Conference Coverage: COA

COA Close to Filing OCM 2.0 for Federal Review

After a year in development, the Community Oncology Alliance (COA) will file its alternative to CMS’ Oncology Care Model (OCM) sometime in April 2019 with the Physician-Focused Payment Model Technical Advisory Committee (PTAC), a federal agency that reviews models for possible use by Medicare.

Bo Gamble, COA’s director of strategic practice initiatives, announced during a panel at the 2019 Community Oncology Conference, held in Orlando, Florida, that the plan known as OCM 2.0 was near completion. Gamble appeared with Basit Chaudhry, MD, PhD, founder and chief executive officer of Tuple Health; Kavita Patel, MD, MS, a former Obama administration policy official also with Tuple Health; and Bruce Gould, MD, medical director of Northwest Georgia Oncology Centers and chair of COA’s committee on oncology payment reform.

Gamble, Patel, and Gould previously reported on OCM 2.0 during COA’s Payer Exchange Summit in October 2018, describing it as a template that could be used by Medicare, commercial payers, and even self-insured employers, by addressing many of the frustrations that community oncology practices see with the current incarnation of OCM. These include issues with patient attribution, a high number of reporting burdens, methodological flaws in the rating of geography and quality measures, and a reimbursement scheme that has not kept pace with the soaring cost of oncology therapies. Most of all, as COA expressed a year ago, a lack of transparency¹ makes it difficult for participants to understand results for their practices.

The session, “From OCM 1.0 to 2.0: Two Paths to Payment Reform,” offered an additional update on the complexities of CMS’ signature 5-year alternative payment model (APM), which covers 176 practices and is scheduled to run through June 2021. So far, no plan for an OCM extension or successor has been announced, and Gamble said after the session that practices need information on what will come next.

Chaudhry explained that the OCM has reached a crossroads. Early on in the model, practices often focused on implementing administrative requirements. As a result, more substantive clinical transformation efforts frequently started later. Results from performance period 3, which were released a few weeks ago, did not show progressive improvement overall. The share of practices that received a performance-based payment in performance period 3 was the same as that in performance period 2. The percentage of practices achieving shared savings did not increase.

With OCM practices facing a deadline to decide whether they will take on 2-sided risk, Chaudhry said, “both of these trends are quite concerning.”

Gamble and Gould said there are many things about the OCM that have improved cancer care, but the way the model handles drug pricing means that practices that are doing everything right can still miss out on shared savings.

“I’m a big believer in personal responsibility,” Gould said. Oncology practices should be good stewards of healthcare dollars; they must provide team-based care that helps patients navigate their way through cancer treatment, including “closing the loop” after a consultation.

But, Gould added, the OCM uses pricing models that were developed with claims data from 2012 to 2015, before the explosion of immuno-oncology drugs. Not only do newer drugs cost more per month, but patients take today’s targeted therapies for longer periods of time. Even with OCM changes like the novel therapy adjustment and the trend factor, Gould said, “[the] pricing model is not relevant with what we do today.”

The complexity of the model also strains practices, Gould said, estimating that a practice with 1000 patients will need to report 8000 to 15,000 data elements, many of them by hand.

When an audience member noted that the OCM doesn’t account for off-label uses that appear in the National Comprehensive Cancer Network guidelines, Patel said it would be unthinkable for a government agency like the Center for Medicare & Medicaid Innovation (CMMI) to look beyond FDA-approved uses in building a reimbursement model. It’s just not how the government operates, she said.

Patel said that instead of trying to stay ahead of rising drug prices with “complex and wrong adjustment factors,” CMMI would be better off coming up with a set price for what it costs to treat a patient “and give you something on top of that so you can survive and thrive.

“But I’m not in charge of CMS, so it’s easy for me to say that,” she added.

During his presentation, Gamble reviewed the process that COA used to develop the proposal that will go to PTAC, which was created to evaluate APMs developed by physicians in addition to those developed by CMMI. Despite expectations early in the Trump administration that PTAC’s profile would increase, so far CMS has not authorized oncology models blessed by the group to compete with the OCM.

COA decided to work with its member practices, some payers, and pharmaceutical companies to develop OCM 2.0 simply because the errors and problems it identified were not being fixed quickly and the escalating costs of oncology drugs in Medicare Part D were not getting enough attention. In short, Gamble said, the alliance asked, “Why is there not a better way to do this?”

As Gould’s committee collected feedback, Gamble said, a key step involved gathering practice leaders responsible for understanding the revenue cycle of the OCM and bringing them together to brainstorm solutions. Another critical step was meeting directly with leaders of drug companies and asking how COA could forge value-based agreements directly with providers—something that payers typically do with pharmaceutical companies while purposely leaving providers in the dark. “That lack of transparency is impacting the patient and the provider teams,” Gamble said.

“We had a series of close to 12 face-to-face discussions with drug companies,” Gamble noted. The tone was, “We see the challenges in your world, you see the challenges in our world,” he added.

OCM 2.0 will not look like other payment models, Gamble said. It will be more of framework based on the best elements seen by other oncology models, including initiatives from the American Society of Clinical Oncology. But Gamble promised it will take on the issue of rising drug costs in ways other models have not.

Meetings with pharmaceutical companies in particular will soon bear fruit, Gamble added. “I believe in a very short while, you’re going to see more value-based scenarios involving providers than you ever have before,” he said.

REFERENCE:

Letter to CMMI detailing OCM concerns. Community Oncology Alliance website. communityoncology.org/letter-to-cmmi-detailing-ocm-concerns-2/. Published March 16, 2018. Accessed April 5, 2019.

Step Therapy in Medicare Advantage Hurts Patients, Providers, Says Schwartzberg

Step therapy, which requires that patients try the payer’s preferred treatment before the one a physician recommends, is harmful to both sides of the doctor—patient relationship, according to Lee B. Schwartzberg, MD, executive director of the West Cancer Center and Research Institute, who spoke on April 5, 2019, at the Community Oncology Conference in Orlando, Florida.

Schwartzberg, who also recently became chief medical officer for OneOncology, a national partnership of community oncologists,¹ discussed the challenges of step therapy with Ted Okon, MBA, executive director of the Community Oncology Alliance (COA).

Okon and COA were among the first to criticize the August 2018 directive from HHS to allow Medicare Advantage plans to include step therapy as a cost-saving measure, calling it a “fail first” strategy.^2,3

During open enrollment last fall, several national insurers declined to say whether they were pursuing step therapy, and if seniors selected plans based on price, they might not know whether their plan featured this provision until after they had received a cancer diagnosis. A report from Deft Research found that the Medicare switch rate increased from 11% in 2018 to 14% in 2019, and UnitedHealthcare’s share of the Medicare Advantage market is now up to 25%, and Humana has 17%.⁴

“When it comes to step therapy, there are so many problems, it’s remarkable we stand for it,” Schwartzberg said. The practice, seen for years in conditions like diabetes, is questionable when treating a chronic disease, Schwartzberg said, but in oncology it’s particularly alarming. Patients with cancer often do not have the luxury to wait for a therapy to fail before moving to the one a physician preferred in the first place, he said.

It’s reasonable to assume that payers use step therapy to force patients to start with older, cheaper drugs or generics, but that’s not always true. The first drug a patient tries “could be the one that’s the most profitable,” Okon said. At least 19 states have passed laws to curb step therapy, and more states are considering legislation, he said.

Schwartzberg said in some cases, step therapy is applied for supportive drugs, but in others, it is used for therapeutic drugs. “This is antithetical to precision medicine,” he said.

He offered an example in which a patient was pushed to try a different drug even though the patient’s serum creatinine levels were already elevated and the substitute would increase them. Pharmacy benefit managers “take a very narrow view of what the ‘cost’ is,” Schwartzberg said. “They don’t take into account the patient experience at all.”

Another example includes different choices for filgrastim. Schwartzberg said he’s all for using biosimilars when they are indicated, but he has some patients who live far from his clinic, and each visit is 100 miles round trip for the patient and the caregiver. Some forms of filgrastim come in a prefilled, subcutaneous injection that the patient or caregiver can administer, but other forms do not.

Another challenge is in variation among payers. Schwartzberg presented a slide showing different policies for denosumab, a subcutaneous injection used to treat bone problems in patients with cancer, including those with solid tumors and multiple myeloma. He compared policies for Humana, the Blues, Cigna, Aetna, and UnitedHealthcare. Among the group, Aetna had the most expansive policy.

Humana requires patients with multiple myeloma and those with solid tumors to try other drugs first but exempts patients with prostate cancer from this requirement, Schwartzberg said. According to the information he presented, UnitedHealthcare also requires patients to try an intravenous bisphosphonate, and once on denosumab, they can take it for only 12 months.

Schwartzberg said knowing what company name is on the insurance card doesn’t tell him much because not all Medicare Advantage plans have step therapy, and typically patients have no idea their plans allow this. It’s not uncommon for his office to get an urgent phone call from a pharmacy saying the health plan will not cover the therapy that Schwartzberg has carefully selected and discussed with the patient. He must default to what the plan allows.

This does not help build trust with patients, he said. “It’s so stress provoking for patients. They say, ‘You prescribed this. Now they are telling me this.’”

Schwartzberg said patients get what’s going on, and he won’t lie to them. “I tell them, ‘That’s not the drug that I would use, but we’ll try it.’”

Okon urged the oncologists in the audience to contact state and federal legislators on this issue. “There are a lot of members of Congress who understand this, and they are very against it,” he said.

REFERENCES:

1. OneOncology announces Dr. Lee Schwartzberg as chief medical officer [news release]. Nashville, TN: OneOncology; April 1, 2019. oneoncology.com/from-oneoncology/oneoncology-announces-dr-lee-schwartzberg-as-chief-medical-officer/. Accessed April 8, 2019.
2. Joszt L. CMS will allow Medicare Advantage plans to use step therapy to negotiate drug price. The American Journal of Managed Care. website. ajmc.com/newsroom/cms-will-allow-medicare-advantage-plans-to-usestep-therapy-to-negotiate-drug-prices. Published August 8, 2018. Accessed April 8, 2019.
3. Community Oncology Alliance statement on CMS guidance allowing step therapy in Medicare Advantage plans [news release]. Washington, DC: Community Oncology Alliance; August 7, 2018. globenewswire.com/news-release/2018/08/08/1548598/0/en/Community-Oncology-Alliance-Statement-on-CMS-Guidance-Allowing-Step-Therapy-in-Medicare-Advantage-Plans.html. Accessed April 8, 2019.
4. New report: Deft Research’s 2019 Medicare shopping and switching study. Precision Senior Marketing website. psmbrokerage.com/blog/new-report-deft-researchs-2019-medicare-shopping-and-switching-study. Published February 20, 2019. Accessed April 8, 2019.

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