Bipartisan Bill Aimed At Expanding CMS Coverage Of Rx Digital Therapeutics Re-Introduced

The Access to Prescription Digital Therapeutics Act of 2025 (S1702/3288) seen here has been re-introduced by Senators Shelley Moore Capito (R-WV) and Jeanne Shaheen (D-NH)) and Representatives Kevin Hern (R-OK) and Mike Thompson (D-CA). The proposed legislation would do the following: 

• Create a reimbursement pathway for software that treats medical conditions

• Create a new Medicare benefit category for Food and Drug Administration (FDA)-cleared prescription digital therapeutics to be prescribed to seniors in the program.

• Require the CMS to develop payment methodologies for prescription digital therapeutics and create product-specific CPT codes to adequately reimburse for the products. 

Lanton Law through its Government Affairs Division Lanton Strategies has been following digital therapeutic policy as it unfolds. This is an oftentimes confusing area of policy since it is innovative and many times mistakenly tied to FDA approvals. 

Stakeholders who are interested in this issue and want to ensure compliance should ensure that an adequate and appropriate FDA approval and CMS reimbursement strategy is in place internally to avoid marketplace delays. Contact us to learn more.  

Congress Reintroduces the Access to Prescription Digital Therapeutics Act

At Lanton Law we have been monitoring the both exciting and emerging field of prescription digital therapeutics. While the technologies we have been witnessing are promising, there does remain the challenge of reimbursement, since there has not yet been a statutory benefit category established for this new technology. However; behavioral health shows the most immediate promise. 

With that in mind, Congress has introduced The Access to Prescription Digital Therapeutics Act of 2023. The bill proposes to “expand Medicare coverage to include PDTs, which are software-based disease treatments designed to directly treat disease. PDTs are designed and tested much like traditional prescription drugs but rather than swallowing a pill or taking an injection, patients receive cognitive therapy through software. The treatments are tested for safety and efficacy in randomized clinical trials, evaluated by the U.S. Food and Drug Administration (FDA) and prescribed by health care providers.” The bill can be read here.

Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our HealthIT practice can help stakeholders understand what’s at issue with topics like digital therapeutics, RTM and RPM so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

What is Remote Patient Monitoring (RPM)?

What is Remote Patient Monitoring (RPM)?

Remote patient monitoring is an innovative way that healthcare providers are using to treat chronic and acute conditions. With COVID-19 spurring faster adoption of telehealth and RPM, the subject of RPM involves the connection of digital tools that record healthcare data that is reviewed by an off-site provider. According to HHS, new treatment methods like RPM can help with the following conditions:

• High blood pressure

• Diabetes

• Weight loss or gain

• Heart conditions

• Chronic obstructive pulmonary disease

• Sleep apnea

• Asthma

Many of the devices that patients will use may be familiar to them, including:

• Weight scales

• Pulse oximeters

• Blood glucose meters

• Blood pressure monitors Telehealth.hhs.gov

At Lanton Law we have been monitoring the both exciting and emerging field of RPM. We fully anticipate the conversation to continue to evolve into further regulatory definitions as well as appropriate reimbursement schemes. 

Lanton Law is a national healthcare and technology boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our HealthIT practice can help stakeholders understand what’s at issue with topics like RPM, RTM and digital therapeutics so that we can help our valued clients. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

Prescription Digital Therapeutics Bill Introduced in Congress

The Medicaid and CHIP Access to Prescription Digital Therapeutics Act also known as S. 5238 seen here was introduced on December 12, 2022 by Senator Capito (R-WV). The bill seeks to “require the Administrator of the Centers for Medicare & Medicaid Services to provide guidance regarding coverage of prescription digital therapeutics under Medicaid and the State Children's Health Insurance Program.” While this bill is a step forward for digital therapeutics, questions remain about this bill such as whether this bill will get introduced in the new Congress, will this bill create more access, reduce costs and is the correct reimbursement model?

At Lanton Law we have been monitoring the both exciting and emerging field of prescription digital therapeutics. While the technologies we have been witnessing are promising, there does remain the challenge of reimbursement, since there has not yet been a statutory benefit category established for this new technology. 

Lanton Law is a national healthcare and technology boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our HealthIT practice can help stakeholders understand what’s at issue with topics like digital therapeutics, RTM and RPM so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

How to Choose a Lobbyist

Since the early 2000s, there has been a steady increase in the amount of government activity that has directly affected healthcare stakeholders. Prior to this time-period, companies could afford to focus only on differentiating their products from their competitors. Now companies are finding that during their strategic planning meetings, they must account for how state and federal government activity may impact their bottom line. In addition to having a Government Affairs staff, these same companies are starting to realize the importance of having established a relationship with a lobbyist. The question is how do you find the right lobbyist for your organization? 

First you want to make sure the lobbyist has experience. To be a good lobbyist there is no magic number of how many years you have worked within the political system. However; many lobbyists have worked an average of six months in the legislature as an aide to a legislator or on the other side of the spectrum, many legislators have left the legislature to work as a lobbyist. These individuals have an insider’s perspective into how the legislature works such as when a bill filing deadline date is and whether or not a bill can be introduced due to if a state is in an emergency session where the rules for introducing legislation is different from regular session. 

Second the lobbyist should have a minimum number of contacts in the legislature. Whether it is in Congress or on the state level, the lobbyist should be able to have a go to legislator that can get a bill introduced quickly. However; the most successful lobbyist will not be limited to one party. Having contacts on both sides of the aisle will allow the lobbyist the opportunity to bring any bill at any time regardless of what political party has the majority.   

Third the best lobbyist should be strategic. He or she should be able to know when a good time to introduce legislation is. The lobbyist should know what legislator to target as the bill sponsor. This is important because the bill sponsor will be the champion for your particular bill from start to finish. The lobbyist will need to educate the bill sponsor on the nuances of the bill so that the sponsor will be educated enough to be able to respond to technical questions during a hearing or when the sponsor is in caucus meetings; explaining to their respective party about why your bill should be voted on. The lobbyists should be able to pick and choose what committee will be best for your bill to go into, who to use as strategic allies for your legislation and be intuitive enough on when to negotiate and when not to.   

Next it is important for your lobbyist to know the industry and to have foresight. You need to be comfortable knowing that your lobbyist understands your industry because if not, how can you be sure that your lobbyist is communicating the correct outcome for you? The lobbyist should be skilled enough to draft a bill that solves your problem without having to continuously ask you how something works. Additionally, while many lobbyists only focus on the legislature, the best lobbyists will think long-term to determine if a regulatory body will be involved once your bill passes. If so a lobbyist should be able to guide you through the regulatory process without leaving you to fend for yourself after a bill has passed. 

Finally, as with any other professional, you need to be aware of the reputation your lobbyist has. Do they take the time to make sure their clients understand everything that is happening? Does the lobbyist prepare the client and relevant legislators ahead of time for crucial hearings? Does the lobbyist make everything easy to understand? Does the lobbyist dress appropriately for meetings and do they have the needed respect from the legislature? Does the lobbyist closely follow the bill from start to finish or are they overloaded with too many clients? These are important issues to talk with your prospective lobbyist about before entering into a contractual relationship. 

While there are other nuances to the lobbying relationship, these should be enough for you to think about as your organization considers whether to engage a lobbyist. Lobbyist should no longer be considered a luxury item. The best lobbyist are quickly becoming essential parts of today’s corporate environment for the value they bring to their clients in either advancing their interests through legislation, or being available to respond to legislative targeting that has been on the rise. You know you have picked the right lobbyist when you can breathe a sigh of relief knowing that they have your back.  

Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. We help stakeholders understand what’s at issue so that we can help our valued clients achieve their priorities. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

UnitedHealthcare (UHC) Announces Virtual Physical Therapy Program

UHC has announced a partnership with Kaia Health on a new virtual physical therapy program. The program is aimed at shoulder or knee problems and other musculoskeletal issues. 

How does it work? 

According to the announcement  “The app uses a front-facing smartphone camera and artificial intelligence technology to analyze a user’s movement patterns while performing PT exercises. The program gives real-time tips for carrying out safe, effective exercise sessions that typically last between 10-25 minutes. If, at any point, a certified health coach is needed, one can be accessed using an in-app chat feature.

The app is part of a broader set of in-person and virtual musculoskeletal support tools available to eligible UnitedHealthcare members recovering from surgery or injury, including knee, back or shoulder problems. The programs are designed to help improve health, reduce costs and avoid often unnecessary invasive treatments, including imaging, surgery or opioid prescriptions.”

We continue to see emerging innovation within healthcare around digital healthcare and digital therapeutics. Opportunities abound for those looking for new ways to care for patients. 

Lanton Law is an innovative firm at the center of tomorrow’s legal, policy and market trends. We continue to monitor the developments of emerging sectors such as digital healthcare and give counsel to stakeholders accordingly. Contact Lanton Law to discuss your lobbying and legal strategies.     

Lanton Law’s publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without prior written consent of us. To request reprint permission for any of our publications, please use our “Let’s Chat” form, which can be found on our website at www.lantonlaw.com. The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship.

Prescription Digital Therapeutics Presses Ahead for Behavioral Health

At Lanton Law we have been monitoring the both exciting and emerging field of prescription digital therapeutics. While the technologies we have been witnessing are promising, there does remain the challenge of reimbursement, since there has not yet been a statutory benefit category established for this new technology. However; behavioral health shows the most immediate promise. 

A recent CMS meeting illustrates this point. CMS released a document titled “Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Application Summaries and Coding Recommendations” for the Second Biannual, 2021 HCPCS Coding Cycle. The document can be viewed here. The document describes Pear Therapeutics’ reSET-O which is a “12-week interval prescription digital therapeutic for opioid use disorder (OUD).” CMS’ examination ended with its decision effective April 1, 2022 to establish a HCPCS Code to “facilitate options for non-Medicare payers to provide access to this therapy in the home setting,” so that CMS can continue its marketplace monitoring. This on top of the AMA’s CPT Editorial Panel’s actions (seen here) to establish a new CPT code for Cognitive Behavioral Therapy Monitoring effective January 2023 shows that there will definitely be more certainty in this field in the next coming years. 

Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our HealthIT practice can help stakeholders understand what’s at issue with topics like digital therapeutics, RTM and RPM so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.