Medicare Part D

News & Analysis as of

Pharmacy Qui Tam Based On U&C Price Billing Survives Motion to Dismiss

Once again, a pharmacy employee has filed a qui tam involving a drug discount program, alleging that the failure of the pharmacy to use the discounted pricing as the “usual and customary” price in Medicaid and Medicare Part D...more

CMS Proposes Changes to 2016 Star Rating Calculations - Medicare Advantage and Medicare Part D Prescription Drug Plans May Be...

The Centers for Medicare and Medicaid Services (CMS or the Agency) released a memorandum requesting comments regarding proposed changes to the 2016 star ratings systems for Medicare Advantage Plans (MA Plans) and Medicare...more

CMS Seeks Comments on Proposed Enhancements and Modifications to the Star Ratings for Medicare Advantage and Part D Prescription...

On November 21, 2014, the Centers for Medicare & Medicaid Services (“CMS”) released a Request for Comments on proposed enhancements and modifications to the 2016 Star Ratings for Medicare Advantage (“MA”) and Part D...more

Federal Judge Awards Attorneys’ Fees to Defendant in Dismissed Qui Tam Case, Calls Whistleblower a “Serial Relator”

In November 2013 and this past October, Mintz Levin’s Health Care Qui Tam Update highlighted three separate qui tam False Claims Act (FCA) cases filed by Fox RX, Inc. (Fox), a former Medicare Part D plan sponsor. Fox filed...more

Health Care Update - December 2014

In This Issue: - FDA Releases Menu Labeling Rule - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Upcoming Congressional Hearings - Excerpt from FDA...more

2015 Medicare OPPS and ASC Final Rule

On November 10, 2014, the Centers for Medicare and Medicaid Services (CMS) published the Outpatient Prospective Payment System (OPPS) final rule for 2015. The rule updates CMS’s payment rates and policies, value-based...more

Survive The Season With Our Open Enrollment Checklist

It’s that time of year again, when fall weather brings with it a host of legal obligations for plan sponsors running open enrollment. Here’s what you need to know to survive the season....more

Changes Proposed for Anti-Kickback Statute

It has been said before—healthcare is changing. Most often providers must adapt their practices to comply with governing regulations. Sometimes, governing regulations must be revised to adapt to providers practices. And on...more

Key Takeaways from OIG’s 2015 Work Plan

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Fiscal Year 2015 Work Plan on October 31. The Work Plan provides the OIG’s planned reviews and activities with respect to...more

Blog: HHS OIG Hands Out 2015 Work Plan For Halloween

On Friday October 31, 2014, the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its annual “Work Plan” for fiscal year 2015. The Work Plan is a compilation of the OIG’s plans for...more

Report Shows CMP Enforcement Actions On the Rise Against Part C and Part D Sponsors

A new report issued October 16, 2014 by the Medicare Parts C & D Oversight and Enforcement Group (MOEG) reveals that civil monetary penalty (CMP) enforcement actions in these two programs more than tripled from 2012 to 2013....more

Do You Offer or Accept Copayment Coupons? OIG says YOU are Responsible for Compliance with Federal Law

In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order...more

Health Law Alert: OIG Releases Proposed Revisions to Anti-Kickback Safe Harbors and Civil Monetary Penalty Rules

The Department of Health and Human Services Office of Inspector General (OIG) recently released a proposed rule that revises safe harbors under the Anti-Kickback Statute (AKS) and Civil Monetary Penalty (CMP) rules regarding...more

OIG Announces Proposed AKS and CMP Regulations

On October 3, 2014, the Office of the Inspector General (“OIG”) issued a proposed rule codifying into regulation several statutory changes to the Antikickback Statute (“AKS”) and the Civil Monetary Penalty (“CMP”) Law. Nearly...more

Front End Changes and, Again, More DIR Columns

Since the beginning of the Medicare Part D program, CMS has introduced many reporting mechanisms for trying to understand drug pricing, price concessions, and the cost of providing services to Part D members. The tool CMS...more

Health Care Reform Implementation Update

In the past week, CMS has released several advisories including updates to the rating system for nursing homes, premium and deductible information for Medicare Part B and Part D for 2015, Pioneer ACO results, payment dispute...more

OIG Proposed Anti-Kickback Safe Harbors and CMP Regulations: The End of Frustration or Just the Beginning?

On October 3, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published an unexpected, yet long-awaited, set of proposed rules that would add new anti-kickback law safe harbors,...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act Cases: October 2014

Trends & Analysis - Between our last Qui Tam Update and the end of June, 65 health care–related qui tam cases were unsealed (28 in April, 18 in May, and 19 in June). Within those 65 cases...more

Health & Human Services, Office of Inspector General, Proposes New Fraud and Abuse Rules

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) published 79 Fed. Reg. 59717 on October 3, 2014. This proposed rule has the potential to have an impact on a broad array of financial...more

A Possible Green Light for Patient Transportation Services: OIG Proposes Revised Safe Harbors to the Anti-Kickback Statute for...

On October 3, 2014, the Office of Inspector General of the Department of Health and Human Services (“OIG”) published a proposed rule and request for comments (“Proposed Rule”), which would amend the Anti-Kickback Statute...more

HHS Office of Inspector General Proposes Expansions of Anti-Kickback Safe Harbors and Civil Monetary Penalties Law Exceptions

On October 3, 2014, the Office of the Inspector General (the “OIG”) of the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule that would amend regulations implementing the federal anti-kickback...more

Proposed Rule Issued by OIG Realigns Its Enforcement Views with Health Care Reform Goals

Fridays never seem to be slow in the health care regulatory world. On Friday, October 3rd, the HHS Office of the Inspector General (OIG) issued a highly anticipated proposed rule (the Proposed Rule) that provides amendments...more

OIG Releases Proposed Rule Adding New Safe Harbors to the Anti-Kickback Statute

Last week, the HHS OIG released a proposed rule published in the October 3 Federal Register that would add new safe harbors to the Anti-Kickback Statute and expand the list of conduct exempt from civil monetary penalties...more

OIG Proposes Expanding Anti-Kickback Statute Safe Harbors and Revising Civil Monetary Penalty Regulations

On October 2, 2014, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) published a proposed rule containing revisions to both the Anti-Kickback Statute (AKS) safe harbors and the civil...more

FDA Regulatory and Compliance Monthly Recap - September 2014

In This Issue: - FDA sends warning letters to companies that made claims on social media that their products treat, cure Ebola, marking the first time the agency singles out Pinterest - OIG issues special...more

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