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HEADLINES
Wednesday, June 25, 2008

CCH® Health Care Compliance Integrated Library
The Health Care Compliance Integrated Library delivers the latest information on health law. The Library includes seven invaluable titles:
  • Civil False Claims and Qui Tam Actions - An essential tool for bringing or defending Qui Tam action.
  • Clinical Research Compliance Manual: An Administrative Guide - Essential guidance on the laws and regulations affecting clinical research and trials.
  • Defending and Preventing Health Care Fraud and Abuse Cases: An Attorney's Guide - Clear, expert guidance on protecting against charges of health care fraud and abuse.
  • Health Care Fraud and Abuse Compliance Manual - Giving health care providers a clear perspective on fraud and abuse laws, written in plain-language.
  • Health Law and Compliance Update - Find the latest information on emerging issues. Each section is authored by an expert in the area and includes in-depth analysis of the latest health law and compliance issues.
  • Hospital Contracts Manual - Expert, current know-how in dealing with numerous hospital contract scenarios.
  • Hospital Law Manual - Health Law expertise covering treatment and payment issues in the delivery of health care services.

For more details, contact your sales rep.

Health Care Compliance Integrated Library

Reimbursement Advisor

Health Care Compliance Professional’s Manual June 2008

The Health Care Compliance Professional’s Manual is updated quarterly by experienced compliance practitioners and Health Care Compliance Association board members ensuring that the information is always accurate and current. The June 2008 update includes the following new chapters:

  • New Chapter on The 2008-2010 Implementation of the Deficit Reduction Act, written by Brian G. Flood, JD, CIG, CHC, AHFI, CFS.
  • Revised Chapter on Equal Employment and Labor Standards Laws, edited by William P. Schurgin, JD.
  • Revised Chapter on Corporate Integrity Agreements and Certification of Compliance Agreements, edited by Shawn Y. DeGroot, CHC, CCEP.

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Receivables Report

CCH HIPAA Privacy Guide

The CCH HIPAA Privacy Guide June quarterly update includes:

  • In Chapter I-1, Introduction:
    • News articles, surveys of providers and health professional conference participants have focused on concerns over threats to the security of medical data due to increased use of electronic health records, including private EHR repositories;
    • Reports that organizations with data breaches had delayed or failed to notify patients whose information was compromised;
    • Editorials and public interest groups calling for the adoption of a comprehensive framework for protection of health data held by public and private entities.
  • In Chapter I-2, Administrative Simplification:
    • The Office of Civil Rights "pipeline" of complaints is starting to fill up with cases that will go to more formal forms of enforcement;
    • The OCR website has been enhanced to show state-specific case investigation results; calendar-year enforcement-results; calendar-year graph showing complaint receipts; and yearly variation in the issues in cases resolved through corrective action;
    • Recent cases and state laws.

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Headlines

CMS revises reimbursement determination appeal procedures

Various provisions governing Medicare Part A provider reimbursement determinations, appeals before the intermediary hearing officers and the Provider Reimbursement Review Board (PRRB), and CMS Administrator review of PRRB decisions will become effective August 21, 2008, under a Final rule published by CMS on May 23, 2008. Final rule, 73 FR 30190, May 23, 2008, Health Care Compliance Reporter p700,067. Full Story

CMS, FDA join forces to improve quality, safety of medical products

A Final rule issued by CMS and a white paper released by the Food and Drug Administration (FDA) "will complement each other to improve patient safety and the quality of medical care," according to HHS Secretary Michael Leavitt. HHS Press Release, May 22, 2008. Full Story

Medicare recovery process draws criticism from stakeholders

The current process governing Medicare's recovery audit contractors (RACs) is harmful to small providers, according to Rep. Charles Gonzalez (D-Tex.), Chairman of the House Committee on Small Business, Subcommittee on Regulations, Health Care, and Trade. Testifying at a May 14, 2008, Subcommittee hearing, Gonzales noted that RACs get a part of every overpayment they recover. CCH Washington Bureau, May 16, 2008. Full Story

CMS approves software licensing arrangement

A hospital system's proposal to license a custom software interface ("Physician Practice Interface") to the physicians on its medical staffs for the sole purpose of ordering or communicating the results of laboratory tests and procedures would not result in an improper compensation arrangement, according to a recent CMS advisory opinion. The arrangement, therefore, would not run afoul of the prohibition against physician self-referral (Social Security Act Section 1877(h)(1)(A) ("Stark law")). CMS Advisory Opinion, No. CMS-AO-2008-01, May 2008, Health Care Compliance Reporter p350,084. Full Story

Secretary names EHR demonstration participants

The 12 communities that will participate in a national Medicare demonstration project that provides incentive payments to physicians for using certified electronic health records (EHRs) to improve the quality of patient care were identified by HHS Secretary Michael Leavitt. CMS Press Release, June 10, 2008. Full Story

Lawmakers tout health IT, encourage privacy initiatives

Lawmakers and industry officials marked the 12th annual National Health Information Technology (IT) Week on Capitol Hill with a call to fully integrate technology in the health care market. CCH Washington Bureau, June 10, 2008. Full Story

Senators offer plan to halt physician payment cuts

A plan to stop physician pay cuts from taking effect on July 1, 2008, has been outlined by Senate Finance Committee Republicans. CCH Washington Bureau, June 4, 2008. Full Story
On The Front Lines

How to conduct clinical trials in the EU and Eastern Europe: Overview and comparison with the U.S. system

by Paul R. DeMuro, J.D., MBA and Andrea Jaeger-Lenz, J.D., Contributing Editors

The global clinical trials industry currently is estimated to be worth more than $10 billion. Considering the ever increasing demand for treatments of more illnesses and more sophisticated medicines, it is bound to grow considerably in the future. Yet, escalating domestic costs and difficulties in recruiting patients for certain types of studies have led U.S. pharmaceutical companies to look abroad more and more to conduct clinical trials. Thus, globalization of clinical trials is one of the most notable trends in current clinical research. Full Story
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