Mark Painter, BA1; Nathan Diller, MBA, MHSA2; Kirsten Anderson, MHA3
1PRS Managed Services LLC, Westminster, Colorado
2Brandywine Urology Consultants, PA, Wilmington, Delaware
3AUC Urologists LLC, Myrtle Beach, South Carolina
KEYWORDS:
Insurance, health, reimbursement; workflow; biomedical technology; prior authorization; Current Procedural Terminology; Healthcare Common Procedure Coding System
Over the past several years, we have seen exciting innovations for the diagnosis and treatment of urologic diseases. This period of innovation does not seem to be slowing down, and urologists have the opportunity to incorporate these new technologies and drugs into treatment protocols for their patients.
Unfortunately, insurance companies and government payers such as Medicare do not develop payment policies for potential treatments or diagnostic options in advance. Instead, payers respond to payment issues as they emerge. This means that urologists must adopt new technologies and drugs and bill for the services, drugs, and supplies before payers have adopted payment policies to cover them.
Urologists have been pioneers and champions for their patients. The adoption of new technology or drugs soon after they are approved by the US Food and Drug Administration (FDA) and before the payer has adopted a payment policy comes with the additional work and risk of nonpayment or underpayment. That risk is accompanied by potential financial reward to offset the costs for early adopters in the form of reimbursements that are higher than those established for the long term. Physicians who take early risks eventually drive coverage and payment policies to make these new options available to the patients who will benefit. Here, we discuss preparation, coding considerations, and protocols to help reduce the risk of adopting new technology.
One of the biggest complaints we have heard is premature use of new technology. For discussion, we define premature use of new technology as an encounter that includes new technology or drugs provided to a patient by a physician without discussion with support staff. In today’s market of declining reimbursement and with the increased expenses associated with new technologies, practices cannot afford the financial costs of a premature launch. Remember the old adage: “Failing to plan is planning to fail.”
Careful planning and coordinated communication are essential in the launch of a new line of business. Therefore, the foundation of adopting any new technology is a coordinated discussion among the leadership team, including clinical and administrative staff. The goal of this discussion is to develop a plan to introduce the new product to patients. The discussion should include consideration of the practice’s current strengths and weaknesses and the team’s ability to use internal and external resources (if available) to optimize clinical and financial success while minimizing disruption and risk.
Ideally this discussion would be followed by the development of a business plan that includes the capabilities of the practice; analysis of the market (competition); analysis of the patients to be treated (target market); effect on the existing service line (enhancement or cannibalization); physician and advanced practice professional understanding of and support for the new product; identification of clinical documentation requirements; coding and coverage, if available; locations of service; projected return on investment (cost vs potential revenue); and an implementation plan. We will not cover the full development of a business plan here but instead will focus on the coding and related operational considerations and rollout.
To begin, the team must determine which Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes will be used to report the services provided and the appropriate International Statistical Classification of Diseases, Tenth Revision (ICD-10) codes supported by published articles and FDA clearance documents (Figure 1). Use coding tools, information from vendors, and payer websites to research appropriate coding. New drugs will probably need to be reported with “unclassified” or “not otherwise classified” codes from the appropriate drug or biologic classification until an appropriate code is released. New technologies or procedures will require the use of a category III CPT code or HCPCS code, if available, or may require the use of an unlisted procedure code from the correct CPT section if no code can be found elsewhere. Consult with known experts and colleagues to verify that this research is accurate. Once they have determined the appropriate coding to report the chosen treatment, the team should begin developing appropriate protocols and responses for each stage of claim submission and integrate them into the plan.
As part of integrating new technology or drugs into a practice, the staff should consider the first several services provided as teaching and learning opportunities. The teaching opportunity is directed at the payer, and the learning opportunity is for the practice. In teaching the payer about the new technology or drug, the practice must pay careful attention to FDA labeling and peer-reviewed articles. The learning opportunity includes communicating systems and protocols to the clinical and administrative staff. To ensure that the payer learns the intended lesson, the practice must track and show positive outcomes for their beneficiaries.
In the development of a rollout for new technology, understanding the payer mix is essential (Figure 2). Medicare, the second-largest source of health care coverage in the United States, is required to pay for services considered medically reasonable and necessary. (The largest source of health care coverage in the United States is Medicaid.) Medicare is also 1 of the few health care coverage entities that does not require prior authorization for its traditional program. Most practices target patients with traditional Medicare as the first patients to receive treatment with any new technology or drug. If Medicare covers the new service, Medicare Advantage plans can then be brought on board. Medicare Advantage plans are administered by the larger commercial plans; therefore, coverage by a Medicare Advantage plan often leads to payment in the commercial markets. If Medicare cannot be targeted initially or if a commercial plan is willing to cover the new technology, the practice must conform to contracts and include protections for the practice with the patient or use other funding options during the initial billing phase.
Preservice work is essential for any services provided by the practice, and new technology is no exception. Eligibility must be confirmed before services are provided to the patient. When eligibility has been verified for insurance companies other than traditional Medicare, prior authorization is often required for new technology or services. Prior authorization is often tricky for category III codes and unlisted codes. Even if the prior authorization is inconclusive or suspicious, the practice should clearly record the attempt and the response from the payer. Prior authorizations should clearly identify category III or unlisted codes that will be used for the service. We recommend pursuing predetermination for high-cost items with known CPT codes and coverage.
For services that are reported with category III codes or unlisted codes or for services with unknown coverage, a predetermination can provide additional information about the patient’s specific plan and benefits. The practice should record this process before providing the service. We have found that insurance companies are slower to respond to predetermination requests; therefore, we use this option for high-cost services, supplies, and drugs. For commercial payers, it is prudent also to review the current contracts related to the use of unlisted or category III codes. As part of the process for integrating new technology, it may be wise to intermittently test predetermination requests rather than pursuing them for every case. Some payers may require additional documentation for the prior authorization or predetermination, in which case the clinical team may need to develop documentation appropriate to the service to be provided.
When the preservice work has been completed and the patient is scheduled for the service, the clinical team must carefully document a complete and descriptive note, including the diagnosis, reason for service, technique, approach, and equipment used (Figure 3):
Drugs. When a drug is administered to the patient, carefully document the drug used, the lot number, the strength and dosage of the drug administered, and any discarded drug amount.
New procedures or technology. It is recommended that if the new technology is included in a procedure that is not described by an existing CPT code (unlisted code required) or is described by a category III code, a summary of the procedure, including the relative time and clinical effort, is compared with that of a procedure that has an established reimbursement. In addition to clear documentation supporting medical necessity for the service, the record should include a clinically justified reason for choosing the new technology or drug over existing treatments.
When the service or drug is reported to the revenue cycle management team, the claim must be entered appropriately before submission. The ICD-10 codes should be double-checked for accuracy. The CPT codes should clearly reflect the service provided:
Billing for any drug will require the use of the appropriately identified HCPCS code and may require a modifier (“-JZ” or “-JW”). In addition, the accurate National Drug Code, dosage administered, and amount discarded must be included on the claim form.
If an unlisted code is used to report the new technology, add a concise description of the service and a comparison service for valuation in the narrative portion of the claim (box 19 of the Health Care Financing Administration 1500 form). The “not otherwise classified” description field should be completed with a short but descriptive explanation of the service provided. If the service is being billed for more than 1 patient, care should be taken to use the same letters and spacing in both the “not otherwise classified” field and the narrative field to educate the payer and speed future payment adjudication.
As part of the planned rollout for a new technology or drug, the team should develop appeal letters and documentation to further educate the payer on the drug or device. Develop a customizable cover letter explaining the medical necessity of the treatment choice and the work efforts involved, with comparatively valued CPT codes, the patient’s condition, peer-reviewed literature, and FDA references. The cover letter must be provided in addition to the clinical report in response to a denial or request for additional information before processing by the payer.
If the claim is denied, as is expected in early stages, it is important to understand the reason for the denial so that the response addresses the payer’s argument. Because payers may respond differently, it may be necessary to adapt response protocols.
Consider building a library of these responses, noting the success or failure of each argument. In some cases, additional actions in the form of peer-topeer review may be necessary in the early stages of payer education. Patience and diligence are needed in both the initiation and the follow-up phase to support the addition of a new technology or drug. Expectations of all involved should be managed, and clear communication between team members will assist in this process. It may be necessary to communicate beyond the team focusing on implementation of the new technology or drug to administrative staff, explaining the progress and processes that may be or are affecting the overall company accounts receivable. Monitor reports noting denial stages and types, timelines, and responses that are successful, and communicate this information to the team.
Consider the following example:
Product. New bladder cancer treatment drug instilled in bladder.
Diagnosis group:– ICD-10 codes: C67.0-C67.9.
Delivery procedure:
– CPT code: 51720 established code with coverage for target disease state.
Coding for new drug:
– HCPCS code for drug not established: J9999, Not otherwise classified, antineoplastic drugs.
Patient population. Current patients under care 800 with Dx C67.X, new treatments per year for recurrent and new diagnoses 200.
Rollout plan. 3-5 patients to be provided with new drug in initial phase, with patient insurance mix determined by individual practice dynamics. All patients will be assigned to same physician and treatment team.
Clinical team. Mock documentation for selection of new drug and medical necessity for inclusion in clinical record for patients. Patients will be chosen by clinical team.
Revenue cycle management considerations:
– Prior authorization team provided with FDA documentation and training on timing and dosage by clinical staff. Will attempt prior authorization with Blue Cross Blue Shield, and recording of responses will be noted.
– Billing team provided with National Coverage Determination and appropriate drug name and dosage.
– Accounts receivable team provided with clear appeal documentation, FDA indications, and supporting documentation from clinical team.
Planned rollout (assuming positive patient clinical response and payment). If Medicare payment is received, expand to additional patients in Medicare and additional patients with Medicare Advantage as identified. Consider rollout to additional team members based on delivery and treatment protocol and patient load.
Once J code is established, retrain team for coding change.
Stick with the general protocol developed in the planning stage, if you are successful. Examine and adjust if you encounter stumbling blocks or failures. Continue to roll out the new technology or drug to other members of the team and your patients, based on the data and the results. Unfortunately, there are no special awards for the pioneers who initiate the payer education that benefits all urologists and their patients. The satisfaction of helping more than just your patients and the higher reimbursements often received before the final development of average sales price plus 6% or the final relative value units may be enough. We all need urology pioneers to continue to advance urology care.
Published: June 23, 2025.
Conflict of Interest Disclosures: M. Painter is a consultant for SRS Medical, Photocure, KLS Martin, Boston Scientific, Medtronic, SonaCare, Soundable Health, Stream Dx, UroGen, Vensica, Fellow, Swan Valley Medical, Bard, Applaud Medical, GenomeDx, IntrinsiQ, Vituro Health, Johnson & Johnson, Pusen, Olympus, Bright Uro, UrynX, Spire Medical, Calyxo, CG Oncology, Minze, and Emmanoflo; he has received honoraria from Laborie. N. Diller reports no conflicts of interest. K. Anderson is a paid speaker for Johnson & Johnson.
Funding/Support: None.
Author Contributions: All authors contributed to writing and editing this article and the decision to submit it for publication.
Data Availability Statement: Sources for this article include CPT and various government publications that are openly accessible. Workflows were created during process development with individual organizations and so are not available.
Acknowledgments: We would like to acknowledge our staff and members of the urology practices across the country who have joined us in our work to provide the latest technology and drugs to patients across the United States.
Citation: Painter M, Diller N, Anderson K. Newly FDA-approved products: coding integration. Rev Urol. 2025;24(2):e119-e124.
Corresponding author: Mark Painter, Managing Partner, PRS Managed Services, LLC, 1333 W 120th Ave, Suite 214, Westminster, CO 80234 (mpainter@prsdata.com)