Applied Policy has worked extensively with manufacturers facing health policy issues to help them get their products to the patients that need them. From large corporations developing and marketing a broad portfolio covering multiple therapies to small, single-product biotechs, we bring insight and color to help navigate federal and state policy to ensure patients get access to their therapies. Whether you have an established product or a pipeline product in development, Applied Policy has the expertise to help you understand how public policies can impact your goals and objectives.

Our staff has decades of experience in the Centers for Medicare & Medicaid Services, Department of Health and Human Services, Departmental Appeals Board, and directly for durable medical equipment (DME) manufacturers that we leverage to ensure that our clients receive optimal reimbursement. We help companies ranging from startups to Fortune 500 firms navigate the complex government healthcare landscape, with an emphasis on working collaboratively with every client to improve the lives of the patients they serve.

We pride ourselves on our collaborative work approach that is individually tailored to your needs. Our past engagements have included:

• Developing strategies for new product reimbursement to obtain optimal coding, coverage, and payment
• Supporting a manufacturer through the process of obtaining first-time Medicare coverage, including:
  • Press rollout
  • Pricing strategy
  • Supplier interactions
  • Regulatory analysis
  • Government program impact
  • Managed care implementation
  • Establishing a Medicare distribution line of business
  • Understanding coverage determinations and fee schedules
• Working with CMS and the White House Office of Management and Budget to revise incorrectly set fee schedule amounts
• Engaging external stakeholders, including:
  • National Quality Forum
  • Pharmacy Quality Alliance
  • National Minority Quality Forum
  • Patient Advocacy Organizations
  • Physician and Clinician Specialty Societies
• Creating and executing a coding and reimbursement strategy for physician-administered products, including:
  • HCPCS Coding Application and Strategy
  • Billing and Reimbursement Guide Development
  • Support After Launch with Billing Issues
• Successfully filing PDAC coding applications
• Supporting efforts to obtain state Medicaid coverage for devices
• Analyzing changes in federal and state policy that could impact individual patient coverage, formulary coverage, or other policies that could threaten patient access.
• Serving as “staff extenders” for small companies developing innovative products.

One of our clients was preparing to launch a new product to treat one type of a condition that has several types. The ICD-10 code system was not granular enough to specify which condition type a patient had been diagnosed with, meaning there was no easy way for payers to determine whether patients were getting clinically appropriate therapy. Applied Policy worked with the client to file an application for new codes to differentiate the different types of condition, and engaged patient advocacy organizations and physician specialty societies to support the request. The application was approved, and the 2017 ICD-10 update included new codes to specify the condition type that patients had been diagnosed. This makes it less administratively burdensome for plans to implement utilization management, meaning that patients can access the therapy they need faster.

Applied Policy provided full service to our client from:

• Researching the application process;
• Filing the application;
• Engaging stakeholders;
• Preparing for and attending public meetings; and
• Maintaining an open line of communication with government staff until a final decision was announced.