helping you ensure coverage for your novel medical device

Healthcare Common Procedure Coding System (HCPCS) and Current Procedural Terminology (CPT) Code Analysis and Applications provide the basis for all medtech reimbursement in the U.S., which are often more important than companies wish to acknowledge. HCPCS coding directs new products and services into the proper pre-determined payment methodologies, rates and coverage policies where they may exist. Coding systems vary throughout the world, and standardization is many years away.

In the U.S., when new HCPCS Level I (CPT) or Level II coding is required, NAMSA successfully guides clients to achieve new codes through the American Medical Association (AMA) CPT™ process or the Centers for Medicare and Medicaid (CMS) HCPCS Workgroup process. We maintain strong relationships with medical societies whose sponsorship is critical to success throughout medical technology adoption. Although it can be a long process, it can catapult a new technology into the payment pipeline.

NAMSA helps you open the doors for coverage by conducting Medical Policy Research and Coverage Advocacy to provide insight into the probable coverage status of new and emerging technologies among government and private health insurers around the globe.

Coverage for specific products and services can vary widely among government and commercial insurance companies, independent of the fact that they often administer similar benefits. When medical coverage policies do not cover specific technologies, or they do not exist, NAMSA’s experts will meet with health plan medical policy makers to advocate for change. Most private payers are unwilling to meet directly with medical device Sponsors, 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 (KOLs) on behalf of clients, ensuring an appropriate, compliant and comprehensive exchange of information regarding medical products. Responsibilities include education of KOLs, physicians, health plan medical policy leaders and others throughout the product lifecycle, including support in conjunction with the launch or approval of an expanded indication or new medical device.

Do you require payer relations expertise for the long haul? NAMSA’s experts are available globally throughout the product adoption phase.

NAMSA provides payer relations expertise for the long haul by delivering global capabilities and special services throughout the product adoption phase, including ongoing clinical-user support for coding, billing and coverage support.

• Coverage Throughout IDE Clinical Trials: Many device manufacturers do not realize that Medicare, as well as some commercial insurers, will cover new devices during the course of a Category B Investigational Device Exemption (IDE) clinical study. We work with Medicare and health insurance providers to set-up payment and billing systems for IDE studies to support ongoing provider enrollment within clinical studies.
• Reimbursement Guides: NAMSA’s global reimbursement experts assist clinical users in providing guidance to hospitals and physicians for proper billing and coding of manufacturer-sponsored products. These guides also assist hospitals and physicians to understand the likely level of payment for the services associated with new technologies, thereby supporting device adoption.
• FAQs for Payers: We often help Sponsors in creating a list of frequently asked questions for payers 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 avoid long payment delays.
• Draft Appeal Letters: Physicians using new technologies to treat patients often hit roadblocks when payers do not understand the technology. NAMSA can draft appeal standardized letters for clients who want to help physicians readily appeal insurance denials.
• FAQs for Sales Staff: Your sales staff is 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.

The Patient Protection and Affordable Care Act of 2010 changed the dynamics of healthcare delivery and financing in the United States; other countries are also experiencing challenges within financing systems given the number of constant technological evolutions in medicine. NAMSA understands government and private payer coverage and payment policies under the current global health economics environment. As such, our team designs strategies surrounding specific objectives which are targeted toward reimbursement barriers that would otherwise limit broad market adoption of emerging medical technology, including use of clinical and health economics evidence to secure coverage.

Some ways in which NAMSA assists global device manufacturers to proactively address potential medical device reimbursement barriers, include:

• A Reimbursement Assessment is a research-based report that identifies possible barriers to appropriate coding, coverage and payment for a specific medical technology. During an assessment, variations in clinical indications for coverage—based on service setting (inpatient vs. outpatient, hospital, clinic, home care)—are identified, as are payer mix and comparable technologies. This critical assessment forms the basis for creating a medical device reimbursement process strategy to achieve successful product adoption.
• Medical Director Interviews and Physician Advisory Boards
  NAMSA conducts primary research with existing health plan Medical Directors to evaluate payer reaction to new technologies, either pre-release 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, while 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. When NAMSA interviews medical directors, we do so individually in face-to-face meetings, whereas in situations when clients want direct access and active interchange, Physician Advisory Board meetings are arranged.
• Often, novel medical technologies that are targets for acquisition require Reimbursement Due Diligence for Investors. NAMSA can perform Reimbursement Due Diligence for venture capital companies and other investors to assess market risk for reimbursement prior to investment.
• Our team of experts will also meet with hospital and finance staff in advance of major new technology to Assess Adoption. This assists hospitals in determining positive or negative projected margins from Medicare and private payers prior to investing in new medical technologies.