In this installment of our post-Dobbs risk assessment series for hospitals and academic medical centers, we consider the ongoing impact of Dobbs v. Jackson Women’s Health Organization on delivery of clinical services beyond...more
As more states adopt consumer data privacy laws, Nevada and Washington stand out for their recent passage of legislation aimed specifically at protecting “consumer health data.” Both states’ laws are notably broad in their...more
The recently passed Consolidated Appropriations Act (CAA) of 2023 includes a new Stark Law exception and Anti-Kickback Statute (AKS) safe harbor, allowing hospitals and other health care entities to offer their physicians...more
6/13/2023
/ Anti-Kickback Statute ,
Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Healthcare ,
Hospitals ,
Medicare ,
Mental Health ,
Physicians ,
Safe Harbors ,
Stark Law ,
Wellness Programs
Telehealth experienced massive growth during the COVID-19 pandemic, due in no small part to various regulatory and reimbursement policies that federal agencies implemented following a declaration by the US Department of...more
6/6/2023
/ CARES Act ,
Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare ,
OCR ,
Public Health Emergency ,
Regulatory Agenda ,
Reimbursements ,
SAMHSA ,
Telehealth
On February 17, 2023, the US Department of Health and Human Services Office for Civil Rights (OCR) released two companion reports to Congress detailing its actions in 2021 to enforce the privacy, security, and breach...more
4/4/2023
/ Audits ,
Civil Monetary Penalty ,
Compliance ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Hackers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Technology ,
OCR ,
PHI
In the landmark case of Dobbs v. Jackson Women’s Health Organization, the US Supreme Court overturned its prior rulings in Roe v. Wade and Planned Parenthood of Southeastern Pennsylvania v. Casey, which had recognized a...more
With the new year underway, the ArentFox Schiff Health Care team highlights 10 of the most pressing legal issues facing the industry in 2023.
End of the COVID-19 Public Health Emergency. After being in effect for more than...more
2/17/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Dobbs v. Jackson Women’s Health Organization ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Healthcare ,
HIPAA Privacy Rule ,
Inflation Reduction Act (IRA) ,
No Surprises Act (NSA) ,
Popular ,
Proposed Rules ,
Public Health Emergency ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS ,
Telehealth
With the start of the new year, the ArentFox Schiff Hospitality Industry team reviews 10 of the most pressing legal issues for hospitality companies in 2023.
1. Potential Down Market Pressures. Interest rate increases are...more
1/5/2023
/ Artificial Intelligence ,
Brand ,
Compliance ,
Coronavirus/COVID-19 ,
Data Privacy ,
Environmental Social & Governance (ESG) ,
Franchise Agreements ,
FTC Act ,
Greenwashing ,
Hospitality Industry ,
Intellectual Property Protection ,
Interest Rate Adjustments ,
Investment ,
Labor Shortage ,
LEED Certified ,
Metaverse ,
NASAA ,
NLRB
Since the US Supreme Court ruled in Dobbs v. Jackson Women’s Health Organization (Dobbs) in June 2022, the impact of the Court’s decision continues to ripple across the health care delivery system. In this multi-part series,...more
12/9/2022
/ Abortion ,
Centers for Medicare & Medicaid Services (CMS) ,
Dobbs v. Jackson Women’s Health Organization ,
EMTALA ,
Environmental Social & Governance (ESG) ,
Hospitals ,
Planned Parenthood of Southeastern Pennsylvania v Casey ,
Reproductive Healthcare Issues ,
Risk Assessment ,
Roe v Wade ,
SCOTUS
Most violations of the Health Information Portability and Accountability Act (HIPAA) are addressed through administrative enforcement action. But, in some circumstances of improper conduct affecting the privacy or security of...more
In Advisory Opinion 22-17, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) concluded that a proposed restructuring of a loan and other contractual relationships between a health system...more
9/30/2022
/ Anti-Kickback Statute ,
Debt Restructuring ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Federal Health Care Programs (FHCP) ,
HRSA ,
Liens ,
Master Service Agreement ,
Medicaid ,
Medicare ,
OIG ,
Patient Referrals ,
Quality of Care Standards ,
Regulatory Oversight ,
Safe Harbors
The recently unveiled California Health and Human Services Data Exchange Framework (the Framework) creates a new regulatory and governance structure to promote the exchange of health information between health care providers...more
9/9/2022
/ California ,
Data Privacy ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Governance Standards ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Medi-Cal ,
PHI ,
Physicians ,
Policies and Procedures
In a newly filed lawsuit against the State of Idaho, the federal government argues that Idaho’s “near-total ban on abortion,” scheduled to take effect on August 25, 2022, overreaches by prohibiting abortion even where federal...more
On July 20, 2022, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert cautioning physicians and other health care practitioners to use “heightened scrutiny” when entering into telemedicine arrangements that...more
8/1/2022
/ Anti-Kickback Statute ,
Bribery ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Durable Medical Equipment ,
Enforcement ,
False Claims Act (FCA) ,
Fraud ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicare Fraud ,
OIG ,
Telehealth ,
Telemedicine
The HHS Office for Civil Rights (OCR) recently imposed a $50,000 civil monetary penalty on a dental practice that disclosed patient-identifying information in response to a negative online review. The case is a reminder that...more
8/1/2022
/ Business Development ,
Civil Monetary Penalty ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Online Reviews ,
PHI ,
Risk Management ,
Social Media ,
Websites
According to guidance published by the Centers for Medicare and Medicaid Services (CMS) on July 11, 2022, EMTALA, the Emergency Medical Treatment and Labor Act of 1986, requires hospitals to provide abortion services when...more
7/28/2022
/ Abortion ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
EMTALA ,
First Amendment ,
New Guidance ,
Planned Parenthood ,
Planned Parenthood of Southeastern Pennsylvania v Casey ,
Pregnancy ,
Religious Institutions ,
Roe v Wade ,
SCOTUS
In Khoiny v. Dignity Health, the California Court of Appeal held that hospital residency programs are primarily employment programs and medical residents are primarily employees. Therefore, courts should not give special...more
The US Department of Health and Human Services’ (HHS) declaration that COVID-19 remains a public health emergency (PHE) will continue through July 15, 2022, and is expected to be renewed again through October 13, 2022....more
6/23/2022
/ California ,
Centers for Medicare & Medicaid Services (CMS) ,
CMIA ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Public Health Emergency ,
Public Health Service Act
The metaverse is widely regarded as the next frontier in digital commerce, with businesses across all industries spending millions of dollars to acquire a digital presence for positioning as market leaders. While it offers...more
6/14/2022
/ Artificial Intelligence ,
Blockchain ,
Cryptocurrency ,
CVS ,
Data Privacy ,
Digital Assets ,
Digital Marketplace ,
Fraud ,
Healthcare ,
Internet of Things ,
Licenses ,
Metaverse ,
Non-Fungible Tokens (NFTs) ,
Telehealth ,
Trademarks ,
Virtual Reality
Physician-owned companies that generate revenue from the sale of medical devices ordered by their physician owners have in recent years been the target of federal fraud and abuse enforcement actions. OIG Advisory Opinion...more
The HHS Office for Civil Rights is requesting comments about HIPAA covered entities’ and business associates’ implementation of “recognized security practices” and payments to “harmed individuals” from funds the agency...more
The US Department of Health and Human Services Office of Inspector General (OIG) recently published a favorable determination, Advisory Opinion 22-06, on behalf of a biopharmaceutical company (the Requestor) regarding the...more
Hospitals and Other Providers Should Make Sure Any Items or Services of Value That They Provide to Their Referring Physicians To Alleviate Burnout Comply With the Stark Law -
Amidst the ongoing labor market shortages and...more
4/27/2022
/ American Medical Association ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Hospitals ,
Labor Shortage ,
Medicare ,
Physicians ,
Public Health Emergency ,
Remuneration ,
Stark Law ,
Work-Induced Stress