Physician self-referral on the fast track

One of the most hotly debated areas of health care fraud and abuse has been the prohibition on physician self-referral. Now, this prohibition is limited to physicians referring patients to clinical laboratories in which they have an ownership interest and for which the services are reimbursed under the Medicare program. However, this law may be expanded to include other health care services to which physicians cannot refer, as well as to other federal programs and private payers. While Congress works toward this end, many state governments have already taken the lead in expanding the prohibition beyond clinical laboratories and the Medicare program. "Health Law" is a regular feature of Physician Executive contributed by Epstein, Becker, and Green. Mark Lutes of the firm's Washington, D.C., offices serves as editor of the column.     

Patient bill of rights 2001

Breaking gridlock on managed care reform, a bipartisan coalition in Congress introduced the newest version of a patient bill of rights. Unlike last year's ill-fated Norwood-Dingell bill, the Bipartisan Patient Protection Act of 2001 has strong bipartisan support; concern remains, however, on the provisions that allow patients to sue their managed care plan. The debate now focuses on the type of liability reform that Congress and the White House can agree on. If they are able to agree, a patient bill of rights may soon become law.     

Legal issues in accepting capitation

The effort to reduce the cost of medical, hospital, and ancillary services increasingly focuses on shifting the financial risk for the cost of these services to those who provide them. Shifting arrangements include capitation for physicians classified as "primary care" physicians; capitation arrangements that include primary and specialty services; risk shifting to medical groups, IPAs, and other physician organizations; as well as the packaging of physician and hospital services on a "full risk," "per case," or other basis. Accepting financial risk for the cost of medical and other health care services, as well as the responsibility for managing the provision of services, may very well be the only remaining opportunity for providers to maximize reimbursement and maintain administrative and clinical self-direction. However, physicians must work with managed care organizations (MCOs) through negotiation of contracts and throughout the relationship to make sure: Unnecessary financial and legal risks to the MCO and physicians are eliminated. Risks that cannot be eliminated are apportioned between the MCO and physicians. All risks are managed in a coordinated fashion between the MCO and physicians.     

《萨班斯法案》对美国公司董事会影响的分析

2002年度美国出台的《萨班斯法案》全方位地对安然等事件暴露出来的问题作出相应的调整性规定,必将对公司治理产生深切的影响。《萨班斯法案》对审计委员会提出了修正性和提高性要求,本文选择外部董事、女性董事、财务专家、CEO兼任董事会主席、CEO在提名委员会任职等指标进行分析。实证分析结果说明:《萨班斯法案》有效消除了董事会和管理层任人唯亲的现象,董事会的独立性和专业性均有所提高。其实,《萨班斯法案》颁布之前就有加强公司治理的要求,公司治理就有改进的趋势,但《萨班斯法案》关于审计委员会方面的明文规定加速了公司董事会的变化,使得公司治理改革超越了法律的既定要求。     

Assess your quality of care quotient

The upsurge of large, single/multi-specialty group practices in contemporary health care has precipitated a corresponding surge in marketing strategies aimed at promoting group speed, efficiency, and/or productivity. Subsequently, the quality of care is often overlooked or redefined in financial terms. However, assessing quality of care--above and beyond strictly economic factors--can provide crucial information for executives concerned with making informed managerial decisions. This article explores one prototypical physician group's quest to assess their "quality care quotient," and explicates the process by which they obtained important data from patients, as well as how they used the assessment to improve their practice. The process may serve as an exemplar to physician groups concerned with conducting such analyses.     

HCFA issues final Stark I rules

While final rules clarify many "gray" areas of statutory interpretation under Stark I, some questions of interpretation under this law will remain largely unanswered until further Stark II regulations are issued. Thus, the health care industry is without definitive guidance on many issues. It must continue to make "best guesses" in interpreting the intent of the statute. However, bad guesses could mean imposition of severe penalties, including recoupment and substantial civil money penalties for making prohibited referrals. Moreover, the regulations confirm the Department of Health and Human Services' position that no advisory opinions are available. Because the final regulations were not issued until after the effective dates of the Stark Law, yet another round of restructuring may be required to effect regulatory compliance and avoid imposition of penalties. "Health Law" is a regular feature of Physician Executive from the Washington, D.C., law firm Epstein Becker & Green. Mark Lutes of that law firm serves as editor of the column.     

Orphan Drug Act on congressional agenda.

In 1983, Congress passed the Orphan Drug Act to encourage development of pharmaceuticals used in the treatment or diagnosis of diseases that occur so rarely that there is no financial incentive for development of these so-called "orphan drugs." The Act established, among other things, exclusive marketing rights on unpatentable orphan drugs for a period of seven years and a tax credit equal to 50 percent of the cost of conducting human clinical trials. It also authorized the Secretary of Health and Human Services (HHS) to make grants and enter into contracts to reduce the costs of clinical testing in orphan drug development.     

Constitutional rights versus malpractice insurance settlements

The increasing costs and complexity of malpractice litigation have created an statutory right that allows malpractice insurance companies to settle malpractice claims regardless of the desires of the defendant physician. In the past, the consequences of settling a malpractice claim out of court were not as important as they are today. The Health Care Quality Improvement Act of 1986 mandates that any settlement in behalf of a physician be documented in the National Practitioner Data Bank (NPDB), which must be consulted every time the physician is credentialed. This NPDB requirement denies due process to health care providers and thus becomes a violation of the federal and many state constitutions. Physician executives and medical leaders must bring these issues to the table and negotiate solutions before damage to practicing physicians and the U.S. health care delivery system caused by this legal paradox become too severe.     

New peer review law provides immunity with obligations.

In the expectation that vigorous peer review will reduce incidents of medical malpractice nationwide, a new federal law, the Health Care Quality Improvement Act of 1986 (P.L. 99-660), provides immunity from most lawsuits for those who sponsor and participate in physician peer review activities. However, this immunity does not extend automatically to all peer review activities. Those who wish to qualify for immunity must comply with the new law's obligations.     

Professionalism is judged by appearances ... like it or not

Exploring the larger subject of executive professionalism should include the whole range of behavior issues that affect others' perceptions of you. In this competitive environment, with limited time to manage relationships, physician executives must take control of all aspects affecting their credibility and communications. This is not to suggest that you become the stereotyped, air-brushed news anchor, all style and little substance, but that you create a total package, one in which the "inside" and the "outside" of your presentation are complementary. Focus your attention on how well you have developed these factors as a physician executive: Appearance; demeanor; professionalism; and integrity. To create a "total package," it is helpful to consider the following recommendations: Write "commercials" for yourself and your organization; use every interaction as a selling opportunity; make every context a platform; don't hide from criticism--seek it out; and use every opportunity that comes your way to listen.     

公司财务与投资者法律保护研究述评

近年来,财务学的研究发生了一系列方向性的变化,其中之一是"法律与财务"交叉研究思潮的兴起,简称"Law and Finance".从宏观层面看,其主要研究法与金融发展和经济增长的关系;从微观层面看,其主要研究法,特别是中小投资者法律保护与公司财务的关系.文章从微观层面,系统地回顾投资者法律保护与公司财务的研究现状和发展动态,特别是对投资者法律保护与公司财务研究的八大热点问题进行系统的总结和评述,并讨论当前"法与财务"研究存在的两大问题,最后指出"法与财务"未来研究的三大趋势.     

Statistical Issues in the Estimation of Assigned Shares for Carcinogenesis Liability

Congress is currently considering adopting a mathematical formula to assign shares in cancer causation to specific doses of radiation, for use in establishing liability and compensation awards. The proposed formula, if it were sound, would allow difficult problems in tort law and public policy to be resolved by reference to tabulated "probabilities of causation." This article examines the statistical and conceptual bases for the proposed methodology. We find that the proposed formula is incorrect as an expression for "probability and causation," that it implies hidden, debatable policy judgments in its treatment of factor interactions and uncertainties, and that it can not in general be quantified with sufficient precision to be useful. Three generic sources of statistical uncertainty are identified--sampling variability, population heterogeneity, and error propagation--that prevent accurate quantification of "assigned shares." These uncertainties arise whenever aggregate epidemiological or risk data are used to draw causal inferences about individual cases.     

Physician financial relationships in the new regulatory environment

In recent months, physicians have been under scrutiny by the federal government with respect to their financial relationships with both drug manufacturers and home care companies. This heightened scrutiny can be attributed, in part, to the attention that has been placed on health care fraud and abuse in this country as a major cause of rising health care costs. Federal investigators currently are examining physician financial relationships in light of the Medicare/Medicaid antikickback statute to determine whether certain payments made to physicians are intended as inducements to refer patients or to prescribe certain products. "Health Law" is a regular feature of Physician Executive contributed by Epstein Becker & Green. Mark Lutes of the law firm's Washington, D.C., offices serves as column editor.     

The Cost of Compensating Asbestos Victims Under the Occupational Disease Compensation Act of 1983

The potentially huge financial liability due to asbestos product suits and the resulting filings for reorganization in bankruptcy by Manville, UNR Industries, Inc., and Amatex, has become a major public policy concern. In response to the problem several bills have been introduced in the Congress to provide compensation for asbestos (and other occupational disease) victims. This paper estimates the cost of compensating asbestos victims under the provisions of the "Occupational Disease Compensation Act of 1983," introduced by Congressman George Miller. Utilizing fatality projections from studies by Enterline, Selikoff, and Walker, and assumptions regarding likely claims filing and success rates, duration and degree of disability, and medical expenses, first year costs for this legislation are estimated to range from a low of $131 million to a high of $ billion. Present value cost estimates at a 2% real discount rate range from $3 billion to $56 billion. The paper also estimates the impact of possible modifications to the compensation provisions of the legislation. Reducing medical payments by the amount received from medicare would lower costs by 3-4%. Providing survivors with a 3-year lump sum benefit rather than a 5-year lump sum payment would save 20-25% as would offsetting the 5-year lump sum by expected social security old age and disability benefits. Combining all of these changes would reduce costs by almost 50%.     

Physician-centered management guidelines.

The "Fortune 500 Most Admired" companies fully understand the irreverent premise "the customer comes second" and that there is a direct correlation between a satisfied work force and productivity, service quality, and, ultimately, organizational success. If health care organizations hope to recruit and retain the quality workforce upon which their core competency depends, they must develop a vision strategic plan, organizational structure, and managerial style that acknowledges the vital and central role of physicians in the delivery of care. This article outlines a conceptual framework for effective physician management, a "critical pathway," that will enable health care organizations to add their name to the list of "most admired." The nine principles described in this article are based on a more respectful and solicitous treatment of physicians and their more central directing role in organizational change. They would permit the transformation of health care into a system that both preserves the virtues of the physician-patient relationship and meets the demand for quality and cost-effectiveness.     

Forty Years of Food Safety Risk Assessment: A History and Analysis

Before the founding of the Society for Risk Analysis (SRA) in 1980, food safety in the United States had long been a concern, but there was a lack of systematic methods to assess food-related risks. In 1906, the U.S. Congress passed, and President Roosevelt signed, the Pure Food and Drug Act and the Meat Inspection Act to regulate food safety at the federal level. This Act followed the publication of multiple reports of food contamination, culminating in Upton Sinclair's novel The Jungle, which highlighted food and worker abuses in the meatpacking industry. Later in the 20th century, important developments in agricultural and food technology greatly increased food production. But chemical exposures from agricultural and other practices resulted in major amendments to federal food laws, including the Delaney Clause, aimed specifically at cancer-causing chemicals. Later in the 20th century, when quantitative risk assessment methods were given greater scientific status in a seminal National Research Council report, food safety risk assessment became more systematized. Additionally, in these last 40 years, food safety research has resulted in increased understanding of a range of health effects from foodborne chemicals, and technological developments have improved U.S. food safety from farm to fork by offering new ways to manage risks. We discuss the history of food safety and the role risk analysis has played in its evolution, starting from over a century ago, but focusing on the last 40 years. While we focus on chemical risk assessment in the U.S., we also discuss microbial risk assessment and international food safety.     

If patients are now "customers," what does that make physicians?

As patients become "members" and "customers," as physicians become "practitioners" and "providers," the practice of medicine becomes more complex and more demanding. The changes that have affected the daily lives of physicians across America will continue and will likely become even more dramatic in the future. There is much to mourn in the passing of the medical practice of the recent past, but there is every reason to celebrate the ongoing triumphs of medicine and its successes in improving the human condition. The job of being a physician is not becoming any less important. The job has just gotten tougher. Successful physicians will cope with the multitude of changes in which the health care field is engaged and make themselves effective agents of change within their organizations.     

Compensation for elected hospital medical staff leadership

As physicians' practices become more complex and their practice incomes more difficult to maintain, hospitals concurrently require more physician input into organizational, utilization, and strategic planning matters. Physicians and hospitals across the country are discussing the question of financial compensation to physicians for the time they spend performing these hospital administrative tasks. It is already common practice for hospitals to pay a salary for medical direction of hospital departments such as intensive care units or pulmonary laboratories. The question has become whether this practice should be extended to elected medical staff leadership.     

Medicare private contracting: increasing patient choice and access?

Congress modified the Medicare program through the Balanced Budget Act of 1997 to expand patient choices for payment to physicians and certain other practitioners by allowing private contracting. This represents a shift in policy that has broad consequences for health care financing and program integrity. The effect of private contracting on quality and access to care remains unknown. Quality and access should be the most important measures of its success or failure. Out of pocket costs to seniors and vulnerable patients must also be watched closely.     

The HIPAAcratic oath: do no harm to patient data

Physician executives need to prepare their organizations for the next great system-wide challenge--HIPAA, the Health Insurance Portability and Accountability Act of 1996. Organizations will have to plan for and execute a compliance program with the same vigor and system-wide participation as they did for Y2K. This article provides a brief overview of HIPAA, emphasizing the privacy and security components that will be the biggest challenge for physician executives. Physician leaders must become actively involved in the policymaking process to ensure a balanced approach to protecting the confidentiality of health information, while giving providers optimal access to data to make informed decisions on patient care and management. Ignoring HIPAA is simply not an option.