The FCA Insider

The FCA Insider

Insights and updates on False Claims Act Litigation

Category Archives: Regulatory

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OIG, Regulatory

Rural FQHC Can Provide Free Space for COVID-19 Vaccinations

As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement discretion would be provided for certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG established this process to provide… Continue Reading
OIG, Regulatory

Free FQHC COVID-19 Testing Approved by OIG

As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement discretion would be provided for certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG established this process to provide regulatory… Continue Reading
OIG, Regulatory

American Rescue Plan Funds OIG’s Provider Relief Fund Oversight

On March 11, 2021, President Joe Biden signed into law H.R. 1319, the American Rescue Plan Act of 2021. The American Rescue Plan’s $1.9 trillion in spending, contains numerous provisions impacting healthcare, including medical insurance, services delivery and providers. The American Rescue Plan also provides $5 million to the HHS Office of Inspector General (OIG)… Continue Reading
OIG, Regulatory

Per-Click Compensation for Philanthropic Entity’s COVID-19 Vaccine Site Low Risk of Fraud According to OIG

As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement discretion would be provided for certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG established this process to provide regulatory… Continue Reading
CMS Guidance, Regulatory, Stark Law

CMS statement clarifies agency’s view that the Stark Law final rule is effective

Industry publication BVWire quoted a statement from the Centers for Medicare & Medicaid Services (CMS) that gives healthcare providers more certainty to rely on the much heralded final rule modernizing the physician self-referral law (the Stark Law). The CMS statement stated, “The regulations finalized in [the final rule discussed in this post] are effective.” The… Continue Reading
CMS Guidance, Regulatory, Stark Law

Fraud and Abuse Rules Part V: Easing Stark Law Compliance

As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules that significantly amend the regulations to the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties (CMP) Law. This client alert, the final in McGuireWoods’ summary series on these final… Continue Reading
OIG, Regulatory

Fraud and Abuse Rules Part IV: Final Changes to Existing and New Anti-Kickback Statute Safe Harbors

As discussed in a prior McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules that significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties Law. The final rules discussed in this alert were originally given a Jan. 19, 2021, effective date.… Continue Reading
CMS Guidance, OIG, Regulatory, Stark Law

Fraud and Abuse Rules Part III: New Value-Based Arrangement Protections

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 federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties (CMP) Law. This client alert, the latest in McGuireWoods’ summary series on these final… Continue Reading
CMS Guidance, OIG, Regulatory, Stark Law

Fraud and Abuse Rules Part II: Amended EHR and New Cybersecurity Donation Safe Harbors and Exceptions

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 (Stark Law) and the federal Anti-Kickback Statute (AKS). This client alert, the latest in McGuireWoods’ summary series on these final rules, focuses… Continue Reading
OIG, Regulatory

Fraud and Abuse Rules Part I: Changes to Patient Inducement and Kickback Policies

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 (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties (CMP) Law. This client alert, the first in McGuireWoods’ summary… Continue Reading
Defense Arguments, OIG, Stark Law

MedMal Plaintiff Uses Anti-Kickback and Stark to Avoid Summary Judgment

A federal court recently allowed a plaintiff’s state law negligence claim, which utilized the Anti-Kickback Statute (“AKS”) and federal physician self-referral law (the “Stark Law”) as legal support to survive a motion for summary judgment. In Post v. AmerisourceBergen Corporation, No. 1:19-CV-73 (N.D.W. Va. Nov. 2, 2020), Plaintiff, Frances G. Post, filed suit against Defendants,… Continue Reading
DOJ, FCA Litigation, OIG

Eleventh Circuit Holds “Knowingly and Willfully” Does Not Require Motive for Kickback Recipient

A recent Eleventh Circuit opinion clarified the mens rea burden the Government must prove to establish criminal intent to violate the Federal Anti-Kickback Statute (“AKS”) for a recipient or payee of a kickback or bribe under 42 U.S.C. § 1320a-7b(b)(1), and affirmed a conviction against a healthcare provider.  The opinion in United States v. Alap Shah… Continue Reading
CMS Guidance, OIG, Regulatory, Stark Law

HHS Finalizes Stark Law, AKS Changes to Reduce Burdens on Healthcare Providers

On Nov. 20, 2020, the U.S. Department of Health and Human Services (HHS) published two long-awaited final rules significantly amending the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties (CMP) Law. These new rules are a direct result of HHS’ Regulatory Sprint to Coordinated Care, and largely adopt… Continue Reading
OIG, Regulatory

OIG Issues Special Fraud Alert That Challenges Industry Norms Regarding Speakers Programs

On Nov. 16, 2020, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued a special fraud alert addressing fraud and abuse concerns with speakers programs conducted by pharmaceutical and medical device companies. While the fraud alert reiterates historical OIG and Department of Justice (DOJ) concerns regarding speakers programs, it… Continue Reading
OIG, Regulatory

OIG Responds to Free/Discounted Lodging and Free Antibody COVID-19 Test Inquiries

As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement discretion would be provided for certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG established this process to provide… Continue Reading
OIG

HHS OIG Adds Audit of CARES Act Provider Relief Funds to Work Plan

On May 22, 2020, the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) updated its Work Plan to reflect its planned audit of the $50 billion disbursed by HHS to hospitals and other providers under the Public Health and Social Services Emergency Fund (Provider Relief Fund), which McGuireWoods most recently… Continue Reading
OIG, Regulatory

OIG Responds to Physician Group COVID-19 Personal Protective Equipment Arrangement Inquiry

As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement discretion would be provided for certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG established this process to provide… Continue Reading
OIG, Regulatory

OIG Updates Enforcement Responses to COVID-19 Arrangement Inquiries

As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement discretion would be provided for certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG established this process to provide… Continue Reading
Regulatory

Price Gouging Investigations Are Coming: What Industry Needs to Understand

In response to the national coronavirus health crisis, federal and state Attorneys General have elevated the investigation and prosecution of COVID-19-related crime, including price gouging, to the forefront of their enforcement priorities. Attorney General William Barr created a national COVID-19 task force staffed with attorneys from all 94 United States Attorney’s Office to coordinate expedited… Continue Reading
OIG, Regulatory

OIG Requests Inquiries on Enforcement Related to COVID-19 Arrangements

On April 3, 2020, OIG issued a process for inquiries to be submitted to OIG about the application of administrative enforcement authorities against certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG particularly asked for inquiries related to the Federal anti-kickback statute and civil monetary penalties prohibition on beneficiary inducements, where enforcement discretion… Continue Reading
OIG, Regulatory

OIG Follows the Stark Law COVID-19 Waivers for Anti-Kickback Statute

On April 3, 2020, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) issued a policy statement announcing that the OIG will exercise its enforcement discretion not to impose administrative sanctions under the federal Anti-Kickback Statute (AKS) for remuneration related to the 2019 novel coronavirus (COVID-19). OIG’s announcement follows… Continue Reading

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