Ari Cohen, MD, MBA, is director of the Transplant Institute at Ochsner Health. 

Ochsner Health recently performed its 4000th liver transplant, marking a milestone for a program that has completed 10,000 organ transplants across kidney, liver, heart, lung, and pancreas transplantation.¹ More than 100,000 people in the United States are waiting for an organ transplant, underscoring ongoing challenges in organ availability and access to transplantation.²

"They don't just show up and get a transplant. It's a long-term relationship that we develop with our patients," Ari Cohen, MD, MBA, director of the Ochsner Transplant Institute, said in an interview with 

Ochsner Health Expands Liver Transplant Access Through Multidisciplinary Care

Multidisciplinary Care Before and After Liver Transplantation

"There’s a lot of management of their care prior to transplant, with coordinated care among our medical team, our surgical team, and the rest of our support services," Cohen said.

He described transplantation as a long-term relationship that extends beyond the surgical procedure, with care tailored to each patient's needs.

"We've developed it to be personalized for each patient, and we have different team support at every step of their pathway through transplant," he said.

Multidisciplinary Clinics Aim to Improve Transplant Access

"Our biggest gap is getting patients in to see us and providing an entryway into the system," Cohen said. "We live in an area that is challenged with access, and we've created innovative ways to get people into our clinic."

Cohen said the institute uses multidisciplinary clinics and one-day evaluations to help patients access transplant services and move through the evaluation process.

Living Donor Liver and Kidney Transplantation

Organ availability remains an important component of transplant access, with deceased donation relying on the decisions of donors and their families.

"Obviously, it starts with donors and donor families," Cohen said. "It's a difficult decision when somebody has passed away, and a donor family agreeing to donate is critical to maintaining access to available organs for our patients."

Ochsner also offers living donor liver and kidney transplantation, which can provide another pathway for eligible patients whose loved ones or other potential donors are willing and medically suitable to donate.

"That's the most ideal situation, and it lets people get transplanted faster with healthy, good organs and recover quickly," he said.

Cohen also pointed to organ preservation machines and robotic techniques as areas of continued innovation in transplantation.

"We always try to put the patient first, and if they're a suitable transplant candidate, we really try to get them a transplant and look forward to them having a successful life afterward," he said.

Ochsner Health. Ochsner Transplant Institute performs 10,000th transplant surgery. Published August 12, 2026. Accessed September 25, 2026. 

https://news.ochsner.org/news-releases/ochsner-transplant-institute-performs-10-000th-transplant-surgery/

Health Resources and Services Administration. Organ donation statistics. Accessed September 25, 2026. 

https://www.organdonor.gov/learn/organ-donation-statistics

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Ochsner Health uses multidisciplinary clinics, living donor programs, and transplant innovations to address access challenges.

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Donald Cutlip, MD, is a professor of medicine at Harvard Medical School.

Donald Cutlip, MD | Image Credit: BAIM Institute for Clinical Research

 approved Cordis’s SELUTION Sustained Limus Release (SLR) Drug-Eluting Balloon (DEB) for 

The approval was based on results from the SELUTION4ISR trial, a single blind, randomized, non-inferiority trial conducted across 48 centers in the US, Europe, Canada, and Brazil. Investigators enrolled patients >18 years with ischemia related to ISR of a previous bare-metal or drug-eluting stent (DES) and randomly assigned them in a 1:1 ratio to either the SELUTION DEB or a control strategy, which was designed as ≥80% repeat DES and ≤20% balloon angioplasty.

The trial’s primary outcome was target lesion failure, including cardiac death, target vessel myocardial infarction, or clinically driven lesion revascularization, which was assessed at 1 year in the per-protocol population. Non-inferiority was determined by whether the upper limit of the 2-sided 95% credible interval was <10%.

A total of 418 patients were assigned to either DEB (n = 210) or control (n = 208), with 390 patients per protocol (197 with DEB, 193 with control). At 12 months, target lesion failure occurred in 32 patients in the DEB arm and 28 in the control group, with an absolute risk difference of 1.7% (95% CI, -5.5% to 8.9%). Clinical follow-up is ongoing, expected to last to 5 years post-operation.

Donald Cutlip, MD, professor of medicine at Harvard Medical School and principal investigator in the SELUTION4ISR trial, sat down with the 

 editorial team to discuss the DEB’s potential for patients with ISR. In the following Q&A, Cutlip explains the SELUTION SLR DEB’s pathway through clinical trials to FDA approval, as well as its pathway forward in clinical use.


Q&A: Cutlip on the SELUTION SLR DEB’s FDA Approval for Coronary In-Stent Restenosis

Could you provide a brief overview of the SELUTION SLR Sirolimus DEB and how it received approval from the FDA?

 Well, the SELUTION SLR drug-eluting balloon, like other drug-coated or drug-eluting balloons, is really a vehicle just for delivering drug to the coronary. After the artery has been opened, we use the balloon to bring the drug there for delivery. What was needed for this study was to show safety and effectiveness, like for any new device to get FDA approval, and the solution SL four trial was designed to do that.

There's lots of interest in having sirolimus, or at least a second drug, available in drug-eluting balloons. We have paclitaxel, which is pretty easy: you can coat it on a balloon, take it up to the artery, and it gets absorbed pretty quickly. However, to allow for loss of drug on the way, you have to put a pretty high dose on. So that's what gets to the coronary artery. It hasn’t been proven, but there's been concern regarding, say, possible toxic effects of paclitaxel with a higher dose.

The way the SLR balloon works is that sirolimus is packaged into microspheres made of polymer, and then protected with a phospholipid layer, so the drug gets delivered, and then you can really dial in and be very specific about the dose you want. The dose of the balloon for sirolimus is really the same as sirolimus or everolimus might be on a drug-eluting stent. We're not putting in a higher dose. And then the polymer and the membrane protect the drug, allowing it to be in contact with the vessel wall long enough to be absorbed. Because sirolimus is not rapidly absorbed like paclitaxel, you need to have this engineering marvel to sort of get it there. I think that's novel. This is the first sirolimus balloon that we have in the U.S., and I think more credit goes to the engineers than to any of us who put the balloons in, but we're excited about it, and I think it's going to be a big addition to the toolbox for interventional cardiology.

ISR is among the most challenging scenarios in interventional cardiology. What does the availability of a sirolimus drug-eluting balloon change about how you approach ISR today?

There's been a lot of interest in using drug-coated balloons rather than putting another stent or multiple layers of stent into an ISR. However, ISR has become fairly uncommon with drug-eluting stents being so effective - we only see it now in about 10% of lesions. This is as opposed to bare metal stents, which is like ≥30%. But when it happens, it's still important, and when it happens once, it can keep happening. So that's why it's so advantageous to have a balloon that you can deliver drug and not leave more metal behind, as opposed to putting in more stents.


: Could you describe the types of ISR patients in whom you think SELUTION SLR is most likely to be particularly useful? Conversely, are there any ISR presentations where you would still strongly favor repeat DES?

We designed the trial to look at what was happening as a standard of care currently, and before we had any drug-eluting balloons at the time we designed the study, what was happening was about 80% use of another drug-eluting stent and about 20% use of plain balloon angioplasty. The problem with that is that putting in that second layer of stent, and then more on top of it, eventually you just create a problem of recurrent restenosis that you can't fix. We were the first, and probably only, trial to compare against the standard of care.

So, 80% of patients in the control arm actually received a drug-eluting stent. We didn't expect to be better than a drug-eluting stent or even necessarily as good, but we did expect to be at least as good as the standard of care and avoid that 80% drug-eluting stent use that was happening. We met that endpoint, as you know, and that's why the FDA was able to approve it. But I think more importantly that we were able to actually identify how much difference is there by not putting in that second layer. For the first restenosis, what our data show is there's about a 6-7% advantage. Drug-eluting stent did better, but at least we know how much better, so we can decide whether we want to take a chance of having maybe a 7% higher rate of recurrence to avoid that second layer of stent in almost 90% of the patients. That's a decision that a clinician will have to make with their patients because there is clearly that trade-off.

I think some would argue that maybe for that first restenosis, the initial treatment, maybe a drug-eluting stent would still be preferred at least in some, and maybe even most patients. But there are certainly many who would rather avoid that layer, either the physician or the patient. They would rather get the drug-eluting balloon and then take the drug-eluting stent next time if you're one of the 10% or so that recur.

 Does the SELUTION4ISR experience suggest that ISR should no longer be viewed as one homogeneous entity, but rather that the mechanism and anatomy of restenosis should determine the treatment strategy?

Our study actually does not show that, but we know that from other from other data. We required all patients to have imaging prior to treatment, and the point of that was to identify those types of lesions that would not best be treated just with a drug-eluting balloon. So, if you see a stent fracture, you see a stent that's not expanded. The initial stent reached the nose because it was never fully expanded. It may be better to treat that with high-pressure balloon inflation to try to get that stent expanded. It may still then be reasonable to use a drug-eluting balloon for final treatment, but it would not be without first expanding that stent. I think if you see pure neointimal hyperplasia as the mechanism, and it's the first restenosis, there again you'd have this debate: should I put a drug-eluting stent? Maybe in those cases where there's lots of neointimal hyperplasia, that may be preferred. Otherwise, a drug-eluting balloon should be a reasonable option.

The SELUTION SLR is currently approved for ISR, while a 960-patient trial is evaluating the technology against DES in de novo lesions and small coronary vessels. What would you need to see from that program before considering drug-eluting balloons for broader PCI indications?

We were involved in the design of that trial also, and our goal there again was to be non-inferior to standard of care. Standard of care there is different; it's a drug-eluting stent, so we need to be non-inferior to a drug-eluting stent. I think we would accept some margin. We would accept some slight difference as long as it meets the non-inferiority criteria. But we're really looking to be as good as a drug-eluting stent, and maybe even better over time by not having that layer of metal there in the first place. And that's going to be more of a long-term outcome.

However, the initial outcome, the one-year outcome, will be just restenosis or target lesion failure, which is mostly restenosis, and I think there's lots of excitement about that. I mean, we did the ISR study first because that seemed to be the best pathway to get the device approved and was where there was a lot of interest and excitement about having drug-eluting balloons available. I think, thanks to the SELUTION investigators in Europe who did this large, 3000-patient trial of de novo, we now know that's very safe. And so, I think in the U.S. now there's a lot more interest in that de novo indication than just for ISR.

Editors’ Note: Cutlip reports being a consultant at Celonova, MedAlliance, and Corvia, and grants/research support from Cordis and Corvia.

Cordis. SELUTION SLR PTCA Drug-Eluting Balloon FDA Approved. September 21, 2026. Accessed September 28, 2026. 

https://cordis.com/na/news/selution-slr-ptca-drug-eluting-balloon-us-fda-approval

Cutlip DE. Or2-20 | SELUTION4ISR – a randomized trial of a sirolimus-eluting balloon versus repeat drug-eluting stenting or balloon angioplasty for coronary in-stent restenosis. Journal of the Society for Cardiovascular Angiography &amp; Interventions. 2026;5(4):104454. 

Articles

Cordis’s SELUTION SLR sirolimus drug-eluting balloon received FDA approval for coronary in-stent restenosis based on SELUTION4ISR, a multicenter, single-blind randomized non-inferiority trial versus contemporary care dominated by repeat DES. Twelve-month target lesion failure was similar between strategies, supporting non-inferiority and providing a stent-sparing option. The device uses polymer microspheres with a phospholipid layer to enable controlled sirolimus dosing and sustained vessel-wall contact. Ongoing follow-up will extend to five years, while larger programs explore de novo indications.

Donald Cutlip, MD, discusses the sirolimus balloon’s approval and its role in clinical practice for patients with ISR.

FDA News

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Structural Heart Disease

The Ochsner Transplant Institute recently performed its 10,000th organ transplant, becoming the first transplant center in Louisiana to reach the milestone.¹ The program, which performs 

, heart, lung, and pancreas transplants, has also completed 4,000 liver transplants and 40 robotic-assisted kidney transplants, as >100,000 people in the US wait for an organ.¹ ²

, Ari Cohen, MD, director of the Ochsner Transplant Institute, discussed what the milestone reflects, how robotic surgery and organ preservation machines are expanding who can be transplanted, and where the biggest gaps in access remain.

HCPLive: What does reaching 10,000 transplants tell you about how transplant medicine has changed since Ochsner performed its first transplant?

 Reaching 10,000 transplants is really more than just a number. It reflects decades of experience that started back in 1970, when we performed the first heart transplant in the Gulf South, and it's led us to develop a comprehensive, high-volume transplant program that performs kidney, liver, heart, lung, and pancreas transplants. I'm a surgeon, but to me, the success doesn't just lie with our surgical expertise. It really relies on multidisciplinary care, ongoing innovation, coordinated access for our patients, the trust of our patients, and the trust that we pass on to our donor families. It's a milestone that gives patients the opportunity to return home to their families healthy and go on to lead the lives they're supposed to live.

HCPLive: Ochsner recently reached 4,000 liver transplants. What have you learned about caring for patients before and after liver transplantation?

 All of our transplants are specialized endeavors, and with liver patients, we've really developed a long-term partnership. They don't just show up and get a transplant. It's a long-term relationship that we develop with our patients. There's a lot of management of their care prior to transplant, with coordinated care among our medical team, our surgical team, and the rest of our support services. We've developed it to be personalized for each patient, and we have different team support at every step of their pathway through transplant.

HCPLive: The program has also performed 40 robotic-assisted kidney transplants. Where do robotic approaches fit into kidney transplantation?

 We've learned that robotic-assisted transplant surgery really has a role within the transplant arena, and it's appropriate for a lot of our patients. It has allowed us to reduce recovery time from surgery and has increased our surgical precision. It has also allowed us to broaden the effort, so that people we previously thought were not candidates for transplant surgery can have it done robotically, get a successful transplant, and continue on with their lives. So it's really played a critical role in performing kidney transplants.

HCPLive: How have advances in organ preservation changed the number and types of organs that can be considered for transplantation?

 Some of the more recent machines that have become available for transplant are commonly called organ pumping machines, but we really view them as having a role in the rehabilitation of some of these organs. They allow us to get more information about the viability of an organ, and they tell us whether it would be a successful transplant or whether it's a usable organ at all. These machines have become critical for our decisions about whether an organ is suitable to transplant, and they've helped us expand the donor pool, because an organ previously thought of as not transplantable can become transplantable after spending some time on one of these machines.

HCPLive: More than 100,000 people in the US are waiting for an organ transplant. Where do you still see the biggest gaps in access?

 Our biggest gap is getting patients in to see us and providing an entryway into the system. We live in an area that is challenged with access, and we've created innovative ways to get people into our clinic. We have multidisciplinary clinics and one-day evaluations, and by providing better access, we hope to provide a pathway for people to move forward with transplantation.

HCPLive: Looking ahead, what developments could have the greatest impact on expanding access or improving outcomes?

 Obviously, it starts with donors and donor families. It's a difficult decision when somebody has passed away, and a donor family agreeing to donate is critical to maintaining access to available organs for our patients. But we've also created other pathways. We have robust living donor programs for both liver and kidney, so when a patient has a loved one, friend, or family member who is willing to donate, we allow them to donate and have a live donor transplant. That's the most ideal situation, and it lets people get transplanted faster with healthy, good organs and recover quickly. Then there's continuing to push on innovation. Using these machines and robotic techniques, all of these things have helped us expand access for our patients.

HCPLive: Is there anything else you'd like to add?

 Our goal has always been patient focused. We always try to put the patient first, and if they're a suitable transplant candidate, we really try to get them a transplant and look forward to them having a successful life afterward.

Editor's Note: This transcript has been edited for clarity. Cohen reports no relevant disclosures.

Ochsner Health. Ochsner Transplant Institute performs 10,000th transplant surgery. News release. August 12, 2026. Accessed September 28, 2026. 

Health Resources and Services Administration. Organ donation statistics. Accessed September 28, 2026. 

The Ochsner Transplant Institute reached 10,000 total transplants, reflecting a decades-long evolution into a high-volume, multidisciplinary program spanning kidney, liver, heart, lung, and pancreas transplantation. Longitudinal, personalized pre- and post-transplant management is emphasized, particularly in liver transplantation, where care pathways extend well before surgery. Robotic-assisted kidney transplantation is positioned as a tool to reduce recovery time, improve precision, and broaden candidacy. Ex vivo organ preservation (“pumping”) platforms are reframed as rehabilitation and viability-assessment technologies that expand donor utilization. Persistent access barriers center on initial system entry.

Ochsner Transplant Institute director discusses liver transplant care, robotic kidney transplant, organ preservation, and access gaps.

Lessons From 10,000 Organ Transplants, With Ari Cohen, MD

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

Brelovitug met the primary endpoint in the phase 3 AZURE-1 study of patients with chronic 

 infection, Mirum Pharmaceuticals announced on September 28, 2026.¹

At week 24, the combined virologic response and alanine aminotransferase (ALT) normalization endpoint was achieved by 56% of patients receiving 300 mg weekly and 45% receiving 900 mg every 4 weeks, compared with 0% in the delayed treatment group (

Brelovitug is an investigational monoclonal antibody targeting hepatitis B surface antigen (HBsAg). AZURE-1 is one of 2 pivotal phase 3 studies intended to support a US regulatory submission for chronic HDV infection.¹

Inside the AZURE Program of Brelovitug for Hepatitis D, With Tatyana Kushner, MD

"The goal of treating chronic HDV is to prevent progression to cirrhosis, liver cancer and liver failure, and that requires controlling both the virus and liver inflammation," Norah Terrault, MD, MPH, professor of medicine and chief of the Division of GI and Liver at the Keck School of Medicine of the University of Southern California and an AZURE-1 investigator, said in a statement.¹

"ALT is a marker of liver injury, so seeing virologic response alongside ALT normalization is encouraging in a long-term therapy. For patients facing the most aggressive form of viral hepatitis, these are important results," Terrault said.

AZURE-1 Phase 3 Design and Patient Population

The phase 3 portion of AZURE-1 enrolled 153 treatment naive patients randomized in a 2:2:1 ratio to receive brelovitug 300 mg by subcutaneous injection once weekly (n = 59), brelovitug 900 mg by subcutaneous injection every 4 weeks (n = 65), or delayed treatment beginning at week 24 (n = 29).¹

The primary endpoint was the proportion of patients achieving both virologic response and ALT normalization at week 24. Virologic response was defined as a ≥2 log10 reduction in HDV RNA from baseline or undetectable HDV RNA (target not detected [TND]).¹

Brelovitug Virologic Response and ALT Normalization at Week 24

Mirum also reported the following individual efficacy outcomes at week 24:¹

Virologic response: 86% with brelovitug 300 mg weekly and 85% with 900 mg every 4 weeks, compared with 0% with delayed treatment.

HDV RNA below the lower limit of quantification (LLOQ; <10 IU/mL): 25% and 26%, respectively, compared with 0%.

HDV RNA TND: 17% in each brelovitug group, compared with 0%.

ALT normalization: 63% with 300 mg weekly and 54% with 900 mg every 4 weeks, compared with 0%.

Individual virologic response and ALT normalization rates were greater than the composite endpoint rates because the primary endpoint required both outcomes in the same patient.

Brelovitug Safety: Adverse Events Through Week 24

At least 1 adverse event (AE) occurred in 45.8% of patients receiving brelovitug 300 mg weekly and 61.5% receiving 900 mg every 4 weeks, compared with 27.6% in the delayed treatment group. Treatment related AEs occurred in 23.7%, 33.8%, and 0% of patients, respectively.¹

No grade ≥3 AEs, serious AEs, or AEs leading to treatment discontinuation were reported in either brelovitug group through week 24. In the delayed treatment group, 1 patient (3.4%) experienced a grade 4 acute myocardial infarction, which was classified as a serious AE.¹

Injection site reactions occurred in 10.2% of patients receiving brelovitug 300 mg weekly and 18.5% receiving 900 mg every 4 weeks. Flulike symptoms occurred in 5.1% and 10.8%, respectively. Neither event type was reported in the delayed treatment group.¹

AZURE-1 Phase 2b Data Show Responses Through Week 48

In April 2026, Mirum reported that the phase 2b portion of AZURE-1 met its primary endpoint at week 24 in both brelovitug dose groups.³ The company has now reported week 48 efficacy findings from this earlier cohort, which included the first 53 patients enrolled in the study, with 20 patients per dose group included in the week 24 and week 48 efficacy analyses.¹

The combined primary endpoint increased from 45% at week 24 to 55% at week 48 among patients receiving brelovitug 300 mg weekly. In the 900 mg every 4 weeks group, the rate increased from 35% to 55%.¹

Virologic response: 100% at week 24 and 95% at week 48 with 300 mg weekly; 75% and 95%, respectively, with 900 mg every 4 weeks.

HDV RNA below the LLOQ: 45% at week 24 and 80% at week 48 with 300 mg weekly; 10% and 40%, respectively, with 900 mg every 4 weeks.

HDV RNA TND: 35% at week 24 and 40% at week 48 with 300 mg weekly; 5% and 25%, respectively, with 900 mg every 4 weeks.

ALT normalization: 45% at week 24 and 55% at week 48 with 300 mg weekly; 40% and 55%, respectively, with 900 mg every 4 weeks.

Mirum reported no new safety signals through week 48.¹

"Chronic hepatitis delta is a lifelong disease, and people living with it need treatment options that are effective, safe and tolerable enough to stay on over time. That's especially true for patients with more advanced disease, who often have the fewest choices," Chari A. Cohen, DrPH, MPH, president of the Hepatitis B Foundation, said in a statement. "Results like these bring hope to a community that has had few options until recently."¹

Mirum expects topline results from the phase 3 AZURE-4 study in the fourth quarter of 2026 and plans to submit a biologics license application (BLA) to the 

 in the first half of 2027. The company has projected a potential US commercial launch in the fourth quarter of 2027.¹

In May 2026, the FDA granted accelerated approval to bulevirtide (Hepcludex), the first treatment approved for chronic HDV in the US.²

 and PRIME and orphan designations from the European Medicines Agency.¹

"These results demonstrate the potential of brelovitug as a well-tolerated, convenient, single agent to deliver both deep viral suppression and ALT normalization, with responses that continue to deepen through 48 weeks of treatment. Notably, these results were achieved in a broad patient population, including those with significant liver inflammation, cirrhosis and clinically significant portal hypertension," Nancy Shulman, MD, executive vice president of clinical development at Mirum, said in a statement.¹

The full phase 3 AZURE-1 results are expected to be presented at an upcoming medical congress.¹

Mirum Pharmaceuticals. Mirum Pharmaceuticals announces primary endpoint met in phase 3 AZURE-1 study of brelovitug in chronic hepatitis delta virus. September 28, 2026. Accessed September 28, 2026. 

https://ir.mirumpharma.com/news/news-details/2026/Mirum-Pharmaceuticals-Announces-Primary-Endpoint-Met-in-Phase-3-AZURE-1-Study-of-Brelovitug-in-Chronic-Hepatitis-Delta-Virus/default.aspx

US Food and Drug Administration. FDA approves first treatment for chronic hepatitis delta virus (HDV) infection. May 22, 2026. Accessed September 28, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-chronic-hepatitis-delta-virus-hdv-infection

Mirum Pharmaceuticals. Mirum Pharmaceuticals announces primary endpoint met in phase 2b portion of the AZURE-1 study of brelovitug in chronic hepatitis delta virus. April 27, 2026. Accessed September 28, 2026. 

https://ir.mirumpharma.com/news/news-details/2026/Mirum-Pharmaceuticals-Announces-Primary-Endpoint-Met-in-Phase-2b-Portion-of-the-AZURE-1-Study-of-Brelovitug-in-Chronic-Hepatitis-Delta-Virus/default.aspx

Brelovitug, an investigational anti-HBsAg monoclonal antibody, demonstrated significant efficacy in treatment-naive chronic HDV infection in the phase 3 AZURE-1 trial. At week 24, a composite endpoint of virologic response plus ALT normalization was achieved in 56% (300 mg weekly) and 45% (900 mg every 4 weeks) versus 0% with delayed treatment. Virologic suppression and ALT normalization were robust as individual endpoints, with no grade ≥3 or serious treatment-emergent AEs through week 24. Responses deepened through week 48 in phase 2b follow-up.

Mirum's antibody led to virologic response and ALT normalization in up to 56% of patients at week 24, vs 0% with delayed treatment.

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Hepatitis C page, resources on the topics of medical news and expert insight into HCV can be found. Content includes articles, interviews, videos, podcasts, and breaking news on hepatitis C virus research, treatment, and drug development.

Brelovitug Meets Primary Endpoint in Phase 3 AZURE-1 Hepatitis Delta Trial

Elizabeth A. Kiracofe, MD, is a board-certified dermatologist and the founder of Airia Comprehensive Dermatology, located in downtown Chicago's Fulton Market District, where she practices medical, surgical, and cosmetic dermatology.

Murad Alam, MD, MBA, is a board-certified dermatologist, vice-chair of dermatology, and professor at Northwestern University Feinberg School of Medicine in Chicago. He is also the president of the American Academy of Dermatology (AAD) for 2026–2027.

Skin of Color Savvy: The Art and Science of Treating Patients of Color

, host Elizabeth Kiracofe, MD, a board-certified dermatologist in Chicago and co-chair of the SOCS Advocacy Committee, speaks alongside Murad Alam, MD. Alam is a dermatologist at Northwestern University, a former SOCS board member, and president of the American Academy of Dermatology (AAD).

The pair of leaders in the field of dermatology discuss how health policy shapes access to 

, particularly for individuals with skin of color. They have met with Illinois legislators together in Washington, DC, and both frame advocacy as a natural extension of patient care rather than a separate or self-serving pursuit.

Murad Alam, MD, and Elizabeth Kiracofe, MD, discuss how reimbursement, coverage, and advocacy shape dermatology access for patients with skin of color.

Skin of Color Savvy: Reimbursement, Coverage, and Care Gaps for Patients With Skin of Color

Alam explains that patients, including those with skin of color, increasingly struggle to get prompt appointments and needed medications. Closing these gaps at scale, he says, requires persuading policymakers to commit more resources. He recommends clinicians start by learning the issues at the state, federal, and regulatory levels. They can then share patient stories that humanize the problem for legislators who never see the effects of prior authorization delays or coverage denials firsthand.

What Policy Barriers Limit Dermatology Access for Underserved Patients?

According to Alam, the first barrier is recognition. Many conditions affecting underserved communities are understudied and poorly documented, so policymakers may not acknowledge them as problems. Beyond that, access depends on basic factors: whether enough dermatologists practice locally, whether patients can afford transportation and visits, and whether medications are covered. He suggests pop-up clinics, trained advanced practice providers, and community education as ways to build care pathways that are at least adequate.

Kiracofe notes that treatments for conditions that disproportionately affect patients with skin of color are often not covered, which raises out-of-pocket costs. These conditions include hyperpigmentation, pseudofolliculitis barbae, and hidradenitis suppurativa. When practices cannot sustain staffing, patients may turn to emergency departments, which shifts costs and lacks dermatology expertise. Alam adds that the resulting delays in diagnosis can allow disease that might have responded to topical therapy to progress until it requires systemic treatment. Kiracofe points to atopic dermatitis as one condition often diagnosed later and at greater severity in patients with skin of color.

How Does the Medicare Conversion Factor Affect Dermatology Practices?

Alam describes the Medicare conversion factor, currently about $32, as the dollar amount multiplied by relative value units to set payment for every service. Many private insurers peg their payments to a multiple of Medicare rates, so a decline reduces reimbursement across the board. Over roughly 25 years, payments to hospitals, nursing homes, and pharmaceutical companies have kept pace with or exceeded inflation. Physician payments have stayed flat and, in the past 5 to 6 years, declined as inflation accelerated. He emphasizes that reimbursement is not about physician income. It funds the staff, rooms, equipment, and appointments that make access possible, and patients without financial reserves are hit hardest when that funding falls short.

How Can Dermatologists Get Involved in Health Policy Advocacy?

Alam encourages clinicians to engage patients as advocates, since constituents describing their own experiences carry significant weight. Professional societies such as SOCS and the AAD can track legislation, alert members, and organize grassroots responses. He notes that recent changes to dermatology residency requirements call for advocacy training, though department chairs and program directors must still implement them. Effective advocacy, he stresses, requires authenticity and preparation rather than showmanship.

As action steps, he recommends contacting legislators through their local district offices and supporting SkinPAC, the AAD's political action committee, which contributes to candidates of both parties who support dermatology priorities. Kiracofe, a former lobbyist, adds that other health care sectors employ far more advocacy professionals than dermatology does. Looking ahead, Alam is hopeful for gradual reimbursement improvements and for artificial intelligence to expand telemedicine and make drug development more efficient.

To learn more about SOCS’s programs and initiatives, visit the 

Editor's note: Both Alam and Kiracofe had no relevant disclosures of note. This episode summary was edited with the help of AI tools.

Podcasts

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

Hosted by Skin of Color Society and produced by HCPLive, 

 delves into the latest research, clinical insights, and culturally intelligent care practices in dermatology with leading experts. 

Whether it’s groundbreaking research, practice-changing insights, or highlights from the SOCS community, this twice-monthly program provides dermatologists and care providers with expert perspectives on treating patients with skin of color.

EoE monitoring does not end when remission is achieved. The panel explores how individualized surveillance and ongoing patient engagement can help clinicians recognize changes in disease control over time.

Video Series

Monitoring Disease Control in EoE

Feeling better does not always mean EoE is fully controlled. The panel explores how patient goals, symptoms, endoscopic findings, and histology come together to provide a more complete picture of treatment success.

Defining Treatment Success and Disease Control in EoE Care

Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

In this segment from the latest episode of Diabetes Dialogue, Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss dosing guidelines for the recently approved efsitora alfa-gobe.

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

This page also hosts content previously published by EndocrinologyNetwork. 


Type 2 Diabetes

Efsitora Dosing and Titration in Type 2 Diabetes

Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

Stress led all triggers, and a sense of an impending attack was the most reliable prodrome in patients with HAE-C1INH in the US HAEA Scientific Registry.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Hereditary Angioedema Triggers, Prodromes Mapped in US HAEA Registry

Stay updated with the latest healthcare breakthroughs, including the FDA approval of insulin efsitora alfa-gobe (Onswik).

Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

The HCPFive: Top News for Healthcare Providers from the Week of 09/20

Approval is based on 36-week data from BRAVE-AA-PEDS, in which 42% of patients on the 4 mg dose achieved a SALT score of 20 or less, compared with 5% on placebo.

Alopecia

FDA Approves Baricitinib for Adolescents With Severe Alopecia Areata

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

The FDA approved once-daily oral zilurgisertib for FOP in patients aged 12 years and older after the phase 2 PROGRESS trial showed reduced new heterotopic ossification vs placebo.

Zilurgisertib Receives FDA Approval for FOP in Patients 12 and Older

In this segment from the latest episode of Diabetes Dialogue, Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the FDA's approval of a new basal insulin for T2D.

FDA Approves a Second Once-Weekly Basal Insulin: What the QWINT Data Show

Approval covers patients aged ≥2 years with frequently relapsing or steroid dependent disease in complete remission.

FDA Approves Obinutuzumab (Gazyva) for Idiopathic Nephrotic Syndrome

An Ochsner transplant surgeon discusses 10,000 transplants and how new tools are expanding who can receive an organ. 

Latest News

Ochsner Health Expands Liver Transplant Access Through Multidisciplinary Care

Q&A: Cutlip on the SELUTION SLR DEB’s FDA Approval for Coronary In-Stent Restenosis

Lessons From 10,000 Organ Transplants, With Ari Cohen, MD

Brelovitug Meets Primary Endpoint in Phase 3 AZURE-1 Hepatitis Delta Trial

Skin of Color Savvy: Reimbursement, Coverage, and Care Gaps for Patients With Skin of Color