Stay Vigilant: Get the Scoop on the OIG Work Plan For August

The HHS OIG continues to add items to its Work Plan. If you want to work smarter, not harder, look at what’s on the OIG’s radar. Here are some of the recently added items:

Audit of Emergency Department E/M Services

Evaluation and Management (E/M) services are some of physicians’ most frequently reported CPT^® (Current Procedural Terminology) codes. This includes emergency room physicians. Certain CPT^® codes should only be used when a beneficiary is seen in an emergency department, and the services described by the CPT^® definition are provided. For example, just because a patient is seen in an emergency room does not mean the condition is life-threatening. If the condition were life-threatening, it might warrant a higher level of the medical necessity of the report CPT^® code. Medicare reimburses physicians based on a patient's documented needs at the time of a visit. All E/M services reported to Medicare must be adequately documented so that medical necessity is evident. In this Work Plan item, the OIG plans to determine whether Medicare payments to providers for emergency department E/M services were appropriate, medically necessary, and paid following Medicare requirements.

Audit of Opioid-Use-Disorder Treatment Services

In recent years most of us have heard of the terrible opioid abuse epidemic throughout the country. The Medicare program attempts to help with solutions by paying for certain treatment services of opioid-use disorders (OUDs).  These services include medication-assisted treatment, which is used to treat substance use disorders, including OUDs; sustain recovery, and prevent overdoses. There are primarily three medications used to treat OUDs: buprenorphine, methadone, and naltrexone. Treatment for OUDs is not limited to one setting. Instead, it is provided in several settings, including freestanding opioid treatment programs (OTPs).

Historically, OTPs could not enroll as providers in Medicare or be paid for services provided to Medicare beneficiaries. However, the SUPPORT Act established a new Medicare Part B benefit for OUD treatment services furnished by OTPs. CMS implemented this benefit beginning January 1, 2020, as required by the SUPPORT Act. OUD treatment services include FDA-approved treatment medication, medication dispensing and administration, substance use counseling, individual and group therapy, and toxicology testing. The OIG plans to audit this area and will focus on claims for OUD treatment services provided by nonresidential (i.e., freestanding) OTPs, identified with the place-of-service code 58. The OIG will review OUD treatment services for Medicare beneficiaries in nonresidential OTPs to determine whether the services were allowable under Medicare requirements.

Data Snapshot for Telehealth Services

The use of telehealth has skyrocketed recently, primarily due to the COVID-19 pandemic. When an increase in the need for telehealth was evident, the federal government responded by expanding access to telehealth for a wide range of services. This expansion enhanced the ability of health care providers to offer care to Medicare beneficiaries remotely during the COVID-19 pandemic. During the expansion, HHS used its enforcement discretion to relax the requirement that a beneficiary has an established relationship with a provider to receive certain telehealth services.

The OIG plans to provide a data snapshot to describe the extent to which Medicare beneficiaries had established relationships with providers from whom they received telehealth services. The OIG will also look for any differences in these relationships between traditional Medicare and Medicare Advantage and among the different types of telehealth services.

Review of the FDA's Accelerated Approval Pathway

The FDA has an accelerated pathway to approve certain drugs when the drugs may treat serious conditions. The drugs fill an unmet medical need based on a surrogate endpoint, which is a marker to predict a clinical benefit.

The FDA recently approved Aduhelm (aducanumab) to treat patients with Alzheimer's disease using this accelerated approval pathway. But this recent approval of Aduhelm raised some concerns due to alleged scientific disputes within the FDA, the advisory committee's vote against approval, allegations of an inappropriately close relationship between the FDA and the industry, and the FDA's use of the accelerated approval pathway.

Because of these concerns, the OIG plans to assess how the FDA implements the accelerated approval pathway. According to the OIG, this will include reviewing interactions between the FDA and outside parties and other aspects of the process, such as deciding on this pathway and scientific disputes. OIG will review relevant policies and procedures, determine compliance with them, and make appropriate findings and recommendations based on a sample of drugs approved using the accelerated approval pathway, which will include Aduhelm. However, the OIG will not assess the scientific appropriateness of the FDA's approval of any of the drugs under review.

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