Publication

Article

Evidence-Based Oncology
May 2024
Volume 30
Issue 5
Pages: SP380-SP387

Conference Coverage: COA 2024

Coverage from the Community Oncology Alliance 2024 Community Oncology Conference, held April 3-5, 2024, in Orlando, Florida.

Navigating the Community Oncology Relationship With the Local Hospital


There had been plenty of tension between oncologists with Alliance Cancer Specialists (ACS) of southeastern Pennsylvania and Jefferson Health, which operates multiple hospitals in the Philadelphia region. After spurning offers to be bought out, ACS was evicted in 2020 from space it had used for 25 years in a building Jefferson now owned.

But Moshe Chasky, MD, admitted that he was shocked when he received the envelope in July 202 that let him know his hospital privileges at Jefferson Health Northeast would end in mid-September, forcing him to either hand off patients admitted to those facilities or reroute them farther away.

ACS filed suit in federal court, alleging antitrust violations. In doing so, the practice, which is part of The US Oncology Network, opened a new front in the ongoing battle between oncology practices fighting to stay independent and hospital systems constantly on the hunt for new revenue, according to those who took part in the April 4, 2024, panel, “Hospitals: Friend or Foe? Examining Independent Practice-Hospital Relationships and Trends,” which opened the 2024 Community Oncology Alliance Community Oncology Conference in Orlando, Florida.

Joining Chasky, who served as moderator, were the following:

  • Barak Bassman, JD, of Blank Rome, LLP, of Philadelphia;
  • Jeff Hunnicutt, of Highlands Oncology, of northwest Arkansas;
  • Martin Palmeri, MD, MBA, of Messino Cancer Centers in Asheville, North Carolina; and
  • Jeffrey Vacirca, MD, FACP, of New York Cancer & Blood Specialists.

The panelists shared varied experiences with hospitals in their regions, from a highly productive collaboration that Vacirca’s practice launched during the pandemic with Memorial Sloan Kettering Cancer Center (MSK),1 which helped MSK monitor its off-site patients, to the situation between ACS and Jefferson that landed in federal court and on the front page of The Philadelphia Inquirer.2

What is key, the panelists said, is that hospitals behave based on what works to their financial advantage—and that will shift over time. Patient concerns can take a back seat amid the hardball tactics, they said.
Palmeri said he has experienced this firsthand. Years ago, he joined a physician group with a service agreement with the regional hospital that allowed for a faster pace of growth than would have occurred organically based on referrals. This was a 340B hospital, but it was not for profit. When a for-profit entity took over, it wanted all the physicians to become direct employees, but many of the terms were unacceptable to the physician group.

The hospital parted ways with the longtime oncology group and sought to replace all the doctors, withheld bonuses, limited access to patient records, and would not let the doctors tell patients what was happening.3

“Now, fortunately, as things unfolded, all the doctors banded together, our staff banded together, the community that supported us banded together,” Palmeri said. “And in about 6 months, we were able to open up 5 new clinics across western North Carolina and get our practice fully up and going again. We noticed that in that first year after we left, our referrals went up by about 30%, and our practice continued to grow over the course of the last few years. So, what I’m pleased to say at this point is that we’ve had a very successful extraction from the hospital system.”

Hunnicutt, whose practice operates in a rapidly growing part of the country, enjoys a peaceful relationship with the local hospital at this stage. “We’re in a unique position of being a community oncology practice with no competition in a market,” he said. “What that leads to is that we get to play the game of grow as fast as the region can grow. It’s different set of challenges—there are challenges nonetheless—but consequently, our relationship with our hospitals is productive.”

There are 3 hospital systems in the area, and Hunnicutt said when his practice adds a service line such as surgery, it takes the approach of not affecting any one system more than the others. “It makes everybody just a little bit angry,” but not enough for any of the systems to walk away from the relationship.

Vacirca, operating in the New York metropolitan area, has a completely different dynamic of having multiple National Cancer Institute–certified centers around him. He cautioned against taking today’s relationship with a hospital for granted. “Because tomorrow, there’s another administration that’s going to completely change that which you had already planned,” he said. “We’re seeing this with some of our major relationships now. Nothing is stable, and it’s all dictated by what system they’re coming from.”

The Jefferson-ACS Litigation
Jefferson’s move against ACS sent off shock waves across community oncology that are still being felt. ACS was not granted a temporary restraining order, Chasky said, even though the judge was sympathetic. The proofs needed to show damage under antitrust law and the harm being done to continuity of patient care are not the same.

“What I learned: there’s no playbook for this,” he said. “It’s not like any legal team made drastic mistakes here…. We were literally ground zero for this.”

Chasky said many of the problems are created by hospitals’ pursuit of 340B status, which allows hospitals to buy prescription drugs at discount and bill all payers at regular prices. This financial strategy helped fuel the ASC dispute. The lawsuit documents how Jefferson facility received 340B designation for a new infusion center just before ACS lost its lease in 2020; however, the independent physicians were able to find new space and continue practicing. The effort to capitalize on 340B proved a financial bust because the ACS doctors continued to get a significant number of referrals from Jefferson hospitalists, Chasky said, until Jefferson took additional steps to reduce referrals.

ACS has found “work-arounds,” including gaining hospital privileges under internal medicine instead of oncology, he said. Surrounding hospitals such as Fox Chase, Trinity Health, and the University of Pennsylvania have been supportive. ACS even had a “world class” surgeon, Mark Shahin, MD, FACOG, FACS, come to the practice from Jefferson.

“We’ve actually gotten more successful,” Chasky said. “All of a sudden, now I’m walking into the hospital at 7 PM at night to see my patient in a hospital where I have don’t have oncology privileges,” and the hospital staff, the nurses, the maintenance staff, and people in the community see this and end up making referrals.

“They’re like, ‘Oh, I want those doctors that don’t even have privileges in this hospital, they come in at 7 PM at night to take care of me,’” he said.

The Health System Mindset

Bassman, who represents large health systems, said these entities do not necessarily see community oncology practices as the competition—they have their eyes on competing health systems. They do, however, stay focused on 4 areas, which he called “hearts, brains, bones, and oncology,” as prime revenue streams. “That’s what keeps the lights on—everything else loses money.”

Over the past decade, the health system’s more typical encounter with independent oncology is that a practice is failing and wants to be bought out, he said. “That is a regular experience of a CEO, particularly in a big system.”

Because of resource disparities, “They’re going to fight with you. They can outlast you,” Bassman said. And, fair or not, he said immunity statutes at state and federal levels tend to favor hospitals. So, how can community oncology fight back? Bassman suggested the following:
Hospital boards care about quality and safety, so any issues that can be presented on these fronts will gain attention.

Finding allies on the medical staff will make hospital leadership less likely to move against an independent practice. Large practices that have good relationships with the hospital CEO tend to fare better than solo practitioners.

Especially in suburban and rural markets, board members are community leaders and have the real power in the health system.

Vacirca pushed back a bit on Bassman’s assessment, saying that community oncology has competed very effectively in recent years. “We don’t have to live off the crumbs of the hospitals’ table,” he said.
Hunnicutt said despite the challenges, community oncology is still a better proposition than a hospital for a physician who wants control over his or her income, practice, and lifestyle. “You’re never going to have an opportunity for more directional input into your organization as you do in independent practice. The data is clear on the cost of care in independent practice vs hospital,” he said.

He did admit that community oncology needed to “crack the nut” and once and for all demonstrate that it has superior quality. “If we can crack that nut, honestly, it’s an overwhelmingly convincing sales pitch to say, ‘Come and join the independent system,’ ” Hunnicutt said. “[Physicians] didn’t spend 4 years of college, 4 years of medical school, 3 years of residency, 3 years of fellowship to be led around by the nose by some midlevel bureaucrat administrator in a hospital system and be told what to do.”

References
1. Gavidia M. Oncology stakeholders must align in the pursuit of health equity, value-based care. Am J Manag Care. 2023;29(SP4):SP284.
2. Brubaker H. Jefferson’s turf war with Northeast Philly cancer doctors is “aggressive,” experts say. Philadelphia Inquirer. November 6, 2023. Accessed April 7, 2024. https://www.inquirer.com/health/jefferson-health-cancer-torresdale-hospital-alliance-20231106.html
3. Messino MJ. Opinion: Mission Hospital used to have world-class cancer center; that changed with HCA. Asheville Citizen-Times. December 17, 2023. Accessed April 7, 2024. https://www.citizen-times.com/story/opinion/2023/12/17/hca-mission-hospital-has-no-medical-oncologists-on-staff/71894784007/

End of OCM Brings Drop-Off in Value-Based Care Volume, and New Questions

The end of the Oncology Care Model (OCM) and the financial incentives that came with it have led to significant drops in the volume of care conducted under value-based designs, according to oncology network and practice leaders who offered an update on April 4, 2024. The change raises important questions about how to deliver care equitably when the revenue picture has shifted so sharply, which the group weighed during the discussion, “Defining Value in Oncology: Executing VBC Accurately & Ethically to Account for all Stakeholders,” during the Community Oncology Alliance 2024 Community Oncology Conference in Orlando, Florida.

Led by Stephen “Fred” Divers, MD, of Genesis Cancer and Blood Institute who is chief medical officer of the American Oncology Network, the panel also featured:

Barry Russo, MBA, CEO of the Center for Cancer and Blood Disorders;
Donny Wade, MD, of the Virginia Cancer Institute; and
Lalan Wilfong, MD, of Texas Oncology and senior vice president, payer and care transformation, The US Oncology Network.

When Divers asked how much the share of practice volume in value-based care had dropped since the end of the OCM, the percentages varied, but Russo estimated that the shift had been 70% to approximately 30%. In addition, the arrangements that remain are largely bonus-type arrangements, or upside risk only; for practices that did not sign on for the Enhancing Oncology Model (EOM), downside risk models are harder to find.

During the OCM, practices were required to extend new services to patients, such as patient navigation and advanced care planning, which improved the patient experience and helped achieve savings. Most practices opted to extend these services to all patients because “it’s the right thing to do,” Wilfong said.

“I wish I knew the secret sauce,” he added. Economics have shifted from the days when drug margin compression was the main issue. Today, before you extend services to patients outside a reimbursement model, “you really have to think through that as a practice when you get into risk-bearing entities,” he said. “Your economics change quite a bit [in] how you practice medicine.”

Comparatively, few practices signed on for Medicare’s EOM because the financial package was seen as unpalatable and because the program did not allow practices a test period of upside risk only, as had been the case with the OCM. Since the launch of the EOM on July 1, 2023, CMS has initiated a rule that allows practices to separately bill for patient navigation—even for practices not inside the EOM—which could make the bottom line more attractive. However, CMS would have to reopen the model for it to expand beyond the 44 practices that initially signed up.
Russo discussed how relationships with primary care providers (PCPs) are increasingly important in cancer care, not only for referrals but also for establishing better continuity of care that is better for patients and helps hold down costs. “That’s becoming a much larger piece of our value-based world,” he said.

Working with primary care. Many oncology practices may have formal or informal relationships with PCPs in capitated payment models with payers, Russo said; these physicians are now keenly interested in keeping patients out of the hospital.

Divers asked whether data are keeping up with the task, and Russo said this is a concern. He said he’d met with a primary care practice that he thought would get data back within 30 days and learned it was closer to 90 days. “The problem with that is if you want to change behavior, you can’t,” Russo said. “It’s too late.”

Like Russo’s practice, Wade’s practice took part in the OCM but did not move forward into the EOM. In the OCM, Virginia Cancer Institute brought services such as dietitians and care managers in house and began practices that have proved valuable. “It’s so important to be able to reach out to your patients at least once a week or so to check and see how they’re doing, [and] to make sure you’re doing everything you can to keep them out of the hospital,” Wade said.

Both Wade and Russo have had PCPs ask questions about the level of care for patients with hard-to-treat cancers. Thus far, Wade’s relationships with PCPs are informal; he deals with physicians one-on-one and is not in any capitated relationships. In Russo’s practice, some of the relationships are more evolved; he got a call from a primary care practice wanting to know why a patient had an extended hospital stay. “He has acute leukemia,” Russo said.

Divers agreed that working with primary care has its pros and cons, as PCPs may need education to understand what levels of care might be needed in oncology—and when it might be necessarily expensive. “Part of a risk-bearing entity here is [we] have to be a good steward of the dollar, but we [have] to keep that patient first,” Divers said. “So, what guardrails do you put in place when you start to set up these guidelines discussions?”

Wilfong said “that’s something we struggle with all the time,” adding that almost every oncologist can point to an example of a patient who was treated too long and a case where a patient did not receive the level of care needed.

What is that balance? The panelists discussed how possible artificial intelligence solutions could help, but this comes at a cost. Both Russo and Wilfong described the number of people it takes to correctly care for patients with cancer, as well as the investment it takes and how revenue streams don’t always align with the costs.

“It takes a village to take care of a patient [with cancer],” Russo said. “That village is not just the people in your organization—it’s a lot of people outside your organization,” which can include foundations or insurance brokers who can help fill gaps for patients who need to get on the right coverage plan. “If they’re not in your village now, you need to start building your village, because it’s essential to make this thing work for your patients in your practice.”


Galvanizing Community Oncology Through Advocacy, Empowerment,
and Stewardship


Reflecting the 2024 Community Oncology Conference theme of “Stronger Together,” a panel discussion to conclude day 1 of this year’s meeting in Orlando, Florida, explored how effective advocacy among physicians, administrators, legislators, and patients through the building of long-term relationships and establishing personal connections galvanizes progress within community oncology, both in person and virtually.

Joining conference cochair Emily Touloukian, DO, medical oncologist/hematologist and president/managing partner of Coastal Cancer Center in Myrtle Beach, South Carolina, for “Stronger Together: The Power of Advocacy to Support Patients & Practices”1 were Rose Gerber, MS, 20-year cancer survivor and director of patient advocacy for the Community Oncology Alliance (COA); Neil Foley, senior vice president of government and sales at New York Cancer & Blood Specialists (NYCBS); and Mary Caffrey, executive editor of Evidence-Based Oncology.

“At COA, our mission is that we’re dedicated to advocating for community oncology patients and practices,” Touloukian emphasized. “Typically, this has been done at the national and federal levels.”

She kicked off the discussion by asking the panelists to differentiate between federal and state legislation and advocacy and asking them to describe the importance of advocacy at the state level. The panelists agreed that principal keys to successful advocacy are building trusted relationships over time and having patience.

“You must realize that unlike members of Congress, where that’s their full-time job, state legislators typically have more than 1 job. They are balancing their state’s goals plus whatever their regular job is, so they are really pressed for time,” Caffrey, who previously covered the New Jersey Legislature as a reporter and later served as a state and local government official, explained.

“Be conscious of how [legislators] want to spend their time and that they often have a lot of competing interests,” she said. “If they can’t give you everything you want, don’t go crazy. Look to building that relationship for the long haul.”

Foley concurred. Having served as town councilman in Brookhaven, New York, for the fifth district for the past 9 years and now serving as deputy supervisor for the town, he is able to provide viewpoints on 2 fronts: as a legislator and outsider to the oncology field and an insider through his position at NYCBS, highlighting the vital role of education in building and fortifying a mutually beneficial advocacy relationship.

“Elected officials have no idea how the oncology world actually works. They understand because cancer touches all our lives, but they don’t understand treatments or medications,” he said. “Our role is to educate our friends in Albany, [New York], and Washington, DC. You have to have a seat at the table; you have to have a voice.”

Having a literal seat is how Gerber explained that the COA Patient Advocacy Network incorporates experiences of patients with cancer to educate members of Congress and their representatives through its Sit in My Chair advocacy program. During these encounters, lawmakers are put through a mock cancer appointment, meet with community oncologists, listen and learn from patient advocates on community oncology’s value, and hear about COA’s policy priorities.2
“Because unless that member of Congress has had cancer or has a family member who’s had cancer, they really do not understand the complexities involved in taking care of patients with cancer,” Gerber said. “Through the Sit in My Chair program, we are introducing to them what it feels like to be a patient with cancer.”

Some of the photos from these experiences have proven so realistic that Gerber noted she has received messages saying people did not know their member of Congress had cancer.

Circling back to the importance of understanding state vs federal issues and effective ways to bring your priorities to legislators’ attention, Caffrey reiterated the importance of starting small. For example, don’t bring issues to your state legislator that only CMS can resolve. This is a waste of their time and not appropriate, she emphasized.

“State legislators really do want to try and solve your problem, and they really do want to come away with a win,” she said. “So if you can bring to them 1 to 3 things and not a whole list, it’s really going to be a win-win for everyone.”

Touloukian continued the discussion by asking each panelist to expound on the importance of in-person advocacy vs virtual advocacy, using experience during the COVID-19 pandemic as a case study. The change in how to effectively advocate and spur positive change was hard to digest, Gerber explained, because of the need to encourage people to stay involved. The experience did have its pluses, in that COA was able to pivot to virtual events and participants enjoyed forgetting about the pandemic for a spell; however, the great thing about in-person advocacy, she reiterated, is the building of those relationships and establishing those in-person connections.

“It’s a completely different experience when I get to see that person,” she stated. “So even though you can do a virtual event and it’s important to have that advantage to advocating, you have to recognize that there are some challenges in doing so.”

Foley and Caffrey echoed her sentiments. He noted that all NYCBS meetings are in person—including several yearly trips to Washington, DC, with Jeff Vacirca, MD, FACP, CEO of NYCBS, and David Eagle, MD, chair of legislative affairs and patient advocacy at NYCBS and a former COA president. Caffrey said that level of visibility does make a difference. The legislators see that you are making this trip to see them and you are making that effort, so they will make an effort to see you. Even if the visit is an invitation for elected officials to tour a cancer care facility or new medical offices, they are seeing what you do, and that can be very powerful, Foley and Caffrey concurred.

“It’s really impactful to be able to talk about these issues, even if they’re not oncology issues,” Touloukian added. “You can clarify issues for the representatives and form those long-term relationships, which can prove invaluable down the line.”

Practical advice was next on the agenda, with Touloukian delivering this prompt: “How would you all recommend that you structure a meeting with legislators so that it can be impactful and successful?” There was no shortage of practical tips from the panelists.

“Remember that a majority of the time, staff members are younger than us. Usually younger than 30 [years],” Foley noted. “But they are the eyes and ears and voices of elected officials.” With meetings that frequently only last 20 minutes and sometimes take place in a hallway outside their office, he advises keeping notes and memos short, with 2 to 3 points at most. Show that although you need their support on these important issues, you also respect their time, he emphasized.

Bios are important as are professional profiles, Caffrey contributed.
“Keep in mind that when you go to meet with legislators, if you have bios on them, they are likely making bios on you as well,” she said. “Keep your LinkedIn profile up to date, especially your photo. If these meetings are going to be a regular thing, these little details do matter.” Details include having a small ask to balance the sting of a big ask, because if your legislator has to say no to your bigger agenda item, that may make it easier for them to say yes to your smaller request, “to something that is kind of easy.”

Gerber remarked that it’s vital to remember what is being asked during these meetings and to ensure that these meetings have a specific agenda. Speaking as a cancer survivor, she noted that meetings on Capitol Hill are not always the best time to share the story of your cancer journey. “For example, you’re there and you are asking them to please stop pharmacy benefit manager abuses, including that you don’t want any interference between you and your doctor,” she said. “When you go to the Hill, you have to be very clear about who you’re representing and what you’re asking for.”

Most important is to focus on the issues, to work both sides of the political aisle, and to not let yourself and your advocacy efforts get stymied by the politics of the person, Touloukian stressed. Foley added how important it is to know that nothing will get done by pitting one side against the other and that if you hope to accomplish what you set out to do, a good idea is to focus on physicians in Congress or those with medical backgrounds—which, unfortunately, is a minority. At present, there are only 19 physicians in the 118th US Congress: 4 senators and 15 representatives.3

Gerber underscored that going into these meetings, it’s essential to ensure you are working with different perspectives.
“It’s OK to not know everything,” she said. “A great thing to do is have different perspectives: doctors, nurses, patients, long-term survivors. It makes the conversations a lot more interesting. It’s all of us together who make that meeting so impactful.”

Something else the 4 panelists also agreed on was the power of education and of sharing knowledge to support advocacy efforts. This can include visiting COA’s website to learn about prior authorization or pharmacy benefit managers, reading an article or writing a letter to the editor in response, building an online network of advocates, marketing your organization by participating in charity events, or vetting candidates for office. Although in-person advocacy is the preferred way to get your message across, every little bit helps, they concurred.

Collectively, the panel agreed that effective advocacy involves not only understanding the legislative process but tailoring your approach for effective communication, focusing meetings on well-defined goals, educating yourself and those you hope to reach through your advocacy efforts, and ensuring every voice is heard and represented. Advocacy is not a short-term engagement, the panelists said, but a long-term relationship and sustained effort.

“Don’t be afraid to seize the moment,” Caffrey stated. “Seizing every opportunity to advocate is important.”

References
1. Touloukian E, Caffrey M, Foley N, Gerber R. Stronger together: the power of advocacy to support patients & practices. Presented at: 2024 Community Oncology Conference; April 3-5, 2024; Orlando, FL.
2. Sit in My Chair Toolkit. Community Oncology Alliance. Accessed April 12, 2024. https://communityoncology.org/wp-content/uploads/2023/02/COA-CPAN-SiMC-Toolkit-2022-FINAL-for-COA-1.pdf
3. Physicians of the 118th Congress. Patients Action Network. January 3, 2023. Accessed April 12, 2024. https://patientsactionnetwork.com/physicians-118th-congress

Oncology Practices Keep Pace With PBMs in Court and Beyond

It’s not like they didn’t see it coming.

Last fall, a CMS rule went into effect to ban a fee on prescription drugs called direct and indirect remuneration (DIR), which pharmacy benefit managers (PBMs) had used to collect fees from oncology practices months after a drug had been dispensed. Because these fees were assessed so long after the practice had been paid for the prescription, it was impossible for practices to know they would be “under water” for a given drug until it was too late.

As Kathy Oubre, MS, CEO of Pontchartrain Cancer Center, put it, many in community oncology were cautiously optimistic about the new rule but had heard the warnings from Community Oncology Alliance (COA) Executive Director Ted Okon, MBA, that if DIR fees expired, then PBMs would get their money some other way. That “other way” turned out to be drastically lower payments for certain drugs, especially from a handful of Centene Corporation plans where Express Scripts had recently taken over as the PBM.

“Lo and behold, on January 2 of this year, Ted was exactly right,” Oubre told the audience who gathered on the second day of the COA 2024 Community Oncology Conference in Orlando, Florida. “It was lower than we had ever thought.”

Oubre chaired the April 5, 2024, panel, “The Post-DIR Hangover: Underwater Reimbursement and Challenges,” which featured fellow veterans of the PBM battles:

  • Jonathan Levitt, JD, of law firm Frier Levitt, who has frequently sued PBMs;
  • Jeff Mortier, of lobbying firm Farragut Partners; and
  • Jeffrey Vacirca, MD, FACP, of New York Cancer & Blood Specialists, which has been a litigant against PBMs.

Although practices have had challenges with PBMs for many years, the particular phenomenon of DIR fees arose around 2016. Levitt explained that although fees started out between 4% and 6% and climbed from there, this was a huge problem. “It would kill the margin,” he said. “So, we started asking questions, we would file arbitrations…. I’d say, ‘How do you justify these fees?’”

Levitt shared the many answers he received: Fees were a medication adherence program designed to improve Medicare star ratings; if so, the practices argued, they were ill suited to oncology, whose physicians don’t prescribe chronic disease medications. Then PBMs said the fees were a program to reduce patient premiums. “[But] none of the money was used to reduce premiums. It just was pure profit,” Levitt said.

With the end of DIR fees, Oubre noted that patients have seen a 3% premium increase, whereas specialty providers who dispense their own medications—including oncologists—have seen drastic cuts in reimbursement. However, Levitt pointed out that other changes that put caps on catastrophic costs generally improve the picture for Medicare beneficiaries.

Congress’ View

Mortier shared how Congress’ view of PBMs has evolved in recent years. From the first briefing on March 14, 2020, just before everything shut down due to COVID-19, to today, Congress has become more educated about the general effects of vertical integration and PBMs in particular, he said. “It has been incredible to watch the evolution of Congress with PBMs,” he said. “It’s a household name for members of Congress. It’s a bipartisan issue, which is not common these days. Everyone wants to figure out how to do it.”

A major complaint about DIR fees—and about PBM behavior in general—is that that there is no way to predict hits to the bottom line. Despite their inquiries, oncologists were given no directives on how they could make changes to avoid fees. Similar complaints have been made about rebate practices.

Thus, transparency seems to be the issue with the most traction, and PBMs aren’t even fighting it these days, Mortier said. And Congress’ “default position” is they don’t trust PBMs, which he said can be seen in routine votes if the name is uttered.

Vacirca’s individual battle over DIR fees traces back to August 2021. “The clawbacks were killing us,” he said. The practice sent a demand letter to CVS Caremark to negotiate, which was ignored. Next came arbitration, which required extensive preparation but led to an award, which is waiting for confirmation from a federal judge.

“The panel concluded that Caremark’s DIR fee program was in bad faith” Levitt said. “In presenting the case, I never used the words ‘bad faith,’ and I never said anything extreme. The panel concluded it was in bad faith.”

During arbitration, it was revealed that Caremark’s program compared the risks and adverse effects of the cholesterol medication atorvastatin to various oral oncolytics. Levitt said that Vacirca calmly explained the profound differences between the 2 classes of medication. The arbitration panel concluded “that Caremark had a willful disregard for any understanding of oncology medication,” according to Levitt.

Oubre highlighted that based on the judge’s past practice, confirmation of the arbitration award by an upcoming April 27, 2024, deadline seems likely. Vacirca noted that the award accrues 9% interest a month, “so I’m not complaining too much,” he said.

What’s more exciting, according to Vacirca , is that the judge’s action will give Levitt—and community oncology more broadly—a landmark precedent to pursue additional arbitration actions.

Post-DIR Challenges

Cuts to reimbursements since the start of the year by Express Scripts means practices must choose whether to dispense some drugs at a loss. Vacirca said the law is supposed to allow fair compensation for dispensing and, right now, that’s not happening. Cigna Healthcare may own Express Scripts, he noted, but many other payers used this PBM, expanding the chances of drugs being under water. “There’s probably no one in this room—probably no one outside the room—[who] doesn’t have a pretty remarkable case,” he said.

Oubre turned back to the recent efforts to include PBM reforms into the budget deal that passed in March, which seemed to be making progress but then fell short. She asked Mortier about the likelihood of passage this year, and he predicted that a major package will come together during the “lame duck,” or the period after the election. “It depends on what happens with the White House” or whether there’s a shift in the Senate or the House. Given the consensus for reform, “once these policies are on the list, they’re really hard to knock off. And there will be PBM reform, whether it happens in this lame duck or next congress. If there’s bipartisan agreement, we call it the 4 corners, which means House and Senate committees have authorizers [who] have all agreed,” he said.

Mortier clarified that although PBM transparency will be the easiest piece to pass, reform won’t stop there. The US Senate Committee on Finance is committed to steps to ensure greater accountability, as well as health care steps outside PBMs such as treatment site neutrality.

As for the current reimbursement situation, Levitt noted that there are already laws that state reimbursement must be “reasonable and relevant,” and CMS will have to step in if rates are under water. He strongly encouraged providers to file complaints with CMS and has drafted a sample form available through the COA. If patients can no longer get their cancer drugs through their oncologist because of PBM behavior, they should complain, too. Complaints matter, Levitt said, because if they affect a plan’s star rating, that can cause a significant drop to the bottom line.

Levitt also highlighted the recent lawsuit, Lewandowski v Johnson & Johnson, a potential class action that represents the first time an employee is suing over an employer’s failure to exercise its fiduciary responsibility over health benefits due to PBM behavior.
Both Oubre and Vacirca emphasized the need for COA members to write and call their members of Congress and remind them of their positions on all these issues. Oubre said even if a doctor can’t travel to Washington, DC, for COA’s Hill Day, a phone call makes a difference.
“Let’s not forget about successes,” Vacirca said. DIR fees are no longer in contracts, he said. “There’s now a glaring light on what PBMs have been doing. We are an incredibly powerful unit together.”

“The power that they can see, because when I first started working on [Capitol] Hill, I remember one of your comments to me: ‘If they don’t hear from us, they’re hearing from the other side,’” Oubre said. “But we’ve got to be there to stand up for the patients and our practices and dispel the myths.”

Change Healthcare Could Get Congress’ Attention Before Break for Election

Part of it is the unprecedented gridlock in Congress, and part of it is the natural rhythm of an election year, but many legislative items of interest to community oncology will wait until after November 5, 2024, when voters select a president and a new Congress. However, that’s not to say Congress won’t air plenty of grievances first—starting with the Change Healthcare debacle.

That’s the assessment of a group of government affairs leaders from across the spectrum of cancer care, who gathered for the annual legislative update during the Community Oncology Alliance (COA) Community Oncology Conference on April 5, 2024, in Orlando, Florida.
Moderated by COA Executive Director Ted Okon, MBA, the panel featured:

  • Jerrica Mathis of Cardinal Health;
  • Ben Jones of McKesson and The US Oncology Network;
  • Kristine Rufener of the Association for Clinical Oncology, the advocacy arm of the American Society of Clinical Oncology;
  • Christian G. Downs, JD, MHA, of the Association of Cancer Care Centers; and
  • Shelly Mui-Lipnik, JD, LLM, of Cencora (formerly AmerisourceBergen).


Okon opened the panel with a discussion of the Change Healthcare cyberattack—both its immediate impact on the providers and drug distributors that the panelists represent and the conditions that made its effects so widespread. Mathis noted that the Senate Committee on Finance has already announced an April hearing and summoned the CEO of parent company UnitedHealthcare, which Okon noted has seized the opportunity to buy up cash-starved clinics.

Mathis noted that although no one wants Congress to overcorrect, the lingering effects of the attack must be addressed. “We are 1.5 months out for the protagonists, and practices are still picking up. People are still waiting to get reimbursed,” in cases where the patients had full coverage for services or prescriptions needed during this period. “This issue is not going anywhere anytime soon,” Mathis said.

After the attack, Jones said he would “never send another eyeroll emoji to the [information technology] team when they require an update for a new email filter or cybersecurity training.”
He also said that “the government got it wrong” in its lack of response. “They looked at this through the lens of COVID-19 and didn’t see the disruption to patient care. What they weren’t realizing is that it was taking practices and providers every last effort—hours of overtime, manual processes that used to be a click of a button—to ensure that patients weren’t impacted.”

More support was needed early on for payments, not only for hospitals but also for physician practices, and requests for relief from prior authorization fell flat. “This is where I think we’re going to have an ongoing issue, because they pushed for all this without any teeth.”

Finally, Jones said, “We’ve got to have a really frank postmortem…. What went right? What went wrong.... We are seeing [several] practices under distress, continued prolonged distress, and it is causing some of them to sell their practice. The fact that they’ve been put in distress through forces outside their control and are now forced to sell should be concerning for all of us.”

Rufener agreed that providers have been left out of many discussions, but she believes that’s going to change as committees take up issues such as artificial intelligence and technology. During the discussion, Okon also asked about whether Congress will revisit UnitedHealthcare’s merger with Change Healthcare, which the US Department of Justice (DOJ) opposed. Downs said beyond the immediate operational issues of coming out of the cyberattack, this is an area that has to be addressed.
After it failed to stop the United-Change Healthcare union, he said, the DOJ has somewhat been set back and has been less aggressive on antitrust. The cyberattack is an event that will cause the issue of consolidation to gain traction on Capitol Hill. “Maybe this is a prime example of what happens when…the physicians, insurance, distribution model, [and] technology is all in 1 place—you are not going to be more controlled,” Downs said.

Mui-Lipnik agreed that the government’s slowness stemmed from the fact that the cyberattack’s effects did not reach patients right away. She said she’d engage members of the staff and they hadn’t seen it in the media clips, which she said are what drive much of the activity on Capitol Hill. She anticipates a federal law that will address the US Department of Health and Human Services’ role in a cyberattack on health care entities.

It’s also time for cancer-related groups to unite and ask members of Congress “hard questions” about the unintended consequences of prior decisions.

“This can’t happen again because it has pushed the practices to the edge,” Okon said. “It’s impacting patient care.”

Okon said CMS has been responsive to him on this issue, but the frustration is that the challenges practices are facing in the cyberattack crisis stem from the power pharmacy benefit managers (PBMs) have acquired through vertical integration in the first place. Jones agreed, saying that The US Oncology Network has focused on the issue of white bagging for this reason—it encapsulates vertical integration, PBM overstepping, and timely patient care. With white bagging, PBMs attempt to force the use of a remote specialty pharmacy for delivery of expensive therapies—including oncology drugs—instead of letting the physician dispense in the office pharmacy based on the blood work taken at the same-day appointment.

“If you don’t have access to timely care because you have to get this drug white bagged, you are fragmenting that care [by nature],” Jones said. “If everyone agrees that personalized medicine is the future, why aren’t we living that?”

Okon noted that in some cases, because of vertical integration, the PBM could be sending the prescription through a specialty pharmacy acquiring drugs under a 340B discount, which are supposed to be limited to safety net hospitals. That discount is not passed to the patient. Okon asked the panelists about the prospects for 340B reform and PBM reform, after much has been written in the past 2 years about these topics.
Jones noted that The US Oncology Network worked with Deborah Patt, MD, PhD, MBA, of Texas Oncology, on an anti–white bagging bill in Texas, and then passed a similar bill in Oregon. This was purposeful, as it would not be lost on members of Congress that 2 states that could not be more different ideologically were united on an issue of patient care.
Rufener and several others said there are real prospects for PBM reform, especially in the “lame duck” session that will come after Election Day, as retiring members of Congress will be motivated to leave behind legacy legislation. Additionally, Downs said that despite the perception that prior authorization has been “solved,” this is not the case.

The panelists said Capitol Hill is very aware of drug shortages—but so far is bereft of solutions. “Where we sit in the supply chain, there is not any 1 cause for drug shortages,” Mathis said, adding that there won’t be 1 solution and overlegislating is a risk.

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