Garfunkel Wild's health care law attorneys have been assisting physicians and physician practice groups establish and grow their medical practices, as well as navigate them through the complex health care regulatory environment for over 40 years. Whether drafting internal corporate documents, assisting with their everyday contract needs, providing vigorous defense against audits or investigations, addressing complicated regulatory issues, carefully handling transactions such as mergers, acquisitions, and other capital transactions, or assisting practice owners in preparing their wills and asset protection, Garfunkel Wild provides our physician clients with all the services they need to thrive and be profitable in a constantly changing legal environment.
Garfunkel Wild's 11th Annual ASC and Health Care Management Virtual Symposium is dedicated to the most important business, legal, clinical, and operational issues facing the ASC and health care management community.
On October 18, 2024, the New York State Department of Health issued guidance pausing implementation of Public Health Law §18-c, a new law that prohibits providers from obtaining a patient’s consent to pay for any health care service prior to the patient receiving the service.
The U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) released a Report outlining concerns about the rapid growth of and significant oversight gaps in the Centers for Medicare & Medicaid’s (“CMS”) use of remote patient monitoring (“RPM”) services, particularly with traditional Medicare patients (the “Report”). Given RPM’s dramatic growth, especially since the COVID-19 pandemic, the Report likely foreshadows OIG enforcement actions in this area.
NYS Public Health Law 18-c, a new law set to become effective on October 20, 2024, will prohibit providers from obtaining a patient’s consent to pay for any health care services prior to the patient receiving services.
The U.S. Department of Health and Human Services, Office of Inspector General (the “OIG”) posted an unfavorable Advisory Opinion (24-08) prohibiting a Corporation offering Medicare Advantage (“MA”), MA-Prescription Drug (“PD”), and MA/MA-PD Employer Group Waiver Plans (“EGWPs”) from sharing a percentage of its savings with its covered groups via a gainshare payment (“Payment”).
The cybersecurity attack on Change Healthcare (“Change”), a subsidiary of the UnitedHealth Group, has caused widespread disruption, impacting health care providers and individuals whose personal data was compromised. This breach has led to numerous class action lawsuits, divided into two main groups: providers affected by the claims processing shutdown and individuals whose data was leaked. In June 2024, approximately 50 lawsuits were centralized into a Multi-District Litigation (MDL) in federal court in Minnesota. On September 17, 2024, the first conference in the matter occurred. As the litigation progresses, motions to dismiss, potential mediation, and class certification are expected to shape the case.
The Federal Departments of Treasury, Labor, and Health and Human Services released final rules strengthening consumer protections for patients seeking mental health and substance use disorder treatments. Despite 15 years since the enactment of the Mental Health Parity and Addiction Equity Act (MHPAEA), barriers still exist, preventing individuals from receiving adequate coverage for these issues.
OIG posted a partially favorable Advisory Opinion (24-05) permitting a biotechnology company to provide transportation, lodging, and payment of associated expenses for certain patients receiving gene therapy treatments for two severe genetic diseases. In the same Advisory Opinion, however, OIG responded unfavorably to the Company’s proposal to subsidize some or all costs related to fertility preservation and storage procedures for these same patients.
The OIG's trend of ensuring access to care in compelling circumstances continued with a recent opinion allowing a pharmaceutical affiliate to refund, waive, or delay payment for a drug treating a rare, fatal pediatric immunodeficiency disorder.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-03) permitting a pharmaceutical manufacturer (Manufacturer) to provide financial assistance to qualified patients undergoing its gene therapy treatment for two severe genetic conditions.
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) released its revamped Semiannual Report (SAR) on June 3, 2024. The SAR’s new format focuses on the oversight work OIG completed during the reporting period, and emphasizes how this work directly addresses the Top Management Challenges Facing HHS.
On May 15, 2024, the New York State Department of Health (DOH) announced a pivotal change in its regulations, as it intends to permit health care providers to use telemedicine to conduct patient evaluations before prescribing controlled substances. Prior to the COVID-19 pandemic, DOH required health care providers to perform an initial in-person physical evaluation of patients before prescribing controlled substances.
Garfunkel’s Compliance Webinar Series rolls on with an examination of the 2024 Work Plan published by the New York State Office of Medicaid Inspector General (OMIG).
The recently enacted New York State (NYS) budget for fiscal year 2025 significantly changed who can be a Fiscal Intermediary (FI) under the state’s Consumer Directed Personal Assistance Program (CDPAP). This change was made by amendment to Social Services Law (SSL) § 365-f by eliminating the CDPAP request for offers (RFO) process that was in place for designating FIs (RFO #20039).
On Tuesday, April 23, 2024, the Federal Trade Commission (FTC) promulgated a final rule banning most non-compete agreements, in any industry, and is set to become effective 120 days after its publication in the Federal Register (the “Final Rule”).
On April 16, 2024, the Supreme Court of New Jersey issued its decision in Comprehensive Neurosurgical, P.C. v. The Valley Hospital. In an over 60-page unanimous opinion, the Court vacated a 23.4 million dollar award against Valley Hospital.
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.
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.
As we have noted in a previous Garfunkel Wild alert, the Department of Health and Human Services (“DHHS”) Office of Civil Rights (‘OCR”) published guidance regarding the use of tracking technologies (i.e., technologies that collect and analyze information about how users interact with websites and mobile applications).
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.
In the last few months of 2023, there has been a flurry of legal activity pertaining to the use, disclosure, and protection of health information. Here is a summary of the latest legal initiatives impacting New York providers.
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 January 1, 2022, the Federal No Surprises Act (NSA) went into effect to protect patients from surprise bills for out-of-network services but the law’s impact on physicians has been significant. Join us as we walk you through what you need to know about the NSA.
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
On October 13, 2023, the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) posted Advisory Opinion 23-07, a favorable opinion regarding an employer’s proposal to pay bonuses to its employed physicians based on net profits derived from certain outpatient surgical procedures the employed physicians perform at the employer’s two planned ambulatory surgery centers (ASCs).
In Advisory Opinion No. 23-06, the U.S. Department of Health and Human Services’ Office of the Inspector General (OIG) declined to approve a proposed arrangement in which an anatomic pathology laboratory operator would purchase the technical component of anatomic pathology services from Physician and Non-Physician Laboratories for commercial payors.
Garfunkel Wild's 10th Annual ASC and Health Care Management Virtual Symposium is dedicated to the most important business, legal, clinical, and operational issues facing the ASC and health care management community.
On August 14, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a request for applications for the Making Care Primary (MCP) Model, its newest innovation program aimed at improving patient care by supporting the delivery of advanced primary care services
Join Garfunkel Wild’s Jeffry Adest, Emily Schwerd, and Jenny Brown as they discuss the OSV process, highlight the areas HRSA reviewers consider, and impart meaningful tips on how FQHCs can be in compliance.
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).
On July 21, 2023, the Executive Director of the Connecticut Office of Health Strategy (“OHS”), sent a letter to Connecticut physicians reminding them of the requirement for certain practice transactions to obtain Certificate of Need (“CON”) approval prior to closing.
Effective July 1, 2023, Connecticut modifies its law governing physician covenants not to compete and extends non-compete protections to advanced practice registered nurses (“APRNs”) and physician assistants (“PAs”). Physicians, APRNs, PAs, and their employers will need to evaluate current non-competition provisions and revise, as needed, to comply with the new law.
On June 5, 2023, the Centers for Medicare and Medicaid Services (“CMS”) published a much anticipated Final Rule surrounding vaccination and related requirements surrounding the COVID-19 Public Health Emergency.
The final budget for fiscal year 2023-2024 passed this week by the New York State legislature requires certain health care entities to pre-notify the Department of Health (the “Department”) of “material transactions” that meet certain financial thresholds.
Garfunkel Wild’s Barry B. Cepelewicz and Andrew L. Zwerling will present at Fairfield County Medical Association’s Webinar “The FTC’S Proposed Ban on Non-Competes: What Does It Mean?” on April 20, 2023.
Governor Phil Murphy signed an Executive Order lifting COVID-19 testing requirements for health care and congregate care settings. This Executive Order took effect April 3, 2023.
Garfunkel Wild Partner Salvatore Puccio and Partner Lauren Levine will present at the National Business Institute Live Online Seminar - How to Bring New York Employee Handbooks Into Compliance on March 8, 2023.
Garfunkel Wild’s Susan L. St. John will present the Webinar “Florida Telehealth – What Florida and Non-Florida Practitioners Need to Know” on February 28, 2023 from 12:00 PM - 1:00 PM ET.
Garfunkel Wild's Health Care Information and Technology Practice Group's Podcast Series "Health Information Technology Podcast- Termination and Transition Periods".
Garfunkel Health Advisors Alicia Shickle, Simon Chaykler, and Garfunkel Wild’s Robert A. Del Giorno will present the webinar ”Major Changes to E/M Coding and Documentation Requirements in 2023 – Will You Be Ready? on November 8 and 9, 2022.
On October 3, 2022, the Department of Justice (“DOJ”) announced that a hematology and oncology practice in Fort Lauderdale, Florida will pay $130,000 to settle allegations that the practice violated the False Claims Act and Anti-Kickback statute by accepting illegal kickbacks from its pharmaceutical distributor.
Garfunkel Wild continues to increase its Health Care practice and lawyer recognition in Chambers USA 2023 annual rankings of the foremost law firms and lawyers in the country.
