The recent increase in use of telehealth as a care modality has been important to patients and providers alike, with significant benefits for public health. However, with the growing mainstream acceptance of virtual care, the...more
The Centers for Medicare & Medicaid Services on July 7 released its proposed rule for the Medicare physician fee schedule for Calendar Year 2023. Among other updates, the proposed rule contains significant programmatic...more
The federal COVID-19 public health emergency’s (PHE) current expiration date is just one week away—July 14, 2022. While no official extension has been issued by the Biden-Harris administration yet, it is increasingly likely...more
Physician Partners of America LLC, a physician practice management company, denies that it violated the False Claims Act by billing Federal health care programs for medically unnecessary testing, among other allegations. The...more
Fraud stemming from the COVID-19 pandemic continues to be a criminal enforcement priority for the US Department of Justice (DOJ). On April 20, DOJ announced a new round of criminal charges against 21 defendants that stem from...more
Perhaps signaling the increasing likelihood of a permanent telehealth solution for the Medicare program, the Office of Inspector General for the US Department of Health and Human Services (OIG) has established a “Featured...more
Last month, we had an engaging Fast Break session covering the growing importance of risk adjustment in various health insurance programs and novel government theories of liability associated with risk adjustment reporting....more
In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more
2/25/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Data Protection ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Regulatory Oversight ,
Telehealth ,
Telemedicine
The US Supreme Court issued two decisions on January 13, 2022 in cases challenging the Occupational Safety and Health Administration’s (OSHA’s) Emergency Temporary Standard (ETS) on Vaccination and Testing and the Centers for...more
1/17/2022
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Constitutional Challenges ,
Coronavirus/COVID-19 ,
Employer Liability Issues ,
Employer Mandates ,
Infectious Diseases ,
OSHA ,
SCOTUS ,
Stays ,
Vaccinations ,
Virus Testing ,
Workplace Safety
Last month, we had an engaging Fast Break session covering compliance topics regarding healthcare professionals’ relationships with pharmaceutical and medical device manufacturers. We were joined by Terrence Burek, senior...more
The Centers for Medicare & Medicaid Services released its CY 2022 Physician Fee Schedule final rule on November 2 reflecting the Biden-Harris administration’s goal of increasing access to and quality of care and reducing...more
11/15/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Health Care Providers ,
Medicare Part B ,
MIPS ,
Payment Rates ,
Physician Fee Schedule ,
Physician Medicare Reimbursements ,
Physicians ,
Telehealth ,
Telemedicine
In our latest Fast Break session and on the heels of recent announcements from the Biden-Harris administration and the US Food and Drug Administration’s (FDA’s) granting of full authorization for the Pfizer vaccine in August,...more
We hosted a very informative Fast Break session last month on CMS telehealth and RPM updates. If you weren't able to join us, the session was led by healthcare litigation associates Jake Harper and Tesch West, with special...more
We hope you were able to join us for our July Fast Break on the US Court of Appeals for the Fourth Circuit's recently affirmed $114 million judgment in United States v. Mallory. If not, you missed a great session, featuring...more
The Centers for Medicare & Medicaid Services (CMS) recently released a table copy of its calendar year 2022 Medicare physician fee schedule proposed rule. The proposed rule is chock full of policy updates concerning...more
We hosted a very informative Fast Break session last week discussing what healthcare providers need to know as they prepare their employees to return to work and try to get back to a sense of normalcy. ...more
Last month we had an incredibly insightful Fast Break analyzing a significant HIPAA enforcement victory for The University of Texas MD Anderson Cancer Center (MD Anderson) in the US Court of Appeals for the Fifth Circuit. ...more
The US Department of Health and Human Services Office of Inspector General (OIG), the Department of Justice (DOJ), and other federal regulators have grown increasingly concerned about the use of telehealth technologies by...more
With coronavirus (COVID-19) vaccines on the horizon amid the surging pandemic, critical extensions expand the scope of liability immunity under the PREP Act....more
12/9/2020
/ Civil Liability ,
Coronavirus/COVID-19 ,
Countermeasures ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Immunity ,
Infectious Diseases ,
Medical Malpractice ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Telehealth ,
Vaccinations
Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare...more
11/25/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Healthcare Reform ,
OIG ,
Rulemaking Process ,
Safe Harbors ,
Stark Law ,
Value-Based Care
DOJ recently announced a massive coordinated effort with other federal agencies to charge 345 defendants allegedly responsible for over $6 billion in fraud. DOJ, OIG, FBI, DEA, and various US Attorneys’ Offices in 51 federal...more
During the coronavirus (COVID-19) pandemic, we have seen a dramatic shift from in-person visits to telehealth services around the globe, unveiling what may be the new normal for providing healthcare services....more
8/14/2020
/ China ,
Coronavirus/COVID-19 ,
Germany ,
Health Care Providers ,
Infrastructure ,
Patient Access ,
Singapore ,
Telehealth ,
Telemedicine ,
United Arab Emirates (UAE) ,
United States
US President Donald Trump issued an executive order on August 3 that aims to expand telehealth access to Medicare beneficiaries beyond the coronavirus (COVID-19) public health emergency (PHE) period. ...more
8/5/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Health Care Providers ,
Medicare ,
Patient Access ,
Relief Measures ,
Telehealth ,
Telemedicine ,
Trump Administration
Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight,...more
7/9/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Immunity ,
Product Defects ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Risk Mitigation ,
Suppliers ,
Supply Chain ,
Telehealth
Texas Governor Greg Abbott issued Executive Order No. GA-27 on June 25 relating to the need for increased hospital capacity during the coronavirus (COVID-19) pandemic. As COVID-19 numbers in Texas surge, the order aims to...more