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Recent Medicare Draft Regulations and Their Impact on Cancer Patients

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Published on June 5, 2019

Healthcare attorney John Wylam from Aimed Alliance joined Patient Power to share what’s happening in Washington that could impact cancer patients’ access to care. John provides an overview of two proposed regulations that may create barriers between patients and novel agents, and result in care delays. Watch now to find out more. 

This is an Aimed Alliance program produced by Patient Power. We thank AbbVie Inc. for their support. These organizations have no editorial control. It is produced solely by Patient Power.

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Transcript | Recent Medicare Draft Regulations and Their Impact on Cancer Patients

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That's how you’ll get care that's most appropriate for you.

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Andrew Schorr:

Okay, John. In Washington, you monitor what’s going on with government agencies that affect all of us with health, and particularly those of us like myself and our viewers with cancer. We’re dealing with regulations and often a lot of expense. So, what’s going on with agencies matters at the federal level and the state levels. So, we’re gonna talk about that in our program. Let’s start with CMS or Medicare and Medicaid. There are some things going on there help us understand what could be significant for us.

John Wylam:   

Of course. So, the federal government has been very busy lately proposing regulations that could impact patient access to care. I’m gonna give you a brief overview of two of them that I think are most relevant. First up is the Six Protected Classes proposed rule, and this was proposed in November 2018. So, this proposed rule is to provide greater flexibility to Medicare Part D and Medicare Advantage Plans to manage the medications that are in the six protected classes. And what are those?

The six protected classes are special types of medications that the government determined should be broadly covered. Medicare Part D plans have historically been required to cover all, or substantially all, medications in each protected class. So, this proposal was issued to save the government money and to improve the ability for plans to negotiate with pharmaceutical manufacturers. 

So, importantly for cancer, one of the protected classes is anti-neoplastics, better known as chemotherapy treatments, which are used to treat cancer specifically. If this proposed rule is finalized, Medicare Part D and Medicare Advantage plans can subject these medications to step therapy and prior authorization. So, this could threaten patient access to care by creating additional barriers between patients and the medications that they need. 

In the context of cancer care specifically, this policy proposal is problematic for patients, because it assumes the cancer medications are freely interchangeable and most of them aren’t. Newer cancer medications are targeted towards specific mutations of cancer and would likely be ineffective at treating other types. So, requiring a patient to try and fail on other medications before being allowed to access the one they were originally prescribed could result in care delays, and as you know, cancer is a progressive condition. So, when you’re dealing with care delays, in that time, a patient’s cancer could progress and that could lead to poor health outcomes and increased costs on the healthcare system.

Andrew Schorr:           

Right, and I’m just gonna comment on that in a second. So, what you’re saying is, it could give more leeway to these insurance companies or the policies here, so that I might get a therapy that my doctor and I know probably wouldn’t be effective for me, and it might be debilitated by that therapy and delayed in getting to what my doctor suggests might be more targeted for me and effective? 

John Wylam:   

Absolutely. That’s exactly what could happen. And in some cases, you might be eligible for an exception where you can override that step therapy protocol, but even in that situation, you and your provider are gonna have to take the time to complete that paperwork and have the request decided by the insurer. And even that by itself is gonna be a care delay. So, it seems like a lose-lose no matter what. 

Andrew Schorr:           

Okay, so that’s one for Medicare that they announced in the fall of last year. What about something else? 

John Wylam:   

Yeah, so this isn’t quite a regulation but it’s equivalent to one. It’s the step therapy in Medicare Advantage guidance that was issued by CMS in August of 2018. So, there was original guidance that was released in 2012 that had prohibited outright Medicare Advantage plans from using step therapy as a utilization management technique. 

So, the guidance that CMS issued last August rescinds that guidance from 2012 and that is gonna allow Medicare Advantage plans to use step therapy; and that’s specifically for medications available through Medicare Part B. Part B medications are usually administered directly by a provider in an office or hospital setting. CMS issued this guidance, again, to save money and improve the ability for Medicare Advantage plans to negotiate with pharmaceutical manufacturers so… 

Andrew Schorr:           

…okay, so it’s the same kind of thing we were talking about a minute ago related to step therapy is, you might get blasted with an old chemo that your doctor knows wouldn’t be right for you, it might be toxic, rather than perhaps a more targeted, more refined therapy that might be right for your condition, and you could get sicker in the process, as you said, cancer, progressive condition, maybe be very debilitated, or quite frankly, some people during that process could pass away? How tragic.  

John Wylam:     

That is correct. So, the one difference between these two, though, is that the previous rule did specifically deal with those six protected classes, so this change wouldn’t apply to chemotherapy drugs, but it could apply to other drugs that patients are prescribed to treat their cancer or their associated symptoms. So, either way, there’s gonna be a lot more step therapy happening in these types of plans.  

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.