Jessica Black, Xcenda

		Despite continued rumblings of uncertainty surrounding the implementation of ICD-10, pharmaceutical manufacturers should continue preparing to reduce the risk for provider claims challenges, payer errors, and other access concerns that could compromise continuity of therapy. While healthcare facilities and physician practices have significant work to do leading up to and after the transition, manufacturers can be a source of information and support around specific disease states to help staff adjust to the new code system.

		ICD-10 coding provides more detailed information that can better support quality reporting and outcomes measurement, and includes coding for new medical procedures. Federal regulations require healthcare providers (HCPs), payers, clearinghouses and billing services to transition to ICD-10 on October 1. The long-anticipated switch to the new system will replace the current coding system, ICD-9, which is 30 years old, includes outdated terms, limits the number of new codes that can be added, and is inconsistent with a number of current medical practices. ICD-9 was created to standardize disease diagnoses for the purposes of healthcare reimbursement, clinical records and epidemiology studies.

		The following simplified example illustrates the changes that could occur in reporting the same encounter for the physician office-based administration of an oncolytic in the treatment of breast cancer.

Scenario 1: Office-based infusion of an oncology therapy for breast cancer

In this example, the 6th digit of the ICD-10 code specifies the right breast of the patient, a detail not represented in the ICD-9 code set. To accurately code the patient’s diagnosis under ICD-10, the coder must be able to review the patient’s chart for the information to make the appropriate code assignment based on laterality. Two other ICD-10 codes would be selected to report a diagnosis of the left breast, or an instance where the laterality was not specified.

		If the administration is performed in the hospital inpatient setting, the coding scenario changes further.

Scenario 2: Hospital inpatient-based infusion of an oncology therapy for breast cancer

In this example, in addition to the same dynamics for the diagnosis code as Scenario 1, the ICD-9 procedure code to report the administration of the drug is a relatively straightforward selection. Under the ICD-10 procedure code set, however, there are many codes that may be appropriate. Again, the coder must carefully review the medical record to identify factors that are not reflected in ICD-9, including approach, body system or region, and type of substance being infused. A keen sense of clinical interpretation based on robust medical documentation is essential to complete claims correctly under ICD-10.

		The switch to the new system presents HCPs, payers and manufacturers with a set of new challenges. If they haven’t already, HCPs and payers need to train staff beyond billers and coders on the transition to ICD-10, update their computer systems, and prepare for potential claims backlogs or delayed reimbursement.

		The ICD-10 contains about 68,000 codes with three to seven characters. There are only 13,000 codes in the ICD-9 set, each three to five characters long. Of course, no single provider will be using all 68,000 new codes when reporting why a patient sought care and how the patient was treated. However, it’s equally important to recognize that all providers will be facing an increase in the number of potentially relevant codes used within their practices. While the increased specificity allows for more information to be conveyed in a code—such as reporting what side of the body or limb is being evaluated&mdash;many in the healthcare industry have voiced concern that there is no simple translation between ICD-9 and ICD-10 diagnosis code sets. There are some one-to-one correspondences, but often a single ICD-9 code can map to a number of ICD-10 codes, or several ICD-9 codes match with one ICD-10 code&mdash;increasing the likelihood of potential miscoding.

		While historically the vast majority of medications have not had their own ICD-9 codes, nor will they have specific medication ICD-10 codes moving forward [1], the implications for drug administration go hand in hand with those of procedures and diagnoses. The increased complexity of the coding system and the intricate mapping from one system to the other elevates the chance for miscoding and subsequent impact on coverage and reimbursement. If needed procedures are held up because of coding issues, there could be an impact and potential delay on patient access to their therapies.

		Payers must ensure they update medical policies to handle the expanded clinical information brought in through the codes. Missing the mark on transitioning from ICD-9 to -10 could mean a backlog of incorrect claims that could compromise continuity of therapy for patients. Providers or payer staff will use valuable time researching causes for denied services and seeking resolution.

		Pharmaceutical, diagnostic and medical device manufacturers can help minimize potential future delays in coverage and reimbursement for their products by offering educational initiatives to providers and payers. Not only will the educational initiatives help providers and payers alike, they could lead to increased positive outcomes by keeping patients connected to vital treatments and services when and where they need them. 

		By taking an active role in preparing for ICD-10 implementation, manufacturers can assist HCPs in minimizing potential reimbursement delays and interruptions in care. To help manufacturers navigate the transitional period, which could last into the second quarter of 2016, Xcenda, a part of AmerisourceBergen, developed a list of action items that manufacturers should follow to prepare for the ICD-10 launch:

			Establish a readiness task force — composed of a diverse group that includes legal, information technology and brand management—as early as possible to identify all key business areas that will be impacted by ICD-10 implementation. The work group will develop a project plan that includes key milestones, as well as an effective communication strategy to ensure all stakeholders are aware of the changes and the implications for their unique day-to-day roles and responsibilities.

			Determine the ICD-10 codes that will be specific for treatments and products, and begin coding assessments to avoid future mishaps. The Centers for Medicare and Medicaid Services or CMS provides bidirectional mapping called General Equivalence Mapping (GEM). It is a crosswalk that maps ICD-9 to ICD-10 codes, and ICD-10 back to ICD-9 codes. Consider using a two-pronged approach that includes GEMs and direct coding to ensure all appropriate codes have been identified.

			Update all reimbursement service materials and components that include ICD-9 coding information, and evaluate the need for additional reimbursement services to address potential patient access and provider reimbursement issues.

			Take advantage of payer websites offering pre- and post-transition information on ICD-10 updates, as well as announcements of any ICD-10 conference calls offered to participating providers and the public. Monitor payer coverage policies to determine whether diagnosis codes appropriately reflect product indications as ICD-10 codes are included in medical criteria for coverage.

			Offer provider education focused on understanding the coding, claims and reimbursement processes relevant to a product, product class or disease state. Also, inform providers about patient assistance/copay assistance program criteria updates, as well as some general information about the ICD-10 transition.

			Consider conducting payer and provider surveys or interviews to gain more insight and determine how to offer any further assistance, especially regarding reimbursement and patient access.

			Update patient assistance and reimbursement systems to capture the new ICD-10 coding to ensure accurate clinical reporting. Meanwhile, start planning for future retrospective studies on claims data by disease to identify any new trends and analyze health outcomes across therapeutic classes and treatment modalities.

		Beyond day-to-day coding and billing, the switch has long-term impacts for how the robust information gathered in the codes can be used by providers and manufacturers. Starting to build bridges between ICD-9 and ICD-10 data in research and clinical trials will save time in the long run and ensure the data is kept viable.

		Without knowledge of both coding sets, providers can’t accurately evaluate trends in outcomes reported both prior to the October deadline and in the years after. Though experts expect a lag in the availability of data, the ICD-10 system will eventually generate more detailed healthcare data, providing insight into patient behavior, risk, outcomes and satisfaction. The greater specificity, federal officials say, makes the system more effective at capturing public health diseases via public health research, reporting and surveillance.

		Though the transition could affect ongoing clinical trials, the switch to the new system—and the increased specificity of ICD-10 codes — could, ultimately, lead to improved clinical trial designs and more insightful retrospective studies to assess outcomes in a defined subset of patients. Manufacturers, payers and providers alike can benefit from a “one-stop” guide or coding aid specific to a manufacturer’s product. Such educational initiatives can alleviate some of the workload inside a practice as the transition begins. As part of their educational initiatives, manufacturers should inform providers about the importance of being familiar with both ICD-9 and ICD-10, in order to make the transition as smooth as possible. 

		In addition, manufacturers should update their patient support programs’ operating procedures and materials like enrollment forms, as well as their data systems, to reflect the switch. They should also consider evaluating the potential need for interim cost share support and patient assistance to prevent any temporary transition-based interruptions in patients’ access to critical therapies. Anticipated hurdles that are not mitigated beforehand, such as miscoding, could lead to a significant disruption for physicians and serious access to care issues for patients.

		It’s critical that manufacturers be sensitive to the burden on already overwhelmed physician practices, while recognizing the opportunity to assume a leading role in educating and assisting providers during the transition. By offering educational initiatives and resources, which could cut down the number of coding mishaps, manufacturers can support patients and providers in mitigating access-to-care problems once the new system goes live. 

[1] A small number of drugs administered predominantly in the hospital inpatient setting have been assigned ICD-9 codes for the purpose of facilitating special payment mechanisms. While ICD-9 and ICD-10 product-specific coding scenarios are uncommon, they are just as complex as more frequently encountered code transition challenges.

	Jessica Black is a director within the Reimbursement Strategy & Tactics discipline at Xcenda, focused on maximizing patient access for medicines. Her experience includes core payer policy and coverage research, analysis, and interpretation across public and private payers. Partnering with Xcenda’s clients, she offers strategic oversight across a wide range of activities, including collaboration in customizing payer segmentation approaches, navigation of changing coding dynamics, and execution of launch plans. Prior experience at AmerisourceBergen Specialty Group (of which Xcenda is a business unit), includes Lash Group, where she managed patient support programs. Before joining AmerisourceBergen Specialty Group, she worked with bilingual children in academic and volunteer settings, taught Spanish in public middle school, and piloted a program for teaching English as a Second Language. Ms. Black has a BS from Georgetown University.

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