News & Analysis as of

Medicaid Anti-Kickback Statute

Medicaid is a partnership program between states and the federal government to provide healthcare coverage for lower income individuals, people with disabilities, older people, and certain families with... more +
Medicaid is a partnership program between states and the federal government to provide healthcare coverage for lower income individuals, people with disabilities, older people, and certain families with children.  less -

Value-Based Contracting for Prescription Drugs and Medical Devices: An Innovative Solution Impaired by Outdated Regulations

by Pepper Hamilton LLP on

Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more

HHS-OIG blesses product replacement program

by Dentons on

The federal health care program anti-kickback statute, 42 U.S.C. § 1320a-7b(b) (AKS), in addition to prohibiting payments for patient referrals, prohibits one party (such as a manufacturer) from providing anything of value to...more

Second Circuit Accepts Appeal of False Claims Act First-To-File Issues

by Farrell Fritz, P.C. on

The Second Circuit recently agreed to accept an interlocutory appeal to decide the question whether a violation of the False Claims Act’s “first-to-file” rule compels dismissal of the complaint or whether it can be cured by...more

Value-based health care: the role of payors

by Ropes & Gray LLP on

Bill Knowlton, Ropes & Gray health care partner, examines the critically important role of payors in value-based health care programs. ____________ Payors are critically important to value-based health care because they're...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: August 2017

by Mintz Levin on

In this issue we report on recent qui tam activity and look at three unsealed cases. One case involves allegations of “up coding” by a hospital that allegedly billed routine transport as emergency transport, reimbursed at...more

OIG Approves Cost-Sharing Arrangement Involving Clinical Research Study

by Baker Ober Health Law on

The U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable advisory opinion, No. 17-02, regarding a proposed arrangement under which the cost-sharing amounts owed by...more

Court Puts the Brakes on Whistleblower's FCA Parking Claims

by Baker Ober Health Law on

The Department of Justice (DOJ) reports that, in fiscal year 2016 ending September 30, it obtained more than $4.7 billion in settlements and judgments from civil cases involving fraud and false claims. More than half of this...more

Healthcare Law Update: June 2017

by Holland & Knight LLP on

Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

Leasing to Health Care Tenants: What You Need to Know

by Pepper Hamilton LLP on

Commercial office building landlords frequently find themselves leasing to health care provider tenants. A landlord may not consider doctor’s offices or diagnostic labs as specialty uses, but there are several lease...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: March 2017

by Mintz Levin on

Trends & Analysis - ..This issue looks at 18 health care–related qui tam cases that were unsealed in whole or in part in late October through November 2016. ..The cases identified were filed in federal district courts...more

What’s in Your Local Transportation Policy?

by Nossaman LLP on

Those in the business of providing healthcare services to Medicare and Medicaid beneficiaries are all too familiar with the federal Anti-kickback Statute (AKS). Among other dreadful sanctions, it imposes criminal penalties on...more

First Circuit Affirms Summary Judgment for Defendant, Rejecting the Use of Aggregate Data to Prove False Claims and Clarifying the...

by Ropes & Gray LLP on

The First Circuit has issued an opinion affirming a complete grant of summary judgment for Pfizer, Inc. in United States ex rel. Booker v. Pfizer Inc., No. 16-1805 (1st Cir. Jan. 30, 2017), a False Claims Act (“FCA”) lawsuit...more

Analysis of HHS OIG Final Rule to Amend the Anti-Kickback Safe Harbors and CMP Rules on Beneficiary Inducements

by Reed Smith on

On December 7, 2016, the Office of Inspector General of the Department of Health and Human Services published a final rule amending the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP)...more

Health Care Institutions

by K&L Gates LLP on

Originally published in Haig, Business and Commercial Litigation in Federal Courts, Fourth Edition §§ 87:1 et seq. © 2016 American Bar Association. This chapter discusses federal court litigation relating to health care...more

Healthcare Law Update: December 2016

by Holland & Knight LLP on

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

OIG Recognizes New Local Transportation Safe Harbor and Exceptions to CMP in Updated Fraud and Abuse Regulations

by Robinson & Cole LLP on

On December 7, 2016, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule (Final Rule) that expands the safe harbor regulations under the Anti-Kickback Statute (AKS)...more

Health Update - December 2016

Balancing Gene Therapy’s Promise and Price - Editor’s Note: Exciting advances in science have led to developing treatment breakthroughs, such as gene scripting therapies, that could represent the first potential cures...more

HHS OIG Adopts NewAnti-Kickback Safe Harbor and Civil Monetary Penalty Exceptions

by Proskauer Rose LLP on

On December 7, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a final rule that will have a widespread impact on health care service providers, medical transport providers,...more

OIG Finalizes New and Expanded Anti-Kickback Safe Harbors, Issues Guidance Regarding Nominal Gifts

by Buchalter on

In an uncertain health care environment following the presidential election, the Department of Health & Human Services Office of Inspector General (“OIG”) finalized a new rule expanding existing safe harbors to the federal...more

HHS-OIG increases beneficiary inducement CMP nominal gift amounts from $10 to $15 per gift and $50 to $75 per year

by Dentons on

The beneficiary inducement civil monetary penalty law generally prohibits health care providers from providing gifts to a Medicare or Medicaid beneficiary—including any free or discounted item or service—if the provider...more

Practical Considerations for Medical Practices Considering Converting Their Vascular Access Centers Into Medicare-Certified...

by McGuireWoods LLP on

On November 2, 2016 the Centers for Medicare & Medicaid Services (CMS) released the 2017 Medicare Physician Fee Schedule (MPFS) Final Rule. Although the impact of the Final Rule on nephrology reimbursement is projected to be...more

Tenet Healthcare Settles Fraud Case for $514 Million

by Michael Volkov on

If you work in compliance in the healthcare industry, you have a tough job. The number and variety of risks that healthcare providers face is daunting. The False Claims Act is a mighty weapon in the hands of federal...more

Strangest Regulatory Interpretation of the Month

by Faegre Baker Daniels on

The Massachusetts federal district court is hands-down winner of the August award for strangest regulatory interpretation of the month. The interpretation came in the context of denial of Omnicare’s summary judgment...more

Health Care Matters, Summer 2016

by JAMS on

Special Masters in Health Care Antitrust Merger Cases: Resolving the Conflicting Interests - One of the most challenging aspects of antitrust cases in the health care field is the rich mixture of public interest...more

The Department of Justice Ups the Ante: Per Claim Penalties for False Claims Act and Anti-Kickback Statute Violations Nearly...

by Sherman & Howard L.L.C. on

On June 30, 2016, the Department of Justice (“DOJ”) published an interim file rule that dramatically increases the per claim penalties for violations of the False Claims Act (“FCA”) and the Anti-Kickback Statute (“AKS”) among...more

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