Hallett Mathews, MD, MBA, is the Executive Vice president and Chief Medical Officer of New York City-based Paradigm Spine, LLC, a non-fusion spinal implant and device technology manufacturer. Dr. Mathews is also a board-certified orthopedic spine surgeon.
Here are Dr. Mathews' four outpatient surgery trends that will have a substantial impact on spine physicians.
1. New innovation can make performing outpatient spine surgery easier. The pedicle screw for minimally invasive spine surgery, particularly fusions, has been routinely accepted for many years as the best method of fixation. However, Dr. Mathews says, pedicle screws are not necessarily a mainstay of decompression for spinal stenosis in outpatient spine surgery.
"Pedicle screw fixation techniques are less invasive than older traditional methods, but there is a gap of evidence to prove they are always needed," he says. "Some of these devices can be placed in an outpatient setting, but surgeons are challenging whether pedicle screws are the best device to do that." Surgeons are discovering the concept of stabilization without fusion and are not necessarily performing fusion as their first choice for restabilization.
Last fall, Paradigm Spine received FDA pre-market approval for its coflex® Interlaminar Technology as a non fusion stabilization device for moderate to severe, one- or two-level lumbar stenosis with up to grade 1 spondylolisthesis in adult spine patients. The coflex procedure is designed as a less invasive approach, and does not require an inpatient stay. New devices, such as the coflex, are an example of motion preserving innovation pushing spine surgery into an outpatient setting, he says.
"Older techniques, more traditional open techniques, have not proven to be better than newer, less invasive techniques with level one evidence as noted in the coflex® PMA study " he says. "The older technologies are being challenged and spine surgery is trending toward the outpatient setting."
2. Patients are searching for low-cost spine care. Historically, physicians have had little involvement with reimbursements at their facilities, Dr. Mathews says. Costs were not in the purview of a practicing physician, but now surgeons must be very aware of reimbursements and payors requirements.
"The economy has challenged many elective and non emergent procedures. Payers have exercised more control of pre-certs and denials of surgeries. Facilities are seeking favorable pricing for implants because of declining reimbursements from payors. More physicians are employed by institutions every year aligning the surgeon with the facility challenging the payors," he says, "This vertical restructuring of stakeholders brings the physician into the discussion and creates opportunity to perform appropriately invasive and cost saving procedures in the appropriate care setting."
For physicians employed by ASCs, cost containment has become a greater priority. Physicians are looking for the "purist and safest, data driven, most financially-correct way to perform surgery," Dr. Mathews says.
If they have not yet begun, surgeons need to shop around for lower implant costs, cut operational waste and work with payors ahead of time to ensure a patient's procedure is appropriately covered. Smaller settings have the advantage when it comes to lowering procedure costs and increasing efficiencies.
"Surgeons need to make sure payors understand in advance that outpatient costs and savings versus inflated institution costs are well outlined," he says. "A smaller setting with more control in an outpatient surgery setting can lower the cost of healthcare, improve outcomes, and the surgeon gains efficiency. It's a win-win for all parties and a nudge toward performing more procedures in the outpatient setting."
3. Surgeons are more willing to adopt new techniques today. Typically, spine surgeons fall into three categories with technology adoption, Dr. Mathews says — there are traditionalists that adhere to the principles they were taught, there are fast followers and rapid adopters of new technology, and there are innovators of product, procedure, and technique.
While he does not foresee this changing, Dr. Mathews says surgeons must acknowledge there are economic forces challenging older techniques and outside pressure to stay current with new technologies. Patients are also driving market changes, including toward less invasive procedures. Patients are challenging traditional fusion as their only option of restabilization. Dr Mathews says he has never had a patient come to his office wanting a spine fusion. In fact, medical education has taught surgeons how to overcome patient fears of fusions. He agrees that fusions are needed in some patients, and he offers that the coflex® PMA has segmented this patient group needing stabilization with fusion and those who can enjoy motion preservation with coflex®.
Surgeons should also clearly communicate that the definition of "minimally invasive" spine procedures. Dr. Mathews prefers the term "appropriately invasive," as varying size incisions are needed to address different pathologies.
"The pathology needs to be addressed, and surgeons can apply concepts to become more minimally invasive for tissue sparing with fewer deleterious effects," he says. "Fifteen years ago, 'minimally invasive' meant through a tube. Now there are certain retractors that allow you to expand the tubular concept to become more appropriate for less tissue trauma."
4. Not all new technology will be beneficial. One concern about less invasive technology is the large learning curve to incorporate the approach into the operating room. Physicians should be vigilant as to whether or not innovation is worth the additional time required in the OR.
"Most new and less invasive procedures historically have not brought a savings of time and an increasing benefit to patients and surgeons because the technology was not focused on these two things," Dr. Mathews says. "It's innovation, but not necessarily better innovation."
He encourages surgeons to search for innovative devices and procedures that are designed for better outcomes than traditional procedures and that have a smaller learning curve. Data driven, simple surgeries that lessen the risks of additional costs and complications are procedures that tend to last.
5. Outcomes data can justify reimbursement rates. As surgeon willingness and patient demand for innovation increases, so must the data substantiation for outpatient spine procedures to receive payor reimbursement. Outpatient procedures will weather the push for more data well, Dr. Mathews says.
"ASCs can easily collect pre-op and post-op outcomes; they can collect data to justify outpatient procedures to payors and patient groups; and they can more easily provide efficacy of procedures that gets lost in big institutions," he says.
He sees data-driven technology as the primary driver of innovation going forward. Technology without data-supported efficacy has little chance of adoption, especially by ASCs.
"The chances of adoption or real, true innovation is not very high going forward because of the data parameters of FDA premarket approval with level 1 data," he said. "The process [of obtaining PMA] tends to open payors' and surgeons' eyes to the understanding that this is true innovation. But it will be difficult for the industry to move forward for the right reasons in the current climate. Innovation needs to have the supporting level 1 evidence from prospective RCT studies to justify its worthiness. Otherwise industry is just increasing capacity of commoditized products."
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Here are Dr. Mathews' four outpatient surgery trends that will have a substantial impact on spine physicians.1. New innovation can make performing outpatient spine surgery easier. The pedicle screw for minimally invasive spine surgery, particularly fusions, has been routinely accepted for many years as the best method of fixation. However, Dr. Mathews says, pedicle screws are not necessarily a mainstay of decompression for spinal stenosis in outpatient spine surgery.
"Pedicle screw fixation techniques are less invasive than older traditional methods, but there is a gap of evidence to prove they are always needed," he says. "Some of these devices can be placed in an outpatient setting, but surgeons are challenging whether pedicle screws are the best device to do that." Surgeons are discovering the concept of stabilization without fusion and are not necessarily performing fusion as their first choice for restabilization.
Last fall, Paradigm Spine received FDA pre-market approval for its coflex® Interlaminar Technology as a non fusion stabilization device for moderate to severe, one- or two-level lumbar stenosis with up to grade 1 spondylolisthesis in adult spine patients. The coflex procedure is designed as a less invasive approach, and does not require an inpatient stay. New devices, such as the coflex, are an example of motion preserving innovation pushing spine surgery into an outpatient setting, he says.
"Older techniques, more traditional open techniques, have not proven to be better than newer, less invasive techniques with level one evidence as noted in the coflex® PMA study " he says. "The older technologies are being challenged and spine surgery is trending toward the outpatient setting."
2. Patients are searching for low-cost spine care. Historically, physicians have had little involvement with reimbursements at their facilities, Dr. Mathews says. Costs were not in the purview of a practicing physician, but now surgeons must be very aware of reimbursements and payors requirements.
"The economy has challenged many elective and non emergent procedures. Payers have exercised more control of pre-certs and denials of surgeries. Facilities are seeking favorable pricing for implants because of declining reimbursements from payors. More physicians are employed by institutions every year aligning the surgeon with the facility challenging the payors," he says, "This vertical restructuring of stakeholders brings the physician into the discussion and creates opportunity to perform appropriately invasive and cost saving procedures in the appropriate care setting."
For physicians employed by ASCs, cost containment has become a greater priority. Physicians are looking for the "purist and safest, data driven, most financially-correct way to perform surgery," Dr. Mathews says.
If they have not yet begun, surgeons need to shop around for lower implant costs, cut operational waste and work with payors ahead of time to ensure a patient's procedure is appropriately covered. Smaller settings have the advantage when it comes to lowering procedure costs and increasing efficiencies.
"Surgeons need to make sure payors understand in advance that outpatient costs and savings versus inflated institution costs are well outlined," he says. "A smaller setting with more control in an outpatient surgery setting can lower the cost of healthcare, improve outcomes, and the surgeon gains efficiency. It's a win-win for all parties and a nudge toward performing more procedures in the outpatient setting."
3. Surgeons are more willing to adopt new techniques today. Typically, spine surgeons fall into three categories with technology adoption, Dr. Mathews says — there are traditionalists that adhere to the principles they were taught, there are fast followers and rapid adopters of new technology, and there are innovators of product, procedure, and technique.
While he does not foresee this changing, Dr. Mathews says surgeons must acknowledge there are economic forces challenging older techniques and outside pressure to stay current with new technologies. Patients are also driving market changes, including toward less invasive procedures. Patients are challenging traditional fusion as their only option of restabilization. Dr Mathews says he has never had a patient come to his office wanting a spine fusion. In fact, medical education has taught surgeons how to overcome patient fears of fusions. He agrees that fusions are needed in some patients, and he offers that the coflex® PMA has segmented this patient group needing stabilization with fusion and those who can enjoy motion preservation with coflex®.
Surgeons should also clearly communicate that the definition of "minimally invasive" spine procedures. Dr. Mathews prefers the term "appropriately invasive," as varying size incisions are needed to address different pathologies.
"The pathology needs to be addressed, and surgeons can apply concepts to become more minimally invasive for tissue sparing with fewer deleterious effects," he says. "Fifteen years ago, 'minimally invasive' meant through a tube. Now there are certain retractors that allow you to expand the tubular concept to become more appropriate for less tissue trauma."
4. Not all new technology will be beneficial. One concern about less invasive technology is the large learning curve to incorporate the approach into the operating room. Physicians should be vigilant as to whether or not innovation is worth the additional time required in the OR.
"Most new and less invasive procedures historically have not brought a savings of time and an increasing benefit to patients and surgeons because the technology was not focused on these two things," Dr. Mathews says. "It's innovation, but not necessarily better innovation."
He encourages surgeons to search for innovative devices and procedures that are designed for better outcomes than traditional procedures and that have a smaller learning curve. Data driven, simple surgeries that lessen the risks of additional costs and complications are procedures that tend to last.
5. Outcomes data can justify reimbursement rates. As surgeon willingness and patient demand for innovation increases, so must the data substantiation for outpatient spine procedures to receive payor reimbursement. Outpatient procedures will weather the push for more data well, Dr. Mathews says.
"ASCs can easily collect pre-op and post-op outcomes; they can collect data to justify outpatient procedures to payors and patient groups; and they can more easily provide efficacy of procedures that gets lost in big institutions," he says.
He sees data-driven technology as the primary driver of innovation going forward. Technology without data-supported efficacy has little chance of adoption, especially by ASCs.
"The chances of adoption or real, true innovation is not very high going forward because of the data parameters of FDA premarket approval with level 1 data," he said. "The process [of obtaining PMA] tends to open payors' and surgeons' eyes to the understanding that this is true innovation. But it will be difficult for the industry to move forward for the right reasons in the current climate. Innovation needs to have the supporting level 1 evidence from prospective RCT studies to justify its worthiness. Otherwise industry is just increasing capacity of commoditized products."
More Articles on Spine ASCs:
Triangle Orthopaedic Associates Unveils Newly Renovated Location
Dr. Ross Richer Becomes AAOS Fellow
Dr. Gbolahan Okubadejo Opens New Jersey Office