Mary Caffrey

Investigators in Canada are studying whether a drug developed to enhance the effects of immunotherapy can be used to protect vulnerable patients with cancer from the worst effects of coronavirus disease 2019 (COVID-19), especially severe respiratory infections.

People with cancer are at higher risk of infection with severe acute respiratory syndrome coronavirus 2 (SARS-2-CoV), the virus that causes COVID-19, and if they develop the disease, it’s deadlier. Add in deferred care and the fact that those who receive a new diagnosis of cancer are typically older with comorbidities, and it’s no wonder that the National Cancer Institute projects that the US streak of improved cancer mortality is likely to end after more than 25 years.

An investigational drug, IMM-101, may help. Under development by Immodulon, IMM-101 is a heat-treated Mycobacterium preparation that is being studied for its ability to both increase the effects of immuno-oncology agents and allow them to be used in combination with fewer toxic effects.

 This new study, to see if the drug can prevent or lessen the effects of COVID-19 among those with cancer, got under way in late August, and the first results could be known by the end of the year.

Chris O’Callaghan, PhD, senior investigator at the Canadian Cancer Trials Group, explained that Rebecca Auer, MD, MSc, FRCSC, a colorectal surgeon at Ottawa Hospital Research Institute, conceived of the idea that IMM-101, could be used in other ways to boost patient immunity. First, Auer studied the use of IMM-101 post-surgery, and then she suggested it could protect cancer patients from COVID-19’s respiratory wrath, O’Callaghan said. In an interview with 

™, O’Callaghan said the mechanism of IMM-101 makes it a particularly good candidate to give patients a measure of protection against respiratory ailments, even though it’s not being developed as a vaccine against SARS-2-CoV.

“IMM-101 is a mycobacterial cell preparation, and it’s very analogous to something called the BCG vaccine,” O’Callaghan said, referring to Bacillus Calmette-Guérin, a tuberculosis vaccine developed in the 1920s that is still used worldwide, although not in the United States. “That vaccine has been noted to have a side effect in not only preventing or reducing the risk of tuberculosis, but it also reduces the risk of multiple other respiratory infections. “So it’s not specifically targeting what most vaccines that we’re familiar with are deriving, what we would call ‘specific immunity’ in the context of the BCG vaccine,” O’Callaghan continued. The BCG vaccine, he explained, is known to have a “side effect of immunity,” in “innate immune response,” or the part of the immune system that reacts any time it encounters a bacterial or viral infection.

“We’re capitalizing on the fact that we know that the BCG vaccine has this side effect, if you will,” he said. And, he said, it should not be a surprise that the century-old BCG vaccine is also in clinical trials asking the same question about COVID-19 protection.

But the BCG vaccine has been administered to healthy people. Those with cancer are already immunocompromised. Isn’t that a risk?

O’Callaghan said the key difference is that IMM-101 is a killed vaccine, one that has already been tested in more than 300 cancer patients. “It’s very, very safe, and it has been used with very
minimal side effects,” he said.


Articles

An investigational drug, IMM-101, already being studied for its ability to increase the effects of immuno-oncology agents, may be able to prevent or lessen the effects of COVID-19 among those with cancer.

Drug That Boosts Immunotherapy Studied as Tool to Battle COVID-19 in Patients With Cancer

After this article went to press, CMS announced that the Radiation Oncology Model will be delayed until July 1, 2021. For more,

A new alternative payment model (APM) for radiation oncology (RO) has drawn fire from providers, who say a mandatory shift to bundled payments in the middle of a pandemic is unfair. 

Transitions cost money, and many have none to spare. CMS Administrator Seema Verma vowed full steam ahead when she finalized the RO Model on September 18, claiming the change that takes effect January 1, 2021, would save $230 million over 5 years and likely mean lower out-of-pocket costs for Medicare beneficiaries.

“Today, Medicare payment for radiotherapy is based on the number of treatments a patient receives and where they receive it, which can lead to spending more time traveling for treatment with
little clinical value,” she said in a statement.

Radiation oncologists have been bracing for a move to a bundled payment model for a while. But they say the timing—in the wake of staffing shortages caused by the coronavirus disease 2019 (COVID-19) pandemic—could not be worse. The American Society for Radiation Oncology (ASTRO) argues that the planned start date is too aggressive for a model that would be mandatory for 30% of providers, and the group said it would go to Congress to seek relief.

“The transition to value-based payment will require significant practice changes and investments to comply with the model’s requirements. ASTRO strongly urges CMS to significantly delay the start date rather than foster unnecessary chaos and burden for the practices this model is designed to support,” the group said in a statement.

The American College of Radiology echoed these concerns.

The RO Model was in the works well before COVID-19, as CMS has been determined to create a payment structure that is site neutral and rewards outcomes, not how many times a patient
receives radiation. Historically, payments have been doled out bit by bit, giving providers an incentive to keep treating and billing. CMS argues that evidence shows “for some cancer types and beneficiary characteristics, a shorter course of [radiotherapy] treatment with more radiation per fraction may be clinically appropriate.”


The RO Model calls for bundled payments over a 90-day episode of care, which would go to radiotherapy providers who treat 1 of 16 cancer types. CMS said it would require participation from
physicians in randomly selected geographic areas covering 30% of all current Medicare fee-for-service episodes (the initial proposal was 40%). The model has a 5-year performance period that would run through December 31, 2025.

According to a CMS fact sheet, the episode payments would be split into 2 components: the professional and technical pieces, which would allow the existing claims systems for the Physicians’
Fee Schedule (PFS) and the Hospital Outpatient Prospective Payment System (OPPS) to be used to pay claims.

A chief mission of the model, according to CMS, is to emphasize “site-neutral payment by establishing a common, adjusted national base-payment amount for the episode, regardless of the setting where it is furnished.”

Payment will be linked to quality through performance measures, clinical data reporting, and patient experience factors. The model allows providers to meet Advanced APM requirements under the Quality Payment Program. Beneficiaries must be notified their provider is taking part in the RO Model.


The RO Model calls for participant-specific payments that take into account a mix of national base rates, trend factors, and “adjustments for each participant’s case mix, historical experience, and geographic location.” CMS then applies a complex system of discount factors. But CMS will be basing 90% of the payment on a practice’s historical payments from 2016 to 2018, even though an ASTRO released in May found that 85% of members reported a decline in visits due to COVID-19, by an average of one-third.

“While these volume declines won’t impact the historical experience data, they likely will impact other aspects of the model, most notably the payment adjustment that accounts for case mix, as we
expect more patients to present with more complex disease due to delayed screening. These issues will likely confound at least the first year of CMS’ evaluation of the model,” Dave Adler, vice president for Advocacy, ASTRO, told 

“Skewed results in the first evaluation report would start the program off on the wrong foot and jeopardize the future of the model. This is an important reason to delay the model until after the pandemic.”

asked if the amounts of bundled payments in the early part of the model could be under valued, as most experts predict a wave of patients with advanced cancers will be diagnosed in late 2020 or early 2021 due to missed screenings. Adler said this is possible.In their statement, ASTRO providers said they remained committed to working toward a value-based payment model, but under the current circumstances they believe a voluntary phase is needed first.

“ASTRO has worked with CMS and bipartisan legislators for several years toward a viable payment model for radiation oncology that would support stable and fair payments, drive adherence to nationally recognized clinical guidelines, and improve patient care,” the statement said. “We are hopeful that CMS and Congress are open to reconsidering a start date that would be realistic and not derail this unique opportunity.”

Adler said ASTRO will seek a delay of implementation until July 1, 2021—and potentially later if the pandemic persists—and to reduce the discount factor payment cuts to 3%. This would put the discount factor cuts in line with other models from CMS, he said.


CMS’ details suggest that along with bundled payments to providers, the current 20% coinsurance paid by benefi ciaries would be configured differently. “Since CMS applies a discount to each
component of the bundled payment, the agency expects that beneficiary cost sharing would be, on average, lower relative to what typically would be paid under Medicare’s fee-for-service system,” the fact sheet states.

The model covers 16 diagnoses that account for the vast majority of solid tumor cancers: anal cancer, bladder cancer, bone metastases, brain metastases, breast cancer, cervical cancer, central nervous system tumors, colorectal cancer, head and neck cancer, liver cancer, lung cancer, lymphoma, pancreatic cancer, prostate cancer, upper gastrointestinal cancer, and uterine cancer.


1. CMS announces innovative payment model to improve care, lower costs for cancer patients. News release. CMS. September 18, 2020. Accessed September 18, 2020. https://www.cms.gov/newsroom/pressreleases/
cmsannouncesinnovativepaymentmodelimprovecarelowercostscancerpatients
2. ASTRO responds to CMS Radiation Oncology Model: implementation delay and more reforms needed. News release. ASTRO. September 18, 2020. Accessed September 18, 2020. https://www.astro.org/NewsandPublications/NewsandMediaCenter/NewsReleases/
2020/ASTROrespondstoCMSRadiationOncologyModelImp
3. ACR joins ASTRO in urging CMS and Congress for changes to RO Model. News release. ACR. September 21, 2020. Accessed September 23, 2020. https://www.acr.org/AdvocacyandEconomics/AdvocacyNews/
AdvocacyNewsIssues/IntheSept262020Issue/
ACRJoinsASTROinUrgingCMSandCongressforChangestoROModel
4. Radiation Oncology (RO) Model fact sheet. CMS. September 18, 2020. Accessed September 18, 2020. https://www.cms.gov/newsroom/factsheets/radiationoncologyromodelfactsheet
5. ASTRO survey: fewer patient visits despite enhanced COVID19 safety measures for radiation oncology clinics. News release. ASTRO. May 20, 2020. Accessed September 23, 2020. https://www.astro.org/NewsandPublications/NewsandMediaCenter/
NewsReleases/2020/ASTROsurveyFewerpatientvisitsdespiteenhanced

A discussion of the final Radiation Oncology Model; after this article went to press, CMS announced a delay until July 2021, reflecting concerns of radiation oncologists.

Too Much, Too Fast: Providers Push Back on CMS’ Final RO Model

For a time, managed care preached that patients should pay some part of every service or medication they receive, lest they not have “skin in the game.”

But A. Mark Fendrick, MD, director of the Center for Value-Based Insurance Design at the University of Michigan and co-editor-in-chief of 

®, feels that there are some services, screenings, and medications that are so essential to life and health—and so key to avoiding long-term costs—that it’s cost-effective to skip out-of-pocket costs altogether.

It starts with identifying “high value” and “low value” care, because eliminating waste can pay for the screenings that save lives down the road, Fendrick said. In oncology, he said making these distinctions is hard work and takes courage, as he led a discussion on the state of value-based insurance design (VBID) in oncology, during the second day of the Community Oncology Alliance Payer Exchange Summit. Joining Fendrick were:

Neil Goldfarb, president, CEO, Greater Philadelphia Business Coalition on Health

Alti Rahman, MHA, MBA, CSSBB, practice administrator, Oncology Consultants

Barry Russo, MBA, CEO, The Center for Cancer and Blood Disorders, based in Forth Worth, Texas

“I like to think VBID is the new skin in the game,” Fendrick said, explaining that while it did not take a pandemic to show the importance of the idea, the effects of coronavirus disease 2019 (COVID-19) on oncology practices certainly highlight the need to tear down every barrier to cancer screening, as attendees heard evidence of skipped mammograms and colorectal cancer screenings—which, in turn, have led to patients showing up now with more advanced cancers.

Ending cost-sharing for key cancer screenings was a big win for VBID in the Affordable Care Act (ACA), but Fendrick said the work wasn’t done: more recently, the center has worked to implement an Internal Revenue Service rule that allows services and drugs for certain chronic conditions to be coverage “pre-deductible.”

“As everyone in the oncology field knows, when the year turns and deductibles reset our oncology patients are really in very tough financial terms,” he said, as patients often had to pay list price for cancer drugs, even if they’ve been taking them for a while. CMS has slowly incorporated more VBID concepts into more payment designs, including some for 2021.

“I’m curious to see how the oncology community would feel about a more nuanced approach to spending,” Fendrick said.

Goldfarb said he’s endorsed VBID for some time, but the challenge for employers is, “How do you actually go about doing this?” And even if VBID designs bring savings, is it worth the effort? Overcoming inertia is tough, he said, in part because, “We don’t necessarily know what is high-value or low-value care in oncology, particularly when we get beyond prevention to treatment and survivorship.”

Rahman said there are multiple considerations:

(1) getting VBID to work requires sharing information, and there are federal and state laws that can limit transfer;

(2) the transition of financial risk cannot be “passive,” because the decision-making drives movement toward high-value care;

(3) more transparency is needed, because “it’s still very difficult for patients to understand what they’re paying for; and

(4) much of what affects cancer care happens first in primary care or other specialty care, and while there are alternative payment models in these areas, they aren’t yet aligned with oncology models.

The mixed progress means that patients can still face huge out-of-pocket costs, which Fendrick says leads to results that no one should find acceptable. “I just think that my patient should not have to have a bake sale, or start a Kickstarter campaign to be able to get a cancer drug that she and her oncologist agree was designed specifically to treat her tumor,” he said.

But Russo said the hunt for cost savings, aided by technology, can yield insights of “low-value care” that would go undiscovered without the pressure of shared risk. “Clearly, there's some low hanging fruit that's easy to identify. But then when you get into the weeds, it's going to be a whole lot more complicated. And the definition of that really evolves,” he said.

Value-based insurance design has made gains in oncology, but there's more work to do.

Bringing Value-Based Insurance Design to Oncology: The New “Skin in the Game”

Paris, Texas, with a population of about 25,000, is a long way in both miles and culture from Detroit, Michigan, where Sucharu “Chris” Prakash, MD, completed a fellowship in oncology and hematology.
The city near the Red River that forms Texas’ boundary with Oklahoma offered an easier pace of life, friendly people, and a good place to raise a family, so 20 years ago Prakash and his wife made it their destination.

Prakash joined the Paris office of Texas Oncology, which serves patients across Texas’ Northeast corner, as well as some from Oklahoma. Now the area medical director, Prakash is passionate about bringing better care to his patients, and he serves on state and national-level committees to address the challenges of rural health care, including the American Society of Clinical Oncology’s Rural Cancer Care Task Force.

Rural health care delivery faces many challenges—from logistics, to finances, to keeping abreast of the scientific revolution in cancer care. Prakash points out that 60 million people, or about 19% of the US population, live in areas considered rural based on the Census Bureau’s definition, and that’s too many people too ignore.

From his vantage point, he sees the many disparities among rural patients—the residents are older, with less education and income than their urban counterparts. When cancer occurs, the outcomes are generally worse.

 “They are diagnosed later,” so mortality is higher, he said. “Access to care is a major issue—that impacts screening and treatment. There are major barriers to insurance coverage and transportation.”

And, within the population are pockets that are particularly high risk: Native Americans, for example, have above average rates of alcohol abuse and higher rates of obesity.

 Veterans often cannot travel long distances to the nearest VA center for care.


Work by the ASCO task force that Prakash joined in 2019 led to a report in June 2020,

 “Closing the Rural Cancer Gap: Three Institutional Approaches,” which identified the same disparities that Prakash sees every day, and more:

• While death rate from cancer are have fallen in both rural and urban areas, they are falling more slowly in rural areas.
• Rural patients have worse health outcomes in survivorship than their counterparts elsewhere, and this is especially true in the South, Appalachia, in tribal communities, and along the US-Mexico border.

• Rural patients are diagnosed later and less likely to receive stand-of-care treatment, follow-up or supportive services than patients in metropolitan areas.

In addition, the ASCO report highlighted the challenge of geography is connecting patients with providers. While the percentage of oncologists in rural counties has expanded somewhat since
2014, data from 2019 show that 12% to 15% of oncologists work in rural settings, and about 20% of rural Americans live more than 60 miles from an oncologist.

“These higher percentages of oncologists practicing in rural areas, however, remain smaller than the share of US population residing there,” the report said.


A major challenge, for both patients and providers, is insurance coverage and reimbursement. The Affordable Care Act (ACA), passed in 2010, was designed with the idea that Medicaid expansion would reach every household with incomes up to 138% of the poverty level. When the Supreme Court allowed states to decide whether or not to expand Medicaid, only half did in 2014, and 12 still have not as of October 1, 2020—including Texas.

 In states with Medicaid expansion, safety-net hospitals saw large drops in uncompensated care, but this was not so in non-expansion states

 Over the past decade, the closure of rural hospitals has been a story across the South

—and Northeast Texas has been hit especially hard, according to data from the University of
North Carolina.

Even when patients have Medicaid, it might not be enough. Depending on where patients live, if reimbursements are too low, not all doctors will accept this form of coverage.

Prakash sees these effects at the individual patient level, as well as the snowball effect that lack of coverage creates across the health system. Many families do not qualify for the tax credit that would allow them to buy coverage on the ACA exchanges, but either they cannot afford coverage, or they do not get it through an employer. “This lack coverage limits access,” he said. “They cannot get their basic  screenings.”

When these patients are eventually diagnosed with cancer, providers must figure out how to absorb the costs, whether it’s through foundation help or patient assistance programs. Add in pressures from the 340B program and pharmacy benefit managers, and the situation can make it hard to attract the best talent, despite the good quality of life in the area. “The hospital is struggling to recruit, because everyone is aware of the problem,” he said.


Historically, fewer patients from rural areas have taken part in clinical trials because they lived too far from academic centers.

 Being part of the Texas Oncology/US Oncology network has allowed Prakash to enroll his patients in clinical trials, and he finds them eager to participate. Rural patients, he said, “are tough and smart and highly adaptable—they reach down and gather strength. If they trust in God, they trust their physician,” he said.


Willingness on the patients’ part is only part of the equation. Trials need enough patients to support a research nurse, for example. Prakash said that ASCO recognizes the inequity that rural patients have experienced, and leaders have worked with rural providers to ease eligibility criteria and protocol design, so that rural patients can participate.


CMS has experimented with rural health care models, but past efforts were limited to certain states. In August, as part of an effort called “Rethinking Rural Health,” the agency updated payment rules under the Inpatient Prospective Payment System (IPPS) to take effect for fiscal year 2020 (October 1, 2020), which officials said were designed with rural providers in mind.

 Although not specific to cancer care, the rule changes purport to address financial disadvantages that rural providers experience. And CMS then launched a payment model, called CHART, that addresses a long-standing complaint about the definition of “originating site” in telehealth, which had been a barrier for providers.

• address wage index disparities by improving the accuracy of the calculation, and change the way the “rural floor” is calculated;
• increase the wage index for hospitals below the 25th percentile; and
• implement a required increase for hospitals taking part in a quality reporting program.

With CHART, which stands for Community Health Access and Rural Transformation, CMS will provide funding to support new payment models, regulatory flexibility, and technology support to implement value-based capitated payment models that will allow an outpatient department or emergency room to be reimbursed as if they were a hospital.


The latest game changer has been the coronavirus disease 2019 (COVID-19). The pandemic has opened the door to telehealth on a scale not seen previously. Not every visit is appropriate for telehealth, as some patients still use a flip phone or want to see their doctor in person. But like many others, Prakash believes there’s no going back, and CMS has proposed making some aspects of the telehealth rule change permanent.

Telehealth is poised to have “a profound impact,” beyond patient care and research, he said, because it offers possibilities for provider education and training for rural physicians, to “reduce the isolation, especially for early career oncologists.”

He sees virtual training as a tool to ensure there is better mentorship and support, and opportunities for young oncologists to more fully participate in major scientific meetings when they simply cannot take time off.

Long term, Prakash sees a need for development of the oncology work force in rural areas; this will require regulatory relief to improve the clinical trial staff and provide the psychological, nutrition, and support services that patients should expect. Meeting the needs of patients who often cannot afford their care is not easy, he said. “It is challenging. They need someone who is dedicated.”

But spending time with each patient, and learning their social and psychological needs has its benefits, too. “You do make a difference in the community. And people appreciate what you do.” 


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A look at the special challenges of delivering cancer care in rural areas, as ASCO seeks to address this issue.

Author | Mary Caffrey

Articles

Drug That Boosts Immunotherapy Studied as Tool to Battle COVID-19 in Patients With Cancer

Too Much, Too Fast: Providers Push Back on CMS’ Final RO Model

Bringing Value-Based Insurance Design to Oncology: The New “Skin in the Game”

Understanding the Challenges of Rural Cancer Care