When a Medicare provider or supplier’s Medicare billing privileges are revoked, commonly called a Medicare revocation, the provider or supplier must ask the following questions: Why? When? Will there be collateral consequences? What are the appeal rights? Why? Federal regulations provide 22 distinct reasons that the Centers for Medicare &…
Wachler & Associates Health Law Blog
False Claims Settlements Illustrate Compliance Challenges for Clinical Labs
Two recent settlements illustrate some of the compliance challenges facing clinical laboratories that perform urine drug testing (UDT). Both settlements involve a clinical laboratory resolving allegations that the lab violated the False Claims Act (FCA). In the first case, the Department of Justice (DOJ) alleged that the lab performed and…
HHS Proposes to Repeal Rules that Limit Its Authority
The Department of Health and Human Services (HHS) recently proposed to repeal two rules implemented under the Trump Administration to moderate the power of the agency. The rules HHS seeks to repeal are the Good Guidance Rule and the Civil Enforcement Rule. Public comments on the proposal are due by…
OIG Updates Work Plan For October 2021
The Department of Health and Human Services (HHS) Office of Inspector General (OIG) included several new items in its work plan update in October 2021. The OIG work plan outlines the projects that OIG plans to implement over the foreseeable future. Such projects typically include OIG audits and evaluations. Below…
UnitedHealth to Repay Providers Shortchanged for COVID Vaccine Administration
UnitedHealth Group has agreed to reprocess the entirety of its commercial claims related to COVID-19 vaccine administration. The move comes after federal investigators concluded that UnitedHealth, as the nation’s largest insurer, paid “millions” of providers 40% less than the Medicare rate for vaccinating patients. According to a letter from the…
Appealing a Medicare Audit
Your practice, agency, or business has been audited by Medicare and now Medicare has stopped paying your claims or is claiming that you owe significant funds that must be repaid to Medicaid. These difficult circumstances can lead to many questions. Who performed the audit? Why are they denying claims or…
HHS Restores Rulemaking Authority to FDA
The Department of Health and Human Services (HHS) recently issued a notice restoring the rulemaking authority of the Food and Drug Administration (FDA). Under the Trump Administration, HHS had issued a memorandum, in September 2020, which required that all rules promulgated from the department’s agencies and offices would need to…
State Relaxes Licensing Requirements to Address Healthcare Worker Shortage
In response to the mounting nationwide shortage of healthcare workers, one state will allow certain healthcare workers to practice solely on out-of-state licenses. This move may signal similar actions by other states and could have wide-ranging implications for the delivery of healthcare services. During the height of the COVID-19 pandemic,…
OCR Settles Twentieth HIPAA Right of Access Initiative Investigation
On September 10, 2021, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced the resolution of its twentieth investigation under its HIPAA Right of Access Initiative. In early 2019, OCR stated that they would create an initiative to enforce patients’ right of…
OCR Issues Guidance on HIPAA, COVID-19 Vaccinations, and the Workplace
On September 30, 2021, the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) issued guidance to help consumers, businesses, and healthcare entities understand when the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule applies to disclosures and requests for information about an individual’s…