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Important Changes for Physicians from the 2016 Medicare Physician Fee Schedule: Part II (Non-Stark Changes)

On November 16, 2015 the Centers for Medicare and Medicaid Services (CMS) published the final Medicare Physician Fee Schedule (Final MPFS).1 The Final MPFS addresses changes to the physician fee schedule and related policies,...more

Partnering with nonprovider sites: Tips to keep in mind

Provided applicable requirements are met, the Medicare program reimburses teaching hospitals for resident training that occurs both at the hospital itself and at clinical nonprovider locations, including, for example,...more

Drug Manufacturer Discount Cards: Accept With Caution

Pharmaceutical manufacturer discount card usage by government program beneficiaries has been an active area for government action in recent years. In a September 2014 Special Advisory Bulletin, the U.S. Department of Health...more

Criminal Conviction Leaves Defendant Defenseless in FCA Civil Action

Pity Dr. Christina Clardy. In 2011 she was convicted of health care fraud, sentenced to 135 months in prison, and ordered to pay $16 million in restitution. Then in 2014 the government added Christina as a defendant in its...more

University of Massachusetts Medical School Not a “Person” Under FCA; 1st Circuit Adopts “Arm-of-the-State” Test

In an opinion issued on January 27, 2016, the United States Court of Appeals for the First Circuit affirmed the dismissal of a qui tam lawsuit against the University of Massachusetts, holding that the University was...more

Recent Corporate Integrity Agreements Highlight HHS OIG’s Compliance Program Priorities

Corporate Integrity Agreements (CIAs) are among the most important tools in the U.S. Department of Health and Human Services Office of Inspector General’s (OIG) toolbox for promoting compliance in the health care industry....more

Implied Certification and the FCA: Legally False or a False Legality? The Supreme Court Is Set to Decide

The United States Supreme Court recently granted certiorari in the case of Universal Health Services, Inc. v. U.S. ex rel. Escobar, No. 15-7, which places implied certification under the False Claims Act (FCA) squarely in the...more

CMS Issues Final Rule on Covered Outpatient Drugs

On January 21, 2016, the Centers for Medicare & Medicaid Services (“CMS”) released a final rule (“Final Rule”) addressing key areas of Medicaid reimbursement for outpatient drugs and changes made to the Medicaid Drug Rebate...more

Further CMS Clarification on EHR Hardship Exceptions

As we reported, the Centers for Medicare & Medicaid Services (CMS) posted revised instructions and application forms on January 22, 2016, for health care providers unable to meet electronic health records (EHR) “meaningful...more

Another Day, Another Whistleblower Retaliation Suit

A False Claims Act (“FCA”) retaliation claim, 31 U.S.C. 3730(h), filed January 26, 2016 in federal district court in Oregon, provides a perfect example of the type of challenging cases confronting health care employers today....more

Supreme Court Rejects Tribe’s Equitable Tolling Argument in Contract Support Litigation

On January 25, 2016, the Supreme Court issued a decision in Menominee Indian Tribe of Wisconsin v. United States, rejecting an argument that equitable tolling preserves some claims against the United States for failure to pay...more

Statistical Sampling Debate: A Growing Web Of FCA Cases

The government and qui tam plaintiffs are increasingly employing statistical sampling in False Claims Act cases, particularly in cases where addressing and analyzing large numbers of allegedly false claims poses substantial...more

Corporate Investigations & White Collar Defense - January 2016

The FCPA in 2016: DOJ and SEC Focus on International Cooperation and Investigation of Individuals - Why it matters: As we reported in our December 2015 newsletter, both SEC Enforcement Director Andrew Ceresney and DOJ...more

Length of funded training: Initial Residency Period (IRP) issues

The payment rules for Medicare graduate medical education (GME) reimbursement inherently incentivize training during a resident's "initial residency period" (IRP), which is defined as the minimum accredited length for each...more

CMS Announces Next Generation ACO Program

On January 11, 2016, the Centers for Medicare & Medicaid Services (CMS) announced the Next Generation ACO program, along with the first group of participants. The program builds on the CMS Pioneer ACO Model and Medicare...more

District Court Dismisses Government’s False Claims Act Complaint for Failure to Allege Actual False Claims with Particularity

On January 7, 2016 the United States District Court for the Middle District of Florida took the rare step of dismissing (with leave to amend) the government’s Complaint in Intervention in a False Claims Act Case. This case...more

False Claims Act: 2015 Year-in-Review

In 2015, the Justice Department (DOJ) continued to give high priority to False Claims Act (FCA) investigations, bringing in nearly $3.6 billion in settlements and judgments. More than 630 qui tam suits were filed. DOJ's...more

Health Care Enforcement in 2016: A Look Back on 2015 and Forecasting the Year Ahead

2015 was a year of transition for the U.S. Department of Justice (“DOJ”), with the installation of a new Attorney General, Deputy Attorney General, and several other high-level officials. In January 2015, Andrew Weissmann...more

Public disclosure bar prohibits "bounty-hunting" relators from filing duplicative FCA claims

The United States Court of Appeals for the Seventh Circuit has issued an opinion that underscores the importance of the "public disclosure bar" in False Claims Act (FCA) litigation. The court affirmed a lower court’s...more

False Claims Act Update: A Statistical Review of 2015 and Key Events for 2016

As reported by the Department of Justice (DOJ) in a December 2015 press release, the False Claims Act (FCA) remains the federal government’s primary means for combating fraud. In 2015, the DOJ recovered $3.583 billion in FCA...more

Nashville Pharmacy Services, LLC Settles FCA Allegations

Last week the Department Of Justice announced a settlement agreement with Nashville Pharmacy Services, LLC (“NPS”) and NPS majority owner Kevin Hartman. Under the agreement, NPS and Mr. Hartman will pay up to $7.8 million to...more

Health Law Pulse - January 2016

CHANGES TO STARK LAW, NEW ADVANCE CARE PAYMENTS INCLUDED IN 2016 PHYSICIAN FEE SCHEDULE - The Centers for Medicare & Medicaid Services (CMS) recently published a final rule (Final Rule) regarding physician payment...more

Record Mega-Settlements May Attract More Whistleblowers

September was a record-setting month for the United States Department of Justice, which entered into major health care fraud settlements with two large Floridabased hospital systems. The settlements were made in the face of...more

Avoiding the Bull’s-Eye

The federal government collected over $200 million from three settlements based on health care fraud and abuse allegations this past September. This staggering amount excludes fees paid to attorneys, consultants and expert...more

FDA Regulatory and Compliance Monthly Recap — December 2015

Pacira secures expanded marketing for painkiller medication as FDA agrees to settle lawsuit, revoke warning letter - The pharmaceutical industry won in its latest bid for more leeway to promote drugs for unapproved uses,...more

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