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OIG to Expand Informal Guidance with New FAQs

The Office of Inspector General (OIG) has announced that it is expanding the topics it considers for new Frequently Asked Questions (FAQs) submitted by healthcare stakeholders. OIG will now answer general questions about the...more

OIG Permits Healthcare Organization’s Smartphone Loan Program For Telehealth Services

On April 22, 2022, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion (no. 22-08) (the “Advisory Opinion”) approving a healthcare organization loaning...more

OIG Removes Mandatory Cost-Sharing Obligations for COVID-19 Ambulance Transport Waiver

As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative...more

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...more

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...more

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...more

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...more

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...more

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...more

Stark Law and Anti-Kickback Statute Reform: Six Key Insights for Private Equity Healthcare Affiliations

Two new healthcare fraud and abuse final rules, effective Jan. 19, 2021, may increase flexibility for private equity firms exploring opportunities in the healthcare space as well as private equity-backed healthcare platforms...more

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...more

HHS Extends Timeline to finalize Stark Law Changes and CMP Inflation Rule

In the last two weeks, the U.S. Department of Health and Human Services (HHS) published two notices in the Federal Register delaying the publication of certain final fraud and abuse rule reforms for up to a full year. First,...more

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...more

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...more

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...more

OIG Issues Advisory Opinion Approving Supermarket Pharmacy Loyalty Program

On December 17, 2019, the Office of Inspector General (OIG) issued an Advisory Opinion regarding a proposed supermarket loyalty program that would have provided customers with rewards points on out-of-pocket costs related to...more

Updated Civil Monetary Penalties

The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 requires agencies to adjust civil monetary penalties for inflation annually. Effective November 5, 2019, the Department of Health and Human...more

HHS to Ease Fraud and Abuse Rules Part 4: Proposed Revisions to the Stark Law

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

HHS to Ease Fraud and Abuse Rules Part 2: Civil Monetary Penalty Law Changes, In-Home Dialysis Telehealth

As discussed in a previous McGuireWoods alert, on Oct. 9, the Department of Health and Human Services (HHS) announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal...more

HHS Proposed Rules Seek to Remove Stark Law, Anti-Kickback Burdens on Providers

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 Statute (AKS) and the Civil Monetary Penalties...more

HHS “Sprints” Toward New AKS Safe Harbors and Penalty Exceptions

The U.S. Department of Health and Human Services (HHS) has launched its “Regulatory Sprint to Coordinated Care” to accelerate the healthcare system’s transformation to a value-based system rewarding coordinated care. This...more

Civil and Criminal Fraud and Abuse Penalties Increase and Stark Law Changes

The Bipartisan Budget Act of 2018 (the Act) continues to ratchet up penalties for fraud and abuse violations under the Medicare and Medicaid programs. The Act doubles statutory civil fines and quadruples some criminal fines,...more

Civil and Criminal Fraud and Abuse Penalties Increase and Stark Law Changes

The Bipartisan Budget Act of 2018 (the Act) continues to ratchet up penalties for fraud and abuse violations under the Medicare and Medicaid programs. The Act doubles statutory civil fines and quadruples some criminal fines,...more

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