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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.

The Clinical Research Compliance Manual presents the main issues and provides analysis of the statutes and regulations associated with clinical research and trials. The 2008 Supplement includes the following new developments:

• Chapter 2, Human Subject Protections in Clinical Research, includes a new section on proposed additional protections for adults with impaired decision making capacity;
• Chapter 4, Institutional Review Boards, includes new sections on requirements for written IRB procedures, proposed changes to Expedited Review Category, IRB record-keeping requirements, 2007 law requiring the registration of clinical trials, use of computerized systems in clinical investigations;
• Chapter 10, A Practical Guide to Good Clinical Practice Standards, includes subsections on FDA inspections for clinical investigators and IRBs;
• Chapter 11, Key Concepts in Reimbursement for Clinical Trials, includes the 2007 clarification and changes to CMS' NCD for clinical trial policies;
• Chapter 12, Best Practices in Clinical Research Compliance, includes a new section on legal principles associated with clinical trial billing compliance;
• New Chapter 14, Research Privacy and Security: Myths, Facts and Practical Approaches, covers HIPAA privacy and security rules, Common Rule and FDA privacy and confidentiality provisions, state privacy and mandatory disclosure laws, electronic records and signatures, information security.

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Rather than relying on states to expand health care coverage through pilot programs, the federal government should work to fix the Medicare system, former HHS Secretary Tommy Thompson said at a Senate Finance Committee hearing on May 6, 2008. CCH Washington Bureau, May 6, 2008. Full Story

A hospital and physician group that wrote referral letters on behalf of an anesthesiologist had no duty to disclose to a future employer their investigation into the anesthesiologist's on-duty use of narcotics, according to a recent decision by the fifth circuit court of appeals. The court found, however, that the hospital and physician group had a duty to avoid affirmative misrepresentations in the referral letters. Kadlec Medical Center v. Lakeview Anesthesia Associates, 5th Cir., May 8, 2008, Health Care Compliance Reporter p800,503. Full Story

When creating, correcting, and adding to a patient's health record, it is crucial for legal purposes to make sure the information is accurate and authentic and that the original record is maintained, according to experts who spoke during a recent American Health Information Management Association webinar on defining and maintaining the legal health record. CCH Washington Bureau, May 5, 2008. Full Story

Senators working to protect the privacy and security of personal health information have reached an agreement that will advance negotiations over provisions in the Wired for Health Care Quality Act ("Wired Act"), a bill sponsored by Senators Edward Kennedy (D-Mass.) and Michael Enzi (R-Wyo.) to help establish a national health information technology system. U.S. Senator Patrick Leahy Press Release, May 14, 2008. Full Story

The Office of Inspector General (OIG) has declined to approve a laboratory's proposal to provide certain services at no cost to dialysis facilities because the arrangement could potentially generate prohibited remuneration and subject the laboratory to administrative sanctions under the anti-kickback statute, according to a recent advisory opinion. OIG Advisory Opinion, No. 08-06, May 2, 2008, Health Care Compliance Reporter p500,185. Full Story

The HHS Office of Civil Rights (OCR) has added new enforcement data to its Web site on Health Insurance Portability and Accountability Act (HIPAA) privacy compliance. HHS Release, May 9, 2008. Full Story

A former employee of a counseling center pled guilty to violating the Health Insurance Portability and Accountability Act by allowing two individuals to take patient files from the counseling center with the intent to obtain personal gain. DOJ Press Release, May 8, 2008. Full Story

McKesson Corporation, a national distributor of branded and generic prescription medications, has agreed to pay $13.25 million to resolve allegations that it violated federal reporting provisions related to the sale of certain prescription medications regulated by the Drug Enforcement Administration (DEA), the Department of Justice announced. DOJ Press Release, May 2, 2008. Full Story

A federal jury in Miami convicted a dermatologist of conspiracy to defraud the U.S. government, conspiracy to cause the submission of false claims to Medicare, conspiracy to solicit and receive kickbacks, and conspiracy to commit health care fraud, the U.S. Attorney for the Southern District of Florida announced. U.S. Attorney, Southern District of Florida Press Release, April 30, 2008. Full Story

Medicare mark-up prohibition on diagnostic tests: Navigating compliance and coding implications

by Charles I. Artz, Esq. and Michael D. Miscoe, CPC, CHCC, Contributing Editors

Medicare providers have long been able to report comprehensive diagnostic services when either the technical or professional component of the service was "purchased" from an outside provider or entity. An issue, however, has arisen regarding the circumstances in which this is permissible and the fee that Medicare may be charged for the purchased component of the test. CMS recently published new rules related to purchased diagnostic services. Full Story