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Women In Healthcare Look For The Beacons: Building Hope Through Behavioral Health

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By Erin L.W. Zacholl

There is a special glimmer when you realize that you are in the presence of someone who didn’t necessarily find the right course in life but were simply placed on it. Perhaps by serendipity or fate, Stephanie Montgomery was led to a small path at an early age. She recognized its direction, worked hard, persevered over tough times and forged a mighty highway out of its humble start.

Stephanie is the Administrative Director of Behavioral Health at Syracuse Community Health. Her SCH career began almost 30 years ago when she served as the receptionist for the Counseling Addiction and Psychological Services (or CAPS) department of SCH. Every promotion she has earned since serving as receptionist was created for her. She has truly pioneered her own career while making opportunities for others to follow. “I firmly believe that all of us must stay focused and use what we have in front of us as an advantage, nota hurdle,” Stephanie speaks these words with a laser focus.

At an early age, she found herself the victim of domestic violence and used this experience as a building block, not a crushing boulder. “Syracuse Community Health was my safe place,” Stephanie recalls with accomplishment. “I used this period of my life to propel myself. I kept pulling myself up and that experience helps me with much of what we do in Behavioral Health.” Stephanie continued, “It’s not always easy, but we all must recognize our own strengths and stay committed. Keeping my word is so important; to the people I serve and to myself.”

Stephanie feels that is both her responsibility and honor to especially reach areas of our general population that are often misheard and misunderstood. “As a biracial woman, I understand what it’s like to feel connected to more than one place, but not necessarily feel grounded in either,” she speaks from the heart, “I am proud to help other biracial women, as well as others in our community who are most vulnerable. We all need to recognize our value and belonging, and SCH is such a wonderful platform for this purpose,” her words are spoken with a smile. “There is so much here to offer our community.”

Through her own journey at SCH, Stephanie attests that her years at SCH have seen, much change, yet much has also stayed the same. “While the stigma of mental health has alleviated over time, I would love to see it gone,” Stephanie reflects, “it’s still a roadblock.” When Stephanie speaks, her words are annunciated from such a place of solid experience, ,“When someone is diagnosed with cancer, there is no judgment when the patient needs help and treatment. Society needs to treat people facing addiction and mental illness the same as they would treat someone with a terminal disease.” She believes that the department title Behavioral Health helps integrate all the services the SCH offers while hopefully helping to eliminate the stigma associated with the “addiction” portion of CAPS. “The majority of addiction patients are navigating a deeper illness,” Stephanie says, “often, overdosing is a result of self-medicating for an underlying condition.” Through her decades at SCH, Stephanie has seen the, addiction crisis evolve from crack cocaine toward opioids. “It’s eye-opening when you look around,” she says, “mental health and the opioid addiction have exploded; waiting lists are long, but hope exists.”

Stephanie’s department at SCH offers a personalized approach to care and treatment. Their individualized method of care is respectful, educational and focuses on a person-centered journey. “We treat the whole person,” Stephanie explains the approach to SCH’s services. “It’s important to respect each person’s perspective by listening to them and by supporting  improvements in their mind, body and spiritual well-being.” She also stresses the importance of seeing someone in person. “Since COVID, there is such a shortage of mental health providers, social workers, marriage-family and crisis therapists.” Additionally, the pandemic found many providers with their own issues and unable to provide services to others. Since COVID, New York State has also started telehealth, services, to include mental health. While this helps broaden the possibilities for more people to seek help, Stephanie cautions that “many professionals went into private practice with the convenience of telehealth, even though providers really do need to see people in person (at least sometimes).”

The Behavioral Health Department at SCH is small and intimate, but large in the services offered and the accreditations of their team. “It’s important that our community understands all that is offered here,” Stephanie proudly states. “W are a unique behavioral health department with a team that specializes in Medication Assistance Treatment Services, Out-patient Addiction Services (inclusive of impaired driver assessments) as well as Individual and Family Therapy.” Stephanie says that she loves watching the transformation in people that are seeking help and pursuing help, “I was brought up here and to be able to work in such a place that is so patient focused and understanding about the populations we serve is a tremendous feeling.”

At SCH, Stephanie Montgomery makes every day intentional. “Did I do my best today?” she asks herself nightly. “I have gone through seasons of my careers at SCH and each one found me right where I needed to be,” reflecting on her years. “I feel so blessed to be part of this humbly wonderful team.” Stephanie is often asked how she balances her work and professional lives. In addition to her gratitude for the environment at SCH, she always replies, “My simple answer is Faith, Family and a good support system; no matter how large or small that system may be.”

Is Your Restrictive Covenant Still Enforceable?

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By: Sarah E. Steinmann

The Federal Trade Commission (“FTC”) made a big splash this spring when it published its Final Non-Compete Clause Rule (“Rule”), which bans most post-employment non-compete agreements between employers and workers.

The FTC issued the Rule under its authority to regulate “unfair restraints on trade and business” and intends for the Rule to open the door for new businesses, innovation, and increased wages for workers.

Until now, non-compete covenants have been governed by state law, with the scope and enforceability of such arrangements varying widely. The Rule—set to go into effect on September 4—will affect businesses nationwide and across industries, including those operating in the healthcare space.

Applicability
Most healthcare entities will be subject to the Rule, which applies to “all persons and private for profit business entities,” regardless of business structure. While non-profits are generally not subject to the Rule, the FTC will scrutinize non-profit corporations to determine “whether either the corporation or its members derive a profit.” If they do, the Rule will apply.

On the other hand, anyone who produces work for a business, including employees, independent contractors, interns, and even unpaid volunteers, is considered a “worker” protected under the Rule.

FTC Defines Non-Compete Clause
A non-compete agreement is a restrictive covenant that prevents a worker from working for or operating a business that is competitive with the employer after the worker ceases to work for the employer.

The Rule implements a broad definition of “non-compete clause” to include restrictions in employment agreements, workplace policies and even oral agreements between parties. Any term or condition of employment that “prohibits a worker from, penalizes a worker for, or functions to prevent a worker from” working for or operating a business after their employment with the employer ends is prohibited under the Rule.

The Rule also extends to other types of restrictive covenants such as non-disclosure and non solicitation agreements—if they have the same effect as a standard non-compete (i.e. if they prevent a worker from, or penalize a worker for, seeking or accepting work after their employment ends). Businesses that offer on-the-job training should be aware that training repayment agreements might be challenged under the Rule.

Exceptions
The Rule does not prohibit restrictions on workers during their employment, so a business can prevent workers from simultaneously working for their competitors. The Rule also allows noncompete restrictions between buyers and sellers of a business in connection with the sale of a business or an individual’s ownership interest.

Existing Covenants
The Rule is retroactive, so non  compete agreements made before September 4 between businesses and their workers will become unenforceable. 

One notable exception will allow businesses to enforce existing noncompetes against their senior executives. A “senior executive” is an employee who earns more than $151,164 per year, who is in a “policy-making position,” and who has “final authority” over decisions controlling a significant aspect of the business. For most physicians, the question of whether they are in a “policy making position” will be the most controversial in determining the enforceability of a restrictive covenant.

State Laws
Physicians and healthcare businesses may be familiar with existing state laws and regulations and shouldn’t assume they no longer apply. While the Rule supersedes existing state laws and regulations that conflict with it, states are free to regulate non, compete covenants outside the Rule’s scope.

Next Steps for Employers 

Employers will need to notify every worker subject to a non compete that it is no longer enforceable, so businesses should start identifying workers affected by the Rule. They should also start preparing the notices, which must be “on paper” and delivered personally or by mail, e mail, or text message. Businesses might also consider why they used noncompetes and how they might achieve their business aims within the bounds of the Rule.

Legal Challenges
Employers rushed to challenge the Rule in court, seeking injunctions to prevent it from going into effect. A federal judge in Texas issued a preliminary injunction temporarily halting implementation of the Rule and is expected to issue a final decision by August 30. In a separate case in Pennsylvania, the court rejected the employer’s request for an injunction. Businesses should keep an eye out for developments as the September 4 effective date approaches. Because of the pending litigation and the plethora of cases we expect to be filed in the coming months, ultimately, this is an issue that will probably reach the Supreme Court for a final determination. 

If you have questions about the enforceability of your restrictive covenants, it is crucial to act now to ensure your agreements are in full compliance with the FTC’s new Rule before the September 4 deadline. For questions, contact Lippes Mathias attorney Sarah E. Steinmann by phone at 315-477- 6232 or by email at ssteinmann@lippes.com.

Significant research for this piece was performed by Jennifer E. Forward, summer associate, Albany Law School (anticipated Class of 2025).

Cardiovascular Disease Research:One Phase Ahead of Alzheimer’s Studies?

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By: Robert C. Cupelo, MD Principal Investigator

For everyone involved in neurological disease research, the last two years have brought about major advances in our understanding of Alzheimer’s disease and related neurodegenerative disorders. Along with the discovery of new avenues for effective therapies, we now have, for the first time, proven disease modifying treatments. And as we acquire more options shown to be effective, we look forward to applying these tools and developing regimens not only to treat this disease, but also to prevent the very onset of its clinical manifestations.

But when it comes to the area of metabolic disorders and their role in causing cardiovascular disease, science is in an historical phase ahead. As someone who started his medical training in the late 1970s, I can attest to the lack of effective, convenient, and tolerable treatments for conditions like diabetes and hyperlipidemia at that time,relegating many patients to a life with relentless symptom progression, cardiac events and frequent essentially palliative surgical procedures. I can even remember a very respected and prominent cardiovascular surgeon who could predict with uncanny but somewhat sad accuracy when his successful bypass patients would be back in the OR requiring another procedure. With limited therapeutic options available, patients often endured a poor quality of life, many experiencing a feeling of helplessness, despite valiant efforts at lifestyle modification.

The release of lovastatin (Mevacor) in 1987 changed all that. The first statin to gain FDA approval, it was the first truly effective treatment for hypercholesterolemia. Actual statistical proof that it reduced cardiovascular events and surgeries would come a little later (it’s now required for approval of these medications), but we all knew from the start that this was a game changer. It could be said that it was, in effect, the first viable disease modifying medication for coronary artery disease. And in the years since, countless pharmaceutical advances have followed, treating not just elevated LDL cholesterol, but numerous other metabolic conditions which increased risk for cardiovascular disease, such as other dyslipidemia, type II diabetes, chronic renal disease, coagulation abnormalities, obesity, and acquired diseases of myocardial function.

We at Velocity Clinical Research Syracuse embrace the study of the prevention and treatment of metabolic and cardiovascular diseases with today’s therapeutic tools and ask, “How do we best help the further development of our current available medications, and how do we promote their best use both in primary (warding off the first event) and secondary (warding off subsequent events) prevention?” The dedicated and competent staff at our research site on Brittonfield Parkway have run and are actively running several studies in multiple, areas of metabolic disorders including two studies for hypertriglyceridemia, an oral PCSK9 inhibitor for patients with hypercholesterolemia at increased cardiovascular risk (currently in maintenance phase), a long-acting basal insulin dosed weekly, an oral GLP- 1 that is more effective and tolerable than currently available options, and several classes of injectable weight loss medications, assessing not only their efficacy with weight loss but also the metabolic consequences of the therapy.

As always, clinical research studies are fluid in nature, often starting and ending enrollment somewhat suddenly and unpredictably. So, if you have any interest in participating in this research, or would just like to know more about it, we encourage you to call us to learn of our latest developments. We can also keep you up to date on our ongoing efforts to study Alzheimer’s disease, another core focus at our site. Indeed, we look to a vision of the future when, just as we now have with metabolic disorders, we will have numerous and varied options available to people at risk of dementia and other neurodegenerative diseases.

At Velocity Syracuse, we encourage our Central New York medical community colleagues to keep us in mind as a dynamic and viable partner in your efforts to provide preventative care and treatment to your patients, including ones at elevated cardiovascular risk. And as always, we especially seek people from diverse backgrounds and those who are traditionally underserved, as they can potentially benefit in many ways from participation in clinical research. A culture of inclusion is especially vital to the accuracy and validity of our results.

Heart disease is still the number one cause of death for Americans, but our health care system has been making progress on this for quite a few years now. Let us at Velocity Clinical Research Syracuse help you and your patients keep that ball rolling.

Comprehensive Care Alliance: Enhancing Back Pain Management through a Full Spectrum Partnership

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Primary care physicians are familiar with diagnosing back pain. But when it comes to discerning the source of the pain and how to treat it, a referral to the physicians at Syracuse Orthopedic Specialists (SOS) and New York Spine & Wellness Center (NYS&WC) is often the next step. The medical groups are in partnership to provide a continuum of care, creating the most complete musculoskeletal group in Central New York and helping patients navigate through their back pain.

Chronic back pain, defined as lasting at least three months, accounts for the most common pain complaint among American adults, according to a 2019 study by the Centers for Disease Control and Prevention, afflicting 39 percent of patients. In 2023, the World Health Organization outlined these key points about low back pain:

  • It is the single leading cause of disability worldwide and the condition for which the greatest number of people may benefit from rehabilitation.
  • It can be experienced at any age, and most people experience it at least once in their life.
  • Prevalence increases with age up to 80 years, while the highest number of low back pain cases occurs at ages 50 to 55, and more prevalently with women.
  • Non-specific low back pain is its most common presentation (about 90 percent of cases).

Providers at both SOS and NYS&WC offer initial consultations to patients experiencing back pain. “It’s really important having a trusted partner because there are many sides to pain management,” said Jessica Albanese, MD, a spine surgeon with the SOS Neck and Back Team. “Between our two practices, we offer the full spectrum of interventions. Patients can begin care at either practice and providers will diagnose and navigate patients to the most appropriate specialist to support their treatment and recovery.”

“The best first step for a patient with back pain is to seek treatment and guidance from their primary care provider” shared Dr. Brendan McGinn a specialist in Anesthesiology and Interventional Pain Management at NYS&WC. “By having an initial consultation with their PCP, patients can most effectively take first steps to help manage their pain by trialing a nonsteroidal anti-inflammatory drug (NSAID) or an oral steroid, physical

 therapy, and then if it’s indicated, a referral to SOS or NYS&WC”.

Patients are also welcome to contact SOS and NYS&WC directly to request appointments. Both practices accept nearly all insurance types and do not require referrals unless the patient’s insurance company requires it.

Dr. Ryan McConn a specialist in Anesthesiology and Interventional Pain Management at NYS&WC shares, “The benefit of the close partnership between our two organizations is that patients have seamless access to both groups and the services they provide once within our doors. Each practice will consult patients and ensure care is given by the most appropriate provider.”

Upon initial consultation at either organization, patients may meet with a physician assistant, nurse practitioner, or physician. Each clinical team is highly trained, working in tandem to deliver specialized medical care to every patient.

Together, from initial consultation through treatment, clinicians focus on patient education. “A lot of time is spent with our patients, in both practices, educating them and having a discussion about what is going on, the options they have, and the risks and benefits of each option,” Dr. McConn continued. “I refer to it as ‘getting organized’ because when they first come in, they’re in distress, they don’t know exactly why and they’re not sure how this ends for them and they’re nervous.”

After an initial consultation, conservative treatment options are discussed at both practices. Because of the partnership and symbiosis of SOS and NYS&WC, providers can discuss all options from the musculoskeletal perspective to make people feel better. Between the two practices, services include: physical therapy, behavioral therapy, diagnostic and prescriptive services, electrodiagnostic lab, X-ray and MRI Imaging, and ultimately surgery if all conservative measures fail.

Conservative Approach to Spine Care

When pain is reported, figuring out where it hurts is the first step. “We are able to identify the source of the pain using technologies such as X-rays, MRIs and electrodiagnostics to narrow down the diagnosis,” said Dr. Albanese. New York Spine and Wellness Center has the only accredited electrodiagnostic lab in Central New York.

A conservative approach works best, especially with any spinal issue. “We always maximize non-surgical care first,” Dr. Warren Wulff, a spine surgeon with the SOS Neck and Back Team, said. “Only the smallest percentage of patients where that doesn’t work do we consider for surgery. In our toolbox of surgical procedures, we always select the least invasive way that works. We match the procedure to the problem, giving the best chance for a good outcome.”

Still, the first order of business is reducing the pain, and there’s the expertise of Dr. McConn and Dr. McGinn. “Surgery is never the first line treatment for pain unless the patient has neurological deficits.” Dr. McGinn said. “When pain is the issue, there are many interventions along the continuum of care before reaching the surgery option.” 

Some patients ask for a cortisone shot, thinking that will solve the problem. “But that injection is intended to be more of a bridge toward a faster recovery as the body heals and gets stronger with exercise,” Dr. McGinn added. “It’s supposed to allow for improved functionality and to get patients moving again above all. An injection is part of a multi-modal approach to recovery that can also include chiropractic care, acupuncture, physical therapy, and surgical intervention.”

Importance and Impact of Physical Therapy

Physical therapy is one of the most common treatment choices. “Motion is what makes people feel better, and we typically start treatment with PT,” Dr. Albanese said, “and having patients relearn how to move. They may have some mechanical dysfunction, so they work with the therapy team on strength and mobility.”

Physical therapy includes therapist-guided strengthening, stabilization, and stretching, re-training functional movements, hands-on joint and tissue mobilization, and patient education. At SOS, the therapists pride themselves on individualized, personalized care. SOS offers Orthopedic & Sports Therapy at 5 locations surrounding Central New York, as well as offering remote physical therapy (RTM). RTM is offered to patients living outside the area, to those with limited access to transportation, as well as to patients who prefer online care.

One of the greatest benefits of the Orthopedic & Sports Therapy department within SOS is the close relationship built with the physicians. This direct connection enhances communication amongst the entire care team to expedite patient recovery.

On average, SOS patients achieve superior outcomes with fewer visits and shorter treatment durations compared to national averages. This is consistently shown through the outcomes and patient satisfaction data measured by FOTO Inc. (Focus on Therapeutic Outcomes, Inc.). FOTO has 26 million patients, which is the largest database of outpatient orthopedic therapy patients to compare and the greatest participation by therapy providers.

Non-Operative Interventions 

If pain persists, other interventions remain, which is a huge benefit to starting with conservative treatments. “That’s where New York Spine & Wellness Comes in. They can prescribe medications that may be appropriate and perform minimally invasive procedures – options that are still non-surgical,” Dr. Albanese said.

“While we specialize in spine pain and back disorders, we treat all types of acute and chronic pain” said Dr. McGinn. “Some of our interventions can help patients avoid surgery by working through injuries and healing while others can be used as maintenance therapy for chronic arthritic or disc-based pain in the spine for which there is no real surgical option. Other procedures can involve temporary or permanent implants that can treat debilitating nerve pain that may be severely affecting quality of life. We also perform minimally invasive surgeries in patients with spinal stenosis who may be poor candidates for more invasive surgery due to their age or medical comorbidities.”

Surgical Innovation

“Given enough time and attention, many painful spinal conditions will resolve with non-surgical measures only.” shared Dr. Warren Wulff. In instances when surgical intervention is recommended, we use the latest technology and newest techniques such as neuromodulation and minimally invasive surgery at our orthopedic focused surgery center”.

Neuromodulation, through the use of a spinal cord stimulator, is a recent trend in pain management, and Wulff is expert in the procedure. The International Neuromodulation Society defines it as “the alteration of nerve activity through targeted delivery of a stimulus, such as electrical stimulation or chemical agents, to specific neurological sites in the body.” The goal is to re-establish normal function of the nervous system.

Neuromodulation itself is nothing new. Cardiologists have been using the technology for more than 90 years. “People whose hearts don’t beat regularly, most often get a pacemaker, which is a neuromodulator,” said Wulff. “Similar systems are being investigated to treat tremors, epilepsy, limb ischemia, obesity and eating disorders, and even depression—stimulating the brain with painless magnetic pulses.”

Again, that approach begins conservatively. “We can attach an external version of the neurostimulator for a week,” Wulff said. “If the patient has a good reaction, a permanent device is implanted. This is a 1-2 hour procedure that requires an overnight stay. The benefits can be lifelong.”

“These patients may have been highly medicated for years, taking higher doses of opioids with all the negative consequences,” Wulff continued. “Once you get patients off opioids, they feel better and think clearer. It also leads to reduced need for spinal procedures, and medications, which results in long term savings to the healthcare system.”

Reducing a patient’s pain is the ultimate goal, and both practices advocate for attempting the least invasive, most conservative treatments first. “With everybody being unique,” said Dr. McConn, “there is no one modality that is going to relieve symptoms long-term. It’s actually a combination of all these modalities. I tell patients I don’t know what’s going to work for you but we have the access to all options and we’re going to find a combination that’s going to make the pain more manageable and enhance your quality of life.”



The Importance of Culture in Health Care

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By: Kathy Ruscitto

A few months ago I had the opportunity to hear two physicians talk about their careers as they received recognition. Dr. Kara Kort, a surgeon, and Dr. James Tucker, a family physician.

Both are esteemed by their patients and colleagues. They are passionate about the profession they chose and the work they do as physicians and leaders in their disciplines.

As they spoke, the words, tone, and tears they shared all spoke to service to others. They chose medicine to help people.

In his remarks Dr. Tucker thanked to his patients for letting him be part of their villages, lives and families.

Dr. Kort talked about how being vulnerable in her own life experiences , enabled her to help patients at critical points in their lives.

Health professionals often choose their career to contribute to improving  the  health of others. Clinicians  value their  professional expertise, training, the ability to give their patients high quality care , and collegiality across a health care system.

The reality is they are facing complex systems that require automation, long hours to balance their complex demands, and frustrated patients with payer barriers. We knew we were going to face a large segment of retirements across physicians and nurses, COVID accelerated those trends. The current system feels broken to many clinicians and patients.

In an article in Medscape, Drs. Toprol, Verghese and Pearl discuss Physicians’ roles in accelerating  system changes to improve patient care. They all suggest some of the challenge is clinician resistance to letting go of old culture, and adopting new more efficient options like telemedicine. Changes that allow patient access and follow up during workforce shortages is better than delayed, or no care at all.

Other experts feel the most important investment we can  make is a shift away from fee for service care to value based care, aligning incentives around patient outcomes. 

While these examples may be part of structural system redesign, shared culture is equally important.

Medicine is a team sport. It requires collaboration across a spectrum of disciplines, workforces, and payers. We must listen and value the input of the health professionals if we are to rebuild our health systems culture and workforce to continue to provide high quality patient centered care. System redesign alone, in the absence of shared culture will not resolve our issues.

Right care, right time, right place, right cost is often included in marketing and headlines these days. The underlying assumption being we have a shared culture of achieving this care. 

As you plan retreats , strategy and future goal sessions, spend time discussing culture and clinician input into our future in health care. It is the most important thing we need to do to meet our challenges.

Resources:

Healing the Professional Culture of Medicine – Mayo Clinic Proceedings

To End Burnout, Doctors Must Change the Culture of Medicine

https://hbr.org/2022/09/5-steps-to-restore-trust-in-u-s-health-care

Change Healthcare Cyber Attack: Cybersecurity Lessons Learned

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With consequences and impact of Change Healthcare actively being determined, I wanted to share some insights below from our Cyber Team Leader Allen Blount

Change Healthcare’s recent cyber-attack sparked a crucial discussion on cybersecurity, business continuity, and contingent liability insurance within the healthcare sector. Cyber-attacks in healthcare have been increasing in severity, with far-reaching consequences for businesses, physicians, and insurers alike. Here are key observations and tips for protecting your organization.

Analyze the broad impacts of the Change Healthcare cyber attack

The Change Healthcare attack did more than compromise patient data. This breach halted operations and affected multiple sectors. It disrupted billing for physicians and pharmacies, threatening their financial stability. Three takeaways:

  1. The event highlighted the interconnected nature of our digital world, showing how finance, technology, and retail sectors are vulnerable, too. All organizations can gain insights from studying this cyber-attack.
  2. The situation demonstrated how third-party vendors can pose unintentional cyber risks. It’s worth taking a second look at your vendor cybersecurity. Could you benefit from additional technical and contractual safeguards?
  3. The Change Healthcare situation underscores the importance of strong business continuity planning (BCP). A swift, decisive response to a cyber-attack helps protect sensitive information, preserve customer trust, and maintain organizational resilience against catastrophic outcomes.

Assess vendor management and oversight

Effective vendor management involves assessing and mitigating risks throughout the vendor lifecycle, from selection and onboarding to continuous monitoring and management. Businesses need to:

  • Conduct thorough due diligence and risk assessments before engaging with any vendor to understand their cybersecurity posture and risk exposure.
  • Include specific cybersecurity requirements and obligations in vendor contracts. Ensure clear definitions of roles and responsibilities in the event of a data breach or cyber incident.
  • Implement continuous monitoring of vendor security practices. Evaluate compliance with contractual obligations to identify and address vulnerabilities promptly.
  • Ensure vendors have robust incident response plans that align with your organization’s response strategies. How will you coordinate efforts in the event of a cyber-attack?
  • Establish a comprehensive vendor risk management program that incorporates regular reviews, audits, and updates to security requirements based on evolving threats.

Revisit cyber liability insurance and business interruption coverage

The Change Healthcare cyber-attack illustrates the complexities of contingent business interruption claims, a major financial strain for affected parties. Cyber liability insurance policies differentiate between direct losses from cyber incidents and contingent business interruptions. This creates a maze of requirements for proving a claim.

The role of companies like Change Healthcare is under debate. Are they IT or data management suppliers within UnitedHealth Group? This distinction affects contingent business interruption claims directly. As a result, healthcare providers and other stakeholders face difficulties in securing timely reimbursements, complicating the recovery process.

Here are three tactical best practices to consider when navigating cyber liability insurance claims after a breach:

  • Keep detailed records of all disruptions and expenses incurred due to the cyber incident. Documentation is key in substantiating claims for lost income versus lost revenue and deciphering between direct and contingent business interruptions.
  • Review your cyber liability insurance policy thoroughly to understand the coverage scope, including breach response and contingent business interruption coverage. This understanding is key for identifying potential gaps and ensuring that claims fall within the policy’s parameters.
  • Engage with your insurance carrier early and maintain open lines of communication throughout the claims process. Providing updates and being responsive to inquiries can facilitate a smoother claims process and help in advocating for your coverage rights.

While there are nuances to each carrier’s standalone cyber coverage it is typically more robust than any throw in coverage you might have with your malpractice policy, so we do encourage you to review how you are covered.  

The contents of this article are for general informational purposes only and Risk Strategies Company makes no representation or warranty of any kind, express or implied, regarding the accuracy or completeness of any information contained herein. Any recommendations contained herein are intended to provide insight based on currently available information for consideration and should be vetted against applicable legal and business needs before application to a specific client. 

Understanding Fatty Liver Disease

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Nathan Hamm, DC, FNP-C.

In 2023 a group of over 200 physicians, public health experts, and industry leaders from around the globe voted to rename non-alcoholic fatty liver disease or NAFLD to metabolic dysfunction-associated steatotic liver disease or MASLD.  The goal was to update outdated nomenclature and better reflect the metabolic nature of the disease.  Experts hope that the rebrand will spark more conversation – and research interest – around these conditions that still lack treatment options.

Non-alcoholic steatohepatitis or NASH was coined in the 1980s and was meant to differentiate from fatty liver that was traditionally caused by excessive alcohol consumption. NAFLD and NASH are used interchangeably and over the past few decades several attempts were made to update the terminology unsuccessfully. But all that changed last year and NASH is now MASH, metabolic dysfunction associated steatohepatitis.

What is MASH?

MASLD or MASH is a form of liver disease caused by metabolic risk factors where excess fat accumulates in the liver and creates inflammation. When not diagnosed or left untreated it can lead to scarring and permanent liver damage. Common risk factors for MASH include: Obesity, type 2 diabetes, insulin resistance, high cholesterol or triglycerides, and high blood pressure.

Although only around 4.5 million adults in the U.S. have been diagnosed with some form of liver disease it’s estimated that up to 25% of the U.S. adult population could have MASH or some other type of liver condition and not even know it.  MASH affects nearly 12% of the global population and is most commonly seen in patients with obesity and type 2 diabetes. Survey data suggests that MASH is an underdiagnosed condition. Hopefully, the recent name change will help to increase public awareness.

In general, symptoms of liver disease are often vague or non-existent. Some symptoms of a fatty liver may include, excess weight around the midsection, right upper abdominal pain discomfort or fullness, gastrointestinal upset including nausea and/or bloating, and fatigue or weakness. Most people don’t have any symptoms and a diagnosis of MASH is often made due to abnormal liver function tests.

Velocity Clinical Research is proud to help develop innovative therapies that are designed to assist in the diagnosis, treatment and prevention of liver disease. Velocity uses FibroScan Technology to help detect and stage fatty liver disease for their patients. Excessive inflammation from MASH can cause fibrosis and scarring of the liver and these changes are measured on a scale of 0-4. The FibroScan is a non-invasive type of elastography that uses ultrasound technology to measure the stiffness(hardness) and fatty changes to the liver to help assist in the diagnosis of MASH.

Regarding treatment, weight loss and healthy lifestyle choices remain the cornerstone for the management of MASH. But earlier this year Madrigal Pharmaceuticals received FDA approval for Rezdiffra (resmetirom) as the first ever therapy for adults with MASH. Jeff McIntyre, vice president of Liver Health Programs at non-profit Global Liver Institute, said in a statement. “This approval gives patients and healthcare providers a long-awaited tool to change the trajectory of their chronic liver disease.”   

Velocity Clinical Research was part of the research that went into that approval. We worked with that study for about 2 years, screened over 65 patients and enrolled almost half of them. Currently we have other liver studies that are enrolling. Many people find joining a clinical trial to be a rewarding experience, especially when you see the therapy you help develop actually come to market. Velocity aims to be a resource in the community for medical decision making.

If you are interested in hearing more about clinical trials or what we have to offer please contact our office at 315-760-5905.

Healthcare Organizations Very Vulnerable to Cyberattacks

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By: William Ecenbarger

Like most other organizations, healthcare facilities have moved toward total digitization. The major benefit of this change is that it has provided an efficient way of sharing patient records among healthcare professionals. Compared to paper-based records, electronic health records require less workforce, time, and physical storage.

However, this shift has created a new and growing risk: cyber-attacks that are compromising patient information, delaying patient procedures and tests, and rerouting ambulances to alternative emergency rooms.

“The health care sector is experiencing a significant rise in cyberattacks, putting patient safety at risk,” warns Andrea Palm, deputy secretary of the U.S. Departent of Health and Human Services. “These attacks expose vulnerabilities in our health care system, degrade patient trust, and ultimately endanger patient safety.”

The HHS Office for Civil Rights said the medical information of some 88 million Americans was exposed in the first 10 months of 2023. HHS also reported a 93 percent increase in large, healthcare-related cyber breaches between 2018 and 2022.

Much of the official concern is focused on breaches of patient privacy.

Healthcare institutions are a gold mine for cyber attackers. They hold huge amounts of information on patients–not just medical records, but also financial information, Social Security numbers, names and addresses. Moreover, unlike most businesses, they are open all the time–meaning, as the Seattle Times pointed out in a recent article, “they might be more likely to prioritize avoiding disruptions and, therefore, more likely to pay a hacker’s ransom.”

Geetha Thamilarasu, an associate professor of computing and software systems at the University of Washington and a specialist in health care security, said patients’ health information is valuable to cyber-attackers, who can use stolen medical records to buy bogus prescriptions, sell identity information online and file fraudulent insurance claims.

“There is a huge underground market on the dark web,” Thamilarasu told the Seattle Times. “Research shows that if a compromised credit card sells for about $1 to $5 each, a compromised medical record can sell anywhere from $400 to $500 — sometimes even $1,000.”

Moreover, anyone concerned about stolen Social Security numbers can enroll in a credit-monitoring agency, but patients have little recourse if their personal health information is stolen.

There are often hundreds of Internet-connected devices in a hospital, each of which may require a different type of security. “While an X-ray machine itself might not carry any patient data, it can act as an entry point for attackers trying to break into an organization’s broader network,” Thamilarasu said.

The American Hospital Association recently warned: “Health care organizations are particularly vulnerable and targeted by cyberattacks because they possess so much information of high monetary and intelligence value to cyber thieves. The targeted data includes patients’ protected health information (PHI), financial information like credit card and bank account numbers, personally identifying information (PII) such as Social Security numbers, and intellectual property related to medical research and innovation.”

John Riggi, the AHA’s Senior Advisor for Cybersecurity and Risk, said hospitals and other healthcare organizations constantly face attacks that can put patient safety at risk. “That’s why I advise hospital senior leaders not to view cybersecurity as a purely technical issue falling solely under the domain of their IT departments. Rather, it’s critical to view cybersecurity as a patient safety, enterprise risk and strategic priority and instill it into the hospital’s existing enterprise, risk-management, governance and business-continuity framework.”

Riggi, a former FBI cybersecurity specialist, urges hospitals to adopt “a culture of cybersecurity” that would result in staff members seeing themselves as “proactive defenders of patients and their data.”

“The cyber bad guys spend every waking moment thinking about how to compromise your cybersecurity procedures and controls. The best defense begins with elevating the issue of cyber risk as an enterprise and strategic risk-management issue. If possible, you should also dedicate at least one person full time to lead the information security program, and prioritize that role so that he or she has sufficient authority, status and independence to be effective. Furthermore, you and your team should receive regular updates on your organization’s strategic cyber risk profile and whether adequate measures are dynamically being taken to mitigate the constantly evolving cyber risk.”  

According to the healthcare news publication HealthcareDive, cyber-attacks exposed 385 million patient records from 2010 to 2022. though individual patient records could be counted multiple times. The HIPAA Journal says the number of healthcare data breaches has been increasing over the past 14 years. In 2023, 5,887 data breaches of 500 or more records were reported to the federal officials. In 2023, more than 540 organizations reported healthcare data breaches to HHS, affecting more than 112 million people.

Riggi said hospitals have been working to put in place better safeguards and more backup systems to prevent such attacks and respond to them when they occur. But he said it is almost impossible to make them completely safe, especially because the systems need to rely on Internet and network-connected technologies to share patient information among clinicians involved in a patient’s care. “Overall, that’s a good thing,” he said. “But it also expands our digital attack surface.”

The HHS recently released a cybersecurity strategy for the healthcare sector that includes these actions:

 –Publish voluntary healthcare sector cybersecurity performance goals to “help healthcare institutions plan and prioritize implementation of high-impact cybersecurity practices.”

 –Provide resources to “incentivize and implement cybersecurity practices.” HHS said it would work with Congress to obtain new authority and funding to administer financial support and incentives for domestic hospitals to implement high-impact cybersecurity practices.

–Implement an HHS-wide strategy to support greater enforcement and accountability. HHS will propose new enforceable cybersecurity standards.

–Expand and mature the one-stop shop within HHS for healthcare sector cybersecurity. This will “deepen HHS and the Federal government’s partnership with industry, improve access and uptake of government support and services, and increase HHS’s incident response capabilities.”

The AHA’s Riggi offered his expertise. “I am available to assist your organization in uncovering strategic cyber risk and vulnerabilities by conducting an in-depth cyber-risk profile, and by providing other cybersecurity advisory services such as risk mitigation strategies; incident response planning; vendor risk management review; and customized education, training and cyber incident exercises for executives and boards. Please contact me for more information at 202-626-2272 or jriggi@aha.org.

New TB Vaccine A Strong Possibility

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by William Ecenbarger

Tuberculosis is the 13th leading cause of death in the world and its second worst infectious killer. Only COVID 19 claimed more lives, and there were fewer deaths from HIV and AIDS. According to the World Health Organization (WHO), 10.6 million people fell ill with TB in 2021, and 1.6 million of them died. The WHO estimates that one in every four people in the world has latent TB, meaning they are infected with bacterium that causes TB. Up to 10 percent of them will develop TB.

Despite these numbers, the only TB vaccine in use today was developed in 1921 and is only moderately effective.

But a new TB vaccine, called M72, is now on the horizon. A trial is being backed by the Gates Foundation ($400 million) and the United Kingdom’s Wellcome Trust ($150 million). The trial, at sites in Africa and Asia, will take between four and six years.

The M72 vaccine was initially developed some 20 years ago by the British firm GSK (formerly GlaxoSmithKline), but GSK abandoned it in 20l9 because the company believed it lacked economic return.

But in the GSK trials, the shot showed a 54 percent efficacy in reducing pulmonary TB. Maziar Divangahi, associate director of the McGill International TB Centre, said this was “really a big deal.” He went on to note that the WHO concludes that over 25 years, a vaccine with at least 50 percent efficacy could prevent up to 76 million new TB cases and 8.5 million deaths, avert the need for 42 million courses of antibiotic treatment, and prevent US$41.5 billion in TB related catastrophic household costs, especially for the world’s poorest and most vulnerable people.

Julia Gillard, chair of the Board of Governors at Wellcome, concurred. “The development of an affordable, accessible vaccine for adults and adolescents would be game-changing in turning the tide against TB. Philanthropy can be a catalyst to drive progress, as shown by this funding of the M72 vaccine as a potential new tool in preventing escalating infectious diseases to protect those most affected. Sustainable progress against TB and wider disease threats will depend on global collaboration, financial backing, and political will. By working with communities and researchers in countries with a high burden of the disease, we can get one step closer to eliminating TB as a public health threat.”

WHO Director-General Dr. Tedros Adhanom Ghebreyesus said the support by the Gates Foundation and Wellcome to develop a new TB vaccine shows the world can turn the tide on the TB crisis through sustained political and financial action.

Although TB occurs in every part of the world, the WHO says over 80 percent of TB cases and deaths are in low- and middle-income countries. Indeed, more than two thirds of the global total occurs in eight nations–Bangladesh, China, the Democratic Republic of the Congo, India, Indonesia, Nigeria, Pakistan, and the Philippines.

Lippes Mathias LLP Combines With Syracuse-Based Health Care Firm CCB Law

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Lippes Mathias LLP Combines with Syracuse-Based Health Care Firm CCBLaw, Expands  Lippes’ National Footprint to Include Every Major City in New York The combination creates one of the largest New York health care teams outside of New York City.

Lippes Mathias today announced it has combined with CCBLaw, a Syracusebased law firm with a respected national reputation for providing innovative legal services to clients in the areas of health care, business, labor and employment and real estate. Eleven attorneys, with two set to be admitted on June 17, as well as eight staff members, will join Lippes Mathias as part of the move.

With this combination, Lippes Mathias now has 197 total attorneys with 158 staff and 15 offices across the country.

“When we execute our growth vision, we continue to emphasize the right cultural synergies, and the match with CCBLaw is no exception,” Kevin J. Cross, Lippes Mathias’ managing partner and chairman, said. “The new Lippes attorneys bring exceptional experience and capabilities that pair perfectly with our health care team creating one of the largest health care practices outside of New York City. I’m proud to note that this expansion also marks a significant milestone in Lippes Mathias’ growth story as our national footprint of 15 locations now reaches every major New York market.”

CCBLaw, one of only two Central New York law firms ranked Metro Tier I in health care law by Best Law Firms, provides legal and consulting services to health care clients, including group medical practices, private practice physicians, dentists, and allied health professionals, hospitals, ACOs, physician organizations, independent practice associations, ambulatory surgery centers, and other facilities throughout the United States.

“This is the right move at the right time, compounding value and opportunity for both groups,” Michael J. Compagni, former CCBLaw managing member and new Syracuse office leader, said. “Our entire team is excited to join Lippes Mathias—well-known and regarded for its people-first approach to the business of law. Lippes’ emphasis on culture creates an environment where attorneys and staff thrive. We’re thrilled to be a part of a growing firm that is doing it differently.”

Marc S. Beckman, a founding member of CCBLaw, will co lead Lippes Mathias’ health care practice team alongside Brigid M. Maloney, partner, Lippes Mathias.

“Since we have been representing so many practices with respect to private equity backed transactions in the health care field, we wanted to align ourselves with a firm such as Lippes that will benefit our clients by allowing us to bring greater breadth and depth to our team,” Beckman said. “Our footprint has always been larger than Central New York, and together with the diverse practice areas, resources, infrastructure, and geographical footprint of Lippes, this mutually beneficial integration allows us to provide a broader scope of legal services to our clients long into the future.”

Former CCBLaw attorneys are nationally recognized for their extensive background in complex federal regulatory and statutory issues, including the federal physician self-referral prohibition or Stark regulations, fraud and abuse and anti-kickback laws, professional license defense as well as compliance and repayment actions involving both entitlement programs and third-party payors. The team regularly handles mergers and acquisitions of professional practices, establishment of ambulatory surgical centers, development of joint ventures among healthcare providers (including both private practices and hospital systems), development and maintenance of large group practices, space sharing arrangements, employment matters including litigation and employee leases, professional services agreements, exclusive provider agreements, and telehealth arrangements. On numerous occasions, the team has successfully defended clients in government and third-party payor audits and investigations and in settlement negotiations of reimbursement issues with Medicare, Medicaid, TRICARE, and all other third-party payors.

Former CCBLaw attorneys and staff will continue to work out of their office space at 507 Plum St. in Syracuse. For more information about the combination or to learn more about Lippes Mathias’ health care services, call (716) 853-5100 or visit lippes.com

About Lippes Mathias LLP
Lippes Mathias is a full-service law firm with nearly 200 attorneys serving clients regionally, nationally, and internationally. With offices in Buffalo, Clarence, Albany, Long Island, New York, Rochester, Saratoga Springs and Syracuse, N.Y.; Greater Toronto Area; Chicago, Ill.; Jacksonville, Fla.; Cleveland, Ohio; San Antonio, Texas; Oklahoma City, Okla. and Washington, D.C., the firm represents publicly and privately owned companies, private equity and venture capital firms, real estate developers, financial institutions, municipalities, governmental entities, and individuals.