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Medicare and Stelara
Published January 28, 2020

New Items in the OIG’s Work Plan Updates – November 2019

The Office of Inspector General (OIG) has published the latest additions to its Work Plan. The following is PYA’s insight on Medicare payments for Stelara. Readers should evaluate this and the additional OIG updates and determine how those additions can be incorporated into their organization’s compliance program to help inform their risk assessment, compliance, and/or internal audit work plan.

Medicare Payments for Stelara—CMS

According to the November 2019 OIG Work Plan Update:

Since 2016, total Medicare Part B payments to physicians for Stelara—an expensive drug used to treat certain autoimmune diseases that is often self-injected by patients in their home—have increased substantially. Such a large increase in payments for a drug that would not typically be covered under Part B raises questions about what is driving the growth, including the possibility of improper billing. In this study, OIG will (1) determine whether versions of Stelara that are typically self-injected meet the criteria for Medicare Part B coverage, (2) identify factors that may be causing the substantial growth in payments, and (3) determine whether claims for Stelara show evidence of improper billing by physicians.

What You Need to Know:

According to the Medicare Benefit Policy Manual, Ch. 15 Section 50.2, “The Medicare program provides limited benefits for outpatient drugs. The program covers drugs that are furnished ‘incident to’ a physician’s service, provided that the drugs are not usually self-administered by the patients who take them.”

What You Need to Do:

Stelara medication starts with a one-time intravenous (IV) infusion with maintenance injections every eight weeks thereafter. Initial administration of Stelara must be provided by a medical professional and can be billed through Medicare Part B outpatient services. A determination of whether the patient or capable caregiver can administer the ongoing eight-week treatment regimen at home is at the discretion of the provider. Patients and their caregivers are required to receive training on preparation and injection of Stelara subcutaneously (under the skin). Providers should implement a strong Prescription Drug Monitoring Program (PDMP) based on “best practices” for prescription drug use. They should use their patient database to ensure charges support accurate billing, documentation includes ongoing support and patient education, potential risks for misuse or abuse are identified, and  both treatment progress and intervention’s impact on patient satisfaction and well-being are evaluated.

How PYA Can Help

PYA compliance consultants combine regulatory expertise with practical experience in healthcare organizations. Our compliance subject matter experts will provide a customized approach to assist you and your organization with today’s ever-changing compliance landscape.

If you would like more information about any matter involving compliance, valuation, or strategy and integration, contact one of our PYA executives below at (800) 270-9629.

© 2020 PYA, P.C.

No portion of this article may be used or duplicated by any person or entity for any purpose without the express written permission of PYA.

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