Alerts
DEA Extends Telemedicine Prescription Rules Through 2025
The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) have jointly issued a third emergency extension allowing health care practitioners to prescribe Schedule II-V controlled substances via audio-video telemedicine encounters without an initial in-person evaluation. This extension, effective from January 1, 2025 through December 31, 2025, also provides the DEA with additional time to finalize permanent regulations for prescribing controlled substances through telemedicine.
Alerts
Changes on the Horizon May Affect Your Estate Plan
Here is an overview of certain estate and gift tax rules currently in effect, the changes on the horizon, and ways you can save estate taxes for your family.
Alerts
NYS Department of Health Pauses Implementing New Patient Consent Requirements
On October 18, 2024, the New York State Department of Health issued guidance pausing implementation of Public Health Law §18-c, a new law that prohibits providers from obtaining a patient’s consent to pay for any health care service prior to the patient receiving the service.
Alerts
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.
Alerts
New Nationwide Patient Assessment Tool for Hospices
The Centers for Medicare and Medicaid Services (CMS) has developed a new patient evaluation tool called Hospice Outcomes Patient Evaluation (HOPE) that will replace the current tool, Hospice Item Set (HIS). Hospices will be required to use HOPE for all patient admissions after October 1, 2025.
Alerts
Remote Patient Monitoring Under the Microscope
The U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) released a Report outlining concerns about the rapid growth of and significant oversight gaps in the Centers for Medicare & Medicaid’s (“CMS”) use of remote patient monitoring (“RPM”) services, particularly with traditional Medicare patients (the “Report”). Given RPM’s dramatic growth, especially since the COVID-19 pandemic, the Report likely foreshadows OIG enforcement actions in this area.
Alerts
New York Enacts Alarming Patient Consent Requirements
NYS Public Health Law 18-c, a new law set to become effective on October 20, 2024, will prohibit providers from obtaining a patient’s consent to pay for any health care services prior to the patient receiving services.
Alerts
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”).
Alerts
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.
Alerts
Federal Rule Released to Address Mental Health Coverage Parity
The Federal Departments of Treasury, Labor, and Health and Human Services released final rules strengthening consumer protections for patients seeking mental health and substance use disorder treatments. Despite 15 years since the enactment of the Mental Health Parity and Addiction Equity Act (MHPAEA), barriers still exist, preventing individuals from receiving adequate coverage for these issues.
Alerts
New Jersey Issues Medicaid Update on FQHC Billing for LCSWs
In June 2024, the New Jersey Department of Human Services, Division of Medical Assistance & Health Services (the Division), issued a Newsletter announcing the ability of Licensed Clinical Social Workers (LCSWs) to enroll as billing providers in NJ FamilyCare/Medicaid for claims with service dates on or after July 1, 2024. This month, the Division issued a Medicaid Alert advising Federally Qualified Health Centers (FQHCs) how they are affected by this change.
Alerts
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).
Alerts
NYS Department of Health Issues Proposed PACE Regulations
On August 7, 2024, the New York State Department of Health’s (DOH) proposed regulations for a new, unified licensure process for Program of All-Inclusive Care for the Elderly (PACE) organizations were published in the New York State Register. The proposed regulations implement New York Public Health Law (PHL) Article 29-EE, which was enacted in 2022. The proposed regulations, if adopted, will impact PACE organizations that are currently operating, as well as entities with pending and future PACE applications.
Alerts
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.
Alerts
Back to School Legal Issues
As the summer draws to a close, that fall back-to-school feeling comes back for many of us and it’s an excellent time to put your estate planning in order and see if any updates should be made.
Alerts
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 generated from committees established to meet CMS or other New Jersey quality assurance or process improvement purposes is not protected by the privilege, even if such committees conduct a self-critical analysis).
Alerts
Preparing for the FTC's Ban on Non-Competes
Many clients are asking whether the Federal Trade Commission (FTC) ban has gone into effect and, if not, what the status is currently. As we reported previously, the FTC enacted a nationwide ban on most non-compete agreements, subject to certain narrow exceptions, that was anticipated to take effect on September 4, 2024. Since that time, however, multiple court challenges have been filed, testing the validity of the ban.
Alerts
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.
Alerts
New York Nursing Homes to Receive Additional 1% Medicaid Rate Increase
On July 16, 2024, the New York State Department of Health (DOH) announced in a letter to nursing home administrators that nursing homes across the state will receive an additional 1% increase in their Medicaid rate after receiving Centers for Medicare and Medicaid Service (CMS) approval.
Alerts
NY Hospital & Long Term Care Legislative Update
Garfunkel Wild’s 2023-24 Legislative Session Update newsletter will keep you up to date on relevant legislation introduced in New York State, particularly involving hospitals and long term care facilities.
Alerts
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.
Alerts
NY Issues Statewide Fiscal Intermediary RFP
As we reported in a prior alert titled "NY Upends CDPAP Fiscal Intermediary Framework", the New York State (NYS) budget for fiscal year 2025 significantly changed who can be a Fiscal Intermediary (FI) under the state’s Consumer Directed Personal Assistance Program (CDPAP).
Alerts
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.
Alerts
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.
Alerts
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.
Alerts
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”).
Alerts
Scam Alert: Fake IRS Form 9710 Targeting Businesses
Fraudsters use fake “Form 9710” to target businesses in an attempt to steal information, including the entity’s identity and/or the owners/officers’ identities. Newly formed entities, such as corporations, partnerships, and limited liability companies, in particular, are being targeted. New entities often receive fake Internal Revenue Service (IRS) mailings and solicitations, which are scams.
Alerts
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.
Alerts
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.
Alerts
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”).
Alerts
New Jersey Now Requires Licensure for the Practice of Applied Behavior Analysis
Pursuant to the New Jersey Applied Behavior Analyst Licensing Act (the “Act”), the Board of Applied Behavior Analyst Examiners (the “Board”) published the official rules concerning the practice of Applied Behavior Analyst (“ABA”) therapy, effective May 6, 2024 (the “Rules”).
Alerts
New York Mandates Paid Prenatal Leave
When passing its final budget for the 2025 fiscal year, New York became the first state in the United States to require employers to provide their pregnant workers paid sick time for health care services, testing, or procedures that relate to their pregnancy.
Alerts
NY Upends CDPAP Fiscal Intermediary Framework
The recently enacted New York State (NYS) budget for fiscal year 2025 significantly changed who can be a Fiscal Intermediary (FI) under the state’s Consumer Directed Personal Assistance Program (CDPAP). This change was made by amendment to Social Services Law (SSL) § 365-f by eliminating the CDPAP request for offers (RFO) process that was in place for designating FIs (RFO #20039).
Alerts
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”).
Alerts
DOL Issues Final Rule Expanding Overtime Eligibility Nationwide
On April 23, 2024, the Department of Labor (DOL) issued a final rule expanding eligibility for overtime pay (the Rule). This is a federal rule and will set the floor for eligibility for overtime pay nationwide. Individual states may require even higher minimum salary thresholds.
Alerts
NJ Supreme Court Vacates $23.4M Award Against Valley Hospital
On April 16, 2024, the Supreme Court of New Jersey issued its decision in Comprehensive Neurosurgical, P.C. v. The Valley Hospital. In an over 60-page unanimous opinion, the Court vacated a 23.4 million dollar award against Valley Hospital.
Alerts
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.
Alerts
FQHC Look-Alike Application Blackout Period: Changes are Coming
The Health Resources and Services Administration (HRSA) has announced that it will not be accepting Federally Qualified Health Center (FQHC) Look-Alike Initial Designation (LAL-ID) applications for approximately one month starting in late June.
Alerts
CMS Announces Payment Program for Providers Impacted by Change Healthcare Cyberattack
On March 9, 2024, CMS announced it will make available Change Healthcare/Optum Payment Disruption accelerated payments to providers experiencing potentially significant cash-flow problems as a result of the cyberattack on UnitedHealth Group’s subsidiary Change Healthcare/Optum .
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.
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
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).