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Patient Protection and Affordable Care Act (PPACA) › Civil Monetary Penalty

The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal... more +
The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal subsidies to reduce the number of uninsured citizens. less -
Gardner Law

CMS Audits on the Horizon: Prepare for Increased CMS Audits Under the Sunshine Act

Gardner Law on

Historically, the Centers for Medicare and Medicaid Services (“CMS”) has not aggressively pursued enforcement activity under the Sunshine Act. However, this may change in 2024. Late last year, CMS updated its Open Payments...more

Mintz - Health Care Viewpoints

CMS Proposed Rule for Refunding Overpayments Would Align With False Claims Act “Knowledge” Standard

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The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims...more

Foley & Lardner LLP

Will CMS’s Proposed Rule on “Identified Overpayments” Increase Reverse FCA Cases?

Foley & Lardner LLP on

On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule which, in part, seeks to amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for when an...more

Foley & Lardner LLP

D.C. Circuit Upholds Hospital Price Transparency: Regulations Paving Way for January 1, 2021 Effectiveness

Foley & Lardner LLP on

On December 29, 2020, the United States Court of Appeals for the District of Columbia issued its opinion in American Hospital Association v. Azar (the Opinion) upholding the Hospital Transparency Regulation (the Rule) issued...more

Rivkin Radler LLP

Medtronic Settles Kickback And Open Payments Violations For $9.2M

Rivkin Radler LLP on

The U.S. Department of Justice (DOJ) announced on October 29 that Medtronic USA Inc. agreed to pay $8.1 million to settle allegations that it violated the False Claims Act (FCA) and federal Anti-Kickback Statute by paying...more

Foley & Lardner LLP

Healthcare Law Review: Overview of the U.S. Healthcare System

Foley & Lardner LLP on

The U.S. healthcare industry remains at a crossroads. The healthcare reform legislation passed under President Barack Obama in 2010, officially called the Patient Protection and Affordable Care Act (ACA) but widely referred...more

Jackson Walker

ERISA Alert: An Update on Health and Welfare and Retirement Plans

Jackson Walker on

Health and Welfare Plan Update - It is 9:00 p.m., do you know where your health plan data is? As IT systems continue to expand, and data is accessed, moved and stored in many new and different ways, the Office for Civil...more

Baker Donelson

HRSA to Enforce 340B Program Oversight of Drug Manufacturers Next Year and Share 340B Ceiling Prices with Covered Entities

Baker Donelson on

Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more

Baker Donelson

OIG Allows Free and Reduced-Cost Services to Strained Caregivers in Advisory Opinion 18-05

Baker Donelson on

In what is becoming a steady trend, the Office of Inspector General (OIG) published another favorable opinion for an arrangement seeking to implement programs that support and engage family members who are increasingly...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on

A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

K&L Gates LLP

340B Update: HRSA Delays Final Rule on 340B Pricing and Manufacturer CMPs Yet Again

K&L Gates LLP on

On August 21, 2017, the Health Resources and Services Administration (“HRSA”) published a Notice of Proposed Rulemaking to further delay the effective date of final rules on drug pricing calculations and civil monetary...more

McDermott Will & Emery

New OIG Rules Change Patient Incentive Program Landscape: Where Are the Limits Now?

McDermott Will & Emery on

With health care becoming more consumer-driven, health care providers and health plans are wrestling with how to incentivize patients to participate in health promotion programs and treatment plans. As payments are...more

Mintz - Health Care Viewpoints

The Walking Dead in Medicaid

Mintz - Health Care Viewpoints on

On March 6, House Republicans revealed The American Health Care Act. It is their plan to repeal and replace the Affordable Care Act. The bill changes the structure of Medicaid financing from the Federal Medical Assistance...more

McDermott Will & Emery

New OIG Exclusion Regulations About to Go into Effect

McDermott Will & Emery on

The Office of Inspector General (OIG) recently published a final rule regarding its exclusion authorities. The final rule goes into effect March 21, 2017, and expands OIG’s authority to exclude certain individuals and...more

Foley & Lardner LLP

White Collar Enforcement and the New Trump Administration: Your Top Ten Questions Answered

Foley & Lardner LLP on

Enforcement activity under the Obama administration often made headlines for the eye-popping level of fines, with the Foreign Corrupt Practices Act (FCPA), Anti-Money Laundering (AML) regulations, and economic sanctions...more

Arnall Golden Gregory LLP

2010’s Health Care Reform Refresher: Revisiting Day-to-Day Provider Obligations that Stem from the Patient Protection and...

Arnall Golden Gregory LLP on

President Donald Trump’s action to repeal 2010’s Patient Protection and Affordable Care Act (ACA) should not be a surprise. After all, President Trump, along with many other candidates for office, made repeal of the ACA a...more

K&L Gates LLP

340B Update: HRSA Finalizes 340B Pricing & Penalties for Drug Manufacturers

K&L Gates LLP on

On January 5, 2017, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) issued a final rule on the calculation of drug ceiling prices under the 340B Drug...more

Hogan Lovells

HHS OIG Finalizes New Exclusion Rules as Administration Exits

Hogan Lovells on

With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more

Hogan Lovells

HRSA Releases Ceiling Price and CMP Final Rule

Hogan Lovells on

The Health Resources and Services Administration (HRSA) released its Final Rule regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties (CMPs) on manufacturers that knowingly and...more

Baker Donelson

OIG Finalizes CMP Regulations, Largely as Proposed

Baker Donelson on

On December 7, 2016, the Department of Health and Human Services, Office of Inspector General (OIG) finalized [PDF] its proposal to update the civil monetary penalty (CMP) regulations – namely, incorporate new CMP authorities...more

McDermott Will & Emery

Money Talks: Important Takeaways from the OIG’s Civil Monetary Penalties Final Rule

McDermott Will & Emery on

In a burst of rulemaking in December 2016, the US Department of Health and Human Services, Office of Inspector General, issued two new final rules containing significant changes to OIG’s Civil Monetary Penalty authorities....more

BakerHostetler

Providers Breathe Sigh of Relief with New Anti-Kickback Safe Harbors and CMP Exceptions

BakerHostetler on

On December 7, 2016, the HHS Office of Inspector General (OIG) finalized a set of rules first proposed in 2014 adding new anti-kickback law safe harbors and protecting additional conduct from enforcement under the civil...more

Manatt, Phelps & Phillips, LLP

Health Update - December 2016

Manatt, Phelps & Phillips, LLP on

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

Saul Ewing LLP

OIG Revises and Adds Anti-Kickback Statute Safe Harbors and Civil Monetary Penalty Rules

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In what may be one of the final federal health care revisions implemented during the Obama Administration, on December 7, 2016 the U.S. Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”),...more

McDermott Will & Emery

OIG Revises Safe Harbors under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements

McDermott Will & Emery on

On December 7, 2016, the Office of Inspector General of the US Department of Health and Human Services published a final rule containing revisions to both the federal Anti-Kickback Statute safe harbors and the beneficiary...more

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