Dermatologists may be first to encounter patients. Learn how to recognize signs.

Skin symptoms associated with rare cancer

In case you missed it, some of this week’s featured content includes a new episode of our podcast, 

, exploring telemedicine use in dermatology. We also published content about negotiating better managed care contracts, female representation within the dermatological surgery space, pulsed dye laser and botulinumtoxinA as a combination treatment for rosacea, nano-pulse stimulation for treatment of nodular basal cell carcinoma and cutaneous, non-genital warts, plus more.

Selling your practice: The due diligence, legal documentation and final negotiation phases

Todd Petersen, CEO of VitalSkin Dermatology, covers the ins and outs of the due diligence, legal documentation and final negotiation stages of selling a practice.

Negotiating better managed care contracts

Jerri Ivey, director of revenue cycle management at VitalSkin Dermatology, shares steps you can take and ways you can educate yourself in order to negotiate better managed care contracts.

This week’s edition of The Mainstream Patient features stories about postpartum hair loss, vitamin C benefits, witch hazel, fraxel laser treatments, isotretinoin’s effect on both the skin and mind, oily skin myths, plus more.

Older adults underrepresented in atopic dermatitis research

A recent review reveals older adults are underrepresented in trials investigating systemic immunomodulators as a treatment for atopic dermatitis.

Dupilumab provides option for severe AD in younger children

In a recent phase 3 trial, dupilumab (Dupixent, Sanofi and Regeneron) demonstrated positive results in itch reduction, skin clearance and quality-of-life. Indicating the biologic as a viable treatment option for severe atopic dermatitis in younger children.

Trial compares NMSC destructive techniques

A recent study showed that curettage and cryotherapy, and electrodesiccation and curettage are two techniques that have comparable cure rates. The study’s findings highlight the efficacy and reliability of these treatment approaches for minimally invasive cutaneous carcinomas.

Women surgeons and Mohs micrographic surgery in the U.S.

Michelle Nguyen, M.D., MPH, sits down with Dermatology Times to discuss her recent presentation at the 2020 American Society for Dermatologic Surgery (ASDS) virtual meeting regarding the representation of women dermatologic surgeons in the U.S.

PDL, botulinumtoxinA improves rosacea symptoms

Treatment with a pulsed dye laser followed immediately by intradermal botulinumtoxinA injections appears safe and improved erythema, flushing, burning and pruritus, according to a recent study.

The Cutaneous Connection- Episode 9: Telemedicine Use in Dermatology

Michael Sherling, M.D., practicing dermatologist and chief medical and strategy officer at Modernizing Medicine, discusses the recent rise in telemedicine use in dermatology, the benefits and detriments, as well as the future for the industry.

Nano-pulse stimulation shows positive results

Promising outcomes are being reported from clinical trials investigating nano-pulse stimulation technology to treat nodular basal cell carcinoma and cutaneous, non-genital warts.

Articles

ICYMI, some of the content featured this week includes a new episode of our podcast focusing on telemedicine use in dermatology, female representation within the dermatological surgery space, pulsed dye laser and botulinumtoxinA as a combination treatment for rosacea, plus more.

Weekly Roundup: October 19-23

Accumulating data show promise for Nano-Pulse Stimulation technology (NPS, Pulse Biosciences) in the treatment of nodular basal cell carcinoma (nBCC) and cutaneous non-genital warts.

The results were presented at the 2020 virtual meeting of the American Society for Laser Medicine and Surgery. Christopher Harmon, M.D., who practices Mohs surgery and aesthetic dermatology in Birmingham, Ala., is an investigator in the nBCC study.

“Nodular BCCs are characterized by discrete large or small nests of basaloid cells in the papillary or reticular dermis,” he says. “Because of the varying degrees and unknown penetration of these deep cellular ‘nests,’ treatment typically requires surgical excision with wide margin control. NPS is exciting because early evidence indicates it can eliminate nBCCs with minimal scarring compared with conventional treatment.”

NPS is performed using a treatment tip containing a microarray of needles that deliver high amplitude, ultrashort electrical bursts to target lesion cells in the epidermis to deep dermis. The energy pulses cause transient nanoporation of the outer cellular membrane, altering the function of internal cellular organelles, including mitochondrial membrane and endo-plasmic reticulum.

This disruption ultimately leads to regulated cell death without any thermal effect or damage to surrounding acellular skin structures. In addition, the treatment is thought to stimulate an adaptive immune response that may contribute to clearing malignant lesions and warts.

The nBCC pilot study enrolled seven patients with a non-facial nBCC. They first underwent a pretreatment 3-mm biopsy for diagnostic confirmation and a blood draw for isolation of peripheral blood mononuclear cells. The NPS treatment was applied to only a portion of the tumor. The response was evaluated three to 12 weeks later with excision of the entire lesional area for histopathologic examination and a repeat

blood draw to identify evidence of an immune response. Treating only a portion of the tumor allowed researchers to validate the effectiveness of NPS through the histopathological examination, Dr. Harmon says.

As enrollment progressed, NPS energy settings were titrated down to find the “sweet spot” providing an optimal balance of efficacy and safety. The first two patients were treated with 15.5 J of energy (310 mJ/mm3). The energy was decreased by 50% for the next three patients to 7.7 J (155 mJ/ mm3), and then lowered by another 50% (3.9 J, 75 mJ/mm3) in the last two cases.

“We found that all of the energy levels were 100% effective. While tumor remained in the untreated area, the NPS-treated zones were consistently clear of nBCC. The biopsies also showed no clinical or histologic evidence of dermal scarring in the patients treated with the two lower energy settings,” Dr. Harmon says. “We were also encouraged to see infiltration of CD8+ T-cells in the untreated area in some histologic samples, which supports the idea that NPS induces a host immune response that may be part of its mechanism for tumor clearance.”

Based on positive findings of this early feasibility study, ongoing and future planned studies will further evaluate the two lower NPS energy settings of 75 or 155 mJ/mm3 to determine if treating the entire visible nBCC will achieve the study endpoint of histology-confirmed BCC elimination.

Although the study is enrolling patients with nBCC, Dr. Harmon believes NPS will also be studied as a minimally invasive option for clearing any BCC classified as low risk according to NCCN guidelines.

“We chose it to study nodular lesions because superficial BCCs may be removed entirely by the pretreatment shave biopsy performed for diagnostic confirmation. Further studies might investigate its use for superficial BCCs or other low-risk BCCs on the trunk and extremities,” Dr. Harmon says.

He notes that NPS technology might also have a role for treating aggressive BCCs on the face. Because those lesions can have a very deep component, modified probes that have longer microneedles and an insulated sheath may be tested for these deeper lesions.

Interim data from an expansion of a study investigating NPS treatment for cutaneous, non-genital warts was presented by E. Victor Ross, M.D., director, Laser and Cosmetic Dermatology Center, Scripps Clinic, San Diego. According to Dr. Ross, this pivotal clinical study included additional sites, an increased number of subjects and the treatment of warts across more anatomic areas, which enabled broader use of NPS to treat this difficult group of skin lesions.

He reported preliminary findings from 27 patients who had a total of 87 warts treated. The hands (n=39), feet (n=19), legs (n=10) and knees (n = 8) were the most common sites. Efficacy was high overall, with the best clearance rates observed for warts on the knee (100%), hands (90%) and leg (80%); 10 (53%) of the 19 warts on the foot were cleared. None of the warts that were eliminated showed evidence of recurrence at follow-up 60 days post-treatment.

“Our most recent data shows a continuing trend toward elimination of the majority of warts with one or two treatments,” Dr. Ross notes. “Cells are the real target of this technology, so any parts of the skin that are more cellular in nature versus stromal in nature will be more vulnerable to NPS energy,” he adds.

The potential for viral plume generated during treatment was investigated as a safety endpoint in a sub-cohort by stationing a sensitive particulate counter near the wart as NPS energy was being delivered. The results showed no evidence that the procedure resulted in aerosol emission of particles.

“Thermal-based cutaneous procedures may produce debris that contain dust, chemicals and infectious material. The absence of plume with NPS technology may be an important safety benefit for physicians and their patients,” Dr. Ross says. “The next steps for the wart protocol are expected to include testing tips with longer microneedles for deeper warts and evaluating optimal follow-on treatment intervals for the subset of warts that did not clear in a single procedure session.”

Dr. Harmon is a consultant to and member of the scientific advisory board for Pulse Biosciences. Dr. Ross is a consultant to and received research support from Pulse Biosciences.

Promising outcomes are being reported from clinical trials investigating Nano-Pulse Stimulation technology to treat nodular basal cell carcinoma and cutaneous, non-genital warts. 

Nano-pulse stimulation shows positive results 

Podcasts

Michael Sherling, M.D., practicing dermatologist and chief medical and strategy officer at Modernizing Medicine, discusses the recent rise in telemedicine use in dermatology, the benefits and detriments, as well as the future for the industry. 

A combination approach using a pulsed dye laser (PDL) and intradermal injection of botulinum toxin-type A (BoNTA) is safe and effectively improves erythema and disease-related symptoms, says Firas Al-Niaimi, M.D., who, with colleagues, summarized experience using this approach in a series of 20 patients with moderate-to-severe erythema and flushing

“As with any treatment, there was variability in the magnitude of response. Overall, however, all patients benefited, and the patient satisfaction rate was high,” he tells 

. Dr. Al-Niaimi is a senior consultant dermatologist in London, UK.

Discussing the basis for combining PDL and intradermal BoNTA, he notes the limitations of PDL, which is a standard treatment for erythema and telangiectasia, and the potential for synergism with BoNTA.

“PDL can improve erythema by addressing the vascular component of inflammation, and by reducing 

density, it can modulate the innate immune system to reduce burning and pruritus. However, PDL treatment has a somewhat limited effect on flushing,” Dr. Al-Niaimi explains. “By targeting neurogenic inflammation, BoNTA is particularly good for relieving bothersome flushing as well as pain and burning.”

The patients were treated at three different centers with the same protocol over an 18-month period and seen for follow-up after three and nine months. Other than appropriate skincare products, they did not use any topical or systemic therapies for rosacea management. Patients received a series of three treatments performed every four to six weeks. The same PDL was used at all centers (VBeam, Candela). A single pass at sub-purpuric settings was performed, but the specific laser parameters were adjusted based on each patient’s skin type, amount of chromophore, skin response and anatomic area. Spot size ranged from 7 to 10 mm, pulse duration was set at three, six, or 10 ms, and fluence ranged from 7 to 10 J/cm2. The intradermal BoNTA injections were administered immediately after the PDL treatment. Ten patients were treated with abobotulinumtoxinA (Dysport, Ipsen) and the others received onabotulinumtoxinA (Botox, Allergan). AbobotulinumtoxinA was reconstituted to achieve a final concentration of 100 units/ mL and onabotulinumtoxinA was reconstituted to achieve a final concentration of 40 units/mL. Injections were delivered only in the area of the cheeks affected by flushing and were performed using a 30-gauge needle with spacing at 1-cm intervals. The total dose was individualized taking into account flushing severity and area.

The efficacy of the treatment for improving erythema was objectively quantified through analysis of spectral uptake on digital images acquired using a 3D camera system (Antera 3D camera, Miravex Limited) and graded subjectively by the treating dermatologists using the six-point Clinician’s Erythema Assessment Grading Scale.

Patients benefited with a discernable reduction in erythema and episodes and severity of flushing lasting several months. Improvements in burning and pruritus were maintained at the nine-month follow-up visit. The reduction in flushing was relatively durable, and although it began to wane as the effect of the BoNTA dissipated, patients maintained improvement compared with baseline. The investigators suggested the benefit may be attributed to laser-induced eradication of vessels involved in flushing.

“Although it has been suggested that abobotulinumtoxinA has a longer duration of action than onaBoNTA, we did not observe any difference between the two products with respect to peak benefit or longevity in our small series of patients,” Dr. Al-Niaimi says.

Side effects were generally limited to expected sequelae of the PDL treatment. A single patient developed mild purpura that resolved after 10 days.

The article presents the outcomes achieved in a small cohort of patients who were selected because they were treated with a standardized protocol and followed prospectively. However, Dr. Al-Niaimi says they have used the combination in a much larger number of patients with equally good results and consider it a valuable treatment option for patients with concomitant flushing and fluctuating erythema.

has no relevant financial interests to disclose. 

1. Al-Niaimi F, Glagoleva E, Araviiskaia E. 

. 2020. Published online ahead of print, July 7, 2020. doi: 10.1111/dth.13976.

Videos

Michelle Nguyen, M.D., MPH, sits down with Dermatology Times to discuss her recent presentation at the 2020 American Society for Dermatologic Surgery (ASDS) virtual meeting regarding the representation of women dermatologic surgeons in the U.S. 

There are several different treatment approaches currently being used to address low-risk nonmelanoma skin cancers such as basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). A recent study found that curettage-cryosurgery (C&C) and electrodesiccation and curettage (ED&C) are two common techniques that have comparable cure rates after a one-year follow-up period, underscoring the sound therapeutic benefit of both treatment approaches.

Of all nonmelanoma skin cancers, BCC comprises approximately 75-80% of these lesions and SCC comprises approximately 20%, experts say. Both are associated with significant morbidity, aesthetic concerns and financial burden. Numerous treatment approaches including surgery, topicals, photodynamic therapy (PDT) and destruction have shown efficacy in clearing these minimally invasive tumors. ED&C is the most common procedure used for minimally invasive BCCs and is recommended as a first-line treatment by the National Comprehensive Cancer Network (NCCN). Similarly, cure rates have also shown to be close to 99% for SCC when this method is used.

In a recent multicenter, prospective, comparative study, Suzel Fournier, M.D., from the oncology division of the CHU of Québec, University of Laval Research Center, Québec, Canada, and colleagues, evaluated the cure rates of minimally invasive BCC and SCC lesions when using C&C or ED&C in a cohort of 100 adult Caucasian male and female patients. Study participants were randomized 1:1 to receive either C&C and ED&C treatment, with cure rates evaluated at six, 12, 18 and 24 months, and aesthetic appearance of scars at 12 months post procedure. Evaluated on a scale from 1-10, the aesthetic appearance of the scars was assessed using the Patient and Observer Scar Assessment Scale (POSAS), which combines the assessments of both physician and patients. The average age of patients receiving C&C (n=53) and ED&C (n=47) treatment was 74 and 77 years, respectively.

Results showed that at the 12-month follow-up, only one patient had a recurrence of cutaneous carcinoma in the C&C cohort (98% cure rate), while no recurrence occurred in the patients treated with ED&C (100% cure rate), statistically demonstrating non-inferiority of the C&C approach, and achieving the primary outcome goal. The aesthetic appearance of scars also showed better results with the C&C approach at the 12-month follow-up, however this was not statistically significant. No other recurrences were recorded in either study group at the 6-, 18-, and 24-month follow-up time points.

Patients’ evaluation of the aesthetic appearance of scars as reflected in the mean POSAS score was 1.39 and 1.50 in the C&C and C&E patient groups, respectively. Data also showed that a global score of 1 (best possible score) was recorded by 74% and 66% of the C&C and ED&C groups, respectively. The researchers noted that the same trend was seen in the clinician evaluations, revealing an overall score of 1 for 36% and 33% of C&C and ED&C study patients, respectively.

According to the researchers, this is the first clinical study evaluating and comparing the efficacy of C&C and ED&C with respect to cure rates and aesthetic appearance of scars for low-risk BCC and SCC tumors.

“Our study tends to demonstrate that C&C provides a high cure rate for minimally invasive basal and squamous cell carcinomas. These findings are comparable to other studies with similar protocols, but longer follow-ups. We’ve demonstrated that the C&C technique seems noninferior to the C&E method found in main guide- lines, and as such we believe that it should be investigated more thoroughly as a first-line therapy,” the study authors wrote.

Regarding aesthetic scar outcomes, the researchers said that future trials could include more objective measurements for scar assessment such as Narrow-Band Spectrophotometry, Tissue Ultrasound Palpation System, and Cutometer Skin Elasticity Meter in order to help minimize potential information bias due to the subjective assessment of scars. In addition, a larger patient study cohort could also help in evaluating the different scars based on anatomical location in future studies.

The authors report no relevant disclosures.

Fournier S, Laroche A, Leblanc M, et al. Prospective Clinical Trial Comparing Curettage and Cryosurgery to Curettage and Electrodesiccation in the Management of Minimally Invasive Basal and Squamous Cell Carcinomas. 

2020 Jul 28;1203475420943258. doi: 10.1177/1203475420943258. Online ahead of print.

A recent study showed that curettage and cryotherapy, and electrodesiccation and curettage are two techniques that have comparable cure rates. The study’s findings highlight the efficacy and reliability of these treatment approaches for minimally invasive cutaneous carcinomas. 

John Jesitus is a medical writer based in Westminster, CO.

The efficacy and safety of dupilumab (Dupixent, Sanofi and Regeneron) in children ages 6 to 11 years with severe atopic dermatitis (AD) provides an acceptable option for a previously underserved population, says the principal investigator on the phase 3 LIBERTY AD PEDS trial.

“We finally have dupilumab for an age group where it’s so critical, and there hasn’t been anything other than immunosuppressants to treat these children,” says Amy S. Paller, M.D, chair and professor in the Department of Dermatology, and professor of pediatrics (dermatology) at Northwestern University Feinberg School of Medicine.

Between ages six and 11, she says, children are starting school and forming early social relationships, which are difficult if children are tormented by AD and associated itching and disturbances of sleep and concentration. “Ages 6 to 11 is their time to venture out into the real world and a very critical time for their psychosocial development.”

In the study, investigators randomized 362 patients to dupilumab every two weeks (100 mg if weight <30 kg, 200 mg if ≥ 30 kg), dupilumab every four weeks (300 mg regardless of weight) or placebo. All patients also used topical corticosteroids (TCS). 

At week 16, significantly more patients on dupilumab every two weeks (29.5%) or four weeks (32.8%) achieved the primary endpoint of investigator global assessment (IGA) score of 0 (clear) or 1 (almost clear) versus placebo (11.4%). Eczema Area and Severity Index (EASI) 75 scores were 67.2%, 69.7% and 26.8%, respectively. Whereas twice-monthly dosing proved most effective in all prior dupilumab AD trials, pharmacokinetic values and clinical impact were greater with the 300 mg every four-week dose versus 100 mg every two weeks in children weighing less than 30 kg. 

“Dupilumab did not just affect the objective signs of atopic dermatitis,” Dr. Paller adds, “but incredibly importantly, it also brought down the itch as early as in the first two weeks and profoundly affected quality of life for these young children.”

As in previous dupilumab trials in AD, injection-site reactions and conjunctivitis (mostly mild to moderate) were the only treatment-emergent adverse events (TEAEs) that occurred more frequently with dupilumab than with placebo. The fact that fewer TEAEs overall occurred with dupilumab may stem from dupilumab’s ameliorative effects on comorbid type 2 inflammatory conditions and on skin (fewer skin infections), write Paller et al.

Dupilumab is highly effective in adolescent asthma, says Dr. Paller, and it is being studied for other type 2 comorbidities. “For example, it’s looking very good for eosinophilic esophagitis. It’s also being studied for severe allergic rhinitis and food allergies. So, we know that it has the promise to be effective across a range of Th2-driven disorders.” Such capability would be welcome, she says, because more than 90% of adolescents with moderate AD, and younger children with severe AD, have at least one other type 2 disorder.

“That means that we may be able to treat more than one of their diseases with a single agent.” The asthma or other comorbidities are usually less severe than the AD, Dr. Paller says. But the possibility of stopping other medications used for some of these comorbidities is appealing for families and children, she adds.

Dupilumab’s success against AD in children ages 6 to 11 years is already a breakthrough, says Dr. Paller. “For kids who have never been able to get the control I wanted because I was unwilling to put them on a systemic medication, now I’ll be able to give them something that’s acceptable to parents, that’s not going to require labs every month, and that’s even going to give them better control than a medication like cyclosporine.”

1. Paller AS, Siegfried EC, Thaçi D, et al. Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: a randomized, double-blinded, placebo-controlled phase 3 trial [published online ahead of print June 20, 2020]. J Am Acad Dermatol. 2020;S0190-9622(20)31152-X. doi:10.1016/j.jaad.2020.06.054.

Dr. Paller has been an investigator and consultant for AbbVie, Castle Creek, Eli Lilly, Galderma, Lenus, LEO, Novartis and Regeneron; an investigator for Incyte, Janssen and Verrica; and a consultant for Almirall, Amgen, Asana, Boehringer Ingelheim, Celgene, Dermavant, Dermira, Exicure, Forte BioPharma, MEDACorp, Meiji Seika, Novan, Pfizer, Sanofi Genzyme, Sol-Gel and UCB.

In a recent phase 3 trial, dupilumab (Dupixent, Sanofi and Regeneron) demonstrated positive results in itch reduction, skin clearance and quality-of-life. Indicating the biologic as a viable treatment option for severe atopic dermatitis in younger children.  

Dupilumab provides option for severe AD in younger children 

a weekly glimpse into what your patients may be reading in the media about skin health.

finds out if witch hazel is beneficial or detrimental to the skin and gets to the bottom of oily skin myths. Meanwhile, 

explains how to take care of both your skin and mind while on isotretinoin (Accutane), and 

writes about the benefits of vitamin C. Finally, 

dives into the anti-aging benefits of fraxel laser treatments and reveals how to deal with postpartum hair loss.

Is Witch Hazel Good or Bad for Your Skin? Here's What Dermatologists Say About This Controversial Ingredient

How to Take Care of Your Skin and Mind While on Accutane — and After

Why The Hype Over Vitamin C’s Skin Benefits Is Real

Dermatologists Say This Is the Most Common Misconception About Oily Skin

What You Need to Know About Fraxel Laser Treatments

Postpartum Hair Loss Is Real — Here's How to Deal with It

The Mainstream Patient: October 20

The lack of older adults in trials of systemic immunomodulators for atopic dermatitis (AD) means that available evidence may not be safely generalizable to these patients, according to a recent review. 

“Both psoriasis and atopic dermatitis are common in older adults. And older adults in general are more at risk for adverse events from medications. We need to know how effective and safe medications for psoriasis and atopic dermatitis are in this population,” says lead study author Aaron Drucker, M.D., ScM. Dr. Drucker is a clinician scientist in the Division of Dermatology at Women’s College Hospital and Women’s College Research Institute and assistant professor in the Department of Medicine at the University of Toronto.

Age-related changes in drug metabolism, as well as the likelihood of increased comorbidities and polypharmacy, make older patients more susceptible to drug-related adverse events, study authors write. For example, methotrexate is considered less safe in this population due to reduced renal clearance. Similarly, cyclosporine is contraindicated in patients with renal impairment, uncontrolled hypertension or relevant malignancies; cyclosporine also interacts with many common medications.

Research from the United States and the United Kingdom suggests that the prevalence of AD in people over 65 years old is approximately 7%. Yet according to the review, published online Aug. 19, 2020 in 

, none of the trials analyzed reported separate efficacy or safety outcomes for older adults.

Investigators searched the Cochrane Central Register of Controlled Trials, Embase, MEDLINE and clinicaltrials.gov through Nov. 7, 2019. Ultimately, 32 trials including 4547 participants total met inclusion criteria.

Of these 32 trials, 11 (most involving cyclosporine) reported explicit upper age limits ranging from 42 to 70 years. Although seven of 12 dupilumab (Dupixent, Sanofi and Regeneron) trials lacked upper age limits, only 67 of 1472 total participants (4%) were over age 65; the gender of older participants was not reported. Overall, 10 trials included at least one participant age 65 or older.

More than two-thirds of the studies reviewed used eligibility criteria that may have disproportionately excluded older patients. The most frequent examples of such criteria included history or presence of malignant neoplasms (56%), uncontrolled hypertension (28%), renal or pelvic dysfunction (25%), use of drugs likely to interfere with study drugs’ pharmacokinetics (22%) and abnormal laboratory values (19%). 

The situation in AD is not unique, authors add, as stringent criteria of clinical trials in many diseases may indirectly exclude older adults. The widely used major diagnostic criterion of flexural dermatitis may represent another obstacle because flexural dermatitis occurs less commonly in older adults than in younger adults and children. 

Dr. Drucker says he hopes that the study’s findings bring awareness to the dearth of data regarding older adults in studies of systemic AD drugs. “When we pick treatments and counsel our patients on these drugs,” he says. “that should be part of the discussion. We have to do the best with the data we have, which in a way means flying blind. We have to use data from younger people and understand that it’s uncertain whether these data apply to older people.”

To help clarify the safety and efficacy of systemic AD treatments for older patients, Dr. Drucker and colleagues suggest conducting observational studies. While randomized clinical trials are the ideal study design, Dr. Drucker notes, such trials are expensive, resource-intensive and unlikely to occur for drugs already approved.

“Observational studies can be done with fewer resources and can provide very helpful data in more generalizable populations outside of clinical trials,” he says. Future trials also could increase participation of older adults by reducing comorbidity-related exclusion criteria, eliminating age-related exclusion criteria and setting specific recruitment targets for older adults.”

1. Lam M, Zhu JW, Maqbool T, et al. Inclusion of older adults in randomized clinical trials for systemic medications for atopic dermatitis: a systematic review [published online ahead of print Aug 19, 2020]. JAMA Dermatol. 2020;10.1001/jamadermatol.2020.2940. doi:10.1001/jamadermatol.2020.2940

Dr. Drucker has received institutional research funding from Sanofi and Regeneron. He has been a consultant for Sanofi and RTI Health Solutions, and his institution has received educational grants from Sanofi and Regeneron.

A recent review reveals older adults are underrepresented in trials investigating systemic immunomodulators as a treatment for atopic dermatitis. 

Older adults underrepresented in atopic dermatitis research  

Director of Revenue Cycle Management at VitalSkin Dermatology

As we discussed earlier this year, revenue pressure can make running a solo practice difficult for many dermatologists. And managed care contracts can create a major impact on a practice’s revenue.

With the ongoing lack of consolidation in the physician space, most practices won’t have the leverage (or often the knowledge) to negotiate with large health insurance companies. As a result, they often sign standard contracts that hinder their practice. 

In these cases, dermatologists may not spot things that can put them at risk or cost them money. With terms that set year-over-year reimbursement rates and allow insurance companies to control billing and coding rules, a dermatologist’s revenue increases can be offset by stricter billing/coding rules and increased denial rates. 

Fortunately, unlike government contracts, managed care contracts can be negotiated. By taking the right opportunities, understanding the language and avoiding certain pitfalls you can put yourself in a better position to negotiate and get the most out of your agreements. Here are some steps to take (and problems to avoid) that can help you negotiate better managed care contracts. 

When it comes to Medicare Advantage reimbursement rates, make sure they’re equal to CMS Professional Fee for Service rates in your region. More general information on CMS rates can be found 

When reviewing a contract, make sure the items below are outlined in the contract. Doing so will help avoid denials and/or claim issues with appeals, payments, preauthorization, etc. 

Notification prior to term, so you can negotiate the contract 

Take-back period – how far back a payer can take back payments 

Confirm you have easy access to any policies or manuals referred to in the contract. These may contain important details or points of clarification if you run into an issue. 

See if the contract says that stipulations (allowed amounts, policies, etc.) may be amended from “time to time.” If so, what are the notice and remediation periods listed? 

Check if the contract specifies how long a patient needs to be treated after the contract is terminated. 

Check if it refers to any “abnormal” reductions in payment due to modifiers or providers (APPs). 

Clarify and understand what your responsibilities are with coordination of benefits. 

See if your practice is required to wait until payment from the payer before you can collect copayments or coinsurance. This is something new that’s been showing up in contracts recently. 

Look for opportunities to educate payers on how you can differentiate yourself in the market compared to other dermatologists. If you’re in a smaller community and competing against larger hospital-owned groups, you may be able to highlight being a lower-cost alternative. 

Try to identify what a payer needs and how you can fill that need. Perhaps they’re trying to launch and expand their Medicare Advantage plan and need the right network in a certain market to show suitable coverage. You might be able to trade participation in their Medicare Advantage plan for higher rates on the PPO side. 

Investigate opportunities to join a health system or independent IPA or CIN and understand their participation requirements. You may be able to get higher rates through these options compared to what you’re receiving directly.  

Stay alert for stipulations that let the payer adjust and pay claims at a lower level than submitted. 

Surprisingly, some contracts do allow this. Seek to contractually reduce a payer’s ability to change claims by asking the contract to state that the payer must notify you and explain any modifications from the Centers for Medicare and Medicaid Services’ Correct Coding Initiative (CCI). 

Be cautious of contracts that can be extended to affiliates. 

Payers and network PPO contracts may include a statement saying that the agreement is entered into by itself and its affiliates (often in the opening paragraph). If the payer you’re contracting with has affiliates, have the contract specify all of them. This will help stop the network from being “leased.” 

Keep an eye out for unilateral change authority statements. 

Often, payers will give themselves power to make unilateral changes to the agreement. This essentially gives them control to make any changes they want, with you being contractually obligated to accept (no matter what the consequences may be). If you come across this, it’s best to work on getting it removed. The payer may not like it and push back, but the effort will be well worth not locking yourself into a potentially problematic situation. 

Appeal limitations put the burden of finding claim-processing errors on you. And if you don’t report an error within a filing limitation, the payer may not reprocess the claim if it’s over 30 days old. Check the Payment and Reimbursement section of the contract to find anything regarding limitations. 

Depending on your size, you may not have the full ability to negotiate with larger companies and payers from the even position you’d prefer. But there are still things you can do, and ways to educate yourself to put yourself in a better position. 

 The risks from managed care contracts can never be fully avoided, but carefully reviewing everything and identifying potential red flags will help you minimize much of this risk when negotiating. 

Jerri Ivey, director of revenue cycle management at VitalSkin Dermatology, shares steps you can take and ways you can educate yourself in order to negotiate better managed care contracts.  

Weekly Roundup: October 19-23

Nano-pulse stimulation shows positive results

The Cutaneous Connection- Episode 9: Telemedicine Use in Dermatology

PDL, botulinumtoxinA improves rosacea symptoms

Women surgeons and Mohs micrographic surgery in the U.S.

Skin symptoms associated with rare cancer

Trial compares NMSC destructive techniques

Dupilumab provides option for severe AD in younger children

The Mainstream Patient: October 20

Older adults underrepresented in atopic dermatitis research

Negotiating better managed care contracts

Negotiating better managed care contracts