In January 2021, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) added several new items to its work plan. The OIG work plan sets forth various projects including OIG audits and evaluations that are underway or planned to be addressed during the fiscal year and…
Wachler & Associates Health Law Blog
MDHHS Partners with Wayne State University and Wayne Health to Expand Mobile COVID-19 Testing
On February 3, 2021, the Michigan Department of Health and Human Services (MDHHS) announced it will expand mobile COVID-19 testing and other public health services in partnership with Wayne State University (WSU) and Wayne Health (WH). The partnership between MDHHS, WSU, and WH began in September 2020 and is an…
A Primer on Medicare Targeted Probe and Educate Reviews
Targeted Probe and Educate (TPE) reviews are a popular audit tool for Medicare Administrative Contractors (MACs) to assess a healthcare provider or supplier’s compliance with Medicare billing requirements. A TPE review consists of up to three rounds of claims review, with education to the provider after each round. A provider…
CMS Codifies Definition of “Reasonable and Necessary” in Medicare Coverage Determinations
On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a final rule codifying a definition for “reasonable and necessary” coverage under Medicare Part A and Part B. CMS hopes codifying the meaning of “reasonable and necessary” will provide clarity and consistency to the current process of…
Uncertainty Surrounding CARES Act Reimbursement for Out-of-Network COVID-19 Testing
In response to the COVID-19 pandemic, Congress has attempted to make COVID-19 testing free to individuals by requiring commercial insurers to cover testing. However, federal guidance and action by commercial insurers have muddied the waters and left clinical laboratories in an unenviable position. The Families First Coronavirus Response Act (FFCRA),…
HHS Updates PRF Reporting Requirements
On January 15, 2021, the Department of Health and Human Services (HHS) released further updates on the reporting requirements for entities that received payments from the Provider Relief Fund (PRF). HHS also pushed back the opening of the PRF reporting portal. The PRF is a $175 billion fund created by…
CMS Implements New Prior Authorization Changes
On January 15, 2021, the Centers for Medicare & Medicaid Services (CMS) finalized the agency’s “CMS Interoperability and Prior Authorization” rule to improve the prior authorization process and give patients more control in accessing and understanding their health data. Under the rule, certain payers, such as Medicaid and CHIP managed…
CMS Finalizes Changes to Medicare Advantage and Part D Prescription Drug Programs
On January 15, 2021, the Centers for Medicare & Medicaid Services (CMS) finalized a rule to help strengthen and streamline the Medicare Advantage and Part D prescription drug programs, with the goal to decrease enrollee cost sharing on expensive prescription drugs. Effective for the 2022 plan year, enrollees will be…
HHS Increases Fairness and Notice in Civil and Administrative Proceedings
On January 12, 2021, the Department of Health and Human Services (HHS) issued sweeping new directives regarding the procedures the Department will follow when relying on guidance documents, initiating enforcement actions, making jurisdictional determinations, and allowing prior notice and opportunity to be heard on agency determinations. These directives apply to…
OCR and HHS Issue Guidance on Health Information Exchanges
On December 18, 2020, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) issued new guidance on the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The guidance addresses important questions related to the definition of a health information exchange (HIE), when…