On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more
12/19/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Digital Health ,
False Claims Act (FCA) ,
Healthcare ,
Incentives ,
Investors ,
Medicare ,
OIG ,
Private Investment Funds ,
REIT ,
Shareholders ,
Transparency
The US Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) are extending telehealth flexibilities that allow providers to prescribe controlled substances. While the...more
5/11/2023
/ Controlled Substances ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
OIG ,
Public Health Emergency ,
Rulemaking Process ,
SAMHSA ,
Substance Abuse ,
Telehealth ,
Telemedicine
Digital health is one of the fast-growing segments of the healthcare market, with patients, clinicians and regulators increasingly aligned behind the opportunities that digitization presents.
Over the last three years,...more
3/21/2023
/ Controlled Substances Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Digital Health ,
Dobbs v. Jackson Women’s Health Organization ,
Healthcare Fraud ,
Medicare ,
New Legislation ,
New Regulations ,
OIG ,
Proposed Legislation ,
Proposed Regulation ,
Public Health Emergency ,
Roe v Wade ,
State and Local Government ,
State Legislatures ,
Telehealth ,
Telemedicine
In a request for information issued on January 5, 2022, the White House Office of Science and Technology Policy (OSTP) announced that it is seeking input from stakeholders across the healthcare spectrum on how digital health...more
1/26/2022
/ Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Community Health Systems ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Executive Orders ,
Healthcare ,
National Institute of Health (NIH) ,
OSTP ,
Request For Information
In a fourth amendment to the March 17, 2020, Public Readiness and Emergency Preparedness Act (PREP Act), the US Department of Health and Human Services (HHS) has expanded access to COVID-19 Covered Countermeasures through...more
12/9/2020
/ Coronavirus/COVID-19 ,
Countermeasures ,
Department of Health and Human Services (HHS) ,
Fourth Amendment ,
Health Care Providers ,
Immunity ,
Licenses ,
Medical Licensure Compact ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
State and Local Government ,
Telehealth
The US Department of Justice and the US Department of Health and Human Services Office of Inspector General recently announced a significant healthcare fraud takedown involving $4.5 billion in allegedly false and fraudulent...more
The Centers for Medicare & Medicaid Services (CMS) continues to loosen the conditions for participation in Medicare, as well as specific reimbursement requirements, to ensure facilities and practitioners are able to practice...more
As healthcare providers face surging demand for services arising out of the COVID-19 pandemic, they are simultaneously dealing with related equipment, space and workforce limitations. In this environment, the US Department of...more
4/1/2020
/ Anti-Discrimination Policies ,
Best Practices ,
Business Continuity Plans ,
Coronavirus/COVID-19 ,
Crisis Management ,
Department of Health and Human Services (HHS) ,
Disability Discrimination ,
Infectious Diseases ,
Policies and Procedures ,
Public Health ,
Risk Management ,
Workplace Safety
In a March 24, 2020, letter, Secretary of Health and Human Services Alex Azar asked state governors to take immediate action to modify state law and regulations to extend the capacity of the healthcare workforce to address...more
3/27/2020
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Governors ,
Healthcare Workers ,
Medical Students ,
Nurses ,
Out-of-State Residents ,
Public Health Emergency ,
Secretary of HHS ,
State Medical Board ,
Telemedicine
On March 24, 2020, the US Department of Health and Humans Services Office of Inspector General (OIG) issued guidance regarding OIG’s March 17, 2020, policy statement on reductions or waivers of cost-sharing obligations owed...more
On March 4, 2020, the House passed the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, a bipartisan bill to aid in COVID-19 preparedness and response. The bill includes, among other things,...more
The Department of Health and Human Services released its draft 2020-2025 Federal Health IT Strategic Plan for public comment. This article outlines the goals of the plan, as well as challenges in healthcare that ONC hopes the...more
2/4/2020
/ 21st Century Cures Act ,
CEHRT ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Health Care Providers ,
Information Technology ,
Medical Research ,
Patient Privacy Rights ,
PHI ,
Strategic Planning ,
Technology ,
Value-Based Care
Certain long-standing laws, such as the civil monetary penalty provision prohibiting patient inducements, have hampered providers’ ability to fully leverage remote patient monitoring and other telehealth tools. Many...more
In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...more
2/6/2019
/ ACOs ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Corporate Integrity Agreement ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Health Record Incentives ,
Enforcement Actions ,
Health Care Providers ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
OIG ,
Popular ,
Regulatory Reform ,
Request For Information ,
Telehealth ,
Telemedicine
As previously noted in our Digital Health Mid-Year Review, 2018 has seen greater acceptance of telemedicine within the Medicare program. Both regulatory and statutory changes have expanded reimbursement opportunities and,...more
Introduction -
Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more
1/10/2018
/ 21st Century Cures Act ,
Artificial Intelligence ,
Biometric Information ,
Consumer Protection Act ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Health Insurance ,
Life Sciences ,
OIG ,
Privacy Policy ,
Research and Development ,
TCPA ,
Telehealth
The promise of health care reform by the incoming administration will result in significant changes; but understanding how those changes may flow through to digital health industry requires an analytic framework that...more
For many decades, at least since the passage of the Health Maintenance Organization Act of 1973, there have been reform efforts focused on moving the United States health care system away from fee-for-service (FFS)...more
Earlier this month, a bipartisan group, led by U.S. Senator Brian Schatz (D-Hawaii), introduced a bill in the Senate focused on promoting cost savings and quality care under the Medicare program through the use of telehealth...more