December 2022 Updates to the OIG Work Plan
Reporting of Monetary Donations in Research
Over the last several years, the medical research community has seen many high-profile announcements about researchers resigning or being fired over not properly disclosing financial interests, especially those related to foreign influence (see https://ashpublications.org/ashclinicalnews/news/5168/54-Scientists-Lose-Jobs-After-NIH-Investigation).
In addition to enforcement actions, Congress has been considering several bills designed to protect the integrity of medical research funded by the federal government, typically through the National Institutes of Health (NIH).Some examples include the following:
- “Fix Nondisclosure of Influence in Health Research Act”
- “Protecting the Integrity of our Biomedical Research Act”
- “Protect America’s Biomedical Research Enterprise Act”
One scrutinized area is the reporting of “Other Support” associated with certain federal grants. Many research institutions have policies and procedures for reporting “Other Support,” such as:
The institutions that receive NIH funding play an important role in compliance with the regulations to protect the integrity and security of U.S. research. One crucial way is identifying investigators’ “Other Support” (including all resources made available to an investigator in support of and/or related to all their research endeavors) and reporting this information to NIH during the grant award process.
When organizations fail to comply with these rules, it is difficult for the NIH to perform their oversight activity.
According to the U.S. Department of Health and Human Services Office of Inspector General (OIG), when an investigator receives a monetary donation with no expectation of anything in return (e.g., time commitment, services, specific research activities), NIH considers it a gift and does not require recipient institutions to report it as “Other Support.” But there is not specific guidance from the NIH to institutions on how specific or explicit the donor's expectation must be for such funds to be considered “Other Support” and not a gift.
With this in mind, the OIG plans to identify how recipient institutions determine whether monetary donations supporting investigators' research are gifts or “Other Support.” They are also going to determine the value of monetary donations that supported investigators' research in FY 2022.
All research compliance professionals should review these updates and start identifying any necessary proactive steps in their organization.
Opioid Treatment Programs
Any compliance professional who reviews OIG or Department of Justice (DOJ) press releases knows that enforcement related to the national opioid epidemic is alive and well. Of course, there are a lot of different components related to wrongdoing associated with opioids.
There are many efforts underway to help those with addictions. In the context of opioids, patients are often treated for opioid use disorder (OUD) and certain medications are used to assist in recovery and prevention of overdoses.
The U.S. Food and Drug Administration (FDA) has approved three medications to treat OUD:
Treating OUD can be done in many different settings, including freestanding opioid treatment programs (OTPs).
Part of the “Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” (SUPPORT Act) created a new benefit in the Medicare Part B program for treating OUD in OTPs.
This benefit began on January 1, 2020 and is paid using certain payment bundles. According to the regulations, OUD treatment services include:
- FDA-approved treatment medication
- Dispensing and administration of treatment medication
- Substance use counseling
- Individual and group therapy
- Toxicology testing
Other items and services that HHS considers to be appropriate
The OIG plans to review OUD treatment services reimbursed under the bundle payments for Medicare beneficiaries. They will determine the types, delivery methods (in-person or via telehealth), and frequency of OUD treatment services provided by OTPs.
OIG also plans to compare the bundled payments for OUD treatment services with the reimbursement amount of the actual OUD treatment services if the services were not part of the bundled payment. And lastly, of course, the OIG plans to examine whether these services complied with certain Medicare requirements.
Rebates for Part B Drugs
Past OIG work suggested Medicare Part B could realize significant savings if a rebate program from drug manufacturers existed in Medicare Part B like the Medicaid drug rebate program. In one specific report, OIG estimated Medicare Part B could have collected over $3 billion in rebates in one year if such a program had existed. In another report, OIG suggested similar savings if an inflation-indexed rebate program existed.
Since the time of those reports, Congress passed the Inflation Reduction Act of 2022. This legislation mandates that the Centers for Medicare & Medicaid Services (CMS) collect rebates from drug manufacturers for certain Part B drugs if prices increase faster than inflation. These requirements begin in the first quarter of 2023, so CMS will need to move quickly to follow the requirements of this law.
Because OIG has done prior work in this area, including the identification of potential implementation issues to establishing rebates for Part B drugs, OIG designed this Work Plan item to summarize their previous insights to help CMS implement the cost-saving program. These steps will significantly affect the pharmaceutical industry.
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