Stark Law Research Articles

Surgeon Perceptions of Performing Transforaminal Lumbar Interbody Fusion in an Ambulatory Surgical Center vs Hospital Setting in the Elderly Population: Results of a Surgeon Survey.

There is an increasing acceptance of conducting minimally invasive transforaminal lumbar interbody fusion (TLIF) in ambulatory surgical centers (ASCs). The Centers for Medicare and Medicaid Services (CMS) introduced the Hospitals Without Walls (HWW) program in March 2020. This program granted hospitals regulatory flexibility to offer services and procedures in nontraditional locations, including ASCs. However, implementation hurdles persist. A survey was sent to 235 surgeons regarding the use of ASCs for performing TLIF surgeries on elderly patients. Multiple-choice questions covering various aspects of TLIF practice preferences, including surgical indications, decision factors for choosing ASCs over hospitals, implementation hurdles, reimbursement concerns, staffing issues, and the impact of CMS rules and regulations on TLIF in ASCs, particularly concerning physician ownership and self-referral conflicts governed by the Stark law, were asked. The survey completion rate was 25.8% (Figure 1). The most common surgical indications for TLIF in ASCs were spondylolisthesis (80%), spinal stenosis (62.5%), and low back pain (47.5%). Most surgeons (78%) believed TLIF could be safely performed in ASCs. Streamlined workflow, lower infection rates, and cost-effectiveness were advantages listed by 58.5% of surgeons. Patient's medical history (75.8%), followed by ASC resources and capabilities (61%) and surgeon preference (61%), were relevant factors. Higher efficiencies at ASCs (14.6%), contractual issues (9.8%), and ownership issues (7.3%) were less relevant to surgeons. About 65.9% of surgeons reported lower reimbursement in ASCs, and 43.9% said it was an implementation hurdle. Lower direct costs were reported by 53.7% of surgeons. Other hurdles included a lack of trained staff (24.4%), inadequate staffing (22.0%), cost overruns (26.8%), high Joint Commission or the Accreditation Association for Ambulatory Health Care credentialing costs, and surgeons feeling uncomfortable performing TLIF in ASCs (22.0%). Only 17.1% listed medical problems as a reason their patient was considered unsuitable for the ASC environment. A majority (53.7%) stated that their ASCs complied with strict Stark requirements by disclosing physician ownership interests. However, 22% of surgeons reported self-referrals under the "In-Office Ancillary Services Exception" allowed by the Stark law. Our survey data show that surgeons' perceptions of current CMS rules and regulations may hinder the transition into the ASC setting because they think the reimbursement is too low and the regulatory burden is too high. ASCs have disproportionally higher initial acquisition and ongoing costs related to staff training and maintenance of the TLIF technology that CMS should consider when determining the appropriate financial remuneration for these complex procedures. ASC offers a viable and attractive option for their TLIF procedure with the advantage of same-day discharge and at-home recovery.

New Federal Guidance Makes It Harder for Patients With Cancer to Access Drugs.

A recent interpretation of the Stark Law limits cancer practices from delivering drugs to their patients by mail or courier-a perverse interpretation of a law meant to curb physician self-referrals and one that has led to patient harm.

THE NEW STARK LAW AND ANTI-KICKBACK STATUTE FINAL RULES PROVIDE NEW OPPORTUNITIES FOR VALUE BASED PROGRAMS AND VALUE BASED ARRANGEMENTS

ABSTRACT The Stark Law and the Anti-Kickback Statute represent two of the most significant areas of liability for providers and participants in the health care industry. Often times, either or both of these laws can form the basis of a False Claims Act case. The key to avoiding liability is to ensure that the relevant exception(s) under the Stark Law and the relevant safe harbors under the Anti-Kickback Statute are met. With the evolution of value-based programs and reimbursement models based one value-based outcomes such as patient care coordination and quality measures, industry participants relayed to the Centre's for Medicare and Medicaid, as well as the U.S. Department of Health and Human Services that they were unable to effectively implement some value-based programs and types of legitimate arrangements for fear of civil and/or criminal exposure. The Government listened and in December 2020, two separate Final Rules were released, opening the door for new initiatives in the healthcare industry to achieve success with value-based programs and arrangements, so long as the new safe harbors and exceptions are met. This article details an overview of some of the critical aspects of the new Final Rules, which became effective on January 19, 2021 (with a couple of provisions that are effective at a later date).

False Claims Act Overview and Implications for Neurologists.

The US Department of Health and Human Services Office of the Inspector General identifies the five most important federal fraud and abuse laws that are most applicable to physicians: the False Claims Act, the Anti-Kickback Statute, the Physician Self-Referral Law (Stark Law), the Exclusion Authorities, and the Civil Monetary Penalties LawThe False Claims Act is the US government's primary tool for combating fraud perpetrated through the filing of false claims for federal government reimbursement. Neurologists and companies serving the needs of neurologic patients have not been immune from False Claims Act-related legal action. This article provides an overview of the False Claims Act, uses real-life neurologic cases to illustrate the range of False Claims Act violations and recoveries, and offers some practical compliance suggestions.

Development of AGA’s Policy Agenda During the COVID-19 Pandemic

Development of AGA’s Policy Agenda During the COVID-19 Pandemic

Value-based Healthcare: The Politics of Value-based Care and its Impact on Orthopaedic Surgery.

Value-based Healthcare: The Politics of Value-based Care and its Impact on Orthopaedic Surgery.

Health Care in the Time of COVID-19: Stark Law Temporary Waivers Make the Case for Permanent Stark Law Reform

Health Care in the Time of COVID-19: Stark Law Temporary Waivers Make the Case for Permanent Stark Law Reform

Recommendations to protect patients and health care practices from Medicare and Medicaid fraud

Fraud is defined as knowingly submitting, or causing to be submitted, false claims or making misrepresentations of a fact to obtain a federal health care payment for which no entitlement would otherwise exist. In today’s health care environment, Medicare and Medicaid fraud is not uncommon. The negative impact of fraud is vast because it diverts resources meant to care for patients in need to the benefit of fraudsters. Fraud increases the overall costs for vital health care services and can potentially be harmful to Medicare and Medicaid beneficiaries. The objectives of this commentary are to describe the types and trends of Medicare and Medicaid fraud that are committed, and provide recommendations to protect patients and health care practices. Specifically, this article identifies types of Medicare and Medicaid fraud at beneficiary (patient) and provider level, and it can be intentional or unintentional. This article also describes the 3 primary laws that prohibit fraud and gives fraud case examples relevant to each law, including the False Claims Act, Anti-Kickback Statute, and the Stark Law. We also discuss currently trending and emerging areas, including opioid and pharmacogenetic testing; both have experienced heavier and higher-profile instances of fraud in today’s health care landscape. Last, the article summarizes detection methods and recommendations for health care providers and patients to protect themselves against fraud. Recommended strategies to combat fraud are discussed at policy, practice, and grassroots levels. Health care practitioners, including pharmacists, can use these strategies to protect themselves and their patients from becoming victims of fraud or unknowingly committing fraud.

Stark Law and Anti-Kickback Statute Modernization, Why Now?

Stark Law and Anti-Kickback Statute Modernization, Why Now?

The Great American Health Care System and the Dire Need for Change

The Great American Health Care System and the Dire Need for Change

The corporatization of dermatopathology

The corporatization of dermatopathology has long preceded that of dermatology and has been driven by federal legislation and economic influences. Although the Clinical Laboratory Improvement Amendments and the Stark Law limited physician-owned laboratories, loopholes via the Safe Harbor Exemptions outlined in the Anti-Kickback Statute allowed corporate laboratories to flourish through relationships built by health information technology donations. The rise of corporatization has had widespread effects on the fields of dermatopathology and dermatology, resulting in reduced numbers of dermatology-trained dermatopathologists and decreased caseloads in academic institutions, potentially compromising dermatology residency education. Although there have been efforts to counteract these effects, more global changes will be required to alter the direction of this subspecialty.

Advocacy Journal Club: Teaching Residents and Faculty About Policy and the Importance of Pathology Societies

Abstract Objectives To describe the Advocacy Journal Club, a novel method to expose pathology residents, fellows, and faculty to critical regulatory and policy issues that affect the practice of laboratory medicine and the importance of involvement in advocacy initiatives. Methods Six voluntary conferences were held for UNMC faculty, local pathologists, and residents during a 1-year period. Each featured a unique, 50-minute interactive discussion led by a faculty member on a topic related to systems-based practice, public health, and/or legislative reform in health care. The six topics included Stark Law, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), Laboratory Developed Tests, Executive Branch Influence on Health Care, Local Coverage Determinants, and Protecting Access to Medicare Act of 2014 (PAMA). In addition, all participants completed an 8- to 10-question pre- and posttest. After the completion, a survey to assess the quality and efficacy of the series was administered. Results Between 5 and 11 residents attended each session. Both residents and faculty demonstrated a marked increase in their posttest scores. In the final survey, 92% stated they gained an understanding of how policy affects their local laboratory and 100% a better appreciation of how involvement in pathology organizations’ advocacy efforts impacts the laws, rules, and regulations that affect laboratory medicine. Most (92.3%) reported that topics of the Advocacy Journal Club are important to pathology training and 100% reported that the format was effective. Conclusion The journal club format is an effective method to teach both residents and faculty about health policy and other issues impacting laboratory medicine and the critical role that participation in the advocacy efforts of pathology societies plays in affecting the future of the specialty.

Socially Accountable Academic Health Centers: Pursuing a Quadripartite Mission.

Academic health centers (AHCs) in the United States have had a leading role in educating the medical workforce, generating new biomedical knowledge, and providing tertiary and quaternary clinical care. Yet the health status of the U.S. population lags behind almost every other developed world economy. One reason is that the health care system is not organized optimally to address the major driver of health status, the social determinants of health (SDOH). The United States' overall poor health status is a reflection of dramatic disparities in health that exist between communities and population groups, and these are associated with variations in the underlying SDOH. Improving health status in the United States thus requires a fundamental reengineering of the health delivery system to address SDOH more explicitly and systematically. AHCs' tripartite mission, which has served so well in the past, is no longer sufficient to position AHCs to lead and resolve the intractable drivers of poor health status, such as unfair and unjust health disparities, health inequities, or differences in a population's SDOH.AHCs enjoy broad public support and have an opportunity-and an obligation-to lead in improving the nation's health. This Perspective proposes a new framework for AHCs to expand on their traditional tripartite mission of education, research, and clinical care to include explicitly a fourth mission of social accountability. Through this fourth mission, comprehensive community engagement can be undertaken, addressing SDOH and measuring the health impact of interventions by using a deliberate structure and process, yielding defined outcomes.

Legal Implications of Physician Investment and Ownership in Health Care Enterprises.

This article presents a case in which a neurology group practice is considering investing in an imaging center that is owned by nonphysician investors with the aim of referring patients to this imaging center. The article reviews some important legal pitfalls in federal law that physicians must be aware of when considering such an investment and focuses on the general outlines of and exceptions to the Stark Law and the Federal Anti-Kickback Statute.

Relaxed Stark Law Means More Flexibility in 2016

Medicare has relaxed some requirements of the Stark Law through its 2016 fee schedule and created new exceptions for compensation arrangements under the statute. The changes make it easier to recruit nonphysician employees, share rental space, and operate on expired contracts without fear of violating the law. “These rules show the government was seeking to give some flexibility in the area of Stark procedure or technical issues,” said Julie E. Kass, JD, a Washington area health law attorney who specializes in Stark and antikickback laws. “I think what [the Centers for Medicare & Medicaid Services] was seeing, and the kinds of issues being disclosed, weren’t things that were going to raise the risk of fraud or Julie E. Kass, JD abuse to the program. Recognizing that, they wanted to make sure there weren’t unnecessary concerns about these, or unnecessary [efforts].” What should y ou know about the Stark Law modifications? Ms. Kass and Philadelphia-based health law attorney Karl A. Thallner Jr., Esq., discussed the latest changes in a recent interview.

Canadian Medical Tourism: Expanding Opportunities and Reducing Legal Risks for American Healthcare Providers

After identifying the economic benefits that increased medical tourism from Canada to the United States may confer on the U.S. healthcare market and local economies, this essay analyzes applicable U.S. legal impediments that certain medical tourism arrangements — to wit, those involving a third-party medical tourist — may implicate. While the authors demonstrate that such arrangements will not run afoul of the U.S. federal Stark Law and federal Anti-kickback Statute, certain state-level anti-kickback and fee-splitting prohibitions impose the most substantial of the potential legal impediments on such arrangements. Given these state restrictions, the article suggests ways to structure these transactions in a manner designed to minimize this risk, and ultimately show that making a Canadian medical practice the medical tourism broker — serving as both the clearinghouse for identifying patients and as the broker for negotiating the arrangements — is critical for legal compliance purposes. Replacing the for-profit lay-owned entity with a medical practice that does not seek to profit from the arrangement serves critically to minimize inappropriate referrals and lowers the risk to the American providers under applicable legal barriers. Finally, the authors propose changes to the applicable laws to further eliminate risk from Inbound Medical Tourism ventures, without compromising the patient protection goals of existing laws.

Fourth Circuit Upholds $237 Million Judgment Against Tuomey Healthcare System

On July 2, 2015, the U.S. Court of Appeals for the Fourth Circuit delivered what could be the final note in Tuomey Healthcare System’s (“Tuomey”) decade long battle with the government regarding the legality of certain physician compensation arrangements under the Stark law and False Claims Act. In its opinion, the court affirmed a $237,454,195 lower court judgment against Tuomey for violating the Stark law and False Claims Act. The court’s affirmance serves as a sobering reminder to hospitals and physicians of the staggering liability that could arise from noncompliant compensation arrangements.

Experts Predict: What's Ahead for PA/LTC in 2015?

Experts Predict: What's Ahead for PA/LTC in 2015?

Here Comes the Sun: Medical Professionalism and the Implications of the Sunshine Act for Gastroenterology Practice

The Affordable Care Act, passed in 2010, contained a number of regulations that directly affect physician practices, behavior, and relationships with others in the health care industry. One such provision is the “Physician Payment Sunshine Act,” which is the subject of this month’s Practice Management: The Road Ahead column. The authors have provided us with a detailed and enlightening review of how our relationships with pharmaceutical and medical device companies have become transparent and public. It will be important for you to understand this law and take the time to review your own data through CMS’s Enterprise Portal (http://www.cms.gov/Regulations-andGuidance/Legislation/National-Physician-Payment-Transp arency-Program/Physicians.html).

Stark Law and the Affordable Care Act: Bridging the Disconnect

First Prize Hirsh Student Writing Competition 2014Law makers intended for the original terms of the Ethics in Patient Referrals Act, or the Stark law, to prevent unethical physician self-referrals ...