On May 2, 2023, legislators approved the $229 billion New York State FY 2023-2024 Budget Bill (“the Budget”), which was signed by Governor Hochul on May 3, 2023. Article VII of the Budget touches almost every aspect of the...more
5/8/2023
/ Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Technology ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Home Health Care ,
Hospitals ,
Life Sciences ,
New York ,
Patient Privacy Rights ,
Reproductive Healthcare Issues ,
State Budgets
Proposed legislation from the New York State Executive Budget for 2024 includes significant changes to the state’s regulatory approach and authority over healthcare transactions. New York is following a trend on the state...more
On June 30, 2022, Governor Gavin Newsom signed the 2022-2023 California state budget, which included a trailer bill, Senate Bill 184 (the Bill) which makes numerous statutory revisions impacting health programs and consumers....more
1/20/2023
/ California ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Hospital Mergers ,
New Legislation ,
Patient Access ,
Regulatory Agencies ,
Regulatory Agenda ,
Regulatory Oversight
New York Governor Vetoes Act Prohibiting Establishment and Expansion of For-Profit Hospices -
On December 23, 2022, New York Governor Kathy Hochul vetoed Assembly Bill Number A8472 “An Act To Amend The Public Health Law,...more
1/6/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Elder Care ,
For-Profit Corporations ,
Governor Vetoes ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Hospice ,
Medicare ,
Medicare Part B ,
New York
On December 23, 2022, New York Governor Kathy Hochul vetoed Assembly Bill Number 8472 entitled “An Act To Amend The Public Health Law, In Relation To The Establishment, Incorporation, Construction, Or Increase In Capacity Of...more
1/5/2023
/ Elder Care ,
Elder Issues ,
For-Profit Corporations ,
Governor Vetoes ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Hospice ,
Long Term Care Facilities ,
New York ,
Skilled Nursing Facility
This fall, California Governor Gavin Newsom signed Assembly Bill No. 2673 (the Bill), which amends various sections of the California Health and Safety Code relating to hospice agencies. Among other things, the Bill prohibits...more
As the year comes to a close, the government has signaled a specific focus on clinical laboratories for 2023. On December 6, 2022, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued...more
CYBERSECURITY -
South Dakota Governor Bans State Workers from Using TikTok -
It is estimated that some 80 million Americans and more than one billion people use TikTok. It is well known that TikTok has a direct...more
On November 28, 2022, the Department of Health and Human Services (HHS) issued a proposed rule to modify the confidentiality protections of Substance Use Disorder (SUD) patient treatment records under 42 CFR Part 2 (Part 2)...more
11/30/2022
/ CARES Act ,
Comment Period ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Breach ,
Patient Rights ,
PHI ,
Proposed Rules ,
Substance Abuse
On October 17, 2022, the United States Department of Justice (DOJ) announced a $13 million settlement with health care services provider Sutter Health, which arose from alleged violations of the federal False Claims Act...more
On September 6, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-17 (Advisory Opinion), in which it declined to impose sanctions against a regional 501(c)(3) not-for-profit health care system that...more
10/31/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Enforcement Actions ,
FQHC ,
Fraud and Abuse ,
Health Care Providers ,
Health Clinics ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
OIG ,
Sanctions
On October 18, 2022, the Department of Justice (DOJ) announced two settlements with CHC Holdings, LLC, an Oklahoma limited liability company doing business as Carter Healthcare (Carter), and two former senior corporate...more
10/31/2022
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Insurance ,
Healthcare Fraud ,
Kickbacks ,
Medicare Fraud ,
Settlement Agreements ,
Stark Law ,
TRICARE ,
Whistleblowers
On October 17, 2022, the Supreme Court denied certiorari in three cases asking the court to resolve a circuit split regarding the application of the particularity pleading requirement for allegations of fraud in False Claims...more
Mark Schena, the President of Arrayit Corporation, has been found guilty by a jury for violations of the Eliminating Kickbacks in Recovery Act (EKRA), healthcare fraud, wire fraud, and securities fraud....more
9/13/2022
/ Bribery ,
Coronavirus/COVID-19 ,
Criminal Conspiracy ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Enforcement Actions ,
False Statements ,
Healthcare ,
Healthcare Fraud ,
Indictments ,
Kickbacks ,
Misleading Statements ,
Securities Fraud ,
Statutory Violations ,
Virus Testing ,
Wire Fraud
The Department of Health and Human Services Office of Inspector General (OIG) recently released a Data Brief summarizing the findings of a review of program integrity risks related to telehealth services reimbursed by...more
On August 18, 2022, New Jersey Governor Phil Murphy signed S-315, “An Act concerning changes in control of health care entities” (the Act). The Act implements employment protection for healthcare workers when certain licensed...more
9/7/2022
/ Change of Ownership ,
Compensation & Benefits ,
Employee Benefits ,
Employees ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Healthcare Provider Corporations ,
New Jersey ,
New Legislation ,
Succession Planning ,
Wage and Hour
On August 19, 2022, the Department of Health and Human Services (HHS), Department of Labor (DOL), and Department of the Treasury (DOT), released “Requirements Related to Surprise Billing: Final Rules” (the Rules). The Rules...more
8/26/2022
/ Billing ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Dispute Resolution ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
No Surprises Act (NSA) ,
Out of Network Provider ,
Out-of-Pocket Expenses ,
Surprise Medical Bills ,
U.S. Treasury
HHS-OIG issued a new Special Fraud Alert on relationships with “purported telemedicine companies” on July 20, 2022. The Special Fraud Alert comes on the heels of a nationally coordinated takedown charging dozens of...more
7/25/2022
/ Clinical Laboratories ,
Department of Health and Human Services (HHS) ,
Durable Medical Equipment ,
False Billing ,
False Claims Act (FCA) ,
Fraud Alerts ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
OIG ,
Telehealth ,
Telemedicine
What To Do When The Government Knocks On Your Lab’s Door -
The volume of federal enforcement actions involving laboratories has increased dramatically over the last few years. Not a month seems to pass without a press...more
7/15/2022
/ Clinical Laboratories ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Healthcare ,
Hospitals ,
Infectious Diseases ,
Life Sciences ,
Pharmaceutical Industry ,
Price Transparency ,
Virus Testing
On June 2, 2022, the New York State Legislature passed A08472, “An Act to Amend the Public Health Law, in Relation to the Establishment, Incorporation, Construction, or Increase in Capacity of For-Profit Hospice” (“the Act”)....more
The New York State Department of Health (DOH) recently released a “Dear Administrator Letter” (DAL) DHCSB 22-02 for Licensed Home Care Services Agencies (LCHSAs). The DAL addresses guidance and procedures for LCHAs as they...more
I. Biden Administration Requirement for Insurance Companies to Cover Cost of At-Home COVID-19 Tests -
On January 10, 2022, the U.S. Department of Health and Human Safety (HHS) announced that the Biden-Harris...more
1/12/2022
/ Billing ,
Coronavirus/COVID-19 ,
Employer Group Health Plans ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Infectious Diseases ,
Medical Reimbursement ,
New Regulations ,
Over The Counter Drugs (OTC) ,
Virus Testing
Effective October 25, 2021, the Federal Trade Commission (FTC) has adopted a new policy providing increased scrutiny of merger and acquisition activity for potential anti-competitive effects. The new policy applies to consent...more
At the start of the COVID-19 pandemic, each state and the federal government announced various states of public health emergencies which enabled them to suspend or modify various laws, rules, and regulations to accommodate...more
On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more
11/17/2021
/ 510(k) RTA ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Infectious Diseases ,
Life Sciences ,
New Guidance ,
Pharmaceutical Distribution ,
Pharmaceutical Industry ,
Premarket Approval Applications ,
Public Health