Services

Our clinical approach leverages decades of unique CMS, FDA, health system, and patient care experience.

Market Access: From Seed to Full Commercialization & Adoption

We share the same goal as our clients and the American public: for the highest-quality care to be adopted, accessible, and covered. For this to happen, innovative care solutions need the support of experts capable of ensuring the needs of all engaged stakeholders—patients, clinicians, health systems, and insurers—are met to allow for appropriate, meaningful adoption of novel products and services.

Our distinguished group of MDs, JDs, MPHs, MBAs, and more will support your team at every point in the Market Access strategy we’ll create together. We are executive-level former regulators, practicing clinicians, lawyers, and patient access experts who have spent our careers dedicated to patients and their care.

Our work specializes in deep knowledge and understanding of commercial and government payers, health system purchasing, quality assessment, and health technology assessment organizations. This allows our team to thoughtfully engage the stakeholders companies will need to navigate as they come to market.

Client: Therapeutic Company Planning their Pivotal Trial
Services: Evidence Generation and Trial Design – Designed clinical studies that demonstrated clinical utility and aligned with industry and payer expectations. This included drafting protocols, manuscripts, statistical analysis, evidence planning, and evidence dissemination into leading journals.

Client: Commercialized Company Looking to Collect Real World Data
Services: Data Strategy – Conducted health economics and data analyses for real-world evidence studies, RCTs, and other evidence pathways. This included assessing commercial plan viability of novel technologies, researching and counseling on areas of unique market opportunity based on economic sustainability, designing and executing data collection strategies for pre-clinical and fully commercial products, and manuscript publication strategy.

Client: Medical Device Company Entering the U.S. Market
Services: FDA engagement – Specialized in FDA filings and engagement including presub, IND, Breakthrough, 510(k), De Novo, and PMA.

Client: Medical Device Company Navigating the Complex Payer Landscape
Services: Payer Coverage – Ensured broad product adoption through coverage by federal and commercial payers. This included major Medicare tactical processes such as filings for NTAP, Pass-through Payments, LCDs & NCDs, TCET, and more. We also crafted payer dossiers, helped engage with CMS, MACs, and commercial payers, and created the framework to meet clinical utility and reasonable, necessary requirements of the payers. Additionally, we assisted in strategies regarding health system adoption and payment of novel products including DRG and independent payment identification.

Client: Series C Company Determining a Path to Payment
Services: Coding and Reimbursement – Developed strategies to ensure efficient product access, appropriate coding, and reimbursement. This includes new code filings, cross-walks, payment applications, pricing counsel, and more.

Client: Diagnostic Company Looking to Shape the Test-to-Treat Paradigm
Services: Care Standards and Guidelines – Shaped clinical guidelines and best practices to support product deployment. This included engagement with guideline stewards, drafting of guideline material, RFI and proposed rule responses, and strategizing around an approach to seizing market opportunity of becoming standard of care.
Regulatory: Meticulous Counsel for Healthcare’s Most Complex Issues
Whether you represent a health system or a medical device, drug, technology, or therapeutic company, regulation of the healthcare industry can be highly technical. With our backgrounds working in leadership positions at CMS, FDA, and major health systems, we are rooted in a wealth of regulatory knowledge.

We are the leading voice to:

Advise health systems and their related stakeholders on Medicare payment, immediate jeopardy status, quality assessment, Medicare standing, quality measurement and outcome reporting, litigation support, expert testimony for the purposes of ALJ or litigation proceedings, FDA compliance, and more.

Advise on regulation of novel technologies including devices, AI, digital therapeutics, pharmaceuticals, and vendor infrastructure.

Provide education on federal processes and procedures across federal agencies.

Guide best practices in order to gain federal recognition for your product or service.
Client: Major Law Firm
Services: Analyzed and explained highly technical aspects of the Medicare program and how hospitals, nursing homes, hospice, and laboratories are accredited or lose accreditation, related to Medicare payment.

Client: Health System
Services: Counseling on quality assessment and outcome reporting to ensure appropriate compliance with the Medicare program.

Client: Medical Device Company
Services: Gave FDA counsel on a wide variety of issues touching product labeling to filing and more.
Policy: Shaping the Healthcare Landscape

Excellent patient care backed by evidence should be fundamentally bipartisan. We approach our policy counsel with a deep bench of clinical, commercial, and regulatory expertise to provide advice that furthers health policy and seeks data-backed reasoning within the complex healthcare landscape.

As an expert, bipartisan counsel, we function like an extension of your team to analyze, draft, and facilitate the dissemination of policy solutions that work for you. This includes responding to RFIs from both Congress and federal agencies and assisting in comment drafting and technical guidance pertaining to regulatory and statutory changes. We do this by partnering with our vast network of connections: patient advocates, physician associations, hospital associations, and other industry leaders.
Client: Digital Health
Services: When a client found that their digital health product was no longer interoperable due to policy changes, we worked together to rescope how they told their story and the importance of collecting that data for patient care. We arranged dozens of meetings with healthcare leaders, patient advocates, EHR and technology vendors, and interoperability experts to educate how stakeholders could communicate to the federal government and third parties the importance of their technology and its need for seamless data transmission.

Client: Technology Company
Services: A client used Artificial Intelligence as a tool for improving patient care but did not have a clear pathway for reimbursement due to a lack of clear benefit category under the current scoping of their tool. We helped to rescope what their product was capable of doing and helped develop their CMS engagement strategy to allow for sufficient payment for the product.

Client: Diagnostic Company
Services: A client had a new diagnostic that could improve the quality of care and patient outcomes. We helped develop a strategy to engage CMS and other key stakeholders to properly incentivize high-quality care, including the use of their technology.

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Services

Market Access: From Seed to Full Commercialization & Adoption

Examples of Previous Market Access Work

Regulatory: Meticulous Counsel for Healthcare’s Most Complex Issues

Examples of Previous Regulatory Work

Policy: Shaping the Healthcare Landscape

Examples of Previous Policy Work

Contact Us