At 30, Stark Law Chugs Along But It's Overdue for Repairs.

The law is supposed to keep physicians from unduly profiting from referrals. But CMS Administrator Seema Verma thinks that it "may prohibit some relationships that are designed to enhance care coordination, improve quality, and reduce waste," and thereby become an obstacle to ACOs and value-based care.

Health Care Efficiencies: Consolidation and Alternative Models vs. Health Care and Antitrust Regulation - Irreconcilable Differences?

Despite the U.S. substantially outspending peer high income nations with almost 18% of GDP dedicated to health care, on any number of statistical measurements from life expectancy to birth rates to chronic disease, 1 the U.S. achieves inferior health outcomes. In short, Americans receive a very disappointing return on investment on their health care dollars, causing economic and social strain. 2 Accordingly, the debates rage on: what is the top driver of health care spending? Among the culprits: poor communication and coordination among disparate providers, paperwork required by payors and regulations, well-intentioned physicians overprescribing treatments, drugs and devices, outright fraud and abuse, and medical malpractice litigation. Fundamentally, what is the best way to reduce U.S. health care spending, while improving the patient experience of care in terms of quality and satisfaction, and driving better patient health outcomes? Mergers, partnerships, and consolidation in the health care industry, new care delivery models like Accountable Care Organizations and integrated care systems, bundled payments, information technology, innovation through new drugs and new medical devices, or some combination of the foregoing? More importantly, recent ambitious reform efforts fall short of a cohesive approach, leaving fundamental internal inconsistencies across divergent arms of the federal government, raising the issue of whether the U.S. health care system can drive sufficient efficiencies within the current health care and antitrust regulatory environments. While debate rages on Capitol Hill over "repeal and replace," only limited attention has been directed toward reforming the current "fee-for-service" model pursuant to which providers are paid for volume of care rather than quality or outcomes. Indeed, both the Patient Protection and Affordable Care Act ("ACA") 3 and proposals for its replacement focus primarily on the reach and cost of providing coverage for health care, rather than specifics for the delivery of health care. 4 With the U.S. expenditures on health care producing inferior results, experts see consolidation and alternatives to fee-for-service as fundamental to reducing costs. 5 Integrating care coordination and delivery and increasing scale to drive efficiencies allows organizations to benefit from shared savings and relationships with payors and vendors. 6 Deloitte forecasts that, by 2024, the current health system landscape-which includes roughly 80 national health systems, 275 regional systems, 130 academic medical centers, and 1,300 small community systems-will morph into just over 900 multi-hospital systems. 7 Even though health care market and payment reforms encourage organizations to consolidate and integrate, innovators must proceed with extreme caution. Health care organizations attempting to drive efficiencies and bring down costs through mergers may run afoul of numerous federal and state laws and regulations. 8 Calls for updates or leniency in these laws are growing, including the possible recognition of an "Obamacare defense" to antitrust restrictions 9 and speculation that laws restricting physicians from having financial relationships will be repealed, ostensibly to allow sharing of the rewards reaped from coordinated care. 10 In the meantime, however, absent specific waivers or exemptions, all the usual rules and regulations apply, including antitrust constraints, 11 physician self-referral 12 and anti-kickback laws and regulations, 13 state fraud and abuse restrictions, 14 and more. In short, a maelstrom of conflicting political prescriptions, health care regulations, and antitrust restrictions undermine the ability of innovators to achieve efficiencies through joint ventures, transactions, innovative models, and other structures. This article first considers the conflicting positions taken by the United States government with respect to achieving efficiencies in health care under the ACA and alternative delivery models, on the one hand, and health care regulatory enforcement and antitrust enforcement, on the other. At almost a fifth of the U.S. economy, 15 health care arguably has grown ungovernable, exceeding the ability of any one law or branch of government to create or implement coherent reform. Indeed, the article posits that although the ACA reformed and expanded access to health care, it failed to transform the way health care is delivered beyond limited "demonstration projects", leaving fee-for-service intact. Nonetheless, even with limited rather than revolutionary goals, the ACA still lacks sufficient authority across disparate branches of government to achieve its stated goals. The article then examines the conflicting positions of the various United States regulatory schemes and enforcement agencies governing health care, and whether they can be reconciled with the stated goal of the government, often referred to as the "Triple Aim": 16 improving quality of care, improving population health, and lowering health care costs. It examines fundamental, systemic challenges to achieving the "Triple Aim": longstanding health care regulatory laws that impede adoption of innovative delivery systems beyond their current "demonstration project" status, and antitrust enforcement that promotes waste and duplication in densely populated areas, while preventing necessary consolidation to more efficiently reach rural areas. The article concludes with recommendations for promoting efficiency through modest reconciliation of the conflicting goals and regulations in health care.

Comanagement and Gainsharing Opportunities for Independent Physicians.

Gainsharing and comanagament programs are both successful means of achieving physician buy-in for all cost containment programs in Orthopaedic Trauma. Under comanagement agreements, physicians are reimbursed for their time and intellectual efforts in program and algorithm creation. The cost is minimal for the hospital in return for the millions of dollars in savings they achieve. Gainsharing models can incentivize physicians to quickly adopt cost-effective implant choices, care plans, and program development. Hospital systems keep the majority of the profits, patients, and insurance carriers benefit from the cost savings and physicians receive remuneration for their efforts. Careful attention must be paid to the legal issues surrounding the Federal Anti-Kickback Statute, the Civil Monetary Penalty Law, and the Physician Self-Referral Law when setting up these agreements. The keys to success for these programs are the presence of a physician champion, economic transparency for both physicians and hospitals, accurate data collection, and adequate economic incentive for physicians to drive change in practice patterns.

Medicare Program; Final Waivers in Connection With the Shared Savings Program. Final rule.

This final rule finalizes waivers of the application of the physician self-referral law, the Federal anti-kickback statute, and the civil monetary penalties (CMP) law provision relating to beneficiary inducements to specified arrangements involving accountable care organizations (ACOs) under section 1899 of the Social Security Act (the Act) (the "Shared Savings Program''), as set forth in the Interim Final Rule with comment period (IFC) dated November 2, 2011. As explained in greater detail below, in light of legislative changes that occurred after publication of the IFC, this final rule does not finalize waivers of the application of the CMP law provision relating to "gainsharing'' arrangements. Section 1899(f) of the Act, as added by the Affordable Care Act, authorizes the Secretary to waive certain fraud and abuse laws as necessary to carry out the provisions of section 1899 of the Act.

Características demográficas de pacientes con enfermedad de pie-mano-boca. Serie de casos atípicos / Demographic characteristics of patients with hand-foot-and-mouth disease. Atypical cases series

La enfermedad de pie-mano-boca es un exantema frecuente en la niñez. Se han descrito varios tipos de lesiones de distribución generalizada en casos atípicos, aunque los datos sobre la predilección respecto de la localización de estas lesiones son insuficientes. Nuestro objetivo fue describir las características demográficas de los pacientes con esta enfermedad y caracterizar las localizaciones de las lesiones en pacientes con erupciones atípicas, tratadas en un centro ambulatorio de dermatología de un hospital pediátrico, entre noviembre de 2011 y agosto de 2013. Se incluyen a 67 pacientes en el estudio. La edad media de los pacientes fue de 34 meses con predominio de varones (60%). Todos los pacientes tuvieron erupciones en la boca, las manos y los pies. Los niños <24 meses se vieron afectados en la zona cubierta por el pañal y las extremidades, con un compromiso significativamente mayor en los que tenían entre 24 y 48 meses y en los >48 meses (p <0,0001 y p= 0,011, respectivamente). Ninguno de los pacientes tuvo complicaciones sistémicas graves.

Hand-foot-and-mouth disease (HFMD) is a common childhood exanthem. Various types of lesions and widespread distribution in atypical cases have been described, but data on the predilection of lesion localizations in atypical cases are insufficient. We aimed to describe the demographic features of patients with HFMD, and to characterize lesion localizations in patients with atypical eruptions treated at an outpatient dermatology clinic of a pediatric hospital, between November 2011 and August 2013.The study included 67 patients. Mean age of the patients was 34 months and there was a male predominance (60%). All the patients had eruptions on hands, feet, and mouth. Children aged <24 months had involvement of the diaper area and extremities, which was significantly higher than those aged 24-48 months and >48 months (P < 0.0001 and P= 0.011, respectively). None of the patients had serious systemic complications.

Medicare and Medicaid programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; physician-owned hospitals: data sources for expansion exception; physician certification of inpatient hospital services; Medicare Advantage organizations and Part D sponsors: CMS-identified overpayments associated with submitted payment data. Final rule with comment period.

This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2015 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In this document, we also are making changes to the data sources permitted for expansion requests for physician-owned hospitals under the physician self-referral regulations; changes to the underlying authority for the requirement of an admission order for all hospital inpatient admissions and changes to require physician certification for hospital inpatient admissions only for long-stay cases and outlier cases; and changes to establish a formal process, including a three-level appeals process, to recoup overpayments that result from the submission of erroneous payment data by Medicare Advantage (MA) organizations and Part D sponsors in the limited circumstances in which the organization or sponsor fails to correct these data.

The Maryland self-referral law: history and implications.

Many previous studies have shown that nonradiologist physicians who can refer advanced MRI and CT examinations to themselves or within their practices use these modalities at a much higher rate than those who refer their examinations to unaffiliated radiology facilities. This led Maryland to pass a unique self-referral law in 1993 to directly address self-referred advanced imaging. The authors discuss the politics and economics of self-referral and provide a comprehensive review of the creation, progression, and impact of this landmark law.