Hit the Ground Running with Remote Monitoring and Care Management Services

Looking to launch a Remote Therapeutic Monitoring (RTM) offering?

Wondering if it makes sense to add a Chronic Care Management (CCM) or Principle Care Management (PCM) service line to your existing revenue model?

Then this fixed-fee service is for you. We tailor this offering 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, Remote Therapeutic Monitoring, and other Virtual Care innovators who need to know the:

  • Most up-to-date RPM, RTM and Virtual Care reimbursement requirements; 

  • Resulting business model implications; 

  • FDA and privacy/security recommendations for devices and SaaS platform; 

  • Updates to Core Documents (or drafting of Core Documents for new clients); 

  • RTM/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, NGL’s fixed-fee “hit the ground running” 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 every time you need to reach out to your attorney—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 RTM and virtual care experts. 

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

  • Reimbursement Framework

    • Implications of MPFS 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 software platform be classified as Software as a Medical Device (SaMD) for purposes of RPM or RTM?

  • Privacy/Security 

    • Review and Implications of new privacy guidance for RTM 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

FIXED FEE, CUSTOM RESULTS

While this is a fixed-fee service in terms of price, your takeaway is customized to reflect your full package, which may include a combination of virtual care services.

You’ll get a comprehensive summary of reimbursement requirements for your offer along with recommendations related to your device(s), protocols, and/or business model.

Your results may also include Privacy/Security recommendations, new or updated Core Documents, FAQs for virtual care customers, and other counsel to support your business plans.

You get to customize your package, and that all starts with clicking one of the buttons below. We’ll walk you through the easy process to get a quote and get started on your new offerings.

HOW TO GET STARTED

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

Already have a Remote Monitoring or Virtual Care program in place?

Then you may want to check out our Remote Monitoring Compliance Assessment to stay updated on changing requirements.