Affordable Care Act

Finally! CMS Publishes the 60-Day Rule for Reporting and Repaying Medicare Overpayments

Posted by Ryan Blaney on February 12, 2016
ACA, Affordable Care Act, False Claims Act, Final Rule, Fraud and Abuse / No Comments

After four years and 200 comments, CMS finalized the much‑awaited “60‑Day Rule” for reporting and repaying Medicare Part A and B overpayments (CMS issued a Final Rule related to Medicare part C and D overpayments in the May 23, 2014 Federal Register, 79 FR 29844, and will address Medicaid overpayments in future rulemaking). The 60-Day Rule is part of CMS’s efforts to reduce fraud, waste, and abuse in the Medicare program.

Section 6402(d) of the Affordable Care Act (ACA), created section 1128J(d) of the Social Security Act (codified at 42 U.S.C. 1320a-7k(d)), requiring a person or entity who has received an overpayment to report and return the overpayment to the appropriate entity by the later of: (1) 60 days after the date on which the overpayment was “identified”; or (2) the date any corresponding cost report is due (if applicable). Importantly, the ACA also made reporting and repaying overpayments within 60 days an “obligation” under the False Claims Act (FCA), and therefore subject to FCA liability. Proof of specific intent to defraud the government is not required for a person or entity to be liable under the 60-Day Rule.

The Final Rule slightly relaxes some of the onerous requirements in the 2012 Proposed Rule:

Six Year Lookback Period: CMS responded to numerous comments and concerns that the proposed 10-year look back period for identifying overpayments was too long. The 60-Day Rule changed the lookback period to 6 years, consistent with the statutory limitations for the FCA.

Definition of Identify: CMS acknowledged the numerous comments submitted on what it means to “identify” an overpayment and said, “We agree and have revised the language … to clarify that part of identification is quantifying the amount, which requires a reasonably diligent investigation.” According to CMS, “[t]he Final Rule clarifies that a person has identified an overpayment when the person has or should have, through the exercise of reasonable diligence, determined that the person has received an overpayment and quantified the amount of the overpayment.” CMS warned Medicare providers and suppliers not to use the “ostrich defense”; reasonable diligence includes both proactive compliance activities conducted in good faith by qualified individuals, and good faith investigation of credible information conducted in a timely manner by qualified individuals. Quantification of the amount of the overpayment may be determined using statistical sampling and extrapolation methodologies.

How to Report and Return Overpayments: The Final Rule states that providers and suppliers must use an applicable claims adjustment, credit balance, self-reported refund, or another appropriate process to satisfy the obligation to report and return overpayments.

The Final 60-Day Rule is available at: https://federalregister.gov/a/2016-02789. By way of comparison, the February 16, 2012 Proposed Rule is available at:  https://www.gpo.gov/fdsys/pkg/FR-2012-02-16/pdf/2012-3642.pdf

To learn more about reporting or making repayments under the Final Rule, please contact Ryan Blaney, Dana Petrillo or any member of Cozen O’Connor’s Health Law team.

Ryan Blaney

Ryan Blaney

Ryan represents health care and life sciences clients in a wide range of litigation, regulatory, and transactional matters, but has particular experience in the areas of privacy law compliance and health care fraud litigation. In his regulatory and transactional practice, Ryan serves public and private health care companies, academic medical centers, health systems, hospitals and physician organizations, manufacturers, medical devices, information technology and health plans

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Co-Chair of Cozen O’Connor’s Health Care Practice Discusses the Affordable Care Act in the New York Times

Posted by Chris Raphaely on March 10, 2015
Affordable Care Act, Medicaid / No Comments

Mark H. Gallant, co-chair of Cozen O’Connor’s Health Care practice group and a nationally respected health care lawyer, was quoted in a recent New York Times article discussing the Supreme Court arguments in the case, King v. Burwell. At issue in the case is the right to federal subsidies for the purchase of health insurance by individuals who reside in states that have chosen to have the federal government run their health insurance exchange.  If decided for the plaintiffs, the case could have a drastic effect on the future of the controversial Affordable Care Act.

Mark has been a go-to contact for the press on these type of issues for many years, recently providing insight into another Supreme Court case regarding the rights of providers to sue states over Medicaid payment rates in Bloomberg Business News. With the Affordable Care Act’s mandate to expand health care coverage and states still facing significant budgetary constraints, various media outlets will no doubt be seeking out Mark’s insights as the issues surrounding the payment for expanded health care coverage play out.

Some Supreme Court Justices Cite 2012 Argument Against Health Care Law as Defense for It Now – New York Times – March 8, 2015

Why the Supreme Court’s Medicaid Decision Matters – Bloomberg Business – January 20, 2015

Chris Raphaely

Chris Raphaely

Chris joined Cozen O’Connor’s Philadelphia office in 2014 as co-chair of the Health Care Practice Group. Prior to joining the firm, Chris served as deputy general counsel to Jefferson Health System and general counsel to the system’s accountable care organization and captive professional liability insurance companies.

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ProMedica and the AHA Seek Guidance from SCOTUS on Hospital Consolidations and Mergers

Posted by Ryan Blaney on February 05, 2015
ACA, Federal Trade Commission, FTC, Supreme Court / No Comments

FTCStatueThe New Year started out with a bang in the healthcare antitrust circles with ProMedica Health Systems Inc.’s (“ProMedica”) well-publicized petition to the US Supreme Court and the American Hospital Association’s (AHA) amicus brief in support of ProMedica.  ProMedica hopes that the Supreme Court will hear the case and overturn a Sixth Circuit ruling requiring ProMedica to divest St. Luke’s Hospital, a non-profit hospital in Toledo, Ohio.  As evidence of the complexity and the lengthy litigation challenges between ProMedica and the Federal Trade Commission (“FTC”) this merger occurred almost five years ago in 2010.  The FTC and the Ohio Attorney General had sued to dissolve the deal because they considered it anti-competitive; arguing that ProMedica would control 60% of the hospitals in the greater Toledo area. The FTC ordered ProMedica to divest St. Luke’s (21 HLR 467, 3/29/12).  The Sixth Circuit agreed with the FTC on the grounds that the merger would likely result in higher prices for payors and consumers and lead to unintended precedent for future hospital mergers.

ProMedica’s petition argues that this case is “a rare and uniquely apt vehicle for consideration of the [merger law] issues based on a fully-developed record.”  Hospital merger cases rarely are litigated through appeal and this case is an opportunity for the Supreme Court to clarify fundamental aspects of merger law nearly 40 years after the United States v. General Dynamics Corp., 415 U.S. 486 (1974) decision.  ProMedica argues that over the last 40 years confusion has developed over the FTC’s unilateral-effects theory and consolidation pressures have increased with the passage of the Affordable Care Act and other federal regulations.

ProMedica’s petition focuses on three merger law questions that the lower courts are divided on as the primary reasons why the Supreme Court should hear the case:

  1. How the FTC defines relevant market product for a merger analysis and whether the FTC can base it on supply-side considerations. ProMedica argued that the FTC should have either analyzed hospital services market by market because one kind of surgery is not a substitute for another or the FTC should have considered all four levels of hospital services as a package-deal market.
  2. Where the FTC relies exclusively on a unilateral-effects theory in challenging a merger may a court adopt a strong presumption of anti-competitive harm based solely on market-share statistics?
  3. Can the FTC rely on market-share statistics to preclude consideration of the merger target’s financial weakness to rebut a presumption of harm based on market-share statistics in unilateral-effects cases?

The unilateral effects analysis is the degree to which the merging hospitals are substitutes for each other.  The higher the substitutability between two merging hospitals, the greater the competition among them and the greater the power.  Here, ProMedica argues that Mercy Hospital, not St. Luke’s, is the closest substitute in the Toledo area.

ProMedica received support from the American Hospital Association (“AHA”) on the third issue, the “weakened competitor” doctrine.  On January 21, 2015, AHA filed an amicus brief asking the US Supreme Court to review the Sixth Circuit decision and the lower court’s characterization that the “weakened competitor” argument is a “Hail Mary” that deserves credence only in rare situations.  AHA argues that the Sixth Circuit’s erosion of the “weakened competitor” doctrine leaves the “viability of many small and stand-alone hospitals in jeopardy.”  AHA also argues that there are conflicting interpretations by the lower courts on how to read the General Dynamics decision.  Clarity is needed from the Supreme Court especially in the context of health care mergers.  Hospitals should not have to wait until they are on the edge of bankruptcy to merge.  AHA believes that the Sixth Circuit errored when it did not apply the General Dynamics weakened competitor analysis to the ProMedica acquisition.

The case is ProMedica Health System Inc. v. Federal Trade Commission, case number 14-762, in the Supreme Court of the United States.  The FTC has until March 2, 2015 to file a response.  It is unknown when the Supreme Court will decide about hearing the case.

For further information contact Ryan P. Blaney, Washington, DC, at [email protected]

Ryan Blaney

Ryan Blaney

Ryan represents health care and life sciences clients in a wide range of litigation, regulatory, and transactional matters, but has particular experience in the areas of privacy law compliance and health care fraud litigation. In his regulatory and transactional practice, Ryan serves public and private health care companies, academic medical centers, health systems, hospitals and physician organizations, manufacturers, medical devices, information technology and health plans

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Are You Prepared? The ACA’s Compliance Program Mandate for All Health Care Providers

Posted by Judy Mayer on April 15, 2013
Affordable Care Act, Medicare / No Comments

While the implementation of compliance programs to encourage the development and use of internal controls to monitor adherence of the health care industry to applicable statutes, regulations, and program requirements has long been considered a best practice, the Patient Protection and Affordable Care Act (“ACA”) has made them mandatory. Continue reading…

Judy Mayer

Judy Mayer

Judy Mayer is an associate in the firm’s Health Law Group. Judy handles a variety of transactional, regulatory and litigation matters, including advising health care providers. She also holds an MBA from Villanova University.

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Taking Aim in 2013: The Government Points Two Barrels at Preventing and Punishing Healthcare Fraud and Abuse

Posted by William P. Conaboy Jr. on November 16, 2012
Affordable Care Act, Fraud and Abuse, HIPAA, HITECH, Medicaid, Medicare / No Comments

A few weeks ago we posted on this Blog an article highlighting the “gathering storm” surrounding HIPAA enforcement and predicted an ominous future for hospitals and other providers who fail to develop and maintain adequate HIPAA compliance policies.  While there is no doubt the future is bleak for those unwilling to abide by HIPAA’s mandate, the forecast for providers who commit healthcare fraud is equally devastating.  This is because, in 2013, the federal government will attack healthcare fraud from two angles. First, the Office of Inspector General (“OIG”), per the terms of its 2013 Work Plan (“Work Plan”), will review many of the government’s anti-fraud efforts to maximize recovery of Medicare and Medicaid overpayments.  Second, many of the new anti-fraud provisions in the Affordable Care Act (“ACA”) will kick into high gear now that the result of the presidential election has guaranteed the law’s survival. Continue reading…

William P. Conaboy Jr.

William P. Conaboy Jr.

Bill Conaboy is an associate in the firm’s Healthcare Law Group. Prior to working with the firm Bill earned a Doctor of Pharmacy degree (Pharm D), and is currently a licensed pharmacist and attorney in both Pennsylvania and New Jersey. Bill focuses on regulatory and litigation matters related to many areas of healthcare law.

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Shedding Some Light on the ACA’s Sunshine Provisions

Posted by Robert A. Chu on October 01, 2012
Affordable Care Act, Fraud and Abuse / No Comments

On September 12, 2012, the Senate Special Committee on Aging held a roundtable hearing on the Sunshine Provisions in Section 6002 of the Patient Protection and Affordable Care Act (the “Sunshine Provisions”).  Under the Sunshine Provisions, certain drug and device manufacturers must annually report to the government many payments and other transfers of value they make to physicians and teaching hospitals.  Certain drug and device manufacturers and group purchasing organizations (“GPOs”) must also report ownership and investment interests in them held by physicians and their immediate family members.  In this post, we will report on the roundtable hearing, provide an overview of a Proposed Rule regarding the Sunshine Provisions, and discuss their implementation. Continue reading…

Robert A. Chu

Robert A. Chu

Rob is a member in the Health Law Practice Group. He primarily represents health care clients in Medicare, Medicaid, and third-party payor reimbursement disputes. Rob also counsels health care clients on regulatory and compliance issues. He was selected as a Super Lawyers Rising Star (Health Care) for 2016-2018.

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