OIG targets off-label use of Medicare Part B drugs

April 19, 2013

In this third and final installment, Robert A. Dowling, MD, explore additional details of the OIG’s 2013 work plan and provide practical tips and resources for managing any risks associated with the activities of the OIG.

A growing concern of many health care providers is an increasingly complex regulatory environment, and a common approach is to “know enough just to stay out of trouble.” Urologists are at risk for financial penalties or worse if they do not keep current in this regard. In a series of three articles, I examine the Office of the Inspector General (OIG), explain its relevance to urologists and their practice, and provide practical tips to understand and manage any risks associated with the activities of this institution. In this third and final installment, I explore additional details of the OIG’s 2013 work plan and provide practical tips and resources for managing any risks associated with the activities of the OIG.

As I noted in the first and second installments in this series, the OIG telegraphs its areas of focus and attention each year in its “Work Plan,” providing an opportunity to do a risk assessment for your practice. (To view the fiscal year 2013 work plan, see https://oig.hhs.gov/reports-and-publications/archives/workplan/2013/Work-Plan-2013.pdf.) Part two of this series examined some of these areas of focus that might affect a urology practice, its physicians, and patients; here are some others.

Off-label use of Medicare Part B drugs. Medications administered in a urology office-sometimes called “buy and bill”-are reimbursed by Medicare Part B as long as they are approved by the FDA for the specific indication or are prescribed in accordance with indications supported in one of three Medicare-approved drug compendia. Urologists are frequently using new and expensive medications that have very narrow indications (certain prostate cancer drugs, for example), and considering new indications-not yet approved by the FDA-for existing drugs.

While the off-label use of medications is a common and generally accepted practice, the Centers for Medicare & Medicaid Services has very strict rules for reimbursement under those circumstances, and the OIG apparently intends to scrutinize Part B prescription drug reimbursement. Urologists may wish to audit their own practice to determine if their use of Medicare Part B Drugs could be considered “off label” and thus not qualify for reimbursement.

Payment for outpatient drugs and their administration. In a related area, the OIG has identified reimbursement for Medicare Part B drugs-like leuprolide for prostate cancer-as another error-prone area they will investigate. They specifically mention number of units billed for chemotherapy as “vulnerable to incorrect coding.” Many urology practices have instituted processes and audits of those processes to be sure they are not missing billing for these expensive drugs; the same processes can be leveraged to audit the accuracy of all such claims.

Also, the OIG has indicated that it will “compare Medicare and Medicaid payments for commonly used physician-administered drugs and biologicals to determine whether changes in the reimbursement methodologies for the Part B drug program would result in significant savings.” While Medicare Part B typically reimburses a physician the average sales price plus 6% based on the Social Security Act, states have more latitude under the Medicaid program to determine reimbursement-and the OIG is apparently investigating the impact of moving toward a Medicaid-like model for physician-administered drugs.

Finally, the OIG has indicated that it will study the impact of rescinding the least costly alternative (LCA) policies for some prostate cancer drugs covered under Part B and how utilization of those drugs may have changed after the LCA policies were rescinded in April 2010. (This is a new area of focus for the OIG.) Many large urology practices have successfully and appropriately negotiated volume discounts when purchasing luteinizing-hormone-releasing hormone agonist or antagonist drugs for their prostate cancer patients, sometimes resulting in shifting patients from one drug to another therapeutically equivalent treatment. The OIG is interested in learning more about utilization of these drugs, which are covered under Medicare Part B and in aggregate can result in large reimbursements to urologists. Urologists should carefully audit their Medicare fee schedules with attention to these codes, recognize that payment policies for expensive and high-volume therapies are on the radar, and audit their practice for claims accuracy.

Evaluation and management services. The Center for Public Integrity and others have clearly documented a trend toward increased utilization of higher paying E&M codes, and some have connected this to the adoption of electronic health records. EHRs certainly make it easier to document and support higher level codes, and many worry that EHR adoption may have contributed to inappropriate billing (“Feds to crack down on Medicare upcoding,” Urology Times Nov. 2012, page 56). The OIG too is interested, and has indicated it will review “multiple E&M services for the same providers and beneficiaries to identify EHR documentation practices associated with potentially inappropriate payments” (2010 claims).

The copy forward or copy/paste functionality has captured the attention of the OIG as well: “Medicare Contractors have noted an increased frequency of medical records with identical documentation across services.” The copy forward tool, when used appropriately, helps providers create meaningful and complete medical records efficiently; when used carelessly, it can create a risk management issue or, worse, a patient safety issue. (For a good discussion of this, see American Medical News’ article, “EHRs: ‘Sloppy and paste’ endures despite patient safety risk, ” http://www.ama-assn.org/amednews/2013/02/04/prl20204.htm). When used to inappropriately inflate the level of E&M code-for example, a physical exam or review of systems-it may create a financial or even criminal risk. Urologists can mitigate this risk by limiting their use of the copy forward functionality, always editing any content brought forward to create contemporary and accurate information, and reviewing their notes carefully for documentation of medical necessity.

Managers in large practices may wish to review their EHR policies, templates, and other administrative tools to be sure default content is appropriate, permissions are in place, and audits are available. Ideally, an EHR system administrator could conduct an appraisal of the utilization, and thus the risk, of copy forward activity, upcoding, and downcoding in the practice.

Bottom line: Our nation’s largest health care insurer-the federal government-has put in place people and processes to monitor the integrity of the federal health care program. Urologists should be familiar with the rules and the areas of focus and scrutiny of oversight agencies like the OIG, analyze the relevance/risk to their own practice, and where appropriate take steps to mitigate or remediate any potential problems.UT