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Pharmacy Innovation Series: the DEA Steps into Telepharmacy Regulation
Articles Nixon Law Group Articles Nixon Law Group

Pharmacy Innovation Series: the DEA Steps into Telepharmacy Regulation

For the first time, the Drug Enforcement Agency (“DEA”) is becoming directly involved in the telepharmacy space, an industry that the DEA has not previously regulated aside from the loose application of its existing regulations governing online pharmacies. Find out what this means for your business and how you can submit comments to the DEA directly in this post.

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3 Key Challenges Facing Tele-dentistry Companies and How to Approach Them
Articles Nixon Law Group Articles Nixon Law Group

3 Key Challenges Facing Tele-dentistry Companies and How to Approach Them

Dentistry is one of a number of clinical specialties that is taking a creative and innovative approach to delivering care using digital health tools. Most of us are now familiar with Byte, SmileDirectClub, and Candid—these companies are pioneers in the space. However, tele-dentistry has far more potential applications than retail clear aligner services. Tele-dentistry entrepreneurs are building solutions for remote examination of sore or swollen teeth and gums, screening for certain oral diseases and cancers, mobile dental hygiene, dental hygiene education, and more.

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Additional Reimbursement for Chronic Care Management and Principal Care Management Finalized in the 2022 MPFS
Articles Rubel Ahmed Articles Rubel Ahmed

Additional Reimbursement for Chronic Care Management and Principal Care Management Finalized in the 2022 MPFS

In the Final Medicare Physician Fee Schedule (“MPFS”) for 2022 (the “Final Rule”) issued on November 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) added five new CPT codes in the categories of Chronic Care Management (“CCM”) and Principal Care Management (“PCM”) and increased reimbursement for already existing codes in the same categories. Despite stakeholder feedback, CMS refrained from making any changes to the existing rules for obtaining beneficiary consent for CCM and PCM.

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Telehealth in the 2022 Medicare Physician Fee Schedule: Audio-Only Telehealth for Mental Health Made Permanent, and CMS Punts on Remote Direct Supervision
Articles Nixon Law Group Articles Nixon Law Group

Telehealth in the 2022 Medicare Physician Fee Schedule: Audio-Only Telehealth for Mental Health Made Permanent, and CMS Punts on Remote Direct Supervision

On November 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) finalized the Medicare Physician Fee Schedule for Calendar Year 2022 (the “Final 2022 MPFS” or the “Final Rule”). As we noted in our July article discussing the Proposed 2022 MPFS, CMS made some significant proposed changes to allow for audio-only telehealth in some limited circumstances. In addition, the agency also proposed to enable remote “direct supervision,” which would allow practitioners to supervise clinical staff billing incident to their services as long as they could be available by audio/video communication as necessary.

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Under 2022 Medicare Physician Fee Schedule, Physician Assistants Will Be Paid Directly for Services
Articles Nixon Law Group Articles Nixon Law Group

Under 2022 Medicare Physician Fee Schedule, Physician Assistants Will Be Paid Directly for Services

On November 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) released its Final Medicare Physician Fee Schedule for 2022 (the “Final 2022 MPFS”), revising certain payment policies for services provided to Medicare beneficiaries by healthcare practitioners. These policies take effect on January 1, 2022.

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The Top 3 Privacy Concerns for Digital Health Innovators
Videos Nixon Law Group Videos Nixon Law Group

The Top 3 Privacy Concerns for Digital Health Innovators

Discover how Privacy compliance impacts Digital Health Startup founders and executives in terms of access to capital and securing key vendor agreements in this webinar replay. You may not have ever looked at Privacy this way before, and we encourage you to explore this perspective so you can close those critical deals without unnecessary delay.

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Remote Therapeutic Monitoring in the 2022 MPFS: How CMS Can (and Should) Get it Right
Articles Carrie Nixon Articles Carrie Nixon

Remote Therapeutic Monitoring in the 2022 MPFS: How CMS Can (and Should) Get it Right

This is our take on the approach CMS should follow in improving and finalizing the RTM codes and associated reimbursement that improve patient outcomes and lower the overall cost of care. It is based on our extensive work with remote patient monitoring and care management digital health companies along with the physician practices who use the existing care management codes – including Remote Patient Monitoring (“RPM”), Chronic Care Management, Principal Care Management, and Behavioral Health Integration.

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Intellectual Property for Digital Health Companies: How a Multi-Faceted Strategy Balances Patentability Barriers
Articles Nixon Law Group Articles Nixon Law Group

Intellectual Property for Digital Health Companies: How a Multi-Faceted Strategy Balances Patentability Barriers

If you’re building a digital health company, it is especially important to develop a multi-faceted intellectual property protection strategy. Here’s why: a strategy that includes multiple pathways for IP protection allows you to protect both tangible assets, like proprietary hardware, software, and documentation, as well as intangible assets, like branding, customer-facing website designs, pricing strategies, business models and projections.

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New Remote Therapeutic Monitoring CPT codes introduced in Proposed 2022 Medicare Physician Fee Schedule
Articles Nixon Law Group Articles Nixon Law Group

New Remote Therapeutic Monitoring CPT codes introduced in Proposed 2022 Medicare Physician Fee Schedule

On July 13th, the Centers for Medicare and Medicaid Services (“CMS”) released its proposed Medicare Physician Fee Schedule for Calendar Year 2022 (the “2022 Proposed MPFS” or the “Proposed Rule”). In doing so, it recognized five new CPT codes for Remote Therapeutic Monitoring (“RTM”) of “non-physiologic” patient data such as “musculoskeletal system status, respiratory system status, therapy (medication) adherence, and therapy (medication) response” as well as pain. While this new code set is welcomed by advocates for virtual care, the 2022 Proposed MPFS that discusses RTM may raise just as many questions as it answers.

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Can Biotech and Pharma Companies pay contracted sales teams a commission-based fee?
Articles Nixon Law Group Articles Nixon Law Group

Can Biotech and Pharma Companies pay contracted sales teams a commission-based fee?

The U.S. Department of Justice (DOJ) just sent a strong message to pharmaceutical and biotechnology companies who rely on contracted sales teams to push their products into the market: “commission-based compensation violates the Federal Anti-Kickback Statute (AKS)”.

This message seems to undermine years’ worth of relative stability in how these companies evaluate risks associated with commission-based compensation that does not fit squarely into a legal safe harbor under the AKS.

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What is a Value-Based Enterprise? New Opportunities for Digital Health and Healthcare Innovation
Articles Nixon Law Group Articles Nixon Law Group

What is a Value-Based Enterprise? New Opportunities for Digital Health and Healthcare Innovation

Dramatic changes to the Anti-Kickback Statute and the Stark Physician Self-Referral Law regulations present an unprecedented opportunity for healthcare providers and digital health companies to create new business arrangements that align incentives around care coordination and patient engagement. Such arrangements are the foundation of the Value-Based Enterprise.

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