Insights & Resources

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-02) permitting a non-profit organization (Non-Profit) to provide financial support to eligible patients with specific rare diseases through assistance programs (Programs) it operates.

The Health Resources and Services Administration (HRSA) has announced that it will not be accepting Federally Qualified Health Center (FQHC) Look-Alike Initial Designation (LAL-ID) applications for approximately one month starting in late June.  
 

The United States Department of Health and Human Services (HHS), Office of Inspector General (OIG) recently posted a new educational resource on its website about Single Audits.  HHS is the largest grant-making agency in the Federal government, and OIG’s new resource is designed to help key stakeholders understand the scope of Single Audits, as well as improve the overall quality of such audits.

Governor Hochul’s 30-day Amendments to her proposed state fiscal year 2025 Executive Budget would significantly change New York State’s (NYS) Consumer Directed Personal Assistance Program (CDPAP) and what licensed home care services agencies (LHCSAs) can enroll or re-enroll in Medicaid.
 

The New York State Office of the Medicaid Inspector General (OMIG) recently updated its Self-Disclosure Guidance and Frequently Asked Questions (collectively, “Updates”). These Updates give participating providers and entities additional insight into how to report overpayments involving unresponsive Medicaid Managed Care Organizations (MMCOs) or multiple entities, as well as those that are untimely, have adjusted or voided claims, or lost or damaged records. 
 

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (23-11) that allows a medical device manufacturer (Manufacturer) to subsidize Medicare cost-sharing obligations as part of a U.S. Food & Drug Administration (FDA)-approved clinical study involving a Category B Investigational Device Exemption.  

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (23-12) that allows a limited liability partnership (the Partnership) consisting of two classes of physician partners to make a one-time, voluntary redemption offer (offer) to individual partners when they reach age 67.  

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (23-15) permitting a consulting company’s (Consultant) proposal to offer gift cards to its current physician practice customers for referring potential new physician practice customers to Consultant.  Notably, OIG determined that the proposed arrangement did not implicate the Anti-Kickback Statute (AKS). 

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) released a new toolkit to help Medicare Advantage (MA) organizations replicate OIG audit methodologies to detect and correct inaccurate diagnosis codes in their own systems.  

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) recently designated oversight of managed care as a “priority area”, and developed a coordinated strategic plan (the Plan) to better align its audits, evaluations, investigations, and enforcement of managed care. 

The New York State Office of the Medicaid Inspector General (OMIG) released its 2024 work plan in furtherance of its mission to coordinate and conduct activities to prevent, detect and investigate medical assistance program fraud, waste and abuse, and to recover improperly expended Medicaid funds.  

Continuing its year-end reporting blitz, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Semiannual Report (SAR) to Congress on December 1, 2023. 

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted two favorable Advisory Opinions (23-09 and 23-10) to allow a licensed offeror of Medicare Supplemental Health Insurance (Medigap Plan) policies and a preferred health organization (PHO) (collectively, “the requestors”) to incentivize Medigap Plan policyholders to seek inpatient care from a hospital within the PHO’s network.  Notably, OIG issued these favorable opinions even though the proposed incentives implicated the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Civil Money Penalty (CMP), and there was no applicable exception or safe harbor.

This week, the United States Department of Justice (DOJ) and the United States Department of Health and Human Services (HHS) fulfilled its annual statutory obligation by releasing its jointly-authored Health Care Fraud and Abuse Control Program (HCFAC) Report for Fiscal Year 2022.

The OIG fulfilled its annual statutory obligation by releasing its Top Management and Performance Challenges (TMC) document. Providers should take note because the document provides important insight into the specific areas over which HHS (and the OIG) will remain focused.  

On November 6, 2023, the OIG released its General Compliance Program Guidance, the first in a series of new, non-binding reference guides designed to share information with health care compliance professionals and other health care industry stakeholders

In what appears to follow a multi-state trend to protect “temporary” workers, as part of the New York Budget for FY 2023-2024, a new law went into effect that requires any entity that provides temporary staff to health care entities to register with the Department of Health (DOH). 

The U.S. Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration (SAMSHA) is making available grant funding opportunities for community-based behavioral health not-for-profits seeking to form Certified Community Behavioral Health Clinics (CCBHC) and to current CCBHCs looking to enhance or expand their services.

The Small Business Administration (“SBA”) has announced that it intends to issue two questionnaires which will be required to be completed by borrowers of Paycheck Protection Program (“PPP”) loans with principal amounts in excess of two million dollars ($2,000,000.00)

Garfunkel Wild’s Andrew Zwerling, Marianne Monroy, Salvatore Puccio and Lauren Levine will present the webinar “Returning to Work in the COVID-Era: Employee Issues, What to Expect and How to Prepare” on June 12, 2020.

Garfunkel Wild’s Andrew Zwerling, Marianne Monroy, Salvatore Puccio, and Lauren Levine will present the webinar  “An Employer’s Practical Guide To Facing Day-To-Day Coronavirus Challenges” on April 20, 2020.

The Federal Communications Commission (FCC) has issued a new emergency program – the COVID-19 Telehealth Program (Program) – to provide eligible health care providers with funding of up to $1 million to maximize the provision of connected care services (e.g., telehealth) during the pandemic. Following is a brief overview of the Program and its requirements.

Garfunkel Wild’s Andrew Zwerling, Marianne Monroy, Salvatore Puccio, and Lauren Levine will present the webinar  “Navigating A Murky Landscape: An Employer’s Guide To Responding To The Challenges of COVID-19” on March 30, 2020.

Garfunkel Wild Vice Chairman Andrew E. Blustein will present the webinar “Exiting and Entering Contracts in the Age of Coronavirus” on March 24, 2020.

Marianne Monroy and Salvatore Puccio will present at the FCMA’s Webinar – Navigating Sexual Harassment in the Workplace for Managers & Supervisors on May 9, 2019.

Andrew l. Zwerling, Marianne Monroy and Salvatore Puccio will present at the Hudson Valley Annual Institute on April 4, 2019.

In the closing hours of the New York State Legislature (2018), there were two changes enacted to the New York Not-for-Profit Corporation Law.  The analysis below provides an overview of the new legislation.