The Remote Monitoring/Virtual Care Management Compliance Assessment

We tailor this fixed-fee service to your company’s specific needs so you can accelerate customer acquisition, attract venture capital investment, and confidently operate in compliance with federal healthcare laws and regulations.

WHO BENEFITS MOST

Remote Patient Monitoring and Virtual Care Management innovators who need:

1. the most up-to-date RPM and Virtual Care Management reimbursement requirements, including as appropropriate — Remote Physiologic Monitoring, Remote Therapeutic Monitoring, Chronic Care Management, Principal Care Management, Transitional Care Management, Chronic Pain Management, and Behavioral Health Integration.

2. the resulting business model implications; 

3. FDA and privacy/security recommendations for devices and SaaS platform; 

4. updates to Core Documents (or drafting of Core Documents for new clients); 

5. RPM/virtual care FAQs for customers that answer questions with confidence and help close deals faster.

WHAT THESE BENEFITS LOOK LIKE FOR YOUR BUSINESS

In addition to mitigating risk, our fixed-fee Compliance Assessments often result in revenue increases and cost savings for our clients, such as:

• Creating a pilot agreement designed to flow into a full customer agreement so you don't have to go through another round of legal approval. (Bypass that six months or so of back-and-forth over the terms and start earning revenue right away.) 

• Collaborating with unique legal experts within our Firm as needed. You won't often find the caliber or mix of health tech, device, reimbursement, FDA, and digital health resources under the same virtual roof, especially for a fixed fee. (No more mentally calculating the bill when you see three attorneys show up to a meeting—your price is locked in.)

• Undoing inadvertent legal missteps, such as the all-too-common mistake of hiring a general corporate attorney who inadvertently sets up a business model or structure that is very common in other commercial contexts -- but completely illegal in healthcare. (Don't let general advice lock you into very specific consequences!)

HOW IT WORKS

You and your team will have a virtual meeting with Nixon Gwilt Law Remote Monitoring and Virtual Care Management experts. 

During this meeting, we will review your current virtual care management platform with an eye toward:

• Reimbursement Framework

  • Implications of 2021 changes for your current business model

  • Review/discussion of your Policies and Protocols

• FDA Regulatory Compliance  

  • What is the appropriate regulatory status of your device(s)? Not FDA regulated? Enforcement discretion? Registered? Cleared? Approved? 

  • What requirements for outsourced devices do you need to be aware of?

  • What are your obligations relating to imported or white-labeled devices?

  • Could your RPM platform be classified as Software as a Device for purposes of CPT Code 99454?

• Privacy/Security 

  • Review and Implications of new privacy guidance for RPM and virtual care companies and providers

• Fraud and Abuse Compliance

  • Identifying any potentially problematic business arrangements

• We will also review and update your core documents (or draft Core Documents for new clients), including:

  • Terms of Use (Provider-facing; Patient-facing)

  • Privacy Policies

  • Business Associate Agreements (Covered Entity and Subcontractor)

  • Patient Consents 

  • Customer/Master Services Agreement

WHAT YOU’LL GET

As part of the assessment, you will get these takeaways:

• Comprehensive summary of:

  • The latest reimbursement requirements for remote monitoring and virtual care management CPT codes and business model implications

  • Recommendations relating to your device(s), protocols, and/or business model

  • Privacy/Security recommendations

• New or updated Core Documents

• FAQs for remote monitoring/virtual care management customers

This combination will allow you to accelerate customer acquisition, attract venture capital investment, and confidently operate in compliance with federal healthcare laws and regulations.

HOW TO GET STARTED

This targeted service is available for our existing remote monitoirng/virtual care management clients and for new clients (those with existing customers or those just starting). Please click one of the buttons above and provide the requested information.

We look forward to helping you maximize growth in your RPM or Virtual Care business.

Are you looking to launch a Remote Monitoring or Virtual Care offering?

Then you’ll want to check out our Hit the Ground Running with Remote Monitoring and Virtual Care fixed-fee service.