Tag Archives: CMS

DOJ Settlement with Home Health Providers Underscores Strategic Considerations for Self-Disclosure

Eventually, any health care organization with an effective compliance program is very likely to discover an issue that raises potential liability and requires disclosure to a government entity. While we largely discuss False Claims Act (FCA) litigation and defense issues on this blog, a complementary issue is how to address matters that raise potential liability … Continue Reading

False Claims Act Settlement with eClinicalWorks Raises Questions for Electronic Health Record Software Vendors

On May 31, 2017, the US Department of Justice announced a Settlement Agreement under which eClinicalWorks, a vendor of electronic health record software, agreed to pay $155 million and enter into a five-year Corporate Integrity Agreement to resolve allegations that it caused its customers to submit false claims for Medicare and Medicaid meaningful use payments … Continue Reading

Is the Stark Law’s “Signed Writing” Requirement Material to Payment: One Federal Court Says Yes

In a case of first impression, a federal court found that the federal physician self-referral law’s (Stark Law) requirement that financial arrangements with physicians be memorialized in a signed writing could be material to the government’s payment decision. This case raises troubling questions about applying the False Claims Act (FCA) to what many in the … Continue Reading

Third Circuit Affirms Dismissal of FCA Suit against Genentech Based on Supreme Court’s Materiality Standard

On May 1, 2017, the US Court of Appeals for the Third Circuit affirmed the dismissal of United States ex rel. Petratos, et al. v. Genentech, Inc., et al., No. 15-3801 (3d. Cir. May 1, 2017). On appeal from the US District Court for the District of New Jersey, the Third Circuit reinforced the applicability … Continue Reading

Old Dog, New Tricks: Fraud and Abuse in the Age of Payment Reform

The good, reassuring news about that “old dog” fraud and abuse as it enters an age of payment reform is that criminal liability for fraud still requires a specific intent to defraud the federal health care programs, anti-kickback liability still requires actual knowledge of at least the wrongfulness, if not the illegality, of the financial … Continue Reading

Tenth Circuit Says “CMS Is Unfamiliar With Its Own Law” In Pursuing Home Health Agency for Overpayments

In many industries, but especially health care, the amount of regulation and guidance issued by the responsible agencies is tremendous and continues to grow.  The Centers for Medicare and Medicaid Services (CMS) is no exception.  In a recent appeal by a home health agency, the Tenth Circuit examined the “pace [of CMS’] frenetic lawmaking,” finding … Continue Reading

Fifth Circuit Affirms Summary Judgment where Whistleblower Offered No Evidence of the Requisite Scienter

On March 7, the U.S. Court of Appeals for the Fifth Circuit affirmed a grant of summary judgment by the U.S. District Court for the Northern District of Texas in favor of Kaner Medical Group and its owner, David Kaner, in a qui tam suit brought under the False Claims Act (FCA).  United States ex … Continue Reading

CMS Issues Final Rule Governing the Return of Overpayments within 60 Days

On February 11, 2016, the Center for Medicare and Medicaid Services (CMS) issued the much-anticipated final rule concerning Section 6402(a) of the Affordable Care Act, the so-called “60 Day Rule.” This section requires Medicare and Medicaid providers, suppliers and managed care contractors to report and return an overpayment by the later of “60 days after … Continue Reading

District Court Denies Motion to Dismiss in Government’s First Reverse False Claims Case

On August 3, 2015, the United States District Court for the Southern District of New York issued  an opinion interpreting the Affordable Care Act’s (ACA) so-called “60-day rule.”  In United States of America ex rel. Kane v. Continuum Health Partners, Inc., Case No. 11-2325.  The court denied the defendants’ motion to dismiss the government’s False … Continue Reading

Overview of Recent Stark Law Developments

There has been a flurry of judicial and administrative activity regarding the Stark Law in recent weeks, bringing both promises of reprieve for the health care industry in complying with the technicalities of the law, and reminders of the need for executive vigilance when evaluating and approving transactions with referring physicians. On July 15, 2015, … Continue Reading

Court Upholds CMS’ Prohibition on ‘Under-Arrangements’ Transactions, Strikes Down CMS’ Prohibition on ‘Per-Click’ Equipment Rental Arrangements

A 2008 rule change from the Centers for Medicare and Medicaid (CMS)—which effectively prohibited referring physician-owned companies from furnishing hospital services “under arrangements”—has withstood a challenge by a urology trade association. On June 12, 2015, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) held in Council for Urological Interests v. … Continue Reading

New OIG Reports Peg Billing Trends and Prescribing Hotspots as Harbingers of Part D Fraud

On Tuesday, June 23, the U.S. Department of Health & Human Services Office of Inspector General (OIG) released two reports that hone in on data patterns showing potential fraud and abuse in the Medicare Part D program.  These reports were released less than a week after a coordinated national Medicare fraud takedown that included a … Continue Reading

Recent OIG Report Spotlights Millions in Overpayments Caused by Physician Place-of-Service Coding Errors

On May 6, 2015, the Office of Inspector General (OIG) for the U.S. Department of Health & Human Services (HHS) released a report on overpayments attributed to incorrect physician place-of-service coding. The report determined that Medicare potentially overpaid physicians approximately $33.4 million for incorrectly coded services that were provided from January 2010 through September 2012. … Continue Reading

CMS Appears Receptive to Senators’ Requests to Change Focus of RAC Program to Providers with High Claims Denials

Last Thursday, in a hearing before the Senate Special Committee on Aging exploring the relationship between Recovery Audit Contractor (RAC) audits and an increase in claims for hospital observation stays, a bipartisan duo of senators urged the Centers for Medicare & Medicaid Services (CMS) to shift the focus of RAC audits to providers that have … Continue Reading

OIG Audits Begin for Meaningful Use Compliance

The Office of Audit Services of the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services has begun a nationwide audit of a random sample of providers that have received incentive payments for achieving “meaningful use” under the Medicare Electronic Health Record (EHR) Incentive Program from January 1, 2011 to … Continue Reading

Recent Appellate Decisions Underscore Importance of Public Disclosure Bar, But Outcomes Are Highly Dependent on the Facts

Two Circuit Courts of Appeals recently came out on opposite ends of the False Claim Act’s (FCA’s) public disclosure bar.  On February 19, 2015, the United States Court of Appeals for the Third Circuit affirmed the district court’s dismissal of claims related to allegations of fraudulently inflated pharmaceutical prices, holding that the information underlying the … Continue Reading

FCA Enforcement Action to Watch: Government Intervened in Reverse False Claims Case

With a motion to dismiss pending in the United States District Court for the Southern District of New York, United States of America ex rel. Kane v. Continuum Health Partners, Inc., Case No. 11-2325, is the False Claims Act (FCA) case to watch in 2015.  It is the first “reverse false claims” case where the … Continue Reading

CMS Delays Implementation of the 60-Day Overpayment Final Rule

On February 13, 2015, the Center for Medicare and Medicaid Services (CMS) announced a one-year extension to its normal three-year deadline to finalize the proposed rule explaining the Affordable Care Act’s “60-Day Rule” – leaving providers and their counsel with the same unanswered questions on how to comply and manage potential False Claims Act (FCA) … Continue Reading
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