Another far-reaching FCA decision

The number of far-reaching and burdensome False Claims Act (FCA) decisions increases by the day.  In an August 14, 2015 order by the U.S. District Court for the Middle District of Florida, a whistleblower’s complaint survived a motion to dismiss based upon some rather attenuated allegations.  Since this matter was decided at the pleadings stage, the facts may ultimately dictate a different outcome; nevertheless, the cost and burden of defending the case may result in a costly settlement precipitated by this decision.

In the case, U.S. ex rel. Bingham v. BayCare Health System, the claim is that BayCare’s construction of medical office buildings, common areas, walkways and garages on the campus of a BayCare hospital (St. Anthony’s Hospital), provided a benefit to referring physicians sufficient to constitute prohibited remuneration under the Stark law.  The medical office building was constructed by an entity called “St. Pete MOB, LLC”, which is not described as having ownership by referring physicians.   Although the facts are not clear, it appears that the allegedly improper benefit to physicians took the form of BayCare providing a “non-exclusive parking easement” to St. Pete MOB.  Continue reading “Another far-reaching FCA decision”

Court Decision on 60-day Overpayment Rule Imposes Heavy Burden on Providers

As a result of an August 3, 2015 federal court decision, nursing homes and other health care providers that participate in Medicare or Medicaid are well-advised to pay careful attention to the law that requires report and return of any overpayment within 60 days of the date on which the overpayment is “identified.”  In Kane v. Healthfirst, Inc. et al., the Southern District of New York found that the word “identified” means the date on which a provider is “put on notice” that a claim may have been overpaid.  The court said that providers cannot delay commencement of the 60-day period until the overpayment amount has been definitively determined.

The defendants in the case had argued that simply being on notice of a potential overpayment was not enough to trigger the 60-day repayment rule, which was a provision in the 2010 Affordable Care Act.  While recognizing the burden on providers to bring to conclusion a thorough and definitive investigation of a potential overpayment within 60 days, the court was firm in its finding, referring to the “demanding standard of compliance.”  However, there was a suggestion that prosecutorial discretion could act to assist a provider that did not comply with the letter of the law but acted diligently to attempt to determine an overpayment amount within the required timeframe.

This case, triggered by a former employee of one of the  provider defendants under the False Claims Act whistleblower provision, is important because it is the first time there has been a court opinion addressing the meaning of the term “identified” as used in the law.  Draft regulations published in 2012 have not been finalized.

“Per-click” fees OK but don’t count on it

The Stark Law, 42 U.S.C. 1395nn, places restrictions on lease arrangements between physician groups and hospitals for equipment owned by the physicians, leased to the hospitals and then used by the same physicians to treat patients at the hospital.  Under the Stark Law, such leases are prohibited unless the arrangement complies with the equipment rental exception, 42 U.S.C. 1395nn(e)(1)(B).

One requirement of the equipment rental exception, which is both statutory and regulatory (42 C.F.R. 411.357(b)), is that the rental charges be “set in advance.”  In a recent case from the D.C. Circuit Court of Appeals, Council for Urological Interests v. Burwell, the court considered whether a “per-click” or “per-use” fee could be considered “set in advance” and otherwise meet the criteria for the exception.  In an oddly constructed opinion, the court struck down a regulatory prohibition on per-click arrangements, but remanded under terms that would permit the restriction to be re-instated. Continue reading ““Per-click” fees OK but don’t count on it”

Duane Morris Partner Lisa Clark Featured in The Wharton Healthcare Quarterly

In the Spring 2015 edition of The Wharton Healthcare Quarterly, Duane Morris partner Lisa Clark’s article, “Affidavit: Healthcare and the Law – Healthcare Reform Update: What’s in a Name?,” discussed the innovations under the Affordable Care Act (ACA). One of the innovations was the Accountable Care Organization (ACO), where a new healthcare reimbursement system was introduced as an alternative to the tradition fee-for-service model. Over the years, the Accountable Care Organizations and other value-based models will be tested and hopefully, there will be buzz around this new model in the next year.

Gov’t and IPC Continue FCA Fight In Court

The Government and IPC The Hospitalist Company, Inc. (“IPC”) continue their False Claims Act (“FCA“) fight in court, now disputing the scope of discovery in light of the Northern District of Illinois’ partial denial of IPC’s motion to dismiss (detailed by Duane Morris here).  The Government has moved to strike certain of IPC’s general objections to discovery: (1) IPC’s objection to producing documents from IPC’s nationwide operations and (2) IPC’s objection to producing documents dated after December 31, 2010 (“Motion“).

Continue reading “Gov’t and IPC Continue FCA Fight In Court”

California Medicare Appeal Applies Strict Standing Rules

The Medicare Part B appeal process is lengthy and cumbersome, typically requiring full exhaustion of administrative remedies, including an administrative request for reconsideration, an ALJ hearing and Departmental Appeals Board review.  The process is especially frustrating when the appeal involves a challenge to a Local Coverage Determination (“LCD”), likely to have spawned several individual appeals of the same decision.

The Medicare Act does provide a shortcut to a legal review by way of 42 U.S.C. § 1395ff(f)(3) which provides that a Medicare recipient “may seek review [of an LCD] by a court of competent jurisdiction without  … otherwise exhausting other administrative remedies.”  This direct access to court review applies only if “there are no material issues of fact in dispute, and the only issue of law is the constitutionality of a provision of this subchapter or that a regulation, determination or ruling by the Secretary is invalid.” Continue reading “California Medicare Appeal Applies Strict Standing Rules”

Texas Supreme Court Holds That Compounding Pharmacies Are Health Care Providers Under Texas Medical Liability Act

On April 24, 2015, the Texas Supreme Court dismissed claims against a compounding pharmacy and its individual pharmacists which alleged negligence in compounding a lipoic acid medication, finding that the defendants were health care providers entitled to the protections in the Texas Medical Liability Act (“TMLA”).

Continue reading “Texas Supreme Court Holds That Compounding Pharmacies Are Health Care Providers Under Texas Medical Liability Act”

SCOTUS Limits Claims Brought by Healthcare Providers’ for Denied Medicaid Reimbursement

In a recent 5-4 decision by the U.S. Supreme Court, Armstrong v. Exceptional Child Center, Inc., Slip. Op., 575 U.S. ____ (March 31, 2015), Justice Scalia, writing for the majority, took aim at health care providers seeking to enforce Medicaid rate-setting provisions against a state that refused to incorporate those provisions in the state’s Medicaid plan, and instead reimbursed providers for Medicaid services at lower rates.

In Armstrong, the plaintiffs, providers of habilitation services under Idaho’s Medicaid plan sought an injunction to prevent Idaho’s State Department of Health from violating Section 30(A) of Medicaid, 42 U.S.C. § 1396(a)(30)(A), which requires a state to “assure that payments are consistent with efficiency, economy, and quality of care,” while “safeguard[ing] against unnecessary utilization of. . . care and services.”  The Court reversed the Ninth Circuit’s decision that the Supremacy Clause gave the providers an implied right of action to seek an injunction requiring Idaho to comply with Section 30(a). Continue reading “SCOTUS Limits Claims Brought by Healthcare Providers’ for Denied Medicaid Reimbursement”

OIG Issues Guide For Health Care Boards on Compliance Oversight

On April 20, 2015, the Department of Health and Human Services Office of Inspector General (“OIG“) published its “Practical Guidance for Health Care Governing Boards on Compliance Oversight” (the “Guide“).  The Guide was prepared in collaboration with the Association of Healthcare Internal Auditors, the American Health Lawyers Association, the Health Care Compliance Association, and according to the Guide, provides tips to health care boards (“Boards“) on four categories: “(1) roles of, and relationships between, the organization’s audit, compliance, and legal departments; (2) mechanism and process for issue-reporting within an organization; (3) approach to identifying regulatory risk; and (4) methods of encouraging enterprise-wide accountability for achievement of compliance goals and objectives.”  While not a legally binding document, the Guide provides helpful insight for Boards and underscores best practices in these areas. Continue reading “OIG Issues Guide For Health Care Boards on Compliance Oversight”

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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