<img src="https://opedge.com/Content/UserFiles/Articles/2021-08%2F2-1.jpg" alt="" /> Alex Otte was 13 years old in 2010 when she sustained a traumatic brain injury, a broken neck, and bilateral shattered femurs from being hit by a drunk driver in a boat while she sat on a jet ski. Because the boat's propeller severed her right foot and her left leg was damaged, she had a transtibial amputation and a limb-salvage surgery. She spent several weeks in the hospital and inpatient rehabilitation and three months in a wheelchair before receiving her first prosthesis. Little did Otte know that she would also have to battle her insurance provider for approval for her prosthetic device. "Having the leg that I now wear denied several times was undoubtably one of the worst experiences of my life," says Otte, who endured yearly surgeries through 2019. "The leg I was wearing was broken, and I was a college student who couldn't walk to class. So my prosthetist went ahead and ordered it, and insurance was dealing with it on their end." Despite everything Otte had already been through, one moment has become etched in her mind. "As long as I live, I will never forget standing in the hallway of the journalism building at my university learning that my insurance had denied my claim and my appeals, and I needed to return the leg to my prosthetist's office." Otte says she felt shattered. "Devastated and unsure of the future does not even begin to cover my feelings. At this point in my journey, I realized that the drunk driver had already taken so much from me and now the insurance company was allowed to do it too." <strong>Medical Necessity</strong> When it comes to navigating the insurance approval process for O&P devices, it might seem easier for a camel to go through the eye of a needle, as the biblical saying goes. Providing patients with the most appropriate O&P devices can go a long way toward improving their quality of life; trying to achieve that quality of life, however, requires addressing insurance coverage criteria in documentation and knowing the best ways to appeal a denial. This article explores the ups and downs of navigating the insurance approval process to get a patient's device authorized and measures that are proposed and in place to help improve that process. O&P industry experts agree there is no such thing as a typical process when it comes to getting insurance approval, but the submitting parties can help by delivering the mandatory documents and telling their patient's story in a way that justifies their need. "Not all insurance companies have the same process for approval of prosthetic services," says Seth O'Brien, CP, FAAOP, clinical manager for Artificial Limb Specialists, Phoenix. "While all insurance companies have some sort of coverage policy that outlines coverage benefits and criteria, not all insurers review the claims prior to submission." Some will only review a claim for reimbursement after services have been provided, O'Brien says, forcing the provider to act as a compliance auditor across a multidisciplinary team. "Other insurers will require the services to be submitted for prior authorization, giving the provider the advantage of knowing whether a recommended service meets the insurer criteria for reimbursement prior to providing services," he says. Typically, the process begins with a prosthetist evaluating the patient and formulating a plan of care, O'Brien says. Once a treatment plan has been agreed upon, documentation must be obtained from the prescribing physician and other members of the medical team, such as a physical therapist. This documentation, along with a standard written order, can then be submitted to the payer along with the prosthetist's clinical documentation to establish coverage and medical necessity. "The insurance company will review and issue a prior authorization for the prescribed services, if appropriate," O'Brien says. Stephanie Morgan Greene had been part of the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) industry for more than 20 years when she started her career as a respiratory therapist before attending law school. Greene is the compliance officer for Ottobock Patient Care, and she supports Ability Prosthetics & Orthotics, Exton, Pennsylvania, as its acting compliance officer. At Ability, most claims are handled by completing a verification and authorization (V&A) check at the time of the initial visit, she says. "The V&A is done by an employee by phoning the insurance company, or by verifying insurance through a provider portal," Greene says. "The V&A will give us information on whether the patient has coverage available, the current deductible/out-of-pocket liability, and whether a prior authorization is required for coverage for a specific service." If prior authorization is not required, Ability can move directly into providing clinical care and billing once the service is complete. If prior authorization is required, Greene says Ability takes a two-pronged approach, providing clinical care while others work with the treating physician to obtain the necessary medical records. It is also important to keep the patient involved throughout the process—especially when a claim is denied, says Diane Duran, senior manager of reimbursement for Arm Dynamics, Redondo Beach, California. She has spent the last decade working exclusively in upper-limb prosthetics. "We keep the patient apprised and involved because very often it's the patient's involvement that is the key factor in overturning a denial," Duran says. "If necessary, we reach out to the patient's physician(s), therapists, and sometimes their employer to help support the patient's need." <img src="https://opedge.com/Content/UserFiles/Articles/2021-08%2F2-2.jpg" alt="" width="400" /> <strong>Qualifications, OB/GYN Approval?</strong> Speaking of educating reviewers, do they have the proper qualifications to address the limb-loss issue fairly and accurately? Linda Collins, director of reimbursement strategy for Össur, Reykjavik, Iceland, says the employees conducting the reviews have different levels of education based on their roles. "The actual intake person may be more of a layperson," she says. "And there are usually nurses, other [healthcare professionals], and ultimately a medical director involved in the process." Duran says the background and knowledge of the person reviewing the claims is variable. "It is rare for the nurse reviewer or the medical director to have extensive knowledge of prosthetics, the components, or the processes needed to achieve a successful patient outcome," she says. "It's frustrating when we see that an OB/GYN is doing the medical review for a prosthesis, but that is the reality." With some carriers, there is a defined script for approval. "If your request doesn't fit in the script, the answer is no, regardless of the need or reason," says Duran, who explains that often this denial can be overcome with escalation and determination. "If we can, we make a connection with a representative who possesses a higher level of decision-making authority to review the facts and overturn a denial." O'Brien agrees. "Unfortunately, authorization and claim reviewers rarely have a clinical background or understanding of O&P." The reviewer may only be reviewing the clinical documentation against the coverage policy using a checklist, which O'Brien says can create a "frustrating double standard for orthotists and prosthetists who must first document very specialized justifications for their clinical recommendations and then restate their clinical findings and rationale in layman's terms." In addition, it is important to explicitly explain the patient's need for a system or specific component as there is the chance the payer has likely never seen a similar claim, according to Erica Karlson, director of sales for Coapt, Chicago. "The qualifications for the reviewing party do not come into play until the appeals process when a person ‘within the profession' is assigned to review the claim," Karlson says. Even then, she says, "they may be unfamiliar with your exact technology." <strong>Approval, Denial, Appeals, Then What?</strong> The typical approval process timeline varies widely depending on the type of insurance—private, workers' compensation, Medicare—and what is being requested, O&P experts say. "Generally, private insurers take much longer and require more appeals than work comp carriers," Duran says. Arm Dynamics can achieve insurance approval roughly one month after a patient's prosthetic evaluation has been completed, and it's also not unusual to receive an initial denial, which can add at least another 30 to 45 days for the initial appeal process, Duran says. "We've received an authorization approval within minutes and have also had the authorization process take over a year and a half," she says. "The key is that we continue to respond to appeals as long as the patient is engaged in the process." Collins says it has been her experience that denials are typically the result of missing information. "[Healthcare professionals] who take the time to read the coverage policy and make sure they are documenting all necessary requirements seem to have more success," she says. Greene says she believes that O&P providers must acknowledge their role in the cause of denials. "Often the documentation sent to the insurance company is incomplete and does not make a strong case for the medical need for the device." There also remains a feeling by some in O&P that a physician's prescription for the device is enough, or the opinion of the prosthetist is enough to establish medical need, Greene says. "The reality is the insurance company is looking for a complete picture of the patient's needs and abilities from both the prosthetist and the treating physician." Medicare and the commercial insurance system are also not without blame, Greene says. They fail to recognize new technology and emerging treatment modalities, leaving many items in the "experimental and investigational" classification for too long. "While medical practitioners may accept technology as part of medical care, the insurance industry argues against coverage, many times claiming clinical studies and trials are not sufficient to support coverage," Greene says. "The insurance industry often wants to apply the same clinical research standards to O&P technology that applies to the pharmaceutical industry, and that is an unreachable burden due to the limited number of impacted patients." Most of Ability's authorization denials are resolved at the first or second level of appeal and within 45 to 90 days, Greene says. "For some complex, new technology that is being denied as ‘experimental and investigational' we have taken prior authorization appeals through hearings," she says. "In recent history, the longest timeline has been approximately one year from original denial to hearing approval." At that point, the clinical process has to be restarted, she says. "That means that the clinical care is truly delayed up to 18 months from the initial prior authorization denial." Finally, it's also important to stay with the process for the duration, Duran says. "I feel insurance carriers will say no in the hopes the patient will give up and walk away, thus saving the carrier money. It's up to us, the prosthetic provider and the patient, to prove the patient's need." Duran reiterates the importance of the patient staying engaged in the process. "If the provider and the patient do not advocate together for what is necessary, it's easier for the carrier to say no." O'Brien says the system inherently rewards the insurance company for denying claims and places all the burden on the beneficiary and provider to advocate for proper coverage. He gives the example of an insurance company denying a specific component, such as a vacuum system, to ten people and only six of them take the time to fight for the coverage. "The insurance company just saved 40 percent right to the bottom line. Even if denials are eventually overturned, this delay in payments can potentially mean billions of dollars are remaining in investments for an extra month or two—netting the insurance company even larger returns and creating more incentive to delay the reimbursement process." <strong>Has Insurance Approval Always Been a Chore?</strong> The answer for the most part is yes, O&P experts agree. "I would not necessarily say CMS is hard to work with, but I understand the feeling," Greene says. "The DME MACs have taken strides to move toward working with DMEPOS suppliers to correct the issue." Greene gives the example of the Targeted Probe and Educate (TPE) audits. The audits are not random, rather they arise from a concern with a specific provider. A TPE audit includes an education round if there are denials, and time to correct issues before another round of audits begin. "In the end, when a supplier has completed the TPE audit, the DME MAC does not continue to audit them," Greene says. Medicare can be frustrating because it is shielded from full accountability and consequences, says O'Brien, who uses the backlog of Administrative Law Judge cases at the height of the Recovery Audit Contractor (RAC) audits as an example. Although the RAC denials were being overturned at a rate of over 90 percent, a lawsuit seeking relief from this predatory practice was thrown out, and providers were left with little choice but to wait several years for a decision they were entitled to within 180 days, O'Brien says. "There can be a sense of helplessness when you are at odds with the ones making the rules," he says. "When CMS and its contractors tend to make overreaching policy changes such as the proposed lower-limb protheses local coverage determination changes, or retroactively changing the way they interpret the Dear Physician letter, providers and beneficiaries are rightfully questioning CMS as a whole." In addition, more carriers are stating that no pre-authorization is required, Duran says. On the surface, this may sound helpful, but it essentially means that rather than receiving an authorization or denial prior to delivery, appropriateness and medical necessity are reviewed at billing, after the device is delivered. "A denial at billing, upheld upon review, can lead to a very large, unexpected bill for the patient, when they had expected the carrier to approve and pay," Duran says. "We push the carrier for a detailed pre-authorization or pre-service review; however, this option is not always available from certain carriers." Despite the history of frustrating practices by CMS over the years, there is cause for some optimism, O'Brien says. Prior authorization with Medicare is a polarizing topic among O&P providers, but O'Brien says it has the potential to create a more stable and predictable environment for reimbursement. "As a clinician, I would much rather go through a prior authorization process on every claim and have the confidence that it has been reviewed and meets the criteria for reimbursement before providing services, rather than finding out there is an issue after delivery." Finally, Greene says she believes there's a need for more transparency by CMS and the DME MACs. "The trainings they provide are helpful, but it would be even more helpful to provide actual medical record reviews and application of the coverage guidelines to example patients," she says. "I also would like to see the days of the ombudsmen to return when it was much easier to speak to an individual who had training and knowledge of coverage and documentation requirements and could aid on specific claim issues." <strong> </strong> <strong>Better Chances at Getting Approval</strong> What can O&P practitioners and facilities do to increase their chances of receiving approval for a devices? Encouraging patients to self-advocate is one measure that can help, Duran says. "We encourage patients to self-advocate by contacting their insurance carrier directly and by visiting their physician and asking them to provide detailed medical records that document their needs and challenges," she says. "Sometimes, the physician's medical records and test results, as well as a letter from the patient are sufficient to get approval of a device or to overturn a denial." O'Brien says it is important to be systematic in approaching clinical documentation and compliance. "There are many opportunities to cut corners due to time and paperwork burdens, but these come back to haunt you in the end." He also suggests investing time in developing a consistent approach to collecting objective outcome measures. "This will help you to establish more compelling medical necessity and will allow you to create treatment plans based on data that are more likely to be successful on the first submission," he says. Finally, the number-one item practitioners and facilities can do to increase their chances of receiving an approval is to provide a complete medical record from the treating physician and prosthetist, telling the patient's full story, Greene says. "When the needs and abilities or limitations in abilities are fully explained and supported, the decision to provide coverage is generally straightforward," she says. "The insurance company only sees the documentation we submit, and we need to ensure that documentation includes a full description (with objective support) of the patient. When a strong record is used, the path to approval is easier." <strong>Triple A Study Act</strong> The Triple A Study Act is a bipartisan bill introduced in the United States Congress to examine what can be done to help more people obtain prosthetic devices. Rep. Brett Guthrie (R-KY) is a cosponsor of the bill, which would require the Government Accountability Office to conduct a nonpartisan study on barriers to receiving prostheses and quality care for those living with limb loss. "I've heard directly from my constituents about the hurdles they've encountered trying to receive a prosthetic device," Guthrie says. "My hope is that the information learned from this study will help find solutions on how to make prosthetic devices more accessible and improve health outcomes." The act also encourages focus on patient outcomes, Duran says. One of the issues it addresses is the inclusion of occupational and physical therapy with prosthetic care, which rarely happens, she says. "Patients often work with an outside therapist who may have limited or no upper-limb prosthetic experience and potentially no experience with the terminal device and other components the patient has been fit with," she says. "It is important the therapist and prosthetist work together to assure the patient is trained in proper body mechanics, the prosthesis is properly programmed to meet the needs of the patient, and the patient is fully trained and comfortable in how to use the prosthesis to avoid frustration and abandonment. "While the Triple A Study Act includes therapy as well as rates of return-to-work outcomes, it still has a long way to go to help assure that insurance carriers are adequately addressing the patient's needs," Duran says. Otte is a lead advocate for the National Amputee Coalition and attended its Hill Day in Washington DC in 2019 to meet with lawmakers on this issue. "[The Triple A Study Act] means people are paying attention. For those who want prosthetics that aren't available to them currently, I hope this act will later enable them to live their life how they choose. For people like me who have a prosthesis, I hope one day it won't be so hard. No one has to give abled-bodied people permission to walk," Otte says. "I lived 13 years of my life with all my limbs and had my ability to walk ripped away from me. No one, and especially not the insurance companies, should be trying to keep me from being able to walk again." <strong> </strong> <em>Betta Ferrendelli can be contacted at betta@opedge.com.</em>
<img src="https://opedge.com/Content/UserFiles/Articles/2021-08%2F2-1.jpg" alt="" /> Alex Otte was 13 years old in 2010 when she sustained a traumatic brain injury, a broken neck, and bilateral shattered femurs from being hit by a drunk driver in a boat while she sat on a jet ski. Because the boat's propeller severed her right foot and her left leg was damaged, she had a transtibial amputation and a limb-salvage surgery. She spent several weeks in the hospital and inpatient rehabilitation and three months in a wheelchair before receiving her first prosthesis. Little did Otte know that she would also have to battle her insurance provider for approval for her prosthetic device. "Having the leg that I now wear denied several times was undoubtably one of the worst experiences of my life," says Otte, who endured yearly surgeries through 2019. "The leg I was wearing was broken, and I was a college student who couldn't walk to class. So my prosthetist went ahead and ordered it, and insurance was dealing with it on their end." Despite everything Otte had already been through, one moment has become etched in her mind. "As long as I live, I will never forget standing in the hallway of the journalism building at my university learning that my insurance had denied my claim and my appeals, and I needed to return the leg to my prosthetist's office." Otte says she felt shattered. "Devastated and unsure of the future does not even begin to cover my feelings. At this point in my journey, I realized that the drunk driver had already taken so much from me and now the insurance company was allowed to do it too." <strong>Medical Necessity</strong> When it comes to navigating the insurance approval process for O&P devices, it might seem easier for a camel to go through the eye of a needle, as the biblical saying goes. Providing patients with the most appropriate O&P devices can go a long way toward improving their quality of life; trying to achieve that quality of life, however, requires addressing insurance coverage criteria in documentation and knowing the best ways to appeal a denial. This article explores the ups and downs of navigating the insurance approval process to get a patient's device authorized and measures that are proposed and in place to help improve that process. O&P industry experts agree there is no such thing as a typical process when it comes to getting insurance approval, but the submitting parties can help by delivering the mandatory documents and telling their patient's story in a way that justifies their need. "Not all insurance companies have the same process for approval of prosthetic services," says Seth O'Brien, CP, FAAOP, clinical manager for Artificial Limb Specialists, Phoenix. "While all insurance companies have some sort of coverage policy that outlines coverage benefits and criteria, not all insurers review the claims prior to submission." Some will only review a claim for reimbursement after services have been provided, O'Brien says, forcing the provider to act as a compliance auditor across a multidisciplinary team. "Other insurers will require the services to be submitted for prior authorization, giving the provider the advantage of knowing whether a recommended service meets the insurer criteria for reimbursement prior to providing services," he says. Typically, the process begins with a prosthetist evaluating the patient and formulating a plan of care, O'Brien says. Once a treatment plan has been agreed upon, documentation must be obtained from the prescribing physician and other members of the medical team, such as a physical therapist. This documentation, along with a standard written order, can then be submitted to the payer along with the prosthetist's clinical documentation to establish coverage and medical necessity. "The insurance company will review and issue a prior authorization for the prescribed services, if appropriate," O'Brien says. Stephanie Morgan Greene had been part of the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) industry for more than 20 years when she started her career as a respiratory therapist before attending law school. Greene is the compliance officer for Ottobock Patient Care, and she supports Ability Prosthetics & Orthotics, Exton, Pennsylvania, as its acting compliance officer. At Ability, most claims are handled by completing a verification and authorization (V&A) check at the time of the initial visit, she says. "The V&A is done by an employee by phoning the insurance company, or by verifying insurance through a provider portal," Greene says. "The V&A will give us information on whether the patient has coverage available, the current deductible/out-of-pocket liability, and whether a prior authorization is required for coverage for a specific service." If prior authorization is not required, Ability can move directly into providing clinical care and billing once the service is complete. If prior authorization is required, Greene says Ability takes a two-pronged approach, providing clinical care while others work with the treating physician to obtain the necessary medical records. It is also important to keep the patient involved throughout the process—especially when a claim is denied, says Diane Duran, senior manager of reimbursement for Arm Dynamics, Redondo Beach, California. She has spent the last decade working exclusively in upper-limb prosthetics. "We keep the patient apprised and involved because very often it's the patient's involvement that is the key factor in overturning a denial," Duran says. "If necessary, we reach out to the patient's physician(s), therapists, and sometimes their employer to help support the patient's need." <img src="https://opedge.com/Content/UserFiles/Articles/2021-08%2F2-2.jpg" alt="" width="400" /> <strong>Qualifications, OB/GYN Approval?</strong> Speaking of educating reviewers, do they have the proper qualifications to address the limb-loss issue fairly and accurately? Linda Collins, director of reimbursement strategy for Össur, Reykjavik, Iceland, says the employees conducting the reviews have different levels of education based on their roles. "The actual intake person may be more of a layperson," she says. "And there are usually nurses, other [healthcare professionals], and ultimately a medical director involved in the process." Duran says the background and knowledge of the person reviewing the claims is variable. "It is rare for the nurse reviewer or the medical director to have extensive knowledge of prosthetics, the components, or the processes needed to achieve a successful patient outcome," she says. "It's frustrating when we see that an OB/GYN is doing the medical review for a prosthesis, but that is the reality." With some carriers, there is a defined script for approval. "If your request doesn't fit in the script, the answer is no, regardless of the need or reason," says Duran, who explains that often this denial can be overcome with escalation and determination. "If we can, we make a connection with a representative who possesses a higher level of decision-making authority to review the facts and overturn a denial." O'Brien agrees. "Unfortunately, authorization and claim reviewers rarely have a clinical background or understanding of O&P." The reviewer may only be reviewing the clinical documentation against the coverage policy using a checklist, which O'Brien says can create a "frustrating double standard for orthotists and prosthetists who must first document very specialized justifications for their clinical recommendations and then restate their clinical findings and rationale in layman's terms." In addition, it is important to explicitly explain the patient's need for a system or specific component as there is the chance the payer has likely never seen a similar claim, according to Erica Karlson, director of sales for Coapt, Chicago. "The qualifications for the reviewing party do not come into play until the appeals process when a person ‘within the profession' is assigned to review the claim," Karlson says. Even then, she says, "they may be unfamiliar with your exact technology." <strong>Approval, Denial, Appeals, Then What?</strong> The typical approval process timeline varies widely depending on the type of insurance—private, workers' compensation, Medicare—and what is being requested, O&P experts say. "Generally, private insurers take much longer and require more appeals than work comp carriers," Duran says. Arm Dynamics can achieve insurance approval roughly one month after a patient's prosthetic evaluation has been completed, and it's also not unusual to receive an initial denial, which can add at least another 30 to 45 days for the initial appeal process, Duran says. "We've received an authorization approval within minutes and have also had the authorization process take over a year and a half," she says. "The key is that we continue to respond to appeals as long as the patient is engaged in the process." Collins says it has been her experience that denials are typically the result of missing information. "[Healthcare professionals] who take the time to read the coverage policy and make sure they are documenting all necessary requirements seem to have more success," she says. Greene says she believes that O&P providers must acknowledge their role in the cause of denials. "Often the documentation sent to the insurance company is incomplete and does not make a strong case for the medical need for the device." There also remains a feeling by some in O&P that a physician's prescription for the device is enough, or the opinion of the prosthetist is enough to establish medical need, Greene says. "The reality is the insurance company is looking for a complete picture of the patient's needs and abilities from both the prosthetist and the treating physician." Medicare and the commercial insurance system are also not without blame, Greene says. They fail to recognize new technology and emerging treatment modalities, leaving many items in the "experimental and investigational" classification for too long. "While medical practitioners may accept technology as part of medical care, the insurance industry argues against coverage, many times claiming clinical studies and trials are not sufficient to support coverage," Greene says. "The insurance industry often wants to apply the same clinical research standards to O&P technology that applies to the pharmaceutical industry, and that is an unreachable burden due to the limited number of impacted patients." Most of Ability's authorization denials are resolved at the first or second level of appeal and within 45 to 90 days, Greene says. "For some complex, new technology that is being denied as ‘experimental and investigational' we have taken prior authorization appeals through hearings," she says. "In recent history, the longest timeline has been approximately one year from original denial to hearing approval." At that point, the clinical process has to be restarted, she says. "That means that the clinical care is truly delayed up to 18 months from the initial prior authorization denial." Finally, it's also important to stay with the process for the duration, Duran says. "I feel insurance carriers will say no in the hopes the patient will give up and walk away, thus saving the carrier money. It's up to us, the prosthetic provider and the patient, to prove the patient's need." Duran reiterates the importance of the patient staying engaged in the process. "If the provider and the patient do not advocate together for what is necessary, it's easier for the carrier to say no." O'Brien says the system inherently rewards the insurance company for denying claims and places all the burden on the beneficiary and provider to advocate for proper coverage. He gives the example of an insurance company denying a specific component, such as a vacuum system, to ten people and only six of them take the time to fight for the coverage. "The insurance company just saved 40 percent right to the bottom line. Even if denials are eventually overturned, this delay in payments can potentially mean billions of dollars are remaining in investments for an extra month or two—netting the insurance company even larger returns and creating more incentive to delay the reimbursement process." <strong>Has Insurance Approval Always Been a Chore?</strong> The answer for the most part is yes, O&P experts agree. "I would not necessarily say CMS is hard to work with, but I understand the feeling," Greene says. "The DME MACs have taken strides to move toward working with DMEPOS suppliers to correct the issue." Greene gives the example of the Targeted Probe and Educate (TPE) audits. The audits are not random, rather they arise from a concern with a specific provider. A TPE audit includes an education round if there are denials, and time to correct issues before another round of audits begin. "In the end, when a supplier has completed the TPE audit, the DME MAC does not continue to audit them," Greene says. Medicare can be frustrating because it is shielded from full accountability and consequences, says O'Brien, who uses the backlog of Administrative Law Judge cases at the height of the Recovery Audit Contractor (RAC) audits as an example. Although the RAC denials were being overturned at a rate of over 90 percent, a lawsuit seeking relief from this predatory practice was thrown out, and providers were left with little choice but to wait several years for a decision they were entitled to within 180 days, O'Brien says. "There can be a sense of helplessness when you are at odds with the ones making the rules," he says. "When CMS and its contractors tend to make overreaching policy changes such as the proposed lower-limb protheses local coverage determination changes, or retroactively changing the way they interpret the Dear Physician letter, providers and beneficiaries are rightfully questioning CMS as a whole." In addition, more carriers are stating that no pre-authorization is required, Duran says. On the surface, this may sound helpful, but it essentially means that rather than receiving an authorization or denial prior to delivery, appropriateness and medical necessity are reviewed at billing, after the device is delivered. "A denial at billing, upheld upon review, can lead to a very large, unexpected bill for the patient, when they had expected the carrier to approve and pay," Duran says. "We push the carrier for a detailed pre-authorization or pre-service review; however, this option is not always available from certain carriers." Despite the history of frustrating practices by CMS over the years, there is cause for some optimism, O'Brien says. Prior authorization with Medicare is a polarizing topic among O&P providers, but O'Brien says it has the potential to create a more stable and predictable environment for reimbursement. "As a clinician, I would much rather go through a prior authorization process on every claim and have the confidence that it has been reviewed and meets the criteria for reimbursement before providing services, rather than finding out there is an issue after delivery." Finally, Greene says she believes there's a need for more transparency by CMS and the DME MACs. "The trainings they provide are helpful, but it would be even more helpful to provide actual medical record reviews and application of the coverage guidelines to example patients," she says. "I also would like to see the days of the ombudsmen to return when it was much easier to speak to an individual who had training and knowledge of coverage and documentation requirements and could aid on specific claim issues." <strong> </strong> <strong>Better Chances at Getting Approval</strong> What can O&P practitioners and facilities do to increase their chances of receiving approval for a devices? Encouraging patients to self-advocate is one measure that can help, Duran says. "We encourage patients to self-advocate by contacting their insurance carrier directly and by visiting their physician and asking them to provide detailed medical records that document their needs and challenges," she says. "Sometimes, the physician's medical records and test results, as well as a letter from the patient are sufficient to get approval of a device or to overturn a denial." O'Brien says it is important to be systematic in approaching clinical documentation and compliance. "There are many opportunities to cut corners due to time and paperwork burdens, but these come back to haunt you in the end." He also suggests investing time in developing a consistent approach to collecting objective outcome measures. "This will help you to establish more compelling medical necessity and will allow you to create treatment plans based on data that are more likely to be successful on the first submission," he says. Finally, the number-one item practitioners and facilities can do to increase their chances of receiving an approval is to provide a complete medical record from the treating physician and prosthetist, telling the patient's full story, Greene says. "When the needs and abilities or limitations in abilities are fully explained and supported, the decision to provide coverage is generally straightforward," she says. "The insurance company only sees the documentation we submit, and we need to ensure that documentation includes a full description (with objective support) of the patient. When a strong record is used, the path to approval is easier." <strong>Triple A Study Act</strong> The Triple A Study Act is a bipartisan bill introduced in the United States Congress to examine what can be done to help more people obtain prosthetic devices. Rep. Brett Guthrie (R-KY) is a cosponsor of the bill, which would require the Government Accountability Office to conduct a nonpartisan study on barriers to receiving prostheses and quality care for those living with limb loss. "I've heard directly from my constituents about the hurdles they've encountered trying to receive a prosthetic device," Guthrie says. "My hope is that the information learned from this study will help find solutions on how to make prosthetic devices more accessible and improve health outcomes." The act also encourages focus on patient outcomes, Duran says. One of the issues it addresses is the inclusion of occupational and physical therapy with prosthetic care, which rarely happens, she says. "Patients often work with an outside therapist who may have limited or no upper-limb prosthetic experience and potentially no experience with the terminal device and other components the patient has been fit with," she says. "It is important the therapist and prosthetist work together to assure the patient is trained in proper body mechanics, the prosthesis is properly programmed to meet the needs of the patient, and the patient is fully trained and comfortable in how to use the prosthesis to avoid frustration and abandonment. "While the Triple A Study Act includes therapy as well as rates of return-to-work outcomes, it still has a long way to go to help assure that insurance carriers are adequately addressing the patient's needs," Duran says. Otte is a lead advocate for the National Amputee Coalition and attended its Hill Day in Washington DC in 2019 to meet with lawmakers on this issue. "[The Triple A Study Act] means people are paying attention. For those who want prosthetics that aren't available to them currently, I hope this act will later enable them to live their life how they choose. For people like me who have a prosthesis, I hope one day it won't be so hard. No one has to give abled-bodied people permission to walk," Otte says. "I lived 13 years of my life with all my limbs and had my ability to walk ripped away from me. No one, and especially not the insurance companies, should be trying to keep me from being able to walk again." <strong> </strong> <em>Betta Ferrendelli can be contacted at betta@opedge.com.</em>