Infused Specialty Pharmacy and Expanded Opportunities

The FDA continues to crank out approvals in record fashion. Although the government shutdown resulted in several pending approvals being sidelined, things appear to be back on track. Hopefully, our politicians can appreciate the consequences to health care of their high-stakes gamesmanship. We are in the health care business, and decisions they make have an impact on the lives of patients. 

The FDA website can be a treasure trove of information on recently approved products or products in development. For example, I searched for new molecular entity FDA approvals in 2018 and there were 59 search results. Every newly approved product clearly met the definition of specialty and can be categorized as innovative, and they have never been used in clinical practice as listed.

The FDA has prioritized from the top down seeking new treatment options for patients. More specialty products expand the relevance of specialty pharmacy. These approvals feed the lifeline of our industry.

What I found interesting in the list of approvals was the ratio of oral products to infused. Nearly half of all new approvals were for infused specialty products. For the traditional specialty pharmacy, we often think of oral or self-injectable products being sent to the patient’s home. But what about specialty infused products? How might a specialty pharmacy expand their practice? How can an existing practice expand into specialty infused products?

Home and Ambulatory Specialty Infusion

Although many infused products are administered in the acute care or hospital setting, several products lend themselves to being administered in the patient’s home or in an ambulatory infusion center or free-standing infusion center. The clinical, lifestyle, and economic attributes of a product play a factor in choosing the administration setting. 

Traditionally, many of these products were administered in the physician’s clinic and often defined as “buy and bill.” However, there has been a significant trend of declining physician-administered drug reimbursement rates driving these products into home infusion and ambulatory infusion centers. Many hospitals have jumped on this and established accredited specialty pharmacies, for both oral and infused specialty products.

In support of these trends, several specialty pharmacy operations have added infusion centers to their portfolio or an infusion suite to their opera- tion. This is not new, however, as our neighbors in Canada have offered community-based infusion suites for many years. Ambulatory infusion centers can be beneficial to manufacturers, patients, and providers. Many serve as the host pharmacy for home-infusion service providers, in which nurses secure access to the products and devices necessary to administer treatment in the patient’s home.

Some patients may also receive their therapy in a physician’s infusion clinic, where treatment is administered in a familiar setting under the care of their usual physician. Insurers often prefer the ambulatory infusion center option because they may have to pay higher rates for hospital-based medical infusion services. This will likely continue to encourage the use of outpatient infusion centers. Despite the similarities between in-home infusion (trained professionals go into the patient’s home) and ambulatory (patients come to the medical facility), the operational costs and reimbursement are quite different.

Requirements

Ambulatory infusion centers must strictly adhere to Centers for Medicare and Medicaid Services (CMS) supervisor requirements. The owners and operators of ambulatory infusion centers must be prepared to understand and follow CMS rules in this area. The rules for physi- cian supervision for infusion are more stringent in the freestanding centers and physician offices than in hospital out- patient departments in this area. CMS requires direct supervision by physicians, which means that the physician, not an advanced provider, must be “immediately available” and “interruptible” for help and direction throughout the infusion. However, the physician does not need to be in the infusion room when the infusion is given.

Equipment

Equipment and staffing need to be carefully considered prior to establishing an ambulatory infusion center. The physical space for the ambulatory infusion center should have an adequate comfort structure. Some centers might be as simple as a single infusion chair with an intravenous (IV) pole compared with other facilities decked out with 20 high-tech leather recliners, each with its own TV and massage unit. At a minimum, the ambulatory infusion center should have 2 infusion chairs, infusion pumps, blood pressure monitors, patient entertainment equipment, and general supplies (eg, locking refrigerator, IV tubing, needles, gloves, and medications to handle complications).

Staffing

In addition to well-trained pharmacists, staffing should include infusion nurses with adequate training. An ambulatory infusion center must have skilled, competent, and knowledgeable nurses and pharmacists. Consideration of the total time spent giving infusions as well as whether the staff will be involved in helping to obtain authorizations for specialty infused products can be a considerable time outlay. Therefore, ambulatory infusion centers must have the correct state licensing requirements and accreditation and be able to verify that these are met by the infusion nurse or other personnel involved with the infusion of medications to patients in addition to their pharmacy requirements and accreditations.

Billing

Obtaining and billing for specialty infused medications are usually done by ambulatory infusion centers in 1 of 2 ways. There may be a pass-through type of arrangement or buy-and-bill:
  • In a pass-through situation, a specialty pharmacy delivers the drug— and possibly infusion equipment—to the ambulatory center and then the pharmacy bills the insurer directly. The pharmacy is also responsible for the authorization and collection of co-pays.
  • In buy-and-bill, the ambulatory infusion center establishes an account with a wholesaler/distributor. The infusion center then bills the patient’s insurance plan or Medicare directly. This method requires caution and diligence by the infusion center in several areas. It is the center’s responsibility to comply with insurance company and CMS rules, ensure correct and necessary authorizations are obtained, and collect patient co-pays.
Coding

Coding and billing for outpatient infusion services is a key component for any ambulatory infusion center. It is critical that the ambulatory infusion center has competent coders and billers and a clear understanding of the most recent current procedural terminology (CPT) codes to assure the ambulatory infusion center is receiving the appropriate reimbursements. Each insurer may also have their own policies regarding infusion payment.

There are specific rules regarding infusion coding, and they can be complex. It is also very important to record the timing of the entire infusion. For example, the CPT code for the infusion of 1 product may cover the administration and IV infusion techniques for a certain number of hours, whereas another code may cover each additional hour. In addition, codes are listed separately for primary and additional procedures.

The Healthcare Common Procedure Coding System is used to supplement the CPT codes. In the case of infusions, this would cover the drug, IV tubing, syringes, and other supplies for the infusion that are not included in the CPT code. Coding coverage may vary by insurer or between plans with the same insurer. The ambulatory infusion center may need to consult each payer for specific coding policies.

Getting Started

In addition to the steps above, it is important to establish which infused specialty products are available and in your market that may be in demand by providers and patients. To get started, there are several open-distribution infused products available from your specialty distributor or wholesaler. Because many physician practices are assessing their continued participation, reach out to oncologists, rheumatologists, hematologists, neurologists, and immunologists, and other practices, that currently perform in-office infusions to seek guidance and/or a partnership.

Also, stay on top of new product developments via FDA.gov. Your local specialist might be participating in a clinical trial, and following approval of the drug, they will be looking for commercial access to the product as well as infusion services. Get a head start by leveraging those relationships to reach out to manufacturers well before the anticipated approval of a product. Review your payer portfolio, and get on the right provider panels for infusion services, as these will be different than your traditional pharmacy agreements.

We will continue to see a tidal wave of new product approvals and infused specialty products strongly represented. Position your business for that growth.

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