Services

We’re known for solving big problems, challenging assumptions, and thinking differently about established processes. This approach helps medical device, technology, and therapeutics companies, hospital and health systems deliver innovation more quickly to the frontlines.

Market Access: From Seed to Full Commercialization & Adoption
We share the same goal as patients, clinicians, and our clients alike: for the highest-quality health care to be adopted, accessible, and covered.

To achieve this, we design strategies that align clinical evidence with market needs, improving product adoption, reimbursement, and coverage.

While every engagement is tailored to a client’s evidence, product, and specific clinical scenario, we most often help with:

Evidence generation and clinical trial design

Data strategy

FDA engagement

Evidence publication

Payer coverage

Coding and reimbursement

Care standards and guidelines
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
We leverage our deep experience with CMS and FDA to deliver meticulous counsel that helps clients navigate regulatory hurdles and accelerate access for innovative products.

This often includes:

Hospital and health system regulation and compliance

Novel technology regulations

Product labeling and filing

Federal process and procedure education

FDA counsel
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
As a bipartisan firm, we work on both sides of the aisle to shape the healthcare landscape—influencing policy and supporting clients in engaging with public and private stakeholders.

Our capabilities include:

Expert bipartisan counsel

Stakeholder engagement and education

CMS engagement

Lobbying and advocacy

Regulatory communications, including RFI comments and responses
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.
Health System Transformation: Navigating Seismic Shifts
We help hospitals and health systems build resiliency within a rapidly changing health sector. Our team has unmatched experience in improving health system performance through clinical, operational, regulatory, and policy innovations that create sustainable transformation.
Our capabilities include:

Optimizing system-level quality governance

Ensuring standardization, efficiency, and clarity in quality reporting

Identifying organizational drivers of quality and amplifying best practices

Bridging clinical and operational priorities

Delivering data from population-based performance analyses to support clinical care delivery

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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

Health System Transformation: Navigating Seismic Shifts

Examples of our Previous System Transformation work

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