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Managing clinical trials--frustration or bliss?

The proper financial administration of clinical trials is becoming a major priority and necessity for involved institutions. The Office of Inspector General in the Department of Justice is sharpening its radar on this growing field. Institutions involved in the conduct of a clinical trial need to become more proactive in the financial management to successfully pass audits and improve financial outcomes. Budget tools standardizing itemized costs can be built to aid clinical trials managers. Using tools already available in a clinic or hospital setting can help even the most junior budget negotiator. Establishing guidelines to streamline and aid the management of a clinical trial program will make managing less challenging.

Clinical Trials as Topic↗

Medicare: current audit & reimbursement issues.

Home care agencies have been under the Medicare microscope lately for issues of fraud; the Health Care Financing Administration (HCFA) is retooling its audit process in light of this focus. HCFA is also reconsidering its policies on deductible costs of lobbying. What do agencies need to know about this and other issues to stay financially healthy?

Centers for Medicare and Medicaid Services, U.S.↗

Annual audits of IDS risk contract settlements improve payment accuracy.

Integrated delivery systems (IDSs) should conduct annual audits of payers' settlements under risk contracts to verify that the payer attributed the appropriate amounts of revenue and charged the appropriate claims expenses to the IDS. In particular, IDSs should verify that payers calculated revenues and expenses based on consistent member counts and that the determined commercial revenue was based on the actual premiums paid. IDSs also should determine whether payers have used appropriate demographic factors and countywide rates as a basis for determining Medicare revenue, charged the IDS for claims only for valid members, paid capitated providers the correct capitation amounts, and used appropriate historical data to estimate the amounts of incurred-but-not-reported claims attributed to the IDS.

Accounts Payable and Receivable↗

Obstetric audit in resource-poor settings: lessons from a multi-country project auditing 'near miss' obstetrical emergencies.

This paper outlines the practical steps involved in setting up and running multi-professional, in-depth case reviews of 'near miss' obstetrical complications. It draws on lessons learned in 12 referral hospitals in Benin, Côte d'Ivoire, Ghana and Morocco. A range of feasibility indicators are presented which measured the implementation and frequency of audit activities, the quality of participation, adherence to the planned protocol for the near-miss audits, the quality of audit discussions and the sustainability of the project. Although the principles of the audit approach were well accepted and implemented everywhere, near-miss audits appeared most successful in first referral level hospitals. Contextual factors that determine the successful implementation of near-miss audit include staff finding adequate time for audit activities, financial incentives to groups rather than individuals, involvement of senior staff and hospital managers, the ease of communication in smaller units, the employment of social workers for the incorporation of women's views at audits, and the strength of external support provided by the research team. The poor quality of information recorded in case notes was recognized everywhere as a deficiency, but did not present a major obstacle to effective case reviews. Ownership and leadership within the hospital, more easily achieved in the first-level referral hospitals, were probably the most important determinants of successful implementation. Sustainability requires a commitment to audit from policy makers and managers at higher levels of the health system and some devolution of resources for implementing recommendations.

Africa↗

The prophet motive. Interview by Mary-Louise Harding.

Bradford Teaching Hospitals trust's crisis shows how even 'one of the best organisations in the old regime' could be 'suddenly overwhelmed', says Audit Commission chief executive Steve Bundred (pictured). He warns that the 2008 deadline for all trusts to be foundations is 'still achievable, but only if the sector raises its game on the quality of financial management and available data'. He also highlights the costing for the consultant contract as an area where 'the government may need to look again'.

Administrative Personnel↗

COBRA compliance. Audit guidelines.

An employer should evaluate the status of its records on COBRA compliance, paying particular attention to items the IRS will request. Prompt correction of any short-comings can help to decrease exposure during a COBRA audit. An added advantage will be a more systematic administration of this area of employee benefits.

Employee Retirement Income Security Act↗

Managed care under siege: how an effective compliance program can protect your company.

This article discusses the current enforcement emphasis on managed care fraud and examines how managed care organizations can utilize compliance programs, including legal audits, to protect against unwarranted investigations and liability. The article reviews the elements of an effective compliance program, how to conduct an internal audit, and the risks and benefits of a voluntary disclosure in the event fraudulent activity is discovered.

Employee Performance Appraisal↗

Management peer review.

By implementing a management audit program, you can not only improve your clinic's operation, but also demonstrate a forward-thinking management style and strengthen your public image.

Accounting↗

Firms help hospitals retrieve overpayments.

The money hospitals are losing in overpayments to vendors probably won't make or break an organization, but the dollars can start to add up. Managers can turn to companies specializing in retrieving such revenues. One firm said its audits find an average of $90,000 in overpayments at the typical hospital, with the facility and the firm splitting any money actually collected.

Accounts Payable and Receivable↗

The costs and benefits of the Form 5500 annual report.

The author suggests that although the Form 5500 annual report may help to reduce legal violations, it may do so in an unnecessarily expensive way that serves the economic interests of some professional groups. In particular, his investigation suggests that the CPA audit provides questionable benefits and amounts to a special interest group's extraction of rents through the regulatory process.

Accounting↗

Application of a single sampling plan for auditing medical-claim payments made by Taiwan National Health Insurance.

National Health Insurance (NHI) has been implemented in Taiwan for nearly a decade. Owing to growing demand for medical-care, effective sampling auditing is a key factor in obtaining reasonably priced medical-care services. This investigation proposes a conceptual framework "medical-claim payment auditing (MCPA) procedure" based on the "Military Standard 105E (MIL-STD-105E) single sampling plan" for establishing an objective criterion for making medical-claim payments fairly. The MCPA procedure contributes to the following: (1) meeting international standards of sampling technology; (2) reducing the sampling ratio and consequently auditing costs; and (3) encouraging healthcare providers to honestly apply their medical-claim payments thus avoid wasting medical resources.

Financial Audit↗

Special report on taxation. IRS issues stricter guidelines for audits of tax-exempt hospitals.

The new audit guidelines serve as yet another reminder to tax-exempt hospitals that great care must be taken in structuring and documenting business arrangements with physicians and executives so as to withstand scrutiny by the IRS with regard to exempt status. Since increased census and utilization, and enhancement of the hospital's financial position, are no longer acceptable justifications for such activities as physician recruitment incentives (being suggestive of payment for referrals), it is important that hospitals make an effort to ensure that board minutes, recruitment policies, internal memoranda, and other documentation set forth the reasons--other than the benefits to the institution's bottom line--for having entered into such transactions. Hospitals must establish and document a community need for each physician recruited. Hospitals that actively recruit should be armed with studies evaluating recruiting needs in each clinical area, based on objective criteria, taking into consideration managed care contracting needs and the provision of services to the poor and needy. Finally, hospitals should re-examine all joint ventures and other business relationships with physicians to determine whether such arrangements resulted from arm's length negotiation, involve fair market value for goods and services, and conform, insofar as possible, with the Medicare fraud and abuse safe harbor regulations. Under GCM 39862 and the new guidelines, "aggressive" arrangements may not only create exposure under fraud and abuse laws, but could jeopardize the provider's tax-exempt status as well.

Community-Institutional Relations↗

Answers from the audit trail.

It's a lot cheaper to develop a compliance plan than fight fraud charges. Trouble is, off-the-shelf wisdom is hard to come by. Here's sage advice from compliance pros on how to put your plan in motion.

Financial Audit↗

Tax-deferred annuity plans: meeting the IRS audit challenge.

A growing number of nonprofit organizations are being fined for violations of IRS regulations following IRS audits of their tax-deferred annuity (TDA) plans. To ensure that their organizations can withstand the scrutiny of an IRS audit, TDA plan administrators must ensure that plans meet IRS regulations and be prepared for IRS audits. Documentation--particularly of the TDA plan itself, and procedures related to salary reduction programs, compensation limits, excess deferrals and other excess contributions, loans, and distributions--must be comprehensive and in compliance with IRS regulations.

Financial Audit↗