Chelsey Jaworski and Anabel Tapia, MCRA08.14.19
Getting approval from the FDA can be a significant achievement for a company but a bigger challenge awaits for novel technologies: health payor acceptance and coverage. Adopting a novel technology does not occur easily due to complex commercial insurance rules, regulations, and processes in healthcare. This process is difficult to navigate without extensive knowledge of health plan processes and evidence thresholds. Effective relationships with the health plan are critical for early adoption of the technology. Payor outreach to drive positive coverage is a tedious process; these key considerations will be essential in outlining a payor outreach and education strategy.
Correct Point of Contact Identification
One of the most time-consuming components of payor outreach is finding the correct point of contact within a health plan. This contact will be the gatekeeper between the manufacturer and medical policy review team. The indicated contact will not only forward the submission to other committee members but can also provide opportunities to present to the health plan’s Medical Policy Committee. A significant amount of time and research is required for this arduous identification process, but it must be done to have a momentum with the desired health plan. Submitting materials to the wrong contact can create months of delay.
Contact identification through trial and error can also significantly delay the process. For an effective search, it is necessary to comprehend the payor’s Medical Policy committee ladder. The medical director is not always the fastest or most efficient conduit. Additionally, a majority of health plans intentionally do not identify the medical policy review team. This lack of transparency creates an endless struggle in achieving effective communication with the health plan, unless the structure is understood and opportunity for clarification is available from the health plans. Professional websites such as LinkedIn can populate more than 1.5 million healthcare professionals1 but paring through all possible contacts can take considerable time and effort. If the key contact is identified, the individual most likely will initially be unresponsive to correspondence or respond in a timely manner. The lack of proactive and ongoing communication can be highly stressful when applicable medical policies are up for review.
Companies often use consultants who have established relationships to shorten or eliminate this process. Consultants can get the correct information in front of the right decision makers, thereby allowing more time for evidence review and proactive education. Ultimately, the goal is to understand and provide the additional resources needed to convert a negative policy into a positive coverage decision.
The Significance of Key Opinion Leaders
While published clinical evidence is a critical tool for establishing coverage, physician experience can make the evidence more understandable in a community setting. Key Opinion Leaders (KOLs)—physicians who are experienced in using a product—provide an invaluable resource when seeking coverage. The health plan Medical Policy Committee wants surgeons to answer questions about the procedure, the appropriate patient population, and patient selection criteria. The Medical Policy Committee takes into account the opinion of respected physicians who perform on-label cases, are well-established, and participate within the health plan for several years. Opinions and experiences from these leaders act as a catalyst when developing a consensus within local clinical networks, allowing for the possibility of a shift in practice.2 KOLs can compile outcome data from their own practices and provide it to the health plan as evidence of net health benefits. Cultivating a relationship with the KOLs should be part of the manufacturer’s early planning. KOLs can be incorporated into the planning process of an IDE study, or they can collect data and publish non-industry sponsored white papers on the results of their use and experience with the device.
Structure and Role of Health Technology Assessments
When interacting with a health plan, it is imperative to understand the role and impact a health technology assessment (HTA) has on payor policies. HTAs evaluate evidence on safety, efficacy, patient reported outcomes, real-world effectiveness, and cost effectiveness.3 HTAs aim to augment a medical policy’s review. Health plans seek to improve the quality of the healthcare services they provide and do not necessarily use the HTAs as a replacement for clinical judgement.
In the U.S., HTAs are conducted by various organizations in the private and public sectors. Private HTAs in the U.S. include Blue Cross Blue Shield Technology Evaluation Center (TEC), Emergency Care Research Institute, Hayes, Institute for Clinical and Economic Review, and UpToDate.4 Payors also utilize European health technology assessments such as the U.K.’s National Institute for Health and Clinical Excellence, and Australia’s Medical Services Advisory Committee. Large U.S. healthcare providers like BCBS conduct their own technology assessment that enables them to facilitate payment decision.5 Evidence Street, an online platform created by BCBS Association, allows for a more transparent, efficient, and comprehensive review process for medical technologies and therapies. The medical reviews done by BCBSA do not necessarily dictate coverage for the 36 Blue Cross Blue Shield companies nationwide; instead the assessments are utilized to offer opinions as input to a final decision.
HTAs ensure a meticulous review from a multi-disciplinary panel, which includes board-certified physicians and clinical staff. The panel reviews relevant scientific literature and receives input from network providers, community agencies, and consumers. Because private payors don’t want to promote an ineffective technology or early dissemination of a technology that has yet to establish improved patient outcomes, HTAs provide a systematic evaluation, answering key concerns from health plans. The identification of certain questions, concerns, gaps, and clarification streamlines payor costs. This process has captured the attention of private payors and provides them with necessary coverage decision information from independent, nonpartisan private organizations. Although there are well-designed clinical trials for many technologies, payors remain concerned about the uncertainty surrounding the generalization of findings, including company sponsored studies. As such, HTAs’ independent evaluations from external influencers are highly valued due to their rigorous evaluative metrics and objective nature, and can significantly impact how payors perceive available clinical evidence.
Certain payors utilize direct verbiage from HTAs and overall recommendations and positions on technologies from medical societies. However, payors do not include many TEC assessment details in the policy decision because those assessments are not publicly available. Payors also frequently disagree with medical specialty societies’ positions and recommendations. Nevertheless, specialty society guidelines can provide valuable information about the technology’s appropriate patient population.
Payors are utilizing and comparing statements on the same technology to help them construct a complete evidence profile. For certain technologies this is beneficial because, at times, there is no single source that provides a complete evaluation for a procedure or device.
The Necessity of Continuous Payor Communication
Regular communication with the medical director or other appropriate personnel allows for a transparent, available, and receptive manufacturer-health plan relationship. It also allows manufacturers to find and understand gaps that health plans have about the technology.
The goal is to jointly discuss any concerns or questions that will ultimately help the contact better understand the subject technology. Information that should be submitted to the medical policy committee includes executive summary, PowerPoint presentation, published peer-reviewed literature, dossier, and outreach letters from local surgeons. Communication should be frequent and allow for open dialogue and the opportunity to receive clinical knowledge from the plan. Because analysts are assigned specific policies to research, it is imperative that manufacturers continuously meet deadlines to ensure the procedure or device remains a priority for review. Any new publications or data that arise after the original submission should be forwarded to medical policy committee. To keep the procedure or device a priority without overwhelming the contact, send each of the deliverables mentioned above a few weeks apart. This keeps consistent and positive communication with the contact.
Conclusion
The evidence review standards of medical care from private payors are often unclear or inconsistent. This intentional lack of transparency from payors is a huge hurdle for manufacturers that want to market their product, obtain coverage, and secure reimbursement by health plans as soon as possible. Effective payor outreach can be invaluable when it overcomes the common obstacles and allows for key considerations that are often overlooked. Failure to account for payor outreach barriers can delay technology acceptance and outsource cost and resources.
References
Chelsey Jaworski is a manager, Payor Relations at MCRA LLC. She focuses on providing coverage and strategy for a diverse range of healthcare clients, including manufacturers of human tissue, viscosupplement, and orthopedic devices. Jaworski has assisted numerous clients in obtaining coverage from the top 85 health plans. She is adept at obtaining current information and updates regarding Medicare and private insurance plan coverage, regulations, policy changes, and guidelines including CMS, AMA, and specialty societies.
Anabel Tapia is a senior associate, Health Economics, Reimbursement & Public Policy at MCRA. She provides coding and coverage research and strategy for a numerous healthcare clients, including manufacturers of human tissue products, medical devices, and orthobiologics. She works closely with clients to identify coverage issues, develop strategies for health plan education, and work directly with health plans to improve patient access to technologies.
Correct Point of Contact Identification
One of the most time-consuming components of payor outreach is finding the correct point of contact within a health plan. This contact will be the gatekeeper between the manufacturer and medical policy review team. The indicated contact will not only forward the submission to other committee members but can also provide opportunities to present to the health plan’s Medical Policy Committee. A significant amount of time and research is required for this arduous identification process, but it must be done to have a momentum with the desired health plan. Submitting materials to the wrong contact can create months of delay.
Contact identification through trial and error can also significantly delay the process. For an effective search, it is necessary to comprehend the payor’s Medical Policy committee ladder. The medical director is not always the fastest or most efficient conduit. Additionally, a majority of health plans intentionally do not identify the medical policy review team. This lack of transparency creates an endless struggle in achieving effective communication with the health plan, unless the structure is understood and opportunity for clarification is available from the health plans. Professional websites such as LinkedIn can populate more than 1.5 million healthcare professionals1 but paring through all possible contacts can take considerable time and effort. If the key contact is identified, the individual most likely will initially be unresponsive to correspondence or respond in a timely manner. The lack of proactive and ongoing communication can be highly stressful when applicable medical policies are up for review.
Companies often use consultants who have established relationships to shorten or eliminate this process. Consultants can get the correct information in front of the right decision makers, thereby allowing more time for evidence review and proactive education. Ultimately, the goal is to understand and provide the additional resources needed to convert a negative policy into a positive coverage decision.
The Significance of Key Opinion Leaders
While published clinical evidence is a critical tool for establishing coverage, physician experience can make the evidence more understandable in a community setting. Key Opinion Leaders (KOLs)—physicians who are experienced in using a product—provide an invaluable resource when seeking coverage. The health plan Medical Policy Committee wants surgeons to answer questions about the procedure, the appropriate patient population, and patient selection criteria. The Medical Policy Committee takes into account the opinion of respected physicians who perform on-label cases, are well-established, and participate within the health plan for several years. Opinions and experiences from these leaders act as a catalyst when developing a consensus within local clinical networks, allowing for the possibility of a shift in practice.2 KOLs can compile outcome data from their own practices and provide it to the health plan as evidence of net health benefits. Cultivating a relationship with the KOLs should be part of the manufacturer’s early planning. KOLs can be incorporated into the planning process of an IDE study, or they can collect data and publish non-industry sponsored white papers on the results of their use and experience with the device.
Structure and Role of Health Technology Assessments
When interacting with a health plan, it is imperative to understand the role and impact a health technology assessment (HTA) has on payor policies. HTAs evaluate evidence on safety, efficacy, patient reported outcomes, real-world effectiveness, and cost effectiveness.3 HTAs aim to augment a medical policy’s review. Health plans seek to improve the quality of the healthcare services they provide and do not necessarily use the HTAs as a replacement for clinical judgement.
In the U.S., HTAs are conducted by various organizations in the private and public sectors. Private HTAs in the U.S. include Blue Cross Blue Shield Technology Evaluation Center (TEC), Emergency Care Research Institute, Hayes, Institute for Clinical and Economic Review, and UpToDate.4 Payors also utilize European health technology assessments such as the U.K.’s National Institute for Health and Clinical Excellence, and Australia’s Medical Services Advisory Committee. Large U.S. healthcare providers like BCBS conduct their own technology assessment that enables them to facilitate payment decision.5 Evidence Street, an online platform created by BCBS Association, allows for a more transparent, efficient, and comprehensive review process for medical technologies and therapies. The medical reviews done by BCBSA do not necessarily dictate coverage for the 36 Blue Cross Blue Shield companies nationwide; instead the assessments are utilized to offer opinions as input to a final decision.
HTAs ensure a meticulous review from a multi-disciplinary panel, which includes board-certified physicians and clinical staff. The panel reviews relevant scientific literature and receives input from network providers, community agencies, and consumers. Because private payors don’t want to promote an ineffective technology or early dissemination of a technology that has yet to establish improved patient outcomes, HTAs provide a systematic evaluation, answering key concerns from health plans. The identification of certain questions, concerns, gaps, and clarification streamlines payor costs. This process has captured the attention of private payors and provides them with necessary coverage decision information from independent, nonpartisan private organizations. Although there are well-designed clinical trials for many technologies, payors remain concerned about the uncertainty surrounding the generalization of findings, including company sponsored studies. As such, HTAs’ independent evaluations from external influencers are highly valued due to their rigorous evaluative metrics and objective nature, and can significantly impact how payors perceive available clinical evidence.
Certain payors utilize direct verbiage from HTAs and overall recommendations and positions on technologies from medical societies. However, payors do not include many TEC assessment details in the policy decision because those assessments are not publicly available. Payors also frequently disagree with medical specialty societies’ positions and recommendations. Nevertheless, specialty society guidelines can provide valuable information about the technology’s appropriate patient population.
Payors are utilizing and comparing statements on the same technology to help them construct a complete evidence profile. For certain technologies this is beneficial because, at times, there is no single source that provides a complete evaluation for a procedure or device.
The Necessity of Continuous Payor Communication
Regular communication with the medical director or other appropriate personnel allows for a transparent, available, and receptive manufacturer-health plan relationship. It also allows manufacturers to find and understand gaps that health plans have about the technology.
The goal is to jointly discuss any concerns or questions that will ultimately help the contact better understand the subject technology. Information that should be submitted to the medical policy committee includes executive summary, PowerPoint presentation, published peer-reviewed literature, dossier, and outreach letters from local surgeons. Communication should be frequent and allow for open dialogue and the opportunity to receive clinical knowledge from the plan. Because analysts are assigned specific policies to research, it is imperative that manufacturers continuously meet deadlines to ensure the procedure or device remains a priority for review. Any new publications or data that arise after the original submission should be forwarded to medical policy committee. To keep the procedure or device a priority without overwhelming the contact, send each of the deliverables mentioned above a few weeks apart. This keeps consistent and positive communication with the contact.
Conclusion
The evidence review standards of medical care from private payors are often unclear or inconsistent. This intentional lack of transparency from payors is a huge hurdle for manufacturers that want to market their product, obtain coverage, and secure reimbursement by health plans as soon as possible. Effective payor outreach can be invaluable when it overcomes the common obstacles and allows for key considerations that are often overlooked. Failure to account for payor outreach barriers can delay technology acceptance and outsource cost and resources.
References
- Santiago, Andrea. Using LinkedIn for Healthcare Industry Jobs and Networking. Verywell Health. July 14, 2019. http://bit.ly/odt190790
- Locock, L., Dopson, S., Chambers, D., and Gabbay, J. Understanding the role of opinion leaders in improving clinical effectiveness. Social Science and Medicine. 2001. 53(6), 754-757.
- Sullivan, S., et al. Health Technology Assessment in Health-Care Decisions in the United States. International Society for Pharmacoeconomics and Outcomes Research. 2009 Jun;12 Suppl 2:S39-44.
- Trosman, et al. Health Technology Assessment and Private Payer’s Coverage of Personalized Medicine. Journal Oncology Practice. 2011 May; 7 (3 Suppl): 18s-24s.
- Herndon, J.H., Hwang, R., Bozic, K.H., Healthcare Technology and technology assessment. European Spine Journal. 2007. 16:1293-1302.
Chelsey Jaworski is a manager, Payor Relations at MCRA LLC. She focuses on providing coverage and strategy for a diverse range of healthcare clients, including manufacturers of human tissue, viscosupplement, and orthopedic devices. Jaworski has assisted numerous clients in obtaining coverage from the top 85 health plans. She is adept at obtaining current information and updates regarding Medicare and private insurance plan coverage, regulations, policy changes, and guidelines including CMS, AMA, and specialty societies.
Anabel Tapia is a senior associate, Health Economics, Reimbursement & Public Policy at MCRA. She provides coding and coverage research and strategy for a numerous healthcare clients, including manufacturers of human tissue products, medical devices, and orthobiologics. She works closely with clients to identify coverage issues, develop strategies for health plan education, and work directly with health plans to improve patient access to technologies.