In January 2017, the FDA released draft guidance specifying the nature of communications between manufacturers and payers: The first draft guidance, entitled “Drug and Device Manufacturer Communications with Payers, Formulary Committees, and Similar Entities--Questions and Answers,” provides answers to common questions regarding communications of health care economic information (HCEI) about their approved prescription drugs to payers.
The draft guidance also addresses common questions relating to firms’ dissemination of information about investigational drugs and devices to payers before FDA approval or clearance of such products. This will help ensure that payers have information needed to make informed drug selection, formulary management, or coverage and reimbursement decisions and to help ensure that the information is not false or misleading (Notice, 82 FR 6568, January 19, 2017). For purposes of the draft guidance, the term “payors” collectively refers to payers, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis that are responsible for making drug selection, formulary management, or coverage and reimbursement decisions on a population basis regarding drugs or devices for health care organizations, which may include entities such as integrated health care delivery networks, hospitals, and hospital systems.
The timing of your communication matters as well. Industry expert Patty Telgener of Emerson Consulting and Canary Insights notes that “Payers do not typically take HCEI under consideration until after they review clinical data that can show improvement in clinical outcomes.” This underscores the importance of having up to date, accurate and comprehensive information about coding, billing, coverage, and regulatory requirements.
The Big Picture
For life science product manufacturers, the successful and ongoing sales and distribution of US FDA cleared devices depends on your understanding and meeting of compliance requirements and reporting—especially for reimbursement and payment. These are critical for any business to accelerate product adoption and maintenance of strong revenue streams. Do you have a clear understanding of how your medical product is reimbursed, and are you effectively communicating with payers and providers about the benefits of your product?
The U.S. is a complex multi-payer system—how health care providers code, bill, and are reimbursed for drugs, biologics, tests, medical devices, and durable medical equipment is a harsh example of this complexity. Add the rapid changes occurring to the Medicare & Medicaid regulatory landscape, driving significant down-stream changes in coding and billing, and you’re left to unravel a lot of red tape to get to a reimbursement strategy.
We can help!
While the majority of changes occur annually, it is critical to keep abreast of coding, payment, coverage & regulatory issues relevant to your drug device and medical equipment product lines on an ongoing basis.
- The Coding Suite provides life science reimbursement strategy teams with up-to-date coding, coverage, payment and regulatory updates, and can be customized to send you email alerts specific to your product lines. Track all national and state updates for Medicare and Medicaid in one simple tool.
- Canary Insights extends this intelligence into the private payer space, with monitoring of hundreds of private payer sites and customizations based on your therapeutic landscape. Canary even includes a comprehensive payer directory and calendar so that you know when and who to contact.
Download the Life Sciences Reimbursement Strategy Trends white paper here: https://lrus.wolterskluwer.com/product-family/whitepapers/Complimentary-...