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Mark H. Gallant

Chair, Health Law
P (215) 665-4136

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      Health Care

      Cozen O'Connor Blogs

      Health Law Informer

      The U.S. health care industry is one of the largest, most complex, and most heavily regulated systems in the world. It is also one of the most unpredictable. Today, health care providers and institutions have to respond to health care reform, expanded coverage rules, value-based Medicare reimbursements, pressures to reduce costs, and hospital and health system mergers and acquisitions. Tomorrow, they will have to confront a whole new set of changes. In this fluid business environment, Cozen O’Connor’s health law team helps clients address issues with government and non-government payers, stay ahead of and compliant with existing and new regulations, and lead the industry in becoming conversant about the Medicaid, insurance coverage and fraud and abuse aspects of the Affordable Care Act.

      Our firm offers a full array of services to major players in the health industry, including hospitals, health care systems, MCOs, providers and suppliers, device manufacturers, health care entrepreneurs, academic medical institutions, and physician groups. We represent clients in high-stakes health industry litigation including False Claims Act cases, one of the first Stark Law disclosures, and government investigations, including addressing the ACA’s 60 day repayment requirement.  We have a national reputation as the go-to firm for payor disputes.  Our regulatory experience is similarly broad, encompassing privacy and HIPAA/HITECH issues; Medicaid, Medicare, and third-party reimbursement; provider-payor relations; Medicare Secondary Payer Act guidance; provider-based issues; physician-vendor relationships and Physician Payment Sunshine Act; and general compliance, licensure, and certification requirements. Finally, we provide transactional guidance on mergers, acquisitions, restructurings, and joint ventures or co-management arrangements; tax, bankruptcy, and antitrust matters; and all manner of health industry contracts.

      All our work in the health field is grounded on one attribute: a deep knowledge of the governing body of law, including the Medicare and Medicaid statutes and implementing regulations and commercial third party payor law. Health is such a heavily regulated industry that no matter what the client’s goal may be – consolidation of two healthcare systems, launch of an MRI facility, challenge to a Medicaid underpayment, or compliance with complex regulatory requirements – the difference between success and failure often turns on mastery of the complex, ever-changing statutory regime.

      The team at Cozen O’Connor is unique in that our attorneys combine statutory knowledge with hands-on practicality. Our job, after all, is not to produce doctoral theses on the minutiae of every health code. Instead, it is to provide accurate and concise advice that helps clients achieve their goals. That means using our regulatory experience to secure maximum reimbursements, limit liabilities, and complete transactions efficiently and profitably.

      To do that, our health lawyers must be creative. In this confined legal space, one filled with dead ends, narrow passageways, and low ceilings, our talent lies in finding new routes through the maze. Cozen O’Connor’s attorneys are nationally recognized for their ability to identify uncommon legal solutions to seemingly intractable problems. They have successfully reached negotiated solutions in highly contentious litigation matters, achieved favorable results in litigation, and designed innovative transactional models that have been adopted by lawyers in other firms.

      Our health clients also benefit enormously from the professional relationships our attorneys have with officials in key regulatory bodies, including the Centers for Medicaid & Medicare Services, Department of Justice, state attorneys general offices, state departments of welfare, and state and federal legislatures. We have earned the respect of government administrators over decades of practice. This enables us to reach out to officials to resolve potential issues before they crystallize, and it gives us valuable insight into regulators’ priorities.

       

      SERVICES

      Litigation

      • Handle a broad array of third-party payor litigation and arbitration
      • Represent clients in Provider Reimbursement Review Board proceedings
      • Respond to fraud and abuse, and Stark Law claims, including making strategic decisions about disclosures and other repayments
      • Provide False Claims Act representation
      • Conduct internal investigations and respond to government investigations
      • Defend health care clients in enforcement actions brought by federal and state agencies

      Regulatory

      • Advise on privacy, security, and other HIPAA/HITECH-related compliance issues
      • Counsel clients on Medicare, Medicaid, and other third-party reimbursement matters
      • Counsel clients on state and federal Anti-kickback issues and Stark and Codey issues
      • Develop and assess compliance programs
      • Counsel clients on compliance with the Medicare Secondary Payer rules
      • Counsel health care providers and institutions about licensure and certification requirements
      • Develop programs to comply with the Physician Payment Sunshine Act

      Transactional

      • Represent a variety of clients in mergers, acquisitions, divestitures and restructurings
      • Structure joint ventures and co-management arrangements
      • Identify and resolve antitrust, tax, and bankruptcy issues for health care organizations
      • Arrange financing for assisted living facilities, hospitals, and nursing homes
      • Structure contracts between MCOs, third-party payors, and plan administrators
      • Develop integrated delivery systems
      • Structure relationships between hospitals and medical staff
      • Form physician practice groups and physician practice management organizations

       

      CLIENTS

      Our clients include a full range of nonprofit and for-profit health care organizations:

      • Health care systems
      • Hospitals
      • Nursing homes and senior living facilities
      • Hospital, nursing home, and pharmacy trade associations
      • Managed care organizations
      • Physician groups and physician practice management companies
      • Academic medical institutions
      • Entrepreneurs
      • Home health and home care companies
      • Suppliers
      • Device manufacturers
      • Mental health providers
      • Pharmacies
      • Banks, financial institutions and others involved in the financing of health care enterprises

       

      TEAM

      Cozen O’Connor’s health law team has stellar legal, professional, and academic qualifications. The group chair was the former deputy chief counsel to the Centers for Medicare & Medicaid Services overseeing all federal litigation under the Medicare and Medicaid programs. The team includes attorneys with graduate degrees in public health, business, and accounting. Many author scholarly articles and speak about cutting edge health law issues to a wide variety of audiences.

      A notable feature of Cozen O’Connor’s health care practice is its collegiality. This directly benefits clients because it means that colleagues are aware of each other’s skills and can leverage the group’s collective experience to respond to client matters. Health law is also well integrated into the larger firm, and the culture of collaboration extends beyond the practice group. The health team is backed by top practitioners in labor and employment, insurance, bankruptcy, real estate, and litigation. We understand that most problems are multidimensional, so our attorneys work together to devise comprehensive solutions.

      Experience

      Represented a client in an administrative proceeding involving the federal government’s Retiree Drug Subsidy Program (RDSP) in which our attorneys persuaded the government to grant the client a rare exception to the filing requirement to redress the inequitable result of routine application of the program rules.


      Represented Mid-Atlantic Health Care, Baltimore MD, in a $75 million acquisition of five Philadelphia nursing homes.


      Represented New Jersey Hospital Association in New Jersey Hospital Ass'n in v. Waldman, 73 F.3d 509 (3d Cir. 1995). Challenge by New Jersey hospitals under Boren Amendment to reduction of DRG rates and adequacy of disproportionate share payments.


      Represented Mercy Catholic Medical Center in Mercy Catholic Medical Ctr. V. Thompson, 380 F.3d 142 (3d Cir. 2004). Invalidating CMS audit rules used to set average per resident amount; requiring intermediaries to increase costs not previously claimed as GME expense, but verified by subsequent time studies.


      Represented Children's Seashore House in Children's Seashore House v. Waldman, 197 F. 654 (3d Cir. 1999). Ordering New Jersey to pay Medicaid disproportionate share adjustments to out-of-state providers.


      Provided guidance to hospital client regarding inter-relationship of state and federal patient safety laws.


      Represented Internet pharmacy on regulatory and general compliance issues.


      Assisted a local hospital obtain training reimbursement rates from Medicare after an 8-year fight from the intitial administrative appeal challenging the government's interpretation of its re-audit rules to a federal case in the Third Circuit. The court ordered the government to recalculate its reimbursements without reliance on its discriminatory re-audit rule.


      Prohibited Medicare program from recouping pre-petition overpayments from hospitals that have filed for bankruptcy in In re: Universal Medical Center, 973 F.2d 1065 (3d Cir. 1992).


      Advised a physician organization on compliance with the antitrust laws in connection with negotiating managed care contracts on behalf of its member constituents.


      Assisted ambulatory care facility in developing patient safety program.


      Defended a multi-state provider of behavioral health services against a False Claims Act suit brought by the federal and state governments, and advising the client with respect to its obligations under a resulting Corporate Integrity Agreement.


      Represented the American Hospital Association and Association of American Medical Colleges as friends of the court in In re: Cardiac Device Litigation (Second Circuit U.S. Court of Appeal) involving Medicare billings for services including investigational devices


      Represented physician group practices before the New Jersey Board of Medical Examiners in connection with compliance with the New Jersey anti-referral law, commonly referred to as the "Codey Law."


      Handled the consolidation of two Healthcare systems in Pennsylvania including performing due diligence, negotiating and drafting all required definitive documents, communicating with federal and state regulators and with the Pennsylvania Attorney General's office, and obtaining private letter rulings from the Internal Revenue Service related to the consolidation.


      Represented a national pharmacy chain in various regulatory counseling on manufacturer rebate programs, patient refill compliance programs, federal fraud and abuse compliance, and issues related to an affiliated PBM.


      Represented a national pharmacy chain in regulatory advice and defense of claims by state PACE programs involving application of mandatory discounts.


      Represented the National Association of Chain Drug Stores on numerous projects, including: a comprehensive analysis of the statutes, regulations and case law governing reimbursement requirements and rate reductions by State Medicaid programs and in the Massachusetts District Court AWP rebate and pricing litigation (the McKesson AWP case).


      Served as counsel to a national long term care pharmacy specialty providers in connection with Pennsylvania Medicaid rate setting and compliance issues.


      Represented national nursing home chain in Medicare Part A appeals involving "related party" (institutional pharmacy) reimbursements.


      Assisted medical device client in becoming compliant with Physician Payment Sunshine Act.


      Served as compliance counsel for a national insurance company with respect to Medicare Secondary Payer Act.


      Developed HIPAA and HITECH compliance programs for multiple providers, payors and business associates.


      Served as compliance counsel for several long term care organizations.


      Developed compliance programs for hospital based pharmacy and home health provider.


      Served as regulatory counsel for hospice provider.


      Provided counsel to device manufacturer on vendor/marketing issues.


      Represented dental practices in multiple mergers and acquisitions.


      Established ambulatory surgery facilities and assisted in compliance with state and federal regulations, including Stark.


      Represented a holding company in the acquisition of multiple home health agencies.


      Served as corporate and regulatory counsel in acquisition of five nursing homes. Handled financing for sale as well.


      Represented nursing homes in New Jersey and Florida in asset sale of facilities.


      Represented non-profit providers in Orphans Court proceeding and Attorney General approval for fundamental change transactions.


      Advised optometry practices on co-management arrangements.


      Represented a major hospital center in an arbitrated dispute with a Medicaid managed care organization (MCO). Over the hospital’s objection, the MCO sought to justify failures to pay for hospital services on medical necessity grounds, even though the MCO had denied the relevant claims solely for lack of authorization. After the arbitrator ruled in the hospital’s favor on this issue and a variety of others, the matter settled on favorable terms for our client.


      Represented an air ambulance company in a dispute with a Medicaid managed care organization (MCO) that refused to pay more for out-of-network transportation services than the federal default rate applicable to emergency hospital services. We brought suit alleging that the default rate did not apply, that the MCO had breached an implied-in-fact contract with the company and the terms under which it participated as a Medicaid plan, and that the MCO had been unjustly enriched. After the court denied most of a motion to dismiss by defendant, the matter settled on favorable terms for our client.


      Represented various entitites in establishing management companies.


      Attorneys

      Katie R. Beran Associate Philadelphia (215) 665-2141
      Robert A. Chu Associate Philadelphia (215) 665-2101
      William P. Conaboy, Jr. Associate Philadelphia (215) 665-5580
      Gregory M. Fliszar Member Philadelphia (215) 665-7276
      Mark H. Gallant Chair, Health Law Philadelphia (215) 665-4136
      Thomas M. Jones Member Seattle (206) 224-1242
      Aaron Krauss Member Philadelphia (215) 665-4181
      Katherine M. Layman Member Philadelphia (215) 665-2746
      Judy Wang Mayer Associate Philadelphia (215) 665-4737
      Frances B. McGinley Attorney Philadelphia (215) 665-2016
      John P. Moses Of Counsel Wilkes-Barre (570) 970-8030
      Scott W. Reid Member Philadelphia (215) 665-2152
      E. Gerald Riesenbach Member Philadelphia (215) 665-4159
      Colin T. Roskey Member Philadelphia (215) 665-4100

      Publications


      CMS Proposes FY 2014 Prospective Payment System Update Rules for Skilled Nursing Facilities

      May 09, 2013

      MORE


      An Overview of the IRS’s Proposed Rule on Community Health Needs Assessments

      May 07, 2013

      MORE


      An Overview of Proposed Rule on Community Health Needs Assessments [Health Lawyers Weekly]

      May 03, 2013

      MORE


      Congress Drafts Legislation that would Expand the FDA’s Role in Regulating Compounding Pharmacies [Health Law Informer]

      May 02, 2013

      MORE


      CMS Proposes Prospective Payment System Update Rules for Inpatient and Long Term Care Hospitals

      May 01, 2013

      MORE


      IP: Obamacare’s Constitutional Impact on Patents [InsideCounsel]

      April 30, 2013

      MORE


      Hospitals Prevail in Effort to Include Pennsylvania GA Days in the Medicare DSH Calculation [Health Law Alert]

      April 23, 2013

      MORE


      Hospitals Providing Medical Care to Federal Employees Covered by HMOs May Be Subject to OFCCP's Affirmative Action and Other Requirements [Labor and Employment Alert]

      April 08, 2013

      MORE


      Highlights of the Omnibus HIPAA/HITECH Final Rule [Cozen O'Connor Whitepaper]

      March 07, 2013

      MORE


      Implementing the Affordable Care Act: Countdown to 2014 (The 90-Day Waiting Period Limitation) [ACA Alert]

      February 12, 2013

      MORE


      Implementing the Affordable Care Act: Countdown to 2014 (Tax Implications) [ACA Alert]

      January 28, 2013

      MORE


      Implementing the Affordable Care Act: Countdown to 2014 (Introduction) [ACA Alert]

      January 25, 2013

      MORE


      HHS Releases the Long-Awaited Final Omnibus HIPAA Rules [Health Law Alert]

      January 22, 2013

      MORE


      Taking Aim in 2013: The Government Points Two Barrels at Preventing and Punishing Healthcare Fraud and Abuse [Health Law Informer]

      November 16, 2012

      MORE


      HIPAA Enforcement - The Gathering Storm Has Arrived [Health Law Alert]

      November 16, 2012

      MORE


      Seventh Circuit Rules that Medical Necessity Trumps State-Imposed Cap on "Optional" Medicaid Coverage [Health Law Alert]

      October 24, 2012

      MORE


      Pharmaceutical Manufacturers and Consumers, and Congressional Democrats and Republicans AGREE to Increase, Expand and Extend the FDA User Fee Program [Health Law Informer]

      August 15, 2012

      MORE


      Solving the Medicaid secondary payment puzzle [Compliance Today]

      August 01, 2012

      MORE


      Third Circuit Rules that Medicare Advantage Plans have a Private Right of Action Under the Medicare Secondary Payer Act [Health Law Alert]

      July 11, 2012

      MORE


      Supreme Court Rules on Affordable Health Care Act: Upholds Individual Mandate and Limits Scope of Medicaid Expansion [Health Law Alert]

      June 28, 2012

      MORE


      CMS Issues Proposed Guidelines for Protecting Medicare's Interests When a Settlement Involves Future Medical Care [Health Law Alert]

      June 22, 2012

      MORE


      Trojan Horse or Meaningful Medicaid Reform? [Health Law Informer]

      June 22, 2012

      MORE


      Federal Court Sends Mixed Message on Hospital's Right to Payment for Out-of-Network Services [Health Law Alert]

      June 21, 2012

      MORE


      WARNING: HHS Now Combating HIPAA Violations with HITECH Weaponry [Health Law Alert!]

      March 23, 2012

      MORE


      CMS Issues Proposed Rule on Reporting and Returning Medicare Overpayments [Health Law Alert!]

      February 21, 2012

      MORE


      The Medicare Secondary Payer Act - CMS Provides Initial Guidance on Medicare Set Asides in Liability Settlements [Health Law Alert!]

      October 14, 2011

      MORE


      Proposed Rules for Accountable Care Organizations Released March 31, 2011 by the Federal Trade Commission, Department of Justice, and the Center for Medicare & Medicaid Services [Health Law Alert!]

      April 01, 2011

      MORE


      On First Anniversary, a Look at Challenges to Health Care [The Legal Intelligencer]

      March 23, 2011

      MORE


      House Judiciary Hearing Provides Few Answers for ACO Participants [Health Law Alert!]

      December 12, 2010

      MORE


      CMS Voluntary Self-Referral Disclosure Protocol: The Good, The Bad, and The Ugly [Health Law Alert!]

      November 17, 2010

      MORE


      CMS Delays Section 111 Reporting for Liability Insurers [Health Law Alert!]

      November 16, 2010

      MORE


      The Medicare Secondary Payer Act and Its Impact on Litigation [The Legal Intelligencer]

      October 26, 2010

      MORE


      DOJ Follows Through on Pledge; Sues BCBS of Michigan Over MFN Clauses [Health Law Alert!]

      October 18, 2010

      MORE


      Proposed New Rules Implementing HITECH Amendments to HIPAA Make Significant Changes [Health Law Alert!]

      August 03, 2010

      MORE


      Stark Realities of Health Care Reform [Health Law Alert!]

      May 12, 2010

      MORE


      Health Care Reform Includes Reporting Requirements Regarding Drug and Device Manufacturers' Payments to Physicians and Teaching Hospitals [Health Law Alert!]

      May 11, 2010

      MORE


      Health Care Reform Imposes New Compliance Requirements on Tax-Exempt Hospitals [Health Law Alert!]

      May 10, 2010

      MORE


      Providers Beware: Health Care Reforms Make Failing to Promptly Refund Overpayments—Including Those Attributable to Identified Stark Violations—Potential False Claims Act Violations [Health Law Alert!]

      April 26, 2010

      MORE


      Medicare Secondary Payer Update - CMS Delays Reporting Deadlines [Health Law Alert!]

      April 19, 2010

      MORE


      Highmark, Inc. Challenges PA. Insurance Department Investigation [Health Law Alert!]

      March 23, 2010

      MORE


      HHS Expands National Practitioner Data Bank Reporting and Access [Health Law Alert!]

      March 02, 2010

      MORE


      Under New Rules, Plans Offering Mental Health and Substance Use Disorder Benefits Must Ensure Parity in Member Costs and Access to Care [Health Law Alert!]

      February 09, 2010

      MORE


      A New Era in HIPAA Enforcement: Connecticut Attorney General Files First HITECH Act Suit [Health Law Alert!]

      January 18, 2010

      MORE


      HIPAA Breach Notification Rule Contains Some Good News [Health Law Alert!]

      August 27, 2009

      MORE


      FTC Again Delays Enforcement of Red Flags Rule [Health Law Alert!]

      August 07, 2009

      MORE


      New Jersey Enforces Limits on Overpayment Recoveries [Health Law Alert!]

      July 09, 2009

      MORE


      Recent Pennsylvania Decision Requires Disclosure of Medicaid Managed Care Rates [Health Law Alert!]

      July 07, 2009

      MORE


      Red Flags Rule Enforcement Delayed...Again [Health Law Alert!]

      May 08, 2009

      MORE


      New Medicare Secondary Payer Requirement: Mandatory Reporting for Liability, No-Fault and Workers Compensation Insurers [Health Law Alert!]

      April 28, 2009

      MORE


      The American Recovery and Reinvestment Act of 2009: New Markets Tax Credits Increased by $3 Billion [Health Law Alert!]

      March 20, 2009

      MORE


      The American Recovery and Reinvestment Act of 2009: Sweeping Changes to HIPAA Put Business Associates in the Spotlight [Health Law Alert!]

      March 03, 2009

      MORE


      New Codey Legislation to Provide Certainty After a Year of Limbo [Health Law Alert!]

      February 27, 2009

      MORE


      Patent-Tailored Medicine, Part Two: Personalized Medicine and the Legal Landscape [Journal of Health & Life Sciences Law]

      January 01, 2009

      MORE


      Protecting Hospital Managed Care Rates as Trade Secrets [Health Lawyers News]

      November 01, 2008

      MORE


      FTC Delays Enforcement of Red Flags Rule [Health Law Alert!]

      October 27, 2008

      MORE


      HHS' First Resolution Agreement for Alleged HIPAA Violations and What it Means for You [Health Law Alert!]

      October 01, 2008

      MORE


      Supreme Court Weighs in on Scope of False Claims Act [Health Law Alert!]

      June 23, 2008

      MORE

      Events & Seminars

      Managed Care Disputes & Litigation Philadelphia, PA 05/09/2013
      Institute on Medicare and Medicaid Payment Issues Baltimore, MD 03/20/2013
      PBI 19th Annual Health Law Institute Philadelphia, PA 03/12/2013
      Implementing The Affordable Care Act - Countdown to 2014 Philadelphia, PA 02/06/2013
      Developments Under the Affordable Care Act in the Wake of National Federation of Independent Business v. Sebelius Live Webcast 11/05/2012
      Supreme Court Health Care Ruling: What It Means for Employers Houston, TX 08/15/2012
      SUPREME COURT HEALTH CARE RULING: What It Means For Employers via Web 08/15/2012
      U.S. Supreme Court Decision on the Affordable Care Act: Assessing the Impact for Pennsylvania Hospitals Webinar 07/16/2012
      AHLA Institute on Medicare and Medicaid Payment Issues Baltimore, MD 03/28/2012
      PBI 18th Annual Health Law Institute Philadelphia, PA 03/13/2012
      2011 Health Law Year in Review Philadelphia, PA 02/15/2012
      Fundamentals of Health Law Philadelphia, PA 11/15/2011
      Exploring the Changing Landscape of Mental Health and Addictions Treatment Hamilton, NJ 10/03/2011
      Understanding Health-Care Plan Regulations and the Latest Changes to HIPAA and HITECH Harrisburg, PA 06/10/2011
      Institute on Medicare and Medicaid Payment Issues Baltimore, MD 03/30/2011
      17th Annual Health Law Institute Philadelphia, PA 03/15/2011
      Medical Records Law Philadelphia, PA 03/01/2011
      Understanding the Changes to HIPAA & HITECH Webinar Webinar 02/25/2011
      Health Law Forum: 2010 Year in Review Philadelphia, PA 02/08/2011
      Examining Health Care Reform Philadelphia, PA 10/26/2010
      The Patient Protection and Affordable Care Act and the Stark Law: New Rules, New Challenges Webinar via Internet 10/14/2010
      What Every Attorney Needs to Know About Medicaid, Medicare and Long-Term Care Philadelphia, PA 10/07/2010
      Medicare Part A Reimbursement: the PRRB and Beyond Philadelphia, PA 09/21/2010
      HIPAA/HITECH Proposed Rule Discussion Philadelphia 09/20/2010
      The Patient Protection and Affordable Care Act of 2010: Key Fraud and Abuse, Compliance and Program Integrity Implications for Hospitals Webinar 09/16/2010
      Navigating Health Care Reform: Challenges for Insurers and Providers New York, NY 06/23/2010
      The New Federal Health Care Law: Issues For All Of Our Practices Philadelphia, PA 05/26/2010
      Understanding the Latest Changes to HIPAA Online Webinar 05/20/2010
      New Federal Income Tax Requirements for Tax-Exempt Hospital Organizations Philadelphia, PA 05/17/2010
      PBI Presents: 14th Annual Insurance Institute Philadelphia, PA 04/12/2010
      16th Annual Health Law Institute Philadelphia, PA 03/11/2010
      Health Law Forum: 2009 Year in Review Philadelphia, PA 03/02/2010
      DELVACCA Presents: Health Biotech & Pharma Committee Institute Philadelphia, PA 01/28/2010
      Industry Forum: Life Sciences First Party Risks Facing Life Sciences Companies - A Strategic View and Open Forum Discussion New York, NY 06/24/2009
      Health Law Forum: Year In Review 2008 Philadelphia, PA 01/15/2009

      In The News


      Cozen O’Connor Health Law Team Prevails in "Nazareth Hosp. v. Sebelius"

      April 25, 2013

      MORE


      Cozen O’Connor’s Health Care and Public Strategies Groups Featured in Legal Bisnow

      March 07, 2013

      MORE


      Mark Gallant Quoted in Of Counsel Management Report

      February 01, 2013

      MORE


      Mark Gallant and Iden Martyn featured in Bloomberg BNA's Health Care Daily Report

      March 29, 2012

      MORE

      Related Practice Areas

      Business/Corporate

      Government & Regulatory

      Litigation

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