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Alerts

CMS Announces Payment Program for Providers Impacted by Change Healthcare Cyberattack

On March 9, 2024, the U.S. Department of Health and Human Services and Centers for Medicare & Medicaid Services (CMS) announced it will make available Change Healthcare/Optum Payment Disruption accelerated payments to Part A providers and advance payments to Part B suppliers experiencing potentially significant cash-flow problems as a result of the recent cyberattack on UnitedHealth Group’s subsidiary Change Healthcare/Optum (CHOPD Payments).
Alerts

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, pursuant to an action brought by the National Small Business Association (NSBA) and its members against Janet Yellen, in her official capacity as the Secretary of the Treasury (Government).
Alerts

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. 
 
Alerts

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.
Alerts

Governor Hochul Proposes Significant Changes to CDPAP and to LHCSA Enrollment in Medicaid

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

Hospitals Should Consider Legal Action to Resolve Medicare Advantage 340B Drugs Underpayments

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

OSHA’s New Reporting Requirement for Certain Employers

As of January 1, 2024, employers with 100 or more employees in certain high-hazard industries, including some defined health care providers, must submit electronically to OSHA detailed information concerning workplace injuries and illnesses reported on their OSHA Form 300 Log and Form 301 Incident Report from the previous calendar year via OSHA’s new Injury Tracking Application.  
Alerts

New Jersey Medicaid Will Now Reimburse for Services Billed by Social Workers, Counselors

On January 8, 2024, New Jersey passed a law that permits Clinical Social Workers, Professional Counselors, and Marriage and Family Therapists to bill NJ Medicaid/NJ FamilyCare directly for services rendered to Medicaid beneficiaries.
Alerts

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. 
 
Alerts

Beware of Fraudulent Efforts to Obtain FinCEN Beneficial Ownership Information

On January 1, 2024, pursuant to the Corporate Transparency Act (the "CTA"), the Financial Crimes Enforcement Network ("FinCEN"), a bureau of the United States Department of Treasury, began accepting Beneficial Ownership Information Reports ("BOI Reports") from eligible Reporting Companies. 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. 
Alerts

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”).  
Alerts

The Department of Labor Issues Final Rule for Independent Contractor Classification

On January 10, 2024, the United States Department of Labor (DOL) published a long-awaited final rule addressing when employers should classify workers as independent contractors or employees under the Fair Labor Standards Act (FLSA).  
Alerts

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.  
Alerts

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.  
Alerts

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). 
Alerts

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.  
Alerts

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. 
Alerts

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.  
Alerts

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. 
Alerts

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.
Alerts

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.
Alerts

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). 
Alerts

2023 Year-End Estate Planning Opportunities

Estate planning has been challenging in recent years.  Drastic changes were proposed, but not enacted, and a major reduction to the Federal estate tax exemption is scheduled for 2026.  What we do know is that the sooner you act, the more options you have to save estate taxes for your family.  
Alerts

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.
Alerts

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.
 
Alerts

Second Circuit Decision Undercuts Lawsuits Against NYS Nursing Homes

The U.S. Court of Appeals for the Second Circuit decision held that while nursing homes have a general obligation to adequately care for their residents, there is no specific requirement that nursing homes use Medicaid or Medicare reimbursement payments in a certain way because such payments are reimbursements for services already provided to residents, and do not contain “forward-looking conditions” on how the funds must be used. 
Alerts

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.  
Alerts

New York DOH Adopts New Requirements for All Adult Care Facilities

On November 15, 2023, the DOH adopted new regulatory requirements for adult ACFs in an effort to expand resident rights in conformance with the CMS’s HCBS rule final rule. ACFs across the State are now required to allow residents to have visitors at any time, giving them unrestricted access to common areas.
Alerts

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
Alerts

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.
Alerts

Estate Planning Awareness Month: Advance Directives, Explained

This alert discusses Advance Directives, including the Durable Power of Attorney, Health Care Designation, and Living Will, which are essential components of every estate plan.

 
Alerts

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).
Alerts

340B Hospital Cost Report Waiver Ends

In 2020, HRSA waived its requirement that off-site, outpatient hospital facilities be listed as reimbursable on the hospital’s most recently filed Medicare Cost Report, and registered on OPAIS, prior to participating in the 340B program. On October 26, 2023, HRSA released a notice confirming that this waiver has ended. 
Alerts

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). 
 
Alerts

Florida Medicaid Dental Provider Incentive Program

Beginning October 1, 2023, the Agency for Health Care Administration initiated the Dental Provider Incentive Program (“DPIP”). This program is designed to provide bonus reimbursements for those providers treating Medicaid patients who have prioritized the improvement of oral health in Florida.
 
Alerts

Estate Planning Awareness Month: Using Revocable Trusts in Your Estate Plan

In honor of National Estate Planning Awareness Month, Garfunkel Wild, P.C. wants to remind you of the importance of creating and maintaining an estate plan.  Below we provide an overview of the Revocable Trust, an essential part of any estate plan.
 
Alerts

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. 
Alerts

Health Care Providers May Spend Millions Settling Private Pixel Tracking Lawsuits

The use of online tracking technologies has led to multi-million dollar lawsuits alleging that health systems are revealing private information, including personal health information, to third parties such as Google and Meta.  
Alerts

OMIG Updates Self Disclosure Program With Streamlined Process for Routine Overpayments

On August 21, 2023, the New York State Office of the Medicaid Inspector General (OMIG) updated its Self-Disclosure Program to provide a new pathway for all Medicaid-program entities and providers to report, return, and explain overpayments.
Alerts

CMS Releases Updated Request for Applications for New Making Care Primary Model

On August 14, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a request for applications for the Making Care Primary (MCP) Model, its newest innovation program aimed at improving patient care by supporting the delivery of advanced primary care services
Alerts

Temporary Health Care Staffing Agencies Now Required to Register in New York

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

Connecticut Signals Increased Scrutiny of Physician Practice Acquisitions

On July 21, 2023, the Executive Director of the Connecticut Office of Health Strategy (“OHS”), sent a letter to Connecticut physicians reminding them of the requirement for certain practice transactions to obtain Certificate of Need (“CON”) approval prior to closing. 
Alerts

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. 
Alerts

A Ban on Non-Competes in New York Could Be Law…Soon

On June 20, 2023, the New York State legislature passed a bill that would ban new non-compete restrictive covenants for most employees.  
Alerts

Connecticut Modifies Physician Non-Compete Law, Extends Protections to APRNs and PAs

Effective July 1, 2023, Connecticut modifies its law governing physician covenants not to compete and extends non-compete protections to advanced practice registered nurses (“APRNs”) and physician assistants (“PAs”). Physicians, APRNs, PAs, and their employers will need to evaluate current non-competition provisions and revise, as needed, to comply with the new law.
Alerts

CMS Issues Final Rule Ending COVID-19 Vaccination Requirements

On June 5, 2023, the Centers for Medicare and Medicaid Services (“CMS”) published a much anticipated Final Rule surrounding vaccination and related requirements surrounding the COVID-19 Public Health Emergency.
Alerts

New Jersey Permits Entity Conversion and Domestication

On May 8, 2023, New Jersey Governor Phil Murphy signed into law Senate Bill S142 (now P.L.2023, c. 38) (the "Act"), which modifies applicable business filing statutes contained in the New Jersey Business Corporation Act by adding conversion and domestication provisions across all business entity types. 
Alerts

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.
Alerts

New Jersey Publishes Notice of Proposed Rulemaking for ABA Licensure Regulations

The Board proposed new regulations regarding the practice of ABA therapy in New Jersey, including, for example, licensing standards for applied behavior analysts and assistant applied behavior analysts, reciprocity requirements, scope of services, business practices, and telehealth requirements.  
 
Alerts

DEA Proposes Temporary Rule that Impacts In-Person Requirements

The Federal Drug Enforcement Administration (“DEA”) announced that it has submitted a draft temporary rule to extend the COVID-19 PHE flexibilities around prescribing controlled substances (the “Temporary Rule”).