PATIENT PERSPECTIVE

The Impact of COVID on People with Disabilities

A need for proactive planning

BY JOAN WILSHIRE, MPA

People with disabilities, or who have chronic medical conditions, or both, have faced increased and not surprisingly undocumented hardships during the COVID pandemic. Fear and uncertainty are two words that may best describe the feelings it has caused in many people among the disability community. Even though we see the death rates going down and mask mandates being eliminated by most states, the pandemic has not ended yet. The fear and uncertainty leads to further isolation for many in this community. This continued isolation may result in people with disabilities becoming more disabled. In all honesty, a secret killer of this pandemic could well be the isolation of people with disabilities.

The fear is real

Even with vaccinations, booster shots and new antivirals coming out there is still much fear within the disability community. It’s an invisible threat, since we don’t know who is infected or who is contagious. We don’t know how the COVID infection will affect us, or how long it will last. People with disabilities have been hiding for the last two years; it’s like playing a game of hide and seek with the coronavirus. As the isolation continues, it is not surprising for people with disabilities and/or with chronic medical conditions to fear being left behind. Historically, people with disabilities have been left behind during natural disasters like floods, tornadoes, hurricanes and pandemics. They have come to expect it.

A prime example of being left behind is the vaccination priority guideline developed last year. People with disabilities who have chronic medical conditions were not necessarily high on the list because priorities were based on age. The vaccination priorities seemed to say that people with disabilities were an afterthought and nobody ever wants to be an afterthought. You can really see what it is like to be an afterthought when there’s been little consideration for you, there’s no protocol for you and no way for you to have a voice in the process either. I was not eligible to get my first vaccination shot until April 1. In the room where I sat waiting for the injection, several people were using oxygen, some were in power wheelchairs and others were using canes or walkers. Why weren’t all of us on the priority list?

At the beginning of the pandemic, people with disabilities worried “would my life as a person with a disability be deemed valuable enough to live” if there is a shortage of resources? Some people with disabilities are dependent on ventilators to live. If ventilators are scarce, are we going to have to give up a ventilator to provide for COVID ICUs? People with disabilities and chronic medical conditions, are affected in many additional ways, such as restricted breathing and speech, when complying with mask requirements. Virtual doctor visits might not be appropriate but health care centers and clinics were closed to in-person visits, accessible transportation was limited by driver shortages, and many COVID testing sites had limited accessibility.

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www.mppub.com Proactive planning

The biggest issue I’ve seen during the pandemic is the lack of proactive planning by the medical community for people with disabilities. People with disabilities who also have chronic medical conditions and test positive for COVID, need to have a proactive plan set up by their physicians because they are at higher risk. Having a plan gives the person some sense of control and protection if diagnosed with COVID. I was fortunate in that my infectious disease physician created a plan for me around what to do if I were to test positive for COVID. I immediately will contact her office to have a prescription for one of the antiviral medications sent to me. The plan gives me a little peace of mind in that at least there has been a discussion of what I need to do in this scenario. Trust me, when I enter a hospital with my variety of medical issues I present a challenge to figure out what should be done immediately.

Another big concern is not being allowed to have anyone with me to advocate for my treatment plan. The physician’s plan should be available and implemented immediately. I have been living with MS for many decades. I always have been careful during flu season to avoid the latest influenza and I have been pretty lucky avoiding COVID. I order my groceries, clothes and other household necessities on line. I have had virtual doctor appointments

but there are a few doctor appointments require in-person visits to receive the necessary medical care.

Going above and beyond

During the peak COVID surge I had a variety of medical experiences where physicians and nurses certainly went above and beyond routine care to keep me as healthy and safe as possible. In the last two years I’ve had several doctor appointments in my car, literally. You could call them drive-up or drive-by appointments. I’ve had a nurse come out to my car to get the urine specimen container to take up to the lab and I’ve also had the nurses come to my car to monitor an implanted device. The best example is the biopsy I had in my car last year. I have had a history of squamous cell skin cancer and I had a suspicious spot on my hand. I contacted the doctor and she said, “I do not want you to come in the clinic. I will come to your car and do the biopsy.” That is exactly what she did. And yes, it was cancer, so I am grateful we were able to do this immediately rather than waiting. I collaborate with all of my physicians on an ongoing basis to keep myself safe from COVID while managing healthcare needs that can not be put on hold.

I have a sister with an auto immune disease for which she takes a new medication that lowers her body’s ability to develop antibodies. So even though she’s vaccinated and boosted, she does not have enough of the antibodies to protect against COVID. I have not seen her in two years because she has been

homebound. Her game of hide and seek is still very real. COVID has definitely made a negative impact our relationship. Her medical professional created a plan for her that includes taking a newly approved drug that will help her body build antibodies. Now she feels like there is a light at the end of the tunnel. I have a friend with many autoimmune conditions, type I diabetes being the most serious. She does a great job of taking care of herself, as her diabetes is very much uncontrolled. She knows Continued isolation may result in people with disabilities that a COVID infection could be very serious for her and poses an elevated risk of death. She has becoming more disabled. not gone anywhere in the past two years other than 7 a.m. trips to the grocery store. Right before COVID hit she bought a retirement home in Phoenix, Arizona. Unfortunately, she hasn’t even traveled for a short visit because she just doesn’t feel safe flying. She is concerned that as new treatments are developed, as in the earlier vaccine priorities, they won’t be readily available to help people like her. People with disabilities followed the age requirements and those who have chronic medical conditions were not allowed a higher priority to receive vaccinations. When I told her that I had a plan with one of my physicians, she said, “ That is exactly what I need. A plan would me feel like I have options in place to protect myself from COVID.” Another friend, who is mildly affected The Impact of COVID on People With Disabilities to page 304

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The Telephone Equipment Distribution Program is funded through the Department of Commerce – Telecommunications Access Minnesota (TAM) and administered by the Minnesota Department of Human Services.

3COVID-19 Litigation from page 13

A “qualified person” includes a licensed health professional or other individual authorized to prescribe, administer or dispense covered countermeasures under the law of the state in which the covered countermeasure was prescribed, administered or dispensed. Additional entities would fall under a “Covered Person”, as the Act defines a person as “an individual, partnership, corporation, association, entity or public or private corporation, including a federal, state or local government agency or department.”

Covered Countermeasures

A “Covered Countermeasure”, as it relates to this declaration, must be a “qualified pandemic or epidemic product,” a “security countermeasure” or a drug, biological product or device authorized for emergency use.

As is relevant to this analysis, based upon the claims we are seeing now and anticipate later, “a qualified pandemic or epidemic product” includes any drug or device specifically manufactured, used or designed to treat or cure a pandemic/epidemic or to limit the harm the same would otherwise cause. This would also include any drug or device used to treat a serious or life-threatening disease or condition caused by or intended to enhance the efficacy of a drug, biological product or device.

Note that a Covered Countermeasure must be approved or cleared by the Food, Drug and Cosmetics (FD&C) Act, licensed under the Public Health Services Act or authorized for emergency use under the FD&C. We have already seen this in the context of PPE, respiratory devices and the three available vaccines in the United States.

A product may also qualify as a Covered Countermeasure if it is permitted to be used under an Investigational Drug Application or an Investigational Device Exemption defined by the FD&C. Drugs/devices in this category are those that are presently the focus of research conducted to prevent COVID-19. To this end, a provider will likely have to seek approval prior to administration of investigational countermeasures, e.g., COVID-19 vaccines.

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AUGUST 2018

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THE INDEPENDENT MEDICAL BUSINESS JOURNAL Volume XXXII, No. 05

Physician/employer direct contracting

Exploring new potential

BY MICK HANNAFIN

With the continuing escalation of health care costs, large and midsized selfinsured employers are once again looking for an edge to manage their medical plan costs and their bottom line. They understand that they are ultimately funding health care as they pay for their population’s claims.

Many of these employers have employed the same overarching set of strategies: shop for a new carrier that is willing to lower the administrative costs or underprice the risk,

Physician/employer direct contracting to page 124 CAR T-cell therapy

Modifying cells to fight cancer

BY VERONIKA BACHANOVA, MD, PHD

University of Minnesota Health is now among the few selected centers in the nation to offer two new immunotherapy drugs for the treatment of diffuse large B-cell lymphoma. Both drugs—Yescarta and Kymriah—are part of an emerging class of treatments, called CAR T-cell therapies, that harness the power of a patient’s own immune system to eliminate cancer cells.

CAR T-cell therapy involves drawing blood from patients and separating out the T cells. Using a disarmed virus, the patient’s own T cells are genetically engineered to produce chimeric antigen receptors, or CARs, that allow them to recognize and attach to a specific protein, or antigen, on tumor cells. This process takes place in a laboratory and takes about 14 days. After receiving the modification, the engineered CAR-T cells are infused into the patient, where they recognize and attack cancer cells. Kymriah received initial FDA approval in 2017 for the treatment of pediatric acute lymphoblastic leukemia.

CAR T-cell therapy to page 144

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Recommended activities

“Recommended Activities” are those authorized in accordance with the public health and medical response of the federal, state or local authorities to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a declaration of an emergency.

“Administration” is not defined by the Act but has been defined by the Secretary as: physical provision of the countermeasures to recipients or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients; management and operation of countermeasure programs; or management and operation of locations for purposes of distributing and dispensing countermeasures.

Examples of “Administration” provided in the declaration include: physically providing a vaccine or handing drugs to a patient; decisions or actions involving security and queuing as they relate to countermeasure activities.

Courts must dismiss claims brought against covered entities for any loss relating to “any stage of design, development, testing, manufacture, labeling, distribution, formulation, labeling, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing or use of a countermeasure.”

The act also expressly preempts any state law that “is different from, or is in conflict with, any requirement” established regarding the covered countermeasures. The Declaration states that it is the specific intent of the Secretary to preclude liability claims such as allegations of negligence by a manufacturer in creating a vaccine or negligence by a healthcare provider in prescribing the wrong dose.

The Declaration goes as far to state that liability claims such as slip-andfall injuries or vehicle collision by a recipient receiving a countermeasure at a retail store serving as an administration or dispensing location are precluded as they would relate to the management and operation of a countermeasure distribution program or site. However, if the claim is not directly related to a countermeasure activity, which we anticipate will be a point of dispute in any future litigation, no immunity would apply.

Causal nexus to a covered countermeasure

As with any negligence claim, there must be a causal link between the “covered countermeasure,” the “recommended activity” and the injury at issue.

The most basic example of this would be someone suffering a bodily injury from a COVID-19 vaccine or from complications of COVID-19 treatments. Based upon guidance provided by HHS, immunity would extend to the decision-making process for purposes of allocating and administering PPE in the context of an infection control program. We see the latter arise when there are claims that a patient/resident contracted COVID-19 within a facility during the height of the pandemic when there were PPE shortages.

As with each aspect of PREP immunity, a determination should be made at the earliest stages of litigation as to whether there is a causal relationship between the loss asserted and the covered countermeasures being used or

administered. In some circumstances, this may require additional information and potentially limited discovery for purposes of asserting suit immunity.

Exceptions and remedies for the injured

The declaration notes that individuals who sustain a “serious injury” or die as a result of the administration of a Covered Countermeasure are eligible to receive benefits from the Countermeasures Injury Compensation Program (CICP). In order to obtain these benefits, the individual is required to show “direct causation” between the Covered Countermeasure and a serious physical injury with compelling, reliable, valid, medical and scientific evidence.”

Notably, the immunity conveyed under the Act and which has been preserved pursuant to the COVID-19 declaration does not extend to “willful conduct”. Willful conduct is defined as an act or omission that is taken intentionally to achieve a wrongful purpose; knowingly without legal or factual justification; and in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit. In these instances, the Act designates the Federal District Court for the District of Columbia as the proper venue for these claims to be heard.

State-based immunity and defenses available

At the time this article is being written, 38 states have passed some executive or legislative action providing defendants with immunity or an affirmative defense to liability; some have already expired, but should be applicable for specific timeframes. Although each state will be different, there are some common features to look for:

• When is the immunity/defense effective? Generally, the provisions will be effective as of the date of the local emergency declaration. • What does it apply to? Does it apply to direct COVID-19 treatment or preventative measures taken? • Is the immunity/defense conditional to compliance with state or federal guidance? Often the provision will not address the impact of different or conflicting guidance. It will also not distinguish between “strict” or “substantial” compliance. These are likely where the applicability issues will be litigated. • Who does the immunity/defense apply to? Is it “health care providers” or “health care facilities”? How are these terms defined and distinguished within the provisions?

Nearly all of the state immunity provisions will provide exceptions for “gross negligence” or “recklessness.”

As anticipated, plaintiffs have attempted to circumvent the immunities and defenses provided and attempt to couch their claims as non-COVID related. Be aware of this tactic, but do not be afraid to assert the defenses available at the earliest stage in litigation.

Attorneys who are experienced in defending COVID-19 litigation will likely have pleadings, discovery and briefs that may be applicable to the claim. They will also be more educated in federal/state-specific immunities and can provide an efficient and cost-effective claims investigation process.

Sandra M. Cianflone, J.D. is an attorney with Hall Booth Smith, P.C. which specializes in health care law.

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3Moving Medical Education Beyond the Classroom from page 9

What changes in how you can provide care have the recent extensive expansion of the hospital made for your patients?

Several years ago, we built our beautiful Clinic and Specialty Center (CSC) in downtown Minneapolis. It has allowed to us centralize our primary care and subspeciality clinics into one downtown setting. In addition to the primary care clinics located throughout the metro, has helped us provide better access to residents of Hennepin County. The CSC incorporates many local artists’ work and has an abundance of natural light; it feels like a healing environment right when you enter. The onsite parking, new operating rooms and bigger clinic spaces allow for a better experience for our patients.

The pandemic has stretched the concept of physician burnout well beyond what was already a significant issue. What are some of the ways you are addressing these concerns?

Physician burnout is definitely impacting our physicians, our residents and even our medical students like never before. Research has shown that psychological wellbeing connects to several pillars including autonomy, competence and relatedness. Medicine is no different. Medicine has pushed productivity—the movement to see more patients in less time. This has made patient care more of a transaction than a connection. The pandemic added new challenges: exhausting work, the lack of a playbook and available treatments, coupled with a feeling of powerlessness both in treating patients with infection and watching others unable to access their primary care, necessary procedures and critical addiction and mental health support. Our mitigating interventions have centered around building back autonomy in clinical schedules and work, offering easy access to mental health services and fostering onsite connectedness and belonging.

HCMC has many unique partnerships with both large and small organizations providing health care. What can you tell us about some of these and what future partnerships may be in store?

Our community partnerships are critical to our mission, our success and ability to transform healthcare in ways that benefit our patients well into the future. One of the exciting directions I see is related to our commitment to diversity and inclusion at Hennepin. Our Chief Equity Officer, Dr. Nneka Sederstrom, has helped to build a pathway that introduces high school students of color to health care professions and professionals at Hennepin. We are also building business relationships with minority businesses in the community. We all do better when working together.

Meghan Walsh, MD MPH FACP is the chief academic officer at Hennepin Healthcare, the associate dean for affiliate hospitals, and an associate professor of internal medicine at the University of Minnesota School of Medicine. She has worked as a hospitalist for over 15 years.

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3Co-opetition from page 11

Takeaways

There are several benefits to co-opetition, and in health care the most important one is improved patient outcomes. These may manifest in many ways, including increased access to care, whether geographically or through more affordable care. Co-opetition does not preclude continued competition, but it implies sharing strengths. It can allow smaller organizations to compete with larger ones by sharing workloads or workforces. Another benefit can come through increased marketplace penetration through both reaching new patients and improving the standards of care. As the pace of innovation in health care technology expands exponentially, co-opetition can provide a basis for developing and incorporating best practices around change management.

As the costs of health care continue to rise, the current health care delivery system will be forced to find new ways to operate; expanding the role of co-opetition will be part of this. We are seeing exciting examples in new medical facilities construction. Health care workforce shortage issues are at a serious tipping point and it may be through co-opetition that some solutions to these problems arise.

Recently, health plans in Minnesota, which compete fiercely between themselves for market share, came together to share resources around the

topic of COVID vaccine health disparity issues. Working with the MN Department of Health, they found remarkable success. This work could translate to address other issues, such as disparities in behavioral health access, but it could also expand and redefine co-opetition in new ways. Innovations in reimbursement, providing incentives to address work force shortages, might be an example. While co-opetition might be a consideration for your organization as you think about future strategies, it is a mindset you have to embrace as The term co-opetition probably well. Competition does not have to be the evil does not resonate in the that is often warded off by counter moves, it can be vocabularies of most mutual gain for all, especially the consumer who health care leaders. has more of a final say. David J. Voller, MBA, FACHE is currently the Clinic Administrator at Shriners Children’s Twin Cities. His 30 year career has all been in healthcare and health care related services which includes, Mayo Clinic, Gillette Children’s and BWBR. David is a Fellow of the American College of Healthcare Executives, sits on the board of ACHE MN and Chair for Membership and Advancement. He has been published and sat on numerous panels addressing the advancement of health care delivery and services helping to transform the industry to better serve the needs of the consumer.

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3The Impact of COVID on People With Disabilities from page 25

by Cerebral Palsy was sick with COVID last fall. He told me about feeling extremely fatigued and losing his senses of taste and smell. He just didn’t want to eat and had to remind himself to continue to keep his nutrition intake going or he would be too weak to even try to do anything for himself. I asked him if he called his doctor and he said that he did not. He was surprised that the COVID infection made his Cerebral Palsy symptoms, especially spasticity, worse. There hasn’t been enough conversation regarding additional challenges people with disabilities face when they get COVID. Talking to a medical provider could help them plan for possible effects that are specific to their personal medical needs. We need physicians to help guide some of this discussion. No assumption should be made that they have accessible transportation to clinics, that they have adequate personal care assistance or have access to over-the-counter medicines to combat COVID side effects.

Moving forward

Now that more and more states and cities are lifting the mask mandate, individuals with no underlying medical conditions are ecstatic to have their faces uncovered. But people with disabilities who have chronic medical conditions look at this as an ongoing time of uncertainty. During the pandemic there have been many challenges for everyone, but even more so for people with disabilities. These challenges may include the inability to wear a mask or lack of communication tools and barriers to visiting health centers for COVID testing or vaccinations. Trying to figure out accessible transportation to a medical clinic or hospital has been more difficult because of COVID restrictions.

The good news is we are moving into the next phase of the pandemic where we will continue to see fewer cases. However the pandemic isn’t over yet which means the fear and uncertainty will persist among people with disabilities. We will all need to continue to be safe and to partner with our providers in ways that consider more specialized health care needs.

Joan Wilshire, MPA, is a disability inclusion specialist and president of Wilshire Consulting LLC. Prior to this she served for 15 years as executive director of the Minnesota Council on Disability.

Assessing the Negative Impact

The National Council on Disability (NCD) recently issued a report that examines COVID-19’s disproportionate negative impact on people with disabilities across seven critical areas releasing findings and recommendations. For decades, federal and state healthcare data collection practices failed to capture baseline information about the functional disability status. This data dearth created barriers in collecting real-time accurate data about the impact of COVID-19 on people with disabilities and the healthcare disparities they experienced.

Findings COVID-19 exacted a steep toll on people with disabilities, posing unique problems and barriers. People with intellectual or developmental disabilities, and medically fragile and technology dependent individuals, faced a high risk of being triaged out of COVID-19 treatment; were denied the use of their personal ventilator devices after admission to a hospital; and at times, were denied the assistance of critical support persons during hospital stays. Informal and formal Crisis Standards of Care (CSC) targeted people with certain disabilities for denial of care.

Limited opportunities to transition out of congregate settings to communitybased settings revealed continuing weaknesses and lack of sufficient Medicaid Home and Community-Based Services (HCBS). People with disabilities and chronic conditions who were at particularly high risk of infection with, or severe consequences from the virus, were not recognized as a priority population by many states when vaccines received emergency use authorization. Both youth and adults who had mental health disabilities that predated the beginning of the pandemic experienced measurable deterioration over its course, made worse by a preexisting shortage of community treatment options, effective peer support, and suicide prevention support.

Recommendations Include

Healthcare Congress or the Department of Health and Human Services (HHS) should require all hospitals and managed care plans that receive federal financial assistance to increase public transparency of, and nondiscrimination and due process within, crisis standard of care (CSC) guidelines and medical rationing policies adopted during public health emergencies and emergency surge situations. HHS’ Office for Civil Rights (HHS OCR) should develop a Patient’s Bill of Rights for People with Disabilities. Congregate Care Facilities Appropriate government agencies should develop and implement a strategy to mitigate the risks of infectious disease transmission in CCFs and address the civil rights concerns that impact the lives of people with disabilities in CCFs. Centers for Disease Control and Prevention (CDC) should emphasize CCF census reduction as an infection control strategy by expanding its guidance beyond long-term care facilities (LTCFs) to include all CCFs and emphasize that reducing the census of CCFs through accelerating discharges and diversions is a critical strategy.

Education Congress should enact measures that include funds dedicated to compensatory education for students with disabilities who could not receive necessary services and supports during the pandemic and who have experienced disruption and regression in their behavioral and educational goals.

Employment The Office of Personnel Management (OPM) should maintain maximum telework flexibility for all federal agencies on a permanent basis and ensure that federal employees with disabilities receive necessary, reasonable accommodations in their technology while working remotely and retain flexibility to work from their designated federal office as needed or desired.

Effective Communication All federal entities involved in public health, emergency management, and the provision of public announcements or briefings of broad public importance should prepare and disseminate information related to any pandemic or public health emergency in accessible formats, including providing sign language interpretation and/or captions during live and prerecorded video briefings; making all written materials available in alternative formats; and making all online materials accessible.

Mental Health and Suicide Prevention States should expand the mental health workforce and peer support workforce, including through using HCBS dollars and mobile crisis dollars available through the American Rescue Plan and Certified Community Behavioral Health Center (CCBHC) funds. To access the full report please visit: https://ncd.gov/progress report/2021/2021-progress-report