Policy Updates: ASCO 2019

July 16, 2019

From the Oncology Care Model to the possibilities of cannabis, policy issues drew big crowds at the 2019 Annual Meeting of the American Society of Clinical Oncology.

Oncology Reimbursement Reform Leaves Stakeholders With More Questions Than Answers

Oncologists and representatives from UnitedHealthcare and the Center for Medicare and Medicaid Innovation (CMMI) took the stage at the 2019 Annual Meeting of the American Society of Clinical Oncology to discuss oncology reimbursement reform and possible changes on the horizon for the promotion of higher-value care.

Jennifer Malin, MD, PhD, FASCO, senior medical director of oncology and genetics at UnitedHealthcare, started off the session by explaining what oncologists and patients already know:

Healthcare costs are unsustainable.

“When we talk about the cost in healthcare, oftentimes we focus on just the pricing of the drugs and what individual out-of-pocket costs are. But the overall impact on the total cost of care is what impacts people’s premiums and what the federal or state government has to pay for Medicaid. That impacts the overall affordability for people to buy insurance in the first place,” said Malin.

She then reviewed some strategies oncologists are all too familiar with that payers use to improve the value of cancer therapy, such as clinical pathways, episode-payment shared savings, bundled payments, and shared-risk capitation.

UnitedHealthcare utilized each of these strategies in creating their own cancer episode program. The program, first implemented by Malin’s predecessor Lee Newcomer, underwent a proof-of-concept pilot study from 2009 to 2012. Afterward, results showed that the program had a 34% reduction in costs for the 5 practices that were enrolled.

“Our cancer episode program is a new payment model based on the treatment of cancer episodes instead of drug margins. The program removes an oncology practice’s dependency on drug margins and rewards physicians for improved quality and reduction in the total cost of cancer treatment. It also builds a learning system to identify best practices for improved quality and value,” she said.

After the results of the initial pilot, UnitedHealthcare rolled the program out to 250 practice sites. Due to the larger number of practices enrolled, collaboration between UnitedHealthcare and the practices went from monthly interactions in the pilot to less often. This, in part, contributed to the lower amount of savings—13%—seen once the program expanded.

In talking about the revolution toward value-based care, the faults with traditional fee-for-service (FFS) programs are often discussed. Karen Hoffman, MD, MPH, of The University of Texas MD Anderson Cancer Center, presented provocative data regarding practices that use FFS costing more money and more often referring their patients for more expensive treatments.

“In a model where physicians and healthcare providers are reimbursed for each service rendered, it may provide financial incentives to increase utilization of services or recommend services that are more expensive,” said Hoffman.

She explained that while physicians are prohibited by national statute from referring Medicare patients for designated health services at entities with which they have a financial relationship, study results show more services are used by physician “owners” versus nonowners.

“Specifically, the data show that there is an increase in anatomic pathology services by self-referring providers. In 2010, it was estimated that self-referring providers made 918,000 more referrals for pathology, which ended up costing Medicare $69 million,” she said.

Finally, Lara Strawbridge, MPH, of CMMI, presented about an effort to address costs that oncologists are quite familiar with: the Oncology Care Model (OCM). The OCM, which was implemented in 2016 as a 5-year model, is an episode-based payment model that targets chemotherapy and related care during a 6-month period that begins with a patient’s receipt of chemotherapy.

“The OCM has 176 practices, about 7000 practitioners, and sees 200,000 unique beneficiaries per year, with 260,000 episodes of care per year,” said Strawbridge. She provided an overview of some of the positive outcomes of the program, including an anecdotal story from a provider saying that “[the OCM] enables us to provide the care we’ve always wanted to do.” However, as the program nears the end of its 5-year pilot phase and CMMI looks to implement changes for the next version of the program, what spoke louder in Strawbridge’s presentation were the unanswered questions.

The OCM has generated a lot of actionable, valuable data for practices, although this has come at a cost of a high administrative reporting burden. Strawbridge didn’t mention those reporting burdens when discussing the challenges the OCM has seen over the past few years. What was mentioned, such as the limitations of the Medicare claims system and the complexity of practice business and coding models, are multifaceted issues that may not be addressed by the next rendition of the program.

For example, in a recent meeting of the Institute for Value-Based Medicine®, Jessica Walradt, manager of Managed Care of Government Programs, Value-Based Care at Northwestern Memorial Healthcare, explained there’s a lot of confusion around how episodes are triggered with the OCM due to an episode starting at the receipt of chemotherapy. This is because patients could be administered chemotherapy as maintenance therapy as well as an active treatment. Due to this, Waldradt said her institution is sometimes unsure which patients are even meant to be included in the OCM. This too, was not mentioned by Strawbridge.

In terms of the future of the OCM, much remains unclear. Strawbridge said, “We’re working on the next version of the model to include further improvement in quality of care and health outcomes, moving farther away from fee-for-service infrastructure for payments, considering chemotherapy and supportive care, and looking into the adoption of 2-sided risk.”

ASCO Town Hall Brings Tense Conversation on Drug Pricing

The American Society of Clinical Oncology (ASCO) held a town hall meeting to discuss drug pricing at its 2019 meeting, with moderator Jeffrey Ward, MD, FASCO, hematologist at the Swedish Cancer Institute, joining Rodney Whitlock, PhD, of McDermott+Consulting.

Drug pricing seemed like an appropriate topic for ASCO’s town hall as the Trump administration has made lowering the cost of medications a major objective. The administration has put out a series of proposals looking to address the cost of drugs, such as the International Pricing Index (IPI) and the recently finalized rule around direct-to-consumer advertising for pharmaceutical companies.

“What we have is 3 types of issues out there that you see policymakers discussing,” Whitlock said. “There are blockbuster drugs coming out with significant price tags attached, speculation issues around astronomical drug price increases given the ‘villian’ made-for-our-time Martin Shkreli, and finally, there’re regular drug price increases where drug companies raise their prices in January. Why? Because it’s January. And then again in June. Why? Well, because it’s June.”

However, the issue of drug pricing has not yet been linked to a single direct, surefire cause. It’s no secret that patients are feeling the effects of out-of-pocket costs of drugs, whether it’s in co-pays or co-insurance costs, but who is to blame? “There’s a tremendous amount of ‘not it’ and finger pointing going on. Drug makers want you to believe that the issues are the $700 aspirins at the hospital—that it’s everyone but them. But on the other side, you see other stakeholders who set the prices and they’re also saying it’s not them, but we don’t know because it’s not a transparent system,” he said.

When asked if he believes the politics will change around whether the government should have a place in instituting drug prices, Whitlock said there’s definitely renewed interest in and openness now to say that if the marketplace isn’t working for consumers under the current system, then the government will come in and set pricing.

“An example would be, look what’s happening with surprise billing. Congress has given that great interest, and once they heard about it, they took it on and basically said, ‘Well then, let’s just stop this right now,’” said Whitlock. “It’s a gateway drug to larger price controls. Once you do it there, can’t you go other places to set price controls? I mean, the government has been doing that in the Medicare space for quite some time now.”

Regarding the IPI model, Whitlock offered a word of caution for what the drug companies’ response to such a model would be. He hypothesized whether the companies would try to get underneath the IPI and raise costs in other countries, so as to not lose money in the United States, or would they simply accept the lower payments?

“[This is something] that hasn’t been discussed with this issue. It’s the point that there is clearly a trade issue at hand here. Other countries are able to tell drug companies, ‘You have to sell at this price to sell in our countries.’ Now, yes, drug companies could get out of [the problem the IPI poses] by raising the prices in other countries. But what isn’t being addressed—and this is truly a trade issue—is the inability of drug companies to raise prices in other countries even a nickel,” said Whitlock.

The question remains, “What will the administration do regarding the IPI? Although there was a final rule put out, it has yet to take an effect. Whitlock floated the notion that the administration is using this proposal, and others, as a bargaining chip for what may come together in the fall as a larger deal with Congress. Perhaps not. Either way, Whitlock stressed that healthcare stakeholders need to pay attention to what’s happening in Washington, DC, and stay clued in as to what’s to come. “As they say, if you’re not at the table, you’re on the table.”

In an attempt to bring the conversation back to the oncology stakeholders in the room, Michael Kolodziej, MD, vice president and chief innovation officer at ADVI Health, Inc, poised his question in earnest: “We, as oncologists, are floating on the Titanic, and we’re worried about what next song the orchestra will play because all of the stuff we’ve been doing forever is going to become incredibly irrelevant as we move into combination I-O [immuno-oncology] therapy, CRISPR [Clustered Regularly Interspaced Short Palindromic Repeats], and CAR T [chimeric antigen receptor T-cell therapy].

These are therapies that will cost, per patient, $500,000 to $1 million…. Help me understand why we’re not interested in pursuing outcomes-based contracting—through a model, through legislation, anything—because as we move technology forward, and the prices will go up with that advance, we need to find a way to pay for it.”

Whitlock’s response largely explained what healthcare stakeholders already know: Policymakers really don’t understand how this world works.

“The core mission of the FDA in approving a drug is safety and efficacy. That’s it. The FDA is not in any way tasked to determine whether or not drugs have comparative value or that they meet a certain outcome-based type metric. CMS, their core task is to pay the freaking bills,” he said. “So, when you talk about the 2 federal agencies most capable of engaging the conversation you just raised—which is critically important—you first need to grasp how utterly [incapable] they are at raising the conversation, because they don’t have the skill set to do it.”

Rather than taking on the challenge and bringing the suggestion back to Washington, DC, Whitlock called on the stakeholders in the room and ASCO members to push the conversation forward. “Moving in the direction of value, we are so far removed from that. Don’t wait on the federal government. If you, as an organization, want to drive that conversation, you’re better equipped than waiting for someone else at the ‘mothership’ in Baltimore where CMS is located, to come up with the idea,” Whitlock said.

The Importance of Including Primary Care Physicians in a Patient’s Cancer Journey

“How do you currently collaborate with your primary care colleagues in caring for patients with cancer?” This was how Larissa Nekhlyudov, MD, MPH, opened the session, “Bringing the Primary Care Physician Back Into Cancer Care.”

Answers to Nekhlyudov’s question ranged from communication through electronic health record (EHR) systems to picking up the phone and calling the primary care physician (PCP). One thing remained consistent throughout every answer: We need to be doing better.

Nekhlyudov was joined by panelists Piyush Srivastava, MD, gastrointestinal medical oncologist at Kaiser Permanente; Trevor Jolly, MBBS, medical oncologist at UNC Health Care; and Elizabeth Schiff, a patient advocate and 2-time cancer survivor, to discuss and present interactive case studies in which PCPs should be a part of the conversation.

The first case involved a 75-year-old post-menopausal female with newly diagnosed, screen-detected, left-sided invasive breast cancer; her medical history included a body mass index of 31.4 and several years of hypertension. The audience and panelists were asked which medical condition was most likely to cause the patient’s death in the next 10 years. Most answered cardiovascular disease, as one of the highest risk factors for cardiovascular disease is hypertension. When the audience was asked who they would prefer to manage the patient’s blood pressure and other cardiovascular disease risk factors, a cardiologist or a PCP, most preferred a PCP.

This surprised Nekhlyudov, who expected most audience members to recommend a cardiologist. She presented data from a study published in JAMA in February 2019, which showed that PCPs “have a huge effect on mortality for [patients with cancer]. Every 10 additional PCPs per 100,000 population is associated with 51.5 extra days of life expectancy versus 19.2 days for additional specialists. Also, every 10 additional PCPs per 100,000 population was associated with reduced cardiovascular, cancer, and respiratory mortality by 0.9% to 1.4%,” said Nekhlyudov.

Jolly couldn’t agree more regarding the importance of a PCP in the journey of a patient with cancer. He explained that what he often sees in practices is that the oncologist will let the PCP deal with the hypertension and the oncologist will deal with the cancer, as with the case study. “But we need to collaborate more. If you see that your patient has hypertension, call her physician. Bring it to their attention. Ask them to follow up, if you started her on a hypertension medication. That communication is key.”

Although the panelists and the audience seemed to agree on this matter, 1 audience member brought up a point that had not yet been mentioned: “You haven’t addressed the medical economics of these visits. Some patients have a co-pay, and they can’t afford to see their primary care physician as often as they see their oncologist during active treatment.”

Schiff agreed. Having been through her own cancer journey, she explained that she knew the care coordination could get complicated. “If you need to choose between seeing your oncologist and seeing your PCP, well, that would be hard. If you’re in active treatment, I would imagine you’d see your oncologist. But this is where the communication between the oncologist and the PCP is essential. If the patient can only economically see the oncologist on a regular basis, that oncologist needs to communicate with the PCP to make sure they’re kept up-to-date on the patient’s treatment journey and condition.”

Cannabis Risks and Benefits in Cancer Symptom Management: Much Remains Unknown

When asked to describe ways to improve communication between PCPs and oncologists, the overarching responses included creating an integrated EHR system across the providers and needing more time to meet with each patient. Open chairs were scarce as a session titled “Is There a Role for Cannabis in Cancer Symptom Management?” was set to begin. The session featured knowledgeable oncologists Mellar Davis, MD, of Geisinger Health System; Claude Cyr, MD, of McGill University; Brooke Worster, MD, of Thomas Jefferson University; and Ilana Braun, MD, of Dana-Farber Cancer Institute.

Oncologists, patient advocates, patients, and other stakeholders from around the world gathered to hear different perspectives regarding the use of cannabis in symptom management for patients with cancer. Panelist after panelist went up to present available data, and each reiterated the same point: We need more research.

As it stands right now, the legal landscape of cannabis use, particularly in the United States, is puzzling, to say the least. At the time of the presentation, 33 states have some form of legal marijuana. Of these, 10 offer a parallel recreational law, 14 have approved only limited medical use, and only 3 fully prohibit it. Federally, however, marijuana remains a Schedule 1 drug, which deems that it offers “no acceptable medical use, lacking [a] safety profile acceptable for use under medical supervision, and a high abuse potential,” according to Braun.

This creates problems in terms of prescribing, administering, and even researching the drug. Additionally, it presents a problem for patients with cancer who do want to access it—sometimes with the permission or urging of their healthcare provider. These same patients might walk into a dispensary and be offered products that have not gone under FDA review for safety, efficacy, or potency.

“Cannabis is commonly used by patients during cancer therapy, frequently without the oncologist’s knowledge,” said Davis. This presents a problem because, as each panelist pointed out, “how cannabis influences cancer therapy and cancer course is completely unknown.”

Cyr began his presentation by taking a poll of the audience. He asked, “How many people feel uncomfortable offering cannabis to patients?” Although a decent number of oncologists raised their hands, it was noted that there were significantly fewer than in recent years. He then asked the audience why they were uncomfortable, and the response was largely that they were waiting for more evidence.

Cyr’s presentation was somewhat unconventional by usual standards of cannabis use in patients with cancer. He explained that many of the most common adverse events (euphoria, aversive memory extinction, slowed down sense of time, and relaxation, among others) could actually be positive for patients with cancer.

“If you have a patient who is nearing end of life, who is feeling extremely depressed, well cannabis may be the safest drug to prescribe that elicits euphoria,” he said. “Though aversive memory extinction may seem like a bad thing for other patients, I would offer that cancer patients may not want to remember every minute of sitting through chemotherapy. And for patients who consistently report feeling like their lives are slipping away from them and that they don’t have much time left, a slowed down sense of time could be a great thing.”

Although the available research is mixed regarding the risks and benefits of cannabis use in patients with cancer, Worster works with the geriatric population and stressed that she has some different concerns than her colleagues working with younger patients with cancer.

“Age is just a number. There are large differences in the rate of aging, and different organ systems age at different rates. An individual’s age, per se, is not the problem; however, it does raise the statistical likelihood of certain events—such as falls—if patients are initiating cannabis use,” she said.

In this population, she explained, adverse events of cannabis use, such as dizziness, could have life-threatening consequences.

When moving forward in this space, although the law conflicts across states, as well as federally, Braun offered a few closing thoughts: “Healthcare providers should become versed in the endocannabinoid system the same way we’re versed in other systems. Cannabis’ benefits and risk should be included in medical education and CME [continuing medical education] curricula. Medical infrastructure should take medical marijuana into account. Everyone should advocate for loosening of restrictions on medical marijuana clinical trials, and professional societies, such as the American Society of Clinical Oncology, should develop consensus guidelines either for or against the prescribing of these products.”