By Josh Davis, Associate Editor

(May 31, 2018) Thousands of Medicare patients nationwide taking certain drugs at infusion therapy outpatient centers are finding themselves in a difficult position. As these centers refer patients to less costly home-based therapy, Medicare patients are being left out because Medicare, unlike other major insurers, won’t cover it.

Locally, the policy has apparently affected several patients at the Atlantic General Hospital Medical Infusion Center in Berlin.

Atlantic General Hospital sent a letter, dated March 12 and signed by Pharmacy Director James McGinnis, stating as of April 2, “Due to recent changes in insurance coverage and medication costs, Atlantic General has determined that home infusion therapy would offer a cost savings to you and/or your health insurance provider.”

The letter said AGH is “encouraging health care providers to begin referring eligible patients to receive infusions in the home setting for the following medications: Intravenous Immune Globulin, Infliximab, Tocilizumab, Vedolizumab and Abatacept.”

Exceptions would be made “based on certain criteria, which have been shared with your health care provider,” the letter said.

Confirming the new policy, AGH Director of Marketing Sarah Yonker said, “We have made some changes, like many hospitals and infusion services across the country,” Yonker said. “Our goal is to provide the right medication in the right environment.

“This results in a need to look at alternatives such as home health infusion services, own med models and drug choice alternatives,” she continued. “Every patient is an individual with different circumstances, needs and medications. No patient currently under our care will be without service or medication necessary for their treatment.

“We will facilitate an acceptable transition or continue care here on campus,” Yonker said. “There have been some barriers, and we are working with several alterative companies to help fill future gaps for our patients. Until these barriers are resolved, we continue to work directly with our patients.”

Roger Follebout, community relations director at Peninsula Regional Medical Center, said the Salisbury hospital also transitioned patients on identical medications to home infusion therapy on Jan. 1 “for the same reasons as our counterparts at AGH.”

“It is the accepted best practice for those patients who do not have exceptions based on specific criteria,” he said.

Patient Valerie Norman, who takes intravenous immune globulin, also known as IVIG, said she received the letter from AGH during a visit to the hospital earlier this month.

“I have autoimmune diseases that require me to receive infusions that I’ve received for many years to maintain my health,” she said in a phone interview earlier this month. “They’re kind of like part of my family, because I have to go do this every three weeks.

“That was a letter that they actually decided to postdate March 12, telling me that they had decided that, for the benefit of myself and for my health insurance carrier, that they had chosen five medications and they would no longer be servicing me at their facility,” she continued. “Anyone who received these medications would no longer be eligible to be treated at the infusion center.”

Norman said when she and other patients, all of whom were covered by Medicare, asked why they could no longer be treated, they were told, “it was for our benefit.”

“We said, actually it isn’t, because Medicare doesn’t cover these services outside of a hospital setting, so it would be financially unfeasible for us to receive what we need,” she said. “They told us it was between us and our doctor, and that our doctor should have informed us.

A spokesperson for the Centers for Medicare & Medicaid Services, in an email statement, said Medicare helps pay for IVIG for people with a diagnosis of primary immune deficiency disease.

They added, “A doctor must decide that it’s medically appropriate for the IVIG to be given in the patient’s home. Part B covers the IVIG itself. But, Part B doesn’t pay for other items and services related to the patient getting the IVIG at home.”

Norman called the situation “very ugly.”

“[The hospital] said it was our problem to figure out how to take care of our health care – not theirs – and they very much weren’t very interested in helping us when we were obviously quite upset,” she said.

She added representatives from Medicare said, “This was not what they wanted,” because Medicare doesn’t pay for home infusions.

“They said this is clearly about the profit for the hospital,” Norman said.

“One of [AGH’s] executives that came down to speak with us did admit that this was about the hospital’s profit margin,” she continued. “I’m like, well this is a nonprofit hospital that is really is only worried about their bottom line – you’ve chosen to kick out people who receive these five medications for your bottom line.”

Because of the prohibitive cost of the medication, Norman said her only option is to stop treatment.

“I did as they had asked and spoke with my neurologist and they referred me to their home health services … and the home health services informed me that, yes, Medicare does not cover this and it would require me to be a self-pay,” she said.

“Looking at the Medicare statements that I received from the hospital, I already know that would require me to come up with $13,000 to $15,000 every 13 weeks, which, clearly, is not going to happen,” Norman added.

She said the manufacturer may agree to provide the medication for a limited period of time, but, “they’re obviously not going to pay for the nurse to come administer the drug, they’re not going to pay for the equipment it would require … so those would all come out of pocket.

“Even if they agree to give it for a short time period, manufacturers don’t agree to give you drugs unendingly, forever,” Norman said. “I’m not going to agree to take a drug for three months that I know I need for a lifetime commitment.

“Three months would just be three months, and then I would be right back where I am today. And the hospital just keeps saying, ‘that’s not our problem,’” she added.

Norman previously received treatments at an outpatient facility at Peninsula Regional Medical Center in Salisbury, but because policy changed there as well that is no longer an option.

“Unfortunately, that’s the problem with this situation, that most of the hospitals have determined that these services … are now covered under outpatient home infusion therapies [under most insurances], and so it is more cost-effective for a Blue Cross Blue Shield to pay a nurse to come to someone’s home,” she said. “Medicare, nationally, is the one standalone that will not do that – they want their patients to be seen in a hospital.

“I’m stuck between the federal government and their policies,” Norman continued. “Medicare has a lot of safeguards and guardrails in place that they expect for their patients in case something goes wrong … most of us are either disabled or elderly that are on these treatments – which is why we have Medicare.

“The hospital, despite being paid, they feel that they could make more money putting someone else in the chair,” Norman said.

She was not sure how many patients were affected by the new policy and said the hospital refused to provide that information.

“When I was there, there was me and another gentleman who were both being given our letters at the same time,” Norman said, adding the other patient was “quite upset as well.”

“We’ve been communicating back and forth to try and find an alternative,” she said. “But there really isn’t much of an alternative for us.

“At this point we’re … kind of at a standoff,” Norman continued. “They’ve agreed that I’m coming back for my next treatment at the end of May, and then I don’t know where we go from there.”

If untreated, Norman said her autoimmune condition would cause her red blood cell count to drop and she may eventually require hospitalization.

“AGH is well aware of this as they often run my blood work,” she said. “I am fearful of the coming months, but have little say as I cannot change Medicare or AGH. I had hopes that a nonprofit, 100 percent community-focused and patient-centered hospital wasn’t just PR on their front page.”

Norman’s father, Frank Keller, in an email to the paper earlier this month, said, “This story really needs to be told as this will be a death sentence for my daughter and many others.”

Ken Van Pool, vice president of government affairs for the National Home Infusion Association, said patients nationwide were experiencing similar issues with their treatment.

“Medicare, when it comes to home infusion in general … has a weird coverage paradigm,” he said, adding many of the medications were affected by legislation passed in 2003.

“There is not a reimbursement for home infusion services or the supplies, so you really end up getting a reimbursement for the drug itself, which leads to broken coverage,” he said. “IVIG is a unique scenario.”

Van Pool said there was some coverage in Medicare Part B under the Durable Medical Equipment Benefit, or DME.

“There is a limited set of home infusion drugs that are covered in the Part B DME Benefit, because they require a mechanical infusion pump to be delivered,” he said. “The way it works is the durable medical equipment – the pump – is what’s covered, and the drug is actually considered a supply to make that pump work. So it’s a little odd in its coverage.”

He said that applies to subcutaneous, or under the skin, Immune Globulin therapy, but not to intravenous treatments.

“In the case of IV Immune Globulin therapy, it’s only covered for the diagnosis of primary immune deficiency disorder,” Van Pool said, adding other diagnosis were covered in Medicare Part D. “It’s a very tangled web when it comes to IVIG.”

In the case primary immune disorders, he said patients have to find a provider covered by Medicare Part B.

“There’s kind of limited coverage … because there’s really no access to a home infusion provider because of the reimbursement structure,” Van Pool said. “Home infusion providers really can’t be able to provide these therapies when it’s unreimbursed, except for the drug and maybe some of the supplies around it.

“That’s where the problem lies and it’s something that the Home Infusion Association has long sought to fix. It’s a very big deal for us and we’ve been fighting for this for a while,” he added.

Van Pool said home infusion providers “really are kind of underwater when providing [intravenous infusion] therapies.”

“So often they can provide them through private coverage, so if we’re talking about somebody that’s a Blue Cross Blue Shield insured individual, they can get these therapies, but when they get into the Medicare space that coverage goes away,” he said.

“It’s a national issue and I’m not going to say that people aren’t trying to fix this – people are on Capital Hill. They’ve been doing a lot of work around home infusion in the last couple of years and Medicare takes its cues from Congress on this, so we need to get some legislation passed,” Van Pool continued. “That’s how we fix this.”

While he did not have exact numbers on how many patients were affected nationwide, Van Pool said Medicare Part B patients with primary immune deficiency disorders numbered around 25,000.

“There are many more that are diagnosed with that nationwide. I’ve heard the numbers of 250,000, so as those individuals age into Medicare coverage or go into disability Medicare coverage, there will be more and more,” he said.

As for why patients were being transitioned to home-based care, Van Pool said the reasons were twofold.

“Immune-compromised individuals you don’t want to have in the hospital [because] you could be spreading infection or catching infection, and they’re really trying to get this individual into the home environment,” he said. “Not only is the home environment convenient, it’s actually a form of getting them out so these health care acquired-infection rates can go down – it becomes a public health issue at that point.”

He said home infusion treatments were “fairly readily available” locally.

“I can say on the Eastern Shore, there are providers. It really becomes a coverage problem,” he said.

Ironically, the worst-case scenario for patients who cannot receive home care treatments is hospitalization.

“What will probably end up happening is either hospital-based care, which is a greater cost and effort and possibly clinically inappropriate, or a skilled nursing facility – again, not cost effective, not clinically appropriate, especially for someone who has a disability,” Van Pool said. “At a younger age, that’s just not good for the constitution of the individual.”

In the case of Valerie Norman, Van Pool said, “I have no question in my mind that care would be available to this individual – it just wouldn’t be appropriate care. And it’s a travesty that that is the case.”

“No one with an immune deficiency disorder really should be in one of those sites of care,” he said.

He added the letter from AGH read as a “site of care optimization letter.”

“The site of care that they’re attempting to shift this lady to is a scenario where it’s not availed because of the reimbursement structure,” he said. “If this was a private-pay patient – if this was a Blue Cross Blue Shield – I have no doubt in my mind that they would have moved her right along and found a home infusion provider.

“With this circumstance, you have them saying ‘we want to optimize your site of care.’ The letter is very straightforward – you’ll save money, your insurer will save more. It’s a good thing,” Van Pool continued. “The problem in this circumstance is Medicare isn’t keeping up.”

Marilyn Tretler, vice president of communications for the National Home Infusion Association, said it is important to raise awareness for the issue.

“You can imagine there are a lot of patients out there in the same scenario,” she said. “With legislative efforts and raising awareness, that goes a long way.”