Coverage From ACCC 2023 Spring Business Summit

Stops and Starts Abound in the Oncology Payment Landscape

The landscape of policies and processes surrounding cancer treatment and financial aspects of care is evolving, with each new rule affecting oncologists and patients. In a presentation March 10 at the Association of Community Cancer Centers (ACCC) 2023 Annual Meeting and Cancer Center Business Summit, government affairs experts reviewed updates and considerations involving several policies.

During the “Emergent Payment Issues in Oncology” session, Jennifer Walsh, director of public affairs at Foley & Lardner LLP, and Adria Warren, a partner with the law firm, gave overviews on Cures 2.0, the No Surprises Act (NSA), and the 340B Drug Pricing Program.

The Halt of Cures 2.0
Walsh opened the presentation with an overview of the Cures 2.0 Act, a follow-up to the 21st Century Cures Act, which was signed into law in 2016 and still has funds to be distributed. Cures 2.0 was introduced in the US House of Representatives by Reps Diana DeGette (D, Colorado) and Fred Upton (R, Michigan) in November 2021. The legislation was well received by cancer care providers, associations, and other stakeholders.

“The legislation received high praise from stakeholders in the cancer community, and included provisions aimed at speeding up the delivery of groundbreaking cures, treatments, and innovations to patients. Further, it modernized certain aspects of the Medicare program, including those related to clinical trials,” Walsh said.

The bill also included extensions for a variety of programs and allocated $6.5 billion for the establishment of the Advanced Research Projects Agency for Health at the National Institutes of Health, which aims to facilitate expedited research for the prevention, detection, and treatment of a host of diseases, including cancer.

Although the bill did not move through the normal legislative process, several provisions were included in a 2022 Consolidated Appropriations Act. Some provisions from the PREVENT Pandemics Act were also included in the year-end omnibus act. The path forward for the remaining provisions remains unclear, Walsh said, although there is still hope that some will eventually pass and that additional funds will be reauthorized for cancer research.

Legal Challenges to NSA
The NSA, a federal law protecting patients from some types of unexpected medical bills, was signed into law as part of a larger year-end omnibus package in 2020. Under the legislation, practices such as surprise bills for emergency services—even out-of-network services that did not receive prior authorization—are banned. This includes bills that patients reasonably could not have expected, such as being treated by out-of-network providers at an in-network hospital, for example.

In 2021, HHS released the first rule, which outlined the patients covered by the law: those who are covered by job-based and individual health plans, who get emergency care, nonemergency care from out-of-network providers at in-network facilities, and air ambulance services from out-of-network providers.

A second rule in 2021 established a process for independent dispute resolution (IDR) to resolve disputes between providers and health plans. The Texas Medical Association sued CMS—arguing that the IDR process skewed in favor of commercial insurers—and won, then sued again and won again.
“Now we’re awaiting the third and hopefully final version of this rule on how the IDR process is supposed to work,” Walsh said. “Meanwhile, all of this created significant backlog within the IDR process, compounding the backlog where the massive number of claims being filed [was] beyond what was originally anticipated. As a result, CMS had to pause and then later resumed the IDR process. But it’s really not going to be effective until HHS issues that updated rule on the criteria that arbiters must consider to reach a decision on payment for services.”

Ongoing Issues With 340B
Although the 340B Drug Pricing Program intends to help safety-net providers deliver comprehensive care and effective drugs to more eligible patients, it has not been without challenges.

The 340B program gives eligible entities significant discounts on covered outpatient drugs by establishing a ceiling price that these entities can pay for the drugs. Eligible entities include certain public and nonprofit hospitals, federally qualified health centers, entities with certain federal grants, and outpatient clinics at eligible hospitals. Private practices are not eligible—which community oncologists argue has contributed to the consolidation of oncology care to the hospital setting.

“For many drugs, the 340B pricing is the lowest price that’s offered by manufacturers,” Warren said. Capping what covered entity spends on drugs before the institution seeks reimbursement, and allowing it to keep the difference in margin, can allow reinvestment in the hospital and the community, “ideally, and despite some of the things you can see in the newspaper,” Warren said.

“As a health care transactions lawyer, I should note that the 340B program is an important consideration for hospitals that are considering opening provider-based outpatient oncology centers, and it continues to be a factor,” she said. The reimbursement for provider-based outpatient departments was reduced in the Bipartisan Budget Act of 2015, which applies to provider-based hospital outpatient departments that did not exist before November 2015. However, 340B pricing is still available for new hospital-based centers that meet the requirements.

In 2018, CMS reduced the reimbursement by almost 30% for drugs acquired via the 340B program—the intention was to approximate the discount received by 340B entities when purchasing from manufacturers, but this effectively shifted savings generated by the program from providers to Medicare, Warren said.

Litigation followed immediately, but CMS continued this track until June 2022 while litigation made its way through the courts. Last year, the US Supreme Court ruled in favor of the hospitals.

“The implications of the decision for 340B-covered entities [are] enormous, because its implication is not just for 2018 and 2019, but the years since,” Warren said. “The estimated reimbursement amount in CMS’ opinion is $1.96 billion to hospitals.” The ruling was that CMS did not follow the proper processes for varying those payments, she said.

CMS is required to implement the payment and changes in a budget-neutral manner, which it also did in 2018 and presumably increased payments for other services and non-340B drugs as budget offset. The Supreme Court did not propose a remedy or suggestions to “unscramble the egg,” as Warren put it. There is also the question of how CMS will address the retroactive period, although it began reimbursing at the higher rate again immediately. Additional rulemaking is expected in April 2023, Warren noted.

Commercial payers and pharmacy benefit managers are also considering rate cuts, and Congress and the states are considering ways to eliminate price discrimination for 340B entities. On the other hand, litigation brought by drug companies to limit the use of contract pharmacies to distribute 340B drugs was successful, which restricts the use of outside pharmacies for entities who have in-house pharmacies, with a series of cases ongoing.
In addition to ongoing processes, Walsh and Warren emphasized the dynamic landscape of oncology payment and reimbursement policy, highlighting a reignited Cancer Moonshot initiative, the launch of the Enhancing Oncology Model, delays in the Radiation Oncology Model, and merit-based incentive payment and value-based care arrangements. 

Multicancer Early Detection May Change the Screening Game—if We Learn From the Past

Catching cancer in its early stages is essential to improving outcomes for patients, and multicancer early detection (MCED) technology has potential in this area. But anticipating and addressing potential risks from the oncology and primary care standpoints is crucial to maximizing the potential of MCED testing.

A presentation at the Association of Community Cancer Centers 2023 Annual Meeting and Cancer Center Business Summit, held March 9 through 10, 2023, in Washington, DC, focused on progress made in MCED technology and the pros and cons of MCED testing from a primary care physician viewpoint. Tomasz Beer, MD, FACP, vice president and chief medical officer of multicancer early detection at Exact Sciences, Portland, Oregon; and Christopher V. Chambers, MD, professor and director of clinical trials in the Department of Family and Community Medicine at Thomas Jefferson University in Philadelphia, Pennsylvania, presented the session.

“The concept of MCED is to develop a single blood test that is capable of detecting multiple cancer types. The idea here is that if we’re successful, we’ll substantially expand the reach of early detection beyond the 4 standard of care (SOC) cancers that we have today and will identify cancers in the earlier stages when you’re more amenable to effective therapies,” Beer said. “Because these tests are blood tests, [there is] opportunity to expand access to screening, including hard-to-reach populations.”

Although routine screening is recommended for breast, colorectal, cervical, and lung cancers, Beer noted that the highest cancer incidence and cancer-related deaths are from cancers that do not have SOC screening recommendations. MCED testing has potential to increase the number of cancers that can be identified early with regular testing, and the simplicity of a blood draw may help expand access to underserved communities.

Beer cited results from DETECT-A (NCT04161716), the first ever, large, prospective study of MCED testing, which included 10,006 women aged 65 to 75 years who did not have a history of cancer.¹ Incorporating MCED testing in addition to SOC screening more than doubled the number of cancers identified through screening, and more than half of the cancers detected were localized or regional stage I to stage III cancers.

The 26 cancers identified by MCED testing in the study were in 10 different organs, only 3 of which (breast, colorectal, and lung) had SOC screening protocol. Beer also cited a study presented at the European Society for Medical Oncology Congress comparing a 3-biomarker design with a 4-biomarker design. With a 4-biomarker design, overall sensitivity was 61% (95% CI, 56.9%-65.0%) and specificity was 98.2% (95% CI, 97.1%-99.4%).2 The sensitivity is lower than that of single-cancer detection, Beer noted, but given the broad range of cancers MCED can detect, this sensitivity result is encouraging.

The potential benefits of MCED testing are substantial: early diagnosis of a range of cancers, the majority of which have no screening recommendations in place, as well as a high specificity design that would limit false positives. However, drawbacks would affect not just patients but also physicians.
“Unfortunately, medicine is full of examples of where technology was way ahead of our understanding about how best to apply it [and] how best to implement it into care,” Chambers said. “So, I think we should be wary as we move forward to make sure we do this correctly.”

Chambers lauds the advances that have resulted from progress in genomic testing, such as targeted therapies and personalized medicine. But in other instances, genomic testing has increased stress on patients and their primary care physicians—at his practice, for instance, the popularity of at-home genetic testing led to an influx of patients concerned about the risk of certain health conditions based on their gene variants.

Patient stress is also a concern due to the possibility of false positives, which can lead to overdiagnosis and overtreatment, as well as increased health care system costs. From a patient’s perspective, there may be a significant level of anxiety while waiting for results or in the case of a false positive.

Another worry is that patients may be inclined to forego SOC screening, which would still be recommended even when MCED testing is implemented.

In addition to concerns surrounding patient reactions to MCED testing, there is a question of accessibility when new, potentially impactful technologies are introduced. On one hand, the relatively easy process of drawing blood for an MCED test could bring screening to underserved areas where it may be difficult to access the equipment needed for SOC screening. But if history repeats itself, the latest technology might not reach those who could benefit from it.

“The history of medicine is that new technology is not applied equitably when it first comes out,” Chambers said. “Later, if it’s shown to be useful and helpful, it might be covered by insurance, and then more people will have access to it. As it stands now, it might be only available to people who have more dollars.”

Like any novel technology, there are advantages and disadvantages to be considered and lessons that can inform the implementation of MCED in the future. Gradual and intentional introduction of MCED testing is crucial, both presenters agreed.

“We’re mindful of the lessons of the past about overdiagnosis and overtreatment and focusing the development of this assay on detecting clinically significant cancers,” Chambers said. “And we’re deeply concerned about cancer disparities—these are readily apparent, [and] all of us are keenly aware of the fact that novel technologies historically have at least initially exacerbated, not closed, disparities in care for cancer. So, we want to develop this assay in a manner that enables us to reduce disparities rather than contributing to [them].” 

References
Lennon AM, Buchanan AH, Kinde I, et al. Feasibility of blood testing combined with PET-CT to screen for cancer and guide intervention. Science. 2020;369(6499):eabb9601. doi:10.1126/science.abb9601

Douville C, Nobles C, Hwang HJ, et al. Multi-cancer early detection through evaluation of aneuploidy, methylation, and protein biomarkers in plasma. Ann Oncol. 2022;33(suppl 7):S27-S54. Abstract 73P. doi:10.1016/annonc/annonc1037

CRISPR Holds Promise in Cancer Treatment, but Challenges Remain

CRISPR genome editing is a game-changing technological advance that earned its inventors a Nobel Prize, but this innovative technology comes with logistical challenges and has been the subject of controversy. In the first keynote session at the Association of Community Cancer Centers 2023 Annual Meeting and Cancer Center Business Summit, held March 9 through 10, 2023, in Washington, DC, the history of CRISPR genome editing and its potential in cancer and other settings took center stage.

Keynote speaker Kevin Davies, PhD, founding executive editor of The CRISPR Journal; editor at large of GEN Biotechnology; and author of Editing Humanity: The CRISPR Revolution and the New Era of Genome Editing, Breakthrough: The Race to Find the Breast Cancer Gene, and Cracking the Genome: Inside the Race to Unlock Human DNA, took attendees through the development of CRISPR along with progress and setbacks up to the present day.

The presentation also served as a celebration of the 70th anniversary of the discovery of the double helix, an essential first step to modern-day genomic sequencing and gene editing technology. Advances in next-generation sequencing revolutionized genomic research, making it possible to sequence and analyze the genome in much less time and at a lower cost.

“All these advances in what they call next-generation sequencing were the first glimpses that we had the tools to change the sequence of DNA,” Davies said.

CRISPR technology was inspired by the way some microbes defend themselves by storing parts of DNA from viruses or other threats within DNA segments called CRISPRs (clustered regularly interspaced short palindromic repeats). If the threat returns, stored bits of RNA are helped by an enzyme called CRISPR-associated sequence (Cas), which guides CRISPR segments to the invading DNA. CRISPRs, often compared to a trusty pair of scissors, can then target and cut through those DNA sections. This discovery inspired researchers to create CRISPR tools and CRISPR-inspired tools capable of editing human genome, usually with Cas9 enzymes.

“When you cut the DNA, many things can happen. It could either be repaired naturally by the cell—sometimes we want it to repair and literally break up the original sequences; we’re trying to disrupt something,” Davies said. “Or we could provide a foreign replacement gene or sequence and have it stitched in there. So that’s the basis of CRISPR.”

Several patients with sickle cell disease have been successfully treated with CRISPR using an ex vivo editing approach, and FDA applications may be imminent, Davies noted. In the context of cancer, CRISPR is thought to hold significant potential. Although using an ex vivo approach has been successful in the clinic, he added, it is not ideal.

“This is not an easy or cheap or even scalable procedure, so many experts and physicians feel we’ve got to move towards a more of an in vivo approach, meaning some sort of injection we could just give directly to the patient that should be easier and much less expensive,” Davies said.

One potential implementation of CRISPR is in the development of chimeric antigen receptor (CAR) T cells. CAR T-cell therapy, which entails reintroducing genetically engineered cancer-targeting CAR T cells to a patient, is a form of immunotherapy that expanded the treatment armamentarium for a number of hematological cancers.

Davies cited a case in which an adolescent girl with a form of T-acute lymphoblastic leukemia thought to be incurable responded well to CAR T base edited cells. Base editing utilizes CRISPR as a sort of delivery system to attach different enzymes that can perform more precise “DNA surgeries.”

“The current estimate is that about 200 patients have received or are currently receiving some form of CRISPR gene editing in clinical trials,” Davies said. “So, this isn’t science fiction anymore—this is actual, medical fact.”

CRISPR has also been the subject of controversy, Davies said, particularly in 2015 when a team of Chinese researchers edited the genes of a human embryo aiming to make the baby immune to HIV. Other scientists argued that the study was not addressing an unmet medical need and called the ethics of the experiment into question. Utilizing CRISPR in the context of disease treatment does not live within the same ethical gray area as the embryo experiment, Davies noted, because those edits are somatic and do not pass on to offspring.

Despite the astounding possibilities of CRISPR, Davies highlighted concerns surrounding care access and potential disparities due to the high cost of the latest, most high-tech therapies.

“There are still concerns that the potential of CRISPR isn’t going to reach all of the patients we want to reach—all the cancer patients, and all of the patients with literally thousands of known, catalogued genetic diseases who in principle could be treated more or less today if we had the infrastructure, resources, and money to do it,” Davies said.

The prices of novel and potentially game-changing therapies for cancer and other diseases may be limiting factors for many patients who may benefit from—or even be cured by—these treatments.

“We are in an arms race, it seems, to develop the world’s most expensive drug. It’s like a badge of honor,” Davies said. Although he noted that determining cost is a complex process, it is undeniable that for most patients, therapies that run in the millions of dollars would not be an option.
Logistical challenges remain and further research is needed to determine the ideal role of CRISPR in diseases such as cancer, but it is a promising technological advance that Davies hopes will be effective in a range of disease settings. 

Even Oncologists Sold on Value-Based Care Hesitate to Embrace the EOM

Value-based care is a notion often discussed in the context of oncology, and the on-paper goals of value-based models—improving the patient experience and minimizing excess procedures and costs—align with the goals of most oncologists. But developing a model that best serves all stakeholders is no easy feat.

This was the basis of a panel discussion March 10, 2023, at the Association of Community Cancer Centers (ACCC) 2023 Annual Meeting and Cancer Center Business Summit. The panel featured members of the ACCC Alternative Payment Model Coalition (APMC) and representatives from the Center for Medicare & Medicaid Innovation (CMMI) within CMS to talk value-based care and the new Enhancing Oncology Model (EOM), a value-based model set to launch in July 2023.

Panelists from the APMC were Jeff Hunnicutt, CEO of Highlands Oncology in Arkansas; Mark Liu, MHA, senior director of oncology strategy, transformation, and analytics at Mount Sinai Health System and Tisch Cancer Institute in New York, New York; Anne Marie Rainey, MSN, RN, CHC, director of quality and value-based care, Clearview Cancer Institute in Alabama; and Barry Russo, MHA, the CEO of The Center for Cancer and Blood Disorders in Fort Worth, Texas.

Representing CMMI were Alexandra Chong, PhD, a CMMI analyst and policy lead for EOM; and Elizabeth Ela, PhD, a social science research analyst at CMMI and the payment lead for EOM.

The session began with high-level takeaways from the Oncology Care Model (OCM), a value-based model that launched on July 1, 2016, and ran through June 30, 2022. The voluntary program incentivized providers to focus on high-quality care while avoiding unnecessary procedures and costs.

The OCM, which moved away from typical Medicare fee-for-service (FFS) reimbursement, ran on 6-month “episodes” triggered by the start of treatment such as chemotherapy. During these episodes, OCM participants could bill CMS for Monthly Enhanced Oncology Services (MEOS), which required that patients have 24/7 access to clinicians, that practices use certified electronic health record (EHR) technology, and that data are collected and used to continuously improve care quality. OCM practices were also required to use therapies in line with national clinical guidelines, provide patient navigation services, and complete a care management plan from the National Academy of Medicine.

“We do think that we learned a lot from OCM,” Rainey said. “And it informs a lot of other programs that are currently taking place—of course, that informs what’s going to happen with EOM.” She highlighted the use of EHR technology, 24-7 access to clinicians, and using data for continuous improvement as areas that have been beneficial to the patient experience and providers. Using pathways and patient navigation appropriately are also key, she noted.

The EOM, set to launch on July 1, 2023, shares some components and themes, but with key differences that are a cause for concern among the panelists.

“There’s a lot of infrastructure that many of us who participated in OCM put together in our practice that are important. That translates then [to the] EOM.…Essentially, the infrastructure translates, but the program itself is very different. At least, that’s our perception of it,” Russo said.

One big difference is the scope of the model. Rather than covering all cancer types, the EOM covers only 7: lymphoma, chronic lymphocytic leukemia, multiple myeloma, and breast, lung, colorectal, and prostate cancers. An episode begins with therapy and an evaluation and management visit, and lasts 6 months. A patient is attributed to a physician based on incurring at least 23% of the evaluation and management visits, as well as the first visit after therapy initiation.

In the EOM, claims will be paid through FFS and then settled based on the cost of care per disease, with reconciliation and a decision about whether the provider must pay money back or will receive a performance-based payment. Pricing benchmarks will be stratified by cancer type and determined with a regression model factoring in national data on average spending, according to Ela, who clarified that practices will not be competing against their own best benchmarks in the model.

One notable sticking point for oncologists is a reduction in the MEOS amounts in the EOM, which are lower than in the OCM. MEOS payments under the EOM will be $70 per month per beneficiary, plus an additional $30 per beneficiary per month for dual-eligible patients on Medicare or Medicaid, down from $160 per beneficiary per month. Barry noted that being proactive about identifying cases of dual eligibility and applying for it will be important.

“The adjustment to MEOS is probably the first thing that really jumps off the page for me. I think the majority of people in the room would agree that transforming our practices to be more value based, to be more value minded, and to think of reducing costs and emphasizing quality—the things that we learned during OCM—are all good things and we want to continue to do those things,” Hunnicutt said. “MEOS in OCM at least allowed us to be able to pay for those things.” The cut in MEOS with EOM may not afford practices the same opportunity, he said.

The EOM also makes practices and providers take on risk, which is further exacerbated by the lower number of patients who will be eligible under EOM. All panel members noted they would have fewer monthly patients under EOM. One potential solution Russo presented is pooling with other practices, although there are additional regulations and challenges to consider, he noted.

“Where health care is financially right now, are we in a position to take on risks? It’s hard to convince even the most progressive [chief financial officers] to say, ‘Yeah, this is something that we can do comfortably with the information that we have,’ ” Liu said. He also noted that having a single pool for all patients vs siloed targets per cancer type was helpful in the OCM, and it remains to be seen how EOM’s per-disease targets will serve providers.

For the panelists’ part, all are undecided about participating in EOM. And in the end, EOM is voluntary, so individual practices must consider their data and their options. CMS has indicated that practices would receive data from OCM ahead of EOM, which will add to the practice-collected data that those who participated in OCM have been able to analyze.