Feedback on the Direction, Challenges of the OCM
The Oncology Care Model (OCM), CMS’ bundled payment program for oncology, is a 5-year model that began 2 years ago,1 and early experiences have revealed areas for improvement, as well as just how hard it can be for practices to perform well.
During a webcast, Bruce Feinberg, DO, of Cardinal Health Specialty Solutions, moderated a conversation with Bruce Gould, MD, of Northwest Georgia Oncology Centers (NGOC), and Mark Liu, of Mount Sinai Health System, regarding the implications of feedback to the model, so far.
This discussion was part of an OCM webcast series by The American Journal of Managed Care®.2
Most practices participating in the OCM are sophisticated practices that deliver quality care and have a background with alternative payment models. NGOC has had years of experience already through UnitedHealthcare’s episodes of care program and the COME HOME program, developed by Barbara McAneny, MD, and Innovative Oncology Business Solutions.3
Participating in both of these programs prior to the OCM gave NGOC the confidence that it could meet many of the practice transformations required for OCM participation. However, Liu noted, Mount Sinai spent a lot of time the first year on building the infrastructure and educating employees to get in the right mind-set.
Although NGOC might have had the infrastructure mostly in place, it—like most other participating practices—struggled with the “onerous” reporting requirements, Gould said. The practice also had difficulties compiling data for the 13-point care plan of the Institute of Medicine (IOM), which is mandatory for all OCM participants.4 “A lot of the information that’s required for that 13-point IOM plan is not in the [electronic medical record], where we can push a button and just have it spit out,” he explained.
Liu echoed the challenges Gould faced at NGOC, adding that, when it came time to presenting the information to CMS, Sinai realized that most of it didn’t live in a structured field. As a result, Sinai studied the clinical documentation to see if it could redo how information was being captured in a way that didn’t greatly affect the care team.
Looking at the first results of the program, Feinberg noted that drug costs were higher among OCM participants than nonparticipants. Because the participants represent some of the most sophisticated in the country, he wondered if those higher costs come as a result of these practices being more up to date on the latest treatments and early adopters of them.
Gould agreed that the assessment was likely accurate. NGOC gets experience with newer drugs before they’re on the market, which means the practices are comfortable using them and adopt them “right out of the gate,” he said.
The challenge is that newer therapies are increasingly expensive, which can negatively affect practices trying to meet a target price. For example, during 2012-2015, a patient diagnosed with breast cancer and placed on aromatase inhibitors had relatively low costs. The episode was priced at about $5000 for 6 months, Gould said. But now, cyclin-dependent kinase (CDK) 4/6 inhibitors, which nearly double progression-free survival, are priced at roughly $50,000 for 6 months. “And that, of course, blows away the target price,” he said.
Although there is a novel therapy adjustment, Liu said that Sinai expected CMS to provide more of an adjustment than it actually did. Sinai hoped that the adjustment would offset the vast majority of the amount it was over the target price, but that was not the case.
Both Liu and Gould admitted that their practices were in the red as of the first reconciliation reports, released in February. Gould said the challenge was that NGOC was being compared against itself, so the bar was a lot higher.
“We’ve got probably the most sophisticated practice in the country with the most experience doing this work [in the red], which is fascinating and scary at the same time,” Feinberg said.
Both Liu and Gould agreed that even if they would like to see some aspects changed and adjusted, the OCM is headed in the right direction. “Value-based care is here to stay,” Liu said, and the OCM has allowed practices of all shapes and sizes to work together.
Gould added that he has been glad to see CMS get into the value-based care arena. NGOC and other practices participating in the OCM are working hard to provide feedback to improve the program and make it sustainable.
“At the end of the day, I think it’s imperative upon physicians to really not only use good clinical judgment but [also] be good financial stewards of the healthcare dollar so that we’re able to afford these new, expensive treatments,” Gould said.
In the United States, spending on cancer drugs continues to substantially increase, and targeted cancer drugs contribute significantly to this growth. Experts recently proposed 3 steps to promote targeted cancer drugs that yield clinical benefits and also reduce overall price growth.
“The distorted pricing of marginally effective drugs risks crowding out the capacity of the US health system to pay for highly effective cancer drugs or other therapies of public health importance, potentially jeopardizing valuable innovation and escalating out-of-pocket expenses,” the authors said. “The combination of high prices and marginal effectiveness is unsustainable.”
First, the report suggested that the FDA should develop guidance on minimum clinically meaningful effect sizes for cancer drugs. This would explain past FDA guidance and establish a consensus-driven definition of minimum clinically meaningful effect sizes. To achieve this, multidisciplinary advisory councils of scientists, oncologists, patient advocates, and industry representatives should work together.
The authors noted that clinical experts have already supported this principal: The American Society of Clinical Oncology endorsed a minimum absolute improvement of 3 to 6 months in overall survival over best available treatment for drug trials among metastatic disease patients.
“Guidance could separately address cases in which, despite little or no change in median overall survival or hazard ratios, small proportions of patients experience large gains and the challenge of estimating benefits when pivotal trials involve head-to-head comparisons against active controls, thereby potentially underestimating the overall efficacy of novel agents,” the authors wrote. “By defining norms, the FDA would encourage manufacturers to design trials that demonstrate clinically meaningful benefits.”
The next step the experts proposed stated that Medicare should negotiate for targeted cancer drugs. Specifically, it was suggested that Congress could direct CMS to conduct a demonstration project. In this project, Medicare should negotiate the prices of targeted cancer drugs paid for by parts B and D, and it is authorized to apply limited formulary tools to marginally effective targeted cancer drugs.
The last recommended step to promote targeted cancer drugs and reduce overall price growth was that guidelines should prioritize drugs by benefit and price. The authors explained that evidence-based guidelines are best suited to complete this, and such guidelines should distinguish marginally effective drugs from highly effective drugs, as well as promote price transparency by reporting the estimated monthly price of cancer drugs.
“Successfully implementing steps to limit the use of high-priced, marginally effective drugs will be difficult; patients with life-threatening diseases may expect access to drugs despite their high costs and limited benefits,” the report concluded. “Nevertheless, the ultimate beneficiaries of these changes will be patients, who deserve the substantial efficacy, reduced toxicity, and enhanced value that were the original promise of targeted cancer drugs.”
Bekelman JE, Joffe S. Three steps toward a more sustainable path for targeted cancer drugs. JAMA. 2018;319(21):2167-2168. doi: 10.1001/jama.2018.3414.
When it comes to cervical cancer screening, most women receive a cytology-based Papanicolaou (Pap) smear, in which cells are scraped from the back of the cervix. However, human papillomavirus (HPV)—based testing may be a more accurate way to screen for cervical cancer, new study results suggest.1
Despite the widespread use of Pap smears, it was estimated that 12,820 women in the United States would develop, and 4210 would die from, cervical cancer in 2017. Because more than 99% of all cervical cancers are associated with HPV, testing for the infection has been touted as an alternative for cervical cancer screening. Previous research has indicated that HPV testing alone or combined with a Pap smear is linked to increased detection of precancerous lesions in the first screening round, followed by a reduction in lesions.
However, major organizations, such as the American Society of Clinical Oncology, have called for clinical trials involving HPV testing alone for more than 1 round of screening to further inform the implementation of the screening.
To determine the efficacy of primary HPV testing alone, researchers conducted the 4-year HPV For Cervical Cancer (HPV FOCAL) screening trial of women aged 25 to 65 years. Women were recruited from January 2008 through May 2012 and followed through December 2016.
A total of 19,009 women were randomized to receive either HPV testing (intervention group) or a Pap smear (control group). Women with negative Pap smear results received a second Pap smear after 24 months. After 48 months, both groups received HPV screening and a Pap smear.
Consistent with prior studies, more cases of abnormal cells in the cervix, known as cervical intraepithelial neoplasia (CIN), grade 3 or worse (CIN3+), were detected in the intervention group compared with the control group in the first round of screening. By 48 months, there were significantly fewer cases of CIN2+ and CIN3+ detected among all age groups in the intervention group.
The researchers observed that women who were HPV-negative at baseline were significantly less likely to have CIN2+ or CIN3+ at 48 months compared with those who had negative Pap smear results at baseline. “These results have demonstrated that primary HPV testing detects cervical neoplasia earlier and more accurately than cytology,” they wrote.
However, by the end of follow-up (72 months), incidence was similar across both groups.
The researchers also noted concerns regarding lower CIN2+ specificity with HPV testing, leading to higher rates of positive screens and therefore more colonoscopies and biopsies, which could cause unintended harm for women and increased costs if the tests prove unnecessary.
In 2017, the US Preventive Services Task Force made a draft recommendation that women 30 years or older receive just 1 screening method—a Pap smear or an HPV test—instead of cotesting.2 Chris Zahn, MD, vice president of practice for the American College of Obstetricians and Gynecologists, said in an email that studies like the HPV FOCAL trial can lead to a change in the guidelines.
Even if guidelines do change for women 30 years or older, the Pap smear is still important for women age 21 to 29, according to Kathleen Schmeler, MD, a gynecologic oncologist at The University of Texas MD Anderson Cancer Center. She told National Public Radio that she believes that the age group can’t rely on HPV testing because the majority will contract HPV at some point, and in many cases, it goes away on its own.3
However, if the virus persists until women are in their 30s, it becomes a problem, Schmeler said. “If you tested everyone for HPV in their 20s, they are almost all going to be positive, but there’s going to be all of this intervention that’s not needed,” she said.
1. Ogilvie G, Niekerk D, Krajden M, et al. Effect of screening with primary cervical HPV testing vs cytology testing on high-grade cervical intraepithelial neoplasia at 48 months: the HPV FOCAL randomized clinical trial [published online July 3, 2018]. JAMA. doi: 10.1001/jama.2018.7464.
2. US Preventive Services Task Force. Draft recommendation statement. cervical cancer: screening. USPSTF website. uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/cervical-cancer-screening2. Published September 2017. Accessed July 9, 2018.
3. Watson SK. For women over 30, there may be a better choice than the Pap smear. National Public Radio website. npr.org/sections/health-shots/2018/07/03/625696664/for-women-over-30-there-may-be-a-better-choice-than-the-pap-smear. Published July 3, 2018. Accessed July 9, 2018.