Wells Health Group is a health policy consulting and government relations firm based in Washington D.C.
WHG helps clients navigate the “2020 Pandemic New Normal” healthcare delivery system and beyond:
- New CMS reimbursement pathways in aggregate with the new Medicare Technology Coding and Pricing Group to allow for faster access to innovative technologies.
- New FDA Emergency Use Authorization (EUA) regulations to allow for unapproved medical products or unapproved uses of approved medical products to be used in an emergency.
- New CDC public health guidance, evolving as the knowledge base grows, and expanded/refined data reporting.
- New NIH infectious disease research and expanded medical and behavioral health research.
Wells Health Group Areas of Expertise
WHG's innovative approach to health policy consulting is built on a two-step sequential process founded on 70+ years successful healthcare industry and government relations experience:
WHG provides clients a systematic and targeted engagement by working sequentially through interconnected groups of analytics to verify solid sustainable health policy strategies and reimbursement pathway tactics.
Our mission is to help clients maximize stakeholder value
Why Our 70+ Years Healthcare & Government Relations Experience Matters
- Because we come from industry - WHG is uniquely positioned to best understand our client’s challenges and develop targeted government relations’ strategies.
- Because of our government relations experience representing industry we knew it was critical to have a Washington D.C. presence.
- Because WHG is strategically located on Pennsylvania Avenue between the Capitol and the White House and just six blocks for the main HHS building, WHG has been able to more readily access face-to-face meetings at multiple levels of the HHS Agencies and on Capitol Hill.
- Because WHG's previous years of Washington D.C. presence with face-to-face meetings at multiple levels of the HHS Agencies and on Capitol Hill, we are a known entity and know how to leverage virtual access to multiple levels of the HHS Agencies and on Capitol Hill.
The U.S. healthcare delivery system, unlike any other industry and unlike any other country's healthcare system is:
Post Pandemic Outbreak - Health policy decision-making guidance and reimbursement methodologies are driven by federal government initiatives (HHS, CMS, CDC, FDA & NIH) and generally adopted by commercial payers.
Pandemic Health Policy Challenges That Effect CMS Reimbursement, CDC Guidance and FDA Market Access Corridors
On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. On the basis of this determination, the Secretary then declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19.
In continuing response to the COVID-19 pandemic, on March 24, 2020, and based on the February 4, 2020 HHS EUA determination, the HHS Secretary declared that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, due to shortages during the COVID-19 outbreak. EUAs for home collection kits reference this declaration.
The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.
FDA Emergency Use Authorization (EUA), FDA Approval or FDA Clearance allows for commercialization. It does not mean that a product is covered or eligible for reimbursement by Medicare, Medicaid, or commercial insurance.
FDA assigned product categories determine a companies commercialization pathway; Emergency Use Authorization (EUA), FDA Approval or FDA Clearance
FDA approved or authorized indications for use and FDA product coding can result in downstream consequences with significant reimbursement pathway implications.
FDA controlled regulations affect CMS controlled policies determining site of care utilization, benefit category, coverage criteria and payment mechanisms.
FDA regulations and CMS reimbursement processes are not intuitive and can lead to uncertainties and market access complications especially during the HHS authorization of emergency use.
Wells Health Group Consulting Services
Health Policy Consulting - WHG's innovative approach is built on a two-step sequential process.
Strategy Analytics - Comprehensive Medicare, Medicaid and commercial insurance reimbursement pathway analysis.
Reimbursement Pathways – We identify the foundation of reimbursement hurdles and opportunities.
DC Based Government Relations - WHG understands the nuances of how the Administration, Congress and Federal Agencies shape healthcare policy.
The WHG team’s years of healthcare industry and government relations experience positions us uniquely to best understand our client’s challenges and develop targeted government relations strategies.
Health Policy Legislation - In Congress at least 6 different full committees and their respective subcommittees have appropriations, jurisdiction and oversight responsibility over healthcare.
Health Policy Implementation - HHS - CMS - FDA have multiple centers, offices and administrative contractors with regulatory oversight and often-overlapping jurisdiction over healthcare reimbursement coding, coverage and payment methodologies.
Evaluating CMS Reimbursement Pathways, CDC Guidance and FDA Market Access Corridors - One of the most critical and challenging analytics of healthcare M&A due diligence
WHG can help clients prepare for a successful due diligence process.
How well is the client positioned for funding or coverage challenges and the inevitable shift from fee-for-service to value-based payments?
WHG understands the health policy challenges and misconceptions that can affect transactions.
WHG help's clients evaluate a transaction’s potential to maximize stakeholder value based on real-life experiences.