The treatment of retinal disease has drastically changed with the introduction of anti-VEGF injections, which not only can reduce disease progression but also can, in many cases, improve visual acuity. However, innovation came with a new set of problems. For the first time, physicians were asked to order, stock, deliver, and bill for high-priced medications through Medicare part B, a virtual first in delivering drug treatment. Unfortunately, few if any practices had the infrastructure to efficiently handle these pharmaceuticals.

Practices had to develop systems to efficiently order drugs without running large inventories and tying up capital. Billing practices needed to be developed to ensure timely payments to reduce the chance of losing money on administered drug. It seemed that the introduction of a novel treatment would not only affect patients but also have a profound impact on the way retina specialists ran their practices. In our practice, we were required to add multiple layers of control to ensure accurate monitoring of drug use. In addition to adding personnel in the billing department, we needed to train staff on ordering procedures, drug log monitoring, and inventory management, processes that came with the advent of injection therapy.

ESTABLISH A PROCEDURE FOR ORDERING

Today, the use of anti-VEGF therapy and high-priced drugs has become an integral part of most retinal practices. It is imperative to the success of these practices that they have procedures in place to allow for the efficient use of these drugs. The first hurdle they must face is the prospect of managing inventory. The difficulty is multifaceted. First, most practices will want to try to maintain ordering on an “as-needed” basis to avoid tying up large amounts of capital. Most distributors allow for next-day delivery, which allows practices to estimate their next-day clinic needs and to order according to those estimates, allowing for some leeway. This ordering is most efficiently completed through online portals that allow direct ordering with drop shipments directly to the offices administering the drugs instead of to a central hub. Coordinators at each individual office call in to our billing office and a designated staff member will log in to the distributor website and place all the orders for the next day. Orders can be placed until 3:00 pm the day before shipment is needed, allowing for the most efficient management of inventory.

INVENTORY ACCURATELY

The efficient use of high-priced drugs starts with accurate inventory controls. Many practices still do this manually, entering the lot numbers and drugs into a drug inventory log. There are also commercially available inventory systems such as Podis (podis.org) and CubixxMD (cubixxmd.com) that automatically inventory the drug as it is placed into the monitored refrigeration unit. These systems not only keep track of the drugs as they are entered into the system, they also monitor their usage, assigning each dose to the patient for whom it was administered and allowing the practice to track that dose from administration to payment. While this automation may improve efficiency, it comes with a cost. Most systems charge a per-physician per-month fee. Start-up costs can also include linking the system to the practice’s EMR and its practice management system.

For practices entering the data manually, technicians typically enter the delivered dose into a registry accompanied by the patient name and lot number. This log is then manually checked against the billings at the end of the day to make sure that all drugs are accounted for. Additionally, the drug log will be checked against the remaining inventory to account for all doses. The drug lot number can also be manually entered into the patient’s record for better tracking.

BILLING CONSIDERATIONS

Inventory is only the first step in establishing a system for effective drug use. Accurate and timely billing for administered drugs, in conjunction with a well-organized billing staff, is key to successful integration of these drugs into a practice. Even before the drug is used, the billing cycle is set in motion. The office must review each patient’s insurance to check for the need for a referral or preauthorization request prior to administering the drug. An increasing number of insurance plans will require preauthorization for each drug administered, meaning that a switch from one drug to another will require a new authorization.

Also, many insurance plans now require step therapy and demonstration of treatment with lower-cost drugs before utilization of a brand new drug is allowed. Failure to obtain preauthorization or to adhere to the step therapy will result in denial of payment. It is also important to determine if the patient has been in a skilled nursing facility for fewer than 60 days as this will also result in a denial of payment or the need for appeal. The most efficient way of monitoring the insurance requirements is to assign staff to check on the patient’s insurance a day or two prior to the patient’s visit. We routinely assign staff at each office to verify insurance coverage and the need for any preauthorization a few days prior to the patient visit. The staff will document on the billing form which drug the patient is authorized to receive, if an authorization is required, and any other requirements that need to be fulfilled prior to administration of a given drug. This helps the physician know in advance whether the patient’s insurance will cover the injected drug.

Once the drug is administered, it must be accurately billed. The entry must include the drug name, the number of units administered, the NDC code, if required, and the billable diagnosis. An error in any of these can cause the claim to be rejected or delayed. Common mistakes include entering the wrong number of units or linking the drug to an uncovered diagnosis. The first step in accurate billing is to have the administering physician confirm the billable diagnosis ICD code in the EMR or on the superbill prior to the patient checking out. Medicare publishes a list of covered diagnoses for each administered drug and this should be kept in the office for reference. Commercial payers publish a similar document.

The biller should check the diagnosis code against the documented diagnosis to make sure it is an acceptable code. Many codes will require a secondary diagnosis to allow for payment, even with the new ICD-10. One such example is the need to bill CRVO with macular edema with the diagnosis code for retinal edema. Secondly, the biller needs to make sure the correct number of units are billed. It is important to check on each drug as the units do not always correlate with the dose administered. The patient should then be offered the ability to enroll in a copay benefits program. These plans help to cover out-of-pocket expenses that the patient may incur and help protect the practice from unrecoverable patient pay balances. Programs are available for most of the branded drugs utilized in a retina practice. The Good Days copay assistance program provides copay assistance for both Eylea (aflibercept; Regeneron) and Lucentis (ranibizumab; Genentech). Additional information for programs is available through both Genetech and Regeneron.

MONITOR AND TROUBLESHOOT PAYMENTS

Unfortunately, even with implementation of the above steps, payment is not guaranteed. It is critical that the practice designate a biller whose primary job is to monitor the accounts receivable for the drugs. This individual or another biller should also oversee confirming that every patient is registered for a copay program. It is too easy for a nonpayment to slip by that becomes two nonpayments due to lack of an authorization or billing for a noncovered diagnosis. Most practice management systems will generate a log automatically. The report should include the amount charged, payment expected, payments received, insurance balance, and patient balance. Outstanding receivables should be tracked daily to reduce the chance of large balances building up. Physicians should be notified at the next patient visit of any unpaid balances on administered doses so they can address them with the patient or make arrangements for alternative therapies.

BE PROACTIVE FOR SUCCESS

New therapeutic interventions in the treatment of retinal diseases have revolutionized the management of what used to be uniformly progressive conditions. However, these drugs come with a price that is not only a result of their high cost. Poor management of the use of these drugs can have a devastating effect on a retinal practice. The breakdown in any aspect of their utilization from inventory to collection can put a practice at enormous financial risk. It should be clear that the use of these drugs comes with added cost to the physicians. Accounts payable can run in the hundreds of thousands of dollars depending on the volume of injections that the practice performs. Increased staffing costs both in billing and in the office can greatly add to overhead. Payment for inventory control systems and increased staffing to accurately record, monitor, and bill for these drugs have added greatly to practice overhead. Practices must assure that policies and procedures are built into the system to allow them to manage these drugs or risk financial disaster. RP