Leah Ralph discusses the ACCC’s position on the Afforadable Care Act repeal bill, the Medicare Payment Advisory Commission’s Part B cost control proposals, and the possibility for comprehensive reform on the 340B Drug Discount Program.
In the wake of the Affordable Care Act (ACA) repeal bill, the Association of Community Cancer Centers (ACCC) is concerned with maintaining the critical patient protections of the law, says Leah Ralph, director of health policy for the ACCC.
OncLive: Can you discuss ACCC’s take on the latest GOP proposal to reform healthcare?
In an interview with OncLive, Ralph discussed the ACCC’s position on the ACA repeal bill, the Medicare Payment Advisory Commission’s (MedPAC) Part B cost control proposals, and the possibility for comprehensive reform on the 340B Drug Discount Program.Ralph: In recent days, we have seen some negotiation between the heads of the Freedom Caucus and the moderate Republican group on the House side and there is an effort to find a path forward on the ACA repeal bill. The new amendment language that we have seen allows states more flexibility to implement a lot of the insurance provisions in the ACA—things like essential health benefits and community health ratings. It's allowing states to apply for waivers to allow insurers to opt out of those requirements.
ACCC's position on the ACA repeal bill is that we want to maintain those critical patient protections that are in the bill that seem particularly critical for cancer patients who, inherently, can't predict what their out-of-pocket costs will be. That population needs access to comprehensive, affordable health insurance coverage.
There are some concerns with the new amendment that would change the underlying American Health Care Act (AHCA) that we have seen. It's unclear at this point how many states would apply for these waivers or what the impact would be. But there are concerns about undermining a lot of those patient protections that we have gained in the ACA. In early April, we saw MedPAC come out with a series of recommendations around Part B reimbursement—these are policies that we have seen MedPAC, as a group, discuss in the past. Not a huge surprise, but the recommendations fall into 2 buckets. The first is what they are calling an improved Average Sale Price (ASP) reimbursement system, and the second bucket is a proposal for what they are calling a Drug Value Program, which is essentially, in some ways, a modified version of the Competitive Acquisition Program that was in effect from 2006 to 2008.
At ACCC, we are committed to working with Congress and with Centers for Medicare and Medicaid Services (CMS) to make sure that we can develop a healthcare system where cancer patients can receive access to the drugs they need. We are also committed to finding a way forward on a less costly system for patients and for providers of the Medicare program. I think there is not enough detail in the Drug Value Program proposal for us to understand what that looks like and what the impact would be on patients and providers.
Do you expect these MedPAC recommendations to gain a foothold in Congress? And do you expect that CMS will go through with the changes?
We are still working our way through the proposal, but I think there are some big concerns with what this would do to patient access to care for the cancer drugs they need, particularly in smaller, rural communities where providers are not able to access those drugs like other providers might be able to. We need to look closely at those proposals and be sure that it's not having a detrimental impact on access. As is everything that comes out of MedPAC, they are simply recommendations. They're often looked at very closely by Congress as they are developing legislation, but as of now, they are just recommendations. I would say that a number of them would have to go through legislatively and, given this political environment and the administration, it seems like that would be very tough. Congress certainly has a lot on their plate at the moment, so I would imagine that if any of these work their way through Congress, or perhaps through a demonstration program at the Center for Medicare and Medicaid Innovation (CMMI), it would have to be through some sort of must-pass legislation. So if the administration decides that they want to do something on drug pricing reform, some of these ideas could be folded in. But I think, as of now, it's hard to see what the path forward is on Part B reimbursement issues in the current political environment.I think the current political environment creates a lot of uncertainty around when, or if, we will see comprehensive reform on the 340B program. This is something that people have been calling for for a long time to fundamentally revisit the program and understand the reach that it is having, the patient that it is serving, and the purpose of the program. We have seen attempts to put some parameters around the program. With the Mega-Guidance that they have recently released, in January, that rule was pulled back, largely because of the Trump administration's regulatory review effort, as a new administration does when they come to the White House. But I think it's a challenging issue and it's hard to see a path forward on what policy maker is able to fundamentally make some of those changes.
You mentioned the difficulty of the current political environment. Do you think that drug pricing changes will still be a challenge to implement even though they are a bi-partisan issue?
Can you discuss the issues addressed at this year’s Hill Day?
Again, in the Mega-Guidance, we did see this effort to tighten the definition of a patient that would be eligible for discounted 340B drugs. I think in some ways, the guidance was trying to please both sides, and maybe not both sides were entirely happy. And they are also limited in their authority. They have been strictly limited in the legal authority they have to regulate around the program, which is why we are seeing things like guidance and not regulations. I think it's unclear what the path forward is on that, and I think that's another example of if the administration is as interested in drug pricing reform as some of the Tweets we have seen from the President. But I think it's going to need to be part of a broader vehicle to get anything accomplished.I think we have seen how difficult it has been with the ACA repeal, which is something that Republicans have campaigned on for 7 years. Now we have both a Republican House and Senate, a full Congress that has majority Republican control, and a Republican in the White House, and I think we have seen how challenging healthcare can be. In terms of drug pricing reform, it's very hard, so we'll see if people can come together in a way that they haven't been able to yet on ACA repeal. I think a lot of Republicans thought it could have been an easy win, and it's harder than everyone thinks. I think it comes down to the specifics of the proposals in a drug pricing reform package, whether you can get everyone to the table. I think there are certainly areas where we can find a consensus, but moving that through Congress can be challenging, depending on what it is. This year, ACCC had a very successful Hill Day. It was certainly a great time for us to have our big policy meeting at the end of March, and it was in the midst of the debates around the AHCA and the repeal bill for the ACA, but we went up to the Hill with a number of requests for lawmakers. One of them was, separate and apart from the ACA repeal bill, our strong concerns and opposition to the President's proposed level of funding for the National Institutes of Health [NIH]. There were significant cuts that were proposed, and while we understand that that is a budget blueprint, you certainly have to make your voices heard. It was a very significant decrease in NIH funding, which has traditionally had bi-partisan support. It has seen increases in funding every year, so our members went to the Hill to talk about how detrimental that would be to the advancement of scientific research in this country. It was very well received. I don't think we had 1 office that said they were going to support such a dramatic decrease in funding for NIH. We felt our message was heard on that particular issue.
We also went to the Hill to talk about the CMMI, which sometimes can be a target because it was created in the ACA. It's inherently bi-partisan. CMMI's goals to improve the quality of care and reduce costs are things people on both sides of the aisle can agree with. But because it was created in the ACA, it's had a bit of a target on its back.
ACCC has done a ton of work with the Oncology Care Model practices, the first oncology-specific alternative payment model that came out of CMMI, and we're really committed to helping our members be successful in that program. In many ways, they're paving the way for oncology payment reform, and we're seeing the broad trends—what’s working, what's not working, what's hard, what's not as hard. We thought it was important to go to the Hill and talk about our support for the goals and mission of the innovation center. But we are also concerned with certain demonstration programs. The Part B demonstration that we saw come out of the innovation center last year was bad policy, and it had a lot to do with politics, so we wanted to be sure we said to Congress: please, if you are thinking through what is coming out of the innovation center, and what we are seeing come out of CMMI, let's be sure that we put some parameters on those programs and that they continue to be voluntary targeted demonstration programs that can help us with lessons learned about how to move forward in value-based care, rather than these mandatory national demonstrations that can have a detrimental impact on patients' access to cancer care.
Other issues we discussed are the Medicare Access & CHIP Reauthorization Act (MACRA), the huge physician payment reform law that we saw come down last year, and we've now seen the quality payment reform created from that legislation, which [creates] a whole host of new requirements for our members to receive their Medicare reimbursements—lots of reporting requirements. It will mean big changes for a lot of our cancer programs, so we're asking that CMS continue to give our members some flexibility to comply with the requirements of that program. We saw some considerable flexibility in 2017, and we hope to see that moving forward so we can get cancer programs that are situated very differently across the country, in a place to be successful in the quality payment program as well.