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
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
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
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
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
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
The Centers for Medicare & Medicaid Services released a second, sweeping interim final rule in response to the coronavirus (COVID-19) pandemic on April 30, 2020. Building on the agency’s unprecedented March 31, 2020...more
CMS posted an expanded set, dated April 29, of Medicare regulatory flexibility measures for hospice organizations related to the coronavirus (COVID-19) pandemic, supplementing the previous COVID hospice flexibilities guidance...more
The Center for Medicare and Medicaid Services (CMS) released a far-reaching interim final rule (IFR) to address the coronavirus (COVID-19) pandemic on March 30. The IFR represents a comprehensive set of policy changes...more
On March 30, 2020, the Centers for Medicare & Medicaid Services released a stunning and far-reaching interim final rule to address the coronavirus (COVID-19) crisis. The rule is a comprehensive set of policy changes designed...more
CMS issued program instructions on March 17 (through a Fact Sheet and FAQ) to implement the Coronavirus Preparedness and Response Supplemental Appropriations Act (CPRSAA), which was enacted on March 6 in response to the...more
3/18/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Response ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare ,
OCR ,
Physicians ,
Public Health ,
Relief Measures ,
Telehealth ,
Telemedicine ,
Waivers
Following President Donald Trump’s national emergency declaration on March 13, the US Department of Health and Human Services has finalized licensure waivers that would permit physicians participating in Federal health care...more
3/17/2020
/ Children's Health Insurance Program (CHIP) ,
China ,
Coronavirus/COVID-19 ,
Crisis Management ,
Department of Health and Human Services (HHS) ,
Emergency Management Plans ,
Health and Safety ,
Health Care Providers ,
Infectious Diseases ,
Licensing Rules ,
Professional License ,
Public Health ,
Regulatory Requirements ,
Relief Measures ,
State and Local Government ,
Telehealth
As part of emergency funding to combat the threat of the 2019 Novel Coronavirus (COVID-19), last week Congress waived many of the telehealth restrictions for Medicare services in certain situations. This monumental change...more
3/10/2020
/ Anti-Kickback Statute ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Emergency Response ,
Federal Funding ,
Health and Safety ,
Health Care Providers ,
Infectious Diseases ,
Legislative Agendas ,
Medicare ,
Policies and Procedures ,
Public Health ,
Stark Law ,
Telehealth
In the Care Alternatives False Claims Act (FCA) appeal, a panel of the US Court of Appeals for the Third Circuit on March 4 reversed the summary judgment granted to hospice provider Care Alternatives at the district court,...more
3/6/2020
/ Appeals ,
Cooperative Compliance Regime ,
Department of Justice (DOJ) ,
Eligibility Determination ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Fraud ,
Hospice ,
Medicare ,
Medicare Billing Privileges ,
Qui Tam ,
Reversal ,
Risk Management ,
Whistleblowers
The Medicare Payment Advisory Commission (MedPAC), which advises Congress on Medicare issues, recently finalized and approved a series of recommended updates on January 16 that include payment reductions for hospice and home...more