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HEADLINES
Wednesday, June 25, 2008
Click on a headline below for the
full story.
On
The Front Lines
CCH®
Health Care Compliance Integrated
Library
The Health Care Compliance
Integrated Library delivers the
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The Library includes seven
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Research Compliance Manual: An
Administrative Guide -
Essential guidance on the laws
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clinical research and trials.
- Defending
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and Abuse Cases: An Attorney's
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Health
Care Compliance Integrated Library
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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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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