CMS’ Most Favored Nation Rule Stopped for Now

A seven-year model proposed by the Center for Medicare & Medicaid Services (CMS) has been temporarily restrained following multiple lawsuits filed by pharmaceutical corporations and physician organizations. The Most Favored Nation (MFN) model, which was scheduled to go live on January 1, 2021, is now stalled.

The CMS Innovation Center announced the mandatory MFN model on November 20, 2020, to test whether reimbursing care providers for Medicare Part B drugs and biologicals (these are drugs administered in a doctor’s office or at an infusion center) at rates that match international prices would reduce the nation’s health care spending. This would also meet the requirements of President Trump’s Executive Order on lowering drug prices for U.S. patients.

The model has the following key payment structure:

  • MFN price: Instead of basing reimbursement on the drug manufacturer’s average sales price (ASP), Medicare would calculate reimbursement for a drug by blending the drug’s lowest adjusted international price (MFN price) and the ASP. There is also a single add-on payment per dose that Medicare enrollees are not responsible for.
  • Four-year phase-in period: The MFN price will be introduced at 25% per year over the first four years, and will be 100% of the MFN price during years four to seven
  • ASP: To control patient cost-sharing, the formula will not allow the model payment amount to exceed the ASP

This nationwide mandatory model requires participation by all providers and suppliers that receive Medicare Part B fee-for-service payments for the 50 drugs currently included in this model, chosen based on annual spending in 2019 and expected to be updated annually.

Several physician organizations have strongly denounced this rule and filed lawsuits that stopped CMS from implementing the MFN model at the beginning of January 2021. This includes a multi-organization lawsuit filed by the Association of Community Cancer Centers (ACCC) in collaboration with the Pharmaceutical Research and Manufacturers of America, the Global Colon Cancer Association, and the National Infusion Center Association, asserting that CMS has exceeded its statutory authority with implementing this model while simultaneously failing to follow appropriate rulemaking procedures.

“This a temporary victory for cancer patients and providers yet we still have a way to go.  It is important that any policies enacted don’t limit our ability to serve patients and their families. Poorly designed policies such as MFN can have devastating impacts on patients, particular those in rural and underserved areas who are vulnerable to changes that will limit the care they receive,” said ACCC President Dr. Randall A. Oyer, in a statement.

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Increased Risk of CRC in Patients With Slow-Transit Constipation

Slow-transit constipation (STC) is reported to occur in 15-30% of people in the U.S. The most widely accepted definition of STC is two or fewer bowel movements per week or straining at stool more than 25% of the time. Research continues to point to STC as a risk factor for colorectal cancer (CRC).

A study published in 2020 that looked at 2,165 patients (median age 54 years), found that the cumulative probability of CRC was 0.2% 5 years after STC diagnosis and 0.4% 10 years after STC diagnosis. This was not significantly different (p=0.575) than among those without STC diagnosis. However, this may be due to the small number of patients (5) who were diagnosed with CRC.

Although the authors of the 2020 study did not find a significant difference among those with and without STC diagnosis, it is well established that STC increases CRC risk. Gurérin et al. in their 2014 study of over 100,000 patients identified a statistically significant risk of CRC among those with STC:

  • 56% higher for CRC
  • 260% higher for benign neoplasm
  • 256% higher for benign neoplasm in colon
  • 262% higher for anal and rectal polyps

Current management options for STC range from dietary counseling, pharmacological therapy, and surgery. 

While the etiology of STC remains unclear, there is increasing evidence that it is caused by an imbalance in the gut microbiome. Zhang et al. in their 2021 review published in Gastroenterology Report found that gut microbiota may play a major role in modulating colonic motility, secretion, and absorption. However, there is still much research needed to understand how the gut microbiome modulates movement of fecal matter through the small intestine and colon.

Conversations about the role of the gut microbiome in CRC development were a part of the Early-Age Onset Colorectal Cancer Summit held by the Colon Cancer Foundation in May 2022.

 

Gargi Patel is a Colon Cancer Prevention Intern with the Colon Cancer Foundation.

 

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In Conversation With Dr. Dooreck: Colorectal Cancer Provider Outreach Program: Part I

The Colon Cancer Foundation’s Lakshmi Yeturu sat down (virtually!) with Dr. Brian Dooreck to find out more about his initiative to arm newly diagnosed colorectal cancer patients and caregivers with substantial resources as they bravely face their diagnosis and treatment.

Can you tell me a little bit about yourself: your personal and academic background and your interests?

My name is Dr. Brian Dooreck. I am a gastroenterologist focused on GI [gastrointestinal] and liver disease. I trained at the University of Miami Jackson Memorial Hospital and have been in clinical practice for 15 years in South Florida, seeing patients for all GI-related issues. My training goes back to New York, Boston, Tel Aviv, NYC, and Miami. As a clinical gastroenterologist, I am quite involved with my patients in a relatively busy practice, but I am also engaged in other aspects of the medical, nonprofit, and entrepreneurial worlds.

The Colorectal Cancer Provider Outreach Program [CRC POP] was just an idea a few months ago that quickly became reality. What I have repeatedly experienced over the years is that when we diagnose people with colorectal cancer, we’re telling them that they have a problem. As they are waking up from sedation [following a colonoscopy], we tell them: ‘You have a problem and this is what we need to do: you need to get labs, you need to get a CAT scan, you need to see a surgeon, you need to get the follow-up biopsies and then see me in a week or two. We will get through this; we will work together.’

But what we have not been doing—and I have realized this now after having spoken to groups representing over 1200 gastroenterologists—is telling patients, ‘Listen, go home, look into these websites and call these numbers. I will see you in a week or two and we will go over things.’ But you have support starting now:

  1. You want to take out your phone and text this number: COLON to 48-48-48, which pops up a PDF with all the organizations, their websites, and their phone numbers
  2. Go to our website, go to the Colorectal Cancer Help Page that has links to the websites of patient organizations
  3. Look at your EMR discharge instructions; you’ll find more information there

So, there are these three areas which we can share with patients at the bedside, post-procedure as we’re delivering their diagnosis, and it can direct them to resources that they are otherwise, and most likely, going to trip over if they were Googling, ‘Am I going to die from colon cancer?’ They’re not going to find it on their own, but they may join a social media network group and see a Facebook posting. They’ll probably trip over rather than go to it directly, or they’ll go to it much later in the game.

What I am trying to do is get patients to these resources much earlier, when they have just been diagnosed.

What prompted you to work within gastroenterology and hepatology? Specifically, within colorectal cancer?

I chose gastroenterology early on in my internal medicine training, probably by my first or second year in New York City. I specifically remember just having related to it. From the aspect of your social life or social disposition, having abdominal pain, colitis, diarrhea, or bloody stools is a real damper to your Saturday night dating and it would really affect your social life.

I also understood it. I think we’ve all had diarrhea, we’ve all had abdominal pain and I know what it’s like. You can walk around with heart disease, kidney failure, lung disease, and lung cancer and you may not have to tell someone. But to have to urgently run to the bathroom, not be able to eat meals, have severe cramping, or if you are losing weight because of it, you will be forced to tell someone. That really is something I related to. I felt I could help people’s quality of life in a much broader, quicker way.

Would you mind describing your past work and research efforts within this field and their significance to colorectal cancer?

Over the years, during my clinical research and fellowship at the university, I have been involved in different aspects of research and I’ve always had an alignment with colorectal cancer. I started realizing that GI is my field of interest quite early on. I remember rotating through Memorial Sloan Kettering Cancer Center, where Dr. Sidney Winawer was one of the pioneers of colon polyp detection. So, for me I’ve always had a proximity and drive towards it; I’ve always been much more interested in the clinical aspects of the field.

Personally, being engaged with social media platforms, I saw a great ability to leverage technology to further benefit our patients. This tool that we have created allows patients to get the support they need at the time of diagnosis ‘here and now,’ and it will alleviate so many levels of burden. There is nothing more shocking than telling someone ‘you have cancer.’ There are about 14,000 gastroenterologists in the United States and about 150,000 people diagnosed each year with colorectal cancer. So, we have 14,000 gastroenterologists making those diagnoses each year. You can add multiples of that to account for family members and other people that are simultaneously affected by that one diagnosis.

How many of those people are going to go through the support services that are available from the five organizations we’re partnering with at the time of diagnosis? We expect that very soon, the support that we are providing at the time of diagnosis can not only help the patient and their family, but also promote screening and prevention for those organizations that have preventive screening programs. So, the benefits are huge and using the providers for this is our goal.

What was your primary inspiration to develop this program aimed at newly diagnosed colorectal cancer patients?

Like I said, having seen this now a thousand times if not more. We are not leveraging the available resources, and you know it is quite different for colorectal cancer. For breast cancer, for example, if you feel a lump, you can get a mammogram, get a biopsy and ultrasound, and follow up with the doctor. It is a period of 2-3 weeks, probably, and you as the patient know what’s going on and you’re aware of the conversation. With prostate cancer, you know something is not feeling right if the PSA is high, the physical exam is off. When you get the biopsy results, you are awake or aware the whole time, so you know what’s going on and you are a part of the conversation.

In the case of colon cancer, you come to me saying, ‘I have some rectal bleeding’, ‘Oh I have hemorrhoids’, ‘I feel perfectly fine’, ‘I need to get a screening’, ‘I’ve been 5 six years late’, ‘OMG I have colon cancer and I kind of blew it off for a few years.’ You come to me feeling fine and not suspecting a problem. Then you go to sleep [for the colonoscopy procedure], wake up 15-20 minutes later and you have colon cancer. We don’t hear anything after the cancer diagnosis. That’s our differentiator and what we do in my field, in my space, in my world is we’re dealing with a cancer where the diagnosis is made at the bedside post-sedation and more than ever everything becomes very clouded for the patient. So, with CRC POP, we can help people through that cloud.

 What inspired you to be at the forefront of the Colorectal Cancer Provider Outreach Program (CRC POP)? Who are your lead collaborators on this project and are you looking to expand your partner organizations?

The focus of the Colorectal Cancer Provider Outreach Program [CRC POP] is reaching the providers who will then share the resources with their patients.

We are currently partnering with five supporting organizations: American Cancer Society, Colorectal Cancer Alliance, Fight Colorectal Cancer, Colon Cancer Coalition, and the Colon Cancer Foundation. These five organizations are, in my eyes, equal partners and our goal is to reach providers and to give patients the options of these five organizations. Each organization has its own strengths and weakness, specialty, and focus—it is up to the patients to find what best serves their needs.

We received support from a company called Easy Texting that’s giving us the ability to allow patients to text the word ‘COLON’ to 48-48-48 at the bedside. This will generate a PDF with the link and phone numbers to these five organizations. My goal is to work closely with three national associations: the American College of Gastroenterology, the American Gastrointestinal Association, and the American Society of Gastrointestinal Endoscopy, to develop better communication with the 14,000 gastroenterologists in the U.S., and to use their influence to quickly, and easily, reach more providers and in turn more patients.

Part II of this interview can be found here.

 

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Congressional Approval Will Eliminate CRC Screening Barrier for Seniors

H.R. 1570 – Removing Barriers to Colorectal Cancer Screening Act of 2020 has been passed by Congress. The bill—which passed the House vote on December 9, 2020, and the Senate on December 21, 2020, and will become law once signed by the President—will be phased in over the next eight years. This bill has been devised to improve colorectal cancer (CRC) screening rates within the Medicare population, which in turn will allow earlier diagnosis and improve health outcomes. The Colon Cancer Foundation was a co-signee on a letter drafted by 35 other organizations and led by the American Cancer Society Cancer Action Network, urging Congressional leaders to include this bill in the end-of-year funding package.

The bill modifies cost-sharing requirements for CRC screening among seniors enrolled in Medicare such that they will no longer be required to pay coinsurance if a polyp is discovered and removed during a regular screening colonoscopy. While the 2010 Affordable Care Act ensured that Medicare fully covers preventive screening for colorectal cancer, removing a polyp found during a routine screen makes it a diagnostic procedure, which adds a cost-sharing responsibility on the patient. As a result, the patient may end up having to pay 20% of the cost for removing the polyp as co-insurance, and this surprise bill may amount to several hundred dollars, depending on the facility where the procedure was conducted. For seniors living on a fixed income, this unexpected cost could be a financial burden.

When caught early, removing a polyp not only improves patient outcomes and quality of life, but also saves downstream costs for the health care system as a whole. However, prior knowledge of the cost-sharing requirement associated with polyp removal during a routine screening procedure could deter individuals from going in for their regular screening and raise the risk of a polyp or a potential tumor going undetected.

Cindy Borassi, Interim President, Colon Cancer Foundation, said, “This is a big win and significant step toward correcting the “colonoscopy loophole.” By addressing and eliminating the loophole of financial obligations in case a polyp is detected during a screening procedure, we are ensuring that our seniors will continue to make their preventive care a priority and undergo this routine yet potentially life-saving screening test without cost. Once made into law, H.R. 1570 will also help reduce advanced colorectal cancer cases among our Medicare enrollees.”

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Implications of Colorectal Cancer Surgical Outcomes During the Era of COVID-19

The ongoing COVID-19 pandemic has affected elective colorectal cancer (CRC) surgical practices, and its impact on mortality after CRC surgical resections has been slowly emerging.  Early on, studies done in Italy and the United Kingdom presented specific recommendations in hopes of reducing the impact on CRC surgical outcomes, but have yet to conclude which of the proposed ideas can be implemented.

During the early weeks of the pandemic, there was uncertainty surrounding the influence of the SARS-CoV-2 virus on CRC surgical patients as well as intensive care capacity. Various recommendations were put in place to alter CRC surgical practices, which in turn would help reduce mortality. Researchers in Italy proposed that a benefit of changing surgical practices would be that it would reduce postoperative complications such as anastomotic leaks. They hypothesized that laparoscopic surgery for CRC would be the answer, although there remains a lot of uncertainty in regards to whether or not the SARS-CoV-2 virus would survive in the CO2

used for the surgery. Hematologists in the U.K. suggested that another benefit would be to decrease the need for intensive care at a time when hospital resources are being redirected towards the pandemic. A third benefit would be to reduce complications which would drastically reduce the length of hospital stay while releasing bed space, which would in turn reduce the risk of hospital-acquired infections. Despite the benefits of the proposed changes in CRC surgical practices, elective CRC surgeries must continue in order to prevent delayed operations and/or an increase in emergency procedures at a later time. 

A cohort study at the University of Birmingham, U.K., conducted by Bhangu. A et a,l analyzed patients undergoing CRC resection without any suspicion of COVID-19. The data were collected on eligible patients from the first recorded case of COVID-19 through April 19, 2020. Eligible patients were 18 years and older, looking to undergo elective CRC surgery. The study particularly focused on patients who had a stoma, in which their surgeons were asked if this was their “normal practice” or a “change in practice due to COVID-19.” Patients with a stoma with a change in practice due to COVID-19 were labelled as “COVID-end-stoma.” The study concluded that the rate of stoma formation was 34.2% as opposed to the 27.2% which was seen before the pandemic started. A total of 1.8% of patients died within 30 days of surgery, 3.8% went onto develop postoperative COVID-19, and 4.9% had an anastomotic leak. While anastomotic leaks were lower pre-pandemic (4.9% vs 7.7%) and length of hospital stays was shorter (6 vs 7 days), mortality was higher post-pandemic (1.7% vs 1.1%). The causes of change in practice in patients who had a COVID-stoma were recommendations from specialty associations, to avoid possible complications requiring critical care, wish to reduce length of inpatient stay, fear of patients suffering from a SARS-CoV-2 infection postoperatively, lack of access to postoperative intensive care, and very difficult working conditions with donning full PPE.

Alterations in surgical practices for CRC surgeries is an effort to decrease the duration of surgery, resource usage, and hospital stay.

 

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CURE Media Group Bolsters Strategic Alliance Partnership Program With 12 New Partners

December 16, 2020 02:05 PM Eastern Standard Time

CRANBURY, N.J.–(BUSINESS WIRE)–CURE Media Group is excited to announce that its has expanded its Strategic Alliance Partnership (SAP) program roster with the addition of 12 new partners.

“We are excited to join forces with such prominent organizations across different cancer communities during these past few months,” said Mike Hennessy Jr., president and CEO of MJH Life Sciences™, parent company of CURE Media Group. “Each of these partners are dedicated to improving the overall quality of life for patients with cancer through research, education and awareness, and we look forward to collaborating together with them to provide relevant, practical information that meet their audience needs across CURE and MJH multi-dimensional media platforms.” The new partners are as follows:

Bone Marrow & Cancer Foundation is dedicated to improving the quality of life for cancer and transplant patients and their families by providing vital financial assistance, comprehensive resources, educational information, physician referrals, and emotional support programs.

Cancer Support Community is an organization whose mission is to ensure that all people impacted by cancer are empowered by knowledge, strengthened by action and sustained by community. CSC focuses on three areas of support: direct service delivery, research, and advocacy.

The Clearity Foundation’s programs Treatment Decision Support and Steps Through OC help women with ovarian cancer and their families select the best possible therapies for their unique disease and receive the emotional support they need for their OC journey.

Colon Cancer Foundation is a national non-profit organization with a mission to lead the fight against colorectal cancer (CRC) by supporting research, leading advocacy efforts, and promoting treatment and prevention through education and awareness.

Colorectal Cancer Alliance is a national non-profit organization committed to ending colorectal cancer with programs to screen, care and cure.

Foundation for Women’s Cancer is a non-profit organization dedicated to supporting research, education and public awareness of gynecologic cancers. FWC is the official foundation of the Society of Gynecologic Oncology.

Imerman Angels is a non-profit organization with a mission to provide comfort and understanding for all cancer fighters, survivors, previvors and caregivers through a personalized, one-on-one connection with someone who has been there.

LUNgevity is the nation’s leading lung cancer organization investing in lifesaving, translational research and providing support services and education.

Lymphoma Research Foundation is the nation’s largest non-profit organization devoted to funding innovative lymphoma research and providing people with lymphoma and healthcare professionals with up-to-date education about this type of cancer.

MMRF is the largest nonprofit organization in the world focused on accelerating the cure for multiple myeloma.

Partnership to Reduce Cancer in Rhode Island – a 501c3 tax-exempt, charitable non-profit is the state’s comprehensive cancer control coalition, operating in conjunction with the support of the Rhode Island Department of Health’s Comprehensive Cancer Control Program.

Tigerlily Foundation is a national breast cancer foundation providing education, awareness, advocacy and support to young women 15-45 years old before, during and after breast cancer.

The SAP program provides partnering advocacy organizations, medical associations and institutions, and community cancer centers with national reach and visibility, utilizing the breadth of the MJH oncology communications platform to showcase their cutting edge initiatives, content, research, and thought leadership. Through the SAP program, we foster collaboration and an open exchange of information among trusted peers for the benefit of patients and their families. As part of this joint effort, CURE Media Group will work with the partners to share information and highlight the different cancer communities they support.

For a full list of CURE Media Group’s SAP partners, click here.

About CURE Media Group

CURE Media Group is the leading resource for cancer updates, research and education. It combines a full suite of media products, including its industry-leading website, CUREtoday.com; innovative video programs, such as “CURE Connections®”; a series of widely attended live events; CURE® magazine, which reaches more than 1 million readers; and the dynamic website for oncology nurses, OncNursingNews.com, and its companion publication, Oncology Nursing News®. CURE Media Group is a brand of MJH Life Sciences™, the largest privately held, independent, full-service medical media company in North America, dedicated to delivering trusted health care news across multiple channels.

 

Contacts

CURE Media Group Media Contact

Alexandra Ventura, 609-716-7777

aventura@mjhlifesciences.com

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Prioritizing Surgical Care During COVID-19 Using the SWALIS 2020 Model

As the COVID-19 pandemic shows no evidence of slowing down, many cancer surgeons worldwide have begun to devise models to aid with the prioritization of canceled (backlog) elective and upcoming cancer surgeries. Researchers have also strongly advised conducting COVID-19 testing at various time points before and after any surgical procedures with the aim of minimizing the risk of COVID-19—related mortality peri- and postoperatively, particularly in high-risk patients undergoing major surgeries. Thus, in most ways, it can be argued that elective surgeries on non-COVID patients are burdened similarly to those with COVID-19, by increasing waiting times and costs.

 

The SWALIS 2020 Model 

In 2009, the SWALIS prioritization model was developed “to implicit urgency criteria, time-based priority-based scheduling, and waiting list measuring indexes.” During the 2020 European Society of Surgical Oncology (ESSO)’s annual meeting, speaker and scientist, Roberto Valente, MD, Ph.D., who was involved in modifying this model, shared their findings from implementing it in Spring 2020 to prioritize elective surgery throughout and beyond the COVID-19 pandemic in Italy.

The SWALIS 2020 is a ‘software-aided inter-hospital multidisciplinary pathway’ that dynamically reorders the surgical waiting list for cancer patients from least to most urgent in real-time, thereby ensuring priority-based surgical access and scheduling for past, present, and incoming patients. There are three main stages to this dynamic scheduling:

  • Clinical triage assessed using patient clinical history, pre-administrative information, clinical urgency, and demand modulation
  • Prioritization and selection calculated by dividing the maximum by the actual waiting time for that patient
  • Timely allocation of the surgery computed by the expected priority and weekly forecasted capacity demand

SWALIS 2020 uses these three steps to automatically allocate resources on the basis of oncological demand and significantly reduces the timeframe from consult to surgery by autonomously putting together an MDT for the patient, allowing hospitals adopting SWALIS 2020 to rapidly respond to the patients’ needs depending on the level of surgical urgency. Data shows that these three urgency categories were most commonly used to classify tumor progression when using the SWALIS 2020 model during the pandemic: A1 – 15 days (certain rapid disease progression), A2 – 21 days (probably progression), and A3 – 30 days (potential progression).

The results following the SWALIS 2020 feasibility phase (n=55 patients) showed that 240 referrals were successfully prioritized using this model without any major criticalities. Additionally, when researchers monitored the waiting time data for patients and operation theatre allocation for surgeons, they found that 222 cancer patients underwent surgery without related complications or delayed discharges. These results allowed Dr. Valente and his team to objectively quantify the effectiveness of the SWALIS 2020 model—it was 88.7% effective in week 1, then persistently 100% effective during the remainder of the phase. Even at a 30% or lower capacity, this model can consistently and smoothly manage active and backlogged waiting lists, making it one of the first autonomic models for dynamic patient scheduling. Dr. Valente and his team concluded that the SWALIS 2020 model for dynamic patient scheduling was effectively optimizing oncological surgeries based on urgency. The success of this early pilot study paves the way for future collaboration to create an effective dynamic waiting list and surgical scheduling platform during the next phase of the pandemic.

 

Conclusions

While health care professionals may argue that the change in cancer surgical oncology catalyzed by the ongoing COVID-19 pandemic is disruptive, scientists and researchers strongly believe that this reshaping will vastly improve the future of cancer care and strengthen the health economy. One could make the argument that this restructuring is necessary for improving patient outcomes and facilitating patient care. Consequently, many automated models similar to SWALIS 2020, which create waiting lists and guide elective prioritization, are being developed to fundamentally alter the field of surgical oncology for the better.

 

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Has COVID-19 Reshaped the Future of Surgical Oncology in High-Income Countries for the Better or Worse?

As COVID-19 continues to spread like wildfire, it becomes increasingly important to tackle the growing backlog of cancer surgeries. While returning to normal is currently not an option, a lot of hospitals around the world, especially hospitals in COVID-19 hot spots, have begun implementing COVID-19 surgical pathways to help ease the surgical burden. The 2020 European Society of Surgical Oncology (ESSO)’s virtual summit opened our eyes to the inescapable fact that COVID-19 will reshape the face of surgical oncology.

 

Impact of COVID-19 on High-Income Regions

With the pandemic in full swing and cases ever on the rise, surgeons, particularly cancer surgeons, across the world are debating the necessities of implementing long-term change with operation scheduling, minimal person-to-person contact, and elective surgery cancellations. As expected, COVID-19 has resulted in a drastic reduction of surgical activity worldwide, with coronavirus hot spots Europe and the U.S. seeing massive reductions.

 

What Was the Cancer Surgery Burden in Europe’s Biggest Hotspot, Italy?

An elective oncological survey was conducted by Marco Montorsi, MD, and his team to understand how COVID-19 had affected surgical care of Italian cancer patients. The survey was sent to 54 surgical units in three stages: before, during, and after the first wave of the COVID-19 pandemic in March 2020.

During the peak of the first wave, the survey identified a clear reduction in the number of cancer resections scheduled per week, alongside:

  • 70% reduction in surgical beds
  • 76% reduction in surgical activity
  • Almost complete cancellation of outpatient surgeries

Also seen was a prolongation in the time-interval between cancer multidisciplinary team (MDT) discussions and the surgery itself. Disease biology, tumor aggressiveness, and interval from neoadjuvant treatments were the three primary criteria that defined the urgency of the surgery and thereby its need to be performed during the pandemic.

 

Dr. Montorsi stated that a follow-up elective survey is in the making to monitor the effects of the ongoing second wave. He explained that the aims of the second survey are “to investigate the impact of COVID-19 in surgical departments in the past months of heavy pandemic, understand outcomes of COVID-19 patients undergoing oncological surgery, and to investigate how many alternative treatments to surgery have been performed and how many of these are considered to be a bridge to surgery.”

Dr. Montorsi also highlighted that during the heat of the pandemic in Italy, surgeons tried to devise a new priority model for elective surgeries performed on cancer patients. They found that of the minimally invasive surgeries performed during the COVID-19 pandemic, liver and pancreatic cancer surgeries were vastly reduced but colorectal cancer surgery rates in Italy remained similar to previous years, showing that certain hospitals remained a safe environment to perform cancer surgeries in, if strict Personal Protective Equipment guidelines were followed.

However, as the pandemic continues to be a destructive force in the health care industry, an increasing number of surgeons are becoming unavailable to perform surgeries after contracting COVID-19. So, the large question remains, “How do we proceed?” Dr. Montorsi asked. In Italy alone, an estimated 400,000 cancer surgeries need reprogramming in the gap between the COVID-19 waves, and with more and more of the workforce becoming susceptible to COVID-19, this question really needs to be addressed sooner rather than later.

 

How Does the U.S. Compare to Italy?

Let’s look at the big picture. The U.S is now the worst COVID-19 affected country worldwide, with a total of 13.5 million cases and 268k deaths by December 1st 2020 and climbing. It is no surprise that cancer patients are suffering more and fighting harder to survive than they have ever before. The fight is real for everyone but increasing amounts of data show that cancer patients are more vulnerable to worsened outcomes if they contract SARS-CoV-2, which includes increased need for oxygenation via ventilation and raised infection-associated mortality.

Secondly, cancer patients are getting delayed diagnoses due to the decreased availability or suspension of diagnostic and screening services. This alone is terrifying because a patient’s diagnosis for their cancer stage and grade is the only way treatment can be determined. Additionally, pre-diagnosed but un-staged cancer patients are also reluctant to be screened because they do not want to risk contracting COVID-19. This effectively means that patients are being diagnosed later and later, thereby worsening their prognosis and increasing their fight for survival by 100-fold. Thirdly, pre-determined treatment options for patients prior to COVID-19 outbreaks have been altered or cancelled altogether depending on the rate of tumor progression, to free hospital bed availability for terminal or life-threatening COVID-19 patients and to minimize exposure to vulnerable immunosuppressed individuals like cancer patients during treatment or surgery. While this is done with careful consideration by the patients’ MDT, there is no guarantee that tumor progression is unaffected when the patient is not receiving treatment or is receiving an alternative treatment.

 

What Are the Implications for Cancer Surgery?

Capacity for surgery has been drastically reduced as operation theatre space and ventilators have been reallocated to provide for the critical care capacity of COVID-19 patients. Moreover, reports have shown that there is increased risk for contracting COVID-19 postoperatively for any non-COVID elective surgeries, making patients, especially vulnerable ones (i.e., cancer patients, immunosuppressed, and the elderly), more reluctant to undergo surgery in COVID-19 overflow hospitals. Studies conducted in China, Europe, and North America have shown that cancer patients, particularly lung-cancer patients, who contract COVID-19 have a higher risk of mortality, increased ICU admission risk, and severe clinical effects when compared to non-cancer COVID-19 patients. Additionally, a recent meta-analysis showed that all-cause mortality was significantly higher in cancer patients when compared to non-cancer patients, and similar to previous coronavirus outbreaks, the reported mortality rate was 84% in cancer patients compared to 39% in non-cancer patients, further demonstrating the vulnerability of cancer patients to the SARS-CoV-2 infection.

As a result, most MDT’s have opted to put their patients on neoadjuvant chemotherapy, radiotherapy, or hormonal therapy as therapeutic buffers until surgery become available again. However, these options are usually not effective as primary treatment options and therefore also increase the risk of cancer-associated mortality. In order to help oncologists and cancer surgeons navigate this complex field of decisions, the American College of Surgeons “has recommended that in early stages of the pandemic, semi-elective surgery, such as for nearly obstructing colon cancers, stenting for oesophageal cancers and most gynecological cancers, should continue.” In response, health care facilities like hospitals, cancer care centers, and surgical centers are trying to rapidly reorganize elective cancer procedures to ensure that cancer patients continue to receive all the essential care while minimizing their exposure to the deadly COVID-19 infection.

 

Conclusion

The COVID-19 pandemic has led to a catastrophic global disruption in the field of surgical oncology, severely delayed cancer diagnoses and treatment, and halted many ground-breaking surgical clinical trials. Many studies including Dr. Montorsi’s elective oncological survey, Mehta and Goel’s COVID-19 and cancer patient outcome, Rickards et al., study on COVID-19’s impact, have repeatedly tried to objectively quantify the impact of COVID-19 on cancer care. However, with the continuous progress of this pandemic, it has become impossible to gather data and understand the real-time effects on surgical care. While models are under development to try and ease this burden, much of the work to recenter surgical oncology remains to be done.

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FAQ: Colon Cancer Foundation’s Newly Formed Partnership with Backpack Health, a Konica Minolta Service

With the holiday season upon us, whether you meet with your family virtually or safely in person, keeping up to date on your health information and easily sharing it with your family members is a great gift. Additionally, knowledge about family health history is particularly important to understand your risk of colorectal cancer. During Thanksgiving and into the end of the year, take control of your and your family’s health information and consider joining The Colon Cancer Patient Registry on Backpack Health.

Aside from the physical challenges associated with colorectal cancer, managing the many health administrative aspects of a chronic disease is an added burden to the lives of patients and their caregivers. The Colon Cancer Foundation has recently announced a collaboration with Backpack Health, a Konica Minolta Service, to offer a solution that helps patients organize, share, and manage their health records. Living with a chronic illness doesn’t need to feel like a full-time job.

Similar to a real backpack, Backpack Health’s platform allows users to both portably store and access their health information via an app on iOS or Android phones, or via the website on a tablet or computer. Through the Colon Cancer Foundation’s group on Backpack Health, users living with colorectal cancer will be able to share their health information, including lab reports, information from their specialists, and medications, with designated family members and health care providers. All of the data users enter in Backpack Health is stored in the cloud, encrypted in Backpack’s database, and 256-bit encryption protects data sent over the network and secure HTTPS (HTTPS) sessions. To learn more about data security with Backpack Health you can visit here.

We have answered some frequently asked questions to help you get started with this new tool:

 

How do I join the Colon Cancer Foundation’s group?

You can join CCF’s group for FREE at https://my.backpackhealth.com/join/colorectalcancerregistry.

 

What is Backpack Health and how can it help me?

Backpack Health is a platform available on the web and in your mobile app store that can be used for storing your own and your family’s medical records, letting you access your health information anywhere and at any time. By having an organized location for your medical records, you can easily manage and share new information such as test results or care plans with your healthcare team and your family. Eliminating the administrative need of compiling records in a physical folder or journal can help keep your records secure and in one spot—to be accessed either on the website or the app.

Additionally, once you’ve made a data connection with your patient portal, you’ll see periodic notifications to review and add new data to your Backpack profile. The data connection scans for new information in your patient portal every few days, so you don’t have to worry about doing it yourself.

 

What are some important features of this tool?

You are in control of what information is shared, inputted, or viewed. As a user, you will have access to a user profile, where you can connect to your patient portals, include information about meal plans, medications, notes from your doctor, and so much more. Additionally, you can add family members, parents, or anyone you care for on your profile and include all of their health information, doctors’ contact information, etc.

Some features allow you to make personal notes or reminders to yourself, for when you visit your next specialist, for example. You can be reminded to ask your doctor if you can eat certain foods or use a certain product. Backpack Health is designed to make your health a priority, without consuming other aspects of your life.

 

Who can I share my information with?

 The Share Card feature on the platform puts you in charge of who sees your or your dependent’s health information. Some may choose to share their child’s health information with the school nurse or a new babysitter, with a family member that is accompanying you to a procedure, or even a friend you may be traveling with—the possibilities are entirely your choice, depending on what is best for you and your dependent’s health.

You have the option of creating a general health history Share Card and an emergency Share Card. You can also create custom Share Cards where you choose what information is displayed. The card can be shared as:

  • A secure URL
  • As a downloadable PDF

 

Are my healthcare providers able to edit my information?

No, your healthcare provider cannot edit your health information. However, you can create a data connection to your patient portal in order to pull in medical records that your provider has made available to you and store them in your Backpack profile.

You can also share parts or all of your health history with a new or existing provider by creating a Share Card and providing the URL and passcode to the person you want to review that information, or printing off a PDF.

 

What if English isn’t my first language?

Backpack Health is available for use in six languages (English, Spanish, French, Portuguese, Italian, and German), eliminating barriers between you and your health care team. This could also be a big advantage during international travel.

 

How will I know my health information will be secure?

Backpack Health explains on their security and privacy page that “All of the information you store on Backpack Health is encrypted. Information stored in the cloud is encrypted in our database, and 256-bit encryption protects data sent over the network and secure HTTP (HTTPS) sessions. Threat-detection services monitor Backpack Health’s systems continuously for unauthorized or malicious activity. And you can also keep your data extra safe on all of your devices by enabling two-factor authentication.”

Keeping your health information safe is a main priority.

 

What if I can’t figure out how to use Backpack Health?

No worries, you can watch this video, visit their website, or contact Backpack Health at health@backpackhealth.com!

 

 

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Naomi M. Sell, M.D. – SSO 2020 Dr. Thomas K. Weber Colorectal Cancer Research Scholar Award

– Describe yourself (Personal background, academic background, interests…)

I am a general surgery resident at Massachusetts General Hospital (MGH). I just completed two years (2018-2020) of dedicated research in the field of colorectal surgery and surgical oncology with a specific interest in colorectal cancer and surgical prehabilitation.

 I am originally from the California Bay Area but have done all of my education and training out east. My undergraduate years were spent at Johns Hopkins University and I subsequently received a Masters in Microbiology & Immunology from the Johns Hopkins Bloomberg School of Public Health. I graduated from Jefferson Medical College in 2015 with AOA distinction before heading up to Boston for my surgical training. I am now in the midst of my 6th of 7 years at MGH with plans to pursue a fellowship in colorectal surgery.

 

– Tell us about any awards and distinctions you have received

I have been fortunate to have received numerous prior awards for my research that has been presented at other regional and national meetings both in medical school and residency. In medical school, I was elected to AOA in my third year. In residency, I was named the General Surgery Consultant of the Year in 2018 by our MGH Emergency Medicine colleagues. My research work in prehabilitation was funded by an NIH T32 training grant and my NCT clinical trial is funded by numerous institutional grants.

 

– What made you interested in doing work in colon cancer?

Unfortunately, my family does have a history of colon cancer within it and I know firsthand the struggles that my family members have gone through. Therefore when I began residency, I had not originally believed that I would choose a career in colorectal surgery. However, once I rotated on our service here at MGH and interacted with the patients and was able to create personal connections with them based on shared experiences with this disease, I realized that this was my calling to treat these patients.

 

– Tell us about your past work and research efforts in the past and its significance to colon cancer

Much of my prior work was focused on colon cancer among octogenarians and how we can improve care for that population, which is significant given the growing number of aging citizens within this country paired with a longer lifespan. My latest work on this topic, which is to be published in Surgery next month, introduces the idea that older patients (>80) may have a different phenotype and both medical and surgical treatments may need to be tailored more specifically to their needs.

 

– Describe the current work you are conducting

 My current work is in surgical prehabilitation or “prehab” where I designed and am a co-investigator on a clinical trial purposed to investigate if exercise and nutritional prehabilitation benefits patients with gastrointestinal cancers. Specifically, we are investigating if these prescribed modalities improve surgical outcomes, survival, tumor biologics, and quality of life. The progress of our trial, unfortunately, got a bit derailed by the pandemic but we are hoping to restart this fall.

 

– What is your mission and goals in the current work that you are doing?

Currently, there is a time window between the date of colon cancer diagnosis and the date of surgery that is not being optimized to its full potential. My goal is to introduce prehab into this time window. During this time, we should be building our patient’s cardiopulmonary fitness and increasing their protein reserves in preparation for the stress of their surgery. Just as runners train for a marathon, we should be preparing our patients. My mission is to determine the optimal components of prehab, personalize them for individual patients, and ultimately prove the benefit that I believe exists.

 

– What are your goals for your future?

 My short-term goals are to successfully complete a residency in June 2022 followed by a fellowship in colorectal surgery. Long-term I plan to become an academic colorectal surgeon with both clinical and research pursuits that continuously try to improve care for patients with colon cancer.

 

– When did you first know that you wanted to work in this particular field of research, and why were you so passionate about that?

 As a former college athlete, I have always been interested in how I can intersect exercise and surgery. The concept of prehabilitation was speculated upon in some of my early readings in residency and I was fortunate to find a mentor who shared a passion for this topic. This helped me harness my focus and work on this particular field during my two years of dedicated research within residency.

While working on prehab and speculating on how exercise might be able to affect tumor biology, the topic of pathologic complete response (pCR) arose. We speculated, could exercise work synergistically with neoadjuvant therapy to promote a pCR? This is entirely pure speculation as there is currently no data to that exists to study this idea, however, it did spark my interest into pCR and led to the research project for which I received this award.

 

– For those who may not have the scientific background that you do, why is it so important that we all support the research being done in the field of colon cancer treatment and prevention?

It is tremendously important! Despite having great screening tools, colon cancer is the second leading cause of cancer death in this country. So much work is still left to be done and research support is critical so that physicians and scientists can continue to make improvements on how this disease is detected, treated, and ultimately prevented. 

 

– How has this award changed your life so far?

I am extremely grateful for this award. It has been incredibly beneficial for my career already in that it has sparked new acquaintances and conversations with other leaders and researchers of colon cancer. My hope is that some of these conversations turn into collaborations to help unite and synergize our efforts to fight this disease.

 

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