Analyzing the Pandemic’s Impact on Clinical Trials & Healthcare Law

By: Ron DiGiaimo, MBA, FACHE, Ben Adams, and Briauna Driggers

Cancer growth and cancer care have never stopped in the world of Oncology and the COVID-19 pandemic. Hospitals and cancer centers faced unique challenges like reduced clinical trials, elective procedure, and PPC access. We were forced to adapt quickly to ensure the safety of cancer patients, at heightened risk for COVID-19. Across the nation, we saw oncologists, healthcare workers, and patients come together to overcome the challenges and produce incredible solutions that may be with us for years post-pandemic. 
​
We sat down with Dr. Debra Patt, MD, Ph.D., MBA, VP of Texas Oncology, an expert in breast cancer, member of the ASCO Board, and Professor of Oncology at UT Austin to get her perspective on large-scale changes to oncology, telemedicine, and health care as a result of the ongoing pandemic with potential impact for decades to come.

The Effects of Diminishing Screenings and Clinical Trials on Cancer Care

Industry leaders like Dr. Debra Patt, Texas Oncology Vice President, and societies like ASCO are forecasting long-term challenges and repercussions of diminished cancer screenings throughout the Medical Oncology side of cancer care. Results of the above paper showed, there was a substantial decrease in cancer screenings, visits, therapy, and surgeries, in March-July 2020, in comparison with the baseline period of March-July 2019, with variation by cancer type and site of service. 

“At the peak of the pandemic in April, screenings for breast, colon, prostate, and lung cancers were lower by 85%, 75%, 74%, and 56%, respectively.” Screenings were not the only thing reduced, however, as “significant utilization reductions were observed in April for hospital outpatient evaluation and management (E&M) visits (−74%), new patient E&M visits (−70%) and established patient E&M visits (−60%).”

Similarly, and according to survey research done by ASTRO, representing the Radiation Oncology side of cancer care; two-thirds of physicians said new patients are presenting with more advanced disease compared to pre-pandemic.

Dr. Patt’s team partnered with Avalere Health to study cancer screening visits in 2020 compared to 2019 and found that they were down more than 58% in April 2020 and averaged a net decrease of about 30% through the year. Cancer-related procedures across the board had decreased due to natural barriers related to the pandemic. Fear of leaving home, the replacement of elective procedures with high priority COVID-19 cases, and limited capacities at places like breast cancer mammography screening centers all contributed.

“The results we are seeing now will lead to increased cancer morbidity and mortality in the next 5 to 10 years,” Dr. Patt continued “and anecdotally, one of the other reasons I witnessed was related to many patients losing their health insurance. About 5,000,000 Texans do not have health insurance.”

Disparities in care were highlighted by the pandemic, as disadvantaged groups saw more intense socioeconomic barriers to care, considering the increased burdens that Americans felt within the last year of tumultuous events.

Participation in clinical trials also diminished greatly and will prove to have lingering effects on research for the next half-decade or more. While clinical trials were still open and available, “patients do not have the individual ability to consider clinical trials given their surroundings” Dr. Patt reasoned, as patients have spent double the normal amount of time receiving information, proceeding with safety measures, and managing higher rates of stress due to the pandemic.

In the face of this crisis, maintaining clinical trials was a low priority, but the lingering effects are already beginning to be felt in the oncology sector and will remain for years to come.

2021: Banner Year for Legislation and Digital Technologies in Oncology

“There was an unprecedented change to the entire house of medicine, and the entire world,” Dr. Patt begins; referencing the quick and brutal effects on health care, headed by COVID-19 and followed by smaller, but impactful events like Texas’s “snowpocalypse” where Dr. Patt saw struggles with statewide energy crises in early 2021. 

Despite the challenges of the past two years, Dr. Patt believes there have been numerous promising developments in medicine, due to PDM reforms, anti-steerage, and anti-clawback legislation, which can have incredibly meaningful effects for patients. These updates, in addition to changes that can liberalize the ability to care for patients out of state “signal the most significant and promising progress in medicine we have seen in 20 years, all due to and in spite of COVID-19.”

“Not as promising as I would like of course, but you don’t always get everything you want.”

With cancer care being perennially “on the chopping block” from federal legislative changes, drug pricing strategies, and insurance distribution; cancer care and health care associations need to take the opportunity of change within the industry to push for positive legislation and action. Heightened awareness for complicated, multi-faceted issues is necessary, as, at their core, they limit the ability of patients to receive the care they need. With regard to cancer care, Dr. Patt believes that “we’re either going to be at the table or on the menu.”

The push for change in legislation was kickstarted by the immediate need for virtual care and telemedicine expansion in health care. Early in the pandemic and backed by guidelines formed by task forces and organizations like ASCO (American Society Clinical Oncology), Dr. Patt assisted these goals by testifying before state courts. 

Expanding and cementing telemedicine as a viable alternative for care early on allowed health care to tackle the pandemic and care for patients much easier and in a safe environment. Across the nation, transportation and face to face exposure came with risk, cancer care in transportation-effected areas like Hawaii, and disadvantaged populations like the Navajo Nation in New Mexico were immediately impacted and helped to spur the quickest legislative action tied to care, financials, documentation requirements, and operations ever experienced by our specialty within the United States.

“The digital reformation of healthcare was catalyzed during the pandemic, headed by a robust buy-in to telemedicine.” Dr. Patt said, in reference to the expedited decision-making for digital technologies like telehealth and virtual care, along with general optimized communication across the board. Dr. Patt’s team at Texas Oncology launched an electronic health patient-reported outcomes platform during the pandemic and set aside time to optimize and facilitate communication through catch-up calls, regular touchpoints within the large organization, and emerging digital communication like podcasts and town halls. 

These necessary and innovative changes were a silver lining of the pandemic. Their emergence and implementation showcased digital solutions out of urgent needs and will likely remain for decades to come. The time of fast and impactful change in cancer care has not ended and will continue to be spurred on by oncology leaders, advocacy groups, and cancer centers in the industry; “we will need nationwide support and unity to push these very possible improvements into reality at the rate we now know is possible,” Ron DiGiaimo echoes.

Overcoming COVID-19, the Delta Variant, and the Nurse Shortage While Treating Cancer

For Texas Oncology, a large practice that represents over 210 sites of service to immediately implement the CDC protocols, screenings, and over 250,000 telemedicine visits, overcoming the pure volume of functionality changes and expansions, required fantastic, adaptable teams to successfully treat cancer. Dr. Patt is proud to say they did just that.

“Our team at every level rose to the challenge, and everyone worked a lot harder in the last year and a half, it was amazing to experience” Dr. Patt reports.

With the Delta Variant reaching peak pandemic levels in many communities; information crowdsourcing, as well as continuously evolving CDC guidelines and vaccine boosters are the tools that health care needs to overcome another wave of the pandemic. Taking what was learned the first round will allow for better and faster solutions through the diffusion of accurate information for everyone.
​
For cancer patients, infusion site visits at cancer centers are still the most ideal and safest way to get chemotherapy, tests, and some treatment, despite the usefulness of virtual care. Safety protocols to ensure immuno-compromised had to be perfect in all offices across Texas, as most procedures still required patients to come into the office. “As of 2021, and the foreseeable future, I don’t think we are ready for procedures like home infusion to be done consistently, efficiently, or safely” Dr. Patt stated.

​Furthermore, the shortage of nurses prevents economically efficient ways to deliver care to patients in homes nationwide. “Even if it weren’t for the pandemic, we would be in a national crisis due to the availability of nurses,” Dr. Patt said, “I think that the pandemic has escalated that need, as our nurses have been with us on the frontlines fearing for their lives and their families.”

The Great Resignation may be on the horizon and will undoubtedly drive the future of cancer care in the years to come.

Leaving the Details to Dr. Debra Patt

Debra Patt, MD, Ph.D., MBA, is an expert in breast cancer, policymaker and advocate in oncology, member of the ASCO Board, Professor of Oncology at UT Austin, all while having time to lead the world’s largest independent, physician-led practice as Vice President of Texas Oncology. For Dr. Patt, it all started with the need to help people with cancer in detailed, innovative ways, and building relationships over time with patients, while improving cancer care. Across her state’s 210 sites of service, Dr. Patt’s drive is to answer the question: How can we best deliver great care at each of these sites and their communities?

“Even 15 years in, it still gets me up every morning excited, and I think that we’re doing really good work.”

Additionally, her work in policy and advocacy ensures that across the country, work is being done to improve cancer care and lead the nation towards delivering the best possible service.  She testifies in front of the Senate, produces telemedicine guidelines with ASCO, and works with other leaders in oncology to prepare and handle issues on the horizon that all impact the industry at large.

Dr. Patt’s work in these various roles and environments allows for broadening her admittedly monocular lens from just the world of cancer care to social factors impacting the world at large. In response to working on COVID-related legislation, Dr. Patt said she was “shocked to review statistics illustrating a fourfold increase in anxiety and depression. Psychiatrists and social workers also informed us about the increase in domestic violence, homelessness, and mental health that have been exacerbated during the pandemic.” This is a horrendous statistic by any measure but combined with a diagnosis of cancer can be easily and justifiably overwhelming. 
​
Open-mindedness and taking on multiple roles in cancer care and the broader world of health care are key in her abilities as a leader and driver of oncology legislation and technology adoption, especially in a world threatened to slow down and stop by COVID-19 and the Delta Variant. Luckily for Texas and her patients, Dr. Patt’s journey to deliver great care every day will continue through the pandemic and long after.