News & Analysis as of

Health Care E-Note - November 2015

With medical device related acquisitions at all-time highs, and regulatory interest intense from the Federal Trade Commission, the Food and Drug Administration, the Securities and Exchange Commission, and the Office of...more

District Court Rejects FCA Claim Against Healthcare Provider That Submitted False Claims But Did So Without Necessary Mental State

Healthcare provider Fresenius Medical Care North America claimed victory in a False Claims Act (“FCA”) lawsuit recently when a federal district court ruled that there was no evidence that its practice of billing for...more

OIG Guidance Addresses Compliance Risks of Emerging Trends in the Healthcare Industry

The Office of Inspector General of the U.S. Department of Health and Human Services (OIG) recently released new compliance guidance to help healthcare governing boards, attorneys, compliance officers and internal auditors...more

Record-breaking FCA settlements underscore importance of Stark Law compliance

In September and October, the Department of Justice (DOJ) announced four record-breaking False Claims Act settlements – ranging from $25 million to $115 million – involving health care systems that allegedly made improper...more

No False Claims Act Case Where There is No False Claim – DNJ Throws Out Qui Tam Action Against Genentech

Halloween has come and gone. The Drug and Device Law Little Dogs stayed in their costumes (Batgirl and a rabbi) long enough to be photographed for (unsuccessful) entries for a pet costume contest. There was ample candy –...more

Skeletons in the Closet? Beware of Potential Enforcement Actions

With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement...more

OMB Receives Final Medicare Parts A and B 60-Day Overpayment Rule from CMS

On October 21, 2015, the Office of Management and Budget (OMB) received the Medicare Parts A and B overpayment final rule from CMS which is the last phase before the rule is issued in the Federal Register. While the text of...more

Legal Risks Facing Nursing Home Providers and Reducing Risk with Clinical Documentation

Documentation in Electronic Health Records: - Nursing homes lag behind other providers in electronic health record system adoption - Of 472 nursing homes in New York, there was a 7.7 percent increase in EHR adoption...more

Millennium Health and DOJ Settle False Claims Act Allegations for $256 Million

On October 19, 2015, the Department of Justice (DOJ), through the United States Attorney’s Office for the District of Massachusetts, announced that Millennium Health (formerly Millennium Laboratories) had agreed to resolve...more

CMS Sends Long-Awaited Medicare 60-Day Overpayment Rule to OMB for Final Clearance

CMS is moving ahead on its much-anticipated final rule implementing Affordable Care Act (ACA) requirements on reporting and returning of Medicare overpayments. Under the ACA, enrolled providers and suppliers (and certain...more

Health Law Pulse - October 2015

The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

Recent Cases Involving 60-Day Overpayment Rule Should Put Healthcare Providers on Alert

Two recent federal court cases show that the federal government intends to vigorously enforce the so-called “60-day Rule” for the return of overpayments enacted as part of the Affordable Care Act (the “ACA”) even though the...more

Huge Stark Law Hospital Settlements and Physician Culpability - The New Normal Post-Tuomey?

After the federal government’s victory against Tuomey Hospital, we have seen an increasing number of large False Claims Act (FCA) settlements with hospitals involving Stark Law allegations. Relators are even citing, as...more

Health Update - September 2015

Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more

Removing the Barriers to Coordinated Care: the Stark Law

August 10, 2015 was the 22nd anniversary of the expansion of the Medicare self-referral prohibition to include 10 “designated health services” in addition to clinical laboratory tests. This law is the so-called Stark Law....more

Hospitals Accused of Violating the False Claims Act Through Ownership of the PPO For Their Self-Funded Employee Health Plans

On August 27, 2015, following notification by the government that it had decided not to intervene, the United States District Court for the Middle District of North Carolina, ordered that a qui tam complaint charging...more

Government Latin Lessons

A couple of years ago, we discussed in an article in this publication the willingness of Centers for Medicare & Medicaid (“CMS”)and the United States Attorneys’ Office to pursue actions for violations of the False Claims Act...more

The Definition of Identify: The 60-Day Rule

The Patient Protection and Affordable Care Act (“PPACA”) established that any person who receives an overpayment from the Medicare or Medicaid programs and who does not report and return the overpayment within 60 days after...more

The 60 Day Rule — Identification and Knowing Avoidance

On August 3, 2015, the United States District Court for the Southern District of New York issued an opinion and order in Kane v. Healthfirst, Inc., et al.[1] that provides the first judicial interpretation of the requirement...more

CMS Releases Data Regarding Hospital and Physician Utilization

CMS recently announced that it would be releasing Medicare hospital utilization and payment data, as well as physician and supplier utilization and payment data. This is the third year that the hospital data has been released...more

Federal Court Rejects Health System's Efforts to Dismiss 60-Day Rule Suit

On August 3, 2015, the United States District Court in the Southern District of New York issued a long-awaited opinion and order rejecting a motion to dismiss filed by the defendants in U.S. ex rel. Kane v. Continuum Health...more

Court Imposes Potentially Unworkable Burden on Providers Under ACA's Report and Return Rule

In Kane ex rel. U.S. v. Healthfirst, Inc., the federal district court for the Southern District of New York (District Court or Court) provided on August 3 the first and long-awaited interpretation as to when a health care...more

Identification of Overpayments: A Win for DOJ Cautions 'Prosecutorial Discretion' in Enforcement of an 'Unforgiving Rule'

On August 3, 2015, the Southern District of New York issued the first judicial opinion interpreting the Affordable Care Act’s “60-Day Overpayment Rule” in a False Claims Act (“FCA”) case. In a clear win for the Department of...more

When an Overpayment Becomes a False Claims Act Issue: Explaining the First Judicial Interpretation of the 60-Day Rule

On August 3, 2015, Judge Edgardo Ramos of the United States District Court for the Southern District of New York issued the first judicial opinion addressing when a health care provider has “identified” a Medicare or Medicaid...more

Kane and the “60-Day Rule”: The Unforgiving World of Medicare and Medicaid Overpayments

The Southern District of New York has spoken on one of the first issues to confront those seeking compliance with the new “60-day rule” under the Affordable Care Act (ACA), and it does not bode well for defendant hospitals...more

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