On June 7, 2022, Governor Jared Polis signed into law the Colorado False Claims Act (CFCA) at Colo. Rev. Stat. Ann. § 24-31-101 et seq. The CFCA is largely based on the Federal False Claims Act (FCA), but is not an exact...more
It has been almost two years since the Centers for Medicare & Medicaid Services (CMS) first issued blanket waivers of certain hospital conditions of participation allowing healthcare systems and hospitals to provide hospital...more
In this second installment of this blog series on the No Surprises Act interim regulations (NSA) we discuss: i) notice and consent requirements for out of network providers providing services at participating health care...more
In this two-part blog series, we dive into the key points for telemedicine providers in the several hundred pages of the No Surprises Act interim regulations (NSA). The good news for the telemedicine industry is that the...more
On December 21, 2021, New Jersey amended its telemedicine laws via SB 2559. The new changes expressly allow the use of asynchronous store-and-forward telemedicine as a standalone modality, remove prior prohibitions on...more
The CMS vaccine rule -- which applies to the staff of many Medicare- and Medicaid-certified providers such as hospitals, long-term care facilities, home-health agencies, and hospices (“covered entities”), and which has...more
12/16/2021
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Employer Mandates ,
Executive Orders ,
Medicaid ,
Medicare ,
OSHA ,
Vaccinations ,
Virus Testing ,
Workplace Safety
When a company decides to self-disclose misconduct (or conduct that may be construed as such) to the government, that decision triggers a stream of additional questions. In the weighty deliberations about whether and what to...more
12/2/2021
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Disclosure Requirements ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Legal Representatives ,
Liability ,
OIG ,
Self-Disclosure Requirements ,
Suppliers
On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule that requires most Medicare and Medicaid certified providers and suppliers to vaccinate staff members within 60 days. The...more
11/8/2021
/ Anti-Discrimination Policies ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Employer Mandates ,
Executive Orders ,
Healthcare Workers ,
OSHA ,
Reasonable Accommodation ,
Religious Exemption ,
Rulemaking Process ,
Vaccinations ,
Virus Testing ,
Workplace Safety
New Jersey recently finalized regulations requiring all telemedicine or telehealth organizations providing telemedicine services to patients located in New Jersey to register with New Jersey’s Department of Health...more
...The Centers for Medicare & Medicaid Services (CMS) has proposed permanent Medicare coverage of audio-only mental health telehealth services. Currently, Medicare covers audio-only telehealth under temporary waivers that...more
The U.S. Food and Drug Administration (FDA) has continued to publish food safety updates relating to the coronavirus (COVID-19) pandemic throughout the pandemic. Foley’s Food and Beverage team have continued to monitor and...more
Not necessarily. In the past two weeks, the Office of Inspector General (OIG), the Department of Health and Human Services (HHS) watchdog, released two new FAQs regarding the Application of OIG’s Administrative Enforcement...more
The U.S. Food and Drug Administration (“FDA”) in March 2020 temporarily halted its domestic inspection program amid the coronavirus disease (COVID-19) pandemic. During this time, FDA continued to use other tools, including...more
On May 4, 2020, the Food and Drug Administration (FDA) updated its “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) | Immediately in Effect Guidance for Clinical Laboratories, Commercial...more
On Sunday, April 26th, the Centers for Disease Control and Prevention (CDC) and the Department of Labor (DOL) issued interim guidance specific to the meat and poultry processing industry to facilitate ongoing operations and...more
Massachusetts section below updated as of April 17, 2020 -
As the coronavirus pandemic grips the United States, many state and local governments have enacted stay in place restrictions that limit not only routine personal...more
In light of the COVID-19 public health emergency (Pandemic), on April 2, 2020, Governor Brad Little of Idaho issued a proclamation (Proclamation) that suspended 18 regulations (in addition to the 125 previously suspended...more
In the wake of the COVID-19 pandemic, the FDA has sought to expand the availability of needed personal protective equipment (PPE) for the general public and healthcare professionals. Recently, for example, FDA published two...more
4/7/2020
/ 510(k) RTA ,
Affordable Care Act ,
Centers for Disease Control and Prevention (CDC) ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicaid ,
Medical Devices ,
Medicare ,
Personal Protective Equipment ,
Prescription Drugs
As the coronavirus pandemic grips the United States, many state and local governments have enacted stay in place restrictions that limit not only routine personal activity but commercial activities as well. In the absence of...more
...The coronavirus (provisionally named SARS-CoV-2, with its disease being named COVID-19) has been documented in six of the world’s seven continents (sparing only Antarctica), in more than 70 countries and territories. More...more
3/6/2020
/ Beverage Manufacturers ,
Business Continuity Plans ,
Business Interruption ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Force Majeure Clause ,
Imports ,
Infectious Diseases ,
Material Adverse Change Clauses (MACs) ,
OSHA ,
Performance Standards ,
Public Health ,
Risk Management ,
Suppliers ,
Supply Chain ,
Supply Contracts ,
World Health Organization
Massachusetts Governor Charlie Baker has restarted the discussion on health care cost containment in the Commonwealth with a proposed bill that contains a raft of initiatives. Foley & Lardner LLP will be addressing each of...more