You may find it surprising that there is a $100+ billion dollar healthcare delivery model that you have never heard of. That’s right, “Billion” with a “B”. Unless you or someone you know has a rare chronic disease, you likely have never heard of this amazing (and expensive) group of specialty biologic medications delivered primarily by intravenous infusion or injection through non-oncology Infusion Centers and Infusion Suites.
Even if you have never heard the term: “autoimmune disease” (AD for short), you likely are familiar with Multiple Sclerosis, Crohn’s Disease, Lupus, Rheumatoid Arthritis, and Psoriasis. It’s less likely you have heard of many other AD diseases: CIDP (Chronic Inflammatory Demyelinating Polyneuritis), Ulcerative Colitis, Hypogammaglobulinemia, or other less known chronic disorders. These AD diseases are considered “rare” by most, but if you group the incidence of them all together, the numbers are unsettlingly large.
The National Institutes of Health estimates that over *23.5 million people in the US currently live with an autoimmune disease of some kind. The American Autoimmune Disease Association estimates that this number may be as high as 50 million and growing. (https://www.aarda.org/news-information/statistics/)
To put those numbers in perspective, cancer affects up to 9 million and heart disease up to 22 million. Looking at these statistics, autoimmune disorders as a group hardly qualifies as “rare”. (https://www.aarda.org/news-information/statistics/)
What do Autoimmune Disorders have to do with Infusion Centers?
Most of the medications that treat AD are large molecule biologic or intravenous immune globulin (IVIG) products. Without going into all the science here, just know that many these specialty medications are not available in a pill you can swallow at home.
That means that most of the treatments for AD must be administered by either intravenous (IV) or injectable methods. These treatments are not a one-time dose or a cure; instead, most of these specialty meds manage the disease and must be administered chronically over frequent intervals (every week, 2 weeks, 6 weeks, 6 months, etc.) for long durations and some, for a lifetime, or at least until a cure for the disease is discovered.
Some of these medications are self-administered, meaning that they have been formulated in a way that allows the patient to administer the injection to themselves, once the patient is trained in the proper technique.
That still leaves many of these medications, especially the intravenous-only ones, as requiring a registered nurse (RN), to safely and effectively administer the infusion treatment.
The specific requirements for proper medication preparation, patient safety, and the current economics of our healthcare situation dictate that sending a single nurse to each patient’s home to give these medications is not a workable solution.
This means that most AD patients who need intravenous or non-self-administered injectable medications will receive them in a facility setting of some kind. Facility options include hospitals, doctor’s offices with infusion suites, or stand-alone Infusion Centers.
Don’t cancer patients receive chemotherapy infusions all the time? Why is this problem any different?
For starters, cancer is typically not a “chronic” disease. Most chemotherapy regimens are meant to be started and stopped in short (less than a year) intervals. AD patient’s medications have longer frequencies and progressive treatment process that can last decades or longer.
Because the treatment approaches are different, the facilities, processes, and economics are too. Some AD patients are receiving their treatments in oncology Infusion Centers, but these situations are usually a means to an end due to a lack of appropriate access in other preferable settings. The possible oncology solution to this problem is more complex than I want to dive into here, but I can say that if you do your own research, you will find that Oncology Infusion Centers are not a likely or effective solution to the medication access problem for AD patients.
AD Patient Access Options
Every year, millions of AD patients receive their medications in hospitals, doctor’s offices, and stand-alone Infusion Centers across the country. NIH estimates annual direct health care costs for AD to be in the range of $100 billion. (https://www.aarda.org/news-information/statistics/ – source: NIH presentation by Dr. Fauci, NIAID)
You would think that with these kinds of statistics there would now be a streamlined and efficient delivery model to help these patients – and you would be wrong. How we got here is probably worth exploring in another article, but I believe that some investigative work would reveal that the recent advances in biologic medications have simply outpaced the healthcare markets ability to react to and create an efficient delivery model for these drugs.
The Hospital Option
Most hospitals will have some form of outpatient option for both the oncology and non-oncology patient needing specialty infusions. In most cases, the hospital option exists due to a lack of any other alternative. Yes, there are indeed some very nice hospital Infusion Centers that focus on the non-oncology patient, but many of these locations are also used for the hospital’s oncology and short stay needs. The major issue with a hospital outpatient Infusion Center (HOPD) is that it typically cost twice as much as the other, non-hospital outpatient options. Remember, we are not talking about costs of $10 to $20, these drugs are much more expensive…
“For commercial, medical benefit drug cost is often more than double in the hospital outpatient setting versus the physician office”
“…despite the physician office being the most cost-effective site of care, the trend is shifting away from the physician office and toward the hospital outpatient. Several reasons may be contributors: practice consolidation, decreased reimbursement to physician offices, and large health systems continuing to expand and acquire groups and services.”
– Magellan Pharmacy Trends Report 2016
Biologics by Cost per Claim and Unit by Site of Service
|COST PER CLAIM|
2015 Biologic Drugs for Autoimmune Disorders (BDAIDS)
From Magellan Health’s 2016 Pharmacy Trend Report – Full Report Linked Here
To recap, the Hospital option is at least 2X the cost of other options, and the use of HOPD’s for products is growing at a faster rate than other, lower cost options.
While these HOPD’s will remain a necessity for clinically high-risk patients and for those patients with no other viable option for access to these medications, they are far from being the best delivery model due to the extreme cost and inefficiency that comes from these large institutional services.
The Provider’s In-Office Infusion Suite Option
The most prevalent infusion option for patients is the physician office setting. These are physician created “Infusion Suites” for patients to receive their infusions or injections. In most cases, the provider offering the Infusion Suite option is in a specialty that lends itself to prescribing for AD patients. Rheumatology, Neurology, Gastroenterology, Allergy & Immunology, and Infectious Disease are all specialties that often prescribe and administer these products in their office settings.
While this is likely the most cost-effective delivery model today for these medications, it is a very fractionated and non-standardized model. In some cases, providers build out beautiful Infusion Suites within their practice – complete with friendly registered nurses, comfortable recliners and free coffee and Wi-Fi. For others, you could be looking at a simple chair in a very small room with a nail in the wall to hold the IV bag.
Downward trends in both the administration and drug cost reimbursement associated with these medications are putting increased pressure on providers with in-office capabilities, who are operating their Infusion Suites on the backs of existing staff and in addition to managing their busy practices.
It would seem logical that both public and private payers would take actions to not only ensure the survivability of these in-office Infusion Suites but also to encourage their continued creation and growth. There are still many geographies across the country that have no hospital-alternative for AD patients. While some payers have recently taken up efforts to steer patients away from high-cost HOPDs, (See UHC’s Updated policy here: UnitedHealthcare Site of Care Update), there has been little movement to increase reimbursements to these in-office providers to encourage the increased creation of new Infusion Suites and growth of existing ones.
The Stand-Alone Infusion Center Option
A newer option is quietly appearing across the country that combines the entrepreneurial spirit of the in-office Infusion Suite model with some of the enterprise systems you would expect from an institutional or Hospital option. These stand-alone options come in many flavors, but most have some foundation in either home infusion pharmacy or a previous physician in-office Infusion Suite model spinoff. In my previous company, we operated stand-alone Infusion Centers where a Nurse Practitioner served as the supervising provider to comply with Medicare and some private payer requirements.
Stand-alone Infusion Centers are unique in that they usually are not specialty specific and are not diagnosing disease but are instead a service for all the providers in a healthcare community. For physicians who do not have in-office Infusion Suites, the stand-alone Infusion Center becomes a viable hospital-alternative for their patients. These locations typically have longer hours – including weekends and tend to be more service focused on the patient experience.
Like the physician in-office Infusion Suites, the problem remains that payers and industry have yet to recognize the significant role these kinds of locations play as an efficient and cost-effective medication delivery solution. Many of the regulations created for the physician-office, home health, and pharmacy markets have been applied to these stand-alone operators, creating a “square peg in a round hole situation.”
First and foremost, we must work to educate our policymakers and our insurance providers (both public and private) about the prevalence of autoimmune diseases. The impact of AD’s economically is at least, if not more significant than cancer, yet policies to increase access to AD treatments are not nearly as actively sought by policymakers.
Solutions for decreasing the high cost for these treatments is, of course, part of the solution and will remain a hotly debated topic for a long time. One un-contested solution, that most parties agree with, is that driving these medications away from the Hospital / Institutional setting is the single simplest way to quickly reduce the insurance expense and patient out-of-pocket cost on these products.
We need physician based Infusion Suites and stand-alone Infusion Centers! A larger and larger share of new FDA approved medications are now infusible biologics. We need an efficient and cost-effective delivery system for these medications.
“With biologics making up a larger share of the new drugs approved by the FDA, the pricing of drugs, and the impact of those prices on the U.S. healthcare budget is poised to become a bigger issue going forward.” (http://www.bioworld.com/content/biologics-share-medicine-chest-grows-and-so-do-pricing-concerns)
There is no one-size-fits-all solution to the patient access problem; however, there is a logical and economic need for policymakers, payers, and industry stakeholders to begin crafting the kinds of payment and regulatory reform that will encourage the sustainability and growth of both the physician office-based Infusion Suite and stand-alone Infusion Center delivery model. To do nothing is to encourage the growth of only other option: the high-cost, low-efficiency hospital outpatient option.
Are you interested in learning more about having your own In-office Infusion Suite or Infusion Center? Do you already offer in-office infusions/injections and want to grow and improve your current Infusion Suite? Send us a message at firstname.lastname@example.org or message us through our contact form. Let’s talk Infusion soon.