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
On September 17, 2020, the Office of Management and Budget received an Interim Final Rule for review from the Office of the National Coordinator for Health IT (ONC) entitled “Information Blocking and the ONC Health IT...more
In this installment of the Healthcare Enforcement Roundup we cover new and longstanding issues impacting the healthcare enforcement landscape. First, we explore the impact of the Coronavirus (COVID-19) on the healthcare...more
7/27/2020
/ 1135 Waivers ,
Compliance ,
Continuing Legal Education ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
e ,
False Claims Act (FCA) ,
Guidance Update ,
Health Care Providers ,
Hospitals ,
Objective Falsity ,
Physicians ,
Split of Authority ,
Stark Law ,
Whistleblowers
Under the Office of the National Coordinator for Health IT (ONC) 21st Century Cures Act final rule, effective July 1, 2020, health care providers, in their capacities as such, are not subject to civil monetary penalties....more
On April 21, 2020, the Centers for Medicare and Medicaid Services (CMS) issued explanatory guidance on the scope and application of a series of nationwide Section 1135 waivers of the physician self-referral law (Stark Law)...more
On April 21, 2020, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS) announced that they will...more
The Office of the National Coordinator for Health Information Technology recently released a final rule under the 21st Century Cures Act to promote interoperability of health IT and advance access, exchange or use of...more
The Centers for Medicare & Medicaid Services (CMS) published its highly anticipated final rule aimed at enhancing interoperability and increasing patient access to health information. CMS’s final rule will require hospitals...more
3/18/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Department of Health and Human Services (HHS) ,
Electronic Health Record Incentives ,
Final Rules ,
Health Care Providers ,
Hospitals ,
Information Technology ,
Medicaid ,
Medicare ,
Qualified Health Plans
ONC finalized changes to the certification criteria for application programming interfaces (APIs) that have the potential to improve the ability of patients to access electronic health information through a third party...more
The ONC's information blocking prohibition applies to certified health IT developers and health care providers, as well as health information exchanges and health information networks. It prohibits certain fees and other...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
Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product...more
1/29/2020
/ Anti-Kickback Statute ,
Biometric Information ,
California Consumer Privacy Act (CCPA) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Regulatory Standards ,
Stark Law ,
Telemedicine
To help accelerate the transformation of the US healthcare system from a fee-for-service to a value-based system, the US Department of Health & Human Services (HHS) launched its “Regulatory Sprint to Coordinated Care”...more
11/13/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Health Care Providers ,
Healthcare Reform ,
Incentives ,
Patients ,
Physicians ,
Proposed Rules ,
Regulatory Burden ,
Reimbursements ,
Safe Harbors ,
Self-Referral ,
Stark Law ,
Value-Based Care ,
Webinars
A recent update to the Office of Management and Budget (OMB) website suggests that the answer is “yes”—though that depends on how one defines “soon.” According to its website, OMB received the Office of the National...more
On October 9, 2019, the US Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) published proposed changes to the physician self-referral law (Stark Law). Physician practices are subject to...more
The Department of Health & Human Services’ (HHS) proposed changes to the Stark Law, the Anti-Kickback Statute, and the Civil Monetary Penalty Law, released today as part of the Regulatory Sprint to Coordinated Care, would...more
10/11/2019
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Exceptions ,
Health Care Providers ,
Healthcare Reform ,
Hospitals ,
OIG ,
Physicians ,
Proposed Rules ,
Public Comment ,
Regulatory Requirements ,
Safe Harbors ,
Stark Law ,
Value-Based Care
Introduction -
In this first installment of the Health Care Enforcement Quarterly Roundup for 2019, we continue to monitor trends we identified in 2018 and introduce new enforcement efforts that are expected to persist in...more
4/26/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
EHR ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Contractors ,
Health Care Providers ,
OIG ,
Opioid ,
Prescription Drugs ,
Qui Tam ,
Statute of Limitations ,
Telemedicine ,
The Granston Memo
The ONC recently released a proposed rule under the 21st Century Cures Act to promote interoperability of health IT and advance access, exchange or use of electronic health information. If finalized, the proposed rule would...more
3/28/2019
/ 21st Century Cures Act ,
APIs ,
Conditional Certification ,
Cost Recovery ,
Data Blocking ,
Data Privacy ,
Data Protection ,
Data-Sharing ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Information Technologies ,
License Fees ,
ONC ,
Proposed Rules
On February 6, 2019, the DOJ announced a settlement agreement with Greenway Health, a vendor of EHR software, under which Greenway agreed to pay approximately $57 million to resolve allegations that it caused its health care...more
2/26/2019
/ Anti-Kickback Statute ,
CEHRT ,
Department of Justice (DOJ) ,
Electronic Health Record Incentives ,
False Claims Act (FCA) ,
False Statements ,
Health Care Providers ,
Health Information Technologies ,
OIG ,
Settlement Agreements ,
Vendors
CMS issued a long-awaited proposed rule aimed at enhancing interoperability and increasing patient access to health information. If finalized, CMS’s proposed rule may require hospitals and payors to make significant...more
2/21/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Conditions of Participation (CoP) ,
Data Collection ,
Data-Sharing ,
Electronic Medical Records ,
Health Care Providers ,
Health Information Technologies ,
Hospitals ,
Medicaid ,
Medical Records ,
Medicare ,
Patient Access ,
Proposed Rules ,
Public Comment ,
Qualified Health Plans ,
Request For Information
The ONC finally released its long-awaited proposed rule to implement the “information blocking” prohibition of the 21st Century Cures Act by identifying conduct that is not information blocking. If finalized, ONC’s proposed...more
2/15/2019
/ 21st Century Cures Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Data Privacy ,
Data Protection ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Exceptions ,
Health Care Providers ,
Health Information Technologies ,
Hospitals ,
ONC ,
Patient Privacy Rights ,
Policies and Procedures ,
Proposed Rules ,
Public Comment ,
Regulatory Agenda ,
Regulatory Requirements
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
Introduction -
The past year was an active one for data privacy and security legislation and enforcement. Protection for certain personal data was enhanced internationally by the EU General Data Protection Regulation...more
1/29/2019
/ Biometric Information ,
Biometric Information Privacy Act ,
California Consumer Privacy Act (CCPA) ,
Cybersecurity ,
Data Protection ,
Digital Health ,
Electronic Protected Health Information (ePHI) ,
EU ,
General Data Protection Regulation (GDPR) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Personally Identifiable Information ,
State Data Breach Notification Statutes ,
UK
The Office of Inspector General, Department of Health and Human Services posted an unusual negative Advisory Opinion (AO 18-14) on a drug company’s proposal to provide free drugs to hospitals for use with pediatric patients...more
A massive bill intended to address the nation’s opioid crisis is about to become law—the House overwhelmingly voted in favor of the SUPPORT for Patients and Communities Act (H.R. 6) on Friday, September 28, 2018, and the...more