Expert Insights on December 2024 OIG Work Plan Updates
compliance, medicare, Medicaid, oig work plan, FDA, OIG Work Plan Updates, RPM, OIG Work Plan 2024, Remote Patient Monitoring
Explore these updates to understand the risks, regulatory changes, and the potential implications for compliance in these areas of healthcare oversight.
Risks of Improper Medicaid Provider Enrollment
Before the COVID-19 Public Health Emergency (PHE), HHS OIG issued a report outlining concerns with the Medicaid provider enrollment process. Provider enrollment is the gateway to billing the Medicaid program. If this gateway is not adequately safeguarded, Medicaid is at risk of fraud, waste, and abuse. The OIG concluded that many states were not ensuring that all high-risk Medicaid providers were properly undergoing criminal background checks (see the report here).
During the PHE, many requirements were loosened, and it became much easier to enroll as a provider in Medicaid. This ease of enrollment can be abused by those purporting to be providers.
In December 2024, the OIG added a Work Plan item that would revisit this issue. According to the OIG, Federal law requires state Medicaid agencies to screen providers as part of the Medicaid enrollment process. For high-risk provider types, including durable medical equipment, prosthetics, and orthotics suppliers and home health agencies, required screening activities include site visits and fingerprint-based criminal background checks.
This newly announced Work Plan study will determine the status of states' required Medicaid provider enrollment and screening and will assess states' standards and processes for screening.
Remote Patient Monitoring (RPM)
Remote patient monitoring (RPM) typically involves the collection of patient physiological data that is used to develop and manage care related to a chronic and/or acute health illness or condition. One example includes sensors that monitor temperature in a patient's extremities. Such monitoring may help prevent diabetic ulcers that can lead to amputations. RPM has the potential to improve patient health and delivery of care in many different scenarios. But the OIG feels these services warrant additional oversight.
About 13 months ago, the OIG issued a Consumer Fraud Alert related to remote patient monitoring. As a part of the alert, the OIG stated that unscrupulous companies were signing up Medicare enrollees for remote monitoring services, regardless of medical necessity. One enforcement action by the U.S. Department of Justice last year resulted in an organization paying $14.7 million to resolve allegations that they were submitting claims to federal health care programs for a higher level of remote cardiac monitoring than physicians had intended to order or that was medically necessary, thus inflating the level of reimbursement.
This newly added December 2024 Work Plan item revisits some of the OIG concerns with remote patient monitoring. OIG states that, since 2018, the way that providers bill for certain Medicare Part B RPM services has changed significantly, and Medicare payments for those services have increased dramatically. They plan to determine whether providers furnished and billed for RPM services in accordance with Medicare requirements.
FDA Employees’ Conflicts of Interest
The FDA’s responsibilities include protecting the public’s health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, and by ensuring the safety of the nation's food supply, cosmetics, and products that emit radiation. FDA employees engaged in this important effort need to be as free from bias and improper influence as much as possible.
FDA workers are subject to the Standards of Ethical Conduct for Employees of the Executive Branch. FDA employees are also subject to additional requirements to assure that FDA's business is conducted effectively, objectively, and without improper influence or the appearance of improper influence.
The purpose of the OIG adding this item to their Work Plan is to determine whether FDA's ethics program complied with Federal requirements to prevent, identify, and resolve potential conflicts of interest.
Conclusion
The December 2024 OIG Work Plan updates highlight critical areas for improving oversight and compliance, including Medicaid provider enrollment, remote patient monitoring, and FDA ethics. These updates emphasize the importance of proactive measures to address potential risks and ensure adherence to regulatory standards.
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