The Latest OIG Updates Might Impact Your Organization: Nursing Homes, Covid-19 Assistance, and More
Emergency Preparedness for Nursing Homes
Emergencies are challenging for the average person to handle. Think of the struggles we deal with when there is an infectious disease outbreak or a natural disaster like a hurricane, earthquake, or wildfire. Now, imagine you are a nursing home patient and probably can’t respond to these types of emergencies by yourself. The fact that a person is in a nursing home, to begin with, probably means they are incredibly vulnerable when it comes to emergencies.
Nursing homes must develop and maintain an emergency preparedness program to address a broad set of issues and emergencies. Such preparedness programs should include maintaining emergency supplies and collaborating with local emergency responders. However, the OIG has stated, “despite these requirements, recent emergencies have exposed weaknesses in nursing home emergency preparedness.”
So, the OIG is planning a study to examine and survey the challenges nursing homes face in preparing for emergencies. Managing resident care during emergencies will be a particular focus area of the study. Another area of focus will include how well nursing homes collaborate with community partners (e.g., other healthcare providers or emergency management agencies). The OIG plans to present its findings in a data brief. They also plan to use a portion of the data collected for developing a new Key Performance Indicator that will track the prevalence and severity of challenges experienced by nursing homes over time.
CDC's COVID-19 Funding to State Departments of Health During 2020 and in response to the COVID pandemic, the U.S. Congress approved five different spending bills related to COVID:
- Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020
- Families First Coronavirus Response Act
- CARES Act (Coronavirus Aid, Relief, and Economic Security Act
- Paycheck Protection Program and Healthcare Enhancement Act
- Coronavirus Response and Relief Supplemental Appropriations Act, 2021
The CDC distributed funds through grants and other agreements to support many important public health activities at the local and state level. According to the OIG, some states received funding three to four times the amount of their average annual distribution from the CDC.
As we all know, audits and reviews often follow the distribution of significant funding, and the OIG had identified potential risk areas related to these types of distributions in prior audits. With this in mind, the OIG plans to determine whether selected State Departments of Health used their CDC COVID-19 funding per award requirements.
Medicare Patients and the Treatment of Opioid Use Disorder
Before COVID-19 came along, there was another significant public health concern in the United States: Opioid Abuse. And just because COVID-19 has taken center stage, it does not mean opioid abuse has automatically declined. In fact, according to the OIG, opioid-related overdose deaths in the U.S. are at an all-time high, with an estimated 76,000 in the 12-month period ending in June 2021. One of the most commonly used medications to treat opioid use disorder is Buprenorphine. It has been shown that this medication decreases illicit opioid use and opioid-related overdose deaths.
But this drug itself has a risk of diversion. One of the safeguards to prevent diversion of buprenorphine includes requiring providers to obtain a waiver through the Substance Abuse and Mental Health Services Administration to prescribe or administer buprenorphine in office-based settings. President Biden’s drug policy includes removing unnecessary barriers to prescribing buprenorphine and identifying opportunities to expand low-barrier treatment services. Of course, it is vital to balance the need to increase access while minimizing diversion. So, the OIG has planned a study to provide insight into the use of buprenorphine among Medicare Part D beneficiaries, including the number who are receiving concerning levels of buprenorphine. The report will also detail providers' prescribing patterns for buprenorphine for these beneficiaries.
Biosimilars and Medicare
The FDA has stated, “In contrast to most drugs that are chemically synthesized and their structure is known, most biologics are complex mixtures that are not easily identified or characterized.” Additionally, biologic drugs are among the most expensive drugs on the U.S. market. According to the OIG, Biosimilar drugs are highly similar and have no clinically meaningful difference from their reference biologics and tend to be less expensive.
And, whenever high-cost/low-cost situations exist in healthcare, the OIG will likely have an interest. And rightfully so. Medicare dollars are a finite resource and should be used wisely. With that in mind, Medicare Part B patients have the potential to spend less on prescription drugs with the increased use of biosimilars rather than their reference biologics, but their use remains low. The OIG has stated that “limited biosimilar use in Part B may be related to how providers are reimbursed for these drugs-currently, providers do not have strong financial incentives to use less expensive biosimilars.”
With that in mind, the OIG is planning a study to describe the use and cost trends of biosimilars and reference biologics covered by Part B over time. The study will also determine how much Medicare and patients paid for biosimilars and reference biologics covered by Part B in 2021 and then compare those costs to determine how much Part B and beneficiaries could have spent with increased use biosimilars or with different reimbursement policies.
Of course, there are many other newly added OIG Work Plan items from February 2022. A conscientious compliance professional will review the items written here and examine the additional items on the work plan. Proactively looking in your organization for similar risks and issues as raised in these work plan items should be part of the mission of your compliance program.
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