The primary threat government and public health officials must immediately confront is the potential overcrowding of hospital emergency rooms, urgent care facilities, and clinics. Adopting telehealth solutions now will help mitigate overloading the system by allowing healthcare professionals to assess low-risk individuals with disease exposure concerns and provide remote guidance lessening the need for in-person visits.

In response to the coronavirus pandemic, the Centers for Medicare & Medicaid Services (CMS) issued sweeping new regulatory changes to mitigate the strain on the healthcare system. In its March 30 announcement, CMS further expanded reimbursement for telehealth services to Medicare beneficiaries adding 80 additional services to be covered. This action followed the March 17 CMS announcement which expanded telehealth coverage in response to the pandemic.

With the high risk of transmission of the coronavirus, many patients are refraining from making routine chronic health care visits. However, for the more than 100 million Americans with chronic health conditions, this is not an option. For this population, telemedicine is an essential resource to address their ongoing needs while reducing in-person clinic visits.

“These changes allow seniors to communicate with their doctors without having to travel to a healthcare facility so that they can limit risk of exposure and spread of this virus. Clinicians on the frontlines will now have greater flexibility to safely treat our beneficiaries,” said CMS Administrator Seema Verma.

Chronic care management services can be offered via telemedicine to optimize the care of these patients with chronic conditions, address the reduction of human exposures (among healthcare workers and patients), and ensure that finite medical services on the front lines are reserved for patients who need them most.

With a growing array of cloud-based telehealth platforms, physicians can continue treating patients with adhering to social distancing guidelines. For medical practices and systems that have not yet embraced telemedicine, this is a critical moment to adopt telehealth solutions and begin providing a functional service that could eventually grow the practice. As more people use live video chat platforms like Zoom, Facetime and Skype, patients will be more receptive to telemedicine.

Given that telemedicine is poised to address several unique challenges posed by the COVID-19 outbreak, the CDC, state public health agencies and numerous industry associations have all indicated that telehealth solutions need to be considered a part of healthcare provider coronavirus response systems. For healthcare providers who have not yet adopted telemedicine capabilities, now is the time to consider partnering with third-party healthcare technology service providers who can help implement telehealth solutions today and ensure patients continue to receive quality care as we all adapt to the changing healthcare landscape ahead of us.

Would you like to see a demonstration of PharmD Live®’s Chronic Care Management tool? We can easily show you a remote demo of how our board-certified pharmacists and SaaS software can help you better care for your patients and increase your Medicare reimbursement and Quality Incentive Payments.

Contact PharmDLive

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Most patients infected with COVID-19 are asymptomatic or suffer a mild or uncomplicated illness, but approximately 15% of patients develop severe disease requiring hospitalization, oxygen support, or intensive care unit (ICU) admission due to complications like acute respiratory disease syndrome (ARDS), septic shock, multiorgan failure, etc. Possible risk factors for progressing to severe illness may include but are not limited to older age and underlying chronic medical conditions such as lung disease, cardiovascular diseases, diabetes, immunocompromising conditions, etc.

Currently, only hydroxychloroquine and chloroquine have been given emergency, experimental approval by the U.S. Food and Drug Administration (FDA) to prevent or treat patients with COVID-19, so treatment has been largely around symptom management with analgesics, antipyretics, antitussives, fluids, and rest in mild-moderate cases, or supportive management of severe complications.

Researchers all around the world are racing towards finding an effective vaccine and treatments to combat the novel coronavirus while new case counts skyrocket globally as the days unfold. Since halting this disease will require a combination of preventative and treatment approaches, several clinical trials are underway including a multi-country mega clinical trial recently launched by the World Health Organization (WHO), which will focus on the four most promising therapies.

These studies are looking at either the repurposing of readily available safe drugs approved for other diseases or exploring unapproved drug compounds which have shown promising results in animal studies with the other strains of coronaviruses, which cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). A registry of international clinical trials can be found on the WHO website and at clinicaltrials.gov. Here is a listing of the investigational therapies researchers are zeroing in on:

Remdesivir: Nucleoside analogue

Mechanism of Action: Blocks RNA polymerase needed by coronaviruses and related RNA viruses genome replication and proliferation in the host body

Dose: 200 mg intravenously on day 1, followed by 100 mg once-daily for the duration of the hospitalization up to a 10 days total course

Side Effects: Nausea, vomiting, LFT elevations, headaches

Tested in patients with: Mild to severe COVID-19 on a compassionate use basis

Note: Access paused by manufacturer due to overwhelming demand with the exceptions for patients with severe illness and pregnant women and children with confirmed infection

Clinical Impact on COVID-19: unknown

Timeline: First data could become available in April 2023

Chloroquine OR Hydroxychloroquine (relatively more potent antiviral activity against SARS-CoV-2): Heme polymerase inhibitors

Mechanism of Action: Interferes with the SARS-CoV-2 virus cell entry, receptor glycosylation and replication by increasing endosomal pH. Significant decrease in detectable concentrations of SARS-CoV-2.

Dose: Hydroxychloroquine – 400 mg two times daily x2 followed by 400 mg daily while hospitalized, up to 5 days. Chloroquine phosphate – 500 mg two times daily for up to 10 days.

Side Effects: QT prolongation, nausea, vomiting, diarrhea, visual changes, cardiovascular collapse, respiratory arrest.

Note: Check ECG prior to initiation given risk of QT prolongation. Increased risk in patients on other QT-prolonging drugs.

Tested in patients with: Moderate to severe COVID-19

Clinical Impact on COVID-19: unknown

Timeline: First data could become available in May 2021

Chloroquine OR hydroxychloroquine PLUS Azithromycin: Amplified decrease in detectable concentrations of SARS-CoV-2

Lopinavir/ritonavir (LPV/r or Kaletra): HIV Protease inhibitors

Mechanism of Action: Acts against the viral 3CL protease, has modest antiviral activity against SARS-CoV-2 – protease inhibitors – lopinavir is primary antiviral, ritonavir acts as a pharmacodynamic booster via 3A4 inhibition.

Dose: 400/100 mg two times daily for 10 days

Side Effects: QT prolongation, hyperglycemia, hypertriglyceridemia, renal failure, anemia, leukopenia, neutropenia, pancreatitis, hepatotoxicity

Tested in patients with: Moderate to severe COVID-19

Clinical Impact on COVID-19: Not effective in severe COVID-19 cases based on this study. Additional studies needed.

Timeline: Additional data could become available in May 2020

Note: If LPV/r not available, consider using darunavir/cobicistat (DRV/c or Prezcobix) 800/150mg daily

Ritonavir/lopinavir and beta interferon beta B1 (Betaseron) based on this study December 2020: HIV Protease inhibitors plus immunomodulator

Mechanism of Action: Viral 3CL protease inhibition (Ritonavir/lopinavir) plus enhancement of suppressor T-cell activity, reduction of proinflammatory cytokines and down-regulation of antigen presentation (beta interferon)

Dose: Lopinavir/ritonavir (400 mg/100 mg) every 12 h for 14 days. Interferon ß1a 44 µg subcutaneously for a total of 3 doses in 6 days (day 1, day 3, day 6).

Side Effects: QT prolongation, hyperglycemia, hypertriglyceridemia, renal failure, anemia, leukopenia, neutropenia, pancreatitis, hepatotoxicity, depression, injection site reaction, flu-like syndrome

Tested in patients with: Severe, refractory or progressive COVID-19 patients

Clinical Impact on COVID-19: unknown

Timeline: Estimated study completion in March 2023

While there are a few anecdotal reports from China and Europe suggesting some degree of potential therapeutic activity of some of these aforementioned drug compounds (especially hydroxychloroquine) against COVID-19 and related coronaviruses, at this time there are limited clinical data from randomized controlled trials in humans to support the recommendation of any of these investigational drugs in patients with confirmed or suspected COVID-19. 

It is extremely important to note the potential serious adverse effects (including the risk of death in geriatrics or patients with underlying chronic diseases) associated with these experimental drugs, which may also overlap with the clinical manifestations of COVID-19. 

A number of drugs are being investigated for treatment and/or prevention of COVID-19 and researchers from the major public health agencies at the forefront of the promising therapeutic options continue to monitor these developments and assess clinical data as they emerge. 

Cynthia C. Nwaubani is a board-certified geriatric consultant pharmacist and the CEO and founder of PharmD Live®. 

References

1. World Health Organization Coronavirus (COVID-2019) R&D. https://www.who.int/blueprint/priority-diseases/key-action/novel-coronavirus/en/ 
2. Dong L, Hu S, Gao J. Discovering drugs to treat coronavirus disease 2019 (COVID-19). Drug Discov Ther. 2020; 14:58-60
3. Wang M, Cao R, Zhang L et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res.2020;30:267-271
4. Holshue ML, DeBolt C, Lindquist S. et al. First case of 2019 novel coronavirus in the United States. N Engl J Med. 2020;382:929-936
5. A multicenter, adaptive, randomized blinded controlled trial of the safety and efficacy of investigational therapeutics for the treatment of COVID-19 in hospitalized adults. – Full Text View- ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04280705?cond=Corona+Virus+Infection&draw=4&rank=21  
6. U.S. National Library of Medicine. ClinicalTrials.gov 
7. CDC Website
8. FDA Website
9. Chu CM, Cheng VCC, Hung IFN, et al. Role of lopinavir/ritonavir in the treatment of SARS: Initial virological and clinical findings. Thorax 2004;59(3):252–256.
10. Devaux CA, Rolain JM, Colson P et al. New insights on the antiviral effects of chloroquine against coronavirus: what to expect for COVID-19?. Int J Antimicrob Agents. 2020; :105938. (PubMed 32171740) (DOI 10.1016/j. ijantimicag.2020.105938) 
11. Colson P, Rolain JM, Lagier JC et al. Chloroquine and hydroxychloroquine as available weapons to fight COVID-19. Int J Antimicrob Agents. 2020; :105932. Editorial. (PubMed 32145363) (DOI 10.1016/j. ijantimicag.2020.105932)
12. Arabi YM, Alothman A, Balkhy HH et al. Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial. Trials. 2018; 19:81. (PubMed 29382391) (DOI 10.1186/s13063-017-2427-0)

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CCM is a service designed to improve the quality of care and clinical outcomes for patients with multiple chronic diseases by increasing their engagement with clinicians and improving the overall management of their chronic conditions. This may be especially important for those who become infected with COVID-19, as early studies indicate that patients with chronic diseases such as asthma, COPD, heart conditions, cancer, autoimmune diseases, diabetes, kidney and liver disease, and others may be at an increased risk of contracting COVID-19, as well as experiencing more severe symptoms, including pneumonia, respiratory failure, and death. Ensuring that those with chronic diseases are well-controlled may be an important step in limiting the spread or severity of this novel virus.

Telehealth services such as CCM promote patient and provider safety during times of viral outbreak by limiting unnecessary personal contact. Many conditions that typically cause patients to seek a visit with their primary care physician may be appropriate for a telehealth evaluation. Recently the Centers for Medicare and Medicaid Services (CMS) was ordered to pay providers for telehealth services delivered to any Medicare beneficiary during the current national health emergency. This provides an excellent opportunity for the healthcare system to demonstrate the value of telehealth as well as limit the spread of this virus, freeing valuable space in clinics for the treatment of those with the most serious concerns. This change in CMS guidelines, while temporary, may serve as the stepping stone to wider acceptance of telehealth services by policymakers and payers, as the benefits of this technology become more widely understood.

References

• Bashshur RL, Shannon GW, Smith BR, Alverson DC, Antoniotti N, Barsan WG, et al. The empirical foundations of telemedicine interventions for chronic disease management. Telemed J E Health. 2014;20(9):769–800
• Centers for Medicare & Medicaid Services. President Trump Expands Telehealth Benefits for Medicare Beneficiaries During COVID-19 Outbreak. CMS.gov. Published online March 17, 2020. https://www.https://www.cms.gov/newsroom/press-releases/president-trump-expands-telehealth-benefits-medicare-beneficiaries-during-covid-19-outbreak
• Monkowski D, Rhodes LV III, Templer S, et al. A retrospective cohort study to assess the impact of an inpatient infectious disease telemedicine consultation service on hospital and patient outcomes [published online April 19, 2019] Clin Infect Dis. doi:10.1093/cid/ciz293
• Schurrer J, O’Malley A, Wilson C, McCall N, Jain N. Evaluation of the Diffusion and Impact of the Chronic Care Management (CCM) Services: Final Report. Washington, D.C. Mathematica Policy Research. 2 Nov 2017; cited 26 March 2020.
• US Center for Disease Control. Coronavirus Disease 2019: People who are at higher risk for severe illness. CDC.gov. Published online March 26, 2020. https://www.cdc.gov/coronavirus/2019-ncov/specific-groups/people-at-higher-risk.html

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As the COVID-19 pandemic continues to progress, so does the research of vaccines and treatments to eradicate the elusive virus. Billions of dollars are being spent on research and development efforts to create effective immunity, particularly in elderly adults. As we age, chronic diseases, combined with treatments and immune response, greatly affect how we respond to vaccines and infectious diseases such as this coronavirus. The SARS-CoV-2 is the virus that causes COVID-19, manifesting through the Angiotensin Converting Enzyme 2 (ACE-2) receptor. The levels of ACE-2 have been shown to vary in younger vs. older patients, with older patients succumbing to the virus at higher rates. There is a vital urgency to understand the effect of COVID-19 upon older patients, especially in those with chronic medical conditions.

Based on the confirmed cases thus far, there is a marked vulnerability in the elderly population. This poses a big challenge in the development of vaccines and immunotherapeutic agents. Several studies have shown a decreased efficacy of vaccines in elderly patients, likely due to the decline of the innate and adaptive immune responses as we age. However, some vaccines are very effective in protecting elderly patients, such as the herpes zoster vaccine. Are there variables in the immune response from one elderly patient to another? How can we use the understanding of this variability to develop new vaccines and therapeutics?

The effects of COVID-19 on the elderly population have shed some light on the upcoming challenges the world is facing. The United Nations has reported that by the year 2050, there will be twice as many individuals over the age of 65 years old as there are under age 5, and this cohort will surpass people in the age range of 15-24 years old. Additionally, by 2050, the number of deaths from antimicrobial resistance is expected to reach 10 million, which will exceed the cancer mortality rate. Climate change from tropical vector-borne disease and more potential pandemic diseases will put an additional billion people at risk. Protecting the aging population will be a very important goal in maintaining global health and biosecurity.

Numerous recent technological advances in biomedical and computer science provide opportunities to decode the human immune system. Innovations in systems biology, specifically in clinical immunology, have allowed for detailed measurements of human transcriptomic, proteomic, immune, and metabolic responses. These new advances have led to an improved understanding of human responses in different populations, leading to new immune therapeutic strategies and potential novel vaccines. Innovations in bioinformatics, causal inference, and artificial intelligence can all potentially differentiate people who develop immunity to a disease or explain why some people respond to vaccines and some do not. These advancements will inform research for accelerating discoveries of COVID-19 vaccines and other future vaccinations.

The tools needed to develop therapeutics and vaccines to be effective in the aging population are available. Over time, a new generation of multidisciplinary scientists trained in biomedical, informatics, and computer sciences are warranted to develop these and to prepare for the next wave of infectious diseases. In the long run, the medical community will have to shift our focus from disease-specific research and therapy to targeting how to decode the human immune system, particularly in the elderly population.

References:

• Koff WC, Williams MA. Covid-19 and Immunity in Aging Populations. NEJM. 2020 April 17.

Source:https://www.nejm.org/doi/10.1056/NEJMp2006761

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