On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more
7/15/2025
/ Advisory Opinions ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Healthcare ,
Hospitals ,
Manufacturers ,
Medical Devices ,
OIG ,
Penalties ,
Safe Harbors ,
Third-Party Service Provider
On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 25-03 (Opinion), which provided favorable guidance for physician practices seeking to contract with...more
On June 9, 2025, Oregon Governor Tina Kotek signed S.B. 951 into law (the "Bill"), which significantly limits a common "PC/MSO" model allowing management services organizations (MSO) to provide administrative services to a...more
Investment in the healthcare industry requires careful consideration, as it involves numerous distinct areas of the law. Venable's Private Equity Investment in Healthcare webinar series explores the unique issues and timely...more
12/24/2024
/ Acquisitions ,
Complex Corporate Transactions ,
Corporate Practice of Medicine ,
Disclosure Requirements ,
Due Diligence ,
Health Care Providers ,
Hospitals ,
Licensing Rules ,
Mergers ,
Operational Permits ,
Permits ,
Private Equity
Investment in the healthcare industry requires careful consideration, as it involves numerous distinct areas of the law. Venable's Private Equity Investment in Healthcare webinar series explores the unique issues and timely...more
8/2/2024
/ Acquisitions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Corporate Practice of Medicine ,
Covered Transactions ,
Due Diligence ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Mergers ,
Physicians ,
Portfolio Companies ,
Privacy Laws ,
Private Equity ,
Risk Mitigation
In a monumental opinion issued today, the U.S. Supreme Court in Loper Bright Enterprises v. Raimondo overruled Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., holding (6-3) that deference to an agency's...more
7/1/2024
/ Administrative Procedure Act ,
Chevron Deference ,
Chevron v NRDC ,
Constitutional Challenges ,
Government Agencies ,
Judicial Authority ,
Loper Bright Enterprises v Raimondo ,
National Marine Fisheries Service ,
Regulatory Authority ,
Relentless Inc v US Department of Commerce ,
SCOTUS ,
Stare Decisis ,
Statutory Interpretation ,
Unconstitutional Condition
The use of technology in healthcare services and payment for healthcare is evolving at an unprecedented pace, reshaping how medical services are delivered, managed, and paid for. The use of artificial intelligence systems...more
3/25/2024
/ Algorithms ,
Anti-Discrimination Policies ,
Artificial Intelligence ,
Bias ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Consent ,
Final Rules ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
PHI ,
Software
After a nearly two-year delay, the U.S. Department of Health & Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office for Civil Rights, promulgated a Final Rule...more
On December 23, 2024, New York Governor Kathy Hochul signed the LLC Transparency Act (LLCTA) into law, but not without a considerable compromise relative to its original form...more
In a significant stride toward expanding access to addiction treatment services, the Substance Abuse and Mental Health Services Administration (SAMHSA) published, on January 31, its Final Rule allowing telehealth access to...more
There has been increasing government interest in obtaining ownership information with respect to the class of commercial real estate comprising nursing facilities. Specifically, the government is focused on nursing home...more
1/12/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Commercial Leases ,
Commercial Property Owners ,
Leases ,
Nursing Homes ,
Ownership Interest ,
Private Equity ,
Private Equity Firms ,
Property Owners ,
Proposed Rules ,
REIT ,
Skilled Nursing Facility ,
Transparency
The Federal Corporate Transparency Act (the CTA), 31 U.S.C. §5336, will soon require certain entities to disclose to the U.S. Treasury's Financial Crimes Enforcement Network (FinCEN) certain pieces of identifying information...more
12/8/2023
/ Anti-Money Laundering ,
Beneficial Owner ,
Centers for Medicare & Medicaid Services (CMS) ,
Corporate Transparency Act ,
Covered Entities ,
Disclosure Requirements ,
Exemptions ,
Filing Deadlines ,
Financial Crimes ,
FinCEN ,
Foreign Entities ,
Health Care Providers ,
Healthcare Facilities ,
Medicaid ,
Medicare ,
National Security ,
Regulatory Requirements ,
Reporting Requirements ,
Shell Corporations
Join Venable’s Ari J. Markenson, partner in the Healthcare and Corporate practices, as he talks with Pete Tedesco, managing director at Avesi Partners, about their perspectives on the healthcare services investment landscape....more
On October 13, 2023, the Department of Health and Human Services Office of Inspector General (the OIG) released an advisory opinion regarding a multi-specialty physician practice's (the Practice) proposed plan to pay bonuses...more
This August, a working group sponsored by the National Association of Insurance Commissioners (the "NAIC") unanimously approved revisions to the NAIC's Unfair Trade Practices Act Model #880 (the "Model Law") to restrain...more
9/20/2023
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
False Marking ,
Health Insurance ,
Insurance Industry ,
Lead Generators ,
Marketing ,
Medicaid ,
Medicare ,
NAIC ,
Open Enrollment ,
The Model Law ,
Unfair or Deceptive Trade Practices ,
Working Groups
On July 13, 2023, the Centers for Medicare & Medicaid Services (CMS) announced a proposal to significantly expand behavioral health coverage provided under Medicare. The proposal, presented as a part of the calendar year 2024...more
8/9/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Treatment ,
Health Care Providers ,
Medicare ,
Mental Health ,
Outpatient Services ,
Physician Fee Schedule ,
Prescription Drugs ,
Proposed Rules ,
Substance Abuse
On July 10, 2023, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule (Proposed Rule) that would (i) include hospices in the 36-month rule ownership transfer restrictions that currently exist for home...more
7/28/2023
/ Accreditation ,
Centers for Medicare & Medicaid Services (CMS) ,
Change of Ownership ,
Dispute Resolution ,
Elder Abuse ,
Elder Issues ,
Fraud ,
Fraud Abuse and Waste ,
Fraud and Abuse ,
Home Health Agencies ,
Hospice ,
MACs ,
Medicare ,
Proposed Regulation ,
Prospective Payment System (PPS) ,
Regulatory Agenda ,
Regulatory Reform ,
Screening Procedures ,
Transfer Restrictions
New York recently joined a growing number of states enacting legislation that increases oversight of certain healthcare transactions. Article 45-A of the 2024 Executive Budget is titled "Disclosure of Material Transactions"...more
6/12/2023
/ ACOs ,
Acquisitions ,
Certificate of Need ,
Corporate Sales Transactions ,
Disclosure Requirements ,
Healthcare Facilities ,
Hospital Mergers ,
Hospitals ,
Joint Venture ,
Mergers ,
New Regulations ,
State Attorneys General ,
State Budgets ,
State Health Departments
On June 1, 2023, the U.S. Supreme Court issued a unanimous opinion in United States ex rel. Schutte v. SuperValu Inc. reversing a pair of False Claims Act (FCA) cases on review from the Seventh Circuit Court of Appeals. In...more
6/7/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Fraud ,
Medicaid ,
Medicare ,
Objective Falsity ,
Objective Standard ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Qui Tam ,
Reasonable Interpretations ,
Scienter ,
SCOTUS ,
Subjective Standard ,
Universal Health Services Inc v United States ex rel Escobar ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
The recently released New York State Executive Budget for 2024 includes proposed legislation that would significantly expand the state's regulatory authority over healthcare transactions. The bill introduces Article 45-A...more
2/17/2023
/ Acquisitions ,
Corporate Practice of Medicine ,
Healthcare Facilities ,
Hospitals ,
Investors ,
Mergers ,
Physician Hospital Organizations ,
Physician-Owned Hospitals ,
Private Equity ,
Regulatory Oversight ,
State Budgets ,
State Health Departments
On June 30, 2022, California Governor Gavin Newsom signed SB-184 into law, which, among other things, created a new Office of Health Care Affordability (OHCA) within the CA Department of Health Care Access and Information. ...more
As states roll back emergency provisions that allowed out-of-state providers to offer telehealth services during the COVID 19 pandemic, more permanent changes in interstate telehealth are under way. In April 2022, the...more
There are many things to consider if you plan to invest in middle-market healthcare professional practice management (PPM) businesses this year. The hypercompetitive market, combined with residual effects of the pandemic, has...more
In January 2020, Alex M. Azar, II, then secretary of the U.S. Department of Health and Human Services (HHS), signed a nationwide declaration of a Public Health Emergency (PHE) that would largely shape the response of public...more
12/1/2022
/ Advance Notice ,
Children's Health Insurance Program (CHIP) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Infectious Diseases ,
Medicaid ,
Medicare ,
Notice Requirements ,
Public Health Emergency ,
Secretary of HHS ,
Social Security Act ,
Waivers
The transaction marketplace for physician practices is incredibly active for physician owners, transaction lawyers, financing sources, consultants, tax advisors, and many other stakeholders. Whether it’s health systems and...more