Category: Advocacy

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Advocacy

Uninsured? Healthcare Help is Available

Professional support when you need it the most

David didn’t have health insurance when he was diagnosed with diabetes recently. The shock of having to cope with a severe chronic condition was bad enough, but now he was faced with having to pay nearly $700 per month just for the medication to treat his disease. Along with this, the American Diabetes Association estimates the added annual expense of treating this chronic condition is almost $18,000. With a family income of less than $24,000 a year, there was no way David would be able to afford this condition.

Unfortunately, when he turned to the two health insurance options available for low-income individuals, he fell through the cracks. Medicaid would cover his wife, and the Children’s Health Insurance Program (CHIP) would cover his two young children. But the Medicaid program is administered by states, each of which has their own rules and eligibility criteria. In Texas, a man like David who is not disabled and is under the age of 65, does not qualify for benefits. He could get coverage through the Health Insurance Marketplace Exchange, but it would cost him more than $300/month. This too was unaffordable.

When you’re in a situation where you need life-saving therapy, but you can’t afford insurance coverage, there are a variety of resources available to help cover the costs. Sometimes we just need help finding them.

While these resources may not be available for all chronic disease conditions, especially those that are rare, you may be surprised how much help is out there if you know where to look.  

Confide in your healthcare provider. This will help providers understand your needs better so they can help you stay healthy. For example, they may be able to prescribe a generic treatment or an alternative drug that is less expensive. Some may also be able to provide resources and suggestions for other options. David’s doctor, for example, gave him drug samples that could tide him over until he found a more sustainable way to pay for treatment.

Look for manufacturer assistance programs. Many pharmaceutical companies have programs that can provide financial assistance for the uninsured and copay assistance for those with insurance who are still unable to afford their medication. You can find this information by doing an internet search for the company that makes your medication, the name of the medication, and the term “patient assistance” or “financial assistance.”  

When David explained his situation to the patient care coordinator at the company that makes his medication, he was able to apply for and receive his medication free for several months until he could find a long-term solution.

See if you qualify for Social Security disability. If your disease makes it impossible for you to work, consider this option. The process is not easy or quick, but if you are accepted for Social Security Disability Insurance (SSDI) or Supplemental Security Income (SSI), you will also qualify for Medicaid. The added good news about this program is Medicaid benefits will start retroactive to the date you applied for disability. Here’s the Social Security link.

Look for local resources. Local health departments and federally funded health clinics can help those with chronic conditions find medical care at little or no cost. The following directories can help you locate resources in your community:

Explore patient support groups. Nonprofit organizations exist for nearly every chronic disease. These groups can put you in touch with others who can provide support and real-world experience of living with your disease. Most also share evidence-based information and the latest research about how to live well with the condition. In addition, a number of these organizations also have an assistance fund to help those in financial need afford the care they need.

CSI Pharmacy’s website provides support group contact information for many of the patient communities that we serve.

For other conditions, do an internet search using terms that include the name of the disease and “support group.”

Look for help through charity organizations. A variety of nonprofit foundations provide financial assistance grants targeting specific conditions or medications. The following are organizations we are aware of that provide this sort of help. You may find others by searching for “financial assistance” and the name of your disease or medication.

  • Accessia Health (formerly known as Patient Services, Inc.) helps with insurance copays and premiums, ancillary costs of care, travel expenses, and infusion costs for a range of chronic and rare diseases. They also provide free legal help for those trying to navigate the confusing systems of disability and health insurance.
  • The Assistance Fund provides financial assistance for copayments, coinsurance, deductibles, and other health-related expenses for 80 specific disease communities. Be aware that this source will only support medications that are FDA-approved for the condition you have.
  • Healthwell Foundation provides financial assistance to help with prescription copays; health insurance premiums, deductibles, and coinsurance; pediatric treatment costs; and health-related travel costs. Their list of disease funds is limited, and they often exhaust available funds quickly, so you may need to keep checking to see if funds relevant to you are available.
  • National Organization for Rare Diseases (NORD) provides financial assistance to help pay for medications, insurance premiums and co-pays, diagnostic testing, and travel for clinical trials or consultation with disease specialists. The list of diseases with which they work is limited to specific rare diseases. They also have a list of resources that provide financial assistance beyond rare disease.
  • Patient Advocate Foundation provides qualified patients with financial assistance for co-pays and co-insurance for prescription drugs for those living with specific disease states. In some instances, assistance with insurance premiums and/or ancillary services associated with the disease also may be available. Individuals must have health insurance, have a confirmed diagnosis, live in the US, and meet certain income limits.

These resources are provided as a service to our patient communities. CSI Pharmacy does not certify or vouch for any of the organizations listed here nor do we benefit in any way from providing this information. If you choose to access these resources, please review the organization’s information carefully before committing to its services or benefits. 

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Advocacy

Copay Accumulators Raise Barriers to Care

pharmaceutical equipment on money showing the value of CSI pharmacy

Alyse has always been the one to come down with every infectious disease that’s going around. As a child, she often spent much of the winter with colds, sinus infections, and ear infections, which were treated with antibiotics. When she was hospitalized with her second bout of pneumonia in one year, her primary care doctor referred her to an immunologist who diagnosed her with common variable immune deficiency (CVID).

CVID is one of more than 450 rare, chronic conditions called primary immune deficiency diseases (PIDD) that are caused by a hereditary defect in the way the body fights infections. For PIDD patients, a part of the immune system is missing or doesn’t function properly, opening the person to all types of potentially dangerous infections.

When Alyse was finally diagnosed properly, her immunologist started her on immune globulin (IG) therapy. These treatments, which she gets intravenously every four weeks, replace the important immune proteins her body is missing. Now, Alyse can live more normally without fear of contracting the kind of severe infections that once made her chronically sick.

Immune globulin is made from donated human plasma and is very expensive. A single infusion can cost as much as $20,000. Until recently, Alyse’s insurance plan covered much of the cost, assessing a manageable $50 per month as a copayment. Over the last few years, however, the out-of-pocket cost for her IG therapy has increased due to a higher deductible plan. Alyse now has a $5,000 deductible before her insurance will cover any of her IG therapy in addition to copays she has to pay until she meets her out-of-pocket maximum of $10,000.

Still, she’d been able to afford her out-of-pocket costs due to the copay assistance offered by the drug manufacturer. For PIDD, the drug manufacturers have copay assistance programs from $2,500 to $10,000 a calendar year which helps her cover the costs

While it was still a struggle, this copay assistance helped Alyse afford the copay for the first few months of the year. This was because the amount paid by the manufacturer’s assistance program counted toward her insurance plan’s $10,000 annual out-of-pocket maximum, which includes all her copays and coinsurance and the deductible she must pay each year. Once she reached this maximum, the plan would pick up the entire cost of her treatments for the rest of the year.

A New Surprise

This year, however, without informing her, Alyse’s insurance plan instituted a copay accumulator program (also called a copay adjustment or maximizer program). This is an insurance industry trend intended to encourage patients to choose lesser expensive or generic medications rather than the more expensive brand names. Unfortunately, there are no less expensive alternatives for this essential treatment for PIDD and many other diseases.

With the copay accumulator program, copay assistance from a third party, like the drug manufacturer, a charitable organization, or a patient support group, is not counted toward a patient’s out-of-pocket maximum. That means the assistance Alyse receives to offset the monthly cost of her treatments no longer counts. After her assistance is used up, she is still responsible for the full amount of the copay charges until she reaches the annual out-of-pocket maximum.   

This has sent Alyse into a panic. There’s no way she can afford to pay $5,000 deductible all at once, as well as the additional copays until she meets her out-of-pocket maximum for her treatments. And without the treatment, she’s terrified that she will again fall victim to chronic, debilitating infections.

Many patients depend on the assistance they get from manufacturers and charities to afford the high cost of specialty medications. Copay accumulators limit a patient’s access to these life-saving therapies. They are extremely harmful to patients, both financially and in terms of their health and wellbeing.

Legislation that Will HELP

Many states and the federal government are now looking at this insurance industry practice and working to eliminate copay accumulator programs. A dozen states and Puerto Rico have already banned the practice. At the federal level, Congress is moving to control high out-of-pocket health insurance costs with the Help Ensure Lower Patient (HELP) Copays Act, a bipartisan bill (HR 5801) introduced in the House of Representatives last November.

The Immune Deficiency Foundation (IDF), the National Hemophilia Foundation, the National Organization for Rare Disorders (NORD), and more than 60 other organizations supporting serious and chronic disease patients have come together to form the All Copays Count Coalition, an organization committed to eliminating this barrier to care at both the state and federal level. Addressing this issue at both legislative levels is important because some insurance plans are regulated by the federal government, while others are regulated at the state level. 

IDF encourages those who use immune globulin therapy to support efforts to make #AllCopaysCount. They encourage you to contact your members of Congress and let them know that you support the HELP Copays Act. NORD and IDF are also following state-level legislation.

In the meantime, not all health insurance plans include a copay accumulator program. When you sign up for a new plan, it’s important to be sure to look for this restriction in the fine print (or call the company) and choose one that doesn’t restrict third-party copays. This may not be easy to determine. If you need help, our Patient Advocates are available to help you find the plan that’s right for you. Email us at [email protected].

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Advocacy IG Therapy

Peace of Mind with PNS

image of child for illustration purposes

Recently, we received word of a voluntary recall of a particular brand of immune globulin (IG). The manufacturer requested pharmacies to return all units of two specific lot numbers of the product because of reports of allergic-type reactions in patients who had been infused with these specific lots.

The hives, swelling, and skin redness that patients experienced quickly resolved when they were treated with antihistamines (Benadryl, for example), steroids, and Tylenol. Still, the manufacturer wanted to be sure others were not unduly affected by these uncomfortable symptoms caused by their intravenous IG infusions.

While news of a recall may alarm some patients, making them question the safety of their therapy, veteran IG users know that the rare recall of medications is usually not a cause for concern. In fact, the idea that the manufacturer is vigilant enough about their products to take this step voluntarily makes them feel more confident in their treatments.

Product recall or withdrawal is a common practice in industries across the country, including pharmaceuticals and medical devices. A product recall or withdrawal has several different levels; the highest is a Patient Level Recall, which is a request or warning to stop using a product. This directive can come from the Food and Drug Administration (FDA), which oversees drug safety. More often, however, the request comes voluntarily from the manufacturer, usually in response to some safety concern they’ve noticed.

“We get recall notices from both the FDA and manufacturers,” says Jack Lemley, Pharm.D., Chief Pharmacy Officer at CSI Pharmacy. “Any time we receive a recall alert, we review our electronic inventory to determine if we have ever purchased the affected lot numbers. If we have, we then check to see if any of it is still in stock and remove it.”

Still, there are times when a recalled product may be dispensed before pharmacists are aware of the recall. At CSI Pharmacy, if such a product has been shipped to a patient, pharmacists contact the person immediately and advise not to infuse the therapy, if appropriate to the level of the recall. If the patient has already infused the product, pharmacists will evaluate them for any adverse reactions. Patients are urged to notify their healthcare provider(s) of any potential adverse effects for their IG therapy, even if there is no known recall.

As a partner in their own healthcare, we strongly encourage patients to keep their own records. This should include the manufacturer of the product, the lot number (found on the side of the bottle or container), and the way it was administered (IV or subcutaneous). CSI Pharmacy provides patients with an infusion log used to record this information.

Patients can be proactive in finding out about IG product “events,” as recalls and withdrawals are called, by registering for the Patient Notification System (PNS). Through this free, confidential early warning system, patients can be made aware of a recall before they infuse or inject their therapy.

The PNS was developed by producers and distributors of plasma products and is led by the Plasma Protein Therapeutics Association (PPTA) in response to consumer requests. It provides registrants with automatic updates about plasma product withdrawals and recalls from all participating manufacturers.

To access the Patient Notification System, call 1-888-UPDATE-U (1-888-873-2838) or register online at www.patientnotificationsystem.org. You can choose the products with which you would like to receive notifications, as well as the method of notification: via telephone, fax, e-mail, or overnight letter. You will also receive a first-class letter by the US Postal Service when there are notifications.

While pharmacists do everything possible to ensure the safety of patients, there’s always a chance that a product may slip through. The Patient Notification System in one more way you can team up with your pharmacists to ensure your health and peace of mind.

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Advocacy

Patient Advocates are on Your Side

We know how hard it can be for those who live with chronic or rare diseases to cope with their health challenges. It can be even more overwhelming when you add on all the other questions about specialist care, health insurance coverage, finances, and so much more. A patient advocate can be a lifeline, helping you find the resources to get the care you need, so you can focus on getting well.

A patient advocate is a person who supports your healthcare journey by helping you work with healthcare providers, insurance companies, employers, case managers, lawyers, and others on issues related to your health. These knowledgeable and committed individuals can help resolve issues around access to care, medical billing disputes, and job discrimination related to your medical condition.

Patient advocates can examine your insurance plan and help you understand your coverage. They can also help you choose a new health insurance policy during open enrollment, work with providers to resolve your healthcare needs, and help you apply for disability.

At CSI Pharmacy, we take patient advocacy seriously, going beyond just working with the individuals for whom we provide therapies. We believe advocacy also extends to providing actionable information for patients and their families. One way we do this is by supporting and promoting the wider efforts of disease-based patient support groups throughout the country.

Our nurses, pharmacists, and patient advocates volunteer to speak at patient support groups, national conferences, and webinars. Through these talks, we educate patients and caregivers on issues such as navigating insurance, tailoring therapies to meet your unique needs, infusing specialty therapies in the home, understanding social security disability, and helping patients choose the best health insurance plan for them.

Another way we advocate for patient communities is by providing valuable resources on the CSI Pharmacy news page. We encourage you to subscribe to this page on our website, where you will receive ongoing information about treatments and wellness, patient stories, provider profiles, insurance, policy issues, and much more. You can sign up here.  

Our quarterly email newsletter also provides important news from the pharmacy as well as links to a broader range of news from around the rare disease community and a seasonal recipe too! You don’t need to be a CSI Pharmacy customer to sign up for the newsletter. And please follow CSI Pharmacy on Facebook, Twitter, and LinkedIn where we also post about issues of interest to the rare disease community.

Our patient advocates are always available for you, regardless of whether or not you are a patient of the pharmacy. To schedule a one-on-one consultation, just email us at [email protected].

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Advocacy Patient stories

Buyer Beware

Successful client photo

The cost of health insurance had been a struggle for Diane Steele for years. Even the plans offered by her husband’s employer were too expensive when they had children at home. For a while, the family had to go without insurance. When Diane learned about health share programs, she saw this as an affordable way to protect her family.

Health share programs (sometimes called medishare or healthcare sharing ministries) are faith-based programs in which members pay a monthly “share” (notably not called a premium), which is pooled together with other members to pay for approved medical expenses.

While health share programs have been around for decades, because they are significantly less expensive than traditional health insurance, their popularity has increased in recent years as healthcare costs and insurance rates have skyrocketed. Part of the reason they are less expensive is they are not actual health insurance.

Program guidelines for what will be covered are often limited and may be determined by religious beliefs rather than medical need. Some health shares, for example, specifically exclude things like birth control, addiction treatment, or conditions related to smoking or alcohol abuse. Health share programs may even require members to sign a statement of faith, and some require verification of regular church attendance.

Because these programs have a religious affiliation, they also are not subject to mandates imposed by the Affordable Care Act (ACA), such as coverage for preexisting conditions and no lifetime caps on coverage. Most also specifically exclude drug coverage, especially for long-term treatment of chronic conditions such as diabetes or heart disease. Instead, members are steered to prescription discount cards like GoodRx and NeedyMeds to help pay for insulin and high blood pressure medication.

“We went with the health share because of the cost, and because we liked the idea of helping other people,” Diane says. “The funds go into a universal plan, and as people need it and qualify for it, they cover your costs. The only thing is you have to get approval up front for any kind of major outlay.”

Having to get approval for major healthcare expenses seemed like a small concession for Diane and her family, one that seemed routine when her husband needed major open-heart surgery a few years ago. The health share covered all of the expenses of that hospitalization with little hassle.

When Diane was diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP) in 2017, however, she discovered limitations that were much more of a hassle. CIDP is a rare disease of the nerves and muscles in which inflammation causes disabling numbness, weakness, and pain in the legs and arms. It is a chronic condition that often requires a lifetime of treatment.

“I was so sick,” Diane says. “I couldn’t walk. I couldn’t drive. I was basically in a wheelchair most of the time. And I was gradually getting worse and worse.” 

Among the medications her neurologist prescribed for the condition was Gammagard, a form of intravenous immune globulin therapy (IVIG). This treatment, derived from donated human plasma, is very expensive, but it’s also very effective for a wide variety of autoimmune conditions like Diane’s. IVIG treatments did allow Diane to return to a more normal life, one that no longer includes a wheelchair, but the health share refused to pay for it.

“I worked and worked with the health share,” Diane says. “I talked to all kinds of people over there, and often had to ask for the supervisor’s supervisor. It was so complicated. They didn’t even know what Gammagard was.”

The health share required Diane to have a number of different tests to prove the diagnosis. They also required her to try other, less expensive medications (a process known as step therapy) to show that these treatments didn’t work for her condition. And they wouldn’t approve it just based on the doctor’s prescription. Her neurologist had to send them an extensive written report to justify the scientific basis for using IG for Diane’s disease.

To be fair, Diane’s experience with the health share program was not unique. Even traditional health insurance companies require preapproval for expensive treatments like IG therapy. Many also impose limitations on doses or frequency. There is often a large copay, and some will completely deny coverage for the treatment, especially if it is being prescribed off label (for a treatment that is not approved by the FDA for a particular condition).

But even after jumping through all these hoops, the health share only approved the treatment for forty-five days as a test to see if it would work. And the dose they allowed was also lower than what the doctor prescribed. Even when it did prove to be effective, the health share refused to cover the cost.

After the forty-five-day trial period, Diane worked with her specialty pharmacy to access the life-saving treatments she needed. They helped her apply for a special patient assistance program through the manufacturer that provided the medication for free. The specialty pharmacy then provided the nursing services and supplies at no cost. They also helped her apply for Social Security Disability, which would allow her to enroll in the more comprehensive benefits available through Medicare.

Diane’s story is a cautionary tale that underscores the need to know what you’re buying when you purchase healthcare coverage. All plans have restrictions and limitation. But when a plan is so inexpensive compared to the norm, you have to be especially careful to understand what they will pay for and be sure it covers the care you need.

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Advocacy IG Therapy

Don’t Take No for an Answer

The agency licenses, permits, and oversees pharmacists and pharmacies, as well as the distribution system where there is the sale, delivery, or distribution

Karen has struggled for many years with intense pain and muscle weakness, symptoms of chronic inflammatory demyelinating polyneuropathy (CIDP). This rare nerve disease causes gradually increasing loss of sensation, numbness and tingling, intense pain, and weakness in the extremities. For the last two years, though, Karen has been doing well with monthly infusions of intravenous immune globulin (IVIG) therapy.

Now, however, Karen is terrified that this life-saving treatment will be yanked away from her, not by her doctors, but by her health insurance company.

Karen receives IVIG infusions at home through an independent specialty pharmacy. But after every monthly treatment, she receives a letter from her insurance company’s pharmacy benefits manager (PBM) telling her that her plan requires that she obtain this medication from their preferred specialty pharmacy.

“We’ve just been living with this every month,” Karen’s husband David says. “It’s so nerve racking. We’re always afraid that they will deny coverage and we will get a bill for thousands of dollars.”

This scenario is happening more often lately, according to James Sheets, CEO of CSI Pharmacy, a small, independent specialty pharmacy that caters to patients who use IVIG. Between five and ten percent of new referrals to his pharmacy are rejected by the patient’s insurance plan because of preferred pharmacy limitations.

“The thing is, this is not always true,” James says. “Even when the claim is denied, we have to do some investigating to see what the truth really is. Often, we are, in fact, able to provide services to these patients.”

So far, Karen is still able to get her treatments through her pharmacy of choice. But last month the PBM, a middleman in servicing pharmacy benefits for health insurance companies, stepped up the pressure. In a letter she received, they stated that there was a nationwide shortage of IVIG and again stated Karen was required to switch to their preferred pharmacy.

Someone from the preferred pharmacy even followed up with a phone call out of the blue, insisting that her health plan would not pay for the treatment if she didn’t get her medication through their company, a large, nationwide chain that is financially linked to both the insurance company and the PBM.

“IVIG is extremely expensive,” Karen says. “There’s no way we can pay for it ourselves. They’ve been writing these letters and now they’re calling me. I’m terrified! These people have no concern for my diagnosis or my medical care.”

While plasma donations decreased last year as a result of pandemic restrictions and many expect some immune globulin (IG) products to be in short supply, an IG shortage has not yet materialized. In fact, the only agency authorized to make a declaration of a drug shortage is the Food and Drug Administration (FDA), and to date no such declaration has been issued for immune globulin.

“It’s just wrong that there is an IG shortage,” James says. “Even if there were, the pharmacy in question would not be the only place that has availability of IG products. In fact, patients at small pharmacies like CSI Pharmacy would be more likely to be protected than those at a large national chain pharmacy.”

For patients like Karen who might be feeling more pressure to change to a new pharmacy for specialty medications like IVIG, James has a few suggestions. For starters, if you are already receiving services that you are happy with, don’t automatically agree to change.

“Be an advocate for yourself,” James says. “Tell your plan, look, I have been stable with my current pharmacy. I’m happy with the services they provide. I have a good relationship with my infusion nurse. I do not want all that change, and I would like to opt out and continue to use my current provider.”

It’s also a good idea to call your specialty pharmacy’s patient advocate and let them know what’s going on with the insurance company. You have a relationship with the people at your pharmacy, and they can do the necessary investigating to see if anything has changed with your coverage.

As Karen and David found out when they called their specialty pharmacy, the insurer was continuing to cover the cost of Karen’s infusions, despite the threatening letters they were sending to her. And her pharmacy had no intention of billing her for anything more than her copay.

If you have Medicare and your IVIG is covered under the Medicare Part D drug plan, you are protected against this practice. Language in the Medicare legislation specifies that patients can choose to get their medications from “any willing provider.” So by law, insurers are not allowed to force patients to a certain pharmacy.

“I believe that patients deserve to have the power to make their own health care decisions,” James says. “That’s when the best care takes place. I hate to see patients being forced, against their will, to use specific pharmacies simply as a business decision. The problem with that is there’s no incentive for the big chain pharmacies to do a great job, because when patients don’t have a choice, they never have to make patients happy in order to keep their business.”

CSI Pharmacy would like to know if this sort of pressure to change pharmacies is happening to others. If you’ve received communication from your insurance plan or their pharmacy benefits manager urging you to move your care to their preferred specialty pharmacy, please drop us a note at [email protected].

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Advocacy IG Therapy Patient stories

IG Shortage is Coming

Bonnie and Walter Joslin smiling in front of their home door.

Walter “Kip” Caro started noticing tingling, numbness, and pain in his feet back in 2007. Gradually these symptoms progressed up his legs and into his body to the point where he had to be hospitalized because his torso was affected and he couldn’t breathe. It took three years for doctors to diagnose him with chronic inflammatory demyelinating polyneuropathy (CIDP). In that time, Kip suffered permanent nerve damage in his
feet.

For the last 11 years, however, Kip has been treated with intravenous immune globulin (IVIG), which has worked like a charm. He never has to worry about his symptoms, unless he can’t get his treatments every three weeks. If he doesn’t, as happened last June when there was a shortage and his infusion center couldn’t get immune globulin (IG) products from their distributor, his disease starts to relapse.

“It was scary,” he says of this experience.

“Over the years, we’ve met people said they could make a change to their treatment schedule, and their symptoms would not be affected,” says Kip’s wife Bonnie Joslin. “But we’ve learned, for Kip, his body just can’t do that.”

Kip feels lucky that Bonnie is such an advocate for him. By the time his infusion center called and told him they weren’t able to get his medication, Bonnie had already been reading about other patients’ experiences
online. She reached out Facebook and was put in touch with CSI Pharmacy, which was able to get Kip hooked up
with home infusions within a week.

“He was already starting to relapse,” Bonnie says. “But CSI pushed it through, and Natalie Edwards in the insurance department worked to get approval. I know it wasn’t easy, but it was like a miracle
happened.”

By early 2021, however, nearly all IG manufacturers expect to see shortages again. This time it’s because pandemic shutdowns earlier in the spring have decreased plasma donations. Plasma is the raw material from which IG and other protein therapies are made. The manufacturing process takes seven to nine months to create IG from donated plasma, so unlike last year’s shortage, this time we know it’s coming and can be prepared.

When IG products are in short supply, rationing does happen. Certain sites of care may stop treating outpatients. If they do treat outpatients, they may limit treatment to primary immune deficiency, Kawasaki disease, and transplant patients.”

That’s because supplies of IG are not universally distributed. Hospitals and infusion centers have contracts with
certain manufacturers or distributors, so they can only get specific brands. Last year, patients like Kip who were served by these sites of care sometimes found their treatments delayed or dropped completely.

Specialty pharmacies like CSI Pharmacy that offer home infusion services, however, have access to more brands
of IVIG as well as subcutaneous immune globulin (SCIG). In 2019, CSI Pharmacy was able to work with patients, their healthcare providers, and their insurance plans to allow them to continue IG treatment in the home.

At times this meant switching to a different brand of IVIG when certain brands were not available. Some patients even switched to subcutaneous (meaning under the skin) infusion after being on the intravenous (IV) form.

While changing to a different product can be scary for patients who have confidence in a brand of IG that is working well for them, please be assured that  a switch can be relatively comfortable if you
work closely with your doctor and pharmacist. The pharmacist can find a brand that is close in formulation to your current brand, for example. If side effects become a problem, the infusion rate can be reduced
and pre-medications prescribed. 

If you depend on IG therapy, now is the time to prepare. We suggest you have a conversation with your provider and current site of care. 

  • Ask your provider what other brands are good options if your brand is in short supply, and ask your care site if they are able to obtain one of these brands if needed.
  • Ask the site of care if they will prioritize patients if there is a shortage. Will it be based on disease, IgG levels, and/or rationing product by the number of grams or frequency?
  • Ask how the site of care handled past shortages.

If it turns out that your site of care does not prioritize patients with your disease or they are unable to obtain your brand of IG, you may want to consider how important is it to you that you continue IG therapy. (Some patients feel comfortable skipping their treatment for a month or two if it means they don’t have to make changes.)

If you’re like Kip, however, and can’t function without regular IG infusions, you’ll need to think about what options are available to enable you to access this treatment. Are you willing to switch brands? Are you willing to move to home infusion? Are you willing to switch to SCIG?

If home infusion becomes your alternative, we urge patients to make that move now. Specialty
pharmacies are more flexible and were less affected during the last shortage, but that may not be the case this time. 

If you are a patient of a specialty pharmacy when this crisis hits, you may be able to get access to IG since they do not ration based on disease and have access to more brands. However, we do not know how the shortage will affect sites of care. 

At CSI, we want to see all patients have access to all brands in their preferred site of care. But we just don’t know what the impact is going to be. We expect this shortage will be across all manufacturers. Patients should understand that this is not going to be a perfect scenario. You may still run into hurdles like access to your preferred brand.

CSI Pharmacy’s patient advocates are available to discuss your options related to IG therapy, regardless of whether or not you are our patient. If we can’t service your needs, we will gladly help you find other resources. No patient should suffer alone.

Categories
Advocacy Patient stories

Disability Benefits in Danger

Andrea Williams

Andrea Williams had a panic attack when she opened her mail earlier this year. Her hands were shaking even before she tore into the envelope from the Social Security Administration (SSA). The letter inside informed her that, according to SSA, she was no longer disabled and would no longer receive disability benefits, including Social Security Disability Income (SSDI) and Medicare.

Andrea is one of thousands of American citizens who are unable to work because of severe, chronic health problems who can expect to receive these notices in the coming year. This is because SSA wants to cut $2.6 billion dollars from SSDI and its sister program Supplemental Security Income (SSI) by changing the rules they use to terminate people like Andrea, who have depended on the disability safety net for years.

Six years ago, Andrea was diagnosed with a rare, debilitating disease of the muscles called myositis. She had trouble lifting her head, she couldn’t pick up her newborn baby, she couldn’t climb stairs, she couldn’t even lift her arms enough to wash her hair. For months she went back and forth to the doctor saying, “I feel like I’m dying.” It wasn’t until she was referred to a specialist and ended up in the hospital for a week that she was finally diagnosed.

Myositis causes chronic pain, disabling weakness, and extreme fatigue. Treatment has helped Andrea, but she has lost too much muscle tissue that she will never regain. She can’t stand for any length of time, she drops things, and the brain fog from her medications makes it difficult for her to think. Her doctor told her she would never work again. When she applied for SSDI benefits in 2016, her application was accepted on the first try, which almost never happens.

“I’m scared to death,” she says. “My biggest fear is not having the medications, and I already can’t afford the doctors.”

An “Explanation of Determination” letter like the one Andrea received is a notice an SSDI or SSI recipient gets when they have been identified by SSA for “Continuing Disability Review” (CDR). This is the agency’s review process to see if beneficiaries are still medically eligible for the program. After this review, if SSA believes the person no longer meets their criteria for disability, their benefits are terminated.

A medical CDR is done at least once every three years, unless the SSA expects your medical condition to improve sooner. Those who have a medical condition that is not expected to improve undergo a CDR every seven years.

A rules change that took effect earlier this year, however, dramatically increases how often a person must undergo a CDR review. This change adds a new category for those whose condition is “likely to improve.” Hundreds of thousands of people now in less frequent CDR categories will be moved into this new category to be reviewed every two years.

This new rules change is especially disturbing because it targets people like Andrea who have chronic conditions that flare up unpredictably. Those who are approaching retirement age and those with mental illness are some of the other people this rules change aims to remove from benefits.

If you get one of these letters, the first thing you need to do is notify Social Security that you want to appeal this decision. To appeal, you need to submit a Request for Reconsideration form within 60 days of receiving the notice of denial of benefits. If you want to continue receiving benefits while your case is being decided, you will need to submit this form withing 10 days of the denial, and you need to specifically ask that benefits continue. Be aware, however, that if your case is unsuccessful, SSA can require you to return the overpaid benefits.

Andrea has followed this advice and is awaiting a response from SSA. She is hopeful that, with the support of her doctors and her patient advocate, her appeal will be granted and she will once again be able to sleep at night.  

For others like her, Andrea offers this advice:

“You have to reach out and get some help from someone like a patient advocate,” she says. “You have to have your medicine. You have to see your doctors. You can’t take no for an answer.”

CSI Pharmacy has patient advocates who can help you navigate this and other health care access challenges. We offer this service regardless of whether you are a CSI Pharmacy patient.

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Advocacy CSI Pharmacy stories

CSI Pharmacy’s Plasma Donor Superhero

Justin McNeil Headshot

Maddie was in high school when she developed juvenile dermatomyositis, a rare autoimmune disease of the muscles that made her so weak she couldn’t walk. Bill developed myasthenia gravis, another autoimmune neuromuscular disease, after having anesthesia for bypass surgery. Amanda and her daughter have immune deficiency diseases that make them susceptible to all kinds of infections. Immune globulin (IG) has been a life-saving therapy for all of these individuals.

IG is one of a number of treatments that can only be made from donated human plasma. This year, as a result of coronavirus restrictions, plasma therapeutics companies have experienced a significant drop in donations, which will limit supplies of plasma products such as IG by the end of the year. For patients, this is their worst fear. It means they may not be able to get the medications that allow them to live a normal life.

When Justin McNeill learned that plasma donations were down by as much as 40%, he thought of patients like Maddie, Bill, Amanda, and her daughter. Much of CSI Pharmacy’s business involves providing home infusion services for those who depend on IG therapy. As a delivery technician for CSI Pharmacy, it’s Justin’s job to pack up shipments of immune globulin and the supplies needed to administer it and make sure it all gets to the patient’s home in time for their infusion. 

In the spring, CSI Pharmacy joined the Immunoglobulin National Society in an effort to raise awareness about plasma donation and to inspire more healthy donors to contribute. As part of that effort, the company initiated an internal contest to encourage employees to become plasma donors. Justin was among the first to respond.

“We were told that with all the coronavirus restrictions, people aren’t donating plasma as much,” Justin says. “That means patients aren’t going to be able to get the medicine they need. I figured I’m able to give, so there’s no reason not to.”

Justin started donating in May and has given twice a week ever since—the maximum weekly donations allowed. To date, he has donated plasma 24 times. And even though he works full time and goes to school in the evenings, showing up at the BPL Plasma donation center is part of his weekly routine. He plans to keep on giving as long as they’ll let him.

Justin may have run away with this contest, but he’s not the only CSI Pharmacy employee to participate in the plasma donor drive. Eleven other members of the staff have also donated at least twice. (Regulations require two donations before the plasma can be used to make plasma protein therapies like IG.)

The rules governing who can qualify as a plasma donor are very strict. Justin, who is 24 years old and healthy, had no problem qualifying. When several other employees attempted to donate, however, they were turned away because they have chronic health conditions or other restrictions. This only made Justin more committed to continue donating.

“I knew a lot of the people here in the office couldn’t donate because of various health issues or medications, so I said, why not me?”

“Justin is very modest,” says James Sheets, CEO of CSI Pharmacy. “I know he doesn’t like to call attention to himself. But for us he is a superhero. We are pleased that our employees take this so seriously and are willing to donate plasma. And we’re extremely proud of Justin for his ongoing commitment to making plasma donation a part of his life.”

For Justin, it’s all about Maddie, Bill, Amanda and her daughter, and others for whom he packs up the products and supplies for their home infusions. He urges anyone who qualifies to consider becoming a plasma donor.

“We’re probably about to get hit with a really bad shortage of IG products,” he says. “Our patients need this medicine that’s made from human plasma. We’ve got a lot of people who are really sick and really need this medicine. Even donating just twice will help save lives. You can make a big difference.”

As the winner of CSI Pharmacy’s Plasma Donation Incentive Program, Justin McNeill was presented with a trophy and a monetary gift during a ceremony in September.

Find a plasma donation center near you.

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Advocacy Health Information

Tips and Tricks for Managing MG

We recently spoke with neurologist Charlene Hafer-Macko, MD from the University of Maryland’s Myasthenia Gravis Center about ways myasthenia gravis (MG) patients can keep themselves healthy and stay out of crisis. Here are some of her tips and tricks:

Communicating about your condition with healthcare providers, especially in an emergency situation, can be a challenge.

  • Wear a medical ID bracelet, such as the MedicAlert, that identifies you as having myasthenia gravis.
  • Know what medications MG patients need to avoid, and carry a list of them in your wallet for easy reference.
  • Download the MyMG app from the Myasthenia Gravis Foundation of America. The app also has a list of medications to be avoided with MG.
  • Document your symptoms, treatments, and how they affect your daily life so you can have these data readily available when your doctor asks, “How have you been feeling?”
  • Always ask your healthcare provider or pharmacist if a newly prescribed medication is on the list of drugs MG patients need to avoid.
  • Use online resources to look up conditions and medications. Just be sure the source is reliable and informed by science.

Weak muscles can make breathing difficult, but there are things you can do to make breathing more efficient.

  • Use pursed-lip breathing, a technique in which you breathe out through puckered lips. See this demonstration.
  • Learn how to breathe into your belly by lowering your diaphragm. Learn how here.
  • Explore mindfulness practices that focus on breathing. This is also helpful for stress reduction. Find a guided exercise here.

MG symptoms tend to get worse with heat for many people. To avoid melting when it’s warm:

  • Take tepid showers. If you really like a hot shower, finish it off with a cold splash.
  • Avoid being out in the sun for long periods of time.
  • When the weather is hot, plan big activities for the cooler part of the day, and take advantage of air conditioning as much as possible. Ask your electric power company for a form that will ensure you are a higher priority for power when the electric goes out a storm.
  • Consider using a cooling vest if, for example, you want to sit in the hot sun for hours at the baseball game. Here is a sample of some available models.
  • Sporting goods stores also sell cooling towels and reusable, freezable gel packs.

Not getting enough sleep will make anybody more fatigued. For those with MG, insomnia can be related to corticosteroid use, anxiety, stress, and other effects of chronic illness. Good sleep habits can help. Here are some tips:

  • If you take prednisone, do so early in the day.
  • Schedule your bedtime so you get at least 7-8 hours of sleep.
  • Make a habit of going to bed at the same time every night and getting up at the same time each morning, even on the weekends.
  • Keep your bedroom quiet, dark, relaxing, and at a cool temperature.
  • Create a relaxing bedtime routine.
  • Ban electronic devices, such as TVs, computers, and smart phones, from the bedroom, and avoid using screens during the hour before you go to sleep.
  • Avoid large meals, caffeine, and alcohol before bedtime.
  • Exercise regularly to help you fall asleep at night.

And finally, Hafer-Macko advises that those living with MG watch their bodies, learn how their treatments affect them, and plan activities accordingly. For example, if you (or those you live with) notice that you start to slow down as you get closer to your next pyridostigmine (Mestinon) dose or IVIG infusion, that may not be the best time to schedule a big day with the kids that will use up a lot of your energy.

Similarly, if you take pyridostigmine, notice how it affects you. If it starts to wear off too soon, mention it to your doctor; you might need to adjust the dose. Also, be aware of scheduling high-energy activities like shopping or cleaning during times when your meds are wearing off.

The following organizations offer additional resources, including support groups, education, and research: