Rachel Lamparelli on Department of Health and Human Services (HHS)

OIG’s Advisory Opinion No. 25-08: Negative Opinion Highlights Potential Broad Reach of AKS

In a relatively rare move, the US Department of Health and Human Services Office of Inspector General (OIG) recently issued an unfavorable Advisory Opinion (No. 25-08) (Opinion) reinforcing the agency’s expansive view of the...more

8/1/2025 / Advisory Opinions , Anti-Kickback Statute , Department of Health and Human Services (HHS) , Fraud and Abuse , Health Care Providers , Manufacturers , Medical Devices , OIG , Regulatory Oversight

340B Under the Microscope: Key Trends and Takeaways for 2025

The 340B Drug Pricing Program (the Program) has long been a cornerstone for healthcare providers seeking to deliver affordable care to underserved communities. However, as the regulatory and compliance landscape evolves,...more

6/11/2025 / Department of Health and Human Services (HHS) , Drug Pricing , Hospitals , Pharmaceutical Industry , Pharmacies , Section 340B , State Legislatures

Bipartisan Drug Pricing Reform: The FPDP Act and Revival of Most-Favored-Nation Pricing

As part of a broader resurgence in pharmaceutical pricing reform and manufacturing policies in 2025, President Donald Trump and bipartisan congressional leaders have introduced contemporaneous proposals to lower prescription...more

5/21/2025 / Department of Health and Human Services (HHS) , Drug Pricing , Executive Orders , Medicaid , Medicare , Most-Favored Nations , Pharmaceutical Industry , Prescription Drugs , Proposed Legislation , Trump Administration

District Court Affirms Louisianas Protection of 340B Contract Pharmacy Arrangements

340B litigation remains full speed ahead. Manufacturer and covered entity (CE) disputes, not all of which are being actively litigated, include, but are not limited to, federal and state regulation of contract pharmacies,...more

10/21/2024 / Covered Entities , Department of Health and Human Services (HHS) , Drug Pricing , Medicaid , Pharmaceutical Industry , Pharmacies , Prescription Drugs , Section 340B

CMS Increases Hospice Scrutiny through Provider Enrollment and Oversight Tools

The US Centers for Medicare & Medicaid Services (CMS) has implemented a final rule, effective November 13, 2023, designed to enhance the oversight of hospice providers throughout the United States and increase regulatory...more

11/6/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Health Care Providers , Medicare , Physicians

OIG Rejects the Formation and Operation of Surgeon-Owned IONM Businesses

The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently evaluated the risks associated with certain intraoperative neuromonitoring (IONM) services arrangements in its release of...more

8/30/2023 / Ambulatory Surgery Centers , Anti-Kickback Statute , Department of Health and Human Services (HHS) , Health Care Providers , Hospitals , OIG

How the End of the PHE Will Impact the Healthcare Industry

The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more

5/11/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Life Sciences , Medicare , OCR , Public Health Emergency , Telehealth

Fraud Scheme Alert for Healthcare Providers: Bogus Nursing Degrees Sold to Thousands

The US Department of Justice and Department of Health and Human Services Office of Inspector General have identified a wire fraud scheme to sell false and fraudulent nursing degree diplomas and transcripts. Coined as...more

2/6/2023 / Department of Health and Human Services (HHS) , Department of Justice (DOJ) , Health Care Providers , OIG , Wire Fraud

OIG Lauds UPIC Program and Recommends Expansion, Additional Targeting of Medicaid Providers

On October 3, the Office of Inspector General (OIG) of the US Department of Health and Human Services issued a report titled “UPICs Hold Promise to Enhance Program Integrity Across Medicare and Medicaid, But Challenges...more

10/14/2022 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Health Care Providers , Medicaid , Medicare , OIG

Rachel Lamparelli

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