News & Analysis as of

HHS OIG Issues Final Regulation Addressing Exclusion Authority

On January 12, 2017, the HHS OIG issued its final rule amending regulations relating to its authority under the Affordable Care Act (ACA) to exclude individuals and entities from participation in federal healthcare programs....more

Blog: OIG Issues Final Rule Re: Exclusion Authority

The Final Rule related to the Health and Human Services Office of Inspector General’s (OIG) exclusion authority pursuant to the Social Security Act (the Act), as amended by the Affordable Care Act (ACA) and the Medicare...more

HHS OIG Finalizes New Exclusion Rules as Administration Exits

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

DOJ False Claims Act recoveries – implications for the health industry

The US Department of Justice Civil Division released its False Claims Act (FCA) recovery statistics for Fiscal Year 2016 on December 13, 2016, announcing that it had recovered $4.76 billion. This represents an increase of...more

At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors

More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback...more

2016 Health Care Year in Review

Since I began writing this year-end review in 2013, there have been some common themes – a shift to pay for quality and away from fee-for service, much of which has been brought about by the Affordable Care Act (ACA): efforts...more

White Collar Crime Law Enforcement in a Trump Justice Department - 8 Predictions

After a conventional presidential campaign, determining the policy priorities and direction of the incoming administration with respect to the Justice Department’s white collar law enforcement responsibilities can be a...more

Looking Ahead to a Trump Administration: Health Care and Life Sciences Industry Perspectives

Observers are digesting what the Trump Administration will mean for the health care and life sciences industry. Forecasting is more challenging for this incoming Administration than most given the relatively sparse policy...more

Proposed Rule to Strengthen State Medicaid Fraud Control Units

A recently published proposed rule expands the functions and responsibilities of state Medicaid Fraud Control Units (MFCUs). The rule was issued by the Centers for Medicare and Medicaid Services (CMS) and the Office of...more

Weekly Update Newsletter - October 2016 #2

GOVERNMENT CONTRACTS - Implementing Category Management for Common Goods and Services - The Office of Federal Procurement Policy (“OFPP”) in the Office of Management and Budget (“OMB”) has proposed the issuance of a...more

Washington Healthcare Update

This Week: Congress remains in recess, but members write letters on Mylan’s EpiPen…CBO says repealing Part B Demo would cost $395 million…CMS releases data on hospice utilization and finds spending and utilization vary in...more

Health Update - September 2016

The Election’s Impact on Healthcare: Preparing for Potential Scenarios - Editor’s Note: Election 2016 will have a major impact on federal and state healthcare policy. To be prepared for all the possibilities, it’s...more

Update on First 60-Day Case

A settlement was reached on August 23, 2016, in U.S. ex rel. Kane v. Healthfirst, Inc., et al., No. 11 CIV. 2325 (ER) (SDNY), a little over one year after the judge in that case issued the first judicial interpretation of the...more

Raising Kane: CMS’s 60-Day Rule Commands More Than Treble Damages

In August 2015, we published a client advisory on the first judicial opinion interpreting the Affordable Care Act’s (ACA) “60-day overpayment rule,” which requires providers to “report and return” an overpayment of Medicare...more

Health Law Pulse - September 2016

DOJ, NY AG REACH SETTLEMENT WITH HOSPITALS IN LANDMARK 60 - DAY RULE CASE - On August 24, 2016, the U.S. attorney for the Southern District of New York and the New York State attorney general announced a $2.95 million...more

60-Day Overpayment FCA Enforcement Action Results in $2.95 Million Settlement

On August 23, 2016, a New York hospital system settled False Claims Act (FCA) allegations that it violated the 60-day overpayment rule by improperly retaining Medicaid overpayments. The whistleblower alleged that three of the...more

Health Care Matters, Summer 2016

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

Health Update - July 2016

The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more

The Overpayment Rule and the Implied False Claims Theory: “What You Don’t Know Can Still Hurt You”

In 2010, the Affordable Care Act (“ACA”) enacted new rules governing overpayments made by the Medicare and Medicaid programs. Under these rules, providers have 60 days from the date that the overpayment has been identified to...more

Senate Committee Releases Report on Potential Stark Law Changes, Hearing Scheduled

On June 30, 2016, the Senate Finance Committee’s Republican staff issued a 20-page report discussing comments made by industry stakeholders after a December 2015 round-table on the future of the physician self-referral law,...more

Senate Finance Committee Examines Repeal of the Stark Law

A new report suggests that the Stark law is obsolete in new payment models. On June 30, the US Senate Committee on Finance (the Committee) released the report Why Stark, Why Now? Suggestions to Improve the Stark Law to...more

CMS Finally Publishes the Final Rule on Returning Medicare Overpayments

On February 12, 2016, six years after the passage of the Affordable Care Act (ACA), CMS published the final rule with respect to returning self-identified overpayments. The ACA established a requirement that any person...more

Health Law Insights Newsletter - Issue 10 - June 2016

McCarter & English, LLP’s Health Care Group presents Issue 10 of the Health Law Insights, which discusses the latest legal issues in the health care industry. NATIONAL - Drug Diversion Case Raises Red Flags for...more

CMS Finalizes Rule on Reporting and Returning Medicare Overpayments

The Affordable Care Act (sometimes referred to as Obamacare) included a requirement for providers to report and return all Medicare and Medicaid overpayments within 60 days of identification. Although this requirement has...more

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