Barry B. Cepelewicz M.D. Esq.
Partner/Director
203-316-0483
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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.
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Post-Shutdown Telehealth Guidance
As we explained in our previous client alert, at the time the government shutdown ended, it was unclear whether Medicare telehealth services provided during that time (October 1 through November 12, 2025) would be reimbursed. CMS has since issued updated guidance.
NEW TELEHEALTH UPDATE: Medicare Waivers Extended to January 30, 2026
Congress has once again temporarily extended key Medicare telehealth flexibilities, this time through January 30, 2026.
FTC Continues to Focus on Non-Competes in Health Care: A Timely Reminder for Connecticut Providers
In press releases on September 4 & 5, 2025, the Federal Trade Commission (FTC) announced that it would no longer pursue appeals to the cases that blocked its nationwide ban on employee non-competes. While this move was expected with the change of administration, the FTC was quick to stress that it is not backing away from the issue of non-competes.
OIG Allows Grants to Offset Therapy Costs
Access to and the cost of health care for children with complex medical needs is a significant burden for many families. Grants can serve as an important lifeline that allows families to obtain and afford medically necessary and appropriate care for their children. The U.S. Department of Health and Human Services, Office of Inspector General’s (OIG) favorable advisory opinion (25-10) is another positive step towards ensuring that children with special medical needs receive timely and affordable care.
OIG Scrutinizes Remote Patient Monitoring
As remote patient monitoring (RPM) continues to grow in popularity, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) is keeping close watch on how providers are billing, coding, and documenting these services.
2026 Proposed Fee Schedule Changes
Each year, the Centers for Medicare & Medicaid Services’ issuance of its proposed rule for the Medicare Physician Fee Schedule creates potentially significant changes to PFS payments and Part B in particular. The impact of these proposed changes can be widespread and complex, and it is important to understand how these changes may affect you or your practice.
OIG Approves Physician Ownership of Device Company
In an increasingly competitive environment, many physicians seek creative ways to grow their personal brands, their practices, and their revenue. One common vehicle for achieving these goals involves physician-owned entities that derive revenue from selling, or arranging for the sale of, medical devices that the physician-owners order and use in procedures they perform at hospitals. Although OIG has long-standing concerns about such arrangements, OIG recently issued a favorable advisory opinion (25-09) regarding a proposed arrangement involving physicians with an ownership interest in a medical device company.
New 340B Rebate Model Pilot Program—What Covered Entities Need to Know
On August 1, 2025, the Health Resources and Services Administration issued a new pilot initiative under the 340B Drug Pricing Program that may significantly reshape longstanding pricing and discount frameworks. The 340B Rebate Model Pilot Program will allow participating drug manufacturers to offer post-sale, rebates to eligible 340B Covered Entities for select drugs, rather than providing upfront discounts.
New York Mental Hygiene Laws Modified
As part of Governor Kathy Hochul’s commitment “to transform the mental health care system (in New York) over the next several years,” the state has enacted new legislation and allotted $160 million dollars towards increasing the number of in-patient psychiatric beds in New York.
Health Care Providers Sued Over Web Tracking Tools
Health care providers and other entities are increasingly facing class action lawsuits over the use of tracking technologies on their websites—particularly pixels that transmit user data to platforms like Meta and Google. One such case recently settled for $6.75 million. These lawsuits often catch providers off guard, as they stem from routine, widely used website configurations.
OIG Rejects Flat Fee Business Arrangement
OIG issued an unfavorable opinion (25-08) in which a medical device company proposed to pay a third-party vendor a yearly flat fee to access Vendor’s electronic billing portal.
OIG Approves Free Lab Tests
An essential component of patient care hinges on a provider’s ability to accurately and efficiently diagnose diseases and prescribe effective treatments. The U.S. Department of Health and Human Services, Office of Inspector General’s (OIG) favorable advisory opinion (25-07) facilitates a provider’s ability to do just that.
Vendor Warranty Gets OIG Approval
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) approved a medical device manufacturer’s proposed arrangement to reimburse pharmacies, hospitals, clinics, and laboratories up to $2,500 for the actual costs of certain services related to needlestick injuries. OIG’s favorable Advisory Opinion (25-05) found that the Arrangement implicates the Federal Anti-Kickback Statute, but that it is protected by the regulatory safe harbor for warranties.
New CMS Model Targets Skin Substitutes
Traditionally, the Centers for Medicare & Medicaid Services (CMS) has relied on a “pay and chase” approach to recover monies CMS believes it may have paid to providers erroneously. CMS relies on this approach not only for collecting routine overpayments, but also when it believes evidence of fraud, waste, or abuse exists. More recently, CMS has used this approach to target providers who render medically reasonable and necessary services to patients in certain areas that CMS deems to be vulnerable to fraud such as skin and tissue substitutes, among others.
Cap on NJ Ambulatory Care Facility Assessment Lifted
Ambulatory care facilities in New Jersey are currently subject to an annual “assessment” by the Department of Health equal to approximately 3% of gross revenue, not to exceed $350,000 annually per facility. However, the recently enacted Healthcare Finance Enhancement Act reduces the assessment rate to 2.5% but also removes the $350,000 cap starting in Fiscal Year 2026.
Surgical Practices Are Now Subject to NJ Ambulatory Care Facility Assessment
Governor Murphy recently signed the Fiscal Year 2026 Budget into law, simultaneously with numerous other bills, including the “Healthcare Finance Enhancement Act”. The Act subjects surgical practices that are required to become licensed as ASCs to the “ambulatory care facility assessment” starting in Fiscal Year 2026.
Ruling: No Surprises Act Does Not Stop Out-of-Network Providers from Suing Insurance Companies
On June 20, 2025, the United States District Court for the Southern District of New York issued an Opinion and Order finding, among other things, that the Federal No Surprises Act (NSA) does not automatically prevent health care providers from suing insurance companies when the insurer fails to pay for their services.
OIG Rejects Payments for Exclusion Screenings
OIG recently rejected a medical device company’s (Company) novel proposal to pay a third-party (Screener) to perform exclusion screenings of the Company for the Company’s customers. OIG’s unfavorable Advisory Opinion (25-04) determined that this proposed arrangement (Arrangement) implicates the Federal Anti-Kickback Statute and raises concerns about inappropriate steering and anti-competitiveness.
RICO Lawsuit Related to Workers’ Compensation Claims Dismissed
Over the past several months, Roosevelt Road Re, Ltd. and Tradesman Program Managers, LLC have filed multiple lawsuits alleging a RICO scheme in which various law firms and medical providers purportedly directed workers to stage worksite injuries and undergo unnecessary medical procedures to inflate the value of workers’ compensation claims.
OIG Approves Telehealth Arrangement for Leased Employees
The U.S. Department of Health and Human Services, Office of Inspector General (OIG), recently issued a favorable Advisory Opinion (25-03) regarding a proposed arrangement (Arrangement) where a non-clinical management support organization and an affiliated professional corporation wholly owned by physician shareholders (PC) enters into lease agreements with telehealth platforms (Platforms) and providers employed by or contracted with these Platforms (Platform Providers).
Legal Considerations: Setting Up Your Practice
Garfunkel Wild’s Barry B. Cepelewicz and Elisabeth Pimentel will present “Legal Considerations: Setting Up Your Practice” at the Fairfield County Medical Association's (FCMA) event "Physicians: How to Start a Concierge Practice or Side Gig" on June 8, 2025.
New Regulations for Maryland Assisted Living Programs
The Maryland Department of Health’s (DOH) Office of Health Care Quality (OHCQ) recently announced revisions to the regulations that govern Assisted Living Programs (ALPs).
OIG Report Identifies Emerging Priorities
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) recently released its Semiannual Report (SAR) covering the period October 1, 2024 to March 31, 2025. The SAR is a must-read because it identifies a wide array of risk areas, which will undoubtedly help providers modify their own risk assessments and audit work plans to stay ahead of government regulators in the ongoing fight against fraud, waste, and abuse.
A New Look for DOJ White Collar Enforcement
The U.S. Department of Justice, Criminal Division (DOJ) recently and unexpectedly announced changes to the manner in which it handles criminal investigations and prosecutions of white-collar and corporate cases. These changes are aimed at clarifying DOJ’s criminal enforcement priorities, increasing the efficiency with which cases are investigated and resolved, and emphasizing the benefits of voluntarily self-disclosing potential misconduct. They also signal a more business-friendly approach than in the past, and will be undoubtedly welcomed by corporations and executives alike.
CMS Expands Medicare Advantage Audits – Providers Be Wary
On May 21, 2025, Centers for Medicare & Medicaid Services (CMS) announced it will immediately expand its audits of Medicare Advantage (MA) plans to verify that the MA plans only submit accurate diagnoses for its enrollees. Although CMS directs these audits toward the MA plans, they inevitably impact providers.
NY DOH Publishes Form for Reporting of Material Health Care Transactions
This month, the New York Department of Health (DOH) published a Material Transactions Notice Form for “heath care entities” to report “material transactions” to DOH.
Connecticut Court Holds Providers Can Sue to Enforce NSA IDR Awards
On May 14, 2025, Judge Michael P. Shea of the Connecticut District Court soundly rejected the Texas NSA decision, and held that “the NSA creates a private cause of action to enforce IDR awards.”
CMS Extends SNF Revalidation Deadline
The Centers for Medicare & Medicaid Services (CMS) extended the previous deadline of May 1, 2025 to August 1, 2025, for skilled nursing facilities (SNFs) to provide ownership and management information as well as information about other parties with which the SNFs are associated and the ownership structures of those parties.
Starting the Patient Journey: Essential Documentation for Treatment and Payment
Garfunkel Wild's Stacey L. Gulick, Kathleen M. Brown, and Alison T. Schimel will present the webinar "Starting the Patient Journey: Essential Documentation for Treatment and Payment" on April 16, 2025, from 12:00 PM - 1:00 PM ET.
NY DOH Publishes FAQs Regarding Reporting of Health Care Transactions
In March, the New York Department of Health (DOH) published “frequently asked questions” (FAQs) related to the law that requires “health care entities” party to a “material transaction” to report the transaction to the DOH in advance.
New Telehealth Update: Medicare Waivers Extended To September 30, 2025
Congress has once again extended certain telehealth flexibilities until September 30, 2025 (which coincides with the end of the Congressional fiscal year).
OIG Approves Certification of Heavy Assistance Program
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (25-01) allowing a Pharmaceutical Company (Company) to provide free access to its U.S. Food and Drug Administration (FDA)-approved product (Product) for eligible patients with mild cognitive impairment or disease-related dementia and related symptoms.
Another Win for Patient Assistant Programs
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-13) allowing a pharmaceutical manufacturer (Manufacturer) to provide transportation, lodging, meal vouchers, and other authorized expenses to eligible patients receiving Manufacturer’s one-time, potentially curative treatment product (Product).
OIG Opinion is a Win for Patients
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-12) allowing a pharmaceutical manufacturer (Manufacturer) to sponsor a genetic testing, genetic counseling, and disease-state awareness education program for certain eligible patients with an “ultra-rare” genetic condition that causes kidney stones.
OIG Greenlights Free Vaccine Program
The U.S. Department of Health and Human Services, Office of Inspector General (OIG), posted a favorable Advisory Opinion (24-11) allowing a pharmaceutical manufacturer (Manufacturer) to provide free meningococcal vaccinations to eligible patients, including Federal health care program enrollees who receive Manufacturer’s U.S. Food and Drug Administration (FDA)-approved products that treat rare disorders.
OIG Gives Discount Program Favorable Treatment
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-10) allowing the expansion of an existing loyalty program offered by a medical and dental supply distributor (Company) to its member customers (Customers), while cautioning that “discount” programs are typically high risk.
New York Proposes More Scrutiny for Health Care Transactions
On January 21, 2025, New York Governor Kathy Hochul released the proposed FY 2026 New York State Executive Budget, which includes enhanced scrutiny of material transactions involving health care entities.
Second Circuit Adopts “One Purpose” Test
The United States Court of Appeals for the Second Circuit (Second Circuit or Court), which has Federal jurisdiction in Connecticut, New York, and Vermont, recently issued an important decision regarding health care provider liability under the False Claims Act (FCA) when a whistleblower alleges a violation of the Anti-Kickback Statute (AKS). The Second Circuit explicitly adopted the “one purpose” test for the first time to determine whether a financial arrangement between a provider and a referral source violates the AKS, and thus potentially subjects the parties to substantial fines and penalties under the FCA.
New DOJ Report: Providers Beware
Last week, the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) released its annual, jointly authored Health Care Fraud and Abuse Control Program Report (the Report) for Fiscal Year 2023.
New OIG Priorities Emerge in Report
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) released its Semiannual Report (SAR) to Congress on December 4, 2024.
OIG Highlights New Concerns
This week, the U.S. Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) fulfilled its annual statutory obligation by releasing its 2024 Top Management and Performance Challenges Report (the “Report”). Historically, the Report has not attracted widespread interest in the provider community because it largely focuses on HHS operational challenges. Importantly for providers and other stakeholders, however, the Report reveals crucial insights about compliance priorities for the year ahead.
DEA Extends Telemedicine Prescription Rules Through 2025
The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) have jointly issued a third emergency extension allowing health care practitioners to prescribe Schedule II-V controlled substances via audio-video telemedicine encounters without an initial in-person evaluation. This extension, effective from January 1, 2025 through December 31, 2025, also provides the DEA with additional time to finalize permanent regulations for prescribing controlled substances through telemedicine.
11th Annual ASC and Health Care Management Symposium
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.
NYS Department of Health Pauses Implementing New Patient Consent Requirements
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.
New York Enacts Alarming Patient Consent Requirements
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.
OIG Nixes Medicare Advantage Gainsharing Payments
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”).
Update on Change Healthcare Class Action Litigation
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.
Curalta Foot + Ankle‘s 2nd Annual Management and Educational Conference
Garfunkel Wild will be a sponsor at Curalta Foot + Ankle‘s 2nd Annual Management and Educational Conference.
Federal Rule Released to Address Mental Health Coverage Parity
This week, the Federal Departments of Treasury, Labor, and Health and Human Services (the Departments) released final rules strengthening consumer protections for patients seeking mental health and substance use disorder treatments.
OIG Approves Patient Travel, but Not Fertility Services
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.
OIG Approves Drug Refund and Discount Program
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.
OIG Greenlights Gene Therapy Assistance Program
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.
OIG Report Highlights Enforcement Priorities
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.
Telehealth Update: NY Proposes Controlled Substance Prescribing, Waiting on DEA
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.
Be Prepared! NYS OMIG’s 2024 Work Plan Provides an Audit Roadmap for Health Care Providers of All Types
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).
NY Upends CDPAP Fiscal Intermediary Framework
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).
FTC Bans Non-Competes Across the Nation
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”).
NJ Supreme Court Vacates $23.4M Award Against Valley Hospital
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.
OIG Allows Patient Assistance Programs Funded by Drug Manufacturers
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.
FQHC Look-Alike Application Blackout Period: Changes are Coming
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.
OIG Issues New Resource for Single Audits
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.
Chemed’s 6th Annual Medicine & Ethics Conference
Garfunkel Wild sponsored the 6th Annual CHEMED Medicine & Ethics Conference, February 15-18, 2024.
New York OMIG Updates Self-Disclosure Guidance
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.
OMIG’s 2024 Work Plan Gives Critical Insights into Program Integrity Initiatives
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.
OIG’s Newest Strategic Plan Prioritizes Managed Care Oversight
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.
OIG Issues Toolkit for Medicare Advantage Organizations
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.
OIG Approves Use of Gift Cards for Referrals in Certification-Heavy Advisory Opinion
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).
OIG Approves Creative Approach to Restructuring Medical Practice Partnerships
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.
Favorable OIG Advisory Opinion Allows Subsidies for FDA-Approved Clinical Studies
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.
OIG’s Favorable Advisory Opinions Allow Incentives to Medigap Plan Policyholders
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.
More Provider “Nuggets” From OIG’s Year-End Reporting Blitz
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.
Updates on Tracking Technologies and Information Blocking
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).
DOJ/HHS Jointly Release “Highlight Reel” Report
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.
Flurry of Activity Around Patient Information Impacting New York Providers
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.
OIG Provides Roadmap to Hot-Button Issues
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.
The Federal No Surprises Act – Its Impact on Florida Physicians
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.
OIG Releases New General Compliance Program Reference Guide
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
Favorable Employee Bonus Opinion on ASC Profits
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).
OIG Finds Lab to Lab Technical Component Arrangement Poses Anti-Kickback Risk
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.
10th Annual ASC and Health Care Management Symposium
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.
New York State Society of Orthopaedic Surgeons 2023 Annual Meeting & Symposium
Garfunkel Wild's Barry Cepelewicz, M.D., will present at the New York State Society of Orthopaedic Surgeons 2023 Annual Meeting & Symposium.
CMS Releases Updated Request for Applications for New Making Care Primary Model
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
FQHC Lessons Learned from the Field: Tips to Avoid OSV Non-Compliance
Join Garfunkel Wild’s attorneys as they discuss the OSV process, highlight the areas HRSA reviewers consider, and impart meaningful tips on how FQHCs can be in compliance.
Temporary Health Care Staffing Agencies Now Required to Register in New York
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).
Connecticut Signals Increased Scrutiny of Physician Practice Acquisitions
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.
Connecticut Modifies Physician Non-Compete Law, Extends Protections to APRNs and PAs
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.
CMS Issues Final Rule Ending COVID-19 Vaccination Requirements
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.
New York Enacts Notice Requirement for Health Care Transactions
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.
Fairfield County Medical Association Webinar – The FTC’S Proposed Ban on Non-Competes: What Does It Mean?
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.
New Jersey Lifts COVID-19 Testing Requirements in Health Care and Congregate Care Settings
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.
National Business Institute Live Online Seminar – How to Bring New York Employee Handbooks Into Compliance
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.
Florida Telehealth – What Florida and Non-Florida Practitioners Need to Know
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.
Chemed’s 5th Annual Medicine & Ethics Conference
Garfunkel Wild will present at the 5th Annual CHEMED Medicine & Ethics Conference, February 16-19, 2023.
Health Information Technology Podcast – Termination and Transition Periods
Garfunkel Wild's Health Care Information and Technology Practice Group's Podcast Series "Health Information Technology Podcast- Termination and Transition Periods".
Garfunkel Wild and Garfunkel Health Advisors Complimentary Webinar – Major Changes to E/M Coding and Documentation Requirements in 2023 – Will You Be Ready?
Garfunkel Health Advisors 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.
Protect Your Medical License: Use Certified Coders to Help Ward Off Licensure Sanctions
There has been a steady trend of increased scrutiny by governmental agencies responsible for investigating complaints against physicians and for prosecuting acts of professional misconduct by physicians, including the coding and billing practices of physicians. All practitioners should be aware that billing improprieties may constitute a form of professional misconduct that such agencies may rely […]
Properly Address Billing and Overpayment Issues: Use Billing and Documentation Experts to Ensure Payer Rules are Being Followed
It is not at all unusual for health care providers to discover potential billing and overpayment issues in the course of their day-to-day operations. Such issues may arise in any number of ways. For instance, they may be identified as the result of a provider’s internal compliance efforts, including compliance program audits or reviews, or […]
Florida Medical Practice Pays Hefty Price for Alleged Kickback Payments From Pharmaceutical Distributor
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 Health Care Rankings in 2023 Edition of Chambers USA
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.
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.
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Post-Shutdown Telehealth Guidance
As we explained in our previous client alert, at the time the government shutdown ended, it was unclear whether Medicare telehealth services provided during that time (October 1 through November 12, 2025) would be reimbursed. CMS has since issued updated guidance.
NEW TELEHEALTH UPDATE: Medicare Waivers Extended to January 30, 2026
Congress has once again temporarily extended key Medicare telehealth flexibilities, this time through January 30, 2026.
FTC Continues to Focus on Non-Competes in Health Care: A Timely Reminder for Connecticut Providers
In press releases on September 4 & 5, 2025, the Federal Trade Commission (FTC) announced that it would no longer pursue appeals to the cases that blocked its nationwide ban on employee non-competes. While this move was expected with the change of administration, the FTC was quick to stress that it is not backing away from the issue of non-competes.
OIG Allows Grants to Offset Therapy Costs
Access to and the cost of health care for children with complex medical needs is a significant burden for many families. Grants can serve as an important lifeline that allows families to obtain and afford medically necessary and appropriate care for their children. The U.S. Department of Health and Human Services, Office of Inspector General’s (OIG) favorable advisory opinion (25-10) is another positive step towards ensuring that children with special medical needs receive timely and affordable care.
OIG Scrutinizes Remote Patient Monitoring
As remote patient monitoring (RPM) continues to grow in popularity, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) is keeping close watch on how providers are billing, coding, and documenting these services.
2026 Proposed Fee Schedule Changes
Each year, the Centers for Medicare & Medicaid Services’ issuance of its proposed rule for the Medicare Physician Fee Schedule creates potentially significant changes to PFS payments and Part B in particular. The impact of these proposed changes can be widespread and complex, and it is important to understand how these changes may affect you or your practice.
OIG Approves Physician Ownership of Device Company
In an increasingly competitive environment, many physicians seek creative ways to grow their personal brands, their practices, and their revenue. One common vehicle for achieving these goals involves physician-owned entities that derive revenue from selling, or arranging for the sale of, medical devices that the physician-owners order and use in procedures they perform at hospitals. Although OIG has long-standing concerns about such arrangements, OIG recently issued a favorable advisory opinion (25-09) regarding a proposed arrangement involving physicians with an ownership interest in a medical device company.
New 340B Rebate Model Pilot Program—What Covered Entities Need to Know
On August 1, 2025, the Health Resources and Services Administration issued a new pilot initiative under the 340B Drug Pricing Program that may significantly reshape longstanding pricing and discount frameworks. The 340B Rebate Model Pilot Program will allow participating drug manufacturers to offer post-sale, rebates to eligible 340B Covered Entities for select drugs, rather than providing upfront discounts.
New York Mental Hygiene Laws Modified
As part of Governor Kathy Hochul’s commitment “to transform the mental health care system (in New York) over the next several years,” the state has enacted new legislation and allotted $160 million dollars towards increasing the number of in-patient psychiatric beds in New York.
Health Care Providers Sued Over Web Tracking Tools
Health care providers and other entities are increasingly facing class action lawsuits over the use of tracking technologies on their websites—particularly pixels that transmit user data to platforms like Meta and Google. One such case recently settled for $6.75 million. These lawsuits often catch providers off guard, as they stem from routine, widely used website configurations.
OIG Rejects Flat Fee Business Arrangement
OIG issued an unfavorable opinion (25-08) in which a medical device company proposed to pay a third-party vendor a yearly flat fee to access Vendor’s electronic billing portal.
OIG Approves Free Lab Tests
An essential component of patient care hinges on a provider’s ability to accurately and efficiently diagnose diseases and prescribe effective treatments. The U.S. Department of Health and Human Services, Office of Inspector General’s (OIG) favorable advisory opinion (25-07) facilitates a provider’s ability to do just that.
Vendor Warranty Gets OIG Approval
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) approved a medical device manufacturer’s proposed arrangement to reimburse pharmacies, hospitals, clinics, and laboratories up to $2,500 for the actual costs of certain services related to needlestick injuries. OIG’s favorable Advisory Opinion (25-05) found that the Arrangement implicates the Federal Anti-Kickback Statute, but that it is protected by the regulatory safe harbor for warranties.
New CMS Model Targets Skin Substitutes
Traditionally, the Centers for Medicare & Medicaid Services (CMS) has relied on a “pay and chase” approach to recover monies CMS believes it may have paid to providers erroneously. CMS relies on this approach not only for collecting routine overpayments, but also when it believes evidence of fraud, waste, or abuse exists. More recently, CMS has used this approach to target providers who render medically reasonable and necessary services to patients in certain areas that CMS deems to be vulnerable to fraud such as skin and tissue substitutes, among others.
Cap on NJ Ambulatory Care Facility Assessment Lifted
Ambulatory care facilities in New Jersey are currently subject to an annual “assessment” by the Department of Health equal to approximately 3% of gross revenue, not to exceed $350,000 annually per facility. However, the recently enacted Healthcare Finance Enhancement Act reduces the assessment rate to 2.5% but also removes the $350,000 cap starting in Fiscal Year 2026.
Surgical Practices Are Now Subject to NJ Ambulatory Care Facility Assessment
Governor Murphy recently signed the Fiscal Year 2026 Budget into law, simultaneously with numerous other bills, including the “Healthcare Finance Enhancement Act”. The Act subjects surgical practices that are required to become licensed as ASCs to the “ambulatory care facility assessment” starting in Fiscal Year 2026.
Ruling: No Surprises Act Does Not Stop Out-of-Network Providers from Suing Insurance Companies
On June 20, 2025, the United States District Court for the Southern District of New York issued an Opinion and Order finding, among other things, that the Federal No Surprises Act (NSA) does not automatically prevent health care providers from suing insurance companies when the insurer fails to pay for their services.
OIG Rejects Payments for Exclusion Screenings
OIG recently rejected a medical device company’s (Company) novel proposal to pay a third-party (Screener) to perform exclusion screenings of the Company for the Company’s customers. OIG’s unfavorable Advisory Opinion (25-04) determined that this proposed arrangement (Arrangement) implicates the Federal Anti-Kickback Statute and raises concerns about inappropriate steering and anti-competitiveness.
RICO Lawsuit Related to Workers’ Compensation Claims Dismissed
Over the past several months, Roosevelt Road Re, Ltd. and Tradesman Program Managers, LLC have filed multiple lawsuits alleging a RICO scheme in which various law firms and medical providers purportedly directed workers to stage worksite injuries and undergo unnecessary medical procedures to inflate the value of workers’ compensation claims.
OIG Approves Telehealth Arrangement for Leased Employees
The U.S. Department of Health and Human Services, Office of Inspector General (OIG), recently issued a favorable Advisory Opinion (25-03) regarding a proposed arrangement (Arrangement) where a non-clinical management support organization and an affiliated professional corporation wholly owned by physician shareholders (PC) enters into lease agreements with telehealth platforms (Platforms) and providers employed by or contracted with these Platforms (Platform Providers).
Legal Considerations: Setting Up Your Practice
Garfunkel Wild’s Barry B. Cepelewicz and Elisabeth Pimentel will present “Legal Considerations: Setting Up Your Practice” at the Fairfield County Medical Association's (FCMA) event "Physicians: How to Start a Concierge Practice or Side Gig" on June 8, 2025.
New Regulations for Maryland Assisted Living Programs
The Maryland Department of Health’s (DOH) Office of Health Care Quality (OHCQ) recently announced revisions to the regulations that govern Assisted Living Programs (ALPs).
OIG Report Identifies Emerging Priorities
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) recently released its Semiannual Report (SAR) covering the period October 1, 2024 to March 31, 2025. The SAR is a must-read because it identifies a wide array of risk areas, which will undoubtedly help providers modify their own risk assessments and audit work plans to stay ahead of government regulators in the ongoing fight against fraud, waste, and abuse.
A New Look for DOJ White Collar Enforcement
The U.S. Department of Justice, Criminal Division (DOJ) recently and unexpectedly announced changes to the manner in which it handles criminal investigations and prosecutions of white-collar and corporate cases. These changes are aimed at clarifying DOJ’s criminal enforcement priorities, increasing the efficiency with which cases are investigated and resolved, and emphasizing the benefits of voluntarily self-disclosing potential misconduct. They also signal a more business-friendly approach than in the past, and will be undoubtedly welcomed by corporations and executives alike.
CMS Expands Medicare Advantage Audits – Providers Be Wary
On May 21, 2025, Centers for Medicare & Medicaid Services (CMS) announced it will immediately expand its audits of Medicare Advantage (MA) plans to verify that the MA plans only submit accurate diagnoses for its enrollees. Although CMS directs these audits toward the MA plans, they inevitably impact providers.
NY DOH Publishes Form for Reporting of Material Health Care Transactions
This month, the New York Department of Health (DOH) published a Material Transactions Notice Form for “heath care entities” to report “material transactions” to DOH.
Connecticut Court Holds Providers Can Sue to Enforce NSA IDR Awards
On May 14, 2025, Judge Michael P. Shea of the Connecticut District Court soundly rejected the Texas NSA decision, and held that “the NSA creates a private cause of action to enforce IDR awards.”
CMS Extends SNF Revalidation Deadline
The Centers for Medicare & Medicaid Services (CMS) extended the previous deadline of May 1, 2025 to August 1, 2025, for skilled nursing facilities (SNFs) to provide ownership and management information as well as information about other parties with which the SNFs are associated and the ownership structures of those parties.
Starting the Patient Journey: Essential Documentation for Treatment and Payment
Garfunkel Wild's Stacey L. Gulick, Kathleen M. Brown, and Alison T. Schimel will present the webinar "Starting the Patient Journey: Essential Documentation for Treatment and Payment" on April 16, 2025, from 12:00 PM - 1:00 PM ET.
NY DOH Publishes FAQs Regarding Reporting of Health Care Transactions
In March, the New York Department of Health (DOH) published “frequently asked questions” (FAQs) related to the law that requires “health care entities” party to a “material transaction” to report the transaction to the DOH in advance.
New Telehealth Update: Medicare Waivers Extended To September 30, 2025
Congress has once again extended certain telehealth flexibilities until September 30, 2025 (which coincides with the end of the Congressional fiscal year).
OIG Approves Certification of Heavy Assistance Program
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (25-01) allowing a Pharmaceutical Company (Company) to provide free access to its U.S. Food and Drug Administration (FDA)-approved product (Product) for eligible patients with mild cognitive impairment or disease-related dementia and related symptoms.
Another Win for Patient Assistant Programs
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-13) allowing a pharmaceutical manufacturer (Manufacturer) to provide transportation, lodging, meal vouchers, and other authorized expenses to eligible patients receiving Manufacturer’s one-time, potentially curative treatment product (Product).
OIG Opinion is a Win for Patients
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-12) allowing a pharmaceutical manufacturer (Manufacturer) to sponsor a genetic testing, genetic counseling, and disease-state awareness education program for certain eligible patients with an “ultra-rare” genetic condition that causes kidney stones.
OIG Greenlights Free Vaccine Program
The U.S. Department of Health and Human Services, Office of Inspector General (OIG), posted a favorable Advisory Opinion (24-11) allowing a pharmaceutical manufacturer (Manufacturer) to provide free meningococcal vaccinations to eligible patients, including Federal health care program enrollees who receive Manufacturer’s U.S. Food and Drug Administration (FDA)-approved products that treat rare disorders.
OIG Gives Discount Program Favorable Treatment
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-10) allowing the expansion of an existing loyalty program offered by a medical and dental supply distributor (Company) to its member customers (Customers), while cautioning that “discount” programs are typically high risk.
New York Proposes More Scrutiny for Health Care Transactions
On January 21, 2025, New York Governor Kathy Hochul released the proposed FY 2026 New York State Executive Budget, which includes enhanced scrutiny of material transactions involving health care entities.
Second Circuit Adopts “One Purpose” Test
The United States Court of Appeals for the Second Circuit (Second Circuit or Court), which has Federal jurisdiction in Connecticut, New York, and Vermont, recently issued an important decision regarding health care provider liability under the False Claims Act (FCA) when a whistleblower alleges a violation of the Anti-Kickback Statute (AKS). The Second Circuit explicitly adopted the “one purpose” test for the first time to determine whether a financial arrangement between a provider and a referral source violates the AKS, and thus potentially subjects the parties to substantial fines and penalties under the FCA.
New DOJ Report: Providers Beware
Last week, the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) released its annual, jointly authored Health Care Fraud and Abuse Control Program Report (the Report) for Fiscal Year 2023.
New OIG Priorities Emerge in Report
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) released its Semiannual Report (SAR) to Congress on December 4, 2024.
OIG Highlights New Concerns
This week, the U.S. Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) fulfilled its annual statutory obligation by releasing its 2024 Top Management and Performance Challenges Report (the “Report”). Historically, the Report has not attracted widespread interest in the provider community because it largely focuses on HHS operational challenges. Importantly for providers and other stakeholders, however, the Report reveals crucial insights about compliance priorities for the year ahead.
DEA Extends Telemedicine Prescription Rules Through 2025
The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) have jointly issued a third emergency extension allowing health care practitioners to prescribe Schedule II-V controlled substances via audio-video telemedicine encounters without an initial in-person evaluation. This extension, effective from January 1, 2025 through December 31, 2025, also provides the DEA with additional time to finalize permanent regulations for prescribing controlled substances through telemedicine.
11th Annual ASC and Health Care Management Symposium
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.
NYS Department of Health Pauses Implementing New Patient Consent Requirements
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.
New York Enacts Alarming Patient Consent Requirements
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.
OIG Nixes Medicare Advantage Gainsharing Payments
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”).
Update on Change Healthcare Class Action Litigation
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.
Curalta Foot + Ankle‘s 2nd Annual Management and Educational Conference
Garfunkel Wild will be a sponsor at Curalta Foot + Ankle‘s 2nd Annual Management and Educational Conference.
Federal Rule Released to Address Mental Health Coverage Parity
This week, the Federal Departments of Treasury, Labor, and Health and Human Services (the Departments) released final rules strengthening consumer protections for patients seeking mental health and substance use disorder treatments.
OIG Approves Patient Travel, but Not Fertility Services
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.
OIG Approves Drug Refund and Discount Program
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.
OIG Greenlights Gene Therapy Assistance Program
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.
OIG Report Highlights Enforcement Priorities
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.
Telehealth Update: NY Proposes Controlled Substance Prescribing, Waiting on DEA
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.
Be Prepared! NYS OMIG’s 2024 Work Plan Provides an Audit Roadmap for Health Care Providers of All Types
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).
NY Upends CDPAP Fiscal Intermediary Framework
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).
FTC Bans Non-Competes Across the Nation
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”).
NJ Supreme Court Vacates $23.4M Award Against Valley Hospital
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.
OIG Allows Patient Assistance Programs Funded by Drug Manufacturers
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.
FQHC Look-Alike Application Blackout Period: Changes are Coming
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.
OIG Issues New Resource for Single Audits
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.
Chemed’s 6th Annual Medicine & Ethics Conference
Garfunkel Wild sponsored the 6th Annual CHEMED Medicine & Ethics Conference, February 15-18, 2024.
New York OMIG Updates Self-Disclosure Guidance
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.
OMIG’s 2024 Work Plan Gives Critical Insights into Program Integrity Initiatives
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.
OIG’s Newest Strategic Plan Prioritizes Managed Care Oversight
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.
OIG Issues Toolkit for Medicare Advantage Organizations
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.
OIG Approves Use of Gift Cards for Referrals in Certification-Heavy Advisory Opinion
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).
OIG Approves Creative Approach to Restructuring Medical Practice Partnerships
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.
Favorable OIG Advisory Opinion Allows Subsidies for FDA-Approved Clinical Studies
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.
OIG’s Favorable Advisory Opinions Allow Incentives to Medigap Plan Policyholders
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.
More Provider “Nuggets” From OIG’s Year-End Reporting Blitz
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.
Updates on Tracking Technologies and Information Blocking
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).
DOJ/HHS Jointly Release “Highlight Reel” Report
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.
Flurry of Activity Around Patient Information Impacting New York Providers
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.
OIG Provides Roadmap to Hot-Button Issues
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.
The Federal No Surprises Act – Its Impact on Florida Physicians
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.
OIG Releases New General Compliance Program Reference Guide
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
Favorable Employee Bonus Opinion on ASC Profits
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).
OIG Finds Lab to Lab Technical Component Arrangement Poses Anti-Kickback Risk
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.
10th Annual ASC and Health Care Management Symposium
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.
New York State Society of Orthopaedic Surgeons 2023 Annual Meeting & Symposium
Garfunkel Wild's Barry Cepelewicz, M.D., will present at the New York State Society of Orthopaedic Surgeons 2023 Annual Meeting & Symposium.
CMS Releases Updated Request for Applications for New Making Care Primary Model
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
FQHC Lessons Learned from the Field: Tips to Avoid OSV Non-Compliance
Join Garfunkel Wild’s attorneys as they discuss the OSV process, highlight the areas HRSA reviewers consider, and impart meaningful tips on how FQHCs can be in compliance.
Temporary Health Care Staffing Agencies Now Required to Register in New York
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).
Connecticut Signals Increased Scrutiny of Physician Practice Acquisitions
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.
Connecticut Modifies Physician Non-Compete Law, Extends Protections to APRNs and PAs
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.
CMS Issues Final Rule Ending COVID-19 Vaccination Requirements
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.
New York Enacts Notice Requirement for Health Care Transactions
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.
Fairfield County Medical Association Webinar – The FTC’S Proposed Ban on Non-Competes: What Does It Mean?
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.
New Jersey Lifts COVID-19 Testing Requirements in Health Care and Congregate Care Settings
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.
National Business Institute Live Online Seminar – How to Bring New York Employee Handbooks Into Compliance
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.
Florida Telehealth – What Florida and Non-Florida Practitioners Need to Know
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.
Chemed’s 5th Annual Medicine & Ethics Conference
Garfunkel Wild will present at the 5th Annual CHEMED Medicine & Ethics Conference, February 16-19, 2023.
Health Information Technology Podcast – Termination and Transition Periods
Garfunkel Wild's Health Care Information and Technology Practice Group's Podcast Series "Health Information Technology Podcast- Termination and Transition Periods".
Garfunkel Wild and Garfunkel Health Advisors Complimentary Webinar – Major Changes to E/M Coding and Documentation Requirements in 2023 – Will You Be Ready?
Garfunkel Health Advisors 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.
Protect Your Medical License: Use Certified Coders to Help Ward Off Licensure Sanctions
There has been a steady trend of increased scrutiny by governmental agencies responsible for investigating complaints against physicians and for prosecuting acts of professional misconduct by physicians, including the coding and billing practices of physicians. All practitioners should be aware that billing improprieties may constitute a form of professional misconduct that such agencies may rely […]
Properly Address Billing and Overpayment Issues: Use Billing and Documentation Experts to Ensure Payer Rules are Being Followed
It is not at all unusual for health care providers to discover potential billing and overpayment issues in the course of their day-to-day operations. Such issues may arise in any number of ways. For instance, they may be identified as the result of a provider’s internal compliance efforts, including compliance program audits or reviews, or […]
Florida Medical Practice Pays Hefty Price for Alleged Kickback Payments From Pharmaceutical Distributor
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 Health Care Rankings in 2023 Edition of Chambers USA
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.
