Solutions for Complex Needs
Healthcare in the United States is complex. Any medical technology company looking for answers about how or whether a new technology or device will be reimbursed needs a team of experts in medical reimbursement strategies and payer relations. Achieving the right reimbursement strategy—one focused on proper coding, appropriate insurance coverage, and adequate payment—is critical for bringing a medical device to market in the U.S. successfully today.
LSI offers a full spectrum of reimbursement strategy services and solutions. Our team specializes in payer relations for new and existing medical technologies and focus on reimbursement strategy, medical policy research and coverage advocacy, HCPCS and CPT code analysis and applications, health economics analysis, and special services such as access to a Helpline/Hotline Support and contract president or COO services throughout the product adoption phase.
Reimbursement Strategy Development
Do you know the reimbursement barriers in your way to take your medical technology to market?
The Patient Protection and Affordable Care Act of 2010 changed the dynamics of all healthcare delivery and financing. LSI understands government and private payer coverage and payment policies within the context of the current health economics environment. We design strategies around specific objectives targeted toward any reimbursement barriers that would otherwise limit broad market adoption of emerging medical technology.
A Reimbursement Assessment is a research-based report that identifies possible barriers to appropriate coding, coverage and payment for a technology. In conducting assessments, LSI identifies any differences in clinical indications for coverage based on place of service (inpatient vs. outpatient hospital, clinic, or home care setting), payer mix and comparable technologies. The assessment forms the basis for creating a reimbursement strategy.
Interviews can be arranged with existing health plan medical directors to assess payer reaction to new technologies either pre-lease or prior to final design. The former can help guide the extent of payer relations work that will be required for successful medical policy coverage. The latter can be used to determine if a new product is perceived as reasonable and necessary before making final product decisions, thereby de-risking the investment. These interviews can be done individually or via facilitated advisory board discussion.
Medical Policy Research and Coverage Advocacy
Does your new medical technology meet the coverage requirements of government and private health insurers?
We can find out and then help you open doors for coverage.
LSI conducts Medical Policy Research and Coverage Advocacy to provide companies with insight into the probable coverage status of new and emerging technologies among government and private health insurers. Advocacy opens the doors for coverage.
Most Medicare coverage determinations are made among the Medical Administrative Contractors who serve 10 different jurisdictions. Coverage for products and services can vary widely among these administrators, even though they all administer the same Medicare benefits. Private insurer medical coverage policy varies widely throughout the country. Medical policy research and analysis is a critical component of any product business risk evaluation.
When medical coverage policies do not cover such technologies or do not exist, LSI staff will meet with health plan medical policy makers to advocate for change. Most private payers are unwilling to meet directly with manufacturers, but will make accommodations for third party representation among consultants they trust. Medical Science Liaisons (MSLs) are thoroughly vetted health care professionals who engage in peer-to-peer discussions with clinicians, nurses, payers, and key opinion leaders on behalf of our clients, ensuring an appropriate, compliant and comprehensive exchange of information on their products. Responsibilities include education of KOLs, physicians, health plan medical policy leaders and others throughout a product’s lifecycle, including support in conjunction with the launch or approval of an expanded indication, new pharmaceutical product or medical device.
A Clinical Dossier is a marketing tool targeted to the specific interests and concerns of payers and is frequently required to secure government and private payer coverage. Payers have different motivations as compared to hospitals, physicians or patients. LSI understands this and creates clinical dossiers to address their concerns related to key attributes about the medical product or service, clinical indications for use, mechanism of operation, supporting technology, literature reviews, cost effectiveness, and prevalence of the disease condition for which the product is targeted. A dossier is often used with MSL work.
Health Economics Analysis
Proving clinical effectiveness is half the solution. We can help you demonstrate evidence of cost to payers so they’ll cover your medical technology.
Health Economics Analysis has become increasingly important as payers often demand evidence of cost, not just clinical effectiveness before covering new technology and services. LSI works with medtech companies with varying types of analyses which may be required to demonstrate cost effectiveness and to accelerate favorable medical policy coverage.
Cost Analysis provides a complete accounting of the expenses related to a given policy or program decision. It supplies the most basic cost information that both decision makers and practitioners require and forms the foundation of all other economic analyses.
A Fiscal Impact Analysis is a comprehensive study of all governmental revenues, expenditures, and savings that will result from the proposed policy or program. This type of analysis helps policymakers determine whether a proposed initiative is affordable from a budgetary standpoint.
Cost Effectiveness Analysis (CEA) is used to evaluate which program or policy creates the result payers want at the lowest cost. CEA is a valuable tool for weighing programs or policies with similar outcomes, but it should not be used to compare programs that have different outcomes.
Cost-Benefit Analysis (CBA) is a method for comparing the economic pros and cons of policies and programs to help policymakers identify the best or most valuable options to pursue. A characteristic feature of CBA is that it monetizes all the benefits and all the costs associated with an initiative so that they can be directly compared.
HCPCS and CPT Code Analysis and Applications
How familiar are you with HCPCS and CPT analysis and applications?
Not only are we experts, we’re also connected to those whose new coding sponsorship is critical.
Healthcare Common Procedure Coding System (HCPCS) and Current Procedural Terminology (CPT) Code Analysis and Applications provide the basis for all medtech reimbursement. They are often more important than companies want to acknowledge. HCPCS coding directs new products and services into the proper pre-determined payment methodologies and rates and coverage policy wherever they may exist.
When new HCPCS Level I (CPT) or Level II coding is required, LSI has successfully guided clients to achieve new codes through the American Medical Association (AMA) CPT™ Editorial Panel or the Centers for Medicare and Medicaid (CMS) HCPCS Workgroup process. We maintain strong relationships with medical societies whose sponsorship is critical to success in these endeavors. It is a long process, but one that can catapult a new technology into the payment pipeline.
Many items of Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) are already defined in HCPCS. For audit protection and distributor assurance, LSI can verify through CMS’ Provider Data Analysis and Coding (PDAC) contractors. Professional services enabled by new technologies may already be captured under existing CPT coding. LSI can verify information through medical societies before the companies advise clinical users of this option.
Medical Technology Product Adoption Special Services
Do you need or want payer relations expertise throughout the entire product life cycle?
We’re available throughout the entire product life cycle including early, middle -product adoption phase and late phase.
LSI provides special services often required throughout the product adoption phase including ongoing clinical-user support for coding, billing, coverage support and procedure prior authorization.
Reimbursement Helpline/Hotline Support. Our highly-trained team is available via a Helpline to service clients whose customers require guidance in reimbursement issues throughout the product lifecycle.
Reimbursement Guides. LSI professionals assist clinical users in providing guidance to hospitals and physicians in the proper billing and coding of manufacturer-sponsored products.
FAQs for Payers/Providers. We often help clients in creating a list of frequently asked questions for payers and providers to help communicate key information for use by hospitals and physicians when first billing for new technologies and services. These may be sufficient in many cases to get new procedures paid.
Draft Appeal Letters. Physicians using new technology to treat patients often hit road blocks when payers do not understand the technology. LSI can draft appeal letters for clients who want to help physicians readily appeal insurance denials.
FAQs for Sales Staff. Your sales staff is, or will be, on the front lines introducing prospective customers to your new product. That’s why it is so important to provide them with fundamental education to accurately pass onto physicians, nurses, and hospital administration when promoting your medical technology. Our team helps clients develop information such as FAQs for sales staff to use.
