Beyond the basics: implementing the HIPAA Privacy Standards in real life situations.
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Biomedical subjects
Publications and source records attributed to W A Sarraille.
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The original Stark Law, commonly referred to as "Stark I," was enacted in 1989. Stark I prohibited a physician from ordering a clinical laboratory test or service from an entity with which the physician, or an immediate family member, had a financial relationship if the test or service was reimbursable by Medicare, unless an exception to the law applies. The Stark Law was amended in 1993. The amendments are commonly referred to as "Stark II." Stark II extended the referral prohibition to services reimbursable under Medicaid and greatly expanded the list of items and services covered by the law i.e., "designated health services." HCFA published phase I of the Final Stark Rules on January 4, 2001. These rules dealt with referral definition issues, volume or value of referrals, in-office ancillary services exception, group practice definition, and definitions of designated health services. This article describes phase I of Stark II Final Rules, and its impact on interventional pain medicine practices.
The model compliance program for small physician practices, recently released by the Office of the Inspector General (OIG) shows a remarkable degree of flexibility reflective of the OIG's acknowledgment that small physician practices have such limited resources that they might not be in a position to implement a full compliance program. The OIG suggests a step by step approach to the implementation of a compliance program which includes auditing and monitoring, establishing practice standards and procedures, designating na compliance officer or contact, conducting training and education, responding to offenses and corrective actions, opening uses of communication, and enforcing discipline through well published guidelines. The OIG's final plan also lists a wide variety of risk areas that a small practice should address in its program, many of the identified risk areas relate to situations in which physicians interact with other types of providers-including durable medical equipment suppliers, home health agencies, clinical laboratories, hospitals, and others. Although physicians have tended to equate the term "compliance" with "billing and coding" compliance, the OIG's list of risk areas reveals a much broader range of compliance issues and concerns, with particular emphasis on financial relationships between physicians and other providers. In conclusion, Physician practices are clearly at greater risk today if they fail to do so in light of the publication of the OIG's final plan.
A recent flurry of activity in terms of litigation and legislation involving the managed care industry has produced mixed results. Common trends among actions include delayed or diminished payment and network termination, breach of fiduciary duty, negligence in plan administration, breach of contract and fraud, and prompt pay among physician cases, among plan member cases, and among regulatory enforcement cases. The results indicate that physicians face an uphill battle in their efforts to sue managed care organizations for financial causes, although they generally fare better if state regulators adopt their cause; plan members are somewhat more successful than providers, particularly in situations where an alleged denial of care results in injury; by far, the most successful litigant against managed care has been state enforcement agencies, as the states have been particularly successful in actions enforcing their prompt payment regulations. However, the managed care industry has done well in warding off suits against plan members under the Employee Retirement Income Security Act's pre-emption provisions. Despite the somewhat varying degree of success, it appears that there is a perception among managed care enrollees, providers of care, and state and federal regulators and legislators that the managed care industry is wrongfully enhancing its bottom line at the expense of members' health.
Interventional physicians, like many other small physician practices, are bracing for a soon-to-be released document from the Office of the Inspector General (OIG) for the Department of Health and Human Services that will provide guidance to physician practices interested in developing compliance programs for their practices. The purpose of these compliance programs is to demonstrate to government authorities that a provider has made an institutional commitment to adhere to all relevant laws as a matter of everyday practice, and may establish a strong basis for minimizing any penalties if a violation actually occurs. Even though these guidances issued by OIG are non-binding, they are particularly useful as they reflect the OIG's position on a wide range of compliance issues directly impacting physician practices. Physician compliance documents should include the elements that OIG believes are crucial for an effective plan including: written compliance policies and procedures, compliance officer/compliance committee, effective training and education, effective lines of communication, disciplinary protocols to enforce the plan, monitoring and auditing of the plan/program, and responsiveness to detected offenses and the development of corrective action plans.
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