The Justice Department continues to pile up healthcare enforcement actions — false claims, anti-kickback, and fraud. DOJ is on its way to a record year....more
The Anti-Kickback Statute (AKS) protects healthcare beneficiaries from the influence of money in their medical decision-making. Overall, the AKS criminalizes renumeration “intended to induce patient referrals or influence the...more
Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements between the U.S....more
The Department of Justice (DOJ) and U.S. Attorney’s Offices have been quite busy settling False Claims Act (FCA) cases during the first month and a half of 2021. Two recent FCA lawsuits based, at least in part, on allegations...more
On January 19, 2021, significant changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law) went into effect. The sweeping changes come...more
CMS and OIG released highly anticipated final changes to the rules implementing the Stark Law, the safe harbors issued under the Anti-Kickback Statute (AKS) and the beneficiary inducements provision in the civil monetary...more
On Friday of last week, HHS published two long-awaited final rules implementing significant changes to the regulations under the Stark Law and Anti-Kickback Statute (AKS). The two final rules are: (i) Revisions to the Safe...more
On November 20, 2020 the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of the Inspector General (OIG) issued two final rules to modernize and clarify the Physician...more
On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) each published a final rule (collectively, the Final...more
Health care providers looking for long-awaited answers to new proposed rules changes governing physician self-referral arrangements may have to wait a bit longer. ...more
The Situation: Though not universal, Electronic Health Records ("EHR") technology adoption is now widespread in the health care industry. And, while an existing safe harbor under the federal Anti-Kickback Statute ("AKS") and...more
Connecticut healthcare providers should give heed to three sets of recently proposed rules issued by the U.S. Department of Health & Human Services (HHS) interpreting some of the federal laws relating to electronic health...more
As discussed in a previous McGuireWoods alert, on Oct. 9, 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...more
In its second quarter Securities Exchange Commission (SEC) filing, Allscripts addressed its announced agreement in principle with the Department of Justice (DOJ) to resolve investigations into certain alleged practices of...more
Greenway Health LLC, a Tampa-based developer of electronic health records (EHR) software, recently agreed to pay $57.25 million to resolve False Claims Act (FCA) allegations that it overstated the capabilities of and failed...more
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
The Department of Justice (DOJ) recently announced two high-dollar False Claims Act (FCA) enforcement actions involving allegedly fraudulent arrangements tied to the implementation and use of electronic health record systems...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
On October 6, 2015, the Office of Inspector General (OIG) of the Department of Health and Human Services issued OIG Policy Reminder: Information Blocking and the Federal Anti-Kickback Statute, which “reminds” providers that...more
For those of us who work in the privacy and security space this past week has been a whirlwind with focus on the ramifications of the European Court of Justice (ECJ) decision invalidating the EU-U.S. Safe Harbor Agreement....more