News & Analysis as of September 23, 2024

Anti-Kickback Statute › Digital Health

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The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

McDermott Will & Emery on 6/25/2024

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more

What to Learn From DOJ’s First Telehealth-Prescribed Controlled Substances Case

Husch Blackwell LLP on 6/14/2024

On June 13, 2024, the Justice Department announced arrests in what it called the nation’s first criminal case against digital health company executives over allegations that those executives caused illegal prescriptions for...more

OIG Permits Medical Device Manufacturer’s Cost-Sharing Subsidies for Medicare Beneficiaries in Clinical Trial

Sheppard Mullin Richter & Hampton LLP on 1/31/2024

Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on 5/26/2023

Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. Companies that once only developed hardware-based solutions for...more

Sham Transactions in Digital Health Industry

Cozen O'Connor on 9/26/2022

In its recently published Special Fraud Alert, the Office of Inspector General (“OIG”) presented a list of suspect characteristics related to arrangements with telehealth and telemedicine companies, which may help determine...more

OIG Approves Cash Equivalents Paid to Patients Participating in Contingency Management Program Offered Through Digital Health...

Proskauer - Health Care Law Brief on 4/11/2022

Contingency management (CM) is a form of intervention treatment program that incentivizes patients with substance use disorders to observe certain conditions—such as non-use of drugs or alcohol confirmed via urine drug...more

OIG Issues Another Favorable Advisory Opinion on Treatment-Based Patient Incentives

Mintz - Health Care Viewpoints on 3/15/2022

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued another favorable Advisory Opinion on patient incentives (e.g. gift cards or cash equivalents) given as part of patients’...more

OIG Approves Arrangement That Provides Cash Equivalents to Patients in Digital Contingency Management Program

Arnall Golden Gregory LLP on 3/9/2022

On March 2, 2022, the Department of Health and Human Services, Office of Inspector General (OIG) published Advisory Opinion No. 22-04 (the “Opinion”), analyzing a program whereby the Requestor provides comprehensive digital...more

DOJ False Claims Act Recoveries Exceed $5.6 Billion in 2021

Goodwin on 3/8/2022

The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more

New OIG Guidance Permits Federally Qualified Health Centers to Offer Remote Patient Monitoring, Big-Box Store Gift Cards, and...

Hinshaw & Culbertson - Health Care on 2/23/2021

Federally Qualified Health Centers (FQHCs) deliver care to some of the nation's most vulnerable individuals and families, including federal Medicare and Medicaid health care program beneficiaries. As safety net providers,...more

New Safe Harbors Offer Opportunities for Innovative Arrangements, Including Digital Health

ArentFox Schiff on 2/17/2021

Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...more

Fraud and abuse risks in digital health: What tech companies need to know about healthcare enforcement – Part II

White & Case LLP on 2/10/2021

For companies looking to monetize their hard-earned innovations in digital health, there is a minefield of potential healthcare enforcement to avoid. As discussed in Part I of this alert, such healthcare enforcement can lead...more

Fraud and abuse risks in digital health: What tech companies need to know about healthcare enforcement - Part I

White & Case LLP on 1/28/2021

Digital health is exciting, innovative and forward-looking. Investors have invested billions of dollars anticipating dividends from the next phase of the Big Data revolution: collecting and synthesizing millions of data...more

[Webinar] Unpacking the Anti-Kickback and Stark Reforms: Promoting Value-Based Care and Easing Regulatory Compliance - January...

Manatt, Phelps & Phillips, LLP on 12/22/2020

A New Manatt Webinar Guides You Through New Reforms Promoting Value-Based Care and Easing Regulatory Compliance—the Most Significant Changes to the Federal Fraud and Abuse Landscape in the Last Decade. On November 20,...more

New HHS Regulations Create Opportunities for Digital Health Partnerships

Manatt, Phelps & Phillips, LLP on 12/14/2020

On November 20, 2020, the Department of Health and Human Services (HHS) finalized a set of sweeping changes to the regulatory framework that governs fraud and abuse in the Medicare and Medicaid programs. Among other changes,...more

Major Changes Finalized to Stark Rules, Anti-Kickback Statute Safe Harbors and the Beneficiary Inducements CMP

King & Spalding on 12/1/2020

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

Anti-Kickback Statute and Stark Law Regulations: Final Rules Issued

Nilan Johnson Lewis PA on 11/30/2020

On November 20, 2020, the Department of Health and Human Services (HHS) published two final rules that aim to reduce regulatory barriers to care coordination and accelerate the transformation of the healthcare system to...more

Special Report - 2019 Digital Health Year in Review - January 2020

McDermott Will & Emery on 1/29/2020

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

Triage in 2020: Health Care Topics to Watch in the New Year

K&L Gates LLP on 1/23/2020

In this week's episode, Lindsey Rogers-Seitz forecasts a number of critical issues spanning the health care industry that are likely to be points of focus in the coming year. Among these issues, Ms. Rogers-Seitz discusses the...more

Telemedicine and Digital Health Companies Will Benefit from Newly-Proposed Fraud and Abuse Waivers

Foley & Lardner LLP on 10/28/2019

The OIG recently released proposed revisions to the Anti-Kickback Statute (AKS) and Civil Monetary Penalties (CMP) Law. Several of these changes, if finalized, will directly benefit companies offering telemedicine and digital...more

AdvaMed Updates Its "Code of Ethics on Interactions with U.S. Health Care Professionals"

Wilson Sonsini Goodrich & Rosati on 2/15/2019

On January 9, 2019, the Advanced Medical Technology Association (AdvaMed) released an updated version of its "Code of Ethics on Interactions with U.S. Health Care Professionals" (HCPs) (the Code), which will take effect on...more

OIG Advisory Opinion Has Key Takeaways for Programs Designed to Assist Needy Patients

Troutman Pepper on 2/11/2019

Can a pharmaceutical manufacturer provide free items or services to financially needy Medicare and Medicaid beneficiaries without running afoul of the Beneficiary Inducements Civil Monetary Penalty (CMP) or the Anti-Kickback...more

OIG Advisory Opinion Allows Smartphone Loan for Needy Patients Taking Digital Drug

Mintz - Health Care Viewpoints on 2/7/2019

Last week, the Office of the Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Manufacturer) to loan a...more

2018 Digital Health Year in Review: Focus on Care Coordination and Reimbursement

McDermott Will & Emery on 2/6/2019

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

OIG Issues Advisory Opinion Giving the Green Light to a Pharmaceutical Manufacturer’s Plan to Provide Limited Functionality...

King & Spalding on 2/5/2019

On January 24, 2019, OIG issued Advisory Opinion No. 19-02, analyzing a proposed arrangement in which a pharmaceutical manufacturer would loan smartphones to patients who meet certain poverty level requirements in order to...more

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Anti-Kickback Statute › Digital Health

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