Listen to the episode IG Infusions in the Home Setting hosted by patient advocate Abbie Cornett.
Episode 5 Transcript
IG Infusions in the Home Setting
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 the growing trend of immune globulin therapy, also referred to as IG infusions, in the home setting. Today, we have guest expert Michelle Greer, executive vice president of sales for Nufactor, a specialty infusion company. Michelle has 20 years of experience with plasma administration management and sales. She has a strong national relationship with key opinion leaders in the autoimmune and immune deficiency arena, and she has a proven record of business growth and development through education and working with clients to understand standards of care and payer policies. Michelle also has expertise in both clinical care reimbursement and associated challenges faced by patients treated with IG. She holds a bachelor of science degree in nursing, as well as a master's of business administration.
Abbie: Good morning Michelle. Thank you for joining me. Michelle, you wrote an article that we published in our April-May edition of IG Living magazine regarding the growing trend of IG infusions in the home setting. Because both patients and providers need to decide together about the transition to the home setting, I thought we could cover some questions they might have today. First, could you please explain some of the differences between how care is provided for IG therapy at home versus in an outpatient setting?
Michelle: Sure. So, there are several differences between infusing in an outpatient setting and at home. When a physician decides he or she wants a patient to be on IG therapy, there are several things they can consider. Where to infuse is a big consideration. The other consideration is route of administration because IG can be administered intravenously or subcutaneously. If the patient is getting subcutaneous infusions, it's a given that the patient will infuse in the home setting almost 100 percent of the time because it's considered a self-administered drug. Another consideration is healthcare coverage and what the policy will allow based on the patient's diagnosis. Every health plan has a medical policy that outlines how IG therapy is covered. There is a growing trend of payers nudging patients into the home setting because it is more cost effective than outpatient therapy. Another thing to consider is brand preference based on whether the patient was treated with IG in the past, whether there is a choice and a preference from the prescribing physician, and whether there is a formulary product for the health plan that the patient is covered by. And then, another consideration is convenience and the schedule that would work best for the patient's lifestyle. What the patient has going on in their life is important to consider.
So, if a patient wants to be infused in the home, a referral is made by the physician to a home infusion specialty pharmacy provider. And, pretty much, I would say 95 percent of the time, the therapy must be submitted for prior authorization to the health plan. And as I said, there may or may not be a formulary product. There may be a specific brand ordered by the physician and the pharmacist who oversees the care at home. The determination will be based on the patient's assessment, any other conditions they have or allergies during prior use of IG. The patient should have a say in the brand as well. The patient will get a nurse and all the equipment and supplies that are needed to administer IG safely and effectively in the home, which includes an anaphylaxis kit in case there are any reactions, which is very rare. The patient can work with the nurse who will be seeing them, as well as the pharmacy to arrange a time in the home that's convenient for the patient.
If a patient infuses in an outpatient setting, the schedule is a little less flexible because the outpatient setting will tell the patient when it has availability. The prior authorization process is a little more fragmented. I'm not sure how that's done these days — in terms of whether the patient is aware of any financial responsibility they may have up front. In the home infusion arena, especially if the specialty infusion company is accredited by any governing body like the joint commission, the company is mandated to advise the patient what their financial responsibility is up front so they know going in what they're responsible for, and they can factor that into the decision about whether they want to infuse at home or in an outpatient setting.
At home, the patient will have one nurse in their presence the entire time overseeing their therapy. In an outpatient setting, there will be more than one patient per nurse. I would also say that the pharmacy oversight is a little more personalized and customized to the patient in the home setting because the pharmacist will really look at all the clinical information for the patient and decide what rate will be best. And, the patient will know how long the infusion will be based on the dose and what the patient can tolerate and how much time they have for the infusion. Some patients work and want the infusion finished as quickly as possible. However, intravenous IG (IVIG) should be run slowly because a lot of the reactions are rate-related. Every product has a package insert that states the rate of infusion and what the maximum rate should be for that product. At home, I would say we tend to run the IVIG infusion a little more slowly because we want to be cautious in the home setting. Even though there's a nurse with an anaphylaxis kit, there is a little more immediate assistance if that's needed. If somebody has a lot of allergies, they may want more clinical oversight in a hospital setting. There are benefits to each site of care based on what's going on with the patient.
Abbie: That was informative. If the patient does decide to infuse at home, can you please explain how reimbursement differs between the two settings: outpatient clinic versus at home? And then, what do patients need to be aware of regarding reimbursement?
Michelle: So that is a complex issue. IG is very expensive, and years ago, a doctor would say this patient needs IVIG or subcutaneous IG (SCIG), and prior authorization wasn't required. But, because IG is such an expensive therapy and because the disease states that IG treats are so complex and can mimic other diseases that are not treated with IG, insurance companies now have pharmacy committees — medical directors — that participate in looking up studies and implementing those medical policies. For instance, they'll say "OK" for this diagnosis. So, when seeking reimbursement, it's not enough to say this is the diagnosis. The prescriber will have to prove the diagnosis, and the insurer will want to see all the work-up that was done to diagnose that patient. So, say you have a patient with chronic inflammatory demyelinating neuropathy (CIDP), an immune-mediated neuropathy. There are many many causes of neuropathy that are not treated with IG, and CIDP is rarer than the other forms of neuropathy. So, insurance companies typically want to see the EMG nerve conduction study and maybe even a lumbar puncture to see what's in the cerebral spinal fluid. We've even seen them want to see a nerve biopsy, although that's kind of gone away because it's kind of a dated way to diagnose a patient. For ongoing therapy, they may want to see that they did respond to the treatment. Response to therapy should show an improvement. There is kind of a misnomer out there that the therapy is working because it's not getting worse. But, instead, the patient should get better; there should be some improvement when on IG therapy. So not only do you have to prove the diagnosis to the insurance company up front and get approval for ongoing therapy and reauthorization, but they're also going to want to see that the patient did improve. And if the patient's improvement plateaus for a while, the insurance company may want the provider to try to wean the patient off treatment to see if it's even still necessary because patients can go into remission with certain conditions that IG is treated with. I would say for primary immune deficiency patients, that's not as much of an issue because that is a lifelong therapy. For them, there really is no other treatment short of a bone marrow transplant or stem cell transplant. The insurance company will typically authorize treatment for a year, and then the provider must keep getting it reauthorized.
As far as how it's covered, IG therapy is less expensive for the payer in the home setting because they're paying for a firmly contracted rate with a home infusion or specialty pharmacy provider. And then they pay a small fee for the supplies and the pump and the medical oversight (called the per diem) and a small amount for the nursing services. There are no other charges that are considered. These are for in-network providers. In the past, it was a little bit easier for an out-of-network provider to bill an insurance company. But now it's strict. The provider must be in network to provide the care for a patient.
Abbie: Thank you, Michelle. Can you explain some of the billing issues or reimbursement issues patients need to be aware of that might come as a surprise to them between the two settings?
Michelle: Yes. As I said, IG is expensive so patients should really be aware of what their financial responsibility is prior to receiving treatment. A lot of patients don't realize that's important. They just think if they're getting the treatment, it must be covered. Or, they're not telling me what my responsibility is, so it must be none. I cannot tell you the number of times that we've had patients come to us in a panic because they've gotten bills for tens of thousands of dollars from both settings — either a hospital outpatient infusion company or a specialty pharmacy that may have been out of network. It's important for patients to understand what their portion is up front so they can make the decision. We've had patients say, "You know what? Then I don't want this therapy." And they get treated a different way.
Abbie: That is so important. As the patient advocate for IG Living, I constantly have patients emailing me for help or calling me for help because they get bills they just were not expecting. And, a lot of times, it is from the out-of-network providers because they don't know about that ahead of time. Our listeners are very interested in reimbursement because it so important and so complicated. A lot of our listeners are on Medicare. Can you explain to our listeners how that can affect their infusion setting and whether there are any issues they need to be aware of before they transition to Medicare and/or transition to the home setting?
Michelle: Yes. Understanding Medicare reimbursement as it pertains to IG therapy is probably one of the most complex things that we deal with in the home infusion arena. There are several parts to Medicare. We all know there is Part A and Part B, and then several years ago, there was the implementation of the ability to purchase a Part D plan, which is basically a prescription drug benefit that the patient can purchase in addition to their Parts A and B. Medicare Part B covers several diagnoses that are immune deficiency-related in the home setting for both intravenous and subcutaneous infusion. For CIDP, Medicare now covers SCIG in the home setting under Medicare Part B. But, that's it. Everything else would be covered under Part D. So, for CIDP, IVIG would be covered under Part D. And any autoimmune conditions such as pemphigus, myasthenia gravis or anything other than an immune deficiency would also be covered under Part D, the prescription drug benefit. There are also two or three diagnoses for immune deficiency that are covered under Part D.
If a patient is covered under Part B, that benefit will cover 80 percent of the patient's services, and the other 20 percent would typically be picked up by a supplemental plan. If the patient has Medicare and Medicaid or a full secondary plan (maybe a commercial benefit as part of their retirement or Tricare if they were in the military) then the Part B benefit would be covered at 100 percent. If a patient infuses in the outpatient setting, regardless of the diagnosis, it would typically be covered at 100 percent. If a patient is infused in the home setting, the Part B benefit would pay 100 percent. Part D is where it gets very complicated and very pricey because there's of an out-of-pocket and co-pays, which go through various phases. We all hear the term "doughnut hole," which is when pretty much nothing is covered. After that, there's catastrophic coverage when almost 100 percent is covered.
A lot of patients are on a lot of oral medications, and Medicare provides some coverage up front, and if they do get a bill for those oral medications, it's just for a small amount. But, when we're talking about IG therapy, depending on the dose, the cost of treatment up front is several thousand dollars. After that, when treatment is covered by catastrophic coverage, then the cost of treatment will be covered. But to hear up front that they are responsible for four or five thousand dollars depending on what their plan says their doughnut hole is, that's where it can get scary. There are options for both commercial and government payers to assist with the co-pays, so it's important to understand what their responsibility is and what options are available to them to assist with out-of-pocket expenses.
Medicare is probably the most complicated insurance, and site of care determines how IG therapy is covered and how much is covered. So, if patients are currently on IG therapy and they're about to transition to Medicare, they probably would want to start that discussion at least six months before the actual transition so they can understand what it will look like. While they may be infusing at home now, they may not want to get it at home anymore. Maybe they want to get it in the outpatient setting now because the coverage would change how it is reimbursed. If they're infusing at home and the specialty pharmacy says it is going to continue to cover in the home, there might be a brand change involved. A brand change is not necessarily a bad or good thing. It's something that happens all the time regardless of site of care. Patients need to understand that if they are getting a different brand, they need to make sure whether they can tolerate the brand change. Most people do totally fine, but some people do react to some brands and not to other brands. So, they would want to understand if there is going to be a brand change and, most importantly, the impact on their patient responsibility. So, preparing to transition to Medicare can't be done just during the month it's going to happen. The planning needs to start early.
Abbie: Absolutely. Michelle, it has been such a pleasure having you with me today, and I want to thank you again for joining us to discuss what information patients need to know when they're considering transitioning from the infusion center setting or hospital setting to the home setting. I'm sure our listeners found it very informative. Please look for Michelle's article titled "IG Infusion in the Home Setting Is Becoming a Growing Trend" in the April-May issue of IG Living. Listeners, thank you again for joining us today
Additional information regarding this podcast can be found on our website at www.igliving.com. If readers have a question that was not answered, please contact me at firstname.lastname@example.org. 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.