Martin Culjat, PhD
Senior Vice President, Global Head of Digital Medicine & Regulatory Innovation
Expertise:
Marty Culjat, PhD is the SVP, Global Head of Digital Medicine & Regulatory Innovation at EVERSANA. In this role, he leads a cross-functional team supporting the commercialization of digital medicine products within companies ranging from startups to large pharma. He is widely recognized as an expert in regulatory affairs and strategy in digital health, having supported more than 50 companies in this area over the past few years, serving as the de-facto regulatory head of digital health within multiple large pharma companies, and serving as a thought leader at various international conferences at the intersection of digital health and pharma.
Prior to EVERSANA, he held various executive roles within the emerging digital medicine sector, including: Dthera Sciences, a pioneering digital therapeutics company targeting Alzheimer’s disease; Mymee, a personalized medicine company focused on autoimmune disease; and CureMatch, a precision oncology company using AI and genomics to optimize cancer treatment. Dr. Culjat has a PhD in Biomedical Engineering from UCLA and BS in Bioengineering from UC San Diego.
Articles by Martin Culjat, PhD
The Evolution of Digital Health Policy: A 2024 Retrospective and 2025 Outlook
The landscape of digital health policy continues to evolve, with significant advancements shaping the regulatory and reimbursement frameworks. Here are some of the key developments that occurred during 2024 as well as our predictions for what lies ahead in 2025. CMS and AMA: Catalyzing Digital Health Adoption Last year was an impactful year for digital […]
Clinical Data Portability for Regulatory Submissions Across Global Markets
Navigating the regulatory landscape for medical devices is complex, especially in relation to using clinical study data from overseas to support regulatory approval and reimbursement in the U.S., EU and U.K. The key question many companies face is whether their completed clinical study in another country can be leveraged for regulatory processes in these regions. […]
PDURS Explained: The FDA’s New Framework for Adding Software to Drug Labels
The U.S. FDA has recently proposed a new draft framework that enables pharma manufacturers to add software to a drug label if they can demonstrate that the software adds clinical benefit to the drug. This prescription drug use-related software (PDURS) framework would allow for the pairing of a companion app to a drug without restrictions […]
Demystifying the New Prescription Drug Use-Related Software Framework
Authors: Martin Culjat, PhD , Kory Dillman and Scott Kellogg The Food and Drug Administration (FDA) unveiled its draft guidance on Regulatory Considerations for Prescription Drug Use-Related Software (PDURS) in September 2023. The document shed light on how the FDA intended to wield its drug-labeling authority over software outputs associated with prescription drugs and drug-device combination products. We […]
Harnessing the Commercial Promise of Prescription Drug Use-Related Software (PDURS)
The FDA’s draft guidance on Prescription Drug Use-Related Software (PDURS) offers pharmaceutical manufacturers a novel strategy to enhance a drug’s label by enabling an HCP to prescribe software alongside the drug at the HCP’s discretion. The new framework makes it easier than before to pair software with a medication to help patients manage complex dosing, […]
An Impactful Year for Global Regulation of Digital Health
2023 was a busy year with FDA and EU advancing key initiatives focused on AI/ML, cybersecurity, global harmonization, real-world evidence, and pharma companion apps…and more is coming in 2024. While 2023 brought its share of challenges for the digital health sector, it ultimately served as a pivotal year for shaping the future of how digital […]
A Framework for Branded Pharma Companion Apps Is Coming Soon
The FDA just announced plans to release a draft guidance on prescription drug-use-related software later this year. What should the pharma industry expect? The past three years have seen a significant increase in the acceptance and adoption of digital health tools. Much of the focus over this time has been on virtual care using telemedicine […]
Breaking Down Q1 2023 Digital Health Policy Updates
Insights and Implications on AI/ML Software, Companion Apps for Pharma, Digital Diagnostics, VR Software, Breakthrough Devices, and More There was a barrage of activity by FDA in Digital Health at the end of 2022, including the wind-down of the Digital Health Pre-Certification program, final guidance on Clinical Decision Support Software, Mobile Medical Applications, Medical Device […]
Can Telehealth Accelerate the Uptake of Digital Therapeutics?
Introducing an industry-first, integrated direct-to-patient telehealth solution for digital therapeutics that includes patient engagement, telehealth consultation, prescription issuing and dispensing, and patient support. Fueled by the pandemic, telehealth has moved from an interest to expectation for most patients, with 76% of patients reporting they are comfortable using telehealth. Digital medicine solutions, including digital therapeutics (DTx), […]
Rounding Up FDA’s Digital Health Actions from 2022 and Looking Forward to 2023
The healthcare sector continued the digitization evolution in 2022. Among the many product launches and technological advances, a recent report from AMA showed that 93% of physicians now see digital health tools as advantageous to patient care and that adoption of telemedicine, remote monitoring, clinical decision support, and patient engagement tools are on the rise. […]
Seven Important Factors for APAC Companies to Consider while Launching Products in the Digital Health and Digital Therapeutics Space
Digital health and digital therapeutics innovation, commercialization, and adoption is accelerating in the APAC region. Digital medicines as an area, globally, is not new, yet even the largest players in the sector can still be considered start-ups in many respects. This is because the regulatory and reimbursement pathways are still evolving, and this has had […]
Regulatory Framework for Digital Therapeutics in the APAC Region
Authored by: Martin Culjat, Kory Dillman, Deval Patel Digital health and digital therapeutics innovation, commercialization, and adoption is accelerating in the APAC region, and this has been in full display at the first-ever DTx Asia conference held in Seoul, South Korea on November 8 and 9, 2022. DTx manufacturers are seeking authorization from global regulatory […]
AMA Scheduled to Deliberate Potential Approval of Additional Digital Medicine CPT Codes
As part of its upcoming meeting in mid-September, members of the American Medical Association’s (AMA) CPT Editorial Panel will consider several new Current Procedural Terminology (CPT) codes that identify digital diagnostic and therapeutic procedures. Between this CPT Editorial Panel meeting and the proposed rule from the Centers for Medicare and Medicaid Services (CMS) previously discussed, […]
Reimbursement Landscape for Digital Medicine Continues to Advance with CMS
The Centers for Medicare and Medicaid Services (CMS) recently announced several new payment and coding proposals that, once finalized, would recognize and advance the use of digital diagnostic and therapeutic modalities. In this week’s update, we provide information on the new payment rules the CMS proposed for Calendar Year 2023. In our next update, we […]
Exploring a Need for Change of Clinical Trials in Digital Medicine | A DTx Europe Panel Discussion
Martin Culjat, Senior VP, Regulatory Innovation & Digital Medicine, EVERSANA joined a panel of experts at DTx Europe to discuss the need for change of clinical trials in digital medicine. The current framework for clinical trials in digital health falls under an umbrella of one size fits all. There is an unwritten dichotomy between regularly updated […]
FDA Moves Cybersecurity Into the Product Life Cycle
Due to rising cyber-attacks and the potential to cause harm to patients, medical facilities and hospitals, the U.S. Food and Drug Administration (FDA) has recently increased scrutiny of cyber controls in FDA premarket submissions of medical devices. Manufacturers must prove that devices, including software-as-a-medical device (SaMD), do not present cybersecurity vulnerabilities that may affect the […]
New Legislation Supports Payment for Digital Therapeutics
Earlier this month, the Access to Digital Prescription Therapeutics Act of 2022 was introduced by Rep. Mike Thompson (D-CA) to the U.S. House of Representatives as H.R. 7051 and by Sen. Shelley Moore Capito (R-WV) to the U.S. Senate as S. 3791. This precedent-setting legislation demonstrates the bicameral, bipartisan commitment to promoting the use of […]
Prescription Digital Therapeutics Coding: A Good First Step by CMS
The Centers for Medicare and Medicaid Services (CMS) recently issued a new code under the Healthcare Common Procedural Coding System (HCPCS) regarding prescription digital therapeutics (PDTs). These types of therapies are generally app- or device-based and can be used in any therapeutic category. This is certainly an exciting development for the PDT sector, as many […]
Breaking News: Updates on Digital Medicine Coding and Payment
Over the past several months, we have been following the activities of the American Medical Association (AMA) and the Centers for Medicare and Medicaid Services (CMS) regarding coding and payment, respectively, for digital medicine products. Both organizations made significant steps forward in the past few weeks to include some of these innovative products in the […]
TOP NEWS: CMS Proposes Repeal on Medicare Coverage of Innovative Technologies Initiative
In a reversal of its upcoming policy to cover breakthrough designated medical devices, the Centers for Medicare and Medicaid Services (CMS) on Monday issued a proposed rule that would completely repeal the Medicare Coverage of Innovative Technologies (MCIT) initiative, and it would not go into effect in December of this year. Their reasoning is as […]
American Medical Association Discusses New CPT Codes to Identify Digital Health Services
In our last update, we discussed the proposed rule that the Centers for Medicare and Medicaid Services (CMS) issued regarding the addition of certain Current Procedural Terminology (CPT®) codes to identify remote therapeutic monitoring (RTM) in parallel to the existing remote physiological monitoring (RPM) codes and their expected payment rates. Now we’re looking at what […]
CMS Releases Remote Therapeutic Monitoring Codes for 2022
The Centers for Medicare and Medicaid Services (CMS) released the proposed Medicare physician fee schedule regulation for 2022, which includes an analysis and payment calculations for the new Remote Therapeutic Monitoring (RTM) CPT codes issued by the American Medical Association (AMA) late last year. As announced in earlier this year, these codes may enable indirect […]
News Alert: MCIT Program Delayed Until December
The Centers for Medicare and Medicaid Services (CMS) again delayed implementation of the Medicare Coverage of Innovative Technology (MCIT) program, now until December 15, 2021. The program, as described in the current and preceding rules, will provide automatic Medicare coverage for four years to medical devices designated as breakthrough and authorized for marketing by the […]
News Alert: MCIT Implementation Delayed
On Friday, March 12, the Centers for Medicare and Medicaid Services (CMS) issued an Interim Final Rule with Comment (IFC) delaying the effective date of the Medicare Coverage of Innovative Technologies (MCIT) initiative from March 15 to May 15, 2021. In postponing the implementation date, CMS cited the President’s Executive Order of January 20, 2021, […]
Reimbursement May Be on the Way for Remote Therapeutic Monitoring
The American Medical Association (AMA) manages the procedure code set that physicians and other healthcare professionals use to identify the services for which they bill. These codes are commonly known as the CPT® code set, which stands for Current Procedural Terminology, and are the standard billing lexicon for medical services. Currently, four CPT codes identify […]
CMS Adopts Automatic Medicare Coverage of Breakthrough Devices
The Centers for Medicare and Medicaid Services (CMS) on January 12 finalized its proposal of Medicare Coverage of Innovative Technology (MCIT), an additional pathway of coverage for breakthrough-designated medical devices, providing timelines and clarifying definitions of eligible items. CMS initially proposed this rule on August 31, 2020, and EVERSANA’s initial analysis is provided here. The […]
CMS Announces Medicare Coverage for FDA-Designated Breakthrough Devices. What Does This Mean?
On August 31, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule change that would automatically provide national Medicare coverage for FDA-designated Breakthrough Devices for a four-year period immediately upon FDA approval. This is big news for patients, health care providers and medical device manufacturers. When the Breakthrough Devices program was […]
5 Trends in Digital Medicine to Watch For
We Are Uniquely Positioned To Deliver EVERSANA is uniquely positioned to follow the trends and introduce new models and strategies to maximize the value of pharmaceutical products through Digital Medicine Solutions and Execution. Digital Solutions can be deployed to impact the entire life cycle of a product in unprecedented ways. Schedule a 30-minute call […]
What does the new FDA Guidance for DTx Products Treating Psychiatric Disorders actually mean?
On April 14, 2020, FDA posted new guidance that eases regulatory enforcement of Digital Therapeutics to improve patient access to psychiatric care during the COVID-19 public health emergency. FDA should be praised for this decision, as there are countless individuals with a variety of mental health conditions who are stuck at home during the COVID-19 […]
What kind of clinical data is required for FDA clearance of a Digital Medicine?
What kind of clinical data is required for FDA clearance of a Digital Medicine? It depends. Digital therapeutics and digital medicines that are subject to FDA regulation are considered medical devices. The amount of clinical data required by FDA generally depends on risk. Many moderate risk (class II) medical devices seeking 510(k) clearance are required […]
What specifically triggers FDA regulation of a digital medicine?
I often meet with Digital Health or Pharmaceutical clients to discuss their commercialization journey, and they ask me the same question. What specifically triggers FDA regulation of a digital medicine? Some of these products require FDA clearance and some do not. Regulatory oversight of digital medicines depends primarily on intended use, which is generally captured […]