Tag Archives: lawsuit

Author Recommends Medicare Use ‘Procedural Triage’ to Eliminate Backlog of Appeals and Restore Faith in the System

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

IndestIn a recent law journal article being considered for publication, Author Matthew J. B. Lawrence of the Harvard University Petrie-Flom Center, makes some bold recommendations for Medicare. His hypothesis seems to be that the extremely long delay that health care providers now face in getting a Medicare appeal hearing might be negatively affecting these providers’ view of the fundamental fairness of the system. Currently, the backlog in obtaining a Medicare Appeal Hearing before an administrative law judge is up to approximately 27 months. Mr. Lawrence argues “procedural triage” may be in order.

Following is an abstract of this article:

Prior scholarship has assumed that the inherent value of a “day in court” is the same for all claimants, and so that when procedural resources (like a jury trial or a hearing) are scarce, they should be rationed in the same way for all claimants. That is incorrect. This Article shows that the inherent value of a “day in court” can be far greater for some claimants, such as first-time filers, than for others, such as corporate entities, and that it can be both desirable and feasible to take this variation into account in doling out scarce procedural protections. In other words, it introduces and demonstrates the usefulness of procedural triage.

The Article demonstrates the real-world potential of procedural triage by showing how Medicare should use this new tool to address a looming administrative crisis that it is facing. In the methodological tradition of Jerry Mashaw’s seminal studies of the Social Security Administration, the Article uses its in-depth study of Medicare to develop a theoretical framework that can be used to think through where and how other adjudicatory processes should engage in procedural triage. The Article concludes by applying this framework to survey other potential applications for procedural triage, from the Department of Veterans’ Affairs to the Federal Rules of Civil Procedure.

Blog Editor’s Comments:

The main point of the justice system is that everyone deserves a “day in court.” In this document, Procedural Triage, Matthew J. B. Lawrence argues that the value of a day is different for all claimants; it can be greater for some, so we shouldn’t treat everyone alike. Lawrence suggests some individuals deserve to have a hearing more than others, but sometimes the system compromises that rule.

One thing this article does is show how useful procedural triage can be. “Procedural triage” being a system that makes all medical institutions who are enrolled in Medicare use statistical tools for peoples to retain their right to a full “day in court.” He suggests Medicare uses the tool to face its current administrative crisis. In the end, it would benefit due process in the entire system.

Comments?

What do you think about procedural triage? Do you agree that Medicare should use it? Please leave any thoughtful comments below.

Contact a Health Care Attorney Experienced with Medicare and Medicaid Cases.

Attorneys with The Health Law Firm represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions and termination from the Medicare or Medicaid Program. We also handle Medicare audits, ZPIC audits and RAC audits throughout Florida and across the U.S.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources:

Lawrence, Matthew J. B. “Procedural Triage.” Social Science Research Network. (June 17, 2015). From: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2619864

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: procedural triage, defense attorney, defense lawyer, medical lawyer, lawsuit, medical professionals, healthcare professionals, health care attorney, health care lawyer, The Health Law Firm, Medicare, court, litigation, day in court, procedural protections, Social Security Administration, adjudicatory, procedural justice, behavioral economics, adjudication, administrative process, civil procedure, due process, justice system

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2015 The Health Law firm. All rights reserved.

Advertisements

Investors can Continue to Bring Claims Against KV Pharmaceutical

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The U.S. Eighth Circuit Court of Appeals ruled that investors can continue to bring claims against KV Pharmaceutical Co. (KV) for making false or misleading statements to the U.S. Food and Drug Administration (FDA). The ruling was reached on June 4, 2012.

To view the appeals court ruling in Public Pension Fund Group v. KV Pharmaceutical Company, click here.

Appeals Court Ruling Revives Securities Fraud Class Action Lawsuit.

The appeals court has revived a securities fraud class action that was dismissed by a trial court in 2010. Investors pursued the fraud claims in a case filed in 2009 in U.S. District Court in St. Louis. In the lawsuit, investors allege that they suffered $1.5 billion in losses. The investors claim that the loss was suffered because KV allegedly misled the FDA in its compliance reports. KV then shut down its manufacturing operations in 2009.

Investors Allege KV Was Not Honest About FDA Compliance.

The lawsuit focused on FDA inspections of KV facilities over a six-year period. Results of those inspections were reported to the company’s management on a document called a Form 483. Investors alleged that information on the forms about KV’s compliance with FDA regulations contradicted statements KV made to investors. Allegedly, the forms stated that KV was not in compliance with FDA regulations.

However, KV said that the forms did not show the FDA’s final determination. The district court agreed with KV and dismissed the suit.

Appeals Court Decision May Have Ramifications for Other Drug Manufacturers.

The appeals court reversed the dismissal of the lawsuit. According to the appeals court, investors could have considered the Form 483 reports significant given the company’s assurance that it was in compliance.

The appeals court decision could have implications for other drug manufacturing companies. The decision represents the first time a federal appeals court has determined that FDA’s issuance of a Form 483 can be considered material under federal securities laws.

KV Has Recently Experienced Several Setbacks in Addition to the Investor Lawsuit.

The appeals court decision is the latest setback for KV. Starting in 2008, the generic drug manufacturer was subject to a series of recalls and investigations by the U.S. Department of Justice and the FDA. The investigations were related to KV’s manufacturing and distribution of oversized morphine pills.

In 2010, KV’s former subsidiary Ethex Corp. pleaded guilty to two felony counts of criminal fraud. Ethex Corp. agreed to pay $27.6 million in fines and restitution related to the charges. To view a press release from the U.S. Department of Justice regarding the charges against Ethex, click here.

In 2011, KV’s former chief executive pleaded guilty to misdemeanor violations of the Food, Drug and Cosmetic Act. He was sentenced to 30 days in jail and ordered to pay $1.9 million in fines and forfeitures.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources Include:

Harris, Andrew. “KV Pharmaceutical Must Face Suit Over Quality Assurances.” Bloomberg News. (June 4, 2012) From: http://www.businessweek.com/news/2012-06-04/kv-pharmaceutical-must-face-suit-over-quality-assurances

Raymond, Nate. “U.S. Court Revives KV Pharmaceutical Investor Suit.” Reuters. (June 4, 2012). From: http://www.msnbc.msn.com/id/47681167/ns/health/t/us-court-revives-kv-pharmaceutical-investor-suit/

About the Author:  George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.