked an average of 37 meters farther at the postoperative stress test, whereas the annuloplasty patients walked on average 24 meters less than their preoperative test.

“The most important finding of this study is that, in patients with CIMR who underwent mitral valve surgery, the improvement in functional capacity at long-term follow-up is mainly related to the type of treatment and to the mitral valve hemodynamic performance, as expressed by changes in IEOA [indexed effective orifice area] during exercise,” reported lead author Dr. Carlo Fino of the Bristol (England) Heart Institute and Pope John XXIII Hospital in Bergamo, Italy, and his colleagues. Investigators from Hospital Dupuytren in Limoges, France, also participated.

The study noted inconclusive results of previous reports of patients treated for mitral regurgitation: the Cardiothoracic Surgical Trials Network study that showed similar 1-year outcomes among patients who had either MVR or annuloplasty (N. Engl. J. Med. 2014;370:23-32) ; an earlier study that showed annuloplasty patients may develop functional mitral stenosis with decreasing functional capacity (J. Am. Coll. Cardiol. 2008;51:1692-1701); and Dr. Fino and colleagues’ previous work that showed worse hemodynamics in annuloplasty patients, compared with MVR counterparts (J. Thorac. Cardiovasc. Surg. 2014;148:447-53).

Other comparative measures the latest study evaluated were: change in exercise indexed effective orifice area, increasing from 1.3 to 1.5 cm²/m² in the MVR group vs. 1.1 to 1.2 cm²/m² in the annuloplasty group; change in mean mitral gradients from rest to exercise, which increased significantly in both groups – from 4.3 to 9 mm Hg in the replacement group and 4.4 to 11 mm Hg in the annuloplasty group; postoperative cardiovascular events – 8% in the MVR group and 21% in the annuloplasty population; and follow-up survival – 88% for MVR vs. 83% for annuloplasty.

The annuloplasty patients received either a Carpentier-Edwards Physio ring (71%) or Carpentier-Edwards Classic ring (29%); Edwards Lifesciences. The MVR group received either a biological or mechanical prosthesis, although the study did not report how many of each. All patients had associated coronary bypass grafting surgery and all achieved complete revascularization. The MVR and annuloplasty groups were similar in terms of demographics and cardiac function, although a higher percentage of patients in the annuloplasty group had severe mitral regurgitation preoperatively – 41% vs. 32% in the MVR group.

Procedures like annuloplasty that aim to restore ventricular geometry or target the subvalvular mechanism “seem to be promising but they require further scientific evidence,” Dr. Fino and his coauthors said. They suggested that until 24-month results from the Cardiothoracic Surgical Trials Network are available, MVR with chordal sparing might be a “reliable option” for patients with chronic ischemic mitral regurgitation.

The authors had no disclosures.

Individuals with chronic ischemic mitral regurgitation who undergo mitral valve replacement show significantly superior exercise performance up to almost 3½ years after the operation when compared with those who have restrictive mitral valve annuloplasty, according to a study in the June issue of the Journal of Cardiovascular Surgery. (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.03.003]).

Doctors at three institutions in France, Italy, and the United Kingdom set out to predict what factors determined long-term functional capacity in patients with chronic ischemic mitral regurgitation (CIMR) who had either mitral valve replacement (MVR) or annuloplasty. They performed a retrospective analysis of 121 patients with significant chronic mitral regurgitation, 62 of whom had restrictive mitral valve annuloplasty and 59 of whom underwent MVR between 2005 and 2011. All the subjects had a resting echocardiography and a 6-minute treadmill test before their procedures and again at an average of 41 months afterwards. The MVR group walked an average of 37 meters farther at the postoperative stress test, whereas the annuloplasty patients walked on average 24 meters less than their preoperative test.

“The most important finding of this study is that, in patients with CIMR who underwent mitral valve surgery, the improvement in functional capacity at long-term follow-up is mainly related to the type of treatment and to the mitral valve hemodynamic performance, as expressed by changes in IEOA [indexed effective orifice area] during exercise,” reported lead author Dr. Carlo Fino of the Bristol (England) Heart Institute and Pope John XXIII Hospital in Bergamo, Italy, and his colleagues. Investigators from Hospital Dupuytren in Limoges, France, also participated.

The study noted inconclusive results of previous reports of patients treated for mitral regurgitation: the Cardiothoracic Surgical Trials Network study that showed similar 1-year outcomes among patients who had either MVR or annuloplasty (N. Engl. J. Med. 2014;370:23-32) ; an earlier study that showed annuloplasty patients may develop functional mitral stenosis with decreasing functional capacity (J. Am. Coll. Cardiol. 2008;51:1692-1701); and Dr. Fino and colleagues’ previous work that showed worse hemodynamics in annuloplasty patients, compared with MVR counterparts (J. Thorac. Cardiovasc. Surg. 2014;148:447-53).

Other comparative measures the latest study evaluated were: change in exercise indexed effective orifice area, increasing from 1.3 to 1.5 cm²/m² in the MVR group vs. 1.1 to 1.2 cm²/m² in the annuloplasty group; change in mean mitral gradients from rest to exercise, which increased significantly in both groups – from 4.3 to 9 mm Hg in the replacement group and 4.4 to 11 mm Hg in the annuloplasty group; postoperative cardiovascular events – 8% in the MVR group and 21% in the annuloplasty population; and follow-up survival – 88% for MVR vs. 83% for annuloplasty.

The annuloplasty patients received either a Carpentier-Edwards Physio ring (71%) or Carpentier-Edwards Classic ring (29%); Edwards Lifesciences. The MVR group received either a biological or mechanical prosthesis, although the study did not report how many of each. All patients had associated coronary bypass grafting surgery and all achieved complete revascularization. The MVR and annuloplasty groups were similar in terms of demographics and cardiac function, although a higher percentage of patients in the annuloplasty group had severe mitral regurgitation preoperatively – 41% vs. 32% in the MVR group.

Procedures like annuloplasty that aim to restore ventricular geometry or target the subvalvular mechanism “seem to be promising but they require further scientific evidence,” Dr. Fino and his coauthors said. They suggested that until 24-month results from the Cardiothoracic Surgical Trials Network are available, MVR with chordal sparing might be a “reliable option” for patients with chronic ischemic mitral regurgitation.

The authors had no disclosures.

Individuals with chronic ischemic mitral regurgitation who undergo mitral valve replacement show significantly superior exercise performance up to almost 3½ years after the operation when compared with those who have restrictive mitral valve annuloplasty, according to a study in the June issue of the Journal of Cardiovascular Surgery. (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.03.003]).

Doctors at three institutions in France, Italy, and the United Kingdom set out to predict what factors determined long-term functional capacity in patients with chronic ischemic mitral regurgitation (CIMR) who had either mitral valve replacement (MVR) or annuloplasty. They performed a retrospective analysis of 121 patients with significant chronic mitral regurgitation, 62 of whom had restrictive mitral valve annuloplasty and 59 of whom underwent MVR between 2005 and 2011. All the subjects had a resting echocardiography and a 6-minute treadmill test before their procedures and again at an average of 41 months afterwards. The MVR group walked an average of 37 meters farther at the postoperative stress test, whereas the annuloplasty patients walked on average 24 meters less than their preoperative test.

“The most important finding of this study is that, in patients with CIMR who underwent mitral valve surgery, the improvement in functional capacity at long-term follow-up is mainly related to the type of treatment and to the mitral valve hemodynamic performance, as expressed by changes in IEOA [indexed effective orifice area] during exercise,” reported lead author Dr. Carlo Fino of the Bristol (England) Heart Institute and Pope John XXIII Hospital in Bergamo, Italy, and his colleagues. Investigators from Hospital Dupuytren in Limoges, France, also participated.

The study noted inconclusive results of previous reports of patients treated for mitral regurgitation: the Cardiothoracic Surgical Trials Network study that showed similar 1-year outcomes among patients who had either MVR or annuloplasty (N. Engl. J. Med. 2014;370:23-32) ; an earlier study that showed annuloplasty patients may develop functional mitral stenosis with decreasing functional capacity (J. Am. Coll. Cardiol. 2008;51:1692-1701); and Dr. Fino and colleagues’ previous work that showed worse hemodynamics in annuloplasty patients, compared with MVR counterparts (J. Thorac. Cardiovasc. Surg. 2014;148:447-53).

Other comparative measures the latest study evaluated were: change in exercise indexed effective orifice area, increasing from 1.3 to 1.5 cm²/m² in the MVR group vs. 1.1 to 1.2 cm²/m² in the annuloplasty group; change in mean mitral gradients from rest to exercise, which increased significantly in both groups – from 4.3 to 9 mm Hg in the replacement group and 4.4 to 11 mm Hg in the annuloplasty group; postoperative cardiovascular events – 8% in the MVR group and 21% in the annuloplasty population; and follow-up survival – 88% for MVR vs. 83% for annuloplasty.

The annuloplasty patients received either a Carpentier-Edwards Physio ring (71%) or Carpentier-Edwards Classic ring (29%); Edwards Lifesciences. The MVR group received either a biological or mechanical prosthesis, although the study did not report how many of each. All patients had associated coronary bypass grafting surgery and all achieved complete revascularization. The MVR and annuloplasty groups were similar in terms of demographics and cardiac function, although a higher percentage of patients in the annuloplasty group had severe mitral regurgitation preoperatively – 41% vs. 32% in the MVR group.

Procedures like annuloplasty that aim to restore ventricular geometry or target the subvalvular mechanism “seem to be promising but they require further scientific evidence,” Dr. Fino and his coauthors said. They suggested that until 24-month results from the Cardiothoracic Surgical Trials Network are available, MVR with chordal sparing might be a “reliable option” for patients with chronic ischemic mitral regurgitation.

The authors had no disclosures.

WASHINGTON – Data are so integral to the transition to value-based care that the health care industry must begin to think of itself as an information industry, according to Centers for Medicare & Medicaid Services Acting Administrator Andy Slavitt.

“Health care will either remain a series of best guesses or it will turn into an information industry,” Mr. Slavitt said during his keynote address at an annual conference on health data transparency. This “requires an enormous amount of change and it is our job to help everyone adapt and succeed. The implication for us at CMS is that we need to be more modern, more strategic, and culturally a fast-moving, responsive, and transparent agency that leads and enables change.”

Gregory Twachtman/Frontline Medical News

Mr. Slavitt identified four key areas for focus: privacy and security, real consumer benefit, learning and productivity, and connectivity. To improve his agency’s connectivity to providers, Mr. Slavitt said that it has recently created a new email box – noinformationblocking@cms.hhs.gov – to allow doctors and others who are experiencing information blocking issues to help the agency address concerns.

“Data blocking will not be tolerated,” Mr. Slavitt said. “We don’t experience care in silos and our data can’t live in silos.”

To spur the transition to a more information-based health care industry, Mr. Slavitt announced a number of data-sharing initiatives aimed at spurring on further data transparency.

First, the agency will be releasing its data to commercial entities. “We are aiming directly at shaking up health care innovation and setting a new standard for data transparency,” Mr. Slavitt said.

Innovators will have access to granular CMS program data, including de-identified Medicare fee-for-service claims data, with the hopes that they will be able to create care management and predictive modeling tools.

“While this is a big departure, we do this with a clear expectation that you will create a new stream of tools that will improve care and personalized decision-making and we are allowing companies to combine CMS data with other data so even what were small silos of data can have enough credibility to have meaning,” he said, challenging other organizations to open up their proprietary databases and match CMS’ move to open its data to commercial interests.

Mr. Slavitt also announced that data updates will be available on a quarterly basis. “In an information age, it is just not acceptable that the most recent Medicare data available to researchers is from 2013.”

He called on innovators to build products not for just the healthiest and wealthiest, but for the sickest in the population.

gtwachtman@frontlinemedcom.com

WASHINGTON – Data are so integral to the transition to value-based care that the health care industry must begin to think of itself as an information industry, according to Centers for Medicare & Medicaid Services Acting Administrator Andy Slavitt.

“Health care will either remain a series of best guesses or it will turn into an information industry,” Mr. Slavitt said during his keynote address at an annual conference on health data transparency. This “requires an enormous amount of change and it is our job to help everyone adapt and succeed. The implication for us at CMS is that we need to be more modern, more strategic, and culturally a fast-moving, responsive, and transparent agency that leads and enables change.”

Gregory Twachtman/Frontline Medical News

Mr. Slavitt identified four key areas for focus: privacy and security, real consumer benefit, learning and productivity, and connectivity. To improve his agency’s connectivity to providers, Mr. Slavitt said that it has recently created a new email box – noinformationblocking@cms.hhs.gov – to allow doctors and others who are experiencing information blocking issues to help the agency address concerns.

“Data blocking will not be tolerated,” Mr. Slavitt said. “We don’t experience care in silos and our data can’t live in silos.”

To spur the transition to a more information-based health care industry, Mr. Slavitt announced a number of data-sharing initiatives aimed at spurring on further data transparency.

First, the agency will be releasing its data to commercial entities. “We are aiming directly at shaking up health care innovation and setting a new standard for data transparency,” Mr. Slavitt said.

Innovators will have access to granular CMS program data, including de-identified Medicare fee-for-service claims data, with the hopes that they will be able to create care management and predictive modeling tools.

“While this is a big departure, we do this with a clear expectation that you will create a new stream of tools that will improve care and personalized decision-making and we are allowing companies to combine CMS data with other data so even what were small silos of data can have enough credibility to have meaning,” he said, challenging other organizations to open up their proprietary databases and match CMS’ move to open its data to commercial interests.

Mr. Slavitt also announced that data updates will be available on a quarterly basis. “In an information age, it is just not acceptable that the most recent Medicare data available to researchers is from 2013.”

He called on innovators to build products not for just the healthiest and wealthiest, but for the sickest in the population.

gtwachtman@frontlinemedcom.com

WASHINGTON – Data are so integral to the transition to value-based care that the health care industry must begin to think of itself as an information industry, according to Centers for Medicare & Medicaid Services Acting Administrator Andy Slavitt.

“Health care will either remain a series of best guesses or it will turn into an information industry,” Mr. Slavitt said during his keynote address at an annual conference on health data transparency. This “requires an enormous amount of change and it is our job to help everyone adapt and succeed. The implication for us at CMS is that we need to be more modern, more strategic, and culturally a fast-moving, responsive, and transparent agency that leads and enables change.”

Gregory Twachtman/Frontline Medical News

Mr. Slavitt identified four key areas for focus: privacy and security, real consumer benefit, learning and productivity, and connectivity. To improve his agency’s connectivity to providers, Mr. Slavitt said that it has recently created a new email box – noinformationblocking@cms.hhs.gov – to allow doctors and others who are experiencing information blocking issues to help the agency address concerns.

“Data blocking will not be tolerated,” Mr. Slavitt said. “We don’t experience care in silos and our data can’t live in silos.”

To spur the transition to a more information-based health care industry, Mr. Slavitt announced a number of data-sharing initiatives aimed at spurring on further data transparency.

First, the agency will be releasing its data to commercial entities. “We are aiming directly at shaking up health care innovation and setting a new standard for data transparency,” Mr. Slavitt said.

Innovators will have access to granular CMS program data, including de-identified Medicare fee-for-service claims data, with the hopes that they will be able to create care management and predictive modeling tools.

“While this is a big departure, we do this with a clear expectation that you will create a new stream of tools that will improve care and personalized decision-making and we are allowing companies to combine CMS data with other data so even what were small silos of data can have enough credibility to have meaning,” he said, challenging other organizations to open up their proprietary databases and match CMS’ move to open its data to commercial interests.

Mr. Slavitt also announced that data updates will be available on a quarterly basis. “In an information age, it is just not acceptable that the most recent Medicare data available to researchers is from 2013.”

He called on innovators to build products not for just the healthiest and wealthiest, but for the sickest in the population.

gtwachtman@frontlinemedcom.com

A government watchdog report suggests that the Centers for Medicare & Medicaid Services may be setting Medicare payment rates inaccurately based on biased recommendations from its panel of physician experts.

The Government Accountability Office (GAO) questions the transparency of the CMS’ rate calculation process and suggests that members of the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC) have conflicts of interest that affect their ability to fairly value physician services, according to a report published May 21.

©sndr/istockphoto.com

The GAO report recommends that the CMS better document its process for establishing relative values and develop a process to inform the public of potentially misvalued services identified by the RUC. The CMS also should develop a plan for using funds appropriated for the collection and use of information on physicians’ services in the determination of relative values, the report stated.

In response, the American Medical Association defended the expertise and objectivity of the RUC, stressing that there is no substitute for input from experienced physicians regarding the time and resources that go into medical services.

“The RUC’s valuable expertise is balanced with the oversight of government officials who have the final say,” an AMA spokesperson said in an interview. “When CMS’ initial efforts to identify potentially misvalued services were unable to obtain reliable data from government contractors, physicians on the RUC took on this important task. When gauging how much time and resources go into one medical service compared with another, no one knows more about what is involved in providing services to Medicare patients than the physicians who care for them.”

Dr. Robert L. Wergin, president of the American Academy of Family Physicians (AAFP) said the GAO report findings are consistent with previous concerns raised by the AAFP about the RUC.

“We have advocated for more transparency” in the past, Dr. Wergin said in an interview. “We have requested that the RUC expose the survey process, and we’ve also given input that we improve it [and] make it more accurate. Adding transparency to the process might be a way to improve it.”

In its review, the GAO – a nonpartisan investigational agency of Congress – cited several weaknesses in the data collected by the RUC, including that some RUC survey data had low response rates, a low total number of responses, and large ranges in responses.

For example, the GAO found that the median number of responses to surveys for payment year 2015 was 52 but the median response rate was only 2%, and that 23 of the 231 surveys had under 30 respondents.

The report also questions the transparency of the CMS process for establishing relative values. Although the CMS states that it complies with statutory requirements to review all Medicare services every 5 years, the agency does not maintain a database to track when a service was last valued or have a documented standardized process for prioritizing its reviews, according to the GAO report.

The CMS also does not publish the potentially misvalued services identified by the RUC, so stakeholders are unaware that these services will be reviewed and payment rates for these services may change.

The report found that the CMS provides some information about its process in its rule-making but does not document the methods used to review specific RUC recommendations. For example, the CMS does not document which resources were considered during its review of RUC recommendations for specific services. The GAO report said the CMS relies too heavily on RUC recommendations when establishing relative values.

“GAO found that, in the majority of cases, CMS accepts the RUC’s recommendations, and participation by other stakeholders is limited,” the report authors said. “Given the process- and data-related weaknesses associated with the RUC’s recommendations, such heavy reliance on the RUC could result in inaccurate Medicare payment rates.”

The AMA argued that the GAO report should have better acknowledged the difficulty in obtaining data on services that are infrequently performed. For example, 80% of services paid with work valuation on the Medicare physician payment schedule have fewer than 10,000 Medicare claims per year, the association noted.

“A service performed 10,000 times per year, is done, on average, less than once per day in any state,” the AMA spokesperson said. “It would be nearly impossible to do accurate direct observation or time/motion studies to collect time data on these low volume services. The survey methodology, followed by rigorous cross-specialty RUC review, is the best way to accomplish this data collection.”

The current GAO report is far from the first to criticize the RUC. The AAFP has long argued that the RUC should include more family physicians, health plans, consumers, employers, and health care economists on its panel. In 2012, the committee added another seat for geriatric medicine and another rotating primary care seat.

In an interview, Dr. Wergin said these additions helped, but that the AAFP would like to see at least one more primary care slot, as well as slots for other stakeholders. In a January 2014 letter, the AAFP called on the CMS to correct what the AAFP referred to as “a disturbing trend seen in the recommendations of RUC.” Specifically, the AAFP urged the CMS to address undervalued services, such as office-based evaluation and management (E/M) codes.

The Medicare Payment Advisory Commission (MedPAC), an independent advisory commission to Congress, has also issued several reports questioning the effectiveness of the RUC, including a 2011 white paper that expressed skepticism about the way in which data is collected by the panel. In 2013, MedPAC executive director Mark E. Miller, in testimony before the Senate Finance Committee, criticized how the RUC operated.

In the last Congress, Rep. Jim McDermott (D-Wash.), ranking member of the Ways and Means Committee’s Subcommittee on Health, introduced the Accuracy in Medicare Physician Payment Act of 2013, which would supplement the work of RUC by establishing an expert panel within Medicare to oversee the valuation of physician services and to help correct distortions in the physician fee schedule. The bill was not considered by the House.

agallegos@frontlinemedcom.com

On Twitter @legal_med

A government watchdog report suggests that the Centers for Medicare & Medicaid Services may be setting Medicare payment rates inaccurately based on biased recommendations from its panel of physician experts.

The Government Accountability Office (GAO) questions the transparency of the CMS’ rate calculation process and suggests that members of the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC) have conflicts of interest that affect their ability to fairly value physician services, according to a report published May 21.

©sndr/istockphoto.com

The GAO report recommends that the CMS better document its process for establishing relative values and develop a process to inform the public of potentially misvalued services identified by the RUC. The CMS also should develop a plan for using funds appropriated for the collection and use of information on physicians’ services in the determination of relative values, the report stated.

In response, the American Medical Association defended the expertise and objectivity of the RUC, stressing that there is no substitute for input from experienced physicians regarding the time and resources that go into medical services.

“The RUC’s valuable expertise is balanced with the oversight of government officials who have the final say,” an AMA spokesperson said in an interview. “When CMS’ initial efforts to identify potentially misvalued services were unable to obtain reliable data from government contractors, physicians on the RUC took on this important task. When gauging how much time and resources go into one medical service compared with another, no one knows more about what is involved in providing services to Medicare patients than the physicians who care for them.”

Dr. Robert L. Wergin, president of the American Academy of Family Physicians (AAFP) said the GAO report findings are consistent with previous concerns raised by the AAFP about the RUC.

“We have advocated for more transparency” in the past, Dr. Wergin said in an interview. “We have requested that the RUC expose the survey process, and we’ve also given input that we improve it [and] make it more accurate. Adding transparency to the process might be a way to improve it.”

In its review, the GAO – a nonpartisan investigational agency of Congress – cited several weaknesses in the data collected by the RUC, including that some RUC survey data had low response rates, a low total number of responses, and large ranges in responses.

For example, the GAO found that the median number of responses to surveys for payment year 2015 was 52 but the median response rate was only 2%, and that 23 of the 231 surveys had under 30 respondents.

The report also questions the transparency of the CMS process for establishing relative values. Although the CMS states that it complies with statutory requirements to review all Medicare services every 5 years, the agency does not maintain a database to track when a service was last valued or have a documented standardized process for prioritizing its reviews, according to the GAO report.

The CMS also does not publish the potentially misvalued services identified by the RUC, so stakeholders are unaware that these services will be reviewed and payment rates for these services may change.

The report found that the CMS provides some information about its process in its rule-making but does not document the methods used to review specific RUC recommendations. For example, the CMS does not document which resources were considered during its review of RUC recommendations for specific services. The GAO report said the CMS relies too heavily on RUC recommendations when establishing relative values.

“GAO found that, in the majority of cases, CMS accepts the RUC’s recommendations, and participation by other stakeholders is limited,” the report authors said. “Given the process- and data-related weaknesses associated with the RUC’s recommendations, such heavy reliance on the RUC could result in inaccurate Medicare payment rates.”

The AMA argued that the GAO report should have better acknowledged the difficulty in obtaining data on services that are infrequently performed. For example, 80% of services paid with work valuation on the Medicare physician payment schedule have fewer than 10,000 Medicare claims per year, the association noted.

“A service performed 10,000 times per year, is done, on average, less than once per day in any state,” the AMA spokesperson said. “It would be nearly impossible to do accurate direct observation or time/motion studies to collect time data on these low volume services. The survey methodology, followed by rigorous cross-specialty RUC review, is the best way to accomplish this data collection.”

The current GAO report is far from the first to criticize the RUC. The AAFP has long argued that the RUC should include more family physicians, health plans, consumers, employers, and health care economists on its panel. In 2012, the committee added another seat for geriatric medicine and another rotating primary care seat.

In an interview, Dr. Wergin said these additions helped, but that the AAFP would like to see at least one more primary care slot, as well as slots for other stakeholders. In a January 2014 letter, the AAFP called on the CMS to correct what the AAFP referred to as “a disturbing trend seen in the recommendations of RUC.” Specifically, the AAFP urged the CMS to address undervalued services, such as office-based evaluation and management (E/M) codes.

The Medicare Payment Advisory Commission (MedPAC), an independent advisory commission to Congress, has also issued several reports questioning the effectiveness of the RUC, including a 2011 white paper that expressed skepticism about the way in which data is collected by the panel. In 2013, MedPAC executive director Mark E. Miller, in testimony before the Senate Finance Committee, criticized how the RUC operated.

In the last Congress, Rep. Jim McDermott (D-Wash.), ranking member of the Ways and Means Committee’s Subcommittee on Health, introduced the Accuracy in Medicare Physician Payment Act of 2013, which would supplement the work of RUC by establishing an expert panel within Medicare to oversee the valuation of physician services and to help correct distortions in the physician fee schedule. The bill was not considered by the House.

agallegos@frontlinemedcom.com

On Twitter @legal_med

A government watchdog report suggests that the Centers for Medicare & Medicaid Services may be setting Medicare payment rates inaccurately based on biased recommendations from its panel of physician experts.

The Government Accountability Office (GAO) questions the transparency of the CMS’ rate calculation process and suggests that members of the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC) have conflicts of interest that affect their ability to fairly value physician services, according to a report published May 21.

©sndr/istockphoto.com

The GAO report recommends that the CMS better document its process for establishing relative values and develop a process to inform the public of potentially misvalued services identified by the RUC. The CMS also should develop a plan for using funds appropriated for the collection and use of information on physicians’ services in the determination of relative values, the report stated.

In response, the American Medical Association defended the expertise and objectivity of the RUC, stressing that there is no substitute for input from experienced physicians regarding the time and resources that go into medical services.

“The RUC’s valuable expertise is balanced with the oversight of government officials who have the final say,” an AMA spokesperson said in an interview. “When CMS’ initial efforts to identify potentially misvalued services were unable to obtain reliable data from government contractors, physicians on the RUC took on this important task. When gauging how much time and resources go into one medical service compared with another, no one knows more about what is involved in providing services to Medicare patients than the physicians who care for them.”

Dr. Robert L. Wergin, president of the American Academy of Family Physicians (AAFP) said the GAO report findings are consistent with previous concerns raised by the AAFP about the RUC.

“We have advocated for more transparency” in the past, Dr. Wergin said in an interview. “We have requested that the RUC expose the survey process, and we’ve also given input that we improve it [and] make it more accurate. Adding transparency to the process might be a way to improve it.”

In its review, the GAO – a nonpartisan investigational agency of Congress – cited several weaknesses in the data collected by the RUC, including that some RUC survey data had low response rates, a low total number of responses, and large ranges in responses.

For example, the GAO found that the median number of responses to surveys for payment year 2015 was 52 but the median response rate was only 2%, and that 23 of the 231 surveys had under 30 respondents.

The report also questions the transparency of the CMS process for establishing relative values. Although the CMS states that it complies with statutory requirements to review all Medicare services every 5 years, the agency does not maintain a database to track when a service was last valued or have a documented standardized process for prioritizing its reviews, according to the GAO report.

The CMS also does not publish the potentially misvalued services identified by the RUC, so stakeholders are unaware that these services will be reviewed and payment rates for these services may change.

The report found that the CMS provides some information about its process in its rule-making but does not document the methods used to review specific RUC recommendations. For example, the CMS does not document which resources were considered during its review of RUC recommendations for specific services. The GAO report said the CMS relies too heavily on RUC recommendations when establishing relative values.

“GAO found that, in the majority of cases, CMS accepts the RUC’s recommendations, and participation by other stakeholders is limited,” the report authors said. “Given the process- and data-related weaknesses associated with the RUC’s recommendations, such heavy reliance on the RUC could result in inaccurate Medicare payment rates.”

The AMA argued that the GAO report should have better acknowledged the difficulty in obtaining data on services that are infrequently performed. For example, 80% of services paid with work valuation on the Medicare physician payment schedule have fewer than 10,000 Medicare claims per year, the association noted.

“A service performed 10,000 times per year, is done, on average, less than once per day in any state,” the AMA spokesperson said. “It would be nearly impossible to do accurate direct observation or time/motion studies to collect time data on these low volume services. The survey methodology, followed by rigorous cross-specialty RUC review, is the best way to accomplish this data collection.”

The current GAO report is far from the first to criticize the RUC. The AAFP has long argued that the RUC should include more family physicians, health plans, consumers, employers, and health care economists on its panel. In 2012, the committee added another seat for geriatric medicine and another rotating primary care seat.

In an interview, Dr. Wergin said these additions helped, but that the AAFP would like to see at least one more primary care slot, as well as slots for other stakeholders. In a January 2014 letter, the AAFP called on the CMS to correct what the AAFP referred to as “a disturbing trend seen in the recommendations of RUC.” Specifically, the AAFP urged the CMS to address undervalued services, such as office-based evaluation and management (E/M) codes.

The Medicare Payment Advisory Commission (MedPAC), an independent advisory commission to Congress, has also issued several reports questioning the effectiveness of the RUC, including a 2011 white paper that expressed skepticism about the way in which data is collected by the panel. In 2013, MedPAC executive director Mark E. Miller, in testimony before the Senate Finance Committee, criticized how the RUC operated.

In the last Congress, Rep. Jim McDermott (D-Wash.), ranking member of the Ways and Means Committee’s Subcommittee on Health, introduced the Accuracy in Medicare Physician Payment Act of 2013, which would supplement the work of RUC by establishing an expert panel within Medicare to oversee the valuation of physician services and to help correct distortions in the physician fee schedule. The bill was not considered by the House.

agallegos@frontlinemedcom.com

On Twitter @legal_med