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.
 

Despite the United States Supreme Court’s finding that the reduction of Medicare reimbursement rates for 340B outpatient drugs was unlawful, Medicare Advantage organizations (“MAOs”) maintain that they have no similar responsibility to make hospitals whole.  

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 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

The Department of Health and Human Services, Office of Civil Rights (“OCR”) has published a Bulletin which officially states that incorporating certain tracking technologies into websites and mobile applications may cause HIPAA violations that could result in breach notification obligations as well as penalties. This includes platforms and services provided by companies like Meta (formerly Facebook) and Google.

Garfunkel Wild’s Debra Silverman and John Martin will present the webinar “Federal No Surprises Act – One month in. What have we learned? What questions remain?" on February 1, 2022, from 12:00 pm – 1:00 pm (EST).

Garfunkel Wild’s Marianne Monroy, Salvatore Puccio, and Lauren Levine will present the webinar “Handling COVID-19 Employee Vaccinations, Updated Leave Entitlements & Addressing Violations of COVID-19 Protocols” on January 26, 2021.

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 will present the webinar “Practical Aspects for ASCs Reopening” on May 21, 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 Partner/Director Debra A. Silverman and Partner Stacey L. Gulick along with Certified Professional Coder and President of ProCode Compliance Solutions, LLC, Alicia Shickle will present the webinar “COVID-19 Billing for Telemedicine Services and Q&A Session” on March 25, 2020.

Lara Jean Ancona will present at the Greater New York Hospital Association’s (GNYHA) Webinar – Clinical Trial Agreements on January 15, 2020.

Stacey L. Gulick will present at the Nassau County Bar Association’s Hospital & Health Law Committee Meeting on November 7, 2019. 

Stacey Gulick will present at Monroe County Medical Society Webinar Survival Series: HIPAA Webinar on September 26, 2019.

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.