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"Are all patients in clinical trials identified as such at registration?"

"After a sponsored study, what is done with any residual funds?"

"Do we know when physicians are using non-Medicare-approved devices?"

"Do we know who discloses protected health information and to whom?"

Compliance questions such as these may be lurking around any corner. And these questions are not just for the compliance officer; most are directly related to the financial well-being of the organization.

Today nine out of 10 U.S. healthcare providers have an organized corporate compliance program that is an integral part of daily operations. (a) Its purpose is to ensure that the organization is aware of and follows all the applicable laws and regulations, from antitrust to zoning. In an industry as heavily regulated as ours, compliance can be an awesome responsibility.

The compliance department deals with such issues as discharge disposition, consolidated billing of skilled nursing facilities, allegations of violations of human resources policy, audits of inpatient billing, supervision of residents in teaching programs, distribution of advance beneficiary notices for Medicare patients, billing for investigational devices, privacy and security concerns under HIPAA, and myriad other questions. To do this, the compliance officer calls on people throughout the organization for their input and assistance in improving polices and processes.

Some of a compliance officer's most important allies are in the finance department: the CFO and those who report to him or her, particularly the persons responsible for the patient-billing process. Experience has shown that compliance audits often uncover missed revenue opportunities that, when corrected, can improve the facility's bottom line. For example, one compliance audit discovered that due to an error in the facility's charge description master (CDM), the charge for pacemakers did not appear on the final bill. In one year alone, correction of this error resulted in more than $i million of additional revenue. Of course, compliance efforts sometimes disclose instances of erroneous billing that require refunds to the payer; however, the consensus in the industry is that hospitals and physicians underbill more often than they overbill.

Aside from monitoring the accuracy of bills, what major issues should readers be concerned with in this age of increased compliance awareness? Following are some of the issues that keep this compliance officer awake at night.

Clinical Research Compliance

Clinical research is a multibillion-dollar industry. The federal government spends about $3o billion on biomedical research, and the pharmaceutical industry spends more than that on research and development of new drugs. More than 16,000 clinical trials are conducted each year, involving millions of patients. Many finance and compliance issues can arise in clinical research, and financial managers need to be aware of what they are. Here are some questions to ask.

"After a sponsored study; what is done with residual funds (funds that are left over after all costs of the study have been paid)?" The answer may depend on the contract with the study's sponsor, but residual funds generally can be used for further research or for a mission-related purpose. They cannot inure to the principal investigator's benefit. Not managed properly, residual funds can cause compliance issues such as unrelated business income tax, private inurement, and conflict of interest.

"Why are there residuals in the first place?" The existence of residual funds may indicate that services were not billed to the research account at all, were billed but were not paid, or were billed inappropriately to another payer.

"Does the budget cover the full cost of performing the trial?" Many organizations consider the amount the sponsor is willing to pay for each patient and then back into a budget. This approach often does not cover administrative costs, staff time, overhead, and other legitimate costs to the organization. Once a budget that estimates all the institution's costs has been prepared, a committee in the facility should review the trial solely from a financial perspective. If a shortfall will occur, the committee can decide whether to renegotiate with the sponsor or take the loss because of the benefit to science, the organization's reputation, or other factors. If the funding is excessive, management needs to address the compliance issues mentioned earlier.

"Are all patients in clinical trials identified as such at registration?" The answer is usually "no" because not all patients in trials know at the time of registration that they will be enrolled. Even those who do know are not always properly identified as such. Identifying research patients is important to ensure that the proper account is charged for the trial-related services. Treatments that would be given to patients whether or not they are enrolled in the trial (that is, services that are considered "standard of care") must be billed to the patient's insurance, not the sponsor's account. (Note: According to Medicare's national coverage decisions, in a "qualified" trial, Medicare will pay for standard therapies that would have been provided in the absence of the trial. These procedures must be separated from those that are trial-related and must be billed separately. As a result, clinical personnel who enter charges need to be educated about the billing distinction, often a difficult proposition.)

# posted by Medical Information : 4:42 AM