Robert A. Del Giorno
Partner/Director
516-393-2505
Investigations, Audits, and Regulatory Compliance
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Garfunkel Wild’s Investigations, Audits and Regulatory Compliance Practice Group is comprised of a team of experienced attorneys who focus on the unique regulatory and business concerns of the health care industry. Our attorneys are counsel to a wide variety of providers, including hospitals and health systems, licensed clinics, skilled nursing facilities, physician practices, clinical laboratories, pharmacies, and community based providers. We routinely advise clients on federal and state Stark and anti-kickback laws and their applicable exceptions and safe harbors, False Claims Acts, Medicare and Medicaid billing and enrollment issues, health care fraud, professional misconduct rules, and other fraud and abuse laws.
Our team is adept at handling complex matters and is well-known for providing practical, real-word compliance advice that clients can implement in their day-to-day operations. With a team of attorneys who are former government prosecutors and criminal defense attorneys, we vigorously defend clients in federal and state criminal, civil and administrative investigations, as well as payer audits, and counsel clients through government oversight actions, such as Corporate Integrity Agreements.
The Investigations, Audits and Regulatory Compliance Practice Group advises our clients in the following representative areas:
- Development and implementation of effective corporate compliance programs
- Internal Investigations
- False Claims Act investigations
- State and Federal criminal health care fraud investigations
- Responding to government inquiries and subpoenas
- Payor and government Audits
- Nursing Home regulatory issues, investigations and appeals of deficiencies/citations
- Review of compensation methodologies under Federal and State “Stark” and Antikickback Laws
- Review of compliance with billing rules and regulations (e.g., “incident-to” rules, modifier use, out of network billing)
- Medicare/Medicaid enrollment, revocation, and exclusion matters
- Office of Professional Medical Conduct (“OPMC”) matters
- Legal audits of relationships under “Stark,” Antikickback and related laws
- Regulatory issues related to Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)
- Clinical Laboratory compliance, billing and investigations
Practice Group Contacts
Team
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.
Federal Court Enjoins the Corporate Transparency Act
On December 3, 2024, a federal district court in Texas issued a nationwide injunction that prohibits the federal government from enforcing the Corporate Transparency Act (CTA) and the regulation that requires corporate entities registered under state law to report detailed information about ownership.
Navigating HHS-OIG’s New Compliance Guidance for Nursing Facilities: Key Risks, Mitigation Strategies, and Evaluation Considerations
Garfunkel Wild’s Robert Del Giorno, David Traskey, and Colleen Pierson will present the webinar “Navigating HHS-OIG’s New Compliance Guidance for Nursing Facilities: Key Risks, Mitigation Strategies, and Evaluation Considerations” on December 17, 2024, from 12:00 PM – 1:00 PM ET.
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.
New York Hospital Cybersecurity Regulations Announced
On October 12, 2024, the New York State Department of Health (“DOH”) published the final cybersecurity regulations for general hospitals (the “Regulations”), with some provisions effective immediately.
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.
HHS Withdraws Its Appeal of Tracking Technologies Decision
On August 29, 2024, the Federal Department of Health and Human Services (“HHS”) withdrew its appeal of a federal court decision that invalidated certain aspects of HHS guidance regarding the use of tracking technologies (e.g., pixels that collect data on website usage to create directed marketing campaigns).
Breaking News: Federal Court Blocks FTC’s Non-Compete Ban Nationally
A Texas Federal Judge issued a decision blocking the FTC’s proposed ban on non-compete agreements, which was set to go into effect on September 4, 2024. As previously reported, the Texas Federal Court had issued a preliminary injunction limiting the enforceability of the FTC’s non-compete ban for the individual plaintiff in that lawsuit only. The Judge has now expanded that ruling nationally – preventing the FTC non-compete ban from going into effect.
Is Your NJ Patient Safety Committee Protected by a Privilege?
In a recent ruling, the New Jersey Supreme Court concluded that the “self-critical analysis” privilege under the Patient Safety Act (“PSA”) and its implementing regulations can only be applicable if the information sought was generated for purposes of an independent patient safety committee that is created solely for the purposes of the PSA (i.e., the information […]
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.
Ensuring Compliance: The Legal and Practical Importance of Accurate Job Descriptions
Garfunkel Wild’s Andrew Zwerling and Harpreet Kaur will host a webinar addressing the legal and practical implications of job descriptions.
Protect Your Pharmacy’s Medicare and Medicaid Enrollment From Termination!
Pharmacy revocations for non-compliance with Medicare Part B and Durable Medical Equipment, Prosthetics, Orthotics and Supplies enrollment requirements are on the rise. Garfunkel Wild’s latest webinar in our Compliance Webinar Series discusses common risks and provides strategies to protect your pharmacy.
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.
NY AG Faces Major Setback in Fight for Control Over Nursing Home
On June 4, 2024, the New York State Supreme Court, Orleans County held that courts cannot appoint independent health care and financial monitors to make binding “recommendations” – the centerpiece of the New York State Attorney General’s campaign against for-profit nursing homes.
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.
NY Upholds Elimination of Nursing Home Residual Equity Reimbursement
The Court of Appeals recently upheld New York State’s elimination of residual equity, a capital cost component of Medicaid rates afforded to for-profit nursing homes with older facilities (the “Elimination”).
Lawsuit Challenges “Nightmare” Federal Nursing Home Minimum Staffing Mandate
On May 23, 2024, the AHCA filed a lawsuit challenging the CMS's Federal Minimum Staffing Mandate, calling it "irrational" and "unattainable" due to staffing shortages and lack of statutory authority.
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.
FCMA and HCMA Webinar – FTC Ruling on Employment Non-Compete Clauses
Garfunkel Wild's Salvatore Puccio and Elisabeth Pimentel will present "FTC Ruling on Employment Non-Compete Clauses" at the Fairfield County Medical Association and Hartford County Medical Association's Webinar on Thursday, May 16, 2024.
HIPAA Amendment Bolsters Privacy for Reproductive & Substance Use Disorder Care
The HIPAA Privacy Rule to Support Reproductive Health Care Privacy was recently announced as a final rule that becomes effective on June 25, 2024 (the “Final Rule”).
NYSHFA | NYSCAL Annual Conference & Expo
Garfunkel Wild will be a sponsor at NYSHFA| NYSCAL’s Annual Conference & Expo.
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).
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”).
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.
HHS-OIG’s Plan for Oversight of Managed Care Programs: How the New Plan Impacts Providers
This Health Care Compliance webinar session will review HHS-OIG’s recently issued strategic plan for oversight of Medicare Managed Care and discuss the impact these initiatives could have on providers who participate in Medicare Advantage plans.
Cybersecurity – It’s More Than HIPAA: NY Regulatory Refresher for 2024
Join the health care professionals of Garfunkel Wild and Withum as they dive into the technical, legal, and financial steps you will need to take to come into compliance with the new cybersecurity regulations for New York hospitals.
New York Adult Care Facilities: How to Obtain Medical Equipment Waivers
This session will explain the medical equipment waiver process and provide clarity on what steps Adult Care Facilities (ACFs) should take to get their waivers approved and remain compliant with State regulations.
Federal District Court Declares Corporate Transparency Act Unconstitutional
On March 1, 2024, the United States District Court for the Northern District of Alabama declared the Corporate Transparency Act (CTA) unconstitutional.
New York State Center for Assisted Living (NYSCAL) – Adult Care Facility (ACF) Medical Equipment Waivers and Equivalencies 101
This session will provide clarity on what steps ACFs should take to remain compliant with State regulations.
Nursing Home Alert: Dramatic Increase in NYS DOH Life Safety Code Citations
Nursing homes being cited for Life Safety Code (LSC) deficiencies by the New York State Department of Health (DOH) are on the rise. The difficulty achieving substantial compliance or obtaining a waiver places nursing homes at risk for termination from Medicare and Medicaid, denial of payments, and monetary penalties.
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.
Wolters Kluwer – The Road to Compliance: Understanding the Corporate Transparency Act and FinCEN Beneficial Ownership
Steven R. Antico and J. David Morrissy will break down the Beneficial Ownership Information Reporting Requirements and how the requirements will affect your business.
HFMA Metropolitan New York Chapter – 2024 Revenue Cycle Academy
Garfunkel Wild's Debra A. Silverman will present at the HFMA Metropolitan New York Chapter - 2024 Revenue Cycle Academy on February 9, 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.
FinCEN’s Beneficial Ownership Information Reporting Portal is Now Available
On January 1, 2024, the United States Department of Treasury’s Financial Crimes Enforcement Network ("FinCEN") opened its Beneficial Ownership Secure System ("BOSS") portal to the public and began accepting Beneficial Ownership Information Reports ("BOI Reports") from Reporting Companies pursuant to the Corporate Transparency Act (“CTA”).
Beware of Fraudulent Efforts to Obtain FinCEN Beneficial Ownership Information
This alert is intended to warn recipients to be wary of fraudulent notices demanding recipients to provide their Beneficial Ownership Information ("BOI") through channels other than those secured by FinCEN.
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.
The Road to Compliance: Understanding the Corporate Transparency Act and FinCEN Beneficial Ownership Reporting Requirements
As of January 1, 2024, many companies in the United States will have to file a Beneficial Ownership Information Report with FinCEN pursuant to the implementing regulations of the Corporate Transparency Act passed in 2021. Join us for an in-depth review of the Corporate Transparency Act.
New CMS Disclosure Requirements for Nursing Homes
On November 17, 2023, the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS) published a final rule (“Final Rule”) imposing new ownership disclosure requirements on Medicare skilled nursing facilities and Medicaid nursing facilities (“nursing homes”). Due to concerns over the quality of patient care in facilities owned by certain types of nursing facility owners, including private equity companies and real estate investment trusts, CMS believes these new disclosure requirements will allow them to monitor and hold nursing homes accountable.
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.
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
OIG Issues Unfavorable Opinion on Supplying Free Device
On October 25, 2023, the OIG posted Advisory Opinion 23-08, an unfavorable opinion regarding a cochlear implant manufacturer’s proposal to offer and provide a free compatible hearing aid to eligible patients.
New Corporate and Entity Ownership Reporting Requirement
Beginning on January 1, 2024, the Corporate Transparency Act (CTA) will require many companies to file a Beneficial Ownership Information (BOI) report with the Financial Crimes Enforcement Network (FinCEN).
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).
The Inside Scoop: A Behind-the-Scenes Look at HHS-OIG (Part III)
Join Garfunkel Wild’s Robert A. Del Giorno and David Traskey, former Senior Counsel with the HHS-OIG as they delve into HHS-OIG’s inner workings.
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.
The Inside Scoop: A Behind-the-Scenes Look at HHS-OIG (Part II)
Join Garfunkel Wild’s Robert A. Del Giorno and John G. Martin for a discussion with David Traskey, the firm’s newest Partner and former Senior Counsel with the HHS-OIG as they delve into HHS-OIG’s inner workings.
The Inside Scoop: A Behind-the-Scenes Look at HHS-OIG (Part I)
Join Garfunkel Wild’s Robert A. Del Giorno and John G. Martin for a discussion with David Traskey, the firm’s newest Partner and former Senior Counsel with the HHS-OIG as they delve into HHS-OIG’s inner workings.
HHS-OIG Posts Final Rule Implementing Information Blocking Penalties
On June 27, 2023, and in response to the 21st Century Cures Act (Cures Act), the U.S. Department of Health and Human Services, Office of the Inspector General (HHS-OIG) posted a final rule that amended its Civil Money Penalty (CMP) regulations to authorize penalties of up to $1 million per violation.
CHCANYS 2023 Finance University
Garfunkel Wild's Robert Del Giorno will present at the Community Health Care Association of New York State (CHCANYS) 2023 Finance University on June 14, 2023.
FQHC Enters Into Agreement To Resolve Disability Discrimination Complaint
On May 10, 2023, MCR Health, Inc. (“MCR” or the “Center”), a federally qualified health center (“FQHC”) based in Florida entered into a voluntary resolution agreement with the Department of Health and Human Services, Office of Civil Rights (“OCR”) to resolve a disability discrimination complaint against the Center.
Labs & Substance Abuse Providers: EKRA Enforcement Update
Given the government’s increasing enforcement of EKRA, now is a good time for providers to understand the enforcement landscape, understand EKRA’s application and to reassess potentially noncompliant compensation structures.
CMS’ Resumes No Surprise Act Independent Dispute Resolution Process
On March 17, 2023, the Centers for Medicare and Medicaid Services (“CMS”) announced that independent dispute resolution (“IDR”) process called for in the Federal No Surprises Act should resume, and that the IDR entities could again make payment determinations in disputes between out-of-network providers and health plans that are subject to the NSA.
The FTC’s Proposed Ban on Non-Competes – What Does It Mean?
On January 5, 2023, the Federal Trade Commission (“FTC”) announced and released a notice of proposed rulemaking (NPRM) to prohibit employers from entering into non-competes with workers, including independent contractors.
New York OMIG Releases Compliance Program Resources for Providers
On March 8, 2023, the New York Office of the Medicaid Inspector General (“OMIG”) posted materials on its website that provide further guidance on OMIG’s new regulations adopted on December 28, 2022.
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.
DOJ Announces Nationwide Voluntary Self-Disclosure Policy for US Attorney’s Offices
On February 22, 2023, the Department of Justice announced a new nationwide voluntary self-disclosure policy that gives companies the opportunity to receive a more favorable outcome when criminal misconduct is identified and the company chooses to voluntarily report the misconduct. The new voluntary self-disclosure policy applies to all United States Attorney’s Offices (“USAOs”) in the Country and it is effective immediately.
Payment Error Rate Measurement Program for Florida Medicaid and Chip Providers
On February 17, 2023, Florida Medicaid released a Health Care Alert reminding providers of their obligations under the Centers for Medicare and Medicaid Services (“CMS”) Payment Error Rate Measurement (“PERM”) program.
Franchise Regulations in the Context of the MSO Model
Associate, Weston Harty authored the article "Franchise Regulations in the Context of the MSO Model", published in the New York State Bar Association Health Law Journal (2023 - Vol. 28 - No.1).
Often Overlooked: Compliance Program Obligations Under Managed Care Agreements (For Providers in All States)
Garfunkel Wild’s Robert Del Giorno and Celia J. Morel will present the Webinar “Often Overlooked: Compliance Program Obligations Under Managed Care Agreements (For Providers in All States)” on January 19, 2023 from 12:00 PM - 1:00 PM ET.
Cultural Training and EMR Requirements for NJ Hospitals and Laboratories
Beginning January 18, 2023, New Jersey hospitals and clinical laboratories must demonstrate compliance with cultural competency requirements recently issued by the New Jersey Department of Health (“DOH”).
OMIG Adopts Significant New Compliance Program Regulations
On December 28, 2022, the New York State Office of the Medicaid Inspector General (“OMIG”) finalized a significant set of new compliance-related regulations. The rules were initially proposed on July 13, 2022 (see our prior Client Alert on the proposed rules here: https://www.garfunkelwild.com/insights/omig-proposes-significant-new-compliance-program-regulations). The final rules contain minimal revisions to the proposed regulations.
Prepare Now: Refresher on NY’s Compliance Program Proposed Regulations (For New York Providers)
Garfunkel Wild’s Robert Del Giorno and Peter M. Hoffman will present the Webinar “Prepare Now: Refresher on NY’s Compliance Program Proposed Regulations (For New York Providers)” on December 20, 2022 from 12:00 PM - 1:00 PM ET.
New York Nursing Home Staffing & Minimum Spending Regulations Have Been Officially Adopted: Is Your Nursing Home in Compliance?
On November 17, 2022, the New York Public Health and Health Planning Council (“PHHPC”) held a meeting (“Meeting”) to discuss the adoption of regulations addressing Direct Care Nursing Home Spending and Minimum Staff Requirements. The Department of Health (“Department”) first introduced these regulations on November 17, 2021, after which they were published in the Federal Register with a 60-day comment period that ended January 18, 2022. Due to a COVID related workforce shortage, Governor Kathy Hochul suspended the implementation of the regulations through April 1, 2022 and gave the Department until November 17, 2022 to hold a meeting to vote on the regulations.
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 […]
Nursing Home Facilities Need to Ensure Compliance with the Federal Arbitration Rule as Supreme Court Declines Review
On October 3, 2022, the Supreme Court of the United States denied the request to review the Eighth Circuit’s decision that upheld a federal rule that limited the use of arbitration agreements in nursing homes.
Health Care Hot Topics: Florida’s New Minimum Wage Requirements For Medicaid Providers
Garfunkel Wild's Susan St. John discusses the things providers need to know about the new minimum wage requirements, and a new civil cause of action for non-compliance.
Proposed New York State Legislation Concerning Nursing Homes and Adult Care Facilities
Garfunkel Wild has been constantly tracking and monitoring the status of all proposed nursing home and residential care facility legislation.
OMIG Proposes Detailed Self-Disclosure Program Regulations
On July 13, 2022, the New York State Office of the Medicaid Inspector General (“OMIG”) published a significant set of proposed compliance-related rules. If finalized, the new rules would repeal the existing regulations governing provider compliance programs (found in 18 NYCRR Part 521), and replace them with three new subparts concerning, respectively: (i) Compliance Programs (proposed 18 NYCRR Subpart 521-1); (ii) Medicaid Managed Care Organization Fraud, Waste and Abuse Prevention (proposed 18 NYCRR Subpart 521-2); and (iii) OMIG’s Self-Disclosure Program (“SDP”) (proposed 18 NYCRR Subpart 521-3).
OMIG Proposes Significant New Compliance Program Regulations
On July 13, 2022, the New York State Office of the Medicaid Inspector General (“OMIG”) published a significant set of proposed compliance-related rules. If finalized, the new rules would repeal the existing regulations governing provider compliance programs (found in 18 NYCRR Part 521), and replace them with three new subparts concerning, respectively: (i) Compliance Programs (proposed 18 NYCRR Subpart 521-1); (ii) Medicaid Managed Care Organization Fraud, Waste and Abuse Prevention (proposed 18 NYCRR Subpart 521-2); and (iii) OMIG’s Self-Disclosure Program (proposed Subpart 521-3).
OIG Approves Loan of Smartphones to Patients
In Advisory Opinion 22-08, posted on April 27, 2022, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) stated that it would not impose sanctions on a federally qualified health center (“FQHC”) that had loaned smartphones to its patients.
CMS Rescinds COVID-19 Emergency Declaration Blanket Waivers for Medicare Long-Term Care Facilities
On April 7, 2022, the Centers for Medicare & Medicaid Services (“CMS”) released a memorandum, QSO-22-15, announcing the restoration of certain minimum regulatory requirements that had been waived in response to the COVID-19 Public Health Emergency. CMS will end the waivers in two groups, under two time frames.
The Supreme Court Approves CMS Vaccine Mandate, but Halts OSHA Mandate
On January 13, 2022, the U.S. Supreme Court permitted the vaccine mandate for health care workers in facilities regulated by Centers for Medicare and Medicaid Services (CMS). Specifically, the CMS vaccine mandate requires all staff of facilities participating in Medicare/Medicaid to be vaccinated.
Reminder: NY Nursing Home Disclosure Requirement Goes into Effect October 1, 2021
As of October 1st, residential health care facilities must inform residents and their families regarding the availability of facility compliance information as part of an intake application. This disclosure must be in a separate document, in no less than twelve point font, and include the following:
New Disclosure Requirement for NY Residential Health Care Facilities
Effective October 1, 2021, residential health care facilities in New York will be required to provide potential residents and their families with a separate document, in no less than twelve point font, as part of their admission packet that includes the following information:
New Laws for New York Nursing Homes Will Take Effect on October 21, 2021
On June 11, 2021, Governor Cuomo signed Senate Bill S6767 into law. The amended law, which takes effect on October 21, 2021, will continue to greatly impact the ownership and operation of nursing homes in New York by imposing broad notice and contract disclosure requirements on nursing homes.
The NJ Health Care Transparency Act: Time is Running Out
The New Jersey Health Care Transparency Act (the “Act”) becomes effective on July 1, 2021. The Act requires health care professionals to clearly inform patients of their training and qualifications when they are providing in-person care to patients and when advertising their practice.
New York Hospital/Nursing Home Staffing Legislation Enacted
On June 18, 2021, Governor Cuomo signed into law two bills related to clinical staffing for hospitals and nursing homes. As reported in our prior Alerts, dated May 7, 2021:
New York DOH Issues Policy on Submission of False Information in License Applications
On June 11, 2021, the New York Department of Health (DOH) posted a “Dear Applicant Letter” informing applicants for certificates of need (CON), licensure for adult care facilities (ACF) or licensed home care services agencies (LHCSA) or transfer of ownership interest notices of its new policy regarding evaluation of the applicant’s character and competency.
New York / Federal Vaccine Requirements for LTC Facilities
In a Dear Administrator Letter (“DAL”) dated May 28, 2021, the New York State Department of Health highlights the differing requirements long-term care (“LTC”) facilities must meet regarding COVID-19 vaccinations under recent federal and state regulations.
Staffing Legislation Impacts New York Nursing Homes
On May 5, 2021, the New York State legislature approved two bills with differing requirements related to clinical staffing for hospitals and nursing homes. With a goal of improving both patient and staff safety, as well as patient outcomes, the Governor is expected to sign each bill (A07119 and A00108B) into law soon. This Alert addresses the requirements for nursing homes. Please see a separate Alert here addressing the hospital staffing requirements.
New OIG Opinion Permits FQHC to Offer Gift Cards to Patients
The Office of Inspector General (“OIG”) posted OIG Advisory Opinion 20-08 on Tuesday, December 30, 2020. The Opinion permits an FQHC to offer $20 gift cards to incentivize pediatric patients who have missed two (2) or more previously scheduled preventative and early intervention care appointments within the previous six (6) months.
OIG Issues Important New And Revised Safe Harbors
The United States Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) recently issued an important final rule (the “Final Rule”) that makes significant changes to existing “Safe Harbors” under the Federal Anti-kickback Statue (“AKS”) and that adds new Safe Harbors that provide protection from AKS sanctions for certain types of arrangements.
OIG Issues Special Fraud Alert Reiterating Concerns Regarding Speaker Programs
On November 16, 2020, the U.S. Department of Health and Human Services, Office of the Inspector General (the “OIG”) issued a Special Fraud Alert (“SFA”) emphasizing the fraud and abuse risks inherent in speaker programs run by pharmaceutical and medical device companies.
Garfunkel Wild Webinar – Health Home Audits and Investigations Are Here: Are You Ready?
Garfunkel Wild’s Peter M. Hoffman will present the webinar “Health Home Audits and Investigations Are Here: Are You Ready?" on November 19, 2020.
Changes To New York State Compliance Program Certification Requirements
Separate Annual SSL and DRA Certifications On OMIG’s Website No Longer Required; Replaced By Annual Certification Statements
New York Physician Practice Settings Must Inform Patients How To Report to OPMC
In legislation enacted on October 7, 2020, New York State is requiring physicians’ practice settings to post notice, visible to patients, that direct patients to the Office of Professional Medical Conduct’s (“OPMC’s”) website to obtain information about their rights and how to file a complaint regarding professional misconduct. The requirement is effective immediately.
Medicus IT Town Hall Webinar – Successfully Navigating the ‘New Normal’: What ASCs Need to Know
Andrew E. Blustein will present at Medicus It Town Hall Webinar – Successfully Navigating the ‘New Normal’: What Ascs Need to Know on September 16, 2020.
New York Proposes to Lift the Cap on Therapy Services Provided to Medicaid Recipients
On September 2, 2020, the New York State Department of Health submitted a proposal to the Centers for Medicare & Medicaid Services (“CMS”) to remove the annual Medicaid caps for physical therapy, occupational therapy, and speech therapy visits available to Medicaid recipients. The change, planned to take effect on October 1, 2020, would remove the current limitation on the number of therapy visits a Medicaid recipient may have and, in its place, allow medical necessity to dictate the number of visits a recipient can receive in a year.
New York Enacts Paid Sick Leave Reform
On April 3, 2020, New York State Governor Andrew Cuomo signed the fiscal year 2021 budget, which included an overhaul of statewide paid sick leave requirements under the New York State Labor Law. Under the new law, all employers must provide sick leave to their employees.
Residential Facilities Required to Create Pandemic Emergency Plans
New York State recently enacted legislation amending Public Health Law Section 2803 to require that each residential health care facility submit a pandemic emergency plan to the Department of Health no later than September 15, 2020, and annually thereafter.
Garfunkel Wild Webinar – “Practical Aspects for ASCs Reopening”
Garfunkel Wild will present the webinar “Practical Aspects for ASCs Reopening” on May 21, 2020.
New CMS Guidance for Nursing Homes Regarding Five Star Quality Rating System, Nursing Home Staffing and Additional FAQ’S
On April 24, 2020, the Centers for Medicare and Medicaid Services (“CMS”) issued a letter to State Agency Directors announcing that it will temporarily maintain the inspection rating for the Five Star Quality Rating System and that it will publish reported nursing home staffing levels to assist local governments in identifying nursing home needs. CMS also issued Frequently Asked Questions (“FAQs”) for nursing homes.
Confidentiality of Medical Information During the COVID-19 Crisis
The Equal Employment Opportunity Commission has issued new guidance for workplaces, dated April 17, 2020, as they start the process of preparing for the impending re-opening of their entities in the face of the Covid-19 pandemic.
Strafford CLE Webinar – National Practitioner Data Bank: Hospital Reporting Obligations, Reporting Immunity, and Physician Strategies
Garfunkel Wild Partner/Director Leonard M. Rosenberg will present at the Strafford Webinar – National Practitioner Data Bank: Hospital Reporting Obligations, Reporting Immunity, and Physician Strategies on April 22, 2020.
Garfunkel Wild Webinar – A State Update: How to Operationalize the Connecticut Administration’s Expectation Regarding Elective Cases in ASCs
Garfunkel Wild Vice Chairman Andrew E. Blustein and Lisa A. Winkler, Executive Director, Connecticut Association of Ambulatory Surgery Center will present the webinar “A State Update: How to Operationalize the Connecticut Administration’s Expectation Regarding Elective Cases in ASCs” on March 27, 2020.
Garfunkel Wild Webinar – COVID-19 Telehealth Rules Applicable to FQHCs
Garfunkel Wild’s Jeff Adest and Sandra Jensen will present the webinar “COVID-19 Telehealth Rules Applicable to FQHCs” on March 26, 2020.
Garfunkel Wild Webinar – COVID-19 Billing for Telemedicine Services and Q&A Session
Garfunkel Wild Partner/Director Debra A. Silverman and Partner Stacey L. Gulick along with Certified Professional Coder and President of ProCode Compliance Solutions, LLC, Alicia Shickle will present the webinar “COVID-19 Billing for Telemedicine Services and Q&A Session” on March 25, 2020.
Garfunkel Wild Webinar – Implementing and Expanding Telehealth to Address COVID-19
Garfunkel Wild Partner/Director Debra A. Silverman and Partners Stacey L. Gulick and Sandra M. Jensen will present the webinar “Implementing and Expanding Telehealth to Address COVID-19” on March 19, 2020.
Greater New York Health Care Facilities Association (GNYHCFA) Seminar – Regulatory Updates
Eve Green Koopersmith will present at the Greater New York Health Care Facilities Association’s (GNYHCFA) Seminar – Regulatory Updates – March 5, 2020.
Garfunkel Wild Webinar – 340B Contract Pharmacy Issues for FQHCs
Garfunkel Wild's Barbara Knothe will present the webinar “340B Contract Pharmacy Issues for FQHCs” on March 4, 2020.
Garfunkel Wild Webinar – Preparing for an OSV; Practical Tips
Garfunkel Wild presented the webinar “Preparing for an OSV; Practical Tips” on February 6, 2020.
New Hospital Financial Reporting Requirements in New Jersey
On January 21, 2020, Governor Phil Murphy signed bills A5916 and A5918 into law which are intended to increase the financial transparency of New Jersey hospitals and to ensure that such hospitals do not suddenly shut down, leaving residents without access to adequate health care in their respective communities as a result of a hospital’s financial distress.
Healthcare Financial Management Association’s (HFMA) Metropolitan New York Chapter Regulatory Compliance Seminar
Afsheen A. Shah will present at the Healthcare Financial Management Association’s (Hfma) Metropolitan New York Chapter Regulatory Compliance Seminar December 11, 2019.
Garfunkel Wild Webinar Series – Achieving Compliance & Operational Success for FQHCs – FTCA Compliance & Preparing for an FTCA Specific On-Site Visit – November 20, 2019
Garfunkel Wild will present the webinar “FTCA Compliance and Preparing for an FTCA Specific On-Site Visit” on November 20, 2019.
New York Department of Health Proposes Rule to Amend Licensed Home Care Services Agencies Regulation
A proposed rule was issued on November 6, 2019 to amend regulations regarding the approval of Licensed Home Care Service Agencies (“LHCSAs”). To comply with changes made to the Public Health Law in 2018, Subpart 765-1 of Title 10 NYCRR must be updated to include the new requirements of public need review and financial feasibility review. This Rule, effective April 1, 2020, would require the following:
Greater New York Health Care Facilities Association (GNYHCFA) Autumn Seminar
Eve Green Koopersmith will present at the Greater New York Health Care Facilities Association’s (GNYHCFA) Autumn Seminar on November 14, 2019.
Major Change to Office of Professions Procedure
The New York State Education Department (“SED”) has implemented a major procedural change, requiring that new professional practice entities submit an affidavit to SED when applying for Certificates of Authority to operate in New York State (whether in connection with original formation or foreign qualification to do business in New York). SED’s new process also requires that an affidavit be submitted for professional practice entity name changes.
Compliance with the New York Shield Act
he New York SHIELD Act has gone into effect today (October 23, 2019) and entities that maintain electronic information regarding New York residents will need to ensure compliance.
Fraud and Abuse – Lessons from Esformes Case
John Martin will present the “Fraud and Abuse – Lessons From Esformes Case” Webinar on September 18, 2019.
Nassau County Bar Association (NCBA) Hospital and Health Law Committee CLE – Recent Trends in Health Care Fraud Investigations
John G. Martin and Robert A. Del Giorno will present at the Nassau County Bar Association’s CLE – Recent Trends in Health Care Fraud Investigations on September 17, 2019.
OCR Settlement Emphasizes Importance of Patient Access to Information
On September 9, 2019, the Department of Health and Human Services, Office of Civil Rights (“OCR”) announced that Bayfront Health – St. Petersburg, a 480-bed Florida hospital (the “Hospital”), paid $85,000 to settle an investigation regarding the Hospital’s failure to provide one patient with timely access to her medical records. In its press release, the OCR emphasized that this settlement is consistent with its Patient Access Initiative, which was announced earlier this year.
New York Shield Act Modifies Breach Notification Requirements
On October 23, 2019, the Stop Hacks and Improve Electric Data Security (“SHIELD”) Act goes into effect and significantly modifies the existing New York State breach notification requirements, including the addition of new requirements for covered entities (e.g., all health care providers and health plans) to report HIPAA breaches to the New York State Attorney General, as well as the Federal Department of Health and Human Services, Office of Civil Rights (“OCR”).
Healthcare Financial Management Association (HFMA) 18th Annual Healthcare Conference
Debra A. Silverman will present at the Healthcare Financial Management Association’s (HFMA) 18th Annual Healthcare Conference on May 22, 2019.
New MOLST Forms and Checklists Published by DOH
The New York State Department of Health has made changes to the Medical Orders for Life Sustaining Treatment (MOLST) form and Nonhospital Order Not to Resuscitate, DOH Forms 5003 and 3474, respectively. These changes were made to comply with statutory changes, which granted authority to Nurse Practitioners to sign the MOLST and Nonhospital Order Not to Resuscitate.
Fairfield County Medical Association’s Webinar– Creating a Medical Record that Protects Your Patients, Your Practice and You
Barry B. Cepelewicz will present at the Fairfield County Medical Association’s Webinar – Creating a Medical Record that Protects Your Patients, Your Practice & You – March 6, 2019.
Medical Society of the State Of New York (“MSSNY”) and Garfunkel Wild in Discussions with Zocdoc
Zocdoc has announced that its pricing model for doctors in New York will change effective April 1, 2019. Zocdoc currently charges its customers a flat annual fee. Under the new pricing model, customers will pay a reduced annual fee, as well as a booking fee. The amount of the booking fee will vary based on the physician’s specialty.
David Traskey Discusses Potential Impact of Supreme Court Ruling on Federal Health Agency Fines with Politico Pro
David Traskey was quoted in a Politico Pro article discussing a Supreme Court decision that could significantly affect the federal health agencies' authority to impose fines.
David Traskey was Quoted in the Health Care Compliance Association’s Report on Medicare Compliance (Volume 33, Number 18)
David Traskey was quoted in the article, "Baptist Health Settles FCA Case Over Copay Waivers, Benefited From DOJ Cooperation Credit", in the Report on Medicare Compliance published by the Health Care Compliance Association (HCCA).
David Traskey was Quoted in the Health Care Compliance Association’s Report on Medicare Compliance (Volume 32, Number 43)
Garfunkel Wild’s David Traskey, Partner and former Senior Counsel with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) was quoted in the article, "Health System, Cardiologist Settle Related FCA Cases Over Cath Procedures, Admissions".
David Traskey was Quoted in the Health Care Compliance Association’s Report on Medicare Compliance
Garfunkel Wild’s David Traskey, Partner and former Senior Counsel with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) was quoted in the article, "Exagen Settles FCA Case for Restitution, Paid Physicians Specimen Fees Despite OIG Alert".
David Traskey Quoted in the Health Care Compliance Association’s Report on Medicare Compliance
In the article, David gives an OIG insider’s view of the self-disclosure protocol (SDP).
Law360 Article Highlights David Traskey Joining the Firm
Garfunkel Wild Chairman Andrew Blustein and Partners David Traskey and Robert A. Del Giorno, are quoted in a Law360 article, “Longtime Gov't Health Care Atty Joins Garfunkel Wild,” regarding David joining the firm.
Former HHS-OIG Senior Attorney Joins Garfunkel Wild
Garfunkel Wild is pleased to announce that David Traskey, former Senior Counsel with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG), has joined the firm as Partner in its Investigations, Audits, and Regulatory Compliance Practice Group.
Garfunkel Wild’s Investigations, Audits and Regulatory Compliance Practice Group is comprised of a team of experienced attorneys who focus on the unique regulatory and business concerns of the health care industry. Our attorneys are counsel to a wide variety of providers, including hospitals and health systems, licensed clinics, skilled nursing facilities, physician practices, clinical laboratories, pharmacies, and community based providers. We routinely advise clients on federal and state Stark and anti-kickback laws and their applicable exceptions and safe harbors, False Claims Acts, Medicare and Medicaid billing and enrollment issues, health care fraud, professional misconduct rules, and other fraud and abuse laws.
Our team is adept at handling complex matters and is well-known for providing practical, real-word compliance advice that clients can implement in their day-to-day operations. With a team of attorneys who are former government prosecutors and criminal defense attorneys, we vigorously defend clients in federal and state criminal, civil and administrative investigations, as well as payer audits, and counsel clients through government oversight actions, such as Corporate Integrity Agreements.
The Investigations, Audits and Regulatory Compliance Practice Group advises our clients in the following representative areas:
- Development and implementation of effective corporate compliance programs
- Internal Investigations
- False Claims Act investigations
- State and Federal criminal health care fraud investigations
- Responding to government inquiries and subpoenas
- Payor and government Audits
- Nursing Home regulatory issues, investigations and appeals of deficiencies/citations
- Review of compensation methodologies under Federal and State “Stark” and Antikickback Laws
- Review of compliance with billing rules and regulations (e.g., “incident-to” rules, modifier use, out of network billing)
- Medicare/Medicaid enrollment, revocation, and exclusion matters
- Office of Professional Medical Conduct (“OPMC”) matters
- Legal audits of relationships under “Stark,” Antikickback and related laws
- Regulatory issues related to Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)
- Clinical Laboratory compliance, billing and investigations
Practice Group Contacts
Team
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.
Federal Court Enjoins the Corporate Transparency Act
On December 3, 2024, a federal district court in Texas issued a nationwide injunction that prohibits the federal government from enforcing the Corporate Transparency Act (CTA) and the regulation that requires corporate entities registered under state law to report detailed information about ownership.
Navigating HHS-OIG’s New Compliance Guidance for Nursing Facilities: Key Risks, Mitigation Strategies, and Evaluation Considerations
Garfunkel Wild’s Robert Del Giorno, David Traskey, and Colleen Pierson will present the webinar “Navigating HHS-OIG’s New Compliance Guidance for Nursing Facilities: Key Risks, Mitigation Strategies, and Evaluation Considerations” on December 17, 2024, from 12:00 PM – 1:00 PM ET.
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.
New York Hospital Cybersecurity Regulations Announced
On October 12, 2024, the New York State Department of Health (“DOH”) published the final cybersecurity regulations for general hospitals (the “Regulations”), with some provisions effective immediately.
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.
HHS Withdraws Its Appeal of Tracking Technologies Decision
On August 29, 2024, the Federal Department of Health and Human Services (“HHS”) withdrew its appeal of a federal court decision that invalidated certain aspects of HHS guidance regarding the use of tracking technologies (e.g., pixels that collect data on website usage to create directed marketing campaigns).
Breaking News: Federal Court Blocks FTC’s Non-Compete Ban Nationally
A Texas Federal Judge issued a decision blocking the FTC’s proposed ban on non-compete agreements, which was set to go into effect on September 4, 2024. As previously reported, the Texas Federal Court had issued a preliminary injunction limiting the enforceability of the FTC’s non-compete ban for the individual plaintiff in that lawsuit only. The Judge has now expanded that ruling nationally – preventing the FTC non-compete ban from going into effect.
Is Your NJ Patient Safety Committee Protected by a Privilege?
In a recent ruling, the New Jersey Supreme Court concluded that the “self-critical analysis” privilege under the Patient Safety Act (“PSA”) and its implementing regulations can only be applicable if the information sought was generated for purposes of an independent patient safety committee that is created solely for the purposes of the PSA (i.e., the information […]
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.
Ensuring Compliance: The Legal and Practical Importance of Accurate Job Descriptions
Garfunkel Wild’s Andrew Zwerling and Harpreet Kaur will host a webinar addressing the legal and practical implications of job descriptions.
Protect Your Pharmacy’s Medicare and Medicaid Enrollment From Termination!
Pharmacy revocations for non-compliance with Medicare Part B and Durable Medical Equipment, Prosthetics, Orthotics and Supplies enrollment requirements are on the rise. Garfunkel Wild’s latest webinar in our Compliance Webinar Series discusses common risks and provides strategies to protect your pharmacy.
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.
NY AG Faces Major Setback in Fight for Control Over Nursing Home
On June 4, 2024, the New York State Supreme Court, Orleans County held that courts cannot appoint independent health care and financial monitors to make binding “recommendations” – the centerpiece of the New York State Attorney General’s campaign against for-profit nursing homes.
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.
NY Upholds Elimination of Nursing Home Residual Equity Reimbursement
The Court of Appeals recently upheld New York State’s elimination of residual equity, a capital cost component of Medicaid rates afforded to for-profit nursing homes with older facilities (the “Elimination”).
Lawsuit Challenges “Nightmare” Federal Nursing Home Minimum Staffing Mandate
On May 23, 2024, the AHCA filed a lawsuit challenging the CMS's Federal Minimum Staffing Mandate, calling it "irrational" and "unattainable" due to staffing shortages and lack of statutory authority.
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.
FCMA and HCMA Webinar – FTC Ruling on Employment Non-Compete Clauses
Garfunkel Wild's Salvatore Puccio and Elisabeth Pimentel will present "FTC Ruling on Employment Non-Compete Clauses" at the Fairfield County Medical Association and Hartford County Medical Association's Webinar on Thursday, May 16, 2024.
HIPAA Amendment Bolsters Privacy for Reproductive & Substance Use Disorder Care
The HIPAA Privacy Rule to Support Reproductive Health Care Privacy was recently announced as a final rule that becomes effective on June 25, 2024 (the “Final Rule”).
NYSHFA | NYSCAL Annual Conference & Expo
Garfunkel Wild will be a sponsor at NYSHFA| NYSCAL’s Annual Conference & Expo.
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).
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”).
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.
HHS-OIG’s Plan for Oversight of Managed Care Programs: How the New Plan Impacts Providers
This Health Care Compliance webinar session will review HHS-OIG’s recently issued strategic plan for oversight of Medicare Managed Care and discuss the impact these initiatives could have on providers who participate in Medicare Advantage plans.
Cybersecurity – It’s More Than HIPAA: NY Regulatory Refresher for 2024
Join the health care professionals of Garfunkel Wild and Withum as they dive into the technical, legal, and financial steps you will need to take to come into compliance with the new cybersecurity regulations for New York hospitals.
New York Adult Care Facilities: How to Obtain Medical Equipment Waivers
This session will explain the medical equipment waiver process and provide clarity on what steps Adult Care Facilities (ACFs) should take to get their waivers approved and remain compliant with State regulations.
Federal District Court Declares Corporate Transparency Act Unconstitutional
On March 1, 2024, the United States District Court for the Northern District of Alabama declared the Corporate Transparency Act (CTA) unconstitutional.
New York State Center for Assisted Living (NYSCAL) – Adult Care Facility (ACF) Medical Equipment Waivers and Equivalencies 101
This session will provide clarity on what steps ACFs should take to remain compliant with State regulations.
Nursing Home Alert: Dramatic Increase in NYS DOH Life Safety Code Citations
Nursing homes being cited for Life Safety Code (LSC) deficiencies by the New York State Department of Health (DOH) are on the rise. The difficulty achieving substantial compliance or obtaining a waiver places nursing homes at risk for termination from Medicare and Medicaid, denial of payments, and monetary penalties.
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.
Wolters Kluwer – The Road to Compliance: Understanding the Corporate Transparency Act and FinCEN Beneficial Ownership
Steven R. Antico and J. David Morrissy will break down the Beneficial Ownership Information Reporting Requirements and how the requirements will affect your business.
HFMA Metropolitan New York Chapter – 2024 Revenue Cycle Academy
Garfunkel Wild's Debra A. Silverman will present at the HFMA Metropolitan New York Chapter - 2024 Revenue Cycle Academy on February 9, 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.
FinCEN’s Beneficial Ownership Information Reporting Portal is Now Available
On January 1, 2024, the United States Department of Treasury’s Financial Crimes Enforcement Network ("FinCEN") opened its Beneficial Ownership Secure System ("BOSS") portal to the public and began accepting Beneficial Ownership Information Reports ("BOI Reports") from Reporting Companies pursuant to the Corporate Transparency Act (“CTA”).
Beware of Fraudulent Efforts to Obtain FinCEN Beneficial Ownership Information
This alert is intended to warn recipients to be wary of fraudulent notices demanding recipients to provide their Beneficial Ownership Information ("BOI") through channels other than those secured by FinCEN.
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.
The Road to Compliance: Understanding the Corporate Transparency Act and FinCEN Beneficial Ownership Reporting Requirements
As of January 1, 2024, many companies in the United States will have to file a Beneficial Ownership Information Report with FinCEN pursuant to the implementing regulations of the Corporate Transparency Act passed in 2021. Join us for an in-depth review of the Corporate Transparency Act.
New CMS Disclosure Requirements for Nursing Homes
On November 17, 2023, the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS) published a final rule (“Final Rule”) imposing new ownership disclosure requirements on Medicare skilled nursing facilities and Medicaid nursing facilities (“nursing homes”). Due to concerns over the quality of patient care in facilities owned by certain types of nursing facility owners, including private equity companies and real estate investment trusts, CMS believes these new disclosure requirements will allow them to monitor and hold nursing homes accountable.
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.
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
OIG Issues Unfavorable Opinion on Supplying Free Device
On October 25, 2023, the OIG posted Advisory Opinion 23-08, an unfavorable opinion regarding a cochlear implant manufacturer’s proposal to offer and provide a free compatible hearing aid to eligible patients.
New Corporate and Entity Ownership Reporting Requirement
Beginning on January 1, 2024, the Corporate Transparency Act (CTA) will require many companies to file a Beneficial Ownership Information (BOI) report with the Financial Crimes Enforcement Network (FinCEN).
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).
The Inside Scoop: A Behind-the-Scenes Look at HHS-OIG (Part III)
Join Garfunkel Wild’s Robert A. Del Giorno and David Traskey, former Senior Counsel with the HHS-OIG as they delve into HHS-OIG’s inner workings.
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.
The Inside Scoop: A Behind-the-Scenes Look at HHS-OIG (Part II)
Join Garfunkel Wild’s Robert A. Del Giorno and John G. Martin for a discussion with David Traskey, the firm’s newest Partner and former Senior Counsel with the HHS-OIG as they delve into HHS-OIG’s inner workings.
The Inside Scoop: A Behind-the-Scenes Look at HHS-OIG (Part I)
Join Garfunkel Wild’s Robert A. Del Giorno and John G. Martin for a discussion with David Traskey, the firm’s newest Partner and former Senior Counsel with the HHS-OIG as they delve into HHS-OIG’s inner workings.
HHS-OIG Posts Final Rule Implementing Information Blocking Penalties
On June 27, 2023, and in response to the 21st Century Cures Act (Cures Act), the U.S. Department of Health and Human Services, Office of the Inspector General (HHS-OIG) posted a final rule that amended its Civil Money Penalty (CMP) regulations to authorize penalties of up to $1 million per violation.
CHCANYS 2023 Finance University
Garfunkel Wild's Robert Del Giorno will present at the Community Health Care Association of New York State (CHCANYS) 2023 Finance University on June 14, 2023.
FQHC Enters Into Agreement To Resolve Disability Discrimination Complaint
On May 10, 2023, MCR Health, Inc. (“MCR” or the “Center”), a federally qualified health center (“FQHC”) based in Florida entered into a voluntary resolution agreement with the Department of Health and Human Services, Office of Civil Rights (“OCR”) to resolve a disability discrimination complaint against the Center.
Labs & Substance Abuse Providers: EKRA Enforcement Update
Given the government’s increasing enforcement of EKRA, now is a good time for providers to understand the enforcement landscape, understand EKRA’s application and to reassess potentially noncompliant compensation structures.
CMS’ Resumes No Surprise Act Independent Dispute Resolution Process
On March 17, 2023, the Centers for Medicare and Medicaid Services (“CMS”) announced that independent dispute resolution (“IDR”) process called for in the Federal No Surprises Act should resume, and that the IDR entities could again make payment determinations in disputes between out-of-network providers and health plans that are subject to the NSA.
The FTC’s Proposed Ban on Non-Competes – What Does It Mean?
On January 5, 2023, the Federal Trade Commission (“FTC”) announced and released a notice of proposed rulemaking (NPRM) to prohibit employers from entering into non-competes with workers, including independent contractors.
New York OMIG Releases Compliance Program Resources for Providers
On March 8, 2023, the New York Office of the Medicaid Inspector General (“OMIG”) posted materials on its website that provide further guidance on OMIG’s new regulations adopted on December 28, 2022.
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.
DOJ Announces Nationwide Voluntary Self-Disclosure Policy for US Attorney’s Offices
On February 22, 2023, the Department of Justice announced a new nationwide voluntary self-disclosure policy that gives companies the opportunity to receive a more favorable outcome when criminal misconduct is identified and the company chooses to voluntarily report the misconduct. The new voluntary self-disclosure policy applies to all United States Attorney’s Offices (“USAOs”) in the Country and it is effective immediately.
Payment Error Rate Measurement Program for Florida Medicaid and Chip Providers
On February 17, 2023, Florida Medicaid released a Health Care Alert reminding providers of their obligations under the Centers for Medicare and Medicaid Services (“CMS”) Payment Error Rate Measurement (“PERM”) program.
Franchise Regulations in the Context of the MSO Model
Associate, Weston Harty authored the article "Franchise Regulations in the Context of the MSO Model", published in the New York State Bar Association Health Law Journal (2023 - Vol. 28 - No.1).
Often Overlooked: Compliance Program Obligations Under Managed Care Agreements (For Providers in All States)
Garfunkel Wild’s Robert Del Giorno and Celia J. Morel will present the Webinar “Often Overlooked: Compliance Program Obligations Under Managed Care Agreements (For Providers in All States)” on January 19, 2023 from 12:00 PM - 1:00 PM ET.
Cultural Training and EMR Requirements for NJ Hospitals and Laboratories
Beginning January 18, 2023, New Jersey hospitals and clinical laboratories must demonstrate compliance with cultural competency requirements recently issued by the New Jersey Department of Health (“DOH”).
OMIG Adopts Significant New Compliance Program Regulations
On December 28, 2022, the New York State Office of the Medicaid Inspector General (“OMIG”) finalized a significant set of new compliance-related regulations. The rules were initially proposed on July 13, 2022 (see our prior Client Alert on the proposed rules here: https://www.garfunkelwild.com/insights/omig-proposes-significant-new-compliance-program-regulations). The final rules contain minimal revisions to the proposed regulations.
Prepare Now: Refresher on NY’s Compliance Program Proposed Regulations (For New York Providers)
Garfunkel Wild’s Robert Del Giorno and Peter M. Hoffman will present the Webinar “Prepare Now: Refresher on NY’s Compliance Program Proposed Regulations (For New York Providers)” on December 20, 2022 from 12:00 PM - 1:00 PM ET.
New York Nursing Home Staffing & Minimum Spending Regulations Have Been Officially Adopted: Is Your Nursing Home in Compliance?
On November 17, 2022, the New York Public Health and Health Planning Council (“PHHPC”) held a meeting (“Meeting”) to discuss the adoption of regulations addressing Direct Care Nursing Home Spending and Minimum Staff Requirements. The Department of Health (“Department”) first introduced these regulations on November 17, 2021, after which they were published in the Federal Register with a 60-day comment period that ended January 18, 2022. Due to a COVID related workforce shortage, Governor Kathy Hochul suspended the implementation of the regulations through April 1, 2022 and gave the Department until November 17, 2022 to hold a meeting to vote on the regulations.
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 […]
Nursing Home Facilities Need to Ensure Compliance with the Federal Arbitration Rule as Supreme Court Declines Review
On October 3, 2022, the Supreme Court of the United States denied the request to review the Eighth Circuit’s decision that upheld a federal rule that limited the use of arbitration agreements in nursing homes.
Health Care Hot Topics: Florida’s New Minimum Wage Requirements For Medicaid Providers
Garfunkel Wild's Susan St. John discusses the things providers need to know about the new minimum wage requirements, and a new civil cause of action for non-compliance.
Proposed New York State Legislation Concerning Nursing Homes and Adult Care Facilities
Garfunkel Wild has been constantly tracking and monitoring the status of all proposed nursing home and residential care facility legislation.
OMIG Proposes Detailed Self-Disclosure Program Regulations
On July 13, 2022, the New York State Office of the Medicaid Inspector General (“OMIG”) published a significant set of proposed compliance-related rules. If finalized, the new rules would repeal the existing regulations governing provider compliance programs (found in 18 NYCRR Part 521), and replace them with three new subparts concerning, respectively: (i) Compliance Programs (proposed 18 NYCRR Subpart 521-1); (ii) Medicaid Managed Care Organization Fraud, Waste and Abuse Prevention (proposed 18 NYCRR Subpart 521-2); and (iii) OMIG’s Self-Disclosure Program (“SDP”) (proposed 18 NYCRR Subpart 521-3).
OMIG Proposes Significant New Compliance Program Regulations
On July 13, 2022, the New York State Office of the Medicaid Inspector General (“OMIG”) published a significant set of proposed compliance-related rules. If finalized, the new rules would repeal the existing regulations governing provider compliance programs (found in 18 NYCRR Part 521), and replace them with three new subparts concerning, respectively: (i) Compliance Programs (proposed 18 NYCRR Subpart 521-1); (ii) Medicaid Managed Care Organization Fraud, Waste and Abuse Prevention (proposed 18 NYCRR Subpart 521-2); and (iii) OMIG’s Self-Disclosure Program (proposed Subpart 521-3).
OIG Approves Loan of Smartphones to Patients
In Advisory Opinion 22-08, posted on April 27, 2022, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) stated that it would not impose sanctions on a federally qualified health center (“FQHC”) that had loaned smartphones to its patients.
CMS Rescinds COVID-19 Emergency Declaration Blanket Waivers for Medicare Long-Term Care Facilities
On April 7, 2022, the Centers for Medicare & Medicaid Services (“CMS”) released a memorandum, QSO-22-15, announcing the restoration of certain minimum regulatory requirements that had been waived in response to the COVID-19 Public Health Emergency. CMS will end the waivers in two groups, under two time frames.
The Supreme Court Approves CMS Vaccine Mandate, but Halts OSHA Mandate
On January 13, 2022, the U.S. Supreme Court permitted the vaccine mandate for health care workers in facilities regulated by Centers for Medicare and Medicaid Services (CMS). Specifically, the CMS vaccine mandate requires all staff of facilities participating in Medicare/Medicaid to be vaccinated.
Reminder: NY Nursing Home Disclosure Requirement Goes into Effect October 1, 2021
As of October 1st, residential health care facilities must inform residents and their families regarding the availability of facility compliance information as part of an intake application. This disclosure must be in a separate document, in no less than twelve point font, and include the following:
New Disclosure Requirement for NY Residential Health Care Facilities
Effective October 1, 2021, residential health care facilities in New York will be required to provide potential residents and their families with a separate document, in no less than twelve point font, as part of their admission packet that includes the following information:
New Laws for New York Nursing Homes Will Take Effect on October 21, 2021
On June 11, 2021, Governor Cuomo signed Senate Bill S6767 into law. The amended law, which takes effect on October 21, 2021, will continue to greatly impact the ownership and operation of nursing homes in New York by imposing broad notice and contract disclosure requirements on nursing homes.
The NJ Health Care Transparency Act: Time is Running Out
The New Jersey Health Care Transparency Act (the “Act”) becomes effective on July 1, 2021. The Act requires health care professionals to clearly inform patients of their training and qualifications when they are providing in-person care to patients and when advertising their practice.
New York Hospital/Nursing Home Staffing Legislation Enacted
On June 18, 2021, Governor Cuomo signed into law two bills related to clinical staffing for hospitals and nursing homes. As reported in our prior Alerts, dated May 7, 2021:
New York DOH Issues Policy on Submission of False Information in License Applications
On June 11, 2021, the New York Department of Health (DOH) posted a “Dear Applicant Letter” informing applicants for certificates of need (CON), licensure for adult care facilities (ACF) or licensed home care services agencies (LHCSA) or transfer of ownership interest notices of its new policy regarding evaluation of the applicant’s character and competency.
New York / Federal Vaccine Requirements for LTC Facilities
In a Dear Administrator Letter (“DAL”) dated May 28, 2021, the New York State Department of Health highlights the differing requirements long-term care (“LTC”) facilities must meet regarding COVID-19 vaccinations under recent federal and state regulations.
Staffing Legislation Impacts New York Nursing Homes
On May 5, 2021, the New York State legislature approved two bills with differing requirements related to clinical staffing for hospitals and nursing homes. With a goal of improving both patient and staff safety, as well as patient outcomes, the Governor is expected to sign each bill (A07119 and A00108B) into law soon. This Alert addresses the requirements for nursing homes. Please see a separate Alert here addressing the hospital staffing requirements.
New OIG Opinion Permits FQHC to Offer Gift Cards to Patients
The Office of Inspector General (“OIG”) posted OIG Advisory Opinion 20-08 on Tuesday, December 30, 2020. The Opinion permits an FQHC to offer $20 gift cards to incentivize pediatric patients who have missed two (2) or more previously scheduled preventative and early intervention care appointments within the previous six (6) months.
OIG Issues Important New And Revised Safe Harbors
The United States Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) recently issued an important final rule (the “Final Rule”) that makes significant changes to existing “Safe Harbors” under the Federal Anti-kickback Statue (“AKS”) and that adds new Safe Harbors that provide protection from AKS sanctions for certain types of arrangements.
OIG Issues Special Fraud Alert Reiterating Concerns Regarding Speaker Programs
On November 16, 2020, the U.S. Department of Health and Human Services, Office of the Inspector General (the “OIG”) issued a Special Fraud Alert (“SFA”) emphasizing the fraud and abuse risks inherent in speaker programs run by pharmaceutical and medical device companies.
Garfunkel Wild Webinar – Health Home Audits and Investigations Are Here: Are You Ready?
Garfunkel Wild’s Peter M. Hoffman will present the webinar “Health Home Audits and Investigations Are Here: Are You Ready?" on November 19, 2020.
Changes To New York State Compliance Program Certification Requirements
Separate Annual SSL and DRA Certifications On OMIG’s Website No Longer Required; Replaced By Annual Certification Statements
New York Physician Practice Settings Must Inform Patients How To Report to OPMC
In legislation enacted on October 7, 2020, New York State is requiring physicians’ practice settings to post notice, visible to patients, that direct patients to the Office of Professional Medical Conduct’s (“OPMC’s”) website to obtain information about their rights and how to file a complaint regarding professional misconduct. The requirement is effective immediately.
Medicus IT Town Hall Webinar – Successfully Navigating the ‘New Normal’: What ASCs Need to Know
Andrew E. Blustein will present at Medicus It Town Hall Webinar – Successfully Navigating the ‘New Normal’: What Ascs Need to Know on September 16, 2020.
New York Proposes to Lift the Cap on Therapy Services Provided to Medicaid Recipients
On September 2, 2020, the New York State Department of Health submitted a proposal to the Centers for Medicare & Medicaid Services (“CMS”) to remove the annual Medicaid caps for physical therapy, occupational therapy, and speech therapy visits available to Medicaid recipients. The change, planned to take effect on October 1, 2020, would remove the current limitation on the number of therapy visits a Medicaid recipient may have and, in its place, allow medical necessity to dictate the number of visits a recipient can receive in a year.
New York Enacts Paid Sick Leave Reform
On April 3, 2020, New York State Governor Andrew Cuomo signed the fiscal year 2021 budget, which included an overhaul of statewide paid sick leave requirements under the New York State Labor Law. Under the new law, all employers must provide sick leave to their employees.
Residential Facilities Required to Create Pandemic Emergency Plans
New York State recently enacted legislation amending Public Health Law Section 2803 to require that each residential health care facility submit a pandemic emergency plan to the Department of Health no later than September 15, 2020, and annually thereafter.
Garfunkel Wild Webinar – “Practical Aspects for ASCs Reopening”
Garfunkel Wild will present the webinar “Practical Aspects for ASCs Reopening” on May 21, 2020.
New CMS Guidance for Nursing Homes Regarding Five Star Quality Rating System, Nursing Home Staffing and Additional FAQ’S
On April 24, 2020, the Centers for Medicare and Medicaid Services (“CMS”) issued a letter to State Agency Directors announcing that it will temporarily maintain the inspection rating for the Five Star Quality Rating System and that it will publish reported nursing home staffing levels to assist local governments in identifying nursing home needs. CMS also issued Frequently Asked Questions (“FAQs”) for nursing homes.
Confidentiality of Medical Information During the COVID-19 Crisis
The Equal Employment Opportunity Commission has issued new guidance for workplaces, dated April 17, 2020, as they start the process of preparing for the impending re-opening of their entities in the face of the Covid-19 pandemic.
Strafford CLE Webinar – National Practitioner Data Bank: Hospital Reporting Obligations, Reporting Immunity, and Physician Strategies
Garfunkel Wild Partner/Director Leonard M. Rosenberg will present at the Strafford Webinar – National Practitioner Data Bank: Hospital Reporting Obligations, Reporting Immunity, and Physician Strategies on April 22, 2020.
Garfunkel Wild Webinar – A State Update: How to Operationalize the Connecticut Administration’s Expectation Regarding Elective Cases in ASCs
Garfunkel Wild Vice Chairman Andrew E. Blustein and Lisa A. Winkler, Executive Director, Connecticut Association of Ambulatory Surgery Center will present the webinar “A State Update: How to Operationalize the Connecticut Administration’s Expectation Regarding Elective Cases in ASCs” on March 27, 2020.
Garfunkel Wild Webinar – COVID-19 Telehealth Rules Applicable to FQHCs
Garfunkel Wild’s Jeff Adest and Sandra Jensen will present the webinar “COVID-19 Telehealth Rules Applicable to FQHCs” on March 26, 2020.
Garfunkel Wild Webinar – COVID-19 Billing for Telemedicine Services and Q&A Session
Garfunkel Wild Partner/Director Debra A. Silverman and Partner Stacey L. Gulick along with Certified Professional Coder and President of ProCode Compliance Solutions, LLC, Alicia Shickle will present the webinar “COVID-19 Billing for Telemedicine Services and Q&A Session” on March 25, 2020.
Garfunkel Wild Webinar – Implementing and Expanding Telehealth to Address COVID-19
Garfunkel Wild Partner/Director Debra A. Silverman and Partners Stacey L. Gulick and Sandra M. Jensen will present the webinar “Implementing and Expanding Telehealth to Address COVID-19” on March 19, 2020.
Greater New York Health Care Facilities Association (GNYHCFA) Seminar – Regulatory Updates
Eve Green Koopersmith will present at the Greater New York Health Care Facilities Association’s (GNYHCFA) Seminar – Regulatory Updates – March 5, 2020.
Garfunkel Wild Webinar – 340B Contract Pharmacy Issues for FQHCs
Garfunkel Wild's Barbara Knothe will present the webinar “340B Contract Pharmacy Issues for FQHCs” on March 4, 2020.
Garfunkel Wild Webinar – Preparing for an OSV; Practical Tips
Garfunkel Wild presented the webinar “Preparing for an OSV; Practical Tips” on February 6, 2020.
New Hospital Financial Reporting Requirements in New Jersey
On January 21, 2020, Governor Phil Murphy signed bills A5916 and A5918 into law which are intended to increase the financial transparency of New Jersey hospitals and to ensure that such hospitals do not suddenly shut down, leaving residents without access to adequate health care in their respective communities as a result of a hospital’s financial distress.
Healthcare Financial Management Association’s (HFMA) Metropolitan New York Chapter Regulatory Compliance Seminar
Afsheen A. Shah will present at the Healthcare Financial Management Association’s (Hfma) Metropolitan New York Chapter Regulatory Compliance Seminar December 11, 2019.
Garfunkel Wild Webinar Series – Achieving Compliance & Operational Success for FQHCs – FTCA Compliance & Preparing for an FTCA Specific On-Site Visit – November 20, 2019
Garfunkel Wild will present the webinar “FTCA Compliance and Preparing for an FTCA Specific On-Site Visit” on November 20, 2019.
New York Department of Health Proposes Rule to Amend Licensed Home Care Services Agencies Regulation
A proposed rule was issued on November 6, 2019 to amend regulations regarding the approval of Licensed Home Care Service Agencies (“LHCSAs”). To comply with changes made to the Public Health Law in 2018, Subpart 765-1 of Title 10 NYCRR must be updated to include the new requirements of public need review and financial feasibility review. This Rule, effective April 1, 2020, would require the following:
Greater New York Health Care Facilities Association (GNYHCFA) Autumn Seminar
Eve Green Koopersmith will present at the Greater New York Health Care Facilities Association’s (GNYHCFA) Autumn Seminar on November 14, 2019.
Major Change to Office of Professions Procedure
The New York State Education Department (“SED”) has implemented a major procedural change, requiring that new professional practice entities submit an affidavit to SED when applying for Certificates of Authority to operate in New York State (whether in connection with original formation or foreign qualification to do business in New York). SED’s new process also requires that an affidavit be submitted for professional practice entity name changes.
Compliance with the New York Shield Act
he New York SHIELD Act has gone into effect today (October 23, 2019) and entities that maintain electronic information regarding New York residents will need to ensure compliance.
Fraud and Abuse – Lessons from Esformes Case
John Martin will present the “Fraud and Abuse – Lessons From Esformes Case” Webinar on September 18, 2019.
Nassau County Bar Association (NCBA) Hospital and Health Law Committee CLE – Recent Trends in Health Care Fraud Investigations
John G. Martin and Robert A. Del Giorno will present at the Nassau County Bar Association’s CLE – Recent Trends in Health Care Fraud Investigations on September 17, 2019.
OCR Settlement Emphasizes Importance of Patient Access to Information
On September 9, 2019, the Department of Health and Human Services, Office of Civil Rights (“OCR”) announced that Bayfront Health – St. Petersburg, a 480-bed Florida hospital (the “Hospital”), paid $85,000 to settle an investigation regarding the Hospital’s failure to provide one patient with timely access to her medical records. In its press release, the OCR emphasized that this settlement is consistent with its Patient Access Initiative, which was announced earlier this year.
New York Shield Act Modifies Breach Notification Requirements
On October 23, 2019, the Stop Hacks and Improve Electric Data Security (“SHIELD”) Act goes into effect and significantly modifies the existing New York State breach notification requirements, including the addition of new requirements for covered entities (e.g., all health care providers and health plans) to report HIPAA breaches to the New York State Attorney General, as well as the Federal Department of Health and Human Services, Office of Civil Rights (“OCR”).
Healthcare Financial Management Association (HFMA) 18th Annual Healthcare Conference
Debra A. Silverman will present at the Healthcare Financial Management Association’s (HFMA) 18th Annual Healthcare Conference on May 22, 2019.
New MOLST Forms and Checklists Published by DOH
The New York State Department of Health has made changes to the Medical Orders for Life Sustaining Treatment (MOLST) form and Nonhospital Order Not to Resuscitate, DOH Forms 5003 and 3474, respectively. These changes were made to comply with statutory changes, which granted authority to Nurse Practitioners to sign the MOLST and Nonhospital Order Not to Resuscitate.
Fairfield County Medical Association’s Webinar– Creating a Medical Record that Protects Your Patients, Your Practice and You
Barry B. Cepelewicz will present at the Fairfield County Medical Association’s Webinar – Creating a Medical Record that Protects Your Patients, Your Practice & You – March 6, 2019.
Medical Society of the State Of New York (“MSSNY”) and Garfunkel Wild in Discussions with Zocdoc
Zocdoc has announced that its pricing model for doctors in New York will change effective April 1, 2019. Zocdoc currently charges its customers a flat annual fee. Under the new pricing model, customers will pay a reduced annual fee, as well as a booking fee. The amount of the booking fee will vary based on the physician’s specialty.
David Traskey Discusses Potential Impact of Supreme Court Ruling on Federal Health Agency Fines with Politico Pro
David Traskey was quoted in a Politico Pro article discussing a Supreme Court decision that could significantly affect the federal health agencies' authority to impose fines.
David Traskey was Quoted in the Health Care Compliance Association’s Report on Medicare Compliance (Volume 33, Number 18)
David Traskey was quoted in the article, "Baptist Health Settles FCA Case Over Copay Waivers, Benefited From DOJ Cooperation Credit", in the Report on Medicare Compliance published by the Health Care Compliance Association (HCCA).
David Traskey was Quoted in the Health Care Compliance Association’s Report on Medicare Compliance (Volume 32, Number 43)
Garfunkel Wild’s David Traskey, Partner and former Senior Counsel with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) was quoted in the article, "Health System, Cardiologist Settle Related FCA Cases Over Cath Procedures, Admissions".
David Traskey was Quoted in the Health Care Compliance Association’s Report on Medicare Compliance
Garfunkel Wild’s David Traskey, Partner and former Senior Counsel with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) was quoted in the article, "Exagen Settles FCA Case for Restitution, Paid Physicians Specimen Fees Despite OIG Alert".
David Traskey Quoted in the Health Care Compliance Association’s Report on Medicare Compliance
In the article, David gives an OIG insider’s view of the self-disclosure protocol (SDP).
Law360 Article Highlights David Traskey Joining the Firm
Garfunkel Wild Chairman Andrew Blustein and Partners David Traskey and Robert A. Del Giorno, are quoted in a Law360 article, “Longtime Gov't Health Care Atty Joins Garfunkel Wild,” regarding David joining the firm.
Former HHS-OIG Senior Attorney Joins Garfunkel Wild
Garfunkel Wild is pleased to announce that David Traskey, former Senior Counsel with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG), has joined the firm as Partner in its Investigations, Audits, and Regulatory Compliance Practice Group.