A Farewell to Falsity: Shifting Standards in Medicare Fraud Enforcement.

For the better part of a decade, Americans have had a front-row seat to a fervent and turbulent debate over the future of their health care system. The passage of the Patient Protection and Affordable Care Act of 2010 (ACA), the most comprehensive health reform effort since the mid-1960s, ushered in a new era in health law and policy, granting millions of Americans access to health care. After multiple legal challenges and congressional efforts that ultimately failed to slay the law, the ACA had become entrenched by the end of the Obama administration, even though pieces of the law had failed to work exactly as planned. Now, with the surprising election of President Donald Trump, reenergized Republicans are targeting the law once more, and it suddenly appears more vulnerable than ever. Dynamic uncertainty again permeates the national debate. Although most powerful protections of the ACA may evaporate--no small event, to be sure--the value-based era which it unleashed seems here to stay. Indeed, this era--focused on efficiency, standardization, and quality within American medicine--has just begun to bear fruit. Illustrated prominently by recent changes to Medicare that alter how the program pays its doctors for services they provide to its beneficiaries, America is moving away from the old strictures of fee-for-service medicine. At the same time, traditional legal tools, and particularly the federal government's most prominent anti-fraud tool, the civil federal False Claims Act (FCA), seem to be facing new limits. This has been recently evident in medical necessity-based fraud cases, and particularly highly publicized fights that have targeted the burgeoning industry of hospice care. This Article tracks this development, ultimately arguing that the move to "reimbursement-based regulation" may be a positive step in finally reining in the worst excesses of American health care. But it also cautions against the deceptive simplicity of allowing medical heterogeneity and clinical complexity to prevent application of America's most powerful anti-fraud tools to its medical industry. Just because reimbursement policy has shifted to shoulder some of the regulatory burden of overtreatment does not mean that health care fraud--like fee-for-service medicine--should be confined to the past. In the end--and regardless of whatever legislation the national debate surrounding American health care produces--American medicine must adequately address its susceptibility to overtreatment, its incentives toward financial excess and waste, and its inability to push providers and entities into adopting more efficient practices. Medicare is finally moving quickly to bring about effective changes, and the program is seeking clarity in the midst of a period of tremendous uncertainty for American health care.

Medical research using governments' health claims databases: with or without patients' consent?

Taking advantage of its single-payer, universal insurance system, Taiwan has leveraged its exhaustive database of health claims data for research purposes. Researchers can apply to receive access to pseudonymized (coded) medical data about insured patients, notably their diagnoses, health status and treatments. In view of the strict safeguards implemented, the Taiwanese government considers that this research use does not require patients' consent (either in the form of an opt-in or in the form of an opt-out). A group of non-governmental organizations has challenged this view in the Taiwanese Courts, but to no avail. The present article reviews the arguments both against and in favor of patients' consent for re-use of their data in research. It concludes that offering patients an opt-out would be appropriate as it would best balance the important interests at issue.

Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims. Final rule.

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2019. Some of these changes implement certain statutory provisions contained in the 21st Century Cures Act and the Bipartisan Budget Act of 2018, and other legislation. We also are making changes relating to Medicare graduate medical education (GME) affiliation agreements for new urban teaching hospitals. In addition, we are providing the market basket update that will apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2019. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2019. In addition, we are establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs). We also are establishing new requirements or revising existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (now referred to as the Promoting Interoperability Programs). In addition, we are finalizing modifications to the requirements that apply to States operating Medicaid Promoting Interoperability Programs. We are updating policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are making changes relating to the required supporting documentation for an acceptable Medicare cost report submission and the supporting information for physician certification and recertification of claims.

A Contemporary Medicolegal Analysis of Implanted Devices for Chronic Pain Management.

BACKGROUND: Analysis of closed malpractice claims allows the study of rare but serious complications and likely results in improved patient safety by raising awareness of such complications. Clinical studies and closed claims analyses have previously reported on the common complications associated with intrathecal drug delivery systems (IDDS) and spinal cord stimulators (SCS). This study provides a contemporary analysis of claims from within the past 10 years. METHODS: We performed a closed claims analysis for a period January 1, 2009 to December 31, 2013 for cases with pain medicine as the primary service. These cases were identified using the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System (CBS), a database containing more than 300,000 malpractice claims from more than 400 academic and community institutions, representing approximately 30% of malpractice cases in the United States. The clinical narratives, which included medical files, claims files, depositions, and expert witness testimony, were reviewed by the authors, as were the CRICO coded variables, which included algorithmically determined contributing factors to the patient injury. RESULTS: Intrathecal drug delivery systems represented 17 of the closed claims; spinal cord stimulators represented 11 of the closed claims. The most common chronic pain diagnoses for which a device was implanted included failed back surgery syndrome and spasticity. The average total incurred for pain medicine claims was $166,028. Damaging events included IDDS refill errors (eg, subcutaneous administration of medication, reprogramming errors), intraoperative nerve damage, and postoperative infection (eg, epidural abscess, meningitis). High-severity outcomes included nerve damage (eg, paraplegia) and death. Medium-severity outcomes included drug reactions (eg, respiratory arrest from opioid overdose) and the need for reoperation. For both IDDS and SCS, deficits in technical skill were the most common contributing factor to injury, followed by deficits in clinical judgment, communication, and documentation. CONCLUSIONS: Implanted devices used for pain management involve a significant risk of morbidity and mortality. Proper education of providers and patients is essential. Providers must acquire the technical skills required for the implantation and refilling of these devices and the clinical skills required for the identification and management of complications such as intrathecal granuloma. Proper patient selection and clear communication between the provider and the patient about these possible complications are of paramount importance.

Obstetric Anesthesia Liability Concerns.

Obstetric practice carries a high risk of medical liability and involves both obstetricians and anesthesiologists. Analysis of data from the Anesthesia Closed Claims Project database shows an increase in the proportion of anesthesia claims for maternal death and brain damage between the 1990s and 2000 and later, primarily due to hemorrhage. The proportion of claims for newborn brain damage remained unchanged while those for maternal nerve injury and minor injuries decreased. Use of massive transfusion protocols and clinical drills have been shown to improve outcomes from hemorrhage. Good communication and teamwork are critical for reducing obstetric liability.

Off-label prescriptions and decisions on reimbursement requests in Germany - a retrospective analysis.

BACKGROUND AND OBJECTIVES: "Off-label use" is defined as the prescription of pharmaceutical products outside their approved indications. Rare diseases frequently lack "on-label" treatment options. In order to avoid reimbursement claims following the prescription of off-label drugs, physicians in Germany can - on a case-by-case basis - file an application for cost coverage with the competent health insurance prior to treatment initiation. PATIENTS AND METHODS: We conducted a chart review for cost coverage requests submitted by two outpatient clinics at a university-affiliated dermatology department between 2010 and 2012 (clinic for autoimmune diseases and urticaria clinic). Insurance providers, acceptance rates, reasons for rejection, and processing times were analyzed. RESULTS: The analysis showed that 56.8 % of applications for off-label use (n = 44) were approved during the first round. The rate increased to 75.0 % when including approvals granted after up to two rejections. The time between initial application and the response of health insurers was 49 days (median). In case of cost coverage approval, treatments were initiated 92 days (median) after the initial request. CONCLUSIONS: The present case series shows that, in the majority of cases, health insurers in Germany have agreed to reimburse the costs of proposed off-label therapies. A prospective study is required in order to evaluate whether current changes to legal regulations (GKV-Versorgungsstrukturgesetz, Patientenrechtegesetz) adequately address the problems identified.

Claims Procedure for Plans Providing Disability Benefits; 90-Day Delay of Applicability Date. Final rule; delay of applicability date.

This document delays for ninety (90) days--through April 1, 2018--the applicability of a final rule amending the claims procedure requirements applicable to ERISA-covered employee benefit plans that provide disability benefits (Final Rule). The Final Rule was published in the Federal Register on December 19, 2016, became effective on January 18, 2017, and was scheduled to become applicable on January 1, 2018. The delay announced in this document is necessary to enable the Department of Labor to carefully consider comments and data as part of its effort, pursuant to Executive Order 13777, to examine regulatory alternatives that meet its objectives of ensuring the full and fair review of disability benefit claims while not imposing unnecessary costs and adverse consequences.

Revisions to Rules Regarding the Evaluation of Medical Evidence. Final rules.

We are revising our medical evidence rules. The revisions include redefining several key terms related to evidence, revising our rules about acceptable medical sources (AMS), revising how we consider and articulate our consideration of medical opinions and prior administrative medical findings, revising our rules about medical consultants (MC) and psychological consultants (PC), revising our rules about treating sources, and reorganizing our evidence regulations for ease of use. These revisions conform our rules to the requirements of the Bipartisan Budget Act of 2015 (BBA), reflect changes in the national healthcare workforce and in the manner that individuals receive medical care, and emphasize the need for objective medical evidence in disability and blindness claims. We expect that these changes will simplify our rules to make them easier to understand and apply, and allow us to continue to make accurate and consistent disability determinations and decisions.

Extension of Expiration Dates for Four Body System Listings. Final rule.

We are extending the expiration dates of the following body systems in the Listing of Impairments (listings) in our regulations: Musculoskeletal System, Cardiovascular System, Digestive System, and Skin Disorders. We are making no other revisions to these body systems in this final rule. This extension ensures that we will continue to have the criteria we need to evaluate impairments in the affected body systems at step three of the sequential evaluation processes for initial claims and continuing disability reviews.

Medicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures. Final rule.

This final rule revises the procedures that the Department of Health and Human Services (HHS) follows at the Administrative Law Judge (ALJ) level for appeals of payment and coverage determinations for items and services furnished to Medicare beneficiaries, enrollees in Medicare Advantage (MA) and other Medicare competitive health plans, and enrollees in Medicare prescription drug plans, as well as appeals of Medicare beneficiary enrollment and entitlement determinations, and certain Medicare premium appeals. In addition, this final rule revises procedures that the Department of Health and Human Services follows at the Centers for Medicare & Medicaid Services (CMS) and the Medicare Appeals Council (Council) levels of appeal for certain matters affecting the ALJ level.

Recognition of Tribal Organizations for Representation of VA Claimants. Final rule.

The Department of Veterans Affairs (VA) is amending its regulations concerning recognition of certain national, State, and regional or local organizations for purposes of VA claims representation. Specifically, this rulemaking allows the Secretary to recognize tribal organizations in a similar manner as the Secretary recognizes State organizations. The final rule allows a tribal organization that is established and funded by one or more tribal governments to be recognized for the purpose of providing assistance on VA benefit claims. In addition, the final rule allows an employee of a tribal government to become accredited through a recognized State organization in a similar manner as a County Veterans' Service Officer (CVSO) may become accredited through a recognized State organization. The effect of this action is to address the needs of Native American populations who are geographically isolated from existing recognized Veterans Service Organizations (VSOs) or who may not be utilizing other recognized VSOs due to cultural barriers or lack of familiarity with those organizations.

Schedule for Rating Disabilities; Dental and Oral Conditions. Final rule.

This document amends the Department of Veterans Affairs (VA) Schedule for Rating Disabilities by revising the portion of the schedule that addresses dental and oral conditions. The effect of this action is to ensure that the rating schedule uses current medical terminology and to provide detailed and updated criteria for evaluation of dental and oral conditions for disability rating purposes.

The Role of Documentation Quality in Anesthesia-Related Closed Claims: A Descriptive Qualitative Study.

Clinical documentation is a critical tool in supporting care provided to patients. Sound documentation provides a picture of clinical events that can be used to improve patient care. However, many other uses for clinical documentation are equally important. Such documentation informs clinical decision support tools, creates a legal record of patient care, assists in financial reimbursement of services, and serves as a repository for secondary data analysis. Conversely, poor documentation can impair patient safety and increase malpractice risk exposure by reflecting poor or inaccurate information that ultimately may guide patient care decisions.Through an examination of anesthesia-related closed claims, a descriptive qualitative study emerged, which explored the antecedents and consequences of documentation quality in the claims reviewed. A secondary data analysis utilized a database generated by the American Association of Nurse Anesthetists Foundation closed claim review team. Four major themes emerged from the analysis. Themes 1, 2, and 4 primarily describe how poor documentation quality can have negative consequences for clinicians. The third theme primarily describes how poor documentation quality that can negatively affect patient safety.

[Aspects of expert opinions of avulsion fractures]. / Gutachtliche Aspekte von Apophysenschäden.

The apophyses as secondary ossification centers are connected with the bone by cartilage. During the growth phase of puberty, the apophyseal plate is a mechanical weak spot. Especially, apophyses in the hip and pelvic area are exposed to considerable tensile and sheer stresses due to the strong muscles which are inserted here. The frequency of injuries to the apophyses correlates with the extent of sporting activities. For athletes participating in "Youth Train for the Olympics", this is the most common injury of all. Most often, the apophysis of the rectus femoris muscle is affected at the anterior inferior iliac spine. In adults, after complete ossification of the apophyseal plate such injuries are rare. However, in a very unusual mechanism of injury with maximum forced hip flexion and simultaneous maximum knee extension, avulsions of the ischial tuberosity are observed in adults. During the causality test-especially in the legal area of statutory accident insurance-the question is always whether the alleged course of events has to be regarded as a legally significant (partial) cause or if a longer period of time has been involved, so that the resulting morbid apophysis detachment was predominately due to fate, in which the alleged event must be interpreted as legally immaterial.

Claims Procedure for Plans Providing Disability Benefits. Final rule.

This document contains a final regulation revising the claims procedure regulations under the Employee Retirement Income Security Act of 1974 (ERISA) for employee benefit plans providing disability benefits. The final rule revises and strengthens the current rules primarily by adopting certain procedural protections and safeguards for disability benefit claims that are currently applicable to claims for group health benefits pursuant to the Affordable Care Act. This rule affects plan administrators and participants and beneficiaries of plans providing disability benefits, and others who assist in the provision of these benefits, such as third-party benefits administrators and other service providers.

Ensuring Program Uniformity at the Hearing and Appeals Council Levels of the Administrative Review Process. Final rule.

We are revising our rules so that more of our procedures at the hearing and Appeals Council levels of our administrative review process are consistent nationwide. We anticipate that these nationally consistent procedures will enable us to administer our disability programs more efficiently and better serve the public.

Returning Evidence at the Appeals Council Level. Final rule.

This final rule adopts the notice of proposed rulemaking (NPRM) that we published in the Federal Register on October 21, 2015. This final rule revises our rules regarding returning evidence at the Appeals Council (AC) level. Under this final rule, the AC will no longer return additional evidence it receives when the AC determines the additional evidence does not relate to the period on or before the date of the administrative law judge (ALJ) decision.

A proposed method for retrospective eye dose assessments for the purposes of resolving cataract compensation claims.

The 2011 International Commission on Radiological Protection (ICRP) statement on tissue reactions suggested a significant reduction in the threshold dose for radiation induced cataracts. This, combined with the potential for a long delay between exposure and cataract diagnosis, may result in an increased requirement to evaluate eye dose from past exposures in order to settle current compensation claims. This article highlights how compensation claims relating to radiation exposure are assessed within the UK legal system and suggests that in vivo Electro Paramagnetic Resonance (EPR) dosimetry of teeth has utility for the retrospective quantification of radiation doses to the eye. It was identified that in vivo EPR in its current form may be sufficiently sensitive to support cataract compensation claims, although further work is required to enable appropriate dose conversion coefficients to be quantified.

Medicaid Program; Mechanized Claims Processing and Information Retrieval Systems (90/10). Final rule.

This final rule will extend enhanced funding for Medicaid eligibility systems as part of a state's mechanized claims processing system, and will update conditions and standards for such systems, including adding to and updating current Medicaid Management Information Systems (MMIS) conditions and standards. These changes will allow states to improve customer service and support the dynamic nature of Medicaid eligibility, enrollment, and delivery systems.

Final Rules for Grandfathered Plans, Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, Dependent Coverage, Appeals, and Patient Protections Under the Affordable Care Act. Final rules.

This document contains final regulations regarding grandfathered health plans, preexisting condition exclusions, lifetime and annual dollar limits on benefits, rescissions, coverage of dependent children to age 26, internal claims and appeal and external review processes, and patient protections under the Affordable Care Act. It finalizes changes to the proposed and interim final rules based on comments and incorporates subregulatory guidance issued since publication of the proposed and interim final rules.