Martin Culjat, PhD
Senior Vice President, Regulatory Innovation and Digital Medicine
Expertise:
Marty is an innovator at the cross-section of product development and regulatory affairs in the medical device and digital medicine sectors. In recent years, he led the effort to obtain the first ever breakthrough device designation from the FDA for a DTx monotherapy at Dthera Sciences, launched a DTx that incorporates AI and telehealth coaching to manage and treat the symptoms of autoimmune disease while at Mymee, launched clinical decision support software using precision oncology and AI algorithms to rank millions of drug combinations at CureMatch, and developed a DTx for asthma self-management that tracks lung function, triggers, and medication use at an early stage startup.
As an industry leader on regulatory affairs in digital therapeutics, Marty has spoken at numerous conferences including DTxWest, DTxEast, and Clinically-Validated Digital Therapeutics Summit. And, he has served as a strategic advisor to a wide range of digital therapeutic, digital medicine, medical device, and pharmaceutical companies.
Marty holds a PhD in biomedical engineering from the University of California Los Angeles (UCLA), and a Bachelor’s degree in bioengineering from the University of California San Diego.
Articles by Martin Culjat, PhD
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 […]