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Objective: Accurate documentation of patient care and acuity is essential to determine appropriate reimbursement as well as accuracy of key publicly reported quality metrics. We sought to investigate the impact of standardized note templates by inpatient advanced practice providers (APPs) on evaluation and management (E/M) charge capture, including outside of the global surgical package (GSP), and quality metrics including case mix index (CMI) and mortality index (MI). We hypothesized this clinical documentation initiative as well as improved coding of E/M services would result in increased reimbursement and quality metrics., Methods: A documentation and coding initiative on the heart and vascular service line was initiated in 2016 with focus on improving inpatient E/M capture by APPs outside the GSP. Comprehensive training sessions and standardized documentation templates were created and implemented in the electronic medical record. Subsequent hospital care E/M (current procedural terminology codes 99231, 99232, 99233) from the years 2015 to 2017 were audited and analyzed for charge capture rates, collections, work relative value units (wRVUs), and billing complexity. Data were compared over time by standardizing CMS values and reimbursement rates. In addition, overall CMI and MI were calculated each year., Results: One year following the documentation initiative, E/M charges on the vascular surgery service line increased by 78.5% with a corresponding increase in APP charges from 0.4% of billable E/M services to 70.4% when compared with pre-initiative data. The charge capture of E/M services among all inpatients rose from 21.4% to 37.9%. Additionally, reimbursement from CMS increased by 65% as total work relative value units generated from E/M services rose by 78.4% (797 to 1422). The MI decreased over the study period by 25.4%. Additionally, there was a corresponding 5.6% increase in the cohort CMI. Distribution of E/M encounter charges did not vary significantly. Meanwhile, the prevalence of 14 clinical comorbidities in our cohort as well as length of stay (P = .88) remained non-statistically different throughout the study period., Conclusions: Accurate clinical documentation of E/M care and ultimately inpatient acuity is critical in determining quality metrics that serve as important measures of overall hospital quality for CMS value-based payments and rankings. A system-based documentation initiative and expanded role of inpatient APPs on vascular surgery teams significantly improved charge capture and reimbursement outside the GSP as well as CMI and MI in a consistently complex patient population., (Published by Elsevier Inc.)

SUMMARY The 1-month drug-dispensing limit is a common drug utilization tool used by state Medicaid agencies to control spending. Since the beginning of the COVID-19 pandemic, many states relaxed the 1-month dispensing limit restriction in order to align with social distancing recommendations. Yet, some states have not relaxed this limit and have differed substantially regarding the policies that have been implemented. Among states that relaxed the 1-month supply limit, determining which chronic disease drugs qualified for this extension can be challenging for patients and clinicians. As more commercial and Medicare insurance beneficiaries are offered 90-day drug supplies, the 30-day drug supply limit with Medicaid has become a health equity issue, since many individuals insured by Medicaid have already experienced a disproportionate impact from and remain at high risk for severe COVID-19 disease. Thus, we propose policy solutions to ensure that Medicaid beneficiaries have safe and uninterrupted access to chronic disease medications during and beyond the COVID-19 pandemic. DISCLOSURES: No funding was received for this work. Alpern has received funding from Arnold Ventures for research related to the use and spending of off-patent drugs, unrelated to this work, and is a member of the Pharmacy and Therapeutics Committee at Regions Hospital, St. Paul, MN. DeSilva has received CDC support for work on Vaccine Safety Datalink, VISION network, and Center of Excellence for Newcomer Health, unrelated to this work. Chomilo is Medicaid Medical Director for the State of Minnesota's Department of Human Services.

Background: There is strong evidence supporting implementation of the Collaborative Care Model within primary care. Fee-for-service payment codes, published by Current Procedural Terminology in 2018, have made collaborative care separately reimbursable for the first time. These codes (ie, 99492-99494) reimburse for time spent per month by any member of the care team engaged in Collaborative Care, including behavioral care managers, primary care providers, and consulting psychiatrists. Time-based billing for these codes presents challenges for providers delivering Collaborative Care services., Objectives: Based on experience from multiple health care organizations, we reflect on these challenges and provide suggestions for implementation and future refinement of the codes., Conclusions: Further refinements to the codes are encouraged, including moving from a calendar month to a 30-day reimbursement cycle. In addition, we recommend payers adopt the new code proposed by the Centers for Medicare and Medicaid Services to account for smaller increments of time., Competing Interests: The authors declare no conflict of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Importance: In many health systems, access to off-label drug use is controlled through reimbursement restrictions by health insurers, especially for expensive cancer drugs., Objective: To determine whether evidence from randomized clinical trials is associated with reimbursement decisions for requested off-label use of anticancer drugs in the Swiss health system., Design, Setting, and Participants: This cross-sectional study used reimbursement requests from routinely collected health records of 5809 patients with drug treatment for cancer between January 2015 and July 2018 in 3 major cancer centers, covering cancer care of approximately 5% of the Swiss population, to identify off-label drug use. For each off-label use indication with 3 or more requests, randomized clinical trial evidence on treatment benefits was systematically identified for overall survival (OS) or progression-free survival (PFS). Data were analyzed from August 2018 to December 2020., Exposures: Available randomized clinical trial evidence on benefits for OS or PFS for requested off-label use indications., Main Outcomes and Measures: The main outcome was the association between evidence for treatment benefit (expressed as improved OS or PFS) and reimbursement in multivariable regression models., Results: Among 3046 patients with cancer, 695 off-label use reimbursement requests in 303 different indications were made for 598 patients (median [interquartile range] age, 64 [53-73] years; 420 [60%] men). Off-label use was intended as first-line treatment in 311 requests (45%). Reimbursement was accepted in 446 requests (64%). For 71 indications, including 431 requests for 376 patients, there were 3 or more requests. Of these, 246 requests (57%) had no supporting evidence for OS or PFS benefit. Reimbursement was granted in 162 of 246 requests without supporting evidence (66%). Of 117 requests supported by OS benefit, 79 (67%) were reimbursed, and of 68 requests supported by PFS benefit alone, 54 (79%) were reimbursed. Evidence of OS benefit from randomized clinical trials was not associated with a higher chance of reimbursement (odds ratio, 0.76, 95% CI, 0.45-1.27)., Conclusions and Relevance: These findings suggest that in a health care system enabling access to off-label use, it was frequently intended as a first-line treatment in cancer care. Availability of randomized clinical trial evidence showing survival benefit was not associated with reimbursement decisions for off-label anticancer drug treatment in Switzerland. A transparent process with criteria considering clinical evidence is needed for evidence-based reimbursement decisions to ensure fair access to cancer treatments.

Implementation of telemedicine for patient encounters optimizes personal safety and allows for continuity of patient care. Embracing telehealth reduces the use of personal protective equipment and other resources consumed during in-person visits. The use of telehealth has increased to historic levels in response to the coronavirus disease 2019 (COVID-19) pandemic. Telehealth may be a key modality to fight against COVID-19, allowing us to take care of patients, conserve personal protective equipment, and protect health care workers all while minimizing the risk of viral spread. We must not neglect vascular health issues while the coronavirus pandemic continues to flood many hospitals and keep people confined to their homes. Patients are not immune to diseases and illnesses such as stroke, critical limb ischemia, and deep vein thrombosis while being confined to their homes and afraid to visit hospitals. Emerging from the COVID-19 crisis, incorporating telemedicine into routine medical care is transformative. By leveraging digital technology, the authors discuss their experience with the implementation, workflow, coding, and reimbursement issues of telehealth during the COVID-19 era., (Copyright © 2020. Published by Elsevier Inc.)

Background: Critical access hospitals (CAHs) play an important role in providing access to care for many patients in rural communities. Prior studies have shown that these facilities are able to provide timely and quality care for patients who undergo various elective and emergency general surgical procedures. However, little is known about the quality and reimbursement of surgical care for patients undergoing surgery for hip fractures at CAHs compared with non-CAH facilities., Questions/purposes: Are there any differences in 90-day complications, readmissions, mortality, and Medicare payments between patients undergoing surgery for hip fractures at CAHs and those undergoing surgery at non-CAHs?, Methods: The 2005 to 2014 Medicare 100% Standard Analytical Files were queried using ICD-9 procedure codes to identify Medicare-eligible beneficiaries undergoing open reduction and internal fixation (79.15, 79.35, and 78.55), hemiarthroplasty (81.52), and THA (81.51) for isolated closed hip fractures. This database was selected because the claims capture inpatient diagnoses, procedures, charged amounts and paid claims, as well as hospital-level information of the care, of Medicare patients across the nation. Patients with concurrent fixation of an upper extremity, lower extremity, and/or polytrauma were excluded from the study to ensure an isolated cohort of hip fractures was captured. The study cohort was divided into two groups based on where the surgery took place: CAHs and non-CAHs. A 1:1 propensity score match, adjusting for baseline demographics (age, gender, Census Bureau-designated region, and Elixhauser comorbidity index), clinical characteristics (fixation type and time to surgery), and hospital characteristics (whether the hospital was located in a rural ZIP code, the average annual procedure volume of the operating facility, hospital bed size, hospital ownership and teaching status), was used to control for the presence of baseline differences in patients presenting at CAHs and those presenting at non-CAHs. A total of 1,467,482 patients with hip fractures were included, 29,058 of whom underwent surgery in a CAH. After propensity score matching, each cohort (CAH and non-CAH) contained 29,058 patients. Multivariate logistic regression analyses were used to assess for differences in 90-day complications, readmissions, and mortality between the two matched cohorts. As funding policies of CAHs are regulated by Medicare, an evaluation of costs-of-care (by using Medicare payments as a proxy) was conducted. Generalized linear regression modeling was used to assess the 90-day Medicare payments among patients undergoing surgery in a CAH, while controlling for differences in baseline demographics and clinical characteristics., Results: Patients undergoing surgery for hip fractures were less likely to experience many serious complications at a critical access hospital (CAH) than at a non-CAH. In particular, after controlling for patient demographics, hospital-level factors and procedural characteristics, patients treated at a CAH were less likely to experience: myocardial infarction (3% (916 of 29,058) versus 4% (1126 of 29,058); OR 0.80 [95% CI 0.74 to 0.88]; p < 0.001), sepsis (3% (765 of 29,058) versus 4% (1084 of 29,058); OR 0.69 [95% CI 0.63 to 0.78]; p < 0.001), acute renal failure (6% (1605 of 29,058) versus 8% (2353 of 29,058); OR 0.65 [95% CI 0.61 to 0.69]; p < 0.001), and Clostridium difficile infections (1% (367 of 29,058) versus 2% (473 of 29,058); OR 0.77 [95% CI 0.67 to 0.88]; p < 0.001) than undergoing surgery in a non-CAH. CAHs also had lower rates of all-cause 90-day readmissions (18% (5133 of 29,058) versus 20% (5931 of 29,058); OR 0.83 [95% CI 0.79 to 0.86]; p < 0.001) and 90-day mortality (4% (1273 of 29,058) versus 5% (1437 of 29,058); OR 0.88 [95% CI 0.82 to 0.95]; p = 0.001) than non-CAHs. Further, CAHs also had risk-adjusted lower 90-day Medicare payments than non-CAHs (USD 800, standard error 89; p < 0.001)., Conclusion: Patients who received hip fracture surgical care at CAHs had a lower risk of major medical and surgical complications than those who had surgery at non-CAHs, even though Medicare reimbursements were lower as well. Although there may be some degree of patient selection at CAHs, these facilities appear to provide high-value care to rural communities. These findings provide evidence for policymakers evaluating the impact of the CAH program and allocating funding resources, as well as for community members seeking emergent care at local CAH facilities., Level of Evidence: Level III, therapeutic study., Competing Interests: Each author certifies that neither he or she, nor any member of his or her immediate family, has funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request., (Copyright © 2020 by the Association of Bone and Joint Surgeons.)

Because of the COVID-19 pandemic, many mental health care services have been shifted from face-to-face to virtual interactions. Several health policy changes have influenced telehealth uptake during this time, including changes in technology, Internet connectivity, prescriptions, and reimbursement for services. These changes have been implemented for the duration of the pandemic, and it is unclear if all, some, or none of these new or amended policies will be retained after the pandemic has ended. Accordingly, in the wake of changing policies, mental health care providers will need to make decisions about the future of their telehealth programs. This article briefly reviews telehealth policy changes due to the COVID-19 pandemic and highlights what providers should consider for future delivery and implementation of their telehealth programs.

Background: The frameworks used by Health Technology Assessment (HTA) agencies for value assessment of medicines aim to optimize healthcare resource allocation. However, they may not be effective at capturing the value of antimicrobial drugs., Objectives: To analyze stakeholder perceptions regarding how antimicrobials are assessed for value for reimbursement purposes and how the Australian HTA framework accommodates the unique attributes of antimicrobials in cost-effectiveness evaluation., Methods: Eighteen individuals representing the pharmaceutical industry or policy-makers were interviewed. Interviews were transcribed verbatim, coded, and thematically analyzed., Results: Key emergent themes were that reimbursement decision-making should consider the antibiotic spectrum when assessing value, risk of shortages, the impact of procurement processes on low-priced comparators, and the need for methodological transparency when antimicrobials are incorporated into the economic evaluation of other treatments., Conclusions: Participants agreed that the current HTA framework for antimicrobial value assessment is inadequate to properly inform funding decisions, as the contemporary definition of cost-effectiveness fails to explicitly incorporate the risk of future resistance. Policy-makers were uncertain about how to incorporate future resistance into economic evaluations without a systematic method to capture costs avoided due to good stewardship. Lacking financial reward for the benefits of narrower-spectrum antimicrobials, companies will likely focus on developing broad-spectrum agents with wider potential use. The perceived risks of shortages have influenced the funding of generic antimicrobials in Australia, with policy-makers suggesting a willingness to pay more for assured supply. Although antibiotics often underpin the effectiveness of other medicines, it is unclear how this is incorporated into economic models.

This article reviews the current experience and the flaws encountered in the rush to deploy telemedicine as a substitute for in-person care in response to the raging coronavirus (COVID-19) pandemic; the preceding fault lines in the U.S. health care system that exacerbated the problem; and the importance of emerging from this calamity with a clear vision for necessary health care reforms. It starts with the premise that the precursors of catastrophes of this magnitude provide a valid basis for planning corrective measures, improved preparedness, and ultimately serious health reform. Such reform should include standardized protocols for proper deployment of telemedicine to triage patients to the appropriate level and source of care at the point of need, proper use of relevant technological innovations to deliver precision medicine, and the development of regional networks to coordinate and improve access to care while streamlining the care process. The other essential element is a universal payment system that puts the United States at par with the rest of the industrialized countries, regardless of variation among them. The ultimate goal is creating an efficient, effective, accessible, and equitable system of care. Although timing is uncertain, the pandemic will be brought under control. The path to a better future after the pandemic offers some consolation for the massive loss of life and treasure during this pandemic.

Objective: To develop the first longitudinal database of state Medicaid policies for paying the cost sharing in Medicare Part B for services provided to dual Medicare-Medicaid enrollees ("duals") and an index summarizing the impact of these policies on payments for physician office services., Data Sources: Medicaid policy data collected from electronic sources and inquiries with states., Study Design: We constructed a national database of Medicaid payment policies for the period 2004-2018, consolidating information from online Medicaid policy documents, state laws, and policy data reported to us by state Medicaid programs. Using this database and state Medicaid fee schedules, we constructed a Medicaid payment index for duals. This index represented the proportion of the Medicare allowed amount that physicians would expect to be paid from Medicare and Medicaid for a subset of physician office services (evaluation and management services) based on annual state payment policies and Medicaid fee schedules., Principal Findings: In 2018, 42 states had policies to limit Medicaid payments of Medicare cost sharing when Medicaid's fee schedule was lower than Medicare's-an increase from 36 such states in 2004. In the preponderance of states with these policies, combined Medicare and Medicaid payments for evaluation and management services provided to duals averaged 78 percent of the Medicare allowed amount for these services, reflecting relatively low Medicaid fee schedules in these states. In 2013 and 2014, physicians who qualified for the Affordable Care Act's Medicaid "fee bump" were paid 100 percent of the Medicare allowed amount for these services., Conclusions: Medicaid programs vary across states and over time in their payments of cost sharing for physician office services provided to duals. Our database and index can facilitate monitoring of these policies and research on the consequences of policy changes for duals., (© Health Research and Educational Trust.)

Introduction: The use of medical cannabis to treat drug-resistant epilepsy in children is increasing; however, there has been limited study of the experiences of parents with the current system of accessing medical cannabis for their children., Methods: In this qualitative study, we used a patient-centered access to care framework to explore the barriers faced by parents of children with drug-resistant epilepsy when trying to access medical cannabis in Canada. We conducted semistructured interviews with 19 parents to elicit their experiences with medical cannabis. We analyzed the data according to five dimensions of access, namely approachability, acceptability, availability, affordability, and appropriateness., Results: Parents sought medical cannabis as a treatment because of a perceived unmet need stemming from the failure of antiepileptic drugs to control their children's seizures. Medical cannabis was viewed as an acceptable treatment, especially compared with adding additional antiepileptic drugs. After learning about medical cannabis from the media, friends and family, or other parents, participants sought authorization for medical use. However, most encountered resistance from their child's neurologist to discuss and/or authorize medical cannabis, and many parents experienced difficulty in obtaining authorization from a member of the child's existing care team, leading them to seek authorization from a cannabis clinic. Participants described spending up to $2000 per month on medical cannabis, and most were frustrated that it was not eligible for reimbursement through public or private insurance programs., Conclusions: Parents pursue medical cannabis as a treatment for their children's drug-resistant epilepsy because of a perceived unmet need. However, parents encounter barriers in accessing medical cannabis in Canada, and strategies are needed to ensure that children using medical cannabis receive proper care from healthcare professionals with training in epilepsy care, antiepileptic drugs, and medical cannabis., Competing Interests: Declaration of competing interest Bláthnaid McCoy is a principal investigator in a study of cannabinoids for Dravet syndrome. The remaining authors have no conflicts of interest., (Copyright © 2020 Elsevier Inc. All rights reserved.)

In the 2020 Final Rule, the Center for Medicare & Medicaid Services adopted a new coding structure and accepted the substantial increase in valuation for office/outpatient Evaluation and Management codes set to begin in 2021. Given budget neutrality requirements, the projected increase in reimbursement will require a reduction in the conversion factor to offset such increases. The aim is to inform neuroradiologists the impact of these proposed changes on reimbursement and the profession., (© 2020 by American Journal of Neuroradiology.)

Policies facilitating integration of public health programs can improve the public health response, but the literature on approaches to integration across multiple system levels is limited. We describe the efforts of the Massachusetts Department of Public Health to integrate its HIV, viral hepatitis, sexually transmitted infection (STI), and tuberculosis response through policies that mandated contracted organizations to submit specimens for testing to the Massachusetts State Public Health Laboratory; co-test blood specimens for HIV, hepatitis C virus (HCV), and syphilis; integrate HIV, viral hepatitis, and STI disease surveillance and case management in a single data system; and implement an integrated infectious disease drug assistance program. From 2014 through 2018, the number of tests performed by the Massachusetts State Public Health Laboratory increased from 16 321 to 33 674 for HIV, from 11 054 to 33 670 for HCV, and from 19 169 to 30 830 for syphilis. Service contracts enabled rapid response to outbreaks of HIV, hepatitis A, and hepatitis B. Key challenges included lack of a billing infrastructure at the Massachusetts State Public Health Laboratory; the need to complete negotiations with insurers and to establish a retained revenue account to receive health insurance reimbursements for testing services; and time to train testing providers in phlebotomy for required testing. Investing in laboratory infrastructure; creating billing mechanisms to maximize health insurance reimbursement; proactively engaging providers, community members, and other stakeholders; and building capacity to transform practices are needed. Using multilevel policy approaches to integrate the public health response to HIV, STI, viral hepatitis, and tuberculosis is feasible and adaptable to other public health programs.

Introduction: Reimbursement of body-contouring surgery (BCS) is a worldwide problem: there is no objective instrument to decide which postbariatric patients should qualify for reimbursement. The British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) has developed a screening tool for this purpose. In this study, we used a modified version of this screening tool in a postbariatric population and describe which patients would qualify for reimbursement using this tool., Methods: In this cross-sectional study postbariatric patients were asked to fill in an online questionnaire based on the BAPRAS screening tool with questions regarding complaints of overhanging skin and medical history. Weight loss data were extracted from a prospective database. The BODY-Q was added to assess patient-reported outcomes., Results: Patients who wanted to undergo BCS (n = 90) had higher screening tool scores and lower BODY-Q scores compared to patients who did not want BCS (n = 24). In total, 25 patients (26%) qualified for reimbursement, these patients had higher weight loss (33.5% versus 29.2%, p = 0.008), lower BMI (27.3 kg/m 2 versus 30.4 kg/m 2 , p = 0.014) and more medical (4.0 versus 2.0, p = 0.004) and psychological complaints (88% versus 61%, p = 0.009). There was a significant, negative correlation between the screening tool scores and almost all BODY-Q scales., Conclusions: Patients with a desire for BCS have more complaints of excess skin, which negatively impacts their well-being. With the modified BAPRAS screening tool, patients with the best weight (loss) and most medical and psychological complaints of excess skin qualified for referral and reimbursement of BCS., Competing Interests: Declaration of Competing Interest, (Copyright © 2020 Elsevier Ltd. All rights reserved.)

In recent years, as the era of deepening healthcare reform in China progresses, there is a gradual development of ambulatory care pharmacy practice. This commentary reviews the current state of ambulatory care pharmacy practice in China and discusses future efforts to advance the practice. Areas of focus include practice standardization, transitions of care, and reimbursements of ambulatory care pharmacy practice.

Medical ethics has become an important and recognized component of physician training. There is one area, however, in which medical students receive little guidance. There is practically no discussion of the financial aspects of medical practice. My objective in this paper is to initiate a discussion about the moral dimension of physician billing practices. I argue that physicians should expand their conception of professional responsibility in order to recognize that their moral obligations toward patients include a commitment to honest and forthright billing practices. I argue that physicians should aspire to a standard of clinical accuracy-not legal adequacy-in describing their activities. More generally, physicians should strive to promote an integrity-based professional culture, first and foremost by stigmatizing rather than celebrating creative billing practices, as well as condemning the misguided sense of solidarity that currently makes it taboo for physicians to criticize each other on this score., (© The Author(s) 2020. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

A well-implemented and adequately funded medical home not only is the best approach to optimize the health of the individual patient but also can function as an effective instrument for improving population health. Key financing elements to providing quality, effective, comprehensive care in the pediatric medical home include the following: (1) first dollar coverage without deductibles, copays, or other cost-sharing for necessary preventive care services as recommended by Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents ; (2) adoption of a uniform definition of medical necessity across payers that embraces services that promote optimal growth and development and prevent, diagnose, and treat the full range of pediatric physical, mental, behavioral, and developmental conditions, in accord with evidence-based science or evidence-informed expert opinion; (3) payment models that promote appropriate use of pediatric primary care and pediatric specialty services and discourage inappropriate, inefficient, or excessive use of medical services; and (4) payment models that strengthen the patient- and family-physician relationship and do not impose additional administrative burdens that will only erode the effectiveness of the medical home. These goals can be met by designing payment models that provide adequate funding of the cost of medical encounters, care coordination, population health services, and quality improvement activities; provide incentives for quality and effectiveness of care; and ease administrative burdens., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2020 by the American Academy of Pediatrics.)

Background: Despite increasing informal and formal use of unmet medical need (UMN) in drug development, regulation, and assessment, there is no insight into its definitions in use. This study aims to provide insight into the current definitions in use and to provide a starting point for a multi-stakeholder discussion on alignment., Methods: A scoping and a gray literature review were performed to locate definitions of UMN in literature and on stakeholder websites. These definitions were categorized and then discussed among the multi-stakeholder author group via semistructured group discussions and open session workshops with a broader stakeholder audience. Issues with the formation of a common definition and mechanisms for use were discussed., Results: The reviews yielded 16 definitions. Differences were evident, but all included 1 or more of the following elements: (adequacy of) available treatments (16 of 16: 100%), disease severity or burden (6 of 16: 38%), and patient population size (1 of 16: 6%). The stakeholder discussions led to a suggestion for a definition including the first 2 items and, depending on context, population size. The discussions also showed that quantification of UMN is highly dependent on the scope and the value framework in which it is used based on different stakeholder preferences and responsibilities., Conclusion: We encourage stakeholders that want to promote alignment on the concept of UMN to prospectively discuss the scope in which they want to apply the concept, what elements they find important for consideration in each case, and how they would measure UMN within the broader regulatory or value framework applicable., (Copyright © 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Purpose: Insurance payers in the United States vary in the indications for which they consider stereotactic body radiation therapy (SBRT) "medically necessary." We compared changes in policies after the last update to the American Society for Radiation Oncology's (ASTRO) SBRT model policy., Methods and Materials: We identified 77 payers with SBRT policies in 2015 from a policy aggregator, as well as 4 national benefits managers (NBMs). Of these, 65 payers and 3 NBMs had publicly available updates since 2015. For each of the indications in ASTRO's model policy, we calculated the proportion of payers that considered SBRT medically necessary. We used Fisher's exact test to compare these proportions between 2015 and now, between policies updated in the past 12 months and those updated less often, and between national and regional payers currently., Results: Payers consider SBRT medically necessary most often for primary lung cancer (97%), reirradiation to the spine (91%), prostate cancer (68%), primary liver cancer (66%), and spinal metastases with radioresistant histologies (66%). Policies have become more aligned with ASTRO's model policy over time. National payers and NBMs cover indications in higher proportions than regional payers., Conclusions: Although there have been improvements over time, more work is needed to align payer policies with ASTRO's model SBRT policy, especially at the regional level., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Enhancing primary health care (PHC) is considered a policy priority for health systems strengthening due to PHC's ability to provide accessible and continuous care and manage multimorbidity. Research in PHC often focuses on the effects of specific interventions (e.g. physicians' contracts) in health care outcomes. This informs narrowly designed policies that disregard the interactions between the health functions (e.g. financing and regulation) and actors involved (i.e. public, professional, private), and their impact in care delivery and outcomes. The purpose of this study is to analyse the interactions between PHC functions and their impact in PHC delivery, particularly in providers' behaviour and practice organisation., Methods: Following a systems thinking approach with data obtained through a three-round European Delphi process, we developed a framework that captures (1) the interactions between PHC functions by analysing correlations between PHC characteristics of participating countries, (2) how actors involved shaped these interactions by identifying the actor and level of devolution (or fragmentation) in the analysis, and (3) their potential effect on care delivery by exploring panellists' opinions., Results: A total of 59 panellists from 24 countries participated in the first round and 76% of the initial panellists (22 countries) completed the last round. Findings show correlations between governance, financing and regulation based on their degree of decentralisation. This is supported by panellists, who agreed that the actors involved in health system governance determine the type of PHC financing (e.g. ownership or payment mechanisms) and regulation (e.g. competences or gatekeeping), and this may impact care delivery and outcomes. Governance in our framework is an overarching function whose impact in PHC delivery is mediated through the degree of decentralisation (both delegation and devolution) of PHC financing and regulation., Conclusions: The application of this approach in policy implementation assessment intends to uncover limitations due to poor accountability and commitment to shared objectives. Its application in the design of health strategies helps foresee (and prevent) undesired or unexpected effects of narrow interventions. This approach will assist in the development of the realistic and long-term policies required for health systems strengthening.

Background: During the introduction of transcatheter aortic-valve replacement (TAVR) in the United States, requirements regarding procedural volume were mandated by the Centers for Medicare and Medicaid Services as a condition of reimbursement. A better understanding of the relationship between hospital volume of TAVR procedures and patient outcomes could inform policy decisions., Methods: We analyzed data from the Transcatheter Valve Therapy Registry regarding procedural volumes and outcomes from 2015 through 2017. The primary analyses examined the association between hospital procedural volume as a continuous variable and risk-adjusted mortality at 30 days after transfemoral TAVR. Secondary analysis included risk-adjusted mortality according to quartile of hospital procedural volume. A sensitivity analysis was performed after exclusion of the first 12 months of transfemoral TAVR procedures at each hospital., Results: Of 113,662 TAVR procedures performed at 555 hospitals by 2960 operators, 96,256 (84.7%) involved a transfemoral approach. There was a significant inverse association between annualized volume of transfemoral TAVR procedures and mortality. Adjusted 30-day mortality was higher and more variable at hospitals in the lowest-volume quartile (3.19%; 95% confidence interval [CI], 2.78 to 3.67) than at hospitals in the highest-volume quartile (2.66%; 95% CI, 2.48 to 2.85) (odds ratio, 1.21; P = 0.02). The difference in adjusted mortality between a mean annualized volume of 27 procedures in the lowest-volume quartile and 143 procedures in the highest-volume quartile was a relative reduction of 19.45% (95% CI, 8.63 to 30.26). After the exclusion of the first 12 months of TAVR procedures at each hospital, 30-day mortality remained higher in the lowest-volume quartile than in the highest-volume quartile (3.10% vs. 2.61%; odds ratio, 1.19; 95% CI, 1.01 to 1.40)., Conclusions: An inverse volume-mortality association was observed for transfemoral TAVR procedures from 2015 through 2017. Mortality at 30 days was higher and more variable at hospitals with a low procedural volume than at hospitals with a high procedural volume. (Funded by the American College of Cardiology Foundation National Cardiovascular Data Registry and the Society of Thoracic Surgeons.)., (Copyright © 2019 Massachusetts Medical Society.)

This study assessed whether five Health Technology Assessment (HTA) bodies in Europe were more negative about drugs with a Conditional Marketing Authorization (CMA) that are approved without controlled studies compared to CMA drugs that are approved based on controlled studies. The HTA recommendations were categorized into positive, restricted, and negative. A total of 92 HTA recommendations were available for 27 drugs. Thirty of 62 (48%) and 17 of 30 (57%) of the recommendations were negative for drugs with and without controlled studies, respectively. Overall, only 12 (13%) recommendations were positive. In all jurisdictions, recommendations between drugs with and drugs without controlled data were comparable, which suggests that the presence of controlled data is not decisive in HTA evaluations. The small proportion of unrestricted positive recommendations highlights difficulties with recommending the drugs in this cohort, which may be caused by scientific uncertainty or other factors. Earlier collaboration between stakeholders is advised in order to improve patient access., (© 2018 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.)

Background: Canada has a long history of the use of clinical evidence to support healthcare decision making. Given improvements in data holdings and analytic capacity in Canada and stakeholder interest, the purpose of this study is to reflect on perceptions of the value of real-world evidence in pricing and reimbursement decisions, barriers to its optimal use in pricing and reimbursement, current initiatives that may lead to its increased use, and what role the pharmaceutical industry may play in this.Methods/ResultsTo capture stakeholder perceptions, ninety-one participants identified as key stakeholders were identified according to background roles and geography and invited to participate in four round table discussions conducted under Chatham House rule. Important themes emerging from these discussions included: (i) the need to understand what "real world" evidence means; (ii) barriers to using real world evidence from differences in access, governance, inter-operability, system structures, expertise, and quality across Canadian health systems; (iii) differing views on industry's role., Conclusions: The use of real-world data in Canada to inform pricing and reimbursement decisions is far from routine but nascent and slowly increasing. Barriers, including interoperability concerns, may also apply to other federated health systems that need to focus on the networking of healthcare administrative data across provincial jurisdictional boundaries. There also appears to be a desire to see better use of pragmatic trials linked to these administrative data sets. Emerging initiatives are under way to use real world evidence more broadly, and include identification of common data elements and approaches to networking data.

Purpose of Review: In an era where healthcare costs are being heavily scrutinized, every expenditure is reviewed for medical necessity. Multiple national gastroenterology societies have issued statements regarding whether an anesthesiologist is necessary for routine colonoscopies in American Society of Anesthesiologist (ASA) 1 and 2 patients., Recent Findings: A large percentage of patients are undergoing screening colonoscopy without any sedation at all, which would not require an independent practitioner to administer medications. Advances in technique and technology are making colonoscopies less stimulating. Advantages to administering sedation, including propofol, have been seen even when not administered under the direction of an anesthesiologist and complications seem to be rare. The additional cost of having monitored anesthesia care appears to be a driving factor in whether a patient receives it or not., Summary: A large multiinstitutional randomized control trial would be necessary to rule out potential confounders and to determine whether there is a safety benefit or detriment to having anesthesiologist-directed care in the setting of routine colonoscopies in ASA 1 and 2 patients. Further discussion would be necessary regarding what the monetary value of that effect is if a small difference were to be detected.

The founding members of the Coalition for Psychotherapy Parity present Clinical Necessity Guidelines for Psychotherapy, Insurance Medical Necessity and Utilization Review Protocols, and Mental Health Parity. These guidelines support access to psychotherapy as prescribed by the clinician without arbitrary limitations on duration or frequency. The authors of the guidelines first review the evidence that psychotherapy is effective, cost-effective, and often provides a cost-offset in decreased overall medical expenses, morbidity, mortality, and disability. They highlight the disparity between clinicians' knowledge of generally accepted standards of care for mental health and substance use disorders and the much more limited "crisis stabilization" focus of many insurance companies. The clinical trials that health insurers cite as justification for authorizing only brief treatment for all patients involve highly selected, atypical populations that are not representative of the general population of patients in need of mental health care, who typically have complex conditions and chronic, recurring symptoms requiring ongoing availability of treatment. The standard for other medical conditions reimbursed by insurance is continuation of effective treatment until meaningful recovery, which is therefore the standard required by the Mental Health Parity and Addiction Equity Act for mental health care. However, insurance companies frequently evade the legal requirement to cover treatment of mental illness at parity with other medical conditions. They do this by applying inaccurate proprietary definitions of medical necessity and imposing utilization review procedures much more restrictively for mental health treatment than for other medical care to block access to ongoing care, thus containing insurance company costs in the short term without consideration of the adverse sequelae of undertreated illness (eg, increased costs of other medical services and increased morbidity, mortality, and costs to society in increased disability). The authors of the guidelines conclude that, given appropriate medical necessity guidelines at parity with other medical care, consistent with provider expertise and a broad range of psychotherapy research, there would be no need or place for utilization review protocols. Individuals and psychotherapy organizations are invited to visit the website psychotherapyparity.org to sign on to the guidelines to indicate agreement and support.

The assessment of "patient value" is fundamental to clinical trials, real world evidence studies, and outcomes-based reimbursement schemes. Measures of health-related quality-of-life (HRQoL) are widely used in health research. Such measures are effective in determining the presence or absence of symptoms and functional ability. However, HRQoL measures were not intended, nor designed, to determine the value to patients of alternative health states. Functions have no intrinsic value-they are a means to fulfil human needs. However, needs can be met in a variety of ways, for example by adopting different functions or by the provision of social services. It is possible to analyze all functions in terms of the needs they satisfy. A needs model has been applied in health research since the 1990s. It is concerned with the extent to which human needs are fulfilled in the presence of disease and its treatment. It is argued that this is the major concern of the patient. Needs-based measures are patient-centric and produce a valid unidimensional index of outcome. Consequently, they provide a direct means of measuring patient value. This approach provides the possibility of evaluating health services in terms of the value they provide to consumers and payers. It also has a role to play in real-world evidence studies and outcomes-based reimbursement. It is recommended that greater attention is given in future to the development of patient-reported outcome measures that provide direct assessments of patient value.

Background: Recent years have seen an influx of location-tracking, activity-monitoring sensors, and Web-cameras to remotely monitor the safety of older adults in their homes and to reduce reliance on in-person assistance. The state of research on these monitoring technologies leaves open crucial financial, social, and ethical cost-benefit questions, which have prevented widespread use. Medicaid is now the first large third-party payer in the United States to pay for these technologies, and their use is likely to increase as states transition to managed long-term services and supports (MLTSS)., Objectives: This is the first study to examine how state Medicaid programs are treating passive remote monitoring technologies. This study identifies (1) which states allow location tracking, sensor systems, and cameras; (2) what policies are in place to track their use; (3) what implementation processes and program monitoring mechanisms are in place; and (4) what related insights Medicaid program stakeholders would like to learn from researchers., Methods: Interviews were conducted with 43 state, federal, and managed care organization (MCO) Medicaid program stakeholders about how these technologies are used in state waivers serving community-dwelling older adults in 15 states, and what policies are in place to regulate them. The interviews were analyzed by the research team using the framework analysis method for applied policy research., Results: Two-thirds of the states cover location tracking and activity-monitoring sensors and one-third cover cameras, but only 3 states have specific service categories that allow them to track when they are paying for any of these technologies, impeding regulation and understanding of their use at the state and federal level. Consideration of ethical and social risks is limited, and states struggle to understand which circumstances warrant use. They are further challenged by extreme resource restrictions and transitions to MLTSS by MCOs inexperienced in serving this growing "high-need, high-cost" population., Conclusions: Decisions about Medicaid reimbursement of technologies that have the potential to dramatically alter the way older adults receive supportive services are being made without research on their use, social and ethical implications, or outcomes. At a minimum, new service categories are needed to enable oversight. Participants prioritized 3 research aims to inform practice: (1) determine cost-effectiveness; (2) identify what type of information beneficiaries want to be generated and whom they want it to be shared with; and (3) understand how to support ethical decision making for beneficiaries with cognitive impairment. These findings provide direction for future research and reveal that greater interaction between policy makers and researchers in this field is needed., (©Clara Berridge. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 21.02.2018.)

Residents of long-term care (LTC) facilities have a significantly higher risk of poor oral health status compared with those living independently; moreover, the provision of oral health services to LTC residents is often limited. This study identifies and classifies state-level policies and funding sources for dental services that are available to LTC residents. The research details variability in coverage levels, payment sources, workforce capacity, and care delivery configuration, finding little coherence between policy and the needs of patients or providers. Reforms to address the oral health care needs of vulnerable populations in LTC settings should start with defining a clearer standard of oral care required for this population. This will allow best practices in policy, practice, and accountability to be structured around care that improves patients' oral health.

States' role in payment as well as coverage will be subject to debate as the administration and the Congress decide how to address the Affordable Care Act (ACA) and otherwise reshape the nation's health policies. Acting as stewards of health care for the entire state population and stimulated by concern about rising costs and federal support under the ACA, the elected and administrative leaders of some states have been using their political influence and authority to improve their state's overall systems of care regardless of who pays the bill. In early 2015 we conducted on-site interviews with key stakeholders in five states to explore their strategies for payment and delivery reform. We found that despite these states' similar goals, differences in their statutory authority and purchasing power, along with their leaders' willingness to use them, significantly influence a state's ability to achieve reform objectives. We caution federal and state policy makers to recognize the reality that state leaders' political desire to exercise stewardship may not be enough to achieve it., (Copyright © 2017 by Duke University Press.)

Background: One in four Medicare patients hospitalized for acute medical illness is discharged to a skilled nursing facility (SNF); 23% of these patients are readmitted to the hospital within 30 days. The care transition from hospital to SNF is often marked by disruptions in care and poor communication among hospital and SNF providers. A study was conducted to identify the perspectives of sending and receiving providers regarding care transitions between the hospital and the SNF., Methods: Hospital (N = 25) and SNF (N = 16) providers participated in qualitative interviews assessing patient transfers and experiences with unplanned hospital readmissions. Data were analyzed by a multidisciplinary coding team using the constant comparison method., Results: Four main themes emerged: increasing patient complexity, identifying an optimal care setting, rising financial pressure, and barriers to effective communication. The data highlighted hospital and SNF providers' shared concerns about patient-level risk factors and escalating costs of care. The data also identified issues that separate hospital and SNF providers, including different access to resources and information., Conclusion: Hospital and SNF providers are challenged to meet the needs of complex patients. They are asked to establish comprehensive care plans for patients with significant medical and psychosocial issues while navigating tense relationships between health care institutions and rising financial pressures. The concerns of both hospital and SNF providers must be considered in order to develop practices that can improve the quality, cost, and safety of care transitions., (Copyright © 2017 The Joint Commission. Published by Elsevier Inc. All rights reserved.)

Successful sleep billing and reimbursement is dependent on correct reporting of proper diagnostic codes for sleep disorders and associated testing. Recent changes in disease classification systems have affected the coding for sleep disorders. Guidelines set forth by the American Academy of Sleep Medicine and followed by third-party payers provide direction for the required techniques and indications for sleep procedures.

Objectives: This study aims to describe how a negative reimbursement decision-based on the health technology assessment (HTA) report of a nondrug intervention-affects healthcare providers in Germany., Methods: Knee arthroscopy was chosen as an example, because as of April 2016 this procedure is no longer reimbursed for osteoarthritis, but is still covered for other indications, including meniscal lesions. The exclusion followed an HTA report prepared by the Institute for Quality and Efficiency in Health Care (IQWiG). Here, we examine how the decision to revoke reimbursement for arthroscopy was perceived by the surgical community. Information was collected from official hospital statistics, the internet, and informal interviews with orthopedic surgeons., Results: In 2015, a total of 37,920 arthroscopic procedures were performed for knee osteoarthritis in Germany. Several surgical societies were unhappy with the negative decision, which was issued as a directive in November 2015, and they challenged the decision-making process as well as the underlying scientific evidence. In March 2016, fifteen societies issued joint recommendations on how to differentiate osteoarthritis from other knee diseases and how to document other diseases in a way that inspections by representatives of health insurance funds would not detect any deficiencies. In informal interviews, orthopedic surgeons indicated that miscoding of the principal diagnosis (meniscal tear rather than knee osteoarthritis) is to be expected, especially in the hospital sector., Conclusions: HTA can have a significant impact on the provision of health services, but various loopholes allow physicians to undermine policy decisions. Therefore, it is important to involve all stakeholders in HTA and to convince them of the benefits of evidence-based medicine.

Objectives: The aim of this study was to examine the evidence payers cited in their coverage policies for multi-gene panels and sequencing tests (panels), and to compare these findings with the evidence payers cited in their coverage policies for other types of medical interventions., Methods: We used the University of California at San Francisco TRANSPERS Payer Coverage Registry to identify coverage policies for panels issued by five of the largest US private payers. We reviewed each policy and categorized the evidence cited within as: clinical studies, systematic reviews, technology assessments, cost-effectiveness analyses (CEAs), budget impact studies, and clinical guidelines. We compared the evidence cited in these coverage policies for panels with the evidence cited in policies for other intervention types (pharmaceuticals, medical devices, diagnostic tests and imaging, and surgical interventions) as reported in a previous study., Results: Fifty-five coverage policies for panels were included. On average, payers cited clinical guidelines in 84 percent of their coverage policies (range, 73-100 percent), clinical studies in 69 percent (50-87 percent), technology assessments 47 percent (33-86 percent), systematic reviews or meta-analyses 31 percent (7-71 percent), and CEAs 5 percent (0-7 percent). No payers cited budget impact studies in their policies. Payers less often cited clinical studies, systematic reviews, technology assessments, and CEAs in their coverage policies for panels than in their policies for other intervention types. Payers cited clinical guidelines in a comparable proportion of policies for panels and other technology types., Conclusions: Payers in our sample less often cited clinical studies and other evidence types in their coverage policies for panels than they did in their coverage policies for other types of medical interventions.

Purpose: The purpose of this study is to compare the rates of recurrent VTE among cancer patients treated with parenteral agents to the oral anticoagulants., Methods: This single-center study was a retrospective chart review of cancer patients with recurrent VTE between January 1, 2009 and December 31, 2014. The primary outcome of the study is the rate of recurrent VTE in patients who received a parenteral anticoagulant (enoxaparin, dalteparin, fondaparinux) versus those who received oral anticoagulants (warfarin and rivaroxaban). Other outcomes investigated include risk factors associated with recurrent VTE events and influence of third-party payer on anticoagulant selection., Results: Four hundred fifty-seven patients met inclusion criteria (178 in the oral anticoagulant group and 279 in the parenteral anticoagulant group). Patients with Medicare were more likely to have received an oral anticoagulant (P = 0.003) and patients with private insurance were more likely to have received a parenteral anticoagulant (P = 0.004). There were 23 recurrent VTE events, 12 events (6.7 %) in the oral anticoagulant group and 11 events (3.94 %) in the parenteral group (P = 0.182). The only significant risk factor noted to increase risk of recurrent VTE was the presence of an IVC filter (adjusted OR 4.38, 95 % CI 1.67-11.53, P = 0.003)., Conclusions: While there is no statistical difference in VTE events between groups, the oral anticoagulant group numerically had a higher rate. Important associations were found to have an influence on anticoagulant selection and risk of recurrent VTE. These factors must be incorporated into decision making when treating cancer patients with VTE.

Objectives: Tackling ethical dilemmas faced by reimbursement decision makers requires deeper understanding of values on which health technology assessment (HTA) agencies are founded and how trade-offs are made. This was explored in this study including the case of rare disease., Methods: Representatives from eight HTA explored values on which institutions are founded using a narrative approach and reflective multicriteria (developed from EVIDEM, criteria derived from ethical imperatives of health care). Trade-offs between criteria and the impact of incorporating defined priorities (including for rare diseases) were explored through a quantitative values elicitation exercise., Results: Participants reported a diversity of substantive and procedural values with a common emphasis on scientific excellence, stakeholder involvement, independence, and transparency. Examining the ethical imperatives behind EVIDEM criteria was found to be useful to further explore substantive values. Most criteria were deemed to reflect institutions' values, while 70 percent of the criteria were reported by at least half of participants to be considered formally by their institutions. The quantitative values elicitation highlighted the difficulty to balance imperatives of "alleviating or preventing patient suffering," "serving the whole population equitably," "upholding healthcare system sustainability," and "making decisions informed by evidence and context" but may help share the ethical reasoning behind decisions. Incorporating "Priorities" (including for rare diseases) helped reveal trade-offs from other criteria and their underlying ethical imperatives., Conclusions: Reflective multicriteria are useful to explore substantive values of HTAs, reflect how these values and their ethical underpinnings can be operationalized into criteria, and explore the ethical reasoning at the heart of the healthcare debate.

As the title implies, much appears amiss with hyperbaric medicine. Long recognized for its life-saving, CNS-sparing,infection-fighting and tissue-salving attributes, its current application has been rightly called into question by a broad cross-section of health care delivery system stakeholders [1, 2, 3, 4, 5]. This paper will examine what lies behind the stunning loss of availability for a majority of the Federal Drug Administration-approved uses, arguably those for which patients have the most to gain. It will address overutilization in the context of an erosion of practice standards and widespread manipulation of the reimbursement process. It will make suggestions aimed at restoring its broader availability across the full extent of FDA-approved uses. Finally, it offers guidance to ensure that HBO₂ therapy is employed only when medically necessary by adoption of the drug administration "rights" principle, namely the right indication for the right patient at the right time and only for the right amount of time., Competing Interests: The author of this paper declares no conflicts of interest exist with this submission., (Copyright© Undersea and Hyperbaric Medical Society.)

Objectives: The aim of this study was to investigate the analysis, discussion, and challenges of the price and reimbursement process of medicinal products in Bulgaria in the period 2000-15 and health technology assessment (HTA) role in these processes., Methods: The dynamics of the reform, with respect to the healthcare and pharmaceutical sectors, are tracked by documentary review of regulations, articles, and reports in the European Union (EU), as well as analytical and historical analysis., Results: Pricing and reimbursement processes have passed through a variety of committees between 2003 and 2012. Separate units for pricing and reimbursement of medicinal products were established in Bulgaria for the first time, in 2013, when an independent body, the National Council at Prices and Reimbursement of Medicinal Products, was set up to approve medicinal products with new international nonproprietary names (INN) for reimbursement in Bulgaria. Over the course of 2 years (2013-14), thirty-three new INNs were approved for reimbursement. In December 2015, a new HTA body was introduced, and assigned to the National Centre for Public Health and Analyses., Conclusions: Although Bulgaria has current legislation on pricing and reimbursement which is in accordance with the EU rules, there is no mechanism for reporting and monitoring these processes or the financial resources annually, so as to provide an overall objective assessment and analysis by year. Therefore, this financial assessment should become a national policy objective for the future.