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Multiple Sclerosis (MS): Signs, Symptoms, Positive Self-Management, and Treatment Options

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Multiple sclerosis (MS) is a disease of the central nervous system (CNS)—i.e. the brain, spinal cord, and optic nerves. The CNS, which controls the entire body, is attacked by the body’s own immune system, damaging the protective layer, or myelin, that insulates the wire-like nerve fibers.

This nerve damage disrupts signals to and from the brain. MS is an immune-mediated disease, which is when the body’s immune system overreacts and attacks itself. Though similar, an immune-mediated disease is different from an autoimmune disease. Both involve the immune system attacking and damaging the body’s own healthy cells via proteins (or autoantigens—antigens produced by one’s own body). However with an autoimmune disease, the proteins/autoantigens which attack the cells have been identified. With an immune-mediated disease, these proteins/autoantigens have not been identified.1

Signs and Symptoms

Though everyone’s experience with MS is different, there are some common signs and symptoms to look out for. These include:3

  • Numbness or weakness in one or more limbs, typically occurring on one side of the body at a time

  • Tingling

  • Electric-shock sensations that occur with certain neck movements, especially when bending the neck forward (Lhermitte sign)

  • Lack of coordination

  • Unsteady gait (having trouble with balance) or inability to walk

  • Partial or complete loss of vision, usually in one eye at a time with pain during eye movement

  • Prolonged double vision

  • Blurry vision

  • Vertigo

  • Problems with sexual, bowel, and bladder function

  • Fatigue

  • Slurred speech

  • Cognitive problems

  • Mood disturbances

Positive Self Management

In addition to a patient’s medical/treatment protocol, positive self management can improve day-to-day quality of life for those living with MS. Patients who self-manage their condition have the skillset to accept and communicate with others their need to move at their own pace. Research has shown that those who have developed self-management skills have more confidence to better communicate their needs to others, therefore receiving improved support.4 Found to be an empowering strategy to improve health for many people living with chronic conditions, self management is a philosophy that acknowledges living with a condition like MS is an ongoing experience.

The National Multiple Sclerosis Society and Multiple Sclerosis Foundation both give resources for developing positive self management skills. 

The National Multiple Sclerosis Society has a section on their website dedicated to “Living Well with MS”. They provide guidance and resources for diet, exercise, and healthy behaviors; emotional well-being (i.e. managing stress and coping skills); spiritual well-being (i.e. building on values and beliefs that provide purpose); and cognitive health (i.e. keeping your mind engaged and challenged). Learn more about these resources here. 

The Multiple Sclerosis Foundation is helping MS patients get connected to support groups and grants. Some of their grants and programs include help with rent or utilities, homecare assistance, and transportation. They also host multiple events for the MS community to join together and learn more about managing their condition. To learn more about these resources and events, click here.

Treatment Options

For some with mild symptoms, no treatment is necessary. For others, treatment to help ease MS symptoms may include corticosteroids or plasma exchange. Although there is no cure for MS, treatment can also help slow disease progression by reducing the amount of damage and scarring to the myelin—the layer surrounding the nerves. This reduction in damage can help MS patients have fewer and less severe relapses. Treatment to slow progression may include injectable, oral, and infusion medications. 

Infusion treatments may help slow the progression of MS and lessen flare-ups for those with aggressive or advanced MS. Because medication is infused directly into the bloodstream, a healthcare professional should be present to administer the infusion and monitor the patient for side effects.

How BioMatrix Can Help

BioMatrix helps manage the individual needs of patients requiring infused medications by providing options for administration site of care, education, and support to help improve quality of life. Knowledgeable pharmacists and care coordination staff guide each patient through the potential medication side effects and, working with the prescribing physician, help manage treatment to reduce the prevalence and severity of relapses.

The BioMatrix clinical team includes compassionate nurses who have extensive training and experience with rare diseases, infusion therapies, and complex medical conditions. Our nurses work together with patients, caregivers, pharmacists, and prescribers to coordinate the optimal site of care (including home infusion), conduct nursing interventions, and provide patient education.

Learn more about how our individualized specialty pharmacy services for MS patients.

Financial Resource Guide

Living with a chronic condition can create additional healthcare costs while also impeding one’s ability to work. Our financial resource guide can help. 

DISCLAIMER: THIS IS NOT MEDICAL OR LEGAL ADVICE. All information, content, and material is for informational purposes only and is not intended to serve as a substitute for the consultation, diagnosis, and/or medical treatment of a qualified physician or healthcare provider or as legal advice. Please consult a physician or other health care professional for your specific health care and/or medical needs or concerns and never disregard professional medical advice or delay in seeking it because of something you have read here or on our website.

Stay informed on the latest trends in healthcare and specialty pharmacy.

Sign up for our monthly e-newsletter, BioMatrix Abstract.

By giving us your contact information and signing up to receive this content, you'll also be receiving marketing materials by email. You can unsubscribe at any time. We value your privacy. Our mailing list is private and will never be sold or shared with a third party. Review our Privacy Policy here.

References

  1. What is an immune-mediated disease? The National Multiple Sclerosis Society. https://www.nationalmssociety.org/What-is-MS/Definition-of-MS/Immune-mediated-disease

  2. About Multiple Sclerosis (MS). Penn Medicine. https://www.pennmedicine.org/for-patients-and-visitors/patient-information/conditions-treated-a-to-z/multiple-sclerosis-ms

  3. (2022). Multiple Sclerosis. Mayo Foundation for Medical Education and Research (MFMER). https://www.mayoclinic.org/diseases-conditions/multiple-sclerosis/symptoms-causes/syc-20350269

  4. (2010). Wazenkewitz, J., McMullen, K., Ehde, D. Self-Management: Keys to Taking Charge of Your MS. Multiple Sclerosis Foundation.

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Time to Rethink Women and Bleeding Disorders: Stop the Unnecessary Suffering!

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By Linda “Lew” E. Wyman-Collins, BSN, RNC-NIC

As a woman with hemophilia A, a platelet disorder and Ehler’s Danlos Syndrome (EDS), the bleeds I experience are more in line with moderate to severe hemophilia. At age 65, I suffer with various medical complications and side effects from receiving a later-in-life diagnosis. I did not obtain a diagnosis or proper/adequate treatment for most of my life. The pursuit of equal or compatible treatment that my blood brothers receive has been a struggle.

Throughout my life, dental work and cleanings caused extensive bleeding. Impacted wisdom teeth caused me needless mouth pain for many years, but because of how easily my mouth bled, no one wanted to extract them. Finally at 52, I found an oral surgeon who agreed to remove them with treatment prior to procedure. I experienced senseless tooth and mouth pain for so many years. Now I treat with DDAVP nasal spray prior to all dental appointments, and the bleeding is minimal.

When I was 11 years old, I began having gastrointestinal bleeding. Physicians believed I had colitis; the treatment was dietary changes and medications. The mucosal lining of my lower intestine is permanently damaged from years of uncontrolled bleeding. Now with a proper diagnosis, I am able to effectively treat with clotting factor, desmopressin (DDAVP®) and tranexamic acid (Lysteda®).

All my life, I have bruised very easily and when my menstrual cycles started, I bled heavily with large clots for more than seven days every month. When I voiced my concern to my doctors, I was told my cycle was “normal” because my mother and grandmother also had heavy cycles and that being a fair-skinned redhead added to the bruising. In retrospect, my mother and grandmother both had undiagnosed bleeding disorders. Due to the prolonged bleeding each month, I had chronic anemia, which greatly affected my quality of life.

In 7th grade I injured my knee during gym class. When I look back at that injury, it was clearly a muscle and joint bleed. As I grew older, my left knee deemed itself my target joint. It is chronically swollen with decreased range of motion; x-rays reveal the knee joint is now bone-on-bone. Steroids and gel injections only offer temporary relief, and I am now considering a knee replacement. Had my joint bleeds been treated properly when I was younger, the extensive joint damage could have been avoided or at least lessened. I now wear rib, back, knee and thumb braces due to impaired joints.

Current studies are revealing a correlation between Factor VIII deficiency and bone health, and I have been diagnosed with osteopenia. Women with a bleeding disorder are developing osteopenia and osteoporosis at an earlier age.

In 1983, when my oldest son was diagnosed with severe hemophilia A at 17 months, scientists had not yet discovered the gene where the mutation occurred. When DNA testing became available, I was tested, and the results showed I had the same gene mutation as all 3 of my children, yet despite my bleeding history, I was labeled as just a “symptomatic” carrier.

At 35, I had an inguinal hernia repair scheduled but at that time, wasn’t being seen by a hematologist. After reading in my medical record that I was a carrier, the anesthesiologist refused to clear me for surgery until I was seen by a hematologist. I went to a hemophilia treatment center and was tested and was diagnosed with a platelet disorder.

Shortly after, I was identified as having EDS and was then prescribed DDAVP via IV for any surgery or invasive procedure. Tranexamic acid and aminocaproic acid (Amicar®) helped with menstrual cycles and mucosal bleeds. In my late 40’s, I was finally properly diagnosed with a bleeding disorder and received appropriate treatment for chronic anemia; yet I was not given access to clotting factor for another 17 years.

Unfortunately, the majority of the medical community is often still under the notion that only males can have a bleeding disorder. The assumption is women are only carriers and do not need treatment. However, rather than basing care on gender, treatment should be based on documented factor levels and bleeding tendencies.

Our national organizations, non-profits, and pharmaceutical companies have done a great job at educating the community on bleeding disorders in men and women. Yet, there still remains a missing piece on prescribing proper treatment for women. Education needs to be expanded at the medical school level to instruct doctors-in-training to recognize that women can and do bleed. In the meantime, women need to advocate for themselves with a much louder voice and not allow themselves to be dismissed. In the 25 years I have been active in the bleeding disorders community on a national level, I have not seen much change in the timely diagnosis and adequate treatment for women. This needs to change.

ABOUT THE AUTHOR

Linda “Lew” E. Wyman-Collins, BSN, RNC-NIC is a mother, wife, aunt, sister, and daughter of someone with a bleeding disorder and has a bleeding disorder of her own. As a nurse, she has much experience in neonatal intensive care and was recognized as Dallas/Fort Worth Great 100 Nurses. Lew served HFA formerly on the Board of Directors, Blood Sisterhood Chair, Symposium Chair, Medical/Professional Advisory Board member, and is a founding member of HFA’s women’s group Focus on the Feminine. She has served on Texas State Bleeding and Clotting Disorders Advisory Council and is a member of Equity in Bleeding Disorders Care for Women and Others. Additionally, Lew has presented frequently at national and international conferences and has authored numerous articles on hemophilia and women with bleeding disorders in industry magazines and journals.

Stay informed on the latest trends in healthcare and specialty pharmacy.

Sign up for our monthly e-newsletter, BioMatrix Abstract.

By giving us your contact information and signing up to receive this content, you'll also be receiving marketing materials by email. You can unsubscribe at any time. We value your privacy. Our mailing list is private and will never be sold or shared with a third party. Review our Privacy Policy here.

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Pemphigus—Types, Symptoms, and Treatment Options

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Pemphigus is a rare group of autoimmune diseases that causes blistering of the skin and the inside of the mouth, nose, throat, eyes, and genitals. With these diseases, the immune system mistakenly attacks healthy proteins that bind skin cells to one another, causing the skin to become fragile. Blisters then form from fluid that collects between the skin’s fragile layers.1,2

Though researchers do not know what causes the immune system to fight the body’s own proteins, they believe that both genetic and environmental factors are involved. Some people may be predisposed to the condition due to their genetic makeup, and something in their environment may trigger an immune response.

Pemphigus Types and Symptoms

Signs and symptoms vary based on the type of pemphigus:1

Pemphigus vulgaris: The most common type in the US, blisters form within the mouth and other mucosal surfaces, as well as in a deep layer of the skin. They are often painful. Blisters can also form in the groin and under the arms in a subtype of the disease called pemphigus vegetans. Blisters typically start in the mouth and then appear on areas on the skin. The skin may become so fragile that it peels off by rubbing a finger on it.

Pemphigus foliaceus: Only affecting the skin, itchy or painful blisters form in upper skin layers. They typically appear first on the face, scalp, chest, or upper back, but can spread to other areas of skin on the body. The affected areas of skin may become inflamed and peel off in layers or scales.

Paraneoplastic pemphigus: Blisters or inflamed lesions typically form in the mouth and on the lips but may also develop on the skin and other mucosal surfaces. People with this type of pemphigus usually have a tumor and may have severe lung problems. If the tumor is surgically removed, the disease may improve.

IgA pemphigus: Caused by the IgA antibody, blisters or pimple-like bumps often form in groups or rings on the skin. 

Drug-induced pemphigus: Pemphigus-like blisters or sores are triggered by certain medicines like antibiotics and blood pressure medications, as well as drugs that contain a chemical group called a thiol. When one stops taking the medication or drug, these blisters and sores typically go away.

Diagnosis and Treatment

Pemphigus is typically diagnosed through a skin biopsy, blood tests, and sometimes an endoscopy to check for sores in the throat.

Treatment is dependent on the type and severity of the disease. Medications like corticosteroid cream and prednisone pills are often prescribed as the first line of treatment intended to suppress blisters. To help suppress the immune system and keep it from attacking healthy proteins, medications such as azathioprine (Imuran, Azasan), mycophenolate (Cellcept) and cyclophosphamide are typically prescribed. If these treatment methods aren’t working, treatments such as intravenous immunoglobulin (IG) therapy are typically prescribed as a second or third-line treatment option.3

Intravenous immunoglobulin (IG) therapy is usually well tolerated with few rare serious side effects. It’s been used to treat dermatological conditions for more than two decades.4

How BioMatrix Can Help

BioMatrix has extensive experience with IG-related support services. As a national provider of IG, BioMatrix has broad access to all brands and inventory. Our IG treatment plans are designed to:

  • Prevent infections

  • Boost the immune system

  • Avoid complications of therapy

  • Prevent long-term organ damage

  • Decrease hospitalizations

  • Encourage patients to participate in disease management

  • Prolong life

  • Improve general health and quality of life

Our nursing team coordinates the best site of care for scheduled infusions—whether in the patient’s home or physician’s office. Providing site-of-care options offers convenience for patients and cost savings to insurance providers.

Together, our clinicians, support staff, and digital health technology offer a comprehensive approach improving quality of life for patients and producing positive outcomes along the entire healthcare continuum.

DISCLAIMER: THIS IS NOT MEDICAL ADVICE. All information, content, and material is for informational purposes only and is not intended to serve as a substitute for the consultation, diagnosis, and/or medical treatment of a qualified physician or healthcare provider. Please consult a physician or other health care professional for your specific health care and/or medical needs or concerns and never disregard professional medical advice or delay in seeking it because of something you have read here or on our website.

Stay informed on the latest trends in healthcare and specialty pharmacy.

Sign up for our monthly e-newsletter, BioMatrix Abstract.

By giving us your contact information and signing up to receive this content, you'll also be receiving marketing materials by email. You can unsubscribe at any time. We value your privacy. Our mailing list is private and will never be sold or shared with a third party. Review our Privacy Policy here.

References

  1. (2021). Pemphigus. National Institutes of Health. https://www.niams.nih.gov/health-topics/pemphigus

  2. Pemphigus Vulgaris. John Hopkins Medicine. https://www.hopkinsmedicine.org/health/conditions-and-diseases/pemphigus-vulgaris

  3. (2022). Pemphigus. Mayo Foundation for Medical Education and Research (MFMER). https://www.mayoclinic.org/diseases-conditions/pemphigus/diagnosis-treatment/drc-20350409

  4. Hoffmann, J.H.O. and Enk, A.H. (2017), High-dose intravenous immunoglobulins for the treatment of dermatological autoimmune diseases. JDDG: Journal der Deutschen Dermatologischen Gesellschaft, 15: 1211-1226. https://doi.org/10.1111/ddg.13389

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Living with Hemophilia: Hope for Help

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By Ashley Gregory

Anthony and Nicholas were born in 1998, and although I had no family history of bleeding disorders, I now had twins with severe hemophilia A. I became informed about their condition and as they grew, stayed in close contact with our hemophilia treatment center. Also in 1998, NHF launched Project Red Flag, which advocated for women with bleeding disorders. I remember being curious because I had experienced puzzling symptoms throughout my time, but life would take a darker turn, and it would be several years before I could revisit this topic.

One day Anthony didn’t seem right; he was lethargic and not eating. I took him to our pediatrician who suspected the flu. I remember looking directly at her and saying, “Shouldn’t we infuse him since his head is hot, but he has no fever?” She said, “No, just take him home.” Instead, we took him to the emergency room where we learned he had a brain bleed. Despite heroic surgical efforts and finally infusing factor, my son died the next morning – he was only 11 months old. Thus began a slow tumble into despair that our family would not emerge from until well into the next decade.

During subsequent years, researchers were learning that women with the hemophilia gene exhibit unexplained bleeding symptoms and need treatment. Some doctors began successfully working with women to determine how to manage symptoms using factor replacement; they were learning that despite “normal” factor levels, women who experienced unexplained bleeding responded well to factor treatment with no adverse reactions. It was unexplained bleeding that pulled me back into a search for a diagnosis.

While volunteering at my local foundation, I heard women discuss similar untreated symptoms around inexplicable bleeding. It didn’t take long to realize there was a common problem. Women in our community, like me, were experiencing puzzling bleeding that was not addressed despite reporting these symptoms to their doctors. The concerns were usually explained away with comments like, sometimes these things happen, sounds like all the women in your family are like this, or this is just your normal. Were we being ignored, or did the doctors simply not believe us?

This led to a personal investigative journey to seek a diagnosis and treatment while, at the same time, pursuing a career in advocacy and education in bleeding disorders. I began attending local, regional and national programs that provided comprehensive education about my bleeding symptoms and brought me in contact with physicians who were successfully treating women’s bleeding issues using all the medications available to men with bleeding disorders.

I learned about lyonization, which is when one of the two X chromosomes in every cell of a female is inactivated. Lyonization can cause an effective X chromosome to stop working, allowing the other ineffective X chromosome to take over, producing lower factor levels. This led to an even greater understanding of my particular bleeding disorder as a woman with two X chromosomes. Thanks to Dr. Barbara Konkle and the My Life, Our Future genetic analysis project, I learned that some mutations present a high factor level but bleed like a severe! I finally learned that connective tissue disorders can also be present in persons with bleeding disorders, which can then exacerbate bleeding.

Empowered with this knowledge, I confidently entered the HTC near me and presented the information I had gathered, along with my symptoms and history. I trusted I would be heard and cared for. I could not have been more wrong. I even brought my mother along who had been by my side through all my pain and could attest to my history. The treatment center told me my factor levels were too high for my swollen ankles and knees to be caused by hemophilia, and my petechiae were birthmarks.

My unexplained bleeding history was useless in gaining a diagnosis here. I was also seen by the genetics specialist who told me I lacked enough markers to have a connective tissue disorder. I was left with the option to do nothing or to have a synovectomy on my right ankle to see what fluid it contained. Based on my past, I instinctively knew without infusing factor prior to the procedure, the healing process would be long and painful. I declined the surgery in pursuit of a better option. 

It was time to try a new approach. I crossed state lines and met with an expert clinician I had met at a national symposium. After a thorough medical evaluation, complete history review of symptoms, physical evaluation and lab workup, I was diagnosed with hemophilia A (symptomatic carrier) and hypermobility syndrome – a connective tissue disorder meaning my joints stretch further than normal. Aminocaproic acid (Amicar®) was prescribed for mucosal bleeding and clotting factor for muscle and joint bleeds. An emergency medical card was prepared with my treater’s name, contact number and diagnosis. A medical alert bracelet was ordered for me, and I was instructed to contact the treatment center and treat on-demand as needed.

Imagine my delight to find when I treated a bleed as my hematologist instructed, my whole body felt better; things that had hurt my entire life stopped hurting; my petechiae cleared, and the swelling in my knees and ankles subsided. Then, as the factor left my body, the pain and baffling bruising would return.

I was able to access treatment from the out-of-state HTC for a short time, and I was emboldened to treat my hemophilia the same way I was as a mother in treating Nicholas’ hemophilia. Since I had been infusing him for years, infusing myself was easy, and I kept a log of bleeds and treatments. I was amazed at the overall improvement in my energy and stamina when using factor!

Moving forward to 2022 – Through my out-of-state HTC, I was able to access free trials of factor products, but those have ended. I am no longer able to have treatment for my bleeds. The system that pays for factor for persons with bleeding disorders requires an in-state doctor to write the prescription. So far, I have not found a doctor in my state who is knowledgeable about the particular genetic mutation that causes me to have a high factor level yet bleed severely. I am now a woman without a treatment center and without treatment.

My chronic pain and suffering affects not only me, but my family as well. Because of my health, we are not living our best life. In spite of this, I am grateful for my experiences, to my sons born with hemophilia, and to Anthony who didn’t survive due to the lack of knowledge that prevails to this very day. This lack prevents his mother from treatment and medication.

I am grateful to Nicholas, who bears witness to the stark contrast of gender care in hemophilia. I have built a career advocating for those like me who are unable to access the care we know is needed. I am appreciative for all of these experiences, but I would also like to be grateful for access to treatment for all women with hemophilia. It is my hope this will be a reality soon.

TIMELINE HIGHLIGHTING A FEW SYMPTOMS THROUGH THE YEARS:

  • Age 4: my first memory of severe pain in my knees. I had no words to describe the pain and it went unattended.

  • Age 9: moved to a home in a hilly area. I had pain that brought tears and immobility. Diagnosed with pre-patellar chondromalacia and was instructed to avoid hills and stairs, and to rest, ice and elevate. The constant pain kept me sedentary.

  • Age 10: my menstrual cycle began with extreme pain, heavy clots, bruises under my eyes and sheer exhaustion. Soaked through sanitary pads and ruined sheets. At school, it seemed I was in the bathroom more than in class. Treatment for this would never come. I spent my menstruating years suffering the effects of anemia.

  • Age 15: cut my ankle on a jagged piece of wood. The wound kept oozing and reopening, taking a year to fully heal.

  • Age 16: worked long shifts standing on a hard restaurant floor, in constant pain, fatigued, with swollen knees and ankles. When sitting, I would draw my legs up under my body to prevent my ankles from dangling as the pain was unbearable. Tired and hurting all the time. By the time I became sexually active, I bled with intercourse regardless of my cycle.

  • Age 21: diagnosed with gout in my toe. I now recognize this was a bleed.

  • Age 25+: with each of my first 3 pregnancies, I experienced anemia, 2nd trimester spotting, petechial hemorrhaging around my face during childbirth and prolonged postpartum bleeding. 2nd pregnancy brought throbbing pain behind my left eye leading to a spinal tap that would not clot causing a week-long leak of cerebrospinal fluid. 3rd pregnancy resulted in prolonged healing of c-section incision.

  • Age 27: wisdom teeth extraction bled for weeks.

  • Age 28: at the ER with excruciating knee pain. Was told there was nothing to be done.

  • Age 32: sons Anthony and Nicholas were born via C-section. A bleed at the incision caused excruciating pain; bleeding and severe bruising in my groin and down my legs.

  • Age 35: diagnosed with fibromyalgia.

  • Age 45: diagnosed with tendinosis (Related to connective tissue disorder).

  • Age 53: finally diagnosed as a symptomatic carrier of hemophilia A and connective tissue disorder reaffirmed. Was prescribed factor, Amicar® and physical therapy.

  • Age 56: free factor trials end; I no longer have access to treatment.

Stay informed on the latest trends in healthcare and specialty pharmacy.

Sign up for our monthly e-newsletter, BioMatrix Abstract.

By giving us your contact information and signing up to receive this content, you'll also be receiving marketing materials by email. You can unsubscribe at any time. We value your privacy. Our mailing list is private and will never be sold or shared with a third party. Review our Privacy Policy here.

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Similarities, Differences, and Correlations Between Allergies, Common Variable Immunodeficiency (CVID), and Autoimmune Disorders

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Allergies, common variable immunodeficiency (CVID), and autoimmune disorders all share similarities and can commonly be mistaken for one another. This article explores those similarities as well as major differences, evidence for potential links, and treatment options.

What is common variable immune deficiency (CVID)?

Let’s first take a look at common variable immunodeficiency (CVID). Characterized by low levels of serum immunoglobulins and antibodies, CVID is a form of primary immunodeficiency—meaning the immune system is deficient in what it needs to fight infection which therefore causes an increased susceptibility to infection. Those with CVID often develop recurring infection in the lungs, sinuses, and ears. The exact cause of CVID is unknown, though genetic defects may play a role.1

What are allergies and how are they related to autoimmune disorders and CVID?

An allergy occurs when your immune system reacts to a foreign substance that is typically not harmful to other people—i.e. pollen or pet dander. Both an allergic reaction and an autoimmune response happen when your body tries to expel a foreign substance. The difference is that with an allergic response, the foreign substance is an allergen (again, typically harmless to most people) while with an autoimmune response, the foreign substance is indeed harmful—i.e. a virus, parasite, or bacteria. Steve Ziegler, PhD, Director of the Immunology Research Program at Benaroya Research Institute states that “In autoimmunity, there is a different type of T-cell involved than in allergies. In an autoimmune response, tissue destruction occurs. With allergies, the immune system overreacts to harmless allergens. Interestingly, this is the same type of response that expels viruses, parasites, and bacteria from the body.”2

It’s important to note that CVID is not an autoimmune disorder. Autoimmune disorders occur when your immune system can’t tell the difference between foreign cells (like bacteria and viruses) and your own cells. Because of this, your immune system will attack healthy cells in your body in addition to unhealthy foreign cells. CVID, on the other hand, occurs when your body has existing low levels of antibodies.

Is there a link between CVID, autoimmune disorders, and allergies?

With 25% of CVID patients having an autoimmune disorder3, there seems to be a positive correlation between CVID and autoimmune disorders. Research has demonstrated that those with defects in their immune system (like having lower amounts of antibodies) carry a high risk for the development of autoimmune disease.4 When compared to the general population, CVID patients also have a greater risk for granulomata (a mass of granulation tissue), tumors, and an increased susceptibility to cancer.1 In a 2021 study, allergic-like disorders and autoimmunity were diagnosed in 41.3% of CVID subjects.5 Though further testing was needed to determine the cause, in a 2009 study, 86.1% of participating CVID patients had rhinosinusitis (inflammation of the nasal cavity and paranasal sinuses).6 With these findings, though a possible link seems likely to exist between these three conditions, researches are still trying to figure out why exactly these conditions occur in the first place. This could lead to finding further causes for these positive correlations as well as even more effective, targeted treatment options.

Treatment

Treatment for allergies and autoimmune conditions varies greatly depending on the type and severity. An allergy treatment plan may involve avoiding allergens, medicine, and/or immunotherapy.7 An autoimmune treatment plan may involve a wide range of therapies—from anti-inflammatory medication to IG treatment.8 CVID is typically treated with immunoglobulin (IG) (subcutaneous) infusions—especially for those with substantial decreased IG production and nonresponse to both protein and polysaccharide vaccines.9 The IG therapy provides antibodies from the blood of healthy donors. Other problems caused by CVID, like bacterial infections, may require additional, tailored treatments.10

Our team has extensive experience with IG related support services. As a national provider of IG, BioMatrix has broad access to leading brands and inventory. Our IG treatment plans are designed to:

  • Prevent infections
  • Boost the immune system
  • Avoid complications of therapy
  • Prevent long-term organ damage
  • Decrease hospitalizations
  • Encourage patients to participate in disease management
  • Prolong life
  • Improve general health and quality of life

Our nursing team coordinates the best site of care for scheduled infusions—whether in the patient’s home or physician’s office. Providing site-of-care options offers convenience for patients and cost savings to insurance providers.

Together, our clinicians, support staff, and digital health technology offer a comprehensive approach improving quality of life for patients and producing positive outcomes along the entire healthcare continuum.

DISCLAIMER: THIS IS NOT MEDICAL ADVICE. All information, content, and material is for informational purposes only and is not intended to serve as a substitute for the consultation, diagnosis, and/or medical treatment of a qualified physician or healthcare provider. Please consult a physician or other health care professional for your specific health care and/or medical needs or concerns and never disregard professional medical advice or delay in seeking it because of something you have read here or on our website.

Stay informed on the latest trends in healthcare and specialty pharmacy.

Sign up for our monthly e-newsletter, BioMatrix Abstract.

By giving us your contact information and signing up to receive this content, you'll also be receiving marketing materials by email. You can unsubscribe at any time. We value your privacy. Our mailing list is private and will never be sold or shared with a third party. Review our Privacy Policy here.

References

  1. Overview of Common Variable Immune Deficiency. Immune Deficiency Foundation. https://primaryimmune.org/about-primary-immunodeficiencies/specific-disease-types/common-variable-immune-deficiency

  2. (2017). Connecting the Dots Between Allergies and Autoimmune Disease. Benaroya Research Institute. https://www.benaroyaresearch.org/blog/post/connecting-dots-between-allergies-and-autoimmune-disease

  3. Common Variable Immune Deficiency. MedlinePlus. https://medlineplus.gov/genetics/condition/common-variable-immune-deficiency

  4. Sleasman J. W. (1996). The association between immunodeficiency and the development of autoimmune disease. Advances in dental research, 10(1), 57–61. https://doi.org/10.1177/08959374960100011101

  5. Rubin, L., Shamriz, O., Toker, O., Kadish, E., Ribak, Y., Talmon, A., Hershko, A. Y., & Tal, Y. (2022). Allergic-like disorders and asthma in patients with common variable immunodeficiency: a multi-center experience. The Journal of asthma : official journal of the Association for the Care of Asthma, 59(3), 476–483. https://doi.org/10.1080/02770903.2020.1862185

  6. Agondi, R. C., Barros, M. T., Kokron, C. M., Cohon, A., Oliveira, A. K., Kalil, J., & Giavina-Bianchi, P. (2013). Can patients with common variable immunodeficiency have allergic rhinitis?. American journal of rhinology & allergy, 27(2), 79–83. https://doi.org/10.2500/ajra.2013.27.3855

  7. (2018). What Are the Best Treatments for Allergies? Asthma and Allergy Foundation of America. https://aafa.org/allergies/allergy-treatments/

  8. (2021). Autoimmune Diseases. Cleveland Clinic. https://my.clevelandclinic.org/health/diseases/21624-autoimmune-diseases

  9. Cunningham-Rundles C. Treatment And Prognosis Of Common Variable Immunodeficiency. (https://www.uptodate.com/contents/treatment-and-prognosis-of-common-variable-immunodeficiency

  10. (2019). Common Variable Immunodeficiency (CVID). National Institute of Allergy and Infectious Diseases. https://www.niaid.nih.gov/diseases-conditions/common-variable-immunodeficiency-cvid

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New Hemophilia Classifications For Women

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By David Clark, Ph.D.

We now recognize women can also have hemophilia, and it is imperative to define diagnostic criteria that apply to them. This is needed for insurance coverage of their treatment as well as their own recognition and self-respect. Imagine if you had to limp around on your damaged joints from doctor to doctor to find one to take you seriously. Too many women in our community have had just that experience. Now, we can give names to their conditions.

An international group of twelve hemophilia treaters and patient advocates has taken on this project under the Scientific and Standardization Committee (SSC) of the International Society on Thrombosis and Haemostasis (ISTH). The project was mainly supported by the NHF, HFA, and the Coalition for Hemophilia B from the U.S., as well as other hemophilia organizations around the world. There was no commercial support. The results were published in an article in the Journal of Thrombosis and Haemostasis on July 31, 2021. [See the complete citation at the end of this article.]

The results are shown in the table below. The same classifications are used for both hemophilia A and B. For factor levels up to 40%, women receive exactly the same diagnoses as their male counterparts. They are classified as severe/moderate/mild based on their factor levels. Above 40%, the tables turn. Men with factor levels above 40% are not considered to have hemophilia in many countries. However, women who are carriers with factor levels above 40% can still have a bleeding diagnosis.

The first thing to recognize is that the term “carrier” is now being returned to its proper definition. Carrier is a genetic description – it does not define a bleeding disorder. A woman is a carrier because she carries a mutated factor VIII or IX gene on her X chromosome that she can pass on to her offspring. She may or may not have a bleeding disorder. Carriers can have normal levels of factor VIII or IX.

Next, we need to discuss the international standard of 40% upper limit for hemophilia. In the U.S., we commonly use 50% as the upper limit for hemophilia and the lower limit for the range of normal factor levels. We recognize men with clotting levels up to 50% may still have mild hemophilia and may need treatment. In the rest of the world, men with levels of 40 – 50% are not considered to have hemophilia.

This gets more complicated because we know women can bleed even at levels up to 60%. We don’t know why they still bleed, but the study’s authors have recognized this and have given women two more categories. If a carrier has a level above 40% and does not have bleeding symptoms, she is classified as an “asymptomatic carrier.” However, if a carrier has a factor VIII or IX level over 40% (with no upper limit) but still has bleeding symptoms, she is classified as a “symptomatic carrier.”

This fuzziness in the over 40% levels could lead to situations where it is now the men who could have trouble getting treated. Going by the international classification, a man with a 50% factor VIII or IX level would not be considered to have mild hemophilia, even if he has bleeding symptoms. Yet, if he were a woman with a 50% level and bleeding symptoms, she would be a symptomatic carrier who might have a better chance of being treated. 

In addition, all of the categories are just approximations. It is the best we can do with our current state of knowledge. We know that about 15% of people (men and women) do not bleed according to their category of mild, moderate or severe, as determined by their factor level. For instance, some people classified as severe bleed like moderates. Some people classified as mild bleed much more heavily.

Another term seen is obligate carrier. This is also a genetic description, not a bleeding diagnosis. If you are genetically female (have two X chromosomes) and your father has/had hemophilia, you are an obligate carrier. That means you carry (have inherited) your father’s mutated factor VIII or IX gene. That’s just how genetics works. You may or may not bleed. Of course, the genetics can always mess up – that’s how we get hemophilia in the first place. However, it is extremely unlikely that when your father passes along his mutated factor VIII or IX gene, there is another mutation that actually fixes the gene.

One interesting point in the article is the estimate that for every male with hemophilia, there are 1.6 female carriers. Since many of these female carriers might have bleeding problems, there may actually be more women with hemophilia than men. Tell that to your doctor who says women don’t get hemophilia!

This is all based on averages, and no one is average! That’s why you always have to talk to your doctor about your individual case. No one should bleed, no matter their factor levels.

ABOUT THE AUTHOR

David Clark, PhD. is an independent consultant to the biotechnology, plasma, and tissue industries. He has 35+ years of experience in the development and manufacturing of plasma and tissue products, including factor VIII and factor IX concentrates, primarily with the American Red Cross. Dr. Clark holds a Ph.D. in chemical engineering from Cornell University.

REFERENCE

van Galen Karin PM, et al., A New Hemophilia Carrier Nomenclature to Define Hemophilia in Women and Girls: Communication from the SSC of the ISTH, Journal of Thrombosis and Haemostasis, 19(8), 1883-1887, 2021. https://pubmed.ncbi.nlm.nih.gov/34327828/

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Home Infusion: The Importance of Qualified, Home Nursing Services

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The benefits of home health care, specifically home infusion, are substantial. With home infusion, patients can receive their medication in the safety and comfort of their own home by a clinically-trained infusion nurse. Benefits include safety, convenience, cost-savings, and patient well being. Here we discuss how our nursing team supports treatment success for patients when and where they need it most.

Extensive Vetting and Training

In addition to our highly-qualified internal nurse clinicians, BioMatrix has contracted with over 200 nursing agencies nationwide and are continually bringing new agencies into the fold. Per our rigorous standards, each agency is thoroughly vetted to make sure they are knowledgeable regarding the Infusion Nurses Society guidelines for infusion therapy in the home. 

Just as the nursing agencies we contract with are thoroughly vetted, so too are the individual home infusion nurses. Every home infusion nurse assigned to enter a patient’s home is required to meet (over the phone or virtually) with our nurse clinicians prior to providing service. Our nurse clinicians:

  • Evaluate the infusion RN’s level of competency to provide the care ordered. If needed, further education or training is arranged and completed before the start of care. 

  • Review prescribed therapy in detail with the home infusion nurse to make sure the appropriate protocols are followed, and the services provided are safe and seamless. 

Every nurse who enters a patient’s home is carefully determined ensuring a right fit for the patient, their condition, and individual treatment need. If at any time our nurse clinicians determine that a particular home infusion nurse does not meet the standard of competency that we at BioMatrix strive for, we re-group, and re-staff the case with an alternate home infusion nurse.

Site-of-Care Coordination

We are well aware of how important it is for patients to avoid conflicts with work and other obligations. Our nurse clinicians strive to come up with a plan for infusions that causes the least disruption as possible for the patient while staying within the parameters that their MD has ordered. Whether administering in-home with assistance from one of our home care nurses, in-office, or at our Ambulatory Infusion Center, our nurses work with patients and prescribers to make therapy administration as safe and convenient as possible.

Safety Protocols

All BioMatrix nurse professionals follow CDC guidelines for hygiene and germ reduction and help patients mitigate any issues to establish a safe environment for home infusion. When entering a patient’s home, the home infusion nurses we work with follow all standard precautions and wear appropriate personal protective equipment. They also take the time to identify and review safety measures the patient can follow in the home both during and after infusion. 

Clinical Interventions

Following each home infusion, the home infusion nurse will submit a report to the BioMatrix clinical team to track response to therapy, monitor for adverse events, and help personalize and improve future care. By synthesizing clinical, social, and drug utilization information, our nursing team’s actionable interventions help improve health and save lives. Our interventions support patient adherence to therapy, reduce side-effects, and help address both critical and every day issues related to life with a chronic health condition.

Patient Education

We understand that starting a new therapy and navigating the treatment process can be challenging and confusing for a patient. Where appropriate, our nursing team provides self-administration training for injectable or infusible drugs, allowing patients to more independently manage their condition. Our nurses can also guide patients post administration to maintain therapy adherence, minimize or manage side-effects, and answer questions that may arise throughout their treatment regimen.

The BioMatrix clinical team includes compassionate nurses who have extensive training and experience with rare diseases, infusion therapies, and complex medical conditions.

Our nurses work together with patients, caregivers, pharmacists, and prescribers to coordinate the optimal site of care, conduct nursing interventions, and provide patient education.

Watch our video here to learn more about our home infusion services.

Stay informed on the latest trends in healthcare and specialty pharmacy.

Sign up for our monthly e-newsletter, BioMatrix Abstract.

By giving us your contact information and signing up to receive this content, you'll also be receiving marketing materials by email. You can unsubscribe at any time. We value your privacy. Our mailing list is private and will never be sold or shared with a third party. Review our Privacy Policy here.

References

1. Le Masson G, Solé G, Desnuelle C, et al. (2018). Home versus hospital immunoglobulin treatment for autoimmune neuropathies: a cost minimization analysis. Brain Behav. 2018;8(2):e00923. doi: 10.1002/brb3.923

2. Luthra R, Quimbo R, Iyer R, Luo M. (2014). An analysis of intravenous immunoglobin site of care: home versus outpatient hospital. Am J Pharm Benefits. 2014;6(2):e41-e49.

3. Schmidt R. (2012). Home Infusion Therapy: Safety, Efficacy, and Cost-Savings. PSQH. https://www.psqh.com/analysis/home-infusion-therapy-safety-efficacy-and-cost-savings/

4. Polinski J, Kowal M, Gagnon M, Brennan T, Shrank W. (2016). Home infusion: Safe, clinically effective, patient preferred, and cost saving. NIH. https://pubmed.ncbi.nlm.nih.gov/28668202/

5. Home Infusion Creates Savings for Patients, Taxpayers. NHIA. https://nhia.org/wp-content/uploads/2020/03/Home_Infusion_Creates_Savings_for_Patients_Taxpayers.pdf

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Home Infusion: Safe, Cost Effective, and Patient Preferred

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In recent years, the home has expanded its role. Though people are moving about freely since the pandemic, many still prefer to work remotely, have groceries and takeout delivered, and do more from the location of their choosing. There’s no place like home, and with medical care, there’s no exception.

For many needing regular infusions, choosing home as their site of care is a convenient and comfortable option. Research indicates home infusion as a safe method of receiving immunoglobulin (IG) therapy for primary immunodeficiencies, autoimmune neuropathies, and a wide range of other acute and chronic conditions.1,2,3 For some home infusion patients, like those with hemophilia, studies have shown clinical outcomes to be better with a 40% (0.50-0.70) reduced likelihood of hospitalization for bleeding complications.4

Additional benefits to home infusion include:
  • Less risk of infection. Hospitals and infusion centers can take every precaution available, yet in these environments patients still have the potential for exposure to bacteria or viruses they would likely not encounter in their homes.
  • Cost savings. Home infusion reduces the burden on costlier sites of care, saving money for both patients and payers.5
  • Patient well being.. Patients report significantly better physical and mental well being with less disruption to daily activities, overwhelmingly prefering home infusion.4

BioMatrix Specialty Pharmacy partners with outpatient hospitals and Ambulatory Infusion Centers (AIC) to coordinate home infusion services for patients. Our home infusion services:

  • Promote positive health outcomes and cost savings

  • Alleviate provider burden and promote timely access to care by facilitating prior authorizations, financial assistance, and appeals

  • Provide transfer-of-care support for patients with narrow or carved out specialty pharmacy networks by initiating a warm transfer to an in-network provider of your choice

  • Ensure patient safety and minimize adverse reactions by remaining with the patient for at least 30 minutes after therapy administration

  • Connect the patient to third-party resources reducing financial barriers to care 

  • Provide nationwide home nursing support, including rural areas 

  • Include therapeutically-focused clinical assessments and targeted interventions meeting the specific clinical and psychosocial needs of every patient

BioMatrix’s focus on safety begins well before the patient is infused with their first dose of medication in the home.

Our nursing and pharmacy teams work hand in hand at every step of the patient journey. This includes our efforts around home infusion services. To support our patients across the country, BioMatrix has contracted with over 200 Nursing agencies nationwide. We continually bring new agencies into the fold. Each agency is thoroughly vetted to ensure that they meet our rigorous standards and are knowledgeable regarding the Infusion Nurses Society guidelines for infusion therapy in the home. 

Just as the nursing agencies we contract with are thoroughly vetted, so too are the individual home infusion nurses. Every home infusion nurse assigned to enter a patient’s home is required to meet (over the phone or virtually) with our nurse clinicians prior to providing service. Our nurses evaluate the infusion RN’s level of competency to provide the care ordered. If further education or training is needed this is arranged and completed before the start of care. Prescribed therapy is reviewed in detail to make sure the appropriate protocols are followed and the services provided are safe and seamless. If at any time our nurse clinicians determine that a particular home infusion nurse does not meet the standard of competency that we at BioMatrix strive for, we re-group and re-staff the case with an alternate home infusion nurse.  

When entering a patient’s home, the home infusion nurses we work with follow all standard precautions and wear appropriate personal protective equipment. They also take the time to identify and review safety measures the patient can follow in the home both during and after infusion. Working together our team helps patients mitigate any issues to establish a safe environment for home infusion.

If you are a provider, consider referring patients who…

• Are at high risk for infection

• Repeatedly miss appointments or need assistance with therapy adherence

• Have transportation challenges

• Have a complex work or personal schedule

Watch our video here to learn more about our home infusion services.

Stay informed on the latest trends in healthcare and specialty pharmacy.

Sign up for our monthly e-newsletter, BioMatrix Abstract.

By giving us your contact information and signing up to receive this content, you'll also be receiving marketing materials by email. You can unsubscribe at any time. We value your privacy. Our mailing list is private and will never be sold or shared with a third party. Review our Privacy Policy here.

References

1. Le Masson G, Solé G, Desnuelle C, et al. (2018). Home versus hospital immunoglobulin treatment for autoimmune neuropathies: a cost minimization analysis. Brain Behav. 2018;8(2):e00923. doi: 10.1002/brb3.923

2. Luthra R, Quimbo R, Iyer R, Luo M. (2014). An analysis of intravenous immunoglobin site of care: home versus outpatient hospital. Am J Pharm Benefits. 2014;6(2):e41-e49.

3. Schmidt R. (2012). Home Infusion Therapy: Safety, Efficacy, and Cost-Savings. PSQH. https://www.psqh.com/analysis/home-infusion-therapy-safety-efficacy-and-cost-savings/

4. Polinski J, Kowal M, Gagnon M, Brennan T, Shrank W. (2016). Home infusion: Safe, clinically effective, patient preferred, and cost saving. NIH. https://pubmed.ncbi.nlm.nih.gov/28668202/

5. Home Infusion Creates Savings for Patients, Taxpayers. NHIA. https://nhia.org/wp-content/uploads/2020/03/Home_Infusion_Creates_Savings_for_Patients_Taxpayers.pdf

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His Blood... the Ink Inside My Veins

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By Sawsen Jamaleddin

The aroma of ginger and garlic swirls in and out of my nostrils, tap dancing inside a wok of hot oil, overpowering the sterility of bleach that has inhabited our house for the past year. The two women in our small kitchen are dressed in matching blue uniforms. They are stirring and whispering as the flame of the oven rises and relaxes against the hum of the microwave vent. The one with brown curly hair notices me and smiles. The other is so tall that I question the ceiling. But I have stopped questioning their presence. Hunger is stronger than my curiosity. Fear is better than knowing.

The tall one moves the wok back and forth with a grace that reminds me of a swaying palm tree. “How was school?” she asks, sprinkling small conversation between us, her eyes as warm as the heat fogging up the windows. I have no words to respond. At ten years old, my tongue refuses to work with my mind. Years of a lisp and speech therapy and I still can’t form the question that is on my mind. What is wrong with my father? I know she knows what I don’t.

She was there the day I opened my parent’s always-closed bedroom door and ran inside with a set of BIC pens that I bought for my father’s upcoming 43rd birthday. When I neared his bed, I did not recognize the skeletal body in front of me. Brown eyes that resembled mine opened, disoriented, turning into droplets of despair when he blinked at me. His dark skin looked faded in the light of sun, the cascading rays revealing an IV that protruded from his arm. He resembled a prisoner of war, starved, resigned. All I wanted to do was bandage the pain, cover his bones with my skin, drape my eyes from seeing, from imprinting the image of my father in front of me.

“Who is she?” he asked staring at me. Shock stood numbly between us. The set of pens fell from my hands, unwilling to write the tragic chapter unfolding.

It was then that I noticed movement in the corner, the tall woman making her presence known, as she stood up from the opposite side of the room and rushed to pick up the set of BIC pens off the floor. She put the jumbled pens in my palm and ushered me out of the room.

Weeks later, my father lost the war of life.

The kettle sputters and seethes. I turn the stove off and pour the water into a floral cup that has survived my move into wifehood. I open the white canister to get a tea bag when I suddenly feel a rush of liquid run down my legs. The vinyl tile in the small kitchen has become a pool of amniotic fluid. At twenty-two years old, I am going into labor for the first time. It seems that my unborn daughter is as patient as boiling water.

“Ahmad,” I call out to my husband of less than a year, “it’s time!” He sprints out of the room, then stands frozen by the murky water in front of him, a look of excitement and fear crisscross across his face. The ride to the hospital took less than ten minutes, but once we got there, labor seemed endless. After more than twenty-four hours of what-the-hell-was-I-thinking screaming, along with spurts of meconium leaking from my womb, an emergency c-section was the only option to deliver my baby safely.

Once the epidural was given, everything became hazy. All I remember before the blackness is hearing the doctor’s panicked voice in the background, “She’s losing a lot of blood.” When I woke up, it took me a while to orient myself to where I was. My husband was seated in a chair facing the window. My mother was seated beside him. My newborn daughter was in a bassinet beside my bed. I tried to move my arms to pick her up, but my limbs felt like spaghetti. Pain ricocheted throughout my body. I stifled my scream when a nurse came in and handed me pain medication. Then the doctor walked in.

He congratulated us and then explained I had lost a lot of blood during surgery. “I’m wondering if you have von Willebrand disease?” he questions me. Von-what? I thought. It was the first time I had heard that word. I shook my head no.

“You lost a lot of blood. I would like you to have a blood transfusion,” he advised. My mother stood up. “No,” she shook her head adamantly, “No blood transfusion.” Why not? I wondered for a fleeting second until brain fog and pain clouded my curiosity that I said nothing. The doctor sighed, “We’ll try an iron infusion instead.” My mother nodded for the both of us.

Depending on who you ask, childbirth seemed like a small pinch compared to a wisdom tooth extraction. Once my teeth were extracted, strong painkillers were prescribed, and I devoured them like M&Ms until I became aware that the more I took, the more my mouth bled. When the pain finally eased without medication, gauze pads still had traces of blood more than a month after the procedure.

During the follow-up appointment, I asked the dentist if the ongoing mouth bleeding was normal. “Everyone is different,” he answered. Instead of demanding he investigate my concern, I walked out with more gauze. It took another month for the bleeding to stop. I have never had another tooth extraction. However, I did have three more children. Motherhood is a dizzying merry-go-round.

A year after my daughter was born, my nephew also made his entrance, granting me the title of Aunt. It was a year of new beginnings, but it was also a year of numerous hospital visits. I couldn’t understand the unexplained bruises that riddled my nephew’s small body. It reminded me of a past life, one I couldn’t quite put my finger on.

After a light fall from a bunk bed when he was five years old, an egg-shaped bump on my nephew’s kneecap formed, making it hard for him to walk. My sister took him to the hospital to get some answers. After waiting nervously for some news, my mother called to share the diagnosis. “The doctors think he has hemophilia,” she said reluctantly. Although it was the first time consciously hearing that word, it felt oddly familiar. “Your father had hemophilia,” she explained, but didn’t elaborate.

That night I googled the word: Hemophilia. Bleeding disorder. I searched for the cure. Incurable. The next day my younger brother and I drove to the hospital together to visit my nephew. “You know Dad had hemophilia, right?” He asked, not waiting for my answer. Something about the way he braced his hands across the headrest made me sit up straight and pay attention to what he was about to say. Although he was younger than me by two years, he was closer to my mother, and I knew whatever he was going to say was going to be insider information. “You know how Dad died, right?” I said nothing. This question was something I’d been wondering about since the day he took his last breath. “He got HIV from a tainted blood infusion.”

Staring out at the twirling hands of a turbine while my father drove, his hands clutching the steering wheel so tightly his olive-colored knuckles looked as faded as the clouds that traveled with us. I never asked where we were going. I was simply happy to miss a day of school, excited to bask in my father’s presence since he was always on the go, even when it seemed like his limp made it hard for him to go the distance. For as long as I remember, my father always walked that way. It was more pronounced when he was standing for a long time. He never complained and I never questioned it, thinking he was just born that way.

But there are things I wish I had questioned then, things that my young mind wondered about, like the vials of medicine in his closet that were neatly stacked beneath his coats, the times he spent a few days in the hospital and came home without an explanation. Or the nurses who used to go into my parent’s room before I went to school, and when I would return, the smell of Asian food would waft through the house – sometimes I wonder if that is where my love for Chinese food came from.

Was I trying to hold on to the time my father was alive? To the moments when I didn’t need answers because he was still alive, and that was all that mattered? Or was I too afraid to wander into the truth for why there were nurses around the clock, and instead, chose to comfort myself with the food they fed me and my siblings? Sometimes I wish I could pause and rewind the years to get the information that medical records no longer contain. I wish I could ask my father just one question: Can you tell me all about you so I can know more about me?

After more tests, my nephew was diagnosed with severe hemophilia. He needed clotting factor. It was then that I examined my lifetime of symptoms. The excessive bleeding. The unexplained bruises. The joint pain. I requested genetic testing for myself as well as testing for my factor VIII level, along with my children. My children were cleared genetically, and their factor levels came back normal. But I held the mutation gene. My factor level came back at 42. I knew then that I too needed factor. I also knew that I too had hemophilia. Not only was it factored in my blood, but in my joints, the result of years without proper diagnosis and treatment.

However, getting diagnosed as a woman with a predominantly male bleeding disorder is like trying to convince a giraffe it is of average height. Or like trying to convince your blood to clot by just shouting at it. The struggle to be heard and be taken seriously is absurd, but painfully real.

Sitting in various waiting rooms has given me a newfound appreciation for HGTV and the Food Network. It has also given me an abundance of patience that seems necessary when dealing with a bleeding disorder. The last hematologist I visited when I was thirty-six told me it was a “mystery of life” why my joints ached. She gave me the classic carrier status associated with being the daughter of a severe hemophiliac. She discarded the results of my genetic mutation, discarded my low factor VIII level, discarded my low ferritin level, and basically told me my symptoms were imaginary.

If only that were the case, then I’d will my blood to clot, I’d will my restless legs at night to stop shaking, heck, I’d will Starbucks to deliver a few shots of espressos on the spot. And I’d request a lot of ice. Because my chronic anemia demands a cold wake-up call in the morning. The truth is if I were a boy, all these symptoms would ensure a quick diagnosis. Hemophilia. And swift treatment. Factor. But my double X-chromosome warrants a shoulder shrug and the concerned-for-my-mental-health stare from various hematologists.

During the pandemic, I learned about the Hemophilia Federation of America and joined my first virtual session. It was then I realized that my story was like many women with bleeding disorders. We have been made to feel like we don’t matter. We are often overlooked and underheard. When I finally received a referral to get diagnosed, I was ecstatic. But the catch was that the clinic was hundreds of miles away from my house. I knew it was the only option for me as a woman to get diagnosed.

Once I arrived at the clinic, I felt reassured. After asking me a few rounds of questions and performing lab work, I was sent home with hope. Once the results came in, I was relieved. Mild hemophilia. It was the truth I had waited for; it was the written proof validating years of pain.

But the reality is that getting diagnosed is not enough. Treatment must be implemented. Words of reassurance that I am fine from healthcare professionals do not stop the bleeding. They do not change history. The Hemophilia Holocaust took my father. If more care isn’t taken, more lives are at risk by not getting the proper treatment.

At thirty-nine years old, my joints ache. My body hurts. You can often find me resting in bed, reading a book, or complaining how depleted of energy I am. I feel a lot of my exhaustion is due to having to fight twice as hard with medical professionals, to warrant a proper diagnosis for my bleeding disorder and to receive treatment. It should not have taken hundreds of miles and numerous hospital visits to find a doctor who acknowledges women with bleeding disorders.

It is time that a woman is taken seriously. She knows her body. If she is seeking help from a medical professional, it is not because she likes to watch paint dry while watching DIY home remodeling shows, no matter how nice the shade, or watch how to cook pasta while wearing an adult diaper, praying the blood doesn’t leak through her clothes until she can meet with a doctor, only to leave empty-handed searching for the nearest restroom to assess the damage.

It is time the past stops bleeding into the present. It is time a woman is given the red-carpet treatment in the bleeding disorders community because she bleeds just as much as a man, if not more.

ABOUT THE AUTHOR

Sawsen Jamaleddin is American by birth and Palestinian by heritage. Sawsen earned her Bachelor of Arts in educational studies from Western Governors University and is a substitute teacher. She lives with her husband and four children. She enjoys writing and traveling and is excited at finally being able to connect with women who share her history in the world of bleeding diagnosis. Sawsen was reintroduced to her family history of hemophilia when she was 29 years old. She is passionate about advocating for women in the bleeding disorders community.

Stay informed on the latest trends in healthcare and specialty pharmacy.

Sign up for our monthly e-newsletter, BioMatrix Abstract.

By giving us your contact information and signing up to receive this content, you'll also be receiving marketing materials by email. You can unsubscribe at any time. We value your privacy. Our mailing list is private and will never be sold or shared with a third party. Review our Privacy Policy here.

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Entendiendo la Redeterminación para los Beneficiarios de Medicaid y CHIP

Todos los beneficiarios de Medicaid se Someterán a una Revisión de Elegibilidad en los Próximos Meses

Si sus beneficios de seguro médico son proporcionados por Medicaid o CHIP (Programa de seguro médico para niños), es importante comprender cómo la redeterminación podría afectar sus beneficios médicos en los próximos meses. Este artículo explica la redeterminación, describe por qué los estados están pasando por el proceso de redeterminación, brinda información sobre cómo prepararse para la redeterminación e incluye recursos para mantener el acceso a la cobertura de seguro si ya no es elegible para Medicaid o CHIP debido al proceso de redeterminación.

¿Qué es la Redeterminación?

Redeterminación es un término que se usa para describir el proceso de volver a verificar la elegibilidad para los beneficios de salud del gobierno, como Medicaid. Todas las personas que actualmente reciben beneficios de Medicaid y/o CHIP se someterán a una redeterminación en los próximos meses. Los estados deben comenzar el proceso de redeterminación antes del 1 de abril, y muchos estados comienzan el 1 de febrero. Los estados tendrán 12 meses para completar el proceso de redeterminación una vez que comiencen. Los beneficiarios de Medicaid que no completen el proceso de redeterminación perderán sus beneficios de Medicaid. Para ayudar en el proceso, la Comisión Federal de Comunicaciones (FCC) está permitiendo que los estados y los planes de atención administrada envíen mensajes de texto a los beneficiarios.

¿Por qué Medicaid y CHIP están pasando por este período de redeterminación?

Durante la pandemia, el mandato federal de emergencia de salud pública de COVID-19 no permitió que los estados cancelaran la inscripción de ninguno de sus beneficiarios de Medicaid. Esto aumentó significativamente el número de beneficiarios de Medicaid. En los últimos dos años, casi 1 de cada 4 estadounidenses se convirtieron en beneficiarios de Medicaid.1 Durante la pandemia, el gobierno envió dinero federal, fondos de emergencia de salud pública (PHE, por sus siglas en inglés), para cubrir la creciente población de Medicaid. Esos fondos de PHE están programados para vencer el 11 de mayo de este año.

¿Qué puedo hacer para prepararme para el proceso de redeterminación?

  1. Asegúrese de que su dirección, correo electrónico, número de teléfono y otra información estén actualizados.

    Asegúrese de recibir su carta y/o mensaje de texto de redeterminación de Medicaid confirme que tengan su información de contacto actualizada.

  2. Revise su correo y correo electrónico, y revíselo con frecuencia.

    Su estado se comunicará con usted eventualmente, así que esté listo para responder. No hay un “quizás” en esta redeterminación. Esto es seguro. Si su estado requiere que complete un formulario de renovación, hágalo de inmediato y devuélvalo a la dirección que figura en el formulario. Esto ayudará a evitar la pérdida de su cobertura.

  3. Tenga listo su comprobante de ingresos para compartir.

    Medicaid es un programa de asistencia federal basado en los ingresos de una persona y el nivel federal de pobreza. La prueba de ingresos probablemente se convertirá en una parte vital de la redeterminación.

¿Dónde puedo ir para obtener más información sobre el proceso de redeterminación de mi estado?

Visite el sitio web de Medicaid de su estado para obtener más información. La Federación Americana de Hemofilia ha creado una página que incluye enlaces, números de teléfono e información sobre los planes de Medicaid de cada estado. Accede a la página aquí.

¿Qué sucede si se cancela mi inscripción en un plan de Medicaid o CHIP como resultado de la redeterminación?

Si se canceló su inscripción, pero cree que todavía es elegible, puede pasar por el proceso de apelación. Puede leer sobre eso aquí, o comunicarse con BioMatrix.

Sin embargo, si se cancela su inscripción porque ya no califica para Medicaid o CHIP, es posible que pueda comprar un plan a través del Mercado de Seguros Médicos en Healthcare.gov. Los planes son integrales y pueden costar tan solo $10/mes.

Lo principal que debe recordar es que, si cumple con los requisitos de Medicaid de su estado y completa todos los formularios de redeterminación solicitados en el plazo solicitado, su Medicaid permanecerá vigente. Si ya no califica para la cobertura de Medicaid, calificará para un "período de inscripción especial" y podrá asegurar la cobertura a través del intercambio de atención médica.

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References

  1. Pradhan, Rachana. “Why Millions on Medicaid are at Risk of Losing Coverage in the Months Ahead.” KHN. 14 Feb. 2022. https://khn.org/news/article/why-millions-on-medicaid-are-at-risk-of-losing-coverage-in-the-months-ahead/.

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Neurological Disorders and Intravenous Immunoglobulin (IVIG) Therapy

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Intravenous immunoglobulin (IVIG) is a type of immunotherapy that has been used for nearly 30 years to treat neurological disorders. IVIG was first approved by US regulatory agencies to treat chronic inflammatory demyelinating polyneuropathy (CIDP), Guillain-Barré syndrome (GBS), and multifocal motor neuropathy (MMN) in 2008. In 2021, IVIG was approved to treat dermatomyositis.1

Neurological conditions for which IVIG currently has indicated use includes CIDP, severe dermatomyositis/polymyositis, Kawasaki syndrome, and multifocal motor neuropathy. IVIG has off-label use for Guillain-Barré syndrome and myasthenia gravis.2 While just as effective as plasmapheresis and steroids, unlike plasmapheresis and steroids, IVIG is found to be safe and effective long term.3

What is intravenous immunoglobulin (IVIG)?

Immunoglobulin (IG) given intravenously, or through a vein, is called intravenous immunoglobulin (IVIG). Immunoglobulin is a human blood product containing proteins that likely link themselves with antibodies or other substances directed at the nerve.4 It’s made from the donated antibodies of between 1,000-15,000 human donors per batch.5 The human body has different antibodies to fight different infections, like how there are different keys for different locks. If the body does not have enough antibodies or has damaged antibodies, IVIG can help replace them.

Where can a patient receive IVIG therapy?

A patient can typically receive IVIG therapy in their home or physician’s office. At BioMatrix, our nursing team coordinates the best site of care for scheduled infusions. For many patients needing regular infusions, choosing home as their site of care is a convenient and comfortable option. Research indicates that home infusion is a safe method of receiving IVIG therapy for neurological conditions.6,7,8

Additional benefits to home infusion include:

  • Less risk of infection. Hospitals and infusion centers can take every precaution available, yet in these environments patients still have the potential for exposure to bacteria or viruses they would likely not encounter in their homes.
  • Cost savings. Home infusion reduces the burden on costlier sites of care, saving money for both patients and payers.9
  • Patient wellbeing. Patients report significantly better physical and mental wellbeing with less disruption to daily activities, overwhelmingly preferring home infusion.10

Summary

The treatment of Neurological disorders using IVIG has become the standard of care in many neurological practices throughout the United States. BioMatrix provides site-of-care options for IVIG that offer convenience for patients and cost-savings to insurance providers. 

As a national provider of IG, BioMatrix also has broad access to brands and inventory supply. We purchase IG directly from manufacturers or manufacturers’ approved distributors, ensuring distribution channel integrity, proper handling, and quality control. 

To learn more about our IVIG capabilities to treat neurological conditions, visit:

DISCLAIMER: THIS IS NOT MEDICAL OR LEGAL ADVICE. All information, content, and material is for informational purposes only and is not intended to serve as a substitute for the consultation, diagnosis, and/or medical treatment of a qualified physician or healthcare provider or as legal advice. Please consult a physician or other health care professional for your specific health care and/or medical needs or concerns and never disregard professional medical advice or delay in seeking it because of something you have read here or on our website.

Stay informed on the latest trends in healthcare and specialty pharmacy.

Sign up for our monthly e-newsletter, BioMatrix Abstract.

By giving us your contact information and signing up to receive this content, you'll also be receiving marketing materials by email. You can unsubscribe at any time. We value your privacy. Our mailing list is private and will never be sold or shared with a third party. Review our Privacy Policy here.

References

  1. Dalakas M. C. (2021). Update on Intravenous Immunoglobulin in Neurology: Modulating Neuro-autoimmunity, Evolving Factors on Efficacy and Dosing and Challenges on Stopping Chronic IVIg Therapy. Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics, 18(4), 2397–2418. https://doi.org/10.1007/s13311-021-01108-4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8585501/#:~:text=IVIg%20inhibits%20the%20differentiation%20and,IVIg%2Dresponding%20autoimmune%20neurological%20diseases.

  2. (2023). Indications. Lexicomp. https://online.lexi.com/lco/action/doc/retrieve/docid/fc_dfc/6647276?cesid=1cTY1wl5C8I&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3DIVIG%26t%3Dname%26acs%3Dfalse%26acq%3DIVIG%26nq%3Dtrue

  3. Zandman-Goddard, G., Krauthammer, A., Levy, Y., Langevitz, P., & Shoenfeld, Y. (2012). Long-term therapy with intravenous immunoglobulin is beneficial in patients with autoimmune diseases. Clinical reviews in allergy & immunology, 42(2), 247–255. https://doi.org/10.1007/s12016-011-8278-7. https://pubmed.ncbi.nlm.nih.gov/21732045/

  4. Shehata N. (2023) Patient education: Intravenous immune globulin (IVIG) (Beyond the Basics). UpToDate. https://www.uptodate.com/contents/intravenous-immune-globulin-ivig-beyond-the-basics#:~:text=WHAT%20IS%20IVIG%3F,to%20help%20you%20fight%20infection

  5. Jolles S, Sewell WA, Misbah SA. Clinical uses of intravenous immunoglobulin. Clin Exp Immunol. 2005 Oct;142(1):1-11. doi: 10.1111/j.1365-2249.2005.02834.x. PMID: 16178850; PMCID: PMC1809480.

  6. Le Masson G, Solé G, Desnuelle C, et al. (2018). Home versus hospital immunoglobulin treatment for autoimmune neuropathies: a cost minimization analysis. Brain Behav. 2018;8(2):e00923. doi: 10.1002/brb3.923

  7. Luthra R, Quimbo R, Iyer R, Luo M. (2014). An analysis of intravenous immunoglobin site of care: home versus outpatient hospital. Am J Pharm Benefits. 2014;6(2):e41-e49.

  8. Schmidt R. (2012). Home Infusion Therapy: Safety, Efficacy, and Cost-Savings. PSQH. https://www.psqh.com/analysis/home-infusion-therapy-safety-efficacy-and-cost-savings/

  9. Home Infusion Creates Savings for Patients, Taxpayers. NHIA. https://nhia.org/wp-content/uploads/2020/03/Home_Infusion_Creates_Savings_for_Patients_Taxpayers.pdf

  10. Polinski J, Kowal M, Gagnon M, Brennan T, Shrank W. (2016). Home infusion: Safe, clinically effective, patient preferred, and cost saving. NIH. https://pubmed.ncbi.nlm.nih.gov/28668202/

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Understanding Redetermination for Medicaid and CHIP Beneficiaries

All Medicaid beneficiaries will undergo an eligibility review in the coming months.

If your health insurance benefits are provided by Medicaid and/or CHIP (Children’s Health Insurance Program), it is important to understand how redetermination could impact your health benefits in the coming months. This article explains redetermination, outlines why states are undergoing the redetermination process, provides information for how to prepare for redetermination, and includes resources for maintaining access to insurance coverage if no longer eligible for Medicaid or CHIP because of the redetermination process.

What is Redetermination?

Redetermination is a term used to describe the process of re-verifying eligibility for government health benefits such as Medicaid. All persons currently receiving Medicaid and/or CHIP benefits will undergo redetermination in the coming months. States must start the redetermination process by April 1, with many states starting as early as February 1. States will have 12 months to complete the redetermination process once they begin. Medicaid beneficiaries who fail to complete the redetermination process will lose their Medicaid benefits. To aid the process, the Federal Communications Commission (FCC) is allowing states and managed care plans to text beneficiaries.

Why are Medicaid and CHIP going through this redetermination period?

During the pandemic, the federal COVID-19 public health emergency mandate did not allow states to disenroll any of its Medicaid recipients. This significantly increased the number of Medicaid beneficiaries. Over the past two years, almost 1 in 4 Americans became Medicaid recipients.1 During the pandemic, the government floated federal money—Public Health Emergency (PHE) funds—to cover the growing Medicaid population. Those PHE funds are scheduled to expire May 11 of this year.

What can I do to prepare for the redetermination process? 

  1. Make sure your address, email, phone number, and other information are up to date. Make sure you get your Medicaid redetermination letter and/or text by assuring they have the most current contact information for you.

  2. Check your mail and email, and check it frequently. Your state will contact you eventually, so be ready to respond. There is no “maybe” in this redetermination. This is certain. If your state requires you to complete a renewal form, do so promptly and return it via the listed address on the form. This will help avoid gap in your coverage.

  3. Have your proof of income ready to share. Medicaid is a federal assistance program based upon an individual’s income and the federal poverty level. Proof of income will likely become a vital part of redetermination.

Where can I go to learn more about my state’s redetermination process?

Go to your state Medicaid’s website to learn more. The Hemophilia Federation of America has created a page including links, phone numbers, and information about each state’s Medicaid plans. Access the page here.

What if I am disenrolled from a Medicaid or CHIP plan as a result of redetermination?

If you are disenrolled but believe you are still eligible, you may go through the appeals process. You can read about that here or reach out to BioMatrix.

If, however, you are disenrolled because you no longer qualify for Medicaid or CHIP, you may be able to buy a plan through Health Insurance Marketplace at Healthcare.gov. Plans are comprehensive and can be as little as $10/mo.

The primary thing to remember is that if you meet your state’s Medicaid requirements and complete all the requested redetermination forms in the time frame requested, your Medicaid will stay in place. If you no longer qualify for Medicaid coverage, you will qualify for a “special enrollment period” and can secure coverage through the healthcare exchange. 

Stay informed on the latest trends in healthcare and specialty pharmacy.

Sign up for our monthly e-newsletter, BioMatrix Abstract.

By giving us your contact information and signing up to receive this content, you'll also be receiving marketing materials by email. You can unsubscribe at any time. We value your privacy. Our mailing list is private and will never be sold or shared with a third party. Review our Privacy Policy here.

References

  1. Pradhan, Rachana. “Why Millions on Medicaid are at Risk of Losing Coverage in the Months Ahead.” KHN. 14 Feb. 2022. https://khn.org/news/article/why-millions-on-medicaid-are-at-risk-of-losing-coverage-in-the-months-ahead/.

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Black History Month Spotlight: Ella P. Stewart

As we celebrate Black History Month, it’s important to pause and remember the achievements by Black Americans and their critical, central role in United States history. Here, we spotlight Ella P. Stewart—a pharmacist, entrepreneur, clubwoman, civic reformer, goodwill ambassador, civil rights leader, and women's rights advocate.

Ella P. Stewart

Ella Nora Philips Stewart was one of the first Black American female pharmacists in the US. She was born March 6th, 1893 during a period of strict, racial segregation. She attended a high school in West Virginia which was the only school in the region that accepted students of all races. After graduating high school, Stewart married a fellow graduate. Their only child, Virginia, died from whooping cough, and the couple went on to divorce. 

Though educated to be a teacher, Stewart went on to work as a pharmacy bookkeeper which led her to pursue her career as a pharmacist. Though initially turned down, she convinced the admissions staff at University of Pittsburgh to let her enroll in their pharmacist program. In 1916 she was the first Black woman to graduate from the School of Pharmacy at University of Pittsburgh. Despite being segregated from other students, Steward graduated with high marks, passing her state exam. After becoming the first Black woman licensed to practice pharmacology in the state of Pennsylvania, Stewart worked at the general hospital and managed a drugstore which she later purchased. She went on to purchase another drugstore, though because of health issues, ended up selling to a fellow pharmacy school graduate, William Stewart, whom she married in 1920. 

The couple moved to Youngstown, Ohio, and Stewart applied for a pharmacist position at a local hospital advertised as being open to whites only. She got the job, and her employment helped influence the elimination of discriminatory practices at the hospital. Some time later after also living in Detroit, the Stewarts moved to Toledo, Ohio and opened the first Black-owned drugstore there called Stewart’s Pharmacy in 1922.

Committed to advancing people in the Black community, the Stewarts opened their apartment above their pharmacy to host club and organization meetings as well as welcome Black travelers who were turned down by local hotels. Stewart served as president of the National Association of Colored Women (NACW) who’s effective lobbying led to passage of anti-lynching and anti-poll tax legislation, fair employment practices legislation, equal opportunity for housing and education, the support of black-owned businesses, and the development and expansion of endowment and scholarship funds for young black women. Stewart also served as the commissioner to UNESCO and vice president of the U.S. Chapter of the Pan-Pacific and Southeast Asia Women’s Association (and its international vice president). In the early 1950’s, she went on to serve on the U.S. Department of Labor’s Women’s Advisory Board. Stewart was also active in her local Young Women’s Christian Association (YWCA), Toledo League of Women Voters (the first African-American member), the League of City Mothers, the Toledo Council of Churches, and The Enterprise Charity Club (a black women's philanthropic club which provided assistance to Toledo families). Stewart received the Distinguished Alumni Award from University of Pittsburgh and was inducted into the Ohio Women’s Hall of Fame in 1978. Of her many awards and recognitions, the one that she treasured the most was the naming of a Toledo elementary school after her—the Ella P. Stewart Academy for Girls.

Stewart’s motto was "Fight for human dignity and world peace." Despite tragedy and much discrimination throughout her life, she continued to press on to overcome educational and career barriers and to help achieve basic human rights both for herself and other Black Americans. Her fight for justice has left an immeasurable legacy both for pharmacy and civil rights as well as local, national, and global policies.

Sources and further reading:

Pharmacist and Civil Rights Leader: The Life of Ella P. Stewart. Ohio History Connection. https://ohiomemory.ohiohistory.org/archives/5315

MS 203 - Ella P. Stewart Collection. BGSU University Libraries. https://lib.bgsu.edu/finding_aids/items/show/795

Stewart, Ella 1893–1987. Encyclopedia.com. https://www.encyclopedia.com/education/news-wires-white-papers-and-books/stewart-ella-1893-1987

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How to Avoid Access-to-Care Issues When Initiating New Coverage

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By Justin Lindhorst

New Year, New Plan 2 (1).jpg

The beginning of the year, for many, can mean initiating new health insurance coverage. When initiating new coverage, individuals living with a chronic health condition sometimes experience challenges that can delay access to prescribed therapy.

This article outlines how specialty pharmacies like BioMatrix can help patients avoid access-to-care issues, provides tips and best practices patients can implement, and includes links to helpful resources.

Specialty Pharmacy Support

Anyone who has a chronic health condition can identify a time they’ve had to spend a significant amount of time on the phone with their health insurance plan. Unfortunately, patients share it’s not entirely uncommon to be told one thing by one customer service representative, only to be told something entirely different by another.

Specialty pharmacies can help break down barriers to care and cut through red tape by conducting a thorough benefits investigation, facilitating access to financial support programs, and working with your insurance plan and medical team to provide support for prior authorizations and appeals.

Specialty pharmacies such as BioMatrix employ staff who are very well versed in promptly identifying and resolving coverage issues specific to your health condition. The first tool at their disposal is conducting a comprehensive benefits investigation. The benefits investigation provides a detailed outline of coverage specific to your therapy, including whether it is covered under the medical or pharmacy benefit, whether the medication requires prior authorization, your financial responsibility, and what specialty pharmacy service providers are available under the plan.

After the benefits investigation is complete, the specialty pharmacy can refer you to available and appropriate patient assistance programs to reduce financial barriers to care. They can also work together with your medical provider and health plan to obtain timely prior authorization for service and assist when and if an appeal is necessary.

Asking your provider to send a referral to BioMatrix or another reputable specialty pharmacy is a good first step in avoiding coverage issues.

Maintaining Access to Care: Tips and Best Practices

There are also steps you can personally take to avoid access issues. Following the guidelines below can go a long way in resolving potential barriers.

Be Proactive

Don’t wait until you are critically low on medication to place your first order with your new health plan. Placing your order in a timely manner will give your medical provider and specialty pharmacy enough time to resolve any issues before it potentially disrupts your care.

Reach Out to a Social Worker

If you are experiencing or anticipate coverage issues, social workers can be a great source of support. Many medical providers supporting patients with rare or chronic health conditions engage social workers as part of a multidisciplinary care team. Ask your provider if there are social workers available to assist with coverage or other issues.

Keep Detailed Records

When you need to contact your insurance provider regarding any issue or concern, it’s very important to document every call. Keep notes on the following: date and time of the call, the reason for the call, name of the person you spoke with, the result of the call, reference number, and any impact on your health resulting from the issue/call.

Document Medical Necessity

Work with your medical provider to document the medical necessity of your treatment. Having robust documentation on file can speed the resolution of issues related to prior authorization, denials, step therapy, or appeals. Ask your provider to write a letter on official letterhead identifying your diagnosis, the therapy you have been prescribed and why, any previously failed treatments, and the consequences of not having access to your prescribed therapy.

Include medical records, clinical evaluations, or other supplemental documentation supporting your diagnosis/treatment. Keep a copy for your personal records, and request a copy be kept on file with your specialty pharmacy.

Check for Copay Accumulators

If you are using a manufacturer or other third-party copay assistance program, determine if your plan is using a copay accumulator. Verify with your specialty pharmacy whether payments are being received from the copay assistance program you are enrolled in.

Once you’ve verified payments are being made, check your Explanation of Benefits (EOB). If the payments from your assistance program are not being applied to your out-of-pocket costs, your plan may be using an accumulator program.

Understand the Appeal Process

Every plan’s process for an appeal varies. Check with your insurance provider to determine their specific appeal process. Don’t hesitate to involve your medical provider and specialty pharmacy for additional assistance.

Understand the denial of the claim by investigating the explanation of benefits statement (EOB). There is often a code noted on the EOB if there is a denial of coverage or a letter with codes and a key code to decipher what the denial was based upon. Identifying the code will allow you to see if it was a true denial or a basic miscoding by the provider or insurance.

Keep all documentation including referrals, doctor’s notes, medical history, medicines or prescriptions, and notes from all contact with providers or insurance regarding the claim. The burden of proof is in your hands.

Organize Your Paperwork

If you have the aforementioned documents, you might also need to write a letter to the insurance company (written appeal). Keep documentation of your claim number, insurance information, provider/services information readily available. Request a reference number and employee name for every phone call to your insurance plan. 

Be cognizant of the appeal timeline (30/60/90 days in many cases). Be sure to file all paperwork and make calls within the timeline allowed. If your appeal is denied a second time you may be able to file another appeal. Some aspects of the ACA mandate states allow an external review process for denied claims.

Follow up on every call, text, email, and mail document you submit. Be sure it has a record of receipt.

Navigating new coverage can be challenging for patients who require specialty medication. Avoid any potential disruptions in care by leveraging every resource at your disposal. Work with your specialty pharmacy and medical providers early in the month to identify and resolve issues before they become an emergency. 

Follow the guidelines as outlined above any time you reach out to your health plan. Working together at the start of a new plan can make all the difference in maintaining uninterrupted access to the therapy and services keeping you healthy.

Useful Links

Centers for Medicare and Medicaid Services: Official website for the Centers for Medicare and Medicaid Services (CMS): https://www.cms.gov/

E-Health Insurance Glossary: eHealth provides a list of common insurance terms on their website: https://www.ehealthinsurance.com/health-insurance-glossary/terms-c/

Employee Benefits Security Administration: https://www.dol.gov/agencies/ebsa

National Association of Insurance Commissioners (NAIC): NAIC is a standard-setting and regulatory support organization. Their website includes a map that will allow you to determine the insurance commissioner in your state: https://content.naic.org/

Patient Advocate Foundation: The Patient Advocate Foundation (PAF) is dedicated to improving healthcare access. Their website offers education, assistance, and resources related to healthcare coverage: https://www.patientadvocate.org/

United States Department of Labor: Includes information on ERISA and COBRA plans: https://www.dol.gov/general/topic/health-plans

Stay informed on the latest trends in healthcare and specialty pharmacy.

Sign up for our monthly e-newsletter, BioMatrix Abstract.

By giving us your contact information and signing up to receive this content, you'll also be receiving marketing materials by email. You can unsubscribe at any time. We value your privacy. Our mailing list is private and will never be sold or shared with a third party. Review our Privacy Policy here.

Reference

National Hemophilia Foundation. (2021). Comprehensive Medical Care. https://www.hemophilia.org/healthcare-professionals/guidelines-on-care/comprehensive-medical-care

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Gender Equality in Bleeding Disorders

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By Danielle Nance, MD

Bleeding symptoms in women have been documented since ancient times and, in modern literature, recognized since the early 1900s.

Women with a genetic mutation for hemophilia have a 40-60% chance of having bleeding episodes during their lifetime requiring treatment and an 80% chance of having heavy menstrual bleeding. Due to X chromosome inactivation, one normal X chromosome is not always enough to produce a full amount of factor.

Even in the same family, the severity of bleeding symptoms in women varies a lot because of X chromosome inactivation, and we know now that bleeding symptoms don’t correlate with factor levels the same way they do in men. Treating bleeding symptoms in women when their factor levels are 30-50% is not always reimbursed by insurance. This can be confusing to treating physicians who were taught to treat based on “the numbers.” Treatment with intravenous medication is seen as invasive and therefore seen as “too difficult” or too expensive to use unless the bleeding is severe.

In men, even a minor bleed is no longer tolerated. Bleeding symptoms in women are often minimized or even dismissed by medical providers. As we understand more about bleeding symptoms and access to medical treatment becomes more widespread, more and more women are being offered treatment for their bleeding symptoms. 

Why should any bleeding be endured in women? Women have the increased burden of bleeding from their ovaries, uterus and reproductive organs during pregnancy, delivery and postpartum.

This issue is dedicated to women who bleed and celebrates the stories of those who have courageously talked about their personal symptoms and challenges. As women, we can help improve care for all by continuing to report bleeding symptoms and insisting on getting imaging with CT scans, MRIs, and ultrasounds to document pain and find out if the discomfort and swelling are from bleeding.

As a physician who treats women with bleeding disorders, I ask that each woman keep a calendar and write down symptoms of bleeding, especially the ones that disrupt home, work and leisure activities. Bring the calendar with you to your clinic appointment. If treatment is refused, be brave enough to ask why and ask for more studies so you can learn about your body and how to better care for yourself. Not all pain is from a bleed, and not all pain needs to be treated. Pain provides a signal for investigation. The more we know about symptoms, the better we can work through them towards better health.

May joy be with you in your journey.

ABOUT THE AUTHOR

Dr. Danielle Nance is a hematologist at Banner MD Anderson Cancer Center in Gilbert, Arizona. As a physician of more than 17 years, Dr. Nance shares, “I seek to bring accessible, expert care to each of my patients. I believe in advocacy for patients with rare diseases, access to care and insurance, and improving the patient experience.”

Stay informed on the latest trends in healthcare and specialty pharmacy.

Sign up for our monthly e-newsletter, BioMatrix Abstract.

By giving us your contact information and signing up to receive this content, you'll also be receiving marketing materials by email. You can unsubscribe at any time. We value your privacy. Our mailing list is private and will never be sold or shared with a third party. Review our Privacy Policy here.

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Patient Navigation: Understanding Surprise Billing

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This article defines “surprise billing”, offers scenarios where a surprise bill may occur, and also provides brief information on the No Surprise Act.

What is “surprise billing”?

Specific to healthcare, a surprise bill refers to a “balanced bill” where a provider bills you, the patient, for the difference between their charge and the amount paid by your health plan. A surprise bill is usually the result of an out-of-network charge. When a cost is in-network, the provider and the insurance plan have a previously agreed-upon arrangement for what the provider will charge and what the insurance will pay. With an out-of-network cost, no such agreement exists: the provider will charge what they feel is appropriate, and the insurer will pay what they feel the service is worth. When these two figures do not align (usually with the provider asking for more than the insurer is willing to pay), the patient is billed by the provider for the balance difference. It will then become an unexpected or “surprise” bill to you, the patient.

In what scenarios might you receive a surprise bill?

There are numerous situations that might lead to a surprise bill, but a majority of these are related to emergency (ER) services. In the ER, providers often have to act quickly, and they may be using contracted help—such as an X-ray that is read by an outsider, third-party source. In another scenario, you might have a blood draw where the phlebotomist is in-network, but the lab result is farmed out to a service that happens to be out-of-network. Another common scenario may involve a procedure where a specialized provider involved in the procedure (like an anesthesiologist) may be out-of-network, even if the procedure facility and the primary physician/surgeon is in-network.

What can I do if I get a surprise bill?

Recently passed legislation protects patients from surprise billing. The No Surprise Act offers consumers billing protections when getting emergency or non-emergency care from out-of-network providers at in-network facilities. It also provides out-of-network protection from air ambulance services.

The No Surprises Act, however, does not protect you if your provider (ER, hospital clinic, or other facility) is out-of-network.

What can BioMatrix do to help with a surprise bill? 

If you think you are a victim of a surprise bill, we can determine if the bill in question falls under the patient protections of the No Surprise Act. We can also help guide you to a resolution.

Stay informed on the latest trends in healthcare and specialty pharmacy.

Sign up for our monthly e-newsletter, BioMatrix Abstract.

By giving us your contact information and signing up to receive this content, you'll also be receiving marketing materials by email. You can unsubscribe at any time. We value your privacy. Our mailing list is private and will never be sold or shared with a third party. Review our Privacy Policy here.

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Patient Navigation: Understanding Step Therapy Mandates

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This article defines “step therapy,” provides helpful information on the patient impact of step therapy programs, and includes resources to learn more about step therapy.

What is step therapy?

Step therapy is a utilization management technique for drugs that prevents the patient from accessing prescribed treatment and instead mandates a therapy as dictated by the insurance plan. In laymen terms, it means trying “less expensive” drug options before “stepping up” to a more costly drug therapy. Step therapy plans could dictate that a patient begin treatment with a cost-effective drug before progressing to a more costly drug therapy if the initial treatment is proven ineffective. Some providers refer to this as a “fail first” plan.

How does step therapy impact me?

Step therapy is more prevalent in commercial plans and may or may not impact you depending on your particular health plan. If your health plan implements a step therapy mandate, you may have to utilize other medication before receiving approval for a more expensive therapy. You will have to document the ineffectiveness of the preferred, less expensive therapy before being permitted to switch. In some limited cases a doctor’s intervention may allow an override of the step therapy program.

For many chronic and rare conditions, a less-expensive (often “generic”) medication may not exist. In this scenario, a health plan may prioritize the most cost-effective medication as the starting step for medication. The health plan may dictate medication choices based on cost savings and may even deem some of the products as interchangeable. Significant documentation is encouraged in order to appeal to use another medication. This can become problematic especially if you change to a new health plan which has instituted a step therapy program; despite perhaps a long history of using a particular medication, the plan could dictate a medicine change.

For government programs such as Medicare and Medicaid, step therapy programs are less prevalent, but caution must be taken when selecting plans. Because Medicare Advantage (MA) plans are managed by commercial payors, they may be more at risk of implementing step therapy programs, but the MA plans must adhere to Part B guidelines for factor medications and must ensure they do not disrupt ongoing Part B drug therapies for beneficiaries. Under new policy guidelines, step therapy can only be applied to new prescriptions or administration of Part B drugs for beneficiaries who are not actively receiving the affected medication. This means that no beneficiary currently receiving drugs under part B will have to change their medication.

What can BioMatrix do to help with a problem with step therapy?

If you’re facing step therapy, our access team at BioMatrix can help you navigate the process. We can help you identify, collect, and submit the documentation required by your health plan and can help file for an exception in order to maintain or return to your original therapy.

Where can I learn more about step therapy?

The Alliance for Patient Access has created a succinct overview for understanding step therapy. Scan the QR code or visit the link to watch.

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Home Infusion for Transplant Patients

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BioMatrix Specialty Pharmacy provides home infusion services allowing patients to receive therapy from the comfort and safety of home. This article provides a brief overview of how our clinical team works to support home infusion for transplant patients.

Home infusion provides a safe and effective means to help transplant patients manage their prescribed therapy. Hospitals and infusion centers can take every precaution available, yet in these environments patients still have the potential for exposure to bacteria or viruses they would likely not encounter in their homes. Transplant patients benefit from home infusion both before and after transplant. Before the transplant, many patients are at greater risk for infection given their diagnosis and the procedures they have endured. Post-transplant, patients are at risk of infection because of immune-suppressing anti-rejection drugs and/or because they develop comorbidities compromising their immune systems. 

BioMatrix’s focus on safety begins well before the patient is infused with their first dose of medication in the home. 

Even before the pandemic, our transplant professionals followed rigorous safety protocols to ensure the health and safety of the patients we serve. Our clinical team includes nurses and pharmacists who are experts in transplant therapy. Many have years of transplant experience, and team members stay up to date on all current literature surrounding the use of specialty medications provided for transplant-related diagnoses. Our team follows transplant-specific protocols to promote the health and safety of our patients and home infusion nurses. Each clinician has the responsibility of not only knowing each transplant-specific or medication-specific protocol, but also ensuring that the protocol is strictly followed for optimal results.  

Our nursing and pharmacy teams work hand in hand at every step of the patient journey. This includes our efforts around home infusion services. To support our patients across the country, BioMatrix has contracted with over 200 Nursing agencies nationwide. We continually bring new agencies into the fold. Each agency is thoroughly vetted to ensure that they meet our rigorous standards and are knowledgeable regarding the Infusion Nurses Society guidelines for infusion therapy in the home.   

Just as the nursing agencies we contract with are thoroughly vetted, so too are the individual home infusion nurses. Every home infusion nurse assigned to enter a patient’s home is required to meet (over the phone or virtually) with our nurse clinicians prior to providing service. Our nurses evaluate the infusion RN’s level of competency to provide the care ordered. If further education or training is needed this is arranged and completed before the start of care. Prescribed therapy is reviewed in detail to make sure the appropriate protocols are followed and the services provided are safe and seamless. If at any time our nurse clinicians determine that a particular home infusion nurse does not meet the standard of competency that we at BioMatrix strive for, we re-group and re-staff the case with an alternate home infusion nurse.  

When entering a patient’s home, the home infusion nurses we work with follow all standard precautions and wear appropriate personal protective equipment. They also take the time to identify and review safety measures the patient can follow in the home both during and after infusion. Working together our team helps patients mitigate any issues to establish a safe environment for home infusion.  

BioMatrix is committed to providing the highest level of specialty pharmacy service and support.

Our team has years of transplant experience and follows highly coordinated, transplant-specific protocols promoting the health, safety, and well-being of every patient served.

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Patient Navigation: Patient Assistance Programs (PAPs)

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This article defines patient assistance programs (PAPs) and provides helpful information for who may be eligible.

What are patient assistance programs (PAPs)?

Patient assistance programs (PAPs) help people without health insurance and those who are underinsured. These programs are often managed by pharmaceutical companies, nonprofits, and government agencies. PAPs may cover free or low-cost medicines if you don’t have insurance, have lost your insurance, or are underinsured and can’t afford your medicine.

Pharmaceutical manufacturers often sponsor PAPs that provide financial assistance or free product for eligible individuals. PAPs may also provide assistance to Part D enrollees and interface with Part D plans by operating “outside the Part D benefit” to ensure separateness of Part D benefits and PAP assistance.

Who should enroll in PAPs?

Anyone who is without insurance, is underinsured, and is unable to pay for their medication should consider a PAP. PAPs were created to ensure continued access to life-saving medicines. 

Are PAPs the same as copay assistance programs like copay cards?

No. PAPs are intended only for the uninsured or the underinsured. PAP programs provide drugs free or at a discount to patients. Copay assistance programs are for commercially-insured individuals and work in tandem with the patient and the insurance plan to help cover a medication’s out-of-pocket cost.

What can BioMatrix do to help connect patients to these resources?

BioMatrix can provide information on available PAPs related to your medication and can connect you to those resources.

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Sign up for our monthly e-newsletter, BioMatrix Abstract.

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Patient Navigation: Understanding Medicare Eligibility

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This article defines Medicare eligibility and provides helpful information for navigating Medicare eligibility.

Am I eligible for Medicare?

You are eligible if you are 65 or older, under 65 with a disability, or have end-stage renal disease.

When and where can I sign up for Medicare?  

Most people sign up for Part A and B at age 65. You may begin the enrollment process 3 months before your 65th birthday. If you are starting your Social Security benefits and are approved, Part A coverage will be granted automatically, but you will have to enroll in Part B by filling out Form CMS-40B.

You can enroll in Medicare by visiting Social Security and signing up online at www.ssa.gov/benefits/medicare/. You can also enroll by calling Social Security at 1-800-772-1213. 

For persons under 65, everyone eligible for Social Security Disability Insurance (SSDI) is also eligible for Medicare 24 months after being awarded disability benefit entitlement. 

Thereafter, the general enrollment period and when changes may be made to plans is Jan. 1 – March 31 every year.

What if I am still working at 65?    

If you or your spouse are still working at a job with more than 20 employees and have insurance, you can wait until you or your spouse stops working (or lose health insurance if that happens first), and you won’t pay a late enrollment penalty for Part B. Your job-based insurance pays first, and Medicare pays second. If you or your spouse’s employer employs fewer than 20 persons, you need to verify with the employer if you need to sign up for Part A and B because your job-based insurance may not cover the costs for services. If you or your spouse are still working and have non-job-based insurance (Medicaid or ACA Marketplace), the rules vary on coverage with Medicare, and you will need to answer a few questions to determine your coverage. 

What if I return to work but am an under-65 disabled Medicare recipient?  

Social Security’s Ticket to Work program allows beneficiaries an opportunity to resume their working careers. If you earn under $1350 during the Trial to Work period, your benefits will remain intact for those 9 months. If you return to work and begin earning more than $1350, you will lose your SSDI benefits, but you will retain premium-free Medicare Part A and B coverage for up to 93 months. After 93 months, beneficiaries will then have the opportunity to purchase Part A and B coverage if they continue to have a disability. 

What can BioMatrix do to help with my Medicare eligibility?  

BioMatrix can check your Medicare benefits and let you know about your eligibility and anticipated coverage. From there we can provide additional information based upon your needs. 

Stay informed on the latest trends in healthcare and specialty pharmacy.

Sign up for our monthly e-newsletter, BioMatrix Abstract.

By giving us your contact information and signing up to receive this content, you'll also be receiving marketing materials by email. You can unsubscribe at any time. We value your privacy. Our mailing list is private and will never be sold or shared with a third party. Review our Privacy Policy here.

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