Naseem S. Miller

Medicare officials have released a coverage proposal for transcatheter aortic valve replacement 3 months after the procedure was approved in the United States.

The Centers for Medicare and Medicaid Services’ proposal restricts the procedure’s coverage to situations in which all of the following five criteria are met:

• The procedure meets Food and Drug Administration–approved criteria, and an FDA-approved device is used.

• Two cardiac surgeons evaluate the patient’s suitability for open valve replacement surgery.

• The procedure is performed in a facility that meets a certain level of experience. The document breaks down the criteria by centers with or without previous transcatheter aortic valve replacement (TAVR) clinical trial experience. All centers are required to participate in a prospective national TAVR stud, and be committed to the Heart Team concept.

• The cardiac surgeon and interventionalist meet certain qualifications and levels of experience.

• The patient is enrolled in the prospective national registry for TAVR. The treating physician team also needs to be participating in the national registry.

The memo arrived ahead of its March 28 due date, just days after four cardiovascular societies issued a document providing detailed guidance on TAVR implementation in centers across the United States. Heart teams, a national registry, and careful selection of patients are also among the societies’ consensus document highlights.

In the United States, the first valve to be used for TAVR (the Edwards Lifesciences Sapien valve) was approved in November 2011. The valve is currently approved for use in inoperable patients with severe aortic stenosis. Other use of the Sapien valve is limited to clinical trials. Medtronic’s CoreValve is also in being studied in large U.S. trials.

In a joint statement, the Society of Thoracic Surgeons and the American College of Cardiology said they were pleased with CMS’s comprehensive approach to the coverage of TAVR, balancing the patients’ needs with measures that would ensure quality of care.

"This coverage analysis achieves these goals through the use of specialized centers with multidisciplinary heart teams and registry enrollment," said STS President Dr. Jeffrey B. Rich, in a statement. "We are especially pleased that CMS has proposed to provide a smooth path to Medicare coverage as the technology continues to evolve and improve," said ACC President Dr. David R. Holmes, in a statement.

CMS opened the national coverage analysis in September, before Sapien was even approved, in response to a request from the ACC and STS to establish the criteria for national Medicare coverage of the minimally invasive valve procedure. The CMS proposal is a step in the national coverage analysis process, in which the agency decides whether an item or service is covered by Medicare.

The agency is expected to have made a final decision by May of this year.

Medicare officials have released a coverage proposal for transcatheter aortic valve replacement 3 months after the procedure was approved in the United States.

The Centers for Medicare and Medicaid Services’ proposal restricts the procedure’s coverage to situations in which all of the following five criteria are met:

• The procedure meets Food and Drug Administration–approved criteria, and an FDA-approved device is used.

• Two cardiac surgeons evaluate the patient’s suitability for open valve replacement surgery.

• The procedure is performed in a facility that meets a certain level of experience. The document breaks down the criteria by centers with or without previous transcatheter aortic valve replacement (TAVR) clinical trial experience. All centers are required to participate in a prospective national TAVR stud, and be committed to the Heart Team concept.

• The cardiac surgeon and interventionalist meet certain qualifications and levels of experience.

• The patient is enrolled in the prospective national registry for TAVR. The treating physician team also needs to be participating in the national registry.

The memo arrived ahead of its March 28 due date, just days after four cardiovascular societies issued a document providing detailed guidance on TAVR implementation in centers across the United States. Heart teams, a national registry, and careful selection of patients are also among the societies’ consensus document highlights.

In the United States, the first valve to be used for TAVR (the Edwards Lifesciences Sapien valve) was approved in November 2011. The valve is currently approved for use in inoperable patients with severe aortic stenosis. Other use of the Sapien valve is limited to clinical trials. Medtronic’s CoreValve is also in being studied in large U.S. trials.

In a joint statement, the Society of Thoracic Surgeons and the American College of Cardiology said they were pleased with CMS’s comprehensive approach to the coverage of TAVR, balancing the patients’ needs with measures that would ensure quality of care.

"This coverage analysis achieves these goals through the use of specialized centers with multidisciplinary heart teams and registry enrollment," said STS President Dr. Jeffrey B. Rich, in a statement. "We are especially pleased that CMS has proposed to provide a smooth path to Medicare coverage as the technology continues to evolve and improve," said ACC President Dr. David R. Holmes, in a statement.

CMS opened the national coverage analysis in September, before Sapien was even approved, in response to a request from the ACC and STS to establish the criteria for national Medicare coverage of the minimally invasive valve procedure. The CMS proposal is a step in the national coverage analysis process, in which the agency decides whether an item or service is covered by Medicare.

The agency is expected to have made a final decision by May of this year.

Medicare officials have released a coverage proposal for transcatheter aortic valve replacement 3 months after the procedure was approved in the United States.

The Centers for Medicare and Medicaid Services’ proposal restricts the procedure’s coverage to situations in which all of the following five criteria are met:

• The procedure meets Food and Drug Administration–approved criteria, and an FDA-approved device is used.

• Two cardiac surgeons evaluate the patient’s suitability for open valve replacement surgery.

• The procedure is performed in a facility that meets a certain level of experience. The document breaks down the criteria by centers with or without previous transcatheter aortic valve replacement (TAVR) clinical trial experience. All centers are required to participate in a prospective national TAVR stud, and be committed to the Heart Team concept.

• The cardiac surgeon and interventionalist meet certain qualifications and levels of experience.

• The patient is enrolled in the prospective national registry for TAVR. The treating physician team also needs to be participating in the national registry.

The memo arrived ahead of its March 28 due date, just days after four cardiovascular societies issued a document providing detailed guidance on TAVR implementation in centers across the United States. Heart teams, a national registry, and careful selection of patients are also among the societies’ consensus document highlights.

In the United States, the first valve to be used for TAVR (the Edwards Lifesciences Sapien valve) was approved in November 2011. The valve is currently approved for use in inoperable patients with severe aortic stenosis. Other use of the Sapien valve is limited to clinical trials. Medtronic’s CoreValve is also in being studied in large U.S. trials.

In a joint statement, the Society of Thoracic Surgeons and the American College of Cardiology said they were pleased with CMS’s comprehensive approach to the coverage of TAVR, balancing the patients’ needs with measures that would ensure quality of care.

"This coverage analysis achieves these goals through the use of specialized centers with multidisciplinary heart teams and registry enrollment," said STS President Dr. Jeffrey B. Rich, in a statement. "We are especially pleased that CMS has proposed to provide a smooth path to Medicare coverage as the technology continues to evolve and improve," said ACC President Dr. David R. Holmes, in a statement.

CMS opened the national coverage analysis in September, before Sapien was even approved, in response to a request from the ACC and STS to establish the criteria for national Medicare coverage of the minimally invasive valve procedure. The CMS proposal is a step in the national coverage analysis process, in which the agency decides whether an item or service is covered by Medicare.

The agency is expected to have made a final decision by May of this year.

Medicare officials have released a coverage proposal for transcatheter aortic valve replacement 3 months after the procedure was approved in the United States.

The Centers for Medicare and Medicaid Services’ proposal restricts the procedure’s coverage to situations in which all of the following five criteria are met:

• The procedure meets Food and Drug Administration–approved criteria, and an FDA-approved device is used.

• Two cardiac surgeons evaluate the patient’s suitability for open valve replacement surgery.

• The procedure is performed in a facility that meets a certain level of experience. The document breaks down the criteria by centers with or without previous transcatheter aortic valve replacement (TAVR) clinical trial experience. All centers are required to participate in a prospective national TAVR stud, and be committed to the Heart Team concept.

• The cardiac surgeon and interventionalist meet certain qualifications and levels of experience.

• The patient is enrolled in the prospective national registry for TAVR. The treating physician team also needs to be participating in the national registry.

The memo arrived ahead of its March 28 due date, just days after four cardiovascular societies issued a document providing detailed guidance on TAVR implementation in centers across the United States. Heart teams, a national registry, and careful selection of patients are also among the societies’ consensus document highlights.

In the United States, the first valve to be used for TAVR (the Edwards Lifesciences Sapien valve) was approved in November 2011. The valve is currently approved for use in inoperable patients with severe aortic stenosis. Other use of the Sapien valve is limited to clinical trials. Medtronic’s CoreValve is also in being studied in large U.S. trials.

In a joint statement, the Society of Thoracic Surgeons and the American College of Cardiology said they were pleased with CMS’s comprehensive approach to the coverage of TAVR, balancing the patients’ needs with measures that would ensure quality of care.

"This coverage analysis achieves these goals through the use of specialized centers with multidisciplinary heart teams and registry enrollment," said STS President Dr. Jeffrey B. Rich, in a statement. "We are especially pleased that CMS has proposed to provide a smooth path to Medicare coverage as the technology continues to evolve and improve," said ACC President Dr. David R. Holmes, in a statement.

CMS opened the national coverage analysis in September, before Sapien was even approved, in response to a request from the ACC and STS to establish the criteria for national Medicare coverage of the minimally invasive valve procedure. The CMS proposal is a step in the national coverage analysis process, in which the agency decides whether an item or service is covered by Medicare.

The agency is expected to have made a final decision by May of this year.

Medicare officials have released a coverage proposal for transcatheter aortic valve replacement 3 months after the procedure was approved in the United States.

The Centers for Medicare and Medicaid Services’ proposal restricts the procedure’s coverage to situations in which all of the following five criteria are met:

• The procedure meets Food and Drug Administration–approved criteria, and an FDA-approved device is used.

• Two cardiac surgeons evaluate the patient’s suitability for open valve replacement surgery.

• The procedure is performed in a facility that meets a certain level of experience. The document breaks down the criteria by centers with or without previous transcatheter aortic valve replacement (TAVR) clinical trial experience. All centers are required to participate in a prospective national TAVR stud, and be committed to the Heart Team concept.

• The cardiac surgeon and interventionalist meet certain qualifications and levels of experience.

• The patient is enrolled in the prospective national registry for TAVR. The treating physician team also needs to be participating in the national registry.

The memo arrived ahead of its March 28 due date, just days after four cardiovascular societies issued a document providing detailed guidance on TAVR implementation in centers across the United States. Heart teams, a national registry, and careful selection of patients are also among the societies’ consensus document highlights.

In the United States, the first valve to be used for TAVR (the Edwards Lifesciences Sapien valve) was approved in November 2011. The valve is currently approved for use in inoperable patients with severe aortic stenosis. Other use of the Sapien valve is limited to clinical trials. Medtronic’s CoreValve is also in being studied in large U.S. trials.

In a joint statement, the Society of Thoracic Surgeons and the American College of Cardiology said they were pleased with CMS’s comprehensive approach to the coverage of TAVR, balancing the patients’ needs with measures that would ensure quality of care.

"This coverage analysis achieves these goals through the use of specialized centers with multidisciplinary heart teams and registry enrollment," said STS President Dr. Jeffrey B. Rich, in a statement. "We are especially pleased that CMS has proposed to provide a smooth path to Medicare coverage as the technology continues to evolve and improve," said ACC President Dr. David R. Holmes, in a statement.

CMS opened the national coverage analysis in September, before Sapien was even approved, in response to a request from the ACC and STS to establish the criteria for national Medicare coverage of the minimally invasive valve procedure. The CMS proposal is a step in the national coverage analysis process, in which the agency decides whether an item or service is covered by Medicare.

The agency is expected to have made a final decision by May of this year.

Medicare officials have released a coverage proposal for transcatheter aortic valve replacement 3 months after the procedure was approved in the United States.

The Centers for Medicare and Medicaid Services’ proposal restricts the procedure’s coverage to situations in which all of the following five criteria are met:

• The procedure meets Food and Drug Administration–approved criteria, and an FDA-approved device is used.

• Two cardiac surgeons evaluate the patient’s suitability for open valve replacement surgery.

• The procedure is performed in a facility that meets a certain level of experience. The document breaks down the criteria by centers with or without previous transcatheter aortic valve replacement (TAVR) clinical trial experience. All centers are required to participate in a prospective national TAVR stud, and be committed to the Heart Team concept.

• The cardiac surgeon and interventionalist meet certain qualifications and levels of experience.

• The patient is enrolled in the prospective national registry for TAVR. The treating physician team also needs to be participating in the national registry.

The memo arrived ahead of its March 28 due date, just days after four cardiovascular societies issued a document providing detailed guidance on TAVR implementation in centers across the United States. Heart teams, a national registry, and careful selection of patients are also among the societies’ consensus document highlights.

In the United States, the first valve to be used for TAVR (the Edwards Lifesciences Sapien valve) was approved in November 2011. The valve is currently approved for use in inoperable patients with severe aortic stenosis. Other use of the Sapien valve is limited to clinical trials. Medtronic’s CoreValve is also in being studied in large U.S. trials.

In a joint statement, the Society of Thoracic Surgeons and the American College of Cardiology said they were pleased with CMS’s comprehensive approach to the coverage of TAVR, balancing the patients’ needs with measures that would ensure quality of care.

"This coverage analysis achieves these goals through the use of specialized centers with multidisciplinary heart teams and registry enrollment," said STS President Dr. Jeffrey B. Rich, in a statement. "We are especially pleased that CMS has proposed to provide a smooth path to Medicare coverage as the technology continues to evolve and improve," said ACC President Dr. David R. Holmes, in a statement.

CMS opened the national coverage analysis in September, before Sapien was even approved, in response to a request from the ACC and STS to establish the criteria for national Medicare coverage of the minimally invasive valve procedure. The CMS proposal is a step in the national coverage analysis process, in which the agency decides whether an item or service is covered by Medicare.

The agency is expected to have made a final decision by May of this year.

Medicare will cover transcatheter aortic valve replacement, or TAVR, under certain conditions, including the presence of a heart team during the procedure and evaluation of the patient by two cardiac surgeons, according to a document released on May 1.

The Centers for Medicare and Medicaid Services’ (CMS’s) final national coverage decision for TAVR arrives as planned, nearly 3 months after the agency released its coverage proposal.

"This decision is particularly important as it highlights cooperative efforts among CMS, the Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality, medical societies, and the medical device industry," said CMS Acting Administrator Marilyn Tavenner in a statement.

Because TAVR is relatively new, the final decision uses "coverage with evidence development," meaning certain criteria must be met as a condition of coverage, according to the statement.

The criteria include:

• The aortic valve and implantation system used in the procedure has received FDA premarket approval.

• Two cardiac surgeons independently examine the patient face-to-face and evaluate the patient’s suitability for open valve replacement surgery.

• Before and after the surgery, the patient is under the care of a heart team: "a cohesive, multidisciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care," according to the decision document. The document breaks down the criteria by centers with or without previous TAVR clinical trial experience.

• The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must work together in the intraoperative technical aspects of TAVR.

• The heart team and hospital are participating in a prospective, national, audited registry.

The agency will cover the procedure in clinical trials that follow criteria listed in the decision memo. Meanwhile, Medicare patients whose comorbidities would prevent them from benefiting from the procedure will not be covered.

CMS also responded to comments, making some changes.

For instance, 23 commenters had disagreed with the requirement that unlabeled uses of TAVR be covered in clinical studies that have superiority designs. Eight had requested that CMS remove the requirement, according to CMS’s final decision memo.

Among those commenters was Edwards Lifesciences, the maker of the Sapien valve.

"CMS’s proposed requirement limiting coverage for unlabeled uses to ‘superiority trials’ undermines the agency’s efforts to promote continued U.S.-based clinical investigations in Medicare beneficiaries aimed at better understanding key determinants of health and quality of life outcomes," according to Edwards’ comments.

"Noninferiority and other clinical trial designs play an important role in the advancement of medical technology," the company added, saying that if the proposed conditions aren’t revised, important, yet relatively small, patient populations may not be able to receive treatment.

Removing the requirement, CMS explained in its final decision memo that "while we believe superiority trial designs provide important advantages that are not completely addressed by non-inferiority design, we recognize that non-inferiority trials have a place in the conduct of medical device regulatory trials. Therefore, we believe a broad non-coverage of non-inferiority trials may have unintended consequences for certain important studies."

CMS opened the national coverage determination analysis in September 2011, before the Edwards Lifesciences Sapien valve was approved, in response to a request from the Society of Thoracic Surgeons and the American College of Cardiology to establish the criteria for national Medicare coverage of the minimally invasive valve procedure.

In the United States, the first valve to be used for TAVR (the Edwards Lifesciences Sapien valve) was approved in November 2011 for use in inoperable patients with severe aortic stenosis. The FDA’s Circulatory System Devices Panel will be meeting to evaluate the Sapien valve’s performance in severe aortic stenosis patients at high surgical risk on June 13. Medtronic’s CoreValve is also in being studied in large U.S. trials.

Medicare will cover transcatheter aortic valve replacement, or TAVR, under certain conditions, including the presence of a heart team during the procedure and evaluation of the patient by two cardiac surgeons, according to a document released on May 1.

The Centers for Medicare and Medicaid Services’ (CMS’s) final national coverage decision for TAVR arrives as planned, nearly 3 months after the agency released its coverage proposal.

"This decision is particularly important as it highlights cooperative efforts among CMS, the Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality, medical societies, and the medical device industry," said CMS Acting Administrator Marilyn Tavenner in a statement.

Because TAVR is relatively new, the final decision uses "coverage with evidence development," meaning certain criteria must be met as a condition of coverage, according to the statement.

The criteria include:

• The aortic valve and implantation system used in the procedure has received FDA premarket approval.

• Two cardiac surgeons independently examine the patient face-to-face and evaluate the patient’s suitability for open valve replacement surgery.

• Before and after the surgery, the patient is under the care of a heart team: "a cohesive, multidisciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care," according to the decision document. The document breaks down the criteria by centers with or without previous TAVR clinical trial experience.

• The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must work together in the intraoperative technical aspects of TAVR.

• The heart team and hospital are participating in a prospective, national, audited registry.

The agency will cover the procedure in clinical trials that follow criteria listed in the decision memo. Meanwhile, Medicare patients whose comorbidities would prevent them from benefiting from the procedure will not be covered.

CMS also responded to comments, making some changes.

For instance, 23 commenters had disagreed with the requirement that unlabeled uses of TAVR be covered in clinical studies that have superiority designs. Eight had requested that CMS remove the requirement, according to CMS’s final decision memo.

Among those commenters was Edwards Lifesciences, the maker of the Sapien valve.

"CMS’s proposed requirement limiting coverage for unlabeled uses to ‘superiority trials’ undermines the agency’s efforts to promote continued U.S.-based clinical investigations in Medicare beneficiaries aimed at better understanding key determinants of health and quality of life outcomes," according to Edwards’ comments.

"Noninferiority and other clinical trial designs play an important role in the advancement of medical technology," the company added, saying that if the proposed conditions aren’t revised, important, yet relatively small, patient populations may not be able to receive treatment.

Removing the requirement, CMS explained in its final decision memo that "while we believe superiority trial designs provide important advantages that are not completely addressed by non-inferiority design, we recognize that non-inferiority trials have a place in the conduct of medical device regulatory trials. Therefore, we believe a broad non-coverage of non-inferiority trials may have unintended consequences for certain important studies."

CMS opened the national coverage determination analysis in September 2011, before the Edwards Lifesciences Sapien valve was approved, in response to a request from the Society of Thoracic Surgeons and the American College of Cardiology to establish the criteria for national Medicare coverage of the minimally invasive valve procedure.

In the United States, the first valve to be used for TAVR (the Edwards Lifesciences Sapien valve) was approved in November 2011 for use in inoperable patients with severe aortic stenosis. The FDA’s Circulatory System Devices Panel will be meeting to evaluate the Sapien valve’s performance in severe aortic stenosis patients at high surgical risk on June 13. Medtronic’s CoreValve is also in being studied in large U.S. trials.

Medicare will cover transcatheter aortic valve replacement, or TAVR, under certain conditions, including the presence of a heart team during the procedure and evaluation of the patient by two cardiac surgeons, according to a document released on May 1.

The Centers for Medicare and Medicaid Services’ (CMS’s) final national coverage decision for TAVR arrives as planned, nearly 3 months after the agency released its coverage proposal.

"This decision is particularly important as it highlights cooperative efforts among CMS, the Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality, medical societies, and the medical device industry," said CMS Acting Administrator Marilyn Tavenner in a statement.

Because TAVR is relatively new, the final decision uses "coverage with evidence development," meaning certain criteria must be met as a condition of coverage, according to the statement.

The criteria include:

• The aortic valve and implantation system used in the procedure has received FDA premarket approval.

• Two cardiac surgeons independently examine the patient face-to-face and evaluate the patient’s suitability for open valve replacement surgery.

• Before and after the surgery, the patient is under the care of a heart team: "a cohesive, multidisciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care," according to the decision document. The document breaks down the criteria by centers with or without previous TAVR clinical trial experience.

• The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must work together in the intraoperative technical aspects of TAVR.

• The heart team and hospital are participating in a prospective, national, audited registry.

The agency will cover the procedure in clinical trials that follow criteria listed in the decision memo. Meanwhile, Medicare patients whose comorbidities would prevent them from benefiting from the procedure will not be covered.

CMS also responded to comments, making some changes.

For instance, 23 commenters had disagreed with the requirement that unlabeled uses of TAVR be covered in clinical studies that have superiority designs. Eight had requested that CMS remove the requirement, according to CMS’s final decision memo.

Among those commenters was Edwards Lifesciences, the maker of the Sapien valve.

"CMS’s proposed requirement limiting coverage for unlabeled uses to ‘superiority trials’ undermines the agency’s efforts to promote continued U.S.-based clinical investigations in Medicare beneficiaries aimed at better understanding key determinants of health and quality of life outcomes," according to Edwards’ comments.

"Noninferiority and other clinical trial designs play an important role in the advancement of medical technology," the company added, saying that if the proposed conditions aren’t revised, important, yet relatively small, patient populations may not be able to receive treatment.

Removing the requirement, CMS explained in its final decision memo that "while we believe superiority trial designs provide important advantages that are not completely addressed by non-inferiority design, we recognize that non-inferiority trials have a place in the conduct of medical device regulatory trials. Therefore, we believe a broad non-coverage of non-inferiority trials may have unintended consequences for certain important studies."

CMS opened the national coverage determination analysis in September 2011, before the Edwards Lifesciences Sapien valve was approved, in response to a request from the Society of Thoracic Surgeons and the American College of Cardiology to establish the criteria for national Medicare coverage of the minimally invasive valve procedure.

In the United States, the first valve to be used for TAVR (the Edwards Lifesciences Sapien valve) was approved in November 2011 for use in inoperable patients with severe aortic stenosis. The FDA’s Circulatory System Devices Panel will be meeting to evaluate the Sapien valve’s performance in severe aortic stenosis patients at high surgical risk on June 13. Medtronic’s CoreValve is also in being studied in large U.S. trials.

Ultrasound, a technology that was once mainly in the purview of radiologists, is becoming an integral part of the surgeon’s toolbox.

Across specialties, an increasing number of surgeons are incorporating ultrasound into their practices, whether in the office or in the operating room, especially as procedures become less invasive.

The once-cumbersome machines have gotten smaller over the past three decades, the technology has improved dramatically, and – compared with some other types of imaging – ultrasound is more cost-effective and affordable, experts say.

"It’s a technology that I think is going to expand in use," said Dr. Jay K. Harness, an early adopter of ultrasound in breast surgery and coauthor of the textbook "Ultrasound in Surgical Practice." "I started using it in the 1990s, and it’s like we’ve gone from analog TV to digital."

Dr. Heidi Frankel, chair of American College of Surgeons’ (ACS) National Ultrasound Faculty, compared the developments in use of ultrasound in surgery to laparoscopy.

"Ultimately, the patients and the market pushed the need for it," said Dr. Frankel, professor of surgery at University of Maryland Shock Trauma Center, Baltimore. "Surgeons who didn’t do it had to learn to do it, and it became part of surgical training. I suspect the same thing is going to happen with ultrasound."

And while training and certification requirements vary widely, the surgeons currently using ultrasound predict that guidelines may ultimately become somewhat standardized within and across specialties.

Breast Surgery

Dr. Harness, who is also a member of the ACS National Ultrasound Faculty and the past-president of the American Society of Breast Surgeons (ASBS), was among the first to incorporate ultrasound into his practice. Today, he said, "for the contemporary breast surgeon, [ultrasound] is a fundamental tool ... Ultrasound is our stethoscope."

In breast surgery, ultrasound is an adjunctive tool for the physical exam, said Dr. Harness. It is used for diagnostic biopsy, and it can speed up the diagnostic process. Ultrasound also is used in the operating room, notably for procedures such as lumpectomies. And finally, ultrasound can help guide the placement of partial breast brachyradiation therapy devices.

Breast surgeons can obtain ultrasound certification through ASBS, although becoming certified is not a requirement. "A major goal of the Society’s breast ultrasound certification program is to improve the quality of care for patients with breast disease by encouraging education and training to advance expertise and clinical competency for surgeons who use ultrasound and ultrasound-guided procedures in their practices," according to the ASBS website.

Dr. Harness said that ultrasound combined with other imaging techniques such as MRI provides the most complete imaging possible, given that there’s no single technology that captures everything.

Abdominal Surgery

In the 1980s, not many surgeons used ultrasound in their day-to-day practice and there were few publications on the topic, said Dr. Junji Machi. At that time, x-rays were commonly used to check areas such as the bile duct for stones. "But, it was cumbersome and took 15-30 minutes. So we used ultrasound instead. It was quicker, and the results were accurate," said Dr. Machi, professor of surgery at University of Hawaii, and director of the Abdominal Ultrasound Module at the ACS.

Dr. Machi has published a number of studies on cases and findings, and he uses ultrasound, especially during liver, biliary, and pancreatic surgery.

"For liver surgery, intraoperative ultrasound is a must," he said. "Without it, we consider the procedure suboptimal, because we may miss lesions and cannot perform the best operations."

Among the indications for ultrasound use in abdominal surgery were laparoscopic procedures, which were introduced in the 1990s, he said. "You can see, but not touch, the tissue," said Dr. Machi. "So we needed something to evaluate under the surface. ... With ultrasound, we can see without much dissection."

Surgeons could be discouraged from using ultrasound because the learning curve is steep (usually several months’ experience is needed) and because the equipment is relatively expensive. Yet, "once you learn it, it’s much more cost effective," he said, adding that this imaging technique does not expose the patient and operative team to radiation.

There’s no specialty limitation in the use of ultrasound, and abdominal surgeons can perform it once they master ultrasound. The ACS ultrasound course is an excellent way to learn, said Dr. Machi. Surgeons receive a certificate upon completion of a course.

Indeed, "the training issues are really paramount," said Dr. Ellen Hagopian, who did her liver training in France, and studied with radiologists and surgeons. Ultrasound is used much more frequently in Europe than in the United States, she said. "I sit on the education and training committee of Americas Hepato-Pancreato-Biliary Association [AHPBA], and I think ultrasound training throughout the fellowship programs needs to be more consistent."

Dr. Hagopian, who sits on ACS’s National Ultrasound Faculty board, coordinated and taught the first advanced ultrasound course in hepato-pancreato-biliary surgery at the AHPBA Annual Meeting in March. The course will be given again this year at the ACS Clinical Congress in San Francisco. Surgeons receive a certification of completion.

"Feedback and interest at AHPBA was excellent," said Dr. Hagopian. "There were many more surgeons who wanted to take the course than we could accommodate." She anticipates that similar interest will be shown during the ACS Clinical Congress.

Head and Neck Surgery

"Basically, the best way to evaluate the thyroid gland is ultrasound," said Dr. Robert Sofferman, an otolaryngologist who does thyroid and parathyroid surgery as part of his practice. "It’s cheaper and incredibly accurate."

Dr. Sofferman, professor emeritus of surgery at the University of Vermont in Burlington, said that some 15 years ago, ultrasound machines were too big and didn’t have good resolution. But over time, the equipment has become smaller, better, portable, and less expensive, he said. He predicts that the machines will eventually shrink to the size of an iPad.

"We operate in the neck on a daily basis," said Dr. Sofferman. "Ultrasound is very helpful for us. I couldn’t do my work without it."

Having the imaging available in the office is also convenient for the patients. "We arrange everything before the patient comes in. We do the physical exam. We do the ultrasound exam. We do ultrasound-guided biopsy, so the patient is done in one visit."

He said ultrasound can be used to evaluate the size and characteristics of a tumor before deciding whether to operate or to monitor the tumor’s response to treatment. "It’s a technology that has some advantages. It’s an extension of our physical examination."

It also comes with a few drawbacks. Aside from the price, which can be upwards of $30,000, ultrasound can slow down the day, and it does have a moderate learning curve, according to Dr. Sofferman.

Neither the ACS nor American Association of Otolaryngology-Head and Neck Surgery (AAO-HNS) require certification for the use of ultrasound. However, the ACS offers training in thyroid/parathyroid ultrasound to all surgeons who do neck surgery, either during the annual Clinical Congress or in other courses. Participants who complete training receive certification from the ACS.

Vascular Surgery

Ultrasound is a major component of vascular surgery training and practice, and many vascular surgeons have obtained the Registered Vascular Technologist (RVT) credential from the American Registry for Diagnostic Medical Sonography (ARDMS.)

While the RVT credential has been available since the 1980s, the ARDMS introduced the Registered Physician in Vascular Interpretation (RPVI) credential in 2006 to provide a certification process that focuses more on interpretation of vascular ultrasound tests than on performing the examinations. The RPVI credential is open to all qualified physicians and is not restricted to vascular surgeons.

"The advantage of the RPVI is that it is a national, standardized credential that is available to all physicians with an interest in vascular testing," said Dr. Gene Zierler, a member of the National Ultrasound Faculty and professor of surgery at the University of Washington, Seattle. "So that means it can document expertise in vascular ultrasound across multiple specialties and training programs."

Starting in 2014, the RPVI will be a requirement for vascular surgery board certification, a decision supported by the Society for Vascular Surgery.

Trauma Surgery

Ultrasound is the quickest and most reliable diagnostic tool under emergency conditions, according to Dr. Frankel.

"We work with very time-sensitive injuries. Ultrasound in my specialty is absolutely necessary. We image trauma patients this way. We can’t wait for a radiologist to come in," she said.

Dr. Frankel, who began using ultrasound in 1994, echoed her colleagues who said that technology has improved over time. Her hospital has begun using ultrasound in the intensive care unit, and "our residents are starting to use it early on. And medical students are picking it up," she said.

Whether surgeons are permitted to use ultrasound in the hospital varies by system or institution. Hospitals may require board-certified surgeons to perform a certain number of ultrasound procedures before granting them certification or to show certain certification or credentialing in ultrasound, experts said.

"There’s no science [to show] how many of these procedures I should have done to get credentialed by the hospital to use ultrasound," Dr. Frankel said.

She and other surgeons predicted that the individual surgical societies will ultimately specify the training, certification, or accreditation requirements for performing ultrasound. In the meantime, ultrasound seems to be finding its place in surgery, and surgeons who have been using it say they wouldn’t practice without it.

"It adds to the joy of practicing medicine," said Dr. Sofferman. "It makes it enjoyable for us to be able to see everything. That’s a definite advantage. I couldn’t be as efficient and as accurate without it."

None of the surgeons reported any relevant disclosures.

Ultrasound, a technology that was once mainly in the purview of radiologists, is becoming an integral part of the surgeon’s toolbox.

Across specialties, an increasing number of surgeons are incorporating ultrasound into their practices, whether in the office or in the operating room, especially as procedures become less invasive.

The once-cumbersome machines have gotten smaller over the past three decades, the technology has improved dramatically, and – compared with some other types of imaging – ultrasound is more cost-effective and affordable, experts say.

"It’s a technology that I think is going to expand in use," said Dr. Jay K. Harness, an early adopter of ultrasound in breast surgery and coauthor of the textbook "Ultrasound in Surgical Practice." "I started using it in the 1990s, and it’s like we’ve gone from analog TV to digital."

Dr. Heidi Frankel, chair of American College of Surgeons’ (ACS) National Ultrasound Faculty, compared the developments in use of ultrasound in surgery to laparoscopy.

"Ultimately, the patients and the market pushed the need for it," said Dr. Frankel, professor of surgery at University of Maryland Shock Trauma Center, Baltimore. "Surgeons who didn’t do it had to learn to do it, and it became part of surgical training. I suspect the same thing is going to happen with ultrasound."

And while training and certification requirements vary widely, the surgeons currently using ultrasound predict that guidelines may ultimately become somewhat standardized within and across specialties.

Breast Surgery

Dr. Harness, who is also a member of the ACS National Ultrasound Faculty and the past-president of the American Society of Breast Surgeons (ASBS), was among the first to incorporate ultrasound into his practice. Today, he said, "for the contemporary breast surgeon, [ultrasound] is a fundamental tool ... Ultrasound is our stethoscope."

In breast surgery, ultrasound is an adjunctive tool for the physical exam, said Dr. Harness. It is used for diagnostic biopsy, and it can speed up the diagnostic process. Ultrasound also is used in the operating room, notably for procedures such as lumpectomies. And finally, ultrasound can help guide the placement of partial breast brachyradiation therapy devices.

Breast surgeons can obtain ultrasound certification through ASBS, although becoming certified is not a requirement. "A major goal of the Society’s breast ultrasound certification program is to improve the quality of care for patients with breast disease by encouraging education and training to advance expertise and clinical competency for surgeons who use ultrasound and ultrasound-guided procedures in their practices," according to the ASBS website.

Dr. Harness said that ultrasound combined with other imaging techniques such as MRI provides the most complete imaging possible, given that there’s no single technology that captures everything.

Abdominal Surgery

In the 1980s, not many surgeons used ultrasound in their day-to-day practice and there were few publications on the topic, said Dr. Junji Machi. At that time, x-rays were commonly used to check areas such as the bile duct for stones. "But, it was cumbersome and took 15-30 minutes. So we used ultrasound instead. It was quicker, and the results were accurate," said Dr. Machi, professor of surgery at University of Hawaii, and director of the Abdominal Ultrasound Module at the ACS.

Dr. Machi has published a number of studies on cases and findings, and he uses ultrasound, especially during liver, biliary, and pancreatic surgery.

"For liver surgery, intraoperative ultrasound is a must," he said. "Without it, we consider the procedure suboptimal, because we may miss lesions and cannot perform the best operations."

Among the indications for ultrasound use in abdominal surgery were laparoscopic procedures, which were introduced in the 1990s, he said. "You can see, but not touch, the tissue," said Dr. Machi. "So we needed something to evaluate under the surface. ... With ultrasound, we can see without much dissection."

Surgeons could be discouraged from using ultrasound because the learning curve is steep (usually several months’ experience is needed) and because the equipment is relatively expensive. Yet, "once you learn it, it’s much more cost effective," he said, adding that this imaging technique does not expose the patient and operative team to radiation.

There’s no specialty limitation in the use of ultrasound, and abdominal surgeons can perform it once they master ultrasound. The ACS ultrasound course is an excellent way to learn, said Dr. Machi. Surgeons receive a certificate upon completion of a course.

Indeed, "the training issues are really paramount," said Dr. Ellen Hagopian, who did her liver training in France, and studied with radiologists and surgeons. Ultrasound is used much more frequently in Europe than in the United States, she said. "I sit on the education and training committee of Americas Hepato-Pancreato-Biliary Association [AHPBA], and I think ultrasound training throughout the fellowship programs needs to be more consistent."

Dr. Hagopian, who sits on ACS’s National Ultrasound Faculty board, coordinated and taught the first advanced ultrasound course in hepato-pancreato-biliary surgery at the AHPBA Annual Meeting in March. The course will be given again this year at the ACS Clinical Congress in San Francisco. Surgeons receive a certification of completion.

"Feedback and interest at AHPBA was excellent," said Dr. Hagopian. "There were many more surgeons who wanted to take the course than we could accommodate." She anticipates that similar interest will be shown during the ACS Clinical Congress.

Head and Neck Surgery

"Basically, the best way to evaluate the thyroid gland is ultrasound," said Dr. Robert Sofferman, an otolaryngologist who does thyroid and parathyroid surgery as part of his practice. "It’s cheaper and incredibly accurate."

Dr. Sofferman, professor emeritus of surgery at the University of Vermont in Burlington, said that some 15 years ago, ultrasound machines were too big and didn’t have good resolution. But over time, the equipment has become smaller, better, portable, and less expensive, he said. He predicts that the machines will eventually shrink to the size of an iPad.

"We operate in the neck on a daily basis," said Dr. Sofferman. "Ultrasound is very helpful for us. I couldn’t do my work without it."

Having the imaging available in the office is also convenient for the patients. "We arrange everything before the patient comes in. We do the physical exam. We do the ultrasound exam. We do ultrasound-guided biopsy, so the patient is done in one visit."

He said ultrasound can be used to evaluate the size and characteristics of a tumor before deciding whether to operate or to monitor the tumor’s response to treatment. "It’s a technology that has some advantages. It’s an extension of our physical examination."

It also comes with a few drawbacks. Aside from the price, which can be upwards of $30,000, ultrasound can slow down the day, and it does have a moderate learning curve, according to Dr. Sofferman.

Neither the ACS nor American Association of Otolaryngology-Head and Neck Surgery (AAO-HNS) require certification for the use of ultrasound. However, the ACS offers training in thyroid/parathyroid ultrasound to all surgeons who do neck surgery, either during the annual Clinical Congress or in other courses. Participants who complete training receive certification from the ACS.

Vascular Surgery

Ultrasound is a major component of vascular surgery training and practice, and many vascular surgeons have obtained the Registered Vascular Technologist (RVT) credential from the American Registry for Diagnostic Medical Sonography (ARDMS.)

While the RVT credential has been available since the 1980s, the ARDMS introduced the Registered Physician in Vascular Interpretation (RPVI) credential in 2006 to provide a certification process that focuses more on interpretation of vascular ultrasound tests than on performing the examinations. The RPVI credential is open to all qualified physicians and is not restricted to vascular surgeons.

"The advantage of the RPVI is that it is a national, standardized credential that is available to all physicians with an interest in vascular testing," said Dr. Gene Zierler, a member of the National Ultrasound Faculty and professor of surgery at the University of Washington, Seattle. "So that means it can document expertise in vascular ultrasound across multiple specialties and training programs."

Starting in 2014, the RPVI will be a requirement for vascular surgery board certification, a decision supported by the Society for Vascular Surgery.

Trauma Surgery

Ultrasound is the quickest and most reliable diagnostic tool under emergency conditions, according to Dr. Frankel.

"We work with very time-sensitive injuries. Ultrasound in my specialty is absolutely necessary. We image trauma patients this way. We can’t wait for a radiologist to come in," she said.

Dr. Frankel, who began using ultrasound in 1994, echoed her colleagues who said that technology has improved over time. Her hospital has begun using ultrasound in the intensive care unit, and "our residents are starting to use it early on. And medical students are picking it up," she said.

Whether surgeons are permitted to use ultrasound in the hospital varies by system or institution. Hospitals may require board-certified surgeons to perform a certain number of ultrasound procedures before granting them certification or to show certain certification or credentialing in ultrasound, experts said.

"There’s no science [to show] how many of these procedures I should have done to get credentialed by the hospital to use ultrasound," Dr. Frankel said.

She and other surgeons predicted that the individual surgical societies will ultimately specify the training, certification, or accreditation requirements for performing ultrasound. In the meantime, ultrasound seems to be finding its place in surgery, and surgeons who have been using it say they wouldn’t practice without it.

"It adds to the joy of practicing medicine," said Dr. Sofferman. "It makes it enjoyable for us to be able to see everything. That’s a definite advantage. I couldn’t be as efficient and as accurate without it."

None of the surgeons reported any relevant disclosures.

Ultrasound, a technology that was once mainly in the purview of radiologists, is becoming an integral part of the surgeon’s toolbox.

Across specialties, an increasing number of surgeons are incorporating ultrasound into their practices, whether in the office or in the operating room, especially as procedures become less invasive.

The once-cumbersome machines have gotten smaller over the past three decades, the technology has improved dramatically, and – compared with some other types of imaging – ultrasound is more cost-effective and affordable, experts say.

"It’s a technology that I think is going to expand in use," said Dr. Jay K. Harness, an early adopter of ultrasound in breast surgery and coauthor of the textbook "Ultrasound in Surgical Practice." "I started using it in the 1990s, and it’s like we’ve gone from analog TV to digital."

Dr. Heidi Frankel, chair of American College of Surgeons’ (ACS) National Ultrasound Faculty, compared the developments in use of ultrasound in surgery to laparoscopy.

"Ultimately, the patients and the market pushed the need for it," said Dr. Frankel, professor of surgery at University of Maryland Shock Trauma Center, Baltimore. "Surgeons who didn’t do it had to learn to do it, and it became part of surgical training. I suspect the same thing is going to happen with ultrasound."

And while training and certification requirements vary widely, the surgeons currently using ultrasound predict that guidelines may ultimately become somewhat standardized within and across specialties.

Breast Surgery

Dr. Harness, who is also a member of the ACS National Ultrasound Faculty and the past-president of the American Society of Breast Surgeons (ASBS), was among the first to incorporate ultrasound into his practice. Today, he said, "for the contemporary breast surgeon, [ultrasound] is a fundamental tool ... Ultrasound is our stethoscope."

In breast surgery, ultrasound is an adjunctive tool for the physical exam, said Dr. Harness. It is used for diagnostic biopsy, and it can speed up the diagnostic process. Ultrasound also is used in the operating room, notably for procedures such as lumpectomies. And finally, ultrasound can help guide the placement of partial breast brachyradiation therapy devices.

Breast surgeons can obtain ultrasound certification through ASBS, although becoming certified is not a requirement. "A major goal of the Society’s breast ultrasound certification program is to improve the quality of care for patients with breast disease by encouraging education and training to advance expertise and clinical competency for surgeons who use ultrasound and ultrasound-guided procedures in their practices," according to the ASBS website.

Dr. Harness said that ultrasound combined with other imaging techniques such as MRI provides the most complete imaging possible, given that there’s no single technology that captures everything.

Abdominal Surgery

In the 1980s, not many surgeons used ultrasound in their day-to-day practice and there were few publications on the topic, said Dr. Junji Machi. At that time, x-rays were commonly used to check areas such as the bile duct for stones. "But, it was cumbersome and took 15-30 minutes. So we used ultrasound instead. It was quicker, and the results were accurate," said Dr. Machi, professor of surgery at University of Hawaii, and director of the Abdominal Ultrasound Module at the ACS.

Dr. Machi has published a number of studies on cases and findings, and he uses ultrasound, especially during liver, biliary, and pancreatic surgery.

"For liver surgery, intraoperative ultrasound is a must," he said. "Without it, we consider the procedure suboptimal, because we may miss lesions and cannot perform the best operations."

Among the indications for ultrasound use in abdominal surgery were laparoscopic procedures, which were introduced in the 1990s, he said. "You can see, but not touch, the tissue," said Dr. Machi. "So we needed something to evaluate under the surface. ... With ultrasound, we can see without much dissection."

Surgeons could be discouraged from using ultrasound because the learning curve is steep (usually several months’ experience is needed) and because the equipment is relatively expensive. Yet, "once you learn it, it’s much more cost effective," he said, adding that this imaging technique does not expose the patient and operative team to radiation.

There’s no specialty limitation in the use of ultrasound, and abdominal surgeons can perform it once they master ultrasound. The ACS ultrasound course is an excellent way to learn, said Dr. Machi. Surgeons receive a certificate upon completion of a course.

Indeed, "the training issues are really paramount," said Dr. Ellen Hagopian, who did her liver training in France, and studied with radiologists and surgeons. Ultrasound is used much more frequently in Europe than in the United States, she said. "I sit on the education and training committee of Americas Hepato-Pancreato-Biliary Association [AHPBA], and I think ultrasound training throughout the fellowship programs needs to be more consistent."

Dr. Hagopian, who sits on ACS’s National Ultrasound Faculty board, coordinated and taught the first advanced ultrasound course in hepato-pancreato-biliary surgery at the AHPBA Annual Meeting in March. The course will be given again this year at the ACS Clinical Congress in San Francisco. Surgeons receive a certification of completion.

"Feedback and interest at AHPBA was excellent," said Dr. Hagopian. "There were many more surgeons who wanted to take the course than we could accommodate." She anticipates that similar interest will be shown during the ACS Clinical Congress.

Head and Neck Surgery

"Basically, the best way to evaluate the thyroid gland is ultrasound," said Dr. Robert Sofferman, an otolaryngologist who does thyroid and parathyroid surgery as part of his practice. "It’s cheaper and incredibly accurate."

Dr. Sofferman, professor emeritus of surgery at the University of Vermont in Burlington, said that some 15 years ago, ultrasound machines were too big and didn’t have good resolution. But over time, the equipment has become smaller, better, portable, and less expensive, he said. He predicts that the machines will eventually shrink to the size of an iPad.

"We operate in the neck on a daily basis," said Dr. Sofferman. "Ultrasound is very helpful for us. I couldn’t do my work without it."

Having the imaging available in the office is also convenient for the patients. "We arrange everything before the patient comes in. We do the physical exam. We do the ultrasound exam. We do ultrasound-guided biopsy, so the patient is done in one visit."

He said ultrasound can be used to evaluate the size and characteristics of a tumor before deciding whether to operate or to monitor the tumor’s response to treatment. "It’s a technology that has some advantages. It’s an extension of our physical examination."

It also comes with a few drawbacks. Aside from the price, which can be upwards of $30,000, ultrasound can slow down the day, and it does have a moderate learning curve, according to Dr. Sofferman.

Neither the ACS nor American Association of Otolaryngology-Head and Neck Surgery (AAO-HNS) require certification for the use of ultrasound. However, the ACS offers training in thyroid/parathyroid ultrasound to all surgeons who do neck surgery, either during the annual Clinical Congress or in other courses. Participants who complete training receive certification from the ACS.

Vascular Surgery

Ultrasound is a major component of vascular surgery training and practice, and many vascular surgeons have obtained the Registered Vascular Technologist (RVT) credential from the American Registry for Diagnostic Medical Sonography (ARDMS.)

While the RVT credential has been available since the 1980s, the ARDMS introduced the Registered Physician in Vascular Interpretation (RPVI) credential in 2006 to provide a certification process that focuses more on interpretation of vascular ultrasound tests than on performing the examinations. The RPVI credential is open to all qualified physicians and is not restricted to vascular surgeons.

"The advantage of the RPVI is that it is a national, standardized credential that is available to all physicians with an interest in vascular testing," said Dr. Gene Zierler, a member of the National Ultrasound Faculty and professor of surgery at the University of Washington, Seattle. "So that means it can document expertise in vascular ultrasound across multiple specialties and training programs."

Starting in 2014, the RPVI will be a requirement for vascular surgery board certification, a decision supported by the Society for Vascular Surgery.

Trauma Surgery

Ultrasound is the quickest and most reliable diagnostic tool under emergency conditions, according to Dr. Frankel.

"We work with very time-sensitive injuries. Ultrasound in my specialty is absolutely necessary. We image trauma patients this way. We can’t wait for a radiologist to come in," she said.

Dr. Frankel, who began using ultrasound in 1994, echoed her colleagues who said that technology has improved over time. Her hospital has begun using ultrasound in the intensive care unit, and "our residents are starting to use it early on. And medical students are picking it up," she said.

Whether surgeons are permitted to use ultrasound in the hospital varies by system or institution. Hospitals may require board-certified surgeons to perform a certain number of ultrasound procedures before granting them certification or to show certain certification or credentialing in ultrasound, experts said.

"There’s no science [to show] how many of these procedures I should have done to get credentialed by the hospital to use ultrasound," Dr. Frankel said.

She and other surgeons predicted that the individual surgical societies will ultimately specify the training, certification, or accreditation requirements for performing ultrasound. In the meantime, ultrasound seems to be finding its place in surgery, and surgeons who have been using it say they wouldn’t practice without it.

"It adds to the joy of practicing medicine," said Dr. Sofferman. "It makes it enjoyable for us to be able to see everything. That’s a definite advantage. I couldn’t be as efficient and as accurate without it."

None of the surgeons reported any relevant disclosures.

New federal regulations aim to accelerate the use of electronic payments to health care providers while reducing administrative costs and saving resources.

The interim final regulations – part of a series of regulations coming from the Department of Health and Human Services – standardize the format and content of the transmissions that health plans send to banks when paying claims via electronic funds transfer (EFT) and will require plans to use a trace number to match the EFT with the remittance advice sent to providers. Currently the EFT and the remittance documents are sent to providers separately, and matching them is difficult.

The new standards took effect on Jan. 1; full compliance will be required by Jan. 1, 2014, according to the agency.

Under the new rules, "health care professionals will spend less time filling out paperwork and more time focusing on delivering the best care for patients," HHS Secretary Kathleen Sebelius said in a statement.

Further, the rules will cost physicians, hospitals, and other providers little or nothing, since "providers are the receivers of the standardized transactions and not the senders," according to HHS.

The agency also estimated that widespread use of EFT should save physician practices and hospitals between $3 billion and $4.5 billion over the next 10 years. The most common savings from implementation of electronic fund transfers are in paper, printing, and postage, as well as staff time for processing paper payments and depositing checks.

The cost to implement the new standards across all commercial health plans is estimated at between $18 million and $28 million. Implementation in Medicaid, the Children’s Health Insurance Plan, and the Indian Health Service is estimated at $400,000-$600,000. Meanwhile, the savings for commercial health plans could be as much as $40 million over 10 years, and $31 million for Medicaid, CHIP, and IHS, according to an HHS fact sheet.

Use of EFT, while widespread in many industries – has been slow in health care, partly due to lack of standardization of transactions, HHS officials said.

The new standards are required by the Affordable Care Act, and fall under the Health Insurance Portability and Accountability Act (HIPAA). They are second in a series of regulations that aim to streamline health care administrative transactions within the next 5 years. Future efforts are slated to include a standard unique identifier for health plans and standardized claim attachments.

New federal regulations aim to accelerate the use of electronic payments to health care providers while reducing administrative costs and saving resources.

The interim final regulations – part of a series of regulations coming from the Department of Health and Human Services – standardize the format and content of the transmissions that health plans send to banks when paying claims via electronic funds transfer (EFT) and will require plans to use a trace number to match the EFT with the remittance advice sent to providers. Currently the EFT and the remittance documents are sent to providers separately, and matching them is difficult.

The new standards took effect on Jan. 1; full compliance will be required by Jan. 1, 2014, according to the agency.

Under the new rules, "health care professionals will spend less time filling out paperwork and more time focusing on delivering the best care for patients," HHS Secretary Kathleen Sebelius said in a statement.

Further, the rules will cost physicians, hospitals, and other providers little or nothing, since "providers are the receivers of the standardized transactions and not the senders," according to HHS.

The agency also estimated that widespread use of EFT should save physician practices and hospitals between $3 billion and $4.5 billion over the next 10 years. The most common savings from implementation of electronic fund transfers are in paper, printing, and postage, as well as staff time for processing paper payments and depositing checks.

The cost to implement the new standards across all commercial health plans is estimated at between $18 million and $28 million. Implementation in Medicaid, the Children’s Health Insurance Plan, and the Indian Health Service is estimated at $400,000-$600,000. Meanwhile, the savings for commercial health plans could be as much as $40 million over 10 years, and $31 million for Medicaid, CHIP, and IHS, according to an HHS fact sheet.

Use of EFT, while widespread in many industries – has been slow in health care, partly due to lack of standardization of transactions, HHS officials said.

The new standards are required by the Affordable Care Act, and fall under the Health Insurance Portability and Accountability Act (HIPAA). They are second in a series of regulations that aim to streamline health care administrative transactions within the next 5 years. Future efforts are slated to include a standard unique identifier for health plans and standardized claim attachments.

New federal regulations aim to accelerate the use of electronic payments to health care providers while reducing administrative costs and saving resources.

The interim final regulations – part of a series of regulations coming from the Department of Health and Human Services – standardize the format and content of the transmissions that health plans send to banks when paying claims via electronic funds transfer (EFT) and will require plans to use a trace number to match the EFT with the remittance advice sent to providers. Currently the EFT and the remittance documents are sent to providers separately, and matching them is difficult.

The new standards took effect on Jan. 1; full compliance will be required by Jan. 1, 2014, according to the agency.

Under the new rules, "health care professionals will spend less time filling out paperwork and more time focusing on delivering the best care for patients," HHS Secretary Kathleen Sebelius said in a statement.

Further, the rules will cost physicians, hospitals, and other providers little or nothing, since "providers are the receivers of the standardized transactions and not the senders," according to HHS.

The agency also estimated that widespread use of EFT should save physician practices and hospitals between $3 billion and $4.5 billion over the next 10 years. The most common savings from implementation of electronic fund transfers are in paper, printing, and postage, as well as staff time for processing paper payments and depositing checks.

The cost to implement the new standards across all commercial health plans is estimated at between $18 million and $28 million. Implementation in Medicaid, the Children’s Health Insurance Plan, and the Indian Health Service is estimated at $400,000-$600,000. Meanwhile, the savings for commercial health plans could be as much as $40 million over 10 years, and $31 million for Medicaid, CHIP, and IHS, according to an HHS fact sheet.

Use of EFT, while widespread in many industries – has been slow in health care, partly due to lack of standardization of transactions, HHS officials said.

The new standards are required by the Affordable Care Act, and fall under the Health Insurance Portability and Accountability Act (HIPAA). They are second in a series of regulations that aim to streamline health care administrative transactions within the next 5 years. Future efforts are slated to include a standard unique identifier for health plans and standardized claim attachments.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

While commending the Centers for Medicare and Medicaid Services on its proposed coverage of the transcatheter aortic valve replacement procedure, makers of the SAPIEN artificial valve asked for more flexibility in the clinical trial limitations set by the agency, in an official comment they released on March 5.

Edwards Lifesciences, the manufacturer of the only valve approved for the TAVR procedure in the United States, posted its comment during the 60-day period, which began after CMS released its coverage proposal for TAVR in February.

In its proposal, CMS restricts TAVR coverage to five criteria, including the use of an approved valve, presence of multidisciplinary teams, and enrollment in a registry.

Edwards officials wrote they were pleased that CMS had proposed "clear and flexible national coverage for TAVR," and added that "for appropriately selected Medicare beneficiaries, the evidence is more than adequate for CMS to conclude that TAVR improves health outcomes and should be considered reasonable and necessary under the Medicare statute," if provided under the CMS criteria.

The Edwards SAPIEN valve is currently approved for use in inoperable patients with severe aortic stenosis. Other use of the SAPIEN valve is limited to clinical trials. In their comments, Edwards officials asked CMS for flexibility in the trials they consider for coverage determination.

"CMS’s proposed requirement limiting coverage for unlabeled uses to ‘superiority trials’ undermines the agency’s efforts to promote continued US-based clinical investigations in Medicare beneficiaries aimed at better understanding key determinants of health and quality of life outcomes," according to the Edwards’ comments.

"Noninferiority and other clinical trial designs play an important role in the advancement of medical technology," the company added, saying that if the proposed conditions aren’t revised, important, yet relatively small, patient populations may not be able to receive treatment.

Edwards, which said its transcatheter aortic valves have been implanted in more than 25,000 patients around the world, came in strong support of multidisciplinary heart teams, one of the requirements set by CMS for TAVR coverage, and strongly encouraged by leading cardiovascular organizations.

"It is imperative that at least two engaged cardiothoracic surgeons and two interventional cardiologists at each site coordinate all clinicians to form a high-functioning multi-disciplinary heart team, a key concept integral to assuring TAVR success," Edwards officials wrote in their comment.

The company also addressed credentialing, an issue which four leading cardiovascular organizations also addressed in a consensus document (see story at right).

"We support appropriate facility and heart team criteria – rather than traditional individual physician-based credentialing," to achieve TAVR success.

Following the CMS proposal, the Society of Thoracic Surgeons and the American College of Cardiology issued a statement, saying that they were pleased with CMS’s comprehensive approach to the coverage of TAVR.

CMS is expected to issue a final decision on TAVR coverage by May.

While commending the Centers for Medicare and Medicaid Services on its proposed coverage of the transcatheter aortic valve replacement procedure, makers of the SAPIEN artificial valve asked for more flexibility in the clinical trial limitations set by the agency, in an official comment they released on March 5.

Edwards Lifesciences, the manufacturer of the only valve approved for the TAVR procedure in the United States, posted its comment during the 60-day period, which began after CMS released its coverage proposal for TAVR in February.

In its proposal, CMS restricts TAVR coverage to five criteria, including the use of an approved valve, presence of multidisciplinary teams, and enrollment in a registry.

Edwards officials wrote they were pleased that CMS had proposed "clear and flexible national coverage for TAVR," and added that "for appropriately selected Medicare beneficiaries, the evidence is more than adequate for CMS to conclude that TAVR improves health outcomes and should be considered reasonable and necessary under the Medicare statute," if provided under the CMS criteria.

The Edwards SAPIEN valve is currently approved for use in inoperable patients with severe aortic stenosis. Other use of the SAPIEN valve is limited to clinical trials. In their comments, Edwards officials asked CMS for flexibility in the trials they consider for coverage determination.

"CMS’s proposed requirement limiting coverage for unlabeled uses to ‘superiority trials’ undermines the agency’s efforts to promote continued US-based clinical investigations in Medicare beneficiaries aimed at better understanding key determinants of health and quality of life outcomes," according to the Edwards’ comments.

"Noninferiority and other clinical trial designs play an important role in the advancement of medical technology," the company added, saying that if the proposed conditions aren’t revised, important, yet relatively small, patient populations may not be able to receive treatment.

Edwards, which said its transcatheter aortic valves have been implanted in more than 25,000 patients around the world, came in strong support of multidisciplinary heart teams, one of the requirements set by CMS for TAVR coverage, and strongly encouraged by leading cardiovascular organizations.

"It is imperative that at least two engaged cardiothoracic surgeons and two interventional cardiologists at each site coordinate all clinicians to form a high-functioning multi-disciplinary heart team, a key concept integral to assuring TAVR success," Edwards officials wrote in their comment.

The company also addressed credentialing, an issue which four leading cardiovascular organizations also addressed in a consensus document (see story at right).

"We support appropriate facility and heart team criteria – rather than traditional individual physician-based credentialing," to achieve TAVR success.

Following the CMS proposal, the Society of Thoracic Surgeons and the American College of Cardiology issued a statement, saying that they were pleased with CMS’s comprehensive approach to the coverage of TAVR.

CMS is expected to issue a final decision on TAVR coverage by May.

While commending the Centers for Medicare and Medicaid Services on its proposed coverage of the transcatheter aortic valve replacement procedure, makers of the SAPIEN artificial valve asked for more flexibility in the clinical trial limitations set by the agency, in an official comment they released on March 5.

Edwards Lifesciences, the manufacturer of the only valve approved for the TAVR procedure in the United States, posted its comment during the 60-day period, which began after CMS released its coverage proposal for TAVR in February.

In its proposal, CMS restricts TAVR coverage to five criteria, including the use of an approved valve, presence of multidisciplinary teams, and enrollment in a registry.

Edwards officials wrote they were pleased that CMS had proposed "clear and flexible national coverage for TAVR," and added that "for appropriately selected Medicare beneficiaries, the evidence is more than adequate for CMS to conclude that TAVR improves health outcomes and should be considered reasonable and necessary under the Medicare statute," if provided under the CMS criteria.

The Edwards SAPIEN valve is currently approved for use in inoperable patients with severe aortic stenosis. Other use of the SAPIEN valve is limited to clinical trials. In their comments, Edwards officials asked CMS for flexibility in the trials they consider for coverage determination.

"CMS’s proposed requirement limiting coverage for unlabeled uses to ‘superiority trials’ undermines the agency’s efforts to promote continued US-based clinical investigations in Medicare beneficiaries aimed at better understanding key determinants of health and quality of life outcomes," according to the Edwards’ comments.

"Noninferiority and other clinical trial designs play an important role in the advancement of medical technology," the company added, saying that if the proposed conditions aren’t revised, important, yet relatively small, patient populations may not be able to receive treatment.

Edwards, which said its transcatheter aortic valves have been implanted in more than 25,000 patients around the world, came in strong support of multidisciplinary heart teams, one of the requirements set by CMS for TAVR coverage, and strongly encouraged by leading cardiovascular organizations.

"It is imperative that at least two engaged cardiothoracic surgeons and two interventional cardiologists at each site coordinate all clinicians to form a high-functioning multi-disciplinary heart team, a key concept integral to assuring TAVR success," Edwards officials wrote in their comment.

The company also addressed credentialing, an issue which four leading cardiovascular organizations also addressed in a consensus document (see story at right).

"We support appropriate facility and heart team criteria – rather than traditional individual physician-based credentialing," to achieve TAVR success.

Following the CMS proposal, the Society of Thoracic Surgeons and the American College of Cardiology issued a statement, saying that they were pleased with CMS’s comprehensive approach to the coverage of TAVR.

CMS is expected to issue a final decision on TAVR coverage by May.