Deeper Than the Headlines: June OIG Work Plan Additions

In June 2019, we saw more than the average number of additions to the OIG Work Plan. There were a total of 8 new items added. Here are few of the additions most likely to impact all of you:

Opioid Use in Medicare Part D in 2018

The opioid crisis remains a public health emergency. In 2017, 47,600 opioid-related overdose deaths occurred in the United States. Identifying patients who are at risk of overdose or abuse is key to addressing this crisis. This data brief will provide 2018 data on Part D spending for opioids, as well as on beneficiaries who received extreme amounts of opioids through Part D and those who appeared to be doctor shopping. It will also provide data on prescribers who ordered opioids for large numbers of these beneficiaries.  These data briefs are very useful for compliance programs as they go about setting standards and using data to identify areas of risk.

Review of Medicare Part B Claims for Intravitreal Injections of Eylea and Lucentis

Medicare Part B covers ophthalmology services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Ophthalmology services include intravitreal injections of Eylea and Lucentis to treat eye diseases such as wet age-related macular degeneration. Medicare pays for an intravitreal injection (which is considered a minor surgery) as part of a global surgical package that includes the preoperative, intraoperative, and postoperative services routinely performed by the physician.

Medicare pays for Eylea and Lucentis separately from the intravitreal injection. Chapter 12, section 40.1 of the Centers for Medicare & Medicaid Services' Medicare Claims Processing Manual states that separate payment can be made for other services provided by the same physician on the same day as the global surgery if the services are significant and separately identifiable or unrelated to the surgery. OIG will review claims for intravitreal injections of Eylea and/or Lucentis and the other services billed on the same day as the injection, including evaluation and management services, to determine whether the services were reasonable and necessary and met Medicare requirements.

Opioid Use in Medicare Part D in Missouri

Drug overdose deaths are at epidemic levels, and the opioid crisis is a public health emergency. In 2017, there were 47,600 opioid-related overdose deaths in the United States. A total of 952 of these deaths occurred in Missouri. Identifying beneficiaries who are at risk of overdose or abuse is key to addressing this crisis. This data brief will provide information on opioid use in Medicare Part D in Missouri in 2018, including data on beneficiaries who received opioids and data on beneficiaries who may be at serious risk of opioid misuse or overdose.

Review of the Food and Drug Administration's Foreign Drug Inspection Process

The Food and Drug Administration (FDA) is responsible for overseeing the safety and effectiveness of all drugs marketed in the United States. However, FDA's oversight of the nation's drug supply chain has become increasingly complicated because many drugs used in the U.S. are manufactured overseas. FDA estimates that nearly 40 percent of finished drugs and approximately 80 percent of active pharmaceutical ingredients are manufactured in registered establishments in more than 150 countries. To ensure that drugs are manufactured in compliance with current good manufacturing practice regulations, FDA conducts inspections of foreign facilities that manufacture drugs for the U.S. market. At the end of an inspection, observations are made and a determination of whether any condition or practice violates Federal requirements. FDA may take additional actions to ensure that the violations are corrected. In May 2017, FDA began implementing major programmatic changes to enhance its ability to protect public health. FDA's major programmatic changes included a structural realignment of its Office of Regulatory Affairs (ORA) and an agreement between FDA's Center for Drug Evaluation and Research and ORA that aligns and coordinates FDA's field professionals who conduct inspections and it's review staff who evaluate drug products. Recently, Congress raised concerns about the safety of certain drugs manufactured overseas and the challenges that the FDA faces with its foreign drug inspection process. OIG’s review will determine whether recent programmatic changes have improved FDA's foreign drug inspection process.

Overturned Denials in Medicaid Managed Care

Managed care organizations (MCOs) contract with State Medicaid agencies to provide beneficiaries with Medicaid services. MCOs must cover services in at least the same amount, duration, and scope that would be covered under Medicaid fee-for-service. However, capitated payment models in managed care may create an incentive for MCOs to inappropriately limit or deny access to covered services to increase profits. OIG will review the extent to which selected MCOs' denied services and payments were overturned upon appeal. They will also review any concerns about the selected MCOs' performance related to denials and appeals that were identified through State oversight and monitoring efforts. Make sure you keep an eye on the results of these work plan items if your organization is involved in these kinds of services.

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