Stark II and physician compensation models: integrating business and legal issues

In March of 2004, the Centers for Medicare & Medicaid Services released new regulations that interpreted the Federal Physician Self Referral Act, otherwise known as Stark II. The new regulations, commonly referred to as the Phase II regulations, must be carefully considered when structuring physician compensation models. Stark II generally holds that physicians may not make a referral for designated health services to an entity with which they have a direct or indirect financial relationship. This Article outlines the provisions of Stark II that are applicable to physician compensation methodologies. In addition, the authors evaluate hypothetical transactions involving physician groups seeking viable compensation schemes and explore the validity and risks of each.     

Understanding the physician-owned specialty hospital phenomenon: the confluence of DRG payment methodology and physician self-referral laws

Physician-owned specialty hospitals have flourished in today's healthcare arena, but also have been the subject of a great deal of controversy. The author argues that the rise of specialty hospitals has been the result of a confluence of two healthcare policies: (1) skewed DRG payment methodologies and (2) the misapplication of exemptions to the Stark Law's ban on physician self-referral. This Article examines the aspects of these healthcare policies that have allowed for the explosion of specialty hospitals, as well as the arguments for and against the creation and need for specialty hospitals. The Article also analyzes the reform proposals to correct the Stark and DRG methodologies and how those proposals will affect both specialty and general hospitals.     

Medicare program; physicians' referrals to health care entities with which they have financial relationships (Phase III). Final rule

This final rule is the third phase (Phase III) of a final rulemaking amending our regulations regarding the physician self-referral prohibition in section 1877 of the Social Security Act (the Act). Specifically, this rule finalizes, and responds to public comments regarding, the Phase II interim final rule with comment period published on March 26, 2004, which set forth the self-referral prohibition and applicable definitions, interpreted various statutory exceptions to the prohibition, and created additional regulatory exceptions for arrangements that do not pose a risk of program or patient abuse (69 FR 16054). In general, in response to public comments, in this Phase III final rule, we have reduced the regulatory burden on the health care industry through the interpretation of statutory exceptions and modification of the exceptions that were created using the Secretary's discretionary authority under section 1877(b)(4) of the Act to promulgate exceptions for financial relationships that pose no risk of program or patient abuse.     

Medicare program; physician self-referral regulations: change in date for submission of group attestation statement--HCFA. Final rule--technical amendment

This final rule changes (delays) the date by which a group of physicians that wishes to be identified as a group practice for purposes of the physician self-referral regulations (42 CFR 411.350 through 411.361) must file a statement attesting that it meets certain specified conditions.     

Special report on reimbursement. The safe harbor for small investment interests: where do joint ventures go from here?

There is no specific federal self-referral legislation presently proposed or in effect that statutorily prohibits providers from referring Medicare or other patients to entities in which the referrers have an investment interest, except for existing "Stark" legislation, which applies only to clinical laboratory services, effective January 1, 1992. (See Newsletter, Vol. 6, No. 1, January 1991, at 3.) Thus, health care joint ventures are not per se illegal. The publication of the Safe Harbor Regulations does nothing to change this fundamental fact, and it should not cause providers to abandon existing joint ventures, or planned ones, in a "knee-jerk" fashion, without careful analysis. Of course, there is no guarantee that expanded "Stark" legislation, or some other new self-referral legislation, will not be enacted in the future to prohibit providers from referring patients to entities in which they have an investment interest. Because of this uncertainty, all health care joint ventures should contain "unwinding" provisions to govern the rights and obligations of investors in the event that the venture is required to, or the participants voluntarily elect to, dissolve. Any new venture being contemplated should plan for dissolution, and existing ventures should undertake an internal review of their charter documents to assess whether the rights and duties of all participants upon dissolution are properly spelled out. If not, amendments should be made now, while all participants are on good terms. A failure to agree in advance upon such important issues is an invitation to discord, and possibly even litigation.     

Death of an exception or much ado about nothing

Hospitals often engage in physician recruitment in an effort to fulfill a community need for a particular medical specialty. In doing so, the hospital must comply with the regulatory requirements of the physician recruitment exception of the Stark law, which over the years has generated a great deal of discussion and perhaps confusion. The publication of the Stark II, Phase II regulations in March 2004 was supposed to provide guidance and clarity, but the new regulations have raised a number of new issues and concerns, particularly regarding the requirements imposed on recruiting arrangements involving group practices. This Article reviews the regulatory requirements of the new physician recruitment exception and addresses several of the concerns that have been raised. Specifically, it examines the new regulatory definition of the "geographic area served by the hospital," the restrictions on income guarantees when the recruited physician joins a group practice, and the prohibition on additional practice restrictions. The author concludes that, while some of these concerns are legitimate, others will have little practical implication and should not hinder the ability of hospitals to engage in reasonable, beneficial recruitment activities.     

"Just scanning around" with diagnostic medical ultrasound: should states regulate the non-diagnostic uses of this technology?

This article examines how the non-diagnostic uses of medical ultrasound may violate the prudent use of this technology and supports the proposal of state-based legislative efforts to protect consumers from abuse. The author identifies the potential health risks to consumers and reviews the existing federal and state regulations, ultimately recommending increased legislation and mandated control of this technology.     

Federal anti-referral status raises unanswered questions. Part I: Group practice issues

Although legislation is pending that would require the federal government is issue advisory opinions to those seeking to comply with Stark II (see Press Release #26-A, Committee on Ways and Means, U.S. House of Representatives, July 1, 1994, at 26), such legislation would not entirely solve these interpretive problems, as questions encountered under Stark II are likely to be far too frequent and the response time too long to make it practical to obtain opinions each time. Thus, until such time as Stark II is amended, clarifying regulations are issued, or courts interpret it meaning, physicians who practice in groups that provide designated services must hope that federal enforcement agencies use common sense and understanding in applying an ambiguous statute to real life situations, affording leniency toward participants in arrangements that fit within reasonable interpretations of the statute's exceptions.     

The medical review officer: a potential role for the medical examiner

Drug use in the workplace is a problem, both in terms of public health and expense. Workplace drug testing programs serve as deterrents to drug use. Model programs, such as that of the Department of Transportation, use urine screening and are federally regulated or follow federal standards. An essential participant in this process is the medical review officer (MRO), a licensed physician who interprets the laboratory results generated from a workplace drug testing program. As a result of their training and experience with toxicology, collection of evidence, testimony, and recognition of the physical signs of drug abuse, medical examiners and forensic pathologists are well suited to serve as MROs. Recent regulations require the completion of training courses and MRO certification as prerequisites for participation in federal drug testing programs. Several courses are available to train physicians to participate as MROs.     

论医疗损害赔偿案件的责任主体和法律适用

在借鉴法国法律规定和实践作法的基础上,探讨了我国医疗损害案件的责任主体,认为我国医疗损害赔偿案件应根据雇主责任,由医疗机构承担。同时,结合我国法律、法规和司法解释的规定,对医疗损害赔偿案件的法律适用问题进行了分析和论证。     

Expert psychiatric evidence in sexual misconduct cases before state medical boards.

The growing problem of physician sexual misconduct has captured the attention not only of the medical and legal communities, but of the public as well. State medical boards, administrative agencies with generous rules of evidence and varying levels of expertise, face the difficult task of responding to patients' allegations of physician sexual abuse. This Article, based in large part on the author's survey of current state medical board practice, reveals an increasing reliance on expert psychiatric testimony to explain the behavior of complainants and accused physicians. Drawing analogies from the use of psychiatric evidence in child sexual abuse cases, the author examines the factors that boards must consider in determining the admissibility of expert testimony in physician sexual misconduct cases, and calls upon states to establish clear evidentiary rules to govern the use of such testimony in administrative hearings.     

Practitioner fraud and abuse in medical benefit programs: government regulation and professional white-collar crime

Physicians who defraud and abuse medical benefit programs provide a unique group of lawbreakers for scientific study. They could be considered to epitomize white collar criminals given their exceedingly high socioeconomic status and power as a professional group. Using official reports and documents, as well as interviews with enforcement and program personnel at both state and federal levels, this study examines the problem of physician fraud and abuse in Medicare and Medicaid. Major areas relevant to understanding this phenomenon and its control are presented and policy implications of present knowledge in the area are discussed.     

Medicare program; revisions to payment policies under the physician fee schedule for calendar year 2004. Final rule with comment period

This final rule will refine the resource-based practice expense relative value units (RVUs) and make other changes to Medicare Part B payment policy. The policy changes concern: Medicare Economic Index, practice expense for professional component services, definition of diabetes for diabetes self-management training, supplemental survey data for practice expense, geographic practice cost indices, and several coding issues. In addition, this rule updates the codes subject to the physician self-referral prohibition. We also make revisions to the sustainable growth rate and the anesthesia conversion factor. These changes will ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. We are also finalizing the calendar year (CY) 2003 interim RVUs and are issuing interim RVUs for new and revised procedure codes for CY 2004. As required by the statute, we are announcing that the physician fee schedule update for CY 2004 is -4.5 percent, the initial estimate of the sustainable growth rate for CY 2004 is 7.4 percent, and the conversion factor for CY 2004 is $35.1339. We published a proposed rule (68 FR 50428) in the Federal Register on Part B drug payment reform on August 20, 2003. This proposed rule would also make changes to Medicare payment for furnishing or administering certain drugs and biologicals. We have not finalized these proposals to take into account that the Congress is considering legislation that would address these issues. We will continue to monitor legislative activity that would reform the Medicare Part B drug payment system. If legislation is not enacted soon on this issue, we remain committed to completing the regulatory process.     

Seven years until electronic health records: the negative effects of the new Stark exceptions and anti-kickback safe harbors

Last year's introduction of an exception to the Stark Regulations and a new Anti-Kickback safe harbor allows donors (mainly hospitals) to assist recipients (mainly physicians) with the establishment of electronic health records systems. This Article analyses the new regulations and makes the case that, among other negative effects, they will create an undesirable shift in physician referrals in the short term.     

药品专利审查和新药注册制度的链接与完善

在医药知识产权保护体系内,目前我国十分突出的一个问题就是药品专利审查和注册管理制度的不匹配,不完善.提出要将药品专利审查和注册管理进行制度链接,必须同时在专利立法中进行防范有关注册时出现专利纠纷问题的制度设计和在药品注册立法中进行有关专利链接制度的设计.     

医务人员兼职执业法律探讨

医务人员能否到其他医疗机构兼职执业,而不仅限于其依法注册所在的医疗机构?此话题受到社会的广泛关注并引发激烈争论。本文作者试从法律角度探讨现行法律框架内的可行性解决方案,同时也对可以期待的医疗行业相关立法发表个人一点拙见。     

Medical use of byproduct material; draft policy statement--NRC. draft policy statement

The Nuclear Regulatory Commission (NRC) is proposing, for formal comment, revisions of its 1979 policy statement on the medical use of byproduct material. These proposed revisions are one component of the Commission's overall program, as previously announced in the Federal Register, for revising its regulatory framework for medical use, including its regulations that govern the medical use of byproduct material. The overall goals of this program are to focus NRC regulation of medical use on those medical procedures that pose the highest risk and to structure its regulations to be risk-informed and performance-based, where appropriate, consistent with NRC's "Strategic Plan for Fiscal Year 1970 Fiscal Year 2002".     

Priority goals in international co-operation of the Republic of Serbia in the field of environment and sustainable development

The paper points to the significance of some factors of international co-operation in the field of environment and sustainable development as a general framework for understanding of the fundamental goals in international co-operation of the Republic of Serbia (RS). It is especially pointed to the place and importance of the activities that are carried out in the European Union (EU), to the harmonisation of national legislation with EU legislation including regulations in the field of climate change, to the significance of international environmental agreements and various forms of global, regional, subregional and bilateral co-operation as well as to the co-operation with international financial institutions which are important for environment and sustainable development. The paper is based on the thesis that the fundamental goals in international co-operation of RS in the field of environment and sustainable development are mostly determined by the “European perspective” of RS and in accordance with this, with global trends in the contemporary environmental and sustainable development policy and law. Opening the prospect of the EU membership (potential candidate status and the status of the candidate for EU membership) has resulted in the acceleration of the process of harmonisation of national legislation with the EU’s as well as speeding up the process of ratification of the international treaties in the field of the environmental protection.     

Changing housing policy: women escaping domestic violence

Domestic violence has risen up the political agenda, as women's action has inspired changes in police, social work and legal practice. At the same time, one of the oldest pieces of legislation that protected women from violence - the Homeless Persons Act of 1977 - has been transmuted into the Housing Act of 1996. This legislation was introduced by a Conservative government, which was anxious to reduce the rights of homeless people to secure permanent accommodation, on the grounds that these rights gave incentives to pregnancy, lone parenthood and economic migrants. New Labour have softened the Housing Act to give more scope to local authorities to respond to homelessness. This article asks: What are the implications of changing homelessness rights under this legislation and subsequent regulations for women's ability to escape violent relationships and find long term solutions to the housing needs which domestic violence creates? How new is New Labour policy as expressed in housing regulations and its policy Green Paper?     

Medicare program; revisions to payment policies under the Physician Fee Schedule, and other part B payment policies for CY 2008; delay of the date of applicability of the revised anti-markup provisions for certain services furnished in certain locations (Sec. 414.50). Final rule

This final rule delays until January 1, 2009 the applicability of the anti-markup provisions in Sec. 414.50, as revised at 72 FR 66222, except with respect to the technical component of a purchased diagnostic test and with respect to any anatomic pathology diagnostic testing services furnished in space that: Is utilized by a physician group practice as a "centralized building" (as defined at Sec. 411.351 of this chapter) for purposes of complying with the physician self-referral rules; and does not qualify as a "same building" under Sec. 411.355(b)(2)(i) of this chapter.