• In 2021, HITECH was amended to add “recognized cybersecurity practices” as a mitigating factor when determining fines, audits and remedies against covered entities and business associates for violations of HIPAA....more
On Feb. 9, 2022, U.S. Senators Bill Cassidy (R-LA) and Tammy Baldwin (D-WI) introduced S. 3620, the Health Data Use and Privacy Commission Act.
The bill proposes to create a Commission on Health Data Use and Privacy...more
Recent advancements in sensor technology and data transmission methods stand to benefit clinical trials by facilitating data collection through digital health technologies (DHTs). The U.S. Food and Drug Administration (FDA)...more
On July 1, 2021, Georgia’s new anti-kickback statute related to substance abuse patient brokering began prohibiting payment, or the offer of remuneration, to induce the referral of a patient to or from a substance abuse...more
In response to the COVID-19 public health emergency (PHE), many states expanded access to healthcare via telehealth through regulatory waivers. Experts have speculated how governments will regulate and reimburse telehealth...more
On January 21, 2021, the Department of Health and Human Services (HHS) published proposed modifications to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for...more
As of late March 2021, 475 million people worldwide have received a COVID-19 vaccine. Although a return to normalcy is drawing closer, it is unclear how state and federal governments will regulate and reimburse for telehealth...more
Technology is affecting the way healthcare is delivered daily — and health technology, focused on facilitating and enabling healthcare functions, is creating new opportunities for private equity investors....more
On November 4, 2020, the Office of the National Coordinator for Health Information Technology (ONC) published an Interim Final Rule with Comment Period (IFC) that delays compliance dates necessary to meet certain requirements...more
As discussed in a previous McGuireWoods alert, the Department of Health and Human Services (HHS) published final rules, effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law (Stark Law), the...more
1/21/2021
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Fraud and Abuse ,
Health Care Providers ,
OIG ,
Physicians ,
Safe Harbors ,
Stark Law ,
Value-Based Care
Passed by Congress Dec. 21, 2020, and signed by President Donald Trump Dec. 27, 2020, the $1.4 trillion omnibus Consolidated Appropriations Act, 2021 (H.R. 133), includes numerous statutory provisions that directly affect...more
As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules expected to be effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law...more
1/13/2021
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Cost-Sharing ,
Cybersecurity ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
EHR ,
Fraud and Abuse ,
Health Care Providers ,
OIG ,
Physicians ,
Popular ,
Safe Harbors
On September 15, 2020, Doctor Akikur R. Mohammad, a California resident and drug treatment facility owner, pled guilty before the U.S. District Court of New Jersey for violating the Eliminating Kickbacks in Recovery Act...more
This alert is part of a series discussing the comprehensive actions taken by the Centers for Medicare & Medicaid Services in response to the COVID-19 pandemic that are most important to healthcare providers....more
On March 30, 2020, Christi A. Grimm, Principal Deputy Inspector General of the Department of Health and Human Services (HHS) Office of Inspector General (OIG), issued a letter to the OIG’s website outlining the OIG’s...more
On December 19, 2019, the Department of Justice (DOJ) announced that Van Andel Research Institute (VARI) has agreed to pay $5.5 million to resolve allegations that it violated the False Claims Act by submitting grant...more
As discussed in an Oct. 9 alert, the Department of Health and Human Services announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute and the Civil...more