Changes in Medicare That Affect Patients Treated with Immune Globulin

IG Living Advocate Podcast Episode 4

Published: Sep. 23, 2021 @ 1PM

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Listen to the episode Changes in Medicare That Affect Patients Treated with Immune Globulin hosted by patient advocate Abbie Cornett.

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Episode 4 Transcript

Changes in Medicare That Affect Patients Treated with Immune Globulin

Welcome to the IG Living Advocate podcast. I am your host, Abbie Cornett, the patient advocate for IG Living magazine, the only magazine dedicated to patients treated with immune globulin (IG) products and their care providers. Each podcast episode will give listeners an opportunity to hear from experts on a topic important to them.

In this episode, we will be talking about changes in Medicare and how they affect patients treated with IG products. Today, we have with us guest expert Leslie Vaughan, chief operations officer for Nufactor, a Specialty Pharmacy. Leslie has been a licensed pharmacist since 1990 and has spent the majority of her career in the home infusion specialty pharmacy space with a specific focus on IG products. Her expertise is in both clinical care and understanding reimbursement and the associated challenges faced by patients treated with IG. She is licensed in multiple states and is currently certified as an IG certified pharmacist and certified specialty pharmacist.

Abbie: Good afternoon, Leslie. Thank you for joining us. Medicare can be confusing for everyone, but for those with a chronic illness, it can be even more challenging. Today, I thought we could cover some of the questions patients have about reimbursement for IG treatment. I am frequently asked about the Medicare IVIG Demonstration Project. Could you please give us a little background on it?

Leslie: Good morning, Abbie, I would be happy to give a little bit of background on it. Thank you for inviting me to your podcast today.

The Medicare IVIG Demonstration Project has been in effect since October 2014, and it has been slated to end a couple of times. But, twice now, it has been extended by Congress. The original intent of the project was to determine if adding payment for supplies and services for nursing would improve access to home infusion therapy for patients with specific primary immune deficiency diagnoses receiving IVIG.

Abbie: Thank you. We get a lot of questions about that, so that was very informative. Next, what are the beneficiary eligibility requirements for the Demonstration Project?

Leslie: Eligibility is limited to beneficiaries covered by traditional fee-for-service Medicare Part B and are actively enrolled in Part B. So, enrollment wouldn't apply to someone who has a Medicare Advantage plan or any other sort of Medicare bill for denial or something along those lines. The beneficiary needs to be receiving IVIG for one of the diagnosis codes currently covered by Medicare Part B in the home setting, which includes some but not all of the primary immune deficiency diagnosis codes. Twenty-four diagnosis codes are covered under Medicare Part B for home infusion.

One thing to consider is if someone is receiving other home health services such as a home health aide for diabetic medication or another home health episode of care, there isn't coverage for the Demonstration Project until that episode of home healthcare has ended. Therefore, individuals can apply to be a part of the Demonstration Project as long as they're not under another home health episode of care that can be billed to Medicare Part B.

Abbie: I know the Demonstration Project had originally been scheduled to end last December, but it has been extended a number of times. It has now been extended through Dec. 31, 2023. Could you tell us about the extension of the project and how that will affect patients? And, do you foresee another extension at the end of 2023?

Leslie: Sure, happy to do so. As I mentioned, when the Demonstration Project was initially started in 2014, it allowed for a total of 4,000 beneficiaries to access the program. That's 4,000 distinct patients, not necessarily 4,000 patients at any one given time. So, for example, if a person was on the Demonstration Project receiving IVIG and then was changed to subcutaneous IG (SCIG) therapy even though he or she wasn't still accessing the Demonstration Project, that person was still counted as one of those 4,000 people. One of the nice things about the extension is that it increased the total number of beneficiaries who can access the Demonstration Project from 4,000 to 6,500. So, it opened up registration for an additional 2,500 beneficiaries.

As you mentioned, the project slated to end in December 2023, and I'm not sure if it will be extended. But again, one difference between the previous extension and this extension is this extension calls for a report of the services to be evaluated and submitted in 2022. Therefore, assuming the project has accomplished what was hoped, perhaps we'll see a long-term permanent coverage for supplies and services in the home for all beneficiaries receiving IVIG rather than just the Demonstration Project beneficiaries.

Just for informational purposes, the current reimbursement rate for IVIG in the home in 2021 is $381.57 for each infusion. For the most part, that amount covers the cost of the services to provide the nursing supplies, unless it's a particularly long infusion.

Abbie: Thank you. There are a couple of other topics I'd like to cover today. Many of our listeners are treated with SCIG products. Could you go over the new permanent codes for billing and nursing associated with SCIG and what patients need to know?

Leslie: At the end of 2016, Congress passed a really large piece of legislation called the 21st Century Cures Act that included changes to SCIG. The first change was the way in which Medicare Part B reimburses home infusion providers for SCIG. Previously, reimbursement based on average wholesale price; however, with the passage of the act, reimbursement was changed to average sales price plus 6 percent for Medicare rates. That was a fairly significant reduction in reimbursement for home infusion providers. To offset that reduction, the act included a requirement to determine a method to reimburse for nursing services. From 2019 to 2021, this was accomplished by using a few transitional codes that allowed the infusion provider to bill Medicare for services when a nurse was in the home helping the patient infuse. Effective January 2021, the transitional codes were retired, and new permanent codes were put in place. Now, there are two specific codes to bill for SCIG: G0089 that allows the home infusion provider to bill for the initial teaching visit, and G0069 that allows the home infusion provider to bill for subsequent visits for either teaching continuation or, for patients who can't become independent with their therapy, coverage for long-term nursing services. The rates vary by state in how they reimburse the home infusion providers for the initial visit. Reimbursement for that ranges from around $250 to $340 for the initial visit, and for subsequent visits, reimbursement ranges from $150 to $200. So, much like the IVIG Demonstration rates, these rates are close to covering the cost of providing nursing services. But, once again, if the visit is significantly longer, sometimes the nursing costs may be more. I will caveat that by saying patients aren't asked to pay for additional nursing services if it's a long visit. Generally, the home infusion provider will try to figure out a way to reduce the visit such as by splitting the charge over a couple of days. So, patients shouldn't be asked to pay anything on top of what either the IVIG Demonstration Project pays or what is being paid for these new permanent SCIG rates.

Abbie: Thank you, Leslie. Let's move on to my last question. Can you explain the changes in coverage for Hizentra for chronic inflammatory demyelinating polyneuropathy, also known as CIDP, from Medicare Part D coverage to Part B coverage at home?

Leslie: This change became effective July 18, 2021. Prior to this change, Hizentra was generally covered under the Medicare Part D as a drug benefit. But with this change, it is now covered under what's called the external infusion pump policy to add coverage for CIDP and a very specific diagnosis code G61.81. That policy shifted covered for patients with G61.81 CIDP treated with Hizentra and infusing it with the pump from Part D to Part B. This could impact the home infusion specialty pharmacy providers. As I mentioned earlier, the 21st Century Cures Act reduced reimbursement for SCIG. So, in some situations, home infusion or specialty pharmacy providers may struggle to continue to provide services at this reimbursement rate because the cost to acquire the drug is very close to the reimbursement rate. Again, the nice thing is with the new permanent nursing codes, some of that reduction in reimbursement is offset, and there is also a small payment for the pump and supplies. So, we'll see how things change with Hizentra switching to the Part B benefit for CIDP patients. Very similar to the IVIG Demonstration Project, the goal of this change is to improve access for patients to receive care in the home.

Abbie: Thank you, Leslie. It's been a real pleasure to have you today as our guest. I want to thank you again for joining us to discuss the changes in Medicare and how they affect patients treated with IG products.

Additional information regarding this podcast can be found on our website at If readers have a question that was not answered, please contact me at Look for the next IG Living Advocate podcast announcement on our website for the opportunity to submit your questions.

IG Living Advocate is a copyright production of IG Living magazine published by FFF Enterprises. It is the only magazine for the immune globulin community comprised of patients who suffer from chronic illness and their caregivers.